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We See You,
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We Are Here With You

Each day at argenx, we are motivated to pursue

a better tomorrow alongside patients.

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Patient
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236 Kim V. - MG

eR ad her ts ory on page 214

6 | Patient Stories Patient Stories | 7

Table of Contents æX  Oo]P}v}(SRR}ovMu}(RMvP]vP}B }]o}
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5 General description of the Company and it’s Share Capital

æX LPoIv(}u}v}vR}uv˙ C 9 Information incorporated by reference
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8 | Table of Contents Table of Contents | 9

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To Our
Shareholders
Contents
Message from the CEO and the chairman of our Board of Directors 15

2021 in brief 16

Outlook 2022 22
 To Our
Shareholders
Message from the CEO and the chairman
of our Board of Directors
Tim Van Hauwermeiren
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14 | Message from the CEO and the chairman of our Board of Directors
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Tim Van Hauwermeiren & Peter Verhaeghe
Message from the CEO and the chairman of our Board of Directors | 15
 Global Efgartigimod Launch

2021
In Brief
Efgartigimod
{  Ov D u U U R FDA } VYVGART¡ ~(PP]u} o(r( Z
(} R uv }( PMG ]v o v `R} v r˙oR}o]v }
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Operational Highlights
2021 was another pivotal year for argenx even through the con-
tinued challenges of the COVID-19 pandemic. We transitioned to
a fully integrated immunology company following the approval
of our first product, VYVGART™ for the treatment of gMG. In ad-
dition, we advanced our late-stage efgartigimod trials across four
indications, announced two new efgartigimod indications and
started patient trials with our second candidate, ARGX-117.

16 | 2021 In Brief - Operational Highlights Global Efgartigimod Launch | 17

Pipeline of Differentiated Corporate Achievements
Antibody Candidates

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18 | Pipeline of Differentiated Antibody Candidates Corporate Achievements | 19

Collaborations Financial Highlights

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v `R]R ` ] }o }( ¤ æ u]oo]}v ]v }oo}}v ˙uv
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20 | Collaborations Financial Highlights | 21

 Global Efgartigimod Launch

2022
Outlook
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Efgartigimod } vv}v ]v R `}o ˘v Po}o v RX
ARGX-113

With the approval of VYVGART™ as the first-and-only

approved neonatal Fc receptor (FcRn) blocker in the U.S and
Japan, we enter 2022 in a strong position to execute on our ARGX-117
plans for a global launch and advance our pipeline of assets,
including further efgartigimod development, across our
four commercial franchises in neuromuscular, hematology,
dermatology and nephrology.

22 | 2022 Outlook Global Efgartigimod Launch | 23

Pipeline of Differentiated
Antibody Candidates

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}v Ro( }( v COVIDr ıru] }o }R} R˙]
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ARGX-117
{  PR ]o }( ARGXr (} o˙ PL (v}v v l} oo}PL (]o L

ARGX-119

24 | Pipeline of Differentiated Antibody Candidates Pipeline of Differentiated Antibody Candidates | 25

1
Presentation

PART I
of the Group
Contents
1.1 Company Profile 30

1.2 Strategy and objectives 34

1.3 Our Products and Product Candidates 38

1.4 Collaboration Agreements 56

1.5 License Agreements 60

1.6 Distribution Agreements 66

1.7 Manufacturing and Supply 66

1.8 Intellectual Property 66

1.9 Regulation 72
 Our
Our values guide our business relationships and
collaborations both within and beyond our walls.

PART I
Values
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Humillity
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Excellence
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Empowerment
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} v. R } uX

Innovation
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28 | Our Values Our Values | 29

1 Presentation • Pv˘ C v Iv XU ]v}} v R o` }( C v U R]vP ] P] }8 ]v T}}v}U C v v ]
ı T}o}v C v U VPRvU Ov]}U C v U L H X X

of the group TR (}oo}`]vP R }] `]R v }]` }( R G} }( D u U v }v R }( R] Uv]o

RP]}v D}uv X PvP ( } }R R R }( ]o v }vP ]PR X

PART I
1.1 Company Profile
1.1.1 General

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](}Ruv}(}]uuv]X˙B }u]v]vP}]}(v}˙vP]v]vPRv}o}P]`]RR
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}vv}uoURu}o}P˙Uu}o}P˙vvR}o}P˙]v]}vR}PR}P}`]vP}uu]o(vR]XTR}PR
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}voovR}}}]uuv}o}P˙]o]vXOvDuUURFD}A (PP]u}U`R]R`]oo ~Z Pv˘ C v Iv X ` ]v}} }v F ˙ U X
ulVYVGART¡~(PP]u}o(r(ZU(}Ruv}(PMG]vov`R}CRR
A v}˙}]X
OvJv˙UURJvPMD}A VYVGART¡~(PP]u}o(Z(}Ruv}(ov`]RPMG
`R}}v}R8]v}v}}]}v}vr}]oISTXW]RRPo}˙u]o}vUVYVGART¡]R.r
vr}vo˙}v}voFRvo}l]vRUXSvJvX 1.1.2 History

Pv˘ ] D R E }v o] }uv˙ ~S}] E } Z `]R ] }˙ ]v R}'uU R NRov X W ` (}v }v A ]o æ U GE N rX B XVX }u v˙ `]R o]u] o] ]o]˙ ~ besloten vennootschap) incor-
Pv˘ ] P] `]R R P] }( R D R CRu }( C}uu v vu æ X Pv˘ [ } v R o` }( R N R ov U R ]vP ] P] ]v B U R N R ov X Ov M˙ U U R
P] }8 ] W]oou æU AHU B U R NRov X Pv˘ ` ]v}} }v A ]o æU ]v }u v˙ ` }v ]v} o] o]u] }u v˙ ~ naamloze vennootschap Z `]R R oPo vu GE N rX N XVU ]v
R NRov v v D R o`X I }uu]o vu ] SPv˘ _ v U ]v A ]o U U ] }} vu ] ]}v }( } ]v]]o o] }((]vP X S]v R (o ]v]]o o] }((]vP }v Jo˙ U U } R o] -
SPv˘ SE_X Pv˘ R }v r P}vv }v]vP }( v ˘ ]} v v}vr˘ ]} X }v R Po u l }( E }v˘ B o X Ov A ]o U U ` RvP } oPo vu } Pv˘ N XVX } o]Pv
`]R } o}P} v vu X Ov A ]o U U R }u v˙ ` }v ]v} D R E } v o] }u v˙
TR }]v˙ R ]v Pv˘ o] }v R Po ul }( E }v˘ B o ]v B oP]u v ISIN (Societas Europaea } SE Z `]R R oPo vu Pv˘ SE U (}oo}` ˙ R (o ]v]]o o] }((]vP }( } A D S
NL v R ˙u}o SARGX_X Pv˘ [ADS U R vvP }v }]v˙ R ]v Pv˘ ~} ]PR }v N ]v N` Y}l X
} ] R R ZU o] }v R N Go}o So Ml ~N Z v R ˙u}o SARGX_X
Ov A P U ıU } . ]]˙ Pv˘ BV ` ]v}} ]v B oP]u v }v A P æU U } ]]˙
Pv˘ ] R } v˙ }( R G} v R }o RR}o }( Pv˘ IIP BV ` ]v}} o} ]v B oP]uX

{  Pv˘ IIP BVU ] }uv˙ `]R o]u] o]]o]˙ ~ besloten vennootschapZ ]v}} v R o` }( Ov D u U U } . } VYVGART¡ (} R uv }( PMG ]v R UXSX ` } ˙ R FDAU
B oP]uU R]vP ] P] ]v Z`]iv U B oP]u v ] Iv ]lrZ`]iv U ı æ u}]vP (}` (}u o]v]orP } }uu]orP ]}Rv}o}P˙ }uv˙X Ov Jv˙ U U VYVGART¡
Z`]iv U B oP]u v (} R uv }( PMG ` } ]v JvX
{  Pv˘ BVU ] }uv˙ `]R o]u] o]]o]˙ ~ besloten vennootschapZ ]v}} v R o` }( B oP]uU
R]vP ] P] ]v Z`]iv U B oP]u v ] Iv ] lrZ`]iv U ı æ Z`]iv U
B oP]uX Pv˘ BV ] R }o RR}o }( 1.1.3 Overview
• Pv˘ US Iv U ]v}} v R o` }( D o` U UXSXU R]vP ] P] }8 ]v W]ou]vP}vU D o`
v ] A R S U B}}vU M R' V Our Pipeline
•  Pv˘ Jv KXKXU ]v}} v R o` }( JvU R]vP ] P] }8 ]v T}l˙}U Jv v ] • Efgartigimod (FcRn blocker)P(PP]u}E ] Ruv IPG F (Puv R ] ]Pv } P R FRv v
HULIC JP All B ]o]vP rær U AllU M]v}rlU T}l˙}U r æ U JvV ]uuv}Po}o]v G ~ IgGZX FRv ] (}v}vo } R ]uuv ˙u v (v}v } ˙o IPGU ˘v]vP ] u
• Pv˘S`]ovSAU]v}}vRo`}(S`]ovUR]vP]P]}8]vGvUS`]ovU Ro(ro]( } }R ]uuv}Po}o]v R v} ˙o ˙ FRvX IPG R ]v } FRv (}u o˙}}uoX
v ] R} CR!v U Gv U S`]ov V B˙ ]v]vP } FRvU (PP]u} v IPG ˙o]vP v ]v IPG P}vX I R R }vo }
• Pv˘ Fv SASU ]v}} v R o` }( Fv U R]vP ] P] }8 ]v P] U Fv U v ] - uo }( }]uuv ] `R R}Pv] IPG o] } u]} }( ] X
C u]oo D u}o]v U ı I˙ L M}o]v˘U Fv V • PMG P Iv M˙ U ` vv}v }]] }o]v o (}u R PR A D PT ]o }( ]v v} ~ IV),
• Pv˘ Guv˙ GuHU ]v}} v R o` }( Guv˙U R]vP ] P] }8 ]v Mv]RU Guv˙U (PP]u} (} R uv }( PMGX TR }o]v o (}u R ADPT ]o R}` R (PP]u} `
v ] K}v rZ rPo U ı Mv]RV v `oor}o U u}v o]v]oo˙ uv]vP(o ]u}uv ]v vPR v o]˙ }( o]( u U v

30 | Company Profile Company Profile | 31

 }] R }}v }( v ]v]]o] }]vP Ro (} PMG v X TR (oo PR ADPT o `
o]R ]v TR Lv N}o}P˙ ]v Jo˙ X TR (}u R ADPT ]o v R v }vroo ˘v]}v
~ADAPTA=Z (}u R ] (} R Po}˙ }o }( VYVGART¡ ]v R UXSX ~D u U Z v Jv
~Jv˙ U ZX
• RP]}vo ]o }vP}]vP ]v (} ]}vo }]uuv ]v]}v `]R v ]}vo P]}vo ]o }
]v R }v }( P
AL ITPP TR ADVANCE ]o }( IV (PP]u} ` ]v] ]v R (}R }( ı v }o]v ˘
]v R }v }( X TR ADVANCErSC ]o }( SC (PP]u} ]v R (}R v
}o]v ˘ ]v R . }( X
AL PV v PFP TR AD RESS ]o }( SC (PP]u} ` ]v] ]v X T]u]vP }( }o]v ] vo˙ v
]` P]v R P}}o]o v ]v Ul]v X
AL CIDPP TR ADHERE ]o }( SC (PP]u} ` ]v] R v }( ı v }o]v ˘ ]v R
. }( X
AL P B PTRLLA AB ]o
D }(SC(PP]u}`]v]Rv}(vv]v]uvo˙]]ovv}(vX
AL u˙}] P TR ALKIVIA ]o }( SC (PP]u} `]oo ]v] ]v R }v }( X
•  Co]v]o ]o } ]v ]v (} ]}vo }]uuv ]v]}v R}PR vR] Puv `]R Z ]
L v IQVIAP
AL Z ] L } ovR }}(r}(r}v ]o ]v `} l]v˙ ]v]}v U LN v MNX
AL IQVIA } ovR }}(r}(r}v ]o ]v ]u˙ SiS ]v }v Ro( }( v COVIDr ıru] POTS ]v
u] r X
• ARGX-117 (C2 inhibitor)P ARGXr ] v}o }uouv ]vR]]} PvP }uouv }u}vv ~
]vP (v}v }( }R R o]o v ov R`˙ `R]o o]vP R ov R`˙ ]v X ARGXr R R
}vo } ]o]v r]vr r} v] `]R ]v]}v R . `]R]v } (} }uu]o (vR] X
• PR }( ARGXr ` } ]v Jo˙ R}`]vP (}o (˙ }.o } ]vPo v uoo
v]vP } }( }R IV v SC (}uo}v X PRu}l]v ~ PKZ v Ru}˙vu] ~ PDZ }.o u}v
}vo (} ]v( v }]vP Ro X
• F] PR }}(r}(r}v ]o v }( ]v MMN `]R }v PR }}(r}(r}v ]o }
]v ]v o˙ PL (v}v v l} oo}PL (]o L l]v˙ vov}vX
• ARGX-119 (MusK agonist)P ARGXr ı ] v P}v] SIMPLE Av}˙¡ } R uo r]. l]v ~
`]R }vo ]v uoo v}u o ]v]}v X PR } ro}v ]o } L Co]v]o T]o A o]
}v .o]vP ]v (}R }( X
• ARGX-118 (Galectin-10)P ARGXr ] v v}˙ P]v Govr U R }]v }( CR}rL˙v ˙o `R]R
]uo] ui} }v]} } ]`˙ ]vGuu}v v } R ]v }( u oP X
• Cusatuzumab (Anti-CD70 Antibody)P C u ] v v rCD u}v}o}vo v}˙X CD U u} v}] (}
} o]Pv U v ] } CD ˘ }v olu] u oo v u˙o}] olu] ~
v} }v Ru}}] u oo X
• Iv Jv U ` P]v Po}o ]PR } u (}u C]oP (}oo}`]vP R u]v}v }( }oo}}v v
o]v]vP Puv } o} u ]v AML v u˙o}˙o ˙v}u ~ MDS)
• W }vv } o }vo ov } v u R}PR vR]
• Iv ]}v } } `R}oo˙r}`v ]o]v U ` R v] R uP (}u R IIP R R v }ro]v
} v (} (R o}uv v (} `R]R ` R u]o}v U }˙o˙ } }.rR Puv X TR
v] ]vo P
• ARGXr ı ~GB ZU SIMPLE Av}˙¡ ]vR]]} }( ILr v }ro]v } Gv} B]}PRu
• ARGXr ~LPr æZU SIMPLE Av}˙¡ ]vR]]} }( ILr R v }ro]v } LEO PRu
• ARGXr ~AGMBr ZU SIMPLE Av}˙¡ P}v] } R MET } v }ro]v } AP}uA TR
• ARGXr æ ~ABVr æ ZU SIMPLE Av}˙¡ ]vR]]} }( GARPrTGFr v }ro]v } A V]
• ARGXr ~STTræ æ ZU SIMPLE Av}˙¡ ]vR]]} }( A }C v }ro]v } Sv B]}Rv}o}P˙
Immunology Innovation Program
O IIP ] } ]v P˙ }( }r}v v ]vv}}vX TR IIP o} } ]}˙ vP]v } ]v(˙
v}o P v }PRU ]v }oo}}v `]R } ]v. v u] v U } ]o }vo v` ]o]v
v] X E ˙ v ]o]v v] (}u }R } `R}oo˙r}`v v v ]o]v uP (}u v IIP
}oo}}vX A }( } o}vPru P˙U ` R }uu]' } }vv ]vuv ]v R IIPX A R }(
32 | Company Profile
- R] Uv]o RP]}v D}uv U ` R ˘ }v } }uu]uv v ]u } }vv } ]vP (}R o
}v v` ˙ (}u R IIPX
E˘uo }( l˙ }oo}}v `]R ]v. v u] v P
{  (PP]u}
E uP (}u }oo}}v `]R P}(} Soo˙ W v UT S}R`v R o u }v
PART I
- }( R o ]v (} } IIPX P}(} W [ R ]v. R ]o }o R FRv o˙ ]v u]v]v]vP v
]]vP IPG R}PR} R }˙U ]v X(PP]u}
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GTM u}v U `R]R ` ]vro]v (}u UT S}R`vX TR }]˙ u}v u}]. (PP]u} }
]v ] 8v]˙ (} FRv `R]o ]v]vP R Hrvv ]v]vP R ] R ] }( FRv ]v}v `]R ]
vo o]Pv U v}Pv} IPGX
{  ARGXr ` ]o ]v }oo}}v `]R B}]} PRu `R]R ` ovR ]v `]R } (}u P}(} E ]l
Hl v R Uv]]˙ }( UR U } }v R } u}v o]v]o }}(r}(r}v }( R uR -
v]u }( ARGXr X P}(} Hl R }v v}`v R ]v R }o }( ]vGuu}v ]v ] U ].oo˙ ]v
R }uouv ˙uU v R }v] R v ˘ } R }o }( `} }uouv ]vR]]} X
H] vv]vP }( R u]o Rv}˙ }] `]R vo C .]v˙ v C [v] }]}v]vP R
iv}v }( R o]o v ov R`˙ o } } ]v ]v vP]v]vP ARGXr U `R]R ] ] `]R }
}]˙ NHANCE¡ u}v v LALA u}v X
Our Suite of Technologies
TR}PR } IIPU ` }oo} `]R ]v. v u] v } ]v(˙ ]uuv}o}P˙ lR}PR v ]o
C2ZU o}l - }vo ]o]v v] X TR] ] }v R}PR }r}v `R ` ]vP } R }oo}}v } v] ] }(
v}˙ vP]v]vP Rv}o}P] v ˘]v ]v o]v]o o}uv v } v ]vP `oR }( ] v
P ]}o}P˙ ˘ X
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o (}u U }v R }` (o oou ]uuv
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(}u R ]uuv ˙ u }( } oou U R }( `R]R R ](( v Pv ] lP}v X TR oou }
R]PRo˙ ] vo }( v]}] `]R R]PR Ruv R}u}o}P˙U } ]u]o ]˙U ]v R] Vr P]}v `Rv ]uuv]
MuSKZ } `]R P }( Ruv ] X O SIMPLE A v]}˙ TM
o (}u oo}` } v ˘o} } P v] -
- `R]o } v]oo˙ u]v]u]]vP R o}vP ]uo]v }] `]R Pv ]vP v]}˙ v] ]vP
]]}vo u R} X
• NHance®, ABDEGTM, POTELLIGENT®U v DHS u}v (} }v vP]v]vP R F P]}v }( v}] ]v } }
Puv R] ]v]v] R } X Iv ]}vU ` }]v v}vr˘o] R o]v v }}v
(}u CRP] (} R SMART-Ig® v ACT-Ig® Rv}o}P] X TR Rv}o}P] ]Pv } vo } ˘v
AMLZ o R R ]v˘ }( } } v] U `R]R ] R } `v }˘] v R } U ˙ }voo˙
u}](˙]vP R] Ro(ro](U v}vU }( ] P ov v }v˙X
{  Ho}˙u [ ENHANZE® SC P o]˙ Rv}o}P˙P ` R ˘o] } ENHANZE (} R FRv v C P
v (} ]}vo P X TR Po}o }oo}}v v o]v Puv `]R Ho}˙u ` vv}v ]v F ˙
ı v ˘v ]v O} X TR ENHANZE Rv}o}P˙ R R }vo } R}v P u]v]}v u U
RoR }v u U v }+ ]}vo G˘]]o]˙ v }vv]v (} v X
1.1.4 Recent Developments
Ov F ˙ U U R] vv}v R ] }} } }Pv] R }roo D}vl P}o [Ro] v
LPvl P}o [Ro] ]vvv o] v }v F ˙ U U R] (R vv}v R }uuv -
uv }( `R ] ] S]o u]o]˙ }}v_ ]v Ul]v X S]v R vv}vuv U R]v (} R v -
Ul]v v U R }( R] Uv]o RP]}v D}uv U R ] v }vP}]vP u]o]˙ }vG] ]v Ul]v X
Iv }vv}v `]R R v U v` v}v R v ]u} ˙ R UXSX v E }v Uv]}vU `oo uv˙
}R }v] }v R `}o U }v ]v R]v }uv] v R]v ]v]]o U `]R R v v ˘v }(
R v}v }o]vP }v v }vP}]vP ] X
TR] }vP}]vP }vG] `v R] v R Ul]v R ] U o]u] ]u }v } }}v U P]v R `
Strategy and objectives | 33
}v vP o]v]o ]o ]v oP vu }( i]]}v U ]vo]vP R] v Ul]v X D } R }vG] U ` ` o] R }u]]vP o]˙ ]v ] } v }o}v (oo }] } }uu]o (vR] }
]v }u vo } R] uo (}u R ] } } R] ˙ vo o}}˙ (} vo˙] U ] ' ˙ R } }( oP ]}Ru o }uv] X Iv ]}v } }oo}vP }v } }
v u˙ v} o}vP o } ] ]v } o]v]o ]o U v ]8o `]R ]vP v ]v R] v v } v] U ` u˙ o} o } v ]v} }oo}}v (} } v Rv}o}P˙ o}u }
Ul]v u]PR R v ]v] o]u] ]u }v } ]v ` l ov ]uv }}v X S˙ ]o] (}u `R]R ` v o} ]+v }vo ]o]v X
}oo R]v } Ul]v]v ] u˙ v} . (} u]]}v } ]v}uov } o o]u] - • Implement our “argenx 2025” vision. WR} } ul (PP]u} Po}oo˙ ]oo } v } } ˘v -
}v }v ]]o]˙ }( R X A R] u ` } v} ˘ u]o vP ]u }v } }}v o }( ]vP }uu]o (vR] X W ] } ul (PP]u} ]R }uu]oo˙ ]oo } ]v o]v]o o}uv

PART I
R ]] U ` } ˘ u]vP }( }o]v (} R AD RESS ]o }( SC (PP]u} (} PF v PV u˙ o˙ U ]v .Lv ]v]}v X W ov } ul }P } } } ]uuv}o}P˙ ]o]v `]R ARGXr ]v
oR}PR ` vo˙ vv} ]( R] ] R v R}` ]Pv].v R o˙ }o X W }vv } R uoo o rP ]o v u}v }}(r}(r}v `]R ARGXr ıX F]voo˙U ` `]oo ]v ]v R }vv ˘ -
o}uv }v ]o˙ ] X v]}v }( } ]+v ]o]v R}PR R IIP v ]u } }vv } Pv }v v` ]v} R ]o]v
R ˙X
W } v} Pv v ]v R] } R Ul]v v ` } v} ˘ R }vG] lv}`v } R }( • Continue to build innovation into every step of our development, highlighted by our collaborative IIP translating
R] Uv]o RP]}v D}uv } R u]o ]u }v } ( o X O o˙ R]v R v ]o˙ immunology breakthroughs into medicines. TR IIP ] } } ]v P˙ }vvvP R ]o] ]v]PR
+ ]v }u U `R ` vo } R] ˙ P } o]v]o ] U ` v} o˙]vP (}u R] ]v} ] v P ]}o}P˙ }( } ˘vo ]v. v u] }oo}} `]R } vooo ˘]v
} R Ul]v }vo˙ } R }v] (} }vP}]vP o}uv ] U ` ˘ R ]u `]oo o]u] } v}˙ vP]v X C}r}v R o } ]o]v }( R]PRo˙ ]+v } v] X TR}PR R
}vP}]vP o]v]o ] ]v R }v] X Iv ]}vU ` ˘ v }oo ]v ]v ] ˙ R }vG] v IIPU ` R} } }PR vv lR}PR R v o]}v } } ou v v](˙]vP u]]}v }(
Po}o ]vG}vX vP v` }vo uv }}v (} v X

O }v}u] (}uv ] U R }( R] Uv]o RP]}v D}uv U v} ]o˙ ]u ˙ R }vG] X

W vo˙ ˘ R ]}vo } (} v˙ o˙ v R }v]vP }( ]}vo ]o ] } oo˙ o]u] 1.2.2 Trends
v v} u]o } } }oo .vv]o (}uv X
OR Rv ]o} ]v R SPv}v }( R G} _U SR]l F} _ v SS]v]o]˙ Pv˘ _ ]v R]
Uv]o RP]}v D}uv U ` v} ` }( v˙ v U v ]v U uv U }uu]uv } v (}
R v .vv]o ]} R }vo˙ o]lo˙ } R u]o + }v } v v U ]v}u U }.]o]˙U

1.2 Strategy and objectives

o]]]˙U ]o } } } U } R R ]o} .vv]o ]v(}u}v } v} v ]o˙ ]v]
}( ( }vP o } .vv]o }v]}v X

F}oo}`]vP R }o }( VYVGART¡ (} R uv }( PMG ]v R UXSX ˙ R FDA }v D u U U ` v] -

1.2.1 Company’s Strategies }v (}u o]v]orP } }uu]orP ]}Rv}o}P˙ }uv˙ v `}l]vP }v R }vP}]vP ovR }( R
}uu]o]}v }( VYVGART¡X
O P}o ] } o] R] R ]R .r]vro } r]vro } v +]vP (}u v}u oU
Ru}o}P˙U u}o}P˙ v vR}o}P˙ ]v]}v (} `R]R ]Pv].v vu u]o v ˘] X W(} }v TR R v v} ]Pv].v RvP ]v R .vv]o (}uv } R .vv]o }]}v }( R G} ]v R ov
']v]vP R] P}o ]v uvv R ] ]]o]v (} }uv˙ }( } ] X W ov }P R }( D u U } R }( R] Uv]o RP]}v D}uv X
• Execute our global launch. W]R R }o }( VYVGART¡ R .rv r}vo˙ } v}vo FRv o}l ]v
R UXS v JvU ` R o˙ lv R . ]v ˘vP } ov (} Po}o ovR (} VYVGART (} F} u} ]v(}u}vU o ( } R SR]l F} _U R SPv}v }( R G} _ v } v} ı
R uv }( PMGX W˘ EMA ]]}v }v }o ]v R }v Ro( }( v ]u (} (R } - SC}uu]uv _ }( } }v}o] .vv]o uv ]v R SC}v}o] F]vv]o Suv W ] }(
o ]v }R i]]}v ]v R } }( R ˙X WR o˙ ]o } }uu]o ]v( } } v (} R ˙ v D u U U v ı_X
R ovR }( VYVGART¡ ]v R UXSX v ]v Jv `oo ]o } ]}vo }uu]o]}v ]v( }
} ]o˙ P}`]vP vu }( ]v]}v ]v } l˙ ]}] U R UXSXU E } v JvX
• Expand applications for our lead product efgartigimod. O P}o ] } u˘]u] R }uu]o }vo }( } 1.2.3 Competitive position
˘]vP } v } v] ˙ ˘o}]vP ]}vo ]v]}v U `oo (}uo}v R u˙ ˘v
R P v }o}v `]R]v ˘]vP ]v]}v X W (R o}]vP } o } U (PP]u} U W ] ]v R]PRo˙ ]vv} ]v ˙ R ] ˙ ]o˙ P}`]vP vv]vP }( ] ]}o}P˙U ]lo˙
} ul Po}˙ }o (} R uv }( PMGU ITPU PVU CIDPU BPU u˙}] U COVIDr ı u] POTSU SiSU MN RvP]vP Rv}o}P] U }vP ]voo o } ˙ ] } v˙U v uo }( }uv] ]v}o ]v R
v LNX B˙ R v }( U ` ]u } ˙ (} (} ]}vo }uu]o ovR }( PMG ~`]R SC (PP]u} ZU }vU o}uv v }uu]o]}v }( v}o R X TR }uv] R]PRo˙ }R] v }Lv
ITPU PV v CIDPX W˘v R }( } } v } v] ]v ˘]vP ]v]}v ˙ o}]vP v` P]oo˙ }oo} `]R R }RX
(}uo}v U R v} ]}v }( (PP]u} U R u˙ R u} v P} ˙ ]vP ]+ -
v v (v v }]]vP ]}vo }}vo]˙ `]R P } }]vPX W }u `]R `] vP }( Ru o }uv] U ]}Rv}o}P˙ }uv] U u] ]v }v v
• Advance our pipeline of assets. Iv ]}v } v` ]v]}v (} (PP]u} U ` ov } v } }R } }R R }Pv]}v (} v}o R v}˙ P U v` Rv}o}P] (} }u]]vP v}] U ov U
v] X Iv oU ` ov } v R o]v]o o}uv }( ARGXr ]v uoo PR }}( }( }v - .vv]o } U ]voo o } ˙ ]PR v }oo}}v }}v] X Mv˙ }( } }u} v }v -
]o ]v MMN v o˙ PL (v}v ]v R }v˘ }( l]v˙ vov V } v ARGXr ı v o˙rP o }u} R voo˙ P ]v. U R v } o}uv ]o] `oo P
]o]v v] ]v } }uu]o (vR] U R v}u oU Ru}o}P˙U u}o}P˙ v vR}o}P˙ (v - .vv]oU uv( ]vP U ulvP v o v Ruv } Rv ` }X Iv ]}vU R ] ]vv }u}v
R] V v } ˘v } ]o]v }( ( } v] R}PR R IIPX (} o]R]vP o]v]o ]o ] v P]]vP v (} o]v]o ]o X Mv˙ ]o] ]}Rv}o}P˙ .u R
• Leverage our suite of technologies to seek strategic collaborations and maximize the value of our pipeline. O ] (}u }oo}}v `]R oP U o]R }uv] } } R RU o}uv v }uu]o]}v
}( Rv}o}P] v } ]}˙ ]o] R ˙]o o }vo } v] (} `R]R ` }( } R u˙ }u `]R } X A }]vPo˙U } }u} u˙ u} (o Rv ` u˙ ]v
l } o U `R]o u]v]v]vP } (} v ]]o]v X W ov } }oo} }v } v] R o}]vP U }uu]o]]vP v R]]vP `] ul v X

34 | Strategy and objectives Strategy and objectives | 35

C}u}v ]v R }]uuv .o ] ]vv v ]v}o uoo u}v}o}vo v}] U }R ]}o}P] v uoo
u}oo ]R o˙ ul } ]v o}uv ˙ uv˙ ]+v }uv] ]vo]vP oP Ru o }u -
CIDP
v] R A V] Iv X ~Hu] lRu}] R] ZV AuPv Iv X ~EvolRu}] R] ZV B]}PvU Iv X ~T˙]l Patient
uoo o}] ZV Go˘}Su]RKo]v o ~ GSKZ ~B vo˙ lo ZV FX H}+uvrL R}R AG ~ RocheZ ~R]˘vl}Lv }+ o -
oZV v Jvv ~Ru] lRu}] R] v So l}]] ZX Iv ]}vU R v }R Ru o }u -
v] R u}v}o}vo v}] } }R ]}o}P] ]v o]v]o o}uv (} R uv }( }]uuv ] X

Iv ]}v } R v v }( U ` ` R A Zv PLC ] oo]vP S}o]] (} R uv }( o

v `]R PMG `R} ACRR v}˙ }] v R GSKU R}R U N} AGU CSL B R]vP U G](}o U SXAXU B]}M]v
PRu o Iv XU C U UCB SXAXlRA PRu U DAS TR U Tl U RuGvU Iuuv}v U C ]v TR -
U H}]}v TR U A Zv PLCU CRP] PRu lGvvRU RPv}vlAov˙ou v J}Rv}v J}Rv}v
Ivv}}v Iv XU u}vP }R U o}]vP P R u˙ R o]˙ (} R uv }( MGX C}u}v (} }R
~}voZ ( ]v]}v ] o} . U `]R ]Pv].v o}uv ] ]v ou} oo }( R ]v]}v `R
` vo˙ o}]vP } ovv]vP } o} } } } } v] X

1.2.4 Our Competitive Strengths

W o] R R }u]v}v }( } Rv}o}P] U ˘ v (} `]oo vo } }}u uv˙ }( R Ro -

ovP }] `]R v}˙ P o}uv v }]}v } o ]v o]]vP R] } v
+]vP (}u }]uuv U v}u oU Ru}o}P˙U u}o}P˙ v vR}o}P˙ ] (} `R]R R
v uv ]Pu ] ]v X

P} ]}˙ ]o] R}PR} IIP(o ]o]v}(o]v]ov o]v]o} v] XW

v]vP ]o]v}(}Ro]v]orv o]v]orP} v] (} R uv}( }]uuv
] XLP]vP} Rv}o}P˙ ] v o]v]o˘ U`R v o v] v o] R]oo
}(}]˙+} R}(}}v`]RP}]vvvo˙ v]vP} v]vP} ]o]v X

Iv N}u U ` vv}v R Puv } ] v FDA P]}]˙ R]` V}R ~ PRVZ (}u B˙ HoR -
PRu o U Iv X (} ¤ı u]oo]}vX A PRV vo R R}o } FDA ]}]˙ ]` }( ]vPo v` P o] -

Kelly
}v } ]}o}P] o]v o]}v ~ BLAZU `R]R R P ]` u v u˙ }voo˙ o } v ˘]
}oX W˘ } u R PRV (} ( ulvP o]}v (} (PP]u} (} v}R ]v]}vX

“All I have ever wanted is to

help provide a voice for those who do not
have one and to offer support to patients
like me. I am so fortunate to have found
myself at the GBS|CIDP Foundation in
a role that does just that.’’

36 | Strategy and objectives  CIDP

Regulation
Patient | | 37
37
 1.3 Our Products and Product Candidates
TR PR AD PT ]o ` v}u] U }o ro]v U o }r}v}oo U uo rvU Po}o ]o o vP R
(˙ v 8 ˙ }( (P P]u} ]v v `]R PMGX A }o }( o v `]R PMG ]v N}R Au] U
E } v J v v}oo ]v R ]o v ` X Pv ` o]P]o } v}oo ]v AD PT Po }( v}˙
U ]vo]vP v `]R ACRR v}] ~ACRRrA A=Z v v `R ACRR v}] ` v} X
TR(}oo}`]vPouu]l˙]v(}u}v}v}}}o]}}(o}v}v]}(R}( Pv ` v}u] ]v P } } ] (P P]u} } o } (} }o }( `l X AD PT ` ]Pv
R]URDX } vo v ]v]] o] uv }R `]R v ]v]o uv ˙o (}oo}` ˙ ]o vu }( -

PART I
v uv ˙o X

Autoimmune Pipeline Autoimmune Pipeline TR ADPT ]o u ] ]u˙ v}]v U u}vvP R ]Pv].vo˙ u} v rACRR v}˙ }] PMG -
Program Program Indication IndicationPreclinical Phase 1 Preclinical
Proof of Concept
Phase 1 Registrational
Proof of Concept
Commercial
Registrational Update
Commercial Update v ` }v }v R MGrADL o (}oo}`]vP uv `]R VYVGART¡ }u `]R o} ~ A9 X A9V
VYVGART VYVGART gMG gMG US Launch Ongoing US Launch Ongoing AM X ZX R}v ` .v R]vP o `}r}]v }v }v R MGrADL o ]v (} (} }
gMG gMG Data 1Q22 Data 1Q22
u} }v `l ]vP R . uv ˙o X
CIDP CIDP Data 1Q23 Data 1Q23

Myositis Myositis Trial to initiate 1Q22 Trial to initiate 1Q22

Pemphigus Pemphigus Data 4Q22 Data 4Q22 A ]}voo˙U R ` ]Pv].vo˙ u} }v }v R v u˙Rv] P] ~ QMGZ o (}oo}`]vP
Bullous Pemphigoid Bullous Pemphigoid Enrollment Ongoing Enrollment Ongoing
uv `]R VYVGART¡ }u `]R o} ~ A9 X A9V AM X ZX R}v ` .v R]vP o
Efgartigimod ITP Efgartigimod ITP Data 2Q22 Data 2Q22
R r}]v }v }v R QMG o ]v (} (} } u} }v `l ]vP R . uv ˙o X
ITP ITP Data 1Q23 Data 1Q23

Membranous Nephropathy
Membranous Nephropathy POC trial to start in 2022 POC trial to start in 2022

Lupus Nephritis Lupus Nephritis POC trial to start in 2022 POC trial to start in 2022 A R}`v ]v .P U u]v]uo ˙u}u ˘ ]}v ~ MSEZ ] v ]v ]vPo˙ ]u}v }]v (} R˙]]v v -
Sjogren's Syndrome Sjogren's Syndrome POC trial to start in 2H22 POC trial to start in 2H22
v ] ] u }( ˙u}ur( X Iv ADPTU A9 }( v R] MSE W } v MGrADL } }(
COVID-19 Mediated Postural
COVID-19
Orthostatic
Mediated
Tachycardia
Postural Orthostatic Tachycardia
POC trial to start in mid-2022 POC trial to start in mid-2022
Syndrome Syndrome } r v˙ u ]vP ˙o }v X TR ]PR ] R}` R }( }v X O Ro( }( v `]R (PP] -
Multifocal Motor Neuropathy
Multifocal Motor Neuropathy Enrollment Ongoing Enrollment Ongoing
ARGX-117 ARGX-117 u} ˘]v v ]u}uv }( . }]v } u} }v R MGrADL o ˙ `l (}X
Delayed Graft Function After
Delayed
Kidney
Graft
Transplant
Function After Kidney Transplant POC trial to start in 2022 POC trial to start in 2022

ARGX-119 Neuromuscular Indications

ARGX-119 Neuromuscular Indications Phase 1 to start in 2022 Phase 1 to start in 2022

ARGX-120 ARGX-120Undisclosed Undisclosed

Non-Autoimmune Programs
Non-Autoimmune Programs
Cusatuzumab Cusatuzumab AML AML 20 20%

ARGX-118 Airway Inflammation Airway Inflammation

ARGX-118
17%
16%

Key: NEUROMUSCULAR
Key: HEMATOLOGY
NEUROMUSCULAR DERMATOLOGY
HEMATOLOGY NEPHROLOGY
DERMATOLOGY NEPHROLOGY 15 15%
14%
13% 13% 13%
12% 12%

Percent
10 10%

1.3.1 VYVGART™ 8%

6% 6% Placebo
5 5% 5% 5% 5%

Approval 3%
VYVGART

Ov D u U U R FDA } VYVGART¡ ~(PP]u} o(r( Z (} R uv }( PMG ]v o v 2% 2%

`R} ACRR v}˙ }] X TR v v }˘]uo˙ æA9 }( R }o PMG }o}v ~B R]v 0 0%

≥9 8 7 6 5 4 3 2 1 No Worsening
oX N` PR`˙ v TR TP ]v A }]uuv M˙Rv] G] X J N}u D] æX X ær ZX Ov Change
Improvements in Total MG-ADL at Week 4
Jv˙ U U Jv[PMDA } VYVGART¡ ~(PP]u} o(Z (} R uv }( o v `]R PMG
`R} } v} R 8]v }v } }] } v}vr}]o ISTX W]R R Po}˙ u]o}v U VYVGART¡ ] R
.rv r}vo˙ } v}vo FRv o}l ]v R UXSX v JvX
30

26%
PMG ] v R}v] v}u o ] R ] ˙ ]o]vP v }voo˙ o](rRv]vP uo 25 24% 24%

`lv X VYVGART¡ ] Ruv IPG v}˙ (Puv R ]v } FRvU ovP ]v R }v }( ]ovP IPG
20
v}] X TR }v }( ACRR }v}] R v}u o iv}v ] l˙ ] }( PMG ~H}` JF JU U - 19%

P]` KU B v MU oX S(˙ v 8˙ }( 8˙ }( o]u ]v v r˙oR}o]v } v}˙r}]

Percent
15
(}˙ Pvo] u˙Rv] P] ~REGAINZP R U v}u] U }o ro]v U o }r}v}oo U uov
˙X Lv N}oX V P ı r ZX 10
8% 8%
10% 10% 10% 10%
Placebo
7% 7%
6% VYVGART
5 5% 5% 5% 5%

TR }o }( VYVGART¡ ] }v o (}u R Po}o PR ADPT ]oU `R]R ` o]R ]v R Jo˙ 3%

2%
3% 3%

] }( TR Lv N}o}P˙X 0 0% 0% 0%

≥10 9 8 7 6 5 4 3 2 1 No Worsening
Change
Improvements in Total QMG at Week 4
Iv (}u R PMG }uuv]˙ ` ]vP ]v} R ADPT ]o ]PvX TR}PR o]v]vP } v ov]vP (}u R
PMG v }uuv]˙U ` v}} R ˙ PMG v ˘]v R } }( ] ]+vo˙X A o U
` ]Pv ]o } G R ]v]]o] v }( PMG `]R }]vP }R R `}o } R F]P P PvP }( v `]R MGrADL v QMG }o } RvP (} `l L ]v]o ]v(]}v }( R . ˙o ]v ACRRrA }] }o}vX
v []v]]o }v X

38 | Our
 Products and Product Candidates  Our Products and Product Candidates | 39
 0

]v R]PRo˙ o uvvX A R }( R] URDU(PP]u}

E R v o ]v } i v R
-1
v } } ]Pv].vo˙ }vv}v }( oo IPG ˙ `]R} ]vP oo }( }R ]uuv}Po} -
o]v } Ruv u ou]vU `R]R ] o} ˙o ˙ FRvX

-2
Ivv}u]U}oro]vUo}r}v}oo.r]vrRuv
Mean chane (+/-SE)

˙}(RoR˙}ovU(PP]u}uvo

PART I
-3 ]v]v].ov}(uIPGooXS]vPo -
u]v]}v}((PP]u}IPGoo}æ9A `R]o
-4
uoo}]vP(Ro}`IPG}vP˙æA9(}u
Endothelial Cell
Placebo o]vX}˘]uo˙
A ]PR`l(}oo}`]vPRou]v] -
VYVGART

}vUIPGoov}o]vX(PP]u}
E ]v}o
-5
R}u}}(ou]v}]uuv}Po}o]v}RRvIPGv
0 1 2 3 4 5 6 7 8 10
Week
v}]}v.v˙R}uvR}] -
Endosome o}(PP]u}]v(]}v`}X
F]P P Mv RvP ]v }o MGrADL (}u ˙o o]v } u ]v ACRRrA }] }o}vX

B }v ] uRv]u }( }v ]v PvP FRv } o -

VYVGART¡ R u}v (˙ }.o ]v R ADPT o]v]o ]oX TR u} }uu}v v ]v ADPT o˙ ]vP IPG U (PP]u} R R }vo }
` ]}˙ ]v(}v ~ A9 ıA9 o }ZU R R ~ A9 ıA9 o}ZU v ]v˙ ]v(}v ~ A9 uo }( }]uuv ] `R R}Pv]
X æA9 o}ZX IPG o] } u]} }( ] X
Lysosome

TR ] r}o }Pu ~ PAAZ (} PMG v R u]v }v ]v R EUU R Uv] K]vP}uU H}vP A R }( R] URDU ` ovP (PP]u} ]v ]˘
K}vP v C v (} o]P]o v X }]uuv ]v]}v `R ]Pv].v vu v ˘]
IgG Antibody FcRn VYGART ] R ]o]o]˙ }( }uu}vo˙ R] X TR ]v -
Commercialization and Regulatory Plans o PMGU CIDP v u˙}] `]R]v } v}u o (v -
TR UXSX }uu]o ovR (} VYVGART¡ ] }vP}]vP (}oo}`]vP R D u U FDA }oX TR Jv }u - R] V ITP `]R]v } Ru}o}P˙ (vR] V v PV v PF v
u]o ovR }( VYVGART¡ ] ]vv } L R N}vo HoR Ivv ~ NHIZ P ] o]vP U ˘ BP `]R]v } u}o}P˙ (vR] X Iv U ` vv}v
}˘]uo˙ ı ˙ L R }o }v Jv˙ U X WR o]R } }`v o (} ]v R UXSX v R ` `]oo ˘v ]v} (} ]}vo }]uuv ]v] -
F]P P(PP]u}
E [uRv]u }( }v o}l
Jv (} VYVGART¡ (} R uv }( PMGX W ov } ˘v } }`v o v ulvP ]o] v } - R ˙o]vP }( IPG v}] v u} Ru (}u }v U ]vo]vP LN v MN `]R]v } vR}o}P˙ (vR]
u} } } v } v] ]( v `Rv Po}˙ }o R v }]v ]v R ov i]] - ]o}v v ]u˙ SiS v }rCOVIDr ı u] POTSX
}v X Av MAA (} (PP]u} (} R uv }( PMG ] vo˙ v ]` `]R R EMA `]R v v]
]]}v ]v R }v Ro( }( X Pv˘ C v ` o]R ]v . }( ]v }v (} }vo Indication Selection Strategy
HoR C v }o v ]( Pv }uu]o ovR ]v C v X Iv ovP } ]v]}v (} (PP]u} U ` o] R (}oo}`]vP P˙P

o}uv
D v}uu]o]}vu˙o}}vR}PR}oo}}v`]RR]XIvJv˙U`v - {  W. `]R }vP U v](˙]vP ]}o}P]o }voX TR ]v]}v ]v } ]o]v v]. ]v R R ˘]
]v}v˘o]o]vPuv`]R]Z L(}Ro}uvv}uu]o]}v}((PP]u}]vCR]vU `] vP }( } ]v R u}v R R ] IPGru] X TR] vP (}u o]R o] U
T]`vUH}vPK}vPvMXW˘]Z L}o}.o(}}o]vGCR]v˙u]rXUvR o]v]o ]o `]R vo˙ R] R ]vv} ]uuv}Po}o]v ~ IVIgZU PLEXU } R]˘]u U v }R
u}(RP]Puv`]R]Z LU`]¤æu]oo]}v(}v˙uv]vR(}u}(æUv`o˙] - ˘]uv U R ] v( u}o X
]Z LRoo]}(¤Rv¤æu]oo]}vPvo}uv}R]vP˙uv {  W o} o}}l ]v]}v `R ]Pv].v o]v]o } }uu]o }}v]˙ ˘] X TR ] `R
vvo}¤æu]oo]}vu]o}v˙uv]v}vv}v`]RFD}o A }(VYVGART¡XW`]ooo}o]P]o R ] ]Pv].v vu v (} ]vv}}v v }Lv v} `ooruvP ˙ v R] v R]
(}}˙o}vvvovo}((PP]u}]vCR]vUT]`vUH}vPK}vPvMXIvO}U` ] + X F} ˘uo U }] v IST }Lv } uo }( }]uuv ] U
vv}vv˘o]]]}vPuv`]RM]}v}}uu]o](PP]u}(}PMG]vIoXM]}v`]oo (} R ]v]}v ]v } ]o]v R (U R R v } } ol]vP ]v }R (˙ v }o]o]˙X
o}}v]o(}l]vP]]Po}˙}oUv`˘M]}v}o}.o(}}o]vIo {  FRu} U (} R ]v]}vU R ] .v R (}` `]R o]R v (} R}` } v }}(r}(r
]vR}v}(XW]vv}]Pv]}vo]]}vvR](}}R]}]X }v v P]}vo ]o `]R Pvoo˙ o]v]o v Po}˙ v}]v X
{  F]voo˙U ` `}l }` R]]vP } RPv˘ æ[ ]]}vU ` o ]v]}v `R R ] }vo .
`]R]v } P}`]vP v}u oU Ru}o}P˙U u}o}P˙U v vR}o}P˙ (vR] X
1.3.2 Efgartigimod (formerly ARGX-113) Development
Formulations
Mechanism of Action Overview
A R}`v ]v .P U (PP]u} ] Ruv IPG F (Puv ] `]R } ABDEG¡ u}v R ] ]Pv W o}]vP `} (}uo}v }( (PP]u} } R v }( v U R˙]]v U v ˙} } ]v] -
} P R FRv v IPGX FRv ] (}v}vo } R ]uuv ˙u v (v}v } ˙o IPGU ˘v]vP }v v P}PR] U ]vo]vP IV (PP]u} v R ENHANZE ~o]v (}u Ho}˙u Z SC (}uo}vX
] u Ro(ro]( } }R ]uuv}Po}o]v R v} ˙o ˙ FRvX IPG R ]v } FRv (}u
o˙}}uoX B˙ ]v]vP } FRvU (PP]u} v IPG ˙o]vP v ]v IPG P}vX IV
W }v PR o]v]o ]o ]v RoR˙ }ov } o R (˙U }o]o]˙U Ru}l]v U R -
C}u } ov ]uuv} ] }R U R Bro˙uR}˙ ~ B-cellZU ovP Pv U (PP]u} u}˙vu] U v ]uuv}Pv]]˙ }( ]vPo v uoo } }( (PP]u} X Iv R . }( R o]v]o ]oU

40 | Our
 Products and Product Candidates  Our Products and Product Candidates | 41
i ` v}u] } ] ]vPo } }( (PP]u} } o} vP]vP (}u X uP llP } æ uP llPX Iv SC – Partnership with Elektrofi
R }v }( R o]v]o ]oU i ` v}u] } ] uoo v]vP } }( (PP]u} } Iv A ]o U ` v ]v} }oo}}v v o]v Puv `]R Eol}. } ˘o} v` SC (}uo}v o] -
o} } u˘]uu }( æ uP llPX ]vP Eol}.[uoo }ou ]vi}v Rv}o}P˙ (} (PP]u} U v } }v ]}vo P X S }v XæX SO
E˘o] L]v `]R Eol}. (} (PP]u} _ (} u} ]v(}u}vX
Iv R uoo v]vP } }( R PR o]v]o ]oU u]v]}v }( }R uP llP v æ uP llP }(
(PP]u} ˙ v ˙ U (} } ]v }oU v uP llP ˙ (} ˙ U ]˘ } ]v }oU ` }] `]R
1.3.3 Efgartigimod (formerly ARGX-113) Indications

PART I
Po }v ]v oo }( oo (} o }( IPG v}] ˙ A9 } æA9U `]R uP llP } o R}`v ]v .P
X F} oo } ]v R uoo v]vP } }( R PR o]v]o ]oU ` } R }v ]v ]ovP
IPG v}˙ oo } ] (} u} Rv (} `l L R o } `]R oo o}` æA9 }˘]uo˙ R Generalized Myasthenia Gravis (gMG)
`l v ] v} v } o]v oo (} u} Rv }v u}vRX PRu}l]v vo˙] }( u o]v oo Overview
}( (PP]u} ]v] R ] R Ro(ro]( }( }˘]uo˙ R } (} ˙ `]R v} P uo}v (}oo}`]vP PMG ] v R}v] }]uuv ] `R IPG }v}] ] }uuv]}v `v v v
v `lo˙ }]vPX TR }o}vP ]˙ }v R oo }( IPG v}] ] }v]v `]R R uRv]u }( uo U ]vP ]o]vP v }voo˙ o](rRv]vP uo `lv X
}v }( (PP]u} v R + }( } }]˙ ABDEG¡ Rv}o}P˙ ~]o ]v }v X X SPo}u TRv}o -
}P] _Z }v ]v ]vP R ]vooo ˙o]vP }( (PP]u} X Iv }R R ]vPo v uoo v]vP } }}v U Iv u˙Rv] P] ~ MGZU IPG }v}] ]R ]v v }˙ } } ro]vl v ]vvo] R } }v R
v} ]Pv].v }v ]v IPMU IPA } u ou]v ` } X uo oo U R˙ vvP R ]v]vP }( ˙oR}o]v U R ]Pvo v ˙ R v ooX Iv ]}vU R }v -
}] v }v }( R v}u o iv}v ˙ ]vP }uouv U }v oor}˙]vP uR -
SC - Partnership with Halozyme v]u }( R Ruv ]uuv ˙uX TR uo `lv }] `]R MG oo˙ v ]v]oo˙ ]v }o uo
Iv U ` v Ho}˙u ˘v R ˘]vP Po}o }oo}}v v o]v Puv R ` ]Pv ]v F ˙ v v Rv ]v} Pvo] (}u +vP uoo uo U lv}`v PMGX A }˘]uo˙ æA9 }( }o
ıX Uv R ˘v]}vU ` P]v R ]o]˙ } Ho}˙u [ENHANZE P o]˙ Rv}o}P˙ (} R `]R MG }P } PMG `]R]v u}vR ~} P B R]v oX N` PR`˙ v TR TP ]v A }]uuv
M˙Rv] G] X J N}u D] æX X ær ZX MG ]v R }o (}u ]v]oo˙ }}˙ ˙o] v o
} }o ]]}v } o o˙] }( ˙ u}uv X A MG }u Pvo] ] + uo ]v R vl v
IgG1 IgG2

150 active (n=6) 150 active (n=6) i`U ]vP }ou ]v l]vP U R`]vP v `oo}`]vPX MG v o} `lv ]v loo uo o]vP }
placebo (n=2) placebo (n=2)
}ou ]v o]u (v}vX Iv R u} U ]}˙ (v}v v `lv } R }]v `R ] }u
100 100 o](rRv]vPX TR ]}˙ ] } o }v ]v R o] }( }˘]uo˙ æA9 } A9 }( MG v X TR
UXSX ov }( MG ] u }˘]uo˙ U ~} P PR]o] oU Avv NY A S]X V
%T

%T

50 50

Pv `]R }v.u ACRR v}] }v (} }˘]uo˙ æA9 }( R }o PMG }o}v ~B R]v oX N`

0
0 20 40 60
0
0 20 40 60
PR`˙ v TR TP ]v A }]uuv M˙Rv] G] X J N}u D] æX X ær ZX
Days post infusion Days post infusion

ADAPT-SC Trial Design

Iv Jv˙ U ` ]v] ADPTrSCU P]}vo v}vr]v(]}]˙ ]P]vP ˙ }( SC (PP]u} (} R -
IgG3 IgG4 Total IgG

150 active (n=6) 150 active (n=6) 150 active (n=6) uv }( PMGX TR ]Pv }( R ]P]vP ˙ ] }v R u}v }]}v `v }o IPG }v
placebo (n=2) placebo (n=2) placebo (n=2)
v o]v]o v. ]v PMGU v ]v}} ( l (}u R FDAX TR ˙ ] }u]vP R PD + }( uP SC
100 100 100 (PP]u} `]R uP llP IV (PP]u} X TR ]u˙ v}]v ] R v RvP (}u o]v }( }o IPG oo
u ˙ ıX
%T

%T

%T

50 50 50

W˘ } vv}v }o]v o (} R ADPTrSC ]o ]v R . }( X

0 0 0
0 20 40 60 0 20 40 60 0 20 40 60

Days post infusion Days post infusion Days post infusion Other trials
Iv ]}vU ` vo˙ ovP (PP]u} ]v IV (}uo}vU ]v o]v]o ]o ˘o}]vP ]}v }v }]vP ]v
R PMGU ]v R]ov `]R PMGU `oo ]v RoR˙ }ov ]o ovP R ]uuv }v L ]v}v
F]P P R }v ]v R oo }( (} IPG v}˙ o v }o IPG oo ]v R uoo v]vP } }( } PR o]v]o ]o }( ~PNEUMOVAX Z `R]o ]]vP (PP]u} X
(PP]u} ]v RoR˙ }ov } }( uP llP ˙ v ˙ X

Primary Immune Thrombocytopenia (ITP)

Overview
]}vo ˘o] P }v v}u]v}v ]vP]vP R }o } ]˘ }vo P v R }oo}}vX T} U P]u˙ ITP ] v ] }]uuv o]vP ]}U R ] ˙ o}` oo }v ~AM A? ılLZ ]v R -
`} P R v v}u]v ]vo]vP R Ruv v}vo F } FRv v }uouv }u}vv C X v }( }R }] `]R R}u}˙}v] X Iv u} v U IPG }v}] ] P]v oo
} v X TR˙ o oo ov v }vU ]vR]] oo } }vU v ]u]
Iv Jo˙ ıU ` o SC (}uo}v }( (PP]u} R ]v}} Ho}˙u [ENHANZE P o]˙ oo (v}vU ovP ]v ]v ]l }( o]vP v ]u] o]˙ }( o](X P]u˙ ITP ] ]+v (}u -
Rv}o}P˙ ]v PR o]v]o ]o ]v RoR˙ }ov U `R]R u}v ]v Ru}˙vu] }.o }( }v˙ ]uuv R}u}˙}v] U `R]R ] }] `]R }R ]oov U R ]v(}v } }]uuv ] U
IVr(}uo (PP]u} X }`R]R}Lv(]}v}l]vP}RPURvPXPoo.]v˙U}R}u}˙}v]Uv
ENHANZE R u}v } uoo FDAr} } R ]o]˙ } u} ]}vo o]u]}v }v o]vP]vU]]vPvo}`o}}o}«vPL]vi˙XPvu˙+(}u]}vv(P
R }ou }( ]}o}P] R v o] v}o˙U }voo˙ R}v]vP P u]v]}v u U ]vP `oo]+}(˘]vPR]U]u]]vPR]o]˙}(o](XvC R}R]vov}vr].
RoR }v u U v }+]vP ]}vo G˘]]o]˙ v }vv]v (} v X ]uuv}]}v~XPXU}]v]˘]uZU]vR]]}v}(ooov~XPXUov}u˙UIVIPUvrDPo}o]vU

42 | Our
 Products and Product Candidates  Our Products and Product Candidates | 43
vS˙l]vR]]}(}uv]Z}uo}v}(oo}}v~XPXUR}u}}]v}P}v]TPOrRAZX
Sov}u˙u]vR}vo˙uvR}]]vu]]}v}+R˙(}}v˙}o}vP(}R]PR}
}}v}(vXITP+}˘]uo˙Uv]vRUv]S~}PvC M]oRRv
O]v]}vUæPUırııVAuJHu}oXSV~ıZPWæVP]Bo}}CvXFVæ~ZPWZX
Phase 3 ADVANCE Trials
Iv R (}R }( ıU R . }( `} P]}vo ]o U R ADVANCE PR ]oU ` ]v] } o
uP llP IV (PP]u} (} R uv }( ]u˙ ITPX TR }v P]}vo ADVANCErSC ]o }( uP SC
(PP]u} (} R uv }( ]u˙ ITP ` ]v] ]v R (}R }( X W˘ } v}oo }˘]
uo˙ æ v ]v R ]oX T}o]v ˘ (} R ADVANCE ]o ]v R }v }( v (}
R ADVANCErSC ]o ]v R . }( U o˙X TR ]u˙ v}]v }( }R ]o ] R }}}v }(
R}v] ITP v `]R ]v oo }v }v U .v R]]vP oo }v }( o æ A? ılL
(} o (} }( R ]˘ ]] `v `l ı v }( R ]oX
Phase 2 Trial
W }uo v}u] U }o ro]v U o}r}v}oo PR o]v]o ]o } o R (˙U 8˙ v
Ru}l]v }( (PP]u} ]v o ]u˙ ITP v U `R} R oo }v o}` Rv ˘ ılL `R]o
]vP }v o } }( v r}(r uv }v]vP }( }}}] U u]' ]uuv} v }
R}u}}]v } P}v] U } L R]vP vP}v ov}u˙ } `R]o ]vP u}v]} v R`R
`] [ }RX W }v R o]v]o ]o ı o]v]o v } ]PR }v] ]v R E }v Uv]}vX P
v ` v}uo˙ ]Pv } R u }( `o } v (} R o} } (PP]u} u U o˙X
Aoo v ]v R] o]v]o ]o }v P v r}(r uv ` } }vv } ] R] o } }( v
r}(r uv R }}}oX Ov uv u ] æ uP llP (PP]u} U R }v u ]
uP llP (PP]u} v R R] u ] o }X D}]vP }}l o ]v R r`l ]} U `R]R ]vo
(} `lo˙ } }( (PP]u} } o}X Pv (}oo}`r }vv (} `l L uv X Pv (}u
oo R }R} ` o]P]o } v}oo ]v }v r˙ }vroo ˘v]}v ˙ R uP llP } }( (PP]u} U
i } uvP v}oouv ]] U ]vo]vP oo }v o}` Rv ˘ ılLX
Foo o (}u R PR ]o ` o]R ]v R r ]` Au]v J}vo }( Hu}o}P˙X (P
E P]u}
` `oo r}o v R}` } o}v }( IPG o o U ]v oo }v v o ]vP ]v
ITP v X
TR ]u˙ v}]v vo˙] u}v (P P]u} } `oor}o ]v oo v U `]R u} uv
uPv v ~ TEAEZ } R ] u]o ~C TCAE G]vP v ZX TR ` v} } ro
(˙ } }v v R (˙ }.o ` }v]v `]R ]} } }v ]v RoR˙ }ov v u˙
Rv] P] v X N} ]v ]l }( ]v(}v ` v ]v R (P P]u} r P} }u } R
o } P} X
TPvP FRv `]R (PP]u} o ]v ] v o IPG }vU v P vu]o }v `
} ]v R (PP]u} uP llP P} U `]R} ]u vP R oo }( }R ]uuv}Po}o]v ]}˙ X(PP]
E -
u} u]v]}v ] v} o ]v }v }( ou]v oo U PPvP R R F (Puv (PP]u} ] v}
]v(]vP `]R ou]v ]v]vP } ]vGv]vP R ( }( FRvX
R }v ]v oor}] }v}] ` } ]v R ui}]˙ }( v `]R o]v]oo˙ uv]vP(o
oo ]v X
(PP]u}
E r P} R] R]PR u˘]uu uv oo }v RvP (}u o]v }u } R o
} P} X P} R} vo˙ ]]vP P ( v˙ } }v }( oo }v AHæ A? ılLU } ]v oo
}v }AH A? ılLU u}v R 8˙ }( (PP]u} X S]˘ v ~ A9Z ]v }R (PP]u} P}
R}` v ]v ]v oo }v ANæA? ılL }v o `} }]}v X A ]}voo˙U voo˙ u} r
v R] oo }v AHæ A? ılL (} u} Rv uo ˙ }u } R o} P} ~ A9
X A9 U o˙ZX
A v }vP R}` v} o]vP v ]v v˙ v U u]o o]vP v }vo˙ ` } ]v
44 | Our
 Products and Product Candidates
R uP llP u v u]o v u} ]v R æ uP llP v o } uX Iv]v }( o]vP v ` ˙
- (PP]u} uv ˙ R W}o HoR OPv]}v o]vP o U `]R }v (}u o}
o˙ R R] } ]v R uP llP uX Iv]v }( o]vP v ]v R l]v ` ˙ (PP]u} -
uv ˙ R ITPrBTA o]vP o U `]R v} o ]Pvo }( o]vP v ]v R u} } }Pv ]v ]R
uv uX
PART I
L}` }(vrPv}] ` ]v XA9}(o} v v XA9}( v ]vR uP llP
u`]Rv} v+}vRu}l]v } Ru}˙vu]X
-
Phase 3 - IV and SC Trials
Iv R (}R }( ıU R . }vo P]}vo PR ]o }( IV (PP]u} ]v ITPU R ADVANCE ]oU
` ]v] } o } }( uP llP IV (PP]u} X W˘ } v}oo æ v ]v R] PR ]oX TR
}v }vo P]}vo PR ]o }( SC (PP]u} ]v ITPU R ADVANCE SC ]o ` ]v] ]v R (}R
}( } o } }( uP SC (PP]u} X W˘ } v}oo æ v ]v R] ]o `ooX
W˘ } vv}v }o]v o (} R ADVANCE v ADVANCErSC ]o ]v R }v }( v .
}( U o˙X
Pemphigus Vulgaris (PV)
Overview
- PV ] v }]uuv ]} }] `]R u}o v l]v o] R o } ]vU ]8o˙ `oo}`]vP v l]v
]v(}vX TR] R}v] U }voo˙ o](rRv]vP ] ] ]PP ˙ IPG }v}] PvP u}Po]vr v
- r U `R]R v }v R ( }( lv}˙ v ]u}v (} oor}roo R]}v ]v R ]Ro]uX A } -
v}] PvP u}Po]v o ]v o} }( oo R]}vU R ]u˙ }( o] (}u}v ]v PuR]P X
S]u]o } MG v ITPU ] ]˙ }( PuR]P }o } R u}v }( R}Pv] IPG PvP u}Po]v X
C vo˙U R v u U uR]P v ]v R Uv] S U }( `R]R v u U v
+]vP (}u PVX So ] ]˙ u uv ˘] (} R o]v]o o}v }( PV v U ]vo]vP R
uR]P ] ]v˘ ~ PDAIZU }]uuv oo} l]v ]} ]vv]˙ } ~ ABSISZU v R PV ]˙ }
(PVASZX TR PDAI ] } } R R R]PR o]]˙ v ] }uuv (} ]v o]v]o ]o }( PVX
Phase 3 ADDRESS Trial
Iv R (}R }( U R P]}vo AD RESS ]o ` ]v] }( SC (PP]u} (} R uv }( PV
v PFX TR] ] v}u] U }o ro]v U o }r}v}oo ˙U `R R }i ] } 8˙U (˙
v }o]o]˙ ]v } æ v`o˙ ]Pv} } o]vP v `]R u} } uR]P X Pv v -
}u] } ] ]R SC (PP]u} } o} (} `l X Pv }v }v}u]v }] }v `R
- ` u]v } R }u] }]vP P]uv (}u R PR ˙X TR ]u˙ v}]v `]oo R }} -
}v }( v `R} R] }uo u]]}v }v u]v]uo }] } `l X TR AD RESS ]o `]oo o
8˙ v (˙U ]vo]vP R }vo } ] ( }v }( ] }v}o v }uo u]]}v v R ]o]˙
} }}}] X A ov u]v}]˙ }}v }( R v ]v R AD RESS ]o ]vP ]v ] }v -
]v Ul]v } R] X D } R }vG] `v R]v v Ul]v U ` u˙ vo } (oo˙ v. (}u R
˙ }oo } v ` u˙ v } ] ]}vo v `R]R }o o˙ r} }]v (}
} ] U oR}PR ` vo˙ vo } ]( v ˙ R}` uR R o˙ `}o }X A }]vPo˙U u]vP
}( }o]v (} R AD RESS ]o }( SC (PP]u} (} PF v PV u˙ ]u ` vo˙ vo }
R (oo ]u } R ]o˙ o}]vP ]}vX
Phase 2 Trial
W }uo v }vroo PR ]o ]v `R]RU R}PR vo }R} U v ` } }
- æuP llP IV (PP]u} `]R ]} }]vP ( v] U u}v}R˙ } r}v R˙ } o}` } }o v] -
}v X TR ]u˙ v}]v }( R ]o ` (˙ v }o]o]˙X TR (oo PR ]o o ` o]R ]v TR
B ]R J}vo }( D u}o}P˙X
Iv R] ]oU ` } P
{  (}o }o]o]˙ }.o U }v]v `]R (}u ]} (PP]u} ] v R} v `
u}o˙ u]o X
 Our Products and Product Candidates | 45
{  ui}]vu}oIPGvvru}Po]v~DSG}v}] Z v}o`]R]u}PDAI}X
{  R ı A9 ~ l Z }( v u}v o˙ ] }v}oV u]v u } ] }v}o (} u}v}R˙ v
}u]v}v R˙ ` ˙ X
{  }uo o]v]o u]]}v ]v A9 ~ l Z }( v ]]vP }u] }o}vP uv `]R (PP]u} ]v
}u]v}v `]R u]v } }( X uP llP l˙ v]}v `]R]v r `l X
{  (}o }o]o]˙ }.o U }v]v `]R (}u ]} (PP]u} ] X
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Overview of Chronic Inflammatory Demyelinating Polyneuropathy
CIDP ] R}v] }]uuv ]} }( ]Ro v v v }} ˙ v }]uuv ru]
}v }( R u˙o]v RRU } u˙o]v }]vP oo U ]vovP R ˘}v }( R v v vo]vP }( ]Pvo
v }vX TR }( CIDP ] vlv}`vU v}uo] ]v }R ooo v Ru}o ]uuv]˙ R v R}`vX
CIDP ] R}v] v }P] ] P }v v }P]}v } } o ]PR `l ]v }v `]R R
u} G]oo]vrB r˙v}u X D u˙o]v}v v ˘}vo uP ]v CIDP o } o} }( v}˙ v l} u}}
v}v (v}vU `R]R v o } `lv U v}˙ o} U ]uov v l} ]vX CIDP + }˘]uo˙ U
v ]v R Uv] S X
M}CIDPv]uvvIVIP`R]R]R(.ro]vR˙XGo}}}]vou˘
RvP}o˘vR˙]Ro]u]˙]+}vR}v]U]vR}(Po}}}]U
}]v]v}(R}vU`R]R]]}]o]v]v}(ou˘RvPXAo
v]uuv}vPv˙]oo˙(}v]vo]P]o(}}(}˙}IVIPUPo}}}]}
ou˘RvPXWR]oIVIPR˙voo˙}v}oCIDPUu}v]uv˙`}}]˘
`l(}uv˙˙XTR]]}R(RIVIPu}v}R˙}v}oo˙o}o}vPruu]]}vX
ADHERE Trial
A R v }( ıU ` ]v] R P]}vo ADHERE ]o ovP SC (PP]u} (} R uv }( CIDPX TR
ADHERE ]o ] v}u] U `]R`o ˙ ovP uP `lo˙ SC (PP]u} ˘ } v}oo }˘
]uo˙ v X TR ]o }v] }( v }vroo SP A (}oo}` ˙ v}u] U o }r}v}oo SP
B `]R ovv ]v]u }v vo˙] L R . v v}oo ]v SP AX Iv } } v SP A v
] (PP]u} U }R v `R} uvrvb } }v R˙ u . ] }v.u ]Pv}] }(
CIDP ˙ v ]vvv vo }( ˘ v u}v ] X T} R}` ] U v `R} }v
v CIDP R˙ R } u}v u]v]uo o]v]oo˙ uv]vP(o `}v]vP L uv `]R`o
}v o }v CIDP o]v]o uv }}oU ]vo]vP IvGuu}˙ N}R˙ C v Tuv ~
S} U IvGuu}˙ RRr]o Ooo D]]o]˙ So ~
v } u}v u]v]uo o]v]oo˙ uv]vP(o }v } (PP]u} ]ov `]R R o} } }v R
u 8˙ o }v `R]R `}v]vP ] } ]vP R `]R`o ]} X Iv SP BU v v}u] }
]R SC (PP]u} } o} (} } `l X TR ]u˙ v}]v ] vr]v v }v R i
INCTA 8˙ } ]v SP BX
Interim Analysis from ADHERE Trial
Iv F ˙ U ` vv}v SP}_ ]]}v } v]}v ]v} R }v U o} }v}oo P }( R] ]o
}v ovv 8˙ v (˙ uv (}oo}`]vP R v}oouv }( v ]v} R ]v]o }( R ADHERE
]oX TR ADHERE ]o ] ˘ } v}oo }˘]uo˙ v ]v }o } } }vo P]}v }( SC
(PP]u} (} R uv }( CIDPX TR ]v]u vo˙] R] R r.v RR}o (} }vv}vU `R]R
` }v }v v ]v v o]v]o ]o }( v v }( ]v CIDPX TR ]]}v } }vv
v}oouv ` }v.u ˙ v ]vvv u}v]}]vP }uu]' X Iv ]}vU R (˙ v }o]o]˙
} } ] }v]v `]R R }( (PP]u} ]v }R o]v]o ]o X
W˘ } vv}v R }o]v }( R ADHERE ]o ]v R . }( X
Idiopathic Inflammatory Myopathy (Myositis)
Overview of Myositis
M˙}] P} }( }]uuv ] R v uo ]. } + uoo }Pv ]vo]vP R l]vU
i}]v U ovP U P}]vvo v R X M˙}] v ˙ v ]o]vP v R u]o ]u }v
46 | Our
 Products and Product Candidates
o]˙}(o](XIv]oo˙Ru˙}R]`o].]Ru}u˙}]~ DMZ}}o˙u˙}]URvo˙ -
]vPR}R˙]}o}P˙}(u˙}]R}u'v}}U]vo]vPR}PRR]v.}v}(R]} -
v}]Uv`}o˙u˙}]P}RuPXT`}}(R˙]uuvru]v}]vPu˙}R˙
(IMNMZvvr˙vR˙v}u~ ASySZXP}˘]uouo`lv]v](˙]vP(}(Ru˙}]X
{  IMNM ] R ] ˙ loo uo `lv } uo oo v}] X TR uo `lv ] ˙]oo˙ ˙u -
PART I
u]o W }v }R ] }( R }˙ W v + }˘]uo uo ]vo]vP R] U R]PR U u U R}o v
vlX TR uo `lv v v o } ]8o˙ ]v }uovP ]o˙ l X CR ] }v}]
}( IMNMU ]vo v r]Pvo }Pv]}v o ~v rSRPZ v v r rR˙}˘˙r ruR˙oPo˙or}v˙u A
- ~v rHMGCRZ }v}] X
{  AS˙S ] R ] ˙ uo ]vGuu}vU ]vGuu}˙ R] U ]v o ovP ] U R]lv]vP v l]vP
}( R Rv ~uRv] [Rv Z v R˙v Rv}uv}vX A }v}] }] `]R AS˙S 'l RNA ˙vR -
v˙u v ]vo v rJ}r v v rPL v PLr u} }uu}vo˙X
{  DM ] R ] ˙ uo ]vGuu}v v Pv}v v l]v v}uo] U ]vo]vP Ro]}} RU G} -
}v o U ˙Ru} U o]v}] v u X DM ] }] `]R u˙}] r ]. }v}] U ]vo]vP
v rM]r U v rMDAræU v rTIFr v v }R X
- TR v} v FDAr} R] (} IMNM } AS˙SX IVIP ~OPu A9Z ` } ˙ R FDA (} R
uv }( u}u˙}] ]v Jo˙ X M˙}] v u} }Lv `]R R]PRr} }] X
-
ALKIVIA Trial
W]vv } ]v] R P]}vo ALKIVIA ]o }( SC (PP]u} (} R uv }( u˙}] ]v R }v -
}( X W`]oo v}oo v } `]R uP SC (PP]u} ]v R u˙}] ˙ }R} U IMNMU
AS˙ v DMX Av ]v]u vo˙] ] ovv L R . v }( R u˙}] ˙ X
TR ]u˙ v}]v `]oo }v R uv }o ]u}uv } v ]}vo l˙ }v˙ v}]v `]oo
- ]vo u } }v U ]o]˙ }( v. U R o]˙ }( o]( v R ]v]]o }u}vv }( R }o ]u} -
uv } X
Bullous Pemphigoid (BP)
Overview
BP ] R u} }uu}v }]uuv o]]vP ] v ] ]v ˙ }v}] +vP R l]vX TR ]
INCATZ D]]o]˙ ˙]oo˙ + oo˙ }o v o˙ l˙ ˙u}u ]R v R v v o} G] r.oo o] ]vP
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Patient

Linda
“It is very important to me and others like
me, that new innovations are developed
in clinics so that we can continue to
have hope for better treatments and
an improved quality of life.’’

48 | ITP Patient ITP Patient | 49

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50 | Our
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F]P P SIMPLE Av}˙TM v ABDEGTM Rv}o}P] } R v o (} }vP}]vP v ( ]o X C u ` } } `oo }o v R (˙
`}l ]v }v } ` ] P X
` }v]v `]R ]} ] X F]vo o (}u R CULMINATE ]o `]oo v ]v ]` (}uX
A }( ]v]u (}u R ELEVATE ]oU `R]R ] ovP u ]v }u]v}v `]R v}o˘ v -
]]v ]v v`o˙ ]Pv} U oo˙ v `]R AML `R} ]vo]P]o (} ]vv] Ru}R˙U R v v
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]` (}uX
ARGX-119
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Iv Jv˙ U ` vv}v R ARGXr ı ] v v}˙ R P MUSKU }]v o} R v}u o
iv}vU ]v v P}v] } vP uvvX W]vv } o} ARGXr ı ]v vP }( v}u o ] U } -
voo˙ ]vo]vP }vPv]o MGU R]˙ ˙ }( u˙Rv] P] U MUSK MGU }]uuv ˙
}( u˙Rv] P] U ]vo u o }R˙ ~ SMAZ v ALSU }R U v}u o ]v]}v X
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ARGX-118
WR ˘] } }}v } ˘o]o˙ ] ]PR } ARGXr U R]PRo˙ ]+v v}˙ P]v Go -
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vr U R }]v }( CR}rL˙v ˙o U `R]R ]uo] ui} }v]} } Ru v } R
- ]v }( u oP X ARGXr R R (}oo}`]vP ]+v ( P
Cell {  ] }v v}o P ]vv } u oPP]vP U oP vu v ]v ]`˙ ]vGuu}vV
{  ] R v] uRv]u }( }v `]R } ˙or]}o]vP } V v
{  ] } }vo ]v ]`˙ ]vGuu}v ] `R u oPP]vP o˙ l˙ }o U ]vo]vP ovP 'l
SIMPLE Antibody with ABDEG } Ru ˘ }vU ooP] }vR}ou}v˙ P]oo}] U v R}v] R]v}]v] `]R vo }o˙ X
FcRn Target ARGXr ` o} v }oo}}v `]R VIBX L }u]}v `}l }v ARGXr (} ]`˙ ]vGuu}v
`]oo }vv ]v X
 Our Products and Product Candidates | 55
ARGX-120
Iv]}vU`o}]vPRGX
A ‑Uvv}˙P]vvv]o}P`]Ro]}v]v}]uuv]X
Other Partnered Programs
S }v X SC}oo}}v APuv _ v Xæ SL]v APuv _ (} ]}v }( }oo}}v v o]v
Puv R ` R v ]v} } (R oP } IIPX
1.4 Collaboration Agreements
W(}oo}` ]]o]v P˙ } u˘]u] R o }( } ]o]v ˙ ovv]vP } ]v oo o}uv v }uu
]o]}v ]PR } R} } v } v] R ` o] ` v ouo˙ }uu]o] (oo˙U
]( } X
WR v U v ov } }vv } vU } v } v] R ` o] R }u]]vP
o]˙ ]v ] } R v }o}v R u˙ v. (}u } }( }R ]}Ru o }u
v] X W˘ } }vv } }oo} o o˙ `]R Ru o v ]}Rv}o}P˙ }uv] } oP
} o}u Rv}o}P˙ v o } v] o}uv X WR v ]v} uoo }oo}}v
Puv `]R Ru o v U `R]R ] o}`X
1.4.1 Our Strategic Partnership with AbbVie for ARGX-115 (ABBV-151)
Iv A ]o U ` v ]v} }oo}}v Puv `]R A V] SXÁXRXLX ~
ARGXr æ ~ABVr æ Z v ]uuv}R˙ P]v R v}o P GARP ~R
ARGXr æ ~ABVr æ Z uo}˙ } SIMPLE Av}˙¡ Rv}o}P˙ v `}l ˙ uovP v []uuv ˙
u L u} R R ]uuv ˙u ˙ }r}vP ]uuv} ] oo R TP X Uv R
u }( R A V] C}oo}}v APuv U ` }v]o (} }v vP v (v]vP oo ARGXr æ ~ABVr æ Z
R v o}uv ] } }uo}v }( INDrvo]vP ] X
WR Pv A V] v ˘o] }}vU (} ]. ]} (}oo}`]vP }uo}v }( INDrvo]vP ] U } }
]v `}o`] U ˘o] o]v } R ARGXr æ ~ABVr æ Z }Pu } o} v }uu]o] } X F}oo}`
]vP R ˘] }( R }}vU A V] `]oo i } ]o]Pv }o]P}v ]v }( }vv}v }( o}uv
v }uu]o]}v }( R o]v } ~ ZU v A V] `]oo }oo˙ }v]o (} oo RU o}uv v
Po}˙ } ovP } R } X
Iv A P U A V] ˘] ] }}v } o} v }uu]o] ARGXr æ ~ABVr æ Z v R v}` u
o}uv }o]P}v U ]vo]vP R }o }v]]o]˙ (} oo RU o}uv v Po}˙ } ovP }
ARGXr æ ~ABVr æ Zr } X Si } R }vv]vP }P }( ARGXr æ ~ABVr æ Z ˙ A V] U `
o]P]o } ] o}uv U Po}˙ v }uu]o u]o}v ˙uv ]v PPP u}v }( } ¤ X
u]oo]}vU ¤ ı X u]oo]}v v ¤ æX u]oo]}vU o˙U `oo }˙o }v } o vP vP]vP
(}u R u] r]vPo ]P] } R o}` v U i } }u˙ }v X
P v } R A V] C}oo}}v APuv U ` R R ]PR U }v } r˙r} ] U } }r}u} ARGXr
æ ~ABVr æ Zr } ]v R E }v E}v}u] A ~
} }`v ( }v}o}P˙ }Pu ~]( v˙ZX TR }r}u}}v +} `}o P}v ˙ }r}u}}v Puv
vP} ]v P}} (]R ˙ R X
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o]}(~]Rv]o
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56 | Collaboration Agreements
A V] u˙ u]v R A V] C}oo}}v APuv (} v˙ }v }v ]} `]'v v} } X A V] [}˙ -
o˙ ˙uv }o]P}v ˘] U }v } r˙r} v }v˙r˙r}v˙ ] U }v R R ] R o }( ~]Z
R u R v} o] o]u }]vP R } U ~]]Z ˘]}v }( Po}˙ } ul ˘o]]˙ ]v
}( R } } ~]]]Z v ˙ L R . }uu]o o }( R } }o ]v R }v˙ v R A V]
C}oo}}v APuv X
PART I
1.4.2 Our Strategic Partnership with Zai Lab for efgartigimod
Iv Jv˙ U ` v ]v} }oo}}v Puv `]R Z ] L U }uu]orP ]}Ru o }u -
v˙U ovP } v ˘o] }ro]v (} R o}uv v }uu]o]}v }( (PP]u} ]v G CR]v U
]vo]vP u]vov CR]v U H}vP K}vP U T]`v v M ~R Zai Lab AgreementZX P v } R Z ] L APuv U
- Z ] L }]v R ˘o] ]PR } o} v }uu]o] (PP]u} ]v G CR]v X Z ] L `]oo o} }v -
] CR]v v } } Po}o PR ]o }( (PP]u} X A ]}voo˙U R Z ] L APuv ] ˘ }
o (PP]u} Po}o o}uv ˙ ]v]vP uoo PR }}(r}(r}v ]o ]v v` }]uuv
]v]}v v } ]]}vX Iv oU Z ] L `]oo ovR }}(r}(r}v ]o ]v `} v` l]v˙ }v]}v ]v
P LN v MNX
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Pvv}vr]oUv}vr(voo}uv}rR]vP˙uvUv`]PPv]}vo¤æX
u]oo]}vu]o}v˙uv(}oo}`]vPR}o}((PP]u}]vRUXSXWo}o]P]o}]}˙o
~u]rv}o}`r`v}vvP]Z}vvvovo}((PP]u}]vGCR]vX
AbbVieZ } o} v }uu]o] 1.4.3 Our Collaboration with Genor Biopharma for ARGX 109
AbbVie Collaboration AgreementZX
- Iv O} U ` v ]v} v ˘o] o]v Puv `]R B] R}l B]}U Iv X ~ Bird Rock BioU (}uo˙ lv}`v
R]Y] Iv X v AvR} U Iv XZU } o} v }uu]o] ARGXr ıU `R]R uo}˙ } SIMPLE Av}˙¡ v
NHv Rv}o}P] v o}l ]vol]v ~IL ZU oo ]Pvo]vP }]v R ] v ]u}v ] }( ]vGuu}˙
}v ]uo] ]v R v]}v (}u } R}v] ]vGuu}vX Iv U ` v B] R}l B]} u oo˙ P
} u]v R] ˘o] o]v Puv X F}oo}`]vP R u]v}v }( } Puv `]R B] R}l B]}U ` P
- ] o]v]vP Puv `]R Gv} B]}Ru C}X L ~ Genor BiopharmaZ v Gv} B]}Ru }vv } -
- o} ARGXr ı (} R CR]v ulX
1.4.4 Our Strategic Partnership with LEO Pharma for LP0145
Iv M˙ æU ` v ]v} }oo}}v Puv `]R LEO PRu AlS ~ LEO PharmaZ } o} v }uu]o -
] LP æ (} R uv }( u}o}P] ]v]}v ]v}o]vP ]vGuu}v ~R LEO Pharma Collaboration Agree-
mentZX LP æ uo}˙ } SIMPLE Av}˙¡ Rv}o}P˙ v o}l R ]vol]vr } ~ILr RZ ]v } } v -
o] R ]Pvo]vP }( ˙}l]v ]uo] ]v }]uuv ] }( R l]vX P v } R LEO PRu C}oo}}v
APuv U LEO PRu (v u} Rv Ro( }( oo } o}uv } } CTA }o }( . } ]v
PR o]v]o ]oU `]R } R }( R } U `R]R ` R] ]v A ]o X S]v RvU LEO PRu
R v }oo˙ }v]o (} (v]vP R o]v]o o}uv }( R }PuX Iv M˙ U CTA }o }( PR
o]v]o ]o (} LP æ ` ] X
EEAZ v S`]ov v } }u]v R } `]R
U R}PR ]. ]} U LEO PRu u˙U P]v ˙uv }( v }}v ( } U ˘] v }}v } }]v v
˘o] U `}o`] o]v } (R o} v }uu]o] } U (}oo}`]vP `R]R LEO PRu `]oo u
(oo }v]]o]˙ (} R }vv o}uv U uv( v }uu]o]}v }( R } v i }
]o]Pv }o]P}v ]v }( }vv}v }( o}uv v }uu]o]}v }( R } X W o]P]o }
] ]}vo o}uv U Po}˙ v }uu]o u]o}v ˙uv ]v PPP u}v }( } ƒ X u]o -
- o]}vU `oo }˙o }v } o vP vP]vP (}u R o}` ]vPo ]P] } R o}` v U i
} }u˙ }v X
Collaboration Agreements | 57
I( R }}v ] v} ˘] U ]( LEO PRu } v} u P o}uv ]o]Pv }o]P}v `]R]v ].
u U } ]( R LEO PRu C}oo}}v APuv ] u]v }R Rv (} }v }( } R } ]v}ov˙U `
R R ]PR } o} v }uu]o] LP æ o}v U i } } }o]P}v } ˙ LEO PRu o}`r]vPo ]P]
vP }˙o }v v o }( v˙ } } ˙ v˙ LEO PRu v U lv}`rR}` } ]PR ]v R
o Pv v R }oo}}vX
Uvo o] u]v U R u }( R LEO PRu C}oo}}v APuv v }v R o }( ~]Z R ˘]
}v }( R }}v ]} U ~]]Z R ˘]}v }( R o o]v Pv v R Puv U v ~]]]Z R (o.ouv }( oo
˙uv }o]P}v v R Puv X LEO PRu u˙ u]v R LEO PRu C}oo}}v APuv (} v˙
}v }v ]} `]'v v} } X LEO PRu [}˙o˙ ˙uv }o]P}v ˘] U }v } r˙r} v
}v˙r˙r}v˙ ] U }v R o }( ~]Z u `Rv v} o] o]u }]vP R } U v ~]]Z ~ Z ]v ui} u
l }v] `]R v} }u}]}v }( u' v }]vP R } U R ˘]}v }( R ˘o]]˙ ]} }
~ Z ]v }v] R v} ui} ul }v] U }o r]P] vu }( ˙ L R . }uu]o o }( R
} }o ]v R }v˙X
Iv U ` ]Pv `} uvuv } R LEO PRu C}oo}}v APuv U } ˘v LEO PRu [}}v ]}
`]R ]˘ u}vR U } oo}` LEO PRu } v l Ru]˙U uv(]vP v }v}o ~CMCZ o}uv `}l ]v
v }( R ˘] ˙ LEO PRu }( ] }}vU v vP R }]]}v P]vP R uvPuv }( v X
1.4.5 Our Research Collaboration with Staten for STT-5058
IvJv˙æU`v]v}}oo}}vPuv`]RSvB]}Rv}o}P˙BXVX~
]o]}]vR}(˙o]]u]R˙~R Staten Collaboration AgreementZXTR}PR}]}v
R]v}]P]vRuvP`]RRov]vR.o}(˙o]]u]vl}]}o
]v}uuv(RR}Pu(}P`]RRov]vRXTR.R
}PuvRSvC}oo}}vAPuv]v.STTrææ(}Ruv}(˙o]]u]R]v]o
}v]XSTTrææuo}˙}SIMPLEAv}˙¡Rv}o}P˙vo}lAPOCUu}o]P]v}o]v]
Po˙]u}o]uXSv]v]}]vP]v.r]vrRuvo]v]o]o}(STTrææXSv˘]]˘o]}}v
}o]vSTTrææ]vMRX
Pv}RSvC}oo}}vAPuvUR`vi}]vo˙}v]o(}}vvPRv
uoo˙PRovU`]RSv]u]vP(}oo}}(˙]vP}}R}v]]o]v
RR}PuXSv]}v]o(}]}voo]v]oo}uvX
OvR}Pur˙rR}Pu]U`RPvSvv}}v}}]vv˘o]U`}o`]U
uvvo]v}RUo}v}uu]o]}]v.]vR}Pu`]R]v].]}}(
uXI(Sv˘]R]}}v(}}~]R(}STTrææZU]`]oo}o]P}˙vP}(v˙
˙uv˙o}}}vRo(}(Sv[RR}o]v]vvU]vo]vPRRvP}(}v}oUv˙o]v]vPU
oU]}]}v}]u]ov}v}(R}U}}R`](}uRRUo}uv}}uu]o]}v}(
R}U]vRUv]vP}vRP}(o}uvvvP]vP}Ro}`r`vUi}}`v`
}}}voiuv]vRv}}v}(R}(}uRo]ov}v}v}]vo˙uv
(}R}v]XSv]vR]o]Pv}o]P}v}}vv}o}v}uu]o]o}v
}]vPRu}(RSvC}oo}}vAPuvX
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v}v`]RRSvC}oo}}vAPuv]vv}PRvo`]R]vu}vR}(R+
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1.4.6 Our Strategic Collaboration with Shire
Iv F ˙ U ` v ]v} }oo}}v Puv `]R SR] AG ~
58 | Collaboration Agreements
- U R}PR ]. ]} U ` R Pv SR] v ˘o] }}vU P]v ˙uv }( }v ru }}v ( U }
Staten}Z o}v}uu
- Iv D u U ` v ]v} }oo}}v Puv `]R C]oP U v 8o] }( Jvv PRu o U Iv X
ShireU v}` lv}`v SR] Ivv}vo
GuH Z } ] } U o} v }uu ]o] v} o Ruv R ] v]}] P]v } R P }
] U v vu ] ~R Shire Collaboration Agreement Z X P v } R SR] C }oo } ]}v
A P uv U (} v˙ P o (} ˙ v R }oo } ]}v U R ] `}l }P R } }v R
v o}uv R}PR ] } ˙ }( v]}] `]R ]v ](]]˙ (} v (v ]}vo ]]˙ P]v R}
PX
PART I
}]v oo ]PR U o v ]v ]v v˙ v}] ]} v ˙ v } }]v v ˘o] U `}o`] o]v
v } ]voo o }˙ `R]R ] v ˙ } (R o} v }uu]o] } ]v}}vP R
v}] X F}oo}`]vP R ˘] U SR] R R ]o]Pv }o]P}v } }vv } o} v }uu]o] o
- }v o]v } X
SR] u˙ ˘] ˘o] }}v } o} v }uu]o] }Pu ]]vP v } ˘v Puv
P]v v }}v ( X Iv Jo˙ U SR] ˘] R v ˘o] }}v } ]vro]v v v}˙ ]} v
o} ]vP } o]v Rv}o}P] U ]PP]vP u]o}v ˙uv ˙ SR] } X
Iv ]}v } }}v ( U SR] ] }o]P } ˙ }v r} ] }v R]uv }( ]. o} -
uv U Po}˙ v }uu]o u]o}v v vP }( v o }˙o˙X A }]vPo˙U ` o]P]o
} ] ˙uv ]v PPP u}v }( } ¤ X u]oo]}vU ¤ Xæ u]oo]}v v ¤ Xæ u]oo]}vU }v R]uv }(
o}uv U Po}˙ v }uu]o u]o}v U o˙U (} } Pv P]v }v }( R R ]v]o
P vu ]v R SR] C}oo}}v APuv X F} } Pv P]v ]}vo P U o}uv
v Po}˙ u]o}v ˙uv u]v R u U v ` o]P]o } ] ˙uv ]v PPP u}v }(
- } ¤ X u]oo]}v (} R]uv }( }uu]o u]o}v X TR }˙o ˙o } U ]vPo ]P] v
i } }u˙ }v X
I( SR] } v} ˘] ] }}v `]R } v˙ ]} v}˙ `]R]v ]. ]} U ` ( }
RU o} v }uu]o] v}] ]v o}v } R o]o ˙ P U i } vP}}v }( o] -
- v (}u SR] (} R }( v˙ v}] R ` ]} ]vP R o]o ˙U } v˙ SR] }v.vo
]v(}u}vU SR] ]voo o }˙ } SR] []v ]v v˙ i}]v ]voo o } ˙X I( ~ Z SR] ~]Z } v} ˘ -
] ] }}vU } ~]]Z ˘] ] }}v o v}v o}uv }( R v}˙ } ~]]]Z R SR] C}oo}}v
APuv ] u]v }R Rv (} } R } ]v}ov˙U v ~ Z SR] ] v} o}vP ]vP o}uv
}Pu `]R } R o]o ˙ P U ` u˙ o } }vv R o}uv }( R v}˙ }
}o } v ˘v U i } vP}}v }( o]v (}u SR] v `R]R SR] `]oo ] ]R ]. }˙o -
U ]( ` }uu]o] R }Pu }o U } vP }( o]v]vP v U ]( R }Pu ] vo˙
o]v } R] ˙X
Uvo o] u]v U R }oo}}v u v `]R R ˘]˙ }( R o }˙o˙ u v R SR] C}oo} -
}v APuv X E R }˙o˙ u ˘] U }v } r˙r} v }v˙r˙r}v˙ ] U }v R R ] R
o }( ~]Z R u R v} o] o]u }]vP R } } ~]]Z v ˙ L R . }uu]o o }(
R } }o ]v R }v˙ v R SR] C}oo}}v APuv X SR] u˙ u]v R Puv (} v˙
}v }v ]} `]'v v} } X
1.4.7 Our Strategic Partnership with Janssen for cusatuzumab
(JanssenZU ]]˙ }( J}Rv}v J}Rv}vU } i}]vo˙ o} v }uu]o] u ~R Janssen Collabora-
tion AgreementZX
W` v}. }( Jvv[ ]]}v } ]}vv R }oo}}v Puv ]vP Poo˙ Ro ]vP
}uu]' uvP }v Jv U X F}oo}`]vP u]v}v }( } }oo}}vU ` R o R C]oP }vv }
}}voo˙ } R uv v (}oo}`r }( v v}oo ]v }vP}]vP u o]v]o ]o X S }v
X Xæ SIuuv}o}P˙ Ivv}}v P}Pu_X
Collaboration Agreements | 59
1.5 License Agreements
W ˙ } o o]v Puv v `R]R ` o]v v U v o]}v v }R ]voo o
}˙ } R] X WR o} v ]v} o o]v Puv v `R]R ` o]v v U v
o]}v v }R ]voo o }˙ (}u R] X L]v Puv v o } R v o}
uv v l} }uu]o]}v }( R ov } v] ~v Rv}o}P] Z } } X TR o]v ]vo
o o } ˙ } }u }( } } v] v }u }( R F vP]v]vP Rv}o}P] R ` X S}u
}( R o]v ]u} ]} ]o]Pv v .vv]o ˙uv }o]P}v }v X W˘ } }vv } v ]v}
R ˙ }( o]v Puv ]v R ( X
1.5.1 Our Exclusive License with Elektrofi for efgartigimod
Iv A ]o U ` v ]v} }oo}}v v o]v Puv `]R Eol}.U } ˘o} v` SC (}uo}v (}
R } ] R Ruv FRvU ]vo]vP (PP]u} U v } }v ]}vo P ~R
AgreementZX TR Eol}.rvo (}uo}v ]u } }u} ]}vo }}vo]˙ (} v R}PR r
R}u v o(ru]v]}v ]o] X
Uv R u }( R Eol}. APuv U ` `]oo ul v (}v ˙uv v ( u]o}v ˙uv }
}R P v]vP R]uv }( r.v o}uv U Po}˙U v }uu]o u]o}v X Eol}. `]oo o}
] u] r]vPo ]P] }˙o˙ }v o }( }uu]o] } X
1.5.2 Our Non-Exclusive Research License with Chugai for SMART-lg® and ACT-lg®
Iv Su U ` v ]v} v}vr˘o] R o]v v }}v Puv `]R CRP] PRu o
C}XU L X ~ChugaiZ oo}`]vP CRP] [SMARTroP v ACTroP F vP]v]vP Rv}o}P] (} }vvP (]
]o]˙ ] X TR Rv}o}P] ]Pv } vo } ˘v R R ]v˘ }( } } v] U
`R]R ] R } `v }˘] v R } U ˙ }voo˙ u}](˙]vP R] Ro(
] P ov v }v˙X
1.5.3 Our Non-exclusive License with the Clayton Foundation for DHS mutations
Iv O} U ` v ]v} v}vr˘o] R Puv `]R R Co˙}v F}v}v ovP } R
v}vr˘o] ]vro]v (} R Co˙}v F}v}v[}]˙ DHS u}v } ˘v R u Ro(ro]( }( R
v] X
1.5.4 Our Exclusive License with Halozyme for ENHANZE®
Iv F ˙ ıU ` v ]v} v ]vro]v Puv `]R Ho}˙u Iv X ~
u]o v lv}`rR}` }`v ˙ Ho}˙u v ovP } ] ENHANZE Rv}o}P˙ ~
R .o }( v}v v uv }( Ruv ] ~R ENHANZE® License AgreementZX P v } R EN
HANZE L]v APuv U ` ` Pv ˘o] ]PR } o˙ ENHANZE } ]}o}P] } P]v r]
. P U ]v } } RU o} v }uu]o] SC (}uo}v }( } R v}˙r }
v] X
O . R P (} `R]R ` R ] v ˘o] o]v (}u Ho}˙u ] FRvU `R]R oo}` }
o˙ ENHANZE } (PP]u} v v˙ }R } v] o v ]. (} FRvX M}}U R R
}( } ˘o] o]v } FRv o ]R Ho}˙u ]o( } v˙ }( ] v } ( v (}u o]]vP
ENHANZE ]v R }v˘ }( v FRvrP } X O }v R P (} `R]R ` ] v ˘o]
60 | License Agreements
o]v (}u Ho}˙u ] Ruv C }] `]R R } v] ARGXr U `R]R ] ]vP o} }
}]uuv ] X P v } R ENHANZE L]v APuv U ` o} R R ]PR } v}u]v (
P (} v ˘o] ENHANZE o]v ]( R P ]v }v R v} o˙ v o]v ˙ Ho}˙u } ] v}
o˙ ]vP ˙ Ho}˙u X F}u R + }( R ENHANZE L]v APuv U ` R (} r˙
]} ]v `R]R } }v R v o]v]o ] }v }R Pr]. u}oo ]v }u]v}v `]R EN -
HANZE v u˙ v}u]v u˘]uu }( }v ]}vo P ` R v} ˙ v}u]v (} v ˘o] }uu]o
PART I
- o]v ]vP R (} r˙ uX
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Iv v (} R]]vP R . v } (} (PP]u} r PR (} ITP ` u ¤ æ u]oo]}v u]o}v ˙uv
]v F ˙ X U}v v}u]v}v }( v˙ ( P (} v ˘o] }uu]o]}v o]v v }v.u}v ˙
Ho}˙u R R o]v ] ]oo U ` `]oo ˙ ¤ u]oo]}v } Ho}˙u P X W`]oo }o]P } ˙ o]v -
]o o}uv U Po}˙ v }uu]o u]o}v }o]vP ¤ u]oo]}v (} R . } R ENHANZE
v ] ]. (} P]v P X TR}PR} R u }( R ENHANZE L]v APuv U ` u }] Ho}˙u
}v v vvo ] P]v (} «vP } oo }i u]o}v ˙uv (} } (} R (}oo}`]vP (}
ov X W o} }o]P } ˙ Ho}˙u vP }( v o }˙o˙ }( v˙ o]v } -
R ENHANZE X TR] }˙o˙ ] `]R v o }ou U vP]vP (}u R o}` } u] r]vPo ]P] U v ] ]
Elektrofi ˙ u˘]uu }( æA9 ]( (}oo}`]vP v ˙ (}u R . }uu]o o }( R } ]v }v˙U R o
o] o]u `]R]v R o]v ENHANZE v ~ Z ˘] X WR ]o]Pv }o]P}v `]R } R }vv -
}v }( o}uv v }uu]o]}v }( } v] U ` v} }o]P } o] ENHANZE (}
˙ } v] ] } P]v ˘o] P ~ ZX
Iv O} U ` R ˘v } }oo}}v `]R Ho}˙u (} ENHANZE P o]˙ Rv}o}P˙ } ]vo
R ]}vo ˘o] P }v v}u]v}v ]vP]vP R }o } ]˘ }vo P X
P v } R ENHANZE L]v APuv U ` R R ]PR } Pv o]v } } ]]] v } R]
}R (} Rlo]v]o `}l ~(} ˘uo U } }v} Z v (} o}uv v }uu]o]}vX
Ho}˙u R v} ]PR } v˙ }( } v } ( } v] `R]R ENHANZE X Ho}˙u }] -
] ]o] } } `R]R ] R } v ˙ }( o]v]vP ENHANZE } ] }oo}} X
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Wu˙ u]v R ENHANZE L]v APuv v˙ u U ]R ]v ] v˙ } }v Pr˙rP ] U ˙
‑o](U v}vU }( v]vP Ho}˙u ]} `]'v v} X A v o˙ u]v}vU R ENHANZE L]v APuv `]oo }uoo˙
˘] }v R ˘]˙ }( } }˙o˙ ˙uv }o]P}v v R Puv X Iv R v R ENHANZE L]v
APuv ] u]v (} v˙ }vU R o]v Pv } `}o u]v Ho}˙u `}o Pv }
o]v ] o]v (}oo}`]vP R u]v}vX Iv R v R ENHANZE L]v APuv ] u]v
}R Rv (} } RU ` `}o ]v R ]PR } oo o]v } Rv }v Rv (} ]v ]} }( u
}ru]v}vX
- A o} } ]v R SC}} G}vv _U } v}vr˘ ]} Ju MX D o˙ ] o} v}vr˘
uu }( R } }( ]} }( Ho}˙u X D ] R] U } v]vP ]v} R ENHANZE L]v APuv `]R
Ho}˙u ` v} o ˙ v }v ]v }v `]R IAS r Ro P˙ D]o} U ]v MX D o˙U ]v
R] }o v}vr˘ ]}U } v} }v}o } R ]Pv].v ]vGv } Pv˘ } Ho}˙u X MX D o˙ ]
v} ] ]v v˙ ] ]}v v ]]}v ul]vP ovP } R ENHANZE L]v APuv X C}v vo˙U v}
(R ]o} P]vP Ho}˙u R v ]v R X X W Ro P˙ Tv }v X
HalozymeZ (} R }( ]v v U
ENHANZE®ZU (} o]}v ]v
- 1.5.5 Our Exclusive License with AgomAb for ARGX-114 (AGMB-101)
-
Iv MR ıU ` v ]v} v ˘o] }ro]v `]R AP}uA TR NV ~ AgomAbZ (} R }( ]v
v ]PR ovP } } }]˙ ] }( Rv}o}P] (} R o}uv v }uu]o]}v }( ]
}( P}v] v rMET SIMPLE Av}] U ]vo]vP ARGXr ~AGMBr ZU v HFGru]u SIMPLE Av}˙¡ ]
P]v R MET }X AP}uA ] ] } }uu]oo˙ }vo +} } o} v }uu]o]
o }v o]v } X Iv }vv}v `]R } v˙ ]v} R] Puv U ` ] }.rR]vP .
`R]R vo } A9 }( oo ]]}v } AP}uA [RR}o ~`R]R Roo } A9 (}oo}`]vP R .o]vP
}( v ]vP}vo v` P ~ INDZ v ] i } (R iuv }v R } v }( ]v .vv]vP ZX
License Agreements | 61
U}v R } v }( o]. ]v]o o] }+ }( AP}uA U R }.rR]vP . `]oo }uoo˙
}v ]v} R ]ov vu }( }]v˙ R ]v AP}uA X TR] Puv ] i } u o u]v}v
(} u]o R } ]v}ov˙ v }uoo˙ ˘] }v R ˘]}v }( R o } ˘] }( } o]v
v ]PR X
1.5.6 Our Exclusive License with Broteio for ARGX-117
Iv MR U ` v ]v} }oo}}v `]R B}]} ]v }vv}v `]R } ]uuv}o}P˙ ]vv}}v }PuU }
o} v v}˙ P]v v}o P ]v R }uouv U ARGXr ~R
u }( R B}]} APuv U ` v B}]} i}]vo˙ o} R }uouvrP v}˙ } l }
o]R o]v]o }}(r}(r}v ]vP } }]˙ ] }( Rv}o}P] X U}v (o }uo}v }( R ] U
` ˘] v ˘o] }}v } ]vro]v R }Pu ]v MR v u }v]]o]˙ (} (R o
}uv v }uu]o]}vX P v } R B}]} APuv U ` }o]P } ulu]o}v ˙uv }v
R } v }( ]v o}uv u]o}v ~ } v PPP }( ƒ X u]oo]}vZU }uu]o]}v u]o}v
~ } v PPP }( ƒ X u]oo]}vZ v ˙ }˙o }v v o ]v R o}` ]vPo ]P] X Wu˙ u]v R
B}]} APuv (} }vv]v }v ı ˙ ]} `]'v v} X TR B}]} APuv ] o} i } u o
u]v}v (} u]o R } ]v}ov˙ v }uoo˙ ˘] }v R ˘]}v }( } .vv]o }o]P}v
RvX
1.5.7 Our Exclusive License with VIB for ARGX-118
Iv N}u U ` v ]v} }oo}}v v } ]uuv}o}P˙ ]vv}}v }Pu `]R VIB } o}
v}] P]v Govr U R }]v }( CR}rL˙rv C ˙o U `R]R o˙ ui} }o ]v Ru v R
]v }( u oP U ]vo]vP ARGXr ~R VIB AgreementZX P v } R VIB APuv U ` v VIB i}]vo˙
o} v}] P]v Govr ]vP } }]˙ ] }( Rv}o}P] X U}v (o }uo}v }( R]
]v]o RU ` ˘] v ˘o] }}v } ]vro]v R }Pu v u }v]]o]˙ (} (R o
}uv v }uu]o]}vX Uv R VIB APuv U ]vo]vP uv ]v N}u U ` }o]P }
ulu]o}v ˙uv }v R } v }( ]v o}uv u]o}v ~ } v PPP }( ƒ X u]oo]}vZU
}uu]o]}v u]o}v ~ } v PPP }( ƒ X u]oo]}vZ v ˙ }˙o }v v o ]v R o}` ]vPo
]P] X Wu˙ u]v R VIB APuv (} }vv]v }v ı ˙ ]} `]'v v} X TR VIB APuv ]
o} i } u o u]v}v (} u]o RU ]v}ov˙ } ]v v RoovP v }uoo˙ ˘]
}v R ˘]}v }( VIB[o]v v ]PR X
1.5.8 Our Exclusive License with the University of Texas for NHance® and ABDEG™
Iv F ˙ U ` v ]v} v ˘o] ]vro]v `]R TR B} }( RPv }( TR Uv]]˙ }( T˘ S˙u
(UoTZ (} }( ]v v ]PR ovP } R NHv o}u (} v˙ `}o`] ~R
TR U}T APuv ` uv }v D u U } o} ]vo ]v ]}vo v ]PR ovP } R
ABDEG¡ o}uX U}v }uu]o]}v }( v˙ }( } } R R ]vro]v v ]PR U ` `]oo }o]
P } ˙ U}T vP }( v o }˙o˙ vo R ˘]}v }( v˙ v }]vP R } X TR] }˙
o˙ ] `]R v o }ou v ] i } v iuv (} }˙o ` ] (}u o]v }( } ]PR
v R U}T APuv U ]v v˙ v } v} ˘ A9X Iv ]}vU ` u ul vvo o]v u]vvv
˙uv } U}T vo u]v}v }( R U}T APuv v ` R u ]v o}uv v }uu]o
u]o}v ˙uv v ]u uv }o]P}v W o} R ]o]Pv ]uv `]R } o}uv
v }uu]o]}v }( } `R]R R ]vro]v v ]PR X
P v } R U}T APuv U ` u˙ Pv o]v } R] X I( ` ] v˙ v}vr}˙o˙ ]v}u ]v
}vv}v `]R R o]v U ` u ˙ U}T vP }( R ]v}u ˙]vP (}u o}`ru]o ]vPo ]P] }
u]o r ]vPo ]P] v]vP }v R v }( R o]v X SR ( `] ]( o]v P } ˙
R u]o}v ˙uv (}R ]v R U}T APuv X
62 | License Agreements
Wu˙ v]ooo˙ u]v R U}T APuv (} }vv]v }v ]} `]'v v} X A v o˙ u]v}vU
R U}T APuv `]oo }uoo˙ ˘] }v R ˘]}v }( oo ] v v .o v o]}v `]R]v
R v ]PR } ˙ R U}T APuv X O }˙o˙ ˙uv }o]P}v ˘] U }v } r˙r} v
}v˙r˙r}v˙ ] U R u R v} o] o]u }]vP R } X
1.5.9 Our Non-Exclusive License with BioWa for POTELLIGENT®
PART I
Iv O} U ` v ]v} v}vr˘o] ]vro]v Puv `]R B]}WU Iv X ~ BioWaZ (} }( ]v
Broteio AgreementZX Uv R v v lv}`rR}` }`v ˙ B]}W v ovP } ] POTELLIGENT o}u Rv}o}P˙U (} ]v R .o }(
- v}v v uv }( Ruv ] ~R POTELLIGENT® License AgreementZX P v } R POTELLIGENT
L]v APuv U ` Pv v}vr˘o] ]PR } POTELLIGENT } RU o} v }uu]o]
- v}] v } }v]v]vP R v}] ]vP POTELLIGENT X B]}W ]v ]PR }( . vP}}v (} R
˘o] ]PR } o} v }uu]o] U ]v ]v }v] }vo˙U v˙ } ` o} ]vP POTELLIGENT X W
(oo˙ o] POTELLIGENT } u U v v rCD uA U v ARGXr U v v r rM uA U v R
POTELLIGENT L]v APuv X
U}v }uu]o]}v }( } } o} ]vP POTELLIGENT U ` `]oo }o]P } ˙ B]}W vP
}( v o }( o]v } }˙o˙X TR] }˙o˙ ] `]R v o }ou U vP]vP ]v R o}` ]vPo ]P] U
v ] ] ˙ Ro( ]( ]vP R (}oo}`]vP v ˙ (}u R . }uu]o o }( R } ]v }v˙ R
o o] o]u `]R]v R o]v v ~ Z R } R } ˘] } v X Iv ]}vU ` u ul vvo
R o]v u]vvv ˙uv `R]R `]R }uuvuv }( } }˙o˙ ˙uv } B]}WX WR
]o]Pv ]uv `]R } R }vv}v }( o}uv v }uu]o]}v }( } X WR
o} u ]v o}uv U Po}˙ v }uu]o u]o}v ˙uv }o]P}v v u } }v
} }P }` R]]vP R u]o}v }v v vvo ] X M]o}v } ] }v }uu]o -
Pr˙r}uu]o P ] U v ` }o]P } ulu]o}v ˙uv ]v PPP u}v }( } ¤ X
u]oo]}v }uu]o P R}o ` R] vvo Po}o o }( } ¤ X ]oo]}vX
-
P v } R POTELLIGENT L]v APuv U ` R R ]PR } Pv o]v } R] X
Wu˙ u]v R POTELLIGENT L]v APuv v˙ u ˙ v]vP B]}W ]} `]'v v} X A v o˙
u]v}vU R POTELLIGENT L]v APuv `]oo }uoo˙ ˘] }v R ˘]˙ }( } }˙o˙ }o]P}v
v R POTELLIGENT L]v APuv X Iv R v R POTELLIGENT L]v APuv ] u]v (} v˙
}vU R o]v Pv } `}o u]v B]}W`}o Pv } o]v ] o]v (}oo}`]vP R
u]v}vX Iv R v R POTELLIGENT L]v APuv ] u]v }R Rv (} } R } ]v}ov˙U
` `}o ]v R ]PR } oo o]v } Rv }v Rv (} ]v ]} }( u }ru]v}vX
1.5.10 Our Non-Exclusive Licenses with BioWa and Lonza for POTELLIGENT® CHOK1SV
UoT AgreementZX
T} o } }v }( } } v] u v ARGXr (} o]v]o ]o v }uu]o o˙U
- ` ] o]v } GMP oo o]v ]v `R]R POTELLIGENT v}] }o ˘ X TR] oo o]v U POTELLI-
- GENT® CHOK1SVU ` i}]vo˙ o} ˙ B]}W v L}v X Iv D u v A P U o˙U ` v -
]v} v}vr˘o] }uu]o ]vro]v Puv (} u v ARGXr `]R B]}W v L}v So
AG ~L}v Z (} R }( ]v v v lv}`rR}` ovP } R POTELLIGENT CHOK SV Rv}o}P˙U `R]R ]
}u]v}v }( L}v [GS ˙u v B]}W[POTELLIGENT o}u Rv}o}P˙U (} ]v R .o }( v}v v
uv }( Ruv ] X Uv R u }( R }uu]o o]v U ` ] v}vr˘o] ]PR }
RU o} v }uu]o] } }v]v]vP v v}˙ Pv ].oo˙ P]v ]. P
]vP POTELLIGENT CHOK SVU vuo˙ R P CD ]v R }( u v rM ]v R }( ARGXr X
B}R P ]Pv P v R POTELLIGENT L]v APuv U `R]R }vv } P}v
} RU o}uv v }uu]o]}v }( } o]]vP POTELLIGENT X Uv R u }( R }uu -
]o o]v U B]}W ]v ]PR }( . vP}}v (} R ˘o] ]PR } o} v }uu]o] U ]v ]v }v -
] }vo˙U v˙ } ` o} ]vP POTELLIGENT CHOK SVX TR] ]PR }( . vP}}v ] v} o]o ]v
License Agreements | 63
`R ` ]vv } Pv Po}o o]v } R] ˙ } o} v }uu]o] } X B]}W ]v ]PR
}( . vP}}v (} R ˘o] ]PR } o} v }uu]o] } v r rM v}˙ ARGXr U ]v ]v
}v] }vo˙X
U}v }uu]o]}v }( } } o} ]vP POTELLIGENT CHOK SVU ` `]oo }o]P } ˙ }R B]}
W v L}v vP }( v o }˙o˙X W ] } ˙ }˙o˙ } B]}W}v v o (} v˙ ](
] o]v } v }vo˙ }v o]v W ]R R POTELLIGENT L]v APuv } R Puv ]v o}v }
POTELLIGENT CHOK SVU v} }RX TR B]}W}˙o˙ ] U vP]vP ]v R o}` ]vPo ]P] v ] ˙ Ro(
]( ]vP R (}oo}`]vP v ˙ (}u R . }uu]o o }( R } ]v }v˙ R o o] o]u `]R]v R
o]v B]}W v ~ Z R } R } ˘] } v X TR L}v }˙o˙ ] }v `RR R }
] uv( ˙ L}v U } R] ˙U ]v v˙ v ] ]v R o}` ]vPo ]P] v ] ˙ Ro( ]( ]vP
R (}oo}`]vP v ˙ (}u R . }uu]o o }( R } ]v }v˙ R o o] o]u `]R]v R o]v
L}v v ~ Z R } R } ˘] } v X Iv ]}vU ` u ul vvo }uu]o o]v u]v
vv ˙uv } B]}W}v } ] `R]R `]R }uuvuv }( ˙uv }( R B]}W}˙o˙ (}
R } U v vvo ˙uv } L}v ]v R v R v˙ } ] uv( ˙ ˙ }R
Rv L}v U } }v }( } 8o] } P] v vu ]v R Puv X
WR u ]v o}uv U Po}˙ v }uu]o u]o}v ˙uv }o]P}v } }R B]}W v
L}v v u } }v } }P }` R]]vP R u]o}v }v v vvo ] X W ] } ˙
R u]o}v } B]}W v }vo˙ }v o]v W ]R R POTELLIGENT L]v APuv } R Puv
]v o}v } POTELLIGENT CHOK SVU v} }RX P˙uv o } R o}uv v }uu]o]}v }(
u v ARGXr (} v v R] POTELLIGENT CHOK SV Puv X M]o}v }
] }v } r˙r} ] U v ` }o]P } ul o}uv U Po}˙ v }uu]o u]o}v
˙uv } B]}W]v PPP u}v }( } ¤ X u]oo]}v } R}o ` R] Po}o vvo o }(
¤ X ]oo]}vX W }o]P } ul o}uv U Po}˙ v }uu]o u]o}v ˙uv } L}v }
U o} v]vP }v R } ]vP uv( ˙ L}v U } }v }( } 8o] } P] v
} }R`] X
Uv R u }( }R u v ARGXr }uu]o o]v U ` R R ]PR } Pv o]v }
]v r} R] U }R`] u }]v B]}W v L}v [ ]} `]'v }vv X
Wu˙ u]v v˙ }( R v}vr˘o] }uu]o o]v Puv v˙ u ˙ v]vP B]}W v l} L}v
]} `]'v v} X A v o˙ u]v}vU R Puv `]oo }uoo˙ ˘] }v R ˘]˙ }( } }˙o˙
}o]P}v v R Puv X Iv R v v Puv ] u]v (} v˙ }vU R o]v Pv
} `}o u]v B]}W v L}v `}o Pv } o]v ] o]v (}oo}`]vP R
u]v}vX Iv R v v Puv ] u]v }R Rv (} } (]o } ulu]o}v } }˙o˙ ˙uv U
` `}o ]v R ]PR } oo R } Rv }v Rv (} ]v ]} }( u }ru]v}vX O
}˙o˙ ˙uv }o]P}v ˘] U }v } r˙r} v }v˙r˙r}v˙ ] U }v R R ] R o }(
~]Z v ˙ L R . }uu]o o }( R } }o ]v R }v˙ v R Puv } ~]]Z R u
R v} o] o]u }]vP R } X
1.5.11 Our non-exclusive license with Lonza for Multi-product GS Xceed-License
Ov F ˙ U æ ` v ]v} v}vr˘o] uo r} ]vro]v Puv `]R L}v ~R
AgreementZ (} }( L}v [}]˙ Pou]v ˙vR Pv ˘ ]}v ˙u lv}`v GS X ¡ }v]vP
}( CR]v Ru }˙ oo o]v v R } (} R uv( ]vP }( P v ~R S˙uZX TR S˙u ]
(} R uv( ]vP }( (PP]u} U u ARGXr U ARGXr ı v LP æX
P v } R Mo rP} APuv U ` R R ]PR } Pv o]v } ]v r} R]
`]R} ]} `]'v }vv }( L}v U }R`] u }]v L}v [ ]} `]'v }vv X
64 | License Agreements
WR u ]v o}uv U Po}˙ v }uu]o u]o}v ˙uv }o]P}v } L}v X W
] } ˙ R u]o}v }vo˙ ]v }( R . } uv( ]vP R S˙uX W }o]P }
ul o}uv U Po}˙ v }uu]o u]o}v ˙uv } L}v ]v PPP u}v }( } ‹æ æU (}
R . } uv( ˙ L}v U } }v }( } 8o] } P] v X TR}PR D u U U `
- R ] L}v v PPP u}v }( ‹ X u]oo]}vU `R]R ]vo u]o}v ˙uv u v R Mo rP}
- APuv X U}v }uu]o]}v }( } } o} ]vP R S˙uU ` `]oo }o]P } ˙ L}v
PART I
vP }( v o }˙o˙ (} R } uv( X TR L}v }˙o˙ ] U vP]vP ]v R o}` ]vPo
]P] v ] ˙ Ro( ]( R } ]v }v˙ ] v} } ˙ o] o]uX
Wu˙ u]v R Mo rP} APuv }v } r˙r} ] ˙ P]]vP L}v ]} `]'v v} X
L}v u˙ u]v R Mo rP} APuv }oo˙ ]v }( R } ]v}ov˙ v X A v o˙ u]v -
}vU R Mo rP} APuv `]oo }uoo˙ ˘] }v R ˘]˙ }( R o o] o]u (} R } X W
- } } P] v `}o ]v R ]PR } oo R } Rv }v Rv }ru]v}vX
1.5.12 Our Collaboration with UCL and Sopartec for GARP
Iv Jv˙ U ` v ]v} }oo}}v v ˘o] } o]v Puv `]R Uv]] C R}o]
L}]v ~ UCLZ v ] Rv}o}P˙ v( }uv˙ S} SXAX ~S} Z } ]} v o} v}o Ruv R -
v}] P]v GARP ~R GARP AgreementZX P v } R GARP APuv U R ˙ ` }v]o (}
oo }( ] }`v } v ]v }vv}v `]R R ] ]Pv } ] v u oo˙ P R ovX
Iv Jv˙ æU ` ˘] R }}v ` R v Pv v R GARP APuv } v ]v} v ˘o] U
`}o`] }uu]o ]vro]v (} }( ]v GARPro ]voo o } ˙ ]PR }`v ˙ UCL v R
- L`]P Iv (} C v R R } (R o} v }uu]o] o]v } U ]vo]vP R GARPrv -
o]]vP v}˙ ARGXr æ ~ABVr æ Z `R]R ` ]} v R }]P]vo }oo}}v ~R GARP LicenseZX
U}v R ˘]}v }( R GARP APuv U R GARP L]v `}o }u (oo˙ ] U o `}o`]
˘o] o]v v R GARP ]voo o } ˙ (} v˙ } U i } UCL[ v}v }( v}vr}uu]o
- R ]PR X
P v } R GARP L]v U ` u˙ Pv o]v } R] v 8o] }( R R] X F}u v˙
]v}u ` ] ]v }vv}v `]R R o]v U R ]v }vv}v `]R A V] C}oo}}v APuv U
` u ˙ S} vP }( R ]v}u ]v R o}` v ]P] vP X R}˙o˙ ˙uv }o]P}v ˘] }v
} r˙r} v }v˙r˙r}v˙ ] `Rv R v} o] o]u }]vP R ARGXr æ ~ABVr æ Z
} X W o} R ]o]Pv }o]P}v `]R } R }vv o}uv v }uu]o]}v }( ARGXr
æ ~ABVr æ Z } X
1.5.13 Our Exclusive License with NYU Langone Health and LUMC for ARGX-119
Iv ı v U ` v ]v} }oo}}v v ˘o] o]v Puv `]R NYU LvP}v HoR v LUMC
v } ]uuv}o}P˙ ]vv}}v }Pu } o} v}] PvP R MSKU (} R uv v}u o
] U `R]R o˙ ui} }o R v}u o iv}v ~R NYU v LUMC AgreementsZX P v } R NYU
v LUMC APuv U ` U NYU v LUMC i}]vo˙ o} v}] P]v MSK ]vP } }]˙ ] }(
Multi-Product Rv}o}P] X Uv R NYU v LUMC APuv U uv U ` }o]P } ulu]o}v ˙uv }v
R } v }( ]v o}uv u]o}v U }uu]o]}v u]o}v v ˙ }˙o }v v o ]v
R o}` ]vPo ]P] X
License Agreements | 65
1.6 Distribution Agreements
1.6.1 Our Exclusive Distribution Agreement with Medison for efgartigimod
Iv O} U ` vv}v v ˘o] ]]}v Puv `]R M]}v } }uu]o] (PP]u} (}
PMG ]v IoV v R Puv U M]}v `]oo o} }v]o (} l]vP ]] Po}˙ }o X
1.6.2 Our Exclusive Distribution Agreement with Genpharm for efgartigimod
Ov Jv˙ U U ` v ]v} vR] Puv `]R GvRu S] FZrLLC ~
GvRu Roo R VYVGART¡ (}u (} R o ]v R Go( C}}}v C}v]o ~
(} GvRu[}`v }v v }`v vu ~R Genpharm AgreementZX
1.7 Manufacturing and Supply
W o] R] r ˙ }v uv( `R} ]v }v `]R R FD[A P}} o}}˙ ~
v P}} uv( ]vP ~ cGMPZ (} R uv( }( P v v P } X A R }(
R] URDU ` }v `]R L}v ]v So}PRU Uv] K]vP}uU P}u}RU UXSX v S]vP} (} oo ] o
]vP } R o}uv }( } oo vl U o}uv }( } uv( ]vP } v R uv( ]vP }( oo P
v U R˙ ]vP o] v oo ˙u }o˙ ]v } ]v ˙X W ]}vo }v
uv( } .ooU ooU lP U } v ]] ]vP}vo P } X
(PP]u}
E U u U ARGXr U ARGXr U ARGXr ı v LP æ R uv( ]vP R S˙uU `R]R
]vo v ]v ˙rv uuuo]v oo o }( CR]v Ru }˙ oo o]v R ˘ R } U
(}oo}` ˙ uoo ].}v v .o}v ˙]oo˙ ]v }]vP u}v}o}vo v}] X S o} }v
XæX SO v}vr˘o] o]v `]R L}v (} Mo r} GS X rL]v _X
Aoo }( } v}] uv( ˙ vP `]R oo U `R]R } ]v oo vlX WR }v u oo
vl (} R } uv( ]v }v `]R GMPX Ho( }( R u oo vl ] } ]
} v R U ]v }( }R] v }v ] U 8]v ]o }( R u oo vl `}o u]v R
ov }P ] } }vv uv( ]vPX
1.8 Intellectual Property
1.8.1 Introduction
W ] } } R }]˙ Rv}o}P] R ` o] ]u}v } } ]v U ]vo]vP ]vP v
u]v]v]vP v }}v ]vv } } R o}u Rv}o}P] ]v}} ]v}U } } } U }
} v] U R }u}]}v }( u' }( } } v] v R] uR} }( U `oo }R
]vv}v R ]u}v } } ]v X Iv ]}v } v }}vU ` o} o˙ }v ul v
} } }( } ]v R v} uvo }U } R ` } v} }v] }] (}U v
}}vU ]vo]vP ]v }( } oou ]uuv]}v v v}˙ 8v]˙ u }v }R X
66 | Distribution Agreements
O }uu]o v ]v }v } ]o]˙ } }]v v u]v]v v v }R }]˙ }}v
(} }uu]oo˙ ]u}v Rv}o}P] U ]vv}v v lv}`rR}` o } } ]v U (v v v(} }
]voo o } ˙ ]PR U oo˙ } v ]PR U R }v.vo]˙ }( } v }
`]R} ]v(]vP]vP o] v v(} o ]voo o }˙ ]PR }( }R X S].oo˙U ` u]oo˙ vv
}v v v }R }]˙ }}v o } } } o}u Rv}o}P] U ] ]v R X X WPo -
(}u TRv}o}P] U v } } v] U ] ]v R X X W P} C v] P O WR}oo˙rO`v
PART I
P}Pu v R X X W P} C v] P O Pv P}Pu X
TR v }]}v (} ]}Rv}o}P˙ }uv] o]l Pvoo˙ v ]v v v ]v}o }uo˘ oPoU ]v.
v ( o ] X Iv ]}vU R }P o]u ]v v o]}v v ]Pv].vo˙ (} v
] ] U v ] } v ]v v v RoovP L ] v X A o U ` vv} Pv R
v˙ }( } o}u Rv}o}P] v } v] `]oo } o } u]v } ˙ v(} o v X
GenpharmZU v `R]R W vv} ] `RR R v o]}v ` vo˙ ]vP `]oo ] v ]v v˙ o i] -
GCCZ }v v ˘o] ] ]}v } `RR R o]u }( v˙ ] v `]oo }] 8]v }]˙ }}v (}u }u} X Av˙
v R ` R}o u˙ RoovP U ]uv } ]vo] ˙ R] X
A }( Jv˙ U U } v }}o]} ~`R]R ]vo }R }]˙ v ]vro]v v (u]o] Z }u]
}˘]uo˙ Pv v v }˘]uo˙ v]vP v o]}v U ]vo]vP }˘]uo˙ æ
] UXSX v U }˘]uo˙ æ Pv E }v v v }˘]uo˙ æ ] v ]v }R
i]]}v X
GLPZ v 1.8.2 Platform Technologies
- W]R P } } o}u Rv}o}P] U ` }`v } R ]voo o } ˙ ]PR ] } } SIMPLE Av}˙¡
]}˙ o}uU R ABDEG¡ v NHv o}u v R POTELLIGENT o}uX
W]R P } } SIMPLE Av}˙¡ ]}˙ o}uU ` }`v v (u]o˙ }v]v]vP ]˘ ] UXSX v `]R
}u}]}v }( u' o]u ] } R]u] v}] }v]v]vP ]o }u]v }u]]vP CDR }]v
(}u }vv}vo R}u] oou v}] ( } }v } u} }u]v }( Ruv v}˙U }o˙vo -
} v}]vP R R]u] v}] U o]] }( ˘ ]}v } }u]]vP DNA v v}]vP uo]
v}] U uR} o]u ] } R }v }( R R]u] v}] U v uR} }( u}ovP R ]v -
]vP }( Ruv P vPv } ] o]Pv } } ˙ u]v]]vP R R]u] v}˙X TR UXSX v
˘ } ˘] ]v ı } X Iv ]}vU R v (u]o˙ }v]v v R R v Pv ]v A o] U
C v U E } U R Uv] K]vP}uU IoU Iv] v JvU v v]vP o]}v ]v CR]v v Jv ~]]]}voZX
Iv ]}vU ` R }v v (u]o˙ }v]v]vP v Pv ]v R Uv] S ~`}ZU A o] U E } U
R Uv] K]vP}uU IoU Iv] v JvU v }v v o]}v v]vP ]v C v U `]R }u}]}v }( u'
o]u ] } R]u] v}˙ }v]v]vP ]o P]}v `]R CDR ] (}u oou v}˙ v ]v
u]v} ] }v } }v]vP } u]v} ] v ]v Ruv Puo]v ]o P]}vX TR Pv v
R ] v ˘]˙ ]v X
W]R P } R ABDEG¡ o}uU ` }r}`v `]RU v ˘o]o˙ o]v (}uU R Uv]]˙ }( T˘ U v (u -
]o˙ }v]v]vP Pv UXSX v `]R }u}]}v }( u' o]u ] } v ]}o FRvrvP}v] }u]]vP
]v ]uuv}Po}o]v F P]}v R]vP v ]v 8v]˙ (} v F Puu } o } `]o r˙ IPG F
P]}vU v uR} }( o]u ] } uR} }( ]vP R v FRvrvP}v] } ]v v}˙ u] -
]} X TR UXSX v v ˘] ]v ~]vo]vP v u iuv ZX Iv ]}vU ]v R] v (u -
]o˙U ` o} R Pv v ]v A o] U CR]v U E ] U E } U JvU M}U M˘]}U N` Z ov v S]vP} U
v ` R v o]}v v]vP ]v UXSX ~]]]}voZ v ]} }R }v] v P]}v ]v N}R Au] U
S}R Au] U E } U A ] v S}R A(] X TR Pv v R ] ˘]˙ ]v X Iv ]}vU ` }`v
}v v (u]o˙ }v]v]vP v]vP v o]}v ]v R Uv] S v æ }R i]]}v `]R o]u
] } uR} }( ]vP R u oo }( v Fr}v]v]vP Pv ]v i ˙ u]v]]vP } R i
v FRvrvP}v] }v]v]vP ]v ]uuv}Po}o]v F P]}v }v]v]vP ]v u]v} ] }v X A UXSX
v U ]( ] (}u R UXSX v o]}vU ] ˘ } ˘] ]v X
Intellectual Property | 67
W]R P } R NHv o}uU ` R ˘o]o˙ o]v (}u R Uv]]˙ }( T˘ `} UXSX v `]R
}u}]}v }( u' o]u ] } v IPG u}oo }u]]vP ]v Ruv F }u]vU v uR} }(
o]u ] } uR} }( o}l]vP FRv (v}v ]v i ˙ }]]vP } R i R v IPG u}oo X TR
UXSX v ˘ } ˘] o] ]v } X TR v (u]o˙ o} ]vo Pv E }v v X
W]R P } R POTELLIGENT o}uU `R]R ] vo˙ ]v R } }v }( } u } v]
U ` R v}vr˘o]o˙ o]v (}u B]}W ]v ]voo o } ˙ ]PR R o } ]+v }(
R POTELLIGENT o}uX
1.8.3 Product Candidates: Our Wholly-Owned Programs
Efgartigimod
W]R P } (PP]u} U (PP]u} ]v}} R ABDEG¡ o}u Rv}o}P˙X
Our ARGX-117 Product Candidate
W]R P } R ARGXr } v] U ` }`v } R ]PR ]v R v (u]o] ~]vo]vP }v ]vro]v
v (u]o˙ (}u B}]}Z `]R o Pv v v v]vP v o]}v ]v uoo i]]}v ]v
N}R Au] U S}R Au] U E } v A ] U ] } }u}]}v }( u' o]u v uR} }( uv
o]u X TR ]vro]v v (u]o˙ (}u B}]} R Pv v ]v A o] U CR]v U E } U H}vP K}vP U M˘]}
v UXSX ~`} ] v ]v UXSXZU `R]R R ] ˘]˙ ]v X TR }R `} v (u]o] R ]
˘]˙ ]v ı v X
Our ARGX-119 Product Candidate
W]R P } R ARGXr ı } v] U ` ]vro]v `} v (u]o] (}ul`]R NYU LvP}v HoRU
UXSX u]o v ]v N` Y}lU v R v (u]o] (}ul`]R R L]v Uv]]˙ M]o C v
(LUMCZU D R Uv]]˙ H}]o ]v L]vU `]R }v UXSX Pv v v o v]vP o]}v ]v
uoo i]]}v X
Our ARGX-118 Product Candidate
W]RP}R ARGXr } v]U`}r}`v}v v(u]o˙`]RVIB`~VIBZUv]vGuu}v
R v]vGRvUB oUv Uv]]]GvU`]R}vUXSXPv v v v]vP v o]}v ]v
uoo i]]}v ]vN}RAu]US}RAu]UE} vA]XTR v(u]o˙R ]˘]˙ ]v ıX
Our Cusatuzumab Product Candidate
W]R P } R u } v] U ` R (} ] UXSX v U v }v oo}` UXSX v
o]}vU ]vo]vP U }v UXSX Pv v `]R }u}]}v }( u' o]u ] } R u v}˙U
}v UXSX Pv v `]R o]u ] } R ]} u ]v }U }v UXSX Pv v `]R o]u
] } }o˙vo} R v} v}] R ]v } R ]} u ]v }U v U }v UXSX Pv
v v }v UXSX oo}` v o]}v `]R uR} }( o]u ] } R uv }( v v
]uuv}o}P]o ]} `]R R u v}˙X TR ] UXSX v ˘] ]v v U `]R} l]vP
}vo v u ˘v]}v ]v} }v X Iv ]}vU ` R v R R v Pv ]v A o] U CR]v U
E } U Iv}v] U IoU Iv] U Jv v R] v v o]}v v]vP ]v B ]o v C v X C u
]v}} } uo}˙ R SIMPLE Av}˙¡ v POTELLIGENT o}u Rv}o}P] X
1.8.4 Product Candidates: Our Partnered Programs
Our ARGX-115 (ABBV-151) Product Candidate
W]R P } R ARGXr æ ~ABVr æ Z } v] U ` }r}`v `]RU v ˘o]o˙ o]v (}uU R L`]P
Iv (} C v R R v Uv]] C R}o] L}]vU Pv UXSX v `]R }u}]}v }( u'
o]u ] } v v}˙ R ]v GARP R v }( TGFrW v uR} }( o]u ] } R }(
R v v}˙ ]v R uv }( vX TR UXSX v R ] ˘]˙ ]v U `]R} l]vP }vo
68 | Intellectual Property
v u ˘v]}v ]v} }v X Iv ]}vU R v (u]o˙ }v]v o v o]}v v]vP ]v
UXSX ~}vv}vr]vr Z v ]} }R }v] v P]}v ]v N}R Au] U S}R Au] U E } v A ] X
FRU ` }r}`v `]RU v ˘o]o˙ o]v (}uU R Uv]] C R}o] L}]v `} u} v (u]o]
`]R }u}]}v }( u' o]u ] } v v}˙ R ]v v ]} }( }uo˘ (}u ˙ Ruv GARP
v TGFrW `oo uR} }( o]u ] } R }( R v v}˙ ]v R uv }( vX TR `}
- v (u]o] R ] ˘]˙ ]v v X FRu} U ARGXr æ ~ABVr æ Z ]v}} } uo}˙
PART I
R SIMPLE Av}˙¡ o}u Rv}o}P˙X
Our ARGX-109 Product Candidate
W]R P } R ARGXr ı } v] U ` R }v v (u]o˙ `]R }u}]}v }( u' o]u ]
} ARGXr ıX TR] v (u]o˙ R Pv v ]v A o] U C v U CR]o U CR]v U C}o}u] U H}vP K}vP U IoU
JvU M˘]}U N` Z ov U R] U UXSX v S}R A(] U v v]vP v o]}v ]v B ]oU Iv] v UXSX ~] -
]]}vo o]}vZX TR v (u]o˙ R ] ˘]˙ ]v X FRu} U ARGXr ı ]v}} } uo}˙
R SIMPLE Av}˙¡ o}u Rv}o}P˙ v R NHv o}u Rv}o}P˙X
Our ARGX-112 (LP-0145) Product Candidate
W]R P } R ARGXr ~LPr æZ } v] U ` R }v v (u]o˙ `]R }u}]}v }( u' o]u
] } v v}˙ R ]v Ruv ILr RX TR v (u]o˙ R ] ˘]˙ ]v X FRu} U ARGXr
~LPr æZ ]v}} R SIMPLE Av}˙¡ o}u Rv}o}P˙X
TR u }( ]v]]o v v }v R oPo u }( R v ]v R }v] ]v `R]R R˙ }]v X
Iv u} }v] ]v `R]R ` .o U R v u ] ˙ (}u R o] }( .o]vP v}vr}]]}vo v
o]}vX
Iv R UXSXU R u }( v }]vP v FDAr} P u˙ o]P]o (} v u ˘v]}v v R
HRrW˘uv A }uv}v (} R o} }( v u ]vP R FDA Po}˙ ]` } X TR ]} }(
˘v]}v u˙ } . ˙ ˙}v R ˘]}v }( R v vv} ˘v R u]v]vP u }( v
˙}v }o }( ˙ (}u R }( } }oX Ovo˙ }v v u}vP R} o]P]o (} v ˘v]}v u˙
˘v X S]u]o }]]}v ]oo ]v E } v ]v ]v }R i]]}v } ˘v R u }( v
R } v } PX I ] }]o R ] UXSX v }]vP R }( } } v] u˙
- vo } v u ˘v]}v X I( } } v] ] FDA }oU ` ]vv } o˙ (} v u
˘v]}v U ]( ]oo U } ˘v R u }( v R } R } } v] X W o} ]vv }
l v u ˘v]}v ]v v˙ i]]}v `R R˙ ]oo U R}`U R ] v} Pv R R o] -
o R}] U ]vo]vP R FDAU `]oo P `]R } uv }( `RR R ˘v]}v R}o Pv U v ](
Pv U R ovPR }( R ˘v]}v X
1.8.5 Trade Secret Protection
-
Iv ]}v } v }}vU ` o} o˙ }v }}v (} } }]˙ ]v(}u}v R ] v}
uvo }U } R ` } v} }v] }] (}U v }}vU ]vo]vP U (} ˘uo U ]v }(
} oou ]uuv]}v v v}˙ 8v]˙ u }v }R X H}`U v ]8o } } X
AoR}PR ` l } } } }]˙ ]v(}u}vU ]vo]vP ]vP } } u] v }
}v.vo ]v(}u}vU `oo v]vP ]v} Puv `]R } uo}˙ U }vov U ]} v }vo
}oo}} U R] u˙ ]vvvo˙ o} R u } ]u]o }]˙ ]v(}u}v } u˙ }R`]
P]v } } }]˙ ]v(}u}vX A o U ` u˙ vo } uv]vP(oo˙ } } v
}]˙ ]v(}u}vX
Intellectual Property | 69
How has life changed because of

Zach
myasthenia gravis?

E ˙R]vP RvP X I } o } } ˙˙
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B˙ R u I ` ]Pv} `]R MGU I }o o˙

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Zach Leans on his
How did you adapt to all these changes
going on in your life? Support System to Help
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70 | Patient Story Patient Story | 71

1.9 Regulation
G}vuv R}] ]v R UXSXU R (oU v o}o ooU v ]v R E }v Uv]}v v }R }v]
v i]]}v U ˘v]o˙ Po U u}vP }R R]vP U R RU o}uv U vP U uv( U o]˙
}v}oU }oU lP]vP U }P U }l]vP U oo]vP U ]vP U }u}}vU ]]}vU ulvP U }r
}o u}v]}]vP v }vP U v ]u} v ˘} }( Ru o } U ]vo]vP ]}o}P]o } X Iv
]}vU }u i]]}v Po R ]]vP }( Ru o } X TR } (} }]v]vP ulvP
}o ]v R UXSX v ]v }R }v] v i]]}v U o}vP `]R v }uo]v `]R o]o
v Po}v v }R Po}˙ R}] U ] R ˘v] }( vo u v .vv]o } X
1.9.1 Licensure and Regulation of Biologics in the U.S.
Iv R UXS X U } } v] v } Po ]}o}P] o } U } ]}o}P] U v R P o]
H oR S ] A ~ PHSA Z U v R F o F}} U D P U v C }u ] A ~
]}v X TR (]o } }uo˙ `]R R o] o UXS X ] uv v˙ ]u ]vP R } o}uv
} U ]vo ]vP v}vo]v] o ]vP v o]v] o ]vP U R } o } } } r } o } u˙ i
v o] v } o˙ ]v R }v }( ˙U Po }˙ ]` v } o U v l} u]v] ] } i ]]o
v ]}v X TR v ]}v u˙ ]vo U v} o]u] }U R FDA[ ( o } oo}` v o] v } }
`]R o]v] o ]vP U ( o } } v]vP o] ]}v U o] v v]}v } } ]}v U ` v]vP } v]o
o U o]]˙U } oo U } ] U } o } ]o v]}v }( } ]}v } ] ] ]}v U
]viv ]}v U (]v v ]]o } ]u]vo ]v ]P]}v v vo] }PR ˙ R FDA } R D uv }( J ]
} }R P} vuvo v]] X
Av o]v l]vP }o } ul v ]] v` ]}o}P] ]v R UXSX Pvoo˙ u (}]o˙ }uo
R }( R (}oo}`]vP P
{  v}vo]v]o o}}˙ U v]uo ] v (}uo}v ] oo (}u ]v }v `]R o]o
Po}v U ]vo]vP R GLP Po}v V
{  u]]}v } R FDA }( v IND o]}v (} Ruv o]v]o vP U `R]R u }u + (} Ruv
o]v]o ]o u˙ P]vV
{  }o ˙ v ]v }vo ]` } ~IRBZ vvP R o]v]o ] (} R o]v]o ]o u˙ ]v] V
{  (}uv }( v `oor}v}oo Ruv o]v]o ]o } o]R R (˙U }v˙ v ]˙ }( R
} v] (} R }} ]v]}vU ]v }v `]R G}} Co]v]o P ~
{  }v v u]]}v } R FDA }( BLA (} ]}o}P]o } vP ulvP (} }v } u} }
} ]v]}v U ]vo]vP u]]}v }( ]o ]v(}u}v }v R uv( v }u}]}v }( R } ]v
o]v]o o}uv v }} oo]vPV
{  ]` }( R } ˙ v FDA ]}˙ }uu]' U ]( o]o V
{  }v } u} FDA ]v }v }( R uv( ]vP (]o]˙ } (]o] U ]vo]vP R} }( R] U `R]R R
} U } }u}vv R}(U } } }uo]v `]R GMP ]uv v } R R
(]o] U uR} v }v}o } R } []v˙U vPRU o]˙ v ]˙V
{  FDA]}(Ro]v]o˙]}}uo]v`]RGCPUvR]vP]˙}(o]v]o]v}}(RBLAV
{  ˙uv }( ( v ]vP FDA }o }( R BLA v o]v }( R v` ]}o}P]o } V v
{  }uo]v `]R v˙ }r}o ]uv U ]vo]vP R }vo ]uv } ]uouv ]l o}v
v u]P}v P˙ ~ REMSZ v v˙ }r}o ] ] ˙ R FDAX
Nonclinical Studies and Investigational New Drug Application
B (} vP v˙ ]}o}P]o } v] ]v Ruv U R } v] u vP} v}vo]v]o vPX
N}vo]v]o ]vo o}}˙ o}v }( } Ru]˙U (}uo}v v ]o]˙U `oo v]uo ]
} o R }vo (} ]˙ v }˘]]˙X TR }v }( R v}vo]v]o v (}uo}v }( R }u}v
(} vP u }uo˙ `]R (o Po}v v ]uv X TR o }( R v}vo]v]o U }PR `]R
uv( ]vP ]v(}u}v v vo˙o U u]' } R FDA }( v IND o]}vX TR IND }u
72 | R
 egulation
]oo˙ }u + ˙ L ] ˙ R FDAU vo (} R u R FDA ] }vv } }v
} R } v] } }v }( R }} o]v]o ]oU ]vo]vP }vv R Ruv R i
`]oo ˘} } v}vo RoR ]l X Iv R U R IND }v} v R FDA u }o v˙ }v]vP
FDA }vv (} R o]v]o ]o v P]vX
A o U u]]}v }( R IND u˙ o ]v R FDA v} oo}`]vP R ]o } }uuv } }v R u }]P]voo˙
PART I
- ]. ˙ R }v} ]v R INDX I( R FDA ] }vv } }v ]R ]vP R] ]v]o r˙ ]} U }
v˙ u ]vP R IND } U ] u˙ R}} } ]u} o } }uo o]v]o R}o X TR] } ] ˙ R FDA
`}o o˙ ]R }} o]v]o ˙ } v]}v }( v }vP}]vP ˙U } ]v R }( o o]v]o
R}o o o]u]}v }v R }v }( R ˙ R }v }( uv U vo oo }v]vP }vv R
v o˙ v R FDA R v}. R }uv˙ R ]vP}v u˙ } v Rv }vo˙ v
u R}] ˙ R FDAX TR] }o ]Pv].v o˙ } ]8o ]v }uovP ovv o]v]o ]o ]v
uo˙ uvvX TR FDA u˙ ]u} o]v]o R}o }v ]}o}P]o } v] v˙ u (} } ]vP o]v]o
]o } (˙ }vv } v}vr}uo]v X
Human Clinical Trials in Support of a BLA
FDCA Z v R] ]uouv]vP Po - Co]v]o ]o]v}o R u]v]}v}(R]vP}vo} v] }RoR˙}ov } v `]R
R ] } v R ]]}v}( o]. ]v]o]vP}]v }v `]RGCP ]uvX
Co]v]o ]o }v v ˙}}}o ]o]vPUu}vP}R R]vPUR}i }(R ˙U]vo]}vv
˘o]}v ]]UR u } ]vu}v]}]vP (˙Uv R +v ]] } o XA}} -
}o(} Ro]v]o ]ov v˙ v}}}ouvuv u u]'}RFDA }(RINDX
A }v} `R} `]R } }v o]v]o ]o }] R UXSX u˙U v v} U }]v FDA R}]}v } }v
R o]v]o ]o v v INDX I( (}]Pv o]v]o ]o ] v} }v v v INDU R }v} u˙ u] (}u
R o]v]o ]o } R FDA ]v } }( R BLA } o}vP R o]v]o ]o ] `oor]Pv v `oor}v ]v } -
v `]R GCPU ]vo]vP ]` v }o ˙ v ]vvv R] }uu]' U v R FDA ] o } o] R
˙ R}PR v }v] ]v }vU ]( v ˙X
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`R]RRo]v]o]o`]oo}vXTRIRB`]oo}v]Uu}vP}RR]vPUo]v]o]o]PvUv]v(}u
}vvUR]o(}vR(˙}(RuviXAvIRBu}]v}uo]v`]RFDPo}v
A XTR
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.v]vPRRo]v]o]o]v}]vP}v]v}v`]RFD]uv
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]v(}u}vvXA]}voo˙U}uo]v]o]o}v˙v]vvvP}}(o].˘}Pv]˙
GCPZV Ro]v]o]o}v}Ulv}`v(˙u}v]}]vP}}}uu]'XTR]P}u˙}uuv}vv}v
- }(R˙ovvURvP]v˙}vU}}v}(R˙]PvRl}]v}v}
]v(}uR˙XIv(}u}v}]vo]v]o]uu]'`]R]v].u(u}R
N}voIv}(HoR(}o]]u]v}v```Xo]v]o]oXP}X
Co]v]o ]o ˙]oo˙ }v ]v R vo R U R R u˙ }o } }u]v X A ]}vo
] u˙ ] L }oX
{  PR o]v]o ]o ]v]oo˙ }v ]v o]u] }o}v } R } v] (} (˙U ]vo]vP
+ U } }ov U }}vU u}o]uU ]]}vU ˘}v v Ru}˙vu] ]v RoR˙
Ruv }U }v }]}vU ]v v U R v v X
{  PR o]v]o ]o Pvoo˙ }v ]v o]u] v }o}v } ]v(˙ }]o + v
(˙ ]l U o R 8˙ }( R } v] (} ]. P ]v]}v v u]v } }o -
v v }uo }P X Moo PR o]v]o ]o u˙ }v ˙ R }v} } }]v ]v(}u}v ]}
} P]vv]vP oP PR o]v]o ]o X
{  PR o]v]o ]o } ]( R PR o]v]o ]o u}v R } vP }( R } v] ]
}voo˙ + v R v o (˙ }.o X PR o]v]o ]o v lv `]R]v v ˘v
v }o}v } PR ]}vo ]v(}u}v } (˙ v +v v ˙ } o R }oo
- v.r]l o}vR] }( R P v } }] v ] (} R˙]]v oo]vPX
 Regulation | 73
Iv }u U R FDA u˙ } BLA (} } v] ] R }v} } }v ]}vo o]v]o
]o } (R R } v] [ (˙ v +v L }oX SR }r}o ]o
˙]oo˙ ( } PR o]v]o ]o X TR ] } P]v ]}vo ˘]v (}u R uv }(
v ]v R ]vv R ]v]}v v } }uv o]v]o v. ]v R }( ]}o}P] } v
o }o Po}v X I( R FDA } } `R]o }uv˙ R }vP}]vP o]v]o ]o R ` v}
v ˙ (} }oU }uv˙ u˙ o } R (}u R o]v]o ]o } u oo } }( v˙ PR
o]v]o ]o ]uv } } RvP ]v R } oo]vPX F]o } ˘R]] ]o]Pv `]R P }
}v vP ] PR o]v]o ]o }o o ]v `]R`o }( }o (} } X
P}P } ]o]vP R o }( R o]v]o ]o U u}vP }R ]v(}u}vU u u]' o vvoo˙
} R FDA v `]'v IND (˙ } u u]' } R FDA v R ]vP} .Lv ˙ L R ]o
}v} u]v R ]v(}u}v o]. (} }vP (} ]} v v˘ v U .v
]vP (}u }R ] } v]uo } ]v ]} vP R PP ]Pv].v ]l (} Ruv i v v˙ o]v]oo˙
]u}v ]v ]v R }( ]} }v } R o] ]v R }}}o } ]vP}
}R X TR }v} u o} v}(˙ R FDA }( v˙ v˘ (o } o](rRv]vP }v
}}v }]o ]v v} o Rv v ov ˙ L R }v} []v]o ] }( R ]v(}u}vX
A P ]vP ] ]v o]v]o ]o u˙ u ]oo } ]v]]o v ]v ]v ]uv X P v }
R C v˙ C A U uv U R uv( }( v ]vP}vo P (} ]} ] } }v]}v
] ] } ul ]oo U R ˙ }vP }v ] `] U ] }o]˙ }v ovP v }v]vP } (}
]v]]o v } R ]vP}vo PX TR] ]uv o] }v R o] }( R . ]v]}v }(
PR } PR ]o }( R ]vP}vo P U } o]o U æ ˙ L R P ] ]Pv}v
lR}PR R˙U ( l } U } Pv v R˙X
Compliance with cGMP Requirements
B (} }]vP BLAU R FDA ˙]oo˙ `]oo ]v R (]o]˙ } (]o] `R R } ] uv( X TR FDA
`]oo v} } v o]}v vo ] u]v R R uv( ]vP } v (]o] ]v (oo }uo]v
`]R GMP ]uv v } }v]v } }v }( R } `]R]v ] ].}v X
TR PHSA uR] R ]u}v }( uv( ]vP }v}o (} } o]l ]}o}P] `R} '] vv}
]o˙ .v X TR uv( ]vP } u o }( }v]vo˙ }]vP o]˙ R }( R }
v] v U u}vP }R R]vP U R }v} u o} uR} (} vP R ]v˙U vPRU o]˙U }v˙U
v ]˙ }( R .vo ]}o}P]o } X A ]}voo˙U }] lP]vP u o v U v ]o]˙
] u }v } u}v R R ]}o}P]o } v] } v} vP} v o ]}
}v } ] Ro( o](X
Mv( v }R ]v}o ]v R uv( v ]]}v }( } u o} P] R] o]R
uv `]R R FDA v ]v Pv] X B}R }u v (}]Pv uv( ]vP o]Ruv u P]
v }] ]}vo ]v(}u}v } R FDA }v R] ]v]o ]}v ]v R uv( ]vP } X Av˙ }
uv( ˙ } ]u} (}u (]o]˙ R R v} P] U `RR (}]Pv } }u U ] u u]v
v R FDCAX E o]Ruv u˙ i } ]}] vvv}v ]v }v ˙ P}vuv R}] }
v }uo]v `]R GMP v }R o` X Mv( u˙ R } }] U }v U o}v] } R˙]o
} P]vP R] o]Ruv X D o˙]vP U v˙]vP U o]u]vP U } (]vP ]v }v ˙ R FDA u˙ o } }
]vP u } o X
Review and Approval of a BLA
TR o }( } v] o}uv U v}vo]v]o vP v o]v]o ]o U ]vo]vP vP } u]P}
o `oo }] .v]vP U u]' } R FDA }( BLA vP o]v } ul R } X
TR BLA u }v]v ˘v] uv( ]vP ]v(}u}v v ]o ]v(}u}v }v R }u}]}v }( R }
v }} oo]vP `oo ˙uv }( ( X
TR FDA R ˙ L u]]}v }( R o]}v } }v v ]v]o ]` } u]v `RR R BLA ]
8]v } (} .o]vP }v R Pv˙ [RR}o u]v}v R ] ] 8]vo˙ }uo } u]
v ]`X I( R FDA u]v R BLA ] v} 8]vo˙ }uo U ] `]oo ( R BLAX Ov R u]]}v
R v (} .o]vP U R FDA P]v v ]vrR ]` }( R o]}vX Uv R P}o v }o]] P
74 | R
 egulation
} ˙ R FDA v R P ]}v D P U F A ~ PDUFAZ R FDA R v u}vR ]v `R]R } }uo ] ]v]o
]` }( v o]}v v }v } R o]v U v ]˘ u}vR (} ]}]˙ ]` }( v o]}vX TR
FDA } v} o`˙ u ] PDUFA P}o (} v v ]}]˙ ]` X TR ]` } u˙ ]Pv].vo˙
˘v ˙ FDA (} ]}vo ]v(}u}v } o].}vX TR ]` } v R PDUFA P}o u˙
o} ˘v ˙ R u}vR ]( R FDA } ]( R o]v }R`] }] ]}vo ]v(}u}v }
o].}v P]vP ]v(}u}v o˙ }] ]v R u]]}v `]R]v R o R u}vR (} R PDUFA
PART I
P}o X
Ov R ] }( R FD[A o}v }( R o]}v v }uv˙]vP ]v(}u}vU ]vo]vP R o }( R
]v }v }( R uv( ]vP (]o] v v˙ FDA ] }( o]v]o ]o ] } }uo]v `]R GCPU R
FDA u˙ ] v }o o'U } }uo }v o'X Av }o o' R}] }uu]o ulvP }(
- R } `]R ]. ]]vP ]v(}u}v (} ]. ]v]}v X Uv R PHSAU R FDA u˙ } BLA ](
] u]v R R } ] (U v }v v R (]o]˙ `R R } `]oo uv( u
v ]Pv } v R ] }vv } (U v }v X I( R o]}v ] v} } U R FDA
u˙ ] }uo }v o'U `R]R `]oo }v]v R }v]}v R u u ]v } } .vo }o
}( R o]}vU v `Rv }]o `]oo }o]v }uuv }v R }v} u]PR l } }]v }o }(
R o]}vX S}v} R ] }uo }v o' u˙ u] } R FDA ]v(}u}v R v
}uo }v } R ] ]v. ˙ R FDA } `]R` R o]}v } R]vPX TR FDA `]oo v}
} v o]}v vo ] ]v. ]v R }uo }v o' R v X
TR FDA u˙ o} ( R o]}v } v ]}˙ }uu]' (} ]`U o}v v }uuv}v }
`RR R o]}v R}o } X Iv oU R FDA u˙ ( o]}v (} v}o ]}o}P]o } }
]}o}P]o } R v ]8o }v }( (˙ } 8˙ } v ]}˙ }uu]' X T˙]oo˙U v ]}˙
}uu]' ] vo }( ]v vv ˘ U ]vo]vP o]v]]v v }R ]v. ˘ U R ]` U o
v }] }uuv}v } `RR R o]}v R}o } v v `R }v]}v X TR FDA
] v} }v ˙ R }uuv}v }( v ]}˙ }uu]' U ] }v] R }uuv}v (oo˙ `Rv
ul]vP ]]}v X
I( R FDA } v` } U ] u˙ o]u] R } ]v]}v (} }( R } X I u˙ o} ] R
}v]v]}v U `v]vP } }v ]vo ]v R } oo]vPX Iv ]}vU R FDA u˙ oo (} }r -
}o ] U ]vo]vP PR o]v]o ]o U } (R R } [ (˙ L }oX TR Pv˙ u˙ o}
] vP v ]oov }Pu } u}v]} R } L }uu]o]}vU } ]u} }R }v]}v U
- ]vo]vP ]]}v ]}v } }R ]l uvPuv uRv]u U ]vo]vP REMSU } Ro v R R v -
. }( R } }`]PR R }vo ]l X REMS v ]vo u]}v P] U }uuv]}v ov (} RoR
}(]}vo U v ouv } ( ~ ETASUZX ETASU v ]vo U v} o]u] }U ]o ]v]vP }
- .}v (} ]]vP } ]v]vP U ]v]vP }vo˙ v ]v ]uv U ]o u}v]}]vP v R
}( v P]] X TR FDA u˙ v } o]u] (R ulvP }( } }v R o }( }rul
] } ]oov }Pu X AL }oU uv˙ ˙ }( RvP } R } } U R ]vP v`
- ]v]}v U uv( ]vP RvP v ]}vo oo]vP o]u U i } (R vP ]uv v FDA
]` v }oX
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SR Po}˙ ]` v o ]v v]o } u}].}v }( R ovv RvP U } ]uv } }v ]}v -
o } o}v R v voo˙ o˙ } ]v R } }( R ovv RvP X
Fast Track, Breakthrough Therapy and Priority Review Designations
TR FDA ] R}] } ]Pv ]v } (} ˘] ]` ]( R˙ ]vv } v vu
u]o v ]v R uv }( ]} } o](rRv]vP ] } }v]}vX TR }Pu ( } (
l ]Pv}vU lR}PR R˙ ]Pv}v v ]}]˙ ]` ]Pv}vX
TR FDA u˙ ]Pv } (} ( l ]` ]( ] ] ]vv U `RR o}v } ]v }u]v}v `]R }v }
u} }R } U (} R uv }( ]} } o](rRv]vP ] } }v]}vU v ] u}v R
}vo } vu u]o v (} R ] } }v]}vX F} ( l } U }v} u˙ R
P ]v}v `]R R FDA v R FDA u˙ ]v] ]` }( }v }( ( l } [ o]}v (}
R o]}v ] }uo X TR] }oo]vP ]` u˙ ]oo ]( R FDA u]v U L o]u]v˙ o}v }(
 Regulation | 75
o]v]o u]' ˙ R }v}U R ( l } u˙ + X TR }v} u o} }] U v R
FDA u } U Ro (} R u]]}v }( R u]v]vP ]v(}u}v v R }v} u ˙ o]o
( X H}`U R FD[A u ]} P}o (} ]`]vP ( l o]}v } v} P]v vo R o }v }( R
o]}v ] u]' X F l ]Pv}v u˙ `]R`v ˙ R FDA ]( R FDA o] R R ]Pv}v ]
v} o}vP } ˙ uP]vP ]v R o]v]o ]o } X
A } u˙ ]Pv lR}PR R˙ ]( ] ] ]vv U ]R o}v } ]v }u]v}v `]R }v } u}
}R } U } ]} } o](rRv]vP ] } }v]}v v o]u]v˙ o]v]o ]v ]v]
R R } u˙ u}v vo ]u}uv } ˘]vP R] }v }v } u} o]v]oo˙ ]Pv].v
v}]v U R vo uv + } o˙ ]v o]v]o o}uv X TR FDA u˙ l ]v }v
`]R } lR}PR R] U ]vo]vP R}o]vP uvP `]R R }v} R}PR} R o}uv }
V }]]vP uo˙ ] } R } }v} P]vP o}uv v }oV ]v}o]vP u} v]} + ]v
R ]` } V ]Pv]vP } r]]o]v˙ }i o (} R ]` uV v l]vP }R } ]Pv R
o]v]o ]o ]v v 8]v uvvX
TR FDA u˙ ]Pv } (} ]}]˙ ]` ]( ] ] } R ]} }v]}v v U ]( } U
`}o }] ]Pv].v ]u}uv ]v (˙ } +v X TR FDA u]v U }v r˙r ] U `RR
R }} } v ]Pv].v ]u}uv `Rv }u `]R }R ]oo R] X S]Pv].v
]u}uv u˙ ]oo ˙ ]v }( ]v +v ]v R uv }( }v]}vU o]u]v}v }
vo }v }( uvro]u]vP } }vU }uv vRvuv }( v }uo]v R
u˙ o } ]u}uv ]v ]} }}u v ]v }( (˙ v +v ]v v` }o}vX A ]}]
˙ ]Pv}v ] ]vv } ] }oo 'v}v v } } R o}v }( R o]}v U v } R}v
R FD[A P}o (} l]vP }v }v ulvP o]}v (}u v u}vR } ]˘ u}vR X
Accelerated Approval Pathway
TR FDA u˙ Pv o }o } } (} ]} } o](rRv]vP }v]}v R }] uv]vP(o
R vP } v } ˘]vP uv }v u]v}v R R } R v +
}v }P v}]v R ] }vo˙ o]lo˙ } ] o]v]o v. } }v o]v]o v}]v R v u
o] Rv v + }v ] ]o u}]]˙ } u}o]˙ ~ IMMZ v R ] }vo˙ o]lo˙ } ] v + }v
IMM } }R o]v]o v. U l]vP ]v} }v R ]˙U ]˙U } ov }( R }v]}v v R ]o]o]˙ }
ol }( ov uv X P} Pv o }o u u R u }˙ v (} (˙
v +v R} Pv ]}vo }oX
F} R } }( o }oU }P v}]v ] ulU R o}}˙ u uv U
]}rPR] ]uP U R˙]o ]PvU } }R u R ] R}PR } ] o]v]o v. ] v} ]o( u
}( o]v]o v. X S}P v}]v v }Lv u u} ]o˙ } u} ]o˙ Rv o]v]o v}]v X Av
]vu] o]v]o v}]v ] u uv }( R + R ] }v] }vo˙ o]lo˙ } ]
R o]v]o v. }( } U R v + }v IMMX TR FDA R o]u] ˘]v `]R o }o
}v ]vu] o]v]o v}]v U R ]v] R R v}]v Pvoo˙ u˙ } o
}o `R R R + u ˙ R v}]v ] v} ]o( o]v]o v. v ] (} ]}vo
}oU ]( R ] ] (} }vo]vP R R R + ] }vo˙ o]lo˙ } ] R ou o]v]o
v. }( } X
TR o }o R`˙ ] u} }Lv ]v «vP ]v `R]R R } }( ] ] o}vP v v ˘v
]} }( u ] ] } u R ]vv o]v]o v. }( } U v ]( R + }v R }P }
]vu] o]v]o v}]v } ]o˙X TR U o }o R v ˘v]o˙ ]v R o}uv
v }o }( } (} uv }( ]˙ }( v ]v `R]R R P}o }( R˙ ] Pvoo˙ } ]u}
]o } u}]]˙ v R }v }( R ˙]o ] } ] ovPR˙ v }uu oP ]o }
u}v o]v]o } ]o v. X
TR o }o R`˙ ] oo˙ }vvPv }v }v} [Puv } }v U ]v ]o]Pv uvvU
]}vo }r}o }v.u}˙ ] } ](˙ v ] R } [o]v]o v. X A o U }
v] } }v R] ] ] i } ]P}} }rulvP }uo]v ]uv U ]vo]vP R }uo
}v }( PR } }r}o o]v]o ]o } }v.u R + }v R o]v]o v}]v X F]o } }v ]
76 | R
 egulation
}r}o ] U } }v.u o]v]o v. ]vP }rulvP ] U `}o oo}` R FDA } `]R` R
} (}u R ul }v v ˘] ] X Uvo }R`] ]v(}u ˙ R FDAU oo }u}}vo u]o (}
} v] } v o Po}v i } ]} ]` ˙ R Pv˙X
Post-Approval Regulation
I( Po}˙ }o (} ulvP }( } } v` ]v]}v (} v ˘]vP } ] }]v U R }v} `]oo
PART I
] } }uo˙ `]R oo }r}o Po}˙ ]uv `oo v˙ }r}o ]uv R
R FDA R ]u} }( R }o } X TR }v} `]oo ] } } ]v }v
v } }v }ou } R FDAU }] (˙ v 8˙ ]v(}u}v v }uo˙ `]R ]uv
}vv]vP ]vP v }u}}vo oo]vPX Mv( v }R ]v}o ]v R P o˙ R]v (}
- ]}v P v ]}o}P]o } u o} }uo˙ `]R } l]vP v ]vP ]uv v (} v} -
(˙]vP R FDA }( }v(] U ] U }ov v ]vv}voo˙ o } } } R }R`] v.
(} ]]}v ]v R UXSX Mv( v ]v }( R] }v} ] } P] R] o]Ruv
`]R R FDA v ]v Pv] U v i } ]}] vvv}v ]v }v ˙ R FDA v ]v
Pv] (} }uo]v `]R }vP}]vP Po}˙ ]uv U ]vo]vP GMP Po}v U `R]R ]u} ]v
} o v }uv}v ]uv }v uv( X A }]vPo˙U R }v} v ] R] r ˙ uv -
- ( u }vv } ˘v u U u}v˙ v +} ]v R }( } }v v o]˙ }v}o } u]v]v
}uo]v `]R GMP Po}v v }R Po}˙ ]uv X
A ]}o}P]o } u˙ o} i } }8]o o} o U uv]vP R R uv( ] ] } (}u
- ]v }v R o} }( R } (} ] ] o (} ]]}vX I( R } ] i } }8]o o} o U
R uv( u u] uo }( R o} U }PR `]R o }}}o R}`]vP uu˙ }( R R]}˙ }(
uv( }( R o} v R o }( oo }( R uv( [ (}u }v R o} U } R FDAX TR FDA u˙ ]v
]}v (}u ]v }v.u}˙ }v o} }( }u } (} o]vP R o} (} ]]}vX F]voo˙U R
FDA `]oo }v o}}˙ R o } R (˙U ]˙U }v˙ v +v }( Ru o } X
Av˙ ]]}v }( ]}v ]}o}P]o } v Ru o uo u }uo˙ `]R R UXSX P ]}v
D P MlvP A v R PHSAX
Ov v }o ] Pv U R FDA u˙ }l} v R }o }( R BLA ]( }uo]v `]R Po}˙
]uv v v ] v} u]v]v } ]( }ou } L R } R R ulX L ]} -
˙ }( ]}o˙ vlv}`v }ou `]R } U ]vo]vP v }( vv] ]˙ } ( v˙U }
`]R uv( ]vP } U } (]o } }uo˙ `]R Po}˙ ]uv U u˙ o ]v ]]}v } R }
oo]vP } v` (˙ ]v(}u}vV ]u}]}v }( }rul ] } o]v]o ]o } v` (˙ ]l V }
- ]u}]}v }( ]]}v } }R ]}v v REMS }PuX FDA o} R R}]˙ } ] }rul
] U ]v ]v ]uv U }v +v }( } v u˙ ] oo]vP RvP o } v`
+v ]v(}u}vX OR }vo }v v (} (]o } u]v]v Po}˙ }uo]v ]vo U
u}vP }R R]vP P
{  ]}v }v R ulvP } uv( ]vP }( R } U }uo `]R`o }( R } (}u R ul }
} oo V
{  .v U vo o' } `v]vP o' } R}o }v }r}o o]v]o ]o V
{  (o }( R FDA } } v]vP o]}v } ouv } } o]}v U } v]}v } } -
}v }( } o]v }o V
{  } ] } v}vU } (o } u] R ]u} } ˘} }( } V }
{  ]viv}v } R ]u}]}v }( ]]o } ]u]vo vo X
- TR FDA ] o˙ Po u l]vP U o o]vP U ]]vP v }u}]}v }( } R o }v R u l X
PR u ] o } u˙ }u} }vo˙ (} R } ]v] ]}v v ]v } v `]R R }] -
]}v }( R } o o X A oR}PR R˙]]v u˙ ] oPoo˙ ]o o } (} v } } ]v
]v } o ]}v R v} ] ]v R } [ } o o]vP ~lv}`v S}((ro o _ Z U }u v]
`]R } } u˙ v} u l } }u} R }((ro o X TR FDA } v} Po R R ]} }(
R˙]]v ]v R] R}] }( uv U R FDA Po ]}v } ]u} ]vPv ] ]}v }v uv( -
- [ }uuv] ]}v P ]vP }((ro o X TR FDA v }R Pv] ] o˙ v(} R o` v Po ]}v
}R]]]vP R }u}]}v }( }((ro o U v }u v˙ R ] (}v } R ]u } o˙ }u} }((ro o
 Regulation | 77
u˙ i } ]Pv](] v o] ]o]˙U ]vo ]vP ]v ]P]}v ˙ ( o v R}]] X P ] ]}v ]}o}P] o
} }u}]}vo u ]o u u] } R FDA ]v }viv ]}v `]R R] (] } (] o] ]}v X
Orphan Drug Designation
ORv P ]Pv}v ]v R UXSX ] ]Pv } v}P }v} } o} } ]vv (} ]
} }v]}v X Iv R UXSXU ] } }v]}v ] }]o˙ .v }v]}v R + (` Rv U
]v]]o ]v R UXSX } R + u} Rv U ]v]]o ]v R UXSX v (} `R]R R ] v} }vo
˘ }v R R } }( o}]vP v ul]vP ]oo R } (} R ] } }v]}v `]oo }
(}u o }( R } ]v R UXSX
ORv P ]Pv}v o]. }uv˙ (} ˘ ] v ul ˘o]]˙ (} v ˙ (}oo}`]vP R }(
R } [ulvP }o ]( Pv ˙ R FDA v ]( ] ] R . FDA }o (} R } (} R ]
(} `R]R ] R R ]Pv}vX Av o]}v (} ]Pv}v v }Rv } v u v˙ u ]} } R
.o]vP }( v o]}v (} }o } ul R } X A } }u v }Rv `Rv ] ] }Rv P
]Pv}v (}u R O8 }( ORv P} D o}uv ~ OOPDZ R FDA }v v o }v.vo
u v R Po}˙ }]]}v X AL R FDA Pv }Rv P ]Pv}vU R Pv] ]v˙ }( R
} v ] }vo }Rv ]o} o]o˙ ˙ R FDAX TR } u Rv P} R}PR R ]` v
}o } o]l v˙ }R } ]v } } ul X
A }v} u˙ }Rv P ]Pv}v }( ]}o˙ v} } } v` }Rv ]v]}v (} v
o˙ ul } X Iv ]}vU }v} }( } R ] }R`] R u } v o˙ }
}Rv P u˙ l v }]v }Rv P ]Pv}v (} R v } (} R u ] }
}v]}v ]( ] v v o]o R˙}R] R ] } u˙ o]v]oo˙ ]} } R . PX M} Rv
}v }v} u˙ ] }Rv P ]Pv}v (} R u } (} R u ] } }v]}vU R
}v} l]vP }Rv P ]Pv}v u .o }uo (} ]Pv}vX
TR ]} }( ˘o]]˙ P]v }v R R R ulvP o]}v ] } ˙ R FDA v o] }vo˙ } R
]v]}v (} `R]R R } R v ]Pv X TR FDA u˙ } }v o]}v (} R u }
(} ]+v } }v o]}v (} o]v]oo˙ ]} ]}v }( R } (} R u X TR FDA v
v} U R}`U } R u } u ˙ v}R }v} (} R u ]v]}v ]vP R ul ˘o]]˙
]} vo ] R R }vv }( R }v} } R }v} ] vo } }] 8]v v }( R } X
Pediatric Studies and Exclusivity
Uv R P]] R R E ]˙ A }( ~ uv U PREAZU BLA } ouv R} u }v]v
R } R (˙ v +v }( R } (} R o]u ]v]}v ]v oo ov ]]
r}o}v U v } } }]vP v u]v]}v (} R ]] }o}v (} `R]R R } ] (
v + X S}v} u o} u] ]] ˙ ov ]} } R uv X TR} ov u }v]v v
}o]v }( R }} ]] ˙ } ] R o]v ov } }v U ]vo]vP ˙ }i v ]PvU
v˙ (o } `] v }R ]v(}u}v ] ˙ Po}vX TR o]v U R FDAU v R FD[A ]v
vo ]` }uu]' u Rv ]` R ]v(}u}v u]' U }vo `]R R }R v P }v .vo ovX
TR FDA } R o]v u˙ v uvuv } R ov v˙ u X
TR FDA u˙U }v ] }`v ]v] } R }( R o]v U Pv (o (} u]]}v }( }u } oo
]] vo L }o }( R } (} ]v o U } (oo } o `] (}u R ]]
]uv X Uvo }R`] ] ˙ Po}vU PREA } v} o˙ } ]}o}P] (} v ]v]}v (} `R]R
}Rv ]Pv}v R v Pv U ˘ R PREA `]oo o˙ } v }]P]vo BLA (} v` ]vP]v R ]
}Rvr]Pv ]( R ]}o}P] ] u}ooo˙ P v } ]vv (} R uv }( v o v
v ] ] u}oo P R FDA u]v } voo˙ ov } R P}`R } }P]}v }(
]] vX
P]] ˘o]]˙ ] v}R ˙ }( v}vrv ulvP ˘o]]˙ ]v R UXSX v U ]( Pv U }] (} R
Ruv }( v ]}vo ]˘ u}vR }( ulvP }}v } R u }( v˙ ˘]vP Po}˙ ˘o]]˙U ]vo]vP
R v}vrv v }Rv ˘o]]˙X TR] ]˘ru}vR ˘o]]˙ u˙ Pv ]( BLA }v} u] ]]
R (]o˙ }v } `]'v (}u R FDA (} R X TR } v} v } R}` R } }
78 | R
 egulation
+ ]v R ]] }o}v ] V RU ]( R o]v]o ]o ] u } (]o˙ }v } R FD[A U
R ]}vo }}v ] Pv X I( } }( ]] ] u]' } v ˙ R FDA
`]R]v R }˙ u o]u] U `R }˙ } Po}˙ ]} }( ˘o]]˙ } v }}v } R
} ˘v ˙ ]˘ u}vR X TR] ] v} v u ˘v]}vU ] +o˙ ˘v R Po}˙ ]}
]vP `R]R R FDA vv} } v}R o]}vX
PART I
Biosimilars and Exclusivity
TR B]}o}P] P] C}u}v v Ivv}}v A ~ BPCIAZ o]R Po}˙ Ru R}]]vP R FDA } -
} ]}]u]o v ]vRvPo ]}]u]o X
Uv R BPCIAU v o]v u˙ u] v o]}v (} o]v }( ]}o}P] } R ] S]}]u]o }_ } S]v -
RvPo `]R_ ]}o˙ } ]}o}P]o } } S(v } X_ F} R FDA } } ]}]u]o
} U ] u .v R R v} o]v]oo˙ uv]vP(o ]+v `v R (v } v }}
]}]u]o } ]v u }( (˙U ]˙ v }v˙X F} R FDA } } ]}]u]o } ]vRvPo
`]R (v } U R Pv˙ u .v R R ]}]u]o } v ˘ } } R u o]v]o
o R (v } U v ~(} } u]v] uoo u Z R R ]}o}P] v R (v ]} -
o}P] u˙ `]R L }v R v ]}o˙ u]v] `]R} ]v ]vP (˙ ]l } ]l }( ]u]v]R
8˙ o } ˘o] }( R (v ]}o}P] X
Uv R BPCIAU v o]}v (} ]}]u]o } u˙ v} u]' } R FDA vo (} ˙ (}oo}`]vP R
}( }o }( R (v } X TR FDA u˙ v} } ]}]u]o } vo `o ˙ (}u R
}v `R]R R (v } ` } X Ev ]( } ] }v] } (v } o]P]o
(} ˘o]]˙U v}R }uv˙ }o ul }uvP ]}v }( R } ]( R FDA } (oo BLA (}
R } }v]v]vP R }v} [}`v v}vo]v]o v (}u v `oor}v}oo o]v]o ]o
} u}v R (˙U ]˙ v }v˙ }( R] } X H}`U } o˙ }v R ˘o]] (} o]R]vP }
}vP } ul }]}v ] v} `]R} ]lU R o` i } RvP ˙ R oP]o X TR BPCIA o}
]v ˘o]]˙ ]} (} ]}]u]o } ]vRvPo } X A R] iv U ] ] vo
`RR } u S]vRvPo _ ˙ R FDA `]ooU ]v ( U ]o˙ ˙ Ru] U `R]R
- P}v ˙ Ru˙ o`X
U.S. Patent Term Restoration
D v]vP }v R u]vP U }v v ]. }( FDA }o }( } } v] U }u }( } UXSX v
u˙ o]P]o (} o]u] v u ˘v]}v v R D P P] C}u}v v Pv Tu R}}v A }(
ı ~R Hatch-Waxman AmendmentsZX TR HRrW˘uv Auvuv u] }}v }( R v u }(
} . ˙ }uv}v (} v u o} ]vP R FDA Po}˙ ]` } X Pvru }}vU
R}`U vv} ˘v R u]v]vP u }( v ˙}v }o }( ˙ (}u R } [ }o
v }vo˙ R} o]u }]vP R } } U uR} (} ]vP ] } uR} (} uv( ]vP ] u˙
˘v X TR vru }}v ]} ] Pvoo˙ }v rRo( R u `v R + }( v IND v
- R u]]}v }( BLA o R u `v R u]]}v }( BLA v R }o }( R o]}vU
˘ R R ]` ]} ] ˙ v˙ u ]vP `R]R R o]v (]o } ˘] ]o]Pv X Ovo˙
}v v o]o } v } ]}o}P] ] o]P]o (} R ˘v]}v v R o]}v (} R ˘v]}v u
u]' ]} } R ˘]}v }( R v X TR USPTOU ]v }vo}v `]R R FDAU ]` v } R
o]}v (} v˙ v u ˘v]}v } }}vX Iv R ( U ` u˙ o˙ (} }}v }( v u (}
} vo˙ }`v } o]v v } v o]( ˙}v ] v ˘]}v U v]vP }v R ˘
ovPR }( R o]v]o ]o v }R (} ]v}o ]v R .o]vP }( R ov BLAX
1.9.2 Regulation and Procedures Governing Approval of Medicinal Products in the
European Union and the United Kingdom
- Iv}}ulv˙u]]vo}}]}(RUXSXU}uv˙o}u}uo˙`]Rvu}v˙]vPP -
o}˙]uv}(}R}v]vi]]}vP]vPo]˙U(˙v8˙vP}v]vPUu}vP}R
R]vPUo]v]o]oUulvPR}]}vU}uu]oov]]}v}(}XWRR}v}]}]vFDA
}o(}}Uvo]v`]oov}}]vRv˙}o˙R}uoPo}˙R}]
 Regulation | 79
(}]v]v]o]v]o]o}ulvP}(R}]vR}}v]}i]]}vXS].oo˙UR}
P}v]vP}o}(u]]vo}]vR}v E Uv]}vvRUv]K]vP}uPvoo˙(}oo}`Ruo]v
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`oor}v}ooo]v]o]o}o]RR(˙v8˙}(Ru]]vo}(}R}}]v]}vXI
o}]Ru]]}v}ov}uvR}](}o]v]o]oR}]}vv}REMA}}}u
vR}]]v}v
E Uv]}vuu(}MAAvPvvP}(ulvPR}]}v˙RR}]
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}v
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RUv]K]vP}u~vRN}RvIovP}}}oUR}v E Uv]}vPo}˙(u`}l`]oo}vv}o˙
]vN}RvIovvvo]}vE Uv]}vR}]}v`]oo}vv}}Pv]ZX
Clinical Trial Approval
Iv A ]o U R E } v Uv]}v } R v` C o]v] o T]o RPo ]}v ~E U Z N} æ l U `R]R o R
C o]v] o T]o D ] ] l lEC (( ] }( Jv ˙ U X TR v]}˙ }]]}v }( R v` RPo ]}v
}(( }v} R } ]]o]˙ } R}} ` v R ] uv }( R ]} D ] ] v R v` RP
o ]}v ]( R (} R}] ]}v }( o]v] o ]o ] u] ]v R ˙ ( R v` RPo ]}v u
o] o X I( R }v} R}} } u] v R ]} D ] ] U R o]v] o ]o }v]v } P} v
˙ R D ] ] v]o R ˙ ( R v` RPo ]}v u o] o X I( o]v] o ]o }v]v (} u}
Rv R ˙ ( R RPo ]}v u o] o U R v` RPo ]}v `]oo R ]u P]v } o˙ }
R o]v] o ]o X TR v` RPo ]}v ~E U Z U `R]R ] ] o˙ o] o ]v oo E } v Uv]}v uu U ]u
]uo](˙]vP v uo]v]vP R } o }( o]v] o ]o ]v R E } v Uv]}v X TR u]v R ] ] }(
R v` RPo ]}v ]vo P uo]v o] ]}v } ] ]vPo rv ˙ }]v R}PR R C o]v] o T]o
Iv(}u ]}v S˙ u V ]vPo }( } uv } v u] (} R o] ]}v `oo ]uo](]
} ]vP } (} o]v] o ]o }v} V v R u}v] } (} R uv }( o] ]}v (}
o]v] o ]o U `R]R ] ]] ]v `} ~P I }v ]v ]v](] v u ]]vo } } uv ]}v v P
II }v ]v R v ]}vo v ]v ro o } uv ]}v Z X P I ] ˙ }} ]v ]` ˙ R }u
v R}]] }( oo E } v Uv]}v uu ]v `R]R v o] ]}v (} R}] ]}v }( o]v] o ]o
R v u] ~ Concerned Member States Z }( ( } ˙ ( v uu X P II ]
o˙ ˙ R C }v v Mu S X S ] o]v R o} v o]R (} R
uv }( o]v] o ]o o] ]}v X
TR Uv] K]vP}u R ]uouv D] l lEC ]v} v}vo o` R}PR R M]]v (} Huv U
~Co]v]o T]o Z RPo}v ~ uv ZXTR ˘v } `R]R R Po}v }( o]v]o ]o ]v R Uv] K]vP}u
`]oo u]} R v` E }v Uv]}v Co]v]o T]o RPo}v R R }u ]v} + ] v} ˙ lv}`vU R}` R
M]]v v HoR } RPo}˙ APv˙ ~ MHRAZU R Uv] K]vP}u u]]v Po}U R }v
}vo}v }v }( }}o ]Pv } ]u} v vPRv R Uv] K]vP}u o]v]o ]o oP]o}vX SR
}vo}v ] }v vo MR U X
Orphan Designation and Exclusivity
RPo}v ~ECZ N}X l v RPo}v ~ECZ N}X l }] R } v ]Pv v }Rv
P ˙ R E }v C}uu]]}v ]( ] }v} v o]RP ~ Z R R } ] ]vv (} R ]Pv}] U v
}v } uv }( o](rRv]vP } R}v]oo˙ ]o]vP }v]}vU ~ Z ]R ~]Z R ov }( R }v]}v ]
v} u} Rv . ]v v R}v }v ]v R E }v Uv]}v `Rv R o]}v ] u U } ~]]Z `]R} ]vv
] ] vo]lo˙ R R ulvP }( R } ]v R E }v Uv]}v `}o Pv 8]v v } i(˙ R
v ˙ ]vuv ]v ] o}uv v ~ Z R ˘] v} (}˙ uR} }( ]Pv}] U v}vU }
uv }( R }v]}v ]v }v R R v R}] ]v R E }v Uv]}v }U ]( R uR} ˘] U R }
R } }( ]Pv].v v. }u } } ]oo (} R }v]}vX
Av }Rv ]Pv}v }] vu }( v. U ]vo]vP ( }v v U Po}˙ ]v X I( ulvP
R}]}v ] Pv (} v }Rv u]]vo } U R] o ]v vr˙ ]} }( ul ˘o]]˙X D ]vP
R] ul ˘o]]˙ ]} U v]R R EMA v} R E }v C}uu]]}v } R E }v Uv]}v uu v
v o]}v } Pv ulvP R}]}v (} S]u]o u]]vo } X_ A S]u]o u]]vo }
_ ] .v u]]vo } }v]v]vP ]u]o v } v }v]v ]v v R}]
}Rv u]]vo } U v `R]R ] ]vv (} R u R ]v]}vX TR ul ˘o]]˙ ]} (}
80 | R
 egulation
R R}] R ]v]}v u˙U R}`U } ]˘ ˙ ](U R v }( R .LR ˙U ] ] o]R
R R } v} o}vP u R ]] (} }Rv ]Pv}v U (} ˘uo U R } ] 8]vo˙
}.o v} } i(˙ ul ˘o]]˙X Ml ˘o]]˙ u˙ o} }l ]v ˙ o U R ]( ~]Z ] ]
o]R R ]u]o u]]vo } ] (U u} + } }R`] o]v]oo˙ ]} V ~]]Z R ulvP
- R}]}v R}o (} R R}] }Rv } }vv } R }v }Rv o]}vV } ~]]]Z R ulvP
R}]}v R}o (} R R}] }Rv } vv} o˙ v}PR }Rv u]]vo } X ORv ]P -
PART I
v}v u (} u]«vP v o]}v (} ulvP }oX ORv ]Pv}v } v} }v˙
v˙ vP ]vU } R}v R }v }(U R Po}˙ ]` v }o } X
S]v Jv ˙ U U } (} } Rv ]Pv ]}v R o] ]v G B ] ]v X TR ] v}` v}
ru l]vP R}] ]}v } Rv ]Pv ]}v ~ R ] ]v R E } v Uv]}v Z v R o] ]}v (} } Rv
]Pv ]}v `]oo ]` ˙ R MHRA U R ]u }( v MA A (} Uv] K]vP}u } G B ] ]v u l]vP -
R}] ]}v X TR ] ] R u ]v R E } v Uv]}v U R R˙ o˙ } G B ] ]v }vo˙ ~ XP X U R
u v} ]( }˙ u R} }( ]Pv}] U v]}v } uv }( R }v]]}v }v v ]v G B ] ]v U
- } } } R E } v Uv]}v U v R ov }( R }v]]}v u v} u} Rv (] ]v U }v ]v
G B ] ]v Z X
Marketing Authorization
T} }]v ulvP R}]}v (} } v R E }v Uv]}v Po}˙ ˙uU v o]v u u]
v MAAU ]R } R EMA ]vP R vo] } } } }uv R}] ]v R E }v Uv]}v ]vP R
}R } ~vo] } U v}vo } U } u o }Pv]}v } ZX A ulvP R}] -
}v u˙ Pv }vo˙ } v o]v o]R ]v R E }v Uv]}vX RPo}v ~ECZ N}X ı l }]
R ]} } }]v]vP ulvP R}]}v ]v R E }v Uv]}vU v o]v u u}v }uo]v `]R
oo u ]vo ]v v EMAr} P]] IvP}v Pov ~ PIPZU }]vP oo }( R ]] } -
o}vU vo R EMA R Pv } r]. `]U o `]U } (o (} }v } u} }( R u
- ]vo ]v R PIPX
TR vo] } }] (} R Pv }( ]vPo ulvP R}]}v ˙ R E }v C}uu]]}v R ]
- o] (} oo EA Mu S X P v } RPo}v ~ECZ N}X l U R vo] } ] }uo}˙ (}
]. } U ]vo]vP (} u]]v } ˙ ]v ]}Rv}o}P]o } U } ]Pv }Rv
u]]vo } U v R˙ u]]vo } ~Pv R˙U }u oo R˙ } vP]v } -
Z v } `]R v` v ]v] (} R uv }( ]v ] U ]vo]vP } (}
R uv }( v v }r]uuv ] v }R ]uuv ˙(v}v v v}Pv ]} X
TR vo] } ] }}vo (} } R }v]v v` v (} v˙ }R ]v]}v U `R]R
]Pv].v R U ]v. } Rv]o ]vv}}v v `R} R}]}v `}o ]v R ]v }( o]
RoR ]v R E }v Uv]}vX
Uv R vo] } U R C}uu]' (} M]]vo P} (} Huv U ~ CHMPZU o]R R EMA
] }v]o (} }v vP R uv }( } } .v ] ]llv. }.o X TR CHMP }uuv}v
] Rv v } R E }v C}uu]]}vU `R]R } ]]}v ]v]vP ]v oo EA Mu S X Uv R vo -
- ] } U R u˘]uu u(u (} R o}v }( v MAA ] ˙ U ˘o]vP o}l } `Rv ]}vo
]v(}u}v } `]'v } }o ˘ov}v ] } }] ˙ R o]v ]v }v } }v l ˙ R CHMPX
- Co}l } u˙ ˘v R u(u }( o}v }( v MAA }v]o˙ ˙}v ˙ X A o o}v
u˙ Pv ˙ R CHMP ]v ˘}vo U `Rv u]]vo } ] }( ui} ]v (}u R }]v }( ]`
- }( o] RoR v U ]v oU (}u R ]`}]v }( R ]vv}}vX I( R CHMP R U R
u o]u] }( ˙ `]oo } æ ˙ ~˘o]vP o}l } ZU ] ] }]o R R CHMP u˙
} R v u o]u] (} R vo] } ]( ] u]v R ] ] v} o}vP }] } }v v
o uv X S]v R Uv] K]vP}u R oL R E }v Uv]}vU G B ]]v `]oo v} o}vP }
˙ vo] ulvP R}]}v ~v R N}Rv Iov P}}}oU vo] E }v Uv]}v R}]}v
`]oo }vv } }Pv] ]v N}Rv Iov ZX Aoo u]]vo } `]R v vo] R}]}v `
}uoo˙ }v } Uv] K]vP}u ulvP R}]}v }v Jv˙ X F} ]} }( `} ˙ (}u
- Jv˙ U R MHRA u˙ o˙ }v ]]}v lv ˙ R E }v C}uu]]}v }v R }o }( v` ulvP
R}]}v ]v R vo] } U ]v } } u} ]lo˙ Pv v` G B ]]v ulvP R}]}vX A
o]}v `]ooU R}`U oo ] X
 Regulation | 81
European Data and Market Exclusivity
Iv R E }v Uv]}vU ]vv} u]]vo } U } }v R ] }( }uo ]vvv lP U
o](˙ (} ]PR ˙ }( ˘o]]˙ }v ulvP R}]}v v v ]}vo `} ˙ }( ul ˘o]]˙X
TR ˘o]]˙U ]( Pv U v Pv] } ]}]u]o o]v (}u (v]vP R ]vv}} [ o]v]o v
o]v]o ]o }v]v ]v R }] }( R (v } `Rv o˙]vP (} Pv] } ]}]u]o ulvP
R}]}v ]v R E }v Uv]}vU (} ]} }( ]PR ˙ (}u R }v `R]R R (v } ` .
R}] ]v R E }v Uv]}vX D ]vP R ]}vo `}r˙ ]} }( ul ˘o]]˙ Pv] } ]}]u]o
MAA v u]' U v R ]vv}} [ u˙ (v U v} Pv] } ]}]u]o } v ul
]v R E }v Uv]}v vo R ˘]}v }( R ul ˘o]]˙ ]} X TR }oo v ˙ ]} `]oo ˘v
} u˘]uu }( ov ˙ ](U ]vP R . ]PR ˙ }( R} v ˙ U R ulvP R}]}v R}o
}]v ulvP R}]}v (} }v } u} v` R ]v]}v `R]RU ]vP R ]v. o}v
]} } R] R}]}vU u]v } ]vP ]Pv].v o]v]o v. ]v }u]}v `]R vo˙ }
R] X TR ] v} Pv R } `]oo }v] ˙ R EMA } v ]vv} u]]vo } U
v } u˙ v} o](˙ (} ˘o]]˙X Ev ]( } ] }v] } v ]vv} u]]vo }
} R R ]vv}} P]v R ] ]} }( ˘o]]˙U v}R }uv˙ v Ro }o o} ul
v}R ]}v }( R } ]( R }uv˙ }]v ulvP R}]}v }v v MAA `]R }uo
]vvv lP }( Ru o U o]v]o v o]v]o ]o X
Periods of Authorization and Renewals
A ulvP R}]}v ] o] (} . ˙ U ]v ]v]o U v ] u˙ v` L . ˙ }v R ] }(
o}v }( R ]l v. ov ˙ R EMA (} voo˙ R}] } U } ˙ R }uv R}]˙ }(
R R}]]vP uu (} v}voo˙ R}] } X Ov v` U R ulvP R}]}v ] o] (}
v vo]u] ]} U vo R E }v C}uu]]}v } R }uv R}]˙ ] U }v i. P}v ovP
} Ru}]P]ov U } } `]R }v ]}vo . r˙ v`o ]} X Av˙ R}]}v R ] v} (}oo}` ˙
R ouv }( R P }v R E }v Uv]}v ul ~]v R }( R vo] } Z } }v R ul }(
R R}]]vP uu ~(} v}voo˙ R}] } Z `]R]v R ˙ L R}]}vU } ]( R P ]
u} (}u R ul (} R }v ˙ U } o] X
Regulatory Requirements after Marketing Authorization
F}oo}`]vP}oURR}o}(RulvPR}]}v]]}}uo˙`]RvP}(]uvo]o
}Ruv(]vPUulvPU}u}}vvo}(Ru]]vo}XTR]vo}uo]v`]RR}vE
Uv]}v[]vPvRu}]P]ov}(˙}vPoUv}`R]R}rR}]}v]v]}vou}v
]}]vP}o]P}vv]u}XIv]}vURuv(]vP}(R}]}U(}`R]Ruv([
o]v]uv}˙Uuo}}v]v]}uo]v`]RREMA[GMP]uvv}uo]
uv}(}RPo}˙}]]vR}v
E Uv]}vU`R]RuvRuR}U(]o]v}v}o]vuv(
]vPU}]vPvl]vP}(}}R](˙v]v˙XF]voo˙URulvPv}u}}v}(R}
]}U]vo]vP]v˙r}v}}vv]vPu]o}vv]vP]}`R]}(
}vl}RPvoo]U]o˙Po]vR}v
E Uv]}vvD]llEU
C uvX
TR (}uv}v E }v Uv]}v o Pvoo˙ o]o ]v R EAX
Brexit and the Regulatory Framework in the United Kingdom
Iv Jv U R o} ]v R Uv] K]vP}u } ]v (} }( o]vP R E }v Uv]}v ~}uu}vo˙ ( }
SB ˘] _ZU v R Uv] K]vP}u }8]oo˙ `]R` (}u R E }v Uv]}v }v Jv˙ U X P v } R
(}uo `]R`o vPuv P `v R Uv] K]vP}u v R E }v Uv]}vU R Uv] K]vP}u `
i } v]}v ]} vo D u U U ]vP `R]R E }v Uv]}v o }vv } o˙X H}`U
R E }v Uv]}v v R Uv] K]vP}u R }vo v }}}v Puv ~
]]}voo˙ o]o ]v Jv˙ U v R v (}uoo˙ o]o ]v M˙ U X TR TCA ]vo ].
}]]}v }vv]vP Ru o U `R]R ]vo R u o }Pv]}v }( GMPU ]v }v }( uv( ]vP (
]o] (} u]]vo } v GMP }uv ] U } v} (} `R}oo u o }Pv]}v }( Uv]
K]vP}u v E }v Uv]}v Ru o Po}v X A v U G B ]]v R ]uouv E }v Uv]}v
oP]o}v }v R ulvP U }u}}v v o }( u]]vo } R}PR R Huv M]]v RPo}v
~ uv ZX TR Po}˙ P]u ]v G B ]]v R(} oPo˙ o]Pv `]R v E }v Uv]}v Po}v U
R}` ] ] }]o R R P]u `]oo ]P ]v ( v}` R G B ]]v[Po}˙ ˙u ] ]vvv
82 | R
 egulation
(}u R E }v Uv]}v v R TCA } v} }] (} u o }Pv]}v }( Uv] K]vP}u v E }v Uv]}v
Ru o oP]o}vX F} ˘uo U R v` Co]v]o T]o RPo}v `R]R u + ]v R E }v Uv]}v
}v Jv˙ U R v} v ]uouv ]v} Uv] K]vP}u o`U v o]}v `]oo v }
u]' (} o]v]o ]o R}]}v ]v R Uv] K]vP}uX
1.9.3 Regulation and Procedures Governing Approval of Medicinal Products in Japan
PART I
-
- Iv } } ul v˙ u]o } ]v JvU }uv˙ u }uo˙ `]R vu} v ˙]vP Po}˙ -
]uv ]v Jv P]vP o]˙U (˙ v 8˙ ]v R }v˘ U u}vP }R R]vP U }( o]v]o ]o U ulvP
}oU }uu]o o v ]]}v }( } X A }v `R} uv( } ul u]o } ]v
Jv ] i } R ]]}v }( R M]v] }( HoRU L} v Wo( ~R MinisterZU ]u]o˙ v R A
}v S ]vP Qo]˙U8˙ E v S(˙ }( PRu o v M]o D ] ~ Pharmaceutical and Medical Device
ActZX TR] v]o R (}˙ }uo}v }( Ru o o}uv U v}vo]v]o ] v v
`oor}v}oo o]v]o ]o } o]R R (˙ v 8˙ }( R u]o } (} R }} ]v]}vX I
o} ] R .o]vP }( v}.}v }( o]v]o ]o `]R R PMDA v R }]v]vP }( ulvP }o (}u R
ov R}] (} R } v ul v }o ]v R Jv ulX
Business License
Uv R PMDAU }v ] ] } }]v (}u R M]v] ulvP o]v ]v } } }v R ]v }(
ulvP U o]vP } }]]vP u]o } R uv( ~} }} } R] ˙ (} uv( -
]vPZ } ]u} ˙ R }vX
Ao}U ]v } } }v R ]v }( uv( ]vP u]o } `R]R `]oo ul ]v JvU }v ]
] } }]v (}u R M]v] uv( ]vP o]v (} R uv( ]vP ] X
Marketing Approval
Uv R PMDAU ] ] Pvoo˙ ] } }]v ulvP }o (}u R M]v] (} R ulvP }( R
u]o } X Av o]}v (} ulvP }o u u R}PR R PMDAU `R]R ]uouv ulvP
}o ]`X
- Clinical Trial
Uv R PMDAU ] ] ] } .o v}.}v }( o]v]o ]o `]R R PMDAX Ao}U R }( o]v]o ]o v }R
- vv U `R]R u 'R (} v o]}v (} ulvP }oU u }]v ]v }uo]v `]R
- R v o]R ˙ R M]v]U R GLP v GCP o ˙ R u]v]]o }]vv }( R M]v]X
-
Regulatory Requirements after Marketing Approval
A ulvP o]v rR}o R R }]v ulvP }o (} v` u]o } u R R u]o
} r˘u]v ˙ R M]v] } ˙ R PMDA (} ]. ]} L ]]vP ulvP }oX TR -
} }( R] r˘u]v}v } ] } v R (˙ v 8˙ }( v`o˙ } u]o } ˙ ]u}]vP
}v R ulvP o]v rR}o R }o]P}v } PR o]v]o (} ]v ]} L R ulvP }o
` Pv } R R M]v] R R }}v]˙ } r˘u]v R } X Ro }( P v }R vv
u 'R (} v o]}v (} r˘u]v}vX A ulvP o]v R}o R R }]v ulvP
}o ] o} ] } ]vP U u}vP }R R]vP U R o }( P v } ]}]oo˙ } } R M]v] -
v } R PMDAX
TCAZU `R]R ` } - Price Regulation
Iv JvU o] u]o ]vv ˙u } ] oo˙ R v Jv }o}vX TR o] u]o ]vv
- ˙uU R}`U } v} } v˙ u]o } `R]R ] v} o] }v R NHI ] o] o]R ˙ R M]v]X
A }]vPo˙U ulvP o]v rR}o }( u]o } u . R v` u]o } o] }v R NHI ]
o] ]v } } }]v ] }P v R o] u]o ]vv ˙uX
TR NHI ] }( u]o } ] u]v ]R ˙ ] }u]}v }( }uo u]o } `]R v -
˙ iuv (} ]vv}v U (ov } ] }( R ulV }U ]v R v }( }uo u]o } U
 Regulation | 83
˙ R } oo}v uR} U u]v L }v]]vP }( R }]v]}v }( R uv(X P] }v R NHI ]
o] `]oo i } ]]}vU Pvoo˙ }v ˙ ˙U }v R ] }( R o ] `R]R R u]o }
R ˙ u]o ]v }v X
1.9.4 Coverage, Pricing and Reimbursement
S]Pv].v v ]v˙ ˘] } R }P v ]u uv }( v˙ } v] (} `R]R ` u˙
}]v Po}˙ }oX Ev ]( } } v] } (} ulvP U o }( R } v]
`]oo v U ]v U }v R ˘v } `R]R R] r ˙ ˙} U ]vo]vP P}vuv RoR }Pu ]v R UXSX ~R
M] v M]] ZU }uu]o RoR ]v U v uvP }Pv]}v U }] }P v o]R
]u uv oo (} R } v] X M}}U ]v ]vP +} ˙ P}vuvo v R] r
˙ ˙} ]v R E }v Uv]}vU R UXSX v }R ul } } RoR } u˙ R }Pv]
}v } o]u] }R }P v R oo }( ]u uv (} v`o˙ } } v U o U R˙ u˙ v}
} } }] ˙uv (} } } v] X W˘ } ˘]v ]]vP ]v }vv}v
`]R R o }( v˙ }( } } v] } R v }` uvP RoR U R ]v ]vP ]vGv }(
RoR u]vvv }Pv]}v v ]}vo oP]o RvP X TR }`v` }v RoR } ]v Pv
oU oo˙ ]}v P v P]o } v }R uv U R }u ˙ ]vv X A o U
]v ]vPo˙ R]PR ] ]vP } R v˙ }( v` } X
Iv R UXSX v ul ]v }R }v] U v Pvoo˙ o˙ }v R] r ˙ ˙} } ]u oo } }( R
} }] `]R R] uv X A }P v ]u uv (}u P}vuvo RoR }Pu U
R M] v M]] U v }uu]o ˙} ] ]o } v` } v X Pv vo]lo˙ }
v˙ } v] ` u˙ o} vo }P ] }] v ]u uv ] } } ]Pv].
v }}v }( R } }( R } v] X
F} ˙} }v] ]v u]v]vP ]u uv }v `RR R } ] ~]Z } v. v
] RoR ovV ~]]Z (U + v u]oo˙ v ˙V ~]]]Z }] (} R ]. v V ~] Z }r+ V v
~ Z v]R ˘]uvo v} ]vP}voX
TR M] v M]] }Pu ]v ]vPo˙ u}o (} R}` ] ˙} v }R P}vuvo
˙} o} R] }P v ]u uv }o]] (} P v ]}o}P] X S}u R] r ˙ ˙} u˙ ]
r}o }( }P (} v` } ]vv} ] } P R] (} R˙ `]oo ]u RoR }
] `R} R R] X I ] ]8o } ] R] u `R R] r ˙ ˙} `]oo ] `]R }
R }P v ]u uv (} } } v] X TR } (} u]v]vP `RR ˙} `]oo }]
}P (} } u˙ (}u R } (} «vP R ] } ]u uv R R ˙} `]oo
˙ (} R } }v }P ] } X TR] r ˙ ˙} ]v ]vPo˙ RoovP]vP R ] v ˘u]v]vP
R u]o v ]˙ v }r+v }( u]o } v ] v ]u}]vP }v}o } uvP } U
]oo˙ P `Rv v ]ov Pv] P } o ˘v] R˙ ] ]oo X I ] }]o R R] r
˙ ˙} u˙ }v] } } v] v }R R] o v }vo˙ }+ } ]u v
(} R o ˘v] } X Ev ]( ` R}` ]u} 8˙ } ]u} }vv]v }( u]v]}v `]R }
} v] U ]]vP }( ˘]vP P u˙ o]u] R u}v ` `]oo o } RP (} } } v] X
TR ˙} u˙ v˙ } }l R ]u uv }( P]v P } } o]R ] (} v` } ˘]vP
ul } oo R }} o}` } vo } o] v }] v }v } ]vuv ]v }
o}uv X I( ]u uv ] v} ]oo } ] ]oo }vo˙ o]u] oo U ` u˙ v} o } (oo˙
}uu]o] } } v] v u˙ v} o } }]v (}˙ .vv]o v }v } R `
u˙ o} X TR] r ˙ ˙} u˙ o]u] }P } ]. } }v v } o] U o} lv}`v (}uo˙U
`R]R u]PR v} ]vo oo }( R } } (} o ]v]}vX
Iv CR]v U R v`o˙ N}vo HoR S ]˙ A u]v]}v ~
CR]v [}]o ]˙ ˙uU }Pv] ] vP}}v `]R P }uv] (} ]v v` P R R v}
v ]vo ]v R N}vo R]u o D P L] ~ NRDLZ R u }( R vP}}v ]v N}u ıU `R]R
o ]v v P ] }v ˙ } A9 (} }( R ı P R R vP}}vX NHSAU }PR
`]R }R P}vuv R}] U ]` R ]vo]}v } u}o }( P (}u CR]v [N}vo D P C o}P (}
84 | R
 egulation
B ] M]o Ivv U W}lro Ivi˙ Ivv v Mv]˙ Ivv U } }]v]o } o}o u]o ]vv
o}P (} R v}vo u]o ]vv }Pu Poo˙U v R v `R]R P } ] `]oo o -
]. U }R }( `R]R + R u}v ]u o } }Pu ]v (} R] R }( R} P X TR
u]v}v u }v vu }( (} U ]vo]vP ] v 8˙X Wu˙ o} ]v] } 'v R
] vP}}v `]R NHSA }v ]]vP Po}˙ }o ]v CR]v U ` `]oo o]lo˙ v } ]Pv].vo˙
} ] U v } vP} `]R R }( R }]v]o RoR ]˙ u]v]}v }v ]u uv } X Ov
PART I
R }R Rv U ]( R NHSA } v˙ }( ] o}o }v ]vo } P v ] ]v R NRDL } }]v]o RDLU
`R]R u˙ ]v R uv (} } P v] v ] U } }vo v (}u R o }( } P
v] v ] u˙ oo o }( o}` ] X M}}U o]P]]o]˙ (} ]u uv ]v CR]v
} v} ]uo˙ R v˙ P } ] `]oo ] (} ]v oo } R } } } U ]vo]vP o]v]vP
( U RU o}uv U uv( U o v ]]}vX
-
- Iv } } }P v ]u uv (} v˙ } R u]PR } (} o U ` R v v
u˙ v } }v ˘v] Ru}}v}u] ] ]v } } u}v R u]o v ]˙ v }r( -
(v }( R } U v R } }( R ] `}o ]v ]}v } R } ] } }]v FDA }
}R }uo ulvP }o X Ev L Ru}Pv}u] ] }v U } v] u˙ v}
- }v] u]oo˙ v ˙ } }r+ X A ]]}v ˙ R] r ˙ ˙} v} } } v˙ } v] -
` u˙ o} }o R˙]]v o]}v }( R } v] }v } v R u]o
+ }v } o U o }( }}v v .vv]o }v]}vX A ]}voo˙U ˙} [ ]]}v } }] } -
P (} } } v} ]uo˙ R v ]u uv `]oo } X F} ˘uo U R ˙} u˙
] }r˙uv R v .v v o˙ R]PRX FRU }v ˙} [ u]v}v } }] }P (}
} } v} R }R ˙} `]oo o} }] }P v ]u uv (} R } U v R oo
}( }P v ]u uv v ]+ ]Pv].vo˙ (}u ˙} } ˙}X TR] r ˙ ]u uv v }P
- u˙ v} } vo } u]v]v ] oo 8]v } o] v }] v }v } ]vuv ]v
} o}uv X TR ]vv }P v ]u uv }( v`o˙ } } (} }Rv ] -
] oo˙ v ]vU v (]o } }]v } u]v]v }P v ]u uv (} v˙ R }
v] }o o]u] } ]o]˙ } Pv v X FRU } R COVIDr ı vu] U u]oo]}v }( ]v]]o
R o} l`]oo o}]vP uo}˙r ]vv }P U `R]R u˙ o˙ + } ]o]˙ } }uu]o] }
} U A v} } U ]v R UXSXU ` ov } R ]} }Pu } Ro v +} } } U ]vo]vP
v ]v }Pu v }r˙ }}v }Pu (} o]P]o v X
TR }v]vuv }( RoR } o} R }u ]}]˙ }( UXSX (oU v ]vv}vo P}vuv v
- R ] }( Ru o R v (} ]v R] +} X G}vuv R R}`v ]Pv].v ]v ]v ]uo -
uvvP }r}v]vuv }Pu U ]vo]vP ] }v}o U ]}v }v ]u uv v ]uv (} -
}v }( Pv] } X N ] (} P u˙ ˙ uv}˙ ]}v } ] ˙ P}v -
uv RoR }Pu } ] ˙} v ˙ v˙ ( o˘}v }( o` R vo˙ ] ]u} }( P
(}u }v] `R R˙ u˙ }o o}` ] Rv ]v R Uv] S X Iv ]vPo˙U R] r ˙ ˙}
]]vP R P }uv] }] Ru `]R u]v ]}v (}u o] ] v RoovP]vP R ]
- RP (} u]o } X W vv} R ]u uv `]oo ]oo (} v˙ ( } v]
R ` }uu]o] v U ]( ]u uv ] ]oo U R oo }( ]u uv X Iv ]}vU uv˙ Ru o
uv( u oo v } ]v ] }vP u] } R P}vuv U R P o ]
~ASPZ v ] X Pvo u˙ o˙ ]v }u `Rv R u] v} u]' o˙ v uo˙X
FRU R ] (} P u˙ ˙ uv}˙ ]}v } ] ˙ P}vuv RoR
}Pu X A }}v }( ] }v}o v }r}v]vuv u U v }}v }( u} ] }o]] ]v i] -
]}v `]R ˘]vP }v}o v u U }o (R o]u] } }vo v (}u R o }( v˙ } (}
`R]R ` u˙ }]v }oX C}P }o]] v R] r ˙ ]u uv u˙ RvP v˙ u X Ev ](
(}o }P v ]u uv ] ']v (} }v } u} }( } } (} `R]R ` } } }oo} -
} ] ulvP }oU o (}o }P }o]] v ]u uv u˙ ]uouv ]v R
( X O]v]vP v u]v]v]vP ]u uv ] u r}vu]vP v }o˙X
NHSAZ v Pv˙ }v]o (} u]v]]vP
N} v](}u }o]˙ (} }P v ]u uv (} P } ˘] u}vP R] r ˙ ˙} ]v R UXSX
TR(} U }P v ]u uv (} P } v ]+ ]Pv].vo˙ (}u ˙} } ˙}X A o U R
- }P u]v}v } ] }Lv u r}vu]vP v }o˙ } R `]oo ] } }] ]v.
v o]v]o } (} R }( } } } R ˙} o˙U `]R v} v R }P v
 Regulation | 85
]u uv `]oo o] }v]vo˙ } }]v ]v R . ]vv X FRu} U o v Po}v P]vP
]u uv RvP ( vo˙U ]v }u R} v} U v ` o] R RvP ]v R o v Po -
}v o]lo˙X O] R UXSXU ` `]oo ( RoovP ]v v]vP }]v]vP }P v ˙uv (} v˙
} v] ` u˙ o} X P]]vP }( ]}v Ru o ] i } P}vuvo }v}o ]v uv˙
}v] X P]]vP vP}}v `]R P}vuvo R}] v ˘v `oo ˙}v R ] }( Po}˙ ul -
]vP }o (} } v u˙ ] } }v o]v]o ]o R }u R +v }( v˙ }

PART I
v] ` u˙ o} } }R ]oo R] } } }r+v X TR }v }( R o]v]o ]o
}o ˘v] U ]v}o ]}vo ]l v o ]v o˙ ]v } }uu]o]}v +} X

Iv R E }v Uv]}vU ]]vP v ]u uv Ru ˙ `]o˙ (}u }v˙ } }v˙X S}u }v] }]

R } u˙ ul }vo˙ L ]u uv ] R v P X S}u }v] u˙ ] R }u -
o}v }( ]}vo ] R }u R }r+v }( o } v] } vo˙ ]oo
R] ~} oo RoR Rv}o}P˙ uv Z ]v } } }]v ]u uv } ]]vP }oX F} ˘uo U
R E }v Uv]}v }] }}v (} ] uu } ] R vP }( } (} `R]R R] v}vo
RoR ]vv ˙u }] ]u uv v } }v}o R ] }( u]]vo } (} Ruv X E } -
v Uv]}v uu u˙ } ]. ] (} } } u˙ ]v } ˙u }( ] } ]v]
}v}o }v R }.]o]˙ }( R }uv˙ o]vP R } }v R ulX OR uu oo}` }uv] }
.˘ R] }`v ] (} } u}v]} v }v}o ]}v }ou v ] P]v } R˙]]v } o]u]
Infinity
]}v X Rvo˙U uv˙ }v] ]v R E }v Uv]}v R ]v R u}v }( ]}v ] }v R -
u o v R +} }o }vv }v] 'u } uvP RoR ˘v] U ]oo˙ ]v o]PR
}( R .o v ] ˘]v ˙ uv˙ }v] ]v R E }v Uv]}vX TR }`v` }v
RoR } ]v PvoU oo˙ ]}v } U R }u ]vv X A o U ]v ]vPo˙ R]PR ]
]vP } R v˙ }( v` } X P}o]oU }v}u] v Po}˙ o}uv u˙ (R }uo]
]]vP vP}}v U v ]]vP vP}}v u˙ }vv L ]u uv R v }]v X R(v ]]vP
˙ ]} E }v Uv]}v Mu S v ooo ~]P `v o}`r] v R]PRr] uu -
Z v (R ] X S]o ]]vP v ]u uv o u˙ o˙ } }Rv P X Ivo]}v }(
}Rv P ]v ]u uv ˙u v } (} }v R u]o (ov U v U o]˙ v }v}u] v. }
v v R RoR ˙u (} v˙ PX A v }( v˙ u]]vo } (} ]u uv u˙ }u
`]R } U v }Lv }ou ]}v U `R]R P]v v ˙ ˙ }v˙X Iv ]}vU o r o }( ]u -
uv u˙ o˙X TR v v} v R v˙ }v˙ R R ] }v}o } ]u uv o]u]}v
(} Ru o } `]oo oo}` (}o ]u uv v ]]vP vPuv (} v˙ }( } } U ](
} ]v R} }v] X H]}]oo˙U } ovR ]v R E }v Uv]}v } v} (}oo}` ] }( R
UXSX v Pvoo˙ ] v } ]Pv].vo˙ o}`X

O] R UXSXU ]vv}vo }}v Pvoo˙ i } ˘v] P}vuvo ] }v}o v }R

ul Po}v U v ` o] R ]v ]vP uR] }v }r}v]vuv ]v] ]v E } U C v v }R
}v] R v `]oo }vv } }v R ]]vP v P }( } } v] X Iv uv˙ }v] U
R ] }( u]o } i } ˙]vP ] }v}o uRv]u }( v}vo RoR ˙u X OR O}uu]uv}vv
}v] oo}` }uv] } .˘ R] }`v ] (} u]o } u}v]} v }v}o }uv˙ }. X A ] - ]vv}}vRv}}v
}vo (}]Pv ] }v}o } }R RvP ]v ]]vP Po}v }o ] R u}v R ` o } RP
(} } } v] X A }]vPo˙U ]v ul }] R UXSXU R ]u uv (} } } u˙
}u `]R R UXSX v u˙ ]v8]v } Pv }uu]oo˙ }vo v v }. X

TR o]˙ }( RoR ]v R E }v Uv]}vU ]vo]vP R o]Ruv v }}v }( RoR ] v R

]]vP v ]u uv }( u]]v U ] ou} ˘o]o˙ u' (} v}voU R Rv E }v Uv]}vU o`
v }o]˙X N}vo P}vuv v RoR ] }] R ]+v ]}] v }R } R o]˙ }(
RoR v R ]]vP v ]u uv }( } ]v R }v˘ X Iv PvoU R}`U R RoR P˙
}v]v ]v u} E }v Uv]}v uu R o ]v ]}v }v R ]]vP v ]u uv }(
u]]v ˙ ov RoR ] }] X C}o `]R r]v ]vP E }v Uv]}v v v}vo Po}˙
v }v R} `]R]vP } o} v ul } U R] }o v } o˙ ulvP }o }( } }
v] U ] } Po }r}o ] v + } ]o]˙ } }uu]o] v˙ } (} `R]R `
}]v ulvP }oX

86 | R
 egulation
1.9.5 Healthcare Law and Regulation
HoR }] v R] r ˙ ˙} o˙ ]u˙ }o ]v R }uuv}v v ]}v }( Ru
o } R Pv ulvP }oX O v v ( vPuv `]R }] U R U }v
ov U R] r ˙ ˙} v }u i } }o˙ o]o (o v ( v U v rl]l
lU (o o]u U v v˙ v v ]˙ o` v Po}v v }R RoR o` v Po}v R
u˙ }v]v } ]v v l} .vv]o vPuv X R]}v v o]o (o v RoR
o` v Po}v ]vo U `]R} o]u]}vU R (}oo}`]vPP
{  R UXSX (o Av rK]ll S ~ AKSZ `R]R }R]] U u}vP }R R]vP U }v v v (}u lv}`]vPo˙
v `]oo(oo˙ }o]]vP U ]]vP U }+]vP U } ˙]vP uv}vU ]o˙ } ]v]o˙U ]v R } ]v l]v U } ]v }
` ]R R (o }( v ]v]]o (}U } R R U } } }uuv}v }(U v˙ P}} } ] U (}
`R]R ˙uv u˙ u U ]v `R}o } ]v U v (o RoR }Pu R M] v M]] X
TR] R v ]v } o˙ } vPuv `v Ru o uv( }v R }v Rv
v ] U R v (}uo˙ uvP }v R }RX A }v } v˙ v (}v P]o˙ }( ]}ovP
R AKS `]R} o lv}`oP }( R } ]. ]vv } ]}o ] X Iv ]}vU R P}vuv u˙
R o]u ]vo]vP ]u } ] ovP (}u ]}o}v }( R AKS }v (o } (ov o]u (}
} }( R (o Fo Co]u A } (o ]]o u}v˙ vo X V]}o}v }( R AKS ˙ }voo˙
]Pv].v ]]o v ]u]vo vo U ]vo]vP ]u]}vuv U .v U u]v] ]]o u}v˙ vo U v ˘
o]}v (}u ]}v ]v (o RoR }Pu X Ov D u U U R O8 }( Iv } Gvo ~OIGZ
o]R (R u}].}v } R (o Av rK]ll S X Uv R .vo o U OIG ( R} }
}v v R Av rK]ll S (} ]v }}]v v o r vPuv u}vP o]v]]v U
}] U v }R X TR] o ~`]R ˘}v Z u + Jv˙ ıU X W }vv } o `R
+ U ]( v˙U R o `]oo R }v } ]v V
{  R UXSX (o (o o]u v ]]o u}v˙ vo o` U ]vo]vP R ]]o Fo Co]u A v (o ]]o u}v
˙ vo˙ o` U `R]RU u}vP }R R]vP U ]u} ]u]vo v ]]o vo U ]vo]vP R}PR ]]o `R]oo}`
} ] u }v U P]v ]v]]o } v (} lv}`]vPo˙ vvP U } ]vP } v U } R UXSX
(o P}vuv U o]u (} ˙uv } }o R (o } (ov U lv}`]vPo˙ ul]vP U ]vP } ]vP
} u } U (o } } uv u]o } (o } (ov o]u } }o]P}v } ˙ } v
u] u}v˙ } R (o P}vuv U } (}u lv}`]vPo˙ ul]vP (o uv } }] U } }vo v
}o]P}v } ˙ u}v˙ } R UXSX (o P}vuv X Iv ]}vU R P}vuv u˙ R o]u ]vo]vP
]u v ] ovP (}u ]}o}v }( R UXSX (o Av rK]ll S }v (o } (ov
o]u (} } }( R Fo Co]u A X Mv( v Ro o]o v R Fo Co]u A v `Rv R˙
} v} u] o]u ]o˙ } P}vuv ˙} ]( R˙ u } S _ R u]]}v }( (o } (
ov o]u X TR Fo Co]u A o} u] ] ]v]]o vP S`R]oo}` _ } ]vP ] u }v
}v Ro( }( R (o P}vuv ooP]vP ]}o}v }( R Fo Co]u A v } R ]v v˙ u}v˙ }˙X
WRv v v˙ ] u]v } R ]}o R (o ]]o Fo Co]u A U R P}vuv u˙ ]u} ]]o .v
v vo (} R (o o]uU o o uP U v ˘o R v˙ (}u ]}v ]v M] U M]
] v }R (o RoR }Pu V
{  R UXSX (o HoR Ivv P}]o]˙ v A }v]o]˙ A }( ıı ~
o]]o]˙ (}U u}vP }R R]vP U lv}`]vPo˙ v `]oo(oo˙ ˘vP U } 'uvP } ˘ U Ru } ( v˙
RoR v. }PuU } }]v]vP ˙ uv }( (o } (ov v U v}v U } }u] U v˙
}( R u}v˙ } }˙ }`v ˙U } v R }˙ } }v}o }(U v˙ RoR v. }PuU Po }(
R ˙ ~ XPXU o] } ] Z } lv}`]vPo˙ v `]oo(oo˙ (o](˙]vP U }vo]vP } }]vP u]o ( } ul]vP
v˙ u]oo˙ (o uv U ]v }vv}v `]R R o]˙ }(U } ˙uv (}U RoR v. U ]u }
] ovP } RoR u' V ]u]o } R UXSX (o Av rK]ll S U }v } v˙ } v} v
} R o lv}`oP }( R } ]. ]vv } ]}o ] ]v } } R }uu]' ]}o}vV
{  HIPAAU uv ˙ R HoR Iv(}u}v TRv}o}P˙ (} E}v}u] v Co]v]o HoR A }( ı ~
] ]uouvvP Po}v U v uv P]v ˙ R Ouv] Ro ]v U `R]R ]u} ]v }o]P}v U
]vo]vP uv}˙ }v o u U `]R } (P]vP R ]˙U ]˙ v vu]]}v }( ]v]]
oo˙ ]v.o RoR ]v(}u}v `]R} }] R}]}v ˙ } v i } R F]vo HIPAA
Ouv] Ro U ]X XU ]v } RoR ov U RoR o]vPR} v RoR }] U `oo R]
]v }] U R} ]v vv }v} } Pv }( } v R (}u ]v ] (} }
}v R] Ro( ]v}o]vP R } ]o} }( ]v]]oo˙ ]v.o RoR ]v(}u}vX HITECH o} v`
88 | R
 egulation
}( ]]o u}v˙ vo U uv HIPAA } ul ]]o v ]u]vo vo ]o˙ o]o } ]v
}] v }]o˙ }R }v U v P '}v˙ Pvo v` R}]˙ } .o ]]o }v (} uP
- } ]viv}v ]v (o } } v(} R (o HIPAA o` v l '}v˙ [ ( v } }] `]R
- ]vP (o ]]o }v V
- {  R (o v v˙ ]uv lv}`v R (o PR˙]]v P˙uv SvR]v A U v R Pv P} -
}v v A+}o C A U uv ˙ R HoR C v E }v R}v]o]}v A }( ~}oo o˙U
PART I
R ACAZU `R]R ] ]v uv( }( P U ] U ]}o}P] v u]o o] } } vvoo˙
} R C v (} M] M]] S] ~ CMSZ `]R]v R UXSX D uv }( HoR v Huv S] U
]v(}u}v o } ˙uv v }R v( }( o u ˙ R v˙ } R˙]]v ~ vo˙ .v }
]vo }} U v U }}u] U }]] v R]}} Z v R]vP R}]o U `oo }`vR] v
]vuv ]v Ro ˙ R˙]]v v R] ]uu] (u]o˙ uu X F]o } u] ] ]v(}u}v
u˙ o ]v ]]o u}v˙ vo (} oo ˙uv U v( }( o } }`vR] } ]vuv ]v R
v} uo˙U o˙U v }uoo˙ } ]v v vvo u]]}vX+ E Jv˙ U U R } -
]vP }o]P}v ` ˘v } ]vo v( }( o u } ]v v}vrR˙]]v }] R R˙]]v
]v v v }v V
{  (o P}vuv ] }vP o` U `R]R ] } oo v } }uo˘ ]]vP u] ]v v -
v uo˙ uvv } P}vuv }Pu V
{  (o }vu }}v v v(] }u}v o` U `R]R }o˙ Po ulo ] v ]
- R }voo˙ Ru }vu V
{  vo}P} o` v Po}v U ]vo]vPP v rl]ll v (o o]u o` U `R]R u˙ o˙ } }
- ]v U ]vo]vP U v} o]u] }U RU ]]}vU o v ulvP vPuv v o]u
]v}o]vP RoR ]u } ] ]u ˙ v˙ R] ˙ ˙}U ]vo]vP }uu]o ]v V o`
R ] Ru o }uv] } }uo˙ `]R R Ru o ]v ˙ [}ov˙ }uo]v P]o]v
v R ov }uo]v P]v }uoP ˙ R UXSX (o P}vuv U } }R`] ] ˙uv
- R u˙ u } RoR }] v }R }vo (o } V v o}o o` R ] R
- o]v }( o v V o` R ] P uv( } } ]v(}u}v o } ˙ -
uv v }R v( }( o } R˙]]v v }R RoR }] } ulvP ˘v] v ]]vP
]v(}u}vV o` P}v]vP R ]˙ v ]˙ }( RoR ]v(}u}v ]v ]v ]uv U uv˙ }(
- `R]R ]+ (}u R }R ]v ]Pv].v `˙ v u˙ v} R R u + V v o` o } ]vv
( ]v R }( o]u ]v}o]vP ] ]v V v
{  E }v v }R (}]Pv o` ]ov }( R }( R o` U ]vo]vP }vP ]uv ]o]vP ]v}v
`]R v ˙uv } RoR }] v ]˙ v ]˙ o` v Po}v R u˙ u} ]v -
Pv Rv R} ]v R UXSX
-
S}u o` ] Ru o }uv] } }uo˙ `]R R A ]o O8 }( Iv } Gvo C}uo]v
P}Pu G]v (} PRu o Mv( v l} R PRu o R R v Mv( }( Au] -
[C} }v Iv}v `]R HoR P}(]}vo U ]v ]}v } ]]vP Ru o uv( } }
- ]v(}u}v o } ˙uv } R˙]]v v }R RoR }] } ulvP ˘v] X So
o} ]u} }R ulvP ]}v } ] Ru o }uv] } ululvP } ] ]o} }
HIPAAZ `R]R ]u} ]u]vo v ]]o R v ] R P]}v }( Ru o o v S v (}]Pv o` U ]vo]vP (} ˘uo
R E }v Uv]}v Gvo D P}}v RPo}vU `R]R u + M˙ U o} P}v R ]˙ v -
]˙ }( RoR ]v(}u}v ]v }u ]uv U uv˙ }( `R]R ]+ (}u R }R ]v ]Pv].v `˙ v }Lv
v} u ˙ HIPAAU R }uo]vP }uo]v +} X TR u]P] } `R ] ] } }uo˙ `]R
R ]uv v ]( ` (]o } }uo˙ `]R v o]o o` ]uv ` }o i } vo X
- W`]oo ] } v vo u v u}v˙ } v R } ]v vPuv `]R R]
}uo˙ `]R o]o RoR o` v Po}v X Rv RoR (}u oP]o}v R vPRv R
(o v RoR o` X B }( R R }( R o` v R v}`v }( R }˙ ˘}v
HITECHZ v v ( R} ]oo U ] ] }]o R }u }( } ]v ] }o i } RoovP v }v }
u} }( R o` X
-
OR o` R u˙ + } ]o]˙ } } ]vo P
{  R v r]vuv o` }R]] U u}vP }R R]vP U R }+]vP } P]]vP }( uv}vU `R]R ]vo U `]R}
o]u]}vU v˙ v( }( ]u } ] (} ( } (} o Rv (] ul o ~`]R o]u] ˘}v ZU }
 Regulation | 89
 M] } M]] v.]˙ R R }v lv}` } R}o lv}` ] o]lo˙ } ]vGv R v.]˙ [ o}v
}( o o] }( ]u } ] ]u o ˙ (o } P}vuvo }PuV v
{  E }v v }R (}]Pv o` ]ov }( R }( R o` U ]vo]vP }vP ]uv ]o]vP ]v}v
`]R v ˙uv } RoR }] X
Iv R UXSXU } Ro v +} } } } U ` u˙ o] }Pu } ] RuU ]vo]vP v
]v }Pu v }r˙ }}v }Pu (} o]P]o v X G} vuv v(} uv Pv] R R}`v
]v ]v ]v Ru o }uv] [ } v v ]v }Pu U ]vo]vP ]u uv
} ] U v vu }( ]v P}v ]v} R }Pu R o ]v ]Pv].v ]]o v ]u]vo
ouv X Iv ]}v U o }v ]v R ] ] v`}l Ru] } v} o}vP } r˙ }}v (}
]v ]o˙ P R ]v ]v. X O } r˙ }}v }Pu }o }u R P }( ]u]o ]v
}v X Iv ]}v U ]v N}u U R CMS ] P]v } R ] }( o]. RoR ov }o R}PR
R AC[ulo v}P]vP R ov } i v } rR]vP } (}u R] v ]v] vP
R R C MS ]vv } u}v]} R }]]}v }( R } v u˙ l Po}˙ }v } o]u] ] ]v R ( X
TR C MS vo˙ ] o ]]vP ]v]] o ul o]. RoR ov } R] r ˙ u]u
v } rR]vP ˙uv (}u ]v P} vuvro v X Iv S u U R OIG }( R HHS ]
S ]o A ]}˙ B oov `v]vP uv( R R˙ u˙ i } v}v v R ( o v rl]l l
v l} ]]o u}v ˙ vo˙ o` ]( R˙ } v} l }] } ˘o P D v.]] (}u
]vP } r˙ }}v X A }]vPo˙U }uv] ˘o R P D v.]] (}u ]vP } r˙ }}v X I ] }]
o R RvP ]v ]v }o]] P]vP } r˙ }}v v l} R ]v} }v v v uv }( v` oP]o}v
} Po}˙ }v }o ] } }R`] vP o˙ + R v } }Pu U `R]R }o o ]v
(` v ]vP + } U v R(} }o R u ]o + }v } o U ]v U v
.vv]o }v]}v X
TR] ˙ v ]v }Pu R ] .vv]o } (}u }uv] R }u R i }(
vRv P} vuv v Po}˙ v˙X TR OIG R o]R P]o]v R PP R ] ] o`(o (} R
u o uv( } ul }v}v } R] o }Pv]}v `R} }] } r˙ ]v } M]
v U }] R R }Pv]}v U u}vP }R R]vP U }v . R] U vo˙ ]v vv }( v
v} }v}oo ˙ R uv( U }] ] } o]v }v . r}u ] }]vP } }v]v .vv]o ]
] v } v} o]vl ] } }( }v} [ } X H}` U }v}v } v ]v }Pu R ]
}u vP o]]˙ v R v R i }( uoo P} vuv v(} uv }v U o } ooP}v
P]vP R] } }u} v Ru o } } }R o }o˙ o v X S ].oo˙U ]v
v ˙ U R R v uoo 'ouv ovP } }( P} vuv o]u RoovP]vP R oPo]˙ }( R]
v ]v }Pu v ]˙ }( ( o v o` X I ] }]o R ` u˙ ul Pv } ]v v
v R] o (}v }v R Ro .vv]oo˙ v ˙ v `]R R] u]uU } r˙U v } r]v v }o]P
}v X I( ` R}} } } }U v ]( ` } } v} } }v}v ]]v u } (]o } }uo˙ `]R ov
o` U Po}v } }o]vP P} vuv P]v ]v R } }v }( R }Pu U ` }o i } uP U
.v U vo U } }R ]u]voU ]]oU } u]v] v}v } v(} uv }v X W vv} v R }
}uo]v }v}o U }o]] U v } `]oo 8]v } } P]v }( } uo}˙ U ]v
v U } v} R u˙ ]}o R o` } Po}v }( R i]]}v ]v `R]R ` } X RPo }( `RR
` R }uo] `]R R o`U P} vuv ]v P}v }o ]u } ]v U Ru } }vU
] R 'v}v }( uvPuv U ]v } ˘v U v R ]o]o]˙ }( (}v }v } (} }
v `R} v ]v X
Ov D u U U R HHS o]R Po}v u}]vP ( R} }}v (} ] }v (}u R
u o uv( } ov }v} v P U D ]R ]o˙ } R}PR Ru˙ v. uvP ~PBM ZU
vo R ] }v ] ] ˙ o`X TR o o} v` ( R} (} ] }v G R
}]vr}(ro U `oo ( R} (} ]v .˘ ( vPuv `v PBM v uv( X Iuouv
}v }( R] RvP v v` ( R} (} }]vr}(ro }v ]v ] (} ]}v Ru o }
v PBM ] ( vo˙ v ]` ˙ R v UXSX ]vo u]v]}v v u˙ uv }
o X FRU }v D u U U CMS o]R v` o U + Jv˙ U U ]]vP uv(
} v R (oo o }( }r˙ ]v ] }v } R v } R }oo `]oo }v }` R A P
Mv( P] v B P] oo}v }( R PX Ov M˙ U U PRRMA R HHS ]v R UXSX D]]
C} (} R D]] }( C}ou] U } } R ]uouv}v }( R o o]u]vP R R o }v] (o o`
90 | R
 egulation
}v]vP M]] X I ] vo R}` R }}u }( R] o]P}v `]oo + R o X W vv} ] R}`
R ]uouv}v }( v v˙ (R RvP } R] o `]oo + } ]v X AoR}PR vu }( R v }R -
}} u u˙ ] R}]}v R}PR ]}vo oP]o}v } }u + U v R v UXSX
]vo u]v]}v u˙ } }R`] RvP R u U }R R v UXSX ]vo u]v] -
}v v C}vP R ]v] R R˙ `]oo }vv } l v` oP]o u } }v}o P } X
PART I
V]}o}v}(R o` v i } ]u]voU]]ov u]v] v}v]vo]vPu}v˙ vo U u -
PU.vU]P}PuvU]v]]o]u]}vuv v˘o]}v(}u ]}v]vP}vuv(v RoR
- }PuU R M] vM]]U ]}vo }vP ]uv v}]PR](` }u i }
}}]vP]˙Puv} ]u]o Puv} }o ooP}v}(v}vr}uo]v `]RR o`U }vo
RuUv`u˙ ] } ]o} } }}vXM}}U`˘ R R `]oo}vv }
(ov o` v Po}vU}} v]uouvUR }o]u } ( }}v v ]v X
B }( R R }( R o` v R v}`v }( R }˙ ˘}v v ( R} ]oo U ] ] } -
]o R }u }( } ]v ] }o i } RoovP v }v } u} }( R o` X Ev]vP R }
]vvo }}v v ( ]v vPuv `]R R] }uo˙ `]R o]o RoR o` v P -
o}v `]oo ]v}o vo } X I ] }]o R P}vuvo R}] `]oo }vo R } ]v -
} v} }uo˙ `]R v } ( U Po}v U Pv˙ P]v } o` ]v}o]vP o]o ( v
- } }R RoR o` v Po}v X I( } }}v (}v } ]v ]}o}v }( v˙ }( R o` ]
} } v˙ }R P}vuvo o` v Po}v R u˙ o˙ } U ` u˙ i } ]Pv].v vo U
]vo]vP u]v] U ]]o v ]u]vo vo U uP U .v U ]P}Puv U R ˘o]}v (}u ]}v ]v
(o v RoR }Pu U ]v]]o ]u]}vuv U }vo RuU v R ]ouv } ]vP
}( } }}v U `oo ]}vo }vP }o]P}v v }]PR ]( ` }u i } }} ]vP]˙
Puv } }R Puv } }o ooP}v }( v}vr}uo]v `]R R o` X FRU (v]vP P]v v˙
R }v v }o˙ v u }vu]vP U v u˙ ] ]Pv].v .vv]o v }vvo } X TR(} U
- v ]( ` (o ]v (v]vP P]v v˙ R }v R u˙ }PR P]v U } ]v u˙
]u] X I( v˙ }( R R˙]]v } }R }] } v `]R `R}u ` ˘ } } ]v (}v } v}
]v }uo]v `]R o]o o` U R˙ u˙ i } ]u]voU ]]o } u]v] v}v U ]vo]vP ˘o]}v
- (}u P}vuv (v RoR }Pu v ]u]}vuv X I( v˙ }( R } }U } ]o]˙ } } }
]v v } o }( }}v }o o˙ + X
1.9.6 Healthcare Reform
-
- Iv R UXSXU R E }v Uv]}v v }R (}]Pv i]]}v U R R v vu }( oP]o v Po} -
˙ RvP } R RoR ˙u R }o + } ( o }( }}v X Iv oU R R v
v }vv } vu }( ]v] R UXSX (o v oo R l } RoR } v
]u} R o]˙ }( RoR X F} ˘uo U ]v MR U R AC v ]v} (} X TR AC ] `]vP o` ]v -
- v } }v } RoR ]vv U } }v]v R P}`R }( RoR v]vP U vRv u]
P]v ( v U v` v v˙ ]uv (} R RoR v RoR ]vv ]v ] U ]u}
v` ˘ v ( }v R RoR ]v ˙ v ]u} ]}vo RoR }o]˙ (}u X
Au}vP R }]]}v }( R AC }( ]u}v } } }vo } v] R (}oo}`]vPP
- {  v vvoU v}v o ( }v v˙ v˙ R uv( } ]u} ]. v ]}v P v
]}o}P] } U }}v u}vP R v }]vP } R] ul R ]v ]v P}vuv RoR
}Pu U oR}PR R] ( `}o v} o˙ } o }( ]v } } ˘o]o˙ (} }Rv ]v]}v V
- {  ˘v]}v }( o]P]]o]˙ ]] (} M]] }Pu ˙U u}vP }R R]vP U oo}`]vP } }+ M]] } -
P } ]v ]v]]o `]R ]v}u } o}` A9 }( R (o }˙ ooU R˙ }voo˙ ]v ]vP
uv( [M]] o]]o]˙V
{  ˘v]}v }( uv( [ o]]o]˙ v R M]] D P R P}Pu ˙ ]v ]vP R u]v]uu
(} }R v v Pv] P v ]]vP R .v]}v }( SP uv( ] U_ } AMPU (}
oovP v }vP M]] P }v } v ]}v P ] v ˘v]vP o]]o]˙ }
]}v (} ]v]]o v}oo ]v M] A vP ov V
 Regulation | 91
{  v` uR}}o}P˙ ˙ `R]R }` ˙ uv( v R M]] D P R P}Pu oo
(} } R ]vRo U ]v( U ]voo U ]uov } ]vi V
{  ˘v]vP R ˙ }( v o]P]o (} R B P ]}v }PuV
{  o]R]vP R M] P D }P P ]}v }PuU `R]R ] uv( } }] æ A9 ~]v
} A9 + Jv˙ U ı v } v oP]o}vZ }]vr}(ro r]}v }+ R vP}
] }( o]o } } o]P]o v.]] ]vP R] }P P ]} }v]}v (} R uv(
[ } v } } } v M] P DV
{  v` PvrC v O}u R R Iv } } U ]v(˙ ]}] ]v v }v }u o]v]o
+v RU o}vP `]R (v]vP (} R RV v
{  o]Ruv}(RCv(}M]vM]]Ivv}}v~
]o]˙u}o}o}`M]vM]]v]vPU}voo˙]vo]vP]}v}v]vPX
S]v ] vuv U }u }( R }]]}v }( R AC R ˙ } (oo˙ ]uouv U `R]o ]v }]]}v R
v i } i]]oU }vP]}voU v ˘ RoovP X A o U R R v o˙ ]v R ]uouv
}v }(U v }v lv } o } o U ]v }( R AC X
S]v ] vuv U R R v i]]oU C}vP]}vo v ˘ RoovP } ]v }( R AC X Ov
Jv U U R UXSX Su C} ]u] R u} v i]]o RoovP } R AC }PR ˙ o
`]R} ].oo˙ o]vP }v R }v }vo]˙ }( R AC X P]} } R Su C} [ ]]}vU P]v B]v
] v ˘ } } ]v] ]o v}oouv ]} (}u F ˙ æU R}PR A P æU (}
} }( }]v]vP RoR ]vv }P R}PR R AC ulo X TR ˘ } o} ]v ]v
P}vuvo Pv] } ]` v }v] R] ˘]vP }o]] v o R o]u] } RoR U ]vo]vP
u}vP }R U ˘u]v]vP M]] u}v}v }i v `] }Pu R ]vo `}l ]uv U v
}o]] R vv ˙ ] } }]v]vP } RoR ]vv }P R}PR M]] } R AC X
I ] vo R}` }R RoR (}u u }( R B]v u]v]}v } }R +} U ]( v˙U } RoovP U
o } o R AC `]oo ]u } ]v X
P]} } R B]v u]v]}vU }v O} U U (}u P]v Tu ]Pv v ˘ } u]vvP
R }rR]vP ]] U } CSR U R ]u ]v v R AC X So '}v˙
A Gvo .o ] }
} R u]v]}v (}u u]vvP R ]] U R] (} ]v]vP } ` v] ˙ (o
iP ]v C o](}v] }v O} æU X Ov A P U U R C} }( A o (} R Fo C]] 8u o}`
} o]vP R R (o P}vuv ] o]o } ]v oo]vP ulo RoR ov (} R o} }( }rR]vP
}v ]u uv uv v R AC X I ] vo `R ]u R] `]oo R }v } ]v X FRU }v
Jv U U R UXSX C} }( A o (} R Fo C]] o R R (o P}vuv ` v} ] }
˙ u} Rv ¤ ]oo]}v ]v AC ]l }]} ˙uv } R] r ˙ ˙} `R} P ` }` } RuX Ov A ]o
U U R UXSX Su C} R Fo C]] ]]}v v uv R } R UXSX C} }( F
o Co]u U }vo]vP R P}vuv R v }o]P}v } ˙ R ]l }]} ˙uv v R ov (}uo X I
] vo `R + R] `]oo R }v } ]v X
Iv ]}vU CMS o]R .vo o R `}o P] P G˘]]o]˙ }( ]v «vP vRul (} ]v
]v R ]v]]o v uoo P} ulo U `R]R u˙ R R + }( o˘]vP R vo RoR v.
] v R AC (} ov }o R}PR R ulo X
Ov D u U ıU (}u P]v Tu ]Pv ]v} o` R FR C}v}o] A }]}v A ~HXRX æZU
`R]R o R C ]oo ˘U R RoR ]vv }] ˘U v R u]o ] ˘] ˘X I ] ]u}]o }
u]v `RR ]u]o ˘ }o ]v ]v R ( X
Iv ]}vU }R oP]o RvP R v }} v } ]v R AC ` v X TR v` o` u˙
o ]v ]}vo }v ]v M] v }R RoR (v]vPX F} ˘uo U }v A P U U R B P
C}v}o A }( U u}vP }R R]vP U ]vo PPP }v }( M] ˙uv } }] }( A9
.vv]o ˙X TR }v `v ]v} + }v A ]o U v U } v oP]o uvuv } R
U ]vo]vP `]R} o]u]}v R B] v B P A }( æU `]oo u]v ]v + R}PR U `]R R ˘
}v }( u}˙ v]}v (}u M˙ U R}PR MR U } R COVIDr ı vu] X F}oo}`]vP
R v]}vU A9 ˙uv }v `]oo } P]vv]vP A ]o U R}PR Jv U U v R A9 ˙uv
92 | R
 egulation
}v `]oo u }v Jo˙ U X P}} oP]o}vU ]( U `}o ˘v R] v]}v vo R v }( R
vu] X Ov Jv˙ U U R Au]v T˘˙ Ro]( A }( ` ]Pv ]v} o`U `R]RU u}vP }R R]vP U
(R M] ˙uv } o ˙ }( }] U ]vo]vP R}]o U ]uP]vP v v v -
- uv v U v ]v R }( o]u]}v ]} (} R P}vuv } } }˙uv } }]
(}u R } . ˙ X TR v` o` u˙ o ]v ]}vo }v ]v M] v }R RoR (v]vP U
- `R]R }o R u]o + }v } }u v }]vPo˙U } .vv]o }}v X
PART I
Ov M˙ U ıU CMS ] .vo o } oo}` M] A vP Pov R }}v }( ]vP R˙ (} P B
P P]vv]vP Jv˙ U X TR] .vo o }]. CMS[}o]˙ RvP R ` + Jv˙ U ıX H}`U
CMMIZ`]R]vCMSU}]vv}˙uvv ] ] vo `RR R B]v u]v]}v `]oo RoovP U U }l} }R`] u}](˙ R ˘ v
u]v] }v L Jv˙ U X
Rvo˙ R R v }R ˙ }( R]PRv P}vuvo v˙ } R uvv ]v `R]R uv(
- ] (} R] ul } X S].oo˙U R R v o v UXSX C}vP]}vo ]v]] v }}
]oo ]Pv }U u}vP }R R]vP U ]vP u} v v˙ } P ]]vP U R } }( ]}v P
v M] U ]` R o}vR] `v ]]vP v uv( v }Pu v (}u P}vuv
}Pu ]u uv uR}}o}P] (} P X
A (o ooU P]v B]v ]Pv v E˘ O }v Jo˙ ıU 8u]vP R u]v]}v[}o]˙ } ~]Z
- } oP]o (}u R `}o o}` R ] }( ]}v P v ]}o}P] U ]vo]vP ˙ oo}`]vP M]
} vP} P ] U ˙ ]u}]vP ]vG}v U v U ˙ }vP R o}uv v ul v˙ }( o}`r}
Pv] P v ]}]u]o V v ~]]Z } R vuv }( o] RoR ]vv }}vX Au}vP }R R]vP U
R E˘ O o} ] HHS } }] } }v }v } }u ˘] ]]vP }( ]}v P U
vRv R }u P o˙ R]vU R ] R R Fo P}vuv ˙ (} P U v ]
P}P]vP ]v R ]v ˙V v ] R FDA } `}l `]R v Iv]v T] R }} } o} }v
Iu}}v P}Pu ]v }v `]R R M] P ]}v D P U Iu}uv U v M}v]}v A }( U
v R FD[A ]uouvvP Po}v X FDA o R ]uouvvP Po}v }v Su U U `R]R
`v ]v} + }v N}u U U }]]vP P]v (} } ]o v u] ]u}}v ov (} P
(}u C v X Ov Su æU U CMS P ]u} ˙ v R] o `]oo v} o]P]o (} (o
v S}v ı }( R S}]o S]˙ A v uv( `}o v} } R P (} S ] _ }
A P Mv( P] } X S]v R P v} }v] } } v P U CMS (R -
] `]oo v} o]R N}vo A P D P A ]]}v C} (} R P X I( ]uouv U ]u}}v }( P (}u
C v u˙ u]oo˙ v o˙ + R ] ` ] (} v˙ }( } } v] X FRU }v N}u
U CMS ] v Iv]u F]vo Ro ]uouvvP R M} F} N}v ~MFNZ M}o v `R]R M]
P B ]u uv `}o R v oo (} ]v P v ]}o}P]o }v R o}` ]
- P uv( ] ]v OPv]}v (} E}v}u] C}}}v v D o}uv }v] `]R ]u]o P}
}u } ] X H}`U }v D u ıU CMS ]v R MFN o X A ]}voo˙U }v N}u
U U HHS o]R Po}v u}]vP ( R} }}v (} ] }v (}u Ru o uv -
( } ov }v} v P U D ]R ]o˙ } R}PR Ru˙ v. uvP U vo R ] }v
- ] ] ˙ o`X TR o o} v` ( R} (} ] }v G R }]vr}(ro U `oo
( R} (} ]v .˘ ( vPuv `v Ru˙ v. uvP v uv( X P v }
} }U R u}o v ]}v }( R (}uv}v ( R} ` o˙ v v oP]o}v ]u}
u}}]u }v ]uouv}v }( R o vo Jv˙ U X AoR}PR vu }( R v }R }}
u u˙ ] R}]}v R}PR ]}vo oP]o}v } }u + U v R B]v u]v]}v u˙
} }R`] RvP R u U }R R B]v u]v]}v v C}vP R ]v] R R˙ `]oo
}vv } l v` oP]o u } }v}o P } X
W˘ R ]}vo UXSX (o RoR (}u u `]oo } ]v R ( U v˙ }( `R]R }o
o]u] R u}v R R UXSX (o P}vuv `]oo ˙ (} RoR } v ] U `R]R }o o ]v
uv (} } } v] } ]}vo ]]vP X
- FRU oP]o v Po}˙ }}o R v u } ˘v }r}o ]uv v ] o
v }u}}vo ] (} Ru o } X W vv} `RR ]}vo oP]o RvP `]oo
v U } `RR FDA Po}v U P]v } ]v }v `]oo RvP U } `R R ]u }( R RvP }v
 Regulation | 93
R ulvP }o U ]( v˙U }( } } v] U u˙ X Iv ]}vU ]v v˙ ˙ R UXSX C}vP }(
R FD[A }o } u˙ ]Pv].vo˙ o˙ } v ulvP }oU `oo i } u} ]vPv
} oo]vP v }rulvP }v]}v v }R ]uv X

Iv]]o ]v R UXSX R o} }u ]v ]vPo˙ PP] ]v ]vP oP]o}v v ]uouvvP Po}v

]Pv } }v}o Ru o v ]}o}P]o } ]]vP U ]vo]vP ] } v ]u uv }v]v U
]}v U ]}v }v ]v } v ulvP } ]o} v v v˙ u U v U ]v }u
U ]Pv } v}P ]u}}v (}u }R }v] v ol R]vPX LPoo˙ uv ] }v}o
}v ˙uv u}v ˙ R] r ˙ ˙} } }R ]}v }o Ru } ]v U o }( }}v U .vv -
]o }v]}v v } X Iv ]}vU P]}vo RoR R}] v ]v]]o R}]o ]v ]vPo˙ ]vP
]]vP } } u]v `R Ru o } v `R]R o] `]oo ]vo ]v R] ]}v
P v }R RoR }Pu X TR] }o R ou uv (} } } } }v }
} ]]vP U `R]R }o vPo˙ + } ]v U o }( }}v U .vv]o }v]}v v } X

Iv R E }v Uv]}vU ]u]o }o]oU }v}u] v Po}˙ o}uv u˙ + } ]o]˙ } }.o˙ }u -

u]o] } v } v˙ ( } X Iv ]}v } }vv]vP }v ] v } }v]vuv u -
U oP]o o}uv R E }v Uv]}v } uu oo u˙ o ]v ]Pv].v ]}vo ] -
uv } }o R u˙ ]v } }vP } X TR o]˙ }( RoR ]v R E }v Uv]}vU ]vo]vP
R o]Ruv v }}v }( RoR ] v R ]]vP v ]u uv }( u]]v U ] ou} ˘o]o˙
u' (} v}voU R Rv E }v Uv]}vU o` v }o]˙X N}vo P}vuv v RoR ] }]
R ]+v ]}] v }R } R o]˙ }( RoR v R ]]vP v ]u uv }( }
]v R }v˘ X Iv PvoU R}`U R RoR P˙ }v]v ]v u} E }v Uv]}v uu R
o ]v ]}v }v R ]]vP v ]u uv }( u]]v ˙ ov RoR ] }] X C}o
`]R r]v ]vP E }v Uv]}v v v}vo Po}˙ v }v R} `]R]vP } o} v ul } U
R] }o v } o˙ ulvP }o }( } } v] U ] } Po }r}o ]
v + } ]o]˙ } }uu]o] v˙ } (} `R]R ` }]v ulvP }oX Iv ]vv}vo ul U
]u uv v RoR ˙uv ˙u ˙ ]Pv].vo˙ ˙ }v˙U v uv˙ }v] R ]v ]
]o]vP }v ]. } v R] X

W vv} ] R o]lo]R}} U v } ˘v }( P}vuv Po}v R u˙ ] (}u ( oP]o}v }

u]v] }vU ]R ]v R UXSX } } X I( ` } } }oo}} o}` } vo } } RvP ]v
˘]vP ]uv } R }}v }( v` ]uv } }o]] U } ]( ` } } }oo}} v} o } u]v -
]v Po}˙ }uo]v U } } v] u˙ o} v˙ Po}˙ }o R u˙ R v }]v v
` u˙ v} R] } ]v }.]o]˙U `R]R `}o o˙ + } ]v X

1.9.7 Environmental issues which may influence the use of our material fixed assets

O ]u˙ R v o}uv ] l o ]v } (]o] ]v Z`]iv U B oP]uX F} R ]

` ] U v R }]v U R v ˙ v]}vuvo v ]}R u] (}u R }v]o P}vuv U
] ˙ (} R uvv ]v `R]R ` ] (]o]

94 | R
 egulation
2
Risk

PART II
Factors
Contents
2.1 Risk Factors Related to argenx’s Financial Position and 98
Need for Additional Capital

2.2 Risk Factors Related to the Development and Clinical Testing 100
of argenx’s Products and Product Candidates

2.3 Risk Factors Related to Commercialization of argenx’s 108

Product Candidates

2.4 Risk Factors Related to argenx’s Business and Industry 114

2.5 Risk Factors Related to argenx’s Dependence on Third Parties 119

2.6 Risk Factors Related to argenx’s Intellectual Property 124

2.7 Risk Factors Related to argenx’s Organization and Operations 133

2 Risk Factors
TR}v}(v˙}(Rv}]uv]]vR]l(}U]v]]oo˙}}PR`]R
}R]uvU}oRu]o+}vR]vUo}(}}vU.vv]o}v]}vv}
}(Pv˘XTRv}R}vo˙]lPv˘(X]}vo
A ]lvv]vv}vo˙lv}`v}Pv˘}
R]vo˙}v]]uu]o}v}].u˙o}]u]]]vUo}(}}vv.vv]o}v]}vX
2.1 Risk Factors Related to argenx’s
Financial Position and Need for
Additional Capital
2.1.1 We have incurred significant losses since our inception and expect
to incur losses for the foreseeable future. We may never achieve or
maintain profitability.
W }uu ]o r P ]}R u ] o }u v˙ `]R o]u] } ]vP R] }˙ v ` R }vo˙ ˙
vo˙ }uuv } v]]}v (}u o]v] o r P } }uu ]o r P }u v˙X Ovo˙ VYVGA RT ¡ ~(P ]P]
u} o( ( Z (} R uv }( PMG R } ]v Po }˙ } o ]v R UXS X }v D u U v
]v J v }v Jv ˙ U v ` } v} vo˙ R v˙ } o ]v v˙ }R i ] ] ]}v } (} v˙ }R
} v] X S]v } ]v ]}v U ` R ]v ]Pv](] v } ]vP o} U } o]vP USD U X u]oo]}v
}( uo ] o} X O o} o ]v] oo˙ (}u } ]v ]v R v o}uv U o]v] o
]vP U o]v] o o}uv }( } } v } } v] `oo } ]v (} R
}P u U r}uu ]o ]]] v (}u Pv o v u]v] ] } }] `]R } } ]}v X
Iv ]]}v U ` ˘ } }v]v } ]v ]Pv](] v } }] `]R } o] ]vP ]v R UXS X v ]v E } X
Iv R ( U ` ]v v } }v]v } }v R v o}uv U o]v] o ]vP U o]v] o ]o v
Po }˙ }uo]v ]]] `oo R }uu ]o] ]}v }( VYVGA RT ¡ (} R uv }( PMG ]v R
UXS X v ]v J v v ` ]v v } }v]v } ((} } o]R v u]v ]v o U u l]vP v ] ]
]}v ]v( X TR ˘ v U }P R `]R v]] Pv o v u]v] ] ˘ v U `]oo o ]v
]v ]vP ( R ]Pv](] v o} (} o R v˘ o ˙ X W v]] R } ˘ v `]oo ]v
v]oo˙ ]( v ` ˘ } P] }i ] v ` ˘ ]v o˙ } v}v ] o ]vP
R }U ]vo ]vP (]o ] U u]P} ]o o U (˙ ] } }R Po }˙ RoovP X I( } o}
}u P Rv ˘ U ` u˙ ] ]]}vo (]vv]vP Rv v]] v R (]vv]vP u˙ v}
]o o } }v o u } oo X
T} }u v u]v }(] o U ` u ]v o}]vP v v oo˙ }uu ]o]]vP } R
Pv ]Pv](] v v X TR] `]oo ] } (o ]v vP }( RoovP]vP ]]] U ]vo ]vP }u
o ]vP o]v] o ]vP v o]v] o ]o }( } } v } } v] U ] } ]vP v o}]vP
]]}vo } v] U } ]v]vP Po }˙ } o (} v˙ } v] R (oo˙ }uo
o]v] o ]o U o]R]vP uv( ]vP v u l]vP ]o]] v o]u o˙ oo]vP v˙ } (} `R]R
` u˙ } ]v Po }˙ } o X W u˙ v ]v R ]]] v U v ]( ` }U u˙ v Pv
v R ] ]Pv](] v v}PR } R] }(] ]o]˙X F} ]v v U v R}PR ` R ] } o
}( v }uu ]o] VYVGA RT ¡ (} R uv }( PMG ]v R UXS X v ]v J v U ` v }] v} v
R ` `]oo o } R] }(] ]o]˙ }v o ]v R ]v] ]}v o}v } R ` `]oo o } ]
} o }( v }uu ]o] VYVGA RT ¡ ]v }R ]v] ]}v } ]v }R }v ] X
98 | Risk Factors Related to argenx’s Financial Position and Need for Additional Capital
Ev ]( ` } Pv } }˙o } } o U ` u˙ v R] } ]v }.]o]˙ }v o˙ }
vvo ] X O (]o } R] } ]v }.]o]˙ }o ]u] } ]o]˙ } ] ]oU ˘v } ]v U
]](˙ } } }+]vP } }vv } }}v v R }o R u]o ]u }v } ] -
v U .vv]o }v]}v v o }( }}v X
-
PART II
2.1.2 Substantial additional funding may be required in order to complete the
development and commercialization of our products and product candidates,
but may not be available to us on acceptable terms or at all.
N}`]Rv]vP } ]Pv].v }]}v }( R v R ]ov }( USD U X u]oo]}v v }R v .vv]o
}( USD U X u]oo]}v }( D u U U ]o} ]v } }v}o] .vv]o uv (} R
.vv]o ˙ v D u U U ` ˘ } ] ]}vo (v]vP ]v R ( } 8]vo˙ .vv }
}}v U } v o}uv }( } } v } v] v } }vv } ]v ] -
ovP } R v o}uv v R }uu]o]}v }( } } X O ( ]o ]uv (} VYV -
GART¡ v } v } v˙ ( } v] `]oo v }v uv˙ (} U ]vo]vP ~]Z R }P U u]vP
v }uo}v }( o]v]o vP v o]v]o ]o (} } v } v˙ ( } v] U ~]]Z R vu
}( }vo v` } v] ` ]v(˙ v ] } o} U ~]]]Z R u v } ]v}o ]v }]v]vP P -
o}˙ }o (} } } v] v v˙ o˙ ` u˙ v}v o }( }o]vP Po}˙ ] -
uv } o `]R } v˙ }( } } v] U ~] Z oo]vP v ulvP ] v lv
]v }vv}v `]R R }vo }uu]o]}v }( } v } } } v] } v˙ ( }
v] U ]( } U v } ]v}o ]v R }v }( v + o v ulvP }Pv]}vU ~ Z uv( -
]vP ] v lv R }( R }vo }uu]o]}v }( } v } } } v] }
v˙ ( } v] U ]( } U v } ]v}o ]v R }v }( v + o˙ R]vU ~]Z R }
- ]v}o ]v P}`]vP } }Pv]}v } R ] v } oo}` (} R RU o}uv v }vo }uu -
]o]}v }( } v } } } v] } v˙ ( } v] U ~]]Z R } ]v}o ]v .o]vP
v o]}v v u]v]v]vP v v(}]vP v } (v]vP P]v o]u } ]v(]vPuv ] ˙ R]
U ~]]]Z R u]vvv }( } ˘]vP }oo}}v Puv v v˙ ]v} v` }oo}}v Puv U ~]˘Z
R u}v }( v U ]( v˙U ` u˙ ] ]R ]o˙ } ]v R (}u }( }˙o˙ ˙uv (}u ( o }( }
v } } } v] } v˙ ( } v] U ]( } U v ~˘Z o}uv o }
COVIDr ı v ] ]u }v R } v u]vP }] `]R R }v }( } o]v]o ]o U o]v]o }Pu U
uv( ]vP ] v }R o ] X
Iv }v }( } }uu]o ovR }( VYVGART¡U } R v ]v ]Pv].vo˙ ]v }u }
- v ]} .vv]o ˙ X A ]o} ]v } }v}o] .vv]o uv (} R .vv]o ˙ v
D u U U v R }o}` (}u } }vP ] ]v ˙ ¤ X u]oo]}v } v }o}` }( ¤ X
u]oo]}v (} R ˙ v D u U U }u } v }o}` }( ¤ ı Xæ u]oo]}v (} R ˙ v D u
U X A ]o} ]v } ]} }v}o] .vv]o uv U } R G}` (}u } }vP ]
u}v } v ]vG}` (}u }( ¤ æ X u]oo]}v ~ƒ X u]oo]}vZ (} R ˙ v D u U ıU v }o}` }(
¤ Xæ u]oo]}v ~ƒæ X u]oo]}vZ (} R ˙ v D u U v v }o}` }( ¤ X u]oo]}v ~ƒ Xæ u]oo]}vZ (}
R ˙ v D u U X B }v } v ov } ˘v } }uu]o ]v( v ]+v -
]o]v }( U ` ˘ } R v } }vv } ]Pv].vo˙ ]v ]v X TR ]v v `]oo
} } v]}v } v ]vP ]uuv}o}P˙ }uv˙ v ] U ]v oU ˘ } } ]o }
- }uu]o ]v( } } R }uu]o]}v }( VYVGART¡ ]v R UXSX v ]v Jv (} R uv }(
PMG v U ]( } U (} ]o˙ P}`]vP vu }( ]v]}v ]v R UXSX v Jv v } }R l˙ ]}] ~]v
R EUZU } v R o}uv }( (PP]u} } ul Po}˙ }o (} R uv }( ITPU PVU CIDPU BPU
u˙}] U COVIDr ı u] POTSU SiSU MN v LNU } v o]v]o o}uv }( ARGXr ]v uoo PR
- }}( }( }v ]o ]v MMN v DGF ]v R }v˘ }( l]v˙ vov U } v ARGXr ı v o˙ P
]o]v v] ]v } }uu]o (vR] U R v}u oU Ru}o}P˙U u}o}P˙ v vR}o}P˙ (vR] -
U } ]o } }uu]o o˙ R]v } } } Po}o ovR }( v˙ } } U } ˘v }
]o]v }( ( } v] R}PR R IIPU v } (v }R v v ( R v o}uv
] v Rv}o}P˙ o}uv v (} `}l]vP ]o v }R Pvo }} } X
Risk Factors Related to argenx’s Financial Position and Need for Additional Capital | 99
Av˙ (]o ˙ } l R R v v }v}o ˙ o˙]vP } (v +o˙ v uvP]vP } R v ]v - vP ] ˘v] v v luv˙ ˙ } }uo U v ] }}u ] ]vRvo˙ v ]vX F]o v }
uv }]o˙ }o o ]v .vv]o o} R }o R u]o + }v } ]v X v˙ u ]vP R o]v]o ]o } v } ( o]v]o ]o o u˙ v} (oX TR ] R]PR (]o
(} P v ]}o}P] }]vP R}PR o]v]o ]o X A vu }( }uv] ]v R Ru o v ]} -
Uvo R u ` v Pv ]Pv].v v (}u } o U ]( U ` ˘ } .vv } } }v Rv}o}P˙ ]v ] R + ]Pv].v l ]v o]v]o o}uv v L R]]vP }u]]vP o ]v
R}PR}u]v}v}(o]}]]˙}.vv]vP}}R}U`R]Ru˙]vo}oo}}v o] ] U v v˙ R l ]v } o]v]o o}uv }o R u]o + }v } ]v U
`]RR]XO]o]˙}]]}vo(v`]oov}v.vv]oU}v}u]vul}v]}vv}R }vP o v .vv]o }v]}vX

PART II
(}U}`R]R`u˙Rv}}o]u]}v}oX]}vo A .vv]vPu˙v}]oo}}v -
ouU}ooXTR]v]o]˙(}}]]ov`Rvv`}oRvP]u}v}.vv]o Wu˙ ˘]v o˙ ]v } }vP}]vP o]v]o ]o U ]vo]vP o }( COVIDr ıU v ` } v} lv}` `RR
}v]}vv}]o]˙}}]vP˙vo`u˙(}}o˙U}u]v ovv o]v]o ]o `]oo P]v }v u U v } ]Pv U v}oo v }v u } }uo }v Ro U ](
Ro}uv}}uu]o]}v}(oo}}(}R}Pu}}}}v]U`u˙ ooX Co]v]o ]o v o˙ U v U } u]v (} oP ]˙ }( }v }] } }v}oU ]vo -
]}]Pv].vo˙]oUo˙}]}vv}v}u}}(}R}o}uv}Pu}R}u - ]vP o˙ }( }o (}u Po}˙ R}] U ]v }vo ]` } } R] }uu]' U o˙ } (]o }
u]o]}v}(v˙}(}}}}v]U}vo}˘v}}}v}}R`]]o] ] } ]v v U (]o }( R] } }uo˙ `]R Po}˙ } }v o ]uv } ] ovP
}v}]v}}v]U]}`u˙vo}lvP}((]v}}v]Uoo}( } R v˙U o]˙ } ]o]˙ }( R } } } v] X
`R]Ru˙Ru]o]u}v}]vU.vv]o}v]}vvo}(}}vX
W }o v}v o˙ U (} ˘uo ]( o]v]o ]o ] v } u]v ˙ U ˙ R ]v }vo ]`
}~ IRBsZ }( R ]v }v ]v `R]R R ]o ]vP }v } R] }uu]' U ˙ R D R]`
2.1.3 The investment of our cash and cash equivalents may be subject to risks C}uu]' ~ DRCZ } D S(˙ M}v]}]vP B} ~ DSMBZ (} R ]o } ˙ R EMAU FDAU PMDA } }R Po}˙
which may cause losses and affect the liquidity of these investments. R}] X SR R}] u˙ ]u} v]}v } u]v}v } vu }( (} U ]vo]vP (]o }
}v R o]v]o ]o ]v }v `]R Po}˙ ]uv } } o]v]o }}}o U ]v }v }( R o]v] -
A }( D u U U ` R R v R ]ov v v .vv]o }( USD U X u]oo]}vX W o ]o }}v } ]o ] ˙ R EMAU FDAU PMDA } }R Po}˙ R}] ovP ]v R ]u}]}v }(
R]}]oo˙ R ]v voo˙ oo }( } ]oo R v R ]ov v v .vv]o ]v o]v]o R}o U v(} v (˙ ] } ] + U ]vo]vP R} ovP } R o } `R]R } }
]R v }v U ]vP }v U u }v } R]PRo˙ o]] u}v˙ ul (v U v]vP R] ]v } v } v] o}vP U (]o } u}v v. (}u ]vP } } } v] U RvP ]v
]v X Av˙ ( ]vuv u˙ ]vo u }] U }} }v U }uu]o U . }( }] U P}vuvo Po}v } u]v] }v } ol }( (v]vP } }vv R o]v]o ]oX W }o
P}vuv ] v u}v˙ ul (v ]v }v `]R } R uvPuv }o]˙X TR ]vuv u˙ o} ˘]v }}vo RoovP ` v l v ]v ]vP vu }( o]v]o ]o X I( ` ˘]v o˙ ]v
i } Pvo ] U o]]]˙U v ul v ]v ]l X F} ˘uo U ` u˙ o] o} ]v R (] R }uo}v }(U } u]v}v }(U v˙ o]v]o ]o }( } } } } v] U R }uu]o }
o }( R ]vuv } }uo o} }( R ]vuv U `R]R `}o R vP + }v } .vv]o }( } } v } v] `]oo Ru U v } ]o]˙ } Pv } v (}u v˙ }( R
}v]}vX Iv ]}vU R}o } ]vuv ˙]vP } R u}v }( ]v ] } U } ]v } v } v] `]oo o˙ X Iv ]}vU v˙ o˙ ]v }uovP } o]v]o ]o `]oo ]v
]v}u `}o +X TR ul ]l }] `]R } ]vuv }}o]} u˙ R v + }v } o } } U o}` }`v } } v] o}uv v }o } v i}] } ]o]˙ } }uuv
}( }}v U o]]]˙ v .vv]o }v]}vX } o v Pv v X S]Pv].v o]v]o ]o o˙ }o o} oo}` } }u} } ]vP }
} ul (} ` } } R}v v˙ ]} ]vP `R]R ` R R ˘o] ]PR } }uu]o] } }
v } v] v ]u] } ]o]˙ } }uu]o] } } v } v] v u˙ Ru }
]v U o }( }}v v .vv]o }v]}vX

2.2 Risk Factors Related to the Co]v]o]ou}v]v}v`]RREMAUFDAUPMDAv}Ro]oPo}˙R}][

Development and Clinical Testing

oPo]uvvPo}vvi}}]PR˙RP}vuvoPv]vIRBRu]o]v -
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of argenx’s Products and Product

}(}}v}v]}vGMP]uvv}RPo}vXFRu}U`o˙}v
}vR}Pv]}v~ CROsZvo]v]o]o]}vR}vuo˙}v}(}o]v]o]ov

Candidates
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Wv}v}}oo}}v}vu]o]v}vvCRO}}v}o]v]o]o]v}uo]v`]RGCP
]uvXT}R˘v}}oo}}}RCRO}]vP}(]o}v}oo]v(}}o]v]o]oU(]o
}}vR˙}GCPv}o˙(}]Pv].vu]vR˘}v}(]oU]vo]vPR]]vP(oo
2.2.1 All but one of our products and product candidates are either in preclinical, v}oouvU`u˙+˙]v}U}Puo˙}}RU`R]Ru˙Ru}]vXIv]}vUo]v]o
early-stage clinical or clinical development or market approval has been ]oR}v]v}v]}]R}v
E Uv]}vvRUXSXu˙i}(Ro˙v˘v
requested for them, but has not (yet) been granted, and only VYVGART™ for o}(]vR]uv}U]}voPo}˙]uvvRvPPuv}(v}vrE}vUv]}vv
the treatment of gMG has obtained regulatory approval in the U.S. and in Japan. v}vrUXSXCROU`oo˘}}]l}]`]Ro]v]o]vP}`R}vlv}`v}REMAUFDAUPMDA}
Our trials may fail and even if they succeed we may be unable to commercialize }RPo}˙R}]Uvo˙]+vv}(]Pv}]Uv]vPvu]oX
any or all of our products and product candidates due to a lack of, or delay in,
regulatory approval or for other reasons. (}
B `v}uuvo]v]o]o(}}v]U`u}uo˘v]o]v]ovPv]
R}}ovvINDo]}v]vRUXSX}JvU}o]v]o]oo]}v~ CTAsZ]v}E U}}u -
F} } o]v]o ]o } v ]v } } }]v R ]] Po}˙ }o } ul v oo v˙ }( } oo]}v]v}Ri]]}vXWvv}]v}(Ruo˙}uo}v}}}u}(}o]v]ovP
} v } v] U ` } } }oo}} (} R v] u (oo˙ u}v R}PR v]vvv}]](REMAUFDAUPMDA}}RPo}˙R}]`]oo}}}o]v]o
˘v] o]v]o ] v o]v]o ]o R } } (U v }v } + ]v Ruv X Co]v]o }Pu}](R}}u}(}o]v]ovPv]`]ooouo˙}R(Ro}uv}(R

100 | Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates | 101
}v]XTRU`vv}R``]ooo}u]IND}CTA}}uoo]}v(}}
o]v]o}Pu}vRuo]v`˘U](ooUv`vv}Ru]]}v}(IND}CTA}}u
oo]}v`]ooo]vREMAUFDAUPMDA}}RPo}˙R}]oo}`]vPo]v]o]o}P]vX
Ev ]( o]v]o ]o } P]v (} R o]v]o }Pu U } o}uv +} u˙ v} (oU v o]v]o
]o R ` }v } R R] }v }v } Ro( u˙ v} u}v 8]v (˙U ]˙ v }
v˙ } 8˙ } }]v R ]] Po}˙ }o (} v˙ }( } } v } v] } }
v } v] uo}˙]vP } Rv}o}P˙X Mv˙ }( } o]v]o ]o o]v U `R]R u˙ } ]v
]Pv].v ˘v `]R} v˙ ]]]o]˙ } R o]lo]R}} }( (o o X F} ]vv U ` ˘ } ]
}o]v (} R PR ADVANCE ]o }( uP llP (PP]u} (} R uv }( ]u˙ ITP ]v R }v
}( X A R ˙ o o]v U ` `]oo v} lv}` `RR R ]o R v (o vo ` ]
R v vv} ˙} R R `]oo }v]v }] o X Ev ]( ` }]v }] o (}u o]v
]o ] } ]v]o o]v]o ]o U ` u˙ v} R] R u ]v ( ]o X
Av˙ }( R } v u˙ Ru } ]v U o }( }}v v .vv]o }v]}v ]Pv].vo˙X Iv ]}vU
uv˙ }( R (} R U } o }U o˙ ]v R }uuvuv } }uo}v }( o]v]o ]o u˙ o} o
uo˙ o } R v]o }( Po}˙ }o }( } } v] } o ]v R o}uv }( } }
v] ]vP } o˙X
TR u ] } }]v }o ˙ R FDAU EMAU PMDA v }uo (}]Pv R}] ] v]o
˙]oo˙ l uv˙ ˙ U ]( }]v ooU (}oo}`]vP R }uuvuv }( o]v]o ]o v v }v vu}
(} U ]vo]vP R vo ] }v }( R Po}˙ R}] X Iv ]}vU }o }o]] U Po}v U }
R ˙ v u}v }( o]v]o v ˙ } P]v }o u˙ RvP ]vP R } }( } v] [
o]v]o o}uv v u˙ ˙ u}vP i]]}v X Ovo˙ VYVGART¡ (} R uv }( PMG R }]v Po}
˙ }o ]v R UXSX v ]v Jv v ` } v} vo˙ R v˙ }o (} v˙ }R ]v]}vU ]v v˙ }R i
]]}v } (} v˙ }R } v] v ] ] }]o R v}v }( } }R ˘]vP } v] } v˙
} v] ` u˙ l } o} ]v R ( `]oo }]v Po}˙ }o ]v v˙ }R i]]}v
} ]v]}vX A }o ˙ }v Po}˙ R}]˙ } v} Pv }o ˙ v}R Po}˙ R}]˙ }v R
] }( R u } ooX WR o]u] ˘]v ]v u]«vP v }vP R o]}v v ˙ }
l Po}˙ }o v ˘ } o˙ }v R] r ˙ CRO } ] ]v R] } X S]vP Po}˙ }o
] R u]]}v }( ˘v] v}vo]v]o v o]v]o v }vP ]v(}u}v } Po}˙ R}]
(} R R ]v]}v } o]R R } v] [ (˙ v 8˙X S ]vP Po}˙ }o o}
] R u]]}v }( ]v(}u}v } R } uv( ]vP } }U v ]v }v }( uv( ]vP
(]o] ˙U R Po}˙ R}] X
I( ` vo } }]v Po}˙ }o }( } } v } v] }v uo˙ ] } ooU }
]v `]oo u]oo˙ ]u X F} ]vv U ` R ]v ]Pv].v u v ˘v o } }v
(} R ]o r} }( } Po}o }uu]o ]v( v P } ]vv}˙ R }( R ovR }( VYVGART¡
(} R uv }( PMGX Av MAA (} (PP]u} (} R uv }( PMG ] vo˙ v ]` `]R R EMA
`]R v v] ]]}v ]v R }v Ro( }( v ` ˘ Z ] L } o } .o (} }o ]v G
CR]v ˙ u] r v M]}v ]v Io ]v R }v }( X I( VYVGART¡ ] v} } ]v }v } u}
i]]}v }R Rv R UXSX v JvU } ]( R }o ]Pv].vo˙ o˙ U ] }o R u]o
+ }v } ]v X
2.2.2 Business interruptions resulting from the COVID-19 pandemic could
cause a disruption of the development of our products and product
candidates and adversely impact our business.
Po] RoR ] R vu] } ]u]o } l }o o˙ ]u } ]v U R R COVIDr ı
vu] X TR COVIDr ı vu] ] }o]vP v R o˙ v o ` v ]v U v U }( R
}( R] Uv] o RP] ]}v D } uv U R o } R ]uouv ]}v }( ]} }v U ]vo ]vP P} vuv r
]u} vv U o ]}v v }R o] RoR (˙ u X
102 | Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates
TR ˘v } `R]R R COVIDr ı vu] ]u } ]v v }}v v R} }( } }oo}} U ]v -
- o]vP o]v]o o}uv v Po}˙ +} U `]oo v }v ( o}uv R R]PRo˙ v ]v v
vv} ] `]R }v.v R] u U R R ou P}PR] }( R ] U R }v }(
R } lU R +v }( ]v v }R uv P]v v` ]v } u}v }( R ] U R
}v v + }( ]v ] }v v R R}ru + v ou +v }( R o ]}v U
- vv U }]o ]v]vP ]uv v ]v o} } }v]v v R ] X A }]vPo˙U ` }
PART II
v} ˙ lv}` R (oo ˘v }( }vo o˙ } ]u }v } ]v U } o]v]o v Po}˙ ] v R}
}( } v U RoR ˙u } R Po}o }v}u˙ `R}o X H}`U R ]u }o o˙ + }
]v U .vv]o }v]}vU o }( }}v v P}`R } X Iv ]}vU } R ˘v R }vP}]vP COVIDr ı
- vu] o˙ + } ]v v o }( }}v U ] u˙ o} R R + }( R]PRv]vP uv˙ }( R
}R ]l v v ]v ] R]vX
-
Operational impacts of COVID-19
W }v } o]v]o ]o Po}oo˙U ]vo]vP ]v ]u ˙ COVIDr ı ]v N}R Au] U E } v JvX TR
}vv }( COVIDr ı R v }o }vv } o˙ ]u } ]v v }}v U ]vo]vP } }
- } R] r ˙ v [ ]}˙ ] U o]v]o ] v o]v]o ]o X TR COVIDr ı vu] U v u
v lv } }v}o R }( R COVIDr ı ] U }o ]u] } } } R] r ˙ v [ ]o]˙ } ]v]
o]v]o ]o ] v ] v ]v v ]v]o ]vP} v ] +U RoR }] U
u˙ R R]PRv ˘} } COVIDr ı ]( v } l } ]v R] P}PR˙ } } ]}]}v }( R}]o
} }` R } l v ]}v ]v oX FRu} U }u v u˙ v`]oo]vP } v}oo ]v }
} } R] r ˙ v [ ]o } vo } }uo˙ `]R o]v]o ]o }}}o ]( vv } o ]}v
]u v u}uv } ]v RoR ] X Pv ]v } v } R] r ˙ v [ ]o
]v ]l (} COVIDr ıro RoR ] } vu }( (} U ]vo]vP R] P U R v }( R]
- ] } P }( R] ] X I( v ]v } } } R] r ˙ v [ ]o }v COVIDr ıU ] }o o˙
- ]u R }}u }( R ]oU ]vo]vP ˙ o]u]vP R o]˙U }uov v ]v ]o]˙ }( R `
o } }oo X A o }( R ]}v U v}oouv ]v }u }( R }vP}]vP ]o ` } } R] r ˙ v
}vvPRv}u˙o˙UR˘v}(R(oo]u]v}v.oo}(R}vv
u}v }( R ] v v ]v˙ } R +v }( ]v v uv R(}X TR vu] u˙ o}
o}o˙vu]}]vP}o˙vu]]o}v(}vRRo˙vv}oo
]v }vP}]vP ]o X W v } R] r ˙ v `]oo }vv } u}v]} R ]u }( COVIDr ı }v oo }vP}]vP o]v]o
]o v `]oo ]uouv RvP v ˙X
W v l} } v o R vuv }( R o]v]o }Pu }v }vv} ] l]vP ]v}
}v R i}˙ }( COVIDr ıX I( ` v l} }v }( } v o v} } u} (}` `]R }u } oo }( R
o]v]o }Pu o }( R COVIDr ı vu] } }R`] U ` `}o v} vo } }u } oo }( R
( ˙uv `R]R ` o]P]o } ] v R }oo}}v Puv `]R R vX
WR v ]v(}u ˙ } P v v P } uv( ]vP v } }vo o]u]}v ]v
R ]o]o]˙ }( ]o uv( ]vP u]o } R uv }`]PR]vP R ]oo uv( ]vP ]˙
(} R u]o v ]}]}v ]u} ˙ R UXSX P}vuv }v R uv( ]vP }( COVIDr ı ]v v
R X TR(} U ` u˙ ˘]v o]u]}v ]v uv( ]vP ]˙ `R]R }o ]u } ]o]˙ } ]o
]vv}˙ ` } R }uu]o ovR }( VYVGART¡ ]v PMGU v ` (} R }uu]o
ovR }( (PP]u} ]v ]}vo ]v]}v U ]( } X W `}l]vP o}o˙ `]R } uv( ]vP v }
u]P R} ]l } R ˘v }]o X
S]v M R `Rv (} ]Pv v }u ] ]v ]}v ˙ R FDA }( ( ]o]] ` o Po˙ o }v R}o U R
FDA R v `}l]vP } u } ]v ]oov U ]} R u}v]}]vP v r } o ]v ]}v }v
]}]] ] X S]v A ]o U R FDA R }v o]u] ]v ]}v v uo}˙ u} ]v ]
o ]}v U ]vP ]l uvPuv u R} U } u ( }uu]uv v P}o X TR FDA ] }v]v]vP
} }uo u] ]}v r ]] o `}l U ]}]] }R R]PR r] ]v ]}vo v ~ XP X U (} r ]v ]}v Z U v
˙ } ]oov ]v ]}v ]vP ]lr } R (} o ]vP o] R oR X A }( R }( R]
Uv] o RP] ]}v D } uv U }vP}]vP o ] ]}v v }R v ]v] }v]v } ]u } ]PR
} ]}v X SR}o R FDA u]v R v ]v ]}v ] v ˙ (} } o }( u l]vP o] ]}v v
Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates | 103
v ]v ]}v vv} }uo ]vP R ]` ˙o } ] ]}v }v o U R FDA R R Po}˙]uvURPo}}ol]}}vXTR]vo]u}]vP.v}vU]u}]vP]}v
] Pv oo˙ ]v v } ] U v]vP }v R ] u v U }uo }v o } ( ]}v }v R }vR}}]uv(v]]vP}oo}u}R}(}uRulXTRPo}}o
o] ]}v v]o v ]v ]}v v }uo X A }uo }v o ]v] R R ]` ˙o }( R o}}lUv}`]R`}ulvPR}]}vU]]vP}}v]}voo]v]o]oURvP
o] ]}v ] }uo v R o] ]}v `]oo v} } ]v ] v (}u U v oo˙ ] oo }( R }}oo]vP}u]]}voo]}v(}ulvPR}]}vXI(v˙}(Rv}U}]o]˙
](] (]]v] ]v R v` P o] ]}v ] v](] ˙ R FDA X TR o] v u˙ ]R u] R v` }ooR}u˙]u]Uv`u˙]vvo]}vo˘v}}uo˙`]RPo}˙] -
P o] ]}v U ]vP oo }( R (]]v] ] v](] ]v R o U `]R ` R o] ]}v U } uvU`R]R}ou]oo˙o˙+}]vU.vv]o}v]}vvo}(}}vX

PART II
R ]vP X Iv v U vu }( }u v] vv}v ] }( }uo }v o } R FDA[
]v ]o]˙ } }uo ] ]v ]}v (} R] o] ]}v X RPo }˙ R}]] } ] R UXS X u˙ }
]u]o ] ]}v } }R }o]˙ u ]v }v } R C OVID r ı v u] v u˙ ˘ ]v o˙ ]v 2.2.4 Our products and product candidates may have serious adverse, undesirable
R] Po }˙ ]]] X S R ] ]}v v o˙ }o o˙ (( } ]o]˙ } } ]v Po }˙ } o or unacceptable side effects or even cause death, and we or others may identify
(} v } }uu ]o] } } v } v] v R u ]o (( }v } ]v undesirable or unacceptable side effects caused by VYVGART™ or any of our
v (]vv]o o X product candidates after they receive marketing approval.

Economic impacts of COVID-19 Uv ] o ] (( R u˙ ˙ } } v] } ˙ R }u]v ]}v }( } } v] -

TR }( COVID r ı U `R]R R } ]u Po}oo˙U u˙ u ]oo˙ + }v}u]oo˙X WR]o R `]R }R u ] o } }o } Po }˙ R}]] } ]v U o˙ } Ro o]v] o ]o v
}vo }v}u] ]u }PR ˙U v R }v }(U COVIDr ı u˙ ]8o } } ] U `} v]vP }o o ]v u} ] ] o o } R o˙ } v]o }( Po }˙ } o ˙ R E MA U FDA U PMDA } }R
}( R ]˙ } }( R vu] }o o ]v ]Pv].v ] }v }( Po}o .vv]o ul U ]vP }u o Po }˙ R}]] X WR]o } o]v] o v o]v] o ] (} } } v] } R}`
} ]o]˙ } ]o U `R]R }o ]v R ( vP o˙ + } o]]]˙X Iv ]}vU ]}v } ul R } } v] R Pv oo˙ v `oo }o (}u ]lr v(] ] U ` R }
} }v ovP (}u R }( COVIDr ı }o u ]oo˙ + } ]v v R o }( } ADS v l} v v TEA E ]v } o]v] o ] } U v ` u˙ ]]}vo v v TEA E ]v }
} }]v˙ R X }vP}]vP v ( ]o U `R]R u˙ u} ]} Rv R} } } U v o U } }vP}]vP v
( ]o u˙ vP] o˙ ]u X TR P r o ] (( }o (( ]v ]uv } R ]o]˙
Impacts of COVID-19 on employees or other stakeholders }( v}oo ]v } }uo R ]o } o ]v } v]o } o] ]o]˙ o]u X A v˙ }( R } v u˙
COVIDr ı u˙ o} vPo˙ ]u } uo}˙ v } }R lR}o X P }v˙ u R ` R R u } ]v U o }( } ]}v v (]vv]o }v]]}v ]Pv](] vo˙X F R U oo }( } } v] -
lvU R u}]o˙ ]]vP uo}˙ } `}l u}o˙U v]vP oo v}vr vo o (} } uo}˙ v o]v] o }Pu U `R]R R v} ˙ ] } o ˙ o }v Po }˙ R}]˙ }R Rv
v ]}P]vP uo}˙ 'vv ]v ˙ v U u˙ v} ]v u]v]u]]vP R ]l }( ]v(}v } } VYVGA RT ¡ (} R uv }( PMG U }v } SIMPLE A v]}˙ ¡ o (}u U v˙ (˙ } ((] ˙
uo}˙ U v R u U }PR `]R R COVIDr ı vu] U }o vPo˙ ]u R } ]˙ } (]v]vP o } v˙ } v] } o]v] o }Pu u˙ o˙ ]u R ] ]o]˙ }( } }R } -
u}}vo RoR v `oo]vP }( } uo}˙ X v] } o]v] o }Pu X

A ]}voo˙U ]( ` } }R ]v(˙ v]o } v o ] + ˙ VYVGART¡ } v˙ }( } }R

2.2.3 We may face ongoing obligations and additional expenses even when and } v] L R˙ ] ulvP }oU vu }( }voo˙ ]Pv].v vP }v v
if our product candidates are approved, and we may face restrictions, market }o ] U ]vo]vPP
withdrawal and penalties if we fail to comply with regulatory requirements {  Po}˙ R}] u˙ `]R` }o } }lo]v }( R } v ] } l R
or experience unanticipated problems with our products. } }+ R ulV
{  Po}˙ R}] u˙ ] R ]}v }( oo]vP uv U ]. `v]vP U } }v]v]}v
WRv v ]( R E MA U FDA U PMDA } }u o Po }˙ R}]˙ } v˙ }( } } v] U R } R ] v }( .o o } R˙]]v v Ru] V
uv( ]vP } U o oo]vP U lP]vP U ] ] ]}v U v } ]vP U }P U ]]vP U }u} - {  Po}˙ R}] u˙ ] u]}v P] }o]v]vP R ]l }( R ] + (} ]]}v }
]}v v } l ]vP (} R } `]oo i } ˘ v] v }vP}]vP Po }˙ ] uv X TR v U } R ` ]uouv REMS ov } v R R v. }( R } }`]PR ] ]l V
] uv ]vo u] ]}v }( (˙ v }R } ru l]vP ]v(}u ]}v v } U P] ]}v U `oo {  ` u˙ ] } RvP R `˙ R } ] u]v] U }v ]}vo o]v]o ]o } RvP
}v]v }uo]v `]R GMP v GC P (} v˙ o]v] o ]o R ` }v } r } o U oo }( `R]R u˙ R oo]vP }( R } V
o ]v ]Pv](] v ˘ v v o]u] } ]o]˙ } }uu ]o] R } X Iv ]]}v U v˙ Po }˙ } - { ` u˙ i } o]u]}v }v R}` ` u˙ }u} R } V
o R ` ] (} } } v] u˙ o} i } o]u] ]}v }v R } ]v] (} { o }( R } u˙ ]Pv].vo˙V
`R]R R } u˙ u l } } R }v]]}v }( } o U } }v]v ] uv (} } v]oo˙ ˘ v - { ` u˙ i } o]P}v } } o]]o]˙ o]u V v
] } ru l]vP ]vP U ]vo ]vP PR o]v] o ]o U v ]oov } u}v]} R (˙ v ((] ˙ }( R {  } }v u˙ +X
} v] X
Av˙ }( R v }o v U } }oo}} } } }vo ( v (}u R]]vP } u]v]v]vP
O } v } v] o]. ]}o}P] ]v R UXSX v U R(} U v }vo˙ }o ]( ` }]v ul v }( R + } } }o voo˙ ]v }uu]o]}v } v ˘v U `R]R
BLA (}u R FDA v R(} vv} }o ]v R UXSX ]( ` } v} }]v BLAX TR R}o }( BLA ] }o]P ]v v }o o˙ } v (}u PvvP ]Pv].v v (}u R o }( } } X F} ˘uo U `
} u}v]} v } v v v˙ (]o }( } } u R ].}v ]v R BLAX TR R}o }( vv R v}R }uv˙ o}]vP v FRv vP}v] vo˙ ]v] }ov˙ }( ] }vP}]vP
BLA u o} u] v` } ouvo o]}v v }]v FDA }o (} ]v RvP } R } o]v]o ]o L v } ]Pvo }( o }o R}o}o v o}`rv]˙ o]}}]v ~LDLZ oo ]v }v }( ]
} U } ooo]vP } uv( ]vP } X }vP}]vP ]o X WR o VYVGART¡ ]v } i v v v } ` R v} v ]v
}( o}v ]v R}o}o ul o } uv `]R VYVGART¡X H}`U ]( ` ` } } v˘
I(RRvP]vRo]}v}(oP]o}vUPo}v}Po}˙}o]]U}](}ou]}`]R v }( `R l]v U } ]o }o ]u]oo˙ v ] }o R u]o + }v }
}}}uv(}(}U}](`}}v}(}]]}Uo]v}}rul(]o}}uo˙`]R ]o]˙ } (R R vuv }( } } v] X FRU R FDA } R PMDA }o ] RvP }(

104 | Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates | 105
oo } v }l R o]v U `R]R }o Ru } }v v R u]o + }v } ]o]˙ } 2.2.7 Regional political instability, changes in trade agreements and conflicts, such
}uu]o] VYVGART¡X as the conflict between Russia and Ukraine could cause a disruption of the
development of our products and product candidates, by impairing regulatory
approval processes, and could thereby adversely impact our business.
2.2.5 We face significant competition for our drug discovery and development efforts.
W }v vP ]v o]v]o ]o ]v oP vu }( i]]}v U ]vo]vP ]v R] v Ul]v X Go}o }v -

PART II
TRul(} Ruo} ] R]PRo˙}u XO }u}`( ]vR }]uuv.oUR.o G] U ]vo]vP R }vG] `v R] v Ul]v U `oo }v}u] v}v ]uouv ˙ R UXSXU R
}(olu] v o˙uR}u v Ru}v}o}vov}˙ P]}˙.o]vo uv˙ o]R Ruo E }v Uv]}v v }R }v] P]v R] ]v }v R}U u˙ ] }v }( Po}˙ ]
}uv]U]}Rv}o}P˙}uv]Uv]] v}R R} }uu]o]v}vUuv˙}(`R]RR ovP } o]v]o o}uv ] (}u ]v + P]}v U ]vo]vP R ]o]˙ }( Po}˙ R}] }
voo˙P .vv]oU R v o}uv } Rv`RXLP Ruo}uv]U]v }v ]v }v } o]v]o ]o ] X F} ˘uo U ˙ }oo R]v } Ul]v]v ] u˙ v}
oUR˘v]˘]v ]v o]v]o vPU}]v]vPPo}˙ }oU ]vP v vuv( - . (} u]]}v }( Po}˙ }o } } ]v}uov } } R ( R ]vP }( R
]vP Ruo} XSuoo v o˙P}uv] u˙o}}} ]Pv].v}u}U oo˙ ` v} ~(oo˙Z }]o X TR] }o o˙ r} }]v (} } ] oR}PR ` vo˙ ]v8]vo˙
R}PR}oo} vPuv `]RoP v o]R }uv]XTR R] }u `]R ]v ] - ]v ]( v ˙ R}` uR R o˙ `}o }X WR]o R }( R] Uv]o RP]}v D}uv ` R
]vP v ]v]vP o]. ]v. vuvPuv }vvoU o]R]vPo]v]o ]o] v vP]}v(} v} ]v]}v R R }vG] `v R] v Ul]v v R } }v]vP v}v ]u} }v R] `]oo R]v -
o]v]o ]oU `oo ]v ]]vP Rv}o}P] }uouv˙}U}v˙(}UR o}uv}(} } X Po}˙ ] ov (} } v]vP } ˘ }o U ` vv} ] R + R }vG]
TR .o ]v `R]R ` } R ] ˙ ] Rv}o}P]o RvP v ]vv}}vX TR v v} - u˙ R }v Po}˙ ] ]v + ]v R v ( U v ` vv} ] R vP }( R `]oo
vR}}u}v}vo˙o}]vPU}`]oov}]vR(o}URv}o}P]v}R ouo˙ + U v R ] } ]v] vP ]u R] u˙ R }v } ]v X F} ˘uo U }( R
oo˙}u}+}u}}v}u]oo˙Rv ' v˙}(}v}(Rv}o}P˙}}X}uC - }( R] Uv]o RP]}v D}uv U }vP}]vP o ]}v U R COVIDr ı vu] v }R v ]v
]vP}}Rv}o}P˙o}uu˙P]v(}PulvRv}}}Rv}o}P˙o}u }vv } ]u FD[A }]PR }}v ]vo]vP }v ]oov U ]} R u}v]}]vP v r}o
vu]ov}]Rv}o}P]oo}uv˙}u}u˙o]v}}v}v] ]v }v X Iv ]}vU ` (}u o}uv ] ]v vu }( }v] v]PR}]vP R] v Ul]v X I(
}Rv}o}P˙o}u}u]vPv}vr}u}}}o(}`o}}}Rvo}uv R }vG] `v R] v Ul]v `}o o (RU v]PR}]vP v }R }v] u˙ ]u `R]R
v}uu]o]}v˘vXI(`U}}v}v]}}Rv}o}P˙o}u}v}}u }o o} R v ]u }v } o}uv ] ]v R} }v] X
+o˙U]]o]lo˙}Ru]o+}v}]vU.vv]o}v]}vvo}(}}vX

2.2.8 We may become exposed to costly and damaging liability claims.

2.2.6 We depend on enrollment of patients in our clinical trials for our product
candidates. W˘} }}vo} o]]o]˙v }(]}vo]vuv]˙]l R ]vRv]vR RU o -
}uvUuv(]vPUulvPv }(Ruo} XC vo˙U`R}vo˙VYVGART¡R v
Iv(˙]vPvo](˙]vPv}]]v}o]v]o]o]]o}}XPvv}oouvv}v } ]vRUXSXv]vJv(} }uu]o o(} R uv}(PMGVR}`UR v v( }(
uv˙(}U]vo]vPR]vv}(Rv}o}vUo]P]]o]˙]](}R]oUR}˘]u]˙}(v} } v] ˙ v} }oo}}]vo]v]o ]oUv R o}(v˙ } } Uu˙˘}
o]v]o]UR]Pv}(Ro]v]o}}}oUR]o]o]˙}(}uvPo]v]o]oUR]o]o]˙}(v`P} }o]]o]˙o]uXTR o]uu]PR u ˙ v `R} R } URoR }] URuo
(}R]v]}vRo]v]o]o]]vPvPUvo]v]]v[vv[}v}R}vovP}(R }uv]U} }oo}}}}R oo]vP R} XAv˙o]u P]v UPo }(R]u]U}o
P]vP]]vo}v}}R]ooR]XS]v}u}(}}v](}}v]vP ]8o v }o˙} (v v }ou]oo˙ o˙+ Rul(}} } v } v] }
]v}v]}vURo]u]v}}o]oo}}uo}o]v]o]o]vuo˙v}r+ v˙} (} }uu]o]}v}(} } v } v] XAoR}PRR o]v]o ]o} ] ]Pv
uvvXF}˘uoURvu}(v+]vP(}uR}(MGUITPUPVUPFUIDC PUTrooo˙uR}u~ TCLvZ ML
A ] }]v(˙v }vo] +U]] o`˙ }]o R PU vL Po}˙ }oUu˙˘R]]
uoovRv}vo]R`]R]]}vXI(Rovu}(v`]RR]}]uooRv`v - v(}v] +XI(v˙}(} } v] `} ] + ]vPo]v]o ]o} L
]U`u˙v}v]8o]vv}oo]vPv]v}o]v]o]oUR˙o˙]vP}vvPo}uvv }o}(R } v]U`u˙ ˘} } voo]]o] XPR˙]]v v v u˙v} }uo˙
}o}(}Pv]XvE }vv}oo`u˙vo}]v8]vvu}(v}}uov˙ `]Rv˙`v]vP R ]v(˙lv}`v}vo + v v `R}R}ov} } } v] X
}(}]oXIv]}vUo]u]vu}(vv}oo]v}o]v]o]oo}]vR]}Ul]vXTR}vG] RPo }(Ru] } vo}}uUo]]o]˙o]uu˙ o]vP
`vR]vUl]v~o}]l(}XXSGo}o}v}u]v]v˙v`lv]vP}uv˙
}o]o]v]o]˙URvP]vPuvv}vG]URR}vG]`vR]vUl]vU}oo˙
+}]vv.vv]o(}uvX_u˙ Z vR]}vv]}v]vR]ovu˙v { uv(}} } }vP o] }vV
(}uv}oo]vPv`v(}uR}v]`R]RU]vvUu˙o˙]v]v}vP}]vPo]v]o]oXF}˘uoU { uP}} }vV
ovu]v}]˙}(Rv]vRRE D A SS]o}(SC(PP]u}(}PFvPV]vP]v]}v { `]R`o}(o]v]o ]o ]v } ]8o ]v ]vPv` ]o ]vV
]vUl]v}R]X}]vPo˙
A U`˘RR}vG]`vR]vUl]v`]ooo˙}RE
D A SS]oU`]RR { ]v]}v}(]vP}v ˙Po}V
u]vP}(}o]v(}RRED A SS]o}(SC(PP]u}(}PFvPVvo˙v]`X { } } (v} 'o R o o]P}vV
{ ]]}v}(uvPuv [u v} } V
FRu} U } +} } ]o o}vR] `]R v }uuv] u˙ v} U `R]R }o o ]v o˙ ]v { vou}v˙` } ]o ]v } vV
v v}oouv ]v } o]v]o ]o X Iv ]}vU v˙ vP o ` u˙ } ]v o]v]o ]o }( } P v] - { } ooU`]R`o}oo]vPUulvP} }u}}vo ]}vV
u˙ ul] ]8o } ]u}]o } ] v ]v v ]v }R o]v]o ]o }( R u P v] X { o} }( v (}u} oVv
D o˙ ]v R }uo}v }( v˙ o]v]o ]o }( } } v] `]oo ]v } } U o}` }`v } } { R]v]o]˙}}uu]o]v˙}(} } v] U]( }X
v] o}uv v }o } v o˙ } }voo˙ i}] } ]o]˙ } }uuv } o
v Pv v X Iv ]}vU }u }( R (} R U } o }U o˙ ]v R }uuvuv } }uo - AoR}PR ` u]v]v } o]]o]˙ ]vv (} } } v] U R }P }( `R]R ` R ˘v }
}v }( o]v]o ]o u˙ o} ouo˙ o } R v]o }( Po}˙ }o }( } } v] X ]vo R o }( VYVGART¡U v ` ˘ } ˘v } ]vv }P (R ]( ` }]v ulvP } -

106 | Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates | 107
o (} v˙ }( } }R } v] U ` u˙ v} o } u]v]v ]vv }P }vo } }
} }]v ]vv }P R `]oo } (˙ v˙ o]]o]˙ R u˙ ] X I( (o } o]]o]˙
o]u } ] }( o]u ] }PR P]v (} v]v o]]o] } ]v ˘ }( ]v o]]o] U } u˙ v}
8]v } } R o]u v } ]v }}v }o ]u] X
SR}o v˙ }( R v ] } }U R] }o R u]o + }v } ]v U .vv]o }v
]}v v o }( }}v X
2.3 Risk Factors Related to
Commercialization of argenx’s
Products and Product Candidates
2.3.1 We will face significant challenges in successfully commercializing
our products.
W ]v R } }( }vv]vP } } o v ulvP ]v( U R o]u] ˘]v ]v R o }
ulvP }( Ru o } v u˙ v} } v} uo˙ R R }] ]v( ]v o ~]vo]vP U
R ]v(}u}v Rv}o}P˙U v] } ovv]vP v (} vPZX T} R] }uu]o (} v˙
} } U ` u o} } ] o v ulvP }Pv]}vU }} R (v}v } R]
} v ]v} }oo}}v vPuv `]R R] X WR]o ` R o]R } }`v o (} ]v R UXSX
v ]v Jv (} VYVGART¡ (} R uv }( PMGU ` ov } ˘v } }`v o v ulvP ]o] v
}u} } } v } v] ]( v `Rv Po}˙ }o R v }]v ]v R ov i]]
}v v l} (} }R } v] } }R ]v]}v X TR ]l ]v}o R}o ` ] } ˘v }
}`v o v ulvP ]o] } v ]v} vPuv `]R R] } (}u R ] X Ev ]( `
R o]R } ˘v } }`v o v ulvP ]o] U ` u˙ (]o } ovR } } +o˙ }
} ul } } +o˙X R]vP v ]v]vP o (} ] ˘v] v } }( vP v ]vvv
o v ulvP }Pv]}v v }( ulvP v }u}}v }o } R} v] ˙ X Iv ]}vU
]vP v ]v]vP o (} ] u }vu]vP v }o o˙ v˙ } ovRX Iv R v R v˙ R ovR
] o˙ } } v} } (} v˙ }vU ` `}o R uo˙ } vv ]o˙ ]v R }uu]o]
}v ˘v U v } ]vuv `}o o} ]( ` vv} ]v } }]}v } o v ulvP }vvoX
I(` v ]v} vPuv `]RR] } (}u o vulvP ] UXPXU R } Puv`]R
M]}v]v}vv}v`]RR }uu]o]}v}(VYVGART¡(}PMG]vIoU} } v } R }.]o
]˙}( R } v } }o o}` Rv](``}ulv oov˙} R ` o}}
oXSR}oo} vPuv u˙o R }uu]o]}v}(} } }] }(} }v}ov`}o
ul i } vu }( ]lXTR]]vo R ]lR `u˙v} o }}v}oR u}v} u]vP}(
} R } }oo} v } }} } } R } }oo}} [`]oo]vPv } ]o]˙}}uo˙
`]R v }uo ] }o]P}v v } vPuv u˙ o˙+ ˙ ]v }u]v}v} ]Pv].
v RvP ]v} }oo}} []v P˙XIv ]}vU`u˙v} (o]vv]vP]v} vPuv
`]R R] } oo v ul} } }u˙ vo}}}}v u R (}o } XA o
R] u˙(]o} } R v˙ } v 'v}v} oovul} } +o˙X
I( ` } v} o]R o v ulvP ]o] (oo˙U ]R }v } }`v } ]v }oo}}v `]R R]
U ` u˙ v} (o ]v }uu]o]]vP } } U `R]R ]v v `}o R u]o +
}v } ]v U .vv]o }v]}v v o }( }}v X
108 | Risk Factors Related to Commercialization of argenx’s Product Candidates
2.3.2 The future commercial success of our products and product candidates will
depend on the degree of market acceptance.
WRv ]oo }v R ulU } } u˙ v} R] v oo }( v ˙ R˙]]v U v v
R u]o }uuv]˙U v ` u˙ v} }u }.o X F} ]vv U } } v } v] u˙ v}
- R] v oo }( v ˙ R˙]]v }( }]vP }uo˘]˙ } (}u v }( ]v(]}v
PART II
(P X Iv ]}vU +} } R u]o }uuv]˙ v R] r ˙ ˙ }v R v. }( } } u˙
] ]Pv].v } v u˙ v (o `R]R `}o v (}u PvvP ]Pv].v v
} }u]vP }.o X Ml v }( } ( } ˙ R˙]]v U v v RoR ˙ `]oo
v }v vu }( (} U uv˙ }( `R]R ˙}v } }v}oU ]vo]vP U v} o]u] }P
{ R `}]vP }( R } ooV
{ RvP ]v R v }( (} R P ]v]}v (} v˙ } v } v] V
{ o U ulvP v ]]}v } V
{ }vo } o]]o]˙ o]u V
{ v ˙ R˙]]v U v v RoR ˙ }( R } (U + v }r+ V
{ o }vv]v U }( U }( u]v]}v v }R ] vP } ov } V
{ ov v ]˙ }( v } o]]˙V
{  o]u]}v U }v } `v]vP o] ]v R uu˙ }( } R ] U v ]v(}u}v oG U
lP oo]vP } ]v }v (} V
{ R } }( uv `]R } } ]v o}v } ov uv V
{  R ˘v } `R]R } } (} ]vo]}v v ]u }v (}uo] }( R}]o v uvP
}Pv]}v V v
- {  `RR } } ]Pv ]v R ooU v R˙]]v uv P]o]v } v ]u uv
P]o]v .ro]v U }v ro]v U } R] ro]v } o ro]v R˙X
I( } } } } v] (]o } P]v ul v U R] `]oo R u]o ]u }v } ]o] -
- ˙ } Pv v X Ev ]( }u } R] ul v U R ul u˙ } v} } oP v}PR
} oo}` } Pv ]Pv].v v X
2.3.3 Our products and product candidates for which we have obtained or intend to seek
- approval as biological products may face competition sooner than anticipated.
- TR BPCIA v ] }o R`˙ (} ]}o}P]o } R ]}]u]o } } ]vRvPo `]R
v FDAro]v (v ]}o}P]o } X Uv R BPCIAU v o]}v (} ]}]u]o } u˙ v} -
u]' } R FDA vo (} ˙ (}oo}`]vP R R R (v } ` . o]v ˙ R FDAX Iv ]}vU
R }o }( ]}]u]o } u˙ v} u + ˙ R FDA vo `o ˙ (}u R }v `R]R
- R (v } ` . o]v X D ]vP R] `o r˙ ]} }( ˘o]]˙U v}R }uv˙ u˙ oo ul
- }uvP ]}v }( R (v } ]( R FDA } (oo BLA (} R }uvP } }v]v]vP R
}v} [}`v o]v]o v (}u v `oor}v}oo o]v]o ]o } u}v R (˙U ]˙
v }v˙ }( R] } X TR o` ] }uo˘ v ] oo ]vP ]v v ]uouv ˙ R FDAX A o U
] ou ]u U ]uouv}v v uv]vP i } v ]v˙X
-
W o] R v˙ }( } } v] } ]}o}P]o } v BLA R}o o](˙ (} R
`o r˙ ]} }( ˘o]]˙U ` R `]R VYVGART¡X H}`U R ] ]l R R] ˘o]]˙ }o
R}v } }vP]}vo }v } }R`] U } R R FDA `]oo v} }v] } } v] }
(v } (} }uvP } U }voo˙ vP R }}v]˙ (} Pv] }u}v }}v Rv
v] X OR }( R BPCIAU }u }( `R]R u˙ ]u R BPCIA ˘o]]˙ }]]}v U R o} v R
i }( v o]P}vX M}}U R ˘v } `R]R ]}]u]o } U }v } U `]oo (}
v˙ }v }( } (v } ]v `˙ R ] ]u]o } ]}vo Pv] }v (} v}vr]}o}P]o }
] v} ˙ oU v `]oo v }v vu }( ulo v Po}˙ (} R oo o}]vPX
Risk Factors Related to Commercialization of argenx’s Product Candidates | 109
2.3.4 Enacted and future legislation may increase the difficulty and cost for us to ob-
tain marketing approval of and commercialize our products and product candi-
dates and may affect the prices we may set.
Iv R UXSXU R E }v Uv]}v v }R (}]Pv i]]}v U R R v vu }( oP]o v Po}˙
RvP } R RoR ˙u R }o + } ( o }( }}v X Iv oU R R v v
}vv } vu }( ]v] R UXSX (o v oo R l } RoR } v ]u}
R o]˙ }( RoR X I( R oP]o v l} Po}˙ ]v] v RvP `}o o } ]v ]}v
}v ulvP } } U } o } o]u]vP R (v ]oo (} RoR ]v i]]}v ov } `R]R u˙
]u uv oo v ] o]lo˙ } + R ] ` u˙ U ` `}o vPo˙ ]u ]v } ]o]˙
} (oo˙ v }.o˙ ul } } v } v] X
W vv} ] R o]lo]R}} U v } ˘v }( P}vuv Po}v R u˙ ] (}u ( oP]o}v }
u]v] }vU ]R ]v R UXSX } } X I( ` } } }oo}} o}` } vo } } RvP ]v
˘]vP ]uv } R }}v }( v` ]uv } }o]] U } ]( ` } } }oo}} v} o } u]v
]v Po}˙ }uo]v U } } v } v] u˙ o} v˙ Po}˙ }o R u˙ R v
}]v v ` u˙ v} R] } ]v }.]o]˙U `R]R `}o o˙ + } ]v X
2.3.5 We may not obtain or maintain adequate coverage or reimbursement status
for our products and product candidates.
O]o]˙}(oo˙}uu]o]VYVGART¡}v˙}R}v}v]}(}}uu]o
]}v`]oovU]vU}vR˘v}`R]RR]r˙˙}U]vo]vPP}vuvRoR}Pu]vRUv]
S~RM]vM]]Zv}R}v]U}uu]oRoR]vUvuvP}Pv]}vU
}]}Pvo]R]uuvoo(}R}v}v]XM}}U]v
]vP+}˙P}vuvovR]r˙˙}]vR}vE Uv]}vURUXSXUCR]vv}}}
RoR}u˙R}Pv]}v}o]u]}R}PvRoo}(]uuv(}v`o˙}
}vUoUR˙u˙v}}}}]˙uv(}VYVGART¡}v˙}R}(}}v
}v]}(}}uu]o]}vXL]u]}v}v]uuvv]uuvoou˙]u]v]R
}vo}PRv˙]Pv].vuv(}VYVGART¡}}}R}v]}v}vl}u˙
vvo˙(}uv]vP]vulU`R]R`}ov(}uPvvP]Pv].vv}}u]vP
}.oU`R]R`}oo˙+}]vU.vv]ovo}(}}vX
2.3.6 We may be subject to healthcare laws, regulation and enforcement.
Our failure to comply with these laws could harm our results of operations
and financial conditions.
O v v ( }}v u˙ ]o˙U } ]v]o˙ R}PR } }u v R] r ˙ ˙} U i
} ]} UXSX (o v U E }vU Jv v CR]v RoR o` v Po}v U ]vo]vP U `]R}
o]u]}vU R UXSX (o Av rK]ll S X HoR }] U R˙]]v v }R o˙ ]u˙ }o ]v R
}uuv}v v ]}v }( v˙ } (} `R]R ` }]v ulvP }oX TR o` u˙ ]u U
u}vP }R R]vP U } }} o U ulvP v }v }Pu v }v]v } ]v v .vv]o
vPuv v o}vR] `]R R] r ˙ ˙} U RoR }(]}vo `R} ] ]v } o]v]o R
}PuU RoR }(]}vo v }R `R} }uuv U R U } }] } } } U v }R
R}PR `R]R ` ulU oo v ]] } } (} `R]R ` }]v ulvP }oX Iv ]}vU
` u˙ i } v ]˙ v ]˙ Po}v ˙ }R R UXSX (o P}vuv v R }R
v }v] ]v `R]R ` }v } ]v X F]voo˙U } v v ( }}v i } ]}v
o RoR ro }˙ v Po}˙ ]uv v v(}uv ˙ Po}˙ R}] ]v i]]}v ]v
`R]R ` }v } ]v X F} ˘uo U R }]]}v }( v. } vP } R˙]]v } ]v } v}
P R ]}vU }uuv}vU v}uv U R U o˙U } } }( u]]vo } ] Pvoo˙
110 | Risk Factors Related to Commercialization of argenx’s Product Candidates
v} u]' ]v R }v] R (}u }( R E }v Uv]}vX S}u E }v Uv]}v uu R v
o` ˘o]]o˙ }R]]vP R }]]}v }( R ˙ }( v. v vP } ]v } ` ]u} (} -
uv Pvoo˙U v R Uv] K]vP}u R v R o` R}PR R B ]˙ A X Iv(]vPuv }( R
o` v o ]v vo .v v ]u]}vuv X EU D] l lECU `R]R ] R EU ] P}v]vP
u]]vo } (} Ruv U (R }] R U `R u]]vo } ]vP }u} } }v o -
]. } ] } o˙ RuU v} P]L U v]˙ vP } v. ]v l]v u˙ o] U }+ } }u]
PART II
} R }v vo R˙ ]v˘v] v ov } R }( u]]v } Ru˙X TR] }]]}v R
v v} ]v} R Huv M]]v RPo}v v u]v o]o ]v R Uv] K]vP}uX Av˙ }v
P]v (} ]}o}v }( R o` U v ]( ` (oo˙ (v P]v ] U }o } ]v ]Pv].v oPo
˘v v ] } uvPuv ['v}v (}u R }}v }( } ]v X
TR R]L]vP }uo]v v]}vuv v R v } ]o v u]v]v } v ˘vo ˙u } }uo˙
`]R uoo i]]}v `]R ]+v }uo]v } }vP ]uv ]v R }]]o]˙ R RoR
}uv˙ u˙ v (}o }( }v } u} }( R ]uv X WR o]u] ˘]v ]v R o } ulvP }( R -
- u o } v ` ]o]vP v U ]v o]PR }( v˙ ( }o v }uu]o]}vU `]oo v } }vv
]o]vP v ]vvo }Pu } v }uo]v `]R R ]+v RoR o` v Po}v X TR o]R -
uv U ˘v]}v v u]vvv }( v ]vvo }uo]v }Pu `]oo ]v}o vo } v R }Pu u˙
v} (o ]v }uo˙]vP `]R R ]+v }vP ]uv X
I ] } ]o R P} vuvo R}]] `]oo }vo R } ]v ] } v} }uo˙ `]R v }
( U Po ]}v } o` ]v}o]vP o] o ( v } }R R oR o` v Po ]}v X
I( } } ]}v (}v } ]v ]}o ]}v }( v˙ }( R o` } v˙ }R P} vuvo Po ]}v R u˙
- o˙ } U ` u˙ i } ]Pv](] v ]]o U ]u]vo v u]v] ] vo] U uP U (]v U ]P}Puv U
]u ]}vuv U ˘o ]}v }( P (}u P} vuv (v R oR }Pu U R M ] v M ] ] U
]]}vo } ]vP ] uv v } ]PR ]( ` }u i } } } ]vP]˙ P uv } ]u -
- ]o P uv } }o ooP]}v }( v}v r}uo]v `]R R o` U ]}vo R u v R ]ouv
} ]vP }( } } ]}v X D (v]vP P]v v˙ R ]}v v } o˙ v ]u r}v u]vP v u˙
] ]Pv](] v (]vv]o v }vvo } X TR (} U v ]( ` (o ]v (v]vP P]v v˙
R ]}v R u˙ }PR P]v U } ]v u˙ ]u ] X F R U ]( v˙ }( R R˙]]v } }R
R oR }] } v]] `]R `R}u ` ˘ } } ]v ] (}v } v} ]v }uo]v `]R o] o
o` U R˙ u˙ i } ]u]vo U ]]o } u]v] ] v ]}v U ]vo ]vP ˘o ]}v (}u P} vuv (v
R oR }Pu X
TR } v v(}uv }( R }( R o` ] v ]v v i } ] RvP ]v R v v]}vuv }(
RoR (}uX Fo v v(}uv }] R vo˙ ]v R] v˙ }( ]v}v `v
RoR }uv] v RoR }] U `R]R R o } vu }( ]vP}v U } }v U }v]}v
v 'ouv ]v R RoR ]v ˙X Ev]vP ]v vPuv }uo˙ `]R o]o RoR o` U
`oo }v]vP } }]o ]vP}v ˙ P}vuv R}] U v u v } }vu]vP v v
] }uv˙ ['v}v (}u R ]v X
+}
E } v R } ]v vPuv `]R R] `]oo }uo˙ `]R o]o RoR o` v
Po}v `]oo ]v}o vo } X
Iv ]}vU ]v R Uv] S U R E }v Uv]}v v }R (}]Pv i]]}v U R R v vu }(
oP]o v Po}˙ RvP } R RoR ˙u R }o + } ( o }( }}v X Iv -
oU R R v v }vv } vu }( ]v] R UXSX (o v oo R l }
RoR } U ]vo]vP R } }( ]}v P U v ]u} R o]˙ }( RoR X I( R oP]o v l
} Po}˙ ]v] v RvP `}o o } ]v ]}v }v R ulvP }( VYVGART¡ } v˙ }( }
- } v } v] } (} }uu]o]}vU } o } o]u]vP R (v ]oo (} RoR
]v i]]}v ov } `R]R u˙ ]u uv oo v ] o]lo˙ } + R ] ` u˙ U `
- `}o vPo˙ ]u ]v } ]o]˙ } (oo˙ v }.o˙ ul VYVGART¡ } v˙ }( } } v
} v] } (} }uu]o]}vX
Risk Factors Related to Commercialization of argenx’s Product Candidates | 111
2.3.7 We are subject to privacy laws, regulation and potential enforcement.
Our failure to comply with these laws could harm our results of operations
and financial conditions.
Iv}E UD]lælEC}(R}v
E Po]uvv}(RC}v]o}(Jo˙U}vv]vPR}]vP
}(}vovR}}v}(]˙]vRo}v]}uuv]}v}~uvUR
]REUuu}]uouv}}vo`}u]]˙]uvXV]}o}v}(R
]uvvo]vu]v]uU]vo]vP.vU}]u]vov}vXTRrP]˙D]`]ooo]lo˙
o]vu˙v`rP]˙RPo}v`R]Ru˙]u}]}vo}o]P}vv]l(}}]vX
S]v M˙ æU U RPo}v ~EUZ l ı }( R E }v Po]uv v }( R C}v]o }( A ]o U }v R
}}v }( vo }v `]R P } R }]vP }( }vo v }v R ( u}uv }( R ~R
GDPRZ ]u} } vP }( ] ]uv }v }uv] U ]vo]vP ]uv ovP } R]vP oPo
(} }]vP }vo ]v(}u}v ovP } ]v.o ]v]]o v v(]vP R ]v(}u}v }] R EA
]vo]vP}RUXSX}CR]vU}]]vP]o}R}]v]]oP]vPR}]vP}(R]}vo]v(}u}vU
l]vP }vo ]v(}u}v U R]vP }]vP Puv `]R R] `R} } }vo ]v(}
u}vU }v]vP } ]v]]o [ } ˘] R] ]PR ]v }( R] }vo ]v(}u}vU }vP
]˙ R ]v}o]vP }vo } R }uv v}vo }}v R}]˙ v + ]v]]o U
}]vvP }}v }8 U }v vP }}v ]u uv U v } rl]vPX TR GDPR
voo˙ ]v R vo } `R]R ` }o i ]v R v }( v˙ v}vr}uo]v U ]vo]vP .v }(
} U U E } } } A9 }( } }o `}o`] vvo v} (} ]v }u o˙ u]v} }+v U }
}UU}E }}A9}(}}o`}o`]vvov}(}u}]}}+vXW(v]v˙
} R ˘ ]v }v }( R ]uv v R GDPRU v ` u˙ v (o ]v ]uouvvP oo
u ] ˙ }}v R}] } } ]v ]v }v }( R GDPRX
Iv oU v}vo o` }( uu }( R EU R v } R ]uv v R GDPRU R˙
]uouvvP v}vo o` `R]R u˙ oo˙ ] (}u R GDPR v ]u} ]+v }o]P}v (}u }v˙ }
}v˙U } R ` } v} ˘ } } ]v v](}u oPo ov ]v R EUX Ao}U ]v R .o }( Rvo]vP Pv
U R GDPR ].oo˙ oo}` EU uu o` } ]u} ]}vo v u} ]. ]uv } ]
}v U v E }v o` R R]}]oo˙ ]+ ] voo˙ ]v R] .o U o]vP } ]}vo v ]v˙X
Wu o} v R ` u]v]v (P } vo R v( }( }vo }] }( R EAU
]v o } R UXSX v CR]v U ]v }uo]v `]R EU }}v o` U ]vo]vP R GDPRX W˘ R `
`]oo }vv } ( v ]v˙ } `RR } +} } }uo˙ `]R } }o]P}v v E }v ]˙ o`
`]oo 8]v X I( ` ]vP ˙ v˙ EU }}v R}]˙U ` u˙ ( .v v }R vo X Av˙
R ]vP}v } RP ˙ EU }}v R}] }o R vP + }v } ˘]vP ]v v
}v } ]o]˙ } ' v ]v v` o]v } Ru o v X Wu˙ o} ˘]v R]v˙U ov U
} (o ˙ EU } uo rv}vo o]v } Ru o v } }vv } } } v }o}v
} R }vo ]l ˘} o }( R v ~v U ]v oU ( Z }}v }o]P}v ]u} }v
Ru ˙ ]v }}v R}] ]v ]v }v }( v o`U ]vo]vP R GDPRX SR o]v } R
u o v u˙ o} ]` v˙ ov }R } }uo]v ]vP }} }o˙U }} v}u U }}
oPoo˙ v ]vU } }R`] }i}vo v R(} ] v} } } ]v `]R X Av˙ }( R (}P}]vP }o
u]oo˙ Ru } ]v U } U .vv]o }v]}v v o }( }}v X
2.3.8 If we fail to obtain orphan drug designation or obtain or maintain orphan
drug exclusivity for our products, our competitors may sell products to
treat the same conditions and our revenue will be reduced.
Uv R ORv D P A U R FDA u˙ ]Pv } v }Rv P ]( ] ] ]vv } ] }
}v]}vU .v v }o}v }( (` Rv U ]v R UXSXU } v }o}v P Rv U
]v R UXSX `R R ] v} }vo ˘ }v R R } }( o}]vP R P `]oo } (}u o
112 | Risk Factors Related to Commercialization of argenx’s Product Candidates
]v R UXSX Iv R E }v Uv]}vU L }uuv}v (}u R EMA[C}uu]' (} ORv M]]vo P}
(COMPZ R E }v C}uu]]}v Pv }Rv P ]Pv}v } }u} R o}uv }( } R
]vv (} R ]Pv}] U v}v } uv }( o](rRv]vP } R}v]oo˙ ]o]vP }v]}v ]R + -
]vP v} u} Rv . ]v U }v ]v R E }v Uv]}v } `RvU `]R} ]vv U ] ] vo]lo˙ R o }(
R P ]v R E }v Uv]}v `}o 8]v } i(˙ R v ˙ ]vuv ]v o}]vP R P } ]}o}P -
e-Privacy-Directive) ]o } X Iv R R u v} (}˙ uR} }( ]Pv}] U v}v } uv }( R }v]}vU
PART II
}U ]( R uR} ˘] U R u]]v u }( ]Pv].v v. } R} + ˙ R }v]}vX
Iv R UXSXU }Rv P ]Pv}v vo ˙ } .vv]o ]vv R }}v] (} Pv (v]vP } -
` o]v]o ]o } U ˘ vP v r( `] X Iv ]}vU ]( } ] R . FDA }o (}
R ]v]}v (} `R]R ] R }Rv ]Pv}vU R } ] vo } }Rv P ˘o]]˙U `R]R uv R
FDA u˙ v} } v˙ }R o]}v } ul R u P (} R u ]v]}v (} ]} }( v ˙ U
˘ ]v o]u] ]uv U R R}`]vP }( o]v]o ]}]˙ } R } `]R }Rv ˘o]]˙ }
`R R uv( ] vo } 8]v } v˙X Iv R E }v Uv]}vU }Rv P ]Pv}v
vo ˙ } .vv]o ]vv R }v }( ( } ( `] v v ˙ }( ul ˘o]]˙ (}oo}` -
- ]vP P } ]}o}P]o } }oX TR] ]} u˙ } ]˘ ˙ ]( R }Rv P ]Pv}v ]]
v} o}vP u U ]vo]vP `R ] ] R}`v R R } ] 8]vo˙ }.o v} } i(˙ u]vvv }(
ul ˘o]]˙X I( ` (]o } }]v } ]( ` o} }Rv P (} }v } u} }( } } v } v] -
U R (}uv}v ]vv v ul ˘o]]˙ u˙ v} } v} o}vP ]oo } U `R]R ] o]lo˙ } ]v -
R }oo } }( o}uv v } R }u }]}v }( R } v } v] X
Wu˙ (}u u } u l }Rv P ]Pv}v ]v R UXSX } E } (} ]v ]v]}v ˙ }
} v } v] X F} ˘uo U ]v Su U R FDA Pv }Rv P ]Pv}v (} R
}( VYVGART¡ (} PMGU ]v Jv˙ ıU R FDA Pv }Rv P ]Pv}v (} R }( (PP]u} (}
R uv }( P]u˙ Iuuv TR}u}˙}v] v (} R }( u (} R uv }( AML v ]v
A P U R FDA Pv }Rv P ]Pv}v (} R }( (PP]u} }r(}uo `]R HPH (} R
uv }( IvGuu}˙ D u˙o]vvP P}o˙v}R˙X Ev ]( ` o } }]v }Rv ]Pv}vU ` u˙ v}
R . } }]v ulvP }o (} R ]v]}v } R v ]v }] `]R o}]vP Ru -
- o } X Iv ]}vU ˘o] ulvP ]PR ]v R UXSX u˙ o]u] ]( ` l }o (} v ]v]}v
} Rv R }Rvr]Pv ]v]}v } u˙ o} ]( R FDA o u]v R R (} ]Pv -
}v ` u]oo˙ ( } ]( R uv( ] vo } 8]v v }( R } } u R
v }( v `]R R ] } }v]}vX FRU v ]( ` }]v }Rv P ˘o]]˙ (} } U
R ˘o]]˙ u˙ v} +o˙ } R } (}u }u}v ]+v P `]R ]+v
u}] v } (} R u }v]}vX Ev L v }Rv P ] } U R FDA } R EMA v -
vo˙ } R u P `]R R u u}]˙ (} R u }v]}v ]( R FDA } R EMA }vo R
R o P ] (U u} + U } ul ui} }v]}v } v X ORv P ]Pv}v v]R
R}v R o}uv u } Po}˙ ]` u }( P v} P] R P v˙ vP ]v R Po}˙
]` } }o } X
-
2.3.9 We may not obtain or maintain adequate coverage or reimbursement status for
our products and product candidates.
Ev `Rv v ]( } } v } v] } (} ulvP U o }( R } v }
v] `]oo v U ]v U }v R ˘v } `R]R R] r ˙ ˙} U ]vo]vP P}vuv RoR }Pu ]v R
UXSX ~R M] v M]] Z v }R }v] U }uu]o RoR ]v U v uvP }Pv]}v U
}] }P v o]R ]u uv oo (} R } v } v] X M}}U
]v ]vP +} ˙ P}vuvo v R] r ˙ ˙} ]v R E }v Uv]}vU R UXSXU CR]v v } } }
RoR } u˙ R }Pv]}v } o]u] }R }P v R oo }( ]u uv (} v`o˙
} } v U o U R˙ u˙ v} } } }] ˙uv (} } } v } v -
] X F} ]vv U } VYVGART¡ (} R uv }( PMG u˙ ] ˙ o]u] ˙ }P }
uv ]] U `R]R u˙ v (}u o]]vP ] (oo }uu]o }voX
Risk Factors Related to Commercialization of argenx’s Product Candidates | 113
L]u]}v }v ]u uv v ]u uv oo u˙ ]u]v]R } v o}PR v˙ ]Pv].v uv (}
} } v l} u˙ v vo˙ (}u v]vP ]v ul U `R]R `}o v (}u PvvP ]P
v].v v } }u]vP }.o U `R]R `}o o˙ + } ]v U .vv]o v o }( }}v X
2.3.10 We may not be able to successfully achieve support among healthcare provid-
ers and third-party payors for our products and product candidates, and our
relationships with such parties are subject to regulations.
O v v ( vPuv `]R }] U R U }vov U R] r ˙ ˙} v }u
i } }o˙ o]o v}voU (o v ( v U v rl]llU (o o]u U v v˙ v
v ]˙ o` v Po}v v }R RoR o` v Po}v R u˙ }v]v } ]v v l}
.vv]o vPuv X
W`]oo ] } v vo u v u}v˙ } v R } ]v vPuv `]R R]
}uo˙ `]R o]o RoR o` v Po}v X Rv RoR (}u oP]o}v R vPRv R
(o v RoR o` X V]}o}v }( R o` v i } ]u]voU ]]o v u]v] v}v
]vo]vP u}v˙ vo U uP U .v U ]P}Puv U ]v]]o ]u]}vuv v ˘o]}v (}u ]}v
]v P}vuv (v RoR }Pu U R M] v M]] U ]}vo }vP ]uv v }
]PR ]( ` }u i } }} ]vP]˙ Puv } ]u]o Puv } }o ooP}v }( v}vr}u
o]v `]R R o` U }vo RuU v R ] ]ouv } ]vP }( } }}v X M}}U
` ˘ R R `]oo }vv } (o v o` v Po}v U }} v ]uouv U R }o
]u } ]v U .vv]o }v]}v v o }( }}v X
2.4 Risk Factors Related to argenx’s
Business and Industry
2.4.1 Nearly all aspects of our activities are subject to substantial regulation.
No assurance can be given that any of our products and product candidates
will fulfill regulatory compliance. Failure to comply with such regulations
could result in delays, suspension, refusals and withdrawal of approvals,
as well as fines.
TR ]v v ]}vo ]}R u ] o v u ] o Rv}o}P˙ ]v ] i } R]PR o o }( Po ]}v ˙
R FDA U R E MA U R PMDA v }R }u o Po }˙ R}]] v ˙ }R v ]}vo } rv ]}vo
Po }˙ R}]] X A o] o Po ]}v ]u} v]o ] uv } ]vP v o˙ oo }( }
]]] v R ]]] }( } v v o] v U v} o˙ }v R v o}uv U uv( ]vP U
o]v] o U o]v] o ]o U o o]vP U u l]vP U o U } P U } l ]vP U }u}]}v v ]]vP }( }
} v } v] X
F]o } ~uo˙Z }uo˙ `]R Po}˙ ]uv }o R ( R]vP }v v (} U ]vo]vP ]Pv].v
o˙ ]v } } o}uv o }( Po}˙ R}] }uuv]vP v}vr}o } ]}v }vU }
`]R`o }(U }o }( } v] X Av˙ (]o } o˙ }( v˙ }( } } v] ]v o]v]o ]
} } ] } u]v]v Po}˙ }o }o R u]o + }v } ]v U o }( }}v
v .vv]o }v]}vX I( v˙ }( } } v] (]o } }]v }o }v R ] }( v˙ o]o }vv
Po}˙ }o } U R] `]oo v R } v] (}u }]v]vP }o ]v R}v u (u U
} ooU ovP ]v ]v ˘v `R]R `}o u]oo˙ Ru } ]v X
RPo}v ]+ voo˙ i]]}v v i } }vv RvP X Iv } } ul } ( }
114 | Risk Factors Related to argenx’s Business and Industry
]v P]}v R R EAU R UXSXU A ] P]. v uv˙ }R (}]Pv i]]}v U ` u }]v Po}˙
- }o X TR }o } ˙ u}vP }v] v v ] ]}vo o]v]o vP U v R u ]
} }]v }o u˙ ]+ (}u R ] } }]v }oX M}}U o]v]o ] }v ]v }v }v˙
u˙ v} ˙ Po}˙ R}] ]v }R }v] X A }o ˙ R EMAU R FDA } R PMDA } v}
v }o ˙ R }uo R}] ]v }R }v] U v }o ˙ }v } u} (}]Pv Po}˙ R}] -
} v} v }o ˙ Po}˙ R}] ]v }R (}]Pv }v] } ˙ R EMAU R FDA } R PMDAX
PART II
TR v v} v R } } v] `]oo (o(]o R ] ] ] } } ]v v ˙ Po }˙
} o } R u l X A o}U R] ]u U ` vv} P v } lv}` R ˘ v U ] ]u]vP v
]o } }( R ((} R `]oo v ˙ } }uo R u]v }( R o}uv }( } R
}Pu v } v] X E R }( R FDA U E MA U PMDA v }R }u o Po }˙ R}]] u˙
]u} ] }`v ] uv U u˙ ] }v]v v } o } }l o] v U u˙ ( } Pv } o U } u˙
] ]]}vo (} Pv]vP } o U v}`]R v]vP R } o u˙ R v Pv ˙ R FDA U
E MA U PMDA } }v } u} }R }u o (} ]Pv R}]˙X TR FDA U E MA U PMDA } }R }u o Po -
}˙ R}]] u˙ o} } } v] (} (` } u} o]u] ]v] ]}v } ]v r Puv
Rv } u˙ Pv } o i } R (}uv }( } ru l]vP ] X TR E MA[U R FDA[U R
PMDA[ } }R Po }˙ R}]˙ [ } o u˙ o˙ U o]u] } v] (} vu }( }v U u} }(
`R]R ˙}v } }v}o X S R }v }o ]vo U u}vP }R U R } ]}v } } ] v} u -
]vP R o] o ] uv (} R uv( }( Po } U } R } v} u ]vP o] o
- ] uv (} (˙U ]˙ } } v˙U } ((] ˙U ]vP R o]v] o o}uv P } ( u l]vP X
-
TR FDA U E MA U PMDA v }R }u o Po }˙ R}]] R v]o ] ]}v ]v R } o }
v u]v]vP `Rv } `R R Po }˙ } o `]oo } ]v (} v˙ }( } } v] X A v˙ }( R
FDA U E MA U PMDA v }R }u o Po }˙ R}]] u˙ ] P `]R } ]v ]}v }( u] -
(} R] ]`X E v ]( ` o] R }oo (}u o]v] o ]o }( } } v] }u]]vP U
R u˙ v} ((]]v } } } o ˙ R FDA U E MA U PMDA } v˙ }R Po }˙ R}]˙X F}
]v v U ` R u] (} } o }( VYVGA RT ¡ ]v PMG } R E MA v v]] ] }( R
} o ]v R (] }( v R }v Ro( }( U ] o˙U v }] v} v R
R } o `]oo } ]v }v R ]uo]v R ` ˘ } oo X Iv ]]}v U ` v]] } (]o (}
} o }( VYVGA RT ¡ ]v v` ]v] ]}v U v }] v} v R R `]oo } R
} o `]oo } ]v }v R ]uo]v R ` ˘ } oo X F R u} U R FDA R u ]v ]}v
}( ]v }u ] o]v] o ]o } ]}v v ]o ] X W vv} } ˙ (} R v ]v ]}v }(
R o]v] o ]o } ]}v } ]o ] ˙ R FDA } }R Po }˙ R}]] ]v ]` }( R v]o ]u v
v]}v } ˙ } }vvo } R }uu ]o o vR }( VYVGA RT ¡ (} R uv }( PMG X
W v } }oo } ] v U } u˙ }u i }U vu } }vP}]vP }R Po }˙ }o]P]}v U
R } ]}v U v]}vuvo U R oR v (˙ o` v ] ]}v }v R ˘ ]uvo }( v]uo X
TR } }( }uo]v `]R R o] o Po ]}v U ] uv } P] o]v }o v]o U v (]o
} }uo˙ }o o ]v v ]}v U ]vo ]vP (]v U ]viv ]}v U ]]o vo] U v]o }( o] ]}v (} u l]vP
R}] ]}v }( } } U o˙ U v]}v } `]R `o }( } o U o] v } ]}v U ] } oo }(
} U } ]vP ] ]}v v ]u]vo } ]}v U v˙ }( `R]R }o ]Pv](] vo˙ ]v } } } }oo } -
] v [ } } o˙ R o}uv v }uu ]o] ]}v }( } } v] X
TR ]u ] } } ]v } o ˙ R FDA U E MA U PMDA v }u o Po }˙ R}]] ] v ] o
˙] oo˙ l uv˙ ˙ U ]( } ]v oo U (}oo}`]vP R }uuv uv }( o]v] o ]o v v }v v -
u } ( } U ]vo ]vP R v]o ] ]}v }( R Po }˙ R}]] X TR] ovPR˙ } o } `oo
R v ] ]o]˙ }( ( o]v] o ]o o u˙ o ]v } (]o]vP } } ]v Po }˙ } o } u l
v˙ }( } } v] U ]vo ]vP VYVGA RT ¡ (} R uv }( PMG ]v i ] ] ]}v } ] R UXS X v
J v } (} }R ]v] ]}v U `R]R `}o ]Pv](] vo˙ R u } ]v U o }( } ]}v v } X
Iv ]]}v U v `Rv v ]( ` } ]v } o U Po }˙ R}]] u˙ } v˙ }( } } v }
v] (} (` } u} o]u] ]v] ]}v Rv ` U u˙ v} } R ] ` ]vv } R P (}
} } U u˙ Pv } o }v]vPv }v R (}uv }( } o˙ } ru l]vP o]v] o ]o U } u˙ -
} } v] `]R o o R } v} ]vo R o o]vP o]u v ˙ } ] o (} R -
(o }uu ]o] ]}v }( R } v] X A v˙ }( R (} P}]vP v ]} }o u ]oo˙ R u R }uu ]o
} (} } } v] X
Risk Factors Related to argenx’s Business and Industry | 115
2.4.2 We may become exposed to liability and substantial expenses in connection
with environmental compliance or remediation activities.
O }}v U ]vo]vP } RU o}uv U vP v uv( ]vP ] U i } vu}
v]}vuvoU RoR v (˙ o` v Po}v X TR o` v Po}v P}vU u}vP }R R]vP U R }v
}oo U Rvo]vP U o v ]}o }( v R u]vvv }( P]˙ (}U R} u]o v ]}o}P]o
u]o U R Ru]o }ov U Ruv oo U ]v}Pv] }u}v U uPv] }u}v v }u}v R
R }˘] + }v } }vU o}}˙ } v ˘} } o}} r}v R}Pv X I( ` (]o } }uo˙
`]R R o` v Po}v U ` }o i } .v } }R v}v X
W( ]l }( v]}vuvo o]]o]˙ ]vRv ]v } v v R]}]o ] U ]vo]vP o]]o]˙ ovP }
o }( } ˘} } R} } ]}o}P]o u]o X Ev]}vuvoU RoR v (˙ o` v Po}v
}u]vP u} ]vPv X Wu˙ ] } ]v vo ˘v ]v }vv}v `]R ( v]}vuvo
}uo]v } u]}v ] U ]v `R]R U } } }v v o}uv +} u˙ ]v }
o˙ U v } .vv]o }v]}v v o }( }}v u˙ u]oo˙ o˙ + X
2.4.3 Our employees and relevant third parties may engage in misconduct
or other improper activities, including non-compliance with regulatory
standards and requirements, which could have a material adverse effect
on our business.
W ˘} } R ]l R } uo}˙ U ]v vv }v } U ]v]o ]v P} U CRO U }vov U
v} v }oo}}v v u˙ vPP ]v ( ov }v } }R ]ooPo ] X M]}v ˙ R
}o ]vo ]vv}vo U lo v vPo]Pv }v U uv]o}v ~]v. ( Z } v R}]
] R ]}o P ~] Z R Po}v }( R FDA U EMA U PMDA v }R }u o Po}˙ R}] U ]vo]vP
R} o` R ] R }vP }( U }uo v ]v(}u}v } R R}] V ~]] Z uv( ]vP
v V ~]]] Z ( o v ] ˙U ]˙U ( v v }R RoR o` v Po}v ]v R
UXSX v ]v }R }v] V } ~] Z o` R ] R }vP }( U }uo v .vv]o ]v(}u}v
v X S ].oo˙U o U ulvP v ]v vPuv ]v R RoR ]v ˙ i } ˘v]
o` v Po}v ]vv } v ( U u]}v U l]l l U o(r o]vP v }R ] X TR
o` v Po}v u˙ ] } }R]] `] vP }( ]]vP U ]}vvP U ulvP v }u}}vU o
}uu]]}v U }u ]vv }Pu v }R ]v vPuv X A ] i } R o` }o
o} ]v}o R ]u} } u] v}v }( ]v(}u}v } ]v ]v R } }( o]v]o ]o } vP
( ov ]v } o]v]o ] } o]v]o ]o U `R]R }o o ]v Po}˙ v}v v ]}
Ru } } }v X I ] v} o`˙ }]o } ]v(˙ v u]}v ˙ uo}˙ v }R R] U
v R }v ` l } v v R] ]˙ u˙ v} + ]v }v}oo]vP vlv}`v } vuv
P ]l } o} } ]v } vP (}u P} vuvo ]v P}v } }R }v } o`] uu]vP (}u
(]o } }uo˙ `]R R o` } Po}v X A ]}voo˙U ` i } R ]l R }v }o ooP R
( } }R u]}v U v ]( v}v } X I( v˙ R }v ]v P]v U v ` v}
(o ]v (v]vP } o } vP } ]PR U R} }v }o R ]Pv].v ]u }v } ]v U o
}( } }v v .vv]o }v]}vU ]vo]vP R ]u}]}v }( ]Pv].v ]]oU ]u]vo v u]v] vo U
uP U u}v ˙ .v U ]P}Puv U }]o ˘o]}v (}u ] }v ]v M] U M]] v }R UXSX
} ]vv}vo RoR }Pu U ]v]] o ]u]}vuv U ]}vo }vP ]uv v } ]PR ](
` }u i } }} ]vP]˙ P uv } ]u]o P uv } }o ooP}v }( v}vr}uo]v
`]R R o` U }R v}v U }v o uP U }vo RuU ]u]v]R }. v ( v]vP v
]ouv }( } } }v U v˙ }( `R]R }o o˙ + } ]o]˙ } } } ]v v } o
}( } }v X TR ]l u˙ oo˙ R]PRv P]v } ol }( ˘ ]v `]R }uu ]o]}v v R
] P}`R }( } o v ulvP (v}vX F Ru} U } R R]PRo˙ Po v]}vuv ]v `R]R `
} v } R ˙ o]v }v }o }( } } ˙ P} vuvo v v RoR }] U
}vo ]l o } R u]}v } }R ]u} R]} ] } o]lo˙ } R ]PP ]u
}v Rv }v u} }uv] } vP ]v }R ]v ] X
116 | Risk Factors Related to argenx’s Business and Industry
2.4.4 Our high dependency on public perception of our products may negatively
influence the success of these products.
WRv v ]( v˙ }( } } v] } (} }uu ]o o U ` `]oo R]PRo˙ v v }v
- }v u ]}v }( R (˙ v o]˙ }( } } X W }o o˙ (( ]( ` ` i
} vP] o]]˙ } ]( v˙ }( } } } v˙ ]u]o } ] ] ˙ }R }u v] } } U }
PART II
} U R u(o } ]v X B }( } v v }v }v u ]}v U v˙ o]]˙
}] `]R ]oov } }R (( o]vP (}u ]v [ } u] }( } } } v˙ ]u]o
} ] ] ˙ }R }u v] }o R u ]o ]u }v } ]v U } U (]vv]o
}v]]}v v o }( } ]}v X
F v ]v R ]v} R vU ]vGuu}v v }]uuv ] R ` (} } -
R +} }vU } R ]}Ru o ]v ˙ u} Pvoo˙U }o o} o ]v P P}vuvo Po}vU
] oo]vP ]uv v }vo Po}˙ o˙ ]v R vP } }o }( } } X Av˙ ]v
v˙ }o o˙ } ]v R } }( }]v]vP Po}˙ }o (} } } v] X
2.4.5 We face the risk of computer system failures, data leaks and cybercrimes.
D ] R ]uouv ]}v }( ]˙ u U } ]v vo }u ˙ u v R} }( } R] r ˙ ]
}] ov o } uP (}u }u ] U v R}] U v o ] U }]u U ` v
o }uuv] ]}v v o ] o (]o X C ˙ r l ]v ]vP ]v R] ( v˙U }R] ] ]}v v ]vv]˙U
v R }u ]v ]vPo˙ ]((] o } X C ˙ r l R v R v ˙ } v ] ]] -
v u R} }( } v]o ]v v ]}vo } P ]v ( R v }( v ]}vo } }o]] o P}o X C ˙ r l }o
]vo R o}˙uv }( R u(o uo` U v}u r` U v]o r}(r ] l U }]o vP]v ]vP v }R
u v } (( ] o] ]o]˙ v R v R }v(] v]o]˙U ]vP]˙ v ]o ]o]˙ }( ]v(}u ]}v X C ˙ r -
l o} }o ]vo R]R]vP u } ru]o ( } ˙uv } ]v(}u ]}v } vu] } v
v]vv ]]v X
Av˙ ˙u (]o U ]v } ]˙ R R ]v }v ]v } }`v } ]v R] r ˙ ] v} [
} }v }o o ]v u ]o ] }v }( } } o}uv }Pu X F} ˘uo U R o} }( o]v]o
]o (}u }uo } ( o]v]o ]o }o o ]v o˙ ]v } } } v [ Po}˙ }o +}
v ]Pv].vo˙ ]v } } ]v } } } } } R o} X T} R ˘v R v˙ ] }v }
]˙ R o ]v o} } uP } } } o] }v U } ]v }] ]o} }( }v.vo }
}] ˙ ]v(}u}vU ` u˙ ]v o]]o]˙U } } o}uv }Pu v }u }]}v u˙
o˙ + v R ( R o}uv }( } } v] u˙ o˙ X I( R ]vP]˙ }( }
- ˙ r ]˙ ˙u ] R U ` u˙ ]v ]Pv].v + R u]}v ˘v U o} v U
o]P}v } v ]v ]v v u]u v u˙ o} ˘ ]v }vo uP v R }]}v }(
R R}o o X F Ru} U ` u˙ ]v ]}vo } } u˙ R uP ˙ R ] }v }
- ]˙ R X L]l }R }uv] U ` R }v } ]}v ˘ ]v U v `]oo }vv } ˘ ]v U R }
} v ˙u U ]vo]vP uo]]} } v ] U R]R]vP U ]v u]o }u}u] 'l U } }R ˙ -
r'l X WR v}v }( R ]vv R u ]o ]u } (U R vu v }uo˘]˙ }( R R
}vv } ]v } u X I( u ]o R }( } ]v(}u}v Rv}o}P˙ ˙u } R} }( } R] ˙
] }] } U R ul }v }( R + v }( } ]˙ u }o Ru v }
}v v ]]o]˙ }o uP X
W }o ] } ˘v ]Pv].v u}v }( u}v˙ v }R } } }v } R R }
R v } ] } o ]v(}u}v ˙u } v`}l U v }o + .vv]o o} } R o} }( oo
}v.vo ]v(}u}vX Iv ]}vU ` }o i } Po}˙ }v v l} o]u u ˙ ]v]]o v
- P} ]v ] o]P}v ]v}o]vP ]˙ ] o } }oo}v v v }R ]˙ o`
v Po}v U ]vo]vP o]u (} u] } ]v}] ]o} }( U `oo v(] } X
AoR}PR ` o} v u]v]v ˙u v }v}o ]Pv } v R v (}u } ]vP U v ` R
Risk Factors Related to argenx’s Business and Industry | 117
} } ]v(˙ v u]P R U R o}uv v u]vvv }( R ˙u U }v}o v } ]
}o˙ v ] }vP}]vP u}v]}]vP v vP Rv}o}P] RvP v +} } }}u ]˙ u
}u ]v ]vPo˙ }R] X TR] ]l ] (R ]v ˙ R P}`]vP u}v }( v( ˙
`v E } U CR]v v R UXSX M}}U ] } +} U R }]]o]˙ }( R v } ]vP vv} o]u
]v vo˙ v R v v} v R v˙ u ` l`]oo v ˙ r'l } ]˙ R
R }o o˙ + } ]v X
Iv } } (oo˙ }uu]o] v ul } } ]v R ( ` u˙ v } ]uouv ]}vo v
] } uvPuv ˙u `R]R ] }uo˘ } R u˙ } ( o˙ X Wu˙ o} v
} ]uouv }u ˙u R ]}vo Po}o v ] R ˙u ~ ERP systemsZ ]v `R]R ` R
o]u] ˘]v v `R]R u˙ } }uo˘ } R }o o˙ ]v } }uu]o]}v } X
2.4.6 We may face service, manufacturing or supply chain failures or other
failures, business interruptions or other disasters.
O } v } v] ]}o}P] v ] } ]vP R u} ]8o Rv R}
] (} u} Ru]o Ru o X A }]vPo˙U uoo v } }v}o R uv( ]vP }
X P}ou `]R R uv( ]vP } U R ]˙ ] U } v u]v} ]}v (}u R v}uo
} } (}u R u]o ]v R uv( ]vP } U `R]R u˙ v} o ˙ ]v uo˙ uvvU
}o o } uv( ]vP (]o } } ( U ovP ]v o} (]o U } oo U } o]]o]˙ o]u
v ]v8]v ]vv}˙X FRu} U } o˙ R]v (]o `}o ]l }( v}vr}uo]v }` v
} R}P U (} ˘uo U ]( ` v} o } o] } } } } v ]v CR]v X
Ao}U ]v ` u]o } }R } v ˙ (} R uv( v (}uo}v }( } } v }
v] U }u }( `R]R ]8o } } U }] ˙ ]vPo r} v8o] R] r ˙ o] X Iv
]}vU ` o˙ }v ]v R] } (}u .oo]vP U .v]R]vP U ]]}vU o}}˙ vP v }R ]
o } R uv( }( } } v } v] U v } o˙ ]} ` u]o v }R
} X W`}o vo } }]v R ` u]o U }R } U } ] (} v ]v u]v ]} }(
u ]( v˙ }( R R] ` } } ]v } }v } }R`] (]o } o˙ R u]o U }
U } ] } (} v˙ }vU ]vo]vP } Po}˙ ]uv } }v ~]vo]vP oo ZU
.vv]o o}uv } +vP R o]U (]o ˙ R o] } }uo˙ `]R GMPU }vu]v}vU ]
v ]v }v U } o} R}P } ] X Iv }v ]v R o˙ }( R u]o U } } ]
u˙ o (}u ]vv}vo }vG] U ] } }v}u] v}v v ˙U } ]u} }vU R UXSXU R
E }v Uv]}v } v˙ }R }v˙X Iv v˙ R ]uv U ` u˙ v} o } vPP l } ov
o] } ] }] ]v uo˙ uvv } ooX TR] U ]v vU }o u]oo˙ v o˙ + } ]o]˙ }
o˙ } v } v] U `R]R }o u]oo˙ v o˙ + } ]v U .vv]o }v]}v
v o }( }}v X
C ]v }( R ` u ]o ] ]v R uv( v R (}uo}v }( } } v } v]
u˙ ] (}u ]}o}P]o } U ]vo]vP uuuo]v U }]v u v Ruv u ou]v X TR
]v E } v Po}˙ ]}v }v ]vP R ]}o}P]o } u ]o X I( R RvP ]v R
Po}v ]uv U } o]v]o o}uv } }uu ]o ] u˙ o˙ } ]v X
2.4.7 Failure to successfully identify, develop and commercialize additional
products or product candidates could impair our ability to grow.
AoR}PR vo u}v }( } +} `]oo (} }v R }vv o]v]o v o]v]o vP v }vo
}o }( } } v] ]v } v ]o]v U l˙ ouv }( } o}vPru P}`R P˙ ] } o}
v ul ]]}vo } v } v] X B ` R o]u] (]vv]o v uvP ]o } U
R }Pu } ] v](˙ } v] `]oo ] v]o ]]}vo Rv] o U (]vv]o v Ruv
} U `R R } v} v˙ } v] o]u o˙ ] v](] X TR }( R] P˙ v o˙
}v } ]o]˙ } ] v](˙U o v o} }u]]vP } v] v } X O Rv}o}P˙ o (}u
118 | Risk Factors Related to argenx’s Business and Industry
u˙ (]o } ] } v } Pv ]]}vo } v] R ] o (} ( R o}uv X A oo } -
v] }v } ]l }( (]o ˙] o }( R u ] o } o}uv U ]vo ]vP R } ]]o]˙
- R } v] u˙ v} ] o (} o]v] o o}uv o }( ] R u(o ] (( U o]u]
- ((] ˙ } }R R ] ] R ]v] R ] ] vo]lo˙ } } R `]oo ] } o ˙ R FDA U
E MA U PMDA v }R }u o Po }˙ R}]] v R] u l v X I( ` } v} (oo˙
o} v }uu ]o] } v] }v } Rv}o}P] o } R U ` u˙ v} o } } ]v
PART II
} } }oo}]}v v ]v ( ]} U `R]R `}o o˙ + } ]v U } U .vv]o
- }v]}v v o }( }}v X
O o}vPru P}`R P˙ } o} v ul ]}vo } v } v] ] R]o˙ vv
}v ] U v o]o ]v. } ]v(˙U o v o} }u]]vP Ru o } v] -
v } X O ]v ]]}v u˙ R(} o˙ ]vGv ˙ ]u} } (ov ]v.
} (}u R] X Av˙ ]Po] ]v R ]v. ˙ } u]v } (} ]v R v
o}uv }( } v] v } }o R u]o + }v } ]v U } U .vv -
]o }v]}v v o }( }}v X
-
-
2.5 Risk Factors Related to argenx’s
Dependence on Third Parties
- 2.5.1 We rely, and expect to continue to rely, on third parties, including independent
clinical investigators and CROs, to conduct our preclinical studies and clinical
trials. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, we may not be able to obtain regulatory
approval for or commercialize our products and product candidates and our
- business could be substantially harmed.
- WR o] }v v ov } }vv } o˙ }v R] U ]vo]vP o]v U ]vvv o]v]o ]vP -
} v R] r ˙ CRO U } }v } o]v]o ] v o]v]o ]o v } u}v]} v uvP (} }
}vP}]vP o]v]o v o]v]o }Pu X W o˙ }v R (} ˘}v }( } o]v]o ] v o]v]o
]o U v }v}o }vo˙ ]v }( R] ] X N Ro U ` }v]o (} v]vP R R }( }
] v ]o ] }v ]v }v `]R R o]o }}}oU oPo v Po}˙ ]uv v ]v -
. v U v } o]v }v R R] } v} o] }( } Po}˙ }v]]o] X W v }
v U R] r ˙ }v } v C RO ] } }uo˙ `]R GC P ] uv U `R]R Po ]}v v
P] o]v v(} ˙ R FDA U E MA U PMDA v }u o Po }˙ R}]] (} oo }( } } ]v o]v] o
o}uv X RPo }˙ R}]] v(} R GC P R}PR ]}] ]v ]}v }( ]o }v} U ]v] o
]v ]P} v ]o ] X I( ` U } ]v ]P} } v˙ }( } C RO (]o } }uo˙ `]R o] o GC P U R o]v] o
Pv ]v } o]v] o ]o u˙ u v o] o v R FDA U E MA U PMDA } }u o Po }˙
R}]] u˙ ] } (}u ]]}vo o]v] o ]o (} }]vP } u l]vP o] ]}v X U}v
]v ]}v ˙ P] v Po }˙ R}]˙U R Po }˙ R}]˙ u˙ u]v R } o]v] o ]o } v} (oo˙
}uo˙ `]R GC P Po ]}v X Iv ]]}v U } o]v] o ]o u }v `]R } } v GMP
Po ]}v X O (]o } }uo˙ `]R R Po ]}v u˙ ] } o]v] o ]o U `R]R `}o o˙
R Po }˙ } o } X
FRU R ]vP} v CRO v} } uo}˙ v ` `]oo v} o } }v}oU }R Rv ˙ }v U
R u}v }( } U ]vo]vP u U `R]R R˙ } } } } v] v o]v]o ]o X I( ]vvv
]vP} } CRO (]o } } 8]v } } R o}uv }( } } v] U } ]( R] -
(}uv ] v U ] u˙ o˙ } }u}u] R } (} }o v }uu]o]}v }( v˙ }
v] R ` o} X Iv ]}vU R }( R] r ˙ ] }] ] } ]o} } }]˙
]v(}u}v } R U `R]R }o ]v R ]l R R] ]v(}u}v `]oo u] }] X
Risk Factors Related to argenx’s Dependence on Third Parties | 119
 Can you describe the journey to

Victor
Victor’s MG diagnosis?

I] P TR v ˙ }( o } R MG ]Pv}] X
V]} P«vP ˙u}u U }v ˙ }v X TR .

PARTVII
II
}v ` v ] `]R `oo}`]vPX

PART
V]} P TR }} R}PR ] ` GI }ouX

I] P YRU R GI uv ]v[ Ro X TRv ˙}

& Iris
R }o ]]}vU } ` `v } R }RRou}o}P] X

V]} P TR˙ }ov[ .v v˙R]vP `}vPX B ˙R]vP

` ]vP P R `oo}`]vP ] U R }o ]]}vU
R ]v]o]˙ } R}o u˙ R Q

I]PW`v}vR}(}}XB]`}}`v
}}`R}voo˙.P]}XHR -
R]vPMGL`u]vR[vv](} -
XBR]vP`v}`vR]oo]lo˙LRvR]Pv} -
]vRR}]o]}v`}vo˙˙XV]}`
]Pv}}vWv˙UN}uUX˙B Sv˙R
}ov[]vl`vv}P}}RR}]oX

I ` ]v R R}]o (} ˙ X

Victor and Iris Yipp What happened after you got out of
the hospital? How did life change?

Find Hope in MG* I] P I }}l u}vR (} R]u } }X W]R MG ˙} v

o}}l .v U ˙} u˙ vo } P R}PR R ˙X
Y} R } X F} ]vv U `Rv R . P} } U `
Victor iY p and his wief , Iris, haev been an unts oppable team P} u}˙ Rv] l]vP u] X I o`˙ (o
through the highs and lows of Victor’s MG diagnosis. o]l }o ` P}]vP } iP X

V]} P B I ]v[ o}}l o]lI v Rv] -

l]vPX I R]vl R [R }v R]vP uv˙ }o u]v -
v X Y} o}}l v}uoU R [ o} P}]vP }v ]v]
R }o v[ X

How did you think MG would affect

your future?

I] P I ]v[ oo˙ R]vl R U ˙}v o]vP `]R

Patient R ˙u}u ]PR RvX W ] ˙ }u MG }
Story P} X Av ]v }v }( RuU R ` }u}v ]v u] -
]}v (} } æ ˙ X I R}PR U RW}` R `}o
u]vPX[ I P R} X I R}PR U RY} v } ] V]}X[
*Paid contributor to MG United.

120 | Patient Story Patient Story | 121

O CRO R R ]PR } u]v R] Puv `]R ]v R v }( v v u]o RX Iv ]}vU
}u }( } CRO R v ]o]˙ } u]v R] Puv `]R ]( ] v }vo˙ u}v
R R (˙ }( R i ]vP ]v } o]v]o ]o `v R u]v}vU ]( ` ul Pvo ]Pv
uv (} R v. }( } ]} } ]( ` o]] X
TR ] o]u] vu }( R]r˙ ] }] R ]o]}R R˘ ] } R] }
]v }i XI( v˙}(} o}vR] `]RR R]r˙CRO} o]v]o]vP} u]vU`u˙v}
o} v]v} vPuv `]Rov CRO}]vP}} }}}}v}uu]oo˙ }vo uX
I(CRO } o]v]o]vP} }v} (oo˙ ˙} R] }vo }}o]P}v}u ˘
o]vU]( R˙v } o }](R o]˙} ˙}(R o]v]o R˙}]v] }u}u] }
R (]o } R }} o]v]o}}}oUPo}˙ ]uv }(}}R }vU} o]v]o ]ou˙ ˘
v U o˙} u]v v `u˙v} o }}]vPo}˙ }o(}} (oo˙}uu]o]}
} v } v] XA oU} o }(}}v v R }uu]o} (}} } v
} v] `}o Ru U} } }o]v v} ]o]˙}Pv v }o o˙X
S`] R]vP } ]vP ]]}vo C RO ~} ]v ]P} Z ]v}o ]]}vo } v ] uvPuv ]u v
(} X Iv ]}vU R ] vo v]}v ]} `Rv v` CRO }uuv `}lX A o U o˙ }U `R]R
v u]oo˙ ]u } ]o]˙ } u } ] o]v]o o}uv uo]v X TR}PR ` (oo˙ uvP }
o}vR] `]R } CRO U R v v} v R ` `]oo v} v}v ]u]o RoovP } o˙ ]v R
( } R R o˙ } RoovP `]oo v} R u]o ]u }v } ]v U .vv]o }v]}v
v o }( }}v X
2.5.2 We rely and will continue to rely on collaborative partners regarding the
development of our research programs and product candidates. If we fail
to enter into new strategic relationships our business, financial condition,
commercialization prospects and results of operations may be materially
adversely affected.
W U v ˘ } }vv } U vv }v vR] `]R v ovP } R o}uv v }u
u]o]}v }( } ˘]vP v ( R }Pu v } v] X W vo˙ R }oo}
R o}vR] `]R ]} Ru o }uv] R A V] U SR] U Z ] L v `]R ]} u]
v R ]v }v `}o`] U (} R o}uv }( } v] ovP (}u R }oo}}v X W
R U R v `]oo }vv } R ] ]}v }v }vo v]vP }}v] `]R ]} Ru o }u
v] X I( ` (]o } v ]v} } u]v]v }oo}}v }v }vo u } ooU } ]o]˙ } o} } ˘]vP
} ( R }Pu v } v] }o o˙ U R }uu]o }vo }( } } }o
RvP v } } }( o}uv v }uu]o]}v }o ]v X
O vv }v }oo} v i } vu }( ]l U ]vo]vP U v} o]u] } R u]v}v
}( R }oo}}v Puv `]R oo ] }v v U ]Puv }v R ]v }v }( }v o u } v}
Rv } v ]v }( R }vP}]vP }oo}}vX Iv ]}vU ` u˙ v} o } }v}o } }oo}
v [ }uo]v `]R oo o]o ]uv (} R }uu]o]}v }( } } U `R]R }o
o˙ + R }uu]o]]vP v R }.]o]˙ }( R } ~o} ]l (} X X SO uo}˙ v
ov R] u˙ vPP ]v u]}v } }R ]u} ] U ]vo]vP v}vr}uo]v `]R Po}˙
v v ]uv U `R]R }o R u]o + }v } ]v X_ZX
W( ]Pv].v }u}v ]v l]vP }] }oo} v X O ]o]˙ } R .v] Puv
(} vR] `]oo v U u}vP }R R]vP U }v v uv }( R }oo}} [ } v ˘ U
R u v }v]}v }( R }} vR] v R }} }oo}} [ o}v }( vu }( (} X
TR (} u˙ ]vo R ]Pv } o }( o]v]o ]o U R o]lo]R}} }( Po}˙ }oU R }vo u
l (} R i } v] U R } v }uo˘] }( uv( ]vP v o]]vP R } v]
} v U R }vo }( }uvP } U R ˘]v }( v ]v˙ `]R } } }`vR] }( R
v}o}P˙U `R]R v ˘] ]( R ] RoovP } R }`vR] Po }( R u] }( R RoovP v ]v ˙
v ul }v]}v Pvoo˙X TR }oo}} u˙ o} }v] ov } v] } Rv}o}P] (}
122 | Risk Factors Related to argenx’s Dependence on Third Parties
]u]o ]v]}v R u˙ ]oo } }oo} }v v `RR R vR] }o u} ' Rv
R }v `]R X
-
2.5.3 We rely on third parties to supply and manufacture our products and product
candidates, and we expect to continue to rely on third parties to manufacture
PART II
our products, if approved. The development of such products and product
candidates and the commercialization of any products, when and if approved,
could be stopped, delayed or made less profitable if any such third party fails
to provide us with sufficient quantities of product candidates or products or
- fails to do so at acceptable quality levels or prices or fails to maintain or
achieve satisfactory regulatory compliance.
W}v}vo˙RUv}}`ov}]UR]v(}]o]˙]vvoo˙}uv(}} -
}}v](}]vR}v}(}o]v]o]}(}}uu]oo˙U`Rvv](}}
}XIvU`o˙}vUv˘}}vv}o˙}v}vuv(]vP}Pv]}v~ CMOsZXW
(}}o˙}vo]u]v]vPo}}(uv(]vPXWvo˙o˙u]vo˙}vL}v(}Ruv(]vP}(
RPv}(oo}}XFRu}U`V'PRuIvv}voGuH[.oov.v]R](}
}}XRo]v}vR]r˙}]u˙˘}}u}]lRv](``}uv(}}
v}v]}oXW}v}}v}oRuv(]vP}}(RCMO`}v`]Rv
vv}vR}R](}R}}v}(}}v}v]]v}v`]Rov
Po}v~RGMPZU`R]R]voUu}vP}RR]vPUo]˙}v}oUo]˙vvRu]vvv}(
}v}uv}vX
I(``}˘]vvv˘o}}(o˙}(}](v˙o]`vo}u}uv(}v˙}(}
}v}v]U`}o˘]vo˙]v}R}ovvo]v]o]}}uu]o] -
}vXW}ovo}.vovo]}(oo]˙U]vR}]}ouvvo
}XM}}U}o]}Lvi}]uv(]vP]uvv]P}}vP]uvU
`R]R}oo]u]}o˙}}vXTRo}vPv]}v]}v˙}`]Ruv(vo]U](
- v˙U`}o]Pv].vo˙o˙}o]v]o]vR}uu]o]}v}(}}U](}U`R]R`}o
u]oo˙o˙+}]vU.vv]o}v]}vvo}(}}vX
W v } R] r ˙ o] u˙ o} i } ] ˙ R FDAU EMAU PMDA } }R }uo Po}˙
- R}] X I( v˙ }( } R] r ˙ o] (]o } }uo˙ `]R GMP } }R o]o uv( ]vP Po}v U
} ]o]˙ } o} v }uu]o] R } }o + ]Pv].v ]v }v X W( ]l ]vRv ]v
o˙]vP }v ]vPo CMOU v˙ ] }vU R . U vu] U vo R } vo]u R CMO }o
]Pv].vo˙ ]v } uv( ]vP ]o]˙X Aov } }v ov ]v o } ] r}˙ (]o]
]oo } u˙ v} 8]v X Iv }( ] }vU ` u˙ R } o]R ]}vo ov uv( -
]vP } X TR] `}o ] vo ]vuv }v } U `R]R ` u˙ v} o } }]v }v }uu -
]oo˙ o u } ooX A ]}voo˙U ` u˙ ˘]v ]Pv].v uv( ]vP o˙ ` ]o } o}
- ouv (]o] v l v }]v v ˙ Po}˙ }o X I( R] } U ` `]oo vo } (˙
- uv( ]vP v }v uo˙ ] U ]( ooX Ao}U }vP v˙ v` (]o] u˙ u} ˘v] Rv }vP
} v (]o] X FRU ]v ]v }v ]vv u˙ v} o˙ }uv (} v˙ o} R u˙
}U v ` `}o R } R ]}vo } }( v˙ ] }vX F} R }v U ]Pv].v ] v
}( R uv( ]vP (]o]˙ }o R }v v U ]vo]vP o]vP } .vv]o ]o]˙ ]lX
TR uv( ]vP }( oo }( } } v } v] ] ]vP oo `R]R } ]v oo vl X
W R }v u oo vl (} R } uv( ]v } v `]R GMPX Ho( }( R u oo vl
] } ] } R ]v }( }R] v }v ] ` o] 8]v ]o }( R u
- oo vl oL R o v }P ] } }vv uv( ]vP X W o] 8]v `}l]vP oo vl
}o } (}u R ]o }( R u oo vl } P]v ] } } o˙ (} R ( X
- H}` U ] ] }]o R ` }o o} uoo oo vl v R } uv( ]vP ]Pv].vo˙ ]u ˙ R
v } o R oo vl U `R]R }o u ]oo˙ o˙ + } ]v U } U .vv]o }v]}v
v o }( } }v X
Risk Factors Related to argenx’s Dependence on Third Parties | 123
2.5.4 Accuracy and timing of our financial reporting is partially dependent on
information received from third party partners, which we do not control.
WR }oo} U v ov } }vv } }oo} U `]R R] }v } v] R ` o] R
}u]]vP o]˙ ]v ] } v }o}v R ' ˙ } }( oP ]}Ru o
}uv] X A }( }u }( R }oo}}v U } }oo}}v v }v]o (} }]]vP `]R
.vv]o ]v(}u}v P]vP ]. }i U ]vo]vP (v v U o]]o] ]v v ˘ ( } U }v
`R]R ` o˙ (} } }`v .vv]o }vPX I( } }oo}}v v (]o } }] `]R R v ˙ .vv]o
]v(}u}v `]R]v R P }v u(u U } ]( R .vv]o ]v(}u}v } oo˙ ]v U R] ] o]lo˙
} ]u R ˙ }( } }`v .vv]o }vPX O o]v }v .vv]o ]v(}u}v ] (}u } }oo
}}v v u˙ ]u } }`v ]vvo v ˘vo .vv]o }vP v v˙ o˙ ]v R }]]}v }( R
.vv]o ]v(}u}v } } v˙ (]o ˙ } ]v(˙ u]l ]v R .vv]o ]v(}u}v }] } u˙
} }`v .vv]o uv } oo˙ ]v X Av˙ ]v ˙ ]v } .vv]o }vP }o ]v} }
o} }v.v ]v } .vv]o }vPX TR] ]v v u˙ o } }vo uP v l} + } ]o]˙ }U v
R u }v `R]R ` u˙U }]v ( ~]˙Z .vv]vP `R]R u˙ Ru } ]v X
2.6 Risk Factors Related to argenx’s
Intellectual Property
2.6.1 We rely on patents and other intellectual property rights to protect our prod-
ucts and product candidates and platform technologies. Failure to enforce or
protect these rights adequately could harm our ability to compete and impair
our business.
O }uu]o v ]v }v }]v]vP v u]v]v]vP v v }R (}u }( ]voo o }
˙ ]PR (} } } v } v] U uR} } uv( R} } v R uR} (}
vP v ]vP R} } U } }v o]v]vP ]v R ]PR X S].oo˙U ` u]oo˙ vv }v v
v }R }]˙ }}v o } } } o}u Rv}o}P] v } } v } v] X
F]o } } } } }]vU u]v]v } ˘v v v }R ]voo o }˙ ]PR }o u]oo˙
o˙ + } ]o]˙ } o} v ul } } v } v] X TR v(}uv U (v v
u]vvv }( R v v }R ]voo o } ˙ ]PR u˙ RoovP]vP v }o˙X
W vv} ]v R v `]oo ] } Pv `]R } o]}v R vo˙ v]vPX A
]}Ru o }uv˙ } v }]}v ] v ]v ] ]v}o }uo˘ oPo v ( o }v]}v X
TR v o] ˙ R E }v Pv O8 U R UXSX Pv v Tul O8 ~ USPTOZ v (}]Pv v
}8 ]v PvvP v v} o`˙ o] v](}uo˙ } ]o˙X F} ˘uo U R ] v} v](}u `}o`]
}o]˙ P]vP vo i u' } R } }( o]u oo}`o ]v ]}Ru o v X C}v vo˙U
v u˙ v} ] (}u } v]vP v o]}v X A RU ` } v} lv}` R P }( ( }}v
R ` `]oo R }v } }]˙ } v Rv}o}P˙X TR } }( v }}v R R E }v Pv
O8 v R USPTO `]oo Pv `]R } R v}] ]v } v}] } ]o]v ] v ]vX I ] }
]o R R E }v Pv O8 v R USPTO `]oo v} oo}` } v}˙ o]u R } v}] o}o˙
o } } } v } v] `oo R ]. v}˙X A o U }v ] }( EMA } FDA
}oU }u} u˙ ( } ul v}] ou} ]vo } } U ]vo]vP ]}]u]o v}] U R˙
]vP } ul }voX H}`U }u} vv} u] } R FDA v o]}v (} ]}]u]o }
}v }v }( } } vo (} ˙ (}oo}`]vP R }( }o }( } S(v } U_ v R FDA u˙
v} } R ]}]u]o } vo `o ˙ (}u R }v `R]R R (v } ` } X
TR v } }v } ] ˘v] v u r}vu]vP U v ` v } v } ( o]v} U o]v
124 | Risk Factors Related to argenx’s Intellectual Property
} }oo}}v v u˙ v} o } U .o v } oo v ˙ } ]o v o]}v
}vo } } ]v uo˙ uvvX I ] o} }]o R ` } } o]v} U o]v } }oo}}v v
`]oo (]o } ]v(˙ vo }( ]vv}v u ]v R } }( o}uv v }uu]o]}v ] -
(} ] ] }} o } }]v v }}v }v RuX FRU R ] v U } U o]]˙U v(} ]o]˙ v
}uu]o o }( } v } v } ( o]v} [U o]v [ } }oo}}v v [ v ]PR R]PRo˙
v ]vX O v } o]v} [ v]vP v ( v o]}v u˙ v} o ]v v ]vP ] R } -
PART II
} Rv}o}P˙ } } U ]v `R}o } ]v U } R +o˙ v }R (}u }uu]o]]vP }u
Rv}o}P] v } X M}}U ]v }u ]uv U ` u˙ v} R R ]PR } }v}o R }vU .o]vP
v } }v }( v o]}v U } } u]v]v R v U } ` u˙ v } v ]v} v` o]v } }˙o˙
- Puv U }]vP Rv}o}P˙ R ` o]v (}u } o]v } R] } R o} ]v }oo}}v `]R
} }oo}}v v v o]v }v v }uv ] }( } o]v} U o]v } }oo}}v
v X TR(} U R v v o]}v u˙ v} } v v(} ]v uvv }v]v `]R
R ]v }( } ]v X I( } v } ( o]v} U o]v } }oo}}v v (]o } o]RU
u]v]v } } R v v }R ]voo o } ˙ ]PR U R ]PR u˙ } o]u]v X I(
} o]v} U o]v } }oo}}v v v} (oo˙ }} } ]P `]R } R } }vU
u]vvv } v(}uv }( v˙ v ]PR U R v ]PR }o }u}u] X TR v ˘u]v}v
} u˙ ] } } o]v} U o]v } }oo}}v v } v}` R } }( R o]u }( } }
} o]v} [U o]v [ } }oo}}v v [ v]vP v ( v o]}v U `R]R u˙ o]u] R }
}( v }}v R u˙ }]v X W vv} R oo }( R }voo˙ ov ]} ovP }
} v v v o]}v R v (}v X I( R ]} ˘] U ] v ]vo] v } v v
(}u ]]vP (}u v]vP v o]}vX Ev ]( v } ] v v ]( R v } } } v
} v] U R] u˙ ]v] v }}]}vU ]v(v U r˘u]v}vU }rPv ]`U ]v v
]`U voo].}v } ]}v }v ]v } } (} v }8 U } ]u]o }]vP RoovP]vP R o]]˙U
v(} ]o]˙ } } }( R v U `R]R u˙ o ]v R v o]u ]vP v}` } ]vo] X O v
} o]v} [U o]v [ } }oo}}v v [ v o]}v vv} v(} P]v R] ]vP
R Rv}o}P˙ o]u ]v R o]}v vo v vo v ] (}u R o]}v U v Rv }vo˙ } R
˘v R ] o]u } R Rv}o}P˙X
B v o]}v }v.vo (} ]} }( u L .o]vP U v }u u]v } vo ] U ` vv}
- ]v R ` } } o]v} ` R . } .o v˙ v o]}v o } } v } v] -
X FRu} U } R UXSXU ]( R] R .o R v o]}v }v } (} MR æU U v
]v(v } ]vP v ]v] ˙ R R] } u]v `R} ` R . } ]vv v˙ }( R i
u' } ˙ R v o]u }( } o]}v X I( R] R .o R o]}v L MR æU
U ]}v }]vP v ]v] ˙ R R] } u]v `RR } ]vv}v ` ]
(}u R] X Ev `R ` R o] v v(} o v U ` u˙ v} o } ˘o }R (}u ]vP
} ]vv}v `R R }R ˙ v R}` R R˙ R ]vv}v ]v }uu (} } .o]vP U } ]( R
}R ˙ ] o } }]v }uo}˙ o]v X Av˙ }( R (}uv}v ]}v }o Ru } } ]o]˙
} } } ]voo o } ˙U `R]R ]v v `}o oo}` }u} } ul }uo } `R]R }o
u]oo˙ o˙ + } }u }]}v v R } ]v U .vv]o }v]}v v o }( }}vX
2.6.2 Issued patents could be found invalid or unenforceable if challenged in court.
T} } } }u }]}vU ` u˙ (}u u } u v } } } o]P}v ]v } } v(} } (v
- v˙ v } }R ]voo o }˙ ]PR }`v ˙ } o]v } U } } u]v } RoovP R } }
o]]˙ }( v } }R ]voo o } ˙ ]PR }( R] X Ev(}uv }( ]voo o } ˙ ]PR ]
]8o U v]o v ˘v] U v uv˙ }( } } } o]v} [ } }oo}}v v [ ] ]v R
} ]vP u˙ R R ]o]˙ } ] voo˙ P } } } vP R oPo }v Rv `
} } o]v} } }oo}}v v vX A }]vPo˙U ] } } } o]v} [ } }oo}}v v [ +} U
` } } o]v} } }oo}}v v u˙ v} v R] (}u ]v(]vP]vP }v } u] }]vP
]voo o } ˙ ]PR ` }`v } }v}oU oo˙ ]v }v] `R R o` u˙ v} } R} ]PR
(oo˙ ]v R E }v Uv]}v v R UXSX Wu˙ (]o ]v v(}]vP } ]PR U ]v `R]R } }u} u˙
u]' } } Rv}o}P˙ `]R} ]vP ] } ˙ v˙ o]v ( v l} }˙o X Iv ]}vU o]P -
Risk Factors Related to argenx’s Intellectual Property | 125
}v ]v}o]vP } v ] R ]l R }v } u} }( } v `]oo Ro ]vo] ~]v `R}o } ]v U }v
o]ur˙ro]u ] Z } Ro vv(} o X SR v } o]vP }o oo}` R] } }uu]o] }
} } } SIMPLE Av}˙¡U NHv v ABDEG¡ o}u Rv}o}P] U v Rv }u ]o˙ `]R U
`]R} ˙uv } X
I( ` ` } ]v] oPo } ]vP P]v R] ˙ } v(} v }]vP }v }( } } U R (v
v }o }vo]u R } v ] ]vo] } vv(} o X Iv v o]P}v ]v R UXSX } ]v E } U (v
v }vo]u ooP]vP ]vo]]˙ } vv(} ]o]˙ }uu}vo X A o]u (} o]]˙ RoovP u˙
}v (]o } u v˙ }( o }˙ ]uv U (} ˘uo U ol }( v}o˙U }]}v } v}vrvouv X A
o]u (} vv(} ]o]˙ }o ]v}o v ooP}v R }u}v }vv `]R } }v }( R v `]RRo
ov ]v(}u}v (}u R E }v Pv O8 } R USPTO } u u]o]vP uv U ]vP } }vX
TR }}u (}oo}`]vP oPo }v }( ]vo]]˙ v vv(} ]o]˙ ]vP v o]P}v ] v]o X W]R
} R o]]˙ }vU (} ˘uo U ` vv} ]v R R ] v} ]vo]vP ]} U }( `R]R ` v
R v ˘u]v ` v` ]vP } }vX I( (vv ` } ]o }v oPo }v }( ]vo]]˙ }
vv(} ]o]˙U ` `}o o} o U v R ooU }( R v }}v }v }v } u} }( } } }
]v }( } SIMPLE Av}˙¡U NHv v ABDEG¡ o}u Rv}o}P] X SR o} }( v }}v
}o R u]o ]u }v } ]v X FRU o]P}v }o o ]v vo } v ]]}v }(
uvPuv } U Po }( R }}u U v R] }o Ru } ]v v .vv]o o X Pv v
}R ]voo o } ˙ ]PR o} `]oo v} } } Rv}o}P˙ ]( }u} ]Pv }v } } R
v}o}P˙ `]R} ]v(]vP]vP } v } }R ]voo o } ˙ ]PR X
2.6.3 Intellectual property rights of third parties could adversely affect our ability to
commercialize our products and product candidates and may harm our compet-
itive position.
O }u ]] }]]}v u˙ (( ]( v ] } R] ] } }R R] r ˙ ]v oo o } ˙ ]PR
} } } } ouv R }(U } uv( } o v } } o}uv ov U R P }(
} } v } v] U } }R ] }( } } v } v] } } Rv}o}P˙X
Iv R U ` u˙ v} ]v }]]}v } o} } }uu ]o] } } } v] vo `
(oo˙ o]]P]}v } voo](˙ } ]vo] R R] r ˙ ]v oo o } ˙ ]PR }v v U } v
]v} o] v P uv `]R R ]v oo o } ˙ ]PR R}o U ]( ]o o }v }uu ]oo˙ }v o u X
W ` }( ]v UXS X ] v Ro ˙ R] ] R }u u˙ P } ]v }( }
} v] U ]vo ]vP u X Ov R R] ˙ v (u]o˙ }( } v]o o v } u
] R o } ˘] ]v X Iv R v R v R v} ˘] R ]u }( } o }( R }
v] v R v }`v ` } ]vP v ]v(]vPuv ]}v P]v U ` u˙ R } P R }
} U ] uv( } } v} ]v(]vP o] o]u }( R v ]v ]}v X A o v ] o˙U ]( ` `
} RoovP R o]]˙ }( v˙ ] UXS X v ]v } U ` `}o v } } }u }˙ u ]}v }(
o]]˙ R R } ˙ UXS X v X TR] u v R ]v } } ]o U ` `}o v } v o v
}v]v]vP ] v } R ]vo]]˙ }( R v [ o]u X TR ] v} v R } `}o (]v ]v }
(} }v ]}v }( ]v(]vPuv } o]]˙X Iv R v R v ] (oo˙ P]v R R
R v ] (}v } o] v v(} o v ]v(]vP ˙ } } U vo ` } ]v o] v } R
v U `R]R u˙ v} ]o o }v }uu ]oo˙ }v o u } oo U ` }o v (}u }v]v
]vP } o} } }uu ]o] } } X S]u]o o˙U R P (} ]v }( } } v } v]
R o} v R i }( R ˙ }R }u v] U `R]R R (]o v o] ]}v } R v }v
}( R P } R] X TR v v} v v˙ R v `]oo v} P]v }
R ` `]oo v} v } l o] v (}u R R] ] X W u˙ v} o } R o] v }v
o u U ]( oo U v v˙ R o]]P]}v `}o } o˙ v ]u r}v u]vP X
I ] o} }]o R ` v` } ov v } o]}v X F} ˘uo U ]v UXSX o]}v .o
L N}u ıU R `]oo v} .o }] R UXSX u˙ u]v }v.vo vo v ] X Iv PvoU
v o]}v ]v R UXSX v o`R o]R }˘]uo˙ u}vR L R o] .o]vP (}u `R]R
]}]˙ ] o]u U `]R R o] .o]vP ]vP }uu}vo˙ ( } R ]}]˙ X TR(} U v
126 | Risk Factors Related to argenx’s Intellectual Property
o]}v }]vP } } U } v] } o}u Rv}o}P˙ }o R v .o ˙ }R `]R}
} lv}`oP X FRu} U ` } ]v R]PRo˙ }u .o U v P]v } o]u] } U ] ] v}vo
} u}v]} oo v o]}v }vP } P]v } }P ]v R ]v `R]R ` X A ]}voo˙U
v]vP v o]}v `R]R R v o]R vU i } ]v o]u]}v U o uv ]v uvv
R }o } } o}u Rv}o}P] U } } } R }( } } X
-
PART II
- TR] r ˙ ]voo o }˙ ]PR R}o U ]vo]vP } }u} U u˙ o˙ ]vP ]v(]vPuv o]u P]v
X TR PvvP }( }Rv P ]v }( v˙ }( } } v] } v} Pv } (}u }
} v ] (}u } ]l }( }]o ]v(]vPuv }( R] [ ]voo o } ˙ ]PR X Wu˙ v}
o } (oo˙ 'o } }R`] }o R ]v(]vPuv o]u X I( ` vo } (oo˙ 'o (
o]u }v u o } U ` u˙ ] } vPP } }vv }o˙U v]o v u r}vu]vP
o]P}v v u˙ v (}u } ˘]v vo o˙ ]v ulvP } } X
I(`(]o]vv˙R]U]v]}v}]vP(}}˙uPU`}}o]vu˙u}]o˙} -
uvvo˙}R]](}u}uu]o]]vPv˙}(}}v}v]RRo}]v(]vP]vPXW
u]PRU](}]oUo}(}}]Pv}v}v]}R`v}o}vP]v(]vPRR]r˙
]vooo}˙]PRXWu˙]}lo]v}v˙RRv}o}P˙R`(}v}]v(]vPU
`R]Ro]vu˙v}]oo}v}uu]oo˙}vouU}ooXvE ](`}}o]v}}}oo}}v
- v}]vo]vU]u˙v}vr˘o]~(}˘uoURPOTELLIGENTo}uZUR˙P]]vP}}u}
}RuRv}o}P]o]v}}}o]v}}}oo}}vvXIv]}vU`}o(}vo] -
o(}u}v˙uPU]vo]vPouPv'}v˙[(U](`(}v}R`]oo(oo˙]v(]vPvX
Av˙ }( R v U v ]( ` ` } ouo˙ ]oU }o ] } ] vo .vv]o v uvP -
uv } R ` `}o }R`] o } } } } ]v X
Iv ]}vU ]( R R } vPR }( }}v }] ˙ } } } o]v} [ } }oo}}v v [ v
v v o]}v ] Rv U ] }o ] }uv] (}u }oo}vP `]R } o]v U o} }
}uu]o] v } ( } v } v] X FRu} U }( R vo u}v }(
]}˙ ] ]v }vv}v `]R ]voo o }˙ o]P}vU R ] ]l R }u }( } }v.vo ]v(}u -
}v }o }u}u] ˙ ]o} ]vP R] ˙ }( o]P}vX
2.6.4 Our ability to compete may be adversely affected if we are unsuccessful
- in defending against any claims by competitors or others that we are
infringing upon their intellectual property rights.
TR ]} ul ]v `R]R ` } } ov } } i } ( v v ˘v] o]P}v P]vP
v v }R ]voo o } ˙ ]PR X Iv ]}vU }uv] }]vP R } v }voo˙
v R uo}˙ ]voo o }˙ o]P}v uv } P]v v vP } R] }u} X A
o U ` u˙ ] } (v P]v o]u }( ]voo o } ˙ ]v(]vPuv R u˙ P]v
v U ]( R }}u }( v˙ R o]P}v ] } U ] u˙ + } ]o]˙ } }u +o˙X
- O ]v}ouv ]v o]P}vU v ]vU XPXU v˙ ]v(v U ]}vU ˘u]v}vU inter partes ]`U }}]}v }
}rPv } ]vP } }R ]voo o }˙ }]vP ]v] v }] }( R E }v Uv]}v } R UXSX
u˙ ] uvPuv u (}u (}]vP }v ]v }}v U }o } v ]Pv].v u}v }( u}v -
˙ v u˙ R v} Pv }( X P}vo ]voo o }˙ o]P}v }o o}U u}vP }R R]vP U (}
- } } oo]vP U ]v}}vP U uv( ]vP } ]vP ]v }( } } U } }]v o]v } oo } ]v
Rv}o}P˙ (}u R] ˙ vP ] ]voo o } ˙ ]PR U } ]Pv ]v } } } R
v˙ ooPo˙ ]v(]vP]vP } u] }] Rv}o}P˙ } ˙ uP U ]vo]vP R }]]o]˙ }( o uP ]v
v ]( } .v } R `]oo(oo˙ ]v(]vP ]v ]voo o }˙ ]PR U `R]R u˙ o ]v ]Pv].v
} v l} o˙ } X M}}U ]v o]v u˙ v} ]oo }v }vo u U } ooU } u˙ v}vr˘ -
o] R˙ P]]vP } }u} } R u Rv}o}P] o]v } v ]Pv]vP ]v } }
} }o Rv]oo˙ ]v(]o X
Risk Factors Related to argenx’s Intellectual Property | 127
2.6.5 Intellectual property litigation could cause us to spend substantial
resources and distract our personnel from their normal responsibilities.
Ev ]( }o ]v } (}U o]P}v } }R oPo }]vP ovP } ]voo o } ˙ o]u u˙ }
]v ]Pv].v ˘v v }o ] } Rv]o v uvPuv }vvo (}u R] v}uo }v]]o] X
Iv ]}vU R }o o] vv}vuv }( R o }( R]vP U u}}v } }R ]v]u }]vP }
o}uv v ]( ] vo˙ } ]v} ] R o } vP U R] u˙ vPo˙ ]u X
SR o]P}v } }]vP }o voo˙ ]v } }vP o} v } } ]oo (}
o}uv ] X Wu˙ v} R 8]v .vv]o } }R } } o˙ }v R o]P}v }
} ]vP X S}u }( } }u} u˙ o } ]v R } }( R o]P}v } }]vP u} +o˙
Rv ` v }( R] voo˙ P .vv]o } X Uv ]v ovP (}u R ]v]}v v
}vv}v }( v o]P}v } }R }]vP }o R u]o + }v } ]o]˙ } }u ]v
R ulo X
Mv˙ }( } }vov v uo}˙ U ]vo]vP } v]} uvPuv U ` ]}o˙ uo}˙ }R ]}R
v}o}P˙ } Ru o }uv] U ]vo]vP } }u} } }vo }u} X S}u }( R }vov v
uo}˙ ˘ }]˙ ]PR U v}vr]o} v v}vr}u}v Puv ]v }vv}v `]R R ]
} uo}˙uv X AoR}PR ` ˙ } v R } }vov v uo}˙ } v} R }]˙ ]v(}u}v
} lv}`rR}` }( }R ]v R] `}l (} U ` u˙ i } o]u R ` } R }vov v uo}˙
R } ]o} }v.vo ]v(}u}v } ]voo o } ˙U ]vo]vP } }R }]˙ ]v
(}u}vU }( v˙ R }vov [} uo}˙ [(}u uo}˙U } R R R] v}vr}u}v Puv X
L]P}v u˙ v ˙ } (v P]v R o]u X
I( ` (]o ]v } vP } (v]vP v˙ R o]u U ]v ]}v } ˙]vP u}v˙ uP U ` u˙ o} oo
]voo o } ˙ ]PR } }vvo } ]v uP X SR ]voo o }˙ ]PR }o ` } R]
˙U v ` }o ] } }]v o]v (}u R R] ˙ } }uu]o] } Rv}o}P˙ } } X
SR o]v u˙ v} ]oo }v }uu]oo˙ }vo u } ooX Ev ]( ` (oo˙ } }
(v P]v R o]u U o]P}v }o o ]v vo } v ] uvPuv X
2.6.6 We may not be successful in obtaining or maintaining necessary rights to our
products and product candidates through acquisitions and in-licenses.
}B }Puu˙]R}(}]˙]PRRo˙R]URP}`R}(}]v`]ooo]lo˙
v]v}v}]o]˙}]U]vro]vUu]v]v}R}]˙]PRXWu˙vo}]}
]vro]vv˙}u}]}vUuR}}(U}U}}RR]r˙]vooo}˙]PR(}uR]
R`]v(˙v˙(}}}v]XTRo]v]vPv]]}v}(R]r˙]vooo}
˙]PR]}uUvvu}(u}o]R}uv]u˙P]}o]v}]
R]r˙]vooo}˙]PRR`u˙}v]'XTRo]R}uv]u˙R}u
vP}}R]]UR}vPo]v]oo}uvv}uu]o]}v]o]X
F}˘uoU`}uu}oo}`]RUXSXvv}vrUXSXu]]v}v}o}o]v]oR
} o}uv v `]'v Puv `]R R ]v }v X T˙]oo˙U R ]v }v }] `]R v }}v
} vP} o]v } v˙ }( R ]v }v[]PR ]v Rv}o}P˙ ovP (}u R }oo}}vX RPo }( R
}}vU ` u˙ vo } vP} o]v `]R]v R ]. u(u } v u R o } X
I( ` vo } } }U R ]v }v u˙ }+ R ]voo o } ˙ ]PR } }R U }voo˙ o}l]vP
} ]o]˙ } } o]o } v] } }PuX
Iv ]}vU }uv] R ] } }u} u˙ v`]oo]vP } ]Pv } o]v ]PR } X W o}
u˙ vo } o]v } ] R] r ˙ ]voo o }˙ ]PR }v u R `}o oo}` } ul v
}] v }v } ]vuv X I( ` vo } (oo˙ }]v o]v } R] r ˙ ]voo o } ˙
]PR v ˙ (} R o}uv }( } v] } }PuU ` u˙ R } v}v o}uv }( R
} v] } }Pu v } ]v v .vv]o }v]}v }o +X
128 | Risk Factors Related to argenx’s Intellectual Property
2.6.7 If we fail to comply with our obligations under the agreements pursuant to
which we license intellectual property rights from third parties, or otherwise
experience disruptions to our business relationships with our licensors, we
could lose the rights to intellectual property that are important to our business.
W ˙ } o] v P uv v `R]R ` Pv ]PR } ]v oo o } ˙ R ]u} v
PART II
} } ]v v ` ˘ R ` u˙ v } v ]v} ]]}vo o] v P uv ]v R ( X E ˘] ]vP
o] v P uv ]u} U v ` ˘ R ( o] v P uv `]oo ]u} U ]} o}uv }o]P -
]}v U ˙uv }( }˙o] v ( }v R] ]vP ]v u]o }v U `oo }R }o]P]}v X I( ` (]o }
}uo˙ `]R } }o]P]}v v R P uv U R o] v} u˙ R R ]PR } u]v R o] v X TR
u]v ]}v }( v˙ o] v P uv } (]o } o˙ R o] v P uv }o v
(}u }uu ]o]]vP } } } v] } ˙ R o] v ]v oo o } ˙X S o }( }
˘] ]vP o] v P uv ro] v (}u R] ] `R]R v} R }]P]vo o] v} }( R ]voo o
} ˙ ] X Uv R P uv U ` u o˙ }v } o] v} } }uo˙ `]R ] }o]P]}v v R
- ]u ˙ o] v P uv v `R]R R R] ˙ } ]v ]PR ]v R o] o ]v oo o } ˙U `R
` u˙ R v} o ]}vR] `]R R }]P]vo o] v} }( R ]PR X I( R o] v} (]o } }uo˙ `]R R] }o]P -
- ]}v v R u o] v P uv U R }]P]vo R] r ˙ o] v} u˙ R R ]PR } u]v R
}]P]vo o] v U `R]R u˙ u]v R o] v X I( R] ` } } U ` `}o v} o}vP R ]PR } R -
o] o ]v oo o } ˙ v U ]v R }( o] v U ]( ` ` v} o } } }`v ] o] v `]R
- R }`v }( R o v ]PR U `R]R ] u˙ v} o } } }v o } } }v }v o u U ] u˙
o˙ (( } ]o]˙ } }v]v } o} v }uu ]o] R } v } v] ]v} } -
]vP R o v ]v oo o } ˙X
D] u˙ ] P]vP ]voo o } ˙ i } o]v]vP Puv U ]vo]vPP
{ R } }( ]PR Pv v R o]v Puv v }R ]v }vro ] V
{  R ˘v } `R]R } Rv}o}P˙ v } ]v(]vP }v ]voo o } ˙ }( R o]v} R ] v} i
} R o]v]vP Puv V
{ R o]v]vP }( v v }R ]PR v v˙ }oo}}v o}vR] ` u]PR v ]v} ]v R ( V
{ } ]o]Pv }o]P}v v R o]v Puv v `R ] (˙ R} ]o]Pv }o]P}v V
{  R }`vR] }( ]vv}v v lv}`rR}` ovP (}u R i}]v }v } }( ]voo o } ˙ ˙ }
o]v} v v } v V v
{ R ]}]˙ }( ]vv}v }( v Rv}o}P˙X
I(]}]vooo}˙R`Ro]vv}]u]}]o]˙}u]v]v}vo]v]vP
vPuv}vouU`u˙vo}(oo˙o}v}uu]o]R+}v
- }v]X
-
2.6.8 If our trademarks and trade names are not adequately protected, then
we may not be able to build name recognition in our markets of interest
and our business may be adversely affected.
O P] } v P] u l } vu u˙ RoovP U ]v(]vP U ] uv } o
Pv ] } u]v } ]v(]vP]vP }v }R u l X W u˙ v} o } } } ]PR } R u l
v vu U `R]R ` v } ]o vu }Pv]]}v ˙ } v]o v } }u ]v } u l }( ]v -
X O R o}vP u U ]( ` v o } o]R vu }Pv]]}v }v } u l v vu U
Rv ` u˙ v} o } }u (( ] o˙ v } ]v u˙ o˙ (( X I( }R v]]
u l ]u]o } } ]v ](( v i ] ] ]}v U } R v]} ]PR } } U ] }o ]v ( `]R } }(
} v u l R}PR} R `}o X
Risk Factors Related to argenx’s Intellectual Property | 129
2.6.9 If we do not obtain protection under the Hatch-Waxman Amendments and sim- S}u}v]R}uo}˙o]v]vPo`v`R]Rv}`vu˙}uoo}Pvo]v}R] -
ilar non-U.S. legislation for extending the term of patents covering each of our XIv]}vU}u}v]o]u]Rv(}]o]˙}(vP]vP}vuvPv]}P}vuv}v}XIv
products and product candidates, our business may be materially harmed. R}v]URv}`vu˙Ro]u]u]U`R]R}ou]oo˙]u]v]RRo}(RvXI(`
}v˙}(}o]v}](}}Pvo]v}R]`]R}v˙vov}}]vU}}u -
PvRo]u]}vXIvRUXSXU](oou]vvv(uo˙]URvo˘]}v}(v]Pv - }]}vu˙]u]v}]vUo}(}}vv.vv]o}v]}vu˙o˙+X
oo˙˙(}u]o]UXSXv}vr}]]}vo.o]vPXV]}˘v]}vu˙]ooURo](}(vU

vR}}v]+}U]o]u]XvE ](v}]vP}}v}v]UR]uv(U}
}]vU}vRvo](R˘]U`u˙}v}}u}v(}u}uu]}vU]vo]vP
]}]u]ou]}vXG]vRu}v}(u](}Ro}uvUvPvPo}˙]`}(v`}
v]Uv}vPRv]u]PR˘](}}R}o˙LRv]}uu]o]X
oA U}}`vvo]vv}}o]}u˙v}}]`]R8]v]PR}˘o}R(}u}u
u]o]]vP}]u]o}]vo}}X
Dv]vP}vRu]vPU}vv}v]}v}(FDAulvP}o}(}}v]U}v}u}}(
}UXSXvu˙o]P]o(}o]u]vu˘v]}vvRDPP]C}u}vvPvTuR}
}vA}(ı~R Hatch-Waxman ActZv]u]ooP]o}v]vR}v
E Uv]}vXTRHRrW˘uvAu]
vu˘v]}v}(}.˙(}v}]vPv}}}uv}v(}+v
uo}]vP}o}uvvRFDPo}˙
A ]`}XTRvu˘v]}vvv}˘v
Ru]v]vPu}(v˙}v}o}(˙(}uR}(}}oUv}vo˙}vvo]
o}v}Pu˙˘vXH}`U`u˙v}]v˘v]}v](`(]o}o˙`]R]vo]o
o]vU(]o}o˙]}}˘]}v}(ovv}}R`](]o}(˙o]o]uvXM}}U
RovPR}(R˘v]}v}ooRv`XI(`vo}}]vvu˘v]}v}Ru}(
v˙R˘v]}v]oRv`UR]}]vP`R]R`vv(}}v]PR(}R}`]oo
R}vv}}u}u˙}]v}o}ul}uvP}}}vRv`˘XoA U}
v(}uo]o}}oU}]o˙u]oo˙X
2.6.10 We enjoy only limited geographical protection with respect to certain
patents and may face difficulties in certain jurisdictions, which may
diminish the value of intellectual property rights in those jurisdictions.
W}Lv .o } . v o]}v ~]X XU ]}]˙ .o]vPZ R UK Ivoo o P}˙ O8 U R E }v Pv
O8 } R USPTOX Ivv}vo o]}v v R Pv C}}}v T˙ ~
u}vR L R ]}]˙ .o]vPX B }v R PCT .o]vP U v}vo v P]}vo v o]}v u˙ .o ]v ]
}vo i]]}v `R ` o] } } v } v] u˙ ul X WR } ( v} .o (}
v }}v ]v oo v}vo v P]}vo i]]}v `R R }}v u˙ ]oo X Iv ]}vU ` u˙
] } v}v v}vo v P]}vo v o]}v (} Pv X F]voo˙U R Pv } ]vP }( R v}vol
P]}vo v ] v ]vvv }]vP `R]R u˙ o } ]}v ]v `R]R o]}v u]PR ]v }u i]]
}v ( ˙ R ov v }8 U `R]o Pv ˙ }R X I ] o} ] }uu}v R v]vP }v R
}v˙U R } }( v }}v u˙ ˙ (} R u } } } v] } Rv}o}P˙X
C}u} u˙ } v } o]v} [ } }oo}}v v [ Rv}o}P] ]v i]]}v `R ` R v}
}]v v }}v } o} R] }`v } v U (RU u˙ ˘} }R`] ]v(]vP]vP } }
]}] `R ` v } o]v} } }oo}}v v R v }}vU v(}uv ] v} }vP
R ]v R UXSX v R E }v Uv]}vX TR } u˙ }u `]R } } v } v] U
v } v } o]v} [ } }oo}}v v [ v } }R ]voo o } ˙ ]PR u˙ v} + }
8]v } v Ru (}u }uvPX
TR o` }( }u i]]}v } v} } ]voo o } ˙ ]PR } R u ˘v R o` ]v R UXSX v
R E }v Uv]}vU v }uv] R v}v ]Pv].v ]8o ]v }vP v (v]vP R ]PR ]v
R i]]}v X I( ` } } o]v} v}v ]8o ]v }vP U } }R`] o (}u +o˙
}vP U R ]voo o } ˙ ]PR ]u}v (} } ]v ]v R i]]}v U R o }( R ]PR u˙
]u]v]R v ` u˙ ( ]}vo }u}v (}u }R ]v R} i]]}v X
PART II
P} ]vP } v(} } v } o]v} [ } }oo}}v v [ v ]PR ]v (}]Pv i]]}v }o o
]v vo } v ] } v } o]v} [ } }oo}}v v [ +} v 'v}v (}u }R }(
- } ]v U }o } v } o]v} [ } }oo}}v v [ v ]l }( ]vP ]vo] } ]v
v}`o˙ v } v } o]v} [ } }oo}}v v [ v o]}v ]l }( v} ]]vP v }o }}l
- R] } o]u P]v } } o]v} } }oo}}v v X W} } o]v} } }oo}}v
v u˙ v} ]o ]v v˙ o`] R ` } } o]v} } }oo}}v v ]v] v R uP }
}R u] ` U ]( v˙U u˙ v} }uu]oo˙ uv]vP(oX
-
2.6.11 Intellectual property rights do not necessarily address all potential threats to
our competitive advantage and changes in patent laws or patent jurisprudence
could diminish the value of patents in general, thereby impairing our ability to
- protect our products.
TR Au] Ivv A ~ AIAZ R v v ]v R UXSXU ovP ]v ]Pv].v RvP } R UXSX v ˙uX
Av ]u}v RvP ]v} ˙ R AIA ] R U }( MR U U R UXSX v]}v } S.r}r.o _ ˙u
(} ]]vP `R]R ˙ R}o Pv v `Rv `} } u} v o]}v .o ˙ ]+v
o]u]vP R u ]vv}vX A R] ˙ R .o v o]}v ]v R USPTO L R (} }o
R(} ` v }]vP v ]vv}v }( } v ]( ` R u R ]vv}v (} ] ` u ˙
R R] ˙X TR] `]oo ] } }Pv]v P}]vP (}` }( R u (}u ]vv}v } .o]vP }( v o] -
}vU ]uv }o v (}u }uo˙ .o]vP v o]}v }v } ]vv}v X
Au}vP }u }( R }R RvP ]v} ˙ R AIA RvP R o]u] `R v u˙ .o v ]v -
(]vPuv ] v }]]vP }}v] (} R] } RoovP v˙ ] v ]v R USPTOX TR] o] }
oo }( } UXSX v U v R} ] (} MR U X B }( o}` ]v˙ v ]v USPTO } -
]vP }u } R ]v˙ v ]v UXSX (o } v ˙ } ]vo] v o]uU R] ˙
PCTZ oo˙ .o `]R]v `o }o }voo˙ }] ]v ]v USPTO }]vP 8]v (} R USPTO } R}o o]u ]vo] v R}PR R
- u ]v `}o ]v8]v } ]vo] R o]u ]( . v ]v ]] } }vX A }]vPo˙U R]
˙ u˙ 'u } R USPTO } } ]vo] } v o]u R `}o v} R v ]vo] ](
. RoovP ˙ R R] ˙ (vv ]v ]] } }vX TR AIA v ] ]uouv}v }o ]v
R v ]v v } }v]vP R } }v }( } v o]}v v R v(}uv } (v }(
- } ] vX
A ]}voo˙U R UXSX Su C} R o }v o v ]v v ˙ U ]R v}`]vP R } }( -
v }}v ]oo ]v ]v ]uv } `lv]vP R ]PR }( v }`v ]v ]v ]}v X Iv ]}v
} ]v ]vP v ]v˙ `]R P } } ]o]˙ } }]v v ]v R ( U R] }u]v}v }( v R
v ]v˙ `]R } R o }( v U }v }]v X D v]vP }v ]]}v ˙ R UXSX C}vP U R (o
} v R USPTOU R o` v Po}v P}v]vP v }o RvP ]v v]o `˙ R }o `lv
} ]o]˙ } }]v v` v } } v(} } ˘]vP v v v R ` u]PR }]v ]v R ( X
Av˙ ]v]o]˙ }( } } } }u vP `]R P } v˙ }( } } v } v] u˙
v (}u (oo˙ u}v]vP R } v } v] v R] }o u]oo˙ o˙ +
} ]v U } U .vv]o }v]}v v o }( }}v X

130 | Risk Factors Related to argenx’s Intellectual Property Risk Factors Related to argenx’s Intellectual Property | 131
2.6.12 Obtaining and maintaining our patent protection depends on
compliance with various procedural, document submission, fee payment
and other requirements imposed by governmental patent agencies, and
our patent protection could be reduced or eliminated for non-compliance
with these requirements.
P]}] u]vvv v vv]˙ ( }v v˙ ] v } ] } R USPTOU R E }v Pv O8
v (}]Pv v Pv] ]v o P } R o](u }( R v X TR USPTOU R E }v Pv O8 v
]} (}]Pv P}vuvo v Pv] ] }uo]v `]R vu }( } oU }uv˙U ( ˙
uv v }R ]u]o }]]}v ]vP R v o]}v } X WR]o v ]v v o v ]v uv˙
˙ ˙uv }( o ( } ˙ }R uv ]v }v `]R R o]o o U R ]}v ]v `R]R
v}v}uo]v v o ]v v}vuv } o }( R v } v o]}vU ovP ]v o } }uo
o} }( v ]PR ]v R ov i]]}vX N}vr}uo]v v R }o o ]v v}vuv } o }(
v } v o]}v ]vo (]o } }v } }8]o }v `]R]v ] u o]u] U v}vr˙uv }(
( v (]o } }o˙ oPo] v u] (}uo }uv X I( ` } } o]v} } }oo}}v v (]o }
u]v]v R v v v o]}v }]vP } } v } v] U } }u} u]PR
o } v R ulU `R]R `}o R v + }v } ]v X
2.6.13 Our trade secrets may be misappropriated or disclosed, and
confidentiality agreements with employees, consultants, advisors
and potential collaborators may not adequately prevent disclosure
of trade secrets and protect other proprietary information.
Iv ]}v } v }}vU ` o} o˙ }v }}v (} } }]˙ ]v(}u}v R ] v}
uvo }U } R ` } v} }v] }] (}U v }}vU ]vo]vP U (} ˘uo U ]v }( }
oou ]uuv]}v v v}˙ 8v]˙ u }v }R X H}`U ]8o } } U v `
R o]u] }v}o } R }}v }( ˙ } o]v} U }oo}} v o] X
T} } R] ˙ }( ]v(}u}v P]v ]o} } }]}v ˙ }u} U } o ] } ] }
uo}˙ U }vov U ]} v }vo }oo}} } v ]v} }v.vo]˙ Puv X M}}U `
]v o }] } } ]v(˙ }v.vo u]o v ] } }uv}vX H}`U v
} (}u uo}˙ U }vov U ] v }vo }oo}} u˙ v]vv}voo˙ } `]oo(oo˙ ]o} }
}v.vo ]v(}u}v } }u} X WR v ]v}U v u˙ ]v R ( v ]v} ]}voU }oo}}v
`]R } }u} U v }v.vo]˙ Puv u˙ v} }] v u˙ ]v R v }( vR}]
]o} }( }v.vo ]v(}u}vX Iv ]}vU R v } R v }R }v.vo ]v(}u}v
]v R ]l R R }u lv}`v } } }u} U ]v vo˙ ]v}} ]v} R
Rv}o}P˙ }( }R U } ]o} } ]v ]}o}v }( R Puv X
Ev(}]vP o]u R R] ˙ }]v ]ooPoo˙ v ] ]vP ] ˘v] U u }vu]vP v R
}}u ] v]o U v R v(} ]o]˙ }( }v.vo]˙ Puv u˙ ˙ (}u i]]}v } i]]}vX
M}}U ]( v˙ }( } ` } o`(oo˙ }]v } ]vvvo˙ o} ˙ }u} } }R
R] ˙U ` `}o R v} ]PR } v Ru (}u ]vP R Rv}o}P˙ } ]v(}u}v } }u `]R X
132 | Risk Factors Related to argenx’s Intellectual Property
2.7 Risk Factors Related to argenx’s
Organization and Operations
PART II
2.7.1 Our future growth and ability to compete depends on retaining our
key personnel and recruiting additional qualified personnel.
-
O v }v R }vv }v]}v }( } l˙ uvPuv U ]v. v Rv]o }vvoU uv˙
}( `R}u R v ]vuvo (} v R vo ˘]v `]R } R] v o Rv}o}P] X
TR l˙ uvPuv ]v]]o ]vo R uu }( } B} }( D]} v v]} uvPuv uX
TR o} }( l˙ uvP v v]} ]v }o o˙ } R v o}uv ] X Iv ]}vU } ]o] -
˙ } }u ]v R R]PRo˙ }u ]}Rv}o}P˙ v Ru o ]v ] v }v } ]o]˙ } '
v ]v R]PRo˙ o]. uvPuv U ]v. v u]o }vvoX Mv˙ }R ]}Rv}o}P˙ v Ru o
}uv] v u] ]v }v R ` }u P]v (} o]. }vvo R P .vv]o v }R -
} U ]+v ]l }.o v o}vP R]}˙ ]v R ]v ˙ Rv ` }X TR(} U ` u]PR v} o } '
} ]v R l˙ }v }v }v]}v R }v}u]oo˙ o X
FRu} U ` `]oo v } ] v` uvP v o]. ]v. U }uu]oU Po}˙ v .vv]o }v -
vo } o} } ]v ]( ` ˘v ]v} .o R `]oo ] ]}vo l]oo X O ]v]o]˙ } ' v ]v
R l˙ }v }o v (}u R]]vP } }i v ]uouvvP } ]v P˙U `R]R }o
R u]o + }v } ]v v } X
2.7.2 We expect to expand our development, regulatory and sales and
marketing capabilities, and as a result, we may encounter difficulties
in managing our growth, which could disrupt our operations.
WR P}`v ]Pv].vo˙ ]v vu }( uo}˙ v } }( }}v } R v ˙ v ˘ }
˘]v ]Pv].v P}`R ]v R vu }( } uo}˙ v R } }( } }}v o} ]v R v ( U
oo˙ ]v R }( P RU P o}uv U Po}˙ +] v o v ulvPX T} uvP
} v] ( P}`RU ` u }vv } ]uouv v ]u} } uvP]oU }}vo v .vv]o
˙u U ˘v } (]o] v }vv } ] v ]v ]}vo o]. }vvoX D } } o]u] .vv]o
} v R o]u] ˘]v }( } uvPuv u ]v uvP]vP }uv˙ `]R R v] P}`RU `
u˙ v} o } +o˙ uvP R ˘v]}v }( } }}v } ] v ]v ]}vo o]. }vvoX
F} ˘uo U ` vo˙ }}]vP ]v o}uv `R]R ` vv} } }o } o]u]
}vvo ] U (} ˘uo } Z ] L ]v o}v } }}(r}(r}v ]o ]v `} l]v˙ ]v]}v U LN v MN
} } IQVIA ]v o}v } }}(r}(r}v ]o ]v ]u˙ SiS v COVIDr ıru] POTSX A o }( } o]u]
.vv]oU uv( ]vP v uvPuv } U ` u˙ (}P} } o˙ ] }( }}v] `]R }vo } -
v] R o } } R P ul }voX O } oo}}v ]]}v u˙ } (]o
} ]o] }v ]o }uu]o } } }.o ul }}v] X FRU ` u˙ o]v]R ]PR } R
} v] R}PR }oo}}v U o]v]vP } }˙o˙ vPuv ]v ]uv `R ] `}o R v
u} vP} (} } ]v }o o}uv v }uu]o]}v ]PR X
Risk Factors Related to argenx’s Organization and Operations | 133
TR ˘v]}v }( } }}v u˙ o } ]Pv].v } v u˙ ] } uvPuv v ]v o}
uv } v u˙ ]o } }} o U `R]R ]v v u˙ ul] u} ]8o } ' v ]v u
o}˙ X Av˙ ]v]o]˙ } uvP P}`R }o o˙ R ˘}v }( } P] }i } ] } }}v U
`R]R ]v v }o u]oo˙ Ru } ]v v } X
2.7.3 Public health issues or other catastrophic events could disrupt the
supply, delivery or demand of products, which could negatively affect
our operations and performance.
Po] RoR ] R vu] } ]u]o } l }o o˙ ]u } ]v X T} U R } l
}( COVIDr ı R o˙ o ]v ˘v R}`v }( ]v ]v ]v uv˙ }v] oo } R `}o X TR
}( COVIDr ı R ]u R Po}o }v}u˙ v u˙ ]u } }}v U ]vo]vP R }vo ]v
}v }( } o]v]o ]o ] v } o˙ R]vU v R }}v }( } l˙ ]v v X Go}o RoR
}vv U R R v o}uv }v COVIDr ıU }o o} o ]v }]oU }v}u] U v o} ]v]o]˙
]v R }v] ]v `R]R ` } R R] `]R `R}u ` vPP } X WR o} lv u}˙
}v˙ v o˙ ] u ]vv } Ro u]v]u] R ]l }( COVIDr ı } } uo}˙ U ]vo]vP
u}]o˙ ]]vP } uo}˙ } `}l u}o˙U v]vP v}vrvo o `}o`] (} } uo}˙ v
]}P]vP uo}˙ 'vv ]v ˙ v v ]vr}v `}lro uvP X TR u }o vP
o˙ + } ]v X COVIDr ı R o} }oo]˙ ]v R Po}o .vv]o ul v Rv o}`}`v
]v R Po}o }v}u˙U `R]R u˙ vPo˙ + } ]o]˙ } ] ]}vo ]o }v ' u } ooX W
vv} vo˙ ] R } v ]˙ }( v˙ }vo ]v R}`v } ] }v U ]( ` } v˙ }(
R R] `]R `R}u ` vPP U ]vo]vP R o] U }v uv( U o]v]o ]o ] U Po} v
}R R] `]R `R}u ` }v ]v U ` } ˘]v R}`v } }R ]v ] }v U }
]o]˙ } }v } ]v ]v R uvv v }v R uo]v vo˙ ovv }o u]oo˙ v vPo˙
]u X I ] o} }]o R Po}o RoR }vv R R] }v }o ]}}}vo˙ ]u R o]v]o ]
]v `R]R ` }v v˙ }( } o]v]o ]o U `R]R }o R u]o + }v } ]v v } o
}( }}v v .vv]o }v]}vX
Iv ]}vU }R] v R o ]v R }v } ] }v }( } v } } ]o ]v }
]v(}u}v Rv}o}P˙ ˙u `}o o˙ + } ]o]˙ } }v v}uo ]v }}v v U o U
} }vP o `}o o˙ + X
2.7.4 Global economic uncertainty and weakening product demand caused by politi-
cal instability, changes in trade agreements and conflicts, such as the conflict
between Russia and Ukraine, could adversely affect our business and financial
performance.
E}v}u] v ]v˙ ]v ]} Po}o ul ˙ }o]o ]v]o]˙ u˙ o ]v `lv uv (} }
} v ]8o˙ ]v (} vP } .vv]o o X Go}o }vG] U ]vo]vP R }vG] `v R] v
Ul]v U `oo }v}u] v}v ]uouv ˙ R UXSXU R E }v Uv]}v v }R }v] P]v
R] ]v }v R}U u˙ vPo˙ ]u ul U ]v vP˙ v v}}v } v `l
u}r}v}u] }v]}v X P}o]o o}uv ]u vP P}vuv v]vP v ]vv}vo u˙ o}
vPo˙ ]u ul v `l u}r}v}u] }v]}v X WR]o R }( R] Uv]o RP]}v
D}uv R }vG] `v R] v Ul]v v R } }v]vP v}v ]u} }v R] U ] v} ]o˙
]u } }}v U ` vv} ] R + R }vG] u˙ R }v R E }v v Po}o }v}u] v
R˙U ]v]o˙ } ]o˙ + } }}v X
TR }vG] `v R] v Ul]v ]v ]uv } (} } AD RESS ]o }( SC (PP]u} (} PF v
PV v ] ˘ } o˙ ]v } AD RESS ]oX Iv ]}vU R v}v ]u} ˙ uv˙ }v] U }vP}]vP
o}uv v v ]v˙ o } R }vG] `v R] v Ul]v }o o˙ + ]v }R `˙ X
134 | Risk Factors Related to argenx’s Organization and Operations
- F} ˘uo U ] }o o } ]v ]vP uv( ]vP } (} } } ˙ ]vP ] }v ]v R o˙ R]vU
- ]vo]vP o }( v}}v ]}v U ]v } }( ` u]o U } }v } `oo R]vP
v + }v R ]o]o]˙ }( u]o X TR }vG] `v R] v Ul]v u˙ o} o ]v o]v ]v
R Po}o ]˙ v ]o ul U o]u]vP } ]o]˙ } R ul } }]v .vv]vP } }v }
}}v v P}`RX
PART II
2.7.5 We have obtained significant funding from agencies of the government
of the Flemish region of Belgium and have benefited from certain research
and development incentives, which may be re-evaluated if our shareholder
base changes significantly. The tax authorities may challenge our eligibility
for or our calculation of such incentives.
-
P v } R Pvo u }( R Pv U ]v Fou]R Pv] vo } ro R ]] Pv }
]v }( (vuvo RvP ]v } RR}o]vP U `R]R ] v} .v ]v R Pvo u U ` o]
- `}o ]v}o RvP }( }v}o }( X Av˙ R o}v }o vPo˙ ]u R (v]vP R ` ] }
R ] (}u R Fou]R Pv] X
- TR R v o}uv ]v v] (}u `R]R ` R v(] }u v˙ ] ]v R v o -
}uv ]v B oP]u v }(( P]v B oP]v } } ]v}u ˘ X TR ˘ } ]}v u˙ (v R
v }( (] r˙ (] o ]} (} R B oP]v R v o}uv ]v v] X TR R v o}uv
]v v] }R o o }v R u}v }( o]P]o R v o}uv ˘ v] X TR B oP]v
˘ R}]] u˙ ] R R v o}uv }Pu ]v }( `R]R ˘ ] R v o]u
v `R R ] o](] (} R ˘ ] P]u X TR ˘ R}]] u˙ RoovP } o]P]]o]˙ (}U } }
o o ]}v }(U ]v ˘ ]}v } ]}v ]v }( } R v o}uv ]]] v U R}o
R o]u }( R B oP]v ˘ u]v] ]}v (o U ` u˙ o] o (} ]]}vo } } ]v}u ˘ U v
vo] v ]v o R }U `R]R }o R ]Pv](] v ]u }v } o }( } ]}v v (
R (o}` X F R u} U ]( R B oP]v P} vuv ] } o]u]v U } R } } R }(U R -
R v o}uv ]v v] v(] U ]R }( `R]R ] }o ] } } v˙ ]u U } o }( } ]}v
}o o˙ (( X
2.7.6 Exchange rate fluctuations or abandonment of the euro currency may
materially affect our results of operations and financial condition.
D } R ]vv}vo } }( } }}v v R ]Pv].v }]}v }( R ` v } R ]oo } }vv -
} ]v ] U } U v]vP v R G}` ]vGv ˙ u}uv ]v ˘RvP }( o
v] X O v o v } `]oo + ˙ G }v ]v R }( ˘RvP oo˙ `v R UXSX
}ooU } v` (v}vo v˙ Jv˙ U U v R }U S`] (v U Jv Yv v B ]R }v U
`R]R } u]v .vv]vP v }vo v v] ˙}v R UXSX }ooX TR ui}]˙ }( } }vP
˘v ] ]v USDU ` o} ] ˙uv v ` Poo˙ ] ] U }vuo v u]o ]v
} U S`] (v v B ]R }v X A o U } ]v u˙ + ˙ G }v ]v (}]Pv ˘RvP
`v R UXSX }oo v }R v] U `R]R u˙ o} R ]Pv].v ]u }v } } o }( } -
}v v R G}` (}u ]} } ]} X C vo˙U ` } v} R v˙ ˘RvP RP]vP vPuv ]v o X
Risk Factors Related to argenx’s Organization and Operations | 135
2.7.7 Changing expectations for inflation and deflation and corresponding fluctua-
tions in interest rates could decrease demand for our products and negatively
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2.7.8 We are exposed to unanticipated changes in tax laws and regulations,
adjustments to our tax provisions, exposure to additional tax liabilities,
or forfeiture of our tax assets.

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136 | Risk Factors Related to argenx’s Organization and Operations Risk Factors Related to argenx’s Organization and Operations | 137
3
Non-financial

PART III
Reporting
Requirements
Contents
3.1 Disclosures pursuant to the EU Non-Financial Reporting Directive 142

3.2 EU Environmental Taxonomy 147

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140 | Non-financial Reporting Requirements Non-financial Reporting Requirements | 141

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EU Environmental Taxonomy | 147
4
Corporate

PART IV
Governance
Contents
4.1 Dutch Corporate Governance Code, “Comply or Explain” 150

4.2 Management Structure 151

4.3 Report of the Non-Executive Directors 169

4.4 Remuneration Report of the Remuneration and 174

Nomination Committee

4.5 Risk Appetite & Control 202

4 Corporate Governance
4.1 Dutch Corporate Governance
Code, “Comply or Explain”
A D R }uv˙U ` i } R D R C}} G}vv C} X A }˙ }( R D R C}} G}
vv C} v (}v }v ```XuPXvoX TR D R C}} G}vv C} ] }v R v}}v R }u
v˙ ] o}vPru oo]v `v R ]} lR}o }( R }uv˙X SlR}o P} v ]v]]o
`R}U ]o˙ } ]v]o˙U ]vGv W } ]vGv ˙ W R ']vuv }( Pv˘ [}i P uo}˙ U R
R}o v }R ov U o] U }u v }R lR}o X O B} }( D]} R }v]]o]˙ (}
`]PR]vP R ]v U Pvoo˙ `]R ]` } v]vP R }vv]˙ }( R }uv˙ v ] ]]] U R
}uv˙ l } o}vPru o X I( lR}o } }} `]R]v v `]R R }uv˙U R˙ v }
}v.v R R] ]v o˙ lv ]v} }v]}vX G}} v vR] v + ]]}v
vo }v]}v (} lR}o }v.v ]v uvPuv v ]]}vX TR] ]vo ]vP]˙ v v v˙
}( R }v }(U v }v]o]˙ (} R ]]}v ˙U R B} }( D]} X
TR D R C } } G} vv C } ] }v S}uo˙ } ˘o]v _ ]v]o X A } ]vPo˙U }u v]
] } R ˘ v } `R]R R˙ }uo˙ `]R R ]v]o v ] }]]}v }( R D R C }
} G} vv C } ]v R] vv o } v U `R ] } v} }uo˙ `]R Ru U `R˙ v } `R ˘ v ]
] (}u Ru X
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D R C}} G}vv C} U `R]R ] G ]v }o]˙ R }uo] `]R R }]]}v
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R R R}o Ro (} o . ˙ L R˙ ` X Iv } v `]R } uv }v }o]˙U
v } } E ]˙ Ivv PovU ] }l v] ]v (} o vR U `R]R uv R }v (} R
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R u u U ` o] } v E ]˙ Ivv Pov }u} o}vP u o }vX F} ]vv U }}v
vv} ˘] ˙ } ] } ]v R . R ˙ L R }( PvvP v R (} r˙ vP ]}
}( R ] }l v] v R ] }l v] lP Pv vv} (oo˙ 'o `]R]v (}
˙ L R Pv X Iv ]}vU v } ]} }}v ov U oR}PR }}v }o ˘] `]R]v
R . R ˙ L R }( Pv }( R} }}v ]v } v `]R R Rv o] o vP Ru U
vo R }( R] Uv] o RP] }v D}uv U v}v }( R ] } R }v } X TR E ]˙ Ivv Pov
] Poo˙ ]` ˙ R B } }( D] } v R uv }v v v}u]v}v }uu]' ]v oU
}v ˘ vo vRul]vP }v ˙ v ]v vv R] ˙X TR u]v } }( R ]` v vRul ] }
]( R E ]˙ Ivv PovU ]vo]vP R ˙ U ] v }v]}v }( Pv R v U ] 8]vo˙ }u
v R v } } ]o]˙ } ' v ]v ov X Iv U } B} }( D] } R uv }
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v] } R ]˙ ]vv Ru v ]vo]vP R (}uv}v vP Ru X W vo˙ } v} ˘
} ]uouv ]vP ]}v (} } ] } R `}o ]vP ]v (oo }uo]v `]R R D R C}}
150 | Dutch Corporate Governance Code, “Comply or Explain”
G} vv ]v R] X Ov R] }] U }v] ]vP R ]u} v }( }u uv }v (} } ]o]˙ }
' v ]v R]PRo˙ o]. }v U o]Pvuv `]R R (v P} ] ]}] } }uo]v `]R R]
}]]}v X X X W vo˙ } v} v]]}v } RvP } ]v R] X
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R v ˙uv ]v R v }( ]u] o R}o v} ˘ }v ˙ [ }uv }vX O uv }v
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PART IV
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[ v P P]vP PvvP ]˙ ]vv } v}vr˘ ] } ˙ ]Pv].vo˙ `v R
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B oP]v C}} G} vv C} ] R v}vr˘ ] } ] }( R] uv }v ]v R
(}u }( R U v} }l }}v X O vRul]vP }v.u R }+]vP ]˙ ]vv } v}vr˘
] } ]v R (}u }( }}v v l} R ] }v R }R Rv `]o˙ ul ]v R UXSX W
o] ] ] ]v R ]v }( } lR}o R ` ] } ] R ov }v } B} }( D] }
}}}v } } ]vv}vo u]}v X F} R] }vU ` o]Pv } uv }v `]R R}
ov ]v R l˙ ul ]v `R]R ` v } }u (} ov X C}v] ]vP ].oo˙ } ]Pv].v ]
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- }( ]v R] P]}vU ` v } o]Pv } uv }v (} v}vr˘ ] } `]R R UXSX
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] } } o}vPr u Po}o P}o v u]}v X Ov R] }] U }v] ]vP R ]u} v }( }u
uv }v (} } ]o]˙ } ' v ]v R]PRo˙ o]. }v U o]Pvuv `]R R (v P} ] ] -
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U ` u˙ o˙ }v R}u }v˙ P}vv ]uv v ]v ˘u}v Rv R Rv o˙]vP }v
R }} P}vv ]uv }( N X Iv }v `]R D R o` v Pvoo˙ ]v -
]v R NRov U } A o }( A }]}v } v} }] }u ]uv Pvoo˙ o]o } Pvo
uvP }( RR}o X T} R] ˘v U } ] (}u R ]uv }( N L]vP Ro æ ~ ZU `R]R
] v ] } }] ]v ] ˙o` (} Pvoo˙ o]o }uU v R R }u u˙ v} o Rv
}v rR] }( R }v]vP }vP }lX AoR}PR ` u }] RR}o `]R v Pv v }R ov
}uv (} R Gvo MvP U D R o` } v} R Po}˙ P]u (} R }o]]}v }( }˘] U v R
}o]]}v }( }˘] ] v} Pvoo˙ ]v ]v R NRov V R U } `]oo ˙ (}u
R ]uv }( N L]vP Ro æ ~ ZX
4.2 Management Structure
4.2.1 General
- WR }v r } }v]vP }( ˘ v v}vr˘ ]} U v v]} uvPuv u
}v]o (} R ˙r}r˙ }}v X WR } (} R] } oo}` (} ]]]}v }( }v]]o]
`v } B} }( D]} v } v]} uvPuv uU l]vP } B} }( D]} uvPo ]
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Management Structure | 151
Iv U oo uu }( } v]} uvPuv u Poo˙ ]v}o ]v R ] ]}v }( } B} }( D]
} v ] }uu]' U ]v } } }] ]v(}u}v v }v˘ } R ]} ] R } v } ] }vX
Iv ]}v } ]vP v } uvP (}u u } u U Po }v ~( } ( } ] o}v] uv Z ] l
`v R uu }( R B} }( D]} v ] }uu]' v R uu }( R v]} uvPuv u
`oo }R v]} o ]v R }Pv]}vX
S } o}` ] uu˙ }( ]v }]]}v }( D R }} o` R }( R] Uv]o RP]}v
D}uv U `oo uu˙ }( ov ]v(}u}v }vv]vP } B} }( D]} v ]v }]]}v }( R
A o }( A }]}v v B} B˙rL` ~u }( (v Z }vv]vP } B} }( D]} X
TR] uu˙ } v} } } P] }uo }]` v R}o ]v }viv}v `]RU v ] o]. ]v
] v˙ ˙ (v } R ov }]]}v }( D R o` ]v (} }v R }( R] Uv]o RP]}v D}
uv v R A o }( A }]}v v B} B˙rL` X TR A o }( A }]}v ]oo ]v R P}v]vP D R
ovPP v v v}8]o EvPo]R vo}v R}(U v R B} B˙ro` ]oo ]v EvPo]RU }v } `] X
4.2.2 Statement of the Board of Directors
Responsibilities for the Financial Statements and Management Report
Iv }v `]R A o æP æ ~ Z~ Z }( R DFSAU R B} }( D]} R˙ . R U } R }( } lv}`o
P U R }v}o] .vv]o uv }( Pv˘ SE }( D u U U ]v }v `]R Ivv
}vo F]vv]o R}vP Sv ~IFRSZ } ˙ R E }v Uv]}vU v `]R R oPo ]uv o]o
]v R NRov U P] v (] ]` }( R U o]]o] U .vv]o }]}v v }. } o} }( R }uv˙
v R v l]vP ]vo ]v R }v}o]}v lv `R}o U v R R uvPuv } ]vo (]
]` }( R o}uv v (}uv }( R ]v v R }]}v }( Pv˘ v R v l]vP ]vo ]v
R }v}o]}v lv `R}o U }PR `]R ]}v }( R ]v]o ]l v v ]v R R˙ ( X
Responsibility for this Universal Registration Document
TR B} }( D]} o R R ]v(}u}v }v]v ]v R Uv]o RP]}v D}uv U ]vo]vP R
}v}o] .vv]o uv }( Pv˘ SE }( D u U v R uvPuv } U ] U } R }(
] lv}`oP U ]v }v `]R R ( v }v]v v} }u]]}v o]lo˙ } + ] ]u} X TR B} }( D]} ]
}v]o (} R ]v(}u}v P]v ]v R] Uv]o RP]}v D}uv X
In Control Statement
O B} }( D]} ] }v]o (} R }]PR }( } ]l uvPuv ] v R oP } R ]
v }uo]v }uu]' R }v]]o]˙ } ] } B} }( D]} ]v R] lX WR]o } B} }( D]}
} } ]l uvPuv U } v]} uvPuv ] }v]o (} ˙r}r˙ ]l uvPuv } X O
B} }( D]} ˘ } v]} uvPuv } }v] ]l v ]l uvPuv ]v R ]v ]]}vU }
} o˙ o} v u}v]} ]l uvPuv P] v } (} ˙r}r˙ ] v } +o˙
]uouv ]l uvPuv P] } ˙ R B} }( D]} X W o] R] ]]]}v }( }v]]o] ]
R u} + }R (} ]vP R ]l ` ( X
S }v Xæ SR]l A C}v}o_ (} (R ]v(}u}v }v } ]l v }v}oX
4.2.3 Board of Directors
Responsibilities
Uv DRo`~S}v Pı PR }(RDCZU} B} }(D]}] }ooo˙ }v]o(}} Pvo
+]XO B} }(D]}U} ˘ ]} `oo } v}vr˘ ]}U .v} P˙~ (R
} ]v }v X SSP˙ v }i _ZXO P˙] Poo˙] vu}v]} } } uvPX
P v } } A o }( A }]}vU } B} }( D]} `]oo ]] ] u}vP ] uu U `]R } ˙r
}r˙ uvPuv v } R ˘ ]} ~ ZX TR v}vr˘ ]} l `]R ]]vP R
152 | Management Structure
- uvPuv }( Pv˘ v }]]vP R ˘ ]} ~ Z `]R ] X Iv ]}vU }R R ˘ ]} ~ Z v
R v}vr˘ ]} u (}u R ]Pv } Ru v } R A o }( A }]}vX TR
]]]}v }( l `]R]v } B} }( D]} ] u]v ~v uv U ]( v ˙Z ˙ } B} }( D]} X O
˘ ]} ~ Z u˙ v} oo} R l }(P ~]Z ]vP R] }v }( } B} }( D]} V ~]]Z u]v -
]vP R uv}v }( v ˘ ]} V } ~]]]Z v}u]vvP ]} (} }]vuv X
PART IV
E R ]} R ˙ } }o˙ (}u R ]Pv } R]u } R v } ]v } }} ]v X A
]v]o v D R o`U R }} ]v ˘v } R ]v }( oo }} lR}o U R R -
R}o U ]} U uo}˙ v }R lR}o X
Composition, Appointment and Dismissal
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]v]o XX}(RDRC}}G}vv C}U˘ ]}u˙ r}]v (} ]} }(
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R RoU]v}( R ov(} R (}uv }(R }(v˘ ]}XTRv}u]v}vu
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u R v][PUR]}R }(]}vURvu }(R R} RR}o v R uo}˙uv }]}v
R} RR}oU}R RoU]v}( R ov(} R (}uv }(R }( v}vr˘ ]}X
FRu}URvu }(RoPov }(`R]RR} R] o˙ ]}˙} uu } v}vr˘
uu }(R } Roo ]v] V](R} ]vo oPov `R]R o}vP}R uP}U (v }R
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o MvPX O B} }( D]} ]Pv }v ˘ ]} CR]( E˘ O8X Iv ]}vU R B}
}( D]} u˙ Pv }R o } ˘ ]} X O B} }( D]} ]Pv v}vr˘ ]}
R] }v }( R B} }( D]} v v}vr˘ ]} ] R] }v }( R B} }( D]} X TR oPo
o}vR] `v v ˘ uu }( R B} }( D]} v Pv˘ `]oo v} }v] v uo}˙ -
uv Puv X Euo}˙uv Puv `v v ˘ ]} v P} }uv˙ ~}R Rv Pv˘ SEZ
u]' X Iv R v }( v uo}˙uv Puv U uu }( B} }( D]} Pvoo˙ } v} vi}˙ R
u }}v uo}˙ v D R o} o`X
A (}]Pv ] ] U v R o]vP ]uv v o }( N U ` v} ] } R ]vv -
v ]} }v } B} }( D]} U ˘ R } ] v }uo]v }uu]' ] ] } }v] (oo˙
}( ]v vv ]} U i } ]v R r]v Ro X H}`U } B} }( D]} R u]v R U
l]vP ]v} }v v˙ o]o }uu]' ]vvv v U oo }( } v}vr˘ ]} U ]vo]vP R
uu }( } ] v }uo]v }uu]' U S]vvv ]} _ v Ro Ar }( R E˘RvP A v
R o]o o }( R N S}l Ml v }( R D R C}} G}vv C} X Iv ul]vP R -
u]v}vU } B} }( D]} }v] R o}vR] R R v}vr˘ ]} R `]R v oo }R
( v ]uv } B} }( D]} u ov ]v u]v]vP R ]} []vvv U ]vo]vP
R vu }( }]v˙ R v.]oo˙ }`v ˙ R ]} v R] } R 8o] v ~]( v˙ZX
TRR
D C}}G}vvC}]RR}u}]}v}(Rv}vr˘]}]RRR
Management Structure | 153
uuo}}]vvvo˙v]oo˙]rr]}vv}RUR˘]}Uvv˙o O}o]˙]R``]ooov}B}}(D]}]vu}(PvUPUlP}vvv}vo]˙uR -
]v]v}oXRA }(R]Uv]oRP]}vD}uvUoov}vr˘]}uR]vvv }vo˙}]o`R]oooR]vP}}}u}}(R}]ov]}ooXIRvv`]oou]v}
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}u}]}v}(}v}vr˘]}}uo]`]RR]vvv]uv}(}]]}vXX `R}ulovvo}(]}o}]vP]Pv˘}(RP}`Rv(}oo]lR}oX
}XXı}(RR D C}}G}vvC}XOB}}(D]}R}vvo˙o}u]vRoouu - TR]uv`]vu}(]ovR]}vXC}v]]vPR(}uv}vvR
}(}}uu]']vvvvRo]oo}(RR D C}}G}vvC}X ]o]v}(}]vU``]ooo˙l}(R]u}]]˙}v}}](v`Rv}}]vPv`

PART IV
}]vuv}}B}}(D]}U`R]olv}`oP]vPRPUPvvv}vo]˙]u}vUv}R}vo˙
A }( R }( R] Uv]o RP]}v D}uv ~} ]v v˙ ]} (} ZU v}v }( R uu }( } B} }( (}ov(}Rou]]}v}o}uuXWR}oRP}}uR]v
D]} v v]} uvPuv R } R R (u]o˙ o}vR] `]R v˙ }R uu }( } B} }( D]} oPvov]v}B}}(D]}Uv``]oo}}v}}Pvvoo˙]v}SG
E }X
} v]} uvPuv X
Meetings and decision-making
D]} u˙ v } u} ˙ R RR}o R Gvo MvP v˙ u U `]R } `]R} U O B} B˙rL` U R ] U ]v o] U R } (} R}o]vP uvP }( R B} }( D]} U (} R ] -
˙ uv }( }o}v ˙ ]uo ui}]˙ }( R } X Uv D R o` ~S}v P PR }( ]}vrul]vP ˙ R B} }( D]} v R B} }( D]} [ }vP } X
R DC ZU ˘ ]} u˙ o} v ˙ R } }( ]} X A v]}v }( v ˘ ]} ˙
R } }( ]} u˙ ]}vv ˙ R RR}o v˙ u R Pvo uvPX Iv }v `]R } A o }( A }]}vU } B} }( D]} `]oo u o }v ˙ R u}vR } ] -
R }( +] `]R]v R }uv˙ v R ˘ o}uv X
Diversity Uv R B} B˙rL` U R uu }( } B} }( D]} u v}U ]v}( ] }]o U } v R
W o ]]˙ `˙ }( }Pv]]vP v o]vP R ]+v `v ]v]]o } }u } R u} 8]v }o}v } vv]u}o˙X WR vv]u]˙ vv} R] v D R o`U R A o }( A }]}v }
v + `˙ } R] } P] }i X F} } B} }( D]} U R] uv R `Rv ul]vP }u - R B} B˙rL` } v} ] oP ui}]˙U oo }o}v }( } B} }( D]} u } ˙ ]u -
uv}v } R Pvo uvP (} R ~ r Z }]vuv }( ]} U R } `]oo ]u (} ] }u}]}v o ui}]˙ }( R } ]v uvP `R]R o ui}]˙ }( R uu }( } B} }( D]} Rv ]v
]v u }( R (} Pv v P U ]v }v `]R } ]]˙ }o]˙ u˙ ]v (} (}u u } u X }8 v } v X TR A o }( A }]}v v R B} B˙rL` }] R ]v }( }( } U
Uv D R o` }vP o U Pv˘ `]oo ] } ]]˙ }( } B} }( D]} ]v ] vvo } R R] }v } v} R vP } v R R }}o `]oo i ]v }( X
} ]v R } }( R B} }( D]} ~ oPZP ~]Z }u}]}v }( R B} }( D]} ˙ Pv V ~]]Z }i -
}( R ]]˙ }o]˙V ~]]]Z ]}v }( R}` R ]]˙ }o]˙ ] ]vP ]uouv v R o R}( v Uv R B} B˙rL` U }u ]. u' ] }o }( R ui}]˙ }( R v}vr˘ ]} X TR
~] Z ]( R ] v} ]]˙ }o]˙U R] R}o ˘o]v X u' } ]v SRo }( } B} B˙rL` X O B} B˙rL` ]oo }v } `] X

Ov Jv˙ U U v` oP]o}v v ]v} (} U ]]vP SoP D R }uv] _ } v R}] v Iv ˘}vo U ]( R Pv v ]˙ v R ]v }( Pv˘ ] R] U }o}v }( } B} }( D]}
u]} [ P (} R] uvPuv } U ]}˙ } v v]} ˘ ~R o' u]v ˙ R u˙ o} } ˙ vv]u} `]'v }o }( oo ]} ]v }8 X A ]} u˙ ] }˘˙ (} ].
}uv˙ZX I( }uv˙ R } }v r } U R }] v u]} P o] } }R R } uvP } v}R ]} ]v `]vPX
˘ v v}vr˘ ]} X TR oP]o}v ] }v S}uo˙ } ˘o]v_ ]v]o X A }]vPo˙U ` `]oo
] } ]o} ]v } } }( R B} }( D]} `RR } v} ` ]v }uo]v `]R R o(r]u} TR ˘ ]} ~ Z ] } l R] ]]}v }v R] }`v uv}v ]v }v `]R -
P X Iv ]}vU `]R]v v u}vR }( R v }( R .vv]o ˙U ` `]oo v } } } R Sociaal-Economische }]]}v X X u˙ v} ] ]v R }}v }( }o}v ~]vo]vP v˙ o]}v ]v }( R
Raad ~SERZ `RR } v} ` R }uo] `]R R o(r]u} P X }o}v Z ovP } R] uv}vX

B} D]]˙ M]˘ ~ }( R }( R] Uv]o P]}v D}uv Z Committees

Iv }v `]R R D R C}} G}vv C} U } v}vr˘ ]} v ]o] }uu]'
} vo˙ ]. ] v ] R v}vr˘ ]} }v R} ] X
C}v˙}(P]v]oE˘O8 TRNRov
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D]o}P}R]]˙R
D L` N} B} }( D]} X TR v}vr˘ ]} u]v R u }( (v }( R }uu]' `]R } R
}Pv]}vU } U }o]] v ] }( R }uu]' X
T}oNu}(D]}
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Demographic Background Categories Number of Directors in Each Demographic Category {  v ] v }uo]v }uu]' V v
{  uv}v v v}u]v}v }uu]' X
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LGTBQA=
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v SEC o v Po}v X
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154 | Management Structure Management Structure | 155

Iv ]}v } R (}uv}v oPoo˙ ] }uu]' U } B} }( D]} u˙ o} } } ]v}}
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(]o] ] ]}v v }v]vP } }v ]. }i U `oo }v u} uvv ] X O B}
}( D]} R ]v}} R v o}uv }uu]' v }uu]o }uu]' X
Audit and Compliance Committee
O ] v }uo]v }uu]' }v] }( (} uu P Wv LvRo ~R] }vZU P KX MX VRPR U
AvR}v˙ AX R}vP v Ju MX D o˙X O B} }( D]} R o]R R Wv LvRo o]. v
S] }uu]' .vv]o ˘ _ .v v R E˘RvP A v o ı PR }( D] læ l
EU }( R E }v Po]uv v }( R C}v]o }( A ]o uv]vP D] l lEC }v }˙ ] }(
vvo }v v }v}o] }v v R R }u}]}v }( R ] v }uo]v }uu]' u R
]uv v R D R D }v E o]R]vP A ] C}uu]' X
O ] v }uo]v }uu]' ] } B} }( D]} ]v } ]vP R ˙ v ]vP]˙ }( }
}vvP v .vv]o }vP } v ] v ]` }( } }v}o] .vv]o uv U R ]uo
uv}v v +v }( v ]vvo }v}o ˙u v } }uo]v `]R oPo v Po}˙ ]uv U
R ]vvv ]} [ o].}v v ]vvv v R (}uv }( R ]vvv ]} X
O ] v }uo]v }uu]' ] P}v ˙ R R }uo] `]R N o]vP o v R D R C}
} G}vv C} X O ] v }uo]v }uu]' ] }v]o (}U u}vP }R R]vP U o]R]vP uR
} v } (} ]]vP U v `R v ˙ ]]vP ]u}uv }(U } .vv]o }vP U }uo]v
v }Pv]}v (} R } }( ul]vP }] }uuv}v } } B} }( D]} ]v R P X
O ] v }uo]v }uu]' u }Lv ] ] (} ] } (v}v]vP U o (} u
˙X O ] v }uo]v }uu]' u o }v ˙ `]R } ]v vv ]}X
O ] v }uo]v }uu]' } Poo˙ } } B} }( D]} }v R ˘] }( ] (v}v X I ]v
(}u } B} }( D]} } oo ]v `R]R }v } ]u}uv ] v ˙ ]v ] }]v]}v v }
}uuv}v }vv]vP R v ˙ R v } lvX TR ] ]` v R }vP }v R ]`
} v } ]]] `R}o X TR uu }( R ] v }uo]v }uu]' vo } ] oo
]v(}u}v `R]R R˙ v (} R (}uv }( R] (v}vU (}u } B} }( D]} v uo}˙ X E ˙
uu }( R ] v }uo]v }uu]' Roo ˘] R] ]PR ]v }vo}v `]R R R] }v }( R ]
v }uo]v }uu]' X
Remuneration and Nomination Committee
WR o]R uv}v v v}u]v}v }uu]' U `R]R }R R uv}v }uu]'
v o}v v }]vuv }uu]' ] ˙ R D R C}} G}vv C} X O uv}v
v v}u]v}v }uu]' }v] }( (} uu P JX D}vo B R]˙ ~R] }vZU P KX MX VRPR U Wv
LvRo v Y}vv Gv X
O uv}v v v}u]v}v }uu]' ] }v]o (}U u}vP }R R]vP P
{  Poo˙ ]`]vP R uv}v }o]˙ ]v o]PR }( oo ov ]uv v vRul U v }uuv]vP
} R v}vr˘ ]} R uv}v }( R ]v]]o ˘ ]} V
{  ]]vP } B} }( D]} ]v }( R uv}v (} R v}vr˘ ]} V
{  ]vP R uv}v } } ]vo ]v } vvo } V
{  `]vP o}v ]] v }]vuv } (} ]} v ul]vP }}o (} }]vuv v
r}]vuv }( R ]} V
{  ]}]oo˙ ]vP R ] v }u}]}v }( } B} }( D]} v ul]vP }}o (} }u}]}v
}.o }( R v}vr˘ ]} V
{  ]}]oo˙ ]vP R (v}v]vP }( ]v]]o ]} v }vP }v R] } R v}vr˘ ]} V v
• ]]vP R }o]˙ }( R ˘ ]} }v R o}v ]] v }]vuv } (} v]} uvP
uvX
TR uv}v v v}u]v}v }uu]' }v] }( o R uu X TR uv}v v v}u]v}v
}uu]' u }Lv ] ] (} ] } (v}v]vP U o }v ˙ } o ] (v}v]vPX
156 | Management Structure
Informal subcommittees
Research and Development Committee
TR R v o}uv }uu]' }v] }( uu }( } B} }( D]} v }R }v U `R]R
}u}]}v u˙ ˙ (}u u } u X C vo˙U R R v o}uv }uu]' }v] }( R uu P
D ] LX L˙ ~R] }vZU JX D}vo B R]˙ v Puo Ko]vX JX D}vo B R]˙ v Puo Ko]v uu
}( } B} }( D]} X D ] LX L˙ ]Pv (}u } B} }( D]} M˙ U U }vv }
PART IV
v ]} }v R R R v D o}uv C}uu]' X A rR} ]v } R }uu]' uvP (Ru}
]vo ]˙ }( uo}˙ v l} ˘vo ]} U v]vP }v R v }( R }uu]' v R }] v
] ]}vX
TR R v o}uv }uu]' ] }v]o (}U u}vP }R R]vP P
{  u}v]}]vP v } ]vP } R v o}uv P}o U P] v u V
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- { (}u]vP P] ]` }( } l˙ R v o}uv }Pu V
{  }vP } } B} }( D]} }v R }}u }( R P] ]` V
{  ]`]vP } ]v. o]}v v }uuv]}v ovV
{  ovP v RoovP]vP R +v v }u v }( } R v o}uv v} V
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- {  ]`]vP } o]v]o v o]v]o } ]o]v V v
{  vPP]vP ]v 'vP U ]v]vP v o}]vP } v]} R v o}uv }vvoX
Aoo uu }( R R v o}uv }uu]' Roo R ]v ]oU u] v l} o ˘ -
]v `]R R R v o}uv }( ]}Ru o X
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Management Structure | 157
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158 | Management Structure Management Structure | 159

 PART IV
James M. Daly

Yvonne Greenstreet

160 | Management Structure Management Structure | 161

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162 | Management Structure Management Structure | 163

 PART IV
Prof. Hans de Haard Wim Parys

Dirk Beeusaert

Luc Truyen

Malini Moorthy

164 | Management Structure Management Structure | 165

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166 | Management Structure Management Structure | 167

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4.3 Report of the Non-Executive Directors
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168 | Management Structure Report of the Non-Executive Directors | 169

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WvLvRo l A9 o U D o}]'[v P`C [ ] } U R ]v]u }v}o] .vv]o uv v o U
JXD}voR]˙
B l A9 D o}]'[ ] ovU R ]v]u .vv]o uv U ]` }( o˙ (} U }v ]vvo }v}o
] U }v }} ] ] U v }v RU R ]ov v .vv]o X
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Iv U ]˘ ] v }uo]v }uu]' uvP ` Ro X TR uvP 'vv (} } ]} ]
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l A9
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l A9 Nu 'vv
A A9
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Uvo R] ]Pv}vU D ] LX L˙ 'v v}vr˘ ]} `} } }( R `} B} }( D]} uvP `]R }oo˙ R
WvLvRo~R]}vZ l A9
v}vr˘ ]} ]vP v Ro } ( R ˙X
AvR}v˙AXR}vP l A9
JuMXDo˙ ~Z
l A9

4.3.3 Activities ~ Z Ju MX D o˙ i}]v R ] v }uo]v }uu]' ]v M˙ X

TR Pv (} R B} }( D]} ]vo o}vPru o }v `oo R uvv ]v `R]R R v]}

uvPuv u ]uouv Pv˘ [ P˙U Pv˘ [ o } v } u}v]}]vP ˙ R v}vr˘
]} U R Pv˘ [ .vv]o }]}v `oo R o }( ] ]]] U ]]}v U oP ]vuv }}o U
R ˙o˙ P U ]} RvP v R ]vvo ]l uvPuv v }v}o ˙uX
Iv U ]. 'v}v ` P]v } R }˙ v P}vv }] R R }]vuv }( M X Y}vv
Gv v}vr˘ ]} `oo R r}]vuv }( MX AvR}v˙ R}vP U R ]u }( COVIDr ı
v o u]PvP u U ]v U ]` v }o }( (} U R }} R} v
} }}o]} U ]v }} o}uv U ]` v }o }( }v}o] .vv]o uv U
R o}uv U } R uv}v }o]˙U }uu]' } U .vv]vP }( Pv˘U } }}v
v ]}v } v ovU v R }o }( R }} Pv U ˘ov}˙ v} v }v}}v v} (}
R ~˘}]v˙Z Pvo uvP X
4.3.6 Report Remuneration and Nomination Committee
TR uv}v v v}u]v}v }uu]' ] R B} }( D]} ˙U u}vP }R u' U Poo˙ ]` -
]vP Pv˘ [uv}v }o]˙U ]vP uv}v }}o v ]}]oo˙ ]vP R ] v }u}]}v
}( R B} }( D]} U `oo ]vP R }o]˙ }( R v]} uvPuv u }v R o}v ]] v
}]vuv } (} v]} uvPuv X D ]vP R] o]}v ]v U R u]v }] }( ] ]}v `
R L }( R v` uv}v }o]˙ v R v` ]˙ ]vv ovU R R]uv }( v]} uvPuv [
P v ˙r} }( ]o ˙U R }} ]˙ ]vv Pv v R }}o } u} } ]vPo
vvo ]˙ Pv u}uv (} ]vP ]˙ Pv X

170 | Report of the Non-Executive Directors Report of the Non-Executive Directors | 171
Iv U `} (}uo uv}v v v}u]v}v }uu]' uvP ` Ro X TR uvP 'vv (} }
]} ] } ]v R o o}`X
PV
Patient

Nu}(uvP'v]v
Nu 'vv
A A9
]v}]vuv
PKXMXVRPR l A9
WvLvRo l A9
JXD}voR]˙
B ~R]}vZ l A9
Y}vvGv l A9

4.3.7 Report Research and Development Committee

TR R v o}uv }uu]' (v}v }v]vP } } Pv˘ [ R v o}uv uv -

Puv U Pvo uvPuv v R B} }( D]} U v u}v]} R R v o}uv P}o U P]
v u }( Pv˘X Iv U R }uu]' Ro R (}uo uvP U ]v `R]R ] (} u]vo˙ }v R ]]}v v
P˙ }v ]v Pv˘X

TR uvP 'vv (} } ]} ] } ]v R o o}`X

Nu}(uvP'v]v
Nu 'vv
A A9
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B l A9
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l A9

~ Z D ] LX L˙ ]Pv (}u } B} }( D]} M˙ U X

David
4.3.8 Report Commercial Committee

TR }uu]o }uu]' (v}v }v]vP } }v v v vv P] ulvP ov (} R

B} }( D]} X Iv U R }uu]' Ro }v (}uo uvP U ]v `R]R ] (} u]vo˙ }v Pv˘ [ ]v ]v
R UXSXU Jv v EMEA ]v o]PR }( R v]P ovR }( (PP]u} X

TR uvP 'vv (} } ]} ] } ]v R o o}`X

“ Pemphigus vulgaris has changed the

Nu}(uvP'v]v
Nu 'vv
A A9
]v}]vuv
way I live my life. I’m always watching for
AvR}v˙AXR}vP l A9
JuMXDo˙~R]}vZ l A9 new blisters and lesions and questioning
anytime I feel something strange.’’

172 | Report of the Non-Executive Directors PV Patient | 173

4.4 Remuneration Report of the
US}uv] EU}uv]

CADIAPRuo uA

Remuneration and Nomination Ao}vPRu

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Au]TR B]}NTR
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4.4.1 Remuneration Policy 2021 and Changes to the Policy
o]]} CRISPRTR

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TR ]u ] } R] }o uv}v lP R ' v ]v o]v `]R R ulX Pv˘ ]}]oo˙
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}uv] `]R]v R ]v ] `R]v Pv˘ } X O uv}v }o]˙ v }o }uv}v F]}Gv M}R}S˙

] }]}v }v R ul u]v } o]PRo˙ } R ul u]v (} .˘ }uv}vU v. v R} u Go}oBo}}TR S`]RORvB]}]u

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R æR vo X M]TR ov
Z PRu
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(} }v R ]uouv}v }( ]vo P˙X Tov uvP ]v]vo ]v u }( R]]vP R] SPTR

P}oX TR uv}v }o]˙ ]u } o]vl R] P˙ v R C}uv˙ [}i } R (}uv v uv - STR

}v }( uvPuv X Iv R] `˙U R G} Po}oo˙ }v]v (u`}l (} R o}uv U uv}v Xv}
v u}`uv }( ] }o X TR G} }v] }uu]uv U }Pv]}v v o R] ]u}v (}v}v
(} uo}˙ vPPuv X TR] vo R G} } ' U ]v v u} R ov } R] }R R}r
u v o}vPru }i X TR] ] oo `]R]v R }v˘ }( Po}oo˙ }v]v uv}v }o]˙ R ` R
}v]}v }` v R R]uv }( }uv˙ }i v R Pv}v }( RR}o o X 4.4.2 Remuneration of our Senior Management for 2021 and the Previous Years

TR uv}v }( } v]} uvPuv ~]vo]vP } ˘ ]}U MX T]u Vv H`u]vZ }v] }(

TR (v P} (} } R v ]˙ uv}v vRul]vP }v] }( US v E } }u - R (}oo}`]vP .˘ v ]o }u}vv P
v] U l]vP ]v} }v } Po}o u]}v `oo R ]u˙ ul (} ov ]v `R]R ` }u X TR }u -
v] ]v } (v P} ` o }v }u]v}v }( R ] `R]R ]vo R] ]v ˙U ˙ {  .˘ }uv}vV
]v ]v]o o] }+U vu }( uo}˙ U v U R D ˘v U }o oo }( R Rr]ov U r˙ {  R}ru ]o }uv}vV
P ul v r˙ v r˙ }o v }v }lX F} U R }uv] ]v } (v P} ` P {  o}vPru ]o }uv}vU ]v R (}u }( }l }}v v ] }l v] V
{  v vPuv V v
{ v]}v v (]vP v. X

Fixed base compensation

TR }uv}v }( } v]} uvPuv ] u]v }v R ] }( vRul]vP vo˙] }uo ˙
v ]vvv }vovP .uX TR .˘ R }uv}v oo } }v R æ R vo }( UXSX v
EU }uv] ]v } (v P} (} UXSX v EU ˘ X TR .vo u]v}v }( v ˘ ]} [
.˘ ˙ ] u }v]]vP R] vRulU R ]v]]o[l]oo U ˘]v v (}uv U R uv}v
v }v]}v } R `] }Pv]}v v } ]v}v `]R l˙ lR}o } } o]
} (} } uv}v X

Short-term variable compensation

TR}i }(} R}ruvvo]vv }uv}v] }v R } v]}uvPuv u]]vv -
]} R] (}uv P ]vR R} uXV]o R]vv Pv(} R]]vP u]v
]. (}uv PXAR }( R.vv]o˙URB} }(D]}`]oo u]v} l˙ ]}]
v`]oo ].URoovP]vP (}uv P ]vo]v`]RR ]}] XTRB} }(D]}`]oo u]v
R o `]PR}( RP v Ru] (}u]vPR] R]uvXO v]}uvPuv u
] o]P]o(} vvvoR}ru ]o]vv }(R] vvo }uv}vXTR P vP(} R]

174 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 175
} ` } A9}( R vvo }uv}v}( uu }(R v]}uvPuv uU˘ (}} Financial year ended December 31,
˘ ]} v } R](}vP}8XTR P ]o R]vv (}} ˘ ]} Roo A9 ~IvUSDR}vU
2017 2018 2019 2020 2021
}( R .˘ R}uv}v]( A9}(P R] væA9(}} R](}vP}8XIv }(]Pv].v vo}R`]]v]Z
}R]uvURB} }(D]}u˙ ] }`R]PR ]o ˙}(]o˙G R]v]]o[o N}vr]˙uv}v}(}O
CE U ıUæ ıæUııæ UıU UU
}v]}v}Pv˘U R ]o ˙`]oov}˘ A9}(R.˘ R}uv}vX N}vr]˙u]vo˙]
U Uı U U æUı
}}uo}˙

PART IV
F]vv]o (}uv P o } ]o]vP R ]v v ˙]oo˙ ul A9 }( R }oo ]o R R}uo}˙lCO
E A9 A9 A9 æA9 A9
]vv P v ]u ]Pv].vo˙ }P]vP } } v] }` ul }o v o - P
A }uv}v]}
Uı æıUı U æUıæ æU
uo˙ } R Pv}v }( o v v } (R vRv RR}o o v vo v } } (R v}vr˘]}

R v o}uv ] X F} (R ]v(}u}v }v } .vv]o (}uv P U ]v R] }v Nu}(uo}˙v}(˙ æ æ

o}` v SV]o }uv}v u]v}v W CEO_X SR]v}(˙}v˘
E EUR æXæ æX X X æX
SR]v}(˙}v˘
E USD Xıı ıXææ X ıXı æX
N}vr.vv]o P o } ]o]vP R }Pv]}v v ˙]oo˙ ul A9 }( }oo P v ]u
]o]vP v o}]vP } }Pv]}v ]v} ]vo U }uu]o P U (oo˙ ]vP Po}o ]}Ru o
}uv˙ ]v o]v `]R } ]v˙ v } } o X TR ]v R uv}v } `v } l˙ v]} uvPuv v }R uo}˙ `v v
] ˙ R u]v o˙ ] } } uo}˙ U o} o }( } ˘v]}v ]v R UXSX v
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O B} }( D]} ]vv } ]vv] } v]} uvPuv u ˙ ]]vP }l }}v v l} ]
}l v] (}u u } u } o } ' v ]v `ooro]. v]} uvPuv ]v }vv}v `]R R TR }u]}v }( v}vr]˙ }uv}v } ] u `v R }uv}v ] } } ]vPo ˘
E ]˙ Ivv PovU } o}`X T˙]oo˙U }l }}v v ] }l v] Pv vvoo˙ ]v - ]}U v R u]v }uv}v ] } } uo}˙ X WR } } }u v}vr]˙ o] ]v R]
}v `]R } ]˙ ]vv Pv oo}}v Ru `R]R ] Poo˙ ]` ˙ } B} }( D]} v }u]}vU `R R vu }( }}v Pv ] o]vl } R }oo ] }( uv}v lP
oo˙ } uv}v v v}u]v}v }uu]' X Pv U R o }( ]˙ }u}vv v }v R }ouv }( } R ] U }oo]˙ v R ]lr( U
`R]R ] vlv}`v PvvP v R R (}` o}}l]vP o}v uR} (} }}v v}uoo˙ } v} }] v
Severance arrangements }v}u] o X
WR v ]v} uvPuv }v v uo}˙uv Puv `]R } v]} uvPuv uU R
}( `R]R }] (} ]v u]v]uu v} ]} ]( R] ] } uo}˙uv `]R ] u]v ]v ]v D } R Po}o }( } uo}˙ } uoo }vvv U ` u ] ov } o} ]vo R } }u -
]uv ] o}` ]v }v X X SRo P˙ Tv }v _X ]}v o˙ } } UXSX uo}˙ U EU uo}˙ v Jv uo}˙ X D } R }oo R]PR }uv}v
oo ]v } ]v Puv ]v R UXSX v Jv }u } R EUU R ] ]Pv].v ]+v ]v R ˙ }
Pension and fringe benefits `Rv R CEO[}uv}v ] }u } R u]v }uv}v }( oo } uo}˙ ~R ui}]˙ }( `R]R
O v]} uvPuv u ] ]v .v }v]}v v]}v Ru } ˙ R] r ˙ v]}v EU }v ZU } } U } }u } uo}˙ ]v R UXSX v JvX TR (}oo}`]vP ]v(}u}v ] }] (}
]vv }Pv]}vX O v]} uvPuv u ] vo } }u˙ (]vP v. U R }uv˙ v (v } P
R}]o]}v ovX
R}}(v}vr]˙}uv}v}(RPuo}˙}u
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Iv u]v]vP R uv}v lP }( R ]v]]o uu }( R v]} uvPuv uU v]} vo˙
}v
E uo}˙ A9
(}u vvoo˙ v lv ]v} }v ]v «vP R oo }( R uv}v } ] `oo R
USuo}˙ A9
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Relations between the remuneration of executives in comparison to other company personnel
TR }o }uv˙ ˘v (} R v}vr]˙ uv}v ] } } CR]( E˘ O8 ~v }vo˙ ˘ ] -
} Z (} R ˙ v D u U U o USD U U U vvP A9 }( R }o }uv˙ ˘v F} R R ˙uv R } (}oo}` P
(} R v}vr]˙ u]v }uv}v ] } } uo}˙ X TR] vP ` oo }v R ] }( R o
}uv}v ˙uv ]} }( R ˙ v D u U U } `R]R R u]v v}vr]˙ uv}v Financial year ended December 31,
}( oo Pv˘ uo}˙ o } R] (oo u vP ` lv ]v} }v v }+ P]v R v}vr]˙ 2017 2018 2019 2020 2021
uv}v }( } ˘ ]} (} R u ]} X W oo R (}uv}v vP }v R o
S}l}}vPv}}O
CE U U U æU æU
}uv}v ˙uv }( R ov ]} U } } ] P}`R ` u ] ov } o} ]vo }
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176 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 177
TR }o uo}˙uv } ~˘o]vP v˙ }l }}v Z ] ˙ ]v R .vv]o ˙ ` o] `v P]}v Variable compensation determination – CEO
(}oo}` P TR u]˘ `v .˘ v ]o uv}v }u}vv (} } ˘ ]} (} o R o R
T}ouv}v]]vR.vv]o ˙ ] } o}`X
˙vDuU~]vUSDu]oo]}vZ
EU Xı
2019 2020 2021
UXSX X
V]o OR B V]o OR B V]o OR B

PART IV
Jv Xı ˙ v. o˙ ˙ v. o˙ ˙ v. o˙
æA9 A9 ıA9 A9 A9 A9 A9 A9 ıA9

Total
A o }( o]vl]vP o}vP u P U ]Pv } ]v Pv˘ [ (}uv ]v R v `oo R ( U
R ]o }uv}v }( } v]} uvPuv u ]vv } o]Pv R ]v }( R v]} uvPuv
u } R }( R ~}R Z lR}o }( Pv˘X TR B} }( D]} o] R uv}v lP }u -
] }( .˘ }uv}v ]o }uv}v o]vl } ]v]]o P `oo }}v o]vl } vP E ]˙ E ]˙ L}vP u ]o
]vv ]vv }uv}v
Ru ] u} ]o } R] R] P}oX æA9 A9 A9

Remuneration and Benefits of the CEO

TR (}oo}`]vP o (}R ]v(}u}v P]vP }uv}v ] ˙ (} T]u Vv H`u]v ]vP R ˙
vDu U X Total cash/
non-cash C R C R C R
A9 A9 A9

C}uv}v]vUSD F]vv]o˙vDuU

F]˘}uv}v æUı
Non-cash Non-cash Non-cash
L}vPru]o}uv}vU]vR(}u}(}l}}v ~Z
UıæU 86% 88% A9

L}vPru]o}uv}vU]vR(}u}(
UUæı
]}lv]
Euo}˙}]o]˙}v]}v}l}}v ~Z
W
N}vr]˙]vvov}uv}v æU Total cash fixed/
variable
Pv]}v}v]}v Uı
S}]o]˙} Uæ Variable Variable Variable
38% 35% 35%
OR ~Z
U
F]xe F]xe F]xe
Total 7,263,828 A9 æA9 æA9

~ Z  Au}v R}`v v R ˘v `]R } R }l }}v ` Pv ]v } MX Vv H`u]v u ]vP R Bol

SR}o (}uo X F} ]}v }( R u}v ]v o]vP R ` U v} SSR r ˙uv _ } } }v}o] .vv]o
uv ]v R SC}v}o] F]vv]o Suv W ] }( v (} R ˙ v D u U U v ı_X TR
u}v } v} G R o }v}u] o o] ˙ MX Vv H`u]vX
~ Z  Pv˘ ]v uo}˙ }]o ]˙ } `]R } R }}v ` Pv } R uu }( } v]} uvPuv X TR u}v }( F} U R ]o ˙ P (} } v]} uvPuv ]vo P ovP } R (}oo}`]vP }] ~]v ]}v
uo}˙ }]o ]˙ } v }v R o }v}u] o o] v R(} ] }v R ] }( } }]v˙ R X A R } vu }( v}vr]o} P Z
}vP U Pv˘ ul oo}v }( R ˘} X
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X B ]o]vP R ]v P
X R R }P P N}u]v v` ]v]}v (} ]. } v] V
X C}uu]o o}uv P E o]R ovR l˙ (}uv ]v]} V
X RPo}˙ }o P O]v Po}˙ }o l˙ (}uv ]v]} ovP } VYVGART ]v R UXSX
v JvV
X C R uvPuv v .vv]vPP R] u]v]uu u}v }( ]o } } R ]v }i V
X So˙ R]v ]o] P B ]o } } Po}o o˙ R]v ]v }v }( R }uu]o ovR v o]v]o
o}uv }i }( VYVGARTX

X B ]o]vP R }Pv]}vP
X Tu o}uv P A }uo]R R ]uv }i (} }uu]o }]}v `oo R ]uv
v }v}]vP }( vu }( l˙ v]} o R] }o V
X LPo l }uo]v o}uv P P ]v o vu }( }o]] U } U } v ]v]vP }
R }uv˙ (} ] }uu]o o](V
X C}uv˙ o (} P D o] }v } P}o ]vo] }( ]u]vP v ]v(}]vP } oo o v
o]vP ˙ ˘uo X

178 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 179
Aoo }( R P (} ` R] U `]R } (}uv }( } A9 Pv (} }u P U oo˙ Option Awards for Our Senior Management
`R R P ` }R] ]v }o u U } `R R P ` R] ] ]Pv].v v(} - TR (}oo}`]vP o (}R ]v(}u}v P]vP }}v ` Pv } } v]} uvPuv ]vP R ˙
v }o U ]vo]vP ovP } COVIDr ıX vDu U P

O CEO[ ]o ˙ P o }P E˘]]
Nu S}l}}v E˘]}v ~INUSDZ

PART IV
B ]o]vP R ]v ~ A9ZP T]uVvH`u]v ~Z
æU DuU æX
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• C}uv˙ o ~ A9Z D]lB ~Z

W W W
W]uP˙ ~Z
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O B} }( D]} }o R R }( R ]o ˙ P }( } CEO R v u ]v U v R v } - AivLuuv ~Z
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(}uv `v æ A9 ˙r} }( R ]o ˙U }v]]vP u}vP }R R]vP R (o }}u]vP }(
Av]W]ol ~Z
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]v ]vP v }v}]vP l˙ (v}v ]v R v]} uvPuv uX
~ Z  Ov D u U U R C}uv˙ R Pv }}v (} `R]R R v.]˙ R ˙ ]} } R}} `v }v o
u }( . } v ˙ X
TR } `v .˘ v ]o ˙uv } } CEO (} R .vv]o ˙ v D u U o USD ~ Z  E ] C o] ]Pv (}u R] }]}v R]( .vv]o }8 }v } v]} uvPuv ]v Jv v ` ˙ Ko G] X
~ Z MX B R D u U v U R(} U ` v} Pv v˙ ]˙ ]vv ]v X
æ Uı lUSD æ U } æ X A9l X A9X ~ Z MX P˙ `]oo `]R + (}u MR U v U R(} U ` v} Pv v˙ ]˙ ]vv ]v X

Remuneration of Other Members of the Senior Management

TR (}oo}`]vP o (}R ]v(}u}v P]vP PPP }uv}v ] ˙ (} R uu }( } ˘ TR (}oo}`]vP o (}R ]v(}u}v P]vP ] }l v] Pv } } v]} uvPuv ]vP R
uvPuv ~˘o]vP } CEO T]u Vv H`u]vZ ]vP R ˙ v D u U X Wv} R R ˙ vDu U P
vu o} ]vo }uv}v ] } }v `R} R v }( } ˘ uvPuv (} }(
~]vP Ko G] ZX Nu R]}lv] E˘]˙
T]uVvH`u]v æX DuU

C}uv}v]vUSD F]vv]o˙vDuU E]o]

C ~Z
W W

F]˘}uv}v UU K]RW}} X DuU

L}vPru]o}uv}vU]vR(}u}(}l}}v ~Z
UæUı KoG] ~Z
æX Jo˙Uæ

L}vPru]o}uv}vU]vR(}u}(]}l HvH X DuU

æUıU
v] D]lB ~Z
W W
Euo}˙}]o]˙}v]}v}l}}v ~Z
UU
W]uP˙ ~Z
W W
N}vr]˙]vvov}uv}v UU
AivLuuv X DuU
Tu]v}vv. Uæ
Av]W]ol ı ll
Pv]}v}v]}v U
~ Z  E ] C o] ]Pv (}u R] }]}v R]( .vv]o }8 }v } v]} uvPuv ]v Jv v ` ˙ Ko G] X
S}]o]˙} æUı
~ Z MX B R D u U v U R(} U ` v} Pv v˙ ]˙ ]vv ]v X
OR ~Z
æUıæ ~ Z MX P˙ `]oo `]R + (}u MR U v U R(} U ` v} Pv v˙ ]˙ ]vv ]v X

Total 27,072,693

~ Z  Au}v R}`v v R ˘v `]R } R }l }}v ` Pv ]v } MX K]R W}} U MX Ko G] U P}(X Hv

F}oo}`]vP } vvo uv}v v vRul]vP ˘] R u}v }( ]˙ (} R CEO ` i
H U MX W]u P˙ U MX A iv Luuv v M] Av] W]ol u ]vP R Bol SR}o (}uo X F} ]}v }( R u}v }`v` ~(}u R } uv}v }o]˙ Z } U }l }}v v U ] }l v] X TR
]v R o]vP R ` U v} SSR r ˙uv _ } } }v}o] .vv]o uv ]v R SC}v}o] F]vv]o
Ruv}v v N}u]v}v C}uu]' ] }uuv}v }( A9 }( R] u}v }v (} -
Suv W ] }( v (} R ˙ v D u U U v ı_X TR u}v } v} G R o }v}u] o
o] ˙ R uu }( } v]} uvPuv X uv ~]vP U }l }}v v ıX ] }l v] ZX H}`U (}oo}`]vP }vo}v }( R CEO ]v o]v
~ Z  Pv˘ ]v uo}˙ }]o ]˙ } `]R } R }}v ` Pv } R uu }( } v]} uvPuv X TR u}v }( `]R ]v]o X X X }( R D R C}} G}vv C} U R }( R CEOU R B} }( D] -
uo}˙ }]o ]˙ } v }v R o }v}u] o o] v R(} ] }v R ] }( } }]v˙ R X A R
}vP U Pv˘ ul oo}v }( R ˘} X } P } Pv }vo˙ æU }l }}v v æU ] }l v] } R CEO v } }uuv o]vP
~ Z  C}v] }( USD U '] o } R o }( }uv˙ U USD U ı ]vU R}]vP v }R oo}`v v USD U ]v uo}˙r] R ]+v ~]vP U }l }}v v U ] }l v] Z R ]}]}v }( R CEO (} ]]}v
u]o ]vv u]u X
} l˙ ]v]]o ]v R A ]o U ]˙ Pv X

180 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 181
TR o o}` R}` R }l }}v Ro Jv˙ U v R }l }}v Pv } } v]} uvP -
uv `R]R R ]vP R ˙ v D u U U `oo R }l }}v Ro } ]v
R ˙ v]vP D u U U D u U v D u U ~]v vu }( }l }}v ZU v R
˘] ] }( R }l }}v P

PART IV
T}o}l}}vRo S}l}}v S}l}}v S}l}}v T}o}l}}vRo E˘]] S}l}}v S}l}}v S}l}}v S}l}}v S}l}}v
Nu }vJv˙UU Pv]v (}(]]v ˘]]v }vDuU ~]vUSDZ R}PR R}PR }]v }]v }]v
T]uVvH`u]v ıU æU W W æU Xı U
ıX æU U
æXæ U U U
X U U U
æX U U U
Total 290,000 25,000 – – 315,000 160,000 70,000 51,666 25,001 8,333

E]o]
C ~Z
U – – ~UZ æU Xı æU
ıX æU
æXæ æU
Total 171,400 – – (46,400) 125,000 125,000 – – – –

K]RW}} ææU U – ~UZ U ıX U U

æXæ U U U
X U U U
æX æU æU æU
Total 155,000 16,000 – (30,000) 141,000 25,000 50,000 38,666 22,001 5,333

KoG] ~Z
– U – – U Xı U U U
Total – 24,000 – – 24,000 – – 11,333 8,000 4,667

HvH ææUıæ U – – æUıæ X U

X ıU
X U
Xıı U
X U
Xæ Uæ
Xı U
ıX U U
æXæ U U U
X U U U
æX æU æU æU
Total 545,975 16,000 – – 561,975 445,974 50,002 38,665 22,001 5,333

~ Z  E ] C o] ]Pv (}u R] }]}v R]( .vv]o }8 }v } v]} uvPuv ]v Jv v ` ˙ Ko G] X

182 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 183
 PART IV
T}o}l}}vRo S}l}}v S}l}}v S}l}}v T}o}l}}vRo E˘]] S}l}}v S}l}}v S}l}}v S}l}}v S}l}}v
Nu }vJv˙UU Pv]v (}(]]v ˘]]v }vDuU ~]vUSDZ R}PR R}PR }]v }]v }]v
D]lB ~Z
U W W ~æUZ æU ıXæ Uæ U

ıX Uæ U

Xæ Uæ ıU
X Uæ U
Total 204,682 W – (54,682) 150,000 81,546 68,454 – – –

W]uP˙ æU – – – æU ıX U U
æXæ U U U
X U U U
Total 225,000 – – – 225,000 100,000 75,000 33,333 16,667 –

AivLuuv U U – ~UZ æU Xæ U

Xı U

ıXæ U

ıX Uæ Uæ

æXæ Uı Uæı Uæ
X U U U

æX æU æU æU
Total 136,211 16,000 – (6,430) 145,781 U Uæ Uæ U æU

Av]W]ol ıU U U æXæ Uı Uæ Uæ
X Uææ U U
æX U U U
Total 19,300 4,446 23,746 Uı Uı Uıı U U

~ Z  E ] C o] ]Pv (}u R] }]}v R]( .vv]o }8 }v } v]} uvPuv ]v Jv v ` ˙ Ko G] X

~ Z  D]l B + D u U v ` ˙ Mo]v] M}}R˙ + F ˙ U X

184 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 185
TR o o}` R}` R ] }l v] Ro Jv˙ U v R ] }l v] Pv } }
v]} uvPuv `R]R R ]vP R ˙ v D u U U `oo R ] }l v]
Ro } ]v R ˙ v]vP D u U U D u U U D u U v D u U
æ ~]v vu }( ] }l v] ZP

PART IV
T}o] R]}l R]}l R]}l R]}l R]}l
T}o]}lv] R]}lv] R]}lv] R]}lv] }lv]Ro}v v] v]}]v v]}]v v]}]v v]}]v
Nu Ro}vJv˙UU Pv]v (}(]]v ˘]]v DuU R}PR æ
T]uVvH`u]v – æU – – æU – Uæ Uæ Uæ Uæ
Total – æU – – 5,700 – 1,425 1,425 1,425 1,425

E]o]
C ~Z
– – – – – – – – – –
Total – – – – – – – – – –

K]RW}} – U – – U – ı ı ı ı
Total – U – – 3,600 – 900 900 900 900

KoG] ~Z
– æU – – æU – Uæ Uæ Uæ Uæ
Total – æU – – 5,400 – Uæ Uæ Uæ Uæ

HvH – U – – U – ı ı ı ı
Total – U – – 3,600 – 900 900 900 900

D]lB – – – – – – – – – –
Total – – – – – – – – – –

W]uP˙ – – – – – – – – – –
Total – – – – – – – – – –

AivLuuv – U – – U – ı ı ı ı
Total – U – – 3,600 – 900 900 900 900

Av]W]ol – ı – – ı –
Total – ı – – 988 –

~ Z  E ] C o] ]Pv (}u R] }]}v R]( .vv]o }8 }v } v]} uvPuv ]v Jv v ` ˙ Ko G] X

~ Z  D]l B + D u U v ` ˙ Mo]v] M}}R˙ + F ˙ U X

186 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 187
TR o o}` R}` R u]v]vP u }( R }l }}v v ] }l v] Ro ˙ } v]}
uvPuv ]vP R ˙ v D u U X

Nu}( Ru]v]vPu}vDu Nu}(] Nu}( Ru]v]vPu}vDu Nu}(]

Nu S}l}}v U~}vZ }lv] ~Z Nu S}l}}v U~}vZ }lv]
T]uVvH`u]v ~Z
U ˙ æU W]uP˙ æU ˙ W

PART IV
U ˙ æU ˙
U ˙ æU ˙
æU ı˙
æU æ˙l˙ ~Z
AivLuuv ~Z
Uæ Xæ˙ U
æU ˙
E]o]
C ~Z
U ˙ U æXæ˙
U ˙ U ˙
æU ˙ ıæ Xæ˙
U ˙ æUıæ ˙
U ˙ æU ı˙
U æ˙l˙ ~Z

K]RW}} æU ˙ U
æU ˙ Av]W]ol ~Z
ıU ˙ ı
æU ı˙ ıUı ˙
U ˙ U æ˙l˙ ~Z

~ Z  Ov D u U U Pv˘ Pv }}v (} `R]R R v.]˙ R ˙ ]} } R}} `v }v o u }( . } v ˙ X

KoG] ~Z
U ˙ æU ~Z E ] C o] ]Pv (}u R] }]}v R]( .vv]o }8 }v } v]} uvPuv ]v Jv v ` ˙ Ko G] X
~Z D]l B + D u U v ` ˙ Mo]v] M}}R˙ + F ˙ U X
~ Z  Iv }v `]R R ]˙ ovU ] }l v] U }v U `]oo 'o P]v R ] v }( }]v˙ R ]v Pv˘ SEX SR R
R v} ˘]˙ v u˙ Ro ˙ R ]v `]R} o]u]}vX

HvDH ~Z
Uıı Xæ˙ U
æU ˙ TR o o}` R}` R }l }}v ˘] ˙ } v]} uvPuv ]vP R ˙ v D u U
v R ˘] ] }( R} }l }}v X P ˘] }}vU }v R ` ] X
ıU ˙
Nu}( E˘]]
U ˙ Nu S}l}}v ~]vUSDZ
U Xæ˙ T]uVvH`u]v W W
U æ˙ E]o]
C ~Z
U X
Uæ æXæ˙ U Xı
U ˙ K]RW}} æU Xı
æU ˙ æU ıX
æU ˙ KoG] ~Z
W W
æU ı˙ HvH W W
U æ˙l˙ ~Z
D]lB ~Z
ıU Xæ
æU Xı
D]lB ~Z
U Xæ˙ W W]uP˙ W W
U ˙ AivLuuv Uæ Xıı
æU Xæ˙ AivLuuv Uæ X
æU Xæ˙ Av]W]ol W W
Total 137,512

~ Z  E ] C o] ]Pv (}u R] }]}v R]( .vv]o }8 }v } v]} uvPuv ]v Jv v ` ˙ Ko G] X

~ Z  D]l B + D u U v ` ˙ Mo]v] M}}R˙ + F ˙ U X

188 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 189
4.4.3 Remuneration of Non-Executive Directors

TR uv}v }( R ]v]]o uu }( R B} }( D]} ] u]v ˙ R B} }( D]} U R

Nu Fv} S}l}}v R]}l
}uuv}v }( R uv}v v v}u]v}v }uu]' U `]R]v R o]u] }( R uv}v }o]˙ }
~]vUSDZ ]]vR ` ~Z
v]` ~Z
T}o
˙ R RR}o R Gvo MvPX TR ]}v o}` G R uv}v }o]˙ } ˙ }
PVRPR ıU ıU U ıUæ
Gvo MvP Ro }v M˙ U X

PART IV
]D LXL˙ ~Z
ıU ıU U Uæ
P v } R uv}v }o]˙U R uv}v }( R v}vr˘ ]} }v] }( R (}oo}`]vP .˘ WvLvRo æUæ ıU U Uı
v ]o }u}vv P JXD}voR]˙
B Uı ıU U Uıæ
PuoKo]v æU ıU U æU
{  .˘ (
AXAXR}vP æU ıU U æıU
{  ]( o]o U ( (} R]]vP R ] v }uo]v }uu]' U R R v o}uv }uu]' }U
R uv}v v v}u]v}v }uu]' } R }uu]o }uu]' V JuMXDo˙ æıU ıU U U
{  .˘ ( (} } }uu]' uuR] V v Y}vvGv ~Z
Uæı æUæ U U
{  o}vPru ]o ]vv ]v R (}u }( }l }}v v ] }l v] X
~ Z  TR u}v } v} G R o }v}u] o o] ˙ R v}vr˘ ]}X Au}v R}`v v R ˘v `]R }
R }l }}v ` Pv ]v } R v}vr˘ ]} u ]vP R Bol SR}o (}uo X F} ]}v }( R u}v
Fixed fee ]v o]vP R ` U v} SSR r ˙uv _ } } }v}o] .vv]o uv ]v R SC}v}o] F]vv]o
TR B} }( D]} R R vvo uv}vU R vvo uv}v (} uu }( R ] v Suv W ] }( v (} R ˙ v D u U U v ı_X
~ Z  TR u}v } v} G R o }v}u] o o] ˙ R v}vr˘ ]}X Au}v R}`v v R ˘v `]R
}uo]v }uu]' U R R v o}uv }uu]' U R uv}v v v}u]v}v }uu]' v R
} R ] }l v] ` Pv ]v } R v}vr˘ ]} u ]vP R Bol SR}o (}uo X F} ]}v }( R
}uu]o }uu]' v U ]v R U R ]}vo uv}v (} R R] }v (}oo}` P u}v ]v o]vP R ` U v} SSR r ˙uv _ } } }v}o] .vv]o uv ]v R SC}v}o]
F]vv]o Suv W ] }( v (} R ˙ v D u U U v ı_X
~ Z  D ] LX L˙ ]Pv (}u } B} }( D]} M˙ U v ` ˙ Y}vv Gv X Ov MR U U Y}vv Gv
}`v (}u R }]}v uu }( } B} }( D]} X
Fv}u]v Fv}u]v
RovB}˙ P}]}v ]vUSD ]vEUR
B}}(D]} CR]}v U æU
Mu Uı æU
A]C}uov}uu]'lRD CR]}v U æU
Mu U Uæ
Ruv}vN}u]v}v}uu]'l
CR]}v U U
C}uu]o}uu]'
Mu æUı æU

Long-term incentive plan

TR B} }( D]} ]vv } ]vv] R v}vr˘ ]} ˙ ]]vP }l }}v v l} ] }l
v] (}u u } u } o } ' v ]v `ooro]. v}vr˘ ]} ]v }vv}v `]R R E ] -
˙ Ivv PovX TR B} }( D]} Pv }l }}v v ] }l v] } R v}vr˘ ]} }v
R }uuv}v }( R uv}v v v}u]v}v }uu]' X SR }l }}v v ] }l v] Pv
}v v ]˙ ]vv Pv oo}}v Ru o]R ˙ R B} }( D]} v } R O}v
PovX TR }v]}v }( } E ]˙ Ivv Pov o˙ } } v}vr˘ ]} U (}R ]v }v X X SL}vPr
Tu Ivv Gv } K˙ P}v W E ]˙ Ivv Pov_X

Success payment
Iv ˘}vo ]uv U R B} }( D]} u˙ ] } ` v}vr˘ ]} `]R
˙uv ovP } R } v }( ]. v R] R}PR R ˘}vo +} }( R }v ~R
o}u o]v]vP } } o]v]vP o }l ˙ R v}vr˘ ]} ZX T} U v} R ˙uv
R v u } }u] ˙ } } v}vr˘ ]} X

P v } R uv}v }o]˙U ]v }( ]u]oU v}vr˘ ]} `]oo v} vo } v

˙uv X

TR (}oo}`]vP o (}R R ]v(}u}v P]vP R }uv}v v ˙ } v}vr˘ ]} ]vP

R˙ v D u U P

190 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 191
 Daniel
How did you react when you received
your myasthenia gravis diagnosis?

PART VII
PART IV
VI
I ]v[ oo˙ lv}` uR } MGU } I ]v[ oo˙
lv}` `R } R]vlX TR }vo˙ R]vP I lv` } MG `
]v(}u}v I P]v R}PR u˙ RvrP]o(]v X H
R MGX I}v]oo˙U R R uv}v MG `Rv R `
l]vP u } }]vuv X H ` R }vo˙ }v I
lv`o]]vP`]RMGUvRu}o]]vP'˙
v}uo o](X

What has changed about your life since

your myasthenia gravis diagnosis, and
what has stayed the same?

F} R u} U u˙ o]( ] oo '˙ v}uoX S}u

R]vP ˙ R u U o]lI[u `}l]vP (oo u v
`}l]vP } . } ]˘ u `lU oR}PR I R }
o}`o˙ ]o l } ]vP R] `]PR X I R

How He Found Ways } (o } v} R]vP u˙o( }} R U v I

`}l `]R u˙ }} } .P } `R ˘] `
]PR (} u X I lv}` v} ˙}v `]R MG v }

to Balance Mental and uR I R v o } }X

B }u R]vP ]vo˙ ] RvP X I R } -

Physical Health with MG* vP l }v }]o }vP X M˙ (]v v} U `Rv

I ˘o]v ] } RuU R˙ ` vv]vPX Av
I v u} o Rv I ] (} X F} u U ] [ oo˙
v } .v]vP R ]PR ov }( `R I `v }
G}`]vP U D v]o ` o`˙ ]v}o ]v } v .v U v R voo˙ } v `R I v } } } l }( u˙ }˙X
o]R ]v R .o X WRv R ` ]Pv} `]R u˙Rv] P]
~MGZU R] `}o ` v ] }`vX
What challenges did you face while
continuing to work? Did you have to
set new expectations or modify your
workload or schedule?

I[u ˙ ol˙ } R R i} R I } I
` o } u}](˙ u˙ Ro X I `}l `]R u˙
uvP `Rv u˙ ˙u}u ` oo˙ X I `}o
P} ]v `Rv I }o X M˙ uvP v }`}l lv`
R I `}o } oo R I }o U } R˙ ` vv -
Patient ]vP `Rv I v } }u ]v o } u] ˙X WRv
Story I R u˙Rv] P] Wo P˙U I }}l }u
u}+}}v.vu˙v`ovXWRvI`
˙ } }u lU u˙ }]}v ` `]vP (} u X
*Paid contributor to MG United.

192 | Patient Story Patient Story | 193

TR o o}` R}` R }l }}v Ro Jv˙ U v R }l }}v Pv } R v}vr˘
]} `R]R R ]vP R ˙ v D u U U `oo R }l }}v Ro } ]v
R ˙ v]vP D u U U D u U v D u U ~]v vu }( }l }}v ZU v R
˘] ] }( R }l }}v P

T}o}l}}vRo S}l}}v S}l}}v T}o}l}}vRo E˘]] S}l}}v S}l}}v S}l}}v

PART IV
S}l}}v S}l}}v
Nu }vJv˙UU Pv]v ˘]]v }vDuU ~]vUSDZ R}PR R}PR }]v }]v }]v
PVRPR æUæıæ U – Uıæ X U

X Uıı

X æU

Xı U
ıX U U
æXæ U U U
X U U U
æX U
Total 58,595 2,700 – 61,295 38,595 10,000 6,667 3,333 2,700

]D LXL˙ ~Z
U U ~æUZ æUæ X U
Xı U
Xı æU
ıX U U
æXæ U U U
X U U U
æX U
Total 67,800 2,700 (5,000) 65,500 42,800 10,000 6,667 3,333 2,700

WvLvRo U U ~UZ U ıX U U

æXæ U U

X U U U

æX U
Total 30,000 2,700 (4,420) 28,280 8,914 9,999 3,334 3,333 2,700

JXD}voR]˙
B Uæ U ~UæZ U Xı U
ıX U U
æXæ U U U

X U U U

æX U
Total 47,500 2,700 (7,500) 42,700 20,000 10,000 6,667 3,333 2,700

194 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 195
 T}o}l}}vRo S}l}}v S}l}}v T}o}l}}vRo E˘]] S}l}}v S}l}}v S}l}}v

PART IV
S}l}}v S}l}}v
Nu }vJv˙UU Pv]v ˘]]v }vDuU ~]vUSDZ R}PR R}PR }]v }]v }]v
PuoKo]v æU U ~UæZ æU Xı Uæ
Xı U
ıX U U
æXæ U U U
X U U U
æX U
Total 50,000 2,700 (7,500) 45,200 22,500 10,000 6,667 3,333 2,700

AXAXR}vP æU U (1,160) Uæ X æU
ıX U U
æXæ U U U
X U U U
æX U
Total 45,000 2,700 (1,160) 46,540 23,840 10,000 6,667 3,333 2,700

JuMXDo˙ æU U – U ıXı Uæ Uæ
ıX U U
æXæ U U U
X U U U
æX U
Total 35,000 2,700 – 37,700 12,500 12,500 6,667 3,333 2,700

Y}vvGv ~Z
– Uæ – Uæ Xı æ æ æ
Total – 4,050 – 4,050 – – 1,350 1,350 1,350

~ Z  D ] LX L˙ ]Pv (}u } B} }( D]} M˙ U v ` ˙ Y}vv Gv X

Ov MR U U Y}vv Gv }`v (}u R }]}v uu }( } B} }( D]} X

196 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 197
TR o o}` R}` R ] }l v] Ro Jv˙ U v R ] }l v] Pv } R
v}vr˘ ]} `R]R R ]vP R ˙ v D u U U `oo R ] }l v]
Ro } ]v R ˙ v]vP D u U U D u U U D u U v D u U
æ ~]v vu }( ] }l v] ZP

T}o] R]}l R]}l R]}l

PART IV
R]}l R]}l
T}o]}lv] R]}lv] R]}lv] R]}lv] }lv]Ro}v v] v]}]v v]}]v v]}]v v]}]v
Nu Ro}vJv˙UU Pv]v (}(]]v ˘]]v DuU R}PR æ
PVRPR – – – – æ æ æ æ
Total – – – – 150 150 150 150

]D LXL˙ ~Z
– – – – æ æ æ æ
Total – – – – 150 150 150 150

WvLvRo – – – – æ æ æ æ
Total – – – – 150 150 150 150

JXD}voR]˙
B – – – – æ æ æ æ
Total – – – – 150 150 150 150

PuoKo]v – – – – æ æ æ æ
Total – – – – 150 150 150 150

AXAXR}vP – 600 – – 600 – æ æ æ æ

Total – 600 – – 600 – 150 150 150 150

JuMXDo˙ – 600 – – 600 – æ æ æ æ

Total – 600 – – 600 – 150 150 150 150

Y}vvGv ~Z
– ı – – ı – æ æ æ æ
Total – 900 – – 900 – 225 225 225 225

~ Z  D ] LX L˙ ]Pv (}u } B} }( D]} M˙ U v ` ˙ Y}vv Gv X

Ov MR U U Y}vv Gv }`v (}u R }]}v uu }( } B} }( D]} X

198 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 199
TR o o}` R}` R u]v]vP u }( R }l }}v v ] }l v] Ro ˙ R v}vr˘
]} ]vP R ˙ v D u U X
Nu}( Ru]v]vPu}vDu Nu}(] Nu}( Ru]v]vPu}vDu Nu}(]
Nu S}l}}v U~}vZ }lv] ~Z Nu S}l}}v U~}vZ }lv]
PVRPR U Xæ˙ JuMXDo˙ æU Xæ˙
Uæ ˙ U ˙

æU ˙ U
U Xæ˙
U ˙
U ˙
U ı˙
U ˙
]D LXL˙ ~Z
U ˙
PART IV
˙
U ı˙
U ˙
Y}vvGv Uæ ˙ ı
~ Z  D ] LX L˙ ]Pv (}u } B} }( D]} M˙ U v ` ˙ Y}vv Gv X Ov MR U U
Y}vv Gv }`v (}u R }]}v uu }( } B} }( D]} X
~ Z  Iv }v `]R R ]˙ ovU ] }l v] U }v U `]oo 'o P]v R ] v }( }]v˙ R ]v Pv˘ SEX
SR R R v} ˘]˙ v u˙ Ro ˙ R ]v `]R} o]u]}v

U Xæ˙
æU ˙ TR o o}` R}` R }l }}v ˘] ˙ } v}vr˘ ]} ]vP R ˙ v D u U
v R ˘] ] }( R} }l }}v X P ˘] }}vU }v R ` ] X
U ˙
Nu}( E˘]]
U ˙ Nu S}l}}v ~]vUSDZ

U ı˙ PVRPR W W

U ˙ ]D LXL˙ ~Z
æU X
WvLvRo U æXæ

WvLvRo U ˙ JXD}voR]˙
B Uæ Xı

æUæ ˙ PuoKo]v Uæ Xı

U ı˙ AXAXR}vP U æXæ

U ˙ JuMXDo˙ W W
Y}vvGv ~Z
W W

JXD}voR]˙
B U Xæ˙ Total 25,580

U ˙ ~ Z  D ] LX L˙ ]Pv (}u } B} }( D]} M˙ U v ` ˙ Y}vv Gv X Ov MR U U

Y}vv Gv }`v (}u R }]}v uu }( } B} }( D]} X
U ˙
U ı˙
U ˙
4.4.4 Long-Term Incentives Granted to Key Persons – Equity Incentive Plan
PuoKo]v Uæ Xæ˙
O v ]˙ ]vv ov }]]vP (} R PvvP }( u]˘ }( }l }}v v ] }l v] `
U Xæ˙ } ˙ } B} }( D]} }v MR æU v vo˙ uv }v D u æU ~R Equity
U ˙ Incentive PlanZX TR ]u }( R E ]˙ Ivv Pov ] } v}P } v]} uvPuv U ]} U oo }R l˙
U ˙ uo}˙ U v l˙ }] }vov v ]} } ] v }v}u] v v.]o }`vR] ]v ]v R
P}`R v (}uv }( Pv˘U } ]v R] ]vv } }v] } } o v } ' v ]v ]v]] -
U ı˙
o `R} l˙ } Pv˘X
U ˙

Iv}vv}v`]RR]˙E IvvPovU}}B }(]}

D Ro}o]Rv]˙]vvoo}}vRuX
AXAXR}vP æU æ˙ TR]˙]vvoo}}vRu}v]v~]R Z }v`R]R}l}}vv]}lv]PvR
U ˙ ˙U`R]RRooRuR˙v~]]R Z vu}(}l}}vv]}lv]Pv}R
}v}}RP}}(}vU`R]RRoo}v}i]]}vo˙XSvPJv˙UURPovvo
U ˙
Pv}(]˙]vv}˘]vPuo}˙`]oo}v˙]vJo˙(}oo]v}(R]˙
E IvvPovX
U ı˙
U ˙ O B} }( D]} U ]v R i } R }o }( R ui}]˙ }( R v}vr˘ ]} U u˙ Pv
}l }}v v ] }l v] } } v]} uvPuv U ]} U oo }R l˙ uo}˙ U } l˙ }]

200 | Remuneration Report of the Remuneration and Nomination Committee Remuneration Report of the Remuneration and Nomination Committee | 201
}vov } ]} v ]v }v `]R R ]˙ ]vv oo}}v Ru X O B} }( D]} u˙ o} 4.5.1 Introduction
Pv }l }}v v ] }l v] ] ] }v }] }( R ]˙ ]vv oo}}v Ru U }vo˙
]v ]} `Rv v} ]v] ]v(}u}v ~ ]. ]v } ]v] ]vP }o]˙Z ] ]oo X P}v } `R}u ]˙ TR] Uv]o RP]}v D}uv U ]v o]}v }( o ı }( R P} RPo}v }v]v ~`RR ]v
]vv Pv vv} ( } R ]˙ ]vv X R }˙ }( R }uv } ]v R }uv ]v}} ˙ (v Z R ]v(}u}v ] (} } ] -
o} ]v } vvo .vv]o }vP v R o} } vvo } (} R .vv]o ˙ X
TR PPP vu }( R R u˙ ]oo (} R ] v }( }l }}v v ] }l v] ]

PART IV
`v R æ R
vRæ R
vo }( } (v P} X Uv D R o`U ` ] } ]vo ]v } vvo } Pvo ]}v }( } `]oo]vPv } u]P R
]l v v ]v ` ( ~o} oo } R]l [ZU v } P] ]}v }( R u]PvP }v ` R
S}l}}vPvv}R]˙
E IvvPovRoo`]R}}vR]}(RR}vR. lv `]R P } } u} ov ]l X
vv]˙}(R}(PvU`]RRu]v]vP`}R]vP]v`v˙r(}ou}vRo˙]vouv`]RR
}l}}v(oo˙vP}vRR]vv]˙}(R}(PvUiU]vRU}R}}v[}vv
XS}l}}v˘]o`RvUv]vv˙v}LR}l}}v˘]}v]vo]vR RISKFACTOR MEASURESTAKENTOONTROL
C THESERISKS
]v]]o}l}}vPvU`R]R]~Ro}v}(R}}vZ]R.˙}v˙(}uR}(PvX
WR]v]Pv].vo}]v}]v}vv˘ WR}]vu}ovP]}}o]}
}]vo}(}R(}o(XWu˙vR] uvPuv}R}]l}`R}oo˙r}`v
E R }l }}v Roo Pv `]R v ˘] ] o } R (] ul o }v R }( Pv v Roo }u]v]v}.]o]˙XAoo}v}(}}v] }Pu`oov}PuUv}uvP]l
]R]vo]v]oUo˙rPo]v]o}o]v]oo}uv `]R]v}}`v}]˙}v]]o]vXW
R u o } . } v ˙ (}u R }( Pv X O}v u˙ ( } o R . ˙ ]} R]
}ul}oRv(}RuURv} }vv}v}oU]+v}v](}u
u˙ o]u] R] }vo ˘ }o]P}v ]v }( R }}v ]v } R i]]}v `R }}v ˘ ~˙ZvPvUv}vo˙VYVGART¡(}Ruv}( }}]˙Rv}o}P˙o}u`R]RPoo˙(}
Pv U }u } v ˙ }}vX PMGR}]vPo}˙}o]vRUXSXv]vJvX }v]]o]vX
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}uu]o]]vP}}X }(R}v]R`o]Roo]v]o
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v}uu]o](oo˙U`Rvv](}XO
IvR}(~]ZoUuPU}v}o]}vUv}+}]u]o]]}v}(R}}Rv}v}]}( }uu]o]}vP˙(}v˙}v]R
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R˙]]vv}˙P}U`oo}v}]]vPv
Pv˘[}~]]]Z]}o}vvl}o]]}v}(Pv˘URvA9}(v˙v]˙]vvRooX `]R}}Puvu˘]u]]vP}v
]uuvXWov}v}v]R
`o]R}u]]vPo]˙]v]}v
O B} }( D]} U }v }o }( ui}]˙ }( R v}vr˘ ]} U u˙ uv } u]v R E ]˙ }o}vR'˙R}}(oP
Ivv Pov } u˙ uv R u }( R] E ]˙ Ivv PovU o} (} v˙ }v]vP }l }}v } ] ]}Ruo}uv]X
}l v] U }] R ` `]oo }uv v˙ + }}v (} v˙ ] vP ]u }( R uvuv X
No˙oo}(}]i}vo Wo]R]vP}o]˙uvPuv˙u}
Po}vXN}vvP]vRv˙}(}} v}uo]v`]RvP}}o}}˙U
v]`]oo(o.ooPo}˙}uo]vXF]o}}uo˙ vP}}uv(]vPvvP}}o]v]o
`]RRPo}v}oo]vo˙Uv]}vU(o XWv}}˙}(RvP}oP]o}v
v`]R`o}(}oU`oo.vX v}v}uo]vXWRvPRv}u

4.5 Risk Appetite & Control ˙o]R]vPv]vrR}o]˙vuv}

v}uo]vXE˘REMAvFDAU`oo
]}vovvCROXW]}o}P}}`}l]vP
o}vR]`]RPo}}vo]Pvuv}vRo
o]v]oo}uvvPo}˙R`˙}v}uo
A D R }u (} ]vP R] }vU o (oo˙ ]` R (}oo}`]vP }v˙ uv P Po}˙8]v]R]XFRu}U`l
}u]v]v}v]]o]v}oo}`}
}voo˙}]]vP}}vv}vR}(]vPo
X
IN THIS SECTION WE WILL MAKE THE REQUIRED ISCLOSURES REGARDING OUR RISK APPETITE
AND MITIGATING ACTIONSX THE RISK MITIGATION ACTIONS AND RISK MANAGEMENT DESCRIBED No˙oo}(}]i}vo WRo]R}o]˙uvPuv˙u}
Po}vXN}vvP]vRv˙}(}} v}uo]v`]RvGLPUGMPvvGCPXW
IN THIS SECTION HAVE BE N FULLY TAKEN INTO AC OUNT YB US WHEN PREPARING THE DE - v]`]oo(o.oPo}˙}uo]vXF]o}}uo˙ v}}˙}(RvP}oP]o}vv}v
SCRIPTION OF THE MAIN RISKS AND UNCERTAINTIES WE FACEU AS SET OUT IN SECTION _ RISK `]RRPo}v}oo]vo˙Uv]}vU(o }uo]vXWRvPRv}u˙o]R]vPv
FA C TORS _X ANY MITIGATING LANGUAGE USED IN THIS SECTION DOES NOT HAVE ANY IMPACT ON v`]R`o}(}oU`oo.vX ]vrR}o]˙vu}v}uo]vXW]
}o}P}}`}l]vPo}vR]`]RPo}}v
THE RISKS AND UNCERTAINTIES WE FACE OR THEIR POTENTIAL ADVERSE EFFECTS AS THEY ARE o]Pvuv}vRoo]v]oo}uvvPo}˙
DESCRIBED IN SECTION S RISK FA C TORS _X R`˙}v}uoPo}˙8]v]R]X
FRu}U`l}u]v]v}v]
]o]v}oo}`}}voo˙}]]vP}}vv}v
SECTION S RISK FA C TORS _ DESCRIBES THE MAIN RISKS AND UNCERTAINTIES WE FACE ALREADY R}(]vPoX
FULLY HAVING TAKEN INTO AC OUNT OUR RISK MANAGEMENT AND THE RISK MITIGATING AC -
TIONS DESCRIBED HEREINX

202 | Risk Appetite & Control Risk Appetite & Control | 203
 RISKFACTOR MEASURESTAKENTOONTROL
C THESERISKS 4.5.5 Financial Risks and Controls
Wo˙Uv˘}}vv}o˙U}vR]U]vo]vP Wv}}u}}vo}o]P}vvv˙ov
]vvvo]v]o]vP}vCROU}}v} u]o}vR]uvv}}oo}}v}vXW
Iv vv]vP } ]v U ` l } ]uouv ]vo }o]˙ P]vP ]vvo }v}o v ]l uvPuv X O
o]v]o]vo]v]o]oXI(RR]}v} v}}u]v]v]R]o]v}(}]o}oo}}v B} }( D]} R oP v }o } ] ] v }uo]v }uu]' ]v R ]PvU ]uouv}v v
(oo˙˙}R]}vo}u˘ v`ooP}}o}vR]`]R˘]vPv}vo u}v]}]vP }( v ]vvo ]l uvPuv v }v}o ˙u } uvP R ]Pv].v ]l } `R]R ` ˘} X
o]vU`u˙v}o}}]vPo}˙}o(} (}oo}}vv]v}}o]u]o]v}vo]u]
}}uu]o]}}v]v}]v}o vu}(}oo}}vvXFRu}UR]r˙

PART IV
voo˙RuX }v}o}vvuvPuv]i}}o]˙ O .vv]o }vP ] `]R]v PR (u`}l }( PvP U }vP v (} vPX A ]v}v ]
uvPuv˙uX}u˙
C }voPuv u `v } (} ]vvo v ˘vo X E˘vo }vP P} oo }v] }( v vvo } ~]v
]vo]vv+}}}(}uvr(}uvX
W˙]oo˙]vP}}vo]l}]}] R (}u }( R] Uv]o RP]}v D}uv ZU ]vo]vP .vv]o uv ] ˙ R ]vvv ]}U
}]XP}iuvPuvo}vP}}}]vvo `oo u]rvvo }vP v o˙ U }v]v]vP uu] .vv]o ]v(}u}vX TR ˘vo }
}uvX }v R ]vvo .vv]o }vPX

Wo˙}vvv}R]vooo}˙]PR} W.ov}vo]}v}}}
Ivvo .vv]o }vP }v] }( ˘v] }v}o] u}vRo˙ } ]v `R]R v o}uv }u -
}}}v]vo}uRv}o}P]X }v]vRv}o}P]XW}]vPR]]vo}
F]o}v(}}}R]PRo˙}oRu }oo}}v`]Ro]vP˘.u]vR.o}(]vooo } R u}vRo˙ ~uo Z P v ]} (} X Iv ]}vU R ` ] } }
}]o]˙}}uv]u]}]vX }˙}}vXIv}}}U`u]v]v (} (} R vvo o U ]vo]vP R R G}` }]}v R v }( R .vv]o ˙X TR o˙ P
]}v.vo]˙vvPuv`]R}oo}vP
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}( R vvo P} P U `R]R ] ˙ ˙ ˙ } v]} uvPuv v } ˙ } B}
]PR`]R]v}ov.ovi]]}v}}]]}ovP }( D]} X O ]o] .vv v u]v]}v uv ]u]o˙ }v]o (} ovP R L
v˙R]r˙]PRvo]v}RR]r˙ ]vvo v ˘vo }vP U (} R .voo˙ } ˙ } B} }( D]} X
]PR}vvr}]X

OB}}(D]}]R.vv]oo}(RP}oo(}uo}uvPU`R]RuvPu]vX
O(P}`Rv]o]˙}}uv}v]v]vP W}+}uuv}vlPvR
}l˙}vvov]vP]}voo].}vvoX ]vv]vR(}u}(R]˙
E IvvPovXW(}u
]}]o]}]vRulvo˙`]Rv˘vo] Pv˘ []vvo }v}o } .vv]o }vP }( ]vvo }v}o v ]vo R} }o]] v } -
}]}vR}uv}(R}uv}v RP
}+}}l˙}vvo]v}u]}v}}R~P}Z
}uv]XW˙o}'v}v}vPvv]}vuvR
}R(Ro}uv}(Rov}(}l˙}oX {  ]v } R u]vvv }( } R U ]v }vo ]oU o˙ v (]o˙ G R v }v v ] -
}]}v }( R }( Pv˘V
{  }] }vo v R v }v } v ˙ } u] }v }( .vv]o -
4.5.2 General Description of Our Risk Appetite uv ]v }v `]R IFRS ] ˙ R Ivv}vo A }vvP Sv B} v } ˙ R EUU
v R ] v ˘v] }( Pv˘ ]vP u }vo˙ ˙ R}] }v V v
O ]l P]o]v (} ]v ]]vP `R]R u ` u˙ l]v u]PvP }u }( R ]l v {  }] }vo v P]vP v}v } uo˙ }v }( vR}] ]]}vU } ]}]}v
v ]v ` ( X O ]l ] o]Pv `]R } P˙ v ]}] X TR ]v ` } ]v ] ]vRv - }( Pv˘ [ R }o R u]o + }v R .vv]o uv X
o˙ R]PRr]lX Iv PvoU ` `]oo]vP U v ]v } ]` ] U } l ]Pv].v ]l } o } } (oo˙
]v } o]v }( ]v X S}u }( R ]l v v ]v ` ( vo˙ }] }( } }v}o `R }R S]v Pv˘ R ] P] `]R R UXSX S] v E˘RvP C}uu]]}v ~ SECZ v ] oP o
u˙ ]vGv } u]P X .o `]R]v R uv]vP }( Ro r }( R UXSX S ] E˘RvP A }( ı U Pv˘ v } R + -
v }( R ]vvo }v}o } .vv]o }vP v }] } }v R o }( R] uv X O B}
}( D]} ]` ] ]vvo }v}o } .vv]o }vP }v ]] o]R ]v R Ivvo C}v}o W
4.5.3 Controlling Actions Taken by Us with Regard to Our Most Relevant IvP Fu`}l ~ Z ] ˙ R C}uu]' }( S}v}]vP OPv]}v }( R T`˙ C}uu]]}v ~ COSO)
Risks and Uncertainties v vPP v ˘vo ]} } Ro R +v }( R} }v}o X

A ] ˙ Co P ı }( R D R C]]o C} ]v }viv}v `]R G]o]v X X }v Avvo R}vP U

R (}oo}`]vP ] ]}v }( R u]v ]l v v ]v ` ( ~]vP R . ]l }( R P}˙ }( ]l ( - 4.5.6 Recent or Current Developments in our System of Risk Management
} } ]v }v SR]l F} _Z v ]}v }( R u ` }}l } }v}o RuX A ]}v }( R
˘ ]u }v u]o]}v }( R ]l ] ]vo (} R ]l ]v }v SR]l F} _X Iv U ` R (R ]v } 'v}v } }r ]l uvPuv ˙ ul]vP R o}v }( Pv˘ [
} ]l v v ]v v]vP ] ]}v }] } B} }( D]} X

4.5.4 Material Impact of Risk Materialization in 2021

]v. v˙ u]o ]u }v Pv˘ o }( u]o]}v }( ]}o˙ ]v. ]l v v ]v X

}A ]v}vXXSB]v]v}vovP(}uROVID
C rıvu]}o]}v}(R
o}uv}(}}v}v]vo˙]u}]vX_U`u}v]}]vPR]u}(
ROVID
C rıvu]}v}}}vXW}v}o]v]o]oPo}oo˙U]vo]vP]v]u˙OVID
C rı
]vN}RAu]U}E vJvXTR}vv}(OVID
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]vv}}vU]vo]vP}}}R]˙v[]}˙]Uo]v]o]vo]v]o]oX

204 | Risk Appetite & Control Risk Appetite & Control | 205
5
General description

PART V
of the Company and
it’s Share Capital
Contents
5.1 Legal Information on the Company 208

5.2 Share Capital 209

5.3 Share Classes and Principal Shareholders 216

5.4 General meeting of Shareholders and Voting Rights 217

5.5 Anti-Takeover Provisions 218

5.6 Amendments of Articles of Association 218

5.7 Obligations of Shareholders and Members of the 219

Managing Board to Disclose Holdings

5.8 Short Positions 220

5.9 Market Abuse Regime 220

5.10 Transparency Directive 221

5.11 Dutch Financial Reporting Supervision Act 221

5.12 Dividends and Other Distributions 221

5.13 Financial Calendar 2022 222

5 General description
of the Company and
its Share Capital
5.1 Legal Information
on the Company
5.1.1 General
W` ]v}} }v A ]o æU ]v R NRov v v D R o`X O }uu]o vu ] RPv˘ [ v
]v A ]o U U } }} vu ] RPv˘ SE[X W D R E }v o] }uv˙ ~
SEZ P] `]R R P] }( R D R CRu }( C}uu v vu æ X O }} ]
]v R}'uU R NRov U v } P] }8 ] W]oou æU AHU B U R NRov X O o
R}v vu ] A= ~ Z X O `] ] R' Pll```XPv˘X}uX Iv(}u}v }v R `] }
v} (}u }( R] Uv]o RP]}v D}uv v R v} v v] } } ˙ R AFMU vo R
]v(}u}v ] ]v}} ˙ (v ]v} R] Uv]o RP]}v D}uv ~ o} ı SIv(}u}v ]v}}
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O E }v oPo v˙ ]v. vu ~ LEIZ ] æ ıCæFZE GıODQ X O }]v˙ R o] }v E }v˘
BovISINC}NLvR˙u}oSARGX_XTRADSo]}vNUvR˙u}oSARGX_X
5.1.2 Statutory / Corporate Objects
P v } A o }( } A o }( A }]}vU } }} }i P ~ Z } ˘o}] U ]vo]vP oo ] ovP
} RU o}uv U } }vU ulvP v }uu]o ˘o}]}vV ]}o}P]oU Ru]o } }R } U
} v Rv}o}P] ]v R o]( ]v } ]v PvoU v u} ].oo˙ ]v R ]Pv} U Ru oU
u]oU }u U Ru]o v P]oo } V ~ Z } ]Pv v o} ]vuv `R]R u˙ ]v u]o
]Pv}] v 8o] V ~ Z R `}o`] ]]}v }(U o }( v v]vP ] ovP } } }
v ]]] ]o˙ } }u `oo R}PR R] V ~ Z } ]v}} U } ] ]v v˙ `˙ `R
}U } uvP U } ] U } } v } }u} v ] U ]v v }uv] V ~ Z } v ]
v ] } ]v v }uv] `]R `R]R ` (}u P} v } R] V ~( Z } .vv ]v v
}uv] V ~PZ } }}`U } ov v } ] (v U ]vo]vP R ] }( }v U }u]}˙ v} } }R ]
} ]v }( ]v v `oo } v ]v} Puv ]v }vv}v `]R R (}uv}v V ~RZ } v
Pv U } ]v v } oP } (} }o]P}v }( R }uv] v v] `]R `R]R ` (}u
P} v }v Ro( }( R] V ~]Z } }]vU o]v U uvP v ˘o}] P] }˙ v ]u }( }
˙ ]v PvoV ~iZ } ]v v] U ] v ]u }( } ˙ ]v PvoV ~lZ } o} v ]v v U
ul U o]v U lv}`rR}` v }R ]v ]o } ˙ ]PR V v ~oZ } (}u v˙ v oo ] }( ]v ]oU
.vv]o } }uu]o v U `oo ˙R]vP ]v]vP R (}P}]vP U ovP R} } }v R}U oo
]v R `] v }( R `} X
208 | Legal Information on the Company
5.2 Share Capital
5.2.1 Authorized and Issued Share Capital
PART V
Uv D R L` ~S}v P }( R DC ZU }uv˙ [ R}] R ]o } R u˘]uu u}v v
vu }( R R ] u˙ ] `]R} uv]vP ] o }( }]}vX O A o }( A }]}v }] (} v
R}] R ]o ]v R u}v }( ƒı u]oo]}v ]] ]v} ı u]oo]}v R U R `]R v}u]vo o }( ƒ X X
Aoo ] v }v]vP R R v (oo˙ ] v R R Ro ]v u]o] (}uX
A }( MR U } ] v ] R ]o u}v } ƒæU ı Uæ X U v ˙ æ Uı æU }]v˙
R `]R v}u]vo o }( ƒ X U R vvP v ]vo (}v }( } R ]oX A }( MR U U
v]R ` v} v˙ }( } ]]] Ro v˙ }( } }`v R X
5.2.2 Stock Options and Restricted Stock Units
Iv ]}v}R R o˙}v]vPU`RPv}l}}v`R]R }v˘] `]ooo }v]v
]vRvu }(} }v]vPR XA}o}(æUıU }l}}v~`R R}l}}vvo RR}o
Societas Europaea or } ] (}}vv`}]v˙RZ`}v]vPvPv }(D u U XU}v˘] }(R
æUıU }l}}vU }ou}v}(¤ıXu]oo]}v]v}l}}v˘] ] `}o }u ˙o}Pv˘
- ˙R}}v U]v]vPR Pv˘ [R ]ov R u]u˙R u u}vXA}o}(æU Uıı}l
}}v~`R R}l}}vvo RR}o } ] (}}vv`}]v˙RZ`}v]vPvPv -
}(MRU XU}v˘] }(R æU Uıı}l}}vU }ou}v}(¤ıXu]oo]}v]v}}v˘]
] `}o }u ˙o}Pv˘˙R}}v U]v]vPPv˘ [R ]o˙R u u}vX
FRU ` R Pv ] }l v] `R]R }v ˘] `]oo o } v ]v ]v R vu }( } } -
v]vP R X A }o }( U æ ] }l v] ~`R R R}o ] ] }l v] ] R
o vu }( v` }]v˙ R U u]v ]v vu }( R ] } } ]v } U ]( o]o Z
` }v]vP v Pv }( D u U X A }o }( U æ ] }l v] ~`R R R}o
] ] }l v] ] R o vu }( v` }]v˙ R U u]v ]v vu }( R
] } } ]v } U ]( o]o Z ` }v]vP v Pv }( MR U X
A (}u R }l }}v v ] }l v] Pv v R Pv˘ E ]˙ Ivv PovU ` } v}
vo˙ R }R }l }}v U ] }l v] U }}v } R ] U }vo ] } }R
]PR } ] (} } R ] }v]vPX F} }l }}v ]v(}u}v R}PR D u U U
v} SSR r ˙uv _ ]v } }v}o] .vv]o uv ]v }v SC}v}o] F]vv]o S -
uv W ] }( v (} R ˙ v D u U U v ı_X
-
5.2.3 History of Share Capital
New shares created during 2019
A o }( R ˘] }( }}v v R E ]˙ Ivv PovU ıU v` R ` ]v ıX
-
Ov Jv˙ U ıU J}Rv}v J}Rv}v Ivv}}v JJDCU Iv X R U U ıı }( } }]v˙ R ] }(
ƒ X R U }o]vP ƒ X u]oo]}vU }( } o]v v }oo}}v vPuv (R ]
]v X X SO SP] PvR] `]R Jvv (} u _X TR RR}o]vP }( J}Rv}v J}Rv}v Ivv}}v
R u }( R ] v v }˘]uo˙ X A9 }( } }v]vP R X
Ov N}u U ıU ` }+ U U }( } }]v˙ R R}PR Po}o }+]vP `R]R }v] }( ~]Z -
o] }+]vP }( U U æ ADS ]v R UXSX v ]v }R }v] }] R EA ] }( ¤ X ADSU -
(} v`]vP ]}v v }uu]]}v v }+]vP ˘v V v ~]]Z }v v ] ouv }( Uæ ıUı
Share Capital | 209
}( }]v˙ R ]v R EA v }+]vP ] }( ƒ ıX R U (} v`]vP ]}v v }uu]]}v TR(}oo}`]vPoR}`Ro}uv]v}R]o(}R.vv]o˙v}MRUP
v }+]vP ˘v X Ov N}u U ıU R v`] }( R }+]vP ˘] R] } roo}uv }}v }
R U ]}vo ADS ]v (ooX A o U ` ] ¤ææ X u]oo]}v }( P} } (}u R] }+]vP U Number of shares outstanding on December 31, 2019 42,761,528
˙ ¤ æX u]oo]}v }( v`] ]}v v }uu]]}v U v }+]vP ˘v U }( `R]R ¤ æXæ u]oo]}v R
Number of shares outstanding on December 31, 2020 47,571,283
v (}u ]˙X TR }o v R } (}u R }+]vP u}v } ¤æ X u]oo]}vX
E˘]}(}}v]vJv˙ Uæ

PART V
A o }( R o}uv U Pv˘ [R ]o ]v (}u æUı æU R }( Jv˙ U ı } E˘]}(}}v]vF˙ U
U Uæ R }( D u U ıX Go}o}+]vP}vNv}v˘
E }vF˙U UæU
Oroo}uv}}v˘]˙v`]}vF˙U Uæ
New shares created during 2020
E˘]}(}}v]vMR Uı
A o }( R ˘] }( }}v v R E ]˙ Ivv PovU U v` R ` ]v X
E˘]}(}}v]vA]o U

Ov M˙ U U ` }+ U æ Uæ æ }( } }]v˙ R R}PR Po}o }+]vP `R]R }v] }( ~]Z o] E˘]}(}}v]vM˙ ıUæ

}+]vP }( Uæ U ADS ]v R UXSX v ]v }R }v] }] R EA ] }( ¤ æX ADSU (} E˘]}(}}v]vJv æU
v`]vP ]}v v }uu]]}v v }+]vP ˘v V v ~]]Z }v v ] ouv }( U U E˘]}(}}v]vJo˙ Uı
}]v˙ R ]v R EA v }+]vP ] }( ƒ Xæ R U (} v`]vP ]}v v }uu]]}v v
E˘]}(}}v]vAP æUı
}+]vP ˘v X Ov M˙ ıU U R v`] }( R }+]vP ˘] R] } roo}uv }}v } R
E˘]}(}}v]vSu Uıæ
æ U ]}vo ADS ]v (ooX A o U ` ] ¤ X u]oo]}v }( P} } (}u R] }+]vP U ˙
¤æ X u]oo]}v }( v`] ]}v v }uu]]}v U v }+]vP ˘v U }( `R]R ¤æ X u]oo]}v R v - E˘]}(}}v]vO} Uı
(}u ]˙X TR }o v R } (}u R }+]vP u}v } ¤ X u]oo]}vX E˘]}(}}v]vN}u Uæ
E˘]}(}}v]vDu U
A o }( R o}uv U Pv˘ [R ]o ]v (}u U Uæ R }( Jv˙ U }
Number of shares outstanding on December 31, 2021 51,668,315
Uæ U R }( D u U X
E˘]}(}}v]vJv˙ Uæı

New shares created during 2021 E˘]}(}}v]vF˙

A o }( R ˘] }( }}v v R E ]˙ Ivv PovU æ U v` R ` ]v X Number of shares outstanding on March 1, 2022 æUıæU

Ov F ˙ U U ` }+ U æU }( } }]v˙ R R}PR Po}o }+]vP `R]R }v] }( ~]Z o]

}+]vP }( U U ADS ]v R UXSX v ]v }R }v] }] R EA ] }( ¤ X ADSU (}
v`]vP ]}v v }uu]]}v v }+]vP ˘v V v ~]]Z }v v ] ouv }( Uæ U
}]v˙ R ]v R EA v }+]vP ] }( ƒ æX ı R U (} v`]vP ]}v v }uu]]}v
v }+]vP ˘v X Ov F ˙ U U R v`] }( R }+]vP ˘] R] } roo}uv }}v }
R U æ ]}vo ADS ]v (ooX A o U ` ] ¤ U X u]oo]}v }( P} } (}u R] }+]vP U
˙ ¤æ X u]oo]}v }( v`] ]}v v }uu]]}v U v }+]vP ˘v U }( `R]R ¤æ X u]oo]}v R
v (}u ]˙X TR }o v R } (}u R }+]vP u}v } ¤ U ı X u]oo]}vX
5.2.4 American Depository Shares
Iv }vv}v `]R } IPO }v N U R B vl }( N` Y}l Moo}vU }]˙U P] v o] Au]v
D }]˙ SR U o} ( } ADS X E R ADS v }v R ~} ]PR } ] }v R Z }]
`]R ING B vl NXVXU }]v (} R }]˙ ]v R NRov X E R ADS o} v v˙ }R ] U
R } }R } ˙ `R]R u˙ Ro ˙ R }]˙X TR }]˙ [}8 `R]R R ADS u]v]
] o} B o˙ S U N` Y}lU N` Y}l X TR B vl }( N` Y}l Moo}v[ ]v]o ˘ }8 ]
o} æ L]˙ S U N` Y}lU N` Y}l X

Av ADS R}o `]oo v} }v }( } RR}o v } v} R RR}o ]PR X D R o` P}v

RR}o ]PR X TR }]˙ `]oo R R}o }( R R vo˙]vP R ADS X A P] R}o }( ADS
R ADS R}o ]PR X A }] Puv u}vP U R }]˙U ADS R}o v oo }R }v ]v]o˙ }
v.]oo˙ R}o]vP ADS } ADS R}o ]PR `oo R ]PR v }o]P}v }( R }]˙X N` Y}l o`
P}v R }] Puv v R ADS X

TR }]˙ R P } ˙ } ]] } ADS R}o R R ]]v } }R ]]}v ] } R }]v

] }v R } }R }] ] U }v ˙uv } }v }( ] ( v ˘v X ADS R}o `]oo
] R ]]}v ]v }}}v } R vu }( R R] ADS v X Av ADS R}o u˙ v
R] ADS R }]˙ [}8 X U}v ˙uv }( ] ( v ˘v v }( v˙ ˘ } RP U R u
˘ } }l v( ˘ } ( U R }]˙ `]oo o] R R v v˙ }R }] ] vo˙]vP
R ADS } R ADS R}o } }v R ADS R}o ]Pv R }8 }( R }]vX OU v ADS R}o [
U ]l v ˘v U R }]˙ `]oo o] R }] ] ] }8 U ]( (]o X

TR }]˙ u˙ RP R ADS R}o ( v ] ˘v (} ]v vP R }]v P]vP o]˙ }(

}] ] X ADS R}o u˙ ]v R }]˙ R}` } } R vu }( }] R R] ADS

210 | Share Capital Share Capital | 211

v X I( ` R }]˙ } }o]] R ADS R}o [ }vP ]v }v ~v ` v} ] } } }ZU
R }]˙ `]oo v}(˙ Ru }( Gvo MvP v v } ul }vP u]o ]oo } RuX TR} u
]o `]oo ] R u' } } }v v ˘o]v R}` ADS R}o u˙ ]v R }]˙ R}` } } X F}
]v }v } o] U R˙ u R R }]˙ ˙ ˙ R }]˙X TR }]˙ `]oo ˙U (
oU i } D R o` v R }]]}v }( } A o }( A }]}v } ]u]o }uv U } } } } R
] Pv } R R } }R }] ] ]v ˙ ADS R}o X I( ` } v} R }]
˙ } }o]] R ADS R}o [ }vP ]v }v U v ADS R}o v oo v }vP ]v }v U v U ]v R U R
}]˙ u˙ ˙ } } R ]v U ] ] v} ] } } }X Iv v˙ v U R }]˙ `]oo v} ˘]
v˙ ] }v ]v }vP }] ] v ] `]oo }vo˙ } } 'u } } ]v } ] ]v R
(}oo}`]vP vv X I( ` l R }]˙ } }o]] v ADS R}o []v }v o æ ˙ (} R uvP
R }]˙ } v} ] }vP ]v }v (}u v ADS R}o ˙ R ]. U ] `]oo }v]
R ADS R}o } R R}] v ] ] } P] ] }v˙ }˘˙ } }v ]Pv ˙ } } R
vu }( }] ] v ˙ ] ADS X TR }]˙ `]oo P] ] }v˙ }˘˙ ]v R} ]u
v } } }v oo }v } } }v vo ` v}(˙ R }]˙ R P
{ ` } v} `]R } ] ] }v˙ }˘˙V
{ R ] vo RR}o }}]}v } R o }vV }
{ R o }v `}o R v ]u }v } RR}o X
W ] } v}(˙ R }]˙ ]( }v }( R }v]}v ]. } ˘] X Iv } } P] v ADS R}o
}vo }}v]˙ } ]v R }]˙ } R ˘] }( }vP ]PR ovP } } R U ]( `
R }]˙ } U ` P } P] R }]˙ v} }( v˙ uvP v ]o }vv]vP R u' }
} }v o ˙ ]v v }( R uvP X
5.2.5 Issue of Shares
TRA o }(A }]}v}] R R u˙ ] } ]PR } ] (}} R u˙ Pv
AIv} }o}v}( R RR}o RGvoMvPU} ovo˙U˙} B} }(D]}](} ]Pv
˙ R RR}o R GvoMvPXA }o}v}(R RR}o RGvoMvP}] R U
}Pv ]PR } ] (} R } } ]Pv} B} }(D]} R }}}˙ R}]}}} v
}vo˙lo R }}o}(} B} }(D]}`]RR }vv}(Rui}]˙}(Rv}vr˘ ]}X
SR u˙ ] } ]PR } ] (} R u˙ Pv ˙ }o}v}(} B} }(D]}U](v]v}
( } B} }(D]}] ]Pv }}}˙R RR}o RGvoMvPXD]Pv}v˙ }o}v
}( R RR}o RGvoMvP vv} `]R`vvo u]v }R`] R u}( ]Pv}vX
TR } v }v}(} B} }(D]}[ R}]˙}] R }Pv ]PR } ] (} R ~R
PvvP}l}}v } ]]vP}vo }vZ] u]v ˙ }o}v}(R RR}o RGvo
MvP v oU Ru}U}oov] R ]vPv˘ [R}] ]o R ov uXTR }v}(
R] R}]˙u˙v}˘ ]} }(.˙XD]Pv}v}(} B} }(D]} R }˙ R}]}]
R } Pv ]PR } ] (} R u˙ ˘v ˙ }o}v}(R RR}o RGvoMvP
(} ]} v}˘]vP.˙]v R XTRvu }(R R u˙ ] ] u]v R u}(
]Pv}vXN}RR}o [ }o}v}B} }(D]}[ }o}v] ] }] R v}R˘
] }( ]}o˙Pv ]PR} ] (} R XA }o}v}(} B} }(D]}}] R v }Pv
]PR } ] (} R v}vo˙ lv`]RR }vv}(Rui}]˙}(Rv}vr˘ ]}X
Ov M˙ U U R RR}o R Gvo MvP ]Pv } B} }( D]} R }} }˙
}uv } ] ]}vo R v Pv ]PR } ] (} R } u˘]uu }( A9 }( R }v]vP
]o R }( R Pvo uvP U v } o]u] } ˘o ru ]PR }( RR}o (} R R `]R
R ]} }vv }( R ui}]˙ }( R v}vr˘ ]} (} ]} }( u}vR X
212 | Share Capital
5.2.6 Pre-Emption Rights
-
D R o` ~S}v Pı }( R DC Z v R A o }( A }]}v P] RR}o ru ]PR } ] }v
} ] (} v˙ ] }( v` R }U }v Pv }( ]PR U } ] (} R X H}o }( R R v}
ru ]PR }v ~ Z R ] }( R P]v ˙uv ]v l]v ~]vP }v]}v }R Rv ]v RZV ~ Z
- R ] }( R } } uo}˙ } R uo}˙ }( uu }( } P} V v ~ Z R ] }( R } }v
PART V
˘]]vP ]}o˙ Pv ]PR } ] (} R X
A RR}o u˙ ˘] ru ]PR ]vP ]} }( o `} `l (}u R }( R vv}vuv
}( R ] }( R X P v } R A o }( A }]}vU R RR}o R Gvo MvP u˙ ] }
˘o R ru ]PR }( RR}o X A }o}v }( R RR}o R Gvo MvP } ] } ˘ -
o R ru ]PR } } ]Pv } B} }( D]} } }} }˙ R}] } } }U u˙ }vo˙
- } }v R }}o }( } B} }( D]} `]R R }vv }( R ui}]˙ }( R v}vr˘ ]} X
A }o}v }( R RR}o R Gvo MvP } ˘o } ] ru ]PR U } } R}] }
B} }( D]} } ˘o } ] ru ]PR U ] ui}]˙ }( o `}rR] }( R } U
]( o Rv æA9 }( } ] v }v]vP R ]o ] v } v R Gvo MvPX
W]R } v ] v }( R v } }o}v }( } B} }( D]} U R ru ]PR }(
RR}o u˙ ] } ˘o ˙ }o}v }( } B} }( D]} ]( v ]v}( } B} }( D]}
] ]Pv } } } ˙ R RR}o R Gvo MvPX A }o}v }( } B} }( D]} } ] }
˘o ru ]PR v }vo˙ lv `]R R }vv }( R ui}]˙ }( R v}vr˘ ]} X
TR ]Pv}v }( } B} }( D]} R }˙ }uv } ] } ˘o R ru ]PR u˙
˘v ˙ }o}v }( R RR}o R Gvo MvP (} ]} v} ˘]vP . ˙ ]v R X
D ]Pv}v ˙ }o}v }( R RR}o R Gvo MvP vv} `]R`v vo u]v }R`]
R u }( ]Pv}vX
- S o} æX Xæ SI }( SR _ `]R } R v ]PR }( R B} }( D]} } o]u] } ˘o
- ru ]PR X
5.2.7 Acquisition of Shares in argenx’s Capital
-
W u˙ v} ] (} } }`v R }v ] X W u˙ ] (oo˙ ] r R v˙ ]u (} v} }v] -
]}v }U ](P
{  } RR}o [ ]˙ o R ˙uv ] } ul R ]]}vU } v} (oo o}` R u }( oo r
v ] r]v R ]o v v˙ }˙ V
{  ` v } ]]] `}o RL v} R}o R } R}o oP } R `]R v PPP v}u]vo
o ˘]vP æA9 }( } ] R ]oV v
{ } B} }( D]} R v R}] R} ˙ R RR}o R Gvo MvPX
-
A }( R R}]}vU R RR}o R Gvo MvP u ](˙ R vu }( R R u˙
R U R uvv ]v `R]R R R u˙ ] v R ] vP `]R]v `R]R R R u˙
] X Av R}]}v ˙ R RR}o R Gvo MvP } } B} }( D]} (} R R }(
R v Pv (} u˘]uu ]} }( u}vR X N} R}]}v }( R RR}o R Gvo MvP
] ] ]( }]v˙ R ] ˙ `]R R ]vv}v }( v(]vP R }]v˙ R } } uo}˙
v R E ]˙ Ivv PovX A }o}v }( } B} }( D]} } R R v }vo˙ lv `]R R
}vv }( R ui}]˙ }( R v}vr˘ ]} X
SR Ro ˙ ]v } }`v R ]o } v} ˙ ]PR } v˙ ]]}vX FRu} U v} }vP ]PR u˙
˘] (} v˙ }( R R Ro ˙ } } ]]] vo R R i } R ]PR }( (
Share Capital | 213
 Lisa Ann

PART VII
PART VI
S]v P«vP ]lU L] Avv R v o} }( u `]R
}R }o ]Pv} `]R uR]P oP] X Iv
R }v}v U R o} R } R u}}vo
(} P] U `R]R L] R v} R } }v]
]v R ] i}v˙X L] Avv ] R ˘]v
]v lo]vP R ] `]R} Po P] P

This is the story of SI ]vR R P]U } I ]vR R } `}˙ }

}u}˙ o R u}}vo }vv}vX I ]vR R } -

Lisa Ann from Boston, u}˙ (}]vP u } P } }( v P} } `}lX I( I

]vR `v } o}R }v u˙ `R}o l `
`U v o} }( u˙ (}v ` `U R ` .v X I l]v }(

New York ] v vP R I o] o}v U R I ` o

} v} oo v˙}˙ ]v} R] u X_

L] Avv ` `}l]vP v }`v }( uoo R}}PR˙ .u ]v S}P
S]vP U N` Y}l `Rv R R R . }]uuv 'lX
Live today, not in the future.
F]voo˙ R]vP R uR]P oP] ]Pv}] R o
} }u ]P RvP ]v L] Avv[o](U ]vo]vP v`
}v R}` R `v } o] R o]( L uv˙
˙ }( o«vP R ˙u}u v ] ] R -
]]}v X H ] `R R R } ˙ }v R R ]u[
«P

SY} lv}`U R R ]+v `v o]]vP ˙} o](

R `˙ ˙} `v } o] ] v o]]vP ]v ( oo R u X
I R}} } o] u˙ o](U `R]R ]vo P«vP }v R
u}}˙o v P}]vP v (o]vP R `]v ]v u˙ (
Patient v (o]vP R v }v u˙ }˙X I R}} } o] R] `˙
Story I }o R ] ]v u˙ }}u `]R Ro( }( u˙
l]vX I }o R ] }v u˙ R}}u G}} I ]vR X
I R}} } o] }˙U v} ]v R ( XS

214 | Patient Story Patient Story | 215

} } oP ]v (} }( }v }R Rv } ] ]]] v R }vP ]PR ` ]v R oP } A R }( R] Uv]o RP]}v D}uv U ( ` ` U R v} ] } ]v] o}vR]
( ˙ (} } ] ]]] ] R R X N]R ` v} } ]]] u˙ ˘] }vP ]PR `v v v˙ }( } ]Pv].v RR}o X
]v }( R (} `R]R ` } } ]]] R ]PR }( ( } oP X C]o V}vP
Nu ]v Nu ]PR
Nu}(Bv.]oO`v }(R ~vPZ }(}vP]PR ~vPZ

5.2.8 Reduction of Share Capital TXR}`P]G}UIvX ~Z

UııU ~Z
X UıU ~Z
Xæ

PART V
FMRLLC ~Z
æUæUı ~Z
ıX æUæUı ~Z
ıX
TR RR}o R Gvo MvP u˙U }v }}o }( } B} }( D]} `]R R }vv }( R u - AvIvuvGPLLC ~Z
UææUæ ~æZ
æX UææUæ ~æZ
æX
i}]˙ }( R v}vr˘ ]} U }o } R ] R ]o ˙ voo]vP R } ˙ uv]vP R
F]˙
E MvPuvC}uv˙
A o }( A }]}v } R v}u]vo o }( R R X Ovo˙ R Ro ˙ } R (} `R]R ` R}o R UıæU ~Z
Xı UıæU ~Z
Xı
}(Pvv˙ov] ~Z

}]˙ ] u˙ voo X A }o}v }( R RR}o R Gvo MvP } R vu }(

J}Rv}vJ}Rv}vIvv}}vWJJDU
C IvX ~Z
UUıı X UUıı X
R u ]Pv R R } `R]R R }o}v o] v u o˙ }`v o (} R ]uouv}v }( R
TRVvPG} ~Z
UıU X
}o}vX A }o}v } R ] R ]o ] ui}]˙ }( o `}rR] }( R } U ](
o Rv æ A9 }( } ] v }v]vP R ]o ] v } v R Gvo MvPX BolR}lUIvX ~Z
UıUı ~Z
X UUı ~Z
æX
B]oo]G]+}C}X ~Z
UıU X
Woo]vP}vMvPuvG}LLP ~Z
UU ~ıZ
X

~ Z B }v R vu }( R } ]vU v R u }(U R u} v v v˙ v}.}v .o `]R R AFMX

5.3 Share Classes and Principal ~ Z C}v]vP }( Uæ }]v˙ R v Uıı U æ ADS X TR ] u} v SEC .o]vP `R]R } vu }( æU Uææ R X
~ Z C}v]vP }( }vP ]PR }v Uæ }]v˙ R v Uı æU ı ADS X
~ Z TR ] u} v SEC .o]vP `R]R } vu }( U U R X

Shareholders
A MR U R ] R ]o }( Pv˘ SE u}v } ƒæU ı Uæ X v ] v ˙ æ Uı æU
}]v˙ R X TR }vo˙ }]v˙ R U v R v} ]o ]PR 'R } v˙ }( R }]v˙ R U
v} ]o RR}o ]PR U ]vo]vP }vP ]PR U (} v˙ }( } RR}o X
~æZ C}v]vP }( æU }]v˙ R v U ıU ı U }]vP } R AFM .o]vP U }]}˙ ] v R vu }( }vP ]PR X TR
] u} v SEC .o]vP `R]R } vu }( U U æ R X
~ Z C}v]vP }( Uæ U }]v˙ R v U ADS v R vu }( }vP ]PR X
~ Z C}v]vP }( U Uı }]v˙ R v Uıæ U }]vP } R AFM .o]vP U }]}˙ ] X
~ Z C}v]vP }( }vP ]PR }v U æ U }]v˙ R v U æıU }]vP } R AFM .o]vP U }]}˙ ]
~ıZ C}v]vP }( }vP ]PR }v Uæ æU æ }]v˙ R U ıU ı ADS v U ]˙ ` X

Av˙ voR}o]vP v P} R} }]}v]v]]vP]v}v v R `]R ]o}v}oo]vP ]PR R}
v}. XAv]]vP]v}v] o]o]u] }uv˙~vuo}vv}}RZ]v}} v DRo``R}
~}]˙ ] (}Z R u]'} ]vP}v Po ul]vRNRov }]vv}R uu
}( R E}vUv]}v} vEASU} oPov˙]v}} v Ro`}( R ]v} vEUuu
v `R} ~}]˙ ] (}Z R u]'} ]vP}v Po ul]vRNRovX
A }}v R vo R}o]vP } R} }]}v o } ˘ A9 }( R ] ]oU R R}o R}o }
R] X S vo˙U ] R}o v}(˙ R AFM P]v `Rv R] vo R}o]vP } R} }]}v }v vo˙ R U
˘ } (oo o}` RR}o X TR] v ˙ R ]]}v } ]}o }( R ˙ R RR}o }
R ] ]o }( R ]]vP ]v }v ] ]v } X P v } R æX }( R DFSAU ov
RR}o P A9U æA9U A9U æA9U A9U æA9U A9U A9U æ A9U A9U æA9 v ıæA9X P v } L D R oP]o
}}o o]R (} }vo}v }v M˙ U ı ~R }vo}v ]} }( `R]R v }v Jo˙ U ZU RR
}o }( A9 u˙ } R] o] U R}`U ] ] v} ˙ o ]( v `Rv R] RvP `]oo v ]v} + X
TR ˙ } v}(˙ o] } oPo v `oo vo }v X
A }( R }( R] Uv]o RP]}v D}uv U R (}oo}`]vP ui} RR}o]vP (oo v R uv}˙
v} }]]}v }( R æX }( R DFSA }v R ] }( ]v(}u}v }] ˙ R RR}o v l} R o]
P] }( oo v}.}v u ]oo v } R DFSA R AFM[`] } R }( R] Uv]o
RP]}v D}uv ~ o} }v æX SGvo D ]}v }( SR C ]o_ }v P v (R ZX N} R
R}o]vP } A9 ` } } R C}uv˙ ]o˙X
5.4 General meeting of Shareholders
and Voting Rights
-
TR A o }( A }]}v }] R R vvo Pvo uvP u Ro }v R }v T˙ }( R u}vR
M˙X OR Pvo uvP `]oo Ro `Rv } B} }( D]} u R } v ˙X SRR}o
vvP o}v } ]v PPP o }v rvR }( } ] v }v]vP R ]o u˙U v } R
- D R C]]o C} U R Pvo uvP }vv X W]R]v R u}vR }( ] }u]vP v } }
B} }( D]} R } ]˙ R } v u}v o } } o}` Rv }v rRo( }( R ] r]v v oo r
]oU Pvo uvP `}o Ro } ] v˙ ]] u X
-
W`]oo P] v} }( R Pvo uvP ˙ o]}v }v } `] v (Ru} U } R ˘v ] U ]v
v}R uvv ]v }v `]R R o]o }l ˘RvP Po}v X TR v} }vv]vP v˙ Pvo uvP
u ]vo U u}vP }R ]u U v Pv ]v]vP R o v }( R uvP U R ]u (} ] ]}v v
}vP U R } ]vP (} P]}v ]vo]vP R P]}v U `oo v˙ }}o (} R Pv X P v
} D R o`U RR}o R}o]vP o A9 }( } ] v }v]vP R ]o R ]PR } }
B} }( D]} } ]vo ]u }v R Pv }( R Pvo uvPX O B} }( D]} u P } R
- U }] R ~]Z R ` u ]v `]vP v u} U v ~]]Z R ` ] ˙ R CR]
}( } B} }( D]} o ]˘˙ ˙ ]} } R }( R Pvo uvPX

TR }o vu }( }l }}v v ] }l v] }v]vP }( MR U u}v } æUæ U æ X O B} }( D]} u P] v} }( Pvo uvP U ˙ o R vu }( ˙ ]} } R ˙ }( R

uvP ] ˙ D R o`U `R]R ] vo˙ (}˙r`} ˙ X
A R }( R] Uv]o RP]}v D}uv U ` v} ]o˙ } ]v]o˙ }`v } }v}oo ˙ v˙ R -
R}oU `RR ]v]]oo˙ } vP ]v }v X W v} ` }( v˙ vPuv R u˙U v U E R R R}o ~ `oo }R }v `]R }vP ]PR } u vP ]PR Z u˙ 'v R Pv o u vP U }
o ]v RvP }( }v}o }( } }uv˙X R Pv o u vP v U ]v } ( R˙ R R ]PR U } ˘] }vP ]PR } } ] R R}o]vP U

216 | Share Classes and Principal Shareholders General meeting of Shareholders and Voting Rights | 217

]R ]v }v } ˙ }˘˙X SR R}o u˙ ˘] R ]PR U ]( R˙ R R}o }( R }v R P]
}v `R]R ] vo˙ R R ˙ (} R ˙ }( R u vP U v R˙ } R] }˘˙ R v}. }
B } }( D ] } }( R] ]vv}v } 'v R u vP ]v `]vP R v ˙ R ]. ]v R
v} }( R u vP X
E R RR}o u˙ }v } (} R }]v˙ R Ro X
Mu }( } B} }( D]} u˙ 'v Pvo uvP ]v `R]R R˙ R v ]}˙ }o X TR }vP ]PR
'R } R v o}vP R R Ro ˙ X
R}o}v }( R Pvo uvP lv ˙ v }o ui}]˙U ˘ `R D R o` } } A o }( A }]
}v }] (} o]. ui}]˙ } vv]u]˙X
Ov Pvo uvP ` Ro ]v X TR vvo Pvo uvP ` Ro }v M˙ U X Iv R] uvP ]]}v
` lv }v R }}v }( R v` uv}v }o]˙U R }o }( R uv}v } U R }}v
}( R vvo }v U R oo}}v }( o} ]v R .vv]o ˙ U R o }( R uu }( } B}
}( D]} (}u o]]o]˙ (} R] ] } ]v R .vv]o ˙ U R }]vuv }( Y}vv
Gv v}vr˘ ]} } } B} }( D]} U R }]vuv }( AvR}v˙ R}vP v}vr˘
]} } } B} }( D]} U R R}]}v }( } B} }( D]} } ] R v Pv ]PR }
] (} R ]v } R ]o } u˘]uu }( A9 }( R }v]vP ]o R }( R Pvo
uvP (} ]} }( u}vR (}u R Pvo uvP v } o]u] } ˘o }˙ ru ]PR U v R
}]vuv }( D o}]' A }vv BXVX ˘vo ]} }( Pv˘ (} R .vv]o ˙X
5.5 Anti-Takeover Provisions
V]} } u }]o v u]]o `]R]v R }v] ˙ D R o` v D R o`X
WR v} ]uouv ]. u `]R R ]u }( ]vP l} 'u X H}`U ` R }
o }]]}v R u˙ R R + }( ul]vP l} }( Pv˘ u} ]8o } o ' U ]vo]vP
]uv R ]v u' U ]vo]vP v uvuv }( } A o }( A }]}vU u˙ }vo˙ }PR } }
RR}o (} } }v }}o ˙ } B} }( D]} X N} l} ] R v ]vP ˙ R] ]v
}( } ]˙ ]vP R ]} .vv]o ˙ v R v .vv]o ˙X
5.6 Amendments of Articles
of Association
TRRR}oRGvoMvPu˙}o}uvRAo}(A}]}vUR}}o}(}}}(
]}U`]RR}vv}(Rui}]˙}(Rv}vr˘]}X}o}v
A ˙RRR}oRGvo
MvP}uvRAo}(A}]}v]]uoui}]˙}(R}]vuvP]v`R]RoRo(
}(}]v}v]vP]o]v}vU}o`}rR]}(R}U](oRvRo(}(
}]v}v]vP]o]v}vRuvPX
CRvP]vPR]PR}(v˙}(RRR}o`]oo]RAo}(A}]}v}uvX
218 | Anti-Takeover Provisions
5.7 Obligations of Shareholders and
-
Members of the Managing Board
to Disclose Holdings
PART V
SRR}o u˙ i } v}.}v }o]P}v v R DFSAX P v } R æX }( R DFSAU v˙ -
}v `R}U ]o˙ } ]v]o˙U ] } ]} }( v o } }vo ]o ]v v l} }vP ]PR u
- ]uu]o˙ P] `]'v v} } R AFM }( R ]]}v } ]}o ˙ uv }( v (}u ](U o }(
R ]]}v } ]}oU R vP }( ]o ]v v l} }vP ]PR Ro ˙ R }v R U ˘
} (oo o}` R (}oo}`]vP RR}o P A9U æA9U A9U æA9U A9U æA9U A9U A9U æA9U A9U æA9 v ıæA9X P v }
L D R oP]o }}o o]R (} }vo}v }v M˙ U ı ~R }vo}v ]} }( `R]R v }v
Jo˙ U ZU RR}o }( A9 u˙ } R] o] U R}`U ] ] v} ˙ o ]( v `Rv R] RvP `]oo v
]v} + X Iv ]}vU v˙ }v `R} ]o ]v } }vP ]PR R U ˘ } (oo o}` RR}o
} RvP ]v } }v]vP R ]oU } ]v } R v }v R R v}. } R AFM ˙ U
- R}o v}(˙ R AFM v} o Rv R (}R ]vP ˙ L R AFM R o]R } v}.}v }( R RvP ]v
] }v]vP R ]oX
E R }v R}o]vP v ]v ]v } R ]o } }vP ]PR }( A9 } u} R u }( u]]}v }( } R
} ]vP u ]uu]o˙ v}(˙ R AFMX FRu} U ˙ R}o }( A9 } u} }( } R ]o } }vP
]PR `R} ]v D u u]v]PR ]+ (}u ]} v}.}v } R AFM u v}(˙ R AFM
`]R]v (} `l X
F} R } }( oovP R vP }( ]o ]v } }vP ]PR U R (}oo}`]vP ]v u lv
]v} }v P ~]Z R v l} }vP ]PR ]o˙ Ro ~} ] } ]} }( Z ˙ v˙ }vU ~]]Z R v l}
}vP ]PR Ro ~} ] } ]} }( Z ˙ R }v[ ]]] } ˙ R] ˙ (} R }v[ }v
} ˙ R] ˙ `]R `R}u R }v R }vo v }o } `]'v }vP Puv U ~]]]Z }vP ]PR ]
v } v Puv }]]vP (} u}˙ v( }( }vP ]PR ]v }v]}v (} ˙uv U v ~] Z
R v l} }vP ]PR `R]R R }vU } v˙ }v}oo v˙ } R] ˙ ( } } U u˙ ]
v } v˙ }}v } }R ]PR } ] R v l} R 'R }vP ]PR X
S]o o o˙ } R ']}v }( R v l} }vP ]PR R }( R } ˙ }( vR] } }R
(}u }( i}]v }`vR] X A R}o }( oP } ]PR }( ( ]v }( R v o} i } v}.}v
}o]P}v U ]( R }v R U } v ] U R ]PR } } }v R R X TR ]]}v }( ~}v]}voZ }vP
]PR ˙ oP } v.]o }`v u˙ o}
]PP v}.}v }o]P}v ]( R oP } v.]o }`v ` R oPo R}o }( R R v l} }vP
]PR X W ] } v}(˙ R AFM }uo˙ }( v˙ RvP }( A9 } u} ]v } ] v }v]vP R
]o } }vP ]PR ]v R ]} v}.}vX TR AFM u v}. }( }R RvP ]v } ] v } -
v]vP R ]o } }vP ]PR `]R]v ]PR ˙ L R v }( R ]v `R]R R RvP } X TR
AFM `]oo o]R oo } v}.}v }( } ] v }v]vP R ]o v }vP ]PR ]v o] P]X I(
}v[ ]o ]v v l} }vP ]PR RU ˘ } (oo o}` R } ruv}v RR}o o }(
RvP ]v } ] v }v]vP R ]o } }vP ]PR U R }v ] ] } ul v}.}v v}
o Rv }v R (}R ]vP ˙ L R AFM R o]R } v}.}v ] } X
F R u} U R uu }( } B } }( D ] } v ]v }R }v `R}U ]v o] U R ~} r Z uvP ]o
}v]]o]] U `oo ]v }v o} o˙ }] `]R v˙ R uu } }R }v U u ]uu ] -
o˙ P] `] v v}] } R A FM ˙ u v }( v (}u }( v˙ RvP ]v R] } R R}o]vP }( } R v
}]vP ]PR X
 Obligations of Shareholders and Members of the Managing Board to Disclose Holdings | 219
5.8 Short Positions 5.10 Transparency Directive
E R }v R}o]vP v R} }]}v u}vvP } X A9 } u} }( R ] R ]o }( D R o] }u - W E } v o] }u v˙ `]R o]u] o] ]o]˙ ~ Societas Europaea or SE Z ]v} } v ˘] ]vP v
v˙ u } ] } R AFMX E R v ]v }( R] }]}v ˙ X A9 } X A9 `]oo o} R } } X R o` }( R N R ov X TR N R ov ] } E } v Uv]}v R}u uu ~ lidstaat van herkomst Z (}

PART V
E R v R} }]}v o } XæA9 }( R ] R ]o }( D Rro] }uv˙ v v˙ v ]v R } }( D ] ] l ı lEC ~ uv ˙ D ] ] l æ lE U Z U } R Tv v˙ D ] ] U
}( R }]}v ˙ XA9 `]oo u o] ] R AFM R} oo]vP P]X T} oo `RR vo }v }v v }( `R]R ` i } R D FSA ]v }( ]v }vP}]vP v v˙ v ] o} }o]P -
} oPo }v R v R} }]}vU R] R} }]}v v o}vP }]}v u }+X A R} v}v ]v ]}v X Iv ]]}v U o}vP } R o] }v E }v˘ B o v R A D S }v N U ` ] }
R v }vo˙ }v ]( }vo v u R R R }o v oo˙ o] U `R]R ] o} v˙ Po ]v(}u ]}v `R]R R v ] o} v } R D FSA `oo ]v } v `]R R B o -
] }v.u}v }( R] ˙ R R R R v o} X TR ] o} v }o]P}v } v}(˙ R AFM }( P]v A }( M˙ U U R B oP]v R}˙o D }( N} u U v N o] ]vP o X W u o]R
P} R} }]}v X TR v}.}v RR}o R u o˙ ]v }( R v}.}v }( o } }vo } vv o }v `]R]v (} u}vR ( R v }( R (]vv]o ˙ v } Ro(r˙ o˙ (]P `]R]v `}
]o ]v ]v R ]o v l} }vP ]PR U ] } X u}vR ( R v }( R (] ]˘ u}vR }( R (]vv]o ˙ X W]R]v (] ov ˙ ( } ]}v }( }
vv o }v U ` u (]o } } vv o }v `]R R A FM X P v } R D FSA U ` `]oo ] U
TR AFM l o] P] }( oo v}.}v u v } R ]o} }o]P}v v o]R v˙ v} - u}vP }R R]vP U } ul o] `]R} o˙ v˙ RvP ]v R ]PR R]vP } } R } v˙ ]PR }
.}v ] X Iv U v} R} }]}v ` o } R AFMX ]}RX

5.9 Market Abuse Regime 5.11 Dutch Financial Reporting

Supervision Act
TR Ml A RPo}v ~RPo}v EU vX æı l U MARZ v o C}uu]]}v IuouvvP RPo}v v
D oP RPo}v U }] (} ]. o R ]vv } v ul U R R }R]]}v }v ]v]
]vP U ]oP]vP ]v] ]v(}u}v v ]vP U v ul uv]o}v ~R European Union Market Abuse RulesZX TR D R F]v v ] o R } ]vP S ] ]}v A ~ Wet toezicht financiële verslaggeving Z ~ R DFSA Z o] } (]v v -
W i } R E }v Uv]}v Ml A Ro v v}vr}uo]v `]R R o u˙ o } ]u]vo ] o ˙ ]vP ( }u J v ˙ X Ov R ] }( R D FSA U R A FM ] R o] ]}v }( (]v v ] o
.v U u]v] .v U ]u]}vuv } }R v}v X } ]vP v ˙U u}vP } R U }u v] `R} } } ] ]v R N R o v v `R} ] ]
o] }v D R R P o M l } (} ]Pv } l ˘R vP X P v } R D FSA U R A FM R v ]v -
TR}v
E Uv]}vMlRo A }vuluv]o}vu˙]}]o]˙}˙l]RXIv]v] - v v ]PR } ~] Z v ˘ o v ]}v ( }u P ]vP ] o] ]}v }( R o] o (]v v ] o } ]vP
uvU}]v}vo}i}R}v E Uv]}vMlRo A XPv}oA ıMAR~SMvP - v v ~]] Z }uu v } R u l]vP ]o o }( ( R ˘ o v ]}v X I( ` } v} }u o˙ `] R R
[v}v_U
Z uu}(}}B }(]}
D vv˙v]}˘`R}RPo}]v]]v(}u}v - } }uu v ]}v U R A FM u ˙ R R E v ] C R u } } ~] Z u l ]o o ( -
ovP]o˙}]v]o˙}vRR}`}luvP]o]]}v+vPR(o}uvv]v R ˘ o v ]}v }uu v ˙ R A FM U ~]] Z } ] v ˘ o v ]}v }( R `˙ ` R o] R o] -
}}(U~}v]RP]vPuvP]o}v]]o]U PDMRsU
Z uv}(˙RFM
A }(˙v}v}v o (]v v ] o } ]vP v } ] (]v v ] o } } ~]]] Z } (]v v ] o } ]v } v `] R R
}vR]}`v}vovP}}R}]vuv}}]}}R.vv]o]vuvo]vlR}X E v ] C R u [ ]v ]}v X

Iv]}vU]v}vo}o˙}]`]R}PDMRuo}v}(˙RAFM}(˙v}v}v}v TR] Uv]o RP]}v D}uv o} }vv R vvo .vv]o }vP `]R]v R uv]vP }( æP æ ~ Z DFSAX
R]}`v}vovP}}R}]vuv}}]}}R.vv]o]vuvo]vlR}X
MARu]vR(}oo}`]vPP}]}(}vP~]ZR}}v˙v}v]˙v}voo`]ov
}R}U~]]ZvvR]ovU~]]]Z}Ro`R}RRRuR}R}o(}o}v˙R

5.12 Dividends and Other Distributions

ovv}vv~]ZoPo}vU}vR]URuvP]o}v]]o]}(`R]R] -
RP˙}v]RP]vPuvP]o}v]]o]}˙}v(}]v}]v~]ZU~]]Z}~]]]ZU`R]R]]o˙
}]v]o˙}v}oo˙R}vU`R]R](}Rv.}(R}vU}R}v}u]]v}(`R]R
voo˙]ov}R}}(R}vXTRv}.}vuuv}oRv}vRR]]v
˙(}oo}`]vPRv}vv˙uv}(v(}uXTRv}.}vu˙}}vvoRu}uv WR v} ] } o v˙ R ]]v }v } }]v˙ R U v ` } v} v] ˙]vP v˙ R
RRo}(Rv}v(}u(}RPDMRR}v[}`v}vU}v}v]}˙R ]]v ]v R (} o ( X Aoo }( } }v]vP R R R u ]]v ]PR X W]vv } ]v oo
}vo}o˙}]`]RR}vUR}˘vu}v}(ƒæU]vRov˙]v}vX ]oo (v v v˙ ( v]vP } (v R o}uv v ˘v]}v }( } ]v X

TR AFM l o] P] }( oo v}.}v v o ı MARX TR] v } v}. } - Ev ]( ( }}v o } ]Pv].v oo }( ]] o }. U ` vo˙ ]vv R v˙ v]vP `]oo
uoo˙ ˙ ru]o }( RvP } R o] P]X P v MARU ` `]oo u]v]v o] }( ] ]v] X Iv ]}vU } AI]v ]v } ]v v R R ]]v `]oo v} ] vo ` R v o]R v u }
(R v }uo]v `]R MARU ` R } v ]vvo }o]˙ ovP } R } ]}v }( v v}v } }vv]vP R ]]v X Iv ]}vU ˙uv }( v˙ ( ]]v } RR}o `}o i }
˙ uu }( } PDMR v uo}˙ ]v } R } ]v .vv]o ]vuv }( `R]R R o ] ~}Z u]v RR}o }o } Gvo MvP U }v }}o }( } B} }( D]} U `R]R }}o `}o i
˙ R o }( } R X O Iv] T]vP P}o]˙ R v o]R }v } `] }v R' Pll```XPv˘X}ul } R }o }( R ui}]˙ }( R v}vr˘ ]} L l]vP ]v} }v ]} (} ]vo]vP } ] -
]v} lP}vv lo r} r}uo]v X v } U R ]uv U .vv]o (}uv v v` } o}uv X

220 | S
 hort Positions Transparency Directive | 221
Under Dutch law, a Dutch European public company with limited liability (Societas Europaea or SE) may only pay dividends
if the shareholders’ equity (eigen vermogen) exceeds the sum of the paid-up and called-up share capital plus the reserves
required to be maintained by Dutch law or our Articles of Association. Subject to such restrictions, any future determina-
tion to pay dividends would be at the discretion of the shareholders at our General Meeting.

Our Articles of Association, as incorporated into this URD by reference (see section 9 “Information incorporated by refer-
ence”) contain the provision on the distribution of profits in its article 20 (Profits, distributions and losses).

5.13 Financial Calendar 2022

MRU (oo˙v(}R.vv]oo
M˙æU ..vv]oo
M˙U vvoPvouvP
Jo˙U Ro(˙v}v.vv]oo
O}U R].vv]oo

222 | Financial Calendar 2022

6
Operating

PART VI
and Financial
Review
Contents
6.1 Overview 226

6.2 Basis of Presentation 227

6.3 Capitalization and Indebtedness 233

6.4 Critical Accounting Policies and Significant Judgements 234

and Estimates

6.5 Results of Operation 235

6.6 Liquidity and Capital Resources 241

6.7 Off-Balance Sheet Arrangements 243

6.8 Contractual Obligations 243

6.9 Financial Statements 244

6.10 Information Regarding the Independent Auditor 244

6.11 Material Contracts and Related Party Transactions 244

6.12 Employees 246

6.13 Legal and Arbitration Proceedings 247

6.14 Insurance 247

6 
Operating and v] X F} R ˙ v D u U v U ` ]v } o }u Rv] o} }( ¤ æ X
Financial review
6.1 Overview
S]v } ]v ]}v ]v U ` R (} u} }( } (]vv]o } v ((} }` o}]vP }
SIMPLE A v]}˙ ¡ Po (}u v v]}˙ vP]v ]vP Rv}o}P] U ] v](˙]vP } v]o } v] U
o]R]vP } U o}uv v uv( ]vP ]o]] (} } } v] v v]vP uo]o
] } ˙ }P u ]v} R o]v] X W v]vP ] o]v }( }R o]v] o r v o]v] o r P }
v] (} R uv }( v }u o U Ru }o}P˙U u }o}P˙ v v R}o}P˙ ]v] ]}v `]R]v }
P}`]vP }uu ]o ( vR] X L P]vP } Rv}o}P˙ ] v o]v] o ˘ ] U ` R v o
v] ]v} o r P o]v] o o}uv v ` vo˙ R uo]o }P u ]v R ] } ˙ P X
TR}PR D u U U ` R ] v PP P P} } }( ¤ U æ X u]oo]}v U ]vo ]vP P
]X v PPP }( ¤ æX u]oo]}v ~ƒ X u]oo]}vZ (}u R ] ouv }( ]˙ ] ]v U ı v V
]]X ¤æ Xı u]oo]}v ~ƒ X u]oo]}vZ (}u } ]v]o o] }+]vP }v R E }v˘ B o ]v V
]]]X¤æ Xı u]oo]}v ~ƒ X u]oo]}vZ (}u R ] ouv }( ]˙ ] U ]u]o˙ } UXSX ]v }vo
]v} U ]v V
]X ¤ X u]oo]}v (}u } ]v]o UXSX o] }+]vP }v R N Go}o So Ml ]v M˙ V
X ¤ æXæ u]oo]}v (}u } }v UXS o] }+]vP }v R N Go}o So Ml ]v D u V
]X ¤ X u]oo]}v (}u } R] UXS o] }+]vP }v R N Go}o So Ml ]v Su V
]]X ¤ Xı u]oo]}v ~ƒ X u]oo]}vZ (}u R ] ouv }( ]˙ ] }( R o}]vP }( R Po}o
}oo}}v v o]v Puv `]R Jvv ]v Jv˙ ıV
]]]X¤ææ X u]oo]}v ~ƒæ X u]oo]}vZ (}u Po}o }+]vP ]v N}u ıV
]˘X ¤æı Xæ u]oo]}v (}u } UXSX o] }+]vP }v R N Go}o So Ml v ¤ X u]oo]}v ~ƒ X u]oo]}vZ
(}u }v v ] ouv ]v M˙ V v
˘X ¤ U ı X u]oo]}v (}u (}u } UXSX o] }+]vP }v R N Go}o So Ml ]v Jv˙ X
Iv ]}vU }( D u U U ` R ] (}v ˙uv U u]o}v ˙uv v R v o
}uv ] ( (}u } }oo}} }o]vP ¤æ Xı u]oo]}vX A }( D u U U ` R RU R ]
ov v v .vv]o }( ¤ U X u]oo]}vX
O ov R R}` } }o uo } ¤ U æ X u]oo]}v (} R ˙ v D u U U }u
} ¤ U ıX u]oo]}v (} R ˙ v D u U v ¤ U X u]oo]}v (} R ˙ v D u U
ıX TR u]v }v (} R u]o RvP ]v ov R }o R ]} ]˙ .vv]vP }v ~ ]
]v }v æX X SH]}˙ }( SR C ]o_ZU }uo } R ]} } ˙ R .vv]o uv ]v}}
R]v ˙ (v ~ }v ı SIv(}u}v ]v}} ˙ (v _ZX
S]v } ]v}vU ` R ]v ]Pv].v }vP o} X Ov D u U U R FDA } (PP]
u} U `R]R ] ul VYVGART¡ ~(PP]u} o(r( ZU (} R uv }( PMG ]v o v `R} ACRR
v}˙ }] X Ov Jv˙ U U R Jv PMDA } VYVGART¡ ~(PP]u} o(Z (} R uv
}( o v `]R PMG `R} } v} R 8]v }v } }] } v}vr}]o ISTX TR R }vo˙
} } ` vo˙ R v ` R v} Pv v˙ v (}u } o vo R v }( R
.vv]o ˙ v D u U X
O ]o]˙ } Pv v ((]]v } R] }(] ]o]˙ `]oo v ]Pv](] vo˙ }v R (o }u
u ]o] ]}v }( } } } v o}uv v v o }uu ]o] ]}v }( }v } u} }( } }
226 | Overview
u]oo]}v v ¤ X u]oo]}v U ] o˙X A }( D u U U ` R uo o} }( ¤ U X u]oo]}v X
W˘ } ˘v } ]v voo˙ ]v }vv}v `]R } (R v]}v } v ]vP ]uuv}o}P˙
}uv˙U ]vo]vP R (R ]o r} }( Po}o }uu]o ]v( v P } ]vv}˙ ]v o]PR }( R
Po}o ovR }( VYVGART¡ (} R uv }( PMGU R vuv }( } o]v]orP ]o]v U ]vo]vP }vP}]vP
PART VI
P]}vo ]o } (} ]v]}v }( (PP]u} U v }vv ]vuv ]v } IIPX Iv ]}vU ` ˘
} }vv } ]v ]Pv].v } }] `]R }vP o] }uv˙ ]v R UXSX W v] R }
˘v `]oo ]v voo˙ ]( v ` P
Research and Development activities:
{  ˘ R PR o]v]o ]o }( (PP]u} ]v ITPU CIDPU PF v ]v PVV
{  ˘RPRlo]v]o]o}((PP]u}]vP B vu˙}]vovRPRlo]v]o]o]v}R]v]}vV
{  }vv R R v o}uv }( } }R o]v]or v o]v]orP } v] v ]}˙
P }Pu V v
{  l Po}˙ }o (} v˙ } v] R (oo˙ }uo o]v]o ]o X
Pre-commercial and commercial activities
{  (R ]o r} } o U ulvP v ]]}v ]v( v o r uv( ]vP ]o] }
}uu]o] VYVGART¡ (} `R]R ` }]v R Po}˙ }o (}u FDA v R PMDA v v˙ }
v] (} `R]R ` u˙ }]v }oV v
{  ˘v } Po}o R vo]vP } }uu]o] v˙ } v] (} `R]R ` u˙ }]v Po}˙
}oX
Other activities
{  l } vRv } Rv}o}P˙ o}u v ]} v o} ]}vo } v] V
{  u]v]vU ˘v v } } ]voo o }˙ }}o]}U ]vo]vP o]P}v } }] `]R (v]vP
P]v ooP v ]v(]vPuv o]u V
{  o]v]oU ]v. U }}voU .vv]o v uvPuv ]v(}u}v ˙u v }vvoU ]vo]vP }vvo
} } } } o}uv v }vo ( }uu]o]}v +} V v
{  ˘]v v˙ o˙ } v}v v˙ ] U ]vo]vP (]o ] U u]P} ]o o U (˙ ] } }R
Po}˙ RoovP X
W˘ R R } }( o}uv v }uu]o]}v u]PR o} ]Pv].vo˙ ]v } v v
( }oo}}v `]R R v o}uv v `oo }uu]o v X
-
-
- 6.2 Basis of Presentation
6.2.1 Foreign currency transactions
Functional and presentation currency
- Iu ]vo ]v R }v}o] .vv]o uv }( R }( } v o ]vP R v˙ }( R] } -
v}u] v]}vuv ]v `R]R R v˙ } X A }( Jv˙ U U v (} oo ]} RLU R }v}o]
.vv]o uv v ]v USD ~¤ZU `R]R ] R C}uv˙ [ v}v v˙X
Change in functional and presentation currency as of January 1, 2021
A }( Jv ˙ U U R C }u v˙ RvP ] (v ]}vo v v ]}v v˙ (}u E UR } USDX TR RvP
]v (v ]}vo v˙ ` u } (o R USD R }u R }u]vv v˙ (} R C }u v˙U
- v]vP ]Pv](] v }( R C }u v˙ [ R (o}` v (]vv]vP X TR RvP R v ]uouv `]R
- } ] (( X
Basis of Presentation | 227
TR RvP ]v v}v v˙U + Jv˙ U U (}u EUR } USD ] } o˙ o] } }u
.P }]vP } IAS v IAS U ]( USD R o`˙ v R v}v v˙ }( R }v}o] .vv]o
uv X TR RvP ` u } ' G R }v}u] (}}]v }( R C}uv˙ [ ]v P}]vP (}` X
TR C}uv˙ o] R R v}v v˙ RvP `]oo P] ]v} v }R lR}o o v
v]vP }( R C}uv˙ [ (}uv } u X
6.2.2 Revenue from Collaborations and license agreements
R v } R }v] ]v] oo˙ }( u]o }v U o] v ( U v}v r(v o (}v ( v R v
o}uv ] ( ]v }vv ]}v `]R }oo } ]}v v o] v P uv X
TR C}uv˙ }Pv] v `Rv R }u }]v }v}o }( }u] P}} } ] U ]v v u}v R
G R }v]}v R R C}uv˙ ˘ } ] ]v ˘RvP (} R} P}} v ] X Iv } }
u]v v }Pv]}v (} Puv R R C}uv˙ u]v } ]v R } }( IFRS æU R (}oo}`]vP
. (}u P
1. Identify the contracts
Iv ] v }oo}}v v o]v Puv U R C}uv˙ ] u]vo˙ o]v]vP ] ]voo o }˙ v l}
}]]vP R v o}uv } v ] U `R]R u]PR ]vo } R]vP uRv]u v l} ]v R
( U oo]vP ] } } }oo} v v X Rv ] Pv R}PR R vPuv ]
(}v ˙uv U u]o}v ˙uv }v o]v]o v Po}˙ ]] U R v o}uv ] ( v
( o r u]o}v v o r }˙o X Iv }u U R }oo}}v v o]v Puv o}
]vo v ]˙ ]}v }u}vv X I( R] ] R U R C}uv˙ vo˙ ]( R ]] } }u]v }v U
} ˙ IFRS æU u X
2. Identify performance obligations
D v]vP }v R ˙ }( R Puv U R v }v } u} ]v (}uv }o]P}v v IFRS æX TR]
] }v v uv }( `RR R }u] ]v v Puv o }( ]vP ]v v ]v (}u
R }R }u] } v( P}} v l} ] ]v R }v˘ }( R }v X
F} } u]o }vP}]vP }oo}}v v o]v Puv ~]X XU R Z ] L APuv U ] ]v }v X X
SO SP] PvR] `]R Z ] L (} (PP]u} _ZU R C}uv˙ R R R ] u} Rv }v ]v
(}uv }o]P}vU ]vP R v( }( o]v v o˙ }( o]v]o v }uu]o } X
TR] ] R C}uv˙ }v] R (}uv }o]P}v ] ]v ]v R }v˘ }( R }v R o]
v R v ro}v o `]R} R C}uv˙ ]vP (R ]v}o ]v R R v o}uv }oo}}v
v R R ] v} ]v vv `v R o]v v R o]v]o v }uu]o o˙ } }] X
F} }R u]o }oo}}v v o]v Puv U R C}uv˙ R R R ] }v ]vPo (}uv
}o]P}v ]v } }oo}}v v o]v Puv U ]vP R v( }( o]v }u]v `]R (}uv }(
R v o}uv ] X
3. Determine the transaction price
O u]o }vP}]vP }oo}}v v o]v Puv ]vo v}vr(vo (}v ˙uv } o]v ( V
u]o}v ˙uv U R ] }( `R]R ] vv }v R R]uv }( ]v o]v]oU Po}˙ } }uu
]o u]o}v V }˙o }v o v R v o}uv ] ( X
{  N}vr(vo (}v ˙uv } o]v (
I( R o]v } R C}uv˙ []voo o } ˙ ] u]v } ]v (}u R }R (}uv }o]P
}v ]v. ]v R vPuv U R C}uv˙ }Pv] v (}u v}vr(vo (}v ( oo} } R]
o]v R }]v ]v u R o]v ] v( } R }u v R }u R R ]PR } R o]v X
F} oo } u]o }vP}]vP }oo}}v v o]v Puv U R C}uv˙ }v] R (}uv }o]P}v
228 | Basis of Presentation
o } R v( }( R o]v ]v (}u R }R }u] } v( P}} v l} ] X TR C}uv˙
o] iPuv } R v }( R (}uv }o]P}v } u]v `RR R (}uv }o]P}v
] . } u } }]v ]v u X I( } u U v ] Rv }Pv] }v 'v R G
- R v( }( }v}o }( R ] } R }uX
{ M]o}v ˙uv }R Rv o u]o}v
PART VI
A u]o}v ˙uv U ]vP ]o }v]}vU ] }vo˙ ]vo ]v R v }v ] } R ˘v ] ] R]PRo˙
}o R ]Pv].v o ]v R u}v }( uo v }Pv]}v `]oo v} } `Rv R v ]v˙
}] `]R R ]o }v]}v ] vo˙ }o X TR C}uv˙ u R u}v } ]vo
]v R v }v ] }v R]uv }( R u]o}v v X TR v }v ] ] Rv oo} } R (} -
uv }o]P}v }v v ro}v oo]vP ] ] U (} `R]R R C}uv˙ }Pv] v } `Rv R (} -
uv }o]P}v v R }v . X A R v }( R }vP ]} U R C}uv˙ ro R
}]o]˙ }( R]uv }( R u]o}v v v˙ o }v]v U v U ]( v ˙U i R u }( R
}oo v }v ] X Av˙ R iuv } }v uo Rr ] U `R]R `}o + v
v v]vP ]v R ]} }( iuv X
{ R R v o}uv ] (
O u]o }vP}]vP }oo}}v v o]v Puv u˙ ]vo ]u uv } } R]vP (} R v
- o}uv ] X R D ] (}u v . } u P]v R R }u ]uov}o˙ -
] v }vu R v. }] ˙ X SR } ]u uv ] }Pv] ]v v `Rv
} ]v v P ˙ R X
{ So u]o}v ˙uv v }˙o
O u]o }vP}]vP }oo}}v v o]v Puv ]vo o }˙o U ]vo]vP }uu]o u]o}v
˙uv }v R oo }( o U v R o]v R v u } }u]vv ]u } `R]R R }˙o
v }uu]o u]o}v ˙uv o X Ro v ] }Pv] R v vo˙]vP o }X
4. Allocate the transaction price
Iv ]v]o U v v˙ Roo oo} R v }v ] } R (}uv }o]P}v ]v. ]v R }v }v
o v ro}v oo]vP ] ] X A } }vP}]vP }oo}}v v o]v Puv ~]X XU R Z ] L APuv U
] ]v }v X X SO SP] PvR] `]R Z ] L (} (PP]u} _Z }v]v u} Rv }v (} -
uv }o]P}vU R C}uv˙ } oo} R v }v ] } oo (}uv }o]P}v ]v. X
-
5. Recognize revenue
Rv ] }Pv] `Rv R }u }]v }v}o }( R P}} v l} ] }] ]v R }oo}}v
v o]v Puv X TR }v}o v v( } u } }]v ]v u W `R]R o ]v R }Pv]}v
}( v } u } }]v ]v u X
A } }vP}]vP }oo}}v v o]v Puv ~]X XU R Z ] L APuv U ] ]v }v X X SO S -
P] PvR] `]R Z ] L (} (PP]u} _Z }v]v u} Rv }v (}uv }o]P}vU R C}uv˙ }P -
v] v }]v ]v u (} v( }( o]v v R C}uv˙ }Pv] v } u (} o˙ }( o]v]o
v }uu]o } }u ]uov}o˙ ] R v. }] ˙ R C}uv˙ [ (}uv U
- . } uX
OR }vP}]vP }oo}}v v o]v Puv }vo˙ }v]v }v ]vPo (}uv }o]P}v `R]R ] U R
}u ]uov}o˙ ] R v. }] ˙ R C}uv˙ [ (}uv U . } u U R C}uv˙
- }Pv] v } u X
TR}Pv]}v}(v}u] }v'vRG R(}v}(Ro (}uv
}o]P}vUo˙]vPR]v uR}XTR]v uR}uR(}v}(R (}uv}o]P}v R
vP}(}o}oo}}v}R}uo R]}}u}R}ou}oo}}v}X
Basis of Presentation | 229
R R v o}uv ] ( }Pv] v `Rv } ]v v P ˙ R
R C}uv˙ ] vP ]v]o ]v R } }( ] l}( R R v o}uv ] }( ] }vP}]vP
}oo}}v v o]v Puv X
6.2.3 Other Operating Income
A }uv˙ R ] ˘v] R v o}uv ] U ` v. (}u ]} Pv U R v
o}uv ]vv v ˙}oo ˘ (}u ]v P}vuvo Pv] X TR Pv v R v
o}uv ]vv Pvoo˙ ]u } o˙ ]u } ˘v] ]v ]v } R v o}
uv +} X TR ]u˙ Pv U R v o}uv ]vv v ˙}oo ˘ (}oo}` P
{  G}vuv Gv
WR ] o Pv (}u Pv] }( R Fou]R P}vuv } } ]} R }Pu (}
}v Rv}o}P]o ]vv}}v ]v Fov X TR Pv ] } u]v]v v ]v R Fou]R P]}v (}
vu }( ˙ v ]v }]vP } P P X
{  R R v D o}uv Ivv
C}uv] ]v B oP]u v v. (}u ˘ ]vP }v u}v v }v R v o}uv ˙ o˙]vP
}v u } ]}] ˘ }v }v R v o}uv ˘v] (} R ]]}v } o}uv }(
v X TR] ˘ ] ] }v }( R }} ]v}u ˘ (} B oP]v }˙ } v ] v(o
} R v˘ (} }vvP ]} X TR ˘ ] ] } ]v R L . ˙ } R ˘v R˙ R v}
v }+ P]v }} ˘ X
{  P˙}oo T˘ R
W o} v. (}u ]v }v ˙}oo `]RR}o]vP ˘ (} ]v. }vvoX TR P}vuv Pv
v R v o}uv ]vv Pvoo˙ ]u } o˙ ]u } ˘v] ]v ]v }
R v o}uv +} v ] } R ]v}u uv U v }R }vP ]v}u U `Rv R
ov ˘v] R v ]v v R ] }vo v R R Pv } R v o}uv
]vv ] ]o X
{  CRvP ]v (] o }v v}vr v .vv]o
Iv MR ıU R C}uv˙ v ]v} o]v Puv `]R AP}uA (} R }( HGFru]u SIMPLE
Av}] ¡U o} v R C}uv˙ [IIPX Iv ˘RvP (} PvvP R] o]v U R C}uv˙ ] }.
R ]v AP}uA X
Iv MR U AP}uA ¤ X u]oo]}v ]v S] B .vv]vP ˙ ]]vP U æ P( B SR X Pv˘
R }ru}v˙ o}v }( S] B .vv]vP }v v R vu }( }v]vP R ]v u]v]vP R (] o
}( R }.rR]vP ]vuv U `R]R o ]v RvP ]v (] o }( v}vr v .vv]o }( ¤ X u]oo]}v
} R}PR }. } o} X TR (] o }( v}vr v .vv]o ] R v }( R }vP
]} X
230 | Basis of Presentation
6.2.4 Research and Development Expenses
R R v o}uv ˘v }v] ]v]oo˙ }(P
{  }vvo ˘v o } }uv}v }( R v o}uv + v o ˘v U ]vo]vP o -
] U v. v R r }uv}v ˘v V
PART VI
{  ˘vo R v o}uv ˘v o } ~]Z Ru]˙U uv( ]vP v }v}o } (} } }
v] U }R (} o]v]o v o]v]o vP U oo }( `R]R ] }v ˙ ]o] }v uv( U ~]]Z
( v }R } ] } }v R }Pv]}v ]v }vv}v `]R o]v]o vP v R (}uv
- }( o]v]o ]o (} } } v] v ~]]]Z } }] `]R Po}˙ u]]}v v }o U o]˙
v v Ru}]P]ov V
{  u]o v }vuo ˘v V
{  ]}v v u}}v }( vP]o v ]vvP]o .˘ } o} } } v] V v
- {  }R ˘v }v]vP }( ~]Z } }] `]R }]v]vP v u]v]v]vP v v }R ]voo o } ˙
v ~]]Z }R } R o ˘v o } R v o}uv ] X
TR (}oo}`]vP o R}` } R v o}uv ˘v (} R R .vv]o ˙ P
F]vv]o˙vDuU
~IvUSDR}vZ ı
RRvo}uv˘v æUæ Uæ U
W]v ]} ˘vo ˘v v } }oo}}v v o]v Puv (} u]o v ] }vu
]v R ]}˙ v o}uv }( } v } v] X Uv } Puv `]R A V] U } }`v
R v o}uv ˘v ` v} ]u X Uv } Puv `]R JvvU ` u ]v
o}uv }o]P}v U v ` i}]vo˙ }v]o `]R Jvv (} oo RU o}uv v Po}˙ }
ovP } R } X Uv } Puv `]R Z ]U ` }v]o (} ]v } ovP } ( o]v]o ]o
]v}o]vP (PP]u} }v oo˙ ˙ Z ]X
O R v o}uv ˘v u˙ ˙ voo˙ (}u ]} } ]} }v R u]vP }( } -
R v o}uv ] U ]vo]vP R u]vP }( R ]v]}v }( o]v]o ]o U } }v }( } R
v v}ouv }( v ]v o]v]o ]o X R R v o}uv ˘v ˘ } ]v ` v
R o]v]o o}uv }( (PP]u} v ARGXr v (R v R R v o}uv }( } }R
o˙ P ]o]v v] X TR (o o}uv }( } } v] ] R]PRo˙ v ]vX A R] u U
` vv} }vo˙ u R v U u]vP v u } }( R +} R `]oo v ˙ } }uo
R o}uv }(U } R ]} U ]( v˙U ]v `R]R u]o v R ]vG}` u˙ }uuv (}uU v˙ }( } }
v] X TR] ] } vu} ]l v v ]v }] `]R o}]vP P U (oo˙ ] ]v
R SR]l F} _U v ]vo]vP R v ]v˙ }(P
{  R } U }( }P v ˘v }( } R v o}uv ] V
{  R (o v}oouv ]vU v }uo}v }( o]v]o ]o V
{  R ]o]˙ } ulU }uu]o] v R] ul v (} (PP]u} ~˘ (} R UXSX v JvZU
} v˙ }R } v] R ` u˙ o} ]v R ( U ]( } V
{  o]R]vP v u]v]v]vP }vv o (˙ }.o (} } } v] V
{  R u U u]vP v ] }( Po}˙ }o (}u o]o Po}˙ R}] V
{  R (o }uo}v }( o]v]o ] v ˙ } } IND o]}v ]v R Uv] S } ]u]o
o]}v ]v }R }v] V
{  R ˘v }( .o]vP U } vP U (v]vP v v(}]vP v o]u v }R ]voo o } ˙ ]PR V
v } v v ( }oo}} }vv]vP R] }oo}}v `]R X
Basis of Presentation | 231
6.2.5 Selling, General and Administrative Expenses
6.3 Capitalization and Indebtedness
Soo]vP U Pvo v u]v] ˘v }v] ]u]o˙ }( ~]Z }vvo ˘v ovP } o] v o
} (} }vvoU ]vo]vP R r }uv}vU }( } uo}˙ ]v ˘ U .vv U ]v o}uv U
ulvP U }uu]o v } (v}v U ~]]Z }(]}vo ( (} ]v o}uv U ulvP U ITU ] U TR o o}` (}R } ]o]}v }( D u U }v v o ] P
}uu]oU oPo ] v ]v} o}v } U ~]]]Z } ˘v }v]vP }( ]} [ ( U o ˘v DuA U

PART VI
v R r }uv}v (} v}vr˘ } uu U ~] Z } }] `]R }v }( }uu]o ~IvUSDR}vZ ~]Z
ovR }( VYVGART¡ (} R uv }( PMG ]v R UXSX v }u}}vo ] ~ Z } }] `]R R - Total current debt (including current portion of non-current debt) 0
}v }( R }uu]o ovR ]v Jv v EMEA v }vv ]vuv ]v o˙ R]vU ~]Z oo} (]o]
Gv
} v ~]]Z }R oo]vP U Pvo v u]v] ˘v U ]vo]vP o]vP } U }8 ˘v U o } X
S

W˘ } Pvo v u]v] ˘v } ]v ` }vv } } } P}`R v } UvPvlv

o] }uv˙ ]v R UXSX SR } ]vo ]v ]v } .vv v oPo }vvoU ]}vo ˘vo oPo v Total non-current debt (excluding current portion of non-current debt) 0
] ( U v ˘v v } }] `]R }uo]v `]R R Po}v P}v]vP o] }uv] X W˘ - Gv
} oo]vP v ulvP ˘v } ]v ]Pv].vo˙ } ulvP v }u}}vo ] `]R
S
} R }uu]o ovR }( VYVGART¡ ]v R UXSX v JvX
UvPvlv
Shareholder equity 2,534,224
6.2.6 Financial Income (Expense) SR]o U
SRu]u UUæ
F]vv]o ]v}u u]vo˙ G ]v v }v } R v R ]ov v v .vv]o v v
LPo~Z~Z U
P]v }v } R v R ]ov v v .vv]o Ro (] o R}PR }. } o} X F]vv]o
R]vv]vP ~UUıZ
˘v } }v u]vo˙ } v o} }v R v R ]ov v v .vv]o Ro (] o
R}PR }. } o} v }R .vv]o ˘v X OR Uı
Total 2,534,224

~Z LPo R u}v }( vo}v ]+v X

6.2.7 Exchange Gains (Losses)

O ˘RvP P]v ~o} Z o } ~]Z } v }v v}u]v ]v (}]Pv v] U u]vo˙ ]v E }U S`] (v U TR o o}` (}R } ]v v }( D u U }v v o ] P
B ]R }v v Jv ˙v `R]R Pv ˘RvP P]v } o} v ~]]Z R vo}v R }vP }( DuA U
v o]]o] v}u]v ]v (}]Pv v] ]v} USDU `R]R ] } (v}vo v v}v v˙ ]v ~IvUSDR}vZ ~]Z
Jv˙ U v R(} R v}v v˙ R}PR} R] Uv]o RP]}v D}uv X F} u} A. Cash 242,494
]v(}u}v }v v˙ ˘RvP G }v }v } ]v U o X Xæ SE˘RvP G }v } v}v -
B. Cash equivalents~Z 1,092,182
uv }( R } v˙ u˙ u]oo˙ + } o }( }}v v .vv]o }v]}vX_X WR v} ]
C. Other current financial assets~Z 1,002,052
.vv]o ]vuv } RP ]v v (}]Pv v˙ ]lX
D. Liquidity ~AZA=~BZA=~CZ 2,336,728
E. Current financial debt~]vo]vP]vuvU˘o]vP
0
v}}v}(v}vrv.vv]oZ
6.2.8 Income Tax Expense
F. Current portion of non-current financial debt~Z 3,509
WR R]}˙ }( o} X W˘ } }vv ]v ]vP o} ` }vv } ]v ]v } o]v]o v ro]v - G. Current financial indebtedness~EA=FZ 3,509
]o o}uv }Pu v } ]}˙ o}uU v ` ]v } (} R }uu]o ovR }( VYVGART¡U H. Net current financial indebtedness~GrDZ (2,333,219)
(}oo}`]vP R v Po}˙ }o ˙ R FDA v R PMDAX C}v vo˙U ` } v} R v˙ ( ˘
I. Non-current financial debt (excluding current portion and debt instruments)~Z 7,956
P]vP v ˘ o} }v } }v}o] uv }( .vv]o }]}vX
J. Debt instruments 0

W ]v ]vP v ]v}u ˘ ˘v }v R }. Pv ]v ]} ]]] ]v ]` }( R v( ] K. Non-current trade and other payables 0

Puv `v Pv˘ BV v R ]]] X L. Non-current financial indebtedness~IZA=~JZA=~KZ 7,956

M. Total financial indebtedness~HZA=~LZ (2,325,263)

~ Z  S v} SC R v R ]ov _ } } }v}o] .vv]o uv ]v }v SC}v}o] F]vv]o Suv W ] }( v

(} R ˙ v D u U U v ı_X
~ Z  S v} SF]vv]o W v _ } } }v}o] .vv]o uv ]v }v SC}v}o] F]vv]o Suv W ] }( v
(} R ˙ v D u U U v ı_X
~ Z  Po v} R .vv]o ov v ]v R o } } v} ]vo v˙ ]v] } }vvPv ]v v X F} u} ]v(}u}v
}v R C}uv˙ []v] v }vvPv ]v v U o v} ı SC}uu]uv _ } } }v}o] .vv]o uv ]v }v
SC}v}o] F]vv]o Suv W ] }( v (} R ˙ v D u U U v ı_X

232 | Basis of Presentation Capitalization and Indebtedness | 233

 6.5 Results of Operation
A }( D u U U v .vv]o ~ ]o} ]v ]u EX ]v R o } Z ]vo v o]]o] -
o } R}ru o ]v R u}v }( ¤ Xæ u]oo]}v v v}vr v .vv]o ~ ]o} ]v ]u IX ]v R o
} Z ]vo v}vr v o]]o] o } o}vPru o ]v R u}v }( ¤ X u]oo]}vX

M} ]v(}u}v ] ]vo ]v } }v}o] .vv]o uv v o v} ]vo ]v }v SC}v}o] - B o}` ] R }u]}v }( R }v}o] uv }( }. } o} (} R .vv]o ˙ v D u U
F]vv]o Suv W ] }( v (} R ˙ v D u U U v ı_X U v ıX

PART VI
A9RvP
F]vv]o˙vDuU ~
}u
~IvUSDR}vUvo}R`]]v]Z ı }Z

6.4 Critical Accounting Policies Rv ıU U U U

and Significant Judgments OR}vP]v}u

Total operating income
U
539,418
U
64,911
æUæ
94,025 731

and Estimates RRvo}uv˘v

Soo]vPUPvovu]v]˘v
~æUæZ
~UZ
~UæZ
~UZ
~UZ
~UZ
æ
ı
Total operating expenses (888,164) (542,528) (292,917) 64
Iv R o]}v }( R C}uv˙ [ }vvP }o]] U `R]R ] } U R C}uv˙ ] ] } ul Operating loss (348,746) (477,617) (198,892) (27)
iPuv U u v u}v } R ˙]vP u}v }( v o]]o] R v} ]o˙ v F]vv]o]v}ul~˘vZ ~ıZ ~UæZ æUı ~Z
(}u }R } X TR u v }] u}v }v R]}]o ˘]v v }R (} R
E˘RvPP]v~o}Z ~æUæZ ~UZ Uıı ~Z
}v] } ov X A o o u˙ ]+ (}u R u X
Loss before taxes (399,743) (605,352) (175,919) (34)

TR u v vo˙]vP u}v ]` }v v }vP}]vP ] X R]]}v } }vvP u Iv}u˘˘v ~UæZ ~UZ ~æUıZ æ

}Pv] ]v R ]} ]v `R]R R u ] ] ]( R ]]}v + }vo˙ R ]} } ]v R ]} }( R Loss for the year (408,265) (608,455) (181,208) (33)
]]}v v ( ]} ]( R ]]}v + }R v v ( ]} X W]PRPvu}(R}v]vP æUæU æUU UıU
B]v]oo}R~]vUSDZ ~XııZ ~XZ ~XıZ ~Z

6.4.1 Critical estimates in applying accounting policies

TR (}oo}`]vP `R l˙ u}v }vv]vP R ( U v }R l˙ } }( u}v v - 6.5.1 Revenue

]v˙ R v }( R }vP ]} U R ]Pv].v ]l }( ]vP u]o iuv } R ˙]vP u}v A9RvP
}( v o]]o] `]R]v R v˘ .vv]o ˙X F]vv]o˙vDuU ~
}u
~IvUSDR}vZ ı }Z
Research and development cost accruals
]Z L æUı v v
TR C}uv˙ }Pv] } }( ¤ X u]oo]}vU ]. ]v v} æ ST v }R ˙o _ } R }v}o]
Jvv ıUı Uæı U
.vv]o uv U ]v (} o]v]o ]o ] v uv( ]vP }( P } U R v o} -
uv ˘v }v v o}v }( ] v} [ }P }` }uo}v }( ]. l X T]u]vP }( ˙uv AV] ææ ææ ~ıZ
u˙ ]+ ]Pv].vo˙ (}u R ]} ]v `R]R R } }Pv] ˘v U ovP ]v o]v]o ]o o AP}u v v U
}Pv] `]R]v ST v }R ˙o _ ]v R }v}o] uv }( .vv]o }]}vX OR v æ ~Z
Upfront payments 444,303 34,362 24,975 1,193
Qv.}v }( R R }P v R vo}v }( R }P } R o ] u U
]Z L æU v v
R }P ] v} ]o˙ } o X Iv uvP R v} [ }P }` }uo}v }( ]. l U R
C}uv˙ R(} v}vr.vv]o R v v}oouv U o]v]o ] }v v v} ]v(}u}v Jvv Uæ U U
}( o } ]v X TR] ] }]v R}PR } (}u } ] ]}v `]R C}uv˙ }vvo v }] AV] U ~Z
] }] } R }P } }( }uo}v }( ]o U } R }uo}v }( ] X C} ˘v OR U ı æ Uı
} R ] ]} R ] }] X C} (} ] }] R R v} ˙ v ] }Pv]
Milestone payments 49,815 3,422 31,840 1,356
˘v X
Jvv U Uæ U ~Z
OR ı æ
Research and development service fees 2,326 3,459 21,647 (33)
]Z L v v
Other revenues 833 — — 100
Total revenue 497,277 41,243 78,462 1,106

234 | C
 ritical Accounting Policies and Significant Judgements and Estimates Results of Operation | 235
 MG
Patient

Kim
“Some days I think my current treatments
control my disease, and just when I feel like
things are smooth sailing, my symptoms
come rushing back.’’

236 | M
 G Patient MG Patient | 237
O v ]v ˙ ¤ æ X u]oo]}v } ¤ ı X u]oo]}v (} R ˙ v D u U U }u } ¤ X O R v o}uv ˘v }o ¤æ Xæ u]oo]}v v ¤ Xı u]oo]}v (} R ˙ v D u U
u]oo]}v (} R ˙ v D u U U o }( R }Pv]}v }( R v }v ] }v v }( v U o˙X TR ]v }( ¤ ıX u]oo]}v }u } ]u]o˙ o (}u v ]v ]v
R u]v}v }( R }oo}}v Puv `]R Jvv v R o}]vP }( R P] }oo}}v (} (PP] - ˘vo R v o}uv ˘v v }vvo ˘v U ]u]o˙ o } R (PP]u} }Pu ]v
u} `]R Z ] L X ]} ]v]}v v }R o]v]o v o]v]o }Pu X FRu} U R }vvo ˘v ]v }
ovv ]v ]v R}v X
TR ]v ]v v }Pv]}v (}u (}v ˙uv ] ]u]o˙ ]v ˙ R }Pv]}v }( R (}v ˙uv

PART VI
] (}u Z ] L }v P] }oo}}v (} (PP]u} v R }Pv]}v }( R (}v ˙uv ] TR ]v }( ¤ X u]oo]}v ]v }vvo ˘v (} R ˙ v D u U } }v ]u]o˙ } ~]Z
v R }oo}}v Puv `]R Jvv }v u]v}v }( R Puv X v ]v }( ¤ ıX u]oo]}v (} R r }uv}v ˘v o } R Pv }( }l }}v } } R
v o}uv uo}˙ U v ~]]Z ]v } }] `]R ]}vo R v o}uv }vvoX
TR ]v ]v v }Pv]}v (}u u]o}v ˙uv ] u]vo˙ } R }Pv]}v }( ¤ æX u]oo]}v (}u Z ] W uo}˙ }v P ıX (oo u ]ov ]v } R v o}uv (v}v ]v R ˙ v D -
L }v Po}˙ }o }( (PP]u} ˙ FDA ]v R UXSX v R }Pv]}v }( ¤ Xı u]oo]}v o }( R u U U }u } X ]v R ˙ v D u U X
u]v}v }( R }oo}}v Puv `]R JvvX
O ˘vo R v o}uv ˘v (} R ˙ v D u U }o ¤ Xı u]oo]}vU }u -
TR ]v v }Pv]}v (}u R v o}uv ] ( }( ¤ X u]oo]}v ] ]u]o˙ ]v ˙ } ¤ æıXı u]oo]}v (} R ˙ v D u U X TR ]v G R]PR o]v]o ]o } v uv -
R } R u]v}v }( R }oo}}v Puv `]R JvvX ( ]vP ˘v o } R o}uv }( } } v] }}o]}X TR o o}` }] ]}vo
]o }v } ˘vo R v o}uv ˘v ˙ }PuP

6.5.2 Other Operating Income

A9RvP
F]vv]o˙vDuU ~
}u
A9RvP ~IvUSDR}vZ ı }Z
F]vv]o˙vDuU ~
}u (PP]u} U Uæ ıU
~IvUSDR}vZ ı }Z
u U Uı Uı ~æZ
Gv Uı Uæ Uæ
OR}Pu U U æU æ
RRvo}uv]vv Uı Uæ æU
Total 382,902 259,943 152,889 47
P˙}oo˘ U ıUıæ U ı
CRvP]v(]o}vv}vrv.vv]o Uæ Uıæ U
Total 42,141 23,668 15,563 78
E˘vo R v o}uv ˘v (} } o } v] (PP]u} }o ¤ X u]oo]}v (} R
˙ v D u U U }u } ¤ Xæ u]oo]}v (} R ˙ v D u U X TR] ]v }(
¤ Xæ u]oo]}v } }v ]u]o˙ } ]v uv( ]vP v o]v]o o}uv ] ]v o}v }P
OR }vP ]v}u ]v ˙ ¤ X u]oo]}v } ¤ X u]oo]}v (} R ˙ v D u U U }u
} ¤ X u]oo]}v (} R ˙ v D u U X TR ]v ] ]u]o˙ ]v ˙ {  R ˘}v }( `} PR o]v]o ]o ]v MGV
{  R ]v ]v R v o}uv ]vv U o }( R ]v R v o}uv } {  R ˘}v }( R ]P]vP ˙ (} ENHANZE (PP]u} ]v MGV
]v V {  R ˘}v }( `} PR o]v]o ]o v ]v]}v }( R PR o]v]o ]o ]v CIDPV
{  R ]v ]v ˙}oo ˘ U ] o }( R ]v ]v R uo}˙uv }( R]PRo˙ o]. R {  R ˘}v }( `} PR o]v]o ]o ]v ITPV
v o}uv }vvoU o]P]o (} ]. ˙}oo ˘ V v {  R ˘}v }( R PR o]v]o ]o v ]v]}v }( R PR o]v]o ]o ]v PV v PFV
{ R ]v ]v (] o }v } }. R ]v AP}uA TR NVX {  R ˘}v }( PR o]v]o ]o ]v BPV v
{  R ˘}v }( PR o]v]o ]o ]v M˙}] X
F} u} ]v(}u}v P]vP P}vuvo }o]] R }o + } }}v U Xı SRPo}v_X
E˘vo R v o}uv ˘v (} u }o ¤ X u]oo]}v (} R ˙ v }v D u U
}u } ¤ X u]oo]}v (} R ˙ v D u U X TR] }( ¤ X u]oo]}v ] R o }( R
6.5.3 Research and Development Expenses A9RvP
u]v}v }( R }oo}}v Puv `]R JvvX
F]vv]o˙vDuU ~
}u
~IvUSDR}vZ ı }Z E˘vo R v o}uv ˘v }v }R }Pu ]v ˙ ¤ X u]oo]}v } ¤ X u]oo]}v (} R ˙
v D u U U }u } ¤ X u]oo]}v (} R ˙ v D u U X TR ]v ] ]u]o˙
P}vvo˘v U U æU
} ]v R v o}uv ˘v ]v o}v } R vuv }( } ARGXr }PuU }u -
E˘voRvo}uv˘v Uı æıUı æUı ouvrPvP v}˙ P]v C X
M]ov}vuo Uæ Uæ U ~Z
]}v
D vu}}v U Uæ U
OR˘v U Uæı U
Total 580,520 370,885 220,771 57

238 | Results of Operation Results of Operation | 239

6.5.4 Selling, General and Administrative Expenses
6.6 Liquidity and Capital Resources
A9RvP
~
F]vv]o˙vDuU
}u
6.6.1 Sources of Funds
~IvUSDR}vZ ı }Z

PART VII
VI
P}vvo˘v U Uæ U æ S]v } ]v}v ]v U ` R ]v u} }( } } ]v o}]vP } } v] U ]o]vP }

PART
]voo o } ˙ }}o]}U o}]vP } o˙ R]vU }v vP ]v ovv]vP U ]]vP ]o v }]]vP
P}(]}vo( U U U
Pvo v u]v] } (} R }}v X W vo˙ R }vo˙ }v } } R v}
S]}˙} Uıæ U U
Pv v˙ ]Pv].v v (}u } o X T} U ` R (v } }}v R}PR o] v ]
OR˘v U ıU U æ ouv }( ]˙ ] U (}v U u]o}v v ˘v ]u uv ˙uv ] (}u } }oo} -
Total 307,644 171,643 72,146 79 } U (v]vP (}u P}vuvo }] v ]v ]v}u (}u R ]vuv }( } RU R ]ov v
.vv]o X TR}PR D u U U ` R ] P} } }( ¤ Uæ X u]oo]}v (}u ] v o]
}+]vP }( ]˙ ] v ] ¤æ Xı u]oo]}v ]v v (}u } }oo}} X
O oo]vP U Pvo v u]v] ˘v }o ¤ X u]oo]}v v ¤ X u]oo]}v (} R ˙ v D u -
U v U o˙X TR ]v ]v } oo]vP U Pvo v u]v] ˘v (} R ˙ v O R G}` u˙ G v ]8o } (} v `]oo v }v uv˙ (} X Ov D u U U `
D u U ` ]v]oo˙ } v ]v }( }vvo ˘v v }(]}vo ( U ovP (}uP R RU R ]ov v v .vv]o }( ¤ U X u]oo]}vU }u } ¤ Uıı Xæ u]oo]}v }v D u
UX
{  ]v } }( R R r ˙uv }uv}v ov o } R Pv }( }l }}v } } oo]vP U
Pvo v u]v] uo}˙ V WR v} }vP}]vP u]o .vv]vP }uu]uv U R o]v }( ] } Pv U R ˘ } +
{  ]v } }] `]R ]}vo uo}˙ ] } vPRv } oo]vP U Pvo v u]v] } o]]]˙ } R v˘ . ˙ U }R Rv o v } }uu]uv } L}v `R]R ]o ]v v} ı
] U ]v }v }( R }uu]o ovR }( VYVGART¡ ]v R UXSXV SC}uu]uv _ } } }v}o] .vv]o uv ]v }v SC}v}o] F]vv]o Suv W ] }(
{  ]v }(]}vo ( U ]u]o˙ ]v }v }( R }uu]o ovR }( VYVGART¡ ]v R UXSXV v v (} R ˙ v D u U U v ı_X
{  P}u}}vo v ulvP } }] `]R R }uu]o ovR }( VYVGART¡U (}oo}`]vP R }o ˙ FDA
]v R UXSX F} u} ]v(}u}v } R ]l }] `]R } ( (v]vP v U R }v }( R] vvo } o
X SR]l F} Ro } Pv˘ [F]vv]o P}]}v v N (} A ]}vo C ]o_X
W uo}˙ }v P X (oo u ]ov ]v } oo]vP U Pvo v u]v] (v}v ]v R ˙ v -
D u U U }u } ıXæ ]v R ˙ v D u U X F} u} ]v(}u}v } } .vv]o ]vuv U o v} SF]vv]o uvPuv _ } } }v}o]
.vv]o uv ]v }v SC}v}o] F]vv]o Suv W ] }( v (} R ˙ v D u
U U v ı_X
6.5.5 Financial Income (Expense)

F} R ˙ v D u U U .vv]o ˘v u}v } ¤ Xı u]oo]}v }u } ¤ Xæ u]oo]}v (} R ˙ 6.6.2 Cash Flows

v D u U X TR }( ¤ X u]oo]}v ]v o ]u]o˙ } R]PR .vv]o ˘v ]v
]v o }( ]v v o }v v .vv]o (}oo}`]vP R ]u }( R COVIDr ı TR o o}` uu] } R G}` (} R ˙ v D u U U v ıX
} l }v R .vv]o ul U o˙ }+ ˙ R ]v ] }v } R v R ]ov v v
.vv]o X
F]vv]o˙vDuU V]v
}u
~IvUSDR}vZ ı }
6.5.6 Exchange Gains (Losses) CRvR]ovP]vv]vP}(R]} UU U Uı U
NRG}`~]vZl(}u}vP] ~UZ ~ıUZ æU ~UıZ
Exchange losses totaled $50.1 million for the year ended December 31, 2021, compared to exchange losses of $126.2
NRG}`~]vZl(}u]vvP] ~UZ Uı ~UZ ~ıUZ
million for the year ended December 31, 2020. The decrease was mainly attributable to unrealized exchange rate losses on
NRG}`~]vZl(}u.vv]vP] UU U U Uı
the cash, cash equivalents and current financial assets position in Euro during the financial year ended December 31, 2021
as compared to unrealized exchange rate losses on the cash, cash equivalents and current financial assets position in USD +
E }(˘RvP]+v}vRvR]ov ~ıUæZ æUı ~UZ ~UııZ
during the financial year ended December 31, 2020. Cash and cash equivalents at end of the period 1,334,676 1,216,803 372,162 117,873

Net Cash Used in Operating Activities

N R }o}` (}u } }vP ] ]v ˙ ¤ X u]oo]}v } v }o}` }( ¤ X u]oo]}v (} R ˙
v D u U U }u } v }o}` }( ¤ ı Xæ u]oo]}v (} R ˙ v D u U X TR v
R }o}` (}u }vP ] (} R ˙ v D u U o ]u]o˙ (}u ~]Z R R
v o}uv ˘v ]v ]v o}v } R uv( ]vP v o]v]o o}uv ] }( (PP]u}

240 | Results
Patient Story
of Operation Liquidity and Capital Resources | 241
v R vuv }( }R o]v]oU o]v]o v ]}˙rP } v] U ~]]Z R }vvo ˘v
v }vovP ˘v ]v ]v }v }( R }uu]o ovR }( (PP]u} ]v R UXSX v JvU v
~]]]Z R uv( ]vP }( ]vv}˙ R }( R }uu]o ovR }( (PP]u} ]v R UXSX TR v R }o}`
}( ¤ ı Xæ u]oo]}v (} R ˙ v D u U ` ]u]o˙ ]vGv ˙ ~]Z R R v o}uv
˘v ]v ]v o}v } R uv( ]vP v o]v]o o}uv ] }( (PP]u} U u v
R vuv }( }R o]v]o v ]}˙rP } v] U ~]]Z R }vvo ˘v v }vovP
{  R } ]v}o ]v .o]vP v o]}v v u]v]v]vP v v(}]vP v } (v]vP P]v o]u }
]v(]vPuv ] ˙ R] V
{  R u]vvv }( } ˘]vP }oo}}v Puv v v˙ ]v} v` }oo}}v Puv V
{  R u}v }( v U ]( v˙U ` u˙ ] ]R ]o˙ } ]v R (}u }( }˙o˙ ˙uv (}u ( o }(
} } v] U ]( } V
{  o}uv o } COVIDr ı v ] ]u }v R } v u]vP }] `]R R }v }( } o]v]o

PART VII
VI
˘v ]v ]v }v }( R }vo }uu]o ovR }( (PP]u} ]v R UXSXU v ~]]]Z R uv( - ]o U o]v]o }Pu U uv( ]vP ] v }R o ] V v

PART
]vP }( rovR ]vv}˙ R }( R }vo }uu]o ovR }( (PP]u} ]v R UXSX {  o}uv o } R Po}o }v}u] v ]v v }o]o ]v]o]˙ ovP (}u R }vG] `v
R] v R Ul]v X
Net Cash Used in / from Investing Activities
IvvP ] (} R ˙ v D u U U }v] ]u]o˙ }( R ]uv }( v .vv]o F} u} ]v(}u}v } R ]l }] `]R } ( (v]vP v U R }v }( R] vvo } o
v R R }( ]vvP]o X C R G}` (}u ]vvP ] v v }o}` }( ¤ X u]oo]}v (} X SR]l F} Ro } Pv˘ [F]vv]o P}]}v v N (} A ]}vo C ]o_X
R ˙ v D u U U }u } v ]vG}` }( ¤ X u]oo]}v (} R ˙ v D u U X
TR v }o}` (} R ˙ v D u U o ]u]o˙ } ~]Z R v ]vuv }( ¤ X u]oo]}v ]v
v .vv]o U ]vo]vP u}v˙ ul (v v u }] }v U }u } v ]uv }( 6.6.3 Working Capital Statement
¤ Xı u]oo]}v (} R ˙ v D u U v ~]]Z R R }o}` }( ¤ı X u]oo]}v ]vP ]v o}v }
R R }( PRV (}u B˙ HoR PRu o X Iv }v `]R ]u X }( Avv˘ }( R }uu]]}v oP Po}v ~EUZ ılı ` ul R (}oo}`]vP
uv P
Net Cash Provided by Financing Activities
F]vv]vP ] ]u]o˙ }v] }( v } (}u } ] ouv v o] }+]vP }( } ] Iv } }]v]}vU R `}l]vP ]o }( R C}uv˙ ] 8]v (} R C}uv˙ [ v ]uv U o (}
v ˘] }( }l }}v X TR v R ]vG}` (}u .vv]vP ] ` ¤ U X u]oo]}v (} R ˙ v D - ]} }( `o u}vR (}u R }( R] Uv]o RP]}v D}uv X
u U U }u } v R ]vG}` }( ¤ X u]oo]}v (} R ˙ v D u U X TR v R
]vG}` (} R ˙ v D u U ` '] } ~]Z ¤ U ı X u]oo]}v v R } (}u } Po}o
}+]vP ]v F ˙ U }u } ¤ X u]oo]}v v R } (}u } Po}o }+]vP v }v v ]

6.7 Off-Balance Sheet Arrangements

ouv ]v M˙ v ~]]Z ¤ X u]oo]}v } ] (}u R ˘] }( }l }}v ]v U }u }
¤ Xı u]oo]}v (} R ˙ v X

Operating and Capital Expenditure Requirements

WR v R] }.]o]˙ v U }( D u U U ` R uo o} }( ¤ U X u]oo]}vX W ] v} R ]vP R ]} v U v ` } v} vo˙ R U v˙ }+ ov R vPuv U -
W˘ } }vv } ]v ]Pv].v }vP o} (} R (} o ( ` }vv } R v .v ]v R o]o o v Po}v U R o}vR] `]R v}v}o] v } .vv]o vR] U
o}uv +} U ]v R]PR } (} }uu]o]}v }( (PP]u} ]v R UXSX v JvU v l } }]v `R]R }Lv ( } .vv } ]o } v U o]R (} R } }( (]o]vP
Po}˙ }o v }uu]o]}v }( } } v] ]v E } X .vv]vP v }v R v} ] } G }v } ov R X

Ov R ] }( v u}v U ` ˘ R } ˘]vP R v R ]ov v v .vv]o

`]oo vo } (v } }vP ˘v v ]o ˘v] ]uv R}PR o R v˘ `o

6.8 Contractual Obligations

u}vR X B }( R vu} ]l v v ]v }] `]R R o}uv v }uu]o]}v }(
(PP]u} v } }R } v] v ]}˙ P }Pu v R ˘v } `R]R ` u˙
v ]v} }oo}}v `]R R] (} R o}uv }( R } v] ] vlv}`vU ` vo
} u R u}v }( ]v ]o }o˙ v }vP ˘v }] `]R }uovP R R
v o}uv }( } } v] X O ( ]o ]uv (} (PP]u} v } }R } B o}` v }]` ] P]v }( } u]o }v o }o]P}v D u U P
v] v ]}˙ P }Pu `]oo v }v uv˙ (} U ]vo]vPP

{  R}PUu]vPv}uo}v}(o]v]ovPvo]v]o]o(}}v}v˙(}v]V P˙uv˙]}
{  R vu }( }vo v` } v] ` ]v(˙ v ] } o} V LRv } }æ M}Rv
{  R u v } ]v}o ]v}]v]vPPo}˙ }o(}} } v] v v˙ o˙`u˙v}v - ~IvUSDR}vZ T}o ˙ ˙ ˙ æ˙

o }(}o]vPPo}˙ ]uv } o `]R }v˙}(} } v] V Lo]]o] U Uæı U U v

{  oo]vP v ulvP ] v lv ]v }vv}v `]R R }uu]o]}v }( VYVGART¡ } }vo }u - L}uu]uvv}}uuv ıUææ v v U U
u]o]}v }( v˙ }( } v } v˙ ( } v] U ]( } U v } ]v}o ]v R }v }(
v + o v ulvP }Pv]}vV
{  uv( ]vP ] v lv R }( R }uu]o]}v }( VYVGART¡ } }vo }uu]o]}v W]PvoPuv(}o}}˙v}8]v`]iv
Z UBoP]uU}8]vU B NRovUB}}vU
}( v˙ }( } v } v˙ ( } v] U ]( } U v } ]v}o ]v R }v }( v + UXSXUvT}l˙}UJvU]o}]vv}SP}˙UPovv]uv E _]vR}v}o].vv]ouv]v
o˙ R]vV }vSC}v}o]F]vv]oSuvW]}(v(}R˙vDuUUvı_X
{  R } ]v}o ]v P}`]vP } }Pv]}v } R ] v } oo}` (} R RU o}uv v }vo
}uu]o]}v }( } v } v˙ ( } v] V Iv Jv˙ U ` R v ]v} ]v]vP o Puv o } R v]]}v o}}v }( } Z`]iv

242 | Patient
Liquidity
Story
and Capital Resources Off-Balance Sheet Arrangements | 243
(]o]˙ } v`o˙ ]o }8 ]v Z`]iv U `]R v vvo v }( ¤ Xı u]oo]}vU `R]R `}o }}vo ]v R
}v }( æU v `]R v ]v]o u }( Xæ ˙ X Ivo ]v R ]v]vP o }uu]uv ] v ( Iv ]}vU ]v R ]} } ˙ R .vv]o uv ]v}} R]v ˙ (v U R R v} vU v}
]} }( u}vR (}oo}`]vP R }uo}v }( R ]o]vPX TR }o ( R }o}` o } R] o - ] R vo˙ }} U v˙ u]o v }v } ] }( ]u]o u]o v }v } `R]R ` ` }
v } SL }uu]uv v} }uuv _X ˙ ]v `R]R v˙ }( R uu }( } B} }( D]} } v]} uvPuv U R}o }( u} Rv A9 }( v˙
o }( } }vP ] U } v˙ uu }( R ]uu] (u]o˙ }( v˙ }( R (}P}]vP }v U R } `]oo R
Iv ]}vU } o o]]o] ]vo o ov (} }uv˙ `]R u]˙ } (} ˙ X ] } ]v] u]o ]v U }R Rv R }uv}v v RR}o]vP vPuv ` ] ]v -

PART VII
VI
PR æX SSR Co v P]v]o SRR}o _U v R v }v ` ] o}`X

PART
F}]]}v}(}vo}o]P}vUov}ıSC}uu]uv_]v}}v}o].vv]ouv]v
}vSC}v}o]F]vv]oSuvW]}(v(}R˙vDuUUvı_X F}u u } u U ]v R }]v˙ } }( } ]v U ` u˙ }v (} ] (}u }uv] ]v `R]R ]v
}( R uu }( } v]} uvPuv } ]} u˙ ]} } ]}X TR } }( R ] ]
vP} }v v u[ovPR ] v v}v }( R vPuv u]o } X

6.9 Financial Statements

Agreements with Our Senior Management
WR v ]v} uvPuv Puv `]R T]u Vv H`u]v } CR]( E˘ O8X TR CR](
E˘ O8 ] } }o ˘ ]}X TR l˙ u }( R] Puv (}oo}` P

TR ~}v}o] Z ] .vv]o uv }( R C}uv˙ (} R .vv]o ˙ v]vP }v D u U T]uVvHu]v

v ı ]v}} ]v} R] Uv]o RP]}v D}uv ˙ (v X Po }v ı SIv(}u}v F]˘}uv}v ¤æUı
]v}} ˙ (v _X P
A }(A9}(R.˘}uv}v}v]}o˙
SR}ru]o}uv}v
u]v}vPo]R˙Rv}vr˘]}
Pv]}v}v]}v ~Z
¤Uı
}v
D Iv.v]

6.10  Information Regarding the ~Z Au}v R}`v v v]}v }v]}v ] ]vP R ˙ rv D u U X

Independent Auditor
TR ] }v}o] .vv]o uv }( v (} R .vv]o ˙ v D u U v v
ı R v ] ˙ } ]v vv ]}U D o}]' A }vv BXVX ~D o}]'ZU `R} v v vo].
] } }v R .vv]o uv X TR v }( D o}]' `R} ]Pv R ]} [ } ] uu }( R
NRov Iv }( CR A }vv ~
}( D o}]' ] o} W]oRou]vl U AP R}'uU R NRov X
Koninklijke Nederlandse Beroepsorganisatie van AccountantsZX TR }8
W u˙ u]v MX Vv H ` u] v [ ] }v u}vR [ v}] U } ˙uv }( u}vR [ } r
}u v ]}v ]v o] }( v}] X MX Vv H ` u] v `}o v]o } R u ˙uv ]v o] }( v}]
]v R v R u]v R] ] `]R ]v ] u v ]v `R]R ] vv} }v o˙ ˘ (} R]u
} }v]v }]]vP ] } ~v ( } (]o } u ˙ R }v]]}v ( ]vP }] o
˙ [ v}] Z X MX Vv H ` u] v `}o o} v]o } ˙uv ]v o] }( v}] ]v R v R u]v
R] ] `]R ]v ]v }( } (]o } }uo˙ `]R }o]P]}v v o] o o` } R] P uv
~v ( } (]o } u ˙ R v}v r}uo]v U ]( v}v r o] U ( ]vP }] o ˙ [ v}] Z X
Iv R U R `]oo (oo o ]}v }( R ]vP }( v˙ } v]vP }l } ]}v Ro ˙ MX Vv H ` -
u] v X TR `]oo v} v}] ]} } ˙uv ]v o] }( v}] ]v ]v }( MX Vv H ` u] v [ (]o
} }uo˙ `]R }o]P]}v v o] o o` } R] P uv X MX Vv H ` u] v u˙ ]u] ]uu ] -

6.11 Material Contracts and

o˙ v ˘ ] ] }X

Related Party Transactions

KoG]U}CR](F]vv]oO8URvuo}˙uv}v`]R}]]˙UPv˘USIvXU(}v]v.v]
uXH]uo}˙uv}vu˙u]vv˙u˙Ui}v}]}vv˙uv}(
o`ou}vRX

6.11.1 Material Contracts K]RW}}U}CR](OvPO8URvuo}˙uv}v`]R}]]˙UPv˘USIvXU(}v]v.v]

uXH]uo}˙uv}vu˙u]vv˙u˙Ui}v}]}vv˙uv}(
O u]o }v ] ]v R X SC}oo}}v APuv _U Xæ SL]v APuv _ v X o`ou}vRX
SD]]}v APuv _X
W]uP˙U}CR](M]oO8URvuo}˙uv}v`]R}]]˙Pv˘VB U(}v]v.v]uXH]
uo}˙uv}vu˙u]vv˙u˙Ui}v}]}vv˙uv}(o
6.11.2 Related Party Transactions `ou}vRX

S]v D u U U ]vP R v }( R o .vv]o ]} (} `R]R ] .vv]o uv R v HvHU}CR](S]v.O8URvuo}˙uv}v`]R}]]˙UPv˘VB U(}v]v.v]

o]R U ` R v} v ]v} v˙ v }v `]R v˙ o `R]R W ]vPo v }v } ]v uXH]uo}˙uv}vu˙u]vv˙u˙Ui}v}]}vv˙uv}(
R] v˙ W u]o } X o`ou}vRX

244 | Financial
Patient Story
Statements Material Contracts and Related Party Transactions | 245
AivLuuvU}VPC}}o}uv
D SP˙URvuo}˙uv}v`]R}]]˙UPv˘VB U(} C}oo P]v]vP Puv ~ CBAsZ v v ]v} ]v B oP]u R v}voU ]v ˙U } }uv˙ oo X
v]v.v]uXH]uo}˙uv}vu˙u]vv˙u˙Ui}v}]}v - TR CBA ]v]vP }v }R uo}˙ v uo}˙ X WR v} v]}v v}v } CBA R
v˙uv}(o`ou}vRX }uv˙ ooU ` i } R v}vo v ]v ˙ oo CBA R o } R Ru]o ]v ˙X TR CBA
vo˙ o]o } o } uo}˙uv }v]}v R `P U `}l]vP u U i} ]˙U ]vv}}v v
D]lBU}GvoC}vovoDuUURvuo}˙uv}v`]R}]]˙UPv˘VB U ouv˙ v]}v X WR v} R U v } v} v] R]vP U ] }v v˙ }( R i X CBA u˙U
(}v]v.v]uXTR]Puv`u]v`]RuoPuv`]R+(}uDuUX R}`U RvP R uo}˙uv }v]}v }( } uo}˙ ]v R ( v Rv o˙ + } uo}˙uv

PART VII
VI
o}vR] X

PART
Av]W]olU}Go}oH}(Qo]˙URvuo}˙uv}v`]R}]]˙UPv˘VB U(}v]v.v]uX
Huo}˙uv}vu˙u]vv˙u˙Ui}v}]}vv˙uv}(
o`ou}vRX

Mo]v]M}}R˙U}GvoC}voUi}]vPv˘]vvRvuo}˙uv}v`]R}]]˙UPv˘US 6.13 Legal and Arbitration Proceedings

IvXU(}v]v.v]uXHuo}˙uv}vu˙u]vv˙u˙Ui}v}]}v
v˙uv}(o`ou}vRX
F}u u } u ` u˙ }u ]v}o ]v oPoU P}vuvo } ]}v }]vP } i } o]u
LT˙vU}H}(RRvo}uv
D MvPuvO}vvU(}uA]oU}vU}CR](M]o ]]vP ]v R }]v˙ } }( } ]v X RPo }( R }}u U o]P}v v R v ]u }v -
O8URvuo}˙uv}v`]R}]]˙UPv˘VB U(}v]v.v]uXH]uo}˙uv}vu˙ }( (v v 'ouv } U ]]}v }( uvPuv } v }R (} X D ]vP R ]} `o
u]vv˙u˙Ui}v}]}vv˙uv}(o`ou}vRX u}vR U R R v} v v˙ oPoU P}vuvo } ]}v } ]vP ~]vo]vP v˙ R }]vP `R]R
v]vP } Rv }( `R]R ` ` Z `R]R u˙ R U } R R ]v R v ]Pv].v + }v
Indemnification Agreements Pv˘ v l} R G} [.vv]o }]}v } }.]o]˙X
Iv}vv}v`]R}]v]oUXSXo]}+]vPU`v]v}]vuv].}vPuv`]RR}(}v}vr˘ -
]}vRuu}(}v]}uvPuvXWRv]v}RPuv`]RRv`
v}vr˘]}}uu}(}v]}uvPuv`RvR˙Ri}]v]v}]v]oUXSXo]}+]vPX

6.14 Insurance
Iv}(]vuv].}v(}o]]o]]]vPvRS]Au˙u]'}v}vr˘]}U}8
}}v}v}oo]vPv}R(}P}]vP}]]}vU`Rv]v(}uR]vR}]v]}v}(RSECR
]vuv].}v]P]vo]}o]˙˘]vRS]Av]R(}vv(}oX

Wu]v]v v ]vv }}o]} R ] }uu}v v }] (} } ]v X O u]v ]vv }u -

6.12 Employees
u]o Pvo o]]o]˙ ]vv U ]vo]vP } o]]o]˙ ]vv U ]} v }8 o]]o]˙ ]vv v }
u]u ]vv }]vP R ]l }( o} }( } ]vP v] v }P X

A }( D u U U ` R æ uo}˙ ~˘o]vP }vov Z A R R}`v o}`U ` R R

(}oo}`]vP vu }( uo}˙ U }lv } ˙ uv v P}PR˙X

DuA U MR
A

~IvUSDR}vZ ı
Function
RRvo}uv ı ı
Soo]vPUPvovu]v]
Geography
`]iv
Z UBoP]u ı æ
B}}vUUXSX
T}l˙}UJv æ
U
B RNRov W W W W
GvUS`]ov ı W
I˙LM}o]v˘UFv W W
Mv]RUGuv˙ ı W W
T}}v}UCv W W W W
Total 650 336 188 684

246 | Employees
Patient Story Legal and Arbitration Proceedings | 247
7
Consolidated

PART VII
Financial
Statements
CONSOLIDATED FINANCIAL STATEMENTS – AUDITED AS OF AND FOR
THE YEARS ENDED DECEMBER 31, 2021, 2020 AND 2019

Contents
7.1 Consolidated Statements of Financial Position 248

7.2 Consolidated Statements of Profit or Loss 250

7.3 Consolidated Statements of Comprehensive Income and Loss 251

7.4 Consolidated Statements of Cash Flows 252

7.5 Consolidated Statements of Changes in Equity 253

7.6 Notes to the Consolidated Financial Statements 254

Consolidated Statements of Consolidated Statements of
Financial Position Financial Position
A A}(Du A}(Du A}(Du ]˙
E vL]]o] A}(Du A}(Du A}(Du

PART VII
~IvUSDR}v ¤Z N} U U (*)
Uı (*)
~IvR}v}( ¤Z N} U U (*)
Uı (*)

Current assets                Equity               

CRvR]ov UU UU U ]˙
E ']o}}`v}(Rv
RRvo}uv]vv]ovv v ı Share capital    U æU æUı
F]vv]ovv UUæ ıUı UUıı Share premium    UUæ UıU UææU
P]˘v æUı Uı U Translation differences U U ~UæZ
Tv}R]o U Uı Uææ Accumulated losses    ~UUıZ ~ııUıZ ~UZ
Ivv}] ı ıU æUıæ v Other reserves Uı U Uæ
Total current assets    2,542,971 2,057,001 1,542,675 Total equity    2,534,224 1,674,051 1,180,409

Non‑current assets    Non-current liabilities

ORv}vrv æU U U P}]]}v(}uo}˙v.    æ
RRvo}uv]vv]ovv}vrv U U ıU Lo]]o]vv}vrv Uıæ U æU
(D ˘ Uı æU v (D ˘o]]o] U U v
P}˙Uovv]uv æU Uæ ıUæ (D vvv}vrv v ıUı Uı
IvvP]o æ U U æU Total non-current liabilities 14,811 276,863 250,110
Total non‑current assets    307,303 222,406 67,540
Total assets    2,850,274 2,279,407 1,610,215 Current liabilities   
Lo]]o]vv Uæı U U
* TR C}uv˙ R } RvP ]v ] v}v v˙ (}u EUR } USD Jv˙ U U ] ]v v} X X X A }]vPo˙U R
D u U v D u U ı }u uv }( .vv]o }]}v v o v} R v r v } o˙ Tv}R˙o æ ıUæ æUı ıæU
}v R }vvP }o]] }o]v ]v v} X X X
T˘o]]o] Uæ Uı
(D vvv v U Uæ
TR }uv˙]vP v} (}u v ]vPo }( R }v}o] .vv]o uv X
Total current liabilities 301,239 328,493 179,696
Total liabilities    316,050 605,356 429,806
Total Equity and Liabilities    2,850,274 2,279,407 1,610,215

* TR C}uv˙ R } RvP ]v ] v}v v˙ (}u EUR } USD Jv˙ U U ] ]v v} X X X A }]vPo˙U R

D u U v D u U ı }u uv }( .vv]o }]}v v o v} R v r v } o˙
}v R }vvP }o]] }o]v ]v v} X X X

TR }uv˙]vP v} (}u v ]vPo }( R }v}o] .vv]o uv X

250 | Consolidated Statements of Financial Position Consolidated Statements of Financial Position | 251
Consolidated Statements of Consolidated Statements of
Profit or Loss Comprehensive Income/Loss
YEv YEv YEv YEv YEv YEv
Du Du Du Du Du Du

PART VII
~IvUSDR}v ¤˘(}RvEPSZ N} U U (*)
Uı (*)
~IvUSDR}v ¤˘(}RZ N} U U (*)
Uı (*)

Rv ıU U U Loss for the year    (408,265) (608,455) (181,208)

OR}vP]v}u U U U æUæ Items that may be reclassified subsequently
to profit or loss, net of tax
Total operating income    539,418 64,911 94,025
v˙
C vo}v]+vU]v(}u
~UZ v v
RRvo}uv˘v ı ~æUæZ ~UæZ ~UZ vovP(}]Pv]
Soo]vPUPvovu]v]˘v ~UZ ~UZ ~UZ Tvo}v+ v U ~UæZ

Total operating expenses (888,164) (542,528) (292,917) Items that will not be reclassified subsequently
to profit or loss, net of tax
Operating loss (348,746) (477,617) (198,892)
F]oP]vl~o}Z}v]vuv]v]˙]vuv
~ıUıZ v v
F]vv]o]v}ul~˘vZ    ~ıZ ~UæZ æUı ]PvFVTOCI

E˘RvPP]vl~o}Z    ~æUæZ ~UZ Uıı Other comprehensive loss, net of income tax (42,338) 162,273 (8,587)

Loss before taxes (399,743) (605,352) (175,919) Total comprehensive loss attributable to:

Iv}u˘˘v ~UæZ ~UZ ~æUıZ O`v}(Rv ~æUZ ~UZ ~ıUıæZ

Loss for the year (408,265) (608,455) (181,208)

* TR C}uv˙ R } RvP ]v ] v}v v˙ (}u EUR } USD Jv˙ U U ] ]v v} X X X A }]vPo˙U R
Loss for the year attributable to: D u U v D u U ı }u uv }( }uRv] ]v}u v o} v o v} R v r v
} o˙ }v R }vvP }o]] }o]v ]v v} X X X
O`v}(Rv ~UæZ ~UææZ ~UZ
W]PRPvu}(R}v]vP æUæU æUU UıU
B]v]oo}R~]v¤Z æ ~XııZ ~XZ ~XıZ TR }uv˙]vP v} (}u v ]vPo }( R }v}o] .vv]o uv X

* TR C}uv˙ R } RvP ]v ] v}v v˙ (}u EUR } USD Jv˙ U U ] ]v v} X X X A }]vPo˙U R

D u U v D u U ı }u uv }( }. v o} v o v} R v r v } o˙ }v
R }vvP }o]] }o]v ]v v} X X X

TR }uv˙]vP v} (}u v ]vPo }( R }v}o] .vv]o uv X

252 | Consolidated Statements of Profit or Loss Consolidated Statements of Comprehensive Income and Loss | 253
Consolidated Statements of Cash Flows Consolidated Statements of
CRG}`~]vZl(}u}vP]
YEv
Du
YEv
Du
YEv
Du Changes in Equity
~IvR}v}( ¤Z NOTE U U (*)
Uı (*)

T}o]˙
Operating loss (348,746) (477,617) (198,892) ']o
A }}`v ']o

PART VII
}(Rv (*)
SR SR uo
A Tvo}v OR }}`v}( Total
Aiuv(}v}vrR]u ~IvR}v}( ¤Z ]o u]u o} ]+v Rv equity
Au}}v}(]vvP]o æ Balance at January 1, 2019 4,451 796,894 (202,270) (18,954) 36,341 616,462 616,462
]}v
D }(}˙Uovv]uv æUı U U
P}]]}v(}uo}˙v. L}(}R˙ ~UZ ~UZ ~UZ
E˘v}Pv]]v}(Rr˙uv ıU ıUı U OR}uRv]]v}ul~o}Z ~UæZ ~UæZ ~UæZ
F]oP]v}vv}vrv.vv]o(]o Total comprehensive loss
~UæZ ~UıæZ ~UZ (181,208) (8,587) (189,795) (189,795)
R}PR}.}o} of the period
N}vrRv ~æUZ v v SRr˙uv U U U
(249,405) (379,643) (153,381) I}(R]o æU æU æU
M}uv]vvlo]]o] Tv}v}(}]˙] ~æUZ ~æUZ ~æUZ
~IvZl]vv}R]o ~UZ Uı ~æUıZ }vvP
A uv}(RR ~UæZ ~UæZ ~UæZ
]}vPuv
~IvZl]v]vv}] ı ~UZ ~UæZ v E˘]}(}l}}v æU æU æU
~IvZl]v}Rv ~UııZ ~UıZ ~æUZ Balance year ended 5,209 1,505,641 (383,477) (27,541) 80,577 1,180,409 1,180,409
December 31, 2019
Ivl~Z]vv}R˙o æ Uı æUæ æUı
Ivl~Z]v(vWv ~UZ ~UZ ıUæ L}(}R˙ ~UææZ ~UææZ ~UææZ
M}uv]vv}vrvlo]]o] OR}uRv]]v}ul~o}Z U U U
~IvZl]v}Rv}v‑v ~UıæZ ~UııZ ~UZ Total comprehensive loss (608,455) 162,273 (446,182) (446,182)
of the period
Ivl~Z]v(vWv}vrv ~ıUıZ Uææ Uı Iv}u˘v.(}u
˘˘}vo Uıæ Uıæ Uıæ
Cash flows (used in)/from operating activities (590,356) (395,272) 156,645 }Rr˙uv
Iv] ~Z ~Z ~ıZ SRr˙uv ıUı ıUı ıUı

Iv}u˘] ~æUZ ~UıZ ~UZ I}(v`R U U U

Net cash flow (used in) / from operating activities (606,812) (398,463) 151,630 Tv}v}(}]˙] ~Z ~Z ~Z

PR}(]vvP]o æ ~UZ ~UZ ~UııZ E˘]}(}l}}v U Uæ Uæ

Balance year ended
PR}(}˙Uovv]uv ~UZ ~UZ ~UıZ December 31, 2020 5,744 2,339,033 (991,932) 134,732 186,474 1,674,051 1,674,051

~IvZl]v.vv]oWv ~UıZ Uı ~ıUææZ

Iv] U Uı U L}(}R˙ ~UæZ ~UæZ ~UæZ

Net cash flow (used in) / from investing activities (347,070) 344,692 (833,267) OR}uRv]]v}ul~o}Z ~UZ ~ıUıZ ~UZ ~UZ
T}o}uRv]o}}(R ~UæZ ~UZ ~ıUıZ ~æUZ ~æUZ
P]v]oouv}(o˙uv ~UææZ ~UææZ ~UææZ ]}
Iv}u˘v.(}u
P}(}u]}(v`R UıU U ææU ˘˘}vo Uı Uı Uı
}Rr˙uv
I}] ~æZ ~Z ~æUZ
SRr˙uv ıU ıU ıU
E˘RvPP]v(}uv˙}v]}v}v}(}u]
ı v
}(v`R I}(v`R UıUı UıU UıU
P}(}u˘]}(}l}}v U Uı æUæ Tv}v}(}]˙] ~æZ ~æZ ~æZ
Net cash flow (used in) / from financing activities 1,121,342 833,003 733,726 E˘]}(}l}}v æı U U U
Net increase (decrease) in cash & cash equivalents 167,460 779,232 52,088 Balance year ended 6,233 3,462,775 (1,400,197) 131,684 333,729 2,534,224 2,534,224
December 31, 2021
Cash and cash equivalents at the beginning of the period 1,216,803 372,162 321,791
E˘RvPP]vl~o}Z}vRR]ov ~ıUæZ æUı ~UZ
* TR C}uv˙ R } RvP ]v ] v}v v˙ (}u EUR } USD Jv˙ U U ] ]v v} X X X A }]vPo˙U R
Cash and cash equivalents at the end of the period 1,334,676 1,216,803 372,162 D u U v D u U ı }u uv }( }. v o} v o v} R v r v } o˙ }v
R }vvP }o]] }o]v ]v v} X X X
* TR C}uv˙ R } RvP ]v ] v}v v˙ (}u EUR } USD Jv˙ U U ] ]v v} X X X A }]vPo˙U R
D u U v D u U ı }u uv }( }. v o} v o v} R v r v } o˙ }v
Po ( } v} (} u} ]v(}u}v }v R R ]o v u}uv ]v vu }( R X S o} v}
R }vvP }o]] }o]v ]v v} X X X (} u} ]v(}u}v }v R R r ˙uv X
TR }uv˙]vP v} (}u v ]vPo }( R }v}o] .vv]o uv X TR }uv˙]vP v} (}u v ]vPo }( R }v}o] .vv]o uv X

254 | Consolidated Statements of Cash Flows Consolidated Statements of Changes in Equity | 255
 3.3 Basis of Consolidation
Notes to the Consolidated
Financial Statements
TR }v}o] .vv]o uv ]vo R .vv]o uv }( R C}uv˙ v v }v}oo ˙ R
C}uv˙ ~] ]]] ZX C}v}o ] R] `Rv R C}uv˙V

{  R }` } R ]v V

PART VII
{  ] ˘} U } R ]PR U } ]o v (}u ] ]v}ouv `]R R ]v V v
1 General information about the company {  R R ]o]˙ } ] }` } + ] v X

Pv˘SE]R
D }v
E o]}uv˙`]Ro]u]o]]o]˙]v}}vRo`}(RNRovXTR TR C}uv˙ `RR } v} ] }v}o v ]v ]( ( v ]uv ]v] R R RvP
}uv˙~COCæZR]}8]o]vR}'uURNRovUv]P]}8]W]oouæU } }v } u} }( R R ouv }( }v}o o] } X
AHUU
B RNRovXAv}]`}(R}uv˙v]]]]~RC}uv˙]Z ]vv}X
TR o }( R ]]] ]vo ]v R }v}o] uv }( }. } o} v }v}o] uv
Pv˘ SE ] o]o˙ }uv˙ `]R }]v˙ R o] }v E }v˘ B o v R ˙u}o SARGX_ ]v }( }R }uRv] ]v}u (}u R + }( ]]}v } R `Rv }v}o } ˘] X WRv
Jo˙ v `]R Au]v D }]˙ SR o] }v N v R ˙u}o SARGX_ ]v M˙ X v ˙U iuv u } R .vv]o uv }( ]]] } ]vP R] }vvP }o]] ]v} o]v
`]R R} ˙ }R uu }( R G} X

2 Impacts of COVID-19 on Our Business Aoo ]v r}uv˙ v }v v vo] P]v }v v }v `v P} }uv] o]u]v X Uvo]
o} o} o]u]v vo R v }v }] ]v }( v ]u]uv }( R v( X
TRvvvRoovPo}(ROVID
C rı}lR]uR}``}XWRv
l]vPUv}vv}lURv˙]vu}((˙U]lu]P}vUv.vv]ou}uvP
R}PRRRoovP]vPuXWRvo˙˘]vo]u]]u}v}.vv]o(}uvv.vv]o 3.4 Foreign Currency Transactions
}]}vUoR}PR`}vv}(]}vo]lvRoovP}]`]RR]u}(R}lX
3.4.1 Functional and Presentation Currency
Iu ]vo ]v R }v}o] .vv]o uv }( R }( } v o ]vP R v˙ }( R]
3 Significant Accounting Policies }v}u] v]}vuv ]v `R]R R v˙ } X A }( Jv˙ U U R }v}o] .vv]o uv
v ]v USD ~¤ZU `R]R ] R C}uv˙ [ v}v v˙X
TR ]Pv].v C}uv˙ [ }vvP }o]] uu] o}`X
3.4.2 Transactions and Balances
Tv }v ]v (}]Pv v] vo R ˘RvP o]vP R }( R v }vX M}v˙
3.1 Statement of compliance and basis of preparation v o]]o] v}u]v ]v (}]Pv v] vo R ˘RvP o]vP R }vP X
F}]Pv ˘RvP ]+v ]]vP }v vo}v }Pv] ]v R }v}o] uv }( }. } o} v
TR }v}o] .vv]o uv ]v }v `]R R Ivv}vo F]vv]o R}vP Sv R }v}o] uv }( }R }uRv] ]v}u X N}v u}v˙ v o]]o] v}u]v ]v (}]Pv
~IFRSZU ] ˙ R Ivv}vo A }vvP Sv B} ~IASBZ v R ]v }v ] ˙ R IASB[Iv - v] vo R (}]Pv ˘RvP o]vP R }( R v }vX
v}vo F]vv]o R}vP Iv }v C}uu]' X TR }v}o] .vv]o uv }] Pvo }]`
}( R C}uv˙ [ ] v R o R] X TR˙ v (]o˙ R v˙ [.vv]o }]}vU ] .vv]o (} - 3.4.3 Financial Statements of Foreign Entities
uv v R G}` U }v P}]vP }vv ] X F} (}]Pv v ]vP ]+v (v}vo v˙ Rv USDP

TR ]Pv].v }vvP }o]] o] ]v R }v }( R } }v}o] .vv]o uv } {  v o]]o] (} R ov R v vo R o}]vP R }( R ov

o}`X Aoo u}v v ]v R}v }( }ooU vo }R`] ]v] U }v } R v ¤ R X RX
• ]v}uv˘v(}RuvvvP}.}o}vuv}(uv}(}R}uRv]
TR }v}o] .vv]o uv R v } (} ] ˙ R C}uv˙ [B} }( D]} ~R SB} _Z ]v}uvoP˘RvP~voR]P]v}}vo}˘]u}v}(Ruo
}v MR U X +}(R]o]vP}vRv}vU]v`R]R]v}uv˘vvoR}vR
}(Rv}vZX
{  oo ovP ˘RvP ]+v }Pv] ]v R uv }R }uRv] ]v}u X
3.2 Adoption of New and Revised Standards
3.4.4 Change in functional and presentation currency as of January 1, 2021
New standards and interpretations applicable for the annual period beginning on January 1, 2021 A }( Jv˙ U U R C}uv˙ RvP ] (v}vo v v}v v˙ (}u EUR } USDX TR RvP ]v
N` v v ]v }v (} R vvo ]} P]vv]vP }v Jv˙ U ] v} R v˙ u]o ]u (v}vo v˙ ` u } G R USD R }u R }u]vv v˙ ]v R C}uv˙U vvP
}v } }v}o] .vv]o uv X ]Pv].v }( R C}uv˙ [ R G}` v .vv]vPX TR RvP R v ]uouv `]R } + X

New standards and interpretations issued, but not yet applicable for the annual period beginning on January 1, 2021 TR RvP ]v v}v v˙U + Jv˙ U U (}u EUR } USD ] } o˙ o] }v }u
WRv}o˙}v˙}RvU]v}vU}uvuvRRv]]v}˙+X .P }]vP } IAS v IAS U ]( USD R o`˙ v R v}v v˙ }( R }v}o] .vv]o
O(RvRv}˙+U`˘v}v}Ru]o]u}v}.vv]ouv]v uv X TR RvP ` u } ' G R }v}u] (}}]v }( R C}uv˙ [ ]v P}]vP (}` X TR
R]}}(]v]oo]}vX

256 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 257
C}uv˙ o] R R v}v v˙ RvP `]oo P] ]v} v }R lR}o o vv
]vP }( R C}uv˙ [ (}uv } u X
C}u]}v .P ]v R }v}o] uv }( .vv]o }]}vU R }v}o] uv }( }. } o} v
R }v}o] uv }( }R }uRv] ]v}u U R }v}o] uv }( RvP ]v ]˙U }v}o
] uv }( R G}` U v oo ]o} R v r v U vo }R`] U ]vP R }
}o]v o}`P
{  A v o]]o] vo ]v} USD R o}]vP o]o R v }( R }vP ]} X
{  Iv}u v ˘v vo ˘RvP R }( R v }v } P `R
R ]o }˘˙X
{  D]+v ovP (}u R r v}v R v v vo}v ]+v U }u}vv `]R]v
RR}o [ ]˙X
{  SR ]oU R u]uU v }R vo R]}] ]o]vP R }( v }vX
3.5 Intangible Assets
3.5.1 Internally Generated Intangible Assets
E˘v] }v R ] ] }Pv] v ˘v ]v R ]} ]v `R]R ] ] ]v X
Av ]vvoo˙ Pv ]vvP]o ]]vP (}u o}uv ~} (}u R o}uv R }( v ]vvo }i
Z ] }Pv] ](U v }vo˙ ](U oo }( R (}oo}`]vP R v u}v P
{  R Rv]o (]]o]˙ }( }uovP R ]vvP]o } R ] `]oo ]oo (} } o V
{  R ]vv}v } }uo R ]vvP]o v } oo ] V
{  R ]o]˙ } } oo R ]vvP]o V
{  R}` R ]vvP]o `]oo Pv }o ( }v}u] v. V
{  R ]o]o]˙ }( Rv]oU .vv]o v }R } } }uo R o}uv v } } oo
R ]vvP]o V v
{  R ]o]˙ } u o]o˙ R ˘v] '] o } R ]vvP]o ]vP ] o}uv X
TR u}v ]v]oo˙ }Pv] (} ]vvoo˙ Pv ]vvP]o ] R u }( R ˘v] ]v (}u R
`Rv R ]vvP]o . u R }Pv]}v ]] o] } X WR v} ]vvoo˙ Pv ]vvP]o
v }Pv] U o}uv ˘v] }Pv] ]v R }v}o] uv }( }. } o} v
R }v}o] uv }( }R }uRv] ]v}u ]v R ]} ]v `R]R R˙ ]v X
D } v ]v ]vRv } R o}uv v P]}v `]R R ov RoR R}] }( ] }
U R C}uv˙ u R R }v]}v (} ]o]}v v} u vo R Po}˙ } ]
˙ R RoR R}] R v .vo] X
3.5.2 Acquired In-Process R&D, Software and Databases and Other intangible assets
IvvP]o`]R.v](oo]R]o˙o}]vr}Rvo}uv}i
U}L`vv}R]vvP]o]}ouou}}vvuo
]u]uvo}XIvvP]o`]R]v.v](oo]]}ouo]u]uvo}X
P˙uv (} ] ]vr} R v o}uv }i }]v R}PR ]vro]v]vP vPuv
]o] ]vvP]o }] R R˙ o˙ ]v.o U }v}oo ˙ R C}uv˙ v ˘ }
}] ( }v}u] v. X A R }]o]˙ ]]}v ]v IAS ] o`˙ }v] } . (}
o˙ ] R v o}uv v R u}v }( R ˙uv ] u]vo U (}v v u]o}v
˙uv } R] (} Ru o } } }u}v (} `R]R Po}˙ ulvP }o R v}
˙ v }]v }Pv] ]vvP]o X
OR ]vvP]o ]vo R P]}]˙ R]` V}R ~SPRV _Z ] ]v `R]R R C}uv˙ v }
258 | Notes to the Consolidated Financial Statements
- }]v R ]}]˙ ]` ˙ R FDA (} }v }( ] ( Po}˙ u]]}v } u˙ oo } v( } R] ˙X
TR PRV ] u } v ]` (} ]u]uv `Rv v } ]uv ]v] R R ˙]vP o
u˙ v} }o X A R u R C}uv˙ }uu] ]vP R PRV } o R ]` }( P o]}vU
R ]vvP]o `]oo u} v }Pv] }v .o]vP }( R o B]}o}P] L]v A o]}vX
-
- 3.5.3. Amortization of Intangible Assets
PART VII
IvvP]o U `R]R }u] }( ] ]vr} R v o}uv U }L` v v }R
]vvP]o U u} }v ]PRro]v ] } R u (o o]( (}u R u R˙ ]oo
(} U } `Rv R vo˙]vP P v] ] } U Pvoo˙ }v R (}oo}`]vP ] P
{  A ] IvrP} R D W R o}vP }( R v }}v o]( v R (o o]( }( R }u]v }
{  S}L` v D W W æ ˙
TR u (o o]( v u}}v uR} ]` R v }( R }vP ]} U `]R R + }(
v˙ RvP ]v u ]vP }v (} }v } ] X
3.5.4 Derecognition of Intangible Assets
Av ]vvP]o ] }Pv] ]R }v ]}o } `Rv v} ( }v}u] v. ˘ (}u ] X
G]v } o} ]]vP (}u }Pv]}v }( v ]vvP]o U u R ]+v `v R v ]}o
} U ]( v˙U v R ˙]vP u}v }( R U }Pv] ]v R }v}o] uv }( }. } o} v
R }v}o] uv }( }R }uRv] ]v}u `Rv R ] }Pv] X
-
3.6 Property, plant and equipment
Iu}(}˙Uovv]uvRo(}]vR}}v}o˙}(P}}}]U}(}u]v]
}U]vRuv}(.vv]o}]}vR]}Uouo]}vv]u]uvo}X
D ] ]}v ] }Pv] (}u ]]]}v }v` ~vo ] v} ˙ (} Z } } `] }(( R
} } o ]}v }( ~}R Rv ( R}o ov v } ] v }v ]}v Z o R] ] o o }
R] (o o] U ]vP R ]PR o]v u R} X TR ]u (o o] U ] o o v ] ]}v u R}
]` R v }( R } ]vP ]} U `]R R (( }( v˙ RvP ]v ]u }v (} }v } -
] ]X
Uvo ] } ]. RvP ]v R u (o o](U vvo ]}v (}oo}` P
{  O8 v o ]uv P Wæ ˙
- {  IT ]uv P ˙
A v ] u }( } ˙U ov v ]uv ] }Pv] }v ] } o } `Rv v} ( }v}u] v(]
˘ } ] (}u R }v]v }( R X A v˙ P]v } o} ]]vP }v R ] } o } ] uv }( v ] u
}( } ˙U ov v ]uv ] u]v R ](( v ` v R o } U ]( v˙U v R ˙]vP
- u}v }( R v ] }Pv] ]v R }v}o] uv }( }(] } o} v R }v}o] uv
}( }R }u Rv] ]v}u X
3.7 Inventories
- Ivv}] ] } } v o]o o U `R]R ] o}` X C} ] u]v ]vP R .r]vU .r}
uR} X C} }u] }( } }( R U } }( }v]}v v }R } ]v ]v ]vP]vP R ]vv}] }
R] v o}}v v }v]}vX
I( R ˘ o ] o }uo}v } } ˘ o ~v o]o o Z ] o}` Rv R ˙]vP u}v U
`] r}`v ] }Pv] (} R u}v ˙ `R]R R ˙]vP u}v ˘ ] v o]o o X
Notes to the Consolidated Financial Statements | 259
Ivo ]v ]vv}˙ } `R]R }o U ] }uu]o ] U ]v o]v]o v o]v]o }Pu
`oo ]v v}vr]u r}o }PuX TR } RP } R o}uv ˘
v } oo]vP U Pvo v u]v] ˘v U o˙U `Rv ] } R] RvvoX
W ]o] ]vv}˙ } }] `]R } ]} } R Po}˙ }o }( R } U } (} ]vv
}˙ } ]v } }v (]o] v} ˙ } U `Rv ] ] R]PRo˙ }o R R r}o ]vv}] `]oo
oo X TR u]v}v } ]o] ] }v R o ( v ]uv ovP } R ˘
Po}˙ }o }( R } } } }v (]o]˙ ]vP }v] X TR uv }( `RR } v} R }
] }v] R]PRo˙ }o } oo ] u }v o˙ ] v ]vo U ] v} o]u] }U R}` (
o } } (]o]˙ R }P o}vP R }o } U v˙ lv}`v (˙ } 8˙ }vvU }vo
ooo]vP ]}v v }R ]u]uv X
P]}o˙ ]o] } o } rovR ]vv}] }o ] } `]'v }`v }v RvP ]v R
iPuv } } v]o } o˙ }( }o ˙ Po}˙ }] U o˙ ]v }uu]o]}v } }R }vo
(} U `R]R `]oo } } R v o}uv ˘v X
3.8 Leases
TR C}uv˙ `RR }v ] } }v]v o U ]v}v }( R }v X TR C}uv˙ }Pv]
]PRr}(r v } }v]vP o o]]o]˙ `]R } oo o vPuv ]v `R]R ] ] R o U
˘ (} R}ru o ~.v o `]R o u }( u}vR } o Z v o }( o}` o X F}
R o U R C}uv˙ }Pv] R o ˙uv v }vP ˘v }v ]PRro]v ] } R u
}( R o vo v}R ˙u ] ] u} v }( R u 'v ]v `R]R }v}u] v. (}u
R o }vu X
TR o o] ]o]˙ ] ]v]]oo˙ u R v o }( R o ˙uv R v} ] R }uuv
uv U ] }v ˙ ]vP R ]uo]] ]v R o X I( R] vv} ]o˙ u]v U R o
] ]v uvo } }`]vP X TR o o] ]o]˙ ] vo˙ u ˙ ]v ]vP R ˙]vP u}v
} (o ]v }v R o o] ]o]˙ ~ ]vP R (( ] ]v u R} Z v ˙ ]vP R ˙]vP u}v }
(o R o ˙uv u X TR o o] ]o]˙ ] v o]v ]v R }v}o] uv }(
(]vv]o }]]}v X
TR ]PRr}(r }u] R ]v]o u uv }( R } }v]vP o o]]o]˙U o ˙uv u
} (} R }uuvuv ˙U o v˙ o ]vv ] v v˙ ]v]o ] } X TR˙ vo˙
u } o uo ]}v v ]u]uv o} X R]PRr}(r ] } R
R} ]} }( o u v (o o]( }( R vo˙]vP X I( o v( }`vR] }( R vo˙]vP
} R } }( R ]PRr}(r G R R C}uv˙ ˘ } ˘] R }}vU R o ]PRr}(r
] ] } R (o o]( }( R vo˙]vP X TR ]PRr}(r v ]v R }v}o]
uv }( .vv]o }]}v v R }v SP}˙U ov v ]uv _X
3.9 Impairment of Assets
3.9.1 Financial Assets
TR ]u]uv o} }( .vv]o u u} } ] oo }v R ˘ o} u}oX
F} ]o U ]v R v }( ]Pv].v .vv]vP }u}vv U R oo}`v ] u v u}v o
} o](u ˘ ] o} X TR} R ˘ ] o} R o (}u }]o (o v } R
˘ o]( }( R} ]o X
3.9.2 Property, Plant and Equipment and Intangible Assets
A R v }( R }vP ]} U R C}uv˙ ]` R ˙]vP u}v }( ] vP]o v ]vvP]o
} u]v `RR R ] v˙ ]v]}v R R} R + v ]u]uv o} X I( v˙ R ]v]}v
˘] U R }o u}v }( R ] u ]v } } u]v R ˘v }( R ]u]uv o} U ]( v˙X
260 | Notes to the Consolidated Financial Statements
WR ] ] v} }]o } u R }o u}v }( v ]v]]o U R C}uv˙ u R } -
- o u}v }( R R PvvP v] } `R]R R o}vP X
- IvvP]o `]R ]v.v] (o o] v ]vvP]o v} ˙ ]oo (} (} ]u]uv
o vvoo˙U v `Rv R ] v ]v]}v R R u˙ ]u] X
I( R }o u}v }( v } R PvvP v] ] u } o Rv ] ˙]vP u}v U R ˙ -
PART VII
]vP u}v }( R } R PvvP v] ] } ] }o u}v X Av ]u]uv o} ] }Pv]
]uu]o˙ ]v R uv }( }. } o} v R uv }( }R }uRv] ]v}u X
WR v ]u]uv o} vo˙ U R ˙]vP u}v }( R ] ]v } R ] u
}( ] }o u}v U } R R ]v ˙]vP u}v } v} ˘ R ˙]vP u}v R `}o
R v u]v R v} ]u]uv o} v }Pv] (} R } R PvvP v] ]v ]} ˙ X A
o }( v ]u]uv o} ] }Pv] ]uu]o˙ ]v }. } o} X
3.10 Financial Instruments
F]vv]o v .vv]o o]]o] }Pv] ]v R }v}o] uv }( .vv]o }]}v `Rv R C}u -
v˙ }u ˙ } R }v o }]]}v }( R ]vuv X TR C}uv˙ } v} v˙ ] }
RP ovv ( R G}` U v} } ] ul }( (}` (}]Pv ˘RvP }v X A ]}voo˙U R C}uv˙
} v} R .vv]o D u U X
3.10.1 Financial Assets
F]vv]o ]v]oo˙ }Pv] ]R (] o } v }v ] X Aoo }Pv] .vv]o
vo˙ u ]R u} } } (] o v IFRS ı }v R ] }( }R R C}uv˙ [u}o (}
- uvP]vP R .vv]o v R }v o R G}` R ] }( R .vv]o X
{  A .vv]o R ~]Z ] Ro `]R]v ]v u}o `R} }i ] } }oo R }v o R G}` v
~]]Z R }v o R G}` R }oo˙ ˙uv }( ]v]o v ]v }v R ]v]o u}v }v]vP
] u u} } ~v }( v˙ `] }`v (} ]u]uv ZU vo R ] ]Pv (] o
R}PR }. } o} ~FVTPLZ v R (] o }}vX
{  A .vv]o R ~]Z ] Ro `]R]v ]v u}o `R} }i ] R] }R ˙ }oovP }v o R
G}` v oo]vP .vv]o v ~]]Z R }v o u R P] ] }v ]. } R G}` R
}oo˙ ˙uv }( ]v]o v ]v }v R ]v]o }v]vP U ] u (] o R}PR }R }u -
Rv] ]v}u ~FVTOCIZU vo R ] ]Pv FVTPL v R (] o }}vX
{  Aoo }R .vv]o u FVTPLX
- A.vv]o ] o]. v`RvR RG}`˘ }G}`(}uR]vuvu `]R]v}v˙X
TR C}uv˙ }Pv] .vv]o `Rv R }v o ]PR } R R G}` (}u R ˘] U } R
C}uv˙ v( R ]PR } ] R }v o R G}` }v R .vv]o ]v v }v ]v `R]R v -
oo˙ oo R ]l v ` }( }`vR] }( R .vv]o v( X
TR C}uv˙ o]. v}vr] .vv]o ]v} R (}oo}`]vP P}] V
{  .vv]o (] o R}PR }. } o} } OCI ~v}vr v .vv]o U v .vv]o v R
]ov Z
{  .vv]o u} } ~]o v R v R ]ov Z
Financial assets at fair value through profit or loss or OCI
F]vv]o ]Pv (] o R}PR }. } o} ]( R C}uv˙ uvP R ]vuv v ul
R v o ]]}v }v R] (] o ]v }v `]R R C}uv˙ []vuv P˙X ']
A -
o v }v } }Pv] ]v R }v}o] uv }( }. } o} v R }v}o] uv }(
}R }uRv] ]v}u ]v X F]vv]o (] o R}PR }. } o} u (] o U
Notes to the Consolidated Financial Statements | 261
v RvP R]vU `R]R l]v} }v v˙ ]]v ]v}u U }Pv] ]v R }v}o] uv }(
}. } o} v R }v}o] uv }( }R }uRv] ]v}u X
3.10.1.1 Non-current financial assets at fair value through profit or loss or OCI
TR C}uv˙ R}o ]vuv ]v v}vr v .vv]o U `R]R }v IFRS ıU ]Pv .vv]o
(] o R}PR }. } o} } .vv]o (] o R}PR OCIX TR (] o }( o] ]vuv ]
}v R o}]vP ] }( R ] R }vP X I( R ] v} ul (} v ]˙ ]v
uv U R C}uv˙ o]R R (] o ˙ ]vP o}v Rv] X
B }v IFRS ıU R C}uv˙ ]}o˙ o } ]Pv ]. ]vuv .vv]o (] o
R}PR OCI R ]}v ] v} Ro (} ]vP } v} }vvPv }v]}v }Pv] ˙ v ]
]v ]v }u]v}vX
3.10.1.2 Current financial assets at fair value through profit or loss
C v .vv]o ]vo .vv]o u (] o R}PR }. } o} v }u] }( u}v˙ u
l (v v u }v R R v ]v]o u]˙ o } o Rv u}vR U ˘]vP u}vR X
3.10.1.3 Cash equivalents measured at fair value through profit or loss
C R ]ov u (] o R}PR }. } o} u˙ }u] }( u }v R R v ]v]o u
]˙ }( o } o Rv u}vR v u}v˙ ul (v R ]o˙ }vo } R v i }
]v]Pv].v ]l }( RvP ]v o X TR .vv]o ˙ R C}uv˙ ]v R uvPuv }( R R}r
u }uu]uv X
Financial Assets at Amortized Cost
3.10.1.4 Receivables
T v }R ]o ]Pv .vv]o u u} } X TR˙ ]v]oo˙ u
]R (] o } v }v ] U ]v R v }( ]Pv].v .vv]vP }u}vv X
Aoo ]o vo˙ u u} } U `R]R Pvoo˙ } }v } v}u]vo o o ˘
] o} }]]}vX
R]o u]vo˙ }u] v }R ]o v v v v}vr v R v o}uv ]vv
]o X TR R v o}uv ]vv ]o o } (v ovP (}u R v
o}uv ]vv }v R v o}uv ˘v ]v B oP]u v ] } R }v}o]
uv }( }. } o} v R }v}o] uv }( }R }uRv] ]v}u v R o]v SOR }vP
]v}u _ `Rv R ov ˘v] R v ]v v R ] }vo v R R R v
o}uv ]vv ]o X
3.10.1.5 Cash
C R .vv]o u u} } v }u] }( R ov v ]vP }v X
3.10.1.6 Cash equivalents measured at amortized costs
C R ]ov u u} } }u] }( u }v R R v ]v]o u]˙ }( o Rv
u}vR R i } v ]v]Pv].v ]l }( RvP ]v o X TR .vv]o ˙ R C}uv˙ ]v R
uvPuv }( R}ru }uu]uv X
C R v R ]ov ˘o ] RU `R]R ] v ]v R }v}o] uv }( .vv]o }]}v
v R o]v SOR v}vr v _X
3.10.1.7 Current financial assets measured at amortized costs
C v .vv]o ]vo .vv]o u u} } v }u] }( u }v R R v
]v]o u]˙ o } o Rv u}vR U ˘]vP u}vR X
262 | Notes to the Consolidated Financial Statements
3.10.2 Financial Liabilities
F]vv]o o]]o] ]v]oo˙ u R] v }v ] X S v } ]v]o }Pv]}vU .vv]o o]]o]
u u} } X
F]vv]o o]]o] u]vo˙ }u] }( v }R o]]o] X
PART VII
- T v }R o]]o] }u] }( o]]o] R o Rv }v ˙ (}u R ov R v
]v Pvo v} ]v ]vP v 'o }v v }vP}]vP ] ]vP R .vv]o ˙X TR˙ o} ]vo
˘v o } R C}uv˙ [ R v o}uv } X
3.11 Shareholder’s equity
Av ]˙ ]vuv ] v˙ }v R ]v ]o ]v ]v R }( v v˙ L vP oo }( ]
- o]]o] X E ]˙ ]vuv ] ˙ R C}uv˙ }Pv] R } ] U v }( ] ] } X
TR C}uv˙ R v ]] v˙ ]]v } ] RR}o X A }( D u U U v} }. ` ]oo
(} ]]}vX
-
3.12 Short term employee benefits
SR} u uo}˙ v. ]vo ˙o v o (} o] v }v } ] } R uo}˙ }( R
C}uv˙X TR˙ }Pv] ˘v (} R ]} ]v `R]R uo}˙ (}u R } }v]vP ] X
3.13 Share based payments
- E ]˙ 'o R ˙uv } uo}˙ v }R }]]vP ]u]o ] u R (] o }(
R ]˙ ]vuv R v X
- TR (] o u]v R v }( R ]˙ 'o R ˙uv ] ˘v }v ]PR
o]v ] } R vP ]} U }v R C}uv˙ [ u }( ]˙ ]vuv R `]oo voo˙ U `]R
- } }v]vP ]v ]v ]˙X A R v }( R }vP ]} U R C}uv˙ ] ] u }( R vu
}( ]˙ ]vuv ˘ } X TR ]u }( R ]]}v }( R }]P]vo u U ]( v˙U ] }Pv] ]v R
}v}o] uv }( }. } o} v R }v}o] uv }( }R }uRv] ]v}u R R R
uo ˘v G R ] u U `]R } }v]vP iuv } R ]˙ 'o R
˙uv X
3.14 Deferred revenue
C v v v}vr v ( v o } R ] (}u }oo}}v o]v Puv ]} }
}uo}v }( R v]vP } X TR ˙uv }Pv] v } R u }v }( R C}u -
v˙ []v}ouv ]v R R v o}uv }Pu }] (} v R u }( R Puv X
3.15 Income taxes
Iv}u ˘ ]v R }v}o] uv }( }. } o} v R }v}o] uv }( }R }uRv]
]v}u v R }o }( R v ˘ v ( ˘X
Notes to the Consolidated Financial Statements | 263
TR v ˘ ] }v ˘ o }(] (} R ˙ X T˘ o }(] ](( ( }u }(] } ]v R
u v }( }(] v o} v u v }( } R }u R v ] ]v }u ] ˘o ] u }( ]v }u } ˘ v
R ˘ o } ] o ]v } R ˙ v ] u R v ˘ o } ] o X TR C }u v˙ [ o] ]o
] ˙ (} v ˘ ] o o ]vP ˘ R R v v } v ] o˙ v ˙ R v }( R
} ]vP ]} X
D ( ˘ ] }Pv] }v u}˙ ]+v `v R ˙]vP u}v }( v o]]o] ]v R }v}o]
.vv]o uv v R } }v]vP ˘ ] ]v R }u}v }( ˘o }. X D ( ˘
}Pv] } R ˘v R ] ] }o R ( ˘o }. `]oo ]oo P]v `R]R R} o
u}˙ ]+v v o] X TR ˙]vP u}v }( ( ˘ ] ]` R v }( R }
]vP ]} v } R ˘v R ] ] v} o}vP }o R 8]v ˘o }. `]oo ]oo } oo}`
oo } }( R } } X D ( ˘ v o]]o] }+ ]( R ] oPoo˙ v(} o ]PR
} }+ v ˘ o]]o] v U v R˙ o } ]v}u ˘ o] ˙ R u ˘ R}]˙ }v R u
˘o v˙U } }v ]+v ˘o v `R]R ]vv ]R } 'o v ˘ o]]o] v }v v ] U
} } o] R v 'o R o]]o] ]uov}o˙X
D ( ˘ v o]]o] u R ˘ R ˘ } o˙ ]v R ]} ]v `R]R R
o]]o]˙ ] 'o } R o] U }v ˘ ~v ˘ o` Z R R v v } voo˙ v
˙ R v }( R }vP ]} X
3.16 Revenue and other operating income recognition
3.16.1 Collaborations and license agreements
Rv } R }v] ]v]oo˙ }( u]o}v U o]v ( U v}vr(vo (}v ( v R v
o}uv ] ( ]v }vv}v `]R }oo}}v v o]v Puv X
TR C}uv˙ }Pv] v `Rv R }u }]v }v}o }( }u] P}} } ] U ]v v u}v R
G R }v]}v R R C}uv˙ ˘ } ] ]v ˘RvP (} R} P}} v ] X Iv } }
u]v v }Pv]}v (} Puv R R C}uv˙ u]v } ]v R } }( IFRS æU (}oo}`]vP .
(}u P
1. Identify the contracts
Iv ] v }oo}}v v o]v Puv U R C}uv˙ ] u]vo˙ o]v]vP ] ]voo o }˙ v l} }
]]vP R v o}uv } l] U `R]R u]PR ]vo } R]vP uRv]u v l} ]v R ( U
oo]vP ] } } }oo} v v X Rv ] Pv R}PR R vPuv ] (}v ˙
uv U u]o}v ˙uv }v o]v]o v Po}˙ ]] U R v o}uv ] ( v (
o u]o}v v o }˙o X Iv }u U R }oo}}v v o]v Puv o} ]vo v
]˙ ]}v }u}vv X I( R] ] R U R C}uv˙ vo˙ ]( R ]] } }u]v }v U }
˙ IFRS æU u X
2. Identify performance obligations
D v]vP }v R ˙ }( R Puv U R v }v } u} ]v (}uv }o]P}v v IFRS æX TR]
] }v v uv }( `RR R }u] ]v v Puv o }( ]vP ]v v ]v (}u
R }R }u] } v( P}} v l} ] ]v R }v˘ }( R }v X
F} } u]o }vP}]vP }oo}}v v o]v Puv ~]X X R Z ] L APuv ZU R C}uv˙ R
R R ] u} Rv }v ]v (}uv }o]P}vU ]vP R v( }( o]v v o˙ }( o]v]o v
}uu]o } X
TR] ] R C }u v˙ }v] R (}uv }o]P]}v ] ] ]v ]v R }v˘ }( R }v R
o] v R v ro}v o `]R} R C }u v˙ ]vP ( R ]v}o ]v R R v o}uv }o
o } ]}v v R R ] v} ]v v v ` v R o] v v R o]v] o v }uu ]o o˙ }
}] X
264 | Notes to the Consolidated Financial Statements
- F} }R u]o }oo}}v v o]v Puv U R C}uv˙ R R R ] }v ]vPo (}uv
}o]P}v ]v } }oo}}v v o]v Puv U ]vP R v( }( o]v }u]v `]R (}uv }(
- R v o}uv ] X
3. Determine the transaction price
O u]o }vP}]vP }oo}}v v o]v Puv ]vo v}vr(vo (}v ˙uv } o]v ( V
PART VII
- u]o}v ˙uv U R ] }( `R]R ] vv }v R R]uv }( ]v o]v]oU Po}˙ } }uu -
]o u]o}v V }˙o }v o v R v o}uv ] ( X
- 3.1 Non-refundable upfront payments or license fees
I(Ro]v}RC}uv˙[]vooo}˙]u]v}]v(}uR}R(}uv}o]P}v
]v.]vRvPuvURC}uv˙}Pv]v(}uv}vr(vo(}v(oo}}R]o]v
R}]v]vuRo]v]v(}R}uvR}uRR]PR}Ro]vX
F}oo}u]o}vP}]vP}oo}}vvo]vPuvURC}uv˙}v]R(}uv}o]P}v
o}Rv(}(Ro]v]v(}uR}R}u]}v(P}}vl}]XTRC}uv˙
o]iPuv}Rv}(R(}uv}o]P}v}u]v`RRR(}uv}o]P}v]
.}u}}]v]vuXI(}uUv]Rv}Pv]}v'vRGR
v(}(}v}o}(R]}R}uX
3.2 Milestone payments other than sales based milestones
A u]o}v ˙uv U ]vP ]o }v]}vU ] }vo˙ ]vo ]v R v }v ] } R ˘v ] ] R]PRo˙
}o R ]Pv].v o ]v R u}v }( uo v }Pv]}v `]oo v} } `Rv R v ]v˙
}] `]R R ]o }v]}v ] vo˙ }o X TR C}uv˙ u R u}v } ]vo
]v R v }v ] }v R]uv }( R u]o}v v X TR v }v ] ] Rv oo} } R (} -
uv }o]P}v }v v ro}v oo]vP ] ] U (} `R]R R C}uv˙ }Pv] v } `Rv R (} -
uv }o]P}v v R }v . X A R v }( R }vP ]} U R C}uv˙ ro R
}]o]˙ }( R]uv }( R u]o}v v v˙ o }v]v U v U ]( v ˙U i R u }( R
}oo v }v ] X Av˙ R iuv } }v uo Rr ] U `R]R `}o + v
v v]vP ]v R ]} }( iuv X
3.3 Research and development service fees
O u]o }vP}]vP }oo}}v v o]v Puv u˙ ]vo ]u uv } } R]vP (} R v
- o}uv ] X R D ] (}u v . } u P]v R R }u ]uov}o˙ -
] v }vu R v. }] ˙ X SR } ]u uv ] }Pv] ]v v `Rv
- } ]v v P ˙ R X
3.4 Sales based milestone payments and royalties
O u]o}vP}]vP}oo}}vvo]v Puv ]vo o }˙o U]vo]vP}uu]ou]o}v
˙uv }vRoo}( oUv Ro]v R v u } R }u]vv]u}`R]RR}˙o
v }uu]ou]o}v ˙uv oXRo v ] }Pv] R v vo˙]vP o }X
4. Allocate the transaction price
Iv ]v]o U v v˙ Roo oo} R v }v ] } R (}uv }o]P}v ]v. ]v R }v }v
o v ro}v oo]vP ] ] X A } }vP}]vP }oo}}v v o]v Puv ~]X X R Z ] L AP -
uv Z }v]v u} Rv }v (}uv }o]P}vU R C}uv˙ } oo} R v }v ] } oo
(}uv }o]P}v ]v. X
5. Recognize revenue
Rv ] }Pv] `Rv R }u }]v }v}o }( R P}} v l} ] }] ]v R }oo}}v
v o]v Puv X TR }v}o v v( } u } }]v ]v u W `R]R o ]v R }Pv]}v
- }( v } u } }]v ]v u X
A } }vP}]vP }oo}}v v o]v Puv ~]X X R Z ] L APuv Z }v]v u} Rv }v (}uv
Notes to the Consolidated Financial Statements | 265
}o]P}vU R C}uv˙ }Pv] v }]v ]v u (} v( }( o]v v R C}uv˙ }Pv] v TR (}oo}`]vP `R l˙ u}v }vv]vP R ( U v }R l˙ } }( u}v v -
} u (} o˙ }( o]v]o v }uu]o } }u ]uov}o˙ ] R v. }] ˙ R ]v˙ R v }( R }vP ]} U R ]Pv].v ]l }( ]vP u]o iuv } R ˙]vP u}v
C}uv˙ [ (}uv U . } u X }( v o]]o] `]R]v R v˘ .vv]o ˙X

OR }vP}]vP }oo}}v v o]v Puv }vo˙ }v]v }v ]vPo (}uv }o]P}v `R]R ] U R Critical estimates in applying accounting policies
}u ]uov}o˙ ] R v. }] ˙ R C}uv˙ [ (}uv U . } u X A RU R Research and development cost accruals

PART VII
C}uv˙ }Pv] v } u X TR C}uv˙ }Pv] } }( ¤ X u]oo]}vU ]. ]v v} æ } R .vv]o uv U ]v (} o]v]o
]o ] v uv( ]vP }( P } U R v o}uv ˘v }v v o}v }(
TR}Pv]}v}(v}u]}v'vRGR(}v}(Ro(}uv ] v} [ }P }` }uo}v }( ]. l X T]u]vP }( ˙uv u˙ ]+ ]Pv].vo˙ (}u R ]} ]v
}o]P}vUo˙]vPR]vuR}XTR]vuR}uR(}v}(R(}uv}o]P}vR `R]R R } }Pv] ˘v U ovP ]v o]v]o ]o o }Pv] `]R]v ST v }R ˙ -
vP}(}o}oo}}v}R}uoR]}}u}R}ou}oo}}v}X o _ ]v R }v}o] uv }( .vv]o }]}vX

R R v o}uv ] ( }Pv] v `Rv } ]v v P ˙ R Qv.}v }( R R }P v R vo}v }( R }P } R o ] u U

R C}uv˙ ] vP ]v]o ]v R } }( ] l}( R R v o}uv ] }( ] }vP}]vP R }P ] v} ]o˙ } o X Iv uvP R v} [ }P }` }uo}v }( ]. l U R
}oo}}v v o]v Puv X C}uv˙ R(} v}vr.vv]o R v v}oouv U o]v]o ] }v v v} ]v(}u}v
}( o } ]v X TR] ] }]v R}PR } (}u } ] ]}v `]R C}uv˙ }vvo v }]
3.16.2 Grants, research and development incentives, payroll tax rebates and changes in fair value on ] }] } R }P } }( }uo}v }( ]o U } R }uo}v }( ] X C} ˘v
non-current financial assets } R ] ]} R ] }] X C} (} ] }] R R v} ˙ v ] }Pv]
B ] ] } ˘ v] R v o}uv ]]] U R C }u v˙ v(] (}u ]} Pv U ˘v X
R v o}uv ]v v] v ˙}oo ˘ (}u ]v P} vuvo Pv] X TR Pv U
R v o}uv ]v v] v ˙}oo ˘ Pv oo˙ ]u } o˙ ]u } ˘ v]
]v ]v R v o}uv ((} }( R C }u v˙ v ] } R }v}o] uv }( }( -
] } o} v R }v}o] uv }( }R }u Rv] ]v}u U v R o]v SOR } ]vP ]v}u _U
`Rv R o v ˘ v] R v ]v v R ] }v o v R R Pv } R v
o}uv ]v v] ] o X F] o P]v o]vP (}u R RvP ]v R (] o }( v}v r v
(]vv]o ] } R }v}o] uv }( }(] } o} v R }v}o] uv }( }R
}u Rv] ]v}u U v R o]v SOR } ]vP ]v}u _X

3.17 Segment reporting

SPuv o ]vo v v ˘v ]o˙ '] o } Puv v R ov }}v }( v v

˘v R v oo} }v }vo ] } Puv X SPuv v o]]o] }u] R} } -
]vP v o]]o] R ]o˙ '] o } R Puv } v oo} } R Puv }v }vo
] X SPuv v o]]o] } v} ]vo ]v}u ˘ ]u X

TR C}uv˙ uvP ] ] v } }v ]v v] `R]R ] G ]v ] }Pv]}vo

v ]vvo }vPX TR C}uv˙ } v} ]vP]R ]v ] ]vvo }vP ]+v Puv U v]R ]v
v} P}PR]o Puv X TR R]( }vP ]]}v ul ] R B} }( D]} X

4. Critical Accounting Judgements and Key Sources

of Estimation Uncertainty

Iv R o]}v }( R C}uv˙ [ }vvP }o]] U `R]R ] } U R C}uv˙ ] ] } ul

iPuv U u v u}v } R ˙]vP u}v }( v o]]o] R v} ]o˙ v
(}u }R } X TR u v }] u}v }v R]}]o ˘]v v }R (} R
}v] } ov X A o o u˙ ]+ (}u R u X

TR u v vo˙]vP u}v ]` }v v }vP}]vP ] X R]]}v } }vvP u

}Pv] ]v R ]} ]v `R]R R u ] ] ]( R ]]}v + }vo˙ R ]} } ]v R ]} }( R
]]}v v ( ]} ]( R ]]}v + }R v v ( ]} X

266 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 267
5 Intangible assets 6 Property, Plant and Equipment
A] S}L` OR
~IvR}v}( ¤Z IvrP}RD IvvP]o Total ITU}8 R]PRr}(r R]PRr}(r LR}o
vo ]u} - L
Cost ~IvR}v}( ¤Z ]uv B]o]vP VR]o uv ]uv Total
On January 1, 2019 — 182 — 182 Cost

PART VII
A]}v æU ı v æUı
Tvo}v]+v ~ıZ ~Z v ~Z On January 1, 2019 3,105 — — — 290 3,395
On December 31, 2019 44,802 473 — 45,275 A}}v}(IFRS v U æ v v Uı
A]}v U U ıU Uıı A]}v æ æUı æ ıæ U
Tvo}v]+v Uı æ Uæ æUæ Tvo}v]+v ~ææZ ~Z ~Z ~æZ ~ıZ
On December 31, 2020 65,180 3,543 99,058 167,781 On December 31, 2019 3,906 7,741 1,098 908 317 13,970
A]}v æU v v æU A]}v Uæ U v æUæ
D]}o v ~ıZ v ~ıZ D]}o ~Z v v v v ~Z
On December 31, 2021 70,180 3,353 99,058 172,591 Tvo}v]+v æ ı Uı
On December 31, 2020 4,889 11,721 2,273 1,424 346 20,653
Amortization and impairment A]}v U Uı æ v ıU
On January 1, 2019 — (118) — (118) D]}o ~Z v v v v ~Z
Au}}v v ~Z v ~Z v˙
C vo}viuv ~Z v v ~Z
Tvo}v]+v v v On December 31, 2021 7,938 16,462 3,075 1,981 346 29,802
On December 31, 2019 — (158) — (158)
Au}}v v ~Z v ~Z Depreciation and impairment
Tvo}v]+v v ~Z v ~Z
On December 31, 2020 — (437) — (437) On January 1, 2019 (2,439) — — — (13) (2,452)
Au}}v v ~Z v ~Z ]}v
D ~ææZ ~UZ ~Z ~Z ~Z ~UZ
On December 31, 2021 — (907) — (907) Tvo}v]+v æ ~æZ ~Z v v ı
On December 31, 2019 (2,909) (1,477) (262) (103) (44) (4,795)
Carrying Amount ]}v
D ~ææZ ~UZ ~Z ~Z ~Z ~UZ
OvDuUı U æ v æU D]}o v v v v
OvDuU æU U ııUæ U Tvo}v]+v ~Z ~æZ ~æZ ~ıZ ~Z ~Z
OvDuU U U ııUæ U On December 31, 2020 (3,642) (4,044) (760) (543) (82) (9,071)
]}v
D ~UZ ~UZ ~æZ ~æıZ ~Z ~æUææZ
D]}o æ v v v v æ
TR C}uv˙ (}u v vvo ]u]uv ]` }v R ]vvP]o v} ˙ ]oo (} X TR] ]` ]
v˙
C vo}viuv ~æZ v ~Z v
v} o ]v R }Pv]}v }( v ]u]uv RP X
On December 31, 2021 (4,565) (6,774) (1,411) (1,093) (116) (13,958)

A }( D u U U R v} }uu]uv } ] ]}vo ]vvP]o U ˘ (}R ]v v}

ıX N} ]vvP]o oP ]˙ (} o]]o] v} R v˙ ]vvP]o `R} o ] ] X Carrying Amount
OvDuUı ıı U æ ıUæ
OvDuU U U Uæ Uæ
OvDuU U ıU U æU

1. TRC}uv˙R o v} } `RR }v ]U} }v]vU o R }(]v]o o]}vXIv U(} }v v ]v}

(} R v]}v URC}uv˙o] }v] uvu o˙]vPIAS vIFRIC D u]v]vP`RR vAvPuv}v]v L X

TR v} }uu]uv } ] }˙U ov v ]uv X FRu} U v} ]u }( }˙U ov v

]uv oP X S v} (} ]v(}u}v (} o `R R C}uv˙ ] o X

268 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 269
7 Other Non-Current Assets 8 Deferred Taxes
ORv}vrv}v]}(v}vrv]Rv.vv]oRo(]oR}PR}.} TRu}v}((˘vo]]o]˙˙˙}(u}˙]+vv]o(}oo}`P
o}}R}PROCIX
DuA U
~IvR}v}( ¤Z A L]]o] N
DuA DuA DuA

PART VII
~IvR}v}( ¤Z U U Uı Deferred tax assets / (liabilities)

R]CRrv}vrv U Uæı Aovoo}`v 2,858 v Uæ

N}vrv.vv]oRo(]oR}PR}.}o} Uæı U Uı Iv}u˘v.(}u˘˘}vo

U v U
}Rr˙uv
N}vrv.vv]oRo(]oR}PROCI æU v v
P}.]v]vv}˙ Uæ v Uæ
Total other non-current assets 54,876 7,816 3,624
P}˙Uovv]uv æ ~Z ~Z
IvvP]o v ~UZ ~UZ
N}vrv]R}vDuU`u]vo˙}u}}(}]Pv]vRoP -
uv(}Ro}}˙v}8}(RC}uv˙X N}vrv.˘ v ~UæZ ~UæZ
OR v
N}vrv.vv]oRo(]oR}PR}.}o}]}u]}(R}.R]vAP}uATR N«vP˙˘ov˙ ~Z v
NVXIvMRıURC}uv˙v]v}o]vPuv`]RAP}uATRNV(}R}(HGFru] - Net deferred tax assets / (liabilities) 32,191 (6,438) 25,753
uSIMPLEAv}]¡Uo}vRC}uv˙[Iuuv}o}P˙Ivv}P}PuXIv˘RvP(}PvvPR]
o]vURC}uv˙]}.R]vAP}uATRNVX
DuA U
~IvR}v}( ¤Z A L]]o] N
IvMRUAP}uATRNV¤u]oo]}v]vS]B.vv]vP˙]]vPUæ}(P(BSRX
Deferred tax assets / (liabilities)
TRC}uv˙R}ru}v˙o}v}(S]B.vv]vP}vvRvu}(}v]vPR]v -
u]v]vPR(]o}(R}.rR]vP]vuvU`R]Ro]vRvP]v(]o}(v}vrv.vv]o Aovoo}`v 2,147 v U

}(¤Xu]oo]}v}R}PR}.}o}X Iv}u˘v.(}u˘˘}vo}
U v U
Rr˙uv

F]oRvP}vv}vrv.vv]o`]R(]oR}PR}.}o}}Pv]]vR}v}o] P}.]v]vv}˙ v v v

uv}(}.}o}]vo]vSOR}vP]v}u_X P}˙Uovv]uv v ~Z ~Z
IvvP]o v ~UıZ ~UıZ
A}(Ro]vPuv(}Ro}uvv}uu]o]}v(}(PP]u}]vGCR]v~v} N}vrv.˘ v v v
(}(R]v(}u}vZURC}uv˙}]vUu}vP}RUæUv`o˙]]Z LRoo]
OR v v
}(¤RXTR(]o}(R]˙]vuv}vP]u]v˙(v}Ro}]vP]
}(R]R}vP~o].oo]vR(]oR]R˙ZUovP]vRvP]v(]oX N«vP˙˘ov˙ ~Z v

TRC}uv˙uR]}oo}v}}Pv]vRvP]v(]oR}PROCI]vo]vSF]o Net deferred tax assets / (liabilities) 15,038 (1,487) 13,551

P]vl~o}Z}v]vuv]v]˙]vuv]PvFVTOCI_X
TRRvP]vv(˘}]vR}v}o]uv}(.vv]o}]}vv]o(}oo}`P
TRoo}`]ooRv}vrv.vv]o(]oR}PR}.}o}}OCI}(DuU
UvıX (D ˘ (D ˘
~INTHOUSANDSOF¤Z o]]o]
Balance at January 1, 2021 15,038 (1,487)
DuA DuA DuA R}Pv]]v}.}o} Uæ ~æUZ
~IvR}v}( ¤Z U U Uı
R}Pv]]v]˙ æUı v
Cost at January 1 1,659 1,659 —
+
E }(RvP]v(}]Pv˘RvP
A]}v}(R˙ æU v Uæı
Balance at December 31, 2021 32,191 (6,438)
Cost at December 31 76,659 1,659 1,659

(D ˘ (D ˘
Fair value adjustments at January 1 4,648 1,257 — ~INTHOUSANDSOF¤Z o]]o]
F]oiuv}(R˙R}PR}.}o} Uæ Uıæ U Balance at January 1, 2020 — —
F]oiuv}(R˙R}PROCI ~ıUıZ v v R}Pv]]v}.}o} Uæ ~UZ
Tvo}v]+v v R}Pv]]v]˙ Uæ v
Fair value adjustment at December 31 (23,490) 4,648 1,257 +
E }(RvP]v(}]Pv˘RvP ~Z
Net book value at December 31 53,169 6,307 2,916 Balance at December 31, 2020 15,038 (1,487)

270 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 271
9 Inventories 12 Cash and Cash Equivalents
DuA DuA DuA
~IvR}v}( ¤Z U U Uı
DuA DuA DuA
R`u]ov}vuo U U v ~IvR}v}( ¤Z U U Uı

Ivv}]]v} Uæ Uæ v M}v˙ul(v ııUı æUı v

Tu}v ıæUı Uæ ææU

PART VII
F]v]RP}} U v v
Total inventories 109,076 æUıæ v CRvvlov Uı ıUæ Uæ
Total cash and cash equivalents 1,334,676 UU U
OvDuUU]vv}]u}v}¤ıXu]oo]}vo}(PP]u}XO(R}o]vv}˙U¤Xu]oo]}v
o}]vv}˙`R]R]vo˙`]vP(]o]˙}oXA}(DuUUv}]vv}˙`]r}`v`
}X
CRvR]ovu˙}u]}(RvvlovU]vP}vUu}v`]Rv}]P]vou -
]˙v}˘]vPu}vRvu}v˙ul(vR]o˙}vo}Rvi}v]v]Pv].v
Ivo]v]vv}˙}`R]R}oU]}uu]o]U(}]vrR}o]v]ovo]v]o
]l}(RvP]voX
}PuUv}vr]ur}o}Puvo]v]o}Pu]}˙]Z LX

CR}]}v]v`]R(.vv]ovU`R]Ru}o˙}v]}R]PRo]˙.vv]o]v -
}v`]R}v]vP}]]lX

10 Trade and Other Receivables OvDuUURRvR]ov]voƒXu]oo]}vRo]vEURU`R]R}oPv(}]Pv

v˙˘RvPP]v}o}]v}.vv]oo]v}v`]RRG}v}(RUSDlEUR˘RvP
TRv}R]o}u}}(]o`R]R]oo}`P RC}uv˙[(v}vov˙]USDX

DuA DuA DuA

~IvR}v}( ¤Z U U Uı Poo}(}v}(}u}]v(}u}v}vR.vv]o]luvPuvX

T]o Uæ æU
Iv]o Uæ ıı U
OR]o U æUı U 13 Share Capital and Share Premium
Total trade and other receivables 38,221 6,978 31,585
OvDuUURC}uv˙[R]o`v˙æUUæRXAooR`]U(oo˙
]v}(RuoXTRoo}`uu]}]o]vUo}(}+]vPvR˘]}(
TR˙]vPu}v}(v}R]o}˘]uR](]oXOvDuUU` }l}}vvRC}uv˙[Euo}˙S}lO}vPovX
]v}Rv˙}]]}v(}˘]o}X
R}oo(}`}(vu}(R}v]vPP
Poo}(}v}(}u}]v(}u}v}vR.vv]o]luvPuvX
Number of shares outstanding on January 1, 2019 35,975,312
E˘]}(}l}}v ıU
SR]}v(}uJ}Rv}vJ}Rv}vIvv}}vIvX UUıı
11 Financial Assets — Current Go}oo]}+]vP}v}v˘
E vN}vN}uUı UU
Oroo}uv}}v˘]˙v`]}vN}uUı U
TRv.vv]oo}u}v`]Rv]v]ou]˙o}vPRvu}vRoRvu}vR
vu}v˙ul(vR}v}o](˙R]ovX Number of shares outstanding on December 31, 2019 42,761,528
E˘]}(}l}}v U
DuA DuA DuA
~IvR}v}( ¤Z U U Uı Go}oo]}+]vP]v}v˘
E vN}vM˙U UæUææ
M}v˙ul(v Uæ Uı Uıı Oroo}uv}}v˘]˙v`]}vM˙ıU æU
Tu}v ııU ıUæı U Number of shares outstanding on December 31, 2020 47,571,283
Total current financial assets 1,002,052 779,649 1,128,499 E˘]}(}l}}v æU
Go}oo]}+]vP]v}v˘
E vN}vF˙U UæU
OvDuUURv.vv]o]voƒXu]oo]}vRo]vEURU`R]R}oPv(}]Pv - Oroo}uv}}v˘]˙v`]}vF˙U Uæ
v˙˘RvPP]v}o}]v}.vv]oo]v}v`]RRG}v}(RUSDlEUR˘RvPR Number of shares outstanding on December 31, 2021 51,668,315
C}uv˙[(v}vov˙]USDX

Poo}(}v}(}u}]v(}u}v}vR.vv]o]luvPuvX

272 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 273
Ov F ˙ U U Pv˘ SE }+ U æU }( ] }]v˙ R R}PR Po}o }+]vP `R]R }v] }( E˘]] Ov]vP Ov]vP Ov]vP
}l }l}}v}v }l}}v}v }l}}v}v
U U ADS ]v R UXSX ] }( ¤ X ADSU (} v`]vP ]}v v }uu]]}v v }+]vP ˘ - E˘]˙ }}v~]v¤Z (*)
DuU DuU uD Uı
v V v Uæ U }]v˙ R ]v R E }v E}v}u] A ] }( ƒ æX ı R U (} v`] -
X v v U
]vP ]}v v }uu]]}v v }+]vP ˘v X Ov F ˙ U U R v`] }( R }+]vP ˘]
R] } roo}uv }}v } R U æ ]}vo ADS ]v (ooX A o U Pv˘ SE ] ¤ U X u]oo]}v X æUı v v

]v P} } (}u R] }+]vP U ˙ ¤æ X u]oo]}v }( v`] ]}v v }uu]]}v U v }+]vP X v æUı Uı

PART VII
˘v U }( `R]R ¤æ X u]oo]}v R v (}u ]˙X TR }o v R } (}u R }+]vP u}v - X ıU U Uı
} ¤ U ı X u]oo]}vX X U U U
X Uæ ıU æU
Ov M˙ U R vvo Pvo uvP U R RR}o }( R C}uv˙ } R R}]}v } R
B} } ] u˘]uu }( A9 }( R Rvr}v]vP R ]o (} ]} }( u}vR X æ Xı Uæ Uæ ıU
æ X v ıæ U
Ov D u U U v u}v }( ƒ U æ X U v ˙ U Uæ R U oo u]v ]oo v R æ X æUæ U æU
R}] ]oX Xı U æU æU
Xıı U Uæ ıUı
X Uæ U æU

14 Share-based Payments Xæ æU Uı U
Xı Uæ U ææUı
Stock Option Plans ıXæ æU æU ıU
TRC}uv˙R}l}}vRu(}Ruo}˙}(RC}uv˙v]]]]XIv}v`]RR ıXæ ıUææ ıUæ U
u}(RovU}˙RR}oUuo}˙u˙Pv}l}}v}R}]v˙Rv
ıX U æU U
˘]]uv}vo}`}]v˙RX
ıX æU U U

TR}l}}vPv}uo}˙U}vov}]}}(RC}uv˙v]]]]XTR}l}}v Xæ U U Uı
RvPv(}(RPXR E uo}˙[}l}}v}v]v}}v}]v˙R}(RC}uv˙}v˘ - ı Xæ Uæ U ııUæ
]XTR}l}}v˙v]R]PR}]]vv}}vP]PRXS}l}}vu˙˘]v˙u(}u æXæ Uæ ıæUæ U
R}(vP}R}(R]˘]˙XA}(Jv˙UURC}uv˙]}RvPRvP]}}(
ı æXæ U ıUı Uææ
]]Pvr}v}l}}v(}u˙}˙}ulRvP}v]v(}ooR}}vPvX
æ æX U ıU v

TR}l}}vPv~Pov]Pvr}vU Z ]v]v]oU(}oo}`P æX Uææ U v

• l}(R}o}l}}vPv`]oo}vR.vv]˙}(RPvvP}(R}l}}vUv æ X ıU U v
• lR}(R}oPv}vR.˙}(Ru}vR(}oo}`]vPR.vv]˙}(R}(Pv}(R}l X Uæ æUæ v
}}vX
æ X U U v
X U æU v
U}vo}(Ruo}˙U}vov}]}U}l}}vu˘](}Ro}(~]Zı˙LR
o`}l]vP˙Pv˘U}~]]ZMR}(RR˙(}oo}`]vPR}(Pv}(R}}l}}vUv]vv˙ X ıU Uæ v
v}oRvR˘]}v}(R}}vX æ X U Uæ v
æX U v v
Iv}}.vvR˘R]}vRPv}(}l}}vUBoP]vuo}˙RR]o]˙U]v
Xı Uææ v v
˘RvP(}R˘}vRPv}(R}l}}vU}v(R}v}u]v.o}}(R}
ıXı U v v
}l}}v}R]˙XA}(DuUUR}v}u]v.}(ıUæ}l}}vU(}`R]Ro -
vPo]U`v(}R]˙X æX U v v
Xı U v v
N}}R}v]}v'R}R}l}}vX ıXı ıUæ v v
l ~Z
æX ıUæ v v
TR(}oo}`]vPRr˙uvvPuv`]v˘]v]vPRvv]}˙v`R]R˘ -
5,619,113 5,365,743 4,358,069
]oRv}(R]}vP

~ Z  Au}v R v }v } USD R o}]vP }( D u U X

~Z A}(uD URC}uv˙Pv}}v(}`R]RRv.]]Rr˙]}}R}}`v}vou}(.}v
˙

274 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 275
 ı S}l}}vPv]v A]o Jo˙ O} Du ~Z

W]PR W]PR W]PR Nu}(}}vPv U Uı U ıUæ

Nu P Nu P Nu P
}(}l ˘] }(}l ˘] }(}l ˘] P
A F]o}(}}v~]v¤Z (*)
ıXıræX XæræıX XærX æXærıXı
}}v ] (*)
}}v ] (*)
}}v ] (*)

SR]~]v¤Z (*)
XırX XrXıæ XærXæ æX
Outstanding at January 1 5,365,743 142.87 4,358,069 78.23 3,536,651 37.54
E˘]]~]v¤Z (*)
æX X X ıXı

PART VII
Gv Uæ Xıı UıUæ X UæU X
E˘}oo]˙ æXrXA9 æXærXıA9 XrXA9 XærXæA9
E˘] ~æUZ X ~UZ X ~ıUZ Xæ
P
A E˘}}vo](~]v˙Z rXæ rXæ rXæ XærXæ ~Z

F}(] ~æUıZ Xı ~UææZ Xı ~UZ ııXı

R]l ‑(]v ~XZr~XZA9 ~XZr~XZ ~XZr~XæZA9 XrXæA9
Outstanding at December 31 5,619,113 164.33 5,365,743 142.87 4,358,069 71.62
E˘]]v v v v v
Exercisable at December 31 3,613,371 106.53 2,833,680 65.24 2,203,476 25.38

u}v R v }v } USD R o}]vP }( R ]} X ~ Z  Iv D u U R C}uv˙ Pv }o }( ıUæ }l }}v X TR v.]˙ v R}} `v }v o u }( . } v ˙ X

TR ˘ }}v o]( vP `v X æ v Xæ ˙ X TR] u `]oo }v R v ]} }( ˙ R v R
v.]] `]oo R u R}] `v }v o u }( . } v ˙ X TR }o (] o }( R Pv `}o vP (}u ¤ æX u]oo]}v
~ A9 }( R }l }}v `]R }v o u }( . ˙ Z } ¤æ X u]oo]}v ~ A9 }( R }l }}v `]R }v o u }( v ˙ ZX
TR`]PRPR]R}(˘]}(}}v˘]]vPR˙vDuU` ~ Z  u}v R v }v } USD R o]o ]o]vP R Pv X
¤æXıU}u}¤æXæ]vPR˙vDuUv¤Xı]vPR˙vDuU
ıXTR`]PRPu]v]vP}voo](}(R}l}}v}v]vPu}v}X˙}vDu
U}u}X˙}vDuUvX˙}vDuUıXTRoo}`R}`R Bo}`]v}]`}(Ru]vo}v}Ru]v}v}(R(]o}(Pv]vPP
`]PRPu]v]vP}voo]((}RvP}(˘]]P

S}l}}vPv]v A]o Jv˙ O} Du

Ov]vP}v W]PRPu]v]vP Nu}(}}vPv U ææUı ıUæ ıU

E˘]]~]v¤Z DuU }voo](~]v˙Z P
A F]o}(}}v~]v¤Z (*)
XrX XrıX ıXræX XrıX
XrX æUæ Xæ SR]~]v¤Z (*)
ææXræXı XrXæ æXrıXæ XærX
XrX Uæ X E˘]]~]v¤Z (*)
X X æXı U
XrX æUı X E˘}oo]˙ XrXA9 XræXıA9 XræXA9 XræıXıA9
XærXı Uı æXı P
A E˘}}vo](~]v˙Z rX rX rX rX
ıXærıX ıUıı Xæ R]l ‑(]v ~XZr~XZA9 ~XZr~XZA9 ~XæZr~XZA9 ~XæZr~XZA9
XæræXæ UıUıı Xæ E˘]]v v v v v
XrX UæUı Xæ
~ Z  u}v R v }v } USD R o}]vP }( R ]} X
XıræX ııUæ ıX

Bo}`]v}]`}(Ru]vo}v}Ru]v}v}(R(]o}(Pv]vPıP

TR(]ulo}(R}l}}vRvu]v}vRBolvSR}ou}o]vPR(}oo}`]vP
v}ou}vP S}l}}vPv]v Jvı N}uı Duı

• TR˘}oo]˙Uu]v}vR]}(R]uo]}oo]˙}(RR]}R˘o](}(R Nu}(}}vPv U ıU ıUæ

}}vX P
A F]o}(}}v~]v¤Z (*)
X X XærXæ
• TR˘}}vo](UooRu}vvo˘]Ul]vP]v}}vR].(}(
SR]~]v¤Z (*)
X X XærıX
RovX
E˘]]~]v¤Z (*)
Xı Xı æXæ

Bo}`]v}]`}(Ru]vo}v}Ru]v}v}(R(]o}(RPv]vPP E˘}oo]˙ æXæA9 XA9 XrXA9

P
A ˘}}vo](~]v˙Z Xæı Xæ rXæ
R]l ‑(]v XA9 ~XæZA9 ~XæZr~XZA9
E˘]]v v v v

~ Z  u}v R v }v } USD R o}]vP }( R ]} X

TR}oRr˙uv˘v}Pv]]vR}v}o]uv}(}uRv]]v}u}o¤ıX
u]oo]}v(}R˙vDuUU}u}¤ıXıu]oo]}v(}R˙vDuUv¤X
u]oo]}v(}R˙vDuUıX

276 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 277
15 Trade and Other Payables TRoo}`uu]RRvP]v(vWvv(vWv}vrv(}R˙
vDuUUvıX
DuA DuA DuA
~IvR}v}( ¤Z U U Uı
T˙o Uæ Uæ æUı ~IvR}v}( ¤Z Jvv AV] OR Total
SR} ‑uuo}˙v. U U U On January 1, 2019 — 2,342 133 2,475

PART VII
OR v v R]
Total trade and other payables 293,415 275,192 95,827 U(}v U v v U

T˙o}}v]u]o˙}o]v]ovuv(]vP]v]vo˘vo}R M]o}v æU U v ææU

]X Rv}Pv]}v
U(}v ~UZ ~ææZ ~æZ ~UıZ
A}(DuUvDuUUR˙o]voou}vvP}¤Xu]oo]}vv
M]o}v ~UZ ~UZ ~æZ ~UZ
¤Xæu]oo]}vUo˙Uo}o(}uo]v]ouv(]vP}Pv]}v(}Ruv(]vP}(P} -
v(}uo]v]oR}Pv]}vX Tvo}v]+v ~UææZ ~Z ~UZ
On December 31, 2019 324,629 1,517 56 326,202
SR}ruuo}˙v.]vo˙ovo(}o]v}v}]}Ruo}˙}(R R]
C}uv˙X M]o}v v v v v
Rv}Pv]}v
U(}v ~UæıZ ~ææZ ~Z ~UZ

16 Revenue M]o}v ~UZ ~Z ~ıZ ~UZ

Tvo}v]+v Uıæ Uıı
TR(}oo}`]vPouu]]o}(v(}R˙vDuUUvı˙}oo}}v On December 31, 2020 315,144 223 — 315,367
Puvv˙P}˙}(vP(}v˙uvUu]o}v˙uvvRvo}uv](X
R]
U(}v v v v v
YEv YEv YEv
Du Du Du M]o}v
~IvR}v}( ¤Z U U Uı
Rv}Pv]}v
]Z L æUı v v
U(}v ~ıUıZ ~Z v ~ıUZ
Jvv ıUı Uæı U
M]o}v ~UæZ ~Z v ~UıZ
AV] ææ ææ
On December 31, 2021 — — — —
AP}u v v U
OR v æ
Upfront payments 444,303 34,362 24,975
Bo}`uu]}(Rl˙}oo}}vX
]Z L æU v v
Jvv Uæ U U Zai Lab
AV] U Ov Jv˙ U U Pv˘ v Z ] L vv}v R L]v Puv (} R o}uv v }uu]o]}v }(
OR U ı æ
(PP]u} ]v G CR]v U PvvP Z ] L R ˘o] ]PR } o} v }uu]o] (PP]u} ]v G
CR]v X
Milestone payments 49,815 3,422 31,840
Jvv U Uæ U Uv R u }( R Puv U R C}uv˙ ] ¤ æ u]oo]}v ]v }oo}}v ˙uv U }u] }( ¤ æ
OR ı u]oo]}v (}v ˙uv ]v R (}u }( æ U v`o˙ ] Z ] L R oo ] }( ¤ R U ¤ æ
Research and development service fees 2,326 3,459 21,647 u]oo]}v Pv v}vr]o U v}vr(vo ˙uv U ] ]v R . }( U v v ]}vo
]Z L v v
¤ æ u]oo]}v u]o}v ˙uv }v Po}˙ }o }( (PP]u} ˙ FDA ]v R UXSX TR C}uv˙ ] o} o]P]o
} ] }˙o ~u] rv } o}` `v }v vP ] Z }v vvo v o }( (PP]u} ]v
Other revenues 833 — —
G CR]v X
Total revenue 497,277 41,243 78,462

W]RP}R]}oo}}v`]R]Z LP
F}R˙vDuUUvıURui}]˙}(Rv`PvvRPuv • TRC}uv˙}voR`}(}uv}o]P}vvIFRSæU]vPRv(}(o]vvR
`]R]Z LUJvvvAV]UR]o}`X urovPRo˙}(o]v]ov}uu]o}XTRC}uv˙}voRR(}uv}o]P}v
]v]vR}v˘}(R}vX

278 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 279
• TRC}uv˙}voRRS]}vSRPv˙]Z LU]vo]vRSRIvAPuvU
v]v}}vJv˙UU`}]v}(R˘]vP}o]P}vvRu}(RC}oo}}v
vL]vAPuvUv]R(}}}v]}}(R}oo}v]}v]X
• TRv}v]}(R`}Puv]vo˙}u}}(.˘UR]vPv(}v˙uv}(
¤æu]oo]}v]vR(}u}(v`o˙]]Z LRUv¤æu]oo]}vPvUv}vr]oUv}vr(vo
˙uvv¤æu]oo]}vu]o}v}v}o}((PP]u}]vRUXSXvR}v]}v]]vv(}
Ro˙}(o]v]ov}uu]o}XM]o}v˙uv}vo˙]vo]vRv}v]}R˘v
]]R]PRo˙}oR]Pv].vo]vRu}v}(uov}Pv]}v`]oov}}`RvR
v]v˙}]`]RR}vvPv}v]}v]vo˙}oXWuRu}v}]vo
]vRv}v]}vR]uv}(Ru]o}vv}Ro˙}(o]v]ov}uu]o}X
Soru]o}vvor}˙o}(RC}uv˙ [vPuvv}˙]vo]v]
vX
• TR.˘}(Rv}v]U`ooR¤æu]oo]}vu]o}v}v}o}((PP]u}]vRUXSXR
voo}}Rv(}(o]v(}uv}o]P}vX
• TRC}uv˙}voRRo]v}(R+}(R}vRvo}voXARURC}u
v˙}voRR}u]]vPvvPRo]v}]Z ]}}]]PR}Rv˙ []vooo}˙
]˘]R}]v]vu`R]RRo]v]PvvR(}UvRv}Pv]
}]v]vuXTR]}vo]}v`RUl]vP]v}}v(}oo}`]vPP
• Rv}u]o]}v]vo]vR}v`R]R`}ov]Z L}]R}(Uv}]v
voo˙oo}(Ru]v]vPv.U`]R]vGCR]vv}v]]vPRor}˙o`R]R
}u}RC}uv˙}v(o}uu]o]}vX
• RvR}((PP]u}U(oo˙}uoRPRIII]oX
{  UvR}oo}}vPuvURC}uv˙}]o]v]ov}uu]oo˙}]Z LXC}uv˙}v
o}}Pv]RovP]vRRC}uv˙]v]o]vRv}vR]lo}
]vv}˙]}v˙RC}uv˙voR]vv}˙]v(}]Z XTRvo}o]v]ov}uu]o
o˙]}vo]v]uSORv_`]R]vRv(}}v}X
AbbVie
IvA]oURC}uv˙v]v}}oo}}vPuv`]RAV]SXÀXRXLX~AV]}Z o}v}uu
]o]ARGXræ~AVB ræZXUvRu}(R}oo}}vPuvURC}uv˙`}v]o(}}vvP
v(v]vPooARGXæ~AVB ræRZ vo}uv]}}uo}v}(INDvo]vP]X
TRC}uv˙PvAV]v˘o]}}vU(}].]}(}oo}`]vP}uo}v}(INDvo]vP]U}
}]v`}o`]U˘o]o]v}RARGXæ~AVB ræ}Pu
Z }o}v}uu]o]}XTR
C}uv˙]v(}vUv}vr(voUv}vr]o˙uv}(¤u]oo]}v(}uAV](}R˘o]}}v
}o]vARGXæ~AVB ræZXTRC}uv˙R]`}o]v]ou]o}vUR}(`R]R]PP¤Xu]oo]}v
˙uvX
IvAPUAV]˘]]}}vvRu]vo}uv}o]P}vU]vP}oo˙}v]o(}
ooRUo}uvvPo}˙}ovP}ARGXræ}XIvMRıURC}uv˙R]
R.o}uvu]o}v}v]v]}v}(.r]vrRuvo]v]o]oU]PP]vP¤Xu]oo]}v˙uvXSi
}R}vv]vP}P}(ARGXræ~AVB ræ˙Z AV]URC}uv˙]o]P]o}]o}uvUPo}˙
v}uu]ou]o}v˙uv]vPPPu}v}(}¤u]oo]}vU¤ıu]oo]}vv¤æu]oo]}vU
o˙U`oo}˙o}vovPvP]vP(}uRu]]vPo]P]}Ro}`vUi}
}u˙}vX
TRC}uv˙RR]PRU}v}˙}]}}}u}ARGXæ~AVB ræ}Z ]vR
}v
E }v}u]
E vA S`]ovv}}u]vR}`]RRC}uv˙[}`v(]uuv}}v}o}P˙
}PuXTR}}u}}v+}`}oP}v˙}}u}}vPuvvP}]vP}}(]R˙RX
AV]`]oo(v(RGARPoR˙RC}uv˙(}v]v]o]}}(`}˙XAV]`]ooRR]PR
}o]v]}voR}PuuP]vP(}uR]RU(}`R]RRC}uv˙}o]}]
u]o}vv}˙o˙˙uvX
280 | Notes to the Consolidated Financial Statements
W]RP}]}oo}}v`]RAV]URC}uv˙}vo(}oo}`P
• TR ]}v ]vPo (}uv }o]P}vv IFRSæUR ]vPR v(}( o]v }u]v `]R (} -
uv }( Rv o}uv ] XTRC}uv˙}vo R Ro]v ]v} ]v ]vR }v˘ }(
R }v X
• TRv}v]}(R`}Puv]vo˙}u}}(.˘UR]vPv(}vo]v(U
PART VII
v]oU]vPu]o}v˙uvv}]uuv}(Rvo}uv]o] -
XM]o}v˙uv}vo˙]vo]vRv}v]}R˘v]]R]PRo˙}oR]Pv].v
- o]vRu}v}(uov}Pv]}v`]oov}}`RvRv]v˙}]`]RR]o
}v]}v]vo˙}oXWuRu}v}]vo]vRv}v]}vR] -
uv}(Ru]o}vvXSoru]o}vvor}˙o}(RC}uv˙[vPuv
v}˙]vo]v]vX
• TRv}v]Rvoo}}R]vPo(}uv}o]P}vvvRv}Pv]}
Ru]]}}v'vRGRv(}(Ro]vv}P}}uo( -
- }v}(RRvo}uv]XTR]]`}v]RR]v(}u}voo}v -
R]`vRo]vvRRvo}uv]}o]X
• TRC}uv˙RR}vv]vu}o}uR(}v}(R]vPo(}uv}o]P}vR}v]
vP}(}]v(}R}PuR}uoR]}~vP}(}uo}vuR}ZX
• C}]uuv]}Pv]]vv`Rv}]vvP˙RURC}u -
- v˙]vP]v]o]vR}}(]l}(RRvo}uv]}(]}vP}]vP}oo} -
}vvo]vPuvX
- Janssen
OvJvUURC}uv˙]u]v}vv}.}v(}uC]oPGuHIvv}voUv8o]}(JvvU
`R]Ro]vRu]v}v}(RC}oo}}vAPuv}i}]vo˙o}v}uu]o]uXA
oURC}uv˙P]vR`}o`]]PR}]vrCDv}˙uX
UvRu}(RPuvUJvv}uu]'}v(}v˙uv}(¤æu]oo]}v}v]vP}(o]v
- ˙uv}(¤u]oo]}vv¤u]oo]}v]˙]vuv]vRC}uv˙˙]]vP}UUııv`R
]}(ƒXRU]vo]vPv]vu]uXIvDuıURC}uv˙R]R.o}uv
u]o}vU]PP]vP¤æXu]oo]}v˙uvX
W]RP}R]}oo}}v`]RJvvURC}uv˙}vo(}oo}`P
• TR`}v]vPo(}uv}o]P}vvIFRSæUR]vPRv(}(o]v}u]v`]R(} -
uv}(Rvo}uv]XTRC}uv˙}voRRo]v]v}]v]vR}v˘}(
R}vX
• TRC}uv˙}voRRRu]uRJvv]}Ro}]vP]}vR˙}(v]vP]v}
R]vuvPuv~]vPDuUZ`]}(R˘]vP}o]P}v}o]o}uv
]vRu}(R}oo}}vPuvv`R(}}v]}}(R}oo}v] -
}v]X
• TRv}v]}(R`}Puv}u}}(.˘UR]vPv(}vo]v(Uv]o
- U]vPu]o}v˙uvv}]uuv}(Rvo}uv]o]X
• TRv}v]`oo}}R]vPo(}uv}o]P}vvv`]}o˙}Pv]}R
u]]}}v'vRGRv(}(Ro]vv}P}}uo(}v
}(RRvo}uv]X
F}oo}`]vPRu]v}vURC}uv˙}voR]Rvoo˙.R(}uv}o]P}vUv
}vvU}¤æXu]oo]}v(}Ru}vRv]vPDuUX
Notes to the Consolidated Financial Statements | 281
17 Other Operating Income TRv}vrv}(RC}uv˙U`]RR˘}v}(R(˘UP}PR]oo˙o}R}`v
]vRoo}`P
YEv YEv YEv
Du Du Du
~IvR}v}( ¤Z U U Uı N}vrv DuA DuA DuA
~IvR}v}( ¤Z U U Uı (*)

Gv Uı Uæ Uæ
NRov v

PART VII
RRvo}uv]vv Uı Uæ æU
BoP]u U Uæ Uæ
P˙}oo˘ U ıUıæ U
Uv]S U Uæ Uæ
CRvP]v(]o}vv}vrv.vv]o Uæ Uıæ U
Jv U Uı ı
Total other operating income 42,141 23,668 15,563
S`]ov v v
Total 275,111 207,368 67,540

* Iv ]} ]} R]R v v }vRP}PR]oo}}v}(R }vvPv˙X

17.1 Grants

TR Pv ]v}u ] o } Pv ] (}u R Fov Ivv}}v v Ev vR] APv˙X N} }v]}v

o } R } P}vuv Pv ` v(o.oo U v} ` R v˙ u]o }vvPv] o R}v 19 Research and Development Expenses
R }( R }o }( R }v}o] .vv]o uv X
YEv YEv YEv
Du Du Du
~IvR}v}( ¤Z U U Uı

17.2 Research and development incentives P}vvo˘v U U æU

E˘voRvo}uv˘v Uı æıUı æUı
TR C}uv˙ R }v (} ˘ ]o }( ¤ X u]oo]}v ]v R ˙ v D u U U }u } M]ov}vuo Uæ Uæ U
¤ X v ¤æX u]oo]}v ]v R ˙ v D u U v D u U ıU o˙U (}oo}`]vP R
]}v
D vu}}v U Uæ U
v o}uv ˘ ]vv Ru ]v B oP]u }]vP } `R]R R ]vv `]oo (v L . ˙
]} U ]( v} }+ P]v R v ˘ ˙o } R ]} X OR˘v U Uæı U
Total research and development expenses 580,520 370,885 220,771

17.3 Payroll tax rebates

TR C}uv˙ }v (} ¤ X u]oo]}v ˙}oo ˘ ]v R ˙ v D u U U }u } ¤ıX

v ¤ X u]oo]}v ]v R ˙ v D u U v D u U ıU o˙U }v ]v `]RR}o -
]vP ]v}u ˘ (} ] R]PRo˙ o]. }vvo uo}˙ ]v ] R v o}uv uv X 20 Selling, General and Administrative Expenses
YEv YEv YEv
Du Du Du
~IvR}v}( ¤Z U U Uı

18 Segment Reporting P}vvo˘v U Uæ U

P}(]}vo( U U U
TRC}uv˙}(}uRNRovUBoP]uURUv]S}(Au]UJvUS`]ovUGuv˙v S]}˙} Uıæ U U
FvXRvPv˙˘vo}u`]RR]u]vP]}8P}PR]oo˙o}R}`v]v
ORE˘v U ıU U
Roo}`X
Total Selling, general and administrative expenses 307,644 171,643 72,146
YEv YEv YEv
Rv(}u˘vo}u Du Du Du
~IvR}v}( ¤Z U U Uı (*)

Dvul Uı
BoP]u v v U
Uv]S Uı Uı Uı
CR]v U v v
OR v v
Total 497,277 41,243 78,462

* Iv ]} ]} R]R v v }vRP}PR]oo}}v}( R }vvPv˙X

282 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 283
21 Personnel Expenses TR}v}o]uv}(}.}o}vR}v}o]uv}(}R}uRv]]v}uR}`R
(}oo}`]vPu}vovP}oP
TR}vvo˘vuv}v]vv}ıv}(}oo}`P
YEv YEv YEv
Du Du Du
YEv YEv YEv ~IvR}v}( ¤Z U U Uı
Du Du Du
~IvR}v}( ¤Z U U Uı Depreciation charges

PART VII
SR} ‑uuo}˙v.vSo] æU æU U B]o]vP U U U

SR} ‑uuo}˙v.vS}]oS]˙ Uæ ıU Uıı VR]o æ

P} ‑uo}˙uvv. U U ]uv
E

Tu]v}vv. Uæ 3,399 2,735 1,764

SR‑˙uv Uıæ ıUææ U

Euo}˙}]o]˙}v]}v}l}}v æU æU U Iv˘v~]vo]v.vv}Z

Total personnel expenses 325,110 194,543 95,946 E˘vovP}R}ruo

E˘vovP}o}(o}`roR
v}R}`v}R}ruo
TR}uo}˙uvv.o}Rv]}vovRC}uv˙R]vo(}]uo}˙X

TRPvu}((oou]ov~FTEZuo}˙˙uv]vo}`P TR}oR}o}`(}o]vv`¤Xæu]oo]}vv¤Xu]oo]}vo˙X

YEv YEv YEv TRC}uv˙]v}v]v}v˙oPuv`]R]oo˙uv}]ooPvXTR

Du Du u
P
A Nu}(FTE U U Uı C}uv˙RoR]vo˘v]}v}}vXTR}}v}]G˘]]o]˙]vuvP]vPRovo]Pv
RRvo}uv ıX X X `]RRC}uv˙[]vvXTRC}uv˙˘]iPuv]v]]vP`RR]]}vo˙]vRR
˘v]}v}}v`]oo˘]X
Soo]vPUPvovu]v] X ıXæ æX
614.1 332.5 177.9

23 Financial Result and Exchange Gains/(losses)

22 Leases
TRuv}(.vv]o}]}vR}`R(}oo}`]vPu}vovP}oP YEv YEv YEv
Du Du Du
~IvR}v}( ¤Z U U Uı
YEv YEv YEv
Du Du Du Iv]v}u Uı æUı Uæ
~IvR}v}( ¤Z U U Uı
NP]v}vv.vv]oRo(]o
U U
Right-of-use assets R}PR}.}o}vR]ov

B]o]vP ıU U U Financial income 3,633 6,459 16,122

VR]o U Uæ
]uv
E No}}vv.vv]oRo(]o
~UZ ~UææıZ v
R}PR}.}o}vR]ov
11,583 9,454 7,373
OR.vv]o˘v ~UıZ ~Z ~ıZ
Financial expense (4,578) (7,960) (139)
Lease liabilities
vC Uæı U U
Ro]˘RvPP]vl~o}Z æ ~Z ~æZ
N}vrv Uıæ U æU
Uvo]˘RvPP]vl~o}Z ~æUZ ~æUıZ Uæ
11,465 9,657 7,319
Exchange gains/(losses) (50,053) (126,234) 6,990

A]}v}R]PRr}(ru}v}¤æXu]oo]}v(}R˙vDuUX
TR˘RvPo}}(¤æXu]oo]}v(}R˙vDuU`]u]o˙']o}vo]
TRoo}`R}`u]˙vo˙]}(Roo]]o]}vDuUP
˘RvPo}}v}RvR]ovvv.vv]o}]}v]vEUR}Rv(}o
T}o G}v}(REUR˘RvP}R]}X
LRv M}Rv }vo C˙]vP
~IvR}v}( ¤Z ˙ r˙ ræ˙ æ˙ RG}` u}v
Lo]]o] Uæı U U v U Uæ

284 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 285
24 Income Tax Expense 25 Loss per Share
TR]v}u˘˘v(}R˙v}v]o}R}vvPo}(}oo}`P YEv YEv YEv
Du Du Du
~IvR}v}( ¤Z U U Uı
YEv YEv YEv
Du Du Du L}}(R˙ ~UæZ ~UææZ ~UZ
~IvR}v}( ¤Z U U Uı
W]PRPvu}(R}v]vP æUæU æUU UıU

PART VII
L}(}˘ ııU æUæ æUıı
Basic and diluted loss per share (in $) (7.99) (13.40) (4.69)
Iv}u˘ooæA9 ııUı æU Uı
+
E }(˘vvP]vRv}o
~UZ ~UZ ~UæZ
]vu]v]vP˘oo v]vP
E lo}}]v˙Roo˙]]]vPRo}(}R]}˙R`]PRPvu}(
+
E }(}l]˘vRv}o }]v˙R]vPR˙X
Uı Uı U
]vu]v]vP˘oo
+
E }(}v]}v U Uı æ ARC}uv˙}vo}]vUvıU}l}}vRvv]o+RRv]o
+
E }(˘o}](}`v}}Pv] ~UZ ~UZ ~UıæZ +XARUR]v}]+v`v]v]ov]vPlo}}]v˙RX
+
E }(]+v˘]vi]]}v]v`R]RR}uv˙} ~UZ ~ıæZ ~æZ
(D ˘}RRvo}˙(}`v}}Pv] ~æUıZ ~æUZ ~UZ
W]RR}o]vP˘] ~æUZ v v
26 Financial Risk Management
~Uv}]Zl}}]]v]}˙ ı ~UZ ~UZ
OR ~Z ~Z æ TR.vv]o]luvPvoo˙XTRC}uv˙}}]vR}v}vov]vv}vo.vv]o
Income tax expense recognized in the consolidated ulv}v]vuvP}vv}o˙R.vv]o]l}vv]vPRC}uv˙[]XTRo}
(8,522) (3,103) (5,289)
statements of profit or loss R.vv]oul]lU]]lUo]]]˙]lvv˙]lXTRv}}R]u}v]lUR]v
]l}v}}`]vPURC}uv˙Rv}.vv]oXTRC}uv˙}v}˙}.vv]o]vuv(}
o}X
TR˘(}RUvı}v]o]}v}]R}}]v}u˘}(æA9˙o˙
}}v]vRNRovX P}]
C }(.vv]ovo]]o]P
Muv
TRv}Pv](˘}vv˘o}u}v}¤Xu]oo]}v}vDuUU}u} P}˙ C˙]vPu}v
¤Xu]oo]}v}vDuUX(D ˘Rvu]vPR+R`]ooo˙]vBoP]u DuA DuA DuA
vRNRov~æA9ZXTRC}uv˙Rv˘o}](}`(}vu}v}(¤æXu]oo]}v}vDu - ~IvR}v}( ¤Z U U (*)
Uı (*)

UU}u}¤ıXu]oo]}v}vDuUXTR]U}u]v`]R}Ru}˙]+vUo F]vv]ovv}vrv FVTPL Uæı U Uı

]vv(˘}]}vX}D Rv]v˙}v]vPRC}uv˙[]o]˙}o]˘o}.]vR
F]vv]ovv}vrv FVTOCI æU v v
(URC}uv˙]v}}Pv]v˙(˘U`]RR˘}v}(R}(R]o]vv}X
RRvo}uv]vv]ov
Au}} U U ıU
v}vrv
}uv˙
A ]vRvo}uv]vBoP]uU`˘}v.(}uR]vv}}v]v}u}vU R]Rvv}vrv Au}} U Uæı
}IIDU]vBoP]uXTR]vv}}v]v}u}vP]uoo}`v}.']o}v(}uu}vP}R -
Tv}R]o Au}} U Uı Uææ
v}}˘o}`+˘Rv}RvXR A v}(vU`R
¤Xæu]oo]}vv¤æXu]oo]}v}(˙r(}`IID]vBoP]uX F]vv]ovv FVTPL Uæ Uı Uıı
F]vv]ovv Au}} ııU ıUæı U
Iv}u˘`]o˙}Pv]]vR]v}uuvv]o(}oo}`P RRvo}uv]vv]ov
Au}} v ı
v
CRvvlov Au}} Uı ıUæ Uæ
YEv YEv YEv
Du Du Du CR]ov FVTPL ııUı æUı v
~IvR}v}( ¤Z U U Uı CR]ov Au}} ıæUı Uæ ææU
vC ˙ æU U æUı Tv}R˙o Au}} ıUæ æUı ıæU
Iv}u˘]}˙ ~ıZ U v
* TRR]}]o}v}o] .vv]o]v(}u}v(} v ı v]vR] ]o} v}R v i } v R l}`v
Current tax expense 14,826 9,579 5,289 }( v.vv]o R u FVTPLv u} }X

O]P]vvPvo}(u}˙]+v ~UZ ~UZ v

Deferred tax expense / (income) (6,304) (6,476) v
Total tax expense 8,522 3,103 5,289

286 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 287

* TRR]}]o}v}o] .vv]o]v(}u}v(} v ı v]vR] ]o} v}R v i } v R l}`v}( v

Financial assets held at fair value through profit or loss or OCI D]vPR]o}ov˙Uv}v(}`vRo]oP}]X
F]vv]oRo(]oR}PR}.}o}}OCI}v]}(]˙]vuv}(o]vv}vro]}u -
v]vu}v˙ul(vX Non-current financial assets – Level 3
IvMRıURC}uv˙v]v}o]vPuv`]RAP}uATRNV(}R}(HGFru]u -
TRC}uv˙Rv}]}v}vRo}(R]˙]vuvvRv}oPvv˙}(] ]SIMPLEAv}]¡Uo}vRC}uv˙[Iuuv}o}P˙Ivv}P}PuXIv˘RvP(}PvvPR]
o]]o]XTR]vuvo]..vv]oRo(]oR}PR}.}o}}OCI`R]Ro](˙(}P o]vURC}uv˙]}.R]vAP}uATRNVX

PART VII
• Lo(]ouuv`]R}v.vv]ovR]ov}vRo}]vP] IvMRUAP}uATRNV¤u]oo]}v]vS]B.vv]vP˙]]vPUæ}(P(BSRX
~voZ}(R]R}vPX TRC}uv˙R}ru}v˙o}v}(S]B.vv]vP}vvRvu}(}v]vPR]v -
• Lo(]ouuv`]R}v}vrv.vv]oX u]v]vPR(]o}(R}.rR]vP]vuvU`R]Ro]vRvP]v(]o}(v}vrv.vv]o
}(¤Xu]oo]}v}R}PR}.}o}XS]vAP}uATRNV]]}uv˙URo}v}(R
TRul]}(R.vv]o]vuvu]PR(G}vvu]PR+˙]˙}((}UR }.R]}voou}vX
RPo}o}v}u]]}vXvC .vv]ovR]ov]vo}oo]vuv(vv}u] -
v]vƒv¤}(`R]RRvo˙]vP]vuv]vo}vv}R]vv}vo]XB}vR Non-current financial assets – Level 1
`]PRPu]˙}(Rvo˙]vP]vuvUu}vP}RUR]vuv]Ro].v A}(Ro]vPuv(}Ro}uvv}uu]o]}v(}(PP]u}]vGCR]v~v}
.vv]o}R]ovX (}(R]v(}u}vZURC}uv˙}]vUu}vP}RUæUv`o˙]]Z LRoo]
}(¤RXTR(]o}(R]˙]vuv]}rv]u]v˙(v}Ro}]vP]}(
TRu˘]uu˘}}]]l]R˙]vPu}v}vPX R]R}vP~o].oo]vR(]oR]R˙ZUovP]vRvP]v(]oXTR
C}uv˙uR]}oo}v}}Pv]vRvP]v(]oR}PROCIX
TRC}uv˙]R(}oo}`]vP(]o}vDuUUvıo˙P
Capital risk
TR}uv˙
C uvP]]o}vR]`]ooo}}vvP}]vP}vvXTR]o}(R}u C -
DuA U v˙}v]}(]˙']}RR}o}(]˙]vuv}(R}uv˙
C UR]oUvu -
~IvR}v}( ¤Z Lo Lo Lo oo}uv}v]vR}v}o]uv}(RvP]v]˙XTR}uv˙ C ulRv˙iuv
]vRo]PR}(RvP]vR}v}u]]uvU]l}]}R]+vvR}iRv}(
N}vrv.vv]o æU v Uæı
Rvv}iR]XOvuD UURvR]ovu}v}¤UXu]oo]}v
vC .vv]o Uæ v v
v}o]ou}v}¤Uıu]oo]}vXTRvR]}vvRv]RPv}vRu}
CR]ov
E ııUı v v ]u}vu]v]vPR]oXTR}uv˙
C [}i]}u]v]vR]ooo
Assets carried at fair value 1,105,854 — 17,459 }o}.vv]](}o`ou}vRXR C ]v}u(}u˘]vPvv`vR]]lv]v}
}vvU](vv}]oUR}uv˙
C v]v`R}v]v}.vv]vPPuvX

Credit risk
DuA U (*)
]C ]l(}R]lR}v˙`]oo(o}v]}vo}o]P}vovP]v.vv]oo}}R
~IvR}v}( ¤Z Lo Lo Lo C}uv˙XTRC}uv˙R}}o]˙}(}vo˙o]vP`]R]`}R˙}vv}]v]vP8]v}o -
N}vrv.vv]o v v U ooU`R}]Uuv}(u]PvPR]l}(.vv]oo}(}u(oXC}vv}v]v]]l
u]v}vvvo˙]}(}vvR]]u}v}vR}oo}v]vP}vo}o]P}v
vC .vv]o Uı v v
˙rvX
CR]ov
E æUı v v
Assets carried at fair value 988,581 — 6,307 TRC}uv˙Ro]u]vu}(}oo}}vvo]vvvR(}R]Pv].v}vv}v}(
]]lXH}`U]R}o]]]vo}vR]˘}]l}u]v]uuv]Pv].v}vv -
* TRR]}]o}v}o] .vv]o]v(}u}v(} v]vR] ]o} v}R v i }} (} R u}v }( v.vv]o
R u (] oX }v}(]˘}}vo˙Pv(}R}]}}(u}R]PR]o]˙}oo}}vvX

TRC}uv˙o]RIFRSı]uo].}R}u]vP˘]o}`R]Ro](u˘
DuA Uı (*)
o}oo}`v(}oo]oXT}uR˘]o}U]oRvP}}v]]l
~IvR}v}( ¤Z Lo Lo Lo R]vR˙XTR}]]}v(}˘]o}`v}]Pv].vP]vRRRv
v}]o}}RoR˙vRR]PRo]˙v}(}}uX
N}vrv.vv]o v v Uı
vC .vv]o Uıı v v
CRvR]ovvv.vv]o]v`]RoR]PRo˙ovlv.vv]o]v -
Assets carried at fair value 804,099 — 2,916 }vXTRC}uv˙R}o]RvR]ovu]vo˙`]R]+vvl`R]R]vvvo˙`]R
u]v]uuvP}(RAr[XTRC}uv˙o}R}oR}u]vuv(v]vR(}u}(u}v˙ul(v`]R
* TRR]}]o}v}o] .vv]o]v(}u}v(} ı v]vR] ]o} v}R v i }} (} R u}v }( v.vv]o
R u (] oX
}uuv]vuvR}]}v}(u}vR}R}`]Ro}`R]}]o}oo]˙XTRu}v˙ul(v

28 | tesNo to the Conslidate Finacl taemnsS tesNo to the Conslidate Finacl taemnsS | 289
R]PRo˙o]]]vuvUv]o˙}vo]v}lv}`vu}v}(RXS]vR˙l}((vR] 27.2 Relationship and Transactions with Key Personnel
v}]v]]o]]l]v}oXTR}uv˙R}}o]˙`R˙u}v˙ul(vuRvP
vP}(SBBrS}R]PRX TR C}uv˙ [l˙ uvPuv }vvo }v] }( R uu }( R uvPuv u v R uu }( R
} }( ]} X
Liquidity risk
TRC}uv˙uvPo]]]˙]l˙u]v]v]vPU˙}vv}o˙u}v]}]vP(}voR Remuneration of key management personnel

PART VII
G}`Uv˙uR]vPRu]˙}.o}(.vv]ovo]]o]X Ov D u U U R v]} uvPuv }v] }( uu P CR]( E˘ O8U CR]( OvP O8U
CR]( F]vv]o O8U CR]( S]v. O8U Gvo C}voU CR]( M]o O8U V] P]v C}} D o} -
TRC}uv˙[u]v}}(R]vG}`}]vR}PR]o]vv}oo}}vPuvXTR]R uv v SP˙ v Go}o H }( Qo]˙ A v X TR˙ }] R] ] }v (ooru ] X
]]v]v]vP}vUu}vvR}u]vuv(v]vR(}u}(u}v˙ul(vXTR
u}v˙ul(vvRui}]˙}(RC}uv˙[]oo}}(o]]]˙R}`]voo}(R Ov D u U U R } }( ]} }v] }( uu P P VRPR U D}v B R]˙U Puo MX
]uu]o˙ov}vo]vRR˙Ro]u]]u}vRo]]]˙]lX Ko]vU Wv LvRoU AXAX R}vP U Ju MX D o˙U Y}vv Gv v T]u Vv H`u]vX

Interest rate risk Ovo˙ R CR]( E˘ O8 ] uu }( }R R v]} uvPuv u v R } }( ]} X TR CR](

TR}vo˙]o]vr]vP.vv]o]vuvRvR]ovvv.vv]o]vuvX E˘ O8 } v} ] v˙ uv}v (} R] } uuR] U R] ] }( R] }o uv}v
CRvP]v]vu˙]}v]v]v]v}uv˘vovP(}uR}ru]vr]vP lP ]v R] ]˙ uu }( R v]} uvPuv uX
XMvPuv}v}˘RR}ru]v}]Pv].vo˙]vR]uu](}o
(U`R]Ro]u]R]v˘}}v}RvR]ovvv.vv]oX TR uv}v lP }( R uu }( l˙ uvPuv }vvo }u] P

F}R˙vDuUU](o]o]v`}o]vl˙æ]}]vUR]`}o YEv YEv YEv

~IvR}v}( ¤U˘(} Du Du Du
R}]lvP]u}(¤Xıu]oo]}v~}u}¤Xu]oo]}v(}R˙vDuUv¤X Rvu}(}l}}vRSUZ U U Uı
u]oo]}v(}R˙vDuUıZX
Remuneration of key management personnel
Short-term benefits for senior management members as a group
Foreign exchange risk
TRC}uv˙vlv}vv}u]v]v(}]Pvv]V}vvo˙U˘}}˘RvPG - G}o˙ Uæ U Uı
}v]XTRC}uv˙]u]vo˙˘}}R}E UJv˙vUB]R}vvS`](vXT}o]u]R]]lUR V]o˙ U Uæ Uı
C}uv˙'u}o]Pv]v}u]vPv}P}]vPRG}`]vv]}RRvUSDX Euo}˙}]o]˙ ı æ ı
ORR}uv. æ
TRv˘}}˘RvP]+v}(Ru}v˙~]vPRUR]ovvv.vv]oZ
Tu]v}vBv. æ æ
}(RC}uv˙Rv}(R}vP]}(}oo}`P
Post-employment benefits for senior management members as a group æ
DuA DuA DuA
~IvR}v}( ¤Z U U Uı Cost of stock options granted in the year for senior management members
æU U Uæ
as a group
EUR æıU U æU
Cost of restricted stock units granted in the year for senior management
Uæ v v
JPY U æ members as a group
GBP U Employer social security cost related to stock options U U Uææ

CHF Total benefits for key management personnel 34,337 60,241 40,366
Numbers of stock options granted in the year
OvDuUU](REURlUSD˘RvP`}oR]vl˙A9UR]`}oRRvP - Sv]}MvPuvP} U Uı æU
l}]]u}(¤æXu]oo]}vU}u}¤Xıu]oo]}vv¤æXu]oo]}v}vDuUvDu
Numbers of restricted stock units granted in the year
UıUo˙XOvDuUU](R˘RvP(}}Rv]`}oR]vl˙
Sv]}MvPuvP} U v v
A9UR]`}oRRv}]Pv].v]uX

Remuneration of non-executive directors

27 Related Party Transactions Board fees and other short-term benefits for non-executive directors æ æ
Cost of stock options granted in the year for non-executive directors U ıUæ U
Cost of restricted stock units granted in the year for non-executive directors U v v
27.1 Relationship and Transactions with Subsidiaries
Total benefits for non-executive board members 5,429 9,981 5,270

Sv}(}v}]`}(R}v}o]}uv]}(RP}U`R]Roo`R}oo˙r}`v]]]}(Pv˘SEX Numbers of stock options granted in the year

N}vr˘]} Uıæ U U
B ov v v }v `v R C}uv˙ v ] ]]] U `R]R o }( R C}uv˙U R
Numbers of restricted stock units granted in the year
v o]u]v }v }v}o]}v v v} ]o} ]v R] v} X
N}vr˘]} æU v v

290 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 291
Other 30 Audit fees
N} o}v U ]ro}v } }R Pv ` P]v ˙ R C}uv˙ } v˙ }( ] ]]] } uu }( R }
}( ]} } R ˘ uX WR v} v ]v} v }v `]R } l˙ uvPuv }vvoU }R TR(}oo}`]vP]}[(`˘v]vR]v}uuvP
Rv ] } `]R } uv}v vPuv ovP } R ˘] }( R] uv uu -
}( R ˘ u v R } }( ]} X YEv YEv YEv
Du Du Du
~IvR}v}( ¤Z U U Uı

PART VII
A]F ~Z
U ı
A]roF
28 Contingencies
T˘F ~Z
ı v v

TRC}uv˙]vo˙v}(]vPv˙}v]vPo]u}o]P}vRu˙R]Pv].v]u}vR Aoo}RF v v v
C}uv˙[}v}o].vv]o}]}vX Total 1,529 1,111 995

~ Z  A ] ] (}u ˙ D o}]' A }vv BXVX R ˘vo ]} ( } ]v S}v }( R D R A }vvP F]u O]PR A ~W Z

`oo ˙ R D o}]' v`}lX
~ Z T˘ v }R ] (}u ˙ R D o}]' v`}lX

29 Commitments
ov
A RUR`v}}uu]uv]Pv(}R]]}v}(}˙Uovv]uvXIvJv˙ 31 Overview of Consolidation Scope
URC}uv˙v]v}]v]vPo}uu]uvo}Rv]]}vo}}v}v`o˙]o}8]v
`]iv
Z UBoP]uXIvo]vR]v]vPo}uu]uv]v(]}(}u}vR(}oo}`]vPR}uo}v TRv}uv˙Pv˘SE]}u]]o]vRNRovXTRC}uv˙UPv˘SEUR`}]]]UPv˘VB
}(R]o]vPXTR}o(R}o}`o}R]o(}oo}`P vPv˘IIPVB U]vBoP]uXPv˘VB R.]]˙UPv˘USUIvXU]vRUv]S}(Au]U
Pv˘JvKKU]vJvUPv˘S`]ovSAU]vS`]ovUPv˘FvSAS]vFvvPv˘
Guv˙GuH]vGuv˙X]o
D }(RC}uv˙[}v}o]vRv}(R}vP]}
T}o
LRv M}Rv }vo (}oo}`P
~IvR}v}( ¤Z ˙ r˙ ræ˙ æ˙ RG}`
L}uu]uvv}}uuv v v U U ıUææ
Nu RP]}vvu C}v˙ P]}v M]v]˙
argenx SE OC
C æ TRNRov XA9 H}o]vP}uv˙

IvF˙ıUvuv]vSuURC}uv˙v]v}Po}o}oo}}vvo]vP - B]}Rv]o
R}vP
uv`]RHo}˙uTRUIvXUvRu}(RPuvURC}uv˙`]oo˙¤Xæu]oo]}vP(} Pv˘VB ıı BoP]u XA9
vRu
(Pv}u]v}vv}vo(˙uv}(}¤Xu]oo]}voPi}R]uv }
}(].o}uvUPo}˙voru]o}vv}¤Xu]oo]}vi}RR]uv}( B]}Rv]o
]}voU].oru]o}vXTR]u}vvRu˘]uuu}vR`}o]](oou]o - R}vP
Pv˘IIPVB æıæ BoP]u XA9
vRu
}v`}oR]˘o]o}˙o˙˙uv}vv]oXIvıURC}uv˙˘]R }
}}v}v}u]vv]}voP~]PP]vP¤Xu]oo]}vo}uvu]o}v˙uvZv]v]PR PRuo
o]v]o]o]vPHo}˙u[}]˙ENHANZEPo]˙Rv}o}P˙~]PP]vP¤æXu]oo]}vo}uv vRu˙
Pv˘USUIvX rı USA XA9
u]o}v˙uvZXIvURC}uv˙]v]PRo]v]o]o]vPHo}˙u[}]˙ENHANZEP o]uRv
`R}oo
o]˙Rv}o}P˙~]PP]vP¤æXu]oo]}vo}uvu]o}v˙uvZXIvURC}uv˙]v]PR
PRuo
o]v]o]o]vPHo}˙u[}]˙ENHANZEPo]˙Rv}o}P˙~]PP]vP¤æXu]oo]}vo}uv vRu˙
Pv˘S`]ovUSA CHrXXııXr S`]ov XA9
u]o}v˙uvZX o]uRv
`R}oo

TRC}uv˙[uv(]vP}uu]uv`]RL}vU]Pvuv(]vP}v}Uo}R}vP}]vP PRuo
vRu˙
˘}v}(R]}o}P]o]vo]}v~BLAZ](}(PP]u}v]uv(]vP]o}R Pv˘JvKK rræ Jv XA9
o]uRv
}vo(}uu]o]}vXIvDuURC}uv˙]Pv].}uu]oo˙Puv`]R `R}oo
L}vo}R}v}(}uu]oPvo˙]˙(}(PP]u}XIvRPPPURC}u - PRuo
v˙R}v]vP}uu]uv(}(PP]u}vR.}uu]oo˙Puv}(¤Xu]oo]}vX vRu˙
Pv˘FvSAS ıæı Fv XA9
o]uRv
`R}oo
PRuo
vRu˙
Pv˘Guv˙GuH HRB Guv˙ XA9
o]uRv
`R}oo

292 | Notes to the Consolidated Financial Statements Notes to the Consolidated Financial Statements | 293
32 Events After the Balance Sheet Date
N} v R } ( R B ov SR R }o R u ]o ]u }v R }v}o] (]vv]o
uv X

294 | Notes to the Consolidated Financial Statements

8
Company

PART VIII
Financial
Statements
FOR ARGENX SE - FOR THE YEAR ENDED DECEMBER 31, 2021

Contents
8.1 Signatures of Executive and Non-executive Directors 298

8.2 Company Balance Sheet on December 31, 2021 argenx SE 300

8.3 Company Profit or Loss Account for the Year ended 301
December 31, 2021 argenx SE

8.4 Notes to the Company Financial Statements of argenx SE 302

8.5 Other information 307

8.6 Independent Auditor’s Report 308

Signatures of Executive and Company Financial Statements
Non-Executive Directors for argenx SE

PART VIII
Iv }v `]R o P }( R D R C]]o C} U R vvo }v ` ]Pv ˙ oo ˘ v v}vr˘ - F} Pv˘ SE
]} }v MR U X F} R ˙ v D u U

298 | Signatures of Executive and Non-Executive Directors Company Financial Statements for argenx SE | 299
Company Balance Sheet on December 31, Company Profit or Loss Account for the
2021 argenx SE Year Ended December 31, 2021 argenx SE

PART VIII
Yv Yv
A DuA DuA Du Du
~IvR}v}(¤Z NOTE U U (*)
~IvR}v}(¤Z NOTE U U (*)

Non-current Assets Iv}uv˙RRP v v

F]vv]oF]˘A Total operating income — —
Ivuv]vG}C}uv] UU UæU GAE˘v ~UıZ ~UZ
OR.vv]o Total operating expenses (21,944) (12,738)
T}oF]vv]oF]˘ 2,412,742 1,536,081 Operating result (21,944) (12,738)
T}oN}vrCvA 2,412,742 1,536,081 F]vv]o]v}uv˘v ~æUZ ~UZ
SR]vo}(]]] ı ~UıZ ~æıUZ
Current assets Result before taxation (408,668) (604,032)
R]o Uıı Uææ T˘}v}vo}(}]v˙] ~Z
F]vv]ovv Uıæ æU Result after taxation (408,265) (604,134)
CR]vvl æ Uæ Uııæ
 TR C}uv˙ R } RvP ]v ] v}v v˙ (}u EUR } USD Jv˙ U U ] ]v v} X X A }]vPo˙U R D u
Total Current Assets 149,831 129,579 U }u uv v o v} R v r v } o˙ }v R }vvP }o]] }o]v ]v v} X X
Total Assets    2,562,573 1,665,661

]˙
E vo]]o] DuA DuA
~IvR}v}(¤Z NOTE U U (*)

Equity 6
SRC]o U æU
SRPu]u UUæ UıU
Auoo} ~UUıZ ~ııUıZ
R(}SRrB˙uv æUæ Uæı
Tvo}v U U
Total Equity 2,559,728 1,664,396
Current liabilities
}v
A P˙o
Iv}uv˙˙o U ææ
T˘˙o ıæ
˘v
A
OR˙o
Total Liabilities 2,845 1,265
Total Equity & Liabilities    2,562,573 1,665,661

 TR C}uv˙ R } RvP ]v ] v}v v˙ (}u EUR } USD Jv˙ U U ] ]v v} X X A }]vPo˙U R D u

U }u uv v o v} R v r v } o˙ }v R }vvP }o]] }o]v ]v v} X X

300 | Company Balance Sheet on December 31, 2021 argenx SE Company Profit or Loss Account for the Year Ended December 31, 2021 argenx SE | 301
Notes to The Company Financial
C}u]}v .P ]v R ov SR U }. } o} U v oo ]o} R v r v U vo }R`]
U ]vP R } }o]v o}`P

Statements of argenx SE {  A v o]]o] vo ]v} USD R o}]vP o]o R v }( R }vP ]} X

{  Iv}u v ˘v vo ˘RvP R }( R v }v } P
`R R ]o }˘˙X

PART VIII
{  D]+v ovP (}u R r v}v R v v vo}v ]+v U }u}vv `]R]v
1 Accounting Information and Policies RR}o [ ]˙X
{  SR ]oU R u]uU v }R vo R]}] ]o]vP R }( v }vX

1.1 Basis of Preparation

2. Financial Fixed Assets
TR }uv˙ .vv]o uv }( Pv˘ SE ~RL P R }uv˙Z R v ]v }v `]R P
ıU B}}l }( R D R C]]o C} X Iv }v `]R o U B}}l }( R D R C]]o C} U R }uv˙ [ TR C}uv˙ R `} B oP]v ]]] U Pv˘ BV v Pv˘ IIP BVU `R]R ˙ } R R v o}uv
.vv]o uv }v R }vvP ]v]o }( }Pv]}vU u uv v u]v}v }( ] }( R G} X APv˘ IIP BV ` ]v}} R}PR o uP }( Pv˘ BV ]v X APv˘ BV R
}. U o] ]v R }v}o] IFRS .vv]o uv X . ]]] U Pv˘ US Iv X ~Uv] S ZU Pv˘ Jv KK ~JvZU Pv˘ S`]ov SA ~S`]ov ZU Pv˘
Guv˙ GuH v Pv˘ Fv SASX TR .vv]o .˘ }v] }( R A9 ]}v ]v Pv˘ BV v U
Pv˘ IIP BVU }R P] Iv ] l U Z`]iv U B oP]uX
1.2 Summary of Significant Accounting Policies
TR u}uv ]v .vv]o .˘ ] (}oo}` P
Iv v} }R }o]] uv}v U ( } R }vvP }o]] ] ]v R uu˙ }( ]Pv].v
}vvP}o]]]vR}v}o]IFRS.vv]ouvXF}v}]]v}vUR}uv˙.vv]o
DuA DuA
uv }( Pv˘ SE R}o ]v }viv}v `]R R }v}o] IFRS .vv]o uv X ~IvR}v}(¤Z U U
Investments in Group Companies
Participating interests in group companies
Ov]vPBov UææU UUı
P]vP ]v ]v P} }uv] o ]vP R ]˙ uR} U o˙]vP R IFRS }vvP }o]]
SR}(o}}(]vuv ~UıZ ~æıUZ
v} ˙ R E }v Uv]}vX F}oo}`]vP R }}v }( IFRS ı ˙ R P} U v } ]v }v }( R D R
A }vvP Sv X AU R }uv˙ RooU }v ]v.}v }( ] o} }v v ]v}uv˙ o}v v l SRr˙uv˘v}(]vuv Uıæ ıUı
} ]o U o]u]v R ˙]vP u}v }( R ]v}uv˙ o}v v l} ]o (} R o }( R ]v. Tvo}v v ~UZ
] o} X C]o]vPv˘VB UU ıUıæ
PouPPv˘VB v ~UZ
Result of participating interests
Iv}}}vPv˘IIPVB v U
TR R ]v R o }( ]vP ]v }v] }( R R }( R C}uv˙ ]v R o }( R ]vP
]v X Iv } ( P]v } o} }v v }v ]v}o]vP R v( }( v o]]o] `v R C}uv˙ C]o]vPv˘IIPVB v Uææ
v ] ]vP ]v } `v ]vP ]v Ruo v }v] vo] U R˙ R v} Closing balance 2,411,743 1,535,060
v }Pv] X

R]ol~˙oZ}vG}}uv] ııı U
Aoo u}v v ]v R}v }( USDU vo }R`] X TR ov R v ]v}u uv
(v R v ]vo X TR ( } R v} X
Investments in Group companies 2,412,741 1,536,080

1.3 Change in Functional and Presentation Currency as of January 1, 2021 Other financial assets
Ov]vPBov
A }( Jv˙ U U R C}uv˙ RvP ] (v}vo v v}v v˙ (}u EUR } USDX TR RvP ]v
Balance as at year-end 1 1
(v}vo v˙ ` u } G R USD R }u R }u]vv v˙ ]v R C}uv˙U vvP
]Pv].v }( R C}uv˙ [ R G}` v .vv]vPX TR RvP R v ]uouv `]R } + X
Total financial fixed assets 2,412,742 1,536,081
TR RvP ]v v}v v˙U + Jv˙ U U (}u EUR } USD ] } o˙ o] }v }u
.P }]vP } IAS v IAS U ]( USD R o`˙ v R v}v v˙ }( R }v}o] .vv]o
uv X TR RvP ` u } ' G R }v}u] (}}]v }( R C}uv˙ [ ]v P}]vP (}` X
TR C}uv˙ o] R R v}v v˙ RvP `]oo P] ]v} v }R lR}o o v -
v]vP }( R C}uv˙ [ (}uv } u X

302 | Notes to The Company Financial Statements of argenx SE Notes to The Company Financial Statements of argenx SE | 303
3 Receivables F} R ]o }v SR B P˙uv ` ( } v} }( R }v}o] IFRS .vv]o uv X
TR }uv˙ R}o v} oPo }( R ]˙X
DuA DuA
~IvR}v}(¤Z U U
Iv]o v v
7 Current Liabilities
OR]o ıı ææ

PART VIII
P]˘v U æUæ
DuA DuA
Total Receivables 1,993 6,155 ~IvR}v}(¤Z U U
}v
A ˙o v
R]o (oo ]v o Rv }v ˙X TR (] o }( R ]o }˘]u R v}u]vo o U } R]
Iv}uv˙˙o U ææ
R}ru RX
T˘˙o ıæ v
˘v
A
OR˙o v
4 Financial Assets Total Current Liabilities 2,845 1,265

DuA DuA
Aoo v o]]o] (oo ]v o Rv }v ˙X TR (] o }( R v o]]o] }˘]u R v}u]vo o U
~IvR}v}(¤Z U U } R] R}ru RX
M}v˙ul(v Uıæ æU
Tu}v v v
Total Financial asssets 4,985 5,430
8 Financial Result and Exchange Gains/(Losses)
Yv Yv
Du Du
~IvR}v}(¤Z U U
5 Cash and Cash Equivalents Iv]v}u}vvl}] v
NP]v}v]vuvFVTPL v v
DuA DuA F}oo(}uADSR}o
~IvR}v}(¤Z U U
Iv}vIlCv}v v v
Tu}] Uæ U
Financial income 484 544
vC vl}v ıæU ıUı
Total Cash in banks 142,853 117,995
No}}v]vuvFVTPL ~Z ~æZ
Iv˘v ~Z ~Z
OR.vv]o˘v ~Z ~Z

6 Equity Financial expenses (524) (652)

SR SR R]v OR Tvo}v T}o Exchange gains/(losses) (5,191) (1,519)

~IvR}v}(¤Z C]o Pu]u v]vP
E R R ]˙
E
Equity per 1 January 2021 in EUR 4,757 2,058,122 (861,491) 154,977 — 1,356,365
Financial income and expense (5,231) (1,626)
]˙
E iv˙o}]vP
æU UææUæ ~UæUZ ıU v UUı
USDlEURDu
C}}v(}R]}]o ~ıZ ~UZ æU ~UZ U v
Equity per 1 January 2021 in USD 5,744 2,339,033 (991,931) 177,509 134,041 1,664,396
Ro}(R˙ v v ~UæZ v v ~UæZ
SPBo v v v ıU v ıU
C]o]v˘]}l}}v æı Uı v v v Uıæ
C]o]v.vv]vP UıU v v v UıU
Equity per 31 December 2021 in USD 6,233 3,462,775 (1,400,196) 356,875 134,041 2,559,728

304 | Notes to The Company Financial Statements of argenx SE Notes to The Company Financial Statements of argenx SE | 305
9 Share in Result of Subsidiaries
Other Information
A }( D u U U R C}uv˙ R `} B oP]v ]]] U Pv˘ BV v Pv˘ IIP BVU `R]R i}]vo˙ ˙ }
R R v o}uv ] }( R G} X
Provision in the Articles of Association Governing the Appropriation

PART VIII
Yv Yv
Du Du of Results
~IvR}v}(¤Z U U
Pv˘VB ~UZ ~æUZ
X  TR }uv˙ Roo R }o]˙ }v v ]]v `R]R Roo u]v v u˙ uv ˙ R
Pv˘IIPVB ~UıæZ ~UæZ
} }( ]} X TR }}v v RL R u]o RvP }( R }o]˙ }v v ]]v Roo
(437,968) (589,668)
] R Pvo uvP v Pv ]uX

X  F}u R }. U R}`v ]v R vvo }v U } U R } }( ]} Roo u]v `R]R Roo

X Av˙ }. u]v]vP RL Roo R ]}o }( R Pvo uvPX TR } }( ]}
10 Other Disclosures Roo ul }}o (} R } X A }}o } ˙ ]]v Roo o `]R Pv ]u
R Pvo uvPX
CONTINGENT LIABILITIES
TR }vvPv o]]o] }( R C}uv˙ }v] }( vo Puv (} }8 D}W}l B (} v u}v X D]]}v }( ]]v }v R R Roo u ]v }}}v } R v}u]vo o }( R R X
}( KEUR vvuX TR o v u]v vvoo˙X
X  D]]}v u˙ u }vo˙ ]v}( R }uv˙ [ ]˙ ˘ R u}v }( R ] ]v v oo
RELATEDrPARTY TRANSACTIONS }( R ] ]oU ]v ˙ R `R]R u l ˙ ] }( R o`X
Aoo oPo v R v }v}oo U i}]vo˙ }v}oo } ]Pv].vo˙ ]vGv }v] o ˙X
Ao}U v `R]R v }v}o R }uv˙ }v] o ˙X Iv ]}vU ]} U }R l˙ uvP - æX I( o} ` + ]vP v˙ }v ˙U R } }( ]} u˙ }o } }+ R o} ˙ `]vP ] }+
uv }( Pv˘ SE v o} o P o X OR Rv R ]v}uv˙ } rRP U R P]v `R]R R }uv˙ ] v} ] } l ˙ ] }( R o`X
` v} o ˙ v }v X
X  TR ]]}v }( }. Roo u L R }}v }( R vvo }v U (}u `R]R ] R R
REMUNERATION u ] u]' X
S v} }( R v} } R }v}o] IFRS .vv]o uv X
X  TR } }( ]} u˙U i } } v }( R }o]˙ }( R }uv˙ }v v ]]v U
INFORMATION RELATING TO EMPLOYEES }o } ul v ]v]u ]]}vU }] R ]uv }( PR }( R] o R v }uo]
D ]vP R ˙ U R C}uv˙ R v P }( X FTE ~ P X FTEZX `]RU R}`v ˙ ]v]u }v X SR ]v]u }v Roo R}` R .vv]o }]}v }( R }uv˙ v} o] -
Rv }v R . ˙ }( R R] u}vR (} R u}vR ]v `R]R R }o}v } ul R ]v]u ]]}v
AUDITOR[S FEES ] vv}v X SR ]v]u }v Roo ]Pv ˙ oo uu }( R } }( ]} X I( R ]Pv }( }v
S v} }( R v} } R }v}o] IFRS .vv]o uv X } u} }( Ru ] u]]vP U R] Roo v }v (} R] }u]]}v Roo P]vX TR ]v]u }v
Roo }] ]v R }8 }( R P] `]R]v ]PR ˙ L R ˙ }v `R]R R }o}v } ul
PROPOSAL FOR APPROPRIATION OF THE RESULT R ]v]u ]]}v R v vv}v X
TR C}uv˙ } v o} }( ¤ X u]oo]}v (} R ˙ v }v D u U X TR B} }( D]} } -
} } ˙ (}` R v o} }( R ˙ } R uo o} X Av]vP R }o }( R .vv]o X  A R }}o }( R } }( ]} U R Pvo uvP u˙ }o } ul ]]}v }v R `R}oo˙ }
uv ˙ R RR}o R vvo Pvo uvP }( RR}o U R] }}o R o˙ v G o˙ v} ]v R ]v R X
]v R .vv]o uv X
ıX TR } }( ]} u˙U i } } v }( R }o]˙ }( R }uv˙ }v v ]]v U -
EVENTS AFTER THE BALANCE SHEETTEDA }o R ]]}v } R}o }( R Roo u } }( }v } u} X
F} R v L ov R U ` ( } v} }( R }v}o] IFRS .vv]o uv X
X A o]u }( RR}o (} ˙uv }( ]]}v Roo L . ˙ R o X

B U MR U
TR D]}
T]u Vv H`u]vU CEO

306 | Notes to The Company Financial Statements of argenx SE Other Information | 307
Independent Auditor’s Report
Materiality
B }v} }(]}voiPuv` u]v Ru]o]˙(} R.vv]ouv `R}o USD
ıUæU XTRu]o]˙] }vXæA9}(}vP˘v XWR o}lv]v} }vu]uv vl
} }]ou]uv R ]v} }]v]}v u]o(} R }(R.vv]ouv (} o] }vX

T} R RR}o }(X WP`]RRB}}(D]}Ru]uv]v˘}(USDUæUU`R]R]v.]vPR]U

PART VIII
`}o}}RuU`oouoou]uvR]v}]`u}}vo]P}vX

Report on the Audit of the Financial Statements for the year ended December 31, 2021 Scope of the group audit
included in the Annual Report Pv˘ SE ] R R }( P} }( v X TR .vv]o ]v(}u}v }( R] P} ] ]vo ]v R }v}o]
.vv]o uv }( Pv˘ SEX
Our opinion
WR ] R }uv˙]vP .vv]o uv (} R ˙ v D u U }( Pv˘ SEU B ` ouo˙ }v]o (} R }]v]}vU ` o} }v]o (} ]vP U ]]vP v (}u]vP
]v B U R NRov X TR .vv]o uv }u] R }v}o] .vv]o uv v R }uv˙ R P} ] X Iv R] ` R u]v R v v ˘v }( R ] } } ] }
.vv]o uv X (} P} v X TR ] } }v oo P} v R v (}u ˙ R P} vPPuv uX B˙
(}u]vP R } P} v U }PR `]R ]}vo } P} ooU ` R v o }
Iv } }]v]}vP }]v 8]v v }] ] ]v } R P} [.vv]o ]v(}u}v } }] v }]v]}v } R
}v}o] .vv]o uv X
{  TR }uv˙]vP }v}o] .vv]o uv P] v (] ]` }( R .vv]o }]}v }( Pv˘ SE
D u U U v }( ] o v ] R G}` (} R ˙ v D u U ]v }v `]R Audit approach fraud risks
Ivv}vo F]vv]o R}vP Sv } ˙ R E }v Uv]}v ~EUrIFRSZ v `]R P ı }( B}}l }( Iv }v `]R R D R Sv }v A ]vP U ` }v]o (} }]v]vP }vo v R R
R D R C]]o C} X .vv]o uv lv `R}o ( (}u u]o u]uv U `RR } ( } }X
{  TR }uv˙]vP }uv˙ .vv]o uv P] v (] ]` }( R .vv]o }]}v }( Pv˘ SE
D u U U v }( ] o (} R ˙ v D u U ]v }v `]R P ı }( B}}l }( R IvRv } } }v]]o] (} R ] }( R .vv]o uv U R ] v v}]o ]l R u]o
D R C]]o C} X u]uv P} v U v R}PR R ] ] ovv v (}u ]v }v `]R D R o`X TR ]l
}( v u]o u]uv } ( ] v R]PRU ( u˙ ]v}o }oo]}vU (}P˙U ]vv}vo
TR }v}o] .vv]o uv }u] P }u]]}v U u] v}v U } R }] }( ]vvo }v}oX Ao}U ` v} }v]o (} R v}v v
}v }( ( v v}vr}uo]v `]R oo o` v Po}v X O ] } ]+ (}u (}v] } oPo
X  TR }v}o] uv }( .vv]o }]}v D u U X ]vP}vU `R]R }Lv R u} ]vrR RX
X  TR (}oo}`]vP uv (} R ˙ v D u U P R }v}o] uv }( }. } o} U
R }v}o] uv }( }uRv] ]v}u v o} U R }v}o] uv }( R G}` v R W]v. v R ]l }( u]o u]uv }( R .vv]o uv } ( X D ]vP } ]
}v}o] uv }( RvP ]v ]˙X ` }]v v vv]vP }( R v˙ v ] v]}vuv v R }u}vv }( R ˙u }( ]vvo }v}oU
X  TR v} }u]]vP uu˙ }( R ]Pv].v }vvP }o]] v }R ˘ov}˙ ]v(}u}vX ]vo]vP R ]l uv } v uvPuv [} (} }v]vP } R ]l }( ( v u}v]}]vP R
˙u }( ]vvo }v}o v R}` R B} }( D]} ˘] }]PR U `oo R }}u X Iv }]v]vP }
TR }uv˙ .vv]o uv }u] P vv]vP ` (}u ]v]] `]R uvPuv ~CR]( E˘ O8U CR]( OvP O8U CR]( F]vv]o
O8 ZU R} RP `]R P}vv v }R `]R]v R }uv˙X W o R ]Pv v ov
X  TR }uv˙ ov R D u U X }( R ˙u }( ]vvo }v}o v ]v o R ( ]l uv U `oo u}vP }R R } }( }v
X  TR }uv˙ }. } o} }v (} R ˙ v D u U X v `R]o o}` } X W o R ]Pv v R ]uouv}v v R }vP + -
X  TR v} }u]]vP uu˙ }( R }vvP }o]] v }R ˘ov}˙ ]v(}u}vX v }( ]vvo }v}o ]Pv } u]P ( ]l X A }( } } }( ]v(˙]vP ( ]l U ` o
( ]l (} `]R } .vv]o }vP ( U u] }]}v }( v ]˙ v } }v ]v o}
Basis for our opinion }r}}v `]R } (}v] ]o] X W o `RR R (} ]v] R ]l }( u]o u] -
W }v } ] ]v }v `]R D R o`U ]vo]vP R D R Sv }v A ]vPX O }v]]o] uv } ( ] v X
v R} v (R ] ]v R SO }v]]o] (} R ] }( R .vv]o uv _ }v
}( } } X F}oo}`]vP R } U v R u ]l v R ]o]vP ] v U ` }v] ( ]l o -
} uvPuv }] }( }v}o U ]vo]vP ovP `RR R ` ]v }( ] ˙ R E˘ B} U
W]vvv}(Pv˘SE]v}v`]RREURPo}v}v].]uvP]vP}˙] R ˘ o R] u v }R uu }( uvPuv U `R]R u˙ v ]l }( u]o u]uv
}(o]r]vvURW}]R}vv}Pv]~WUA].u]]}vZURV}v]vP } ( X O ] } } }v } R ( ]l ]vo U u}vP }R U v o}v }( ov ]v -
]vl}vHvlo]ilR]v}vv]ivr}Rv~V]OUC}}(R]
E (}P}(]}vo}vv
A U vo }v}o v ouv˙ v ] } U ]vo]vP ]o vP }( i}vo v] U ovP R
Po}v`]R}]vvvZv}Rov]vvvPo}v]vRNRovXFRu}U }vvP u (} ] v ]` }( R }vP }uv}v ]v o}v } }ro}]vP iuv X D
`R}uo]`]RRV}v]vPPPrv}Po}vv~VGBAUR D C}}(R]
E ZX vo˙ U ]vo]vP o}v }( i}vo v] }v ]lr R ] U (}u }( } ] }R }
R ]v. ( ]l X
W o] R ] ]v ` R }]v ] 8]v v }] } }] ] (} } }]v]}vX
A ]}voo˙U ` (}u (R } ]vo]vP U u}vP }R U R (}oo}`]vPP

308 | Independent Auditor’s Report Independent Auditor’s Report | 309

{  W]v}} ouv }( v]]o]˙ ]v } ] X W o} }v] R }}u }( } }R ] }
v o `RR v˙ .v]vP ` ]v] }( ( } v}vr}uo]v X
{  W o `RR R o}v v o]}v }( }vvP }o]] U oo˙ R} o } i
u uv U u˙ ]v] }( (ov .vv]o }vPX
{  W o `RR R iPuv v ]]}v u ˙ uvPuv ]v ul]vP R }vvP u ]vo
]v R .vv]o uv ]v] }]o ] R u˙ v ]l }( u]o u]uv } ( X
- Our key audit matters
K˙ ] u' R} u' R U ]v } }(]}vo iPuv U ` }( u} ]Pv].v ]v } ] }( R
.vv]o uv X WR }uuv] R l˙ ] u' } R B} }( D]} X TR l˙ ] u'
v} }uRv] G}v }( oo u' ] X
-
TR u' ` ]v R }v˘ }( } ] }( R .vv]o uv `R}o v ]v (}u]vP }

PART VIII
MvPuv ]v]PR U u v u}v R u]PR R ui} ]u }v R .vv]o uv }]v]}v R}vU v ` } v} }] }]v]}v }v R u' X
]o} ]v N} }( R .vv]o uv X

O } } ( ]l ] v} o ]v K˙ A ] M'X Trade and Other Payables – Research and development cost accruals — Refer to Note 15
to the financial statements
Audit approach compliance with laws and regulations
W R o` v Po}v ov } R C}uv˙ R}PR ] ]}v `]R R oPo }voU ]vP D]}v O}v
u]v v } }( ]vvo ] X W]v}o } (}v] ]o] ]v R] o}vX
TR}uv˙}Pv]}}(USDXu]oo]}vU]. O]}o}RRvo}uv
]vN}æ}R.vv]ouvU]v(}o]v]o]o }o]voR(}oo}`]vPUu}vP}RP
A o }( } ]l uv } U v `R]o o]]vP R R + (}u v}vr}uo]v }o }v] - ]Rvo}uv˘v}v
o}v}(]v}[}P}`}uo}v}(]. • W}v}o}R}]v}(R}]vP
o˙ ˙U ` }v] R (}oo}`]vP o` v Po}v P Rv } ~}} Z ˘ o` v .vv]o }vP
lXP˙uvu]vPu˙]+]Pv].vo˙(}uR]}]v }(RRvo}uvoGvPR
Po}v U R ]uv v R Ivv}vo F]vv]o R}vP Sv } ˙ R E }v Uv]}v `R]RR}}Pv]˘vUovP]vR }P}(Ro]v]o]oU]vo]vPRo˙]`
~EUrIFRSZ v P ı }( B}}l }( R D R C]]o C} `]R ] + }v R .vv]o uv v ]vP vo}uv}o}Pv]`]R]vTv uvP`vR.vvuvvo]v]oR
ORP˙o]vRSuv}(F]vv]oP}]}vX }vvoX
}( } ] } U } R ˘v u]o (} R o .vv]o uv X W}]v 8]v }] -
] ]v P]vP }]]}v }( R} o` v Po}v Pvoo˙ }Pv] } R ] + }v R u]v}v
D }(RR}PvRvo}v}(R • WoRv}oo}}vPuvU
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.vv]o uv X
iPuvUR}P]v}]o˙}oX }(Ro]v]o]oGooov}voouvX
IvuvPRv}[}P}`}uo}v}( • W}v]o]o˙]oo]v(}u}v~R
A (}u R U R }uv˙ ] i } }R o` v Po}v `R R }v v }( v}vr}uo]v ].lUR}uv˙R(}Rv ov]v}v}vZv}}(]}[
}o R u]o + }v u}v v l} ]o} ]v R .vv]o uv U (} ]vv U R}PR ]u}]vP v}oouvUo]v]o]}vvv}]v(}u}v}( u]oP]vPR}(o]v]o]o]v
o}]vXTR]]}]vR}PR} oR]]v(}u}v}RiPuvo]]v
.v } o]P}vX G]v R v }( R }uv˙ [ ]v v R }uo˘]˙ }( o` } Po}v U R ] ]l }( (}u}]]}v`]R}uv˙}vvov}]] }]vPRoX
v}vr}uo]v `]R R ]uv }( R o` v Po}v X Iv ]}vU ` }v] ui} o` v Po - }]}R}P}}(}uo}v}(]oU} • F}o}v}(}vU`}uRu}v}(
}v o]o } o] }uv] X R}uo}v}(]XC}˘v}R] oRv}(R]}]}}v˙]˙
]}R]}]XC}(}]}]R voR˙}(R}uv˙[u}v
Rv}˙v]}Pv]oX uR}}o}P˙
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W]v.RRvo}uv}o • W(}u}v.u}v}`]Rv}o
u]v}v}( R u}v v ]o} ]vR.vv]ouvXC}uo]v `]RR o` v Po}v u˙ }R}P}(]Pv].v}i}RRv
]o]u'}Rvu}(}vP}]vPo]v]o]o
(vuvo} R}vP }( R ]v U}Pv˘ []o]˙}}vv ] ]v U} }}]u]o ]vRi]˙]v}o]vuvPR o}uv}]voo}vX
vo ~XPXU`]Ro` v Po}v SECPo}vUDRS}l˘RvPPo}vUFDAPo}v v EMA vo}uv}ov]vPRRv • Wuo}v}(].u}v}Pv]R
o}uv}o]v}oiPuv]vovPR vo}uv˘v`ooR}}Pv]
Po}v }R˘vu]o(} R.vv]ouv }(R }uv˙Zv R(}v}vr}uo]v `]R R
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o` v Po}v u˙R u]o+}vR.vv]ouvXO }v]]o]˙]o]u] }vl]vP R}]vX
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}v R .vv]ouvXO } o]u] }~]Z]v]˙}(uvPuvURB} }(D]} v}R - R}v]ov˙]ooouv}(`}lUR
`]R]v R }uv˙ }`RR R }uv˙]]v}uo]v `]R Ro` v Po}v v~]]Z]vvP} - }U}}R}vP}uv}v}uvPuv[
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v}ZX
v Po}v R u˙R u]o+}vR.vv]ouvX

Noo˙U ` u]v o } ]v]}v }( ~ Z v}vr}uo]v R}PR} R ] X F]voo˙U ` }]v OB SE RVATIONS

`]'v v}v R oo lv}`v ]vv }( ~ Z ( } v}vr}uo]v `]R o` v Po}v R
v ]o} } X TR}vv}(R]}`(}u
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u]uvo}RRvo}uv}
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O }v]]o] U `oo R }v]]o] }( R uvPuv v R B} }( D]} U o } P}]vP
}vv v R ]o]vP v }o]v ]v R SD ]}v }( }v]]o] P]vP R .vv]o -
uv _ }v o}`X Iv (o.oo]vP } }v]]o] U ` (}u } ]vo]vP ovP uvPuv [
uv }( R }uv˙ [ ]o]˙ } }vv P}]vP }vv v }v]]vP R ]u }( .vv]oU }}voU
v }R }v]}v X B }v R } U ` ] v} ]v(˙ v˙ }o .v]vP o } R v˙ [ ]o] -
˙ } }vv P}]vP }vvX

310 | Independent Auditor’s Report Independent Auditor’s Report | 311

Revenue – Determination of appropriate accounting of the license and collaboration Report on the other information included in the Annual Report
agreement — Refer to Note 16 to the financial statements
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D R Sv X TR } }( R } (}u ] voo˙ o Rv R } }( R} (}u ]v
} ] }( R .vv]o uv X
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}v `]R P ı }( B}}l }( R D R C]]o C} U v R }R ]v(}u}v ] ˙ P ı }( B}}l }(
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o}v] }vP (}u ] Po R R Avvo R} }( R }uv˙ R } ]v ]vPo o}v]
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uv ]vo ]v R }vP lP ˙ R C}uv˙U R v ]v oo u]o ]v }v
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R ]uv X WR lv ]v} }v]}v `R ] ]v Ao X O } ]vo P

312 | Independent Auditor’s Report Independent Auditor’s Report | 313

{  O]v]vPvvv]vP}(Rv˙ [.vv]o}vP}U]vo]vPR}v}(R}vPlPV
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Description of responsibilities regarding the Financial Statements
Responsibilities of management and the Board of Directors for the financial statements
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PART VIII
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] X Iv R] ` o} u] v ]}vo } } R ] }uu]' ]v }v `]R A o }( R EU
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Our responsibilities for the audit of the financial statements

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u]o } v ( ]vP } ] X

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] ]v }]v U `RR u]o v ]v˙ ˘] o } v } }v]}v R u˙ ]Pv].v

314 | Independent Auditor’s Report Independent Auditor’s Report | 315

9
Information

PART IX
Incorporated by
Reference
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˙ (v ]v R] RP]}v D}uv P

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Reference

PART IX
C}v}o]uv}(}.}o}v}R}uRv]]v}u Xæ
C}v}o]uv}(RG}` Xæ
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O }v}o] .vv]o uv }( v (} R .vv]o ˙ v D u U U v ı ~]v -

o]vP R ]v vv ]} [ } R }vZ R v ]v}} ˙ (v ]v R] Uv]o RP]}v TR (oo ˘ }( R A o }( A }]}v v v v}8]o EvPo]R vo}v R}( ]v}} ˙ (v ]v
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318 | Information Incorporated by Reference Information Incorporated by Reference | 319

10
PART X
Glossary
Contents
Cross Reference Table for Annual Reporting Requirements 322

Glossary 324
Cross Reference Table for Annual
Management Confirmations
W]R P } ]v]o X X }( R D R C}} G}vv C} U ` }v.u R P

Reporting Requirements ~]Z   TR] Uv]o RP]}v D}uv }] 8]v ]v]PR ]v} v˙ (]o]vP ]v R +v }( R
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PART X
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322 | Cross Reference Table for Annual Reporting Requirements Cross Reference Table for Annual Reporting Requirements | 323
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CIDP R}v]]vGuu}˙u˙o]vvP}o˙v}R˙ PMG Pvo]u˙Rv]P]

324 | Glossary Glossary | 325

 GPCR Gr}]v}o} MuS uu}(RAE
G} Pv˘SE}PR`]R]]]] MET uvR˙uor]Ro]ov]}v(}
GSK Go˘}Su]RKo]vo MFN M}F}N}v
Ho}˙u Ho}˙uIvX MG u˙Rv]P]
HRrW˘uvA RUXSXDPP]C}u}vvPvTuR}}vA}(ı MHRA M]]vvHoR}RPo}˙APv˙
HGF R}˙P}`R(} M]v] M]v]}(HoRUL}vWo(

PART X
HIPAA RUXSX(oHoRIvvP}]o]˙v}v]o]˙
A A}(ıı MMN uo(}ou}}v}R˙
HITECH RHoRIv(}u}vTRv}o}P˙(}}v}u]
E vCo]v]oHoRA}(ı MN uuv}vR}R˙
HTA RoRRv}o}P˙uv MSK uor].l]v
IrRODS IvGuu}˙RRr]oOooD]]o]˙So MSE u]v]uo˙u}u˘]}v
Ivv}voF]vv]oR}vPSvU]˙RIvv}vo}vvP
A u˙}] ]]}R]]vGuu}˙u˙}R]
IFRS
SvB}Uv}˙R}v
E Uv]}v
N RNGo}oSoMl
IgA Iuuv}Po}o]vA
NHI N}voHoRIvv
IPD Iuuv}Po}o]vD
NHSA N}voHoRS]˙Au]v]}v
IPG Iuuv}Po}o]vG
NK vol]oo
IPM Iuuv}Po}o]vM
N}} N}}N}]lAlS
IIP Iuuv}o}P˙Ivv}}vP}Pu
NRDL N}voR]uoDPL]
ILr ]vol]vr
OIG RO8}(Iv}Gvo
ILrR ]vol]vr}
OOPD RUXSXO8}(ORvP}o}uv
D
IMM ]]ou}]]˙}u}o]˙
R]˙]vvov}˙}B}}(D]}}vDuU
IMNM ]uuvru]v}]vPu˙}R˙ `R]R`}˙RGvoMvP}vM˙Uævuv˙RGvo
]˙
E IvvPov
MvP}vA]oUvN}uæUıvRB}}(D]}}vDu
INCTA IvGuu}˙N}R˙CvTuv UıUN}uæUv}vDuæU
IND ]vP}vov`P
PAA r}o}Pu
IQVIA IQVIALTD
PCT PvC}}}vT˙
IRB ]v}vo]`}
PD Ru}˙vu]
IST ]uuv}]R]
PDAI uR]P]]v˘
ITP ]uuvR}u}˙}v]
PDUFA P]}vDPUFA
ITP ]uuvR}u}˙}v]
PF uR]P(}o]}
IV ]vv}
PRuovM]o]D A RA}vS]vPQo]˙U8˙
E vS(˙}(PRuovM]o]D
IVIP ]vv}IPG
PHSA RUXSXPo]HoRS]A
Jvv JvvPRuoUIvX
PIP ]]]vP}vov
JJDC J}Rv}vJ}Rv}vIvv}}vWJJDU
C IvX
PK Ru}l]v
JrMAA JvMlAR}]}vAo]}v
PMDA PRuovM]o]D APv˙~JvZ
JOBSA RUXSXJuOB]vSA}(
POTS }o}R}R˙]˙v}u
LEOPRu PRuLEOPRuAlS
LN ovR] RPo}v~EZlıO(TR}v
E Po]uvAvO(TRC}v]o}(Jv}v
P}RPo}v R}}o]R`Rv]}+}Ro]}u]']vP
L}v L}vSoGA }vPoulUvo]vPD]llEC
LUMC L]vUv]]˙M]oCv
PREA P]]RR]˙
E A}(Uuv
MAA ulvPR}]}vo]}v
PRV P]}]˙R]`V}R
MAD uoov]vP}
PV uR]PoP]
RPo}v~EUZN}æıl}(R}v
E Po]uvv}(RC}v]o}(A]o PVAS uR]PoP]]˙}
}vul~ulPo}vZvo]vPD]llE}v
CE
MAR QMG vu˙Rv]P]
Po]uvv}(RC}v]ovC}uu]]}vD]llEU
C lECv
llEU
C vRovPo}v}uoPvR} RDL R]uDPL]
MDS u˙o}˙o˙v}u RP]}vD}uv R]v]oP]}v}uv
M]}v M]}vPRuLX REMS ]lo}vvu]P}vP˙

326 | Glossary Glossary | 327

 R}R FXH}+uvrLR}RGA
RSU R]}lv]
SAD ]vPov]vP}
SC v}
}v
E C}v]oRPo}v~ECZN}æl}(O}U}vRS(}
SEPo}v
}v
E }uv˙~S}]}E }SEZ

SEC RUXSS]vE˘RvPC}uu]]}v
S}v S}v}(RSvrO˘o˙A}(
S] SR}Au]vD}]˙R]}SR]vRR]o}(Pv˘SE
S]A RUXSXS]A}(ıUuv
SR] SR]GA Uv}`lv}`vSR]Ivv}voGuH
SjS SiPv[˙v}u
SLE ˙u]o˙Ru}
SMA ]vouo}R˙
S} S}SXAX
D]l}(R}v
E Po]uvv}(RC}v]o}(M˙UPR
SRDII
v}Puv}(o}vPruRR}ovPPuv

Staten SvB]}Rv}o}P˙BXVX
TEAE uvuPvv
Tl}L` RBoP]vo`A]oU}vo]l}]
Tl}R}˙oD RBoP]vR}˙o}(
D A]oU}vo]l}]
Troo To˙uR}˙}vPR}˙(}u]v(}v
TCL Trooo˙uR}u
TGFrW v(}u]vPP}`R(}

D]lılEC}(R}v
E Po]uvv}(RC}v]o}(DuæU
}vRRu}v]}v}(vv˙]uv]vo}v}]v(}u}v}]
Tvv˙D] `R}]u]'}]vP}vPoulvuv]vPD]
llECvRovPo}v}uoPvR}Uuv˙
]}]]vo]vPlælEU

TP Troo}o}vu}ovPR]uuv˙u
UXSX RUv]S}(Au]
UCL Uv]] R}o]
C L}]v
UK RUv]K]vP}u
U}T RUv]]˙}(T˘S˙u
USPTO RUv]SPvvTulO8
VIB VIB`
VrP]}v v}˙]oP]}v
Pv˘SE}PR`]R]`R}oo˙}`v]]]Pv˘IIPVB UPv˘VB UPv˘US
`U}} IvUPv˘JvKXKXUvPv˘S`]ovSAUPv˘FvSASvPv˘Guv˙
GuHvUo]oU](}u`R}oo˙}`v]]]

]Z L ]Z LL]u]

328 | Glossary