Clovis Oncology Announces Third Quarter 2018 Operating Results
October 30, 2018
-
$22.8M in Rubraca® sales for the third
quarter of 2018 compared to $16.8M for Q3 2017 -
Free drug increased to 30 percent of overall commercial supply,
equivalent to $9.6 million in commercial value -
Initial TRITON2 data for Rubraca in mCRPC presented at ESMO include
44% confirmed ORR and 51% confirmed PSA response rate in 25
RECIST-evaluable and 45 PSA-evaluable patients with a BRCA1/2
alteration; preliminary safety data are consistent with those observed
in other Rubraca studies -
$604.4 million in cash, cash equivalents and available for sale
securities at September 30, 2018
BOULDER, Colo.–(BUSINESS WIRE)–Clovis
Oncology, Inc. (NASDAQ:CLVS) reported financial results for the
quarter ended September 30, 2018, and provided an update on the
Company’s clinical
development programs and regulatory and commercial outlook for the
remainder of 2018.
“As discussed last quarter, growth remains challenging in the
second-line maintenance ovarian cancer setting, but we have efforts
underway to address this and we are aggressively moving forward to grow
this market and grow our share of this market,” said Patrick J. Mahaffy,
CEO and President of Clovis Oncology. “In addition, our development team
continues to make significant progress in moving Rubraca beyond its
initial ovarian cancer indications. In particular, we were very pleased
with the data from the TRITON studies presented at ESMO and at the
Prostate Cancer Foundation Scientific Retreat, which also served as the
basis for Breakthrough Therapy designation, and we are committed to
developing Rubraca in the prostate setting as rapidly as possible to
support men with this difficult-to-treat disease.”
Third Quarter 2018 Financial Results
Product revenue for the quarter and first nine months ended September
30, 2018 was $22.8 million and $65.0 million, compared to $16.8 million
and $38.5 million for the comparable periods in 2017. The supply of free
drug distributed to eligible patients through the Rubraca patient
assistance program for the three months ended September 30, 2018 was
approximately 30 percent of the overall commercial supply, or the
equivalent of $9.6 million in commercial value. In the nine months ended
September 30, 2018, the supply of this free drug was approximately 26
percent of the overall commercial supply, or the equivalent of $23
million in commercial value. We believe the increase in the free drug
percentage not realized as revenue results primarily from an increase in
the percentage of patients treated with Rubraca who qualify for our
patient assistance program, the majority of whom are on Medicare,
following label expansion to include the earlier-line, all-comers
maintenance treatment label.
Clovis had $604.4 million in cash, cash equivalents and
available-for-sale securities as of September 30, 2018. Cash used in
operating activities was $72.5 million for the third quarter of 2018 and
$283.3 million for the first nine months of 2018, compared with $45.8
million for the third quarter of 2017 and $195.3 million for the first
nine months of 2017. This includes product supply costs of $76.1 million
in the first nine months of 2018 related to Clovis’ previously described
plan to build additional inventory in advance of the transition to a new
manufacturing facility for Rubraca. Additionally, Clovis made one-time
milestone payments to Pfizer of $58 million in the first nine months of
2018 related to U.S. product approvals in December 2016 and April 2018
and European product approval in May 2018.
Clovis reported a net loss for the third quarter of 2018 of $89.9
million, or ($1.71) per share, and $268.8 million, or a net loss of
($5.18) per share for the first nine months of 2018. Net loss was $60.7
million, or a net loss of ($1.24) per share for the third quarter of
2017, and $294.5 million, or a net loss of ($6.39) per share for the
first nine months of 2017.
The net loss for the nine months ended September 30, 2018 includes a
one-time charge of $20 million in the second quarter related to a final
settlement reached with the Securities and Exchange Commission which
resolves their investigation related to rociletinib, and a charge of
$8.0 million in the first quarter related to a legal settlement. The net
loss for the nine months ended September 30, 2017 included a charge of
$117.0 million related to a legal settlement. The adjusted net loss
excluding these items was $240.8 million, or ($4.64) per share for the
first nine months of 2018 and $177.5 million, or ($3.85) per share for
the first nine months of 2017.
Net loss for the third quarter and first nine months of 2018 included
share-based compensation expense of $10.9 million and $37.7 million,
compared to $12.6 million and $32.2 million for the comparable periods
of 2017.
Clovis had approximately 52.7 million shares of common stock outstanding
as of September 30, 2018.
Research and development expenses totaled $63.9 million for the third
quarter of 2018 and $160.1 million for the first nine months of 2018,
compared to $38.9 million and $104.5 million for the comparable periods
in 2017. Research and development expenses will continue to increase
compared to prior year as planned Rubraca studies progress.
Selling, general and administrative expenses totaled $42.5 million for
the third quarter of 2018 and $126.6 million for the first nine months
of 2018, compared to $35.0 million and $100.4 million for the comparable
periods in 2017. Selling, general and administrative expenses will
continue to increase compared to prior year in support of administrative
and commercial activities related to Rubraca in the United States and
Europe.
Guidance for Q4 2018; Anticipate Providing 2019 Guidance in Early
January
Based on current trends in PARP inhibitor adoption, the Company
anticipates Q4 2018 revenues to be consistent with or slightly higher
than Q3 2018 reported revenues of $22.8 million. Clovis anticipates
providing full-year 2019 guidance in early January.
Key Milestones and Objectives for Rubraca
European Union (EU) Maintenance Treatment Variation Under Review
Following the receipt of the initial Marketing Authorization for Rubraca
in late May 2018, Clovis submitted a variation to include the
maintenance indication, which was validated by the European Medicines
Agency (EMA) in early July. The review is underway and an opinion for
the maintenance indication is anticipated from the EMA’s Committee for
Medicinal Products for Human Use (CHMP) by the end of 2018, and, if
positive, a potential formal European Commission approval could follow
in early 2019. Clovis continues to establish its EU organization to
support the planned launch of Rubraca in Europe.
TRITON Datasets at ESMO and Breakthrough Therapy Designation
Initial data from the Company’s ongoing TRITON studies of Rubraca in
advanced prostate cancer were presented at the ESMO 2018 Congress
(European Society for Medical Oncology) earlier this month. The initial
TRITON2 data show a 44% confirmed objective response rate (ORR) by
investigator assessment in 25 RECIST1/PCWG3**
response-evaluable patients with a BRCA1/2 alteration. The median
duration of response in these patients has not yet been reached. In
addition, a 51% confirmed prostate specific antigen (PSA) response rate
was observed in 45 PSA response-evaluable patients with a BRCA1/2
alteration. 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
mutated mCRPC who have received at least one prior androgen receptor
(AR)-directed therapy and taxane-based chemotherapy, which was granted
on October 2, 2018 by the U.S. Food and Drug Administration (FDA). The
TRITON2 study continues to enroll patients.
Also, a TRITON screening poster presented at ESMO provided initial
genomic profiling data from the TRITON clinical program. Plasma samples
identified alterations in BRCA1 or BRCA2 in approximately
12% of mCRPC patients screened for the TRITON2 study, and data
demonstrated that plasma cell-free circulating tumor DNA (cfDNA) samples
were highly consistent with tumor tissue in identifying BRCA1 or BRCA2
alterations.
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 clinical studies are open
for enrollment or are anticipated to open during the next several months:
-
The Clovis-sponsored ARIEL4 confirmatory study in the 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. -
The Clovis-sponsored Phase 3 ATHENA 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 -
The Clovis-sponsored TRITON3 study, a Phase 3 comparative study in
metastatic castration-resistant prostate cancer (mCRPC) enrolling 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
castrate-resistant setting. TRITON3 compares Rubraca to physician’s
choice of AR-targeted therapy or chemotherapy in these patients. This
study is currently enrolling patients. -
The Clovis-sponsored TRITON2 study in mCRPC, a Phase 2 single-arm
study in patients with BRCA mutations (inclusive of germline and
somatic) and also enrolling patients with deleterious mutations of
other homologous recombination (HR) repair genes, including ATM. 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. -
The Clovis-sponsored single-arm Phase 2 open-label monotherapy study
of Rubraca in recurrent, metastatic bladder cancer titled ATLAS: A
Study of Rucaparib in Patients with Locally Advanced or Metastatic
Urothelial Carcinoma. This study is currently enrolling patients. -
The Phase 1 RUCA-J study, sponsored by Clovis, is a Phase 1 study to
identify the recommended dose of rucaparib in Japanese patients, which
will enable development of a bridging strategy and potential inclusion
of Japanese sites in planned or ongoing global studies. This study is
currently enrolling patients. -
The Phase 2, open-label, multi-cohort study evaluating the combination
of Rubraca and Opdivo in patients with relapsed ovarian cancer and in
patients with locally advanced or metastatic bladder carcinoma. This
study is sponsored by Clovis and is expected to begin in early 2019. -
The Phase 1/2 combination study of sacituzumab govitecan and Rubraca
for the treatment of advanced metastatic TNBC, relapsed
platinum-resistant ovarian cancer and metastatic urothelial cancers is
sponsored by Clovis and is expected to begin enrolling patients in the
first half of 2019. -
The Phase 3 pivotal study in advanced triple-negative breast cancer
(TNBC) to evaluate Opdivo and Rubraca in combination. This study is
sponsored by Bristol-Myers Squibb. The protocol for this study is in
development. -
The Phase 2 combination study of Opdivo with Rubraca for the treatment
of mCRPC. This study, sponsored by Bristol-Myers Squibb, is being
conducted as an arm of a larger sponsored prostate cancer study. This
study is currently enrolling patients. -
The Phase 1b combination study of the cancer immunotherapy Tecentriq
(atezolizumab; anti-PDL1) and Rubraca for the treatment of ovarian and
triple-negative breast cancers. This study is sponsored by Roche and
is currently enrolling patients.
Exploratory studies in other tumor types are also underway.
________________________________
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.
Lucitanib Clinical Development
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), which was
previously evaluated in breast and lung cancers in partnership with
Servier. Clovis has global rights (excluding China) for lucitanib.
Lucitanib was originally developed by Clovis and Servier with the
hypothesis of activity in FGFR driven tumors; data in breast and lung
cancer were insufficient to move the program forward. Recent data for a
similar drug that inhibits these same three pathways – when combined
with a PD-1 inhibitor – are extremely encouraging and represent a
validated and alternative hypothesis for the development of lucitanib in
combination with a PD-(L)1 inhibitor, and a Clovis-sponsored combination
study is now being planned. Clovis also intends to initiate a study of
lucitanib in combination with rucaparib, based on encouraging data of
VEGF and PARP inhibitors in combination. Each of these studies is
expected to initiate before the end of Q1 2019.
Conference Call Details
Clovis will hold a conference call to discuss Q3 2018 results this
afternoon, October 30, 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 866.393.4306, International participants
734.385.2616, conference ID: 5885294.
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, lung
and bladder 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.
Rubraca is an unlicensed medical product outside of the U.S. and EU.
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 and Oakland, 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. Examples of forward-looking statements
contained in this press release include, among others, statements
regarding our guidance for future revenues and certain expenses, our
expectation of timing for review and approval of the MA variation for
rucaparib, our expectations for submission of regulatory filings, our
plans to present final or interim data on ongoing clinical trials, the
timing and pace of commencement of and enrollment in our clinical
trials, including those being planned or conducted in collaboration with
partners, 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. 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, the performance of our third-party
manufacturers, our clinical development programs for our drug candidates
and those of our partners, 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 accept or approve drug
applications that may be filed, as well as their decisions regarding
drug labeling, reimbursement and pricing, and other matters that could
affect the development, 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 September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||||||||
| Revenues: | ||||||||||||||||||||||
| Product revenue | $ | 22,757 | $ | 16,806 | $ | 65,037 | $ | 38,471 | ||||||||||||||
| Operating expenses: | ||||||||||||||||||||||
| Cost of sales – product | 4,766 | 3,026 | 13,262 | 6,920 | ||||||||||||||||||
| Cost of sales – intangible asset amortization | 771 | 372 | 1,851 | 1,115 | ||||||||||||||||||
| Research and development | 63,887 | 38,924 | 160,138 | 104,479 | ||||||||||||||||||
| Selling, general and administrative | 42,495 | 35,011 | 126,634 | 100,384 | ||||||||||||||||||
| Total expenses | 111,919 | 77,333 | 301,885 | 212,898 | ||||||||||||||||||
| Operating loss | (89,162 | ) | (60,527 | ) | (236,848 | ) | (174,427 | ) | ||||||||||||||
| Other income (expense): | ||||||||||||||||||||||
| Interest expense | (3,376 | ) | (2,618 | ) | (9,592 | ) | (7,796 | ) | ||||||||||||||
| Foreign currency gain (loss) | 151 | (44 | ) | (34 | ) | (127 | ) | |||||||||||||||
| Legal settlement loss | – | – | (27,975 | ) | (117,000 | ) | ||||||||||||||||
| Other income | 2,536 | 1,291 | 5,419 | 2,237 | ||||||||||||||||||
| Other income (expense), net | (689 | ) | (1,371 | ) | (32,182 | ) | (122,686 | ) | ||||||||||||||
| Loss before income taxes | (89,851 | ) | (61,898 | ) | (269,030 | ) | (297,113 | ) | ||||||||||||||
| Income tax (expense) benefit | (13 | ) | 1,234 | 280 | 2,599 | |||||||||||||||||
| Net loss | $ | (89,864 | ) | $ | (60,664 | ) | $ | (268,750 | ) | $ | (294,514 | ) | ||||||||||
| Basic and diluted net loss per common share | $ | (1.71 | ) | $ | (1.24 | ) | $ | (5.18 | ) | $ | (6.39 | ) | ||||||||||
| Basic and diluted weighted-average common shares outstanding | 52,669 | 48,917 | 51,844 | 46,062 | ||||||||||||||||||
| RECONCILIATION OF GAAP TO NON-GAAP | ||||||||||||||||||||||
| NET LOSS AND NET LOSS PER SHARE | ||||||||||||||||||||||
| (Unaudited, in thousands, except per share amounts) | ||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||||||||
| GAAP net loss | $ | (89,864 | ) | $ | (60,664 | ) | $ | (268,750 | ) | $ | (294,514 | ) | ||||||||||
| Adjustments: | ||||||||||||||||||||||
| Legal settlement loss (1) | – | – | 27,975 | 117,000 | ||||||||||||||||||
| Non-GAAP net loss | $ | (89,864 | ) | $ | (60,664 | ) | $ | (240,775 | ) | $ | (177,514 | ) | ||||||||||
| GAAP net loss per common share | $ | (1.71 | ) | $ | (1.24 | ) | $ | (5.18 | ) | $ | (6.39 | ) | ||||||||||
| Non-GAAP net loss per common share | $ | (1.71 | ) | $ | (1.24 | ) | $ | (4.64 | ) | $ | (3.85 | ) | ||||||||||
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, 2018, the Company recorded a one-time charge of $20.0 million related to an agreement reached with the SEC to resolve its investigation. |
|
|
During the three months ended March 31, 2018, the Company recorded a one-time charge of $8.0 million related to an agreement to resolve a potential litigation claim against us and certain of our officers. |
||
|
During the three months ended June 30, 2017, the Company recorded a one-time charge of $117.0 million related to an agreement to resolve a litigation claim against us and certain of our officers. |
||
| CONSOLIDATED BALANCE SHEET DATA | ||||||||||
| (Unaudited, in thousands) | ||||||||||
| September 30, 2018 | December 31, 2017 | |||||||||
| Cash and cash equivalents | $ | 290,853 | $ | 464,198 | ||||||
| Available-for-sale securities | 313,525 | 99,533 | ||||||||
| Working capital | 614,264 | 545,423 | ||||||||
| Total assets | 891,464 | 735,230 | ||||||||
| Convertible senior notes | 574,828 | 282,406 | ||||||||
| Common stock and additional paid-in capital | 2,022,050 | 1,887,249 | ||||||||
| Total stockholders’ equity | 233,666 | 367,636 | ||||||||
| Other Data | ||||||||||
| (Unaudited, in thousands) | ||||||||||
| Nine Months Ended September 30, | ||||||||||
| 2018 | 2017 | |||||||||
| Net cash used in operating activities | (283,270 | ) | (195,326 | ) | ||||||
| Share Based Compensation Expense | 37,715 | 32,201 | ||||||||
Contacts
Clovis Oncology
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
or
Anna
Sussman, 303-625-5022
asussman@clovisoncology.com