- $33.0M in Rubraca® (rucaparib) net product revenue for Q2 2019
compared to $23.8M for Q2 2018
- U.S. sales increased 3% sequentially in Q2 2019 over Q1
2019
- Global net product revenue guidance of $137 million to $147
million provided for the full year 2019
- Updated data from TRITON2 study of patients with BRCA-mutant
mCRPC to be provided to FDA later this month; RECIST and PSA
response rates consistent with those shown at ESMO 2018
- TRITON2 data to be presented at ESMO 2019 in poster discussion
session in late September
- Supplemental NDA for Rubraca in BRCA-mutant advanced prostate
cancer on track for Q4 2019
- Phase 1b/2 combination study of lucitanib with Rubraca now
enrolling; dose-finding cohort underway, expansion cohort to focus
on advanced ovarian cancer
- Phase 1b/2 combination study of lucitanib and Bristol
Myers-Squibb’s Opdivo now enrolling; dose-finding cohort to be
followed by expansion cohorts in advanced gynecologic cancers and
other solid tumors
- New BMS-sponsored Phase 2 combination study of Opdivo and
Yervoy with Rubraca for the treatment of advanced gastric cancer
planned to initiate in Q4 2019
- Cash burn to significantly reduce in 2H 2019 and 2020 based on
lower milestone and product supply costs and anticipated revenue
growth; further supported by ATHENA clinical trial financing
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended June 30, 2019, and provided an update on
Clovis’ clinical development programs and regulatory and commercial
outlook for the second half of 2019.
“We continue to make progress in the second-line ovarian cancer
maintenance indication in the U.S., and we look forward to the
potential prostate indication in the U.S. and launches in
additional EU countries to support top-line growth in 2020,” said
Patrick J. Mahaffy, CEO and President of Clovis Oncology. “In
addition, we are extremely pleased to have begun our combination
studies of lucitanib plus Rubraca and lucitanib plus Opdivo, and we
look forward to sharing initial data from these studies at medical
meetings next year. We believe these combinations have significant
potential and in almost every case, will study unselected or
all-comer populations.”
Second Quarter 2019 Financial Results
Clovis reported net product revenue for Rubraca of $33.0 million
for Q2 2019, which included U.S. net product revenue of $32.7
million and ex-U.S. net product revenue of $0.3 million, compared
to net product revenue for Q2 2018 of $23.8 million. U.S. net
product revenue increased three percent sequentially from Q1 2019
to Q2 2019. Ex-US net product revenues were lower sequentially in
Q2 2019 than Q1 2019, as initial launch stocking shipments were
made in March and reported in Q1 product revenue. Clovis expects
ex-U.S. net product revenues to increase in Q3 compared to Q2
2019.
Clovis expects global net product revenue to be in the range of
$137 million to $147 million for the full year.
The supply of free drug distributed to eligible patients through
the Rubraca patient assistance program for Q2 2019 was marginally
higher at approximately 22 percent of the overall commercial
supply, compared to 21 percent in Q1 2019 and lower than the 25
percent reported in Q2 2018. This represented $9.3 million in
commercial value for Q2 2019 compared to $8.4 million in Q1 2019
and $7.9 million in Q2 2018.
Net product revenue for the first half of 2019 was $66.1
million, as compared to net product revenue of $42.3 million for
the first half of 2018. The Rubraca label was expanded to include
the broader and earlier-line maintenance treatment indication in
the U.S. in April 2018 and in the EU in January 2019. For the first
half of 2019, the supply of free drug distributed to eligible
patients was an additional approximately 21 percent of the overall
commercial supply compared to 24 percent in the first half of 2018.
This represented $17.7 million in commercial value for the first
half of 2019 compared to $13.4 million in the first half of
2018.
Clovis had $315.9 million in cash, cash equivalents and
available-for-sale securities as of June 30, 2019. Cash used in
operating activities was $98.9 million for Q2 2019 and $197.4
million for the first half of 2019, compared with $110.2 million
for Q2 2018 and $210.8 million for the first half of 2018. For the
first half of 2019, total cash used included product supply costs
of $42.5 million and a $15.75 million milestone payment to Pfizer
related to the second European product approval in Q1 2019. For the
first half of 2018, total cash used included product supply costs
of $76.1 million and milestone payments to Pfizer of $58.0 million
in Q2 2018 related to U.S. product approvals in December 2016 and
April 2018 and European product approval in May 2018.
The amount spent on product supply costs and milestone payments
is expected to decrease substantially in the second half of 2019
and in 2020. These reduced costs, combined with anticipated net
product revenue growth in the global ovarian indications and the
potential U.S. prostate indication in 2020, will significantly
reduce our cash burn in the second half of 2019 and 2020. This will
be additionally supported by the quarterly cash payments provided
by the ATHENA clinical trial financing.
Clovis reported a net loss for Q2 2019 of $120.4 million, or
($2.27) per share, and $206.9 million, or a net loss of ($3.91) per
share for the first half of 2019. Net loss for Q2 2018 was $101.2
million, or ($1.94) per share, and $178.9 million, or a net loss of
($3.48) per share, for the first half of 2018. Net loss for Q2 and
first half of 2019 included share-based compensation expense of
$14.1 million and $27.8 million, compared to $14.9 million and
$26.8 million for the comparable periods of 2018.
Research and development expenses totaled $70.7 million for Q2
2019 and $132.8 million for the first half of 2019, compared to
$52.7 million and $96.3 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 be higher for the full year 2019 compared to
2018. Thereafter, we expect research and development costs to
flatten, and then trend lower in the following years, as the
largest of the Clovis’ sponsored clinical trials near
completion.
Selling, general and administrative expenses totaled $48.0
million for Q2 2019 and $95.8 million for the first half of 2019,
compared to $44.9 million and $84.1 million for the comparable
periods in 2018. The increase year over year is primarily due to
higher selling, general and administrative expenses related to the
commercialization of Rubraca in the U.S. and EU. Clovis also
expects selling, general and administrative costs to be higher for
the full year 2019 compared to 2018, however, these costs will
continue to increase modestly as Clovis prepares for anticipated
product launches in a greater number of countries outside of the
U.S. and launch activities for the anticipated prostate indication
approval in 2020.
In May 2019, Clovis entered into an agreement for up to $175.0
million in non-dilutive clinical trial financing with certain
affiliates of TPG Sixth Street Partners to reimburse Clovis’
quarterly costs and expenses related to the ATHENA clinical trial.
ATHENA is Clovis’ largest clinical trial, with a planned target
enrollment of 1,000 patients across more than 270 sites in at least
25 countries. Clovis plans to borrow amounts required to reimburse
actual costs and expenses incurred during each quarter, beginning
in Q2 2019, and repayment is anticipated to begin in 2022, the
approximate anticipated timing of a potential Rubraca first-line
maintenance approval in advanced ovarian cancer. The financing is
secured by Rubraca assets, and Clovis maintains worldwide rights to
Rubraca.
Rubraca in BRCA-mutant Advanced Prostate Cancer
Initial data from Clovis’ ongoing TRITON studies of Rubraca in
metastatic castrate-resistant prostate cancer (mCRPC) were
presented at the ESMO 2018 Congress (European Society for Medical
Oncology) in October 2018. The initial TRITON2 data showed a 44
percent confirmed objective response rate (ORR) by investigator
assessment in 25 RECIST1/PCWG3** response-evaluable patients with a
BRCA1/2 mutation and results by independent assessment were
consistent. The median duration of response in these patients had
not yet been reached. In addition, a 51 percent confirmed prostate
specific antigen (PSA) response rate was observed in 45 PSA
response-evaluable patients with a BRCA1/2 mutation. Preliminary
safety data for Rubraca in men with mCRPC were consistent with
those observed in patients with ovarian cancer and other solid
tumors.
The TRITON2 results were the basis for Breakthrough Therapy
designation for Rubraca as a monotherapy treatment of adult
patients with BRCA1/2 mutant mCRPC who have received at least one
prior androgen receptor (AR)-directed therapy and taxane-based
chemotherapy, which was granted on October 1, 2018 by the U.S. Food
and Drug Administration (FDA). Both studies in the TRITON program,
TRITON2 and TRITON3, continue to enroll patients.
As a result of Rubraca’s breakthrough therapy status, Clovis
agreed to provide updates to FDA on Clovis’ advanced prostate
cancer development program on a regular basis. Later this month,
Clovis intends to provide an update to FDA on the TRITON2 data for
patients with BRCA-mutant mCRPC. These data will show RECIST and
PSA response rates consistent with the data presented at ESMO 2018.
Clovis will present the TRITON2 data in a poster discussion session
at the European Society for Medical Oncology (ESMO) Annual Meeting
in Barcelona in late September. Clovis intends to file the planned
supplemental New Drug Application (sNDA) during the fourth quarter
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 who have failed 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 who 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 will have progressed
after receiving one line of taxane-based chemotherapy and one or
two lines of AR-targeted therapy. This study is currently enrolling
patients.
- ARIES is a Phase 2, open-label, multi-cohort study evaluating
the combination of Rubraca and Opdivo in patients with relapsed
ovarian cancer. 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 expected to begin enrolling
patients by year-end;
- 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.
Also, a Phase 2 combination study of Opdivo with Rubraca for the
treatment of mCRPC is underway. This study, sponsored by
Bristol-Myers Squibb, is being conducted as an arm in the CHECKMATE
9KD prostate cancer study, and is currently enrolling patients. In
addition, a new Phase 2 combination study of Opdivo and Yervoy with
Rubraca for the treatment of advanced gastric cancer is planned to
initiate in Q4 2019 and will be sponsored by Bristol-Myers
Squibb.
Exploratory studies in other solid tumors are also underway, as
well as active discussions with Bristol-Myers Squibb regarding
additional potential combination studies.
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.
As previously announced, Clovis and Alkermes have initiated a
preclinical research collaboration to evaluate ALKS 4230, Alkermes’
investigational engineered interleukin-2 (IL-2) variant
immunotherapy, in combinations with rucaparib and lucitanib.
Conference Call Details
Clovis will hold a conference call to discuss Q2 2019 results
this morning, August 1, 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
877.698.7048, International participants 647.689.5448, conference
ID: 5192422.
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 (PDFGRα/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 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 and enrollment in 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 therapy using changes in lesion appearance on imaging
studies.
** 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 June
30,
Six Months Ended June
30,
2019
2018
2019
2018
Revenues:
Product revenue, net
$
32,978
$
23,757
$
66,096
$
42,279
Operating expenses:
Cost of sales - product
6,445
4,490
13,851
8,495
Cost of sales - intangible asset amortization
1,217
709
2,337
1,080
Research and development
70,746
52,707
132,777
96,250
Selling, general and administrative
48,029
44,864
95,791
84,138
Total expenses
126,437
102,770
244,756
189,963
Operating loss
(93,459
)
(79,013
)
(178,660
)
(147,684
)
Other income (expense):
Interest expense
(3,817
)
(3,581
)
(7,407
)
(6,216
)
Foreign currency loss
(226
)
(104
)
(419
)
(185
)
Legal settlement loss
(25,000
)
(20,000
)
(25,000
)
(27,975
)
Other income
1,899
1,475
4,300
2,883
Other income (expense), net
(27,144
)
(22,210
)
(28,526
)
(31,493
)
Loss before income taxes
(120,603
)
(101,223
)
(207,186
)
(179,177
)
Income tax benefit
176
33
336
292
Net loss
$
(120,427
)
$
(101,190
)
$
(206,850
)
$
(178,885
)
Basic and diluted net loss per
common share
$
(2.27
)
$
(1.94
)
$
(3.91
)
$
(3.48
)
Basic and diluted
weighted-average common shares outstanding
53,028
52,223
52,960
51,425
CONSOLIDATED BALANCE SHEET DATA (Unaudited, in
thousands)
June 30, 2019 December 31, 2018
Cash and cash equivalents
$
108,607
$
221,876
Available-for-sale securities
207,306
298,270
Working capital
272,646
446,550
Total assets
685,975
863,560
Convertible senior notes
576,763
575,470
Common stock and additional paid-in capital
2,064,446
2,034,195
Total stockholders' equity (deficit)
(29,982
)
146,469
Other Data (Unaudited, in thousands)
Six Months Ended June
30,
2019
2018
Net cash used in operating activities
(197,408
)
(210,844
)
Share Based Compensation Expense
27,769
26,768
Other Information ($ in millions)
Share-based compensation Q1 2019
13.7
Share-based compensation Q2 2019
14.1
Share-based compensation Q2 YTD 2019
27.8
Share-based compensation Q1 2018
11.9
Share-based compensation Q2 2018
14.9
Share-based compensation Q2 YTD 2018
26.8
Net cash used in operating activities Q1 2019
(98.5
)
Net cash used in operating activities Q2 2019
(98.9
)
Net cash used in operating activities Q2 YTD 2019
(197.4
)
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 Q2 YTD 2018
(210.8
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190801005249/en/
Breanna Burkart 303.625.5023 bburkart@clovisoncology.com
Anna Sussman 303.625.5022 asussman@clovisoncology.com
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