- Rubraca® (rucaparib) net product revenue totaled $143.0M for
2019 and $39.3M for Q4 2019
- Net product revenue for 2019 up 50% over 2018
- 46% reduction in net cash utilized in 2H 2019 compared to 1H
2019
- $296.7M in cash, cash equivalents and available for sale
securities at December 31, 2019; continue to anticipate cash runway
into 2H 2021
- Transaction in January 2020 reduced outstanding convertible
debt at year-end 2019 by $123.4M
- Supplemental NDA for Rubraca in patients with BRCA1/2-mutant
recurrent, metastatic castrate-resistant prostate cancer granted
Priority Review by FDA with PDUFA date of May 15, 2020
- Lucitanib combination studies enrolling; initial data
anticipated at medical meetings in 2020
- Acquired rights to FAP-2286, a radiopharmaceutical therapy
targeting FAP; plan to submit an IND in 2H 2020
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter and year ended December 31, 2019, and provided an
update on Clovis’ clinical development programs and regulatory and
commercial outlook for 2020.
“This is an encouraging time for Clovis, as we launch Rubraca in
multiple European countries in the recurrent ovarian cancer
maintenance indication and prepare for a potential U.S. approval
and launch of Rubraca in patients with BRCA1/2-mutant recurrent,
metastatic castrate-resistant prostate cancer,” said Patrick J.
Mahaffy, CEO and President of Clovis Oncology. “We also look
forward to initial clinical data from lucitanib combination studies
later this year, and initiating clinical development with FAP-2286,
our peptide-targeted radiopharmaceutical therapy product candidate.
This program, as well as our ongoing discovery collaboration with
3B Pharmaceuticals, provides us an exciting opportunity to be a
leader in an important new area of oncology drug development.”
Fourth Quarter and Year-End 2019 Financial Results
Clovis reported net product revenue for Rubraca of $39.3 million
for Q4 2019, which included U.S. net product revenue of $36.1
million and ex-U.S. net product revenue of $3.2 million. This
represents a five percent increase sequentially and 30 percent year
over year compared to net product revenues for Q3 2019 and Q4 2018
of $37.6 million and $30.4 million, respectively. U.S. net product
revenues were in line with the $36.5 million reported in Q3 2019
and ex-U.S. net product revenues increased $2.1 million over Q3
2019.
The supply of free drug distributed to eligible patients in the
U.S. through the Rubraca patient assistance program for Q4 2019 was
18 percent of the overall U.S. commercial supply, compared to 20
percent in Q3 2019 and 26 percent reported in Q4 2018. This
represented $8.0 million in commercial value for Q4 2019 compared
to $9.0 million in Q3 2019 and $10.4 million in Q4 2018.
Net product revenue for 2019 was $143.0 million, which included
$137.2 million in the U.S. and $5.8 million in ex- U.S. product
revenues, respectively. This represents a 50 percent increase
year-over-year compared to net product revenue of $95.4 million in
2018, all of which were in the U.S. For the full year ended
December 31, 2019 the supply of free drug distributed to eligible
patients was approximately 20 percent of the overall U.S.
commercial supply compared to 26 percent in 2018. This represented
$34.8 million in commercial value for the full year 2019, compared
to $33.4 million for 2018.
Clovis had $296.7 million in cash, cash equivalents and
available-for-sale securities as of December 31, 2019.
In August 2019, Clovis repurchased $190.3 million aggregate
principal amount of its 2.50% convertible senior notes due 2021.
Approximately $97.2 million aggregate principal amount of these
notes remain outstanding.
In January 2020, Clovis repurchased $123.4 million aggregate
principal amount of its 4.50% convertible senior notes due 2024
that were initially issued in August 2019. This transaction will
save $28 million in cash on interest payments under the notes
issued in August 2019, and approximately $140.0 million aggregate
principal amount of these notes remain outstanding. Additionally,
the Company has $300 million aggregate principal amount outstanding
of its 1.25% convertible senior notes due 2025.
As of December 31, 2019, the Company had drawn approximately $35
million under the TPG ATHENA clinical trial financing and had up to
$140 million available to draw under the agreement to fund the
expenses of the ATHENA trial through Q3 2022.
Based on the Company’s anticipated revenues, spending, available
financing sources and existing cash, cash equivalents and
available-for-sale securities, the Company believes it has
sufficient cash, cash equivalents and available-for-sale securities
to fund its operating plan into the second half of 2021. This does
not include any cash repayment that may be required to pay off
(unless refinanced earlier) the remaining $97.2 million aggregate
principal amount of the 2.50% convertible notes due 2021, at their
maturity in September 2021.
Net cash used in operating activities was $70.1 million for Q4
2019 and $323.6 million for the full year 2019, compared with $82.7
million and $366.0 million for the comparable periods in 2018.
Borrowings under the TPG ATHENA financing provided $13.8 million in
Q4 2019, reducing net cash utilized in operating activities to
$56.3 million in Q4 2019. Net cash used in operating activities for
Q4 2019 included an upfront payment of $9.4 million to 3B
Pharmaceuticals related to the in-licensing of FAP-2286.
Net cash used in operating activities was $127.1 million for the
second half of 2019, and $196.5 million for the first half of 2019,
a reduction of $69.4 million or 35 percent. In addition, borrowings
under the TPG ATHENA financing provided $8.6 million in the first
half and $26.0 million in the second half of 2019, reducing net
cash utilized in operating activities by $86.8 million, or 46
percent, from the first half to second half of 2019.
Clovis reported a net loss for Q4 2019 of $99.5 million, or
($1.81) per share, and $400.4 million, or a net loss of ($7.43) per
share for the full year 2019. Net loss for Q4 2018 was $99.3
million, or ($1.88) per share, and $368.0 million, or a net loss of
($7.07) per share, for the full year 2018. Net loss for Q4 and the
full year 2019 included share-based compensation expense of $12.6
million and $54.3 million, compared to $11.4 million and $49.1
million for the comparable periods of 2018.
Research and development expenses totaled $72.5 million for Q4
2019 and $283.1 million for the full year 2019, compared to $71.2
million and $231.3 million for the comparable periods in 2018. The
increase for the full year is primarily due to higher research and
development costs for rucaparib clinical trials.
Selling, general and administrative expenses totaled $45.2
million for Q4 2019 and $182.8 million for the full year 2019,
compared to $49.1 million and $175.8 million for the comparable
periods in 2018. Selling, general and administrative expenses
increased for the full year due to commercialization activities for
Rubraca including increased costs associated with building out the
European commercial infrastructure.
European Launch of Rubraca in Ovarian Cancer
In January 2019, the European Commission granted a variation to
the marketing authorization for Rubraca to include 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. Following
successful reimbursement negotiations in each country, commercial
launches of Rubraca are underway in each of Germany, England, Italy
and France and planned in Spain shortly.
U.S. Supplemental New Drug Application for Rubraca in
BRCA1/2-mutant Advanced Prostate Cancer
In November 2019, Clovis submitted the planned supplemental New
Drug Application (sNDA) for Rubraca as a monotherapy treatment of
adult patients with BRCA1/2-mutant recurrent, metastatic
castrate-resistant prostate cancer to the Food and Drug
Administration (FDA). The sNDA filing was based on data from the
TRITON clinical program in advanced prostate cancer. In January
2020, Clovis announced that the FDA accepted the Company’s sNDA for
Rubraca and granted priority review status to the application with
a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020.
Conference Call Details
Clovis will hold a conference call to discuss Q4/FY 2019 results
this afternoon, February 24, at 4:30pm ET. The conference call will
be simultaneously webcast on the Clovis Oncology web site
www.clovisoncology.com, and archived for future review. Dial-in
numbers for the conference call are as follows: US participants
(866) 393-4306, International participants (734) 385-2616,
conference ID: 1255036.
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 is planning to submit
an investigational new drug application (IND) for FAP-2286 in the
second half of 2020. 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 second 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. Examples of forward-looking
statements contained in this press release include, among others,
statements regarding our future financial and operating
performance, business plans or prospects, including expectations
concerning our future cash position, our plans for commercial
launch in expanded indications in the United States, our plans for
commercial launch in additional countries, expectations for
submission of regulatory filings, our plans to present final or
interim data on ongoing clinical trials, our plans to submit
additional data to, or meet with, the FDA with respect to the
status of or plans for ongoing or planned trials, the timing and
pace of commencement of enrollment in and conduct of our clinical
trials and the cost of certain trials, including those being
considered, planned or conducted in collaboration with partners,
our plans for commencement of additional planned trials, the
potential results of such clinical trials, changes in drug supply
timing and costs and other expenses and statements regarding our
expectations of the supply of free drug distributed to eligible
patients and our expectations regarding the funding that may be
available to us under the agreement with TPG Sixth Street Partners.
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 the effect our
future revenues 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 performance of our
third-party manufacturers, whether our clinical development
programs for our drug candidates and those of our partners can be
completed on time or at all, whether future study results will be
consistent with study findings to date and whether future study
results will support continued development or regulatory approval,
the corresponding development pathways of our companion
diagnostics, the timing of availability of data from our clinical
trials and the results, the initiation, enrollment, timing and
results of our planned clinical trials, the risk that final results
of ongoing trials may differ from initial or interim results as a
result of factors such as final results from a larger patient
population may be different from initial or interim results from a
smaller patient population, actions by the FDA, the EMA or other
regulatory authorities regarding data required to support drug
applications and whether to accept or approve drug applications
that may be filed, their interpretations of our data and agreement
with our regulatory approval strategies or components of our
filings, including our clinical trial designs, conduct and
methodologies, as well as their decisions regarding drug labeling,
reimbursement and pricing, and other matters that could affect the
development, approval, availability or commercial potential of our
drug candidates or companion diagnostics. 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.
CLOVIS ONCOLOGY, INC CONSOLIDATED FINANCIAL
RESULTS (Unaudited, in thousands, except per share amounts)
Three Months Ended December 31, Twelve Months
Ended December 31,
2019
2018
2019
2018
Revenues: Product revenue, net
$
39,307
$
30,351
$
143,006
$
95,388
Operating expenses: Cost of sales - product
7,942
6,182
29,926
19,444
Cost of sales - intangible asset amortization
1,211
778
4,760
2,630
Research and development
72,473
71,210
283,146
231,347
Selling, general and administrative
45,168
49,148
182,769
175,781
Acquired in-process research and development
-
-
9,440
-
Other operating expenses
4,172
-
9,711
-
Total expenses
130,966
127,318
519,752
429,202
Operating loss
(91,659
)
(96,967
)
(376,746
)
(333,814
)
Other income (expense): Interest expense
(6,720
)
(3,591
)
(19,405
)
(13,183
)
Foreign currency gain (loss)
100
(312
)
(547
)
(346
)
Legal settlement loss
-
-
(26,750
)
(27,975
)
Gain on extinguishment of debt
-
-
18,480
-
Other income
1,262
2,497
6,342
7,917
Other income (expense), net
(5,358
)
(1,406
)
(21,880
)
(33,587
)
Loss before income taxes
(97,017
)
(98,373
)
(398,626
)
(367,401
)
Income tax expense
(2,484
)
(888
)
(1,798
)
(608
)
Net loss
$
(99,501
)
$
(99,261
)
$
(400,424
)
$
(368,009
)
Basic and diluted net loss per common share
$
(1.81
)
$
(1.88
)
$
(7.43
)
$
(7.07
)
Basic and diluted weighted-average common shares outstanding
54,834
52,724
53,873
52,066
CONSOLIDATED BALANCE SHEET DATA (Unaudited, in
thousands)
December 31, 2019 December 31, 2018
Cash and cash equivalents
$
161,833
$
221,876
Available-for-sale securities
134,826
298,270
Working capital
233,384
446,550
Total assets
669,604
863,560
Convertible senior notes
644,751
575,470
Common stock and additional paid-in capital
2,114,123
2,034,195
Total stockholders' (deficit) equity
(174,257
)
146,469
Other Data (Unaudited, in thousands)
Twelve
Months Ended December 31,
2019
2018
Net cash used in operating activities
(323,615
)
(365,997
)
Share Based Compensation Expense
54,304
49,090
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200224005881/en/
Breanna Burkart 303.625.5023 bburkart@clovisoncology.com
Anna Sussman 303.625.5022 asussman@clovisoncology.com
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