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Wednesday, March 26, 2008
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Time to Buy Biotech?
Okay, we know the market has been a brutal, whipsaw place for the past several months. And we know a lot of the forces behind that transcend the issues and concerns of a specific industry. But why is biotech getting handed such an outsized whooping right now?
Popular biotech indices like the AMEX Biotechnology Index (BTK) and the Nasdaq Biotechnology Index (NBI) don't really tell the story here. They are, respectively, highly selected toward large companies and market capitalization-weighted. So the $20 billion-and-up companies like Amgen, Biogen Idec, Genentech, Gilead Sciences, Genzyme, and Celgene pretty much drown out what's going on at the sub-$1 billion companies that make up the bulk of the industry.
So, yeah, the biotech indices are hurting, but anyone who follows the industry can tell you it feels much worse than even the numbers reflect. Many companies are at or below the nadir's set in 2002-2003, when the biotech sector bottomed out in a pique of pessimism--just look at Human Genome Sciences, deCODE Genetics, Exelixis, CV Therapeutics, Protein Design Labs, or Affymetrix…to pick just a few examples. Even Vertex Pharmaceuticals, an investment darling just a year ago, is starting to flirt with its 2003 lows despite any corporate development of real significance.
What's going on here? Well, I'm not here to defend these individual companies or the many others in the same boat. Some have been their own worst enemies, or have simply been unlucky in the clinic. But some have arguably taken a much worse thrashing than they deserve. Investors might want to note that anyone brave enough to wade into the beaten down biotech sector five years ago could have found rich rewards with any number of companies that offered triple-digit returns over the subsequent few years.
Yet they should also be aware of some of the factors leading to the currently low stock prices.
• Hedge funds own a lot of biotech stock--or at least, they used to. They also own a lot of debt instruments, many of which are backed by increasingly risky obligations. As the risk rating of these instruments rise, so does the overall risk ratio of a given fund. To balance this out, the funds could sell the debt instruments--but they're often illiquid and tough to dump these days. Or they could sell their biotech investments. Voila! Problem solved. You can see it in action with some of the more visible hedge funds. Witness Dan Loeb's Third Point, which recently dumped most of a 10% stake in CV Therapeutics, as just one example.
• The companies hardest hit tend to be those without products--which is not by itself too surprising, since speculative investments contingent on favorable clinical studies are hardly favored in already uncertain times. But even companies that do have current or near-term products are also being sent near five-year lows. One factor at play is that many of these are likely to need access to additional capital to reach their goals. That means either taking on debt--not an easy task in the current credit crunch--or issuing more equity--scarcely any better. The biotechs that are holding up OK are the ones with bulletproof balance sheets--that is, the large cap ones that weight the indices toward relative stability. If you think access to capital is going to remain a long-term problem, you'll probably want to steer clear of any company that isn't cash-flow positive or doesn't have enough cash to outlast the crisis.
• You can't sell a drug without first getting approval from FDA. From this understaffed, overburdened, risk-averse FDA. 'Nuff said.
That's why many folks are steering clear. But does it pay to be greedy while others are fearful, and invest in some of biotech's smaller and more unfortunate companies? A typical analyst would say no. They would say there are few catalysts on the horizon to turn sour sentiment around, too much uncertainty about the depth or length of our credit woes, and that it's more prudent to wait for a turn and miss a little upside before taking on a risky investment in a volatile sector.
There's certainly some wisdom to that. But let's not forget that many companies with valuations at multi-year lows are also sporting maturing pipelines of desperately needed products, and that Big Pharma--you know, those companies that do have bulletproof balance sheets--have proven themselves increasingly will to acquire biotech. More importantly, the value of future product sales, even heavily discounted for risk, definitely point to some bargains lurking out there. When this ship finally turns, you'll see some beaten down companies double in value before you know what's happening.
Maybe that's worth a nibble.
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One of a crop of genomics companies founded in the mid-1990s, deCODE Genetics was created with the idea that it could sell information rather than drugs, relying on privileged access to the unique health care records and genetically homogenous population. That didn't quite work out, for legal, financial, and strategic reasons, and deCODE entered the drug discovery game. To date, that hasn't produced any revenues for deCODE, but this month the company showed the richness of its core competence. A study published in Nature picked through an incredibly complex phenotype--obesity--to show the roles that gene expression variations play. It's an impressive achievement, although in this difficult market, deCODE shares are trading near an all-time low -KT
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What's old is new again. In a move that surprised most observers, FDA Commissioner Andrew von Eschenbach asked Janet Woodcock to take a second tour of duty as head of FDA's Center for Drug Evaluation and Research (CDER). Woodcock, who served in the role from 1994-2005, presided over a period of greater productivity than the present in terms of number of drug approval, although she deserves neither all the credit nor all the blame for approval numbers. Nevertheless, despite the fact that this is technically a demotion for her, she was in charge of the committee to find a new CDER head--so she presumably wants the job. Most folks in the industry should be relatively happy to see her back. -KT
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Is there value to be found among fallen biotech companies haunting penny stock never-neverland? Young specialty pharma company EUSA Pharma thinks so. It snapped up troubled Cytogen for mere pennies a share, gaining both a U.S. infrastructure, four marketed oncology products, and some more developmental programs. And it wasn't even looking to reverse merge its way public--EUSA, rather, delisted Cytogen to retain the charms of privacy. I've mentioned my doubts about modern takes on the specialty pharma model (ahem, Cadence Pharmaceuticals), so it's only fair to mention that EUSA actually seems to be doing a remarkable job at finding undervalued assets and quickly building a legitimately global organization. Oh--and in our January issue, I wondered if Lilly would follow the lead of Pfizer and Novo Nordisk and give up on inhalable insulin. Now we have our answer. There's only you, MannKind! -KT
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The Pharm Country Career Fair is coming to King of Prussia, Pennsylvania on April 1, 2008 at the Radisson Valley Forge from 2:00 p.m. to 7:00 p.m.
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The BioSpace Career Fair in BioMidwest is coming to Oak Brook, Illinois on Tuesday, April 15, 2008 at the Chicago Marriott Oak Brook from 11:00 a.m. to 4:00 p.m.
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If you haven't heard of Accelerator Corp., you should check it out. It was founded as a venture capital-backed incubator to nurture inchoate businesses coming out of Leroy Hood's Institute for Systems Biology. (Hood, of course, is the celebrated biologist and inventor of the automated DNA sequencer). But Accelerator has grown into a vehicle that funds very early stage work from a variety of life sciences entrepreneurs--work that likely wouldn't find conventional venture backing but that requires expensive lab facilities and proof of concept studies. Recodagen is the latest company to find a home at Accelerator, and is working on cancer therapeutics that target so-called "junk DNA." It comes not from Hood's lab but from Washington State University at Pullman. -KT
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International Medical Device Compliance Congress will feature the exchange and presentation of company best practice policy and procedures at poster boards throughout the Device Congress Exhibit.
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EuroPLX 36 Istanbul Partnering event for Business Development & Licensing Executives seeking to partner in prescription drugs ranging from clinical candidates to value added generics, including bio-generics and biosimilars.
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On February 27, Theravance reported a last-minute cancellation of an FDA advisory committee meeting on its antibiotic telavancin. Why? According to In Vivo's blog, it's the fallout from the company's decision to remove data from a study site prior to the meeting (itself a matter of some debate). In Vivo suggests this is a sort of zero tolerance stance resulting from Sen. Charles Grassley's (R-IA) investigation into allegedly fraudulent data submitted on Sanofi-Aventis' Ketek. Certainly Grassley's scrutiny into FDA oversight has been intense, but as to whether these dots really connect, I'm not sure. The day after announcing the cancellation, Theravance said its response to FDA's approvable letter from the previous October had been accepted, and that it has a new PDUFA date. Nevertheless, companies should take extra care to dot every' i' and cross every 't' in this environment. Also, note some new developments on two issues raised last month--a new biogenerics bill, and new draft legislation to address the fallout of the Supreme Court's decision in Riegel v. Medtronic. -KT
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Executives, investors, patients--we all love the PDUFA date, which puts a firm timeline on the FDA's review of new drug applications. But the resource-strapped agency came out and said it may just have to go ahead and miss those dates due to heavy workloads. Cardiome and CV Therapeutics are two companies that have already watched a PDUFA date come and go for apparently no reason other than FDA's inability to complete a timely review. Hmm...do they get their user fee back? -KT
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Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.
You may contact Karl Thiel at Karl.thiel@biospace.com.
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