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It's been a pretty good year for biotechs. The iShares Nasdaq Biotechnology Index (NASDAQ: IBB ) is up 33% year to date, nearly doubling the broader Nasdaq market that's up 18%. But rather than rejoicing (for too long), investors should try and gleam some investment lessons from the successes in 2012 that they can use to make next year even more profitable.
Try, try, try, try and try again
After four rejections, Discovery Laboratories (NASDAQ: WINT ) finally gained Food and Drug Administration approval for its Surfaxin, its preventative treatment for respiratory distress syndrome. The premature babies that were treated in the pivotal clinical trial supporting the application are now in elementary school.
Obesity-drug makers VIVUS (NASDAQ: VVUS ) and Arena Pharmaceuticals (NASDAQ: ARNA ) didn't have to wait nearly as long for their approvals, but their tenacity is just as impressive. When their drugs were rejected in 2010, the laundry list of items the FDA wanted addressed before it would approve the drug was daunting. It seemed fairly likely that at least one of the items would trip the companies up on their second time through. Instead, both companies were able to convince the FDA to overlook their warts and approve the drugs.
Investment lesson: Don't write off companies just because the FDA doesn't approve their drug on its first try. Although, be careful, as in the case of Surfaxin, it could be a long wait. Investors that bought after the first rejection may never see a profit.
Drug approved, launch already
Arena hasn't launched its drug yet; it has to wait for the Drug Enforcement Agency to sign off on the potential to abuse Belviq. Shares have suffered as it's waited. Arena hit a high near $12 per share after the approval, but sits 25% lower today. A DEA decision should happen shortly, which would allow its marketing partner Eisai to launch the drug early next year.
Amarin (NASDAQ: AMRN ) hasn't launched its lipid-lowering drug Vascepa yet, either. The drug gained FDA approval in July, but Amarin decided to look for an acquirer or at least a partner that could help it launch the drug.
But one never materialized (at least not at a price management was willing to give up control for) so Amarin has decided to launch the drug on its own. Investors panicked sending shares down 19% on the news.
Investment lesson: Some shareholders are impatient. If you're a long-term investor, look for buying opportunities after the post-approval blues set in.
Regeneron Pharmaceuticals (NASDAQ: REGN ) is up 220% this year in large part by consistently exceeding investor expectations. Muting the expectations from the beginning certainly didn't hurt.
When the company got its macular degeneration drug Eylea approved last year, it wasn't clear how easy it was going to be to take market share away from Roche's (NASDAQOTH: RHHBY) Lucentis. Eylea has a better dosing schedule, but it's not easy to take down an entrenched leader.
Regeneron started the year saying it could manage $140 million in sales of the new drug. It's now predicting $790 million in sales this year. And who knows, it might even be sandbagging that.
Investment lesson: Not every drug launch is a failure. Spotting them might not be easy, but the ones that refrain from spouting lofty initial projections should have more upside potential.
Final Foolish thought
There's nothing like the biotech industry to get your blood pumping. Even if you missed these winners this year, there are lessons to be learned to try and recapitulate the results. And there are lessons to be learned in biotech's failures as well. You can read about them here.
As we head into 2013, the potential market for obesity drugs is massive, but so are the risks. If you're looking for more information on the top two obesity drug players, grab copies of our premium research reports on Arena Pharmaceuticals and VIVUS today. In the reports, we break down each company's strengths and weaknesses, and explains the critical issues you need to know about. News in this space moves fast, so both reports come with a full year of updates. Click now for exclusive information on Arena and VIVUS.