Cancer-drug manufacturer Clovis Oncology Inc. is projecting revenues between $148.3 million and $148.9 million for the full 2021 fiscal year, a significant drop from $164.5 million in revenue the prior year.

Clovis expects Rubraca sales slip for full-year 2021

Estimated $35.5M - $36.1M in Rubraca® (rucaparib) global sales for Q4 2021 and $148.3M - $148.9M for FY 2021
Continuing impact on ovarian cancer diagnoses and treatments from COVID-19
Q4/FY 2021 Operating Results call planned for February 23, 2022
Company to present at J.P. Morgan Healthcare Conference on Wednesday, January 12
January 10, 2022 08:00 AM Eastern Standard Time
BOULDER, Colo.--( BUSINESS WIRE )-- Clovis Oncology , Inc. (NASDAQ:CLVS) today announced its preliminary, unaudited global product revenues for the fourth quarter and full year ended December 31, 2021. The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures. Unaudited preliminary results include:
$35.5M - $36.1M in estimated Rubraca global product revenues for the fourth quarter of 2021 compared to $37.9M for Q3 2021 and $43.3M for Q4 2020
US and Europe product revenues approximately $27.5M - $27.9M and $8.0M - $8.2M
$148.3M - $148.9M in estimated Rubraca product revenues for FY 2021 compared to $164.5M for FY 2020
Approximately $143.4M in cash and cash equivalents and $27.8M in available funding under the ATHENA financing at December 31, 2021
Net cash used in operating activities for the fourth quarter of 2021 approximately $41.1M to $41.7M, down approximately 10 to 11 percent from the prior quarter
Cash used in operating activities does not reflect approximately $9.7M provided to the Company under the ATHENA financing
Clovis plans to discuss these results with investors this week at the 40th Annual J.P. Morgan Healthcare Conference which is being held virtually January 9-13, 2022. “The ongoing COVID-19 pandemic and the consequent reduction in ovarian cancer diagnoses and treatments continue to impact Rubraca sales in both the US and Europe. Despite these continuing commercial headwinds, we anticipate 2022 will be the most significant year of clinical data readouts in the Company’s history,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “For Rubraca, we anticipate three Phase 3 readouts during the year: ATHENA-MONO as monotherapy in the first-line ovarian cancer maintenance treatment setting during Q1, TRITON3 in the second-line prostate cancer treatment setting for selected patients during Q2, and ATHENA-COMBO in combination with Opdivo in the first-line ovarian cancer maintenance treatment setting in the second half of 2022. In addition, for FAP-2286, we are actively enrolling the Phase 1 portion of LuMIERE and anticipate data presentations at nuclear medicine meetings during 2022. We and our investigators are extremely enthusiastic about this program and look forward to initiating the Phase 2 portion of the LuMIERE study later this year.”
Clovis Oncology to Present at 40th Annual J.P. Morgan Healthcare Conference on January 12
Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12 at 9:45 a.m. ET. A live audio webcast of the presentation/Q&A session, as well as the accompanying slide presentation, 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 up to 30 days. Fourth Quarter and Full Year 2021 Financial Results Release Planned for February 23
The Company plans to report financial results for the fourth quarter and full year ended December 31, 2021 on Wednesday, February 23, 2022, before the open of the US 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. Additionally, the Company filed today with the Securities and Exchange Commission a Current Report on Form 8-K that provides additional information about the Company’s financial performance, status of clinical trials, liquidity position and impact of COVID-19. About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in 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 US 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 US and Europe. About FAP-2286
FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel. FAP-2286 is an unlicensed medical product. About Targeted Radionuclide Therapy
Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as “theranostics.” Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds. About the LuMIERE Clinical Study
LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors. The Phase 1 portion of the LuMIERE study -is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types. About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the US, Europe, and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the US and Europe. Please visit www.clovisoncology.com for more information. To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, statements regarding our preliminary estimates of fourth quarter and fiscal year 2021 revenue, net loss and cash used in operating activities and cash and cash equivalents, commencement of clinical trials, availability of study data and submission of regulatory filings and expectations for our development programs. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the impacts of the COVID-19 pandemic and disruption related to efforts to mitigate its spread on our business, results of operations or financial condition, including impacts on the vendors or distribution channels in our supply chain, impacts on our contract manufacturers’ ability to continue to manufacture our products, impacts on our ability to continue our development activities, impacts on the conduct of our clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites or monitoring of data and impact on the ability and timing of our field personnel to conduct their activities with health care providers, the uncertainties inherent in the effect our future revenues or expenses may have on our cash position, the market potential of our approved drug, including the performance of our sales and marketing efforts and the success of competing drugs and therapeutic approaches, changes in gross-to-net or free drug provided through our patient assistance program, the availability of reimbursement and insurance coverage, the timing of availability of data from our clinical trials, the uncertainties inherent in actions or decisions by the FDA, the EMA or other regulatory authorities regarding whether to accept or approve drug applications that may be filed, including delays or denials of regulatory approvals, clearances or authorizations for applications, as well as their decisions regarding drug labeling, reimbursement and pricing. Furthermore, we are in the process of finalizing our financial results for the fourth quarter and fiscal year 2021, and therefore our finalized and audited results and final analysis of those results are not yet available. The preliminary expectations regarding 2021 revenue, net loss, cash used in operating activities and year-end cash and cash equivalents are subject to management’s review and actual results could differ from management’s expectations. The actual results are also subject to audit by our independent registered public accounting firm and no assurance is given by our independent registered public accounting firm on such preliminary expectations. You should not draw any conclusions as to any other financial results as of and for the year ended December 31, 2021 based on the foregoing estimates. These forward-looking statements speak only as of the date hereof. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K. Contacts

Clovis Oncology Announces Preliminary Financial Results for the Fourth Quarter and Full Year 2021

December 09, 2021 08:00 AM Eastern Standard Time
BOULDER, Colo.--( BUSINESS WIRE )--Clovis Oncology, Inc. (NASDAQ: CLVS) announced today’s presentation by Andrew D. Simmons, Ph.D., Clovis’ Senior Vice President, Translational Medicine, at the 3rd Targeted Radiopharmaceuticals Summit being held virtually December 7-9, 2021. Dr. Simmons’ presentation, titled “Innovations in Peptide Targeted Radionuclide Therapies (PTRT) to Target Fibroblast Activation Protein (FAP) in Solid Tumors”, reviews the Company’s preclinical data and describes the Phase 1/2 study currently enrolling for its targeted radiotherapy candidate FAP-2286, the first PTRT and imaging agent targeting FAP to enter clinical development and the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program. “Clinician enthusiasm for the potential of targeted radiopharmaceuticals, and in particular, FAP as a target, continues to increase, and we are committed to becoming a leader in this emerging field,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We look forward to sharing initial data from the ongoing Phase 1 LuMIERE study of our first targeted radiotherapy candidate FAP-2286, anticipated in 2022.”
Following Dr. Simmons’ presentation at 9:35am Eastern time, his slide presentation can be found at https://clovisoncology.com/pipeline/scientific-presentations/ with other recent Clovis-sponsored presentations, posters and supplemental information. For more information about FAP-2286, targeted radionuclide therapy, or Clovis’ TRT development program, please visit targetedradiotherapy.com . About FAP-2286
FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non-small cell lung, squamous head and neck cancers, and cancers of unknown primary. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel. FAP-2286 is an unlicensed medical product. About Targeted Radionuclide Therapy
Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as “theranostics.” Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds. About the LuMIERE Clinical Study
LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors (NCT04939610) . The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types. About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the U.S., Europe, and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information. To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, statements of our intentions and expectations for our development and discovery programs, including the timing and pace of pre-clinical development, plans for and expected timing and pace of clinical development, plans for additional applications of the FAP-2286 peptide, including potential indications, tumor types and combination trials, plans for presentation of data and regulatory plans with respect to FAP-2286. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in drug discovery and pre-clinical and clinical development, including the outcome of pre-clinical studies and clinical trials, whether initial results, findings or research will support future studies or development, whether future study results will be consistent with previous study findings or other results, including pre-clinical studies, results in named-patient or similar programs or clinical trials, whether additional studies not originally contemplated are determined to be necessary, the timing of initiation, enrollment and completion of planned studies and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission. Contacts

Clovis Oncology Highlights FAP-2286 Preclinical Data Presented at the Targeted Radiopharmaceuticals Summit

Disclosures: Harter reports grants from and/or a consultant role with AstraZeneca, Clovis Oncology, F. Hoffmann-La Roche, Genmab, GlaxoSmithKline, Immunogen, Medac Pharma, Merck, Stryker and ZaiLab and a data and safety monitoring board role with Sotio. Please see the study for all authors’ relevant financial disclosures. Chi reports consultant/advisory board roles with Apyx Medical Corporation and Biom’Up France, a speaker role with AstraZeneca, and stock or stock options in BioNTech SE, Moderna and Vertthermia Acquio Inc. Gardner reports no relevant financial disclosures. ADD TOPIC TO EMAIL ALERTS
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Cytoreductive surgery before chemotherapy led to significant and clinically meaningful OS and PFS benefits for women with recurrent ovarian cancer, according to a phase 3 study published in The New England Journal of Medicine. “The role of surgery in relapsed ovarian cancer has not been well defined,” Philipp Harter, MD, PhD, of the department of gynecology and gynecologic oncology at Kliniken Essen-Mitte in Germany, and colleagues wrote. “We initiated the Descriptive Evaluation of Preoperative Selection Criteria for Operability in Recurrent Ovarian Cancer (DESKTOP) series when the evidence consisted only of retrospective trials in heterogeneous populations that suggested a benefit of surgery in patients with platinum-sensitive relapsed disease.”
Data derived from Harter P, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2103294. The prospectively randomized DESKTOP III study included 407 women with recurrent ovarian cancer. As Healio previously reported , researchers randomly assigned women to second-line chemotherapy alone (n = 201; median age, 62.2 years) or secondary cytoreductive surgery followed by chemotherapy (n = 206; median age, 60.8 years). Median follow-up was 69.8 months. According to study results, 75.5% of women who underwent surgery had a complete resection. Median OS was 53.7 months in the surgery group vs. 46 months in the nonsurgical group (HR = 0.75; 95% CI, 0.59-0.96). Women who underwent surgery also had longer median PFS (18.4 months vs. 14 months; HR = 0.66; 95% CI, 0.54-0.82). Among women who achieved complete resection with surgery, researchers observed median OS of 61.9 months, whereas women who underwent surgery with incomplete resection had shorter median OS (27.7 months). “We practice in era of expanded molecular understanding of tumor biology and an ever-increasing opportunity for targeted therapy,” noted Ginger J. Gardner, MD, FACOG, surgeon and vice chair of hospital operations in the department of surgery, and Dennis S. Chi, MD, FACOG, FACS, surgeon, Ronald O. Perelman chair in gynecologic surgery, deputy chief of gynecology service and head of ovarian cancer surgery in the department of surgery, both at Memorial Sloan Kettering Cancer Center, in an editorial that accompanied the study. “If we truly seek to cure ovarian cancer, we need to bring our entire toolbox to the table,” they wrote. “We need to use precision in the selection of medical and surgical options — the right treatment for the right patient. We commend the authors, investigators and patients who participated in the DESKTOP III study for their roles in a high-quality trial in which personalized medicine does not just apply to medical therapy, but to surgical therapy as well. Now is the time to move toward a cure for ovarian cancer and to use all of our best talents to do it.”
References:

Cytoreductive surgery before chemotherapy benefits women with recurrent ovarian cancer

Cancer-drug manufacturer Clovis Oncology Inc. (NYSE: CLVS) reduced its research and development and administrative spending in the third quarter of 2021 as the company’s revenues have slipped, it says, because of the COVID-19 pandemic.

Clovis tightens belt as sales fall

ITM Isotopen Technologien Munchen

BOULDER , Colo. & MUNICH -- -- Clovis Oncology , Inc. and ITM Isotope Technologies Munich SE , a leading radiopharmaceutical biotech company , today announced the signing of a clinical supply agreement that provides Clovis Oncology , Inc. with ITM Isotope Technologies Munich SE 's therapeutic radioisotope no-carrier-added Lutetium-177 , EndolucinBeta ® , for use in the clinical development of FAP-2286 , Clovis Oncology , Inc. ' fibroblast activation protein - targeting therapeutic candidate .

Clovis Oncology and ITM Announce Lutetium-177 Clinical Supply Agreement

Bristol-Myers Squibb

The LIO-1 trial is sponsored by Clovis Oncology , Inc. as part of its broad clinical collaboration with Bristol Myers Squibb .

Clovis Oncology Announces First Patient Enrolled in the Phase 2 Portion of the LIO-1 Trial Evaluating the Combination of Lucitanib and Opdivo in Gynecologic Cancers

Konica Minolta

Clovis Oncology Inc. chose to perform retrospective BRCA testing with Konica Minolta , a high-quality genetics lab positioned to become a key player in the precision medicine space .

Ambry Genetics to Develop Custom Assays Targeted to Patients with Hereditary Ovarian Cancer

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Clovis Oncology is developing cancer treatments for certain patients who have metastatic pancreatic cancer, non-small cell lung cancer, and various solid tumors. The Company is focused on licensing or acquiring rights to oncology compounds in all stages of clinical development.

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Application Date	Grant Date	Title	Related Topics	Status
3/14/2018	11/20/2018	High dosage strength tablets of rucaparib	Dosage forms, Pharmaceutical industry, Fluoroarenes, Antineoplastic drugs, Drug delivery devices	Grant

Application Date	3/14/2018
Grant Date	11/20/2018
Title	High dosage strength tablets of rucaparib
Related Topics	Dosage forms, Pharmaceutical industry, Fluoroarenes, Antineoplastic drugs, Drug delivery devices
Status	Grant

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