Professional Documents
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Sector Update
July 20, 2020 Raising red flag over Global Fund & Institutional
drug suppliers amid COVID-19
Quick Pointers:
Companies Covered in the Report
CMP TP
Global Fund-supported programs across countries witness disruptions.
Company Names Rating
(Rs) (Rs)
Donors could divert their funds to COVID treatment.
Cipla Reduce 674 542
Aurobindo Pharma Acc 824 838
New class of HIV treatment could end the road for Indian players.
Ipca Laboratories BUY 1,790 1,839
Ajanta Pharma NR 1,453 NA
We raise red flag over Indian drug suppliers who are exposed to Global Fund
Strides Pharma Sc. NR 427 NA
Laurus Labs NR 651 NA and sovereign Institutional tender business as the spread of Covid-19 could
Source: PL divert global attention away from serious diseases (Malaria, TB, and AIDS)
and the new class of HIV treatment could end the road for Indian ARV
(Antiretroviral) suppliers. The immediate threat to Indian suppliers because
of Corona virus (SARS-nCOV2) will be felt in near to medium term as 1)
COVID has disrupted 85% Global Funds activities for HIV, TB and malaria
because of reassignment of medical staffs to fight COVID-19 emergencies, 2)
contribution from sovereign and private donors would be significantly lower
than pledged amount, 3) roadblock in the distribution of a new class of ARV
drugs (TLD) vs existing ones (TLE) to HIV patients, 4) US (largest contributor)
could withdraw/reduce its allocation towards The Global funds and 5) price
erosion in malaria drugs due to rising funding gap and increased allocation
towards preventive medicines and diagnostic tests.
Complete cure for HIV would lead Indian ARV suppliers at risk: India supplies
well over 80% volume of all the HIV/AIDS drugs through its participation in global
tenders for country-wise procurement. AIDS being a terminal illness, the treatment
with ARV (Antiretroviral) medicines could only help AIDS patients to live longer.
With Gilead Science, Merck and Viiv healthcare having promising R&D pipeline
aiming at full cure for HIV, Indian generic ARV producer business will get impacted
from global tender business as HIV could be a one-time treatment. Laurus, Cipla,
Strides and Aurobindo and are key Indian listed players in this segment with
contribution of 69%, 10%, 10%, 5% to their total revenue from global tender
business. Globally Mylan, Teva and Aspen are also key players in ARV generics.
Headwinds set to increase for anti-malaria drug suppliers post COVID: In pre-
COVID-19 phase, anti-malaria drug suppliers were already facing issues of rising
funding gaps in the Global Malaria Fund. Price erosion of Anti-malaria medicines
has increased because more focus towards preventives (Insecticide-treated bed
nets) and diagnostics (Rapid Testing Kit). COVID-19 has led to emergence of new
headwinds with divergence of funds towards R&D of COVID tests and treatments,
which could further increase funding gaps and cause disruption of Global Funds
Surajit Pal activities to lower demand for anti-malaria medicines. IPCA and Ajanta are key
surajitpal@plindia.com | 91-22-66322259
players in this segment with revenue exposure of 5% and 14%, while Strides and
Tausif Shaikh
Cipla also participate in Global Fund tender. Guilin (China), Sanofi, Micro Labs and
tausifshaikh@plindia.com | 91-22-66322246
Macleods Pharma also supply to Global Fund.
US withdrawal from WHO will increase risk in Global healthcare: With current
US president Donald Trump intention to terminate its relationship with the World
Health Organization (WHO), this would create several uncertainties around global
health as US has been a largest contributor in multilateral healthcare funds for poor
countries. Along with in-house program, PEPFAR, it contributes 15% (US$450m)
of WHO’s budget and 33% of The Global Fund (US$4.6bn in 2020-22E). We expect
withdrawal of US from WHO (World Health Organization) would also have a
cascading effect on 1) rising costs of clinical trials and its progress for various
diseases and 2) increase in funding gap for Global Funds Malaria, HIV/AIDS and
Tuberculosis program.
500
111
450
400
114
119
107
111
350
300
113
109
110
250
401
200
109
324
110
304
300
282
150
228
222
221
100
112
50 102
0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Source: WHO, PL
Country pledge for the Global Fund 2020-22 Pooled Procurement Mechanism(PPM) program
% of total US $ m % of budget
Donors Type Country US$ (m)
pledge
Anti-retroviral 345 42%
Government United States 4,680 33
Long-Lasting Insecticidal nets 225 27%
Government United Kingdom 1,716 12
Antimalarial medicines 81 10%
Government France 1,429 10
Rapid diagnostic tests 69 8%
Government Germany 1,103 8
Diagnostic 39 5%
Government Japan 840 6
Indoor Residual Sprays 20 2%
Private Bill & Melinda Gates 760 5
Other essential medicine 16 2%
Government Canada 699 5
Laboratory & Medical supplies 13 2%
Government European Commission 607 4
Condoms 12 1%
Government Sweden 290 2
Annual spend by PPM 821
Government Norway 224 2
Others 1,681 12 Source: Global Fund, PL
Total 14,029
HIV-AIDS Malaria TB
4500
4000
3500 571 601
815
3000
462 448
2500 1384 1317
1149
410 950
2000 953
585
1500
1000 1915 1876 1938
1474 1520 1664
500
0
2014 2015 2016 2017 2018 2019
Mefloquine
Primaquine phosphate
3.5
3.0
3.1
2.5 2.7
2.6
2.0 2.3
1.5
1.0 1.3
1.0
0.5
0.0
2016 2017 2018
Number of Testing Kit and Insecticide-treated bed ACT Courses delivered (m)
nets delivered for Malaria (m) 250
300 ITNs Rapid Diagnostic Kit distributed
200
250
150
200
100 198 206 214
150
259 153
245
221 224 50
100 200 197
178 170
50 0
2015 2016 2017 2018
0
2015 2016 2017 2018 Source: Global Malaria Report, PL
Source: Global Malaria Report, PL
Curative treatment of HIV may cut short Indian ARV biz in 2-3 years
Globally, India supplies well over 80% in volume of all the HIV drugs
With Gilead Science and other innovators targeting for complete cure of HIV,
there is a possibility of achieving curative treatment that could replace ARV
drugs in coming years. This may result in significant reduction of ARV tender
business of Indian generic majors. The implication of this could be 1) One-
time treatment may reduce the number of patients globally, 2) advance
treatment can reduce the number of dose, thereby reducing volume, 3) First-
Line of treatment to be shifted away from emerging business of TLD
combinations, may impact Aurobindo and Mylan, 4) PreP (pre-exposure
prophylaxis drug (Truvada and Descovy) is the new global trend to prevent
HIV cases, with GSK’s long-acting injectable Cabotegravir (every two months)
also in the race 5) Increase in API price may become unviable to participate
in long-term tenders and 6) low dosage Dolutegravir (DTG) may lead to a
decline in volumes of API business. ARV drugs are mainly procured by
Institutional clients through long-term tender route where leading Indian
players are Cipla, Aurobindo, Strides, Laurus and Hetero (not listed).
DTG (Dolutegravir) combinations is the new trend for HIV treatment: In 2019,
many low and middle-income countries along with WHO reported to be transitioning
to DTG-based TLD combinations for HIV treatment regimens due to fewer side
effects and lower dose per day than alternative drugs like earlier used TLE
(including other NNRTIs/PIs/INSTIs) and other triple combinations such as
Efavirenz (EFV), Ritonavir-boosted Darunavir and non-inferior to Raltegravir. The
agreements between the MPP and ViiV Healthcare were originally negotiated in
2014 to enable 94% of adults and 99% of children living with HIV in the developing
world to access generic versions of DTG in an accelerated timeframe. Currently, 18
generic manufacturers (17 sublicenses) are authorized to produce DTG and sell in
121 countries. These licensing agreements have also allowed generic
manufacturers to include dolutegravir in a newly developed fixed-dose combination,
tenofovir disoproxil fumarate/ lamivudine/dolutegravir (TLD), which combines the
WHO-preferred treatment regimen into a single pill.
Gilead and GSK (Viiv Healthcare) aims at complete cure regime: Both are
leading innovators and specialist in HIV treatment and preventive drugs. Gilead’s
earlier approach had been focus on Prep drug like Truvada and Descovy but now
they working towards complete cure with 4 products in pipeline. ViiV Healthcare is
a pharmaceutical company specializing in the development of therapies for HIV
infection that was created as a joint venture by Pfizer and GlaxoSmithKline in
November 2009. ViiV Healthcare's products have a market share ~19% of the
global HIV market, which makes it the second largest healthcare company,
following after Gilead Sciences. It has 16 products for HIV treatment and few under
development which could complete cure HIV.
Gilead and GSK (Viiv Healthcare) Product Pipeline for HIV Treatment
Company Product Notes Clinical Stage
first-in-class bNAb for targeted elimination of HIV-infected cells with every two weeks
Gilead Elipovimab (GS-9722) Phase 1
dosing
Is a Potent Inhibitor of Acute HIV-1 Infection in Human Peripheral Blood
Gilead Vesatolimod (GS-9620) Phase 1
Mononuclear Cells with every two week dosing
In collaboration with Hookipa Pharma filed for FDA approval to begin phase 1 clinical
Gilead GS-9723 Pre-Clinical Trial
trial
Early stage for new class with activity at multiple stages of viral lifecycle. Can help
Gilead lenacapavir (GS-6207) some people living with HIV by reducing the burden of daily pill Subcutaneous Phase 2
injection every six months.
treatment of human immunodeficiency virus type 1 (HIV-1) infection in injectable
GSK cabotegravir + rilpivirine Registration
form with once in month dosage
Administered as an injection every 2 months, the investigational drug is 69% more
GSK cabotegravir effective at preventing HIV than currently approved Truvada and Descovy pre- Phase III
exposure prophylaxis
GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be
GSK GSK3640254 Phase II
effective for HIV-1 infection with target for 90% effect in third dose.
Combined adnectin/fusion inhibitor that stops viral entry by targeting multiple sites of
GSK GSK3732394 Phase I
action; potential for self-administered once-weekly injections
An exclusive licensing agreement with the US National Institutes of Health for the
GSK GSK3810109 investigational broadly neutralising antibody (bNAb) N6LS, with potential for long- Phase I
acting HIV treatment and prevention
Source: Company, PL
2.0
1.9
1.9
1.8
1.8 1.9
1.6
2015 2016 2017 2018 2019
Source: WHO, PL
Rating: Reduce | CMP: Rs674 | TP: Rs542 Primarily revenue from ARV tender.
Key Financials – Consolidated
Y/e Mar FY20 FY21E FY22E FY23E Weak tender and latest class of treatment to be a threat.
Sales (Rs. m) 1,66,949 1,78,733 1,92,782 2,08,734
EBITDA (Rs. m) 27,689 31,475 33,853 36,654
Tender business detail: Primarily generates revenue from Africa tender business
Margin (%) 16.6 17.6 17.6 17.6
PAT (Rs. m) 15,940 18,297 19,836 24,979 for ARV drugs and launched malaria product Artemether/ Lumefantrine (AL) tabs in
EPS (Rs.) 19.8 22.7 24.6 31.0 FY19. Cipla began the fight with global pharma majors since CY01 by offering
Gr. (%) 3.1 14.8 8.4 25.9
DPS (Rs.) 2.0 2.0 - -
world's first ever recommended 3-in-1 fixed dose combination (Stavudine +
Yield (%) 0.3 0.3 - - Lamivudine + Nevirapine) to fight AIDS. Cipla has been awarded a share of the
RoE (%) 10.4 11.0 10.8 12.1
South African Government’s National ARV tender for TEE (Tenofovir, Emtricitabine
RoCE (%) 12.5 13.4 13.5 15.6
EV/Sales (x) 3.3 3.0 2.8 2.5 and Efavirenz) and TLD (Tenofovir (TDF), Lamivudine (3TC) and Dolutegravir
EV/EBITDA (x) 19.9 17.2 15.7 14.2 (DTG). The contract is effective from July 2019 and is valid for three years.
PE (x) 34.1 29.7 27.4 21.8
P/BV (x) 3.4 3.1 2.8 2.5
Revenue Mix (%) : SAGA (Ex-Private market)
Other
90%
Source: Company, PL
Business Risk: Cipla made ARV drugs available at less than $1 per day ($365 per
year) compared to over $12,000/patient per year prevailing in most countries
throughout the world in 2001 but increased generic competition has now driven the
price of new triple therapy in poor countries to below $100 a year. With new class
of drugs in Gilead's and GSK product pipeline, AIDS/HIV treatment could achieve
complete cure in years to come which could lower its volume permanently.
350
300
250
334
200
253
226
150
100
FY18 FY19 FY20
Source: Company, PL
Rating: Accumulate | CMP: Rs824 | TP: Rs838 Supplier of latest ARV DTG combinations drugs
Key Financials – Consolidated
Y/e Mar FY20 FY21E FY22E FY23E Lower risk as compared to peers
Sales (Rs. m) 2,27,380 2,56,300 2,79,199 3,04,375
EBITDA (Rs. m) 36,540 53,182 60,447 65,897 Tender Business details: Supplies ARV to Global funds and other country specific
Margin (%) 16.1 20.8 21.7 21.7
bodies through tender. ARBP has long list of ARV products in the offering but
PAT (Rs. m) 19,216 33,561 37,760 41,033
EPS (Rs.) 32.8 57.3 64.4 70.0 growth in the near-term has been driven by early entrant in DTG (Dolutegravir) led
Gr. (%) (25.6) 74.6 12.5 8.7 triple combination drug, TLD, after In-licensing agreement Viiv healthcare. This
DPS (Rs.) 3.0 3.0 3.0 3.0
Yield (%) 0.4 0.4 0.4 0.4
licensing agreement allows manufacturers to include DTG in more efficient fixed
RoE (%) 12.5 18.3 17.5 16.2 dose triple combination, tenofovir disoproxil fumarate/ lamivudine/dolutegravir
RoCE (%) 12.5 17.7 17.7 17.4
(TLD) which replaces earlier WHO-preferred treatment regimen.
EV/Sales (x) 2.2 2.0 1.8 1.5
EV/EBITDA (x) 13.9 9.5 8.1 7.2
PE (x) 25.1 14.4 12.8 11.8 Revenue Mix (%): Aurobindo less exposed to tender business
P/BV (x) 2.9 2.4 2.1 1.8
ARV
5%
Other
95%
Source: Company, PL
Business Risk: Few government agencies continued with older version of ARV
(TLE) due to price difference and Viiv healthcare had out licensed DTG to 17
generics. New risk will be rated to COVID, as new case detection for AIDS/HIV
patients would be lower as shifting of manpower to COVID.This would lead new
tender’s volumes to be lower with significant price erosion. We estimate growth of
8% for FY21E because of new tender win from Africa, while post FY22E growth will
be highly unlikely. However, ARBP has the least risk in tendering business
compared to others because of low exposure and backward integration of API’s.
13.0
12.0
11.0
10.0
9.0
8.0 12.0 12.5
11.8
7.0 9.6 9.7
6.0 8.4
5.0
4.0
FY15 FY16 FY17 FY18 FY19 FY20
Source: Company, PL
Africa Institution
14%
Other
86%
Source: Company, PL
Business Risk: Large share of revenues comes from AL dispersible tablets while
WHO has also listed other products like AL-non dispersible, Artesunate-
Amodiaquine, Artesunate + Sulfadoxine-Pyrimethamine and Artesunate injection
which have seen decent share increase for Malaria treatment in recent time. Earlier,
Ajanta has benefited due to limited competition and IPCA’s absence but in last few
years but now many players have entered in this segment.
Rev trend Africa Inst (Rs bn): CAGR decline of 18% over FY17-20
5.0
4.0
3.0
4.4
2.0 3.8
2.4
1.0 2.0
-
FY17 FY18 FY19 FY20
Source: Company, PL
Rating: BUY | CMP: Rs1,790 | TP: Rs1,839 Re-qualified for the Global Fund tender in FY18
Key Financials – Standalone
Y/e Mar FY20 FY21E FY22E FY23E Near-term growth due to injectable supply
Sales (Rs. m) 46,487 51,261 58,416 66,669
EBITDA (Rs. m) 9,067 10,534 12,705 14,500
Tender Business Model: Global leader in anti-malaria drugs especially in
Margin (%) 19.5 20.5 21.7 21.7
PAT (Rs. m) 6,036 7,287 9,005 11,968 supplying AL (Non-dispersible) medicines for The Global Fund procurement
EPS (Rs.) 47.8 57.7 71.3 94.7 scheme and private sector co-payment mechanism. Also supplies AL dispersible
Gr. (%) 37.3 20.7 23.6 32.9
DPS (Rs.) 8.0 1.0 1.0 1.0 and injectable. Global Fund had stopped buying its anti-malarial drugs from IPCA
Yield (%) 0.4 0.1 0.1 0.1 in FY17 due to regulatory issue and in FY18 IPCA was re-qualified. Currently, Anti-
RoE (%) 18.2 18.6 18.7 20.4
Malaria tender contributes 5%to total revenue.
RoCE (%) 18.8 19.2 20.2 22.7
EV/Sales (x) 4.9 4.3 3.7 3.2
EV/EBITDA (x) 24.9 21.1 17.2 14.9 Revenue Mix (%): Anti-Malaria Tender Arm
PE (x) 37.5 31.0 25.1 18.9
P/BV (x) 6.5 5.2 4.3 3.5
Anti-Malaria
Tender
5%
Other
95%
Source: Company, PL
Business Risk: Fund allocation towards malaria control and elimination have been
on a declining trend estimated at US$2.7bn in CY18, compared to US$3.2bn in
CY17 while funds allocation towards R&D, preventive and diagnostic services have
increased. With guidance of US$35mn for FY21E v/s US$26mn FY20, the guidance
could be unmet for FY21E and FY22E could be bleak as Global Fund and other
Institution’s would focus to procure COVID related drugs.
2.0
1.5
1.0
1.7 1.8
1.6
1.3
0.5
-
FY17 FY18 FY19 FY20
Source: Company, PL
Rating: Not Rated | CMP: Rs427 Supplier of Anti-Malaria, ARV, Hepatitis in global tenders
Key Financials – Consolidated
Y/e Mar FY17 FY18 FY19 FY20 Late entrant in institutional business
Sales (Rs. m) 27,554 28,451 30,117 27,520
EBITDA (Rs. m) 5,999 4,422 4,662 5,300
Tender business model: It manufactures anti-retroviral, anti-malarial, anti-
Margin (%) 21.8 15.5 15.5 19.3
PAT (Rs. m) 3,997 6,645 3,246 306 tuberculosis and Hepatitis. The contribution of the institutional arm is 10% to total
EPS (Rs.) 44.7 74.3 36.3 3.4 revenue. It has In-licensing agreements with Gilead, ViiV Healthcare and others for
Gr. (%) 115.3 -75.4 -1.7 -16.0
DPS (Rs.) 4.0 4.5 3.0 - DTG combination drugs in developing countries. Strides is also a supplier of Anti-
Yield (%) 1.0 1.1 0.7 - Malaria drugs to The Global Fund and have a licensing agreement with Gilead
RoE (%) 14.8 25.5 12.7 1.2
Sciences for Hepatitis B & C drugs.
RoCE (%) 23.4 45.7 29.3 12.0
EV/Sales (x) 2.0 1.9 1.8 2.0
EV/EBITDA (x) 9.0 12.2 11.6 10.2 Revenue Mix (%): Institutional biz with various products
PE (x) 9.3 5.6 11.5 122.4
P/BV (x) 1.4 1.5 1.4 1.5
Institutional Arm
10%
Others
90%
Source: Company, PL
Business Risk: With long-term agreements for institutional business, API price
increase due to disruption from China could impact its earning and macro factors
including the outbreak of Covid-19 that could result in a reduced focus/donor pool
for ARV, Malaria and other infectious diseases. Strides is less backward integrated
when compared to other ARV players.
6.0
5.0
4.0
3.0
5.5
2.0
3.6
1.0 2.3
-
FY18 FY19 FY20
Source: Company, PL
Rating: Not Rated | CMP: Rs651 New class of drugs to lead volume decline for API biz
Key Financials – Consolidated
Y/e Mar FY17 FY18 FY19 FY20 Foray in US formulation
Sales (Rs. m) 18,654 19,971 22,401 27,586
EBITDA (Rs. m) 4,076 4,133 3,560 5,645
Tender Business Model: Laurus is one of the world’s leading suppliers of API’s
Margin (%) 21.9 20.7 15.9 20.5
PAT (Rs. m) 1,903 1,676 938 2,553 and intermediates of ARV products. It continues to participate in ARV tender for low
EPS (Rs.) 20.8 15.8 8.8 23.9 and middle-income countries. The combined contribution to revenue is highest
Gr. (%) -2.8 -23.8 -44.2 171.0
DPS (Rs.) 1.5 1.5 1.5 1.5 amongst Indian companies with 69%(40% ARV API and 29% FDF). Its generic
Yield (%) 0.2 0.2 0.2 0.2 formulation (FDF) mainly comprises of ARV products. There are 15 ANDAs filed in
RoE (%) 17.7 11.9 6.2 15.3
US for ARV products and has large capacity of products for first line of treatments
RoCE (%) 20.5 14.7 9.1 17.5
EV/Sales (x) 4.2 3.9 3.5 2.9 – Lamivudine & Dolutegravir along with Lopinavir / Ritonavir / Darunavir.
EV/EBITDA (x) 19.3 19.1 22.1 14.0
PE (x) 30.1 39.5 70.9 26.2
Revenue Mix (%): Highest Exposure to ARV related products
P/BV (x) 5.0 4.5 4.3 3.8
Others
31%
Source: Company, PL
Business Risk: ARV sales declined by 28% in FY20 primarily from lack of clarity
on the awards of supplementary tender in South Africa, where key customers are
not building up inventory. Nevertheless, the introduction of low dosage DTG will
lead to a decline in volumes of existing API business. Its growth in FY20 was on
account of foray and new approvals for ARV formulations in US. However, the
current growth would not be sustainable once new class of drugs get approval.
Source: Company, PL
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