With 53M shares outstanding, and an estimate of $400M peak sales for Pima in PDP in the US alone, it would seem that a peak stock price approaching 6X sales would be conservative. Obviously, the hurdle of FDA approval is far from a given at this point.
Nevertheless, a stock price of $45 to $50 a share seems quite possible after approval. ???
Any comments?
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Acadia Pharm Inc. ACAD +136.09% said its experimental antipsychotic drug showed significant improvement in patients with Parkinson's disease psychosis in a late-stage trial. Shares of Acadia surged to $5.62 in midday trading Tuesday, up from Monday's close of $2.30. Before Tuesday, the stock already had doubled in 2012 on hopes for the study.
Patients receiving the drug, pimavanserin, had symptoms like hallucinations and delusions of jealousy reduced by more than a third, compared with a reduction of 18.5% in patients receiving a placebo. The study met its primary endpoint.
"We are very excited about the top line results, which successfully met all the objectives of this study," Chief Executive Uli Hacksell said.
Acadia said it would conduct an additional late-stage study to confirm the results before applying for regulatory approval with the Food and Drug Administration. The company didn't specify a timeline for the application.
Still, the positive data increased confidence that pimavanserin may successfully improve types of psychosis that are inadequately treated by current drugs. About one million Americans have Parkinson's disease, the degenerative brain disorder, and about 40% of those experience psychosis at any given time.
"This is a patient population that has very limited treatment options right now," said Jason Butler, a JMP Securities JMP +0.95% analyst. "Being able to use a drug that's as safe and easy to use as this drug could be a really meaningful improvement for patients."
Mr. Butler projects peak sales at a minimum of $350 million to $400 million, a figure that doesn't include international sales or new indications. Through the first nine months of 2012, Acadia had revenue of $4.5 million, mostly the result of collaborations with other drug makers.
The data released Tuesday reignited hopes for the drug, which failed to meet its primary objective in a previous late-stage study in 2009. That study didn't reach statistical significance, primarily because of higher-than-expected improvements among the placebo group.
For this late-stage trial, the company altered the design to exclude non-U.S. trial sites and used a centralized mechanism for rating the improvement of patients, among other changes. The alterations reduced variability in the placebo group, the company said.
After achieving successful results in the latest study, the company should be better able to replicate similar results in the next study.
"There are always risks in a clinical trial," Mr. Butler said. "But the fact that they spent a lot of time thinking about trial design, that gives me a level of confidence going into the next trial."
With news of the drug's positive data, enrolling new study patients and study doctors should be made easier and speed up the timing of the trial, Mr. Butler said.
As many as 60% of patients with Parkinson's will develop psychosis at some point in the progression of their diseases, which leads to increased institutionalization and mortality risk. Current antipsychotics tend to offset the benefits of medications used to treat the underlying disease, which impairs movement.
The late-stage trial showed pimavanserin didn't worsen motor function, the company said, and improved the quality of nighttime sleep, daytime wakefulness and the burden on caregivers.
The study, which began in 2010, compared the use of pimavanserin versus placebos in 199 patients over six weeks. The company said the drug was safe and well-tolerated in the trial.
Acadia also is studying pimavanserin in midstage trials for patients with schizophrenia and Alzheimer's disease psychosis. |
