- 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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220110005355/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