Lupin has carved a unique and best-class business model for itself by creating a robust branded and generics business in the US. We believe the US market will act as a key growth driver followed by emerging markets in the short to medium term. In the short-term, we expect the domestic market to grow at 13-14%.
Lupin has carved a unique and best-class business model for itself by creating a robust branded and generics business in the US. We believe the US market will act as a key growth driver followed by emerging markets in the short to medium term. In the short-term, we expect the domestic market to grow at 13-14%.
Lupin has carved a unique and best-class business model for itself by creating a robust branded and generics business in the US. We believe the US market will act as a key growth driver followed by emerging markets in the short to medium term. In the short-term, we expect the domestic market to grow at 13-14%.
Bloomberg Code LUPIN@IN Face Value (Rs) 10.0 Equity Capital (Rs Cr) 88.7 Market Cap (Rs Cr) 12,758 52W - H/L 1550/537 Sensex 17540 Average Volume 48,889
Comparative return metrics
1M 3M 6M 12M Glenmark 12.1 25.1 22.4 -2.7 Cipla 6.1 29.5 32.4 91.0 Sun Pharma 7.7 19.3 37.1 51.3 Piramal Hlc -2.9 2.0 29.7 69.3 Dr Reddy 8.0 20.4 53.9 150.9 Ranbaxy 23.1 27.0 103.8 140.4 Lupin 10.1 29.1 73.7 147.5 January 11, 2010 | Pharmaceuticals Initiating Coverage Lupin Limited (LUPIN) Predictable growth, good value Lupin has carved a unique and best-in-class business model for itself by creating a robust branded and generics business in the US, revenue crucial presence in Japan via inorganic route, competitive API business and formidable domestic presence. We believe the US market will act as a key growth driver followed by emerging markets in the short to medium term while the domestic market will be a long-term growth driver. In the short-term, we expect the domestic market to grow at ~13-14%. In the US market, Lupin has performed strongly. A better show is expected, going forward. We initiate coverage on Lupin with a STRONG BUY rating. Buoyed by US growth, export will likely be a key growth driver Export, 65% of FY09 sales, is set to be Lupins key growth driver on the back of 31% growth in advanced markets to Rs 3853 crore and 54% in emerging markets to Rs 868 crore. We estimate exports will grow at 28% CAGR over FY09-12E to Rs 5272 crore, 74% of FY12E sales. US business will likely drive advanced markets revenue Lupin has a unique US business model, 29% from branded and 71% revenue from generics business. As the branded business achieved critical mass of US$74 million in FY09, acquisition of Antara (FY08 sales of US$70 million, patent expiry in August 2020 and targeting US$2-3 billion market) will take Lupin to the next growth orbit and lead US branded business growth at 52% CAGR over FY09-12E to US$284 million. Generics business will leverage from rich pipeline of16 ANDAs. Domestic market remains significant despite lower growth Lupin continues to remain a formidable play in the domestic market despite lower 13.4% CAGR over FY09-12E. Domestic formulation contributed 35% to FY09 revenues and the contribution is expected to decline to 26% in FY12E due to high growth in other revenue streams. Valuations Lupin stands out in the Indian pharma space due to its superior business model, which is formed by strong and gradually strengthening US branded, robust generics business, thriving Japanese business, competitive API business and growing domestic market. We believe the recent acquisition of Antara may take Lupin to a new orbit as it targets US$2-3-billion market. Patent on Antara expires in August 2020. We believe the current valuation of 16x FY11E EPS of Rs 92 does not capture the improvement in business model. We value Lupin at 20x FY11E EPS and 16x FY12E EPS, which gives us a target price of Rs 1840, a 30% upside compared to the current price. Current Price Rs 1413 Target Price Rs 1840 Potential upside 30% Time Frame 12-15 months
2 | P a g e Company Background Lupin Ltd (Lupin) was established in 1968 as Lupin Laboratories Ltd. In 1980, the company commissioned a formulations plant and R&D centre in Aurangabad to mark the beginning of its formulations business. In 1989, the company established a JV by the name of Lupin Chemicals (Thailand). In 2001, Lupin Labs and Lupin Chemicals got amalgamated to form Lupin Ltd. Lupin manufactures APIs, finished dosages and herbal products.
Business profile Lupin Ltd is an innovation led transnational pharmaceutical company producing a wide range of generic formulations and APIs for the developed and developing markets. Lupins range of finished dosages includes anti-tuberculosis drugs, cephalosporin, cardiovascular drugs, anti-asthma drugs, non-steroidal, and anti- inflammatory drugs. APIs cater to the therapeutic segment of anti-tuberculosis, cephalosporins both in orals and injectable forms, ace inhibitors, statins and prils. The company is focusing more on IPR-led growth and has also forayed into newer markets such as Japan. It has organised its R&D efforts towards three focus areas viz., generics, NCE and NDDS.
Manufacturing and R&D facilities Lupins manufacturing facilities, spread across India, play a critical role in enabling the company to realise its global aspirations. Benchmarked to international standards, these facilities are approved by international regulatory agencies like USFDA, UKMHRA, TGA Australia, WHO and MCC South Africa. The company has leveraged its strong vertical integration in building a global pharmaceutical powerhouse.
Market position in domestic formulations market Lupin maintained its fifth position in the domestic formulation market with a market share of 2.73% in March 2009 and a field force of 3000 medical representatives. The company continues to gain wide market acceptance with most of its flagship products being market leaders in their respective segments. Six of Lupins products are among the top 300 in India. The leading brands are Tonact, Gluconorm, Rcinex, Rablet, AKT, Ramistar, Clopitab, L-Cin, Odoxil and Lupenox. CVS, anti-TB and Cephalosporins are the top three therapies for Lupin. The chronic segment contributes ~40% to the domestic formulations revenue. All therapeutic areas are growing at higher than industry norms. In the last three years, the company has introduced 12 in-licensed products. Of these, five were first-to-launch in India. The company successfully launched Lupisulin, Ismigen and Faximab in FY09. During FY09, Lupin added gynaecology and oncology to its therapeutic portfolio.
Intellectual property management During FY09, Lupin filed a record 28 ANDAs, which included five first-to-file opportunities, of which two were exclusive first-to-file. Lupins cumulative filings stood at 91, with 35 approvals to date, addressing an estimated market size of US$90 billion. The company has also ventured into the lucrative oral contraceptive and ophthalmic space and had filed seven ANDAs in the oral contraceptive space in FY09. The strength of the intellectual property has helped the company to win the Cefdinir litigation against Abbott Labs and Astellas Pharma. The company also settled litigation relating to Desloratidine tablets, the generic version of Schering-Plough Clarinex tablets. With this Lupin can launch the drug on July 1, 2012, or earlier subject to conditions being met.
Exhibit 2: Milestones achieved by Lupin 2009 Lupin acquired a majority stake in Multicare Pharmaceuticals Philippines Inc, a premium branded generic co, with a presence in WHC & Child HC, strong distribution alliances, 140 sales force Lupin expanded its product basket in Japan-Kyowa and received 10 products approval from the Ministry of Health & Labour Welfare, Japan Lupin acquired Hormosan Pharma GmbH, a generic company in Germany, poised to make its mark in the rapidly evolving INN substitution market Lupin acquired a stake in Generic Health Pty Ltd, in Australia, which has a range of generic prescription & OTC products Lupin acquired Pharma Dynamics in South Africa, among the top 6 generic companies, 38% growth in sales Lupin acquired Vadodara-based Rubamin Laboratories Ltd (rechristened to Novodigm Ltd) -- API plant Lupin acquired Kyowa Pharmaceutical Industry Co Ltd, a leading generic company in Japan Commercial production was started at the new finished dosage facility at Jammu Lupin received Best new manufacturer of the year award from Amerisource Bergen A new facility was set up at Jammu Bonus shares were issued in the ratio of 1:1 Issuance of foreign currency convertible bonds (FCCB) aggregating US$100 million, which are listed on the Singapore Stock Exchange USFDA and MHRA (UK) approvals were received for Goa New Lovastatin plant at Tarapur was approved by the USFDA WHO approval was received for state-of-the-art formulation plants at Goa and Aurangabad 2004 Lupin launched its first brand Suprax (Suprax) Lupin had successfully implemented SAP ERP across the company to unify all business functions and processes Introduced collaborative messaging and workflow solution on the intranet Oral Cefaclor injectible plant at Mandideep was approved by the USFDA Lupin Pharmaceuticals Inc US, was formed for trading, marketing and developmental activities in the US Patent filings crossed 100 Five ANDAs were filed New anti-TB facility was commissioned at Aurangabad Rablet was rated by ORG-Marg as the second best launch ofFY2002-03 Lupin became the only Asian pharmaceutical company to receive USFDA approvals for its sterile cephalosporin facility A state-of-the-art USFDA approvable oral cephalosporin bulk active plant was commissioned State-of-the-art R&D centre at Pune was commissioned Lupin commenced supply of Cephalosporin bulk actives to its alliance partners in the US Lupin Laboratories Ltd was amalgamated with Lupin Chemicals Ltd whose name was changed to Lupin Limited The companys restructuring operations yielded encouraging results Work commenced on the R&D centre at Pune Lupins injectable cephalosporin bulk active plant at Mandideep was approved by UK MCA 1999 Lupins injectable Cephalosporins dosages plant at Mandideep obtained UK MCA approval Lupins formulations facility at Aurangabad was upgraded Three plants of Lupin, manufacturing Cefaclor at Mandideep, seven ACCA at Ankleshwar and Rifampicin at Tarapur, got USFDA approvals ICMA Technology award was given for injectable Cephalosporins The company received the ICMA Technology award for injectable Cephalosporins Sterile plant for injectable Cephalosporins (bulk) was commissioned at Mandideep Lupin Laboratories Ltd and Lupin Chemicals Ltd raised money through IPOs in 1993-94 Won Ficcis award for contribution towards rural development 1991 Lupin won the ICMA technology award for successfully manufacturing Vitamin B6 Joint venture in Thailand Lupin Chemicals (Thailand) Ltd was established Two Plants Ankleshwar and Mandideep received USFDA approvals for maintaining stringent quality standards 1988 The Lupin Human Welfare and Research Foundation (LHWRF) was founded by Dr Desh Bandhu Gupta to provide an alternative, sustainable and replicable model of rural development 1987 Cephalexin Plant at Mandideep and seven ADCA plant at Ankleshwar went on stream 1981 Ethambutol production was started 1980 Lupin commissioned a formulations plant and an R&D centre at Aurangabad 1972 Lupin Laboratories Pvt Ltd was incorporated 1968 Lupin commenced business 2008 2007 (Acquired Kyowa) 2006 (FCCB + BONUS) 2005 1989 1997 1996 1992 2003 2001 2000 2002
5 | P a g e Lupins stock price movement and major developments 0 200 400 600 800 1000 1200 200807 200809 200811 200901 200903 200905 200907 200909 15 manufacturing deficiencies at Lupin Limited's Mandideep plant Received the approval from DCGI to launch Ivabrad tablets, a heart- rate lowering drug Settled litigation with Schering- Plough for generic Desloratadine tablet USFDA approval for Levetiracetam Tablets Oscient Pharma filed a lawsuit against Lupin for infringement of Patent on ANTARA (fenofibrate) capsules. Completes acquisition of Multicare Pharma Shire PLC filed a lawsuit against Natco for infringement of two patents for FOSRENOL Pfizer filed patent infringement suits in respect of its pain management drug lyrica, Settled litigation with Wyeth relating to Venlafaxine XR
Acquisition of worldwide rights for the intra-nasal steroid AllerNaze USFDA approval to sell generic Ethambutol HCL tablets Completed acquisition of a majority stake in Pharma Dynamics in SA
Source: Company, ICICIdirect.com Research
Lupin entered into an alliance with Natco Pharma to jointly commercialise generic equivalents of Shire plc's Fosrenol tablets. Shire filed a lawsuit against Natco for infringement of patents on Fosrenol in response to the ANDA filed under Para IV certification by Natco seeking USFDA approval to market generic versions of Shire's Fosrenol tablets
6 | P a g e Investment rationale Lupin has carved a unique and best-in-class business by creating a strong business in the US generic and branded market along with EU and Japanese presence and a globally competitive API business and deep penetration in domestic market. Lupins recent acquisition of Antara in the US branded business may take the company to a new orbit. Exploiting synergistic benefit from acquired businesses (Suprax, Allernaze, Aerochamber, Antara in the US branded market and Kyowa in Japan), formidable penetration in the domestic market and commercialisation of rich ANDA pipeline of ANDAs (for the US generics market), we believe Lupin is well set to report sales growth of ~23% CAGR to Rs 7062 crore. The bottomline is expected to almost double to Rs 1003 crore during FY09-12E. We expect the US branded business to act as a key growth driver followed by emerging markets. In US dollar terms, US branded revenues are likely to clock more than 50% CAGR over FY09-12E. US generic revenues are expected to register 23.3% CAGR over the period on account of ANDA approval from a stable of 56 ANDAs. On account of a change in the revenue mix and scaling up the value chain, margins are likely to expand from 17.18% to 19.31% over FY09-12E. Though the recent issuance of 483 warning letter on its Mandideep facility remains an overhang on the stock, current US revenues are would not be impacted.
Lupins business model has undergone a complete transformation from being a focused API player to a formulations player. API contribution fell from 55% to 19%, through FY04-09. Revenue mix from the US increased to ~32% in FY09 from ~2% in FY05. This led the EBITDA margin to expand by 660 bps over the period. In the domestic market, the company has increased its exposure across therapies. Excellent growth in the US business and RoW coupled with robust domestic growth will set Lupin to report sales growth of ~23% CAGR and bottomline to almost double to Rs 1003 crore during FY09-12E
Exhibit 9: Focus markets in FY02 Others 10% SEA 19% US/EU 2% India 69%
Source: Company, ICICIdirect.com Research
Exhibit 10: Focus shifting towards advanced markets in FY12E Others 8% Japan 13% RoW 12% US/ EU 41% India 26%
Source: Company, ICICIdirect.com Research RoW: Rest of World
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US a unique blend of branded & generic business We believe the US market will be the key revenue driver for Lupin. Lupin operates a unique business model in the US markets by catering to both branded as well as generics markets. Such business models were tried by Ranbaxy and Dr Reddys in the past but Lupin stands out by being successful. US revenues, which accounted for 31% of FY09 consolidated revenues, are likely to grow at 33% CAGR, buoyed by 52% CAGR in branded sales and 23% CAGR in generics business. We believe a rich ANDA pipeline will drive the generics business while the recent inclusion of Antara (via inorganic route), commencement of sales from Allernaze and addition to the existing brands will drive the branded sales.
Exhibit 11: US revenues to grow at FY09-12E CAGR of ~33% to Rs 2796 crore 93 127 348 639 983 1219 262 593 842 1052 1262 1578 0 600 1200 1800 2400 3000 FY07 FY08 FY09 FY10E FY11E FY12E Brandes Sales, Rs Cr Generic Sales, Rs Cr
Source: Company, ICICIdirect.com Research
Branded businessFocussed play We expect the US branded business of Lupin to grow at 52% CAGR in rupee terms and 56% CAGR in US dollar terms (or in constant currency terms) on expansion in product basket in the branded segment. The company has added Allernaze and Antara to the current offering of Suprax (a Cefixime brand acquired from Wyeth in the paediatric segment) and Aerochamber. Antara and Suprax are Lupins own brands (purchased from Wyeth and Oscient Pharma, respectively) but the other two are in- licensed brands (from Collegium Pharma and Forest Labs, respectively). We believe the margins on the branded segment will expand, going ahead, as revenue from own products is expected to grow faster.
Antara, a US$70 million product is likely to grow at 25-30% targeting a growing segment of triglyceride reduction
Suprax, currently clocking US$65 million is likely to grow at 12%. Competition is rising in the segment post filings with FDA with players like Orchid Chemicals, Nectar Life Sciences filing
Allernaze is for nasal infection in-licensed from Collegium Pharma for worldwide sales. Allernaze is an intra-nasal steroid product, the market for which is ~US$2.5 billion in the US, according to industry sources. Lupin is focusing on this lucrative market. We expect Lupin to launch it in the US market in FY11
AeroChamber Plus is a Valved Holding Chamber (VHC) device, used with metered dose inhalers to improve the delivery of medication to lungs in the treatment of asthma and COPD. US revenues, which accounted for 31% of FY09 consolidated revenue, are likely to grow at 33% CAGR, buoyed by 52% CAGR in branded sales and 23% CAGR in the generics business Inclusion of Antara and AllerNaze to the US branded portfolio will catalyse growth to 52% CAGR over FY09-12E
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Exhibit 12: Revenue matrix of US branded portfolio Revenues in US$, mn FY07 FY08 FY09 FY10E FY11E FY12E Suprax 24.6 41.2 65.0 74.8 82.2 90.5 Aero-Chamber - - 9.0 11.7 15.2 19.8 AllerNaze - - - - 12.8 19.4 Antara - - - 42.0 118.3 153.8 Source: Company, ICICIdirect.com Research
Lupin acquired the Antara (Fenofibrate) brand from the bankrupt Oscient Pharma for a consideration of US$38.6 million. We believe the acquisition is value accretive and will place Lupin into a new growth orbit.
The purchase price of US$38.6 million is 0.55x CY08 sales of US$70 million, which is a bargain price for Lupin considering current deals in the range of 1.5-2x sales
Growth could be very high from Antara under Lupin as the product recorded growth of 20% when it was under Oscient Pharma. Oscient Pharma was under financial distress, so the growth was coming without promotions. After acquisition by Lupin, with promotion the product could log a growth rate faster than the current rate till its patent life expires in August 2020
The Antara (Fenofibrate) products market is estimated at ~US$2 billion. In order to boost Antaras sales, Lupin plans to increase the sales force from 60 to 120 in the next two years.
-- Generic business Gaining market share
In the US generics space, we estimate Lupins sales will grow at 23% CAGR to Rs 1578 crore over FY09-12E on account of commercialisation of its rich ANDA pipeline of 56 products.
Exhibit 13: Generic business to grow at a CAGR of 23% through FY09-12E 74% 82% 71% 56% 56% 62% 0 600 1200 1800 2400 3000 FY07 FY08 FY09 FY10E FY11E FY12E 50% 56% 62% 68% 74% 80% Total US Sales (LHS) Generic Sales (LHS) Generic % contribution (RHS)
Source: Company, ICICIdirect.com Research
Lupin has 22 products in the market of which eight are market leaders. Robust gain in market share across products has seen the generic business growing at FY07-09 CAGR of ~79% to Rs 842 crore. We believe Lupin bought Antara at a bargain price considering 0.55x CY08 sales as such deals were taking place at 1.5-2x We estimate the generic business will grow at 23% CAGR over FY09-12E on account of commercialisation of its rich ANDA pipeline of 56 products
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Exhibit 14: Market share gains across products (%) 34 23 46 30 33 41 29 45 34 66 39 44 0 15 30 45 60 75 Lisinopril Tabs Lisinopril HCTZ Tabs Ramipril Caps Cefadroxil OS Cefprozil OS Cefprozil Tabs Meloxicam Tabs FY08 FY09 M a r k e t
s h a r e
( % )
Source: Company, ICICIdirect.com Research
During FY09, Lupin launched four products in the US generics market. We believe that, going ahead, growth in the US generic business will primarily be driven by a combination of the base business as well as new product launches. We believe the generic business will grow at a CAGR of 23% over FY09-12E to Rs 1578 crore, contributing over 56% to total US sales.
Niche pipeline of filings key to US revenue growth Lupin has ~56 ANDAs pending for approval (including nine with Para IV certification) and 35 ANDAs approved (including 13 tentative approvals). The growth will likely be driven on account of approvals on filings under niche areas, such as oral contraceptives, ophthalmology, bio-similars, controlled-release products and filings with Para IV certification.
With ~US$135 billion worth (on innovator sales) of product going off patent till 2012, we believe the company would aggressively spend on R&D to participate in the unfolding opportunity.
US$135 billion worth (on innovator sales) of product going off patent will throw open a large opportunity from now till 2012. We believe the company would aggressively spend on R&D to participate in the unfolding opportunity
R&D productivity one of the best among peers Lupin has exhibited an excellent R&D productivity both in terms of R&D expenditure per ANDA approved as well as revenue per ANDA approved.
Exhibit 16: R&D productivity best among peers (FY09) Company Revenue (US market) R&D Expenditure ANDA's approved R&D (% to sales) Rev/ANDA Sun Pharma 1589.5 332.0 71 20.9 22.4 Glenmark Pharma 733.8 88.3 45 12.0 16.3 Ranbaxy Labs 1946.5 431.4 137 22.2 14.2 Dr Reddy's 1212.7 409.3 75 33.8 16.2 Lupin 1189.4 266.9 22 22.4 54.1
Source: Company, ICICIdirect.com Research
Oral contraceptive (OC) space a distant but a solid opportunity Lupin has opportunistically targeted the limited competition OC space, which is a US$4-5 billion market. Barr Labs and Watson Pharma are the only two players having a presence in the US OC market. Lupin stands out among them with the advantage that it is backward integrated. Lupin has already filed nine ANDAs as at the end of Q1FY10 in the OC space. It expects to file almost 14 products in the next two to three years with product approvals expected to kick in post Q2FY11. We believe this will present a significant opportunity for Lupin because of low generic penetration and Lupins backward integration with its own APIs. Lupin is also setting up a dedicated facility for OC at the Indore SEZ.
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European business Replicating US strategy for growth We estimate Lupins revenue from EU will grow at ~20% CAGR over FY09-12E to Rs 121 crore on account of improved approvals from its filing pipeline for 54 products. The company has cumulative 54 filings for the European market of which 22 products are pending approval. Lupin has operations in three European regions viz. Germany, UK and France. During FY09, revenues from the European region grew by 99% (on a lower base of Rs 35 crore) and contributed ~3% to the exports revenues and ~4% to the regulated markets formulation segment. Lupin is replicating its US strategy in Europe. It is developing a specialty products pipeline in the CVS, CNS, and anti-infective categories.
Exhibit 17: EU revenues set to expand ~20% through FY09-12E 35.3 70.2 84.3 121.4 101.2 3.6 3.3 3.2 4.1 4.0 0 30 60 90 120 150 FY08 FY09 FY10E FY11E FY12E 0 1 2 3 4 5 EU Sales, Rs Cr (LHS) % Contribution to Advanced Market (RHS)
Source: Company, ICICIdirect.com Research
Lupins revenue from its operations in three European regions of Germany, UK and France is estimated to grow at ~20% CAGR over FY09-12E on higher approvals from its filing pipeline for 54 products
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Japan The next growth engine We expect Kyowa to register sales CAGR of ~28% over FY09-FY12E to Rs 935 crore, led by new product launches and ramp-up in existing product sales. Lupin is the only Indian company to have significant presence in the worlds second largest Japanese pharma market. We cite the following main benefits accruing to Lupin from Kyowa:-
Japan is a US$68 billion pharma market, out of which US$4 billion is the generics market, where Kyowa has a significant presence and ranks among the top 10
Allows Kyowa to leverage low-cost Indian manufacturing advantage, while Lupin gains access to a large and growing market for distribution
While sales have been growing at a strong pace, Lupin intends to shore up Kyowas profitability by backward integrating its existing and future products predominantly from Lupins in-house APIs. The company has recently received approval for 10 products from the Japanese authorities, which are likely to be launched in the coming quarters.
Exhibit 18: Kyowa revenues set to grow at ~28% CAGR through FY09-12E 442.4 575.1 718.9 934.6 131.5 14.8 24.3 25.7 24.5 23.5 0 200 400 600 800 1000 FY08 FY09 FY10E FY11E FY12E 0 6 12 18 24 30 Japan, Rs Cr (LHS) % Contribution to Advanced Market (RHS)
Source: Company, ICICIdirect.com Research We expect Kyowa to register sales CAGR of ~28% over FY09-FY12E to Rs 935 crore, led by new product launches and ramp-up in existing product sales. Lupin is the only Indian company to have a significant presence in the worlds second largest Japanese pharma market
1 4 | P a g e Domestic market niche focus, high margins During FY09, the domestic formulations business registered a healthy growth of 21% vis--vis industry growth of ~13%. We expect Lupin to continue to deliver decent growth in the domestic market and expect the domestic formulation business to post 13% CAGR in FY09-12E on account of new launches and entry into new therapy areas.
Exhibit 19: Domestic formulations business to grow at 13% CAGR (FY09-12E) 753.0 949.6 1141.2 1299.3 1468.5 1663.1 103.6 191.19 193.1 195.0 197.0 277.4 - 400 800 1,200 1,600 FY07 FY08 FY09 FY10E FY11E FY12E R s ,
C r o r e Domestic formulation, Rs Cr Domestic API, Rs Cr
Source: Company, ICICIdirect.com Research
However, as a result of rapid growth in export formulations, revenue contribution of the domestic business declined from 50% of total sales in FY05 to 35% in FY09. Going ahead, due to fast growing export revenues, we expect the contribution from the domestic market to decline over FY09-12E.
Lupin (FY07-09 growth CAGR 23%) has consistently outperformed the Indian pharma market growth rate over years and is ranked among the top five companies in India, with overall market share of 2.73%. It has a leadership position in the anti-TB (48% market share) and anti-asthma segment (12% market share, second after Cipla). During FY09, Lupin introduced 54 products (including six in-licensed products) which is one of the highest among its Indian peers.
We expect Lupin to continue to deliver decent growth in the domestic market and expect the domestic formulation business to post 13% CAGR in FY09-12E on account of new launches and entry into new therapy areas. The API business is expected to register flat growth on account of increased in-house usage of API Lupin (FY07-09 growth CAGR 23%), has consistently outperformed the Indian pharma market growth rate over years and is ranked among the top five companies in India, with overall market share of 2.73%%. It has a leadership position in anti-TB (48% market share)
Risks & Concerns Threat of rising competition to Suprax and Antara Currently contributing highest to the branded US revenue (US$65 million in FY09) Suprax is exposed to competition (not covered by any patent) with few of its Indian peers having filed ANDA with the USFDA.
The recently bought Antara (fenofibrate) from Oscient Pharma is covered under patent, which is expiring in August 2020. However, a competitive product, Tricor of Abbott, is losing patent expiring in 2011, which may pose competition to Antara. Though the market is large at ~US$2 billion, a rise in competition may dilute the opportunity size.
Warning letter on Mandideep facility to remain an overhang on the stock USFDA has issued a 483s warning letter on Lupins Mandideep facility on non-compliance with quality manufacturing standards. Mandideep is a big facility for Lupin and contributes ~25% to the US revenues. It manufactures sterile products, mainly dealing with Cephalosporin. This inspection has been going on for the past three quarters. At present, Lupin sells 10 products and has one pending ANDA from this facility. Although the FDA warning letter would not impact sales of currently marketed products, it would halt any further approval of ANDAs from that facility. If the issue is not resolved quickly, revenues from the US would be impacted.
Rising competition in the domestic market Heightened competition in key therapy areas of the domestic market and greater vulnerability to currency fluctuations (with international business now accounting for ~65% sales) remain the key concern.
1 7 | P a g e Financials Sales to register 23%growth, through FY09-12E Lupin has exhibited an excellent growth track record in the past on account of extensive product mix in niche therapies and selective product strategy for the US and EU market. We expect Lupin to deliver ~23% CAGR on net sales through FY09-12E to Rs 7062 crore. The low priced acquisition of Kyowa in Japan and Pharma Dynamics in South Africa will also be significant contributors to growth, as this will help Lupin to diversify its presence across markets.
We expect the US business to report robust growth of ~33% through FY12E. The generic segment is expected to grow at ~23% CAGR to Rs 1578 crore in FY12E on account of higher realisation from key ANDA filings. Branded segment sales are expected to grow at an FY09-12E CAGR of ~52% to Rs 1219 crore, on account of inclusion of Aerochamber Plus, AllerNaze and Antara to the branded portfolio.
The domestic formulation segment is expected to register ~13% CAGR growth through FY12E to Rs 1663 crore on account of ~13% growth in CVS and ~20% growth in the anti-asthma, CNS and diabetes segment contributing over 23% to FY12E to the total sales.
EBITDA margin will likely witness good expansion in FY12E Even though Lupins US and India business did exceedingly well in the past, EBITDA margin expansion was restricted to ~400 bps during FY06- 09 on account of higher operating expenditure (~86% of sales). Operating expenditure is high due to a significant presence in the US branded market, which has a high SG&A expenditure. During FY09-12E, we believe the EBITDA margin will likely be in the range of ~19% as Lupin is looking to extend the Suprax brand product line and enhance its focus on the high margin gynaecology and oncology business in the domestic market. Margin expansion will also be aided by a better product mix and higher contribution from differentiated products from US markets. We expect the EBITDA margin to expand by ~214 bps during FY09-12E. Exhibit 24: OPM, NPM to witness good expansion in FY09-12E 16.1% 17.2% 17.8% 18.9% 19.3% 15.1% 13.4% 13.0% 13.7% 14.2% 0% 5% 10% 15% 20% 25% FY08 FY09 FY10E FY11E FY12E EBITDA Margins Net Profit Margins
Source: Company, ICICIdirect.com Research
Net profit to grow 26%, through FY09-12E We estimate that net profit will grow at a CAGR of ~26% to Rs 1003 crore over FY09-12E. During FY04-09, Lupins net profit grew by ~42% CAGR to Rs 502 crore due to higher margins on product under the branded segment in the US markets and robust performance in the domestic market. In spite of robust sales growth, we expect the net profit margin to expand marginally by 75 bps on account of likely competition on the Suprax brand and higher tax rates.
Exhibit 25: Profit to grow @26% CAGR over FY09-12E 408.3 501.5 632.9 815.2 1002.7 0 200 400 600 800 1000 1200 FY08 FY09 FY10E FY11E FY12E 0% 7% 14% 21% 28% 35% Net Profit, Rs Cr YoY Gr.
Source: Company, ICICIdirect.com Research The EBITDA margin expansion was restricted to ~400 bps during FY06-09 on account of higher operating expenditure. Operating expenditure was high due to a significant presence in the US branded market, which has a high SG&A expenditure We estimate that net profit will grow at a CAGR of ~26% to Rs 1003 crore over FY09-12E
1 9 | P a g e
Return ratios to remain healthy Robust organic growth led by an exceedingly good performance from the US and the Indian market has led Lupin to maintain higher return ratios during the past three years. In spite of US$100 million raised through FCCBs, Lupins RoNW has expanded by ~22% while RoCE expanded by ~14% over FY05-09. However, going ahead, increasing net worth, due to FCCB conversion, will put pressure on RoNW expansion. Exhibit 26: Return ratios to remain healthy 31.9 35.6 30.3 27.2 24.5 22.2 23.6 25.0 26.4 25.2 0 10 20 30 40 FY08 FY09 FY10E FY11E FY12E RONW (%) ROCE (%)
Source: Company, ICICIdirect.com Research
Exhibit 27: Balance sheet size expanding at 19% CAGR with net worth at 34% over FY08-12E 0 1000 2000 3000 4000 5000 6000 FY08 FY09 FY10E FY11E FY12E BS Total, Rs Cr Networth, Rs Cr
Source: Company, ICICIdirect.com Research
Balance sheet comfortable leverage Lupin had issued FCCBs in January 2006 worth US$100 million at a redemption price of Rs 1134/- maturing in January 2011E. Post bonus the conversion price stands at Rs 567/- (FCCBs in the money). We have incorporated full conversion of outstanding FCCBs in our estimates. We expect the debt/equity to be at a comfortable 0.3x during FY12E (FY09 0.9x). Incremental cash flows will likely support capex requirements. In spite of US$100 million raised through FCCBs, Lupins RoNW has expanded by ~22% and RoCE expanded by ~14% over FY05-09. However, going ahead, increasing net worth, due to FCCB conversion, will put pressure on RoNW expansion
2 0 | P a g e Valuationsmore in store Lupin has carved a unique and best-in-class business model for itself by creating a robust branded and generics business in the US, revenue crucial presence in Japan via the inorganic route, competitive API business and formidable domestic presence. We believe the US market will act as a key growth driver followed by emerging markets in the short to medium term while the domestic market will be a long-term growth driver. In the short-term, we expect the domestic market to grow at ~13-14%. In the US market, Lupin has demonstrated a strong performance and, going forward, we expect Lupin to sustain its performance.
Excellent branding strategy for Suprax and competitive positioning in the branded generic segment will help Lupin to achieve a robust growth rate in the US. Till date, Lupin has been able to competitively get its ANDA through to the US market, either by way of settlement or on the back of its rich-IP strength. We believe its formidable market share in niche therapies in domestic markets and strong pipeline of 56 pending ANDAs approvals in the US market will likely keep its growth momentum upbeat.
Lupin is currently hunting for more acquisitions in GCC, Japan and LatAm in order to establish a widespread geographical presence. It is also scouting for Indian companies specialising in nephrology and urology, since India is a high growth and a high cash generating market. During FY09, Lupin acquired four companies for a total consideration of Rs 167 crore, which are yet to contribute meaningfully to the bottomline. These acquisitions are likely to bring in incremental profits for Lupin and, in turn, drive the return ratios upwards.
Lupin stands out in the Indian pharma space on account of its superior business model, which is formed by strong and gradually strengthening US branded, robust generics business, thriving Japanese business, competitive API business and growing domestic market. We believe the recent acquisition of Antara may take Lupin to a new orbit as it targets the US$2-3 billion market, the patent on which expires in August 2020. We believe the current valuation of 16x FY11E EPS of Rs 92 does not capture the improvement in the business model. We are valuing Lupin on both sum of the part (SoTP) and comparative basis. We value the US business at 5x branded sales and 3x generics sales. The API business is valued at an EV to EBITDA ratio of 12x while the non-US formulation business is valued on a P/E basis. We got an SoTP value of Lupin at 1868.9. On a comparative basis, the fair value of Lupin works out to 1811. We arrived at the target price of Rs 1840, which is the average of SoTP and comparative valuation that is 20x FY11E EPS and 16x FY12E EPS.
We value the US business at 5x branded sales and 3x generics sales. The API business is valued at EV to EBITDA ratio of 12x while the non-US formulation business is valued on PE basis
Moreover, we have also used the sum of the parts (SoTP) valuation approach to value Lupin, wherein we have valued the branded US business on market cap to sales of 5x, US generics business on market cap to sales of 3x, API on EV to EBITDA and non-US business on P/E multiple basis.
Exhibit 29: SoTP Valuation matrix Revenue Basis Multile Valuation US Branded business 1218.5 Market cap to sales 5 6092.7 US Generics business 1578.0 Market cap to sales 3 4733.9 EBITDA API Business 59.2 EV to EBITDA 12 710.2 Net profit India 166.3 PE 14 2328.3 Advanced market other than US 105.6 PE 14 1478.3 Emerging market 86.8 PE 14 1214.7 Total 16558.1 Equity Capital 88.6 Face value 10 Per share value 1868.9
Source: Company, ICICIdirect.com Research
We have also looked at Lupin on a comparative basis to arrive at a fair value of 1811.
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Pankaj Pandey Head Research pankaj.pandey@icicisecurities.com ICICIdirect.com Research Desk, ICICI Securities Limited, 7th Floor, Akruti Centre Point, MIDC Main Road, Marol Naka, Andheri (E) Mumbai 400 093
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