Exelixis Inc. (NASDAQ: EXEL) may have a while longer before it gets to be a serious revenue stage company. Its stock was crushed on Wednesday after news from late Tuesday confirmed that the Independent Data Monitoring Committee (IDMC) notified the company that a planned interim analysis of the COMET-1 Phase III pivotal trial has been completed. The problem is that the study will not end early.
This IDMC recommended that the trial should proceed to its final analysis, and Exelixis said that it continues to anticipate top-line data from COMET-1 in 2014.
Exelixis’s statement said:
COMET-1 is a randomized, double-blind, controlled trial designed to enroll 960 patients with mCRPC who have progressed after treatment with docetaxel, abiraterone and/or enzalutamide. All patients in the trial have bone metastases and there is no limit to the number or type of prior treatments. Patients were randomized 2:1 to receive cabozantinib (60 mg daily) or prednisone (5 mg twice daily). The trial is event-driven and has 90% power to detect a 25% reduction in the risk of death (HR = 0.75) at the time of final analysis, which requires 578 events. The current interim analysis after 387 events was also planned to assess if the trial achieved its primary endpoint; it did not include a futility analysis. The secondary endpoint of the trial is bone scan response as assessed by an independent radiology facility (IRF).
Exelixis’s revenue was $289 million in 2011, falling to $47.5 million in 2012 and then to $31.3 million in 2013. Thomson Reuters had consensus estimates of $27.1 million in revenues in 2014 and $68.1 million in 2015.
After a 35% drop to $4.14 in late-morning trading on Wednesday, the stock now has a 52-week range of $4.05 to $8.41. Exelixis has an $806 million market cap after the drop, which means that the company lost its $1 billion market cap due to this drop. That new 52-week low was put in on Wednesday as well.
Biotech stocks had been weak already in recent days, before a bounce on Tuesday, but this is a different sort of drop. Very different. That being said, Exelixis had close to $400 million in cash at the end of 2013.
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