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.
Source: Thinkstock
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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