Paromita Mam Project

8/2/2019 Paromita Mam Project

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International Finance 2 nd Mid term Assignment(IndianMNC trend)

A Brief study on

Pharma MNCs focus on branded generics in India to drive growth

Submitted By

Samrat Chakraborty Roll(PGDM 024)


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SUMMARY

Multinational corporations (MNCs) in the global pharmaceutical industry have been reporting

sluggish growth over the last few years, being held back by several factors includingimplementation of cost containment measures in developed countries, lack of strong productpipelines, and expiry of patents on existing products.

Emerging markets however represent an exciting opportunity for most pharma MNCs, given thatthese markets are expected to achieve a size of U$400 billion by 2020; the Indian market isexpected to grow to a size of US$40 billion by then.

Pharma MNCs are currently launching branded generics in the Indian market via productlocalisation, a strategy that involves local branding, sourcing and pricing. This strategy helpsthem launch products at competitive prices, thereby addressing affordability issues. Withlocalisation, the pharma MNCs operating in India have been able to improve their growth ratesand this strategy is expected to yield future growth.

The scaling up of field force by pharma MNCs in India to increase geographic penetration andthe launch of new products in the Indian market has led to an increase in personnel costs forthem. This, along with the increase in promotional and marketing expenditure on new launches,has brought pressures on operating margins, although they are still largely within the range of comfort. The margins are expected to improve once the incremental investments in marketingand sales translate into higher sales and profits.

The inorganic route remains one of the preferred routes for pharma MNCs looking to enter theIndian branded generics market or expand their market share therein. Through acquisition,

pharma MNCs get access to a ready product basket and infrastructure, besides managementcapabilities in the Indian market. While the M&A activity in the Indian market has so farinvolved large size deals, smaller acquisitions including licensing opportunities that couldincrease the market shares of the pharma MNCs and fill critical gaps in their portfolio may alsobe expected in future.

Healthy cash flows and parent company linkage help Indian arms of Pharma MNCs to maintain astrong credit profile.


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1.Pharma MNCs facing multiple challenges in the global market;growth likely to be sluggish there

Over the last few years, the global pharma industry has been facing multiple pressures

arising from increasing R&D costs, the implementation of cost control measures bydeveloped countries, issues related to pricing of patented products, and the absence of astrong product pipeline. By 2014, the top 10 innovator companies alone would face theexpiry of patents on brands that generated revenues in excess of US$120 billion (2008sales). Moreover, several countries are currently implementing strong pro-genericpolicies with stricter norms for reimbursement of costs. Further, established drug pricesare also being subjected to increasing pressure as part of the trend towards stricterpharmaceutical cost containment policies with reference pricing schemes (regulatingdrug reimbursement levels using a reference price cap) being extended to includetherapeutic rather than merely generic reference pricing programmes. Of greaterimportance to the pharma MNCs is the imposition of stricter controls on the pricing of,

and insurance reimbursement for, new drugs, given that these MNCs rely significantly onrevenues from new drugs to offset the impact of patent expiries. This has led to pressurecoming onto R&D spends in a scenario in which product pipelines are shrinking even asthe cost of bringing in a new product to the market stands at over US$800 million on anaverage . On the whole, all these factors are expected to restrict the annualised growthrate of the pharma MNCs to around 2.0% over the 2006-2020 period, according tovarious industry estimates. This situation has led to pharma MNCs shifting from thetraditional model of focusing on developed markets and patented products alone, tobeing present across the value chain and also entering newer markets to attain bettergrowth.

2.Emerging markets offer better growth opportunities

The growing use of generic and branded generics drugs has led to pharma companies reorganising theirstrategies by focusing on the generic and branded generics business in developed as well as developingcountries for higher growth. While Novartis, through Sandoz, remains one of the multinationals mostcommitted to generics among the leading pharma companies globally, players such as Pfizer and SanofiAventis also have in-house generic businesses (Greenstone and Winthrop, respectively). It is in thiscontext especially that the emerging markets represent exciting opportunities as they are expected to

grow at a much faster rate (CAGR2of 15.2% during 2006-2020) than their developed counterpart (CAGRof 2.0% during 2006-2020), given their rising health awareness and increasing spending power, among

other factors. The emerging markets are expected to reach a size of US$400 billion by 2020, with Indiabeing a key market. This scenario has led to pharma MNCs reorienting their strategies and resourceallocation for emerging markets. Thus they are now seeking to build up a significant presence in brandedgenerics and over-the-counter (OTC) drugs, launch off-patent products of other innovator companies,and adopt the practice of local pricing for patented drugs so as to attain volumes and capture marketshare.


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Table 1:-Indian operations of pharma MNCs achieve higher growth by focusing on branded generics

Trend In Growth rate of pharma MNC in India

Financial Year ending 2011 2010 2009

ABBOT 14% 12% 16%

NOVARTIS

8% 2% 3%

GLAXO SMITH KINE 13% 5% 2%

AVENTIS

1% 17% -1%MERCK 22% 24% -5%

ASTRA ZENECA 13% 14% 13%

PFIZER 13% 0% 1%

Table 2: Key Launches by Pharma MNCs Indian Operations during Last Few Years (Indicative List)

Brand Molecule launched by Treatment area Innovator companyXyzal M Montelukast+Levocetrizine UCB Respiratory MSD

Obiglo MD Voglibose Abbott Diabetes TakedaDibimet Metformin Novart is Cardiac BMS

Talitex Tremadol+Paracetamol NovartisPain

management J&JVigocil Voglibose Astra zeneca Diabetes TakedaTargit Telmisartan Pfizer Cardiac Boehringer ingelheim

Above 5 Rabeprazole sodium Pfizer Gastro intestinals EisaiXparin Enoxaparin sodium Astra zeneca Cardiac Sanfoi aventis

Esblanem Meropenem GSK Anti infectives Merck

3.Scale-up of marketing and sales efforts raises personnel cost; margins underpressure but still within range of comfort

With the emphasis increasing on new product launches and geographical expansion, the pharma MNCsoperating in India have been scaling up their field force to attain their strategic goals. Leading companiessuch as GSK, Pfizer, and Abbott have invested significantly in expanding their field force to widen thereach of both their current products and the ones in their pipeline. Thus, for instance, Pfizer added 500people to its field force in 2009, while Merck Limited had added 450 in 2008. Some of the pharma MNCshave also outsourced their sales and marketing function in remote rural areas to third parties, given that itis not cost effective for them to have their own field force in such locations. Following the expansion of field force, personnel costs have increased for the pharma MNCs, as is evident from the trend in theiroperating margins during the last few quarters. The cost of field force expansion apart, promotional andmarketing spends on new launches have also increased, with the result that the operating margins of thepharma MNCs operating in India have shrunk, although they are still largely within the


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range of comfort. The margins may improve once the incremental investments in marketing and salestranslate into higher sales and profits.

Chart 2: Quarterly Trends in Personnel Cost and Operating Margin for Pharma MNCs Operating inIndia

4.Pharma MNCs take the inorganic route to attain critical mass in India and drive growth

Pharma MNCs have been looking at acquisit ions, licensing arrangements with generic companies, and

other inorganic growth options in emerging markets to gain access to large generic product portfoliosand boost growth. Recent examples in this regard in the Indian space include the acquisition of Ranbaxyby Daiichi-Sankyo, of Shantha Biotech by Sanofi Aventis, and of Piramal Healthcares domesticformulations business by Abbott. The deals are expected to drive growth for the innovator companies inthe Indian market, especially in the segments in which they have litt le or no presence, by providing themwith a ready prescription base, infrastructure, distribut ion network, and local management capabilit ies.Abbott, which acquired Piramal Healthcares domestic branded generics business in 2010, has seen itsmarket ranking improve to No. 1, while Daiichi-Sankyos acquisit ion of Ranbaxy has given it a strongfoothold in the Indian market, besides providing it access to a large generic product basket that can bemarketed in other markets as well. The pharma MNCs are also able to add value to the acquisit ions by

marketing their global product portfolio in India through the distribution networks of the acquiredentit ies. While the recent M&As by pharma MNCs in India have all involved large size deals, smaller localacquisitions and licensing arrangements that could advance their market shares and fill critical gaps inthe portfolio may also be expected in future. Several global pharma MNCs have also entered intolicensing arrangements with Indian companies in order to be able to dip into a ready basket of genericproducts. For instance, GSK and Pfizer have entered into such arrangements with Indian companies likeDr. Reddys, Aurobindo Pharma, and Claris Lifesciences . These deals are likely to accelerate the launch

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Operating mergin 12.50% 11%10.80% 11% 10% 10.50%

Operating mergin


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of products in various generic markets while offering the MNCs the advantage of cost-effectivemanufacture by Indian companies.

Table3: Capital Structure - Key financial Indicator for Pharma MNCs Indian operations and Ratings

Summary Financials of Select Pharma MNCs Operating in India

In The year of 2010

Particular Merck Abbott GSK Pfizer Sanfoi aventis Novartis Astra zenecaOperating Income 487.5 760.9 1886 797.6 1028 599.5 385.8

Growth 20% 14% 13% 13% 1% 8% 13%

OPBDIT 75.9 97.3 669.8 159.1 201.4 110.3 78.1

Depreciation 7.5 9 16.4 8.3 17.3 2.7 6.1

PAT 65.5 77.5 504.9 136.9 157.4 103.7 57.6

Net worth 467.3 271.6 1759.1 994.3 931.8 514.7 144.5Investment &

Cash 384.5 163.5 1863.5 480.4 591.1 416.5 68.2

OPBDIT/OI 16% 13% 36% 20% 20% 18% 20%

PAT/OI 13% 10% 27% 17% 15% 17% 15%

RoCE 21% 36% 41% 17% 22% 23% 45%

In The Year Of 2010 Rs , in Crore

Particular Merck Abbott GSK PfizerSanfoiaventis Novartis Astra zeneca

Total Debt Nil Nil 5.4 Nil Nil 0.3 Nil

Net worth 467.3 271.6 1759.1 994.3 931.8 514.7 144.5Investment & Cash 384.5 163.5 1863.6 480.4 591.1 416.5 68.2

Moody's Rating Baa2 A1 A1 A1 A1 Aa2 A1ICRA rating LAA+


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5.R&D Cost for Pharma MNCs in Developing a New Drug

6.Recent M&A and Licensing Deals in the Generics segment (Indicative List)

Acquirer Targeted Company Comment Deal Value

DaiichiSankyo

Abbott

Sanofi Aventis

Sanofi Aventis

Ranbaxy Labortories Ltd

PiramalHealthcaresdomesticbranded generic business

Zentiva (Czech Republic)

Shantha Biotech

Daiichi-Sankyo gets access to the Indianmarket for its products, and to the generic

products basket of Ranbaxy for othermarkets

Abbotts market position improves to No. 1and it gets access to over 350 brands andtrademarks of Piramal Healthcare

Broader level of involvement in Indianmarkets through possible generic launchesby Sanofi Aventis

Development and launch of affordablevaccines by Sanofi Aventis

US$4.6 billion

US$3.7 billion

US$2.4 billion

0.55 billion

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200

300

400

500

600

700

800

900

1975 1987 2000


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7.Licensing Deals

Licensor Licensee CommentAstra Zeneca

Pfizer

GSK

GSK

GSK

Aurobindo Pharma

Aurobindo Pharma, ClarisLifesciences

Dr. Reddy's

UCB

Aspen

Aurobindo Pharma will supplysolid dosage and sterile productsto support Astra Zenecasbranded generics portfolio inEmerging Markets

Pfizer acquires the right to sellaround 150 generic products of Aurobindo Pharma and ClarisLifesciences

GSK acquires access to over 100generic products in markets

across Africa, West Asia, LatinAmerica and Asia

GSK buys the portfolio of UCBin a few developing markets

GSK acquires 16% stake in theSouth African generics companyas part of a licensing dealbetween them

8.Strength & weakness of Indian Pharma Industry

Strengths Weaknesses

* Cost advantages* Large pool of highly trained manpower.* 2nd largest number of U.S. FDA approved facilities.* TRIPS (Trade Related Intellectual PropertyRights) compliance.* Lower operating costs.* Growing biotechnology industry.

* Industry concentrated at lower end of value chain.Low level of investment in R&D.

* Highly fragmented industry.* Government price controls.* Low margins.* High tariffs and taxes.


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* Reverse engineering skills.* Largest number of Drug Master Files.* Bio-diversity.* FDI growing at 100 percent.* Strong IT skills for research data management.* Strong marketing and distribution network.* Well established network of laboratories.* It has an excellent record of development of improved, cost-beneficial chemical synthesis forvarious drug molecules.

* Substandard drugs and counterfeiting.* Most Indian companies are small by worldstandards.* Lack of experience in drug discovery.* Corruption.* Weak domestic market.* Low levels of per capita medical expenditure.

9.Domestic companies are transforming their business model to play a larger role in globalpharma market

The Indian pharma industry has been able to claim a share in the global market by leveraging its strengthsand enhancing its regulatory and technical maturity. Formulations manufactured in India constitute 20 percent of the global generics market by value, and the overall share of Indian manufactured formulations isas high as 46 per cent in the generics segment in the emerging markets. However, with the onset of thepatent regime, the traditional reverse engineering capabilities of Indian pharma companies are no longerhelpful, as they would not be able to replicate the patented product and launch it in the domestic market.Hence, going forward, India would be required to leverage its strengths in supply of low cost medicinesacross the world and invest in newer areas to drive growth. Opportunities exist ranging from the low-value added segment, comprising of NDDS ($134 billion opportunity by 20131), super generics ($135billion worth of product expiring between 2010 and 20152) and biosimilars ($115 billion worth of biologics expiring by 20153), to the high value New Chemical Entity (NCE)/New BiopharmaceuticalEntity segment. Thus, domestic companies can look forward to pursue all these opportunities and buildcapabilities to conduct drug discovery and in house development.

Vision 2020

I nd ian pharm aceu t ica l mar ke t by 202 0 ( US $ b il lion)


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Pharma MNCs to continue active participation in India

After years of anaemic growth in the Indian pharma market until the 1990s mainly due to a feebleintellectual property environment pharma MNCs have recorded steroid-led growth in the domesticmarket. They have increased investments in the domestic market over the past few years and are nowcomfortably placed to capture a substantial share of the domestic market. Evidently, pharma MNCs areprojected to capture a 35 per cent market share of the market by 2017, compared with 28 per cent in20095. Over the years, pharma MNCs have adopted India-focused strategies to tap the growing potentialof the countrys pharma market.

Increased patented drug launched in India: The advent of the product patent regime in 2005 instilledconfidence in the countrys IP regime. With renewed confidence, large pharma MNCs are now looking tolaunch their patented drugs in India and such product launches are expected to increase further in future.

Adopting inorganic route to enhance presence: Pharma MNCs have been considering acquisitions of

domestic players to gain sizeable share in the domestic market. These acquisitions have also enabledpharma MNCs to access the infrastructure, distribution networks, and management capabilities of domestic players, thereby strengthening their business operations in the country. On the other hand,licensing agreements with Indian companies have helped pharma MNCs access a ready basket of genericproducts. Going forward, these deals are likely to accelerate the launch of products in various emergingmarkets while offering MNCs the advantage of cost-effective manufacturing. Furthermore, pharmaMNCs consider India as a preferred strategic outsourcing partner with services ranging from ContractResearch Manufacturing (CRO) and clinical research services to sales and marketing, informationtechnology, finance and accounting, and customer-relationship management.

Differential pricing strategy to strengthen market reach: In a bid to compete with domestic genericplayers, pharma MNCs are launching patent-protected drugs in India at relatively low price points than

those in developed markets. Simultaneously, a differential pricing strategy is helping these MNCs toenhance their market reach by addressing affordability issues. Drugs such as Diovan (Novartis), Januvia(Merck Sharp & Dohme), and Galvus (Novartis) are being sold at discounts of up to 80 per cent on globalprices.

Rural-centric initiatives to enhance market access: Robust consumption in the rural economy isexpected to be a key growth driver. Rural India accounts for more than 70 per cent of all Indianhouseholds and close to 40 per cent of the total consumption pie. Henceforth, a large number of companies are organising their efforts to derive a major portion of their overall sales from this untappedmarket.

Additionally, pharma MNCs are looking to implement new and effective business models in India and

improve the health of patients. Delivering patient health outcomes implies getting involved in the cycle of care, rather than just delivering drugs to a health care system.

Few examples include: Sanofi-Aventis Saath 76: In 2009, Sanofi-Aventis launched the Saath 7programme in India, in which certified counsellors help diabetic patients understand their diseases andprovide personalised consultation through home visits.


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Mercks Sparsh7 : In 2009, Mercks Indian subsidiary, MSD Pharmaceuticals, launchedSparsh, a multilingual helpline for diabetics on its drugs Januvia and Janumet to providediet, exercise, and adherence advice.

J&Js Mobile Health for Mothers8: In September 2010, Johnson & Johnson (J&J) launched a mobilehealth initiative for expectant mothers in India. Mobile Health for Mothers provides free text messages onprenatal care, appointment reminders and calls from health coaches.

Pfizer-ITC 9: In July 2011, Pfizer collaborated with FMCG major ITC to enhance its product sales in therural markets. According to the agreement, Pfizer will sell its over-the-counter products through ITCchannels in rural areas.

Such noble initiatives can be expected to help pharma MNCs further augment their brand awareness inthe domestic market and help tap the segments growth potential .

Shifting disease burden in India

Adequate government support to further boost the domestic market

In the last 10 years, the Government of India (GoI) has aggressively adopted prudent strategies to boostthe countrys healthcare industry. From granting 100 per cent Foreign Direct Investment (FDI) in thedrugs and pharma sector to establishing various pharma SEZs across the country, a range of initiativeshave further strengthened the Indian pharma industry. Moreover, the GoI is providing incentives toencourage investment in the pharma sector.

In August 2010, the GoI announced its plans to set up a $639.56-million venture capital (VC) fund to giveimpetus to drug discovery and strengthen the countrys pharma infrastructure. Both domestic and MNC

pharma players are expected to leverage these initiatives to expand their operations in the country9.

The Department of Pharmaceuticals has prepared Pharma Vision 2020, aimed at making India one of the leading destinations for end-to-end drug discovery and innovation. It envisages meeting this objectiveby building top-notch infrastructure for talent and research, encouraging public-private partnership (PPP)models, offering financial incentives to encourage and incubate innovation and shaping a favourableregulatory environment2. The GoI also aims to position India among the top five pharma innovation hubsby 2020, with one out of every five to 10 drug discovered worldwide by 2020 originating from thecountry.


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The GoIs long-term vision is to provide quality and affordable health care services to all classes of Indian society. Consequently, the GoI plans to cover at least 50 per cent of the countrys population underhealth insurance by 2020, compared with the current average of 15 per cent10.

10.FDI in Pharma Industry

THE recent spate of merger and acquisition of Indian pharmaceutical companies by foreign multinational

companies (MNCs) has become a cause of serious concern because if this is allowed unbridled, the

domination of MNCs in the Indian medicine market will take us back to the worst situation of pre-

independence era. About a year ago, the Department of Industrial Promotion and Planning (DIPP), under

the Ministry of Commerce and Industry, has circulated a note expressing concern that the foreign

multinational companies are speedily buying up a number of large Indian pharmaceutical companies. The

purpose for circulating the note was to gather suggestions from the public to arrest such takeover of

Indian companies. This process of acquisition is termed as brown field investment since the acquiring

company does not invest anything for production, establishment of offices or any new activities other than

using the already existing facilities of the acquired company. This issue was subsequently taken up in the

high level committee.

MNCs INCREASING

MARKET SHARE Only 16 countries in the world have at least some arrangement of medicine production among whichcomprehensive infrastructural development is found in not more than half a dozen countries. Thequantum of medicines manufactured by pharmaceutical industry in India is fourth largest in the world.Near self-reliance in medicine production has been achieved due to the policy of the government inencouraging domestic industry to grow. Even in the post TRIPS (Patents) era, Indian companies arecapable of producing all essential medicines in the country. Therefore, the foreign MNCs have nosignificant role to play in medicine production in our country.

HIGH RATE

OF EARNINGS

The growth of domestic market in India has by no means been spectacular. Some studies indicate thatIndian pharmaceutical industry witnessed only marginal growth in sales and operating profits during2010-11. The net sales increased by 13.1 per cent to Rs 1,03,500 crore ($22.8 billion) during 2010-11from Rs 91,518 crore ($20.3 billion) in 2009-10. The net sales growth of almost similar set of companieswas just 11.6 per cent in 2009-10 over the previous year. Only slight growth could be registered inexports also, despite stiff competition, conditions of economic crisis and cost-cutting measures in the US.


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The earnings before depreciation, interest, tax and adjustments (EBDITA) of 100 listed pharmaceuticalcompanies increased by 21.9 per cent to Rs 23,317 crore from Rs 19,133 crore in the previous year. TheEBDITA margins improved to 22.5 per cent from 20.9 per cent. These companies recommendedhandsome dividend to shareholders and created healthy reserve position during 2010-11. This marketstudy includes sales in both domestic and exports, of which nearly 40 per cent is domestic sales.Therefore profitability in domestic market also further attracts the MNCs.

STAGNATION

IN INVESTMENT

he present trend in imports is also a cause for concern where the MNCs are leading. After increasingsharply in the late 1990s, import stabilised a bit. But they began to rise since second half of 2000. TheIndian companies and agents are also involved in such import of finished drugs. Those MNCs which arenot operating in India are entering into marketing alliances to sell their products here. Indian companieswhich act as authorised agents for imported formulations include Elder, USV, Emcure, Cadila Healthcare,Piramal and Ranbaxy. Thus Indian companies are functioning as traders of the MNCs.

Foreign Investment Promotion Board (FIPB) is mandated to play a role in the administration andimplementation of the governments FDI policy. However as seen from above instances, FIPB route haslimitation in addressing these concerns. For example MNCs may enter into informal agreements, by wayof strategic alliances, to bypass the explicit restrictions. Similarly, section 5 of the Competition Act sets avery high threshold for Competition Commission of India (CCI) to act. As per Section 5 9(i) (A), CCI canintervene only when the asset value in India is more than Rs 1000 crore or turnover is more than Rs 1500crore. There may be many deals below this threshold which together can cause domination by the MNCseither in one or multiple companies listed in different countries by the same MNC.

11.Macro factors pushing the industryThe Growing Indian Economy

The Indian economy is growing fast, and is valued at US$1.430 trillion in 2010 GDP growth, calculatedon a Purchasing Power Parity basis has reached 9.66% in the year 2010, and the International MonetaryFund (IMF) expects it to remain consistently above 8% till 2015. Furthermore, Indias share in the worldGDP has been steadily increasing, and is expected to reach 6.28% in 2015, up from 4.17% in 2005.

Growing middle class with higher purchasing power

Indias population is currently just over 1.1 billion and is projected to rise to 1.6 billion by 2050 a45.5% increase that will see it outstrip China as the worlds most populous state.Besides, India has a hugemiddle class population (households with annual incomes of US$4762 to US$23,810 at 2001-02 prices),which has grown rapidly, from 25 million people in 1996 to 153 million people in 2010. If the economycontinues to grow fast and literacy rates keep rising, around a third of the population (34%) is expected to

join the middle class in the near future. The middle class population is rapidly acquiring the purchasingpower necessary to afford quality western medicine due to an increase in disposable income. The Indianpopulation spent 7% of its disposable income on healthcare in 2005; this number is expected to nearlydouble, to 13%, by 2025.


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12.Conclusion

With the pressure of increasing healthcare costs serving to drive upvolumes in the generics business across markets, this segment isbecoming increasingly relevant for all players in the industry, includingthe large innovator companies. In this context, markets like India areespecially attractive, given their potential for higher growth. The pharmaindustry in India has over the last few years have seen some largeinorganic investments by pharma MNCs, and these acquisitions arelikely to play a significant role in expanding the generic footprints of theMNCs concerned both in India and in other major markets. Goingforward, most pharma MNCs are likely to maintain their focus on theIndian market, strengthening their product basket and sales network.


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13.Bibliography

1.WWW.ICRA.IN (Indian credit rating agencies)

2.Moodys investor service

3.WWW.ORGINDIA.COM

4.WWW.PWC.COM (Pricewaterhousecoopers)


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