Clovis posts net loss, plans new-drug application

BOULDER — Officials for Boulder pharmaceutical company Clovis Oncology on Thursday reported a 2015 net loss of $352.9 million, and also said the company is planning to submit a new-drug application for cancer drug rucaparib to the U.S. Food and Drug Administration sometime during the second quarter of this year.

Clovis’ loss amounted to $9.79 per share as the company works toward gaining FDA approval for a pair of its cancer drugs this year.

The FDA is expected to make a decision on lung cancer drug rociletinib by the end of June. In addition to the upcoming NDA for the use of rucaparib in the treatment of ovarian cancer, the company also is planning to initiate a study of that drug in the second half of this year looking at its use in the treatment of prostate cancer.

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If approved, rociletinib would be the first drug to market for Clovis.

“2016 has the potential to be a very transformational year for Clovis,” chief executive Patrick Mahaffy said in the company’s earnings report. “Our U.S. commercial and medical affairs organizations are in place as we work toward the potential launch of two oncology drugs in the U.S. within the next 12 months.”

Clovis, which had no revenue for 2015, reported a fourth-quarter net loss of $119.5 million, or $3.12 per share. The company finished the year with $528.6 million in cash, cash equivalents and available-for-sale securities. Research and development expenses for the fourth quarter totaled $76 million, and $269.3 million for the year. That’s compared with $50.1 million and $137.7 million, respectively, for the fourth quarter and full year 2014.

Thursday’s earnings report came after markets closed.

Despite the company’s optimism surrounding the New Drug Applications, Clovis has seen its share price languish since November when the firm announced the FDA had requested more clinical data on rociletinib. That request caused the goal date for a decision on the drug to be pushed back from March to June, and caused Clovis’ stock price to plunge from a closing price of $99.43 on Nov. 13 to a close of $30.24 the following Monday.

Clovis shares sank 79 cents on Thursday to close at $17.29, not far off their 52-week low.