2019 AUG 14 (NewsRx) -- By a News Reporter-Staff News Editor at NewsRx Women’s Health Daily -- Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2019, and provided an update on Clovis’ clinical development programs and regulatory and commercial outlook for the second half of 2019.
“We continue to make progress in the second-line ovarian cancer maintenance indication in the U.S., and we look forward to the potential prostate indication in the U.S. and launches in additional EU countries to support top-line growth in 2020,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology. “In addition, we are extremely pleased to have begun our combination studies of lucitanib plus Rubraca and lucitanib plus Opdivo, and we look forward to sharing initial data from these studies at medical meetings next year. We believe these combinations have significant potential and in almost every case, will study unselected or all-comer populations.” Second Quarter 2019 Financial Results Clovis reported net product revenue for Rubraca of $33.0 million for Q2 2019, which included U.S. net product revenue of $32.7 million and ex-U.S. net product revenue of $0.3 million, compared to net product revenue for Q2 2018 of $23.8 million. U.S. net product revenue increased three percent sequentially from Q1 2019 to Q2 2019. Ex-US net product revenues were lower sequentially in Q2 2019 than Q1 2019, as initial launch stocking shipments were made in March and reported in Q1 product revenue. Clovis expects ex-U.S. net product revenues to increase in Q3 compared to Q2 2019.
Clovis expects global net product revenue to be in the range of $137 million to $147 million for the full year.
The supply of free drug distributed to eligible patients through the Rubraca patient assistance program for Q2 2019 was marginally higher at approximately 22 percent of the overall commercial supply, compared to 21 percent in Q1 2019 and lower than the 25 percent reported in Q2 2018. This represented $9.3 million in commercial value for Q2 2019 compared to $8.4 million in Q1 2019 and $7.9 million in Q2 2018.
Net product revenue for the first half of 2019 was $66.1 million, as compared to net product revenue of $42.3 million for the first half of 2018. The Rubraca label was expanded to include the broader and earlier-line maintenance treatment indication in the U.S. in April 2018 and in the EU in January 2019. For the first half of 2019, the supply of free drug distributed to eligible patients was an additional approximately 21 percent of the overall commercial supply compared to 24 percent in the first half of 2018. This represented $17.7 million in commercial value for the first half of 2019 compared to $13.4 million in the first half of 2018.
Clovis had $315.9 million in cash, cash equivalents and available-for-sale securities as of June 30, 2019. Cash used in operating activities was $98.9 million for Q2 2019 and $197.4 million for the first half of 2019, compared with $110.2 million for Q2 2018 and $210.8 million for the first half of 2018. For the first half of 2019, total cash used included product supply costs of $42.5 million and a $15.75 million milestone payment to Pfizer related to the second European product approval in Q1 2019. For the first half of 2018, total cash used included product supply costs of $76.1 million and milestone payments to Pfizer of $58.0 million in Q2 2018 related to U.S. product approvals in December 2016 and April 2018 and European product approval in May 2018.
The amount spent on product supply costs and milestone payments is expected to decrease substantially in the second half of 2019 and in 2020. These reduced costs, combined with anticipated net product revenue growth in the global ovarian indications and the potential U.S. prostate indication in 2020, will significantly reduce our cash burn in the second half of 2019 and 2020. This will be additionally supported by the quarterly cash payments provided by the ATHENA clinical trial financing.
Clovis reported a net loss for Q2 2019 of $120.4 million, or ($2.27) per share, and $206.9 million, or a net loss of ($3.91) per share for the first half of 2019. Net loss for Q2 2018 was $101.2 million, or ($1.94) per share, and $178.9 million, or a net loss of ($3.48) per share, for the first half of 2018. Net loss for Q2 and first half of 2019 included share-based compensation expense of $14.1 million and $27.8 million, compared to $14.9 million and $26.8 million for the comparable periods of 2018.
Research and development expenses totaled $70.7 million for Q2 2019 and $132.8 million for the first half of 2019, compared to $52.7 million and $96.3 million for the comparable periods in 2018. The increase is primarily due to higher research and development costs for rucaparib clinical trials. Clovis expects research and development costs to be higher for the full year 2019 compared to 2018. Thereafter, we expect research and development costs to flatten, and then trend lower in the following years, as the largest of the Clovis’ sponsored clinical trials near completion.
Selling, general and administrative expenses totaled $48.0 million for Q2 2019 and $95.8 million for the first half of 2019, compared to $44.9 million and $84.1 million for the comparable periods in 2018. The increase year over year is primarily due to higher selling, general and administrative expenses related to the commercialization of Rubraca in the U.S. and EU. Clovis also expects selling, general and administrative costs to be higher for the full year 2019 compared to 2018, however, these costs will continue to increase modestly as Clovis prepares for anticipated product launches in a greater number of countries outside of the U.S. and launch activities for the anticipated prostate indication approval in 2020.
In May 2019, Clovis entered into an agreement for up to $175.0 million in non-dilutive clinical trial financing with certain affiliates of TPG Sixth Street Partners to reimburse Clovis’ quarterly costs and expenses related to the ATHENA clinical trial. ATHENA is Clovis’ largest clinical trial, with a planned target enrollment of 1,000 patients across more than 270 sites in at least 25 countries. Clovis plans to borrow amounts required to reimburse actual costs and expenses incurred during each quarter, beginning in Q2 2019, and repayment is anticipated to begin in 2022, the approximate anticipated timing of a potential Rubraca first-line maintenance approval in advanced ovarian cancer. The financing is secured by Rubraca assets, and Clovis maintains worldwide rights to Rubraca. Rubraca in BRCA-mutant Advanced Prostate Cancer Initial data from Clovis’ ongoing TRITON studies of Rubraca in metastatic castrate-resistant prostate cancer (mCRPC) were presented at the ESMO 2018 Congress (European Society for Medical Oncology) in October 2018. The initial TRITON2 data showed a 44 percent confirmed objective response rate (ORR) by investigator assessment in 25 RECIST1/PCWG3* * response-evaluable patients with a BRCA1/2 mutation and results by independent assessment were consistent. The median duration of response in these patients had not yet been reached. In addition, a 51 percent confirmed prostate specific antigen (PSA) response rate was observed in 45 PSA response-evaluable patients with a BRCA1/2 mutation. Preliminary safety data for Rubraca in men with mCRPC were consistent with those observed in patients with ovarian cancer and other solid tumors.
The TRITON2 results were the basis for Breakthrough Therapy designation for Rubraca as a monotherapy treatment of adult patients with BRCA1/2 mutant mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy, which was granted on October 1, 2018 by the U.S. Food and Drug Administration (FDA). Both studies in the TRITON program, TRITON2 and TRITON3, continue to enroll patients.
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