Exelixis, Inc. (EXEL) reported fourth quarter 2013 net loss per share of 38 cents, in line with the Zacks Consensus Estimate, but wider than the year-ago loss of 28 cents per share.
Fourth quarter revenues were $4.3 million, down 44.9% from the year-ago quarter. Revenues missed the Zacks Consensus Estimate of $6 million.
Research and development (R&D) expenses increased 52.6% year over year to $49.6 million due to trial costs for COMET-1 and METEOR and start-up cost for the CELESTIAL study.
Selling, general and administrative (SG&A) expenses rose 38.8% year over year to $13.6 million. The rise was mainly driven by expenses relating to the company’s U.S. sales force and its European distribution partner for the sale of Cometriq.
2013 Details
Exelixis reported a 2013 loss of $1.33 per share, wider than the Zacks Consensus Estimate of a loss of $1.32 and the 2012 loss of 92 cents per share.
Full-year revenues were $31.3 million, missing the Zacks Consensus Estimate of $33 million. Revenues in 2012 were $47.5 million. Revenues fell in 2013 due to a decrease in contract and license revenues from collaboration agreements with Bristol-Myers Squibb Co. (BMY).
Pipeline Update
In Nov 2013, Exelixis completed enrolment in the phase III COMET-1 study, evaluating Cometriq versus prednisone for the treatment of patients with advanced metastatic castration-resistant prostate cancer (CRPC).
Exelixis obtained a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorisation Application (MAA) for Cometriq for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid cancer (MTC) in Dec 2013.
In Dec 2013, Exelixis commenced a phase II study comparing Cometriq plus abiraterone and prednisone versus abiraterone/prednisone in patients with CRPC who have bone metastases and have not been previously treated with chemotherapy.
2014 Guidance
Expenses are expected in the range of $250 million to $280 million and interest expenses are expected around $47 million. At the end of the year, Exelixis expects cash and cash equivalents, short- and long-term investments and short- and long-term restricted cash and investments to be greater than $200 million.
Exelixis is investigating Cometriq and cobimetinib in six studies. Cometriq is being evaluated in five pivotal studies for patients with prostate cancer, renal cancer, liver cancer and MTC.
For cobimetinib, Exelixis has a partnership with Roche (RHHBY). The candidate is in the pivotal coBRIM trial, in combination with Zelboraf, in first line patients with BRAF mutation-positive metastatic melanoma. Exelixis expects top-line data from four of these pivotal trials this year. Exelixis also plans to speed up enrollment of the METEOR study on Cometriq for the treatment of renal cancer. Thus, 2014 promises to be an eventful year for Exelixis.
Exelixis currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the biopharma sector may consider Endocyte Inc. (ECYT), which carries a Zacks Rank #1 (Strong Buy).
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