Clovis Oncology Announces Third Quarter 2019 Operating Results

-Clovis Oncology, Inc. reported financial results for the quarter ended September 30, 2019, and provided an update on Clovis’ clinical development programs and regulatory and commercial outlook for the remainder of 2019.

“We are extremely pleased with our progress made on all fronts during the third quarter. We reported encouraging quarter-over-quarter revenue growth in the U.S. and in October launched in England with reimbursement now provided via the Cancer Drugs Fund,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology. “The TRITON2 prostate data presented at ESMO were very encouraging, and we remain on track to file the supplemental New Drug Application for patients with a BRCA1/2 mutation in advanced prostate cancer before year-end. We are pleased that the lucitanib combination studies are now enrolling patients, in particular the combination with nivolumab. And finally, we look forward to providing updates for FAP-2286, our recently-licensed FAP-targeted radiopharmaceutical compound, as we move this preclinical candidate forward.”

Third Quarter 2019 Financial Results

Clovis reported net product revenue for Rubraca of $37.6 million for Q3 2019, which included U.S. net product revenue of $36.5 million and ex-U.S. net product revenue of $1.1 million, compared to net product revenue for Q3 2018 of $22.8 million. Total revenue increased 14 percent sequentially from Q2 2019 to Q3 2019, including a 12 percent increase in U.S. revenues.

Clovis now expects global net product revenue to be in the range of $141 million to $147 million for the full year 2019.

The supply of free drug distributed to eligible patients through the Rubraca patient assistance program for Q3 2019 was lower at 20 percent of the overall commercial supply, compared to 22 percent in Q2 2019 and 30 percent reported in Q3 2018. This represented $9.0 million in commercial value for Q3 2019 compared to $9.6 million in Q3 2018.

Net product revenue for the first nine months of 2019 was $103.7 million, as compared to net product revenue of $65.0 million for the first nine months of 2018. For the nine-month period ended September 30, 2019 the supply of free drug distributed to eligible patients was an additional approximately 21 percent of the overall commercial supply compared to 26 percent in the first nine months of 2018. This represented $26.7 million in commercial value for the nine months ended September 30, 2019, compared to $23.0 million in the comparable period in 2018.

Clovis had $354.1 million in cash, cash equivalents and available-for-sale securities as of September 30, 2019. In August 2019, Clovis completed a private placement sale of $263.0 million aggregate principal amount of 4.50 percent convertible senior notes due 2024. The net proceeds from the offering were $255.0 million, after deducting underwriting discounts and commissions, and offering expenses. A portion of the proceeds, totaling $171.8 million, were used to repurchase $190.3 million of par value of convertible senior notes due 2021, with the remainder of $83.2 million to be used for general corporate purposes. As of September 30, 2019, the Company also had up to $154 million remaining to draw under the TPG ATHENA clinical trial financing agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the Company’s anticipated revenues, spending, available financing sources and existing cash, cash equivalents and available-for-sale securities, the Company believes it has sufficient cash, cash equivalents and available-for-sale securities to fund its operating plan into the second half of 2021. This does not include any cash repayment that may be required to pay off (unless refinanced earlier) the remaining $97 million principal amount of convertible notes at their maturity due September 2021.

Cash used in operating activities was $57.0 million for Q3 2019 and $253.5 million for the first nine months of 2019, compared with $72.5 million for Q3 2018 and $283.3 million for the comparable period in 2018. Cash used in operations decreased year over year for Q3 2019 and the first nine months of 2019 and dropped 42 percent sequentially from $98.0 million in Q2 2019 to $57.0 million in Q3 2019. The TPG ATHENA financing provided $12.2 million in cash in Q3 2019, resulting in a net cash reduction in Q3 2019 of $44.8 million. For the first nine months of 2019, total cash used included product supply costs of $42.5 million and a $15.75 million milestone payment to Pfizer and for the comparable period in 2018, total cash used included product supply costs of $76.1 million and milestone payments to Pfizer of $58.0 million.

Clovis reported a net loss for Q3 2019 of $94.1 million, or ($1.72) per share, and $300.9 million, or a net loss of ($5.62) per share for the first nine months of 2019. Net loss for Q3 2018 was $89.9 million, or ($1.71) per share, and $268.8 million, or a net loss of ($5.18) per share, for the comparable period in 2018. Net loss for Q3 and the first nine months of 2019 included share-based compensation expense of $14.0 million and $41.7 million, compared to $10.9 million and $37.7 million for the comparable periods of 2018.

Research and development expenses totaled $77.9 million for Q3 2019 and $210.7 million for the first nine months of 2019, compared to $63.9 million and $160.1 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 trend lower for the full year starting in 2020 and in the following years, compared to 2019, as the largest of the Clovis-sponsored clinical trials near completion and as the Company reduces spending related to clinical programs and other activities.

Selling, general and administrative expenses totaled $41.8 million for Q3 2019 and $137.6 million for the first nine months of 2019, compared to $42.5 million and $126.6 million for the comparable periods in 2018. Selling, general and administrative expenses decreased year over year for Q3 2019 and also sequentially by 13 percent, from $48.0 million in Q2 2019 to $41.8 million in Q3 2019 based on cost reduction efforts by the Company.-Business Wire