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We're midway through the year, Dendreon is beating the broader market by 10 percentage points, and we're halfway through the issues I outlined.
In March, the Food and Drug Administration signed off on the expansion of its New Jersey plant, and yesterday Dendreon said the agency had followed suit for its new Los Angeles facility.
Dendreon's prostate cancer treatment, Provenge, is made individually for each patient at a workstation. The opening of the Los Angeles plant adds 36 workstations to the 48 workstations in New Jersey, increasing potential production by 75%.
Next up for Dendreon: a final decision by the Centers for Medicare and Medicaid Services on whether to pay for the $93,000 treatment, which is scheduled to be issued by today. In the proposed decision issued in March, the agency said it would pay for the drug, so this seems like more of a rubber stamp than anything else.
That just leaves the plant in Atlanta, which the FDA is supposed to make a decision about by Aug. 28. I wouldn't call this one a rubber stamp, but investors needn't be too worried about gaining an approval, either. The New Jersey and Los Angeles plant approvals prove Dendreon knows what it's doing.
In order to get to $50 per share and beyond, Dendreon has to prove to investors that the demand is truly there. The company is guiding for sales between $350 million and $400 million this year, with approximately half expected in the fourth quarter. Assuming it gains approval and Medicare reimbursement, the guidance doesn't seem unreasonable.
Then what will investors worry about? Probably potential competition from prostate cancer drugs from Johnson & Johnson (NYSE: JNJ ) , Medivation (Nasdaq: MDVN ) , OncoGenex Pharmaceuticals (Nasdaq: OGXI ) , and Teva Pharmaceutical (Nasdaq: TEVA ) . With Dendreon, there's always something to worry about.