) -- Last December, I made
. With September approaching, I went back to see how well I've done so far. Here's my interim report card:
The Amgen (AMGN) - Get Report strategy of returning cash to shareholders in form of share buybacks, Dutch tender offers and dividends is abandoned in favor of ramped up acquisitions i.e. Gilead Sciences (GILD) - Get Report buying Pharmasset. Large-cap biotech firms start acting like Big Pharma -- choosing to buy growth instead of seeking it from internal drug development.
Amgen announced the acquisition of Micromet on Jan. 26, which made me feel really good about the accuracy of my "biotechs buying other biotechs" prediction. Since then, however, the healthcare M&A trend has reverted to the old, boring script. Big Pharma remains the biggest buyer of biotechs in 2012: Witness
purchase of Inhibitex and Amylin Pharmaceuticals (the former a disaster already); and
acquisition of Ardea Pharmaceuticals.
Still, I take solace in smaller deals that support my view:
seeking to acquire
( ALTH), Amgen buying Turkish drug firm Nevzet Pharma, and
both making acquisitions of small, privately held biotech companies. I'm just ahead of the curve with my prediction. I'll be right, eventually.
After much wrangling, lawmakers pass important PDUFA V legislation but it's amended to prohibit FDA from issuing drug approval decisions on Friday evenings.
Correct. PDUFA V legislation was passed, signed into law by President Obama and goes into effect on Oct. 1. Unfortunately, I was unable to convince anyone to add the prohibition against Friday night drug approval decisions.
Cancer immunothera-flop: Phase III cancer "vaccine" studies being run by Merck KGaA and Oncothyreon (ONTY) (Stimuvax in non-small cell lung cancer) and Vical (VICL) (Allovectin in melanoma) both fail. The only positive clinical news in cancer immunotherapy in 2012 will come from GlaxoSmithKline (GSK) - Get Report with its Mage-A3 therapy, in phase III for melanoma.
It's paid well to be bearish on cancer immunotherapy clinical trials in 2012. The highly anticipated interim analysis of the Stimuvax trial failed to produce results robust enough to stop the trial, dropping Oncothyreon shares into free fall. Vical still hasn't released the Allovectin melanoma data but shares are down 20% year to date. Meantime,
shares are 36% lower this year due to worsening problems with its prostate cancer "vaccine" Provenge.
Speculating on risky, early-stage cancer immunotherapy stocks was the best way for investors to ring up profits in 2012:
are all up significantly in the first nine months of the year.
By the end of the year, one or more of these companies will be gobbled up in an M&A deal: Seattle Genetics (CELG) - Get Report, Celgene, Biomarin Pharmaceuticals (BMRN) - Get Report, Amag Pharma (AMAG) - Get Report, Onyx Pharma (ONXX) , Momenta Pharma (MNTA) - Get Report.
0 for 6. Good grief. I still have three months left in the year to get at least one these M&A picks correct.
Cell Therapeutics (CTIC) - Get Report exits 2012 the same way it started -- with pixantrone still not approved anywhere. The only changes at the company will be to its share count and executive compensation -- both higher; and stock price -- lower.
Against all odds, pixantrone was approved in Europe. Investors, smartly, shrugged off the news as irrelevant. Cell Therapeutics, chronically short of cash, continues to dilute shareholders (the few still hanging around) with shares down another 60% this year. Pixantrone's future in the U.S. looks dimmer than ever as the company delays re-filing and instead focuses scant resources developing an old, toxic myelofibrosis drug that's already been abandoned by Onyx Pharmaceuticals. The only thing increasing in the Cell Therapeutics sphere are the salary, bonus and other perks awarded to CEO Jim Bianco.
Booyah. Not that this prediction took many brain cells to conjure. The real point, of course, was to remind investors about the risks in speculating or day-trading small-cap biotech stocks, particularly stocks like Aeterna Zentaris with horrendous drug-development track records. (Perifosine, anyone?)
Leucovorin shortages end, so too does Spectrum Pharma's fairytale ride.
Nope. Leucovorin supplies have not recovered to any appreciable degree, allowing Spectrum to grow Fusilev sales well beyond my expectations. Yet Spectrum shares are down 20% this year with short interest as high as ever and new questions raised about the level of Fusilev discounting.
Vertex Pharma's (VRTX) - Get Report cystic fibrosis drug Kalydeco will be approved. More importantly, studies testing Kalydeco combined with other Vertex's cystic fibrosis drugs will show strong benefit in a larger swath of patients. Vertex becomes a cystic fibrosis company. Hepatitis C? What's that?
I nailed this prediction, too. To my foot, through the floor. Ouch.
Celgene will be the best-performing large-cap (market cap greater than $10 billion) biotech stock in 2012.
Not so much. Celgene, up just 7% year to date, is actually the worst performing biotech stock with a market cap greater than $10 billion.
tops the list, up 162% this year. (The stock didn't even qualify by market cap in January, nor did Vertex at No. 2, up 61% year to date.)
(+49%), Gilead Sciences (+40%), Biogen Idec (+34%) and Amgen (+32%) are all performing better than Celgene. What happened? More like what didn't happen, as in Revlimid's long-delayed European approval for front-line multiple myeloma. I didn't anticipate Celgene management screwing the pooch as badly as they have this year.
--Written by Adam Feuerstein in Boston.
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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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