Exelixis, Inc. (Nasdaq:EXEL) today reported financial results for the quarter ended March 31, 2014.
Q1 2014 Highlights and Recent Events
- The European Commission approved COMETRIQ ® (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid cancer in January 2014. Additionally, the Committee for Orphan Medicinal Products recommended maintenance of orphan drug designation at the time of marketing authorization.
- The Independent Data Monitoring Committee (IDMC) for COMET-1, the phase 3 pivotal trial of cabozantinib in advanced metastatic castration-resistant prostate cancer (mCRPC) with the primary endpoint of overall survival, completed its planned interim analysis and recommended the trial proceed to its final analysis. Exelixis anticipates top-line results from COMET-1 in 2014.
- Appointed Jeffrey J. Hessekiel, J.D. as executive vice president and general counsel. Mr. Hessekiel is a veteran legal professional with more than a decade of corporate and commercial experience specific to the biopharmaceutical industry, most of it gained in senior roles at Gilead Sciences.
- Net product revenue from COMETRIQ sales was $4.9 million for the first quarter of 2014.
- Entered into an amendment to the company's financing arrangement with Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P. (collectively, Deerfield) in January 2014 to provide the company with an option to extend to July 1, 2018 from July 1, 2015, the maturity date of the indebtedness incurred by the company under the financing arrangement.
- Completed an underwritten public offering of 10,000,000 shares of common stock in January 2014, raising net proceeds of approximately $75.6 million after deducting the underwriting discount and estimated offering expenses.
“For Exelixis, 2014 is a year focused on anticipated top-line results from four pivotal trials of cabozantinib and cobimetinib. Positive data from COMET-1 and COMET-2 could support future regulatory filings and help position cabozantinib as a differentiated treatment option for patients with mCRPC,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Concurrently, our partners Roche and Genentech, a member of the Roche Group, are advancing cobimetinib, an Exelixis-discovered MEK inhibitor that is under evaluation in a phase 3 pivotal trial with top-line results expected in 2014. We believe that, together, cabozantinib and cobimetinib have the potential to benefit a significant number of patients, and we look forward to the continued maturing datasets from studies exploring the use of these compounds as we progress through the year.”