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Pharma FDI: Damning Report of Parliamentary Panel, PM Vetoes…and Avoids Ruffling Feathers?

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An interesting situation emerged last week. The Parliamentary Standing Committee (PSC) on Commerce proposed a blanket ban on all FDI in brownfield pharma sector. Just two days after that, the Prime Minister of India vetoed the joint opposition of the Department of Industrial Policy and Promotion (DIPP) and the Ministry of Health to clear the way for all pending pharma FDIs under the current policy.

On August 13, 2013, Department related Parliamentary Standing Committee on Commerce laid on the Table of both the Houses of the Indian Parliament its 154 pages Report on ‘FDI in Pharmaceutical Sector.’

The damning report of the Parliamentary Standing Committee flags several serious concerns over FDI in brownfield pharma sector, which include, among others, the following:

1. Out of 67 FDI investments till September 2011, only one has been in green field, while all the remaining FDI has come in the brown field projects. Moreover, FDI in brown field investments have of late been predominantly used to acquire the domestic pharma companies.

2. Shift of ownership of Indian generic companies to the MNCs also results in significant change of the business model, including the marketing strategy of the acquired entity, which are quite in sync with the same of the acquirer company. In this situation, the acquired entity will not be allowed to use flexibilities such as patent challenges or compulsory license to introduce new affordable generic medicines.

The withdrawal of all patent challenges by Ranbaxy on Pfizer’s blockbuster medicine Lipitor filed in more than eight countries immediately after its acquisition by Daiichi-Sankyo is a case in point.

3. Serial acquisitions of the Indian generic companies by the MNCs will have significant impact on competition, price level and availability. The price difference between Indian ‘generics’ and MNCs’ ‘branded generic’ drugs could  sometimes be as high as 80 to 85 times. A few more larger scale brownfield takeovers may even destroy all the benefits of India’s generics revolution.

4. FDI inflow into Research & Development of the Pharma Industry has been totally unsatisfactory. 

5. FDI flow into brown field projects has not added any significant fresh capacity in manufacturing, distribution network or asset creation. Over last 15 years, MNCs have contributed only 5 per cent of the gross fixed assets creation, that is Rs 3,022 crore against Rs 54,010 crore by the domestic companies. Further, through brownfield acquisitions significant strides have not been made by the MNCs, as yet, for new job creation and technology transfer in the country.

6. Once a foreign company takes over an Indian company, it gets the marketing network of the major Indian companies and, through that network, it changes the product mix and pushes the products, which are more profitable and expensive. There is no legal provision in India to stop any MNC from changing the product mix.

7. Though the drug prices may not have increased significantly after such acquisitions yet, there is still a lurking threat that once India’s highly cost efficient domestic capacity is crushed under the weight of the dominant force of MNCs, the supply of low priced medicines to the people will get circumvented.

8. The ‘decimation’ of the strength of local pharma companies runs contrary to achieving the drug security of the country under any situation, since there would be few or no Indian companies left having necessary wherewithal to manufacture affordable generics once a drug goes off patent or comply with a Compulsory License (CL).

9. Current FIPB approval mechanism for brownfield pharma acquisitions is inadequate and would not be able to measure up to the challenges as mentioned above.

The Committee is also of the opinion that foreign investments per se are not bad. The purpose of liberalizing FDI in pharma was not intended to be just about takeovers or acquisitions of domestic pharma units, but to promote more investments into the pharma industry for greater focus on R&D and high tech manufacturing, ensuring improved availability of affordable essential drugs and greater access to newer medicines, in tandem with creating more competition. 

Based on all these, The Committee felt that FDI in brown field pharma sector has encroached upon the generics base of India and adversely affected Indian pharma industry. Therefore, the considered opinion of the Parliamentary Committee is that the Government must impose a blanket ban on all FDI in brownfield pharma projects.

PM clears pending pharma FDI proposals:

Unmoved by the above report of the Parliamentary Committee, just two days later, on August 16, 2013, the Prime Minister of India, in a meeting of an inter-ministerial group chaired by him, reportedly ruled that the existing FDI policy will apply for approval of all pharmaceutical FDI proposals pending before the Foreign Investments Promotion Board (FIPB). Media reported this decision as, “PM vetoes to clear the way for pharma FDI.”

This veto of the PM includes US $1.6-billion buyout of the injectable facility of Agila Specialties, by US pharma major Mylan, which has already been cleared by the Competition Commission of India (CCI).

This decision was deferred earlier, as the DIPP supported by the Ministry of Health had expressed concerns stating, if MNCs are allowed to acquire existing Indian units, especially those engaged in specialized affordable life-saving drugs, it could possibly lead to lower production of those essential drugs, vaccines and injectibles with consequent price increases. They also expressed the need to protect oncology facilities, manufacturing essential cancer drugs, with assured supply at an affordable price, to protect patients’ interest of the country.

Interestingly, according to Reserve Bank of India, over 96 per cent of FDI in the pharma sector in the last fiscal year came into brownfield projects. FDI in the brownfield projects was US$ 2.02 billion against just US$ 87 million in the green field ventures.

Fresh curb mooted in the PM’s meeting:

In the same August 16, 2013 inter-ministerial group meeting chaired by the Prime Minister, it was also reportedly decided that DIPP  will soon float a discussion paper regarding curbs that could be imposed on foreign takeovers or stake purchases in existing Indian drug companies, after consultations with the ministries concerned.

Arguments allaying apprehensions:

The arguments allaying fears underlying some of the key apprehensions, as raised by the Parliamentary Standing Committee on Commerce, are as follows:

1. FDI in pharma brownfield will reduce competition creating an oligopolistic market:

Indian Pharmaceutical Market (IPM) has over 23,000 players and around 60,000 brands. Even after, all the recent acquisitions, the top ranked pharmaceutical company of India – Abbott enjoys a market share of just 6.6%. The Top 10 groups of companies (each belonging to the same promoter groups and not the individual companies) contribute just over 40% of the IPM (Source: AIOCD/AWACS – Apr. 2013). Thus, IPM is highly fragmented. No company or group of companies enjoys any clear market domination.

In a scenario like this, the apprehension of oligopolistic market being created through brownfield acquisitions by the MNCs, which could compromise with country’s drug security, needs more informed deliberation.

2. Will limit the power of government to grant Compulsory Licensing (CL):

With more than 20,000 registered pharmaceutical producers in India, there is expected to be enough skilled manufacturers available to make needed medicines during any emergency e.g. during H1N1 influenza pandemic, several local companies stepped forward to supply the required medicine for the patients.

Thus, some argue, the idea of creating a legal barrier by fixing a cap on the FDIs to prevent domestic pharma players from selling their respective companies at a price, which they would consider lucrative otherwise, just from the CL point of view may sound unreasonable, if not protectionist in a globalized economy.

3.  Lesser competition will push up drug prices:

Equity holding of a company is believed by some to have no bearing on pricing or access, especially when medicine prices are controlled by the NPPA guidelines and ‘competitive pressure’.

In an environment like this, any threat to ‘public health interest’ due to irresponsible pricing, is unlikely, especially when the medicine prices in India are cheapest in the world, cheaper than even Bangladesh, Pakistan and Sri Lanka (comment: whatever it means).

India still draws lowest FDI within the BRIC countries: 

A study of the United Nations has indicated that large global companies still consider India as their third most favored destination for FDI, after China and the United States.

However, with the attraction of FDI of just US$ 32 billion in 2011, against US$ 124 billion of China, US$ 67 billion of Brazil and US$ 53 billion of Russia during the same period, India still draws the lowest FDI among the BRIC countries.

Commerce Minister concerned on value addition with pharma FDI:

Even after paying heed to all the above arguments, the Commerce Minister of India has been expressing his concerns since quite some time, as follows:

“Foreign Direct Investment (FDI) in the pharma sector has neither proved to be an additionality in terms of creation of production facilities nor has it strengthened the R&D in the country. These facts make a compelling case for revisiting the FDI policy on brownfield pharma.”

As a consequence of which, the Department of Industrial Policy and Promotion (DIPP) has reportedly been opposing FDI in pharma brownfield projects on the grounds that it is likely to make generic life-saving drugs expensive, given the surge in acquisitions of domestic pharma firms by the MNCs.

Critical Indian pharma assets going to MNCs:

Further, the DIPP and the Ministry of Health reportedly fear that besides large generic companies like Ranbaxy and Piramal, highly specialized state-of-the-art facilities for oncology drugs and injectibles in India are becoming the targets of MNCs and cite some examples as follows:

  • Through the big-ticket Mylan-Agila deal, the country would lose yet another critical cancer drug and vaccine plant.
  • In 2009 Shantha Biotechnics, which was bought over by Sanofi, was the only facility to manufacture the Hepatitis B vaccine in India, which used to supply this vaccine at a fraction of the price as compared to MNCs.
  • Mylan, just before announcing the Agila deal, bought over Hyderabad based SMS Pharma’s manufacturing plants, including some of its advanced oncology units in late 2012.
  • In 2008, German pharma company Fresenius Kabi acquired 73 percent stake in India’s largest anti-cancer drug maker Dabur Pharma.
  • Other major injectable firms acquired by MNCs include taking over of India’s Orchid Chemicals & Pharma by Hospira of the United States.
  • With the US market facing acute shortage of many injectibles, especially cancer therapies in the past few years, companies manufacturing these drugs in India have become lucrative targets for MNCs.

An alternative FDI policy is being mooted:

DIPP reportedly is also working on an alternate policy suggesting:

“It should be made mandatory to invest average profits of last three years in the R&D for the next five years. Further, the foreign entity should continue investing average profit of the last three years in the listed essential drugs for the next five years and report the development to the government.”

Another report indicated, a special group set up by the Department of Economic Affairs suggested the government to consider allowing up to 49 per cent FDI for pharma brownfield investments under the automatic route.However, investments of more than 49 per cent would be referred to the Foreign Investment Promotion Board (FIPB).

It now appears, a final decision on the subject would be taken by the Prime Minister after a larger inter-mimisterial consultation, as was decided by him on August 14, 2013.

The cut-off date to ascertain price increases after M&A:

Usually, the cut off point to ascertain any price increases post M&A is taken as the date of acquisition. This process could show false positive results, as no MNC will take the risk of increasing drug prices significantly or changing the product-mix, immediately after acquisition.

Significant price increases could well be initiated even a year before conclusion of M&As and progressed in consultation by both the entities, in tandem with the progress of the deal. Thus, it will be virtually impossible to make out any significant price changes or alteration in the product-mix immediately after M&As.

Some positive fallouts of the current policy:

It is argued that M&As, both in ‘Greenfield’ and ‘Brownfield’ areas, and joint ventures contribute not only to the creation of high-value jobs for Indians but also access to high-tech equipment and capital goods. It cannot be refuted that technology transfer by the MNCs not only stimulates growth in manufacturing and R&D spaces of the domestic industry, but also positively impacts patients’ health with increased access to breakthrough medicines and vaccines. However, examples of technology transfer by the MNCs in India are indeed few and far between.

This school of thought cautions, any restriction to FDI in the pharmaceutical industry could make overseas investments even in the R&D sector of India less inviting.

As listed in the United Nation’s World Investment Report, the pharmaceutical industry offers greater prospects for future FDI relative to other industries.  Thus, restrictive policies on pharmaceutical FDI, some believe, could promote disinvestments and encourage foreign investors to look elsewhere.

Finally, they highlight, while the Government of India is contemplating modification of pharma FDI policy, other countries have stepped forward to attract FDI in pharmaceuticals. Between October 2010 and January 2011, more than 27 countries and economies have adopted policy measures to attract foreign investment.

Need to attract FDI in pharma:

At a time when the Global Companies are sitting on a huge cash pile and waiting for the Euro Zone crisis to melt away before investing overseas, any hasty step by India related to FDI in its pharmaceutical sector may not augur well for the nation.

While India is publicly debating policies to restructure FDI in the ‘Brownfield’ pharma sector, other countries have stepped forward to attract FDI in their respective countries.  Between October 2010 and January 2011, as mentioned earlier, more than 27 countries and economies have adopted policy measures to attract foreign investment.

Thus the moot question is, what type of FDI in the pharma brownfield sector would be good for the country in the longer term and how would the government incentivize such FDIs without jeopardizing the drug security of India in its endeavor to squarely deal with any conceivable  eventualities in future?

Conclusion:

In principle, FDI in the pharma sector, like in any other identified sectors, would indeed benefit India immensely. There is no question about it…but with appropriate checks and balances well in place to protect the national interest, unapologetically.

At the same time, the apprehensions expressed by the Government, other stakeholders and now the honorable members of the Parliament, across the political party lines, in their above report, should not just be wished away by anyone.

This issue calls for an urgent need of a time bound, comprehensive, independent and quantitative assessment of all tangible and intangible gains and losses, along with opportunities and threats to the nation arising out of all the past FDIs in the brownfield pharma sector.

After a well informed debate by experts on these findings, a decision needs to be taken by the law and policy makers, whether or not any change is warranted in the structure of the current pharma FDI policy, especially in the brownfield sector. Loose knots, if any, in its implementation process to achieve the desired national outcome, should be tightened appropriately.

I reckon, it is impractical to expect, come what may, the law and policy makers will keep remaining mere spectators, when Indian Pharma Crown Jewels would be tempted with sacks full of dollars for change in ownerships, jeopardizing presumably long term drug security of the country, created painstakingly over  decades, besides leveraging immense and fast growing drug export potential across the world.

The Competition Commission of India (CCI) can only assess any  possible adverse impact of Mergers & Acquisitions on competition, not all the apprehensions, as expressed by the Parliamentary Standing Committee and so is FIPB.

That said, in absence of a comprehensive impact analysis on pharma FDIs just yet, would the proposal of PSC to ban foreign investments in pharma brownfield sector and the PM’s subsequent one time veto to clear all pending FDI proposals under the current policy, be construed as irreconcilable internal differences…Or a clever attempt to create a win-win situation without ruffling MNC feathers?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

FDI in ‘Brownfield’ Pharma acquisitions and the growth of ‘Greenfield’ projects in India

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Just when global multinational companies are inking deals to get more and more drugs manufactured in India, because of various financial and other considerations, giving a fillip to the domestic manufacturing capacity, recent media reports are carrying news items expressing apprehensions on possible declining trend of pharmaceutical manufacturing activities in the country due to ‘brownfield’ acquisitions of the domestic pharmaceutical companies by large multinationals.

Almost around this time, the Bureau of Labor Statistics data (USA) of May 2010 reported that the number of employees engaged in “pharmaceutical and medicine manufacturing” in the US went down by 5% from what it was about two years ago with around 35000 layoffs in the first half of 2010.

According to ‘New York Times’, there has been around 15,000 manufacturing job loss in Europe around this period.

Where the global manufacturing capacity has started shifting then?

As compared to above, the Department of Pharmaceuticals of the Government of India, as reported by Fierce Pharma, have indicated that pharmaceutical manufacturing industry of the country employed 340,000 people during April 2008 to March 2009 period with a sizable increase in number compared to the previous period. Overall, the industry provides employment to over 4.2 million persons directly or indirectly in India (Source: IDMA). This is happening despite a series of large to medium brownfield acquisitions in the country.

Moreover, a study by the Organization of Pharmaceutical Producers of India and Ernst & Young, based on 50 survey respondents from 30 pharmaceutical companies in the US, Europe and Asia, projects growth of formulations manufacturing and intermediate drugs in India at a rate of 43%, which is three times more than the projected global rate.

Growth in manufacturing through global collaborations:

With a large number of the world class manufacturing facilities conforming to cGMP requirements of various regulatory authorities across the globe, India is fast emerging as a global hub for pharmaceutical manufacturing services.

Emerging pharmaceutical manufacturing environment in the country, no doubt, is attracting a large number of global pharma majors to ink contract manufacturing deals, as mentioned above, with their Indian counterparts. Such collaborative arrangements with global partners are giving a further thrust to the pharmaceutical manufacturing activities of the country. To cater to the growing demand in manufacturing, some domestic companies are setting up ‘greenfield’ projects, while others are getting engaged in major expansion of their existing manufacturing facilities.

As per Frost & Sullivan, contract manufacturing market in India registered a turnover of around US$ 2.3 billion with a CAGR of 33% on 2010. RNCOS, an Industry Research solution company estimates that this sector will grow at a CAGR of over 45% during 2011-2013, in India.

Large global pharma companies like, Eli Lilly, AstraZeneca, Abbott, Merck, GSK and Pfizer have already inked collaborative arrangements with Indian Pharmaceutical companies related to manufacturing.

Eisai Co. Ltd of Japan inaugurated its second largest active pharmaceutical ingredient (API) production facility (after their Kashima plant in Japan) at Visakhapatnam on December 2009. The company is also to start a Research & Development (R&D) center for formulation development around the same place starting with four to five projects.

In the recent past the following predominantly manufacturing collaborative agreements have been signed by the MNCs in India:

Collaborative Deals

Year

 Multinational Companies Indian Companies

2009

 GSK Dr. Reddy’s Lab
Pfizer Aurobindo Pharma

2010

 AstraZeneca Torrent
Abbott Cadila Healthcare
Pfizer Strides Arcolab
AstraZeneca Aurobindo Pharma
Pfizer Biocon

2011

 Bayer Cadila Healthcare
MSD Sun Pharma

 

This is happening mainly because of inherent cost arbitrage, other factors being the same:

Comparison of Cost Advantage in India (%)
Costs in the Western Countries 100.0
Production Costs 50.0
R&D Costs 12.5
Clinical Trials Costs 10.0
Source: Pharmexcil Research

ANDAs and DMFs are manufacturing growth boosters:

Large portfolios of ANDAs and DMFs of domestic pharmaceutical players will also spur manufacturing in India:

ANDA approval by country:

Final ANDA Approvals by Country  (2007) (figs. in Nos.)

Country

Numbers
USA 169
India 132
Israel 40
Germany 25
Canada 24
Switzerland 19
Iceland 14
Jordan 11
Other 25
Source: Thomson Scientific

 

DMF approval by country:

Comparison of Drug Master Filings (Type II) by India, China & World (1998-2007) (Figs. in Nos.)

Year

India

China

World Total

1998

 32 27 316

1999

 26 6 199

2000

 33 9 201

2001

 47 6 238

2002

 55 20 264

2003

 115 19 360

2004

 160 25 435

2005

 233 70 615

2006

 267 78 627

2007

 274 90 656
Source: Thomson Scientific,

Patent challenge to boost manufacturing for exports:

To further boost manufacturing, especially for exports, Indian pharmaceutical players have also started challenging global patents. In fact in patent challenge, India ranks just next to USA with a share of 21% of the total:

Country-wise Number of Patent Challenges (As on March 2008)

Country

Numbers
USA 200
India 113
Israel 89
Canada 43
Switzerland 34
Iceland 17
Germany 10
Other 32
Source: Thomson Scientific,

Boosting up domestic manufacturing with overseas acquisitions and collaborations:

At the same time, domestic Indian companies are also on a spree of overseas acquisition and collaborative deals. The following details from the Ministry of Commerce are a testimony to this fact:

Selected International Acquisitions and Foreign tie-ins by the Indian Pharmaceutical Industry

Company

International Acquisition (s)

Foreign Alliances, JVS, and other tie-ins
Nicholas Piramal Pfizer-Morpeth (UK), Avecia Pharmaceutical (UK), Dobutrex brand acquisition (US), Rhodia’s inhalation business (UK), Biosyntech (NPIL Pharmaceutical) (Canada), Torcan Chemical (Canada), 51 percent of Boots (S. Africa), Biosyntech Ethypharm (France), Genzyme (US), Eli Lilly (US), Biogen Idec (US), Chiese Farmaceutici (Italy), Minrad (US), Pierre Fabre (France), Gilead Sciences (US), Allergan (US), Hoffmann-La Roche (Switzerland)
Ranbaxy Terapia (Romania), Allen-GSK (Spain & Italy), Ethimed (Belgium), Betapharm (Germany), RPG Aventis (France), 40 percent stake in Nihom Pharmaceuticals (Japan), Brand-Veratide (Germany), Efarmes (Spain), Be-Tabs (S. Africa), Akrikhin (Russia), Basic (Germany), Ohm Labs (US) GlaxoSmithKline (UK), Janssen-Ortho (Canada), IPCA Labs (US), Zenotech (India), Sonkel (S. Africa), Cephalon (US), Gilead Sciences (US), Schwartz (Germany)
Dr. Reddy’s Betapharm Group (Germany), Trigenesis (US), BMS Laboratories and Meridian Healthcare (UK), Roche’s active ingredients business (Mexico), BMS Labs (UK) Novo Nordisk, Bayer AG (Germany), Par (US), Novartis (Switzerland), Merck (Germany), Clin Tech, Pharmascience (Canada), ICICI (India), Merck (Germany), Schwartz
Marksans Nova Pharmaceuticals (Australia) NA
Aurobindo Milpharm (UK), Pharmacin (Netherlands) Gilead Science (US), Citadel (India)
Sun Pharmaceutical Able Lab (US), Caraco (US), Valeant Pharmaceuticals (US & Hungary), ICN (Hungary), Caraco (US), MJ Pharmaceutical Dyax
Dishman Amcis (Switzerland), Solutia’s Pharma (Switzerland) Azzurro (Japan)
Orchid Bexel Pharma (US) Stada, Alpharma, Par, Apotex
Biocon Nobex (US) Centre of Molecular Immunology (Cuba)
Wockhardt Wallis Labs (UK), CP Pharmaceutical (UK), Esparma (Germany), Pinewood Laboratories (Ireland), Dumex (India) Pharmaceutical dynamics (S. Africa)
Cadila Alpharma (France-formulations), Dabur Pharma Redrock (UK) Schering (Germany), Boehringer Ingelheim (Germany), Vitaris (Germany), Novopharm (Canada), MCPC (Saudi Arabia), Cilpharm (Ivory Coast), Geneva (US), GSK (UK), Ranbaxy (India), Mallinckrodt (US), Mayne (Australia), Shinjuki (Japan), Zydus Atlanta
Jubliant Organosys Target Research Association (US), PSI (Belgium), Trinity Laboratories (US) NA
Matrix Labs 22 percent controlling stake in Docpharma (Belgium), Explora Lab (Switzerland), MCHEM (China), Fine Chemicals (S. Africa), API (Belgium) Aspen, Emchem, Docpharma, Explora Labs
Glenmark Kinger Lab (Brazil), Uno-Ciclo (Brazil), Srvycal (Argentina), Medicamenta (Czech), Bouwer Bartlett Forest Labs (US), Lehigh Valley Technologies (US), Shasun (India), KV, Apotex (US)
Source: Source: Ministry of commerce, Government of India .(IBEF, Ernst & Young, The Economic Times, Individual company web pages)

Conclusion:

M&A is a natural business processes in any country with appropriate safeguards for any possible adverse effect on competition.  India has already put similar safeguards in place with the scrutiny of the Competition Commission before acquisition and continuous price monitoring by the National Pharmaceutical Pricing Authority (NPPA) after the acquisition is over.

It is worth mentioning, just on September 16, 2011, the Competition Commission of India, after stringent scrutiny on the impact of competition, cleared the proposal of Danone Asia Pacific to acquire the nutrition business of Wockhardt Ltd.

In the wake of all these, the apprehension that the ‘brownfield’ pharmaceutical acquisitions will retard the growth of ’greenfield’ pharmaceutical projects or have adverse impact on competition in the country, does not seem to hold much water. To a great extent FDI in ‘brownfield’ pharmaceutical acquisitions and the growth of ‘greenfield’ pharmaceutical projects in India, are unrelated.

Be that as it may, India should perhaps not expect that the country will continue to remain one of the pharmaceutical manufacturing hotspots for any indefinite period mainly because of cost arbitrage, which, in any case is not sustainable over a long period of time by any country.

As we have seen above, with the emergence of Asia, USA and EU are gradually but surely losing their pharmaceuticals manufacturing hubs’ status to China (API) and India (formulations). Who knows, some time in future, with the awakening of sleeping Africa, Asia will also not have the same fate?

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Could M&As in Pharma create significant stakeholder value?

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At the very outset, I pay my homage to the departed soul of our industry colleague respected Amar Lulla, former joint managing director of Cipla, who passed away on Friday, April 22, 2011 after a prolonged battle against cancer.

As we know, “Merger and Acquisition (M&A)” is an inorganic growth tool of any business. In this model growth in business operations arise from value creation through mergers or takeovers of other companies, rather than from increase in the company’s own existing business activities.

On April 13, 2011, quoting a study released by Burrill & Co, a noted life sciences investment firm, ‘Fierce Pharma’ reported that “drug makers’ deal making over the past 10 years has utterly and completely failed to build value in the industry. Big Pharma has actually lost almost $1 trillion in value during the past decade.”

Big Pharmas lost value in the past decade through deal making:

Burrill argued: “The drug industry’s 17 most active buyers had a combined market value of $1.57 trillion at the end of 2000. By the end of 2010, that value had shrunk to $1.04 trillion–notwithstanding the $425 billion in acquisitions these companies made during the decade with a total loss of $955 billion.”

The report commented that global pharma majors could not make up non-delivery of innovative products through these acquisitions.

M&As triggered by in-market blockbuster products, were successful in the past:

It was observed that those M&As, which were triggered by in-market blockbuster products were successful in the past. Like for example:

Year M&A Product/Products
2000 Pfizer and Warner Lambert Lipitor
2006 Eli Lilly-ICOS Cialis
2008 Eli Lilly- ImClone Erbitux

However, when a company was acquired for products in development or R&D pipelines, it was observed that acquirer could not derive full benefits of their respective inorganic growth plans, as many of those projects did not fructify or could not be continued in the long run for various different reasons. I am not trying to go into those details in this article.

It is usually believed that healthcare companies with diversified interests along with pharmaceuticals and biotech business, like, diagnostic, devices and generic pharmaceuticals encountered much lesser growth pangs in the past. I reckon, it is for this reason, companies like, Abbott, J&J, Roche and Novartis registered overall better business performance than their pure pharmaceutical business counterparts like, Merck, Pfizer etc.

Only future will tell us whether high takeover prices, such as US$ 68 bn paid by Pfizer for Wyeth or US$ 46 bn of Roche for Genentech or US$ 41 bn of Merck for Schering-Plough, mainly to acquire the drug pipelines of the respective companies, can ultimately be justified or not. At this stage, it is indeed extremely difficult to quantify the transaction value of phase III drugs that Pfizer, Roche and Merck acquired with these mega deals.

However, about a couple of years ago ‘Forbes’ in its article titled, “Will Pfizer’s Merger Hurt Innovation?” published in January 26, 2009 commented as follows:

“Between 1998 and now, Pfizer has launched only one medicine with annual sales surpassing $1 billion, despite ploughing more than $60 billion into research and development. That drug, the pain med Lyrica, was already in development at Warner-Lambert when Pfizer bought it.” 

Other significant global M&A initiatives in 2010 were as follows:

Global Companies Value (US $ billion)
Sepracor by Dainippon Sumitomo 2.6
77% of Alcon (the eye care unit of Nestle) by Novartis 50
Millipore by Merck KGA 6
OSI Pharma by Astellas 4
King Pharma by Pfizer 3.6
BioVex by Amgen 1
Ratiopharm by Teva 5

In addition, work is in progress for some more M&A initiatives, like the hostile bid of US $ 20 billion of Sanofi Aventis for Genzyme in 2011. J&J’s offer of US $2.3 billion for vaccines of Crucell; Valeant’s hostile bid for Cephalon of US $ 5.7 billion, and J&J’s talk with Synthes for an acquisition with US $20 billion.

Emerging markets: the Eldorado:

At the same time, IMS Health reports that emerging markets will register a growth rate of 14% to 17% by 2014, significantly driven by generic pharmaceuticals, when the developed markets will be growing by 3% to 6% during this period. It is forecasted that the global pharmaceutical industry will record a turnover of US$1.1 trillion by this time.

Probably prompted by this overall market scenario, the global pharmaceutical majors are still trying to keep their heads above water through deal making and various collaborative initiatives. India, being one of the fastest growing global pharmaceutical markets, has also started experiencing this consolidation process.

Real consolidation process in India commenced in 2006: The consolidation process in India started gaining momentum from the year 2006 with the acquisition of Matrix Lab by Mylan, although 2009 witnessed the biggest merger in the Pharmaceutical Industry of India, thus far, in value terms, when the third largest drug maker of Japan, Daiichi Sankyo acquired 63.9% stake of Ranbaxy Laboratories of India for US $4.6 billion.
This was widely believed to be a win-win deal for both the companies with Daiichi Sankyo leveraging the cost arbitrage of Ranbaxy effectively, while Ranbaxy benefiting from the innovative products range of Daiichi Sankyo. This deal also established Daiichi Sankyo as one of the leading pharmaceutical generic manufacturers of the world, making the merged company a force to reckon with, in the space of both innovative and generic pharmaceuticals business.
Another mega acquisition soon followed:
In May 2010, the Pharma major in the US Abbott catapulted itself to number one position in the Indian Pharmaceutical Market (IPM) by acquiring the branded generics business of Piramal Healthcare with whopping US$3.72 billion. Abbott acquired Piramal Healthcare at around 9 times of its sales multiple against around 4 times of the same paid by Daiichi Sankyo.

According to Michael Warmuth, senior vice-president, established products of Abbott the sales turnover of Abbott in India, after this acquisition, will grow from its current around US$ 480 million to US$2.5 billion by the next decade. 

Was the valuation right for the acquired companies?
Abbott had valued formulations business of Piramal Healthcare at about eight times of sales, which is almost twice of what Japan’s Daiichi Sankyo paid for its US$4.6 billion purchase of a controlling stake in India’s Ranbaxy Laboratories in June 2008.

On the valuation, Warmuth of Abbott has reportedly commented “If you want the best companies you will pay a premium; however, we feel it was the right price.”

This is not surprising at all, as we all remember Daiichi Sankyo commented that the valuation was right for Ranbaxy, even when they wrote off US$3.5 billion on its acquisition.
In my opinion, considering the fact that not too many attractive acquisition targets are available within the domestic pharmaceutical industry, the valuation of any well performed Indian Pharmaceutical Company will continue to remain high, at least in the short to medium term… and why not, when the domestic pharmaceutical industry is growing so well, consistently?

M&As in India from 2006 to 2010:

Year

Indian Companies

Multinational Companies

Value ($Mn)

 Type
2006
Matrix Labs Mylan

736

 Acquisition
Dabur Pharma Fresenius Kabi

219

 Acquisition
Ranbaxy Labs Daiichi Sankyo

4,600

 Acquisition
Shantha Biotech Sanofi-aventis

783

 Acquisition
2009
Orchid Chemicals Hospira

400

 Business Buyout
2010
Piramal Healthcare Abbott

3,720

 Business Buyout
Paras Pharma Reckitt Benkiser

726

 Acquisition

Collaborative deals in India from 2009 to 2011:

Year

Multinational Companies

 Indian Companies
2009
GSK Dr. Reddy’s Lab
Pfizer Aurobindo Pharma
2010
AstraZeneca Torrent
Abbott Cadila Healthcare
Pfizer Strides Arcolab
AstraZeneca Aurobindo Pharma
Pfizer Biocon
2011
Bayer Cadila Healthcare
MSD Sun Pharma

The Key driver for acquisition of large Indian companies:
Such strategies highlight the intent of the global players to quickly grab sizeable share of the highly fragmented IPM – the second fastest growing and one of the most important emerging markets of the world.
If there is one most important key driver for such consolidation process in India, I reckon it will undoubtedly be the strategic intent of the global companies to dig their heel deep into the fast growing Indian branded generic market, contributing over 99% of the IPM. The same process is being witnessed in other fast growing emerging pharmaceutical markets, as well, the growth of which is basically driven by the branded generic business.
Important characteristics to target the branded generic companies:
To a global acquirer the following seem to be important requirements while shortlisting its target companies:
• Current sales and profit volume of the domestic branded generic business • Level of market penetration and the rate of growth of this business • Strength, spread and depth of the product portfolio • Quality of the sales and marketing teams • Valuation of the business
Faster speed of consolidation process could slow down the speed of evolution of the ‘generics pharmaceutical industry’ in India: Though quite unlikely, if the moderate valuation of large Indian companies starts attracting more and more global pharmaceutical majors, the speed of evolution of the ‘local generic pharmaceutical industry’ in the country could slow down, despite entry of newer smaller players in the market.

The global companies will then acquire a cutting edge on both sides of the pharmaceutical business, discovering and developing innovative patented medicines while maintaining a dominant presence in the fast growing emerging branded generics market across the world.
An alarm bell in the Indian Market for a different reason:
It has been reported that being alarmed by these developments, some industry insiders feel, “Lack of available funding is the main reason for the recent spurt in the sale of stakes in domestic companies”.
They have reportedly urged the Government to adequately fund the research and development (R&D) initiatives of the local Pharmaceutical Companies to ensure a safeguard against further acquisition of large Indian generic players by the global pharmaceutical majors. It is a fact that the domestic Indian companies do not have adequate capital to fund cost-intensive R&D projects in India even after having a significant cost arbitrage.
Will such consolidation process now gain momentum in India?
In my view, it will take some more time for acquisitions of large domestic Indian pharmaceutical companies by the Global Pharma majors to gain momentum in the country. In the near future, we shall rather witness more strategic collaborations between Indian and Global pharmaceutical companies, especially in the generic space, as indicated above.
The number of high profile M&As of Indian pharma companies will significantly increase, as I mentioned earlier, when the valuation of the domestic companies appears quite attractive to the global pharma majors. This could happen, as the local players face more cut-throat competition both in Indian and international markets, squeezing their profit margin.
It won’t be a cake walk either…not just yet:
Be that as it may, establishing dominance in the highly fragmented and fiercely competitive IPM will not be a ‘cakewalk’ for any company, not even for the global pharmaceutical majors. Many Indian branded generic players are good marketers too. Companies like, Cipla, Sun Pharma, Alkem, Mankind, Dr.Reddy’s Laboratories (DRL) have proven it time and again, over a period of so many years.
The acquisition of Ranbaxy by Daiichi Sankyo did not change anything in the competition front. Currently the market share of Abbott, post M&A, including Solvay and Piramal Healthcare, comes to just around 6.2% followed by Cipla at 5.5% (Source: AIOCD). This situation in no way signifies domination by Abbott in the IPM, far from creating any oligopolistic pharmaceutical market in India.
Thus the pharmaceutical market in the country will continue to remain fragmented with cut-throat competition from the existing and the newer tough minded, innovative and determined local branded generic players having cost arbitrage, cerebral power and untiring spirit of competitiveness with a burning desire to win.
Simultaneously, some of the domestic pharmaceutical companies are in the process of creating a sizeable Contract Research and Manufacturing Services (CRAMS) sector to service the global pharmaceutical market.
Conclusion:
In my view, it does not make long term business sense to pay such unusually high prices for the branded generics business of any Indian company. Besides the report of Burrill & Co., we also have with us examples of some of the Indian pharmaceutical acquisitions in the overseas market are not working satisfactorily as the regulatory requirements for the low cost generics drugs were changed in those countries.
Most glaring example is the acquisition of the German generic company Betapharm by DRL for US$ 570 million in 2006. It was reported that like Piramals, a significant part of the valuation of Betapharm was for its trained sales team. However, being caught in a regulatory quagmire, the ultimate outcome of this deal turned sour for DRL.
Could similar situation arise in India, as well? Who knows? What happens then to such expensive acquisitions, if for example, prescriptions by generic names are made mandatory by the Government within the country, despite intensive lobbying efforts?

Be that as it may, in India also, a study like, ‘Burrill Report” could be quite useful to ascertain whether or not the deal making of global and local drug majors in the country over a ten year period commencing from 2006 onwards, has succeeded to create desired stakeholder value.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

A time to keep our nose to the Grindstone – Competition Act will take care of M&As, come June 2011

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Full control of powers on Mergers and Acquisitions of the Competition Commission of India (CCI) effective June 1, 2011, has now been notified.

In this evolving scenario, it is indeed difficult to understand, why is the FDI issue on M&A in the Pharmaceutical space of India is still catching headlines of both national and international media. Instead, should we not now keep our nose to the grindstone and take strategic measures to accelerate the inclusive growth of this life-line industry of the nation?

Stipulations for M&As under the Competition Act:

Section 6(1) of the Act prohibits any person or enterprise from entering into a combination which has an “appreciable adverse effect” on competition in India. It also stipulates that any enterprise which intends to enter into such M&A, shall give notice to the CCI furnishing details of the proposed M&A within thirty days of:

(i)  Approval of the merger by the Board of Directors of the concerned enterprise

or

(ii) Execution of any agreement relating to acquisitions referred to in clause 5(a) & (b) of the Act. S.6(2A) provides a period of 210 days to the CCI to complete the investigation relating to such combinations (if the CCI is unable to come to any conclusion within this period then the combination is deemed to be approved)

S.5 of the Act lays down the transactions which will qualify as combinations for the purposes of the Act. The following is the threshold limit for Mergers and Acquisitions:
• Transactions among Indian companies with combined assets of Rs. 1000 Crores or Rs 3000 Crores in turnover of the merged entity
• Cross-border transactions involving both Indian and foreign companies with combined assets of US $500 million or US $1.5 billion in turnover

• Transactions that have a territorial nexus with India, where the acquirer has US $125 million in assets or US $375 million in turnover in India.

Once any transaction reaches the threshold limit as specified in S.5, the enterprise has to take recourse to the procedure as specified in the Competition Act.

A time to keep our nose to the Grindstone:

Last year, though the growth of the Global Pharmaceutical Industry with a turnover of US$ 752 billion significantly slowed down to just 6.7% due to various contributing factors, the Indian Pharmaceutical Industry continued to maintain a robust of growth of 19% with a turnover of US$ 10.1 billion (IMS October, 2010).

R&D will fuel future growth:

However, on a longer term perspective, the domestic industry growth will be significantly driven by the newer products, which will be the outcome of painstaking innovative research and development initiatives. Keeping this point in mind, the fact that today India accounts less than one per cent of over US$130 billion of the worldwide spending on research and development for pharmaceuticals, despite its known strength in process chemistry and abundant talent pool, has started attracting attention of the government.

Government taking appropriate measures:

It is encouraging to note that the Department of Pharmaceuticals of the Government of India through its ‘Vision 2020’ initiatives is planning to create a new echo-system in the country to promote new drug discovery platforms. This is expected to catapult the country as one of the top five global pharmaceutical hubs, by 2020 attracting additional investments of around US$ 20 billion to the GDP of the country.

Primary role of the industry:

The Primary role of the Research based Pharmaceutical Industry in India, like in many other countries of the world, is to make significant contribution to the healthcare objectives of the nation by meeting the unmet needs of the ailing patients, with innovative medicines. This role can be fulfilled by developing newer medicines through painstaking, time-consuming, risky and expensive basic research initiatives. The research based Pharmaceutical Industry in India is committed to its prime function of discovering and developing new medicines not only for the patients in India but all over the world.

Encouraging innovation will be critical:

Despite immense progress made over the past decades in developing new medicines for numerous acute and chronic illnesses, innovation still remains critically important in the continuous and ever complex battle between disease and good health. Ongoing efforts in Research & Development (R&D) would require a robust national policy environment that would encourage, protect and reward innovation. Improving healthcare environment in partnership with the Government remains a priority for the Research based Pharmaceutical Companies in India, both global and local.

Continuous improvement in ‘Access to Medicines’ is critical:

Therefore, improving access to healthcare in general and medicines in particular should be on the top priority agenda of the policy makers in our country. High incidence of mortality and morbidity burden in a country like ours can only be addressed by improving Access to healthcare through a concerted partnership oriented strategy.

Some concerns still linger:

However, in the new paradigm, which has been designed to foster innovation in the country, there are still some loose knots to be tightened up to achieve the set objectives for the inclusive growth of the nation, in the longer term perspective.

These measures, in turn, will help improving the competitiveness of India vis-à-vis countries like China to attract appreciable investments towards R&D related to pharmaceutical and bio-pharmaceutical products. The Government has already initiated measures to expand the capacity of Indian judiciary and setting- up of fast-track specialized courts that can more effectively enforce Pharmaceutical patents with requisite technical expertise.

Industry should set examples in ‘Good Corporate Governance’ and ‘Global Good Manufacturing Practices’:

Another area of focus should be on corporate good governance. This encompasses adherence to high ethical standards in clinical trials, regulatory and legal compliance, working to prevent corrupt practices, high ethical standard in promotion of medicines and addressing all other issues that support good healthcare policies of the Government. In addition, Pharmaceutical Industry should take active measures to involve all concerned to fight the growing menace of counterfeit and spurious medicines, which significantly affect the lives of the ailing patients, all over the country.

All stakeholders should work in tandem:

It is obvious that the Pharmaceutical Industry alone will have a limited role to address key healthcare issues of our nation, especially when around 400 million Below the Poverty Line (BPL) population will not be able to afford any expenses towards healthcare, at all. All stakeholders like the government, corporate and the civil society in general, must work together according to their respective abilities, obligations and enlightened societal interests to effectively address such pressing issues.

Let us move ahead from ‘Price Control’ to ‘Price Monitoring’:

Despite Medicine Prices in India being one of the lowest in the world, mainly because of stiff competition within the industry and watchful eye of an effective price regulator, 100% of the Pharmaceutical market in the country is currently being price regulated by the Government even with the growth restrictive and ‘draconian’ ‘Third Schedule’ of the DPCO 95.

To enable the Industry to be globally competitive in all aspects of its operations, the government should move ahead from ‘Price Control’ to effective ‘Price monitoring’ mechanism and scrap the growth restrictive measures like, ‘third schedule’ of the current DPCO.

Transaction costs of medicines are too high:

Current transaction costs (all taxes) on medicines in India including trade margins is as high as over 50% of the ex-factory cost of a product.

This cost has been further increased in 2011-12 Union Budget proposal. The government should reduce exorbitantly high transaction costs to make medicines even more economical to the common man.

Conclusion:

I am confident, the entire Pharmaceutical Industry in India would continue to act responsibly with demonstrable commitment to help achieving the healthcare objectives of the nation.

Global players will keep on searching for their suitable targets in the emerging markets like India, just as Indian players are searching for the same in the global markets. This is a process of consolidation in any industry and will continue to take place across the world. Adverse impact of M&A on competition, if any, will now be effectively taken care of by the CCI.

So far as the ‘Financial Reform’ process is concerned, India has always been a slow starter, but it never walked backwards. This tradition, I reckon, will continue in the vibrant democracy of the country, in future too.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.