Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and year ended December 31, 2013.
Q4 2013 Highlights and Recent Events
- Completed enrollment in COMET-1, the phase 3 study of cabozantinib versus prednisone with the primary endpoint of overall survival in patients with advanced metastatic castration-resistant prostate cancer (CRPC). The study reached its enrollment target of 960 patients in September 2013 and the enrollment was closed in November 2013.
- Received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorization Application (MAA) for COMETRIQ® (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid cancer (MTC). The opinion is now being reviewed by the European Commission, which has the authority to approve medicines for the European Union.
- Initiated a phase 2 clinical trial comparing cabozantinib plus abiraterone and prednisone versus abiraterone/prednisone in patients with CRPC who have bone metastases and have not been previously treated with chemotherapy. The primary endpoint for the randomized, open-label trial is radiographic progression-free survival (PFS). The company believes that the results of this trial could provide important insight into the role that cabozantinib might play in earlier lines of therapy, including patients who have not yet received chemotherapy.
- 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.
- Reported net product revenue for COMETRIQ (cabozantinib) of $4.3 million in the fourth quarter of 2013.
- 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.
“We made significant progress in 2013 by launching COMETRIQ in MTC in the U.S. and substantially advancing our cabozantinib clinical development efforts by completing enrollment in COMET-1 and initiating pivotal trials in metastatic renal cell cancer (RCC) and advanced hepatocellular cancer (HCC). Building off that success, 2014 has the potential to be a transformational year in advancing our mission to help patients with cancer. We started the year with two internally-discovered compounds in six ongoing pivotal trials, with four of these trials expected to deliver top-line data in 2014,” said Michael M. Morrissey, Ph.D., the company’s president and chief executive officer. “These include the COMET-1 and COMET-2 trials for cabozantinib in metastatic CRPC, and a pivotal trial of cobimetinib conducted by Roche and Genentech in patients with malignant melanoma, in addition to the overall survival readout for EXAM in MTC. While we look forward to these results, we continue to advance the other components of our global clinical development program, which is focused on identifying additional opportunities for cabozantinib to expand its clinical and commercial potential.”