M&A Focus: Biotechnology

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1 Month Follow on head on Master page A May 2013 M&A Focus: Biotechnology By Anna Son Growing pains from the Patent Cliff will lead Big Pharma companies to invest in promising biotechnology, hoping to remain relevant Pharmaceutical companies could lose more than $200.0 million in revenue because of patent expirations With huge piles of cash on hand, largecap pharmaceutical companies, known as Big Pharma, have shown strong interest in acquiring biotech companies with promising drug candidates to help bolster thinning pipelines in the wake of patent expirations. Because of this Patent Cliff, the largest pharmaceutical companies are anticipated to lose about $29.0 billion in revenue this year. After a relatively quiet 2010 for M&A activity, 2013 will be crucial turning point for many pharmaceutical goliaths, especially in the United States and Europe. In the past few years, major biotech firms including Amgen, Roche Holding AG, Merck KGaA and Sanofi have been at the forefront of M&A activity. For example, in 2009, Switzerland-based pharmaceutical giant Roche Holding AG acquired full ownership of Genentech Inc. for an estimated $46.8 billion. Genentech is considered one of the founders of the Biotechnology industry, and it continues to lead the industry with a strong product portfolio and research and development (R&D) activities. In today s environment, which is characterized by the sluggish biotech IPO market, stretched R&D funding and limited venture capital for biotech startups, it is more difficult to replicate the success of biotech giants like Amgen, Gilead Sciences and Biogen Idec. A number of roadblocks stand in the way of revenue growth including patent Performance of key industries related to biotech M&A activity Industry 2013 Revenue ($billion) Annualized growth ( ) Projected annualized growth ( ) Biotechnology in the US % 8.9% Brand Name Pharmaceutical Manufacturing in the US % 1.9% Generic Pharmaceutical Manufacturing in the US % 6.4% Global Biotechnology % 9.2% Global Pharmaceutical Manufacturing 1, % 3.5% Contract Research Organizations % 11.0% SOURCE: info@ibisworld.com

2 May expirations, reimbursement pressure, price cuts, stringent regulations and high costs associated with internally developing new treatments. Therefore, Big Pharma players are trying to acquire and collaborate with small and mediumsized biotech firms with promising, high-margin biologic drugs. During the five years to 2018, IBISWorld projects that M&A activity will continue, providing new prospects for investors seeking to expand their portfolios. Patent Cliff driving consolidation A major driver of mounting M&A activity is the Patent Cliff that Big Pharma companies have been tiptoeing around since The Patent Cliff refers to the phenomena of major blockbusterbranded drugs (e.g. Lipitor for Pfizer, and Plavix and Avapro for Bristol-Myers Squibb) losing patent protection, which allows generic versions of these drugs to be made, increasing competition. During the five years to 2018, global pharmaceutical companies are at risk of losing more than $200.0 billion in revenue because of patent expirations, according to EvaluatePharma, the premier provider of pharmaceutical and biotech analysis. For example, from 2010 to 2012, drugs that make up about 42.0% of Pfizer s pharmaceutical revenue lost patent protection. For Pfizer, the biggest patent loss was its 2011 patent expiration for the cholesterol-lowering drug Lipitor, which accounts for about 14.0% of the company s revenue and is one of the best-selling drugs in the world. Due to patent loss on Lipitor and other drugs, Pfizer s revenue contracted 21.6% in This resulted in the company trimming costs by slashing its labor force. Because of projected competition and loses, Big Pharma companies are seeking to acquire small to mid-sized biotech companies with promising drug candidates. Biotech companies have a strong competitive advantage over generic pharmaceutical manufacturers due to the high costs of developing biological drugs. Biologic drugs are made from complex biological processes and are therefore more expensive to develop and manufacture than drugs produced via chemical synthesis. While the FDA approved only 21 new drugs in 2010, the number of new drug approvals grew to 30 in 2011 and 39 in The faster approval of new drugs by the FDA paves the way for the commercialization of new drugs, particularly those that treat rare diseases and target unmetmedical needs. In June 2012, the U.S. Supreme Court ruled to uphold a law that will keep the 12-year exclusivity period intact. This shed some light on the long-debatable exclusivity period issue granted to original, biologic-drugs manufacturers. Unlike brand name pharmaceutical companies that have faced competition from generic manufacturers since the approval of the Hatch-Waxman Act in 1984, biotech companies have not had a formal regulatory pathway for the approval of biosimilar drugs (e.g. follow-on biologics). The 12-year exclusivity period is expected to benefit biotech companies because it could have been shortened to five years; however, the 12-year guarantee will provide investors with the predictability that is required when forecasting future product sales for biological drugs in development. Consequently, investor confidence is expected to improve and more available financing is projected to follow. Opportunities from emerging markets In addition to rising M&A activity in the domestic market, Big Pharma companies are penetrating burgeoning emerging markets by acquiring foreign firms. With anemic revenue growth in developed markets, triggered by pricing

3 May pressures and higher tax rates, global companies are looking to offshore operations to emerging markets that have less expensive R&D environments. Given the growing aging population, the prevalence of chronic diseases and a growing middle class with increased disposable income, emerging markets that are attracting investors include China, India and Brazil. In fact, in 2011, emerging markets accounted for about 20.0% of global pharmaceutical sales, according to the Economist Intelligence Unit database. For example, one of the world s largest biotech companies Roche Holding AG generates about 28.0% of its pharmaceuticals revenue from emerging markets, compared to 37.0% derived from the United States and 25.0% from Europe. In 2011, Amgen completed the acquisition of privately held Brazilian pharmaceutical company Bergamo and agreed to reacquire its rights in Brazil to products that were previously granted to another company. Because of these transactions, Amgen is expected to have gained an important presence in Brazil and direct access to one of the fastest-growing pharmaceutical markets in the world. Amgen also acquired Mustafa Nevzat Pharmaceuticals, a privately held Turkish company. This acquisition is estimated to have expanded Amgen s footprint in Turkey and its surrounding emerging markets. Additionally, global-biotech giant Merck continued its biotechnology expansion in China by acquiring Beijing Skywing Technology Co., a leading supplier of cell-culture media products and bioreactors for the Chinese biopharmaceutical industry. Given low interest rates and considerable cash on hand, global pharmaceutical and biotech companies will continue mergers, consolidations and partnerships throughout the world. Growing demand for biologic drugs With fewer blockbuster acquisitions expected in coming years, Big Pharma companies are seeking to acquire small and mid-sized companies focused on developing drugs for more targeted populations and rare diseases. The aging population and rising prevalence of chronic disease have spurred demand for innovative treatments and boosted demand for biologic drugs, pushing companies to search for strategies to expand their pipelines. Companies like Sanofi and Celgene are strengthening their market position in the oncology market though acquisitions. This market remains a sought-after therapeutic area. As such, in March 2012, one of the major US stand-alone biotechnology companies, Amgen, acquired Micromet Inc., a publicly held biotech company focused on the development and commercialization of antibody-based therapies for cancer treatment. Although Micromet does not have an approved product on the market, this deal, valued at about $1.16 billion, was a strategic move for Amgen s oncology pipeline because it provides a novel, technological platform with multiple possible applications. Another example of this was Sanofi s acquisition of Genzyme, a leading biotech group specializing in the treatment of rare diseases, renal diseases, endocrinology, oncology and biosurgery, which was completed in This expanded Sanofi s presence in the global biotechnology arena, and boosted the company s revenue and product pipeline. Other therapeutic areas projected to see increased M&A activity are central nervous system disorders, diabetes, Hepatitis C, immunology and inflammation. There are more than 400 biotech products and vaccines currently in clinical trials, attempting to target

4 May About IBISWorld Inc. Recognized as the nation s most trusted independent source of industry and market research, IBISWorld offers a comprehensive database of unique information and analysis on every US industry. With an extensive online portfolio, valued for its depth and scope, the company equips clients with the insight necessary to make better business decisions. Headquartered in Los Angeles, IBISWorld serves a range of business, professional service and government organizations through more than 10 locations worldwide. For more information, visit or call Contact: Savannah Haspel VP, Public Relations IBISWorld Phone: savannahh@ibisworld.com more than 200 diseases, according to the Biotechnology Industry Organization. Risk IBISWorld assesses risk scores based on a scale of one to nine, with one representing the lowest risk and nine representing the highest. In 2013, overall risk in the Biotechnology industry is projected to be 4.27, which is considered a medium-low risk level. The two most significant factors contributing to the risk score are R&D expenditure and regulation. As R&D expenditure increases, development in the industry also advances, boosting sales and demand for novel products. During 2013, R&D is expected to increase slowly, which is an opportunity for the industry. At the same time, regulation is projected to increase slowly in 2013, and this may threaten the industry as any change in the regulatory environment creates volatility, affecting companies bottom lines. During the five years to 2018, growth risk is forecast to remain low with a projected annualized revenue growth rate of 8.9%. Outlook In the five years to 2018, IBISWorld projects M&A activity to continue, with a considerable boost in in-licensing activities and partnerships for the development of new drug candidates. With Big Pharma s declining appetite for high-profile mega deals, smaller acquisitions are forecast to prevail during the next few years. For example, companies like Spectrum, a growing cancer-drug manufacturer, are already drawing investors attention and becoming attractive targets for future M&A deals. After years of incurring losses, Spectrum recorded profitability in 2011, and its revenue is estimated to have almost quadrupled from $74.0 million in 2010 to $266.0 million in Spectrum s Fusilev, a drug aimed to treat osteosarcoma and colorectal cancer, and Zevalin, which treats non- Hodgkin lymphoma, are the biggest revenue drivers for the company. Furthermore, biotech and pharmaceutical companies are increasingly involved in in-licensing and collaborations that help alleviate risks and the extremely high costs associated with the development of new drugs. In addition to sharing similar goals or fields of interest, in-licensing enables companies to use their expertise to achieve the best outcomes in terms of high revenue and profitability. In today s challenging environment of raising cash to survive, small biotech companies are continually seeking deals with larger players that are ready to invest in promising drug candidates. With the much-anticipated, lukewarm market for biopharma IPOs, more players will try to establish partnerships and collaborations. For example, a number of biotech and pharmaceutical companies are already outsourcing services to contract research organizations (CROs), which conduct clinical trials and research, manage data results, provide regulation adherence services, and help develop and formulate new products. Bolstered by rising demand from biopharmaceutical companies, the advantages of strategic partnerships are likely to rise in the five years to 2018 as CROs can provide clients with cost savings, accelerated development and reduced risk. Given favorable demographic trends, such as the aging population and the prevalence of chronic diseases, demand for medical treatments will continue to rise. However, this does not mean the industry will be free of more extensive changes during the next five years. Industry activity such as new market opportunities and anticipated losses due to patent expirations will cause biopharmaceutical companies to continue frequent M&A activity in coming years.

5 At IBISWorld we know that industry intelligence is more than assembling facts. It is combining data with analysis to answer the questions that successful businesses ask. Identify high growth, emerging and shrinking markets Arm yourself with the latest industry intelligence Assess competitive threats from existing and new entrants Benchmark your performance against the competition Make speedy market-ready, profit-maximizing decisions Who is IBISWorld? We are strategists, analysts, researchers and marketers. We provide answers to information-hungry, time-poor businesses. Our goal is to give you the real-world answers that matter to your business in our 700 US industry reports. When tough strategic, budget, sales and marketing decisions need to be made, our suite of Industry and Risk intelligence products give you deeply researched answers quickly. IBISWorld Membership IBISWorld offers tailored membership packages to meet your needs. Join and become an industry expert! Disclaimer This product has been supplied by IBISWorld Inc. ( IBISWorld ) solely for use by its authorized licensees strictly in accordance with their license agreements with IBISWorld. IBISWorld makes no representation to any other person with regard to the completeness or accuracy of the data or information contained herein, and it accepts no responsibility and disclaims all liability (save for liability which cannot be lawfully disclaimed) for loss or damage whatsoever suffered or incurred by any other person resulting from the use of, or reliance upon, the data or information contained herein. Copyright in this publication is owned by IBISWorld Inc. The publication is sold on the basis that the purchaser agrees not to copy the material contained within it for other than the purchasers own purposes. In the event that the purchaser uses or quotes from the material in this publication in papers, reports, or opinions prepared for any other person it is agreed that it will be sourced to: IBISWorld Inc. Copyright IBISWorld Inc.

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