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10 Best-Performing Biopharma Stocks of 2012 and Their 2013 Outlook

BOSTON (TheStreet) -- The 10 best-performing biopharmaceutical stocks of 2012 and their outlook for 2013:

10. Affymax (AFFY) +256%

Not only has the commercial launch of Affymax's once-monthly anemia drug Omontys started off strong, but investors are also rewarding the company for its efforts -- and those of partner Takeda. Affymax shares are up more than 60% since Omontys was approved in late March. In other words, the "short the drug launch" thesis that has been nearly bulletproof in biotech for the past few years is not working with Affymax.

Looking ahead to 2013, Affymax could maintain its momentum by signing Omontys supply agreements with the remaining two mid-sized dialysis organizations (MDOs) that are not yet using the drug. [Four MDOs are already Omontys customers, as are about 90 small-sized dialysis centers.]

A current Omontys supply agreement with Fresenius, one of the two large dialysis service providers, expires in April 2013. A re-up of that contract, particularly for longer/better terms, would be a big boost for Omontys sales and Affymax's stock price in the coming year.

9. Pharmacyclics (PCYC) +259%

I try to steer clear of hyperbole when describing the movement of biotech stocks, but for Pharmacyclics, "rocket" is more than justified. The stock doubled in value in 2011, then more than tripled in 2012.

The object of Wall Street's affection is ibrutinib, a pill designed to block the production of an enzyme known as Bruton's tyrosine kinase (BTK) that is responsible for the unchecked or cancerous growth of B-cells. Investors see blockbuster potential in ibrutinib as a treatment for a variety of B-cell related lymphomas and leukemias, and so does Johnson & Johnson (JNJ), which licensed the drug from Pharmacyclics in December 2011.

Phase III studies of ibrutinib only just began enrolling patients and won't likely have top-line results ready until 2015. But with a market cap already topping $3.7 billion, Pharmacyclics is pricing in a lot of good news already.

8. Galena BioPharma (GALE) +260%

Galena lands a spot on this list despite a breast cancer "vaccine" showing scant evidence of efficacy and disinterest from institutional healthcare investors, who own just 6% of the company's outstanding shares, according to CapitalIQ. Nonetheless, retail investors bought into Galena's risky story, which like many other biotech penny stocks, received a big-time boost this year from the biotech bull market.

It's hard to envision a scenario under which Galena repeats its stock out-performance in 2013, even if the macro market remains strong. The phase III study of NeuVax in breast cancer patients with "low" levels of Her-2 expression is expected to reach full enrollment in mid-2013, with an interim analysis scheduled for the end of the year. If the interim analysis fails or comes up inconclusive -- likely outcomes given the shaky assumptions used to design the study -- a final analysis won't be ready until 2015.

Galena has had no luck attracting a partner, a buyer or institutional investors despite heavy promotional efforts all year. Insiders haven't been buying their own stock either. With less than $15 million in the bank, at least one dilutive financing in 2013 is likely. The best days for Galena are in the rear-view mirror already.

7. Threshold Pharmaceuticals (THLD) +266%

Threshold wins this year's "What have you done for me lately?" award. The company owes its spot on this year's Top 10 list to a super-fantastic February in which 1) Merck KGaA signed on as a development/marketing partner for the pancreatic cancer drug TH-302; and 2) positive results from a phase IIb study of TH-302 in pancreatic cancer were announced.

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