- Strong second quarter of launch for Rubraca® (rucaparib) in U.S. with $14.6M reported in net sales
- Positive topline data from the ARIEL3 study reported on June 19, 2017; presentation of full dataset confirmed at European Society for Medical Oncology 2017 Congress in Madrid
- Clovis plans to submit a supplemental New Drug Application (sNDA) for a second-line and later maintenance treatment indication before the end of October
- Rucaparib E.U. Marketing Authorization Application under review; establishing E.U. organization to support a potential European launch
- Broad clinical collaboration with Bristol-Myers Squibb to evaluate Rubraca in combination with Opdivo® (nivolumab) in several late-stage clinical trials in multiple tumor types; studies are expected to begin before the end of 2017
BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2017, and provided an update on the Company’s clinical development programs and regulatory outlook for the remainder of 2017.
“This is clearly an exciting time for our company, for PARP inhibitors generally, and for Rubraca specifically,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are actively preparing our supplemental New Drug Application for an all-comers population in the platinum-sensitive ovarian cancer second-line and later maintenance treatment setting based on the ARIEL3 data. We anticipate an opinion on our initial treatment indication in Europe by year-end 2017, and we are preparing our supplemental application in Europe in second-line maintenance treatment to be filed immediately upon receipt of a potential treatment approval, which is anticipated in early 2018. And finally, we are extremely enthusiastic about our clinical collaboration with Bristol-Myers Squibb to explore the combination of Opdivo and Rubraca in triple-negative breast, ovarian and prostate cancers, which could represent a potentially foundational therapy in these and other tumor types.”
Second Quarter 2017 Financial Results
Following the approval and launch of Rubraca on December 19, 2016, Clovis reported net product revenue for Rubraca of $14.6 million for the second quarter of 2017, compared to net product revenue of $7.0 million in the first quarter of 2017 for a total of $21.6 million for the first six months of 2017.
Clovis had $671.5 million in cash, cash equivalents and available-for-sale securities as of June 30, 2017. Cash used in operating activities was $69.1 million for the second quarter of 2017 and $149.5 million for the first half of 2017, compared with $68.0 million and $151.7 million for the comparable periods of 2016. Clovis had approximately 45.2 million shares of common stock outstanding as of June 30, 2017. In January 2017, the Company raised net proceeds of $221.2 million through an offering of 5.75 million shares of common stock and in June 2017, the Company raised net proceeds of $324.9 million through an offering of 3.92 million shares of common stock.
Clovis reported a net loss for the second quarter of 2017 of $175.4 million, or a net loss of $3.88 per share, and $233.8 million, or a net loss of $5.24 per share for the first half of 2017. Net loss was $129.3 million, or a net loss of $3.37 per share for the second quarter of 2016, and $212.7 million, or a net loss of $5.54 per share for the first half of 2016. The net loss for the quarter and six months ended June 30, 2017 included a charge of $117.0 million related to a legal settlement. The net loss for the quarter and six months ended June 30, 2016 included a charge of $104.5 million for the impairment of an intangible asset, a gain of $25.5 million for a reduction in fair value of contingent purchase consideration and a $29.2 million non-cash tax benefit related to lucitanib product rights recorded in 2013 in connection with the Company’s acquisition of Ethical Oncology Science S.p.A. The adjusted net loss excluding these items was $58.4 million or $1.29 per share for the second quarter and $116.8 million or $2.62 per share for the six months ended 2017 and $79.4 million or $2.07 per share for the second quarter and $162.8 million or $4.24 per share for the six months ended 2016. Net loss for the second quarter of 2017 included share-based compensation expense of $10.7 million and $19.6 million for the first half of 2017, compared to $9.5 million and $20.5 million for the comparable periods of 2016.
Research and development expenses totaled $33.1 million for the second quarter of 2017 and $65.6 million for the first half of 2017, compared to $67.7 million and $142.3 million for the comparable periods in 2016. The decrease year over year is primarily due to lower spending on rucaparib and rociletinib development activities and selling, general and administrative expenses related to the commercialization of Rubraca, which had been classified as research and development prior to FDA approval.
Selling, general and administrative expenses totaled $36.1 million for the second quarter of 2017 and $65.4 million for the first half of 2017, compared to $9.6 million and $19.4 million for the comparable periods in 2016. The increase year over year is primarily due to selling, general and administrative expenses related to the commercialization of Rubraca, which had been classified as research and development prior to FDA approval.
New Clinical Collaboration with Bristol-Myers Squibb
Earlier in the week, Clovis and Bristol-Myers Squibb announced a broad clinical collaboration to evaluate the combination of Opdivo and rucaparib in Phase 2 and pivotal Phase 3 clinical trials in multiple tumor types. The pivotal Phase 3 trials will evaluate rucaparib in combination with Opdivo, rucaparib as monotherapy and Opdivo as monotherapy in first-line maintenance treatment for advanced ovarian and advanced triple-negative breast cancers. The Phase 2 trial will evaluate Opdivo in combination with rucaparib and other compounds in metastatic castrate-resistant prostate cancer (mCRPC). These trials are anticipated to begin by the end of 2017. The planned multi-arm clinical trials will be conducted in the U.S., Europe and possibly additional countries. Clovis will be the study sponsor and conducting party for the ovarian cancer study, and Bristol-Myers Squibb will be the study sponsor and conducting party for the breast and prostate cancer studies. Specific terms of the agreement were not disclosed.
ARIEL3 Topline Results
On June 19, Clovis announced topline data from the confirmatory phase 3 ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival (PFS) by investigator review in each of the three populations studied. PFS was also improved in the rucaparib group compared with placebo by blinded independent central review (BICR), a key secondary endpoint.
ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) tumor BRCA mutant (tBRCAmut) patients, inclusive of germline and somatic mutations of BRCA; 2) HRD-positive patients, including BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity, or LOH-high patients; and, finally, 3) the intent-to-treat population, or all patients treated in ARIEL3.
Following is a table and a summary of the primary efficacy analyses and selected exploratory PFS endpoints per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by each of investigator review, which was the primary analysis of ARIEL3, and independent review (BICR), a key secondary endpoint of the study.
