- Estimated $38.3M - $39.3M in Rubraca®
sales for Q4 2019 and $142.0M-$143.0M for FY2019 consistent with
guidance
- Q4/FY2019 Operating Results call
planned for February 24, 2020
- sNDA for Rubraca in advanced prostate
cancer submitted in mid-November 2019
- Company to present at J.P. Morgan
Healthcare Conference on Monday, January 13
Clovis Oncology, Inc. (NASDAQ:CLVS) today announced its
preliminary, unaudited revenues for the fourth quarter and full
year ended December 31, 2019. 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:
- $38.3-$39.3M in Rubraca® product
revenues for the fourth quarter of 2019 compared to $37.6M for Q3
2019 and $30.4M for Q4 2018
- $142.0-$143.0M in Rubraca product
revenues for the FY2019 compared to $95.4M for FY2018
Clovis plans to discuss these results with investors this week
at the 38th Annual J.P. Morgan Healthcare Conference in San
Francisco.
“We are very pleased with our sales performance in the fourth
quarter and the momentum it provides us going into this
year,” said Patrick J. Mahaffy, CEO and President of Clovis
Oncology. “In mid-November 2019, we submitted the supplemental
New Drug Application (sNDA) for Rubraca in BRCA1/2-mutant
recurrent, metastatic castrate-resistant prostate cancer, and also
during the quarter announced the first reported human experience of
FAP-2286 and launched Rubraca in England and Italy. With this
progress, we are looking forward to an eventful 2020. Key
milestones include additional EU country ovarian cancer launches
for Rubraca, a potential U.S. Rubraca launch in prostate cancer,
initial data for lucitanib combination studies, and a planned IND
filing for FAP-2286 in the second half of the year.”
Clovis Oncology to Present at 38th Annual J.P.
Morgan Healthcare Conference on January 13, 2019
Clovis’ President and CEO, Patrick J. Mahaffy, will present at
the 38th Annual J.P. Morgan Healthcare Conference to be held at the
Westin St. Francis hotel in San Francisco on Monday, January 13 at
10:00 a.m. PT. A live webcast of the presentation and Q&A
session can be accessed through the investor relations section of
the Company’s website at clovisoncology.com. Following the live
presentations, replays of the webcasts will be available on the
Company’s website for 30 days.
Fourth Quarter and Full Year 2019 Financial Results Release
Planned for February 24, 2020
The Company plans to report financial results for the fourth
quarter and full year ended December 31, 2019 on Monday, February
24, 2020, after the close of the U.S. financial markets. Clovis’
senior management will host a conference call and live audio
webcast at 4:30 p.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 in ovarian cancer as well as several
additional solid tumor indications. Studies open for enrollment or
under consideration include ovarian, prostate, breast,
gastroesophageal, pancreatic, and lung cancers. 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.
In the EU, 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. This
expands rucaparib’s indication beyond its initial marketing
authorization in the EU granted in May 2018 and with this label
expansion, rucaparib is now available to patients regardless of
their BRCA mutation status. Rubraca is also approved in the EU 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
the EU.
About Lucitanib
Lucitanib is an oral, potent inhibitor of the tyrosine kinase
activity of 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 reverses this
immunosuppression and can augment response to immunotherapy.
Lucitanib is an unlicensed medical product.
About FAP-2286
FAP-2286 is a preclinical candidate discovered by 3B
Pharmaceuticals under investigation as a peptide-targeted
radionuclide therapy (PTRT) and imaging agent targeting fibroblast
activation protein alpha (FAP). FAP is highly expressed in many
epithelial cancers, including more than 90 percent of breast, lung,
colorectal and pancreatic carcinomas. Clovis will conduct the
global clinical trials and holds U.S. and global rights, excluding
Europe.
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 2019 revenue, and our expectations
for commercial launches, 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 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 2019, and
therefore our finalized and audited results and final analysis of
those results are not yet available. The preliminary expectations
regarding 2019 revenue, free drug 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, 2019 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/20200107005558/en/
Breanna Burkart303.625.5023bburkart@clovisoncology.comAnna
Sussman303.625.5022asussman@clovisoncology.com
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