Professional Documents
Culture Documents
(%)
45%
39%
Key points
Well-entrenched Indian companies like Divi’s and Syngene are poised to
40%
35%
30% 28%
25% 20%
22% 22%
21%
benefit from increasing pharma outsourcing trends.
20%
15%
13% 13%
11%
Near-term buoyancy aside, our optimism on the Indian API industry rests on
10% 7%
structural tailwinds.
We initiate coverage of Divi’s Labs, Syngene and Solara with a bullish view.
5%
0%
FY20-23E FY20-23E FY23E Avg FY23E Avg FY23E
sales CAGR EBITDA EBITDA ROE (%) ROCE (%)
(%) CAGR (%) margin (%)
Surabhi Bomb +91 22 6720 4039 Divi’s: Leading global company in both CRAMS and API segments. Initiate with
surabhi.bomb@macquarie.com Outperform, TP of Rs3,764. [LINK]
Macquarie Capital Limited Syngene: A pure-play CRAMS company, Syngene is an attractive India
David Ng, CFA +852 3922 1291 innovation play. Initiate with Outperform, TP of Rs708. [LINK]
david.ng@macquarie.com
Solara: Among the top-3 pure-play API suppliers in India, steadfast focus is its
key success mantra. Initiate with Outperform, TP of Rs1,680. [LINK]
Please refer to page 77 for important disclosures and analyst certification, or on our website
www.macquarie.com/research/disclosures.
Focus Charts
Fig 1 Coverage summary – Divi’s, Syngene and Solara are major Indian companies in the CRO/CDMO/API space
CRO: Contract Research Organisation, CDMO: Contract Development and Manufacturing Organisation
Fig 2 Indian and Chinese CRAMS/API companies report significantly better margins than US players
50% 46%
Lonza
TigerMed
Neuland
Charles River
Boji Medical
PRA Health
Wuxi Apptec
Divi's Labs
Syneos Health
Lab Corp
IQVIA
Laurus
Syngene
Dishman
Wuxi Bio
Suven Pharma
Catalent
PPD
Quest
Solara
Pharmaron
ICON
Samsung Bio
Fig 3 Divi’s, Syngene and Solara have superior return ratios despite disproportionately higher capex over the past 2 years
40%
35%
30%
25%
20%
15%
10%
5%
0%
Charles River
Joinn Lab
Lonza
Neuland
TigerMed
Suven Pharma
PRA Health
Laurus
Wuxi Apptec
Divi's Labs
IQVIA
Samsung Bio
Pharmaron
Lab Corp
Asymchem Lab
Catalent
Wuxi Bio
Solara
Syngene
Syneos Health
ICON
Jubilant Life
Boji Medical
Quest
Dishman
6 October 2020 2
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 4 Indian CRAMS/API companies offer an attractive blend of lower costs, quality talent, infrastructure and regulatory
readiness
Source: KPMG CII API industry report, Company data, Macquarie Research, October 2020
6 October 2020 3
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Executive Summary
Key highlights:
• Indian CRO/CDMO companies like Divi’s and Syngene are well poised to take incremental
market share in the US$150bn+ global pharma CRAMS market.
• We expect import substitution and dual sourcing to be structural growth drivers for the Indian
API industry.
• Within Indian API companies, we believe pure-play API suppliers with a long-term focus and
a strong regulatory track record, like Divi’s and Solara, are best placed.
Indian CRAMS companies are well placed to grab incremental market share
As innovator companies Pharma outsourcing continues to evolve from a largely cost arbitrage strategy for innovator
look to further diversify companies to one of enhancing R&D productivity and reducing the time to market. For big pharma
their supply chains post companies, CRAMS offer an opportunity to manage costs, have flexible operations and realise
COVID-19 and geo- efficiencies in R&D and related functions. The increasing need for R&D efficiency and
political tensions, Indian manufacturing cost controls is creating a significant need for high-quality outsourcing companies.
companies offering an Some of the key reasons cited by pharma companies for outsourcing include focus on core
attractive blend of lower competencies, companies being virtual, flexibility, life cycle management and temporary lack of
costs, quality talent, capacity. In addition, big pharma companies have been looking to realign their business models to
infrastructure and the changing landscape, which has accelerated the push towards outsourcing. In our view,
higher regulatory outsourcing is now slowly becoming a strategic function in most big pharma companies as these
readiness have an companies increasingly leverage CROs and CDMOs. Despite the highly fragmented nature of the
opportunity to garner a US$150bn+ global pharma CRO/CDMO industry, the industry has high entry barriers, remains
greater share of this highly regulated, has high switching costs, requires significant technical expertise and is a sticky
growing industry. business. Currently, Indian CRAMS companies command less than 4% share of the global
market, significantly lower than the 16%+ for Chinese CRAMS companies. As innovator
companies look to diversify their supply chains post the pandemic, Indian companies with inherent
strengths like availability of skilled resources, cheap labour, lower IP-security risk vs China,
improving infrastructure and a favourable USD/INR rate have the opportunity to garner a greater
share of the global CRAMS market.
Fig 6 Global CRO market expected to grow at a fast clip… Fig 7 …as also the global CDMO market
US$ bn US$ bn
80.0 140
3.6
70.0 6.8 120 3.0
2.3 22.3
6.2
60.0 15.6 100 1.9 20.0
5.6 17.7
5.1 13.9 1.5
50.0 80 1.2 15.4
4.6 12.8
4.2 11.9 13.0
40.0 11.1 60 10.7
10.2 102.1
30.0 91.8
40 82.2
50.3 64.9 72.5
45.6 58.3
20.0 41.0
33.0 36.5 20
30.2
10.0
0
2017 2018E 2019E 2020E 2021E 2022E
0.0
2017 2018E 2019E 2020E 2021E 2022E
Small molecular CMO/CDMO Global biologics outsourcing
Clinical Discovery Pre-clinical Cell and gene therapy CMO/CDMO
Source: EvaluatePharma, Macquarie Research, October 2020 Source: EvaluatePharma, Macquarie Research, October 2020
As penetration of global However, unlike in the generic API segment, wherein it is relatively easier for clients to switch their
pharma outsourcing vendors, in the case of CRAMS, we expect the transition to play out only over the medium to long
increases further, there term. Despite the highly fragmented nature of the global CDMO industry, the industry has high
is a lucrative entry barriers, remains highly regulated, has high switching costs, requires significant technical
opportunity for well- expertise and is a sticky business. Barriers to entry in the CRAMS space are high, and companies
entrenched players with excelling on parameters like scale, quality, consistency and technical expertise could be rewarded
a strong >25-year disproportionately. Hence, as penetration of global pharma outsourcing with overall R&D spends
execution track record, increases further, there is a lucrative opportunity for well-entrenched Indian CRAMS players with a
like Divi’s and Syngene. strong >25-year execution track record, like Divi’s and Syngene.
6 October 2020 4
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Within Indian API players, look beyond the near-term demand frenzy
Led by the rising need Notwithstanding near-term strength due to channel stocking and supply disruptions due to COVID-
of formulation 19, we believe that even in a more normalised growth scenario, the structural tailwinds for Indian
companies to diversify API companies remain strong. Led by the rising need of formulation companies to diversify their
their supply chains, supply chains, increasing regulatory oversight on API facilities, IP conflicts & competing interests,
increasing regulatory and geo-political tensions driving import substitution, we expect Indian companies to benefit.
oversight on API
facilities, IP conflicts &
Fig 8 Estimated breakdown of the global API market across key segments/regions
competing interests,
and geo-political
tensions driving import
substitution, we expect Global API market
(US$180bn)
Indian companies to
benefit.
Domestic/Captive Exports
US$105bn US$75bn
Regulated Semi-regulated
US$1.8bn US$2.2bn
Our analysis suggests As shown in the following charts, our analysis suggests that there is scope for Indian companies to
that there is scope for benefit from both import substitution, as well as higher API exports. In the base case, our analysis
Indian companies to suggests that import substitution alone could lead to a 280bps YoY jump in domestic API
benefit from both import production through FY25E (broadly doubling in five years). This could cause API imports from
substitution, as well as China into India as percentage of total API consumption to decline from 28% in FY20 to 21% in
higher API exports. FY25E. In the bull case, the shift could even be 150-200bps higher.
Fig 9 We expect import substitution alone to lead to a Fig 10 We expect China’s share of total API consumption in
280bps YoY jump in domestic API production through FY25E India to decline
Rs bn
1000 930 30% 28% 27%
26% 26% 25% 26%
900 24% 25% 24% 25%
25% 23%
800 22% 22% 21%
700 20%
600
497 15%
500
400 10%
300 223
5%
200
100 0%
0
FY12 FY20 FY25E
India's domestic API production China imports as % of total API consumption in India
Source: DGCIS, IQVIA, Macquarie Research, October 2020 Source: DGCIS, IQVIA, Macquarie Research, October 2020
6 October 2020 5
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
In our view, the theme Similarly, India’s API exports, at ~US$4bn, are significantly lower than China’s API (excluding
of diversifying the API KSMs and intermediates) exports of US$20-22bn. Even a US$2bn shift from China could result in
supply chain has just a 50% surge in India’s API exports. Over the past decade, we note that there has been a
started, and Indian API significant difference between the pace of API and formulation exports from India. While India’s
manufacturers are well API exports have been largely flat, formulation exports have reported a 10% CAGR over FY11-20.
poised to capitalise on In our view, the theme of diversifying the API supply chain has just started, and Indian API
this shift. manufacturers are well poised to capitalise on this shift. As formulation companies increasingly
look to de-risk their supply chains, we expect India’s API exports to start picking up and materially
improve over the disappointing performance on the exports front in the past decade.
Fig 11 While India’s API exports have been largely flat… Fig 12 …formulation exports have reported a 10% CAGR
over FY11-20
$bn $bn
5.0 18
4.4 15.9
4.5 4.2 16
3.9 3.9 14.4
4.0 3.6 3.6 3.6 3.6 14 12.9
3.4 3.5 12.6 12.7
3.5 11.1 11.2
12
3.0 10.1
10 8.5
2.5
8 6.7
2.0
6
1.5
1.0 4
0.5 2
0.0 0
FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20
Source: DGCIS, Macquarie Research, October 2020 Source: DGCIS, Macquarie Research, October 2020
On the flip side, our extensive channel checks and discussions with several companies suggest
that while the government’s PLI push is a step in the right direction, unless the incentives are much
more lucrative, the scheme is unlikely to result in any meaningful benefit for most listed companies.
Within Indian API companies, we believe pure-play API suppliers with a long-term focus and a
strong regulatory track record, like Divi’s and Solara, are best placed to play the theme.
6 October 2020 6
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Valuation
Key highlights:
• Well-entrenched CRO/CDMO companies like Divi’s and Syngene have higher secular growth
trends, face lower risks and have superior financial metrics vs generics and branded generics
companies in our coverage.
• Our bull case estimates imply 41%/48%/89% upside from CMP for Divi’s, Syngene and
Solara.
• Our bear case estimates imply 1%/4%/21% upside from CMP for Divi’s, Syngene and Solara.
We note that compared We note that compared to other companies in our pharma coverage, which have a mix of generics
to other companies in and branded generics presence and are more exposed to direct competition and resultant pricing
our pharma coverage, pressures, the outsourcing industry has higher secular growth trends and faces lower risks.
which have a mix of Irrespective of the outcome of R&D projects, CRAMS companies get their share of contracted
generics and branded revenues. Furthermore, while we are cognizant of the structural tailwinds for Indian API
generics presence and companies, fundamentally, CRO/CDMO companies have superior margins, return ratios and a
are more exposed to more structural demand outlook.
direct competition and
resultant pricing
Fig 13 Stark difference between expectations for CRAMS and formulation companies
pressures, the
outsourcing industry
(%)
has higher secular 45%
growth trends and faces 39%
40%
lower risks.
35%
30% 28%
25% 22% 22% 21%
20%
20%
13% 13%
15% 11%
10% 7%
5%
0%
FY20-23E sales FY20-23E EBITDA FY23E EBITDA Avg FY23E ROE Avg FY23E ROCE
CAGR (%) CAGR (%) margin (%) (%) (%)
Our in-depth global comparison of CRAMS companies suggests that Indian companies like Divi’s
and Syngene fare very well on most metrics like growth, margin profile, cash conversion and return
ratios. The only metric where Divi’s and Syngene lag their global competitors is on account of
higher client-concentration risk. Furthermore, while Divi’s and Solara do not have presence in
biologics, Syngene has the requisite capabilities but lags some of its global peers like Wuxi Bio
and Lonza in terms of biologics capacities. Despite scoring well on most parameters, Divi’s and
Syngene are trading at lower multiples vs their CRAMS peers like Wuxi Apptec, Wuxi Bio,
Asymchem Labs, Tigermed, Lonza, Pharmaron, Samsung Bio and Joinn Lab. Even compared to
some Chinese API companies, like Huahai, Nanjing, Zheijian Jiuzhou and Haisco, Divi’s and
Solara are trading at discounts.
We use the EV/EBITDA valuation methodology to value Divi’s, Syngene and Solara, as the
significant recent capex intensity (continuing till FY21E end) and the resultant high depreciation
and higher interest/lower other income for these companies will lead to unnaturally lower profit
after tax (PAT). Thus, near-term PAT might not be a true reflection of future earnings potential from
this incurred capex.
6 October 2020 7
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
With strong growth Divi’s: With strong growth visibility, aided by sectoral tailwinds, a steady margin profile (the best
visibility, aided by in the industry) and a strong regulatory track record, its premium valuations (relative to our
sectoral tailwinds, a existing pharma coverage) are justified, in our view. Given the secular nature of growth in the
steady margin profile CRAMS industry, high entry barriers, sectoral tailwinds, Divi’s moat in both the generic API and
(the best in the industry) custom synthesis segments and the resultant earnings visibility, near spotless regulatory track
and a strong regulatory record and superior financial ratios vs most generic and branded-generic companies in our
track record, its coverage, we expect Divi’s to continue to trade at a significant premium over our existing
premium valuations pharma coverage. Despite the recent run-up in the stock price (up 65% in the last 6 months), at
(relative to our existing our TP, the stock implies a revenue CAGR of 13% and EBITDA CAGR of 16% over FY20-30E,
pharma coverage) are which are achievable, in our view. We assign a 28x September 2022 EV/EBITDA multiple to
justified, in our view. Divi’s, which is still a significant discount to most of its global competitors mentioned earlier, and
incorporate factors like high concentration risk, the lack of a presence in biologics and the
ongoing insider-trading case (allegations of unlawful gains, including interest, of Rs9.7m)
against the CFO. Accordingly, we assign a TP of Rs3,764 for Divi’s and initiate coverage with
an Outperform rating on the stock. On our FY25 estimates (once the benefit of the recent
expansion has accrued entirely), the stock is trading at 15x EV/EBITDA.
Fig 14 In our bull case scenario, Divi’s fair value could be as high as Rs4,292
2000
growth in CDMO and
Lower EV/EBITDA
Higher EV/EBITDA
30-40bps higher
EBITDA margin
500bps lower sales
400-500bps higher
multiple at 25x
multiple at 30x
Nutraceuticals
in nutraceuticals
and generic API
generic API
growth in
margin
A pure-play CRAMS Syngene: A pure-play CRAMS company, Syngene is an attractive India innovation play.
company, Syngene is an Syngene has the highest CFO/EBITDA ratio in the CRAMS industry globally. Additionally,
attractive India given with its strong balance sheet, we note that underlying business fundamentals for
innovation play. Syngene remain robust. Syngene also ranks highly on the corporate governance and
regulatory compliance fronts. Our target price for Syngene implies a revenue CAGR of 13%
and an EBITDA CAGR of 16% over FY20-30E. We assign Syngene a 27x September 2022
EV/EBITDA multiple, which is still a significant discount to most global competitors
mentioned earlier, and incorporate factors like high concentration risk, the delay in
inspection and subsequent ramp-up of the Mangaluru facility. Accordingly, we assign a
target price of Rs708 for Syngene and initiate coverage with an Outperform rating on the
stock. On our FY25 estimates (once the benefit of the recent expansion has accrued
entirely), the stock is trading at 12x EV/EBITDA.
6 October 2020 8
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 15 In our bull case scenario, Syngene’s fair value could be as high as Rs831
74
800 14 20
15 831
75 708
600
10 21
584 19
400
Higher EV/EBITDA
300bps higher sales
200bps lower sales
multiple at 30x
in dedicated &
discovery
discovery
margin
margin
Source: Company data, Macquarie Research, October 2020
With strong API growth Solara: Despite scoring well on most parameters, at 8.8x FY23E EV/EBITDA, Solara is
visibility, increasing among the cheapest API stocks globally. Notwithstanding the growth tailwinds, Solara is
importance of pure-play trading at a substantial discount to Chinese competitors like Huahai, Nanjing, Zheijian
API suppliers, rising Jiuzhou and Haisco. With strong API growth visibility, increasing importance of pure-play
CRAMS contribution, an API suppliers, rising CRAMS contribution, an improving margin profile and strong
improving margin regulatory track record, we expect the stock to re-rate even further (stock up 195% in the
profile and strong last one year). Our target price for Solara implies a top-line CAGR of 12.5% over FY20 and
regulatory track record, EBITDA CAGR of 16% over FY20-30E. We assign Solara a 13x September 2022
we expect the stock to EV/EBITDA multiple (40% discount to Divi’s implied generic API multiple), which is still a
re-rate even further. significant discount to most global and Indian API peers, and incorporate risks like high
client and portfolio concentration. Accordingly, we assign a target price of Rs1,680 for
Solara and initiate coverage with an Outperform rating on the stock. On our FY25 estimates
(once Vizag comfortably reaches optimal utilisation), the stock is trading at just 5x
EV/EBITDA.
Fig 16 In our bull case scenario, Solara’s fair value could be as high as Rs2,064
1,200
1,000
800
Bear case 250-350bps 50bps Lower Base case 450bps 50bps Higher Bull case
(Rs) lower sales lower EV/EBITDA (Rs) higher higher EV/EBITDA (Rs)
growth EBITDA multiple at sales EBITDA multiple at
margin 11x growth margin 15x
6 October 2020 9
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
6 October 2020
Macquarie Research
Fig 17 Global valuation comparison table
Source: Source: Bloomberg, Macquarie Research, October 2020; Note: The table is based on prices as of 1st October, 2020
Divi’s and Syngene are trading at 29x and 34x FY23E PER, respectively, much lower than peers
like Wuxi Biologics, Wuxi Apptec and Pharmaron (trading at 50-80x), despite having a superior
ROE profile. Furthermore, despite having a better earnings growth profile over the next two years,
both companies are trading on par with Lonza and Catalent. Similarly, when looked at from the
perspective of EBITDA margins and EBITDA growth expectations (over the next two years), Divi’s
and Syngene are trading at discounts to Samsung Biologics (78x FY23E EV/EBITDA) and Wuxi
Apptec (30x FY23E EV/EBITDA). Thus, despite the seemingly higher valuation, we believe there is
surely scope for further re-rating of Divi’s and Syngene.
Fig 18 RoE and EPS CAGR vs PER for CRO/CDMO Fig 19 EBITDA margin and EBITDA CAGR vs EV/EBITDA for
companies CRO/CDMO companies
40% TigerMed
35% Divi's Wuxi Bio
25%
Joinn DishmanLonza Samsung Bio
Asymchem 25% Asymchem
20%
Icon
Syngene Wuxi App
PRA Divi's Charles
Charles Jubi Jubi
15%
Wuxi App Pharmaron 20% Catalent
Lonza Wuxi Bio IQVIA IQVIA
10% Catalent
Lab Corp
5% Syneos Samsung Bio 15% PPD ICON PRA
Dishman
IQVIA Lab Corp
0% PPD 10% Syneos
-5% 0% 5% 10% 15% 20% 25% 30% 35% 40%
0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
Next 2 year EPS CAGR Next 2 yr EBITDA CAGR
Source: Bloomberg, Macquarie Research, October 2020 Source: Bloomberg, Macquarie Research, October 2020
Compared with most global API companies, Solara is trading at a significant discount, both in
terms of PER and EV/EBITDA (as represented by the size of the bubbles), despite having higher
earnings growth expectations and similar EBITDA margins.
Fig 20 RoE and EPS CAGR vs PER for API companies Fig 21 EBITDA margin and EBITDA CAGR vs EV/EBITDA
for API companies
Source: Bloomberg, Macquarie Research, October 2020 Source: Bloomberg, Macquarie Research, October 2020
6 October 2020 11
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 22 Divi’s one-year forward PER chart Fig 23 Divi’s one-year forward EV/EBITDA chart
45.0 35.0
40.0 39.9 30.0
28.6
35.0
25.0
30.0
25.0 20.0
20.0 15.0
15.0
10.0
10.0
5.0 5.0
- -
Sep-13
Sep-14
Sep-15
Sep-16
Sep-17
Sep-18
Sep-19
Sep-20
Sep-14
Sep-18
Sep-13
Sep-15
Sep-16
Sep-17
Sep-19
Sep-20
PER Average +1std -1std EV/EBITDA Average +1std -1std
Source: Bloomberg, Macquarie Research, October 2020 Source: Bloomberg, Macquarie Research, October 2020
Fig 24 Syngene’s one-year forward PER chart Fig 25 Syngene’s one-year forward EV/EBITDA chart
60.0 37.0
36.1
50.0 32.0
40.0 27.0
30.0 22.0
20.0 17.0
10.0 12.0
Mar-18
Feb-16
May-17
Jan-19
Jun-19
Nov-19
Dec-16
Apr-20
Oct-17
Jul-16
Sep-15
Sep-20
Aug-18
Feb-16
Mar-18
May-17
Jan-19
Jun-19
Apr-20
Jul-16
Oct-17
Dec-16
Nov-19
Sep-20
Sep-15
Aug-18
Source: Bloomberg, Macquarie Research, October 2020 Source: Bloomberg, Macquarie Research, October 2020
Fig 26 Solara’s one-year forward PER chart Fig 27 Solara’s one-year forward EV/EBITDA chart
25.0 9.0
8.0 7.9
20.0 19.6 7.0
15.0 6.0
5.0
10.0 4.0
3.0
5.0
2.0
- 1.0
Mar-19
Mar-20
Jan-20
Jan-19
May-19
May-20
Sep-18
Sep-19
Sep-20
Nov-18
Jul-19
Nov-19
Jul-20
Mar-19
Mar-20
Jan-19
Jan-20
May-19
May-20
Sep-18
Sep-19
Sep-20
Nov-18
Nov-19
Jul-19
Jul-20
Source: Bloomberg, Macquarie Research, October 2020 Source: Bloomberg, Macquarie Research, October 2020
6 October 2020 12
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
6 October 2020 13
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
6 October 2020 14
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
6 October 2020 15
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Our in-depth global comparison of CRAMS companies suggests that Indian companies like Divi’s
and Syngene fare very well on most parameters like growth, margin profile, cash conversion and
return ratios. The only metric on which Divi’s and Syngene lag their global competitors is on
account of higher client-concentration risk.
Chinese and Indian CRAMS companies are outperforming global biggies on a lower base…
Globally, most CRAMS companies have more than one other-revenue stream, including APIs,
diagnostic services, nutrition and specialty ingredients. For instance, LabCorp’s (operates
Covance, the largest global CRO) latest annual turnover was US$11.5bn. Of this, ~40% was
attributable to CRO operations and the remaining 60% to the diagnostics segment. Lonza is the
largest global CDMO player (based in Switzerland), with a combined annual turnover of US$6.5bn.
Wuxi Apptec is the largest player in China. In India, Piramal Enterprises (pharma segment) and
Divi’s Labs are the largest players, with overall annual revenue of ~US$0.7bn each in FY20.
Piramal’s and Divi’s FY20 CDMO sales stood at US$440m and US$310m, respectively. On a
lower base, we note that Indian and Chinese companies have seen higher revenue growth over
the last three years compared to the larger US and European companies.
6 October 2020 16
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 32 Revenue of Chinese and Indian companies has grown at a 25% CAGR (average) versus 15% (average) for US
companies over the last three years
14 60%
12 50%
10 40%
8
30%
6
4 20%
2 10%
0 0%
Neuland
TigerMed
PRA Health
Joinn Lab
Piramal (Pharma)
Jubilant Life
Wuxi Apptec
Charles River
Lonza
Divi's Labs
Laurus
Lab Corp
Boji Medical
Asymchem
Genscript
IQVIA
Catalent
Dishman
Quest
Wuxi Bio
Syngene
ICON
PPD
Pharmaron
Solara
Syneos Health
Samsung Bio
CY19/FY20/TTM revenues (US$ bn) (LHS) 3 year revenue CAGR (%) (RHS)
Fig 33 Indian and Chinese CRAMS/API companies report significantly better margins than US players
50% 46%
Lonza
TigerMed
Neuland
Charles River
Boji Medical
PRA Health
Wuxi Apptec
Divi's Labs
Syneos Health
Lab Corp
IQVIA
Laurus
Syngene
Dishman
Wuxi Bio
Suven Pharma
Catalent
PPD
Quest
Solara
Pharmaron
ICON
Samsung Bio
6 October 2020 17
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 34 Indian CRAMS/API companies offer an attractive blend of lower costs, talent, infrastructure and regulatory readiness
Indian and US CRAMS fare well in terms of efficiency with higher fixed asset turnover ratios
Indian and US US CROs such as Syneos Health, PRA Health, PPD and Quest Diagnostics have a high fixed
CRO/CDMO companies asset turnover ratio. Including goodwill, the asset turnover is in the 0.8-1.2x range for these
have a better fixed asset companies. As can be seen from the chart below, Indian and US CRO/CDMO companies have a
turnover ratio compared better fixed asset turnover ratio compared to their Chinese counterparts. For example, companies
to their Chinese like Neuland Labs, Suven Pharma and Jubilant Life (though not exactly comparable, given its
counterparts. extremely diversified offering) have healthy fixed asset turnover ratios of more than 1.8x.
Syngene’s relatively low asset turnover in FY20 can be attributed to the high capex incurred by the
company in the recent past. Even for Divi’s and Solara, we expect the asset turnover to improve as
utilisation in new facilities improves over the next two to three years.
Fig 35 Indian and US CRAMS fare well in terms of efficiency with higher fixed asset turnover ratios
4.0 3.5
3.5 3.1
3.0 2.6
2.4
2.5 2.1 2.1
1.8
1.6 1.8 1.8
2.0
1.4 1.4 1.5 1.5 1.6 1.6
1.5 1.2
0.9 1.0 1.0 1.0 1.0 1.1
1.0 0.6 0.6 0.6 0.6 0.7
0.5
-
IQVIA
Catalent
ICON
Syneos Health
Samsung Bio
Syngene
Jubilant Life
Wuxi Bio
Solara
Quest
PPD
Boji Medical
Joinn Lab
Pharmaron
Suven Pharma
Lonza
Charles River
TigerMed
Neuland
PRA Health
Wuxi Apptec
Divi's Labs
Laurus
Lab Corp
Genscript
Dishman
Suven Life
Asymchem
Cash conversion metrics of Syngene, Solara and Divi’s are among the best globally
Most Indian Most Indian CROs/CDMOs rank much higher than their global peers in terms of cash conversion
CROs/CDMOs rank due to favourable working capital terms. In particular, Suven Pharma, Syngene and Solara have a
much higher than their better pre-tax CFO/EBITDA ratio compared to Chinese, Korean, US and European peers. Even
global peers in terms of though Divi’s features within the top quartile in terms of cash conversion, we note that Divi’s would
cash conversion due to have ranked even higher had it not been for its strategy of campaign production of high-volume
favourable working APIs like Naproxen, Dextromethorphan and Gabapentin, given the high degree of confidence in its
capital terms. ability to sell these APIs, which results in elevated inventory days.
6 October 2020 18
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Joinn Lab
Boji Medical
Lonza
Suven Pharma
TigerMed
Parexel
Neuland
PRA Health
Laurus
Divi's Labs
Samsung Bio
IQVIA
Lab Corp
Wuxi Apptec
Pharmaron
Genscript
Covance
Wuxi Bio
Syngene
Solara
Catalent
PPD
Syneos Health
Jubilant Life
Asymchem
Charles River
Quest
Dishman
CY19/FY20/TTM pre tax CFO/EBITDA (x)
Fig 37 Divi’s and Syngene have superior return ratios, despite significant capex over the past two years
40%
35%
30%
25%
20%
15%
10%
5%
0%
Charles River
Joinn Lab
Lonza
Neuland
TigerMed
Suven Pharma
PRA Health
Laurus
Wuxi Apptec
Divi's Labs
IQVIA
Samsung Bio
Pharmaron
Lab Corp
Asymchem Lab
Catalent
Wuxi Bio
Solara
Syngene
Syneos Health
ICON
Jubilant Life
Boji Medical
Quest
Dishman
Only limitation for Divi’s and Syngene vs global peers is their high client concentration
Our analysis shows that Our analysis shows that Divi’s and Syngene fare worse than their global peers only in terms of
Divi’s and Syngene fare client concentration. As shown in the following figure, in terms of revenue contribution from the top-
worse than their global 5 clients, Chinese companies like Wuxi Apptec and Pharmaron have the lowest concentration risk.
peers only in terms of On the other hand, Indian companies like Divi’s Labs, Syngene and Solara have relatively higher
client concentration. client concentration, with their top-5 clients contributing over 30% of their total sales. However,
Solara’s largest client is a group company, Strides Pharma, which contributes 21% of its overall
sales. Adjusted for Strides, Solara’s top 5 clients contribute less than 20% of its sales.
6 October 2020 19
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 38 Divi’s, Syngene and Solara have relatively higher client concentration
Note: Adjusted for its group company, Strides Pharma, Solara’s top 5 clients contribute less than 20% of sales
Source: Company data, Macquarie Research, October 2020
6 October 2020 20
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
• Globally, growth of the CRAMS industry has been outpacing that of the pharma industry.
• Indian CRAMS companies offer advantages like availability of skilled resources, cheap
labour, lower IP-security risk vs China and improving infrastructure.
We note that The global pharma industry uses outsourcing services from CRAMS providers. CRAMS
outsourcing has been companies, given their ability to adopt and integrate advanced technologies and their teams of
gradually evolving from highly qualified scientists, can accelerate the development of a compound. This eliminates the
being largely a cost client companies’ need to maintain its own R&D space, equipment and manpower. We note that
arbitrage strategy for outsourcing has been gradually evolving from being largely a cost arbitrage strategy for big
big pharma companies pharma companies to one of enhancing R&D productivity and reducing time to market. In our view,
to one of enhancing outsourcing is now slowly becoming a strategic function in most big pharma companies as these
R&D productivity and companies increasingly leverage CROs (contract research organisations) and CDMOs (contract
reducing time to market. development and manufacturing organisations). Consequently, CRAMS companies have become
partners of choice for companies of all sizes, from global giants to smaller enterprises. We note
that compared to other companies in our pharma coverage, which have a mix of generics and
branded generics presence and are more exposed to direct competition and resultant pricing
pressures, the outsourcing industry has more secular growth trends and faces lower risks.
Irrespective of the outcome of R&D projects, CRAMS companies get their share of contracted
revenue.
As highlighted by our China Healthcare team in their report, the global pharma outsourcing
industry is divided into two broad categories:
6 October 2020 21
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 39 The roles of CROs and CDMOs in different stages of drug development
• Discovery (target identification, target validation, lead generation, lead optimisation and
lead selection)
• Development (pre-clinical testing, clinical testing and regulatory filings with the FDA and
other relevant regulators)
• Manufacturing (process development and early stage manufacturing)
• Commercialisation (manufacturing and post-marketing follow-up studies on impact and
side effects).
Discovery (target identification, target validation, lead generation, lead optimisation and
lead selection)
In the discovery stage, The processes of target identification, target validation, lead generation and lead optimisation are
the aim is to narrow covered under drug discovery. In the discovery stage, the aim is to narrow down from thousands of
down from thousands of compounds to a few hundred promising possibilities for further R&D. Generally, scientists begin
compounds to a few with basic research on the physiological target and develop hypothetical mechanisms of action that
hundred promising could potentially bring about the desired outcome. Following the basic research, scientists scout
possibilities for further for a lead compound. A lead compound is a promising molecule that could influence the target in
R&D. line with the projected hypotheses and potentially become a medicine. The search for a lead
compound can be conducted in various ways, including through the creation of a molecule using
high-throughput screening techniques, to select a few promising possibilities from among
thousands of potential candidates, finding compounds from nature and using biotech to genetically
engineer living systems to produce disease-fighting molecules.
6 October 2020 22
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
The key steps in the new molecular entity (NME) discovery process are:
• Target validation: Target validation involves intensive in vitro, as well as in vivo studies that
provide information on the effects of the pharmacological intervention. These efforts help build
adequate knowledge so that physiologically relevant model systems can be developed into
assays for downstream screening.
• Lead generation: The aim of lead generation is to refine each hit series to try and produce
more potent and selective compounds that possess properties adequate to examine their
efficacy in any in-vivo models that are available.
• Lead optimisation and selection: Lead optimisation and selection seek to identify and
synthesize lead compounds, new analogs with improved potency, reduced off-target activities,
and physiochemical/metabolic properties suggestive of reasonable in-vivo pharmacokinetics
through the chemical modification of the hit structure. Modifications are chosen by employing
knowledge of the structure activity relationship (SAR), as well as structure-based design, if
structural information about the target is available.
Development (pre-clinical testing, clinical testing and regulatory filings with the FDA and
other relevant regulators)
After the NME discovery stage narrows down from thousands of compounds to a few hundred
promising candidates, these molecules enter the development stage. The key steps in the
development process are:
The pre-clinical stage • Pre-clinical testing: The pre-clinical stage involves exhaustive laboratory and animal
involves exhaustive experimentation of the pre-clinical drug candidates for safety and therapeutic effect to determine
laboratory and animal whether a compound is suitable for human testing. The focus during this stage is largely on
experimentation of the generating data around safety and preliminary efficacy by testing the NMEs on relevant animal
pre-clinical drug models. This process may take several years to come up with a molecule considered suitable
candidates for safety for human testing. The data generated during this stage is a critical part of the dossier that is
and therapeutic effect to submitted to the relevant regulatory bodies to receive approval for the concerned NME to move
determine whether a to clinical trials.
compound is suitable
• Clinical trials: Drug candidates approved by the relevant regulatory body are typically referred
for human testing.
to as an investigational new drug applications (INDs). INDs proceed to clinical trials. Broadly,
clinical trials are studies on humans to determine the safety, efficacy and suitable drug dosage
of potential drug candidates. The major phases of clinical trials are:
Phase 1: Phase 1 trials test compounds on a small group (typically 20-100 healthy
volunteers) to determine the safety of the compound.
Phase 2: In Phase 2 trials, the compound is tested on a larger group (typically 100-500
volunteers) that has the disease or condition that the compound is designed to treat. Phase
2 trials determine the effectiveness of the compound, examine possible short-term side
effects and risks, and identify optimal dosage and schedules.
Phase 3: Phase 3 trials test the compound on a much larger group (typically 1,000-5,000
As an NME passes volunteers) to generate statistically significant information about safety and efficacy, and
through the clinical determine the overall benefit-risk ratio.
development process, Bio-analytical testing of clinical trial samples generated during the aforementioned studies
increasing emphasis is is carried out to quantify the safety, efficacy and associated data related to the clinical trial
placed on developing a end points. The data generated here helps in evaluating the success or failure of the trial
robust, scalable, safe with respect to its predefined objectives.
and efficient
manufacturing process • Drug substance development: Drug substance development covers early stage and late
that can be used for the stage process development and optimisation. This process starts at the candidate selection
subsequent stage, with small quantities of the drug substance being manufactured under non-GMP
commercialisation of conditions for toxicology evaluation and under GMP conditions for initial clinical studies.
the drug. Depending on the outcomes of these studies, larger quantities of the drug substance are
manufactured for late-stage clinical programs. As an NME passes through the clinical
development process, increasing emphasis is placed on developing a robust, scalable, safe and
efficient manufacturing process that can be used for the subsequent commercialisation of the
drug.
6 October 2020 23
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
• Drug product development: Drug product development covers early stage and late stage
formulation development and manufacturing. The drug substance can be formulated in a variety
of forms, depending on the preferred mode of administration. Formulations tend to be simpler
for pre-clinical and phase 1 trials. As the molecule moves further along the development cycle,
the formulation becomes increasingly nuanced, in line with the data being generated through
the trials. The key formulation types are oral solid dosage forms (tablets, capsules and drug-in-
capsule), oral liquid dosage forms (solutions and suspensions), injectable dosage forms
(solutions and lyophilised) and modified release oral dosage forms (functionally coated mini-
tablets and drug layered beads, as well as matrix tablet formulations).
For big pharma companies, CRAMS offer an opportunity to manage costs, have flexible operations
and realise efficiencies in R&D and related functions. Some of the key reasons cited by pharma
companies to outsource include focus on core competencies, companies being virtual, flexibility,
life cycle management and temporary lack of capacity. In addition, big pharma companies have
been looking to realign their business models to the changing landscape, which has accelerated
the push towards outsourcing. While pharma is an innovation-driven industry that keeps
developing new treatments for rare and difficult diseases, competition from generics is intensifying.
As a result, R&D efficiency and manufacturing cost controls are needed more than ever, creating a
significant need for high-quality outsourcing companies. CRAMS partners help improve operational
agility of their clients. Utilising services of CDMOs helps big pharma companies avoid redundant
manufacturing capacity. For instance, capex incurred before drug approval could turn redundant in
case the product is unable to clear clinical trials or get regulatory approval. Similarly, reduction of
operating expenses and time to market are other key factors driving growth for CDMOs. CROs
were involved in 50% of drug development work in 2018, up from 18% in 2006. As per various
global industry experts, 70-75% of global R&D spends can potentially be outsourced. We believe
there is ample scope for structural growth of the CRAMS market, as the partnership model has not
Barriers to entry in the been fully explored yet.
CRAMS space are high,
The CRAMS industry is characterised by high entry barriers
and companies
excelling on parameters Barriers to entry in the CRAMS space are high, and companies excelling on parameters like scale,
like scale, quality, quality, consistency and technical expertise can be rewarded disproportionately. We note that
consistency and entry barriers are high, as it takes many years to build strong relationships with clients. Trust is an
technical expertise can important element in this business, and innovator companies generally prefer to focus only on
be rewarded select vendors with whom they have higher comfort around IP protection, usually vendors with a
disproportionately. We solid multi-year execution track record. Furthermore, this business can be sticky, with innovators
note that entry barriers preferring to go with a CRO/CDMO that has been involved in discovery and development when it
are high, as it takes comes to the commercialisation of the drug as well. It is important to invest time and resources in
many years to build infrastructure, talent and knowledge, which can take years to accumulate. In order to penetrate the
strong relationships global CRAMS market, companies need a robust structure to adapt to the requirements of
with clients. developed countries and offer customised solutions to sponsors. We note that until a decade ago,
the entry barriers for setting up a custom synthesis venture were low, with many PhD students
preparing samples for big pharma companies. However, with stringent regulations, greater
complexity of molecules and higher-quality requirements, clients are demanding higher-calibre
scientists, infrastructure, quality management systems and safety assessments.
6 October 2020 24
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
We list below four key factors driving R&D and manufacturing outsourcing trends:
According to research Focus on core competencies: Most pharma companies are increasingly focussing on core
by Frost & Sullivan, the competencies (marketing, sales and clinical development), suggesting greater willingness to
development duration outsource functions across development and certain discovery research functions such as
for a new drug can be lead optimisation. As new molecules become increasingly complex, big pharma companies
reduced by one-quarter prefer to gain access to these competencies externally, instead of building these in-house.
to one-third with the The same is the case with biotech start-ups, which are focusing on research and outsourcing
help of CROs. Thus, the manufacturing. In addition, there is pressure to reduce internal R&D costs and optimise
CROs aid faster processes. It is estimated that the cost per new molecular entity (NME) approval has
research at a lower cost. increased by 50% between CY14 and CY17. On the contrary, the median peak sales value
per US FDA approval has remained broadly constant at US$1bn in this period. According to
research by Frost & Sullivan, the development duration for a new drug can be reduced by
one-quarter to one-third with the help of CROs. Thus, CROs aid faster research at a lower
cost. The level of scientific and technical sophistication of CROs is also increasing, which
could lead to more functions being outsourced. CROs have been expanding their service
offerings to cater to the full spectrum of R&D and related activities.
Fig 42 Average forecast for peak sales per pipeline asset Fig 43 Faster development of new drugs with CROs
Source: IQVIA, Macquarie Research, October 2020 Source: Frost & Sullivan, Macquarie Research, October 2020
6 October 2020 25
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
To provide flexibility in costs and improve R&D efficiency: Innovator companies are
working on de-risking their R&D efforts and improving time to market while reducing their
development and manufacturing costs. The R&D model has witnessed a major shift over
Factors like the rising the past decade, with CROs emerging as strategic alternatives to in-house R&D, helping
cost of R&D, profit companies control R&D costs, manage stringent regulatory requirements, take strategic
pressure due to patent decisions based on research progress and outcomes, increase the speed to market of their
expirations and the drugs and focus on their core competencies. Factors like the rising cost of R&D, profit
need for higher pressure due to patent expirations and the need for higher flexibility have lowered the
flexibility have lowered ability of big pharma companies to incur large R&D related fixed costs. Outsourcing
the ability of big pharma increases the variable R&D cost component, thereby leading to greater flexibility to shift
companies to incur strategic and development priorities in response to market conditions. Given increasing
large R&D related fixed R&D costs and decreasing probability of success (POS), CROs can increase efficiency by
costs. curbing the time required at different stages and integrating different resources. CROs also
help bridge any temporary capacity gaps at the client’s end. According to a study by the
Tufts Center, the cost per drug developed totalled US$179m in the 1970s and increased to
US$413m in the 1980s and US$1bn in the 1990s and is set to increase to US$2.5bn after
2000. At the other end of the spectrum, the POS has been decreasing, from 21.5% in the
1980s to 17.3% in the 1990s and 15.5% in the 2000s. CROs can deliver value for innovator
companies due to scale benefits, improving their ROCEs, operating cost arbitrage and
intellectual arbitrage. Thus, this is becoming a compelling proposition for big pharma
companies, especially when budgets across the value chain are getting squeezed.
Fig 44 R&D costs are growing and POS is decreasing Fig 45 Declining R&D IRR for big pharma companies
US$ mn
Pre-clinical Clinical R&D IRR
3000 25% 12.0%
Total cost Success rate (RHS)
2558 10.1%
2500 10.0%
20%
7.6%
8.0% 7.3%
2000
15% 5.5%
6.0%
1460 4.8%
1500 4.2% 4.2%
3.7%
1044 1098 10% 4.0%
1000 1.9%
2.0%
608
413 436 5%
500 278
179 0.0%
109 70 135
2010
2011
2016
2017
2018
2012
2013
2014
2015
0 0%
70s 80s 90s 2000-now
Source: Frost & Sullivan, Macquarie Research, October 2020 Source: Deloitte, Macquarie Research, October 2020
Over 40% of innovative More companies being virtual (smaller clients and virtual pharma): The past decade
molecules are being has seen the emergence of a lot of VC-/PE-backed biotech start-ups. Over 40% of
developed by small, innovative molecules are being developed by small, emerging biotech companies without
emerging biotech later-stage manufacturing capabilities. These start-ups focus on a limited range of products
companies without and have limited resources, infrastructure and experience in drug discovery and
later-stage development. Many mid- to small-sized biotech companies rely on CROs for clinical trials
manufacturing after the early-stage development of a drug candidate. Following their capital raises (both in
capabilities. the public and private markets), these smaller clients have higher wherewithal to outsource
discovery and development services to CROs. Smaller biotech companies are relying on
CROs, as they lack in-house development and manufacturing capabilities and sometimes
even the required expertise to complete clinical development. Compared to traditional big
pharma companies, these smaller/virtual companies tend to seek a broader range of
services and are likely to pay a premium. We believe CRAMS providers will continue to
benefit from the emergence of these small, innovative companies.
6 October 2020 26
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 46 Share of the pipeline contributed by top-25 Fig 47 Total number of companies with active pipelines,
companies has been trending lower 2001-2020
%
% of total pipeline
25 6000
20 20 20 19
19 19 19 19 5000
20 18 18
15 4000
18 18
15 17
15 15 3000
13 13
10 12 12 12 2000
11 11
10 10 10
8 1000
5 7 7
5
0
2002
2005
2007
2010
2012
2015
2018
2020
2001
2003
2004
2006
2008
2009
2011
2013
2014
2016
2017
2019
-
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Source: Pharma R&D Annual Review 2020 | Informa, Macquarie Source: Pharma R&D Annual Review 2020 | Informa, Macquarie
Research, October 2020 Research, October 2020
No. of drugs
47%
40 44% 44% 50%
42% 35
35 39% 40% 45%
29 30 29 40%
30 28
32%
25 26 26 27 35%
29% 23 23 24
25 21 21 30%
24%
20 18 25%
15 13 12 20%
10 10 11
8 8 9 15%
10 7% 7
4 5 10%
5 2 3 3 3
5%
0 0%
2013 2014 2015 2016 2017 2018 2019 2020E 2021E 2022E
Large pharma
Mid-sized Pharma
Smaller pharma/biotech/virtual pharma
Proportion of Drug Approval from smaller pharma/biotech/virtual pharma (RHS)
6 October 2020 27
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
annual
Based sales of drugs
on research by High patent expiry impact on drug sales: The importance of R&D innovation and speed
about to lose
EvaluatePharma, their
annual continues to increase for big pharma companies. Several innovative drug patents have
sales ofpatent
drugs protection
about to expired since 2010, exerting added pressure to expedite new-drug development. New
averaged
lose their patentUS$40bn drugs enjoy the highest price premiums and profits in the industry. Based on research by
since averaged
protection 2011, and the EvaluatePharma, annual sales of drugs about to lose their patent protection averaged
potential
US$40bn loss
since due to
2011, US$40bn since 2011, and the potential loss due to competition from generics is ~50%. This
and thecompetition
potential lossfrom increases pressure on pharma companies to develop more innovative drugs as fast as
generics is ~50%.
due to competition from possible and use more CRO services to help them achieve that goal. Innovators can
generics is ~50%. benefit from the unbiased approach of CROs and contributions from skilled and focused
third parties to drug development.
US$ bn
80
70 67
60 56
50
41 40 39
40
32 33 31
29 28
30 26
19 21 22 21 19 21 19 21 19
16 18 17
20 14
13 12 13 12
10 10
10
0
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
We highlight that both Key factors while selecting an outsourcing partner include quality, consistency of performance,
Divi’s and Syngene confidentiality, regulatory inspection history and GMP, and financial stability. Trust is an important
have got more than 25 element in the CRO/CDMO business, and big pharma companies generally prefer to focus only on
years of experience in select vendors with whom they have higher comfort around IP protection. We highlight that both
the CRAMS business Divi’s and Syngene have got more than 25 years of experience in the CRAMS business and enjoy
and enjoy tremendous tremendous trust among clients. We note that pharma companies struggle to fully rationalise their
trust among clients. supply chains when they rely on a high number of suppliers and providers. As a result, there is a
growing demand for integrated, one-stop-shop service providers with a strong track record of
successfully working with clients.
6 October 2020 28
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 51 Results of Contract Pharma’s outsourcing survey in 2014, citing the following
criteria when selecting an outsourcing partner (on a scale of 1 to 5; 5 being most important)
Indian CRAMS Particularly CRAMS companies based in Asia and Eastern Europe provide a significant cost
companies offer an advantage to their clients. Within Asia, China, India and Korea are among the leading outsourcing
attractive blend of lower destinations for innovator companies, due to lower capex as well as operating costs (cost arbitrage
costs, quality talent, is in the range of 40-50%). As shown in Fig 4, Indian CRAMS companies offer an attractive blend
infrastructure and of lower costs, quality talent, infrastructure and higher regulatory readiness. India offers a potent
higher regulatory combination of low cost and chemistry skills, which makes it a favourable destination for pharma
readiness. outsourcing globally. CROs in India have been leveraging India’s large, low-cost scientific talent
pool to deliver services at competitive rates compared to comparable services in developed
countries. Furthermore, Indian CROs are increasingly moving beyond cost arbitrage to R&D
productivity and innovation.
Global drug discovery outsourcing market forecast : CAGR (%) by region - 2015-26
18
16
14
12
10
0
USA EUS Japan China India South Brazil Russia Mexico RoW
Korea
• Availability of skilled resources: India has a high number of highly skilled English-
speaking scientists with demonstrated expertise in areas such as drug discovery
chemistry. A high number of PhDs graduate from top institutes each year.
• Cheap labour: It is estimated that the cost of conducting clinical trials in countries like
India, China and Indonesia is 25-40% lower than in western countries.
6 October 2020 29
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Thousand $
400
353
350
300
257
250
200
150 132
88
100
50
-
India China USA In-house
Source: Syngene, Company data, Macquarie Research, October 2020
While the risk pertaining • Lower IP-security risk vs China: While the risk pertaining to IP security is higher in India
to IP security is higher than in the US and Europe, we highlight that compared to Chinese CROs/CDMOs, Indian
in India than in the US CROs/CDMOs score higher in terms of IP security.
and Europe, we • Improving infrastructure: Along with its IT expertise, India has access to a growing pool
highlight that compared of doctors and improving hospital infrastructure, with access to talent trained in global
to Chinese clinical trials.
CROs/CDMOs, Indian
In addition to the above factors, we note that the higher depreciation of the INR vs the USD (refer
CROs/CDMOs score
chart below) has made Indian CRAMS players more price competitive versus other global
higher in terms of IP
companies, including those in China.
security.
Fig 54 High INR depreciation has made Indian CRAMS companies more price competitive
110
101
100
90
80
70 64
60
50
Sep-10
Sep-11
Sep-12
Sep-13
Sep-14
Sep-15
Sep-16
Sep-17
Sep-18
Sep-19
Sep-20
Jan-11
Jan-13
Jan-15
Jan-12
Jan-14
Jan-16
Jan-17
Jan-18
Jan-19
Jan-20
May-11
May-12
May-13
May-14
May-15
May-16
May-17
May-18
May-19
May-20
INR/USD CNY/USD
6 October 2020 30
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
designs. For example, with chemical drugs, for every 5,000-10,000 lead drug candidates, only one
is finally launched.
Given these challenges, CROs help innovator companies improve their R&D efficiency. CROs also
help clients tactically manage extensions of in-house resources in times of high capacity utilisation.
Most CROs specialise, to some extent, based on their clients’ needs and markets. Contracts are
CROs also help clients awarded based on a CRO’s response to requests for proposals received from organisations across
tactically manage R&D-focussed sectors, not-for-profit groups, academic institutions, government organisations and
extensions of in-house medical-device industries. In addition, there will be work orders executed under existing long-term
resources in times of collaboration agreements. There are two major types of CRO companies, depending on the
high capacity utilisation. services they provide in different stages of the drug development process. Usually drug
Most CROs specialise, development can be divided into pre-clinical and clinical. Pre-clinical includes drug discovery and
to some extent, based pre-clinical research, and clinical includes Phase 1 (P1), Phase 2 (P2) and Phase 3 (P3) studies,
on their clients’ needs registration, and the following conformational Phase 4 (P4) study. As of CY18, clinical CROs
and markets. constituted 66% of the ~US$49bn global CRO market (excluding clinical services, which is a
US$15bn industry globally), while drug discovery and pre-clinical research contributed 20% and
14%, respectively. To further breakdown the CRO business, drug discovery includes molecule
design, drug lead screening, etc. Pre-clinical research includes the chemical and physical
characteristics studies, API synthesis pathway studies, CMC, quality and stability control, PK/PD
studies, safety and toxicity studies, animal studies, IND filings, etc. As for clinical, major services
include clinical trial design, clinical site management, patient enrolment and follow-up, site
management operations (SMO), clinical data storage and management, inspection and audit,
statistical analysis, summary report writing, registration filing, etc.
Fig 55 Roles of pre-clinical and clinical CROs in different stages of drug development
Globally, growth of the CRO industry has been outpacing that of the pharma industry by
450-500bps
According to Global As per IQVIA, global spending on medicines stood at US$1.3tn, growing at ~4% YoY globally.
Market Insights, the IQVIA expects the growth in drug spending to be primarily driven by developed markets, led by
global CRO market is their adoption of a wave of newly launched innovative products. According to the below chart,
expected to grow at a global R&D expenditure was US$139bn in 2014 and US$152bn in 2018, indicating a CAGR of
7.6% CAGR from CY19- 2.3%. In contrast, the global CRO market (excluding clinical services, which is a US$15bn industry
25. globally) reported a CAGR of 8.8% between CY14-18 to reach US$49bn. According to Global
Market Insights, the global CRO market is expected to grow at a 7.6% CAGR from CY19-25. At
Macquarie’s Asia CRO/CDMO Day in Jun-20, various CRAMS companies and industry experts
also reiterated that the global CRO market has strong growth drivers.
6 October 2020 31
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
US$ bn
155 60
152
49
150 50
US$ bn
145 40
35
140 139
30
135 20
130 10
2014 2018
0
2014 2018
Source: Frost & Sullivan, IQ4I, Syngene PPT, Macquarie Research, Source: EvaluatePharma, Macquarie Research, October 2020
October 2020
Post COVID-19, the Key global CROs include LabCorp (Covance), ICON, IQVIA, TigerMed, Syneos Health, PPD and
relevance of drug PRA Health. Among Indian companies, Syngene has the largest CRO operations. With the
discovery, development increasing complexity of drug development and the beginning of the more complicated biotech era,
and manufacturing has we believe CROs will be of even greater importance. Post COVID-19, the relevance of drug
never been higher. discovery, development and manufacturing has never been higher. There is an increased
There is an increased willingness to invest more into innovation R&D. There is a much higher realisation that
willingness to invest fundamental investment in innovation and science needs to be increased. Key indicators like R&D
more into innovation spending, biotech funding, project pipelines, increasing cost pressures for big pharma companies
R&D. and rising penetration of pharma outsourcing make us upbeat on the CRO industry.
US$ bn
80.0
70.0 6.8
6.2
60.0
5.6 15.6
5.1 13.9
50.0
4.6 12.8
4.2 11.9
40.0 3.9 11.1
3.6 10.2
3.3 9.4
30.0 3.1 8.6
7.8
7.1 50.3
45.6
20.0 41.0
33.0 36.5
28.0 30.2
21.8 23.7 25.7
10.0
0.0
2013 2014 2015 2016 2017 2018E 2019E 2020E 2021E 2022E
Clinical Discovery Pre-clinical
As per Grand View Research, within CRO, pre-clinical is expected to be the fastest-growing
As per Grand View segment, with a CAGR of 8.3% over CY18-25E. In recent years, the development of targeted
Research, within CRO, therapies has benefited from new information about the human genome and its relation to disease
pre-clinical is expected progression. A higher number of product approvals by the US FDA has also provided a boost. In
to be the fastest- this backdrop, we expect demand for CROs to stay elevated owing to their diversified expertise
growing segment, with a with respect to the development of drugs in specific therapeutic areas and their ability to undertake
CAGR of 8.3% over clinical trials in a wide array of geographies. Among therapeutic areas, oncology is the largest
CY18-25E. contributor within CRO services, and we expect it to show a strong CAGR, led by the increasing
incidence of cancer, driving demand for new-drug development.
6 October 2020 32
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
US$bn
45.0
40.0 41.2
35.0
30.0
25.0
20.0
15.0
10.0 6.8
6.6
5.0
FY18-25: CAGR: 8.3%
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Key factors influencing While pharma and biotech companies are the primary end-users of CROs, estimated to account
the choice of the CRO for 54% of revenue share in CY18, companies in the realms of medical devices, consumer
partner are the size of products, cosmetics, speciality chemicals and agrochemicals are also working with CROs for
the CRO, core product innovation. While some CROs specifically mould their offerings (like determination of
competencies, toxicology profile) to serve pharma companies largely, any industry looking for the efficient
confidentiality and IP development of new molecules is a potential client for CROs. We note that the global CRO
protection, track record, industry is still fragmented compared to other industries. CROs compete on the basis of a number
financial stability, of factors like reliability, past performance, expertise and experience in specific therapeutic areas,
certification, location, scope of service offerings, infrastructure, track record of intellectual property protection, strengths
communication and in various geographical markets, technological capabilities and pricing. Key factors influencing the
ownership structure. choice of the CRO partner are the size of the CRO, core competencies, confidentiality and IP
protection, track record, financial stability, certification, location, communication and ownership
structure. Having evolved significantly over the past few decades, IQVIA, Covance and Inventive
Health are the top three players, with a combined market share of ~20%.
6 October 2020 33
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
We note that CDMOs are acquiring or developing capabilities of both API and formulation
manufacturing. As the pharma industry has developed, the complexity of drugs and cost-control
practices have increased. Traditional CDMO companies help innovator companies improve their
synthesis techniques to increase efficiency and yield, and lower costs so that end products enjoy
competitive pricing. These trends have turned from purely CMO companies into CDMO
companies. These work with pharma/biotech companies from an early stage (sometimes as early
as pre-clinical) and communicate closely with clients. They use their expertise to ramp-up scale
and integrate different suppliers of materials and help clients with filings. They ensure uniform
quality, which in turn helps to secure final NDA approval. In turn, custom synthesis (CDMO)
operations can help pharma companies secure CMO business, which provides a stable revenue
stream for the company and enables it to benefit from the successful development of innovative
drugs. Importantly, commercial manufacturing contracts are typically long term, thereby providing
higher revenue visibility.
6 October 2020 34
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
The global CDMO The global CDMO market (excluding CROs) is estimated to be worth ~US$90bn, split across
market (excluding pharmaceutical development, drug substance development, drug product and drug substance
CROs) is estimated to commercial. Despite the slew of M&A over the past decade (refer to Fig 110), the global CDMO
be worth ~US$90bn, market is highly fragmented. Consolidation in the industry has been partly driven by the desire to
split across diversify capabilities while reducing operational costs. The top 10 players account for 30-35% of
pharmaceutical the total market. Some of the leading global CDMOs include Lonza, Catalent, Wuxi Biologics,
development, drug Samsung Biologics, Thermo Fisher Scientific, Piramal, Divi’s Labs and Asymchem Lab. Other than
substance development, Piramal and Divi’s, other Indian companies present in the CDMO market include Suven Pharma,
drug product and drug Jubilant Life, Solara, Neuland Labs and Laurus Labs. It is estimated that there are 600 active
substance commercial. CDMOs globally, serving both global and local markets. For both big pharma companies, as well
as small innovators, it is imperative to choose a CDMO with proven reliability and impeccable
quality standards. As with the global CRO market, the global CDMO market is also expected to
grow faster than the global pharma market. We expect pipeline development in next-generation
therapies, opportunities in contract manufacturing for innovator molecules and new market
entrants, as well as start-ups lacking manufacturing capabilities, to drive demand for contract
manufacturing services.
US$ bn
140
3.6
120 3.0
2.3 22.3
100 20.0
1.9
1.5 17.7
80 1.2 15.4
1.0 13.0
60 0.8 10.7
0.6 8.4
0.5 7.2 102.1
6.0 91.8
40 4.8 82.2
64.9 72.5
52.8 58.3
20 42.3 47.1
37.7
0
2013 2014 2015 2016 2017 2018E 2019E 2020E 2021E 2022E
Small molecular CMO/CDMO Global biologics outsourcing Cell and gene therapy CMO/CDMO
The expected growth rate for the global CDMO industry is 100-200bps higher than that of the
global pharma industry, thereby indicating an increased shift towards outsourcing. Some of the key
advantages of CDMOs include:
Increasing pricing pressure on big pharma companies from payers, including insurance
companies
The need for additional capacities to mitigate the risk of supply shortages
Innovators control the bulk of global biologics manufacturing capacity. Thus, there is increased
scope for shift of biologics manufacturing capacity to CDMOs.
6 October 2020 35
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
5000
4000
3000
2000
1000
0
2013 2014 2015 2016 2017 2018 2019
6 October 2020 36
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Annual
Annual R&D as
R&D
Company sales % of Recent commentary on R&D budget/outsourcing
expense
(US$ bn) sales
(US$ bn)
J&J 82.0 11.3 14% Uses CMO. R&D collaborations
Autonomous R&D centres and alliances with more than 200 external partners. Does collaboration with
research organisations.
66.8 12.7 19% Looking to collaborate more
Gazyva in collaboration with Biogen; Polivy in collaboration with Seattle Genetics; Risdiplam in
Roche collaboration with PTC Therapeutics and the SMA Foundation
R&D guidance for CY20 US$8.1-8.5bn.
Increased projected R&D expenses for FY20 by US$500M for COVID-19 research in Q1FY20.
51.8 8.0 15% Collaborated with BioNTech for COVID vaccine.
Pfizer Collaborated with Valneva to co-develop and commercialize Valneva's Lyme disease vaccine candidate.
Insulin glargine, lispro, aspart Diabetes - Collaboration with Gan & Lee natalizumab Multiple sclerosis and
47.4 9.4 20% Crohn’s disease - Collaboration Polpharma Biologics trastuzumab HER2-positive cancer tumors -
Novartis Collaboration EirGenix
R&D will continue to grow.
46.8 8.7 19% In 2019, completed ~80 transactions spanning acquisitions, licensing, technology deals and clinical
Merck collaborations
Entered into a definitive agreement to transfer a large part of Berlin-based small molecule research unit to
43.5 5.3 12% Nuvisan ICB GmbH, Neu-Ulm, Germany. (CRAMS company)
Bayer Outsources research acitivities
R&D in H220 at similar level as H219. (US$3bn in H219. R&D H120 - US$7bn)
36.0 6.0 17% R&D more focused on new products and less on diabities
Sanofi Uses CMO
R&D investment to grow in at a similar rate to 2019 (grew at 17% from PY).
Streamlining no. of CMOs in use to ensure right balance of trusted, cost-efficient manufacturing, with clear
33.7 4.6 14% business continuity plans in place to manage supply stability.
GSK Uses third party clinical research
US$5.8bn for CY20 and will go higher on annualized basis. Steady state R&D level 6bn
Third party contracts for, clinical trails, development and manufacturing
33.2 6.4 19% AbbVie and Genmab A/S announced a broad collaboration agreement to jointly develop and commercialize
AbbVie three of Genmab's early-stage investigational bispecific antibody product candidates
CY20 R&D guidnace US$9.5B - $9.7B (GAAP).
Committed to an aggregate US$20.7 billion of potential future R&D milestone payments to third parties for
25.0 6.0 24% inlicensing, asset acquisitions and development programs
Collaboration with Voluntis to create and investigate digital therapeutic solutions that will support cancer
Bristol-Myers Squibb patients.
Most of API manufacturing outsourced
24.0 6.0 25% Has several projects which are in collaboration with other companies for manufacturing and supply. In
2019, spent approximately US$14bn with suppliers on goods or services critical to the effective operation
AstraZeneca of entire value chain – from discovery to development, manufacturing and supply of medicines to patients.
Plan to increase R&D in H2CY20
23.3 4.0 17% Uses CMO
Amgen
CY20 R&D guidnace US$5.6B - $5.9B.
22.3 5.5 25% Do rely on CRO and CMO
Eli Lilly
Mid Teens % growth in R&D for CY20
22.0 3.7 17% Uses CMO. Have API CMO in India as well
Gilead Plans to use CMO for Remdesivir. Expect to manufacture 2mn or more in CY20
R&D cost ratio to increase gradually
Entered into a collaboration and license agreement providing development and commercialisation rights to
19.3 2.2 11% novel therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s proprietary
Novo Nordisk GalXC™ RNAi platform technology
Source: Company data, Bloomberg, Macquarie Research, October 2020
6 October 2020 37
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
• The demand of CRO and CDMO from Chinese companies should continue to growth, albeit
at a slower growth rate than past five years due to a higher base.
• IP ownership of the know-how discovered through the development process may become a
thorny issue down the road.
Q. What are the key factors that make Chinese companies so dominant in the
CRO/CDMO and API spaces?
For CRO/CDMOs, cost A. For CRO/CDMOs, cost advantage is the biggest factor. This holds true especially in
advantage is the biggest terms of production costs, capex required to set up new facilities, labour costs (of
factor. This holds true scientists) at the discovery and pre-clinical stages and patient recruitment costs during the
especially in terms of clinical stage. We would argue that while pre-clinical and Phase 1 seem to happen faster
production costs, capex overseas, P2/3 and approval seems faster for innovative drugs for the domestic market in
required to set up new China. Historically, API manufacturers in China serve national security interests to ensure
facilities, labour costs independent supply of key medicines in times of war. That was why a lot of them were
(of scientists) at the based in North-eastern China, which was the industrial belt back then.
discovery and pre-
clinical stages and
patient recruitment Q. What is the near- to medium-term growth outlook for the Chinese CRO/CDMO and
costs during the clinical API industries?
stage.
A. The demand of CRO and CDMO from Chinese companies should continue to grow,
albeit at slower growth rate than the past five years due to a higher base. The ability to
convert a CDMO relationship to CMO for biologicals remains to be seen. There is a risk of
successful biological products being able to support construction of in-house facilities,
making future CMO businesses limited to chemical drugs and less spectacular biological
products. The domestic biosimilar market is just beginning, which may see severe pricing
pressure and require better cost control (yield enhancement). Overseas expansion is
attractive for CDMO/CMO due to a still-fragmented market, but acquisition is expensive and
green field projects are more risky and time consuming. Cell/gene business should show
strong growth from a low base and it usually involves a bit of drug discovery services,
which may tie in with downstream milestone and royalties.
Q. Specifically for Chinese CRO/CDMO players, there are strong growth tailwinds
For Wuxi Apptec, its
from the domestic biologics market. However, can you comment on the growth
drug discovery and pre-
outlook for these companies from their overseas clients? Also, are Chinese
clinical CRO segments
companies growing well in small molecules?
derived 70% of their
revenue from overseas A. Wuxi Apptec and Tigermed focus on small molecules, and their growth has been strong.
clients. For clinical For Wuxi Apptec, its drug discovery and pre-clinical CRO segments derived 70% of their
CRO, 30% of the revenue from overseas clients. For clinical CRO, 30% of the revenue is derived from
revenue is derived from overseas clients. For Wuxi Bio (CDMO), 42% of revenue comes from domestic clients. All
overseas clients. plants are in China at this stage. The growth rate has been stronger with reference to
domestic clients, at 43% during 1HCY20, vs only 4% from North America in the same
period for Wuxi Bio.
6 October 2020 38
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
A. Not too sure. Wuxi Bio only has 1 commercial project from clients. The rest are
development-stage projects. There will be quite a few commercial projects coming up, but it
focuses on biologics, thus making it more difficult for clients to switch. Wuxi Apptec (small
molecules) has 26 commercial projects but over 1,000 P1 to P3 projects. The diversification
angle applies more to commercial projects. Pure API commercial CMO in China is not
under our coverage. The one we focus more on is the CMO/CDMO for innovative new
drugs.
Q. Based on your interactions, are any of the Chinese CROs/CDMOs and API
companies worried about losing incremental business to Indian companies?
A. Nope. Growth is still strong. But we think they do want to set up more overseas facilities
to capture the demand.
A. For both CRO/CDMO in China, they are increasing moving upstream to include drug
discovery and optimization as well as downstream to include formulation and commercial
manufacturing. Thus, IP ownership of the know-how discovered through the development
process may become a thorny issue down the road. So far, a lot of innovative drugs in
China are me-too fast-follow products and the start-ups tend to be much smaller than the
service providers. If this dynamic changes, innovators may choose to bring back discovery
and development, especially for de novo products, in house to prevent potential leakage of
IP at CRO/CDMO. However, with strong liquidity in the market, the wave small new
entrants should sustain and continue to present businesses to CRO/CDMO, which have
stronger bargaining power over the smaller innovators.
6 October 2020 39
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
• Our analysis suggests that led by import substitution alone, in a base case, domestic API
production can broadly double in the next five years.
• In our view, the theme of diversifying the API supply chain has just started and Indian API
manufacturers are well poised to capitalise on this shift.
• Our extensive checks suggest that while the government’s ‘Make in India’ push through the
PLI scheme is a step in the right direction, unless the incentives are much more lucrative, the
scheme is unlikely to result in any meaningful benefit for most listed companies.
The global API market is The global API market is estimated to be US$180bn, growing at ~6% annually. Out of the total
estimated to be global API market size, ~42% (US$75bn) is comprised of generic APIs. Including domestic
US$180bn, growing at consumption, the size of the Indian API industry is ~US$11bn. Out of this US$11bn, US$7bn is
~6% annually. Out of the domestic consumption and API exports are US$4bn. The Indian API industry ranks third globally,
total global API market next to China and Italy. France, Germany, and Malaysia are the other countries with high API
size, ~42% (US$75bn) is production units. We note that the global API market is extremely fragmented with the big pharma
comprised of generic companies constituting only 7% of the market.
APIs. Including
domestic consumption,
Fig 64 Estimated break-up of the global API market across key segments/regions
the size of the Indian
API industry is
~US$11bn.
Global API market
(US$180bn)
Domestic/Captive Exports
US$105bn US$75bn
Regulated Semi-regulated
US$1.8bn US$2.2bn
China enjoys a API manufacturing is a global business with different companies adopting different strategies to
dominance in high- achieve success. While some API companies focus on low-cost, high-volume APIs, others focus
volume, low margin on niche, specialty APIs. Given their inability to compete on high volume APIs due to higher costs,
commodity APIs given European API companies are key suppliers of high-potency, niche APIs. India is a global leader in
its cost DMFs, with 46% of US DMF filings being done by Indian companies. In comparison, API firms in
competitiveness. China and Italy hold 12% and 9%, respectively, of DMFs in the US. China enjoys a dominance in
high-volume, low margin commodity APIs given its cost competitiveness. China is a dominant
player in the global API industry given its large-scale manufacturing capabilities, cost efficiency
and adequate availability of commodity bulk drugs and intermediates due to strong technological
capability and fermentation. As per UK MHRA, 40% of global APIs are manufactured in China.
6 October 2020 40
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 65 China bulk drug exports by value Fig 66 China bulk drug exports by volume
US$ bn mn tonnes
40 15% 16% 1,050 10%
1,012
33.7 9%
35 14%
29.5 30.5 9%
1,000 8%
30 12%
25.6 7%
25 10%
950 930 6%
10%
20 8% 5%
896
15 6% 900 4% 4%
3%
10 4%
850 2%
5 3% 2%
1%
0 0% 800 0%
CY16 CY17 CY18 CY19 CY17 CY18 CY19
Exports value (LHS) Growth (YoY) RHS Exports volume (LHS) Growth (YoY) RHS
Source: China Chamber of Commerce for Import & Export of Medicines & Source: China Chamber of Commerce for Import & Export of Medicines &
Health product (CCCMHPIE), Macquarie Research, October 2020 Health product (CCCMHPIE), Macquarie Research, October 2020
With more stringent domestic and international inspections and significantly higher focus on
We expect the thrust on adhering to environmental norms, the global API industry is witnessing a change. Another factor
lowering over-reliance impacting the global API industry is traceability. Globally, there are efforts to enhance traceability.
on China owing to In addition to these, a sharp increase in labour and raw material costs has led to an overall
factors like API increase in operating costs for Chinese API companies. Also, an unstable supply chain of
sourcing from multiple intermediates has increased the incidences of Chinese API companies being unable to meet the
geographically supply requirements on time, thereby denting the confidence of their clients. We expect the thrust
diversified sources to on lowering over-reliance on China owing to factors like API sourcing from multiple geographically
ensure supply security diversified sources to ensure supply security and geo-political tensions to benefit the volume API
and geo-political firms in India. Concurrently, there continues to be increasing interest in high-potency, combination
tensions to benefit the and niche APIs. We expect Indian API companies with the relevant expertise, strong track records
volume API firms in and capacity to benefit from near- to medium-term API sector tailwinds. Especially, the ones that
India. can provide the security of their supply chain from raw materials through to ingredients are likely to
see higher demand.
6 October 2020 41
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
India's domestic API production (Rs bn) 223 247 272 305 349 382 406 449 497 10.6% 555 624 709 810 930 13.4%
% YoY growth 11% 10% 12% 15% 9% 6% 11% 11% 12% 13% 14% 14% 15%
Total API market in India (Rs bn) 365 421 462 503 562 566 599 698 837 10.9% 929 1030 1143 1268 1407 10.9%
% YoY growth 15% 10% 9% 12% 1% 6% 16% 20% 11% 11% 11% 11% 11%
China imports as % of total API consumption in India 24% 26% 26% 25% 25% 22% 22% 24% 28% 27% 26% 25% 23% 21%
Even a US$2bn shift Our analysis suggests that led by import substitution alone, in our base case, there could be a
from China could result 280bp YoY jump in domestic API production out to FY25E. Similarly, India’s annual API exports at
in a 50% surge in India’s ~US$4bn are significantly lower than China’s US$20-22n. In our view, the theme of diversifying the
API exports. API supply chain has just started and Indian API manufacturers are well poised to capitalise on this
shift. Even a US$2bn shift from China could result in a 50% surge in India’s API exports. On the
flipside, our extensive checks suggest that while the government’s ‘Make in India’ push through the
PLI scheme is a step in the right direction, unless the incentives are much more lucrative, the
scheme is unlikely to result in any meaningful benefit for most listed companies. The key themes
driving growth for Indian API companies are:
Fig 68 India has the highest number of USFDA approved Fig 69 Indian players maintained DMF Filings at around 50%
API plants market share
%
35 120
31 31
30 100
25
80
48 50 51 49 51 47 49
20 56 54 54 52 52 53 49 52 52
14 60
15 12
11
40
10
52 50 49 51 49 53 51
20 44 46 46 48 48 47 51 48 48
5 2
0
0 0
2005
2007
2009
2011
2013
2015
2017
2019
2006
2008
2010
2012
2014
2016
2018
2020
Source: Ind-Ra, Macquarie Research, October 2020 Source: Ind-Ra, Macquarie Research, October 2020
6 October 2020 42
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
In light of the recent Supply chain diversification: The “China + one/two” dual/triple sourcing strategy has
COVID-19 pandemic, the accelerated in the past three years post the Chinese government’s crackdown on
efforts to diversify their API/intermediate manufacturing units citing pollution norms. For example, in CY19,
supply chain have Chinese API export volumes to US declined by 11% YoY due to rising trade frictions
further intensified for resulting in levy of import duties on 28 Chinese APIs, which led to an increase in average
many pharma export price by 11% YoY. In light of the recent COVID-19 pandemic, the efforts to diversify
companies. Regulatory their supply chain have further intensified for many pharma companies. Regulatory
requirements are requirements are tightening and will likely continue to do so with a push for more
tightening and will likely transparency in the supply chain. This could result in requiring certification for good
continue to do so with a manufacturing practices for key intermediates and raw materials.
push for more
transparency in the
Fig 70 Chinese API exports to US declined in CY19
supply chain.
2018 2019
IP conflicts and competing interests: Forward integration interest of most of the API
players has led to concerns around potential competition with international customers along
with issues around IP security and conflict. In this regard, pure-play API companies like
Divi’s and Solara certainly have a meaningful advantage.
While operating costs Increasing pollution and environmental concerns: Apart from the quality standpoint,
for Chinese API compliance on the environment standpoint is very important in the API industry. Issues on
suppliers are still lower the latter point had led to lot of facility shutdowns in China in CY18. Globally, governments
than manufacturers in are increasing focus on pollution controls and zero liquid discharge. Environmental
other markets like India, regulations, especially in China are putting pressure on corporations to remedy pollution
we note that the relative problems. Some plants are being shut down or moved causing capacity issues and supply
price advantage of chain interruptions from raw materials to intermediates and APIs. Implementation of the
Chinese API companies Environmental Protection Tax Law has led to significantly higher operating costs especially
has reduced over the for waste management for Chinese API companies. While operating costs for Chinese API
past three years. suppliers are still lower than manufacturers in other markets like India, we note that the
relative price advantage of Chinese API companies has reduced over the past three years.
Generally, Indian API companies have fared better than their Chinese peers on adherence
to the pollution norms.
6 October 2020 43
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 71 Opex has gone up for most smaller Chinese API companies in the last two years
Opex CAGR
70% 64%
60%
50% 45%
40% 38%
40%
32%
30%
0%
Zhejiang NHU Nanjing King- Shenzhen Yifan Pharma Haisco Pharma Apeloa Pharma
Friend Salubris Pharma
Biochemical
CY15-17 CY17-19
Despite these tailwinds, the Indian API ecosystem still fares worse compared to China
On average, set-up and China is a global leader in production and exports of APIs by volume. As of CY19, there were
production costs of API ~12.5K API exporters in China, with most of them being private companies. China has access to
facilities in China are low cost of utilities, labour, and greater government support. Availability of subsidies, tax
still 15-20% lower than incentives, sophisticated manufacturing technology and infrastructure support helps Chinese
in India, which hampers players get economies of scale. Over the past decade, the Chinese government has driven several
the export initiatives to drive API growth including (i) large SEZs with access to subsidized land, common
competitiveness for waste processing and utilities, flexible labour laws, (ii) lower logistics costs (1% of total costs in
Indian companies. China vs 3% for India), (iii) lower borrowing costs and (iv) cheaper labour and electricity costs. On
an average, set-up and production costs of API facilities in China are still 15-20% lower than in
India, which hampers the export competitiveness for Indian companies. API/intermediate units are
highly polluting in nature, which is also one of the reasons why Indian companies have scaled back
on manufacturing. Despite the pollution curbs over the past few years, the government policy in
China has been much more conducive towards manufacturing of APIs/intermediates vis-à-vis
India.
100%
11.0%
80% 4.0%
9.0% 7.8%
10.0% 2.8%
60% 9.0%
8.0%
40%
63.0%
51.0%
20%
0%
India China
Source: KPMG CII API industry report, Macquarie Research, October 2020
6 October 2020 44
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 73 China still ranks higher across all cost competitiveness parameters except labour
Source: KPMG CII API industry report, Macquarie Research, October 2020
As per KMPG CII, the Indian bulk drug industry faces various challenges around government
support, infrastructure, environment clearances, regulatory structure, and price volatility.
The government of India ▪ Longer time frame for government initiatives to play out: Indian API companies lacked
has taken some steps government support in terms of financing option and tax benefits, fast clearances, and capital
towards boosting its subsidies. The government of India has taken some steps towards boosting its API Industry
API Industry such as 1) such as 1) bulk drug parks scheme – three parks will be set up with a budget of Rs30bn over
a bulk drug parks the next five years, and 2) production linked incentive scheme and financial incentive with a
scheme – three parks budget of Rs69.4bn over the next eight years (53 critical API/intermediates). However, our
will be set up with a interactions with multiple API companies and various industry experts lead us to believe that
budget of Rs30bn over these initiatives may take a long time to play out. We address this point in depth later in the
the next five years, and report.
2) production linked
▪ Inadequate infrastructure: India lacks drug specific clusters, access to low-cost utilities
incentive scheme and
(waste management systems, steam, water, electricity etc), R&D support and skilled
financial incentive with
manpower. Lack of API focused SEZ’s leads to higher cost of acquiring land, setting up
a budget of Rs69.4bn
operations and accessing utilities. As per KMPG CII, Indian companies run at a lower capacity
over the next eight
utilisation and lower economies of scale compared to China. Most Chinese plants have 10
years (53 critical
times more capacity compared to Indian manufacturers.
API/intermediates).
6 October 2020 45
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
▪ Complex clearance process: Land acquisition in India typically takes around two years while
Land acquisition in
this is only six months in China. Approvals are needed to be obtained from multiple agencies
India typically takes
such as from State Environment Impact Assessment Authority, State/Union Territory Coastal
around two years while
Zone Management Authority (CZMA), State Pollution Control Board, Central Groundwater
this is only six months
Authority and Ministry of Environment, Forests and Climate Change. As per the KPMG CII API
in China.
Industry report, a manufacturing facility in India has to abide by and comply with around 34
environmental legislations. Compliance with environmental costs account for 5-7% of the
product cost.
▪ Price ceiling impacts ability to take drug price hikes in sync with API prices: All drugs
listed under the National List of Essential Medicines (NLEM) have been given a fixed ceiling
price according to the Drug Price Control Order (DPCO) and their prices are regulated by the
National Pharmaceutical Pricing Authority (NPPA). Price control impacts the bulk drug industry
as it does not allow an increase in selling price linked to the rising cost of raw materials.
Therefore, companies prefer importing raw materials as they are cheaper. The recent NPPA
decision to allow price hikes for essential drugs due to higher API prices is a welcome move.
6 October 2020 46
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
180
163 158
160
140
115
120 105
100
80 68
56
60
40 28
20 5
0
Enforcing contracts Registering property Paying taxes Trading across borders
India China
Source: KMPG CII API Industry report, Macquarie Research, October 2020
3) Capacity creation:
▪ Capacity has been created taking into account the world demand
▪ Thus, per unit overhead, depreciation and operational cost is lower
4) Development of ancillary industries for supplies: Efficient and continuous supply of maize /
liquid glucose, which are basic raw material for fermentation.
5) Investor-friendly simplified labour laws: Workers can be hired and terminated as per company
policy without interference of local government or labour unions. Efficiency and company’s
interest are top priorities.
6 October 2020 47
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
In our view, given the government support and scale advantage, Chinese players are likely to
remain dominant in fermentation-based APIs.
Higher dependence on China for bulk drugs is a concern for Indian pharma industry
Bulk drugs formed 63% Post COVID-19, several countries, including India, have expressed concerns on high dependence
of the total pharma on China for API and intermediates. Bulk drugs formed 63% of the total pharma imports in FY20
imports in FY20 for for India. Measured by value, India, followed by US, is the largest importer of APIs from China.
India. Measured by Especially for key starting materials (KSMs), intermediates and certain critical APIs, the
value, India, followed by dependency on imports is quite high. For instance, India is almost entirely dependent on China for
US, is the largest fermentation based APIs. ~90% of the raw material for antibiotics manufactured in India is
importer of APIs from imported from China. For most of these molecules, manufacturers in other countries have not
China. Especially for renewed their DMFs.
key starting materials
(KSMs), intermediates
Fig 79 India’s dependence on imports remains high for key raw materials
and certain critical APIs,
the dependency on
imports is quite high.
India imported US$3.4bn worth of bulk drugs in FY20. We note that dependency on China for
imports has gone up over the years from 62% in FY12 to 68% in FY20.
Fig 80 Trade in bulk drugs Fig 81 Crisil expects API exports to pick up over FY20-22E
$ bn CAGR 4.8%
5.0 25% 23%
4.4
4.5 4.2 20%
3.9 3.9
4.0 3.6 3.6 3.6 3.6 3.5 3.6 15% 10%
3.5 3.4 6-7%
3.3 3.3 3.4
3.5 3.2 3.2 10% 5-6%
3.0 3.0 5%
3.0 2.7 5% 3%
2.6 1%
2.5 2.2 0%
2.0 -5% -1% -1%
-5% -6%
1.5 -10%
1.0 -15%
-15%
0.5 -20%
FY14
FY15
FY16
FY17
FY11
FY12
FY13
FY18
FY19
FY20
FY21E
FY22E
-
FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20
Import Export
Source: API Policy by Department of Pharmaceuticals, Macquarie Source: Crisil Research, Macquarie Research, October 2020
Research, October 2020
6 October 2020 48
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 82 India’s API imports by country (FY19) Fig 83 India’s API imports and dependency from China
400 70%
340
350 68%
67% 69% 68%
300 68%
Other 249 66%
20% 250 213
190 198 184 193
Hong Kong 200 174 65% 64%
2%
142 64% 64%
Singapore 150
63% 62%
3%
Italy 100 62%
3% 60%
50
US China
4% 68% 0 58%
FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20*
Source: KPMG CII API industry report, Macquarie Research, October Source: KPMG CII API industry report, Macquarie Research, October
2020 2020; Note: FY20 denotes imports between Apr-19 to Dec-19
Until CY05, India was a key manufacturing for API/intermediates hub. Then, there were five
manufacturers of Penicillin G in India. Penicillin G is the basic building block of cephalosporins and
semi-synthetic penicillins. Since then, China has made rapid strides and has taken over this space
by creating huge capacities. Because of cost competitiveness of Chinese companies (prices were
one-fourth of global players, including India), most of the Indian as well as global companies have
stopped manufacturing Penicillin G. Even for key starting materials (KSMs), Indian companies
have ceased production and are largely relying on imports.
Antibiotics 75-80%
Hormones, prostaglandins, thromboxane, leukotrienes 50-55%
Provitamins and vitamins 55-60%
Other heterocyclic compounds 80-85%
Other organic compounds 70-75%
Source: Crisil, Macquarie Research, October 2020
The National List of Essential Medicine (NLEM) 2015 has a total of 376 medicines, for which
import dependency is very high (more than 70%). Many of these fall under the category of
cardiovascular drugs, diabetes drugs, anti-bacterial, anti-inflammatory, anti-tuberculosis, and anti-
protozoal drugs. While India had the manufacturing capacity for many APIs, we believe that
availability of low-cost imports led to erosion of local capacity. Indian manufacturers have also
been reluctant to use their idle capacity or restart closed plants due to not being cost competitive.
6 October 2020 49
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 86 Imports by value (Import data for FY19) Fig 87 Imports by volume (Import data for FY19)
Imports by value (Rs mn) LHS % imports from China (RHS) Imports by volume (in MT) LHS % imports from China (RHS)
Source: KPMG CII API industry report, Macquarie Research, October Source: KPMG CII API industry report, Macquarie Research, October
2020; Note* - APIs are part of National List of Essential Medicines (NLEM) 2020, Note* - APIs are part of National List of Essential Medicines (NLEM)
2015 2015
Indian government is incentivising local bulk drugs manufacturing through two schemes
Our calculation suggests The Department of Pharmaceuticals (DOP) formed a technical committee in Feb-20 to
that these 53 critical assist the department to frame appropriate schemes for lowering dependence on imports
KSMs/intermediates/APIs for bulk drugs. The technical committee identified 53 critical KSMs/intermediates/APIs for a
constitute 75% of India’s product-linked incentive (PLI) scheme and proposed the establishment of bulk drug parks
total bulk drug imports. with higher assistance. Our calculation suggests that these 53 critical
KSMs/intermediates/APIs constitute 75% of India’s total bulk drug imports.
The PLI scheme has been categorized under four segments, with different parameters laid
out for each segment. The government will be announcing the highest incentive for key
fermentation based KSMs / intermediates for antibiotic drugs including Penicillin G, 7-ACA,
TIOC and Clavulanic acid. The incentives will be linked to the threshold investment and
incremental sales over base year. An applicant can apply for multiple products, with
additional investment needed for every product to avail of the incentives. Starting Jul-20
end, the application window extends for 120 days, with approval expected thereafter within
90 days. The selection criteria would be two-fold: (i) capacity of the proposed plant (35%
weightage) and sale price of API (65% weightage). There will be a maximum of 136
selected applicants and there is also a facility of waiting list.
6 October 2020 50
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 90 Segment-1: Key fermentation based KSMs/Dis (all KSMs for antibiotic drugs)
Minimum
Maximum incentive for each selected applicant per annum
Sr No. KSM production capacity
(Rs mn)
(MT)
6 October 2020 51
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
6 October 2020 52
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
1 Meropenem 10 25
2 Atorvastatin 30 25
3 Olmesartan 25 25
4 Valsartan 25 25
5 Losartan 80 25
6 Levofloxacin 115 25
7 Sulfadiazine 20 25
8 Ciprofloxacin 300 25
9 Ofloxacin 100 25
10 Norfloxacin 15 25
11 Artesunate 35 25
12 Telmisartan 80 25
13 Aspirin 2800 25
14 Diclofenac Sodium 175 25
15 Levetiracetam 140 25
16 Carbidopa 2 25
17 Ritonavir 5 25
18 Lopinavir 7 25
19 Acyclovir 175 25
20 Carbamazepine 65 25
21 Oxcarbazepine 65 25
22 Vitamin B6 35 25
23 Levodopa 10 25
Source: Department of Pharma, Macquarie Research, October 2020
Apart from the Central The Indian government through its API policy has promoted bulk drug parks for providing
Government’s proposal easy access to common and R&D infrastructure facilities at one place with assured land,
to set up the three bulk easy access to testing facilities and economies of scale. The Cabinet has granted approval
drug parks, we note that to set up three bulk drug parks with a budget of Rs10bn each. The scheme is expected to
a few state governments lower the cost of production and provide single window for regulatory approvals. Apart from
are also promoting the Central Government’s proposal to set up the three bulk drug parks, we note that few
pharma parks. state governments are also promoting pharma parks. For instance, the Telangana
government has initiated work on a pharma park in Hyderabad. The decision is based on
the assessment that several pharma suppliers could shift out of China post-COVID-19 and
that it is an ideal time to attract them into the state and to consolidate Hyderabad’s pre-
eminent position in the pharma sector. The entire project is being planned in three phases,
spread over 19,333 acres, and targeted for completion by 2025, as per the masterplan of
the Hyderabad Pharma City (HPC) project. The project will feature infrastructure, common
facilities including Zero Liquid Discharge-based Common Effluent Treatment Plant, an
integrated solid waste management facility, district heating and cooling systems, logistic
parks, a Global Pharma University, regulatory facilitation cells, common drug development
and testing laboratories, and start-up and SME hub (link).
6 October 2020 53
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Will the Indian government’s push make a difference? Over the next few years, we believe it
could but only if the current scheme is modified…
The Production linked incentive (PLI) scheme promotes domestic manufacturing of 53 critical bulk
drugs and intermediates in the country with a budget of Rs69.4bn. The incentive is linked with
threshold investment and incremental sales over base year. While it is certainly a step in the right
direction, in its current form, the industry is a bit sceptical about earning attractive return on
investments on this scheme. We list below the key reasons why we believe the government’s API
policy is unlikely to be a gamechanger in its current form and unlikely to benefit most of the listed
Considering the companies:
incentives are only for
domestic sales, we Low quantum of incentives: For 49 of 53 products in the PLI scheme, the annual
expect participation by incentive per company has been capped at just Rs100m. Given the low quantum, in our
most listed companies view, most listed companies are unlikely to take part in the scheme just because of the
to be limited to a few incentives. Also, given the fiscal stress, we do not envisage any significant increase in the
molecules. Domestic incentive quantum. We expect smaller companies (largely unlisted) to benefit more from
value addition the scheme given the extent of the incentive could be meaningful for them.
requirement of 70-90% Incentives are only for domestic sales: Given superior regulatory compliance, adherence
in the products may be to environmental norms and an elevated cost structure, most of the listed companies have
difficult to achieve. higher proportion of API export sales and find it difficult to compete on pricing with smaller
API units operating at a much lower cost structure. Considering the incentives are only for
domestic sales, we expect participation by most listed companies to be limited to a few
molecules. Domestic value addition requirement of 70-90% in the products may be difficult
to achieve.
Even though we do not Scale benefit unlikely: Linked to the previous points, given the low incentives and that too
expect a meaningful only on domestic sales, companies are unlikely to invest in setting up huge capacities just
benefit to accrue for because of the PLI scheme. We note that if investments are only for building smaller units,
listed Indian API these units are unlikely to realise economics of scale which would bring in cost efficiencies
companies from the PLI and margin expansion. Fermentation based products have a high investment requirement
scheme, the compared to chemical synthesis products.
government’s intent to
revive API/intermediate
Fig 94 India needs much more to reach China’s scale
manufacturing in India
has raised industry Minimum capacity (PLI
India's import China capacity scheme)
hopes. API China's share
(tonne) (tonne)
(Tonne per player)
Incentives linked to sale price can lead to price competition: Higher weightage (65%)
on selling price of APIs may lead to pricing disruption.
Land has been kept out of threshold investment: Land cost has been kept out of the
ambit of minimum threshold investment, which is a key dampener. Thus, given this clause,
any big greenfield expansion will be difficult.
Even as we do not expect a meaningful benefit to accrue for listed Indian API companies from the
PLI scheme, the government’s intent to revive API/intermediate manufacturing in India has raised
industry hopes. We have not built in any benefit from the PLI scheme for any company in our
coverage.
6 October 2020 54
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Despite not building in any benefit from the PLI scheme, we believe there is an element of
sustainability to the recent India API strength
Despite not building in Both API companies as well as API segments of formulations-heavy companies delivered a very
any benefit from the PLI strong performance in 1QFY21, both at the top line as well as on the margin front. Our analysis of
scheme, we believe the API performance of 22 Indian companies suggests that aggregate API top-line growth grew
there is an element of 31% YoY and 20% QoQ in 1QFY21. In our view, the 1QFY21 performance benefitted from the
sustainability to the following factors:
recent India API
Stocking up of APIs given supply chain uncertainty with lockdowns in various regions
strength.
across the globe.
Many companies facing facility shutdowns, especially in the first few weeks of April, sold
more high-margin APIs during the remainder of the quarter to protect profitability.
And finally, Chinese API supplies were lower in 1Q for some therapies.
Our checks suggest that To counter these, API production of some companies was negatively impacted due to shutdown of
Indian API facilities as well as higher capacity allocation towards COVID-19 treatment drugs. Does this mean
manufacturers are that the API strength is based solely on one-offs? We do not think so. As mentioned above,
indeed witnessing two we see Indian companies benefitting from trends like increasing regulatory oversight on API
trends – traction from facilities, rising need of formulations companies to diversify their raw material supply chain, IP
new enquiries is conflicts and need to adhere to stringent environmental norms. Most Indian API companies have
increasing and higher started seeing some of these benefits since the past couple of years. Also, post COVID-19, we
business volumes from expect global formulations companies to focus more on lowering API over-dependence from
existing clients. China. Our checks suggest that Indian API manufacturers are indeed witnessing two trends –
traction from new enquiries is increasing and higher business volumes from existing clients.
Diversification of supply-chain is happening across the industry and post COVID-19, the urgency to
look for alternative API sources has increased. Many formulations companies are in the process of
achieving tangible progress in diversifying their API sourcing over the next few years. In our view,
for certain relatively complex APIs including high potent APIs, sartans, statins, and even certain
advanced intermediates, there is an opportunity for Indian companies to benefit.
Fig 95 Most companies delivered a strong API segment performance in 1QFY21; with the aggregate growth being 31% YoY
API revenue (Rs mn) 1Q21 1Q20 YoY growth 4Q20 QoQ growth
Divi's Labs (Generics) 10,210 5,800 76% 7,300 40%
Dr Reddy's 8,553 4,539 88% 7,195 19%
Aurobindo 7,801 7,322 7% 7,556 3%
Sun Pharma 5,537 4,610 20% 4,834 15%
Aarti Drugs 5,447 4,054 34% 4,496 21%
Laurus Labs 5,220 3,720 40% 4,240 23%
IPCA 5,133 2,983 72% 2,751 87%
Biocon 4,791 4,128 16% 4,328 11%
Lupin 4,090 3,489 17% 3,286 24%
Granules 3,500 3,095 13% 2,558 37%
Solara 3,484 3,302 6% 2,968 17%
IOL 3,131 3,087 1% 2,927 7%
Alembic Pharma 2,640 1,720 53% 1,558 69%
Glenmark 2,348 2,306 2% 2,614 -10%
Hikal 2,137 2,039 5% 2,264 -6%
Cipla 1,840 1,820 1% 2,470 -26%
Neuland 1,500 1,325 13% 1,276 18%
Shilpa Medicare 1,471 1,105 33% 1,330 11%
Natco 1,439 717 101% 964 49%
Cadila 1,300 692 88% 1,163 12%
SMS Pharma 1,129 1,171 -4% 964 17%
Indoco Remedies 220 237 -7% 203 8%
Total API revenue 82,921 63,261 31% 69,245 20%
Source: Company data, Macquarie Research, October 2020
6 October 2020 55
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 96 Most companies delivered a strong API segment performance in 1QFY21; with the aggregate growth being 31% YoY
1QFY21 API show Medium term API outlook PLI Scheme
Company
View Details View Details View Details
Formulations/API companies
The philosophy is to leverage the vertical Considering APIs other than antibiotics.
Sun Maintaining a robust position on the API
integration capability of Sun. At the same The idea would be to use this as a way to become fully
Pharma business consistently.
time, Sun is also focusing on available integrated in India.
Very confident about ability to deliver
API growth was strong across products and healthy growth in API. Trends are
regions led by inventory build-up and dual sustainable. Starting to see results of
No plans currently as most of the products in the scheme
Dr. Reddy's sourcing. Mix was more favourable, which focus on external API sales globally. It
are antibiotics which are outside of DRRD's focus areas.
also helped GMs. No specific trend on expects to gain share in some APIs as it
pricing or procurement prices. becomes cost efficient, which will also
improve margins.
Not seeing a tectonic shift in procurement
50-55% of API sales come from antibiotics
of bulk drugs but seeing opportunity
Aurobindo (muted sales) and hence comparison with ARBP is evaluating the PLI scheme and there are few
because of disturbances from China. Due
Pharma other companies is invalid. Non-anti-biotic products within the scheme which appear interesting.
to strong demand, ARBP is expanding API
API sales grew 29% YoY.
capacities.
Expect strong double-digit growth to PLI scheme is a right step, but incentives are light. It is
API sales showed strong positive demand continue. For the Indian API sector, it's a reviewing 6-7 products within the list closely. Industry
Lupin
momentum as well as pricing. great opportunity to earn back the space working with govt in tweaking the scheme so that, 5 years
on intermediates and APIs. later, dependence on China is reduced.
While it is difficult for API production to
Recent increase in API prices has been materially shift from China in next 3-5 Evaluating the scheme. In general, external API is a small
Cipla selective so far and Cipla is not majorly years, there will be greater opportunities business for Cipla and there are no plans to expand,
worried about its hit on gross margins. in select APIs for Indian cos (seeing this barring respiratory APIs.
already in certain niche APIs).
Cadila CDH expects to see a good momentum in
CDH's API business has turned around. -
Healthcare its external API sales in the coming
There was higher demand for certain key Continue to see a good traction in this
Most of the 53 products are legacy ones. ROI will be lower,
APIs across global markets as customers business with good underlying demand
Biocon despite incentives. PLI scheme is not for cos like Biocon,
picked up stocks to ensure continued and a
but for smaller cos who are capex crunched.
availability of drugs. stable pricing environment.
Will stick to making more complex APIs in-
Torrent Do not think that API price hikes will impact Evaluating the scheme. There is a plan to hike API
house and source high-volume APIs from
Pharma overall margins. utilisation over the next 3 years.
third parties.
Weak API show due to the Nanjangud Seeing better demand and pricing for
Jubilant
plant being shut down for two months in APIs. For the next 3 quarters, it expects to -
Life
1Q. perform very well.
Expect good growth in external API sales
1QFY21 API sales were impacted as lot of
from 2Q onwards. GNP expects good
Glenmark capacity got utilised in manufacturing -
opportunity in its API business from
Favipiravir.
diversification away from China.
API growth was driven by opportunities on Guiding for 20% YoY growth in API sales Looking to participate not due to incentives but since it
Ipca Labs
account of chloroquine and HCQS APIs. in FY21. Need to resolve capacity anyways wanted to produce some of these products.
Natco API growth was driven by COVID-19 drugs API base business increase will likely
-
Pharma as well as growth in the base business. sustain for some time.
Alembic Impact from increase of API prices on PLI scheme is not a priority as Alembic doesn't see itself as
-
Pharma formulations business was manageable. a major API player.
API-focussed companies
Strong show was driven by base business, Seeing less encouragement to China and
The PLI scheme is less applicable to Divi's because its
favourable mix and lumpiness. In anti-virals more for Indian API companies from US
Divi's focus is more on API exports. Still trying to understand what
and anti-inflammatory, where Divi's is and European clients. This is definitely
will be the benefit of the PLI scheme.
present, demand is high post COVID-19. encouraging for the Indian API industry.
See pricing strength continuing for some
There was 3 weeks of production stoppage Evaluating the scheme. Can utilise land in Mysuru and
of its products. Solara has guided for
Solara in April and hence there was higher focus Vizag if the company decides on capex for any of the 53
robust 25% YoY growth in revenue and
on gross margin led growth in 1QFY21. products.
EBITDA in FY21.
It has one of the largest high potent API
Reported 40% YoY growth in the generic facilities in India and it is seeing good
Laurus API segment in 1Q. Apart from small traction on the customer front. It is very The PLI scheme is a good step towards self-sufficiency.
Labs contribution from HCQS, there was no one- optimistic about growth prospects of Evaluating the scheme for few APIs.
off sales or one-off gross margin benefit. generic API contract manufacturing as
well.
See a lot of potential in APIs and do have
Didn’t see any major impact from higher Evaluating the scheme. Higher incentives would be
Granules infrastructure to support growth for 4-5
API prices in 1QFY21. needed.
years.
6 October 2020 56
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 97 Strong earnings and share price performance by top specialty companies in the
last three years
Growth %(FY17-20)
350% 700%
314%
579%
300% 600%
250% 500%
193%
200% 176% 400%
140%
150% 300%
193% 105% 195% 99%
91%
100% 146% 200%
74% 107% 59% 63%
37% 46% 42%
50% 32% 51% 100%
0% 0%
Atul Vinati Org Aarti Ind Navin Flourine Alkyl Amines
6 October 2020 57
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Appendix
History of the CRO industry
Contract Research Organisations (CROs) emerged in the 1970s in the US and were created
In the past 20 years, the mainly to assist the research and development of pharmaceutical companies. Early CRO
CRO industry has companies are mainly private companies and provide analytical services. Since the 1980s, with the
become more robust implementation of US FDA drug manufacturing regulatory laws, the development of drugs had
and provides services become more and more complicated and more and more pharma companies started to outsource
from pre-clinical drug part of their jobs to outside CROs, leading to fast-growing period for CROs.
discovery to clinical trial
design and In the 1990s, MNC pharma companies started to expand globally and set up R&D centers
registrational services, overseas. These strategic moves helped global expansion while also increasing R&D expenditure
covering every aspect exponentially. MNC pharma faced a more competitive environment, and with more regulatory
of drug development, pressure to increase R&D efficiency, they started to adjust the R&D system and integrate
and becoming an outsourced CROs to substitute some internal functions, in order to reduce costs, shorten
essential part of the development time and alleviate the huge risks involved with new drug development. In the past 20
healthcare industry. years, the CRO industry has become more robust and provides services from pre-clinical drug
discovery to clinical trial design and registrational services, covering every aspect of drug
development, and becoming an essential part of the healthcare industry.
Discovery chemistry: It is the process of designing novel chemical entities with potential application
across a wide variety of sectors. It involves the synthesis of molecules for integrated discovery and
generation of compound libraries, reference standards, metabolites, impurities, surfactants, dyes and
polymers. The synthesis of these compounds is supported by analytical laboratories which are
equipped to purify and analyse them to ensure that they are at a predetermined purity level before
they are tested in animals or in vitro cell systems for efficacy and safety.
Discovery biology: Discovery biology supports both small and large molecule discovery research.
For small molecules, it plays an important role in target identification and validation and
participates in the lead selection process. For large molecules, the discovery biology team is
responsible for therapeutic molecule generation, protein engineering, screening and lead selection.
The lead selection process for both small and large molecules involves multiple evaluation
parameters, with key inputs from drug metabolism and pharmacokinetics (DMPK) studies and in-
vivo evaluation. Discovery biology also plays a crucial role in development and supply of critical
bio-reagents to support global discovery research for multiple clients.
6 October 2020 58
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Drug substance development: The drug substance development platform supports the
development of a process for facilitating an NME’s transition from the laboratory to a
manufacturing setup based on increasing volumes. This transition is unique for each molecule,
with its own set of challenges. Various technologies and analytical methods are used to support
this transition.
Safety assessment: The safety assessment department assesses the hazard potential of drugs
and other products in animals and in vitro cell systems which are used as surrogate species for
extrapolation of data to humans. These activities are part of the pre-clinical studies conducted to
determine the suitability of a drug before they are tested in humans. Similar studies are also
conducted to assess the safety of pesticides, food additives, cosmetics and other chemicals.
Safety assessment, or toxicology studies, in animals span several disciplines (safety
pharmacology, general toxicology, genetic toxicology, reproductive toxicology, behavioural
toxicology, immune-toxicology and carcinogenicity).
Clinical services: Clinical services include clinical trials, BA/BE studies, bioanalytical testing,
central lab services, medical writing, biostatistics and data management services and
pharmacovigilance services.
Stability services: Stability testing forms an integral part of the drug development process which
helps establish the shelf life of the product. These studies are conducted as per the International
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) stability guidelines. The API and formulation of every NME that goes through the
development continuum are required to be placed on stability to assess their stability. The purpose
of stability testing is to provide evidence on how the quality of an API and formulation varies with
time under the influence of a variety of environmental factors such as temperature, humidity, and
light, and to establish a shelf life and recommended storage conditions. The design of the stability-
testing programme takes into account the intended market and the climatic conditions in the area
in which the product will be used. This is accomplished by placing samples of API and formulations
in stability chambers with variety of light, temperatures and humidity conditions. At pre-determined
time intervals, samples are pulled out of stability chambers for analytical testing to determine their
stability. This data is generated over a typical timeframe of two to three years and is used to define
the shelf life and the recommended storage condition for that product.
Large molecules development: The large molecules development platform supports the
development of a process for manufacturing of a novel biological entity as it transitions from the
laboratory to a manufacturing set-up based on increasing volumes.
6 October 2020 59
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 99 Global drug spending to grow in the 4-5% range until CY23
US$bn
Global Medicine spending and growth 2017-24
1600 7%
5.8%
1400 5.5% 6%
1200 4.8% 4.8%
5%
4.2% 4.0%
1000
3.5% 4%
800 1518
1386 1453 3%
1250 1318
600 1143 1206
2%
400
200 1%
0 0%
2017 2018 2019E 2020E 2021E 2022E 2023E
Source: IQVIA, Solara FY20 annual report, Macquarie Research, September 2020
Fig 100 Total R&D pipeline, by year, 2001-2020 Fig 101 Pipeline by development phase, 2020 vs. 2019
20000 12000
18000
10000
16000
14000 8000
12000
6000
10000
8000 4000
6000
2000
4000
2000 0
Launched
Phase I
N/A
Pre-reg
Preclin
Registered
Suspended
Phase III
Phase II
0
2001
2002
2003
2007
2008
2012
2013
2017
2018
2004
2005
2006
2009
2010
2011
2014
2015
2016
2019
2020
Source: Pharma R&D Annual Review 2020| Informa, Macquarie Source: Pharma R&D Annual Review 2020| Informa, Macquarie
Research, October 2020 Research, October 2020
3000
2500
2000
1500
1000
500
0
Phase I Phase II Phase III
Source: Pharma R&D Annual Review 2020| Informa, Macquarie Research, October 2020
6 October 2020 60
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 103 Distribution of R&D companies by HQ Fig 104 Where is R&D actually occurring?
country/region, 2019 and 2020
Source: Pharma R&D Annual Review 2020| Informa, Macquarie Source: Pharma R&D Annual Review 2020| Informa, Macquarie
Research, October 2020 Research, October 2020
Fig 105 Where are the top-10 companies developing their drugs?
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
USA South America Oceania Europe, Non-EU Europe, EU Canada Asia Africa
Source: Pharma R&D Annual Review 2020| Informa, Macquarie Research, October 2020
Fig 106 The R&D pipeline by therapy group, 2019 and 2020
7000
6000
5000
4000
3000
2000
1000
0
2019 2020
Source: Pharma R&D Annual Review 2020| Informa, Macquarie Research, October 2020
6 October 2020 61
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 107 Proportion of the pipeline which is in development for cancer, 2010–20
38
% of pipeline which is Oncology
36
34
32
30
28
26
24
22
20
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Source: Pharma R&D Annual Review 2020| Informa, Macquarie Research, October 2020
Fig 108 Global drug spending across regions Fig 109 Global drug spending across regions (five-year
CAGR)
$bn
1,800 10.0% 9.3%
1505-1535
1,600 9.0% 5-8%
1,400 1,245 8.0% 7.2%
6.3% 4-7%
1,200 1,205 7.0%
6.0% 3-6%
1,000 4.7%
5.0% 1-4%
800 625-655
507 4.0%
600 355-385
485 195-225 3.0%
400 293
182 89-93 286 2.0% 1.0%
178 86 89
200 1.0% -3-0%
- 0.0%
Source: IQVIA, Macquarie Research, October 2020 Source: IQVIA, Macquarie Research, October 2020
6 October 2020 62
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 110 Major M&A in the global CRAMS space in the past 10 years
Month Acquirer Target Value (US$ m) Target description
Feb-20 Catalent MaSTherCell 315 Cell therapy
Feb-20 ICON MedPass International NA Medical device CRO, regulatory and reimbursement consultancy
Feb-20 Paraxel Model Ansers NA PK and PD modelling, simulation and analysis services
May-19 Catalent Paragon Bioservices 1200 Gene therapy
May-19 ICON MediNova NA Clinical research site
May-19 Ampersand Capital Vibalogics NA CDMO
May-19 Evotec Just Biotherapeutics 90 Molecule to Manufacturing
Mar-19 Thermo Fisher Brammer Bio 1700 Viral Vector manufacturing for gene and cell therapy
Mar-19 Sterling GHO Capital NA API CDMO
Feb-19 Charles River Citoxlab 510 Non-Clinical CRO
Feb-19 ICON Molecular MD NA Molecular diagnostic testing and immunohistochemistry
Jan-19 Elligo Health Research Protenium NA Clinical Research for therapeutic areas
Dec-18 Atlantic Research CCA Clinical Research NA CRO
Nov-18 JLL Partners/ Water Street Cato Research NA CRO
Nov-18 Cobepa BioAgilytix Labs 280 Large Molecule, Bioanalysis Lab services
Nov-18 Cambrex Avista Pharma 252 CDMO
Oct-18 Lonza Octane 58 Cell therapy
Aug-18 Catalent Juniper Pharmaceuticals 130 Therapeutics for women health
Aug-18 Syneos Health Kinapse 160 Life Sciences consulting
Jul-18 Cambrex Halo Pharma 425 CDMO
Jul-18 SK Biotek AMPAC 455 Small molecule API
Jun-18 Precision Therapeutics Helomics Merger Precision - Life Science, devoted to cancer.
Mar-18 Linical Accelovance Merger CRO
Feb-18 Charles River MPI Research 800 Non-Clinical CRO
Jan-18 Spectris Concept Life Sciences 163 Drug Discovery and Development
Jan-18 Charles River KWS BioTest 20 Specialises in vitro and vivo testing services in immunology
Dec-17 JSR Corporation Crown Bioscience 400 CRO
Sep-17 Catalent Cook Pharmica 950 CDMO
Sep-17 3SBio Therapure Biopharma 290 CDMO
Aug-17 Carlyle Group and GTCR Albany Molecular 935 CRO
Aug-17 INC Research inVentive Health Merger CRO. Now Syneos Health
Aug-17 PRA Health Symphony Health 530 GP services
Aug-17 Charles River Brains On-Line 21 Micro dialysis in CNS, vivo efficacy and pharmacokinetics testing
Aug-17 Thermo Fisher Patheon 7200 CDMO
Aug-17 Evotec Aptuit 300 CDMO
Jul-17 Lonza Capsugel 5500 CDMO
Jul-17 Lonza Micro-Macinazione NA CMO in micronization. Sales ~ CHF 20 million in 2016
Jun-17 Pamplona Capital Paraxel 5000 CRO
Jun-17 Eurofins Alphora Research 289 CRAMS for complex and niche small molecule API
Mar-17 Wuxi PharmaTech AppTec Lab Services 151 contract testing, R&D, biologics manufacturing
Feb-17 AGC Asahi Glass CMC Biologics 511
Oct-16 Evotec Cyprotex 677 CRO
Sep-16 Catalent Pharmatek Labs NA CDMO
Aug-16 Lonza InterHealth Nutraceuticals 300 Specialty nutritional ingredients
Aug-16 Cinven BioClinica 1400 Specialised technology-enabled services supporting clinical trials
Aug-16 Piramal Ash Stevens 53 API CMO
May-16 Quintiles IMS Health Merger IMS - data gathering and analysis; Quintiles - clinical applications
May-16 PPD Synexus 258 Site Network Org. developments in clinical trails
May-16 AMRI Euticals 358 API maker
Jan-16 Charles River WIL Research 585 CDMO
Nov-15 RWS Holdings Corporate Translations 70 Life Sciences translation and linguistic validation provider
Sep-15 Venn Life Sciences Kinesis Pharma 36 Drug development consultancy offering CRO
Aug-15 Wuxi Life Science Wuxi PharmaTech 3300 Laboratory and manufacturing services
Jul-15 Lab Corp Chiltern 1200 CRO
Jul-15 Charles River Celsis International 212 Rapid bacterial detection/microbial screening
Jun-15 AMRI Gadea 174 API development and manufacturing
Feb-15 Lab Corp Covance 5600 CRO
Nov-14 Recipharm Lusomedicamenta 140 CDMO
Oct-14 Recipharm Corvette SEK 1.1bn CRO
Jul-14 PCI Pharma Services Penn Pharma Service 215 Drug development, clinical trial supply and manufacturing services
Jul-14 Bridgepoint Phlexglobal 420 Document management solutions to the clinical research market
Jun-14 AMRI Oso Biopharmaceutical 110 CMO
May-14 Covance Medaxial NA Market access/HEOR consultancy
Mar-14 ICON Aptiv Solutions 144 Clinical CRO focused on adaptive & device trials
Feb-14 Cinven Medpace 900 Full- Service CRO
Dec-12 Patheon Banner PharmaCaps 255 Specialty pharma doing R&D of gelatin-based dosage forms.
Jun-12 Piramal Decision Resources Group 635 Research, predictive analytics and consulting services
Dec-11 ICON BeijingWits NA CRO
Source: Company data, Outsourcing Pharma, The Pharma Letter, Pharma’s Almanac, Macquarie Research, October 2020
6 October 2020 63
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Company Notes
Syngene International (SYNG IN) - Follow the molecule: An India innovation play………………...69
6 October 2020 64
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
6 October 2020 India
2.5
2.9
2.9
We see Divi's as an attractive play on outsourcing industry tailwinds - both
2.5 2.5 2.6
2.4
2.5 CRAMS as well as the API segments.
With strong growth visibility, one of the best margins globally and a robust
2.0 2.3
1.5
1.0
regulatory track record, premium valuations are justified, in our view.
Initiate coverage on Divi's with an Outperform and a street-high target price
FY16
FY17
FY18
FY19
FY20
FY21E
FY23E
FY22E
DIVI IN Outperform Divi’s is significantly ahead of its Indian peers on most metrics
Price (at 10:03, 05 Oct 2020 GMT) Rs3,047.40 Divi’s is among the top-3 active pharmaceutical ingredient (API) manufacturers in
Valuation Rs 3,764.00 the world and is a leading custom manufacturer for big pharma companies as
- EV/EBITDA well as a reliable supplier of generic APIs. Divi’s “secret sauce” lies in combining
12-month target Rs 3,764.00 atom chemistry tenets with green chemistry principles to provide a sustainable
Upside/Downside % +23.5 offering. Our extensive checks across its value chain reaffirm our view that Divi’s
12-month TSR % +24.2
outscores Indian peers with its superior product selection, agility, relentless focus
on efficiencies, low-cost manufacturing at its two large facilities and employee
Volatility Index Medium
retention. Also, Divi’s is one of the few dependable, pure-play API manufacturers
GICS sector
globally and goes to great lengths to play a complementary role to eradicate any
Pharmaceuticals, Biotechnology & Life Sciences
IP concerns. It has a track record of maintaining profitability and capital efficiency,
Market cap Rsm 809,085
making it one of the most profitable companies globally in the CRAMS/API space.
Market cap US$m 11,119
Free float % 48 Well placed to capitalise on CRAMS/API sector tailwinds
30-day avg turnover US$m 60.9
Owing to the above factors, Divi’s is very well placed to accept any incremental
Number shares on issue m 265.5
opportunities coming from higher pharma outsourcing to India. We expect it to
Investment fundamentals gain further share in both contract research and manufacturing services
Year end 31 Mar 2020A 2021E 2022E 2023E
(CRAMS) and API as big pharma companies look to diversify their supplier base
Revenue m 53,944 67,261 80,815 97,103 and focus more on stability of supplies rather than just pricing post COVID-19.
EBIT m 16,359 23,183 28,806 36,186 We expect Divi’s top-line CAGR of 22% over FY20-23E to be driven by
EBIT growth % -3.9 41.7 24.3 25.6 debottlenecking of Units 1 and 2, commercialisation of brownfield projects and
Recurring profit m 18,195 24,889 30,598 38,088 strength in all three business segments. Post capex at an opportune time, we
Reported profit m 13,765 18,662 22,887 28,490
expect strong operating leverage to start kicking in with EBITDA margins
Adjusted profit m 13,765 18,662 22,887 28,490
expanding by 675bps over FY20-23E. We note the PLI scheme is less applicable
EPS rep Rs 51.85 70.29 86.21 107.31
EPS rep growth % 1.8 35.6 22.6 24.5 for Divi’s given its scale and higher export focus.
EPS adj Rs 51.85 70.29 86.21 107.31
EPS adj growth % 1.8 35.6 22.6 24.5 At a local premium yet a steep discount to global peers
PER rep x 58.8 43.4 35.3 28.4
PER adj x 58.8 43.4 35.3 28.4
Compared to our existing pharma coverage, we think Divi’s deserves to trade at a
Total DPS Rs 16.00 20.89 25.86 32.19 premium given the secular nature of CRAMS industry growth, high entry barriers
Total div yield % 0.5 0.7 0.8 1.1 and Divi’s moat, sectoral tailwinds, consistent delivery of industry-leading
ROA % 19.7 25.1 26.7 28.4 margins, robust balance sheet and a near spotless regulatory track record. After
ROE % 19.3 23.4 24.2 25.3 the recent stock run-up, the shares still trade at a sharp discount to global
EV/EBITDA x 44.6 32.0 25.7 20.7
CRAMS/API companies. Our target price implies 13% revenue CAGR and 16%
Net debt/equity % -0.1 0.2 -2.1 -4.8
EBITDA CAGR in FY20-30E, which is achievable, in our view. Divi’s also scores
P/BV x 11.1 9.4 7.9 6.6
well in our global pharma quant score, ranking in the top 6%. We assign Divi’s a
Source: FactSet, Macquarie Research, October 2020
(all figures in INR unless noted) 28x Sep-22 EV/EBITDA multiple, still a discount to most global competitors
despite Divi’s scoring above them on most financial metrics. Thus, our fair value
for Divi’s is Rs3,764. In a bull case scenario, building in higher growth, margins
Analysts and at a 30x EV/EBITDA multiple, we derive a value of Rs4,292/share.
Macquarie Capital Securities (India) Pvt. Ltd. Key risks: The biggest risk for Divi’s is its high product and client concentration.
Alankar Garude, CFA +91 22 6720 4134
alankar.garude@macquarie.com
Divi’s is not present in biologics and runs the risk of losing out on this theme. We
would also closely monitor any governance issues.
Surabhi Bomb +91 22 6720 4039
surabhi.bomb@macquarie.com Click here to link to our initiation report
6 October 2020 65
The company follows a • Superior product selection: Divi’s follows a stringent product selection process, with a sharp
stringent product focus on selecting complex molecules where it can command a high market share and have
selection process, with pricing power. One of Divi’s key strengths is the management’s strong research background.
a sharp focus on The belief is in doing less, but doing it well, much better than anyone else.
selecting complex
• Low-cost manufacturing: Divi’s has focussed primarily on leveraging its strengths in chemistry
molecules where it can
to have a cost competitive and fast delivery structure. Its low-cost manufacturing setup helps
command a high market
drive higher than peer’s profitability. The company keeps on revisiting the chemistry constantly
share and hence have
to increase efficiencies, which makes it cost-efficient.
higher pricing power
• Fungibility: Divi’s facilities are flexible and hence it can easily switch products or resize
batches depending on the requirement. Divi’s has had a strong track record of swiftly tweaking
existing capacities to boost production, thereby yielding higher return ratios.
• Robust track record of adhering to IP norms: Divi’s has a strict IP policy and importantly, it
doesn’t file its own products in client markets. This is a key assuring factor for clients, which
makes them comfortable in sharing important product-specific details.
• Complementary role: Divi’s is one of the few reliable, pure-play API manufacturers in the world
and is not present in formulations. Thus, it does not play a competing role with its customers.
Divi’s enjoys a high goodwill from both its customers as well as suppliers.
Fig 3 We expect FY20-23E revenue to grow at 22% CAGR Fig 4 Healthy mix of CDMO and generic API
97 25%
100 26% 100% 7%
25% 81 7% 7% 9% 8% 8% 8% 8%
20%
80 21% 20% 20% 80%
15%
67 49% 49% 49% 49% 51% 51% 51% 51%
60 54 10% 60%
49
41
38 39 9% 5%
40 8% 40%
0%
20 20% 44% 44% 44% 42% 41% 41% 41% 41%
-5%
-5%
- -10% 0%
FY16 FY17 FY18 FY19 FY20 FY21E FY22E FY23E FY16 FY17 FY18 FY19 FY20 FY21E FY22E FY23E
Revenue Growth (YoY) (RHS) Custom Synthesis Manufacturing Generics API Nutraceuticals
Source: Company data, Macquarie Research, October 2020 Source: Company data, Macquarie Research, October 2020
6 October 2020 66
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 5 We expect all the three segments to report strong growth over FY20-23E
60%
40%
20%
0%
-20%
-40%
FY22E
FY21E
FY23E
FY11
FY14
FY18
FY10
FY12
FY13
FY15
FY16
FY17
FY19
FY20
Custom Synthesis Manufacturing Generics & API Nutraceuticals
With commercialisation We note that Divi’s FY20 EBITDA margins were compressed at 33.8% (compared to 38% in FY19)
of all new facilities by due to increase in employee costs (added 900 employees in FY20 for new projects) and other
FY21 end, we expect the operating expenses due to the new facilities getting commissioned. Similar to FY20, Divi’s is
strong operating planning to add 1K+ people in FY21 for its new projects. However, for FY21, we expect factors like
leverage to start kicking higher capacity utilisation (currently at 80%+), continued backward integration and INR
in from FY22 onwards depreciation to offset this incremental cost and support margin expansion for Divi’s. As Divi’s
with EBITDA margins to capacity utilisation increases, we expect the company to deliver elevated top-line growth and
expand by ~675bps over improved margins. With commercialisation of all new facilities by FY21 end, we expect the strong
FY20-23E operating leverage to start kicking in from FY22 onwards with EBITDA margins to expand by
~675bps over FY20-23E.
6 October 2020 67
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Divi's Laboratories (DIVI IN, Outperform, Target Price: Rs3,764.00)
Quarterly Results 1Q/21A 2Q/21E 3Q/21E 4Q/21E Profit & Loss 2020A 2021E 2022E 2023E
Revenue m 17,305 17,485 17,329 15,142 Revenue m 53,944 67,261 80,815 97,103
Gross Profit m 10,906 10,924 10,827 9,365 Gross Profit m 32,859 42,022 50,833 61,563
Cost of Goods Sold m 6,398 6,561 6,503 5,777 Cost of Goods Sold m 21,085 25,239 29,983 35,540
EBITDA m 7,001 6,640 6,581 5,187 EBITDA m 18,222 25,409 31,599 39,356
Depreciation m 562 739 462 462 Depreciation m 1,862 2,225 2,793 3,170
Amortisation of Goodwill m 0 0 0 0 Amortisation of Goodwill m 0 0 0 0
Other Amortisation m 0 0 0 0 Other Amortisation m 0 0 0 0
EBIT m 6,439 5,901 6,119 4,725 EBIT m 16,359 23,183 28,806 36,186
Net Interest Income m -2 -5 -63 50 Net Interest Income m -61 -19 -19 0
Associates m 0 0 0 0 Associates m 0 0 0 0
Exceptionals m 0 0 0 0 Exceptionals m 0 0 0 0
Forex Gains / Losses m 0 0 0 0 Forex Gains / Losses m 0 0 0 0
Other Pre-Tax Income m 173 368 375 809 Other Pre-Tax Income m 1,896 1,726 1,812 1,903
Pre-Tax Profit m 6,610 6,264 6,431 5,584 Pre-Tax Profit m 18,195 24,889 30,598 38,088
Tax Expense m -1,689 -1,597 -1,640 -1,301 Tax Expense m -4,429 -6,227 -7,711 -9,598
Net Profit m 4,921 4,667 4,791 4,283 Net Profit m 13,765 18,662 22,887 28,490
Minority Interests m 0 0 0 0 Minority Interests m 0 0 0 0
Reported Earnings m 4,921 4,667 4,791 4,283 Reported Earnings m 13,765 18,662 22,887 28,490
Adjusted Earnings m 4,921 4,667 4,791 4,283 Adjusted Earnings m 13,765 18,662 22,887 28,490
EPS (rep) 18.53 17.58 18.05 16.13 EPS (rep) 51.85 70.29 86.21 107.31
EPS (adj) 18.53 17.58 18.05 16.13 EPS (adj) 51.85 70.29 86.21 107.31
EPS Growth yoy (adj) % 80.6 30.8 33.4 10.3 EPS Growth (adj) % 1.8 35.6 22.6 24.5
PE (rep) x 58.8 43.4 35.3 28.4
PE (adj) x 58.8 43.4 35.3 28.4
EBITDA Margin % 40.5 38.0 38.0 34.3 Total DPS 16.00 20.89 25.86 32.19
EBIT Margin % 37.2 33.7 35.3 31.2 Total Div Yield % 0.5 0.7 0.8 1.1
Earnings Split % 26.4 25.0 25.7 23.0 Basic Shares Outstanding m 265 265 265 265
Revenue Growth % 48.8 21.0 24.1 9.0 Diluted Shares Outstanding m 265 265 265 265
EBIT Growth % 87.6 30.9 36.8 19.7
Profit and Loss Ratios 2020A 2021E 2022E 2023E Cashflow Analysis 2020A 2021E 2022E 2023E
Revenue Growth % 9.1 24.7 20.2 20.2 EBITDA m 18,222 25,409 31,599 39,356
EBITDA Growth % -2.7 39.4 24.4 24.5 Tax Paid m -4,429 -6,227 -7,711 -9,598
EBIT Growth % -3.9 41.7 24.3 25.6 Chgs in Working Cap m 1,296 -6,524 -6,812 -8,182
Gross Profit Margin % 60.9 62.5 62.9 63.4 Net Interest Paid m -61 -19 -19 0
EBITDA Margin % 33.8 37.8 39.1 40.5 Other m -2,869 900 963 1,009
EBIT Margin % 30.3 34.5 35.6 37.3 Operating Cashflow m 12,159 13,538 18,019 22,585
Net Profit Margin % 25.5 27.7 28.3 29.3 Acquisitions m -10,563 0 0 0
Payout Ratio % 30.9 29.7 30.0 30.0 Capex m -11,832 -9,080 -6,465 -7,186
EV/EBITDA x 44.6 32.0 25.7 20.7 Asset Sales m 4 0 0 0
EV/EBIT x 49.7 35.1 28.2 22.5 Other m 21,557 424 -2,576 -3,276
Investing Cashflow m -835 -8,657 -9,042 -10,462
Balance Sheet Ratios Dividend (Ordinary) m -10,241 -5,121 -6,685 -8,278
ROE % 19.3 23.4 24.2 25.3 Equity Raised m 0 0 0 0
ROA % 19.7 25.1 26.7 28.4 Debt Movements m -612 0 0 0
ROIC % 17.6 23.8 24.9 26.9 Other m -61 -19 -19 0
Net Debt/Equity % -0.1 0.2 -2.1 -4.8 Financing Cashflow m -10,914 -5,140 -6,705 -8,278
Interest Cover x 268.2 1,193.4 1,482.8 nmf
Price/Book x 11.1 9.4 7.9 6.6 Net Chg in Cash/Debt m 411 -259 2,273 3,845
Book Value per Share 275.3 325.7 386.7 462.8
Free Cashflow m 327 4,457 11,554 15,399
6 October 2020 68
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
6 October 2020 India
6 October 2020 69
Syngene has multiple entry points across the life cycle of clients’ molecules
We believe Syngene is well-positioned as a one-stop shop for its clients to advance their R&D
Syngene wants to be a
programmes from the discovery stage to development and then commercialisation. Starting from
one-stop shop. Syngene
solving fundamental scientific questions at the beginning of discovery to elucidating a target to
has worked extensively
selecting a molecule and engaging with that target, then taking it forward to prove that it is ready to
on forward integration –
go into human studies with an IND package, clinical testing to develop the processes to
expanding from being a
commercial manufacturing, Syngene wants to be a one-stop shop. Syngene has worked
dominant CRO to
extensively on forward integration – expanding from being a dominant CRO to having an
having an integrated
integrated CRAMS model. An integrated approach helps the company to extend relationships with
CRAMS model
key customers across multiple service lines and grow its share of the customers’ R&D projects.
Increasingly, big pharma companies are keen on preferred partnerships with full service CROs that
effectively exclude other CROs from the bidding process. Especially over the past few years,
Syngene has evolved from being a discovery chemistry and discovery biology-focussed CRO to a
meaningfully integrated provider of discovery and development services for NMEs across small
molecules, large molecule biologics, ADCs and oligonucleotides. Syngene’s various offerings
provide it multiple entry points during the life cycle of their clients’ molecules across the discovery
and development processes. Some of the global comparable (albeit significantly bigger) vertically
integrated CRO/CDMOs are Lonza and Thermo Fisher Scientific. In our view, success of the
Mangaluru facility will be instrumental in shaping Syngene’s journey as it intends to evolve from a
CRO into a CRO/CDMO with strong commercial-scale manufacturing capabilities.
6 October 2020 70
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 8 Expect strong growth across segments over FY20-23 Fig 9 Gross margins to expand by ~240bps over FY20-23E
30% 49%
46% 45.3%
15% 45.0% 45.1%
45%
10%
44%
5%
43%
0%
FY19 FY20 FY21E FY22E FY23E 42%
FY16 FY17 FY18 FY19 FY20 FY21E FY22E FY23E
Dedicated R&D labs Discovery services
Development & Mfg services Gross margin
Fig 10 EBITDA margins to expand ~450bps over FY20-23E Fig 11 PAT to grow at a 25% CAGR over FY20-23E
(Rs bn)
33.9% 34.5%
32.3% 33.2%
35.0% 6 6.6 35%
10 29.5% 30.0% 29.6% 11.0 30%
27.7% 8.8 30.0% 26% 30%
5 31%
8 5.1
6.6 25.0% 25%
6.0 4
6 5.4 20.0% 20%
3.7
4.1 3 3.3 3.4
3.9 15.0% 3.1 15%
3.6 2.9
4
2 7% 8% 8%
10.0% 2.2 10%
2 3%
5.0% 1 5%
- 0.0% - 0%
FY16 FY17 FY18 FY19 FY20 FY21E FY22E FY23E FY16 FY17 FY18 FY19 FY20 FY21E FY22E FY23E
Source: Company data, Macquarie Research, October 2020 Source: Company data, Macquarie Research, October 2020
6 October 2020 71
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Syngene International (SYNG IN, Outperform, Target Price: Rs708.00)
Quarterly Results 1Q/21A 2Q/21E 3Q/21E 4Q/21E Profit & Loss 2020A 2021E 2022E 2023E
Revenue m 4,216 5,447 6,006 6,720 Revenue m 20,119 22,388 26,481 31,762
Gross Profit m 1,915 2,422 2,670 3,081 Gross Profit m 9,121 10,088 12,489 15,138
Cost of Goods Sold m 2,301 3,025 3,336 3,638 Cost of Goods Sold m 10,998 12,300 13,993 16,624
EBITDA m 1,278 1,676 1,850 1,828 EBITDA m 6,035 6,632 8,795 10,970
Depreciation m 661 665 710 847 Depreciation m 2,193 2,883 3,407 3,825
Amortisation of Goodwill m 0 0 0 0 Amortisation of Goodwill m 0 0 0 0
Other Amortisation m 0 0 0 0 Other Amortisation m 0 0 0 0
EBIT m 617 1,011 1,140 981 EBIT m 3,842 3,749 5,388 7,146
Net Interest Income m -74 -48 -48 -107 Net Interest Income m -346 -278 -200 -50
Associates m 0 0 0 0 Associates m 0 0 0 0
Exceptionals m 0 0 0 0 Exceptionals m 713 0 0 0
Forex Gains / Losses m -33 0 0 33 Forex Gains / Losses m 144 0 0 0
Other Pre-Tax Income m 153 157 151 458 Other Pre-Tax Income m 816 918 981 1,164
Pre-Tax Profit m 663 1,120 1,242 1,364 Pre-Tax Profit m 5,169 4,389 6,169 8,259
Tax Expense m -83 -226 -252 -224 Tax Expense m -1,048 -785 -1,110 -1,652
Net Profit m 580 893 990 1,140 Net Profit m 4,121 3,604 5,059 6,607
Minority Interests m 0 0 0 0 Minority Interests m 0 0 0 0
Reported Earnings m 580 893 990 1,140 Reported Earnings m 4,121 3,604 5,059 6,607
Adjusted Earnings m 580 893 990 1,140 Adjusted Earnings m 3,408 3,604 5,059 6,607
EPS (rep) 1.46 2.24 2.49 2.86 EPS (rep) 10.38 9.06 12.70 16.59
EPS (adj) 1.46 2.24 2.49 2.86 EPS (adj) 8.58 9.05 12.70 16.59
EPS Growth yoy (adj) % -19.8 57.1 7.6 -5.1 EPS Growth (adj) % 2.7 5.6 40.3 30.6
PE (rep) x 53.3 61.1 43.6 33.4
PE (adj) x 64.5 61.1 43.6 33.4
EBITDA Margin % 30.3 30.8 30.8 27.2 Total DPS 0.00 0.50 0.60 0.70
EBIT Margin % 14.6 18.6 19.0 14.6 Total Div Yield % 0.0 0.1 0.1 0.1
Earnings Split % 16.1 24.8 27.5 31.6 Basic Shares Outstanding m 400 400 400 400
Revenue Growth % 0.2 17.2 15.7 10.6 Diluted Shares Outstanding m 397 398 398 398
EBIT Growth % -14.4 21.2 32.1 -31.1
Profit and Loss Ratios 2020A 2021E 2022E 2023E Cashflow Analysis 2020A 2021E 2022E 2023E
Revenue Growth % 10.2 11.3 18.3 19.9 EBITDA m 6,035 6,632 8,795 10,970
EBITDA Growth % 12.0 9.9 32.6 24.7 Tax Paid m -1,048 -785 -1,110 -1,652
EBIT Growth % 2.6 -2.4 43.7 32.6 Chgs in Working Cap m 441 359 525 802
Gross Profit Margin % 45.3 45.1 47.2 47.7 Net Interest Paid m -346 -278 -200 -50
EBITDA Margin % 30.0 29.6 33.2 34.5 Other m 1,689 477 362 378
EBIT Margin % 19.1 16.7 20.3 22.5 Operating Cashflow m 6,771 6,404 8,373 10,449
Net Profit Margin % 16.9 16.1 19.1 20.8 Acquisitions m 0 0 0 0
Payout Ratio % 0.0 5.5 4.7 4.2 Capex m -6,431 -7,534 -5,998 -6,242
EV/EBITDA x 36.9 33.6 25.3 20.3 Asset Sales m 9,123 0 0 0
EV/EBIT x 57.9 59.4 41.3 31.2 Other m -6,976 4,803 819 835
Investing Cashflow m -4,284 -2,731 -5,179 -5,406
Balance Sheet Ratios Dividend (Ordinary) m -241 0 -200 -240
ROE % 16.4 15.3 18.1 19.7 Equity Raised m 7 0 0 0
ROA % 9.8 8.9 11.7 13.5 Debt Movements m -1,620 -3,089 0 0
ROIC % 15.4 13.4 19.0 22.6 Other m -401 -278 -200 -50
Net Debt/Equity % 5.3 -8.8 -16.6 -26.7 Financing Cashflow m -2,255 -3,367 -400 -290
Interest Cover x 11.1 13.5 26.9 142.9
Price/Book x 10.2 8.7 7.3 6.0 Net Chg in Cash/Debt m 232 306 2,793 4,753
Book Value per Share 54.4 63.6 75.8 91.7
Free Cashflow m 340 -1,130 2,374 4,207
6 October 2020 72
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
6 October 2020 India
1,000
1,073
Vizag Phase Key points
Solara is a top 3 pure-play API manufacturer in India.
1 capex of
753
800 Rs2.5bn
600
400
200
145
304
Detailed analysis of its API portfolio, Solara's long-term focus and growing
- presence in CRAMS suggest strong outlook even beyond FY23.
Initiate with an Outperform rating and a Rs1,680 target price (54% TSR).
(200)
(247)
(400)
FY18 FY19 FY20 FY21E FY22E FY23E
FCF
Source: Company data, Macquarie Research, Oct 2020 A steadfast long-term focus is Solara’s key success mantra
Solara was formed after the demerger of human API segments of Strides Pharma
SOLARA IN Outperform and Sequent Scientific in Feb-18. It benefits from a legacy of over three decades
Price (at CLOSE, 01 Oct 2020 GMT) Rs1,093.20 in the API space. Solara is well placed to capitalise on the huge opportunity for
Indian API companies arising from dual-sourcing and import substitution owing to
Valuation Rs 1,680.00
- EV/EBITDA
robust customer relationships with a long-term focus, healthy filings and global
12-month target Rs 1,680.00
cost leadership in key molecules like Ibuprofen. We expect Solara’s strategy of
working with customers on a long-term basis (50-60% contracts are long-term)
Upside/Downside % +53.7
rather than capitalising on short term opportunities to lead to higher wallet share
12-month TSR % +53.9
among existing clients as well as help in winning new customers. As a result, we
Volatility Index High believe Solara’s growth is more sustainable than some of its Indian API peers.
GICS sector
Pharmaceuticals, Biotechnology & Life Sciences Solara has done 150+ regulatory filings across 75+ countries, including more
Market cap Rsm 39,137 than 82 Drug Master Filings (DMFs). Our detailed analysis of Solara’s leading
Market cap US$m 535 molecules reveals that Solara enjoys a solid edge in most of these. While Solara
Free float % 26
has a higher regulated market focus (76% contribution in FY20), it is evaluating
the government’s Production Linked Incentive (PLI) scheme (currently domestic
30-day avg turnover US$m 0.8
sales are 10-12% of sales). Also, barring the recent Official Action Indicated (OAI)
Number shares on issue m 35.80
for Cuddalore (which our analysis suggests was largely linked to the Ranitidine
Investment fundamentals NDMA impurity issue), Solara has had a spotless regulatory compliance record.
Year end 31 Mar 2020A 2021E 2022E 2023E
Revenue m 13,218 16,376 19,230 22,581
Major capex behind, FCF generation to significantly improve
EBIT m 1,653 2,186 2,857 3,535 Over the medium term, we expect Solara’s top-line growth to accelerate, led by
EBIT growth % 20.0 32.3 30.7 23.7
commissioning of the Vizag facility, CRAMS, expansion to new markets and
Recurring profit m 1,149 1,680 2,560 3,404
Reported profit m 1,146 1,597 2,101 2,691
ramp-up of product filings. In addition to steady growth in its legacy products, we
Adjusted profit m 1,146 1,597 2,101 2,691 expect it to expand share of launches done over the past few years. Solara
EPS rep Rs 42.55 46.91 58.65 75.13 intends to grow in CRAMS both organically and inorganically (recent Rs4.6bn
EPS rep growth % 239.4 10.2 25.0 28.1 equity infusion by promoters and TPG provides growth capital) to contribute 30%
EPS adj Rs 42.82 47.51 58.65 75.13 to sales by FY25E from 10% in FY20. Overcoming the Ranitidine recall setback,
EPS adj growth % 91.2 11.0 23.4 28.1
we expect Solara to build on to its ~40% EBITDA CAGR over FY18-20, to deliver
PER rep x 25.7 23.3 18.6 14.6
PER adj x 25.5 23.0 18.6 14.6
25% EBITDA CAGR over FY20-23E. With major capex of Vizag behind, we
Total DPS Rs 2.00 2.00 3.00 4.00 expect Solara to report strong cumulative FCF of Rs2.2bn over FY21-23E.
Total div yield % 0.2 0.2 0.3 0.4
ROA % 8.0 8.9 10.0 11.3 Solara is still among the cheapest API stocks globally
ROE % 11.2 11.7 12.1 13.7
EV/EBITDA x 13.0 13.4 10.6 8.8
Despite scoring well on most parameters in our detailed global comparison, at
Net debt/equity % 48.7 10.9 6.5 -0.5 8.8x FY23E EV/EBITDA, Solara is among the cheapest API stocks globally. With
P/BV x 2.6 2.4 2.1 1.9 strong API growth visibility, increasing importance of pure-play API suppliers,
Source: FactSet, Macquarie Research, October 2020 rising CRAMS contribution, an improving margin profile and a strong regulatory
(all figures in INR unless noted) track record, we expect the stock to re-rate further (stock up 195% in the past one
year vs. Nifty 4%). We assign Solara a 13x Sep-22 EV/EBITDA target multiple,
Analysts which is still at a significant discount to most of its global and Indian API peers,
Macquarie Capital Securities (India) Pvt. Ltd. and incorporate risks like high client and portfolio concentration. Accordingly,
Alankar Garude, CFA +91 22 6720 4134 we assign a target price of Rs1,680 for Solara and initiate coverage with an
alankar.garude@macquarie.com Outperform rating. Our TP implies 12% revenue and 16% EBITDA CAGRs over
Surabhi Bomb +91 22 6720 4039
FY20-30E. Our bear/bull cases derive values per share of Rs1,320/ Rs2,064.
surabhi.bomb@macquarie.com
Click here to link to our initiation report
6 October 2020 73
• Strategic focus: One of the biggest strengths of Solara is that it is a pure play API company.
Solara’s strategic focus is leading to higher penetration for existing molecules. Apart from
For Solara, 50-60% of its bringing in more focus, it also helps gain higher client confidence.
contracts are long-term • Long-term contracts lend visibility: We like Solara’s emphasis on long-term commitments
(3-5 years). and being responsible in taking price hikes. For Solara, 50-60% of its contracts are long-term
(3-5 years). The company remains clear about not harping on short-term opportunities at the
cost of its clients. With increased capacity, the company is in a good position to add further
long-term contracts.
In high volume APIs like • Choosing the right products: A key strength of Solara is development and manufacturing of
Ibuprofen, Solara enjoys polymer-based APIs. Also, Solara is focussing on sterile, high potent and fermentation-based
a global cost leadership. APIs. In high volume APIs like Ibuprofen, Solara enjoys a global cost leadership. Incrementally,
Incrementally, Solara is Solara is focussing on low volume, high value DMF filings and is planning 8-10 filings annually
focussing on low over the next 3-5 years.
volume, high value DMF
• Strong presence in developed markets and expanding in EMs: Two-thirds of Solara’s sales
filings and is planning
are from North America and Europe. Also, the company was an early entrant in the relatively
8-10 filings annually
tough market of Japan. It has already started filing DMFs in China. Increasingly even ROW
over the next 3-5 years.
markets have increased their documentation requirements, thereby aiding companies with a
stronger compliance track record like Solara.
~40% of Solara’s sales • Strong relationships with big pharma and generic pharma companies: ~40% of Solara’s
are to big pharma sales are to big pharma companies and ~60% are to generic companies. For its key molecules,
companies and ~60% Solara has relationships with its clients for more than 15-20 years. This is demonstrated by
are to generic Solara’s ability to seamlessly pass on RM price hikes to its clients.
companies.
• Cost improvement program yielding results: Solara’s cost improvement program (CIP) has
been yielding results (40% EBITDA CAGR over FY18-20 on proforma basis) and the company
is highly cost-competitive in most of its key DMFs. Each of its facilities manages its own P&L.
• Robust culture of compliance: Barring the recent OAI for Cuddalore (which, in our view, was
largely linked to the Ranitidine NDMA impurity issue and Solara has since discontinued
Ranitidine), Solara has had a spotless US FDA compliance track record.
6 October 2020 74
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Fig 4 Management has guided for 15% revenue and 20% EBITDA CAGRs over FY19-23E
Management guidance Macquarie estimates
Rs bn FY19-23E FY19-23E
FY19 FY23 FY23
CAGR CAGR
Revenue 13.9 24.3 15% 22.6 13%
EBITDA 2.2 4.6 20% 5.0 23%
Source: Company data, Macquarie Research, October 2020
Our gross margin On the gross margin front, the company has a steady policy of either rationalising or raising prices
estimates for FY21-23E for APIs which do not meet the 50% gross margin requirement. Even as we are sanguine about
are 170-240bps lower Solara’s margins, we would highlight that Solara has mentioned that 1QFY21 gross margins
than 1QFY21 level of benefitted from a superior product mix as the company focussed on high margin products to make
57%. up for lost sales during the lockdown (three weeks of production stoppage in Apr-20). Thus, there
was a focus on gross margin-led growth in 1QFY21, which is unlikely to sustain, in our view.
Hence, staying conservative, our gross margin estimates for FY21-23E are 170-240bps lower than
1QFY21 level of 57%.
6 October 2020 75
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Solara Active Pharma Sciences (SOLARA IN, Outperform, Target Price: Rs1,680.00)
Quarterly Results 1Q/21A 2Q/21E 3Q/21E 4Q/21E Profit & Loss 2020A 2021E 2022E 2023E
Revenue m 3,484 3,949 3,865 5,079 Revenue m 13,218 16,376 19,230 22,581
Gross Profit m 1,987 2,164 2,118 2,672 Gross Profit m 7,229 8,942 10,557 12,487
Cost of Goods Sold m 1,497 1,785 1,747 2,407 Cost of Goods Sold m 5,989 7,435 8,673 10,094
EBITDA m 838 863 845 779 EBITDA m 2,594 3,324 4,206 5,035
Depreciation m 262 307 285 285 Depreciation m 942 1,138 1,349 1,500
Amortisation of Goodwill m 0 0 0 0 Amortisation of Goodwill m 0 0 0 0
Other Amortisation m 0 0 0 0 Other Amortisation m 0 0 0 0
EBIT m 576 556 560 494 EBIT m 1,653 2,186 2,857 3,535
Net Interest Income m -198 -199 -200 -199 Net Interest Income m -779 -796 -600 -450
Associates m 0 0 0 0 Associates m 0 0 0 0
Exceptionals m 0 0 0 0 Exceptionals m 0 0 0 0
Forex Gains / Losses m 0 0 0 0 Forex Gains / Losses m 0 0 0 0
Other Pre-Tax Income m 46 52 64 127 Other Pre-Tax Income m 275 289 303 319
Pre-Tax Profit m 423 409 424 423 Pre-Tax Profit m 1,149 1,680 2,560 3,404
Tax Expense m -1 -1 -1 -81 Tax Expense m -4 -84 -461 -715
Net Profit m 423 408 423 342 Net Profit m 1,145 1,596 2,100 2,689
Minority Interests m 0 0 0 1 Minority Interests m 1 1 2 2
Reported Earnings m 423 408 423 343 Reported Earnings m 1,146 1,597 2,101 2,691
Adjusted Earnings m 423 408 423 343 Adjusted Earnings m 1,146 1,597 2,101 2,691
EPS (rep) 14.74 11.40 11.81 9.57 EPS (rep) 42.55 46.91 58.65 75.13
EPS (adj) 14.74 11.40 11.81 9.57 EPS (adj) 42.82 47.51 58.65 75.13
EPS Growth yoy (adj) % 44.2 2.1 -22.5 54.4 EPS Growth (adj) % 91.2 11.0 23.4 28.1
PE (rep) x 25.7 23.3 18.6 14.6
PE (adj) x 25.5 23.0 18.6 14.6
EBITDA Margin % 24.1 21.9 21.9 15.3 Total DPS 2.00 2.00 3.00 4.00
EBIT Margin % 16.5 14.1 14.5 9.7 Total Div Yield % 0.2 0.2 0.3 0.4
Earnings Split % 26.5 25.6 26.5 21.5 Basic Shares Outstanding m 26 36 36 36
Revenue Growth % 5.5 12.5 12.5 71.1 Diluted Shares Outstanding m 27 34 36 36
EBIT Growth % 41.1 24.9 4.1 89.0
Profit and Loss Ratios 2020A 2021E 2022E 2023E Cashflow Analysis 2020A 2021E 2022E 2023E
Revenue Growth % -4.7 23.9 17.4 17.4 EBITDA m 2,594 3,324 4,206 5,035
EBITDA Growth % 17.5 28.1 26.5 19.7 Tax Paid m -4 -84 -461 -715
EBIT Growth % 20.0 32.3 30.7 23.7 Chgs in Working Cap m 942 1,138 1,349 1,500
Gross Profit Margin % 54.7 54.6 54.9 55.3 Net Interest Paid m -779 -796 -600 -450
EBITDA Margin % 19.6 20.3 21.9 22.3 Other m -311 -1,066 -1,164 -1,664
EBIT Margin % 12.5 13.4 14.9 15.7 Operating Cashflow m 2,442 2,517 3,329 3,707
Net Profit Margin % 8.7 9.8 10.9 11.9 Acquisitions m -1,050 0 0 0
Payout Ratio % 4.7 4.2 5.1 5.3 Capex m -2,689 -2,129 -2,115 -1,897
EV/EBITDA x 13.0 13.4 10.6 8.8 Asset Sales m 13 0 0 0
EV/EBIT x 20.3 20.4 15.6 12.6 Other m 138 50 50 50
Investing Cashflow m -3,588 -2,079 -2,065 -1,847
Balance Sheet Ratios Dividend (Ordinary) m -129 -52 -72 -107
ROE % 11.2 11.7 12.1 13.7 Equity Raised m 298 86 0 0
ROA % 8.0 8.9 10.0 11.3 Debt Movements m 1,636 0 0 0
ROIC % 12.4 12.8 12.9 14.3 Other m -855 3,044 -600 -450
Net Debt/Equity % 48.7 10.9 6.5 -0.5 Financing Cashflow m 949 3,079 -672 -557
Interest Cover x 2.1 2.7 4.8 7.9
Price/Book x 2.6 2.4 2.1 1.9 Net Chg in Cash/Debt m -197 3,517 592 1,303
Book Value per Share 419.7 455.9 512.5 584.6
Free Cashflow m -247 388 1,214 1,810
6 October 2020 76
jatin.lal@piramal.com Jatin Lal 10/09/20 02:06:38 PM Nicholas Piramal India Limited
Macquarie Research The Prize – India Pharma
Important disclosures:
Recommendation definitions Volatility index definition* Financial definitions
Macquarie – Asia and USA This is calculated from the volatility of historical All "Adjusted" data items have had the following
Outperform – expected return >10% price movements. adjustments made:
Neutral – expected return from -10% to +10% Added back: goodwill amortisation, provision for
Underperform – expected return <-10% Very high–highest risk – Stock should be catastrophe reserves, IFRS derivatives & hedging,
expected to move up or down 60–100% in a year IFRS impairments & IFRS interest expense
Macquarie – Australia/New Zealand – investors should be aware this stock is highly Excluded: non recurring items, asset revals, property
Outperform – expected return >10% speculative. revals, appraisal value uplift, preference dividends &
Neutral – expected return from 0% to 10% minority interests
Underperform – expected return <0% High – stock should be expected to move up or
down at least 40–60% in a year – investors should EPS = adjusted net profit / efpowa*
Note: expected return is reflective of a Medium Volatility be aware this stock could be speculative. ROA = adjusted ebit / average total assets
stock and should be assumed to adjust proportionately ROA Banks/Insurance = adjusted net profit /average
with volatility risk Medium – stock should be expected to move up total assets
or down at least 30–40% in a year. ROE = adjusted net profit / average shareholders funds
Gross cashflow = adjusted net profit + depreciation
Low–medium – stock should be expected to *equivalent fully paid ordinary weighted average
move up or down at least 25–30% in a year. number of shares
Low – stock should be expected to move up or All Reported numbers for Australian/NZ listed stocks
down at least 15–25% in a year. are modelled under IFRS (International Financial
* Applicable to select stocks in Asia/Australia/NZ Reporting Standards).
Recommendations – 12 months
Note: Quant recommendations may differ from
Fundamental Analyst recommendations
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Important disclosure information regarding the subject companies covered in this report is available publicly at
www.macquarie.com/research/disclosures. Clients receiving this report can additionally access previous recommendations (from the year prior to
publication of this report) issued by this report’s author at https://www.macquarieinsights.com.
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