Big Pharma and Biotech

The pharmaceutical industry has witnessed major changes in 2009. Performance has been affected by factors like sluggish prescription trends, intensifying generic competition and limited phase III catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses.

According to IMS Health (RX - Snapshot Report), this is the main reason why global pharmaceutical market growth will be restricted to the mid-single digits through 2013. Over the next five years, products that currently generate about $137 billion in sales are expected to face generic competition, including Lipitor, Plavix and Seretide. At the same time, new products are not expected to generate the same level of sales as the products losing patent protection have.

With most of the big pharma companies already facing patent challenges for their blockbuster products or likely to face them going forward, the companies have been looking toward mergers and acquisitions (M&A) and in-licensing deals to make up for the loss of revenues.

We saw huge M&A activity in the first half of 2009. Major deals include Abbott Laboratories’ (ABT - Analyst Report) acquisition of Advanced Medical Optics, Johnson & Johnson’s (JNJ - Analyst Report) acquisition of Mentor Corp., Pfizer’s (PFE - Analyst Report) acquisition of Wyeth and the merger between Merck (MRK - Analyst Report) and Schering-Plough (SGP).

While these deals took place between large-cap pharma companies, others have been looking toward biotech companies to build their product portfolios. Prime examples include Johnson & Johnson’s acquisition of Cougar Biotechnology, Roche’s acquisition of Genentech, Bristol-Myer Squibbs’ (BMY - Analyst Report) acquisition of Medarex, and Sanofi-Aventis’ (SNY - Analyst Report) acquisition of Fovea Pharmaceuticals, SA.

We expect this trend to continue. Small biotech companies are also game for such deals. Given the current economic situation, most small biotech companies are finding it difficult to raise cash, thereby making it difficult for them to survive and continue with the development of promising pipeline candidates. As such, it makes sense for these companies to seek deals with pharma companies that are sitting on huge piles of cash. We would recommend investors to put their money in biotech stocks that have attractive pipeline candidates or technology that can be used for the development of novel therapeutics.

Another recent trend seen in the pharmaceutical sector is a focus on emerging markets. Companies like Mylan Inc (MYL - Analyst Report), GlaxoSmithKline (GSK - Analyst Report) and Sanofi-Aventis are all looking to expand their presence in India, China, Brazil and other emerging markets.

Until recently, most of the commercialization efforts were focused on the U.S. (the largest pharmaceutical market), Europe and Japan. However, emerging markets are slowly and steadily gaining more importance and several companies are now shifting their focus to these areas. According to IMS Health, China’s pharmaceutical market is expected to continue to grow more than 20% annually, and contribute 21% of overall global growth through 2013. Growth in emerging markets could help stabilize the base business during the industry’s 2010-15 patent cliff.

In addition to patent challenges, pharma companies have been facing headwinds in the form of foreign exchange fluctuations. Increased generic competition and foreign exchange headwinds will continue impacting revenues of major pharmaceutical companies. Johnson & Johnson recently reported that third quarter revenues were down due to the impact of generics and foreign exchange headwinds. With revenue growth stalling or slowing down, companies have been resorting to cost-cutting and share buybacks to drive bottom-line growth.

Valuations, however, are attractive, with several of the largest players trading at PEs below 10x, including: Pfizer (8.3x), Eli Lilly (LLY - Analyst Report) (7.7x), Sanofi-Aventis ( 7.7x), and AstraZeneca (AZN - Analyst Report) (7.2x) based on fiscal 2009 estimates. Attractive valuations, along with big dividend yields and diversified revenues bases, should protect investors from significant downside risk even if the economy continues to languish in the coming quarters.

OPPORTUNITIES

In the pharma space, we are positive on stocks like Alcon (ACL - Analyst Report) and Novartis (NVS - Snapshot Report). We believe these companies will continue witnessing revenue growth based on continued international penetration, new product launches and market share expansion. Pipeline expansion through in-licensing deals and acquisitions should also add to growth.

Novartis should see strong vaccine sales this flu season. The company has received approval from the U.S. Food and Drug Administration for its swine flu vaccine, which should drive revenues.

Although we have Neutral ratings on names like Johnson & Johnson and Abbott Labs, we maintain a positive outlook on these stocks given their diversified revenue base, strong business segments, contributions from recent acquisitions and impressive late-stage pipelines. We also have a positive outlook on Bristol-Myers, which has a strong presence in attractive areas like biologics, cancer and cardiovascular drugs.

In the biotech space, we are positive on names like Gilead Sciences (GILD - Analyst Report) and Biogen Idec (BIIB - Analyst Report) even though we have Neutral recommendations on these stocks. Gilead’s HIV franchise has been helping the company post better-than-expected earnings over the past few quarters and we expect this trend to continue.

Biotech companies that could be acquisition targets provide opportunities for significant returns. Here, we would like to mention two companies that could be potential take-out targets -- Biogen Idec and Acorda Therapeutics (ACOR - Analyst Report). In addition to holding a leading position in the multiple sclerosis market, we believe Biogen has the best pipeline in all of biotech and could be an attractive takeover candidate for pharma companies interested in biologics.

Meanwhile, Acorda is one of the more interesting biotechnology companies under our coverage. We have an Outperform rating on the stock. Acorda recently received a favorable recommendation from an FDA advisory panel on its key pipeline drug, Fampridine-SR, which could have blockbuster potential worldwide.

WEAKNESSES

We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles. The FDA has been exercising more caution before granting approval to new products and several candidates have been facing delays in receiving final approval.

We would also avoid companies like Eli Lilly & Co. (LLY - Analyst Report) which are facing patent expirations on key products and do not have a solid pipeline to make up for the loss of revenues that will take place once generics enter the market.

Meanwhile, we continue to believe Pfizer’s (PFE - Analyst Report) acquisition of Wyeth (WYE) will create an even bigger struggling company. Both companies have significant patent expirations in the years to come, and both have been severely lacking in their R&D productivity over the past few years. We recommend avoiding both names.

In the biotech sector, we have an Underperform rating on Genzyme Corporation (GENZ - Analyst Report), which is facing issues like lower revenues, contracting gross margins, supply constraints, manufacturing hiccups and delays in new product launches.

We would also recommend avoiding biotech companies that are struggling to survive and are unable to strike partnership deals for their pipeline candidates. One name that comes to mind is MannKind Corp. (MNKD - Analyst Report) which has been looking for a partner for its key candidate, Afresa. The company’s stock declined significantly on the news that it will not be able to enter into a partnership deal by year end, contrary to earlier expectations.

Another name to avoid would be Alkermes, Inc. (ALKS - Analyst Report) which is awaiting FDA approval for its type-II diabetes candidate, exenatide once-weekly. Although the efficacy data on exenatide once-weekly is impressive, we are concerned that the approval of the product could be pushed back beyond the first quarter of 2010, given the current regulatory environment and concerns regarding the safety of the candidate.