On January 11, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported its preliminary, unaudited global product revenues for the fourth quarter and full year ended December 31, 2020 (Press release, Clovis Oncology, JAN 11, 2021, View Source [SID1234573792]). The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

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Unaudited preliminary results include:

$43.0M – $43.5M in estimated Rubraca global product revenues for the fourth quarter of 2020 compared to $38.8M for Q3 2020 and $39.3M for Q4 2019;
U.S. product revenues of approximately $36.3M – $36.7M and E.U. of $6.5M – $6.8M
Highest quarterly global and E.U. product revenues to date
$164.2M -$164.7M in estimated Rubraca product revenues for FY 2020 compared to $143.0M for FY 2019
Approximately $240M in cash and cash equivalents at December 31, 2020 which is expected to fund the Company’s operating plan into early 2023 based on current revenue and expense forecasts
Clovis plans to discuss these results with investors this week at the 39th Annual J.P. Morgan Healthcare Conference which is being held virtually January 10-14, 2021.

"We are pleased with our strong finish to a challenging year, including achieving record quarterly and annual sales," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We believe we have set the stage for an important year in 2021, as we seek to continue to grow Rubraca sales and advance our pipeline, including plans to report top-line ATHENA monotherapy data in the second half of the year, initiate a clinical development program for FAP-2286 in the first half of the year, and show initial efficacy data for the LIO-1 lucitanib and Opdivo combination trial at a medical meeting this year."

Clovis Oncology to Present at 39th Annual J.P. Morgan Healthcare Conference on January 12
Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12 at 4:30 p.m. ET. A live webcast of the presentation/Q&A session can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Approximately 24 hours following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

Fourth Quarter and Full Year 2020 Financial Results Release Planned for February 23
The Company plans to report financial results for the fourth quarter and full year ended December 31, 2020 on Tuesday, February 23, 2021, before the open of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company’s results in greater detail.

About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas.i Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey and Israel.

FAP-2286 is an unlicensed medical product.