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US, 28%
China, 13%
India, 18%
India is one of the top formulation drug exporters in the world, but its pharmaceutical industry relies heavily on
imports of bulk drugs, which are a key input for formulations. As the industry matured and grew, Indian players
graduated to the highly lucrative formulation part of the value chain compared to API. Imports from China
have been on a steady rise over the years due to low-cost advantage enjoyed by Chinese manufacturers.
With high import dependency on a single nation, the domestic pharmaceutical industry is at high risk of
supply disruptions and unexpected price movements. This calls for a pressing need for self-sufficiency in the
API industry and reduce the dependence on imports. In line with this, the government is taking measures to
boost API production in the country and this is likely to benefit companies such as SML, which have a higher
presence in the API space.
Emerging Opportunities; Strong product pipeline and expanded capacities to drive the API segment’s
growth: SML’s API segment’s revenue hasstaged a remarkable performance. Revenue increasedby 11.5% for
FY2020 after a decline in the FY2019. Strong momentum continued in Q1FY2021 with API sales growing by an
impressive 33% y-o-y. Better performance in oncology API business drove growth. Going ahead, the strong
performance is expected to sustain as the API segment is opening up to multiple emerging opportunities,
world over. China is a major supplier of pharmaceutical raw materials including - key starting materials (KSM),
intermediates, and APIs. The COVID-19 related disruption has certainly raised concerns in terms of sourcing
of inputs for the global pharma industry, as the dependency on Chinawas substantial for intermediates and
APIs. Consequently, companies world over are hunting for an alternate source for procurement of APIs as
the trend now shifts in favour reliable supplies, which takes precedence over pricing. Players such as SLM
with a substantial presence in the API space (the API revenue accounts for 55% of FY2020 revenue) and a
leadership position in the niche segment of oncology are set to be one of the key beneficiaries.
SML has a strong pipeline of patent fillings. As of June 2020,SMLhas filed for 201 patents, while ithas been
granted approvals for 35. Thus, it is awaiting clearance for 166 patents. Moreover, the company plans to
commercialise3-4 new molecules every year. In addition to this, of the total development pipeline, around
34% of the assets are Oncolytics.Thispoints at a strong product pipeline, which is expected to bear the fruits
in the time to come.Further, the company had increased capacities for various APIs in FY2020.Moreover, the
company is in the process of debottlenecking oncology production blocks by enhancing capacity by 40-70%.
The same is likely to come on stream by FY2021. Moreover SML’s key plants are approved by regulators
across the world. The company has clearance from various regulatory agencies - USFDA, WHO-GMP, EUGMP,
TGA, PMDA, KFDA, and TPD.Moreover, these plants have a multi-product capability for oncology andnon-
oncology,thus pointing at minimal regulatory hindrances. An array of opportunities lies ahead for SML’s API
segment. This is complemented by expanded capacities with regulatory approvals in place and a strong
product pipeline. Cumulatively, these levers are expected to drive the API segment’s performance, which is
expected to report double-digit growth over the next two years.
Formulations segment gaining momentum backed by increased geographic expansion and strong
pipeline: SML is an emerging player in the formulations space. The companyis leveraging its capabilities
in the API space to forward integrate in the formulations segment.In the recent years,the company has
successfully entered regulated markets with formulations products. SML commenced supplies to the US
generic formulations market through the launch of Capecitabine and Azacitidine in FY2017. Since then, the
segment has staged a strong performance. For FY2020, revenue at Rs. 191 crore have almost doubled as
compared to Rs. 89 crore in FY2018. Q1FY2021 performance was also phenomenal with the segment’s topline
growing by an impressive 78% y-o-y. Going ahead, SML has plans to focus on the fast growing and lucrative
formulations space. Management has identified multiple levers that are expected to propel growth for the
segment going ahead.
During FY2019-FY2020,SML has received regulatory approval for ANDAs of the generic versions of
Pirfenidone, Zoledronic Acid, Busulfan,Erlotinib and Bortezomib. In the same year, the company filed for four
ANDAs and one NDA, including one as FTF (First to File). The approved products are expected to be launched
in the US in the near term. A meaningful traction is likely from these in FY2022.In addition to this, the company
has a strong product pipeline with total fillings across US and EU at 61 as of June 2020. Of this, the company
has received approval for 38 products and is awaiting approval for 23. Off the 23 products awaiting approval
17 are filed with the USFDA, while sixare in EU. In FY2019-FY2020, the company filed for fourANDAs and one
NDA, including one as FTF, thus pointing at the strong pipeline. Given the strong in-house R&D, management
looks to file for more products in Europe, especially in the oncology space, in which it has a strong foot
hold. Apart from recent launches and a strong new product pipeline, emphasis on geographical expansion
is also likely to aid growth in the segment. SML is expanding its sales and distribution network for generic
formulations. Recently, the company has established wholly owned subsidiaries in Canada and Spain and is
September 04, 2020 10
Viewpoint
in the process to develop a marketing team across Russia, Europe, Brazil, and other geographies. Therefore,
a strong product pipeline, expanding geographical penetration coupled with enhanced emphasis laid by the
management on growing the formulations business make us optimistic on new order wins in the segment.
The formulations segment yields better margins as compared to the API segment due to better operational
efficiencies. With increased traction in formulations sales, contribution of the segment in the company’s sales
is expected to increase, thus pointing at better operating margins.
Foray in Biologics, OTC, to open up a new growth avenue, provides potential value unlocking opportunities:
In the recent past, SML forayed in the new areas of bio pharmaceuticals (biosimilars). The company sees huge
potential going ahead from this segment. With a view to unlock value in the biologics business, SML has formed a
100% subsidiary company – Shilpa Biologicals, which houses all the biologics assets currently. The subsidiary
company has sixbiosimilars and one new biological entity in its pipeline, with fourof the top 10 biologics in its
pipeline.The company is in advanced stage for setting up of a state-of-the-art biologics manufacturing facility
for Monoclonal antibodies and biologics in Belur, Dharwad. The facility consists of two production lines for
drug substance. SML is awaiting an approval from drug controllers’ office to commercialiseits first molecule
from this facility. Phase I of the facility is on schedule to be commissioned in quarter 2 of 2020. The Dharwad
facility commissioning with a strong in-house R&D would enable the company to vertically integrate in the
biopharmaceutical space, which would be a key plus point from a growth perspective. SML is in the process of
doing clinical trials on 1 Monoclonal antibodies (MAb), 1 fusion protein, and 1 NBE (new Biological entity). The
combined market size of these drugs is around $20 billion. In addition to these, two more are expected to be
added in FY2022 to the clinical trial pipeline, with market size of around $12 billion. The humongous market
opportunity points at a robust growth potential for the segment. SML expects revenue from the biosimilars
segment to kick in from FY2022-FY2023.Moreover, recently, the company has forayed in the OTC segment
with the launch of ready-to-drink Green Tea Films (Oral dissolving films), which management expects to be
moreeffective and safe as compared to competition. Though the OTC segment is currently at a very nascent
stage, over the long run, it could ramp up and constitute for a sizeable share of revenue. Moreover, the other
new areas of transdermal and albumins provide new growth avenues for the company.
As depicted in the table above, SML has a consistent compliance trackrecord. The Jadcherla plant, which
houses formulations manufacturing plants, has received form 483 with 15 observations. SML is working with
the USFDA to address the observations in a comprehensive manner. The receipt of USFDA clearance for this
plant is critical from the growth perspective.
Favourable product mix to aid margin expansion; Earnings to stage strong double-digit growth: SML’s
management has set its sight on growing its formulations business. The company’s strong capabilities in the
API space would enable it to forward integrate in the formulation segment. This augurs well for the company
as the formulations segment commands higher margins as compared to the API business. Further, in the
formulations segment, SML is looking to gain a foothold in the niche, oncology space. Moreover, it is looking
to tap other therapy areas in formulations.
FY2018 FY2020
Others,
Others, 10% Service & 4.90%
Service & License
License Income,
Income, 12.70%
6.60%
Formuations,
16.40%
API, 55.20%
Formuations,
27.20%
API, 67%
0
US, 21.3%
FY2018 FY2019 FY2020 FY2021E FY2022E FY2023E
100
90
80
70
60
P/E (x)
50
40
30
20
10
0
Jul-11
Jul-12
Jul-13
Oct-11
Jul-14
Oct-12
Jul-15
Oct-13
Jul-16
Oct-14
Jul-17
Oct-15
Jul-18
Oct-16
Jul-19
Oct-17
Jul-20
Oct-18
Apr-11
Oct-19
Apr-12
Apr-13
Apr-14
Apr-15
Apr-16
Apr-17
Apr-18
Apr-19
Apr-20
Jan-12
Jan-13
Jan-14
Jan-15
Jan-16
Jan-17
Jan-18
Jan-19
Jan-20
P/E (x) Avg. P/E (x) Peak P/E (x) Trough P/E (x)
Peer valuation
CMP O/S P/E EV / EBITDA RoE (%)
MCAP
Particulars (Rs / Shares
(Rs Cr) FY20 FY21E FY22E FY20E FY21E FY20E FY21E FY20E FY21E
Share) (Cr)
Shilpa Medicare 511 8.2 4,162.0 26.5 22.0 17.8 18.7 15.1 12.1 11.8 12.6 13.5
Laurus Labs 1,182 10.6 12,673.0 49.3 28.1 22.2 24.0 16.0 13.2 14.4 20.2 20.4
Strides Pharma 598 9.0 5362 38.3 18.7 13.0 10.7 8.4 6.7 1.7 11.9 13.0
Sciences
Source: Company, Sharekhan estimates
September 04, 2020 15
Viewpoint
About company
Shilpa Medicare Limited (SML) was incorporated in 1987 at Raichur, Karnataka, India. SML is one of the
leading API and formulations manufacturers with strong capabilities in the therapeutic area of oncology.The
companyis also present in the non-oncology therapy areas and has recently forayed in into formulations,
biologics, oral dissolving films,and transdermal patches. SML supplies more than 30 oncology APIs, including
key products such as Capecitabine, Gemcitabine Hydrochloride, Axitinib, Erlotinib Hydrochloride, and
Irinotecan Hydrochloride for various regulated markets, including US, Europe, Japan, South Korea, Russia,
Mexico, Brazil, and other emerging markets. The companyalso derives a small part of its revenue from sale
of non-oncology APIs,with key products being Ambroxol (Mucolytic agent) in Europe and Tranexmic Acid
and Ursodeoxycholic acid in India.SML operates fivemanufacturing units with fourof them being in India
and onein Austria. SML’s product range includes over 44 oncology and non-oncology APIs. The company’s
formulation product range consists of 16 injectable dosage forms, 19 oral solid dosage forms under SML,
and 13 formulations under SMLs wholly owned subsidiary Shilpa Therapeutics Private Limited.With respect
to geographical mix, India accounts for 32.5% of FY2020 sales. While the US, Europe, and RoW markets
constitute 21.3%, 22.2%, and 24%, respectively.
Investment theme
SML has an established presence in APIs and is an emerging player in formulations. The API segment, which
accounts for around half of the company’s revenue, is standing strong. An array of opportunities lies ahead
for SML’s API segment, including the dual sourcing mandates from global players. This is complemented
by expanded capacities with key regulatory approvals in place and a strong product pipeline, which would
unfold going ahead. The formulations segment is also gaining traction, backed by a sturdy product pipeline
and increasing geographic reach. The share of formulations in total sales has increased meaningfully and
is set to increase over the next two years. A shift in sales mix in favour of high-margin formulations segment
augurs well for the company as it would push the company in a high-growth trajectory. SML has also
recently acquired a research focused drug development company, which is expected to strengthen the R&D
capabilities. SML has also stepped in the biopharmaceutical space, with products offering substantial market
opportunities,although the benefits are likely to accrue over the next two years.
Key Risks
Any adverse change in the regulatory landscape can impact the earnings prospects.
Slower than expected pick up in the formulations segment.
Additional Data
Key management personnel
Omprakash Inani Chairman
Mr. Vishnukant Chaturbhuj Bhutada Managing Director
Mr. Sharath Reddy Whole time Director
Mr. Amit Chander Independent Director
Source: Company Website
Top shareholders
Sr. No. Holder Name Holding (%)
1 BARCLAYS MERCHANT BANK (SINGAPORE) LIMITED - ODI 1.98
2 BARING INDIA PRIVATE EQUITY FUND III LISTED INVEST 1.36
3 TA FII INVESTORS LIMITED 3.71
4 TANO MAURTIUS INDIA FVCI II 7.58
5 DURO ONE INVESTMENTS LIMITED 1.42
6 PIVOTAL ENTERPRISES PRIVATE LIMITED 2.91
7 PIVOTAL BUSINESS MANAGERS LLP 1.09
8 CLSA GLOBAL MARKETS PTE. LTD. 0.98
Source: Bloomberg
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