ICICI Securities Ltd. | Retail Equity Research January 16, 2015 Monthly Update Expect muted Q3 numbers… During the quarter, companies under I-Direct healthcare coverage are expected to post growth of 10.5% YoY to | 28190 crore. The growth rate is the slowest in the last many quarters. But for the traction from domestic formulations and consolidation of the acquired businesses, growth could have been even lower (excluding Actavis and Elder acquisitions by Aurobindo and Torrent, respectively, the growth would be ~8% YoY to | 27562 crore). Consolidated US sales (from select pack) are likely to grow 6% YoY to | 8362 crore. This temperance is mainly on the back of a high base, increased competition in existing products and a slowdown in product approvals from the USFDA. Indian formulations from a select pack are likely to grow 21% YoY to | 6083 crore on the back of new launches and normalcy in trade channels post NLEM price implementation. Currency headwinds from emerging economies such as Russia, Brazil and Venezuela are also likely to impact growth from these markets for a few of the universe companies such as Dr Reddy’s and Glenmark. Among players, Ajanta Pharma, Cipla, Torrent and Aurobindo are expected to do well on the back of strong growth in the domestic market and consolidation of the acquired businesses. On the other hand, a few of the frontline pharma companies like Lupin, Dr Reddy’s and Glenmark are likely to be laggards on account of the slowdown in USFDA approvals and adverse currency movement. In another instance of MNC patent rejection, India's patent office has rejected an application from US based Gilead Sciences Inc for its hepatitis C drug Sovaldi, paving the way for local drug makers to launch cheaper generic versions of the drug. The patent office's order said Gilead's request for Sovaldi, which costs US$84,000 for a 12-week course in the US, was rejected on the basis of the fact that minor and cosmetic changes in the molecule did not improve the efficacy of the drug. In a strategic shift from an earlier stance of growth from establishing tertiary hospital chains, Apollo Hospitals acquired Nova Specialty Hospitals, which is a secondary hospital chain. The chain of 11 facilities of Nova is spread across eight cities, and will add to Apollo's network of 45 modular operation theatres. Acquisition will also add over 300 beds to the current strength of ~9000 beds. But more importantly, it reflects the focus on nursing homes acquisitions, a deviation from the earlier stance of greenfield expansion. Finally, the Indian pharmaceutical market (IPM) registered strong growth of 13.6% YoY to | 7243 crore for December. The YoY growth was driven by- 1) price hikes - 5.3%, 2) volume growth - 5.1% and 3) new product launches - 4.1%. Stocks likely to consolidate post Q3 numbers… The healthcare index maintained its outperformance in CY14 vis-à-vis the broader market (fifth in a row), backed by superior earnings growth and PE expansion. As the Q3 earnings season approaches, we expect some slowdown in most stocks on the back of altered earnings expectations. Even a moderate correction cannot be ruled out, which, we believe is warranted in some stocks that are running ahead of valuations. Going ahead, product approvals and currency fluctuation are likely to weigh on earnings in the near term as will the stock performance. However, long term growth prospects continue to remain healthy. Health Check Sector View Outperformer Index Performance as on January 15, 2015 Return (%) 1M 3M YTD 1Y BSE 500 6 11 3 41 Sensex 5 8 2 32 BSE Healthcare 2 10 0 45 Return (%) Stocks Performance Mcap Company 1M 3M YTD 1Y 15-Jan Sun Pharma.Inds. 0 5 1 41 172585 Lupin 0 9 0 56 64298 Dr Reddy's Labs 4 12 0 23 55431 Cipla 3 11 3 56 51708 Cadila Health. 7 22 2 88 33540 Aurobindo Pharma 4 27 1 188 33344 Glaxosmit Pharma 8 18 -1 7 26936 Divi's Lab. 2 1 -1 33 22736 Glenmark Pharma. -6 1 -6 43 19615 Torrent Pharma. 6 32 -3 131 18584 Apollo Hospitals 4 13 3 26 16208 Wockhardt 6 41 3 144 11399 Pfizer 7 37 -3 90 9598 Ipca Labs. -2 4 -2 -6 9013 Ajanta Pharma -1 51 7 169 8788 Biocon 0 -8 1 -8 8561 Strides Arcolab 4 43 -3 188 5525 Indoco Remedies 10 12 0 124 2863 Jubilant Life 19 -4 22 14 2349 Unichem Labs. -5 6 -4 5 2109 Elder Pharma 20 -25 25 -44 268 Return (%) Mcap: Market cap in | crore Price movement 7500 8500 9500 10500 11500 12500 13500 14500 15500 16500 Jan-14 Apr-14 Jul-14 Oct-14 Jan-15 15000 17000 19000 21000 23000 25000 27000 29000 31000 BSE Healthcare Sensex (RHS) Research Analyst Siddhant Khandekar [email protected]Mitesh Shah [email protected]Nandan Kamat [email protected]
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ICICI Securities Ltd. | Retail Equity Research
January 16, 2015
Monthly Update
Expect muted Q3 numbers… During the quarter, companies under I-Direct healthcare coverage are expected to post growth of 10.5% YoY to | 28190 crore. The growth rate is the slowest in the last many quarters. But for the traction from domestic formulations and consolidation of the acquired businesses, growth could have been even lower (excluding Actavis and Elder acquisitions by Aurobindo and Torrent, respectively, the growth would be ~8% YoY to | 27562 crore). Consolidated US sales (from select pack) are likely to grow 6% YoY to | 8362 crore. This temperance is mainly on the back of a high base, increased competition in existing products and a slowdown in product approvals from the USFDA. Indian formulations from a select pack are likely to grow 21% YoY to | 6083 crore on the back of new launches and normalcy in trade channels post NLEM price implementation. Currency headwinds from emerging economies such as Russia, Brazil and Venezuela are also likely to impact growth from these markets for a few of the universe companies such as Dr Reddy’s and Glenmark. Among players, Ajanta Pharma, Cipla, Torrent and Aurobindo are expected to do well on the back of strong growth in the domestic market and consolidation of the acquired businesses. On the other hand, a few of the frontline pharma companies like Lupin, Dr Reddy’s and Glenmark are likely to be laggards on account of the slowdown in USFDA approvals and adverse currency movement. In another instance of MNC patent rejection, India's patent office has rejected an application from US based Gilead Sciences Inc for its hepatitis C drug Sovaldi, paving the way for local drug makers to launch cheaper generic versions of the drug. The patent office's order said Gilead's request for Sovaldi, which costs US$84,000 for a 12-week course in the US, was rejected on the basis of the fact that minor and cosmetic changes in the molecule did not improve the efficacy of the drug. In a strategic shift from an earlier stance of growth from establishing tertiary hospital chains, Apollo Hospitals acquired Nova Specialty Hospitals, which is a secondary hospital chain. The chain of 11 facilities of Nova is spread across eight cities, and will add to Apollo's network of 45 modular operation theatres. Acquisition will also add over 300 beds to the current strength of ~9000 beds. But more importantly, it reflects the focus on nursing homes acquisitions, a deviation from the earlier stance of greenfield expansion. Finally, the Indian pharmaceutical market (IPM) registered strong growth of 13.6% YoY to | 7243 crore for December. The YoY growth was driven by- 1) price hikes - 5.3%, 2) volume growth - 5.1% and 3) new product launches - 4.1%. Stocks likely to consolidate post Q3 numbers… The healthcare index maintained its outperformance in CY14 vis-à-vis the broader market (fifth in a row), backed by superior earnings growth and PE expansion. As the Q3 earnings season approaches, we expect some slowdown in most stocks on the back of altered earnings expectations. Even a moderate correction cannot be ruled out, which, we believe is warranted in some stocks that are running ahead of valuations. Going ahead, product approvals and currency fluctuation are likely to weigh on earnings in the near term as will the stock performance. However, long term growth prospects continue to remain healthy.
Exhibit 1: Summary of USFDA approvals for December 2014 [5
Company Drug Name Therapeutic Area Innovator company Generic Version of Market SizeStrides Acrolab Calcitriol Oral 0.25MCG, 0.50MCG Vitamins Validus Pharms Rocaltrol US$ 50 millionSun Pharma Bupropion Hydrochloride 150mg Tablet Anti-depressant GSK Wellbutrin US$ 268 millionLupin Lamivudine HIV ViV Healthcare Epivir NAJubilant Rizatriptan Benzoate Anti-Migraine Merck Maxalt US$ 193 million
Final Approvals
CNS: Central Nervous System; CVS: Cardiovascular, NA: Not available; Source: USFDA, ICICIdirect.com Research
Regulatory approvals / IP Issues
Patent office rejects Gilead application for Sovaldi India's patent office has rejected an application from US based Gilead Sciences Inc for its hepatitis C drug Sovaldi, paving the way for local drug makers to launch cheaper generic versions of the drug. The patent office's order said Gilead's request for Sovaldi, which costs US$84,000 for a 12-week course in the US, was rejected on the basis that "minor changes in the molecule" did not improve efficacy of the drug. Lawsuits, court rulings, settlements
Cipla, Novartis in legal tangle The Delhi High Court has asked Cipla to stop selling the cheaper generic version of Novartis’s respiratory drug Onbrez (Indacaterol; COPD). The court, in its interim order restrained Cipla from manufacturing its drug sold under the name of Indaflo but allowed it to sell the stock remaining with it. Novartis in its interim application had sought to restrain Cipla from selling its product during pendency of the patent infringement suit filed by it. Novartis has been selling Onbrez in India as an inhalation powder and inhaler under the trademark name Onbrez through its licensee Lupin Ltd, since 2010. The court has also sought Novartis’ response on the plea of Cipla against an order restraining it from making its respiratory disease drug, Indaflo, till it obtains a compulsory license. Glenmark wins patent suit against Abbott in India Glenmark has won a patent case against Abbott regarding Humira, used for treatment of severe forms of arthritis. Glenmark had filed a pre-grant opposition in September 2008 after Abbott was granted a patent for Humira drug. Price cuts, new launches, recalls
Cadila recalls 19,536 bottles of cough treatment drug in US Cadila is voluntarily recalling 19,536 bottles of Benzonatate capsules, used to treat coughs, in the US due to wet and/or leaking capsules. The recall has been initiated by the company on December 23 and has been initiated under Class-II. M&As, demergers and JVs
Apollo acquires Nova chain of hospitals Apollo Hospitals has acquired Nova Specialty Hospitals at an estimated cost of | 135-145 crore. The acquisition has been funded through debt and equity components. The chain of 11 facilities of Nova is spread across eight cities and will add to Apollo's network of 45 modular operation theatres. The combined network will clock a turnover in the range of | 115-125 crore for the financial year ending March 2015. The acquisition will also add over 300 beds to the current strength of ~9000 beds. Nova has been a loss-making entity. The management expects to break even in the next 18-24 months.
ICICI Securities Ltd. | Retail Equity Research
Page 3
Exhibit 2: Patent litigations in CY14 [5
Mo nth In novato r A NDA Filer Bran d Na me API Used for J an-1 4 Lyne Lab oratories Lupin Pho slyra Calcium Acetate Renal diseaseJ an-1 4 Eli Lilly & Co Glenmark Ph arma Alimta Pemetre xed Disodiu m An ti-CancerJ an-1 4 A lc on Research Cipla Pataday Oloparadine Hydrochloric Inf lam mato ry eye conditionsJ an-1 4 Te ijin Ranb axy Uloric Febu xostat Gou tJ an-1 4 Ceden ce Pharma Wo ckhard t Ofirmev Ace taminoph en An ti- inflammatoryJ an-1 4 Fo rest Labs Sun Pharma Namenda Mem antine HCl CNSJ an-1 4 Fo rest Labs Wo ckhard t Namenda Mem antine HCl CNSJ an-1 4 Senju Pharmaceuticals Lupin Prolensa Bromfenac Eye in flammationFeb -1 4 Novartis Dr Reddy 's Gleevec Imatinib Mesylate FibromyalgiaFeb -1 4 Fo rest Labs Glenmark Ph arma Savella Milnacipran HCl LeukemiaFeb -1 4 Te ijin Lupin Uloric Febu xostat Gou tFeb -1 4 Fo rest Labs Cadila Hea lthcare Namenda Mem antine HCl CNSFeb -1 4 A bbVie A uro bindo Pharm a Zemp lar Paricalcitol Hype rparathyro idismFeb -1 4 Sanof i Glenmark Ph arma Multaq Dronedarone HCl CVSMar-14 Sanof i Sun Pharma Multaq Dronedarone HCl CVSMar-14 Eli Lilly & Co & Daiichi San ky o A uro bindo Pharm a Effien t Prasug rel CVSMar-14 Eli Lilly & Co & Daiichi San ky o Dr Reddy 's Effien t Prasug rel CVSMar-14 Eli Lilly & Co & Daiichi San ky o Glenmark Ph arma Effien t Prasug rel CVSMar-14 Eli Lilly & Co & Daiichi San ky o Sun Pharma Effien t Prasug rel CVSMar-14 Eli Lilly & Co & Daiichi San ky o Cadila Hea lthcare Effien t Prasug rel CVSMar-14 Pfizer To rrent Ph arma Viag ra Sild enafil Citrate Im potencyMar-14 ViiV Health care Lupin Epzicom Zidovud ine CVSMar-14 Otsuka Pharma Wo ckhard t Abilify Aripiprazole schizop hre niaA pr-14 K owa A uro bindo Pharm a Livalo P itavastatin CVSA pr-14 Me dicines co A uro bindo Pharm a Ang iomax Bivalirud in An ginaA pr-14 K owa A uro bindo Pharm a Livalo P itavastatin CVSMay-14 Senju Pharmaceuticals A uro bindo Pharm a Zyma xid Gatifloxacin Conjun ctivit isMay-14 Otsuka Pharmac eutical Co. A lembic Pharma Abilify Aripiprazole Schizoph ran iaMay-14 Dr Redd y's Labs Purdue Pharmace utical P ro duc Inte rmezzo Zolpidem Insom niaMay-14 Otsuka Pharmac eutical Co. Cadila Hea lthcare Abilify Aripiprazole Schizoph ran iaMay-14 Otsuka Pharmac eutical Co. A uro bindo Pharm a Abilify Aripiprazole Schizoph ran iaMay-14 A straZeneca AB A uro bindo Pharm a Onlyza Saxagliptin Typ e 2 Diab etesMay-14 A straZeneca AB Glenmark Generics Onlyza Saxagliptin Typ e 2 Diab etesMay-14 A straZeneca AB Wo ckhard t Onlyza Saxagliptin Typ e 2 Diab etesMay-14 Otsuka Pharmac eutical Co. Wo ckhard t Abilify Aripiprazole Schizoph ran iaMay-14 Fo rest Laborato ries In c. Ranb axy Labs Namenda XR Mem antine Alzh eimer's diseaseJ un-1 4 A straZeneca Pharmaceuticals LP Sun Pharma Global FZE ; Onglyza Saxagliptin DiabetesJ un-1 4 Bristol-Myers Squibb Co. A uro bindo Pharm a Reyataz Atazanavir HIVJ un-1 4 Te va Women's H ealth Lupin Quartette Levonorgestre Contra ceptiveJ un-1 4 Fo rest Laborato ries In c A uro bindo Pharm a Namenda XR Mem antine Alzh eimer's diseaseJ un-1 4 Senju Pharma Lupin Ph arma Inc. Prolensa Bromfenac Ocular Inf lam mationJ ul-14 Pfizer Inc A uro bindo Pharm a Tygacil Tyg ecyclin e InfectionJ ul-14 Glaxo Sm ith Kline LLC Glenmark Generics Inc. Coreg Carved ilo l High Blood Pressu reJ ul-14 A llos Therapuetics Inc Dr Reddy 's Folotyn Pralatrexate LymphomaJ ul-14 A corda Therapeu tics Inc. ; A uro bindo Pharm a Ampyara Dalfampridine Multiple SyrosysJ ul-14 A lc on Pharmaceu ticals Ltd . A uro bindo Pharm a Vig amo x Moxif lo xacin Eye InfectionJ ul-14 Gilead Scien ces Inc. Lupin Ltd. Atripla Efa virenz/Emtricitab in e/T enofo vir HIVJ ul-14 A bbVie Inc. A uro bindo Pharm a Norvir Rito navir HIVJ ul-14 A lkermes Ph arma Ltd. Sun Pharmaceuticals Focalin XR Dexmethylphenidate AD HDJ ul-14 Otsuka Pharma Co. To rrent Ph arma Abilify Aripiprazole Schizoph ren iaJ ul-14 A strazeneca AB Cadila Hea lthcare Nexium Esomeprazole Ac id RefluxA ug-14 J anssen Pro ducts LP Cipla Ltd. Prezista Darunavir HIVA ug-14 Fo rest Labs Lupin Ltd. Namenda Mem antine Hydrochloride Alzh eimer's diseaseA ug-14 Senju Pharma Ltd. Lupin Ltd. Prolensa Bromfenac Ocular Inf lam mationA ug-14 Novartis Pharma Dr. Redd y's Labs Gleevec Imatinib Mesylate Organ Rejec tionSep-14 Millenium Pharmaceu ticals Glenmark Ph arma Valcad e Bortez omib Multiple MylomaSep-14 Te va Ph arma Dr. Redd y's Labs Copaxon Glat iramer Acetate Multiple SclerosisSep-14 Reckitt Be nckiser LLC A uro bindo Pharm a Mucinex Guaif enesin Mucu sSep-14 Ceph alo n Inc. Dr. Redd y's Labs Tre anda Benda mustine LeukemiaSep-14 Ceph alo n Inc. Sun Pharma Tre anda Benda mustine LeukemiaOct-14 Novartis Pharma Dr. Redd y's Labs Gleevec Imatinib LeukemiaOct-14 Braintree Lab oratory Inc. Ta ro Pharm a Su prep Sodium Sulphate Bow el Preparatio nOct-14 Ceph alo n Inc. Wo ckhard t Tre anda Benda mustine LeukemiaNov-1 4 Biomarin Pharm a Dr. Redd y's Labs Kuvan Sapropterin D ih ydrochlorid e phe nylke ton uriaNov-1 4 Otsuka Pharma Cadila Hea lthcare Abilify Aripiprazole schizop hre niaNov-1 4 Otsuka Pharma A lembic Pharma Abilify Aripiprazole schizop hre nia
Source: Bloomberg, ICICIdirect.com Research
ICICI Securities Ltd. | Retail Equity Research
Page 4
IPM growth backed by steepest price hikes in a year • The Indian pharmaceutical market (IPM) registered strong growth of
13.6% YoY to | 7243 crore for the month. The YoY growth was driven by- 1) price hikes - 5.3%, 2) volume growth - 5.1% and 3) new product launches - 4.1%
• Growth on account of price hike of 5.3% was the steepest in the last 12 months
• Drugs under the NLEM list witnessed growth of 8.0% YoY to | 1252 crore mainly due to recovery in volumes (albeit on lower base) while non-NLEM drugs posted growth of 14.8% to | 6123 crore mainly on price hikes
• Among our covered companies, Torrent has registered highest growth of 31.1% YoY followed by Sun Pharma, Glenmark and Ajanta clocking growth of 21.5%, 21.2% and 19.6%, respectively
• Therapy wise, four therapies have outpaced the IPM growth while 14 therapies have double digit growths. Notable among them with growth rates- anti-diabetic – 33.1%, dermatology- 19.6%, cardiac – 18.2% and urology – 29.7%.
• In all, 185 new brands were launched in December • On a MAT basis, IPM growth stood at 10.2% YoY to | 83009 crore • MNC companies grew 17.5% while domestic companies grew 12.1% in
December 2014 Exhibit 3: Domestic formulations - growth trend
12.3
12.7
7.5
7.1 8.
3
11.7 13
.2
9.0 10
.2
6.3
11.0
19.8
13.6
-5
0
5
10
15
20
Dec-
13
Jan-
14
Feb-
14
Mar
-14
Apr-1
4
May
-14
Jun-
14
Jul-1
4
Aug-
14
Sep-
14
Oct-1
4
Nov
-14
Dec-
14
(%)
Indian Pharma Market [
Source: AIOCD data base, ICICIdirect.com Research
Exhibit 4: Companies growth in domestic market in December 2014
Top brands in Indian pharma market Brand Company Therapy Dec'14 Dec'13 Gr. (%)Augmentin GSK Anti-Infectives 285.1 289.1 -1.4Becosules Pfizer Vitamins 237.5 227.5 4.4Corex Pfizer Respiratory 222.5 229.3 -3.0Clavam Alkem Anti-Infectives 213.0 198.7 9.2Lantus Sanofi Anti Diabetic 207.7 160.9 20.2Manforce Mankind Sex Stimulants 178.4 185.2 -4.3Galvus Met Novartis Anti Diabetic 176.7 130.2 6.0Skinlite Zydus Derma 172.6 136.0 33.0Aciloc Cadila * GI 166.6 156.6 31.2Taxim Alkem Anti-Infectives 162.4 149.9 8.4
Source: AIOCD data base; Date as per MAT December14 & December13; *Cadila Pharmaceuticals Industry acute to chronic therapy ratio percentage…
Acute, 58013.0,
70.0%Chronic, 24914.7,
30.0%
Source: AIOCD data base ; As per AIOCD MAT December 2014
ICICI Securities Ltd. | Retail Equity Research
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Price hikes key driver for quarterly growth… • The Indian pharmaceutical market (IPM) has registered growth of 10.3%
YoY to | 21597 crore in Q3FY15 • The YoY growth was largely driven by 4.8% price hikes taken during the
quarter while volume and new product growth was 3.0% and 2.5%, respectively, in Q3FY15
• Growth on account of price hike of 4.8% was the steepest in the last many quarters
• Drugs under the NLEM list witnessed growth of 2.8% YoY to | 3651 crore mainly due to price hikes while non-NLEM drugs posted growth of 11.4% to | 17865 crore
• Among our covered companies, Ajanta registered highest growth of 33.7% YoY followed by Torrent at 19.7%
• Therapy wise, 10 therapies have outpaced IPM growth. Notable among them with growth rates- anti-diabetic – 23.7%, dermatology- 16.6%, cardiac – 11.4% and urology – 26.5%
• In all, 591 new brands were launched in Q3FY15 Exhibit 5: Domestic formulations – quarterly growth trend
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