buy rec for xoma in body of this...
1) ZACKS EQUITY RESEARCH
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With small-cap and mid-cap biotechnology companies finally making notable headway in phase II and III testing, we felt it would be an excellent time to check back with Jason Napodano, CFA, our senior analyst covering pharmaceutical companies, including those in the biotechnology sector. Jason was able to help us determine what products in the pipelines are most promising.
It appears as though biotech is finally making some solid gains in the market. What's your take on how this is going?
The year 2006 should be another positive year for the biotechnology industry. The momentum that started early in 2005 should continue thanks to deep late-stage pipelines and impressive new product launches by some of the industry's largest players. However, we expect 2006 to be the year when several mid-cap companies come of age and become large-cap status.
We are steering investors towards companies with significant phase II or phase III candidates. Companies that are small in capitalization, but have the potential to launch billion- dollar drugs. Three in the cardiology field come to mind: AtheroGenics (AGIX), Renovis (RNVS), and CV Therapeutics (CVTX).
AtheroGenics is developing AGI-1067, an oral anti-oxidant small molecule for the treatment and prevention of atherosclerosis. Renovis is developing Cerovive, a novel nitrone compound for the treatment of acute ischemic stroke. Both of these markets are extremely large and highly underserved by existing therapies. Coincidently, both AtheroGenics and Renovis are partnered with EU-based AstraZeneca for commercialization. We expect phase III results on both compounds during the second half of the year. Likewise, CV Therapeutics should be in store for a great 2006 if the company can present positive data on its phase III candidate, Ranexa. Ranexa is a fatty acid inhibitor for the treatment of chronic angina and acute coronary syndrome (ACS). ACS is yet another very large and underserved market. All three drugs, AGI-1067, Cerovive, and Ranexa have the potential to be blockbusters (greater than $1 billion in sales).
Is this the story about biotech: small-cap companies with lots of room to grow?
Well, we continue to like several large-cap names in biotech also. Amgen (AMGN) made a great move in our view picking up Abgenix (ABGX) for $2.2 billion in December. Amgen now owns 100% of panitumumab, a phase III EGFR inhibitor that looks superior to Erbitux. There is a lot more to Gilead Sciences (GILD) than just Tamiflu royalties! We think the anti-viral business remains strong, and we expect Gilead to be an acquirer of more anti-viral or anti-infectant products in 2006. Finally, Biogen Idec (BIIB) should be in store for a great 2006, given our belief that Tysabri will be (re)- approved by the FDA around the middle of the year.
But as I mentioned, 2006 should be the year that several mid- cap names establish themselves as large-cap players. The coming of age for Celgene (CELG), Protein Design Labs (PDLI), and Amylin Pharmaceuticals (AMLN) should be fun to watch this year. Celgene's recently approved Revlimid for myelodysplastic syndrome (MDS) looks very strong. Additional approvals for multiple myeloma and other hematological cancers should fuel impressive growth over the next several years. The story at Amylin is very similar - a strong new product should drive well above industry-trend growth. Byetta, for type-II diabetes, is quickly picking up market share. A long-acting "Byetta LAR" version could offer multi-billion dollar potential. The story with Protein Design Labs is very different. The company has an impressive royalty stream that consists of blockbusters Avastin, Herceptin and Synagis, but it is the deep mid-stage pipeline that has us excited. We are looking forward to seeing data on candidates for cancer and inflammatory disease throughout the year.
Say I'm looking to find some small-caps with serious growth potential. Do you have any recommendations along these lines?
We recommend two names here, Xoma Ltd. (XOMA) and Acusphere (ACUS). Acusphere is developing AI-700, a dry powder, biodegradable synthetic polymer to be used for ultrasound contrast imaging. The candidate is in two phase III trials in the U.S., with data expected around mid-year. For Xoma, the company continues to sign up licenses for its proprietary Bacterial Cell Expression (BCE) technology. Xoma also receives royalties on sales of psoriasis drug Raptiva at Genentech, and will receive royalties on two new products: Genentech's Lucentis (macular degeneration) and UCB's Cimzia (Crohn's disease) once they gain final approval.
What companies should investors be mindful to steer clear of at this time?
There are several names we would stay away from. We would avoid investment in Mannkind Corp (MNKD) for the time being. The company is developing an inhaled insulin product called Technosphere. We don't see any significant data on Technosphere in the near-term, and the product is not expected to reach the market until 2009. By that time there could be three or four other inhaled insulin products on the market.
We would also avoid ICOS Corp. (ICOS). Development outside of tadalafil (Cialis) has been limited, and the erectile dysfunction (ED) market is just not expanding the way we hoped it would. We still see Cialis as the best-in-class drug, but until ICOS can branch out beyond the ED market we see a risky long-term profile.
Going against the grain a little, we would be sellers of ViroPharma (VPHM) at the current level. ViroPharma, a stock that was up 500% in 2005, is driven by sales of its leading antibiotic, Vancocin Capsules. Sales growth of Vancocin is driven primarily by price increases, and we see the risk of generic competition emerging sooner than expected. From the lows of 2005, ViroPharma's stock is up over 1000%. We think it may be time for a pullback.
Sepracor's (SEPR) Lunesta has been very strong since its launch early last year. Yet Lunesta will face new competition in 2006 from Pfizer and Neurocrine Biosciences with Indiplon. Also, Sanofi-Aventis is heavily marketing a longer-lasting version of its blockbuster Ambien called Ambien CR. Sepracor shares have been very choppy of late, and we think it is the coming competition that has investors spooked.
Finally, we would avoid investment in Trimeris, Inc. (TRMS). Sales of the company's leading product, Fuzeon, have slowed over the past few quarters. Competition is emerging from fusion inhibitors under-development at Schering-Plough and GlaxoSmithKline.
What are your final words on expectations in the biotech industry this year?
All in all, we look for 2006 to be a positive year. Several companies are on our "potential takeout" list, including the three mid-sized biotechs working on the cardiology products we discussed above. Two final names we recommend investors keep an eye on as potential takeout candidates are ACADIA Pharma (ACAD) and Arena Pharma (ARNA), two small biotechs working on drugs for central nervous system disorders. ACADIA is looking to enhance the treatment regimen for schizophrenia and Parkinson's disease, two rather large markets that attract major players in the pharmaceutical market. Likewise, Arena has a phase II candidate for obesity under development that we see several larger-cap pharmaceuticals potentially interested in acquiring.
Jason Napodano, CFA is a senior analyst covering the pharmaceutical industry for Zacks Equity Research. |