- Strong second quarter of launch for
Rubraca® (rucaparib) in U.S. with $14.6M reported in net sales
- Positive topline data from the ARIEL3
study reported on June 19, 2017; presentation of full dataset
confirmed at European Society for Medical Oncology 2017 Congress in
Madrid
- Clovis plans to submit a supplemental
New Drug Application (sNDA) for a second-line and later maintenance
treatment indication before the end of October
- Rucaparib E.U. Marketing Authorization
Application under review; establishing E.U. organization to support
a potential European launch
- Broad clinical collaboration with
Bristol-Myers Squibb to evaluate Rubraca in combination with
Opdivo® (nivolumab) in several late-stage clinical trials in
multiple tumor types; studies are expected to begin before the end
of 2017
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended June 30, 2017, and provided an update on the
Company’s clinical development programs and regulatory outlook for
the remainder of 2017.
“This is clearly an exciting time for our company, for PARP
inhibitors generally, and for Rubraca specifically,” said Patrick
J. Mahaffy, President and CEO of Clovis Oncology. “We are actively
preparing our supplemental New Drug Application for an all-comers
population in the platinum-sensitive ovarian cancer second-line and
later maintenance treatment setting based on the ARIEL3 data. We
anticipate an opinion on our initial treatment indication in Europe
by year-end 2017, and we are preparing our supplemental application
in Europe in second-line maintenance treatment to be filed
immediately upon receipt of a potential treatment approval, which
is anticipated in early 2018. And finally, we are extremely
enthusiastic about our clinical collaboration with Bristol-Myers
Squibb to explore the combination of Opdivo and Rubraca in
triple-negative breast, ovarian and prostate cancers, which could
represent a potentially foundational therapy in these and other
tumor types.”
Second Quarter 2017 Financial Results
Following the approval and launch of Rubraca on December 19,
2016, Clovis reported net product revenue for Rubraca of $14.6
million for the second quarter of 2017, compared to net product
revenue of $7.0 million in the first quarter of 2017 for a total of
$21.6 million for the first six months of 2017.
Clovis had $671.5 million in cash, cash equivalents and
available-for-sale securities as of June 30, 2017. Cash used in
operating activities was $69.1 million for the second quarter of
2017 and $149.5 million for the first half of 2017, compared with
$68.0 million and $151.7 million for the comparable periods of
2016. Clovis had approximately 45.2 million shares of common stock
outstanding as of June 30, 2017. In January 2017, the Company
raised net proceeds of $221.2 million through an offering of 5.75
million shares of common stock and in June 2017, the Company raised
net proceeds of $324.9 million through an offering of 3.92 million
shares of common stock.
Clovis reported a net loss for the second quarter of 2017 of
$175.4 million, or a net loss of $3.88 per share, and $233.8
million, or a net loss of $5.24 per share for the first half of
2017. Net loss was $129.3 million, or a net loss of $3.37 per share
for the second quarter of 2016, and $212.7 million, or a net loss
of $5.54 per share for the first half of 2016. The net loss for the
quarter and six months ended June 30, 2017 included a charge of
$117.0 million related to a legal settlement. The net loss for the
quarter and six months ended June 30, 2016 included a charge of
$104.5 million for the impairment of an intangible asset, a gain of
$25.5 million for a reduction in fair value of contingent purchase
consideration and a $29.2 million non-cash tax benefit related to
lucitanib product rights recorded in 2013 in connection with the
Company’s acquisition of Ethical Oncology Science S.p.A. The
adjusted net loss excluding these items was $58.4 million or $1.29
per share for the second quarter and $116.8 million or $2.62 per
share for the six months ended 2017 and $79.4 million or $2.07 per
share for the second quarter and $162.8 million or $4.24 per share
for the six months ended 2016. Net loss for the second quarter of
2017 included share-based compensation expense of $10.7 million and
$19.6 million for the first half of 2017, compared to $9.5 million
and $20.5 million for the comparable periods of 2016.
Research and development expenses totaled $33.1 million for the
second quarter of 2017 and $65.6 million for the first half of
2017, compared to $67.7 million and $142.3 million for the
comparable periods in 2016. The decrease year over year is
primarily due to lower spending on rucaparib and rociletinib
development activities and selling, general and administrative
expenses related to the commercialization of Rubraca, which had
been classified as research and development prior to FDA
approval.
Selling, general and administrative expenses totaled $36.1
million for the second quarter of 2017 and $65.4 million for the
first half of 2017, compared to $9.6 million and $19.4 million for
the comparable periods in 2016. The increase year over year is
primarily due to selling, general and administrative expenses
related to the commercialization of Rubraca, which had been
classified as research and development prior to FDA approval.
New Clinical Collaboration with Bristol-Myers Squibb
Earlier in the week, Clovis and Bristol-Myers Squibb announced a
broad clinical collaboration to evaluate the combination of Opdivo
and rucaparib in Phase 2 and pivotal Phase 3 clinical trials in
multiple tumor types. The pivotal Phase 3 trials will evaluate
rucaparib in combination with Opdivo, rucaparib as monotherapy and
Opdivo as monotherapy in first-line maintenance treatment for
advanced ovarian and advanced triple-negative breast cancers. The
Phase 2 trial will evaluate Opdivo in combination with rucaparib
and other compounds in metastatic castrate-resistant prostate
cancer (mCRPC). These trials are anticipated to begin by the end of
2017. The planned multi-arm clinical trials will be conducted in
the U.S., Europe and possibly additional countries. Clovis will be
the study sponsor and conducting party for the ovarian cancer
study, and Bristol-Myers Squibb will be the study sponsor and
conducting party for the breast and prostate cancer studies.
Specific terms of the agreement were not disclosed.
ARIEL3 Topline Results
On June 19, Clovis announced topline data from the confirmatory
phase 3 ARIEL3 trial of rucaparib, which successfully achieved the
primary endpoint of improved progression-free survival (PFS) by
investigator review in each of the three populations studied. PFS
was also improved in the rucaparib group compared with placebo by
blinded independent central review (BICR), a key secondary
endpoint.
ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of
rucaparib that enrolled 564 women with platinum-sensitive,
high-grade ovarian, fallopian tube, or primary peritoneal cancer.
The primary efficacy analysis evaluated three prospectively defined
molecular sub-groups in a step-down manner: 1) tumor BRCA mutant
(tBRCAmut) patients, inclusive of germline and somatic mutations of
BRCA; 2) HRD-positive patients, including BRCA-mutant patients and
BRCA wild-type with high loss of heterozygosity, or LOH-high
patients; and, finally, 3) the intent-to-treat population, or all
patients treated in ARIEL3.
Following is a table and a summary of the primary efficacy
analyses and selected exploratory PFS endpoints per Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by each of
investigator review, which was the primary analysis of ARIEL3, and
independent review (BICR), a key secondary endpoint of the
study.
Summary of Primary Efficacy Analyses
and Selected Exploratory Endpoints for ARIEL3
ARIEL3 Analysis
Population
PFS by Investigator
Review(Primary Endpoint)
PFS by Blinded Independent Central
Review(Key Secondary Endpoint)
Primary Analyses Hazard Ratio
Median PFS (months)Rucaparib vs.
Placebo
Hazard Ratio
Median PFS (months)Rucaparib vs.
Placebo
tBRCAmut
0.23; p<0.0001
16.6 vs. 5.4
0.20; p<0.0001
26.8 vs. 5.4 (n=196)
HRD-positive
0.32; p<0.0001
13.6 vs. 5.4
0.34; p<0.0001
22.9 vs. 5.5 (n=354)
Intent-to-Treat
0.36; p<0.0001
10.8 vs. 5.4
0.35; p<0.0001
13.7 vs. 5.4 (n=564)
Exploratory Analyses
BRCAwt / HRD-positive
0.44; p<0.0001
9.7 vs. 5.4 0.55; p=0.0135 11.1 vs. 5.6 (n=158)
BRCAwt / HRD-negative
0.58; p=0.0049 6.7 vs. 5.4 0.47; p=0.0003 8.2 vs. 5.3 (n=161)
PFS: progression-free survival; tBRCAmut: tumor BRCA mutant;
HRD: homologous recombination deficiency; BRCAwt: BRCA wild
type
Exploratory Endpoint of Response
Rate
Enrollment in ARIEL3 included one-third of patients who had
achieved a complete response to their prior platinum-based therapy,
and two-thirds of patients who had achieved a partial response to
their prior platinum-based therapy. Of those with a partial
response, 37% had measurable disease at the time of enrollment and
were therefore evaluable for response. The confirmed overall
response rate by investigator-assessed RECISTv1.1 in the tBRCAmut
group treated with rucaparib was 38% (15/40); of these, 18% (7/40)
were complete responses. This compared with 9% (2/23) in the
placebo group (p=0.0055). No complete responses were seen in the
tBRCAmut placebo group. RECIST responses were also observed in BRCA
wild type HRD positive and BRCA wild type HRD negative
subgroups.
RECIST responses were not assessed by independent blinded
review.
Summary of ARIEL3 Safety
The most common (≥5%) treatment-emergent grade 3/4 adverse
events (TEAEs) among all patients treated with rucaparib in the
ARIEL3 study were anemia/decreased hemoglobin (19%), ALT/AST
increase (11%), asthenia/fatigue (7%), neutropenia (7%), and
thrombocytopenia (5%).The discontinuation rate for TEAEs was 14%
for rucaparib-treated patients and 2.6% for the placebo arm. The
rate of treatment-emergent myelodysplastic syndrome (MDS)/acute
myeloid leukemia (AML) in the rucaparib arm was <1% (3/372), and
no patients on the placebo arm experienced treatment-emergent
MDS/AML.
The ARIEL3 data has been accepted at the European Society for
Medical Oncology 2017 Congress in Madrid this September.
Rucaparib Regulatory Update
Based on the ARIEL3 dataset, the Company plans to submit a
supplemental New Drug Application (sNDA) by the end of October for
a second-line and later maintenance treatment indication for all
women with platinum-sensitive ovarian cancer who have responded to
their most recent platinum therapy.
Clovis’ Marketing Authorization Application (MAA) for rucaparib
to the European Medicines Agency for a comparable ovarian cancer
treatment indication that was submitted to the U.S. FDA is
currently under review. Clovis anticipates an opinion from the
Committee for Medicinal Products for Human Use (CHMP) in late 2017,
and, pending a favorable opinion from CHMP, a potential approval
would follow during the first quarter of 2018. Following a
potential approval for the treatment indication, Clovis intends to
submit a supplemental application for the second-line or later
maintenance treatment indication, for which the Company anticipates
a potential approval during the third quarter of 2018. Clovis
continues to establish its E.U. organization to support a potential
launch of rucaparib.
Rucaparib Clinical Development
Clovis has a robust clinical development program underway in
multiple tumor types, including both Clovis-sponsored and
investigator-initiated trials. The following clinical studies are
open for enrollment or are anticipated to open during 2017:
- The Clovis-sponsored ARIEL4
confirmatory study in the treatment setting is a Phase 3
multicenter, randomized study of rucaparib versus chemotherapy in
relapsed ovarian cancer patients with BRCA mutations (inclusive of
germline and/or somatic) who have failed two prior lines of
therapy. The primary endpoint of the study is PFS. This study is
currently enrolling patients.
- The Clovis-sponsored TRITON2
(Trial of Rucaparib in Prostate Indications) study in mCRPC, a Phase 2 single-arm
study enrolling patients with BRCA mutations and ATM mutations
(both inclusive of germline and somatic) or other deleterious
mutations in other homologous recombination (HR) repair genes and
all patients will have progressed after receiving one line of
taxane-based chemotherapy and one or two lines of androgen-receptor
(AR) targeted therapy. This study is currently enrolling
patients.
- The Clovis-sponsored TRITON3 study, a
Phase 3 comparative study in mCRPC enrolling BRCA mutant and ATM
mutant (both inclusive of germline and somatic) patients who have
progressed on AR-targeted therapy and who have not yet received
chemotherapy in the castrate-resistant setting is also open for
enrollment. TRITON3 will compare rucaparib to physician’s choice of
AR-targeted therapy or chemotherapy in these patients. This study
is currently enrolling patients.
- A Clovis-sponsored Phase 3 study in
advanced ovarian cancer in the first-line maintenance treatment
setting evaluating rucaparib plus the cancer immunotherapy Opdivo
(nivolumab; anti-PD1), rucaparib, 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 expected to begin before the end of
2017.
- The Phase 3 combination study of the
cancer immunotherapy Opdivo plus rucaparib for the treatment of
advanced triple-negative breast cancers (TNBC) associated with
homologous recombination deficiency (HRD). This study is sponsored
by Bristol-Myers Squibb and is expected to begin before the end of
2017.
- The Phase 2 combination study of the
cancer immunotherapy Opdivo plus rucaparib for the treatment of
mCRPC. This study, sponsored by Bristol-Myers Squibb, will be
conducted as an arm of a larger Bristol-Myers Squibb-sponsored
prostate cancer study. This study is expected to begin before the
end of 2017.
- The Phase 1b combination study of the
cancer immunotherapy Tecentriq (atezolizumab; anti-PDL1) and
rucaparib for the treatment of gynecological cancers, with a focus
on ovarian cancer. This study is sponsored by Roche and is
currently enrolling patients.
- The cooperative group-sponsored MITO-25
study evaluating rucaparib and the anti-angiogenic therapy,
bevacizumab, in combination as a first-line maintenance therapy for
advanced ovarian cancer, which is expected to begin enrolling
patients by year-end; and
- Additional investigator-initiated or
cooperative group-initiated studies of rucaparib as single-agent or
in combination therapy are underway or planned, including studies
in ovarian, prostate, breast, gastroesophageal, pancreatic, lung,
bladder and urothelial cancers.
Conference Call Details
Clovis will hold a conference call to discuss second quarter
2017 results on August 2, at 4:30pm ET. The conference call will be
simultaneously webcast on the Company’s web site at
www.clovisoncology.com, and archived for future review. Dial-in
numbers for the conference call are as follows: US participants
866.489.9022, International participants 678.509.7575, conference
ID: 58222782.
About Rubraca® (rucaparib)
Rubraca is a PARP inhibitor indicated as monotherapy for the
treatment of patients with deleterious BRCA mutation (germline
and/or somatic) associated advanced ovarian cancer, who have been
treated with two or more chemotherapies, and selected for therapy
based on an FDA-approved companion diagnostic for Rubraca. The
indication for Rubraca is approved under the FDA’s accelerated
approval program based on objective response rate and duration of
response, and is based on results from two multicenter, single-arm,
open-label clinical trials. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in confirmatory trials. Please visit rubraca.com for more
information.
About Rucaparib
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed in ovarian cancer as well as several
additional solid tumor indications. During the fourth quarter of
2016, the Marketing Authorization Application (MAA) submission in
Europe for rucaparib in the same ovarian cancer treatment
indication was submitted and accepted for review. In October 2017,
Clovis Oncology intends to submit a supplemental New Drug
Application (sNDA) in the U.S. for a second line or later
maintenance treatment indication in ovarian cancer based on the
ARIEL3 data, and in addition, plans to file an MAA in Europe for
the maintenance treatment indication. Studies open for enrollment
or under consideration include ovarian, prostate, breast,
gastroesophageal, pancreatic, lung, bladder and urothelial cancers.
Clovis is also developing rucaparib in patients with mutant BRCA
tumors and other DNA repair deficiencies beyond BRCA – commonly
referred to as homologous recombination deficiencies, or HRD.
Clovis holds worldwide rights for rucaparib.
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 San Francisco, California and Cambridge,
UK. 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 made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. 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, the performance of our
third-party manufacturers, our clinical development programs for
our drug candidates, the corresponding development pathways of our
companion diagnostics, the timing of availability of data from our
clinical trials and the results, the initiation, enrollment and
timing of our planned clinical trials, actions by the FDA, the
EMA or other regulatory authorities regarding whether to approve
drug applications that may be filed, as well as their decisions
that may affect drug labeling, pricing and reimbursement and other
matters that could affect the 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 June 30,
Six Months Ended June 30, 2017
2016 2017 2016 Revenues: Product
revenue, net $ 14,620 $ - $ 21,665 $ -
Operating expenses: Cost of sales - product 2,730 - 3,893 -
Cost of sales - intangible asset amortization 372 - 743 - Research
and development 33,108 67,729 65,555 142,337 Selling, general and
administrative 36,149 9,552 65,373 19,379 Acquired in-process
research and development - 300 - 300 Impairment of intangible asset
- 104,517 - 104,517 Change in fair value of contingent purchase
consideration - (25,452 ) -
(24,936 ) Total expenses 72,359 156,646
135,564 241,597 Operating
loss (57,739 ) (156,646 ) (113,899 ) (241,597 ) Other income
(expense): Interest expense (2,598 ) (2,106 ) (5,178 ) (4,210 )
Foreign currency gain (loss) 76 183 (83 ) (368 ) Legal settlement
loss (117,000 ) - (117,000 ) - Other income 594
196 946 221 Other income
(expense), net (118,928 ) (1,727 ) (121,315 )
(4,357 ) Loss before income taxes (176,667 ) (158,373
) (235,214 ) (245,954 ) Income tax benefit 1,281
29,059 1,365 33,240 Net
loss $ (175,386 ) $ (129,314 ) $ (233,849 ) $ (212,714 )
Basic and diluted net loss per common share $ (3.88 ) $ (3.37 ) $
(5.24 ) $ (5.54 ) Basic and diluted weighted-average common
shares outstanding 45,176 38,389 44,610 38,375
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS AND NET LOSS
PER SHARE (Unaudited, in thousands, except per share amounts)
Three Months Ended June 30,
Six Months Ended June 30, 2017
2016 2017 2016 GAAP net
loss $ (175,386 ) $ (129,314 ) $ (233,849 ) $ (212,714 )
Adjustments: Legal settlement loss (1) 117,000 - 117,000 -
Impairment of intangible asset (2) 104,517 104,517 Change in fair
value of contingent purchase consideration (3) (25,452 ) (25,452 )
Income tax benefit (2) (29,160 ) (29,160 ) Non-GAAP net loss
$ (58,386 ) $ (79,409 ) $ (116,849 ) $ (162,809 ) GAAP net
loss per common share $ (3.88 ) $ (3.37 ) $ (5.24 ) $ (5.54 )
Non-GAAP net loss per common share $ (1.29 ) $ (2.07 ) $
(2.62 ) $ (4.24 )
The Company prepares its consolidated financial statements in
accordance with U.S. GAAP. This press release also contains
non-GAAP measurements of net loss and net loss per common
share that the Company believes provide useful supplemental
information relating to operating performance and trends and
facilitates comparisons with other periods. These non-GAAP
financial measures should be considered in addition to, but not as
a substitute for, the information prepared in accordance with
U.S. GAAP.
Explanation of adjustments:
(1) During the three months ended June 30, 2017, the Company
recorded a $117.0 million legal settlement loss related to a
stipulation and agreement of settlement entered into between the
Clovis Defendants and the plaintiffs to the Consolidated Complaint.
(2)
During the three months ended June 30,
2016, the Company recorded a $104.5 million non-cash impairment
charge to the intangible asset related to the lucitanib product
rights initially recorded in 2013 in connection with the
acquisition of Ethical Oncology Science, S.p.A. (EOS). The Company
also recorded a $29.2 million tax benefit associated with this
charge. This adjustment removes the net of tax effect of this
charge from our net loss.
(3) During the three months ended June 30, 2016, the Company
recorded a $25.5 million non-cash credit to operating expenses to
reflect the reduction in the fair value of the contingent purchase
consideration liability, also associated with the Company's
acquisition of EOS. This adjustment, which excludes the normal
accretion of the liability, removes the effect of this expense
credit from our net loss.
CONSOLIDATED BALANCE
SHEET DATA (Unaudited,in thousands)
June 30, 2017 December 31, 2016 Cash and cash
equivalents $ 491,786 $ 216,186 Available-for-sale securities
179,744 49,997 Working capital 496,394 193,751 Total assets 849,896
364,557 Convertible senior notes 281,761 281,126 Common stock and
additional paid-in capital 1,752,992 1,174,989 Total stockholders'
equity (deficit) 343,793 (3,634 )
Other Data
(Unaudited, in thousands)
Six Months Ended June 30,
2017 2016 Net cash used in operating
activities (149,541 ) $ (151,670 ) Share Based Compensation
Expense 19,563 $ 20,542
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170802006149/en/
Clovis Oncology, Inc.Breanna Burkart,
303-625-5023bburkart@clovisoncology.comorAnna Sussman,
303-625-5022asussman@clovisoncology.com
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