The biotech industry has been absolutely soaring over the past two years, fueled by a rise in drug approvals, an merger-and-acquisition frenzy, and widespread reorganizations that have helped to mitigate the impact of the so-called "patent cliff." Driving this point home, the closely watched iShares Nasdaq Biotechnology Index (NASDAQ:IBB) has appreciated a princely 162% since 2012:
As earnings across the industry are pushing higher at unprecedented rates and a bevy of experimental drugs continue to show promise for particularly hard to treat diseases, I think biotech looks set for another banner year in 2015. With this in mind, here is a look at Flamel Technologies (NASDAQ:FLML), Geron Corporation (NASDAQ:GERN), and Intercept Pharmaceuticals (NASDAQ:ICPT) -- three companies poised for strong growth next year.
Flamel starting to fire on all cylinders; explosive growth looming?
Flamel's turnaround story centers on its strategy to gain FDA approval for marketed but unapproved drugs. In May 2013, the company was granted its first approval for an unapproved product, namely Bloxiverz, an injection of neostigmine methylsulfate, used to reverse the effects of neuromuscular blocking agents after surgery.
With the bulk of unapproved product reportedly coming off the market earlier this month, Flamel could control a large portion of the neostigmine market -- an event that prompted the company to raise Bloxiverz's WAC price from $15.75 to $35.80 per vial.
With a second marketed but unapproved product, Vazculep, gaining FDA approval last June and launched commercially in October, analysts on average are estimating that Flamel could generate $203 million in sales next year. Putting this revenue estimate into context, the company's market cap currently stands at $540 million, suggesting that the market has yet to fully appreciate this compelling growth story.
Geron shooting higher after inking deal with Johnson & Johnson
Investors nearly left Geron for dead earlier this year after a partial clinical hold was placed on its last remaining clinical candidate, imetelstat, a telomerase-inhibitor being studied as a potential treatment for a host of hard-to-treat blood disorders. After the hold was lifted this month, Janssen Biotech, a subsidiary of Johnson & Johnson (NYSE:JNJ), agreed to license the therapy. Initially, Janssen will run two mid-stage studies for imetelstat's indications for myelofibrosis indication, a rare blood disorder that causes scar tissue to form within bone marrow, and another two for its indication for myelodysplastic syndromes -- a broad set of conditions characterized by inefficient blood production. If all goes well, the two companies plan to examine imetelstat in additional blood-based disorders.
Per the terms of the deal, Geron is entitled up to $935 million in milestone payments, and the two companies will split developmental costs. If imetelstat reaches the commercialization phase, Geron will receive low double-digit percentage of sales in royalties (teens to 20's), according to an 8-K filed with the SEC.
All told, Geron is a developmental-stage biotech with huge growth potential next year because of this licensing agreement. The risk is that imetelstat fails during clinical testing, allowing J&J to break off this agreement.
Intercept's NASH drug shrouded in doubt
Earlier this year, shares of Intercept Pharmaceuticals roared higher by over 500% in just two days after announcing unexpectedly strong mid-stage results for its experimental non-alcoholic steatohepatitis, or NASH, therapy called obeticholic acid, or OCA. Since then, the stock has dropped almost 70% from its former highs because of concerns over the validity of those results, as well as some issues with OCA raising lipid levels.With a late-stage study planned for mid-2015, we should learn relatively soon whether OCA is the real deal or not.
My take is that the market has overreacted to these issues. According to Intercept, the company has independently verified the clinical trial results, and the safety issue needs to be viewed in light of the fact that NASH is often fatal. Overall, I think the data so far are strong, making me cautiously optimistic that Intercept shares could rebound in a big way in 2015.
Keep in mind...
All three of these stocks have significant risks that shouldn't be taken lightly. Even so, I like these companies now because they have each overcome their most significant hurdles to unlocking shareholder value in recent months. So while these stocks are definitely not for the faint of heart, I think they warrant consideration by risk-tolerant investors.