BOSTON (TheStreet) -- The Biotech Stock Mailbag has returned -- rested, re-energized and ready to educate, inform (and likely infuriate) for a fifth consecutive year.
Before I get to your emails and tweets, a couple of related housekeeping items. I'll be in San Francisco next week to provide wall-to-wall coverage of the JPMorgan Healthcare Conference. I wrote a preview story about this important gathering of the biotech tribe on Wednesday, so please check that out.
While at the JPMorgan confab, my plan (providing the AT&T network gods shine on me) is to live-blog the company presentations and investor breakout (Q&A) sessions to provide a more real-time and interactive reporting experience.
If this plan works, I'll be able to bring you news and insights from the conference as it happens on the ground in San Francisco -- similar to the live blogs I've used in the past to cover FDA advisory panel meetings.Wish me luck, and please visit TheStreet.com Monday to Wednesday to check out the live blogs. Now, the Mailbag is open: Wendall M. emails, "Adam, what's are favorite top biotech stock picks for 2011? What should investors be looking at in the new year?" I want to hold off on offering top stock picks until I get through next week's conference, and even then, I'm hesitant to put up a definitive list because biotech has become a sector that is so short-term and catalyst-driven that today's hot stock can easily be next week's loser. With that copout of an excuse, I do have a list of highly anticipated 2011 biotech events and catalysts written out on the white board in my office upon which investors -- bulls and bears -- should focus a lot of attention: I'm looking forward to the FDA advisory panel for Delcath Systems' (DCTH) Chemosaturation System. The expected approval and launch of two new hepatitis C drugs -- one from Vertex Pharmaceuticals (VRTX), the other from Merck (MRK) -- is going to be very interesting. Dendreon (DNDN) will reach full manufacturing capacity for Provenge this year, which is going to be a big milestone for the company and investors. In the big-cap arena, Biogen Idec (BIIB) needs positive results from two late-stage studies of its oral multiple sclerosis drug, while Amgen (AMGN) has to show investors it can sell Prolia/Xgeva. Speaking of marketing, Human Genome Sciences (HGSI) is going to launch the first new lupus drug in a gazillion years. Finally, I will be watching to see if mergers and acquisitions accelerate in 2011 after a down year in 2010. One of my 2011 predictions for the biotech sector was that by the end of the year, one or more of these companies will be gobbled up in an M&A deal: Amarin (AMRN), Seattle Genetics (SGEN), Human Genome Sciences, Pharmasset (VRUS), Onyx Pharmaceuticals (ONXX), Biomarin Pharmaceuticals (BMRN).
DMT36 emails, "You were pretty harsh on Xoma (XOMA) on Twitter Monday when they announced the Servier partnership deal for XOMA 052. Don't you think your comments were a bit too negative? The stock was up big which made you look foolish." I was harsh on Xoma. For those who don't follow me on Twitter (and why wouldn't you?), I called Tuesday's Xoma-Servier deal "idiotic," which "reinforced XOMA management's reputation as a bunch of incompetents." I also said the partnership was "bad fundamentally and doesn't validate XOMA 052's potential." Upon further reflection and away from the pressure of snap judgments, I was too critical. DMT36 is right, and I appreciate him pointing out my overreach. I still believe the Servier partnership is less than ideal, but it's probably the best deal Xoma could manage, given its troubles, including a dwindling cash account that threatened to derail the company. This is probably more true now after Xoma on Thursday night released the highly anticipated interim results from the phase IIa study of Xoma 052 in Type 2 diabetes. Disappointing and underwhelming would be the two words I'd use to describe the phase IIa data. Xoma 052 is no longer looking like a potential blockbuster diabetes drug, which probably explains why Xoma was forced to marry up on modest terms with a smallish, private French drugmaker like Servier instead of negotiating a lucrative deal with a larger and stronger partner. Mark Guterman, a thoughtful and active Xoma shareholder, helped me step back from the ledge and see the value in the Servier deal more clearly. "This is clearly not the best deal, but it does get Xoma out of the penalty box and on to the junior varsity team," Guterman told me. Xoma's many missteps have scared off institutional investors, which now make up only 10% of the company's shareholder base, down from 60%," says Guterman. What he likes most about the Servier partnership is that it solves Xoma's cash problem by requiring Servier to pay for much of XOMA 052's development costs. Xoma also has the option to buy back U.S. and Japan rights to diabetes and cardiovascular disease indications. That's why the upfront payment to Xoma, just $35 million and most of that in the form of a loan, is so small, he adds. Guterman acknowledges that the phase IIa diabetes data released Thursday weren't encouraging, but he wants to see results from the larger phase IIb diabetes study later this quarter before reaching any definitive conclusions. "I'm still positive on the company given minimal cash burn and the ability to move preclinical assets through the pipeline," he added. Makes sense to me, although I think Thursday's disappointing Xoma 052 diabetes data puts a new overhang on Xoma's stock, which will take a lot to clear away. Xoma closed Thursday at $6.78 but fell 11% to $6.04 in the after-hours session upon release of the diabetes data. The bottom-line data from the study -- a blood glucose (HbA1c) reduction of just 0.2% for Xoma 052-treated patients compared to an HbA1c reduction of 0.1% for placebo patients -- fell well below expectations. On a more positive note, Xoma 052 did demonstrate a 49% reduction in C-reactive protein, a key marker of inflammation, compared with a 2% reduction in placebo. This finding may bode well for future studies in cardiovascular indications, but this phase IIa study was about diabetes, so the lousy HbA1c reduction is the headline.
Paul K. asks, "Opexa Therapeutics (OPXA). What do you make of this huge move in the stock?" Wednesday's 54% surge in Opexa's stock price (86% at the intraday peak) was great if you're a nimble biotech trader, especially someone who likes to churn through small-float, momentum-driven stocks (and knows when to sell and bank profits.) If you're a biotech investor -- more of a fundamentals oriented, buy-and-hold type -- Wednesday's action was totally unjustified and potentially ruinous if you decided to buy in at the top. I'm a fundamentals guy, so I've followed Opexa and the development of its multiple sclerosis drug Tovaxin for quite some time. I know that the main Tovaxin phase II study failed to demonstrate any benefit for MS patients -- tanking Opexa's stock price in 2008 when the data were released. Since that time, Opexa has been reanalyzing subsets of patient data from that failed study in order to find something positive to say. The company has also, since 2008, been telling investors about plans to meet with FDA to discuss possible phase III studies and of potential partnering interest in Tovaxin from other drug companies.
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