What a month! The Dow set all-time highs. So did the S&P 500. But March wasn't so great for everyone. While the big indexes enjoyed the thrill of victory, these three biotechs experienced the agony of defeat. Here's what happened.
Impax Laboratories (NASDAQ: IPXL ) suffered from a comedy of errors. Unfortunately, the impact on its shares wasn't so funny. Shares sank more than 22% during the month.
The culprit for the stock decline was none other than Impax itself. Back in March of last year, the Food and Drug Administration conducted an inspection of the company's manufacturing facility in Hayward, Calif. Impax Labs had plenty of time to correct those problems. However, when the FDA completed its follow-up inspection earlier this month -- one year later, three of the same problems were cited again. To make things worse, the FDA found nine new issues.
In response to the problems, CEO Larry Hsu stated that the company "committed significant resources in [its] efforts to meet FDA requirements." Obviously, those resources and efforts weren't enough.
A long fuse
With a long fuse on a stick of dynamite, you know the explosion is still coming, even if it might take a little longer. The same type of situation has applied for Spectrum Pharmaceuticals (NASDAQ: SPPI ) . Many observers have expected for quite a while that Fusilev sales would eventually bomb. The explosion finally came in March, resulting in about a 35% drop in Spectrum's shares.
Critics have been saying for months that sales for non-Hodgkin's lymphoma drug Fusilev would fall as providers turned to generic alternatives. Fusilev enjoyed an extended period of high sales volumes resulting largely from shortages of generic leucovorin, driving Spectrum's revenue up tremendously. However, that shortage ultimately ended as Teva (NYSE: TEVA ) and Sagent Pharmaceuticals (NASDAQ: SGNT ) cranked out more supply.
The anticipated firestorm hit in mid-March after Spectrum announced revenue guidance 40% lower than previously expected.This huge guidance cut stemmed from hospitals that switched to generics. No surprise there. Spectrum insisted that demand for Fusilev in clinics was "stable" and that "solid demand" was anticipated for 2013. Unfortunately for Spectrum, "stable" and "solid" aren't words that can be accurately used to describe its stock these days.
The biggest crash of all
Impax and Spectrum might have had bad months, but at least they still look better than Ziopharm Oncology (NASDAQ: ZIOP ) . Ziopharm's stock collapsed more than 60% in March following bad news from a late-stage clinical trial this week.
The company had high hopes that palifosfamide would prove to be a potent treatment for metastatic soft tissue sarcoma. However, the drug failed to significantly improve progression-free survival, the primary endpoint of the phase 3 clinical study. Despite the study's independent data monitoring committee's recommendation for continued analysis to follow up on overall survival rates, Ziopharm decided to pull the plug on the program entirely.
What's next for Ziopharm? The company says it will now regroup and focus on its synthetic biology programs.
Rising from the ashes
Can any of our three biotechs rise from the ashes? I think so. Impax Labs appears to have the easiest path for coming back. The company's self-inflicted woes should be resolvable. Spectrum and Ziopharm could also potentially mount comebacks, but their roads will be much tougher. Looking on the bright side, at least it's unlikely that either will make our list for April.
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