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4. CMOs with weak track record record to utilize sites. Idle capacity is a major
challenge for the industry, ~30% of plants could cover global demand
Operational 5. CMO not achieving structurally higher operational performance than pharmacos,
performance unit cost is not a differentiator, potential impact from complexity and constraints to
optimize
6. Quality controls are often less robust than internal sites, leading to higher risk
7. Revenue is steadily growing with especially FDF players clearly outgrowing the
Printed
industry. Outlook positive with increasing divergence of regions and technologies
8. EBIT margins are slightly growing, however clearly different by technology. 30%+ of
industry players with razor-thin margin
Financial
9. Industry evaluation (EV/ EBITDA multiple) is significant increasing, indicating that
performance
CMOs are moving up the value chain from execution to innovation/ development
and outlook
10. This includes a shift in the industry risk profile, with CMO players significantly
stepping up CAPEX and M&A
11. The industry will see growing differentiation of CMO value propositions, e.g. with
technology specialists and commodity champions as possible success profiles
McKinsey & Company 2
Investor observations on the CMO industry
1. CMO industry is highly strategic for healthcare, supporting >50% of top 50 global
drugs by revenue, in the biotech segment even 90%
4. CMOs with weak track record record to utilize sites. Idle capacity is a major
challenge for the industry, ~30% of plants could cover global demand
Operational 5. CMO not achieving structurally higher operational performance than pharmacos,
performance unit cost is not a differentiator, potential impact from complexity and constraints to
optimize
6. Quality controls are often less robust than internal sites, leading to higher risk
7. Revenue is steadily growing with especially FDF players clearly outgrowing the
Printed
industry. Outlook positive with increasing divergence of regions and technologies
8. EBIT margins are slightly growing, however clearly different by technology. 30%+ of
industry players with razor-thin margin
Financial
9. Industry evaluation (EV/ EBITDA multiple) is significant increasing, indicating that
performance
CMOs are moving up the value chain from execution to innovation/ development
and outlook
10. This includes a shift in the industry risk profile, with CMO players significantly
stepping up CAPEX and M&A
11. The industry will see growing differentiation of CMO value propositions, e.g. with
technology specialists and commodity champions as possible success profiles
McKinsey & Company 3
1 Highly strategic industry for patients – 60% of drugs depend on CMOs in
at least 2 steps of the value chain In-house In-house + outsourced
Outsourced Partner/licensor + outsourced
Printed
Lyrica Oral Conventional 4,966
Advair Inhalation Conventional 4,720
Neulasta Injection Biotechnology 4,648
Copaxone Injection Conventional 4,223
Sovaldi Oral Conventional 4,001
Tecfidera Oral Conventional 3,968
Januvia Oral Conventional 3,908
Opvido Injection Biotechnology 3,774
Truvada Oral Conventional 3,566
Crestor Oral Conventional 3,401
SOURCE: Evaluate Pharma, PharmSource McKinsey & Company 4
1 Clear strategy difference – Big Pharma is less likely to involve CMOs in
their top products than “Challenger” PharmaCos
39 drugs 11 drugs
100% 0%
56%
91%
44%
0% 9%
Printed
Big Pharma "Challenger"/Biotech
▪ Amgen ▪ Merck ▪ AbbVie ▪ Regeneron
▪ AZ ▪ Novartis ▪ Gilead ▪ Alexion
▪ Bayer ▪ Novo Nordisk ▪ Celgene ▪ Astellas
▪ BI ▪ Pfizer ▪ Biogen
▪ Lilly ▪ Roche
▪ GSK ▪ Sanofi
▪ J&J ▪ Teva
SOURCE: Evaluate Pharma, PharmSource Strategic Advantage, Press and Web search McKinsey & Company 5
Pharma/chemicals company providing
2 CDMO market is still highly fragmented, with top 20 CDMO services (estimated sales
from CDMO business shown)
Printed
Vetter 0.5
industry structure and
Nipro 0.5 degree of
Famar 0.5 fragmentation,
consolidation is
Almac 0.5
expected to continue,
Delpharm 0.4 albeit at a slow pace
AbbVie 0.4
79%
Baxter BioPharma 0.4
Dr. Reddy’s 0.3
Samsung Biologics 0.3
27%
34%
56% 60%
Printed
73%
66%
44% 40%
SOURCE: Frost & Sullivan “Global Pharma CMO Market”, 2013 & 2016; VisionGain “Leading Pharmaceutical Contract Manufacturing Organizations”, 2014,
RNCOS API forecast 2017, Annual Reports, Evaluate Pharma, Evaluate MedTech, Nicholas Hall, McKinsey analysis McKinsey & Company 7
2 For comparison, in Electronic Manufacturing Services, top 10 players
account for 65% market
139 31.9%
31 7.0%
25 5.7%
20 4.5%
16 3.7%
15 3.5%
Printed
14 3.2%
7 1.6%
6 1.4%
6 1.3%
Acquisition 300
Printed
Acquisition 160
Acquisition 130
Acquisition 30
SOURCE: Windhover, PharmaDeals, PharmSource Strategic Advantage, Press and Web search McKinsey & Company 9
3 Despite a total of ~80 M&A transactions per year, Other
95
79 77
69 2011 80% 20%
58
55
Printed
2016 73% 27%
2011 12 13 14 15 2016
SOURCE: Frost & Sullivan “Global Pharma CMO Market”, 2013 & 2016; VisionGain “Leading Pharmaceutical Contract Manufacturing Organizations”, 2014,
RNCOS API forecast 2017, Annual Reports, PharmaSource Strategic Advantage, McKinsey analysis McKinsey & Company 10
3 Private Equity owns 29 FDF/DP CMOs (~10%) and we see 2-5 PE based
investment deals p.a. in this industry
Printed
broader
Healthcare
sector
2011 12 13 14 15 2016 ▪ >25% of CMOs
with revenue
over $100m are
owned by PE
SOURCE: PharmSource Strategic Advantage Database of Contract Service Providers, Capital IQ McKinsey & Company 11
Investor observations on the CMO industry
1. CMO industry is highly strategic for healthcare, supporting >50% of top 50 global
drugs by revenue, in the biotech segment even 90%
4. CMOs face challenges to utilize their sites – and idle capacity is a major
challenge for the industry, with ~30% of plants could potentially cover global demand
5. CMOs do not always achieve structurally higher operational performance than
Operational
pharma companies, and their unit cost is not always a differentiator – which could be
performance
driven by complexity and constraints to optimize
6. CMO quality systems burdened with significantly higher complexity, leading to
higher risk than internal sites
7. Revenue is steadily growing with especially FDF players clearly outgrowing the
Printed
industry. Outlook positive with increasing divergence of regions and technologies
8. EBIT margins are slightly growing, however clearly different by technology. 30%+ of
industry players with razor-thin margin
Financial
9. Industry evaluation (EV/ EBITDA multiple) is significant increasing, indicating that
performance
CMOs are moving up the value chain from execution to innovation/ development
and outlook
10. This includes a shift in the industry risk profile, with CMO players significantly
stepping up CAPEX and M&A
11. The industry will see growing differentiation of CMO value propositions, e.g. with
technology specialists and commodity champions as possible success profiles
McKinsey & Company 12
4 Capacity utilization is a major challenge in the industry, Secure future SOLIDS
Uncertain future
~30% of plants is able to cover global demand
UNIT COST, USD CENT PER PU Q3 Q2 Q1
Printed
Capacity needed to cover
the global demand 1
xx xx
xx xx
xx
Printed
CMO sites Pharma sites1
xx xx
xx xx
xx
xx
This material is solely for internal use of the client. Sharing, making available, circulating this material (or parts thereof)
CONFIDENTIAL
to any 3rd party outside the client organization without written permission of McKinsey & Company is strictly prohibited
SOURCE:
AND McKinsey POBOS
PROPRIETARY McKinsey & Company 14
by agreement between Participant and McKinsey.
SOLIDS
Printed
xx specifications: flexibility for CMOs to
xx optimize their processes is often
limited due to strict guidelines and
xx specifications from Pharma companies
xx
xx xx ▪ Capabilities: being smaller in size – it
often is challenging to attract the right
talent to run optimization
CMO sites Pharma sites1
1 Pharma with exclusion of CMO sites
4. CMOs with weak track record record to utilize sites. Idle capacity is a major
challenge for the industry, ~30% of plants could cover global demand
Operational 5. CMO not achieving structurally higher operational performance than pharmacos,
performance unit cost is not a differentiator, potential impact from complexity and constraints to
optimize
6. Quality controls are often less robust than internal sites, leading to higher risk
7. Revenue is steadily growing with especially FDF players are outgrowing the pharma
Printed
industry. Outlook positive with increasing divergence of regions and technologies
8. EBIT margins are slightly growing, however clearly different by technology. 30%+ of
industry players with razor-thin margin
Financial
9. Industry evaluation (EV/ EBITDA multiple) is significant increasing, indicating that
performance
CMOs are moving up the value chain from execution to innovation/ development
and outlook
10. This includes a shift in the industry risk profile, with CMO players significantly
stepping up CAPEX and M&A
11. The industry will see growing differentiation of CMO value propositions, e.g. with
technology specialists and commodity champions as possible success profiles
McKinsey & Company 16
7 CMOs with continuous revenue growth, especially FDF dominated
players more than double of pharma industry growth
Indexed revenue growth of top publicly noted CDMOs (2012 = 100)
API players2 3%
100
Printed
50
0
2012 13 14 15 2016
45
~8% p.a. 42 14%
39
36
33
30 ROW
28
26 4% APAC 7%
24
22 27%
20
18 40%
28%
7%
Printed
North Europe
America
201415 16 17 18 19 20 21 22 23 24 2025 9%
The global contract manufacturing
market of FDF expected to grow at
8% p.a. – faster than that of overall
prescription pharma market (5% p.a.)
1 Regional breakdown based on country of CDMO origination
SOURCE: Global Industry Analyst, expert interviews, McKinsey McKinsey & Company 18
MARKET OVERVIEW
specialization, and injectables and sterile liquids being key growth drivers
Printed
Non-
sterile ophthalmics)
1 Incl. originator drugs, generics, biopharmaceuticals, and vaccines 2 Number of CDMOs producing one of more products within a technology segment
SOURCE: Frost & Sullivan, Global Industry Analyst, McKinsey McKinsey & Company 19
8 EBIT margins are slightly improving, however clearly different by
segment; 30% of players with razor-thin margin
Printed
Catalent 13%
9
Patheon 12%
8
ACS 11%
1
Recipharm 9%
0
Nipro 7%
2012 13 14 15 2016
1 e.g., Patheon, Catalent, Nipro, Recipharm, ACS, others
2 e.g., Lonza, Hisun, Siegfried, Divis, Aesica, others
SOURCE: Capital IQ McKinsey & Company 20
9 EV/EBITDA multiple is significantly increasing …
Enterprise value multiple; times
Printed
Daito 5 6 6 6
Recipharm n/a 11 15 14
Celltrion n/a n/a n/a n/a
Samsung Biologics n/a n/a n/a n/a
Median 11 13 15 16
Note: All data ending Sep 28, 2017; n/a represents “not applicable”
SOURCE: S&P Capital IQ McKinsey & Company 21
9 Successful CDMOs use development services as a growth EXPERT ESTIMATES
▪ Fuel Growth:
20-40% secure a pipeline of
internally developed
products, and
5-10%
▪
Printed
Improve margins:
establish
Commodity Regular Innovators
development
services as a key
differentiator and an
enabler for
improved pricing
SOURCE: Expert interviews, market research, press publications McKinsey & Company 22
9 Many CDMOs have high and growing share of revenue coming from
development services
75%
84% 87%
Printed
25% (475)
16% (80) 13% (240)
SOURCE: Factiva, Hoover’s, web search, company reports McKinsey & Company 23
10 Major CMOs have increased their CAPEX investments in recent years
11%
10%
9% 9%
8%
7% 7%
6% 6%
Printed
3%
SOURCE: Capital IQ, PharmSource, Press and Web search McKinsey & Company 24
10 In the past years, multiple CDMOs have leveraged partnerships and
M&As as a way to increase development capabilities
Printed
capabilities in develop-
development capabilities
ment, formulation and
2015 60 USDm, ▪ Expansion of analytical service capabilities analytical testing
2.2x/10.0x and drug development services to include ▪ Especially when aiming to
sterile injectable formulation development build up specialized
2016 21 USDm ▪ Access to increased development capabilities, such as
operations both in scale and breadth of biologics, or innovative
capabilities technologies (e.g. softgel)
acquisitions are a favorable
2016 25 USDm, ▪ Capabilities in developing, manufacturing option for CDMOs
1.5x/12.5x and scaling up small molecule APIs for
clinical phase projects
value propositions
Printed
technologies or offerings to develop
▪ Bring it as part of strategic partnership facilities
discussions, and build commitments ▪ Operational excellence and cost
▪ Secure investments required, and reduction programs in the sites
start development