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NOTE: Company has recently got listed through IPO on exchanges thus
previous shareholding is not applicable.80
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Alkem Laboratoties , established in 1973 began operations as a healthcare marketing company. It is one of the India’s significant player in thebranded drugs and generic drugs space. The company has wide ranging presence across acute and chronic therapeutic segments with substantialbrand share in the Anti-infective , Gastro-intestinal, Pain Management , Vitamins / Minerals / Nutritions, Central Nervous System, Anti-diabetic,Anti-osteoporosis, Anti-malarial, Cardiovascular, Immunosuppressants, and Nutraceutical segments.
Alkem has in total 16 manufacturing facilities; 14 manufacturing facilities in India and two in the United States. Five of its facilities are USFDA, TGAand UK-MHRA approved. Of the Indian manufacturing facilities, 12 are for manufacturing formulations and two for manufacturing APIs. Thecompany also has four research and development facilities, two in India and two in the United States.
Alkem’s pharmaceutical business is organized into domestic and international operations. For fiscal year 2015, its domestic and internationaloperations accounted for ~74% and ~26%, respectively. It markets its products in 56 countries internationally.
In domestic business, the company has a portfolio of a portfolio of more than 700 brands. Alkem has also the largest number of brands (five) in thetop 50 brands of the Indian pharmaceutical industry for fiscal year 2015.
The company’s business is largely dominated by acute segment namely anti-infectives, gastro-intestinal, pain and analgesics, and vitamins, mineralsand nutrients. These therapeutic areas accounted for ~80% of its domestic sales while in chronic segment the company has lately increased focuson developing portfolio in areas such as neuropsychiatry, cardio, dermatology, diabetology and oncology. It has already built few brands like Olkemfor hypertension, Donep for Alzheimer’s disease, Glucoryl-M for diabetes, Kojiglo for hyper-pigmentation and Melbild for hypo-pigmentation etc.
In international business, the company sells its products in 56 countries, either directly through its subsidiaries or indirectly through supply,distribution and arrangements with various global companies and local distributors. Of the total international business, United States is the majormarket for the company contributing almost 75% to its sales followed by Australia, Europe, South-East Asia, Latin America, Africa and the CIS.
In U.S. the company has filed 70 abbreviated new drug applications (“ANDAs”) (of which 24 have received final approval and three have receivedtentative approval), of which 30 are Para IV filings including first-to-files “FTFs”) and one new drug application (“NDA”).
Going ahead, the management expects to increase its business in both domestic as well as international markets through introduction of newbranded formulations/ generic in its respective markets. We believe Alkem has significant potential to increase its international business based onits regulatory filings while indian business to continue to post higher growth on back of new product launches and increased focus on chronicsegment.
We expect Alkem’s consolidated revenues to grow at a CAGR of ~26% in the next two years and thus initiate our coverage on the stock with a BUYrating and a target price of ₹1,720 per share.
A promising branded generics play in international market along with a strong domestic business franchise
Alkem Laboratories Limited (ALKEM)
3 Anand Rathi Research
History:
Alkem Laboratories Limited (ALKEM)
Year Event1973 Alkem Laboratories Limited was incorporated1978 Established its first plant at Taloja, Mumbai
1992 Established its manufacturing facility in Mandwa, Maharashtra. This facility was converted into an API facility in 2005.
2003 Set up research and development facility for ANDA development at Taloja.
2006Its anti-infective drug Taxim became the first anti-infective drug in the Indian pharmaceutical industry to cross ₹1,000 million in terms of domestic sales in India. (Source: IMS Health)
2007 Filed its first ANDA in the United States for the drug Amlodipine.
2009 Received its first ANDA approval in the United States for Amlodipine.
2009 Acquired Pharmacor Pty Ltd., a generic pharma company in Australia.
2010 Acquired Ascend Laboratories, a generic marketing company in the US.
2011 Acquired Enzene, a company engaged in the development of biosimilars in India.
2012 Acquired an API manufacturing facility in the United States.
2014 Acquired the “Clindac-A” brand in India
2014 Clavam crossed `2,000 million in terms of domestic sales in India (Source: IMS SSA MAT March 2015).
2015 Acquired a formulation manufacturing facility in the United States.
2015 Listed on NSE & BSE through IPO.
4 Anand Rathi Research
Corporate Profile:
Alkem Laboratories Limited (ALKEM)
India Business International Business
Alkem Laboratories Ltd.
U.S. (ThePharmanetwork LLC)
Australia (Pharmacor
Pty Ltd)
Chile (Ascend Laboratories
SpA)
Philippines (Alkem
Laboratories Corp.)
Kazakhastan(The Pharma
Network)
~74% ~26%
Source: Company, Anand Rathi Research
~20%
5 Anand Rathi Research
Alkem has in past three financial years reported an average growth of 23.4% in its revenues. The higher growthwas on back of both domestic business as well as international business. The company’s domestic businesscontributes around 73% to its topline while international business contributes the remaining 27%.
In latest financial quarterly results the company’s 9M-FY16 revenues grew by ~36% at Rs.38,490 million as againstRs.28,314 million in 9M-FY15. Its domestic business during the period grew by ~33% while international businessgrew by ~46%.
On profitability front, the company has reported a significant improvement in its operating margins and hasreported EBITDA margins of 17.9% in 9M-FY16 at Rs.6,902 million as against 10.1% margin in 9M-FY15 at Rs.2,872million.
Historical financial performance has been fairly decent followed by margins improvement…
Alkem’s domestic formulations business is predominantly focused on acute therapy segment in linewith the Indian pharmaceutical market which is approximately 70% acute while remaining 30% ischronic therapy.
However lately the company has started to increase its presence in chronic therapy segmentthrough increased new product launches and expanding geographical footprint.
Alkem’s major brands in India
7 Anand Rathi Research
Making itself one of the top five large companies in IPM
Alkem Laboratories Limited (ALKEM)
Indian Pharma Market (IPM) top companies Market Share
Source: Company, Anand Rathi Research
The domestic formulations market is highly fragmented, and the top 10 pharmaceutical companiesaccounted for 43% of the market share for the fiscal year 2015, with the market leader accountingfor 8.4% of the market share in the same period.
Alkem is one of the top five companies in terms of sales in domestic markets and is the onlycompany having most number of brands listed in brands over ₹1,500 million annual sales.
Alimentary tract and metabolism 98,196 2,06,096 4,02,200 14.3%
Blood and blood-forming organs 17,625 32,535 60,125 13.1%
Cardiovascular system 42,893 85,248 1,54,396 12.6%
Dermatologicals 19,585 44,192 80,736 12.8%
Genito-urinary system and sex hormones 18,239 33,777 55,065 10.3%
Anti-infectives for systemic use 82,222 1,27,436 2,09,556 10.5%
Antineoplastic and immunomodulating agents 3,672 9,571 22,462 18.6%
Musculo-skeletal system 23,781 40,127 70,485 11.9%
Nervous system 28,597 56,883 1,05,627 13.2%
Respiratory system 35,881 61,898 1,09,776 12.1%
Various 30,382 58,097 96,035 10.6%
Source: Company, Anand Rathi Research
8 Anand Rathi Research
On therapy wise, Indian pharmaceuticals market (IPM) continues to be dominated by acute segment than chronicsegment.
However, in terms of growth acute is expected to moderate as preventive healthcare and improving lifestyleimproves along with higher base while chronic segment looks promising.
Looking at global pharmaceutical sales of top therapeutic classes, chronic segment is the major contributor andthis should be the case for India once its demographic distribution shifts towards older age in next decade.
IPM continues to dominated by acute therapy in India…
expenditure.• Social security commitments• Increasing Insurance
Coverage• Growth in Lifestyle Related
Diseases
Growth drivers for IPM
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Small molecules continues to dominate in terms of share for global sales at risk of patent expiry between 2015-2025 with a 47% share followed by biologics at 33%, device associated patents 19% and vaccines at 1%.
Majority of the global sales at risk in next three years are from small molecules and only from 2018 biologicsshare leads.
We believe the global generic market continues to remain robust despite the patent cliff achieved in past fewyears. The patent expirations timeline still remains exploitable by the likes of Alkem in order to achieve highergrowth in international business.
Global patent expiry based generics business still significant in medium term…
Global sales at risk, yearly ($ mn.) % of Global Sales At Risk: 2015 - 2025
Alkem has so far build up healthy pipeline of filings in its U.S. and other international businesses. For U.S.business its current ANDA filings stood at 70 of which 24 has received final approvals while 3 have receivedtentative approvals.
In terms of ANDAs by type, Alkem’s para IV filing (including first to file) stood at 30 followed by DMF at 18 andone NDA filing.
Of the other international markets, the company’s filing in Australia and Europe MAA stood at 22 and 16respectively of which 18 and 7 have been approved.
…presenting greater growth opportunities for Alkem
Alkem’s U.S. ANDA Filings Alkem’s Other applications in international markets
Alkem Laboratories Limited (ALKEM)
ANDA Filings Count
Final Approvals 24
Tentative Approvals 3
Pending 43
Total 70
ANDAs by Type Count
Para IV (incl. FTF) 30
DMF 18
NDA 1
Total 70
Country Filed Approved
Australia 22 18
Europe MAA 16 7
Philippines (Dossiers for each strength) 55 51
Chile (Dossiers for each strength) 110 69
Kazakhstan (Dossiers for each strength) 66 52
Other Countries (Dossiers for each strength) 1166 743
Source: Company, Anand Rathi Research Source: Company, Anand Rathi Research
12 Anand Rathi Research
…translating into higher growth in years ahead.
We expect Alkem’s revenues to grow at a CAGR of ~26% in next two financial years on the back of higher growth
in both domestic and international business.
We expect Alkem’s traditional domestic business to grow at market rate while new launches in non traditional
therapy segment to bring in additional outperformance in medium term.
On impending regulatory uncertainty regarding fixed dosage combination, we have accounted for about ₹700
million sales coming under notification.
Source: Company, Anand Rathi Research
Sales (₹ Mn.) & EBITDA Estimates
Alkem Laboratories Limited (ALKEM)
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A promising international business based on
proven branded generics play coupled with
strong domestic business franchise.
In domestic business, focus on increasing
revenues from chronic therapy segment and
new product launches to drive growth.
Higher institutional sales through new
government schemes and stabilising margins at
current levels to improve valuation multiples.
At CMP the stock is trading at 21x FY-16E and
17x FY17E earnings.
We initiate our coverage on the stock with a
BUY rating and a target price of ₹1720 per
share.
Relative stock performance (Dec’15=100)
Valuation and Recommendation:
Source: Bloomberg, Anand Rathi Research
Source: Company, Anand Rathi Research
(In ₹ mn) FY-14 FY-15 FY-16E FY-17E
EPS (₹) 36.4 38.5 63.8 80.4
P/E (x) 37.1 35.0 21.2 16.8
P/B (x) 6.2 5.4 4.3 3.4
ROE 16.8% 15.3% 20.2% 20.3%
ROCE 14.0% 20.8% 26.6% 26.8%
EV/EBIDTA (x) 28.1 24.3 15.2 12.2
Alkem Laboratories Limited (ALKEM)
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Margins FY-14 FY-15 FY-16E FY-17E
Sales Growth % 25.3% 21.0% 28.9% 22.6%
Operating Margin % 13.1% 12.8% 17.8% 18.3%
Net Margin % 13.9% 12.2% 15.6% 16.1%
Consolidated Financials:
Source: Company, Anand Rathi Research
(In ₹ Mn.) FY-14 FY-15 FY-16E FY-17E
Liabilities
Equity Share Capital 120 239 239 239
Reserves & Surplus 25,730 29,787 37,411 47,019
Total Shareholder's Funds 25,850 30,026 37,650 47,259
The company’s business is highly regulated and strict quality constraints are imposed by various countries and
thus any abrupt removal of any of its plants could impact our projections.
Company is exposed to currency exchange risk.
The company is exposed to sector wide regulatory uncertainty in its domestic business on back of recent
notification by Department of Pharmaceuticals on banning some fixed dosage combination (FDC) drugs in India. It
has been observed from media reports that department is considering to release another list in near future for
the same.
Key Risks:
Alkem Laboratories Limited (ALKEM)
16 Anand Rathi Research
Rating and Target Price history:
Date Rating Target Price (₹) Share Price (₹)
17-Mar-16 BUY 1,720 1350
ALKEM rating detailsALKEM rating history & price chart
Source: Bloomberg, Anand Rathi Research Source: Bloomberg, Anand Rathi Research
NOTE: Prices are as on 17th Mar 2016 close.
Alkem Laboratories Limited (ALKEM)
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Continued…
Alkem Laboratories Limited (ALKEM)
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Disclaimer:
Contd…
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Contd…
Alkem Laboratories Limited (ALKEM)
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Disclaimer:
Contd.
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