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Clovis Oncology Announces Second Quarter 2019 Operating Results

8/1/2019

$33.0M in Rubraca® (rucaparib) net product revenue for Q2 2019 compared to $23.8M for Q2 2018 U.S. sales increased 3% sequentially in Q2 2019 over Q1 2019

Global net product revenue guidance of $137 million to $147 million provided for the full year 2019 Updated data from TRITON2 study of patients with BRCA-mutant mCRPC to be provided to FDA later this month; RECIST and PSA response rates consistent with those shown at ESMO 2018

TRITON2 data to be presented at ESMO 2019 in poster discussion session in late September Supplemental NDA for Rubraca in BRCA-mutant advanced prostate cancer on track for Q4 2019 Phase 1b/2 combination study of lucitanib with Rubraca now enrolling; dose-�nding cohort underway, expansion cohort to focus on advanced ovarian cancer

Phase 1b/2 combination study of lucitanib and Bristol Myers-Squibb's Opdivo now enrolling; dose-�nding cohort to be followed by expansion cohorts in advanced gynecologic cancers and other solid tumors New BMS-sponsored Phase 2 combination study of Opdivo and Yervoy with Rubraca for the treatment of advanced gastric cancer planned to initiate in Q4 2019

Cash burn to signi�cantly reduce in 2H 2019 and 2020 based on lower milestone and product supply costs and anticipated revenue growth; further supported by ATHENA clinical trial �nancing

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ:CLVS) reported �nancial 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. Maha�y, 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 combinationshave signi�cant 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 �rst half of 2019 was $66.1 million, as compared to net product revenue of $42.3 million for the �rst 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 �rst 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 �rst half of 2018. This represented $17.7 million in commercial value for the �rst half of 2019 compared to $13.4 million in the �rst 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 �rst half of 2019, compared with $110.2 million for Q2 2018 and $210.8 million for the �rst half of 2018. For the �rst half of 2019, total cash used included product supply costs of $42.5 million and a $15.75 million milestone payment to P�zer related to the second European product approval in Q1 2019. For the �rst half of 2018, total cash used included product supply costs of $76.1 million and milestone payments to P�zer 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 signi�cantly 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 �nancing.

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 �rst 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 �rst half of 2018. Net loss for Q2 and �rst 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 �rst 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

�atten, 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 �rst 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 �nancing with certain a�liates 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 �rst-line maintenance approval in advanced ovarian cancer. The �nancing 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 con�rmed objective response rate (ORR) by investigator assessment in 25 RECIST1/PCWG3** response-evaluable patients with a BRCA1/2 mutationand results by independent assessment were consistent. The median duration of response in these patients had not yet been reached. In addition, a 51 percent con�rmed prostate speci�c 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.

As a result of Rubraca's breakthrough therapy status, Clovis agreed to provide updates to FDA on Clovis' advanced prostate cancer development program on a regular basis. Later this month, Clovis intends to provide an update to FDA on the TRITON2 data for patients with BRCA-mutant mCRPC. These data will show RECIST and PSA response rates consistent with the data presented at ESMO 2018. Clovis will present the TRITON2 data in a poster discussion session at the European Society for Medical Oncology (ESMO) Annual Meeting in Barcelona in late September.

Clovis intends to �le the planned supplemental New Drug Application (sNDA) during the fourth quarter of 2019.

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Clovis Oncology Inc. published this content on 01 August 2019 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 August 2019 12:04:09 UTC