- $37.6M in Rubraca® (rucaparib) net product revenue for Q3 2019,
up 65% year over year
- Net product revenue increased 14% sequentially in Q3 2019
compared to Q2 2019, including sequential U.S. sales increase of
12%
- Increased FY2019 global net product revenue guidance to
$141M-$147M
- Q3 2019 operating cash burn reduced from Q2 2019 by 42%; net
cash burn reduced to $45M
- $354.1M in cash, cash equivalents and available for sale
securities at September 30, 2019; anticipated cash runway into 2H
2021
- Supplemental NDA for Rubraca in patients with BRCA1/2-mutant
advanced prostate cancer to be filed before year-end
- Lucitanib combination studies enrolling; initial data
anticipated at medical meetings beginning mid-2020
- Acquired rights to FAP-2286, radiopharmaceutical targeting FAP;
Clovis currently planning to file IND in 2H 2020
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended September 30, 2019, and provided an update on
Clovis’ clinical development programs and regulatory and commercial
outlook for the remainder of 2019.
“We are extremely pleased with our progress made on all fronts
during the third quarter. We reported encouraging
quarter-over-quarter revenue growth in the U.S. and in October
launched in England with reimbursement now provided via the Cancer
Drugs Fund,” said Patrick J. Mahaffy, CEO and President of Clovis
Oncology. “The TRITON2 prostate data presented at ESMO were very
encouraging, and we remain on track to file the supplemental New
Drug Application for patients with a BRCA1/2 mutation in advanced
prostate cancer before year-end. We are pleased that the lucitanib
combination studies are now enrolling patients, in particular the
combination with nivolumab. And finally, we look forward to
providing updates for FAP-2286, our recently-licensed FAP-targeted
radiopharmaceutical compound, as we move this preclinical candidate
forward.”
Third Quarter 2019 Financial Results
Clovis reported net product revenue for Rubraca of $37.6 million
for Q3 2019, which included U.S. net product revenue of $36.5
million and ex-U.S. net product revenue of $1.1 million, compared
to net product revenue for Q3 2018 of $22.8 million. Total revenue
increased 14 percent sequentially from Q2 2019 to Q3 2019,
including a 12 percent increase in U.S. revenues.
Clovis now expects global net product revenue to be in the range
of $141 million to $147 million for the full year 2019.
The supply of free drug distributed to eligible patients through
the Rubraca patient assistance program for Q3 2019 was lower at 20
percent of the overall commercial supply, compared to 22 percent in
Q2 2019 and 30 percent reported in Q3 2018. This represented $9.0
million in commercial value for Q3 2019 compared to $9.6 million in
Q3 2018.
Net product revenue for the first nine months of 2019 was $103.7
million, as compared to net product revenue of $65.0 million for
the first nine months of 2018. For the nine-month period ended
September 30, 2019 the supply of free drug distributed to eligible
patients was an additional approximately 21 percent of the overall
commercial supply compared to 26 percent in the first nine months
of 2018. This represented $26.7 million in commercial value for the
nine months ended September 30, 2019, compared to $23.0 million in
the comparable period in 2018.
Clovis had $354.1 million in cash, cash equivalents and
available-for-sale securities as of September 30, 2019. In August
2019, Clovis completed a private placement sale of $263.0 million
aggregate principal amount of 4.50 percent convertible senior notes
due 2024. The net proceeds from the offering were $255.0 million,
after deducting underwriting discounts and commissions, and
offering expenses. A portion of the proceeds, totaling $171.8
million, were used to repurchase $190.3 million of par value of
convertible senior notes due 2021, with the remainder of $83.2
million to be used for general corporate purposes. As of September
30, 2019, the Company also had up to $154 million remaining to draw
under the TPG ATHENA clinical trial financing 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 million principal
amount of convertible notes at their maturity due September
2021.
Cash used in operating activities was $57.0 million for Q3 2019
and $253.5 million for the first nine months of 2019, compared with
$72.5 million for Q3 2018 and $283.3 million for the comparable
period in 2018. Cash used in operations decreased year over year
for Q3 2019 and the first nine months of 2019 and dropped 42
percent sequentially from $98.0 million in Q2 2019 to $57.0 million
in Q3 2019. The TPG ATHENA financing provided $12.2 million in cash
in Q3 2019, resulting in a net cash reduction in Q3 2019 of $44.8
million. For the first nine months of 2019, total cash used
included product supply costs of $42.5 million and a $15.75 million
milestone payment to Pfizer and for the comparable period in 2018,
total cash used included product supply costs of $76.1 million and
milestone payments to Pfizer of $58.0 million.
Clovis reported a net loss for Q3 2019 of $94.1 million, or
($1.72) per share, and $300.9 million, or a net loss of ($5.62) per
share for the first nine months of 2019. Net loss for Q3 2018 was
$89.9 million, or ($1.71) per share, and $268.8 million, or a net
loss of ($5.18) per share, for the comparable period in 2018. Net
loss for Q3 and the first nine months of 2019 included share-based
compensation expense of $14.0 million and $41.7 million, compared
to $10.9 million and $37.7 million for the comparable periods of
2018.
Research and development expenses totaled $77.9 million for Q3
2019 and $210.7 million for the first nine months of 2019, compared
to $63.9 million and $160.1 million for the comparable periods in
2018. The increase is primarily due to higher research and
development costs for rucaparib clinical trials.
Clovis expects research and development costs to trend lower for
the full year starting in 2020 and in the following years, compared
to 2019, as the largest of the Clovis-sponsored clinical trials
near completion and as the Company reduces spending related to
clinical programs and other activities.
Selling, general and administrative expenses totaled $41.8
million for Q3 2019 and $137.6 million for the first nine months of
2019, compared to $42.5 million and $126.6 million for the
comparable periods in 2018. Selling, general and administrative
expenses decreased year over year for Q3 2019 and also sequentially
by 13 percent, from $48.0 million in Q2 2019 to $41.8 million in Q3
2019 based on cost reduction efforts by the Company.
Rubraca in BRCA1/2-mutant Advanced Prostate Cancer
Updated data from Clovis’ ongoing TRITON2 study of Rubraca in
metastatic castrate-resistant prostate cancer (mCRPC) were
presented at the ESMO 2019 Congress (European Society for Medical
Oncology) in September 2019. The data showed a 43.9 percent
confirmed objective response rate (ORR) by investigator assessment
in 57 RECIST1/PCWG32 response-evaluable patients with a BRCA1/2
mutation. When assessed by independent radiological review, which
is the primary endpoint of the trial, the response rate was
consistent (40.4 percent). In addition, a 52.0 percent confirmed
prostate-specific antigen (PSA) response rate was observed in 98
response-evaluable patients with a BRCA1/2 mutation. Confirmed
radiographic responses were durable, with 60 percent lasting 24
weeks or longer (15/25). The safety data for Rubraca in men with
mCRPC were consistent with prior reports from TRITON2 and for
patients with ovarian cancer and other solid tumors.
The TRITON2 data presented at ESMO 2019 will be included in the
filing of Clovis Oncology’s planned supplemental NDA (sNDA) to the
Food and Drug Administration (FDA) for Rubraca in BRCA1/2-mutant
advanced prostate cancer, although the sNDA data set will also
include additional patients, and additional data maturity on the
patients reported at ESMO 2019. Clovis intends to file the planned
sNDA for Rubraca in patients with BRCA1/2-mutant advanced prostate
cancer by the end of 2019.
Rubraca Clinical Development
Clovis has a robust clinical development program underway in
multiple tumor types, including Clovis-sponsored, partner-sponsored
and investigator-initiated trials. The following Clovis-sponsored
clinical studies are open for enrollment or are anticipated to open
during the next several months:
- ARIEL4, a confirmatory study in the ovarian cancer treatment
setting, is a Phase 3 multicenter, randomized study of Rubraca
versus chemotherapy in relapsed ovarian cancer patients with BRCA
mutations whose tumors have progressed on two prior lines of
therapy. This study is currently enrolling patients.
- ATHENA is a Phase 3 study in advanced ovarian cancer in the
first-line maintenance treatment setting evaluating Rubraca plus
Opdivo® (PD-1 inhibitor), Rubraca, Opdivo and placebo in
newly-diagnosed patients who have completed platinum-based
chemotherapy. This study, as part of a broad clinical collaboration
with Bristol-Myers Squibb, is currently enrolling patients.
- TRITON3 is a Phase 3 comparative study in mCRPCenrolling
BRCA-mutant and ATM-mutant (both inclusive of germline and somatic)
patients whose tumors have progressed on androgen-receptor
(AR)-targeted therapy and who have not yet received chemotherapy in
the castration-resistant setting. TRITON3 compares Rubraca to
physician’s choice of AR-targeted therapy or chemotherapy in these
patients. This study is currently enrolling patients.
- TRITON2 is a Phase 2 single-arm study in mCRPC in patients with
BRCA mutations (inclusive of germline and somatic), which is also
enrolling patients with deleterious mutations of other homologous
recombination (HR) repair genes. All patients received one previous
line of taxane-based chemotherapy and one or two lines of
AR-targeted therapy. This study is currently enrolling
patients.
- SEASTAR is a Phase 1b/2 study comprised of multiple single-arm
rucaparib combination studies, which currently includes the
following planned combinations:
- Rubraca and lucitanib, Clovis’ investigational inhibitor of
multiple tyrosine kinases including VEGFR, for the treatment of
ovarian cancer, is currently enrolling patients with locally
advanced or metastatic solid tumors into the Phase 1b portion;
- Rubraca and sacituzumab govitecan, an antibody drug conjugate,
for the treatment of advanced metastatic triple-negative breast
cancer, relapsed platinum-resistant ovarian cancer and advanced
metastatic urothelial cancers, is enrolling patients with solid
tumors into the Phase 1b portion;
- And a planned Phase 2 pan-tumor study in patients with solid
tumors associated with deleterious mutations in homologous
recombination repair genes, which is expected to begin by year-end
2019 or early 2020.
Also, two additional Phase 2 combination studies sponsored by
Bristol-Myers Squibb are underway or expected to initiate in the
near-term:
- The combination of Opdivo with Rubraca for the treatment of
mCRPC is being conducted as an arm in the CHECKMATE 9KD prostate
cancer study, and is currently enrolling patients;
- The combination study of Opdivo and Yervoy with Rubraca for the
treatment of advanced gastric cancer is being conducted as an arm
of the FRACTION advanced gastric cancer study and is planned to
initiate in early 2020.
Lucitanib Clinical Development
Lucitanib is an investigational, 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). Clovis has global rights
(excluding China) for lucitanib.
Recent data for a drug that inhibits these same three pathways -
when combined with a PD-1 inhibitor - are extremely encouraging and
represent a scientific rationale for the development of lucitanib
in combination with a PD-1 inhibitor, and a Clovis-sponsored study
of lucitanib in combination with Opdivo is underway in advanced
gynecologic cancers and other solid tumors. Based on encouraging
data of VEGF and PARP inhibitors in combination, a study of
lucitanib in combination with rucaparib in advanced ovarian cancer
is also underway as an arm of the SEASTAR study. Each of these
Phase 1b/2 studies is currently enrolling patients, and initial
data are anticipated at medical meetings beginning in mid-2020.
In addition, a Phase 1/2 combination study sponsored by
Bristol-Myers Squibb will evaluate multiple combinations with
Opdivo, including an arm in combination with lucitanib, in patients
with stage IV non-small cell lung cancer that has spread or
reoccurred after failure of chemotherapy and immunotherapy. This
study is expected to start by the end of the year.
Newly-Licensed Peptide-Targeted Radionuclide Therapy Program,
including FAP-2286
In September 2019, Clovis and 3B Pharmaceuticals GmbH (3BP)
entered into a global licensing and collaboration agreement with an
initial focus on developing FAP-2286, 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 global
clinical trials and has obtained U.S. and global rights, excluding
Europe (inclusive of Russia, Turkey and Israel), where 3BP retains
rights. The parties have also agreed to collaborate on a discovery
program directed at three additional targets for radionuclide
therapy, to which Clovis will have global rights.
Clovis currently plans to file an Investigational New Drug (IND)
application for FAP-2286 in the second half of 2020.
Conference Call Details
Clovis will hold a conference call to discuss Q3 2019 results
this morning, November 7, at 8:30am 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: 5045559.
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 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 file 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 continued revenue growth from sales of Rubraca, our
share in the field of treatment and maintenance treatment of
advanced ovarian cancer, our expenses and future cash position, 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 , and the timing of repayment, 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 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.
_______________
1 Response Evaluation Criteria in Solid Tumors (RECIST) is a
standardized methodology for determining therapeutic response to
anticancer using changes in lesion appearance on imaging
studies.
2 Prostate Cancer Working Group (PCWG3) is an international
expert committee of prostate cancer clinical investigators who have
recommended modifications to RECIST for use in the conduct of
trials in metastatic castration-resistant prostate cancer (mCRPC),
which were adopted in the TRITON2 protocol.
CLOVIS ONCOLOGY, INC CONSOLIDATED FINANCIAL
RESULTS (Unaudited, in thousands, except per share amounts)
Three Months Ended September 30, Nine Months Ended
September 30,
2019
2018
2019
2018
Revenues: Product revenue, net
$
37,603
$
22,757
$
103,699
$
65,037
Operating expenses: Cost of sales - product
8,134
4,766
21,984
13,262
Cost of sales - intangible asset amortization
1,212
771
3,549
1,851
Research and development
77,896
63,887
210,674
160,138
Selling, general and administrative
41,811
42,495
137,601
126,634
Acquired in-process research and development
9,440
-
9,440
-
Other operating expenses
5,539
-
5,539
-
Total expenses
144,032
111,919
388,787
301,885
Operating loss
(106,429
)
(89,162
)
(285,088
)
(236,848
)
Other income (expense): Interest expense
(5,278
)
(3,376
)
(12,684
)
(9,592
)
Foreign currency (loss) gain
(229
)
151
(648
)
(34
)
Legal settlement loss
(1,750
)
-
(26,750
)
(27,975
)
Gain on extinguishment of debt
18,480
-
18,480
-
Other income
781
2,536
5,081
5,419
Other income (expense), net
12,004
(689
)
(16,521
)
(32,182
)
Loss before income taxes
(94,425
)
(89,851
)
(301,609
)
(269,030
)
Income tax benefit (expense)
350
(13
)
686
280
Net loss
$
(94,075
)
$
(89,864
)
$
(300,923
)
$
(268,750
)
Basic and diluted net loss per common share
$
(1.72
)
$
(1.71
)
$
(5.62
)
$
(5.18
)
Basic and diluted weighted-average common shares outstanding
54,707
52,669
53,549
51,844
CONSOLIDATED BALANCE SHEET DATA (Unaudited, in
thousands)
September 30, 2019 December 31,
2018 Cash and cash equivalents
$
201,481
$
221,876
Available-for-sale securities
152,622
298,270
Working capital
307,115
446,550
Total assets
716,892
863,560
Convertible senior notes
644,095
575,470
Common stock and additional paid-in capital
2,101,217
2,034,195
Total stockholders' (deficit) equity
(87,495
)
146,469
Other Data (Unaudited, in thousands)
Nine
Months Ended September 30,
2019
2018
Net cash used in operating activities
(253,468
)
(283,270
)
Share Based Compensation Expense
41,748
37,715
Other Information
($ in millions)
Share-based compensation Q1 2019
13.6
Share-based compensation Q2 2019
14.1
Share-based compensation Q3 2019
14.0
Share-based compensation Q3 YTD 2019
41.7
Share-based compensation
Q1 2018
11.9
Share-based compensation Q2 2018
14.9
Share-based compensation Q3 2018
10.9
Share-based compensation Q3 YTD 2018
37.7
Net cash used in
operating activities Q1 2019
(98.5
)
Net cash used in operating activities Q2 2019
(98.0
)
Net cash used in operating activities Q3 2019
(57.0
)
Net cash used in operating activities Q3 YTD 2019
(253.5
)
Net cash used in
operating activities Q1 2018
(100.6
)
Net cash used in operating activities Q2 2018
(110.2
)
Net cash used in operating activities Q3 2018
(72.5
)
Net cash used in operating activities Q3 YTD 2018
(283.3
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191107005162/en/
Breanna Burkart 303.625.5023 bburkart@clovisoncology.com
Anna Sussman 303.625.5022 asussman@clovisoncology.com
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