1. The Amgen (AMGN) 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) 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 Bristol-Myers Squibb's (BMY) purchase of Inhibitex and Amylin Pharmaceuticals (the former a disaster already); and AstraZeneca's (AZN) acquisition of Ardea Pharmaceuticals.
Still, I take solace in smaller deals that support my view: Spectrum Pharmaceuticals (SPPI) seeking to acquire Allos Pharmaceuticals (ALTH), Amgen buying Turkish drug firm Nevzet Pharma, and Celgene (CELG - Get Report) and Biogen Idec (BIIB) both making acquisitions of small, privately held biotech companies. I'm just ahead of the curve with my prediction. I'll be right, eventually.2. 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. 3. 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) 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, Dendreon (DNDN) 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: Galena Biopharma (GALE), ImmunoCellular Therapeutics (IMUC) and Celldex Therapeutics (CLDX) are all up significantly in the first nine months of the year. 4. 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), Amag Pharma (AMAG), Onyx Pharma (ONXX), Momenta Pharma (MNTA). 0 for 6. Good grief. I still have three months left in the year to get at least one these M&A picks correct. 5. 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.