- Estimated $43.0M - $43.5M in Rubraca® (rucaparib) global sales
for Q4 2020 and $164.2M - $164.7M for FY 2020
- Q4/FY 2020 Operating Results call planned for February 23,
2021
- Company to present at J.P. Morgan Healthcare Conference on
Tuesday, January 12
Clovis Oncology, Inc. (NASDAQ:CLVS) today announced its
preliminary, unaudited global product revenues for the fourth
quarter and full year ended December 31, 2020. 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:
- $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.
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,
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, and has additional
offices in the U.S. and Europe. Please visit 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. Examples of forward-looking
statements contained in this press release include, among others,
statements regarding our preliminary estimates of fourth quarter
and fiscal year 2020 revenue and cash, cash equivalents and
available for sale securities, and our expectations for our future
cash position, commencement of clinical trials, availability of
study data and submission of regulatory filings. 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 2020, and therefore our finalized
and audited results and final analysis of those results are not yet
available. The preliminary expectations regarding 2020 revenue and
year-end cash, cash equivalents and available for sale securities
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, 2020 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.
i Rettig WJ et al. Regulation and Heteromeric Structure of the
Fibroblast Activation Protein in Normal and Transformed Cells of
Mesenchymal and Neuroectodermal Origin. Cancer Res.
1993;53:3327–3335.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210111005446/en/
Breanna Burkart 303.625.5023 bburkart@clovisoncology.com Anna
Sussman 303.625.5022 asussman@clovisoncology.com
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Apr 2023 to Apr 2024