- $39.9M in Rubraca® (rucaparib) global sales for Q2 2020 and
$82.5M for H1 2020; net product revenue up 21% over Q2 2019 and 25%
over H1 2019
- $261.4M in cash and cash equivalents at June 30, 2020;
anticipated to fund operating plan into early 2022
- Rubraca approved in the U.S. as monotherapy treatment for
patients with BRCA1/2-mutant recurrent, metastatic
castrate-resistant prostate cancer (mCRPC) on May 15; virtual U.S.
launch in mCRPC underway
- Completed target enrollment in the Phase 3 ATHENA trial
evaluating Rubraca with and without Opdivo® in front-line,
newly-diagnosed advanced ovarian cancer
- Phase 2 portion of LIO-1 combination study of lucitanib and
Opdivo in gynecologic cancers now enrolling
- Investigational New Drug (IND) applications for FAP-2286 as
both imaging and treatment agent planned in Q4 2020
- Data for all three of Clovis Oncology commercial or
development-stage products to be presented at the 2020 ESMO Virtual
Congress in September
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended June 30, 2020, and provided an update on the
Company’s clinical development programs and regulatory and
commercial outlook for the rest of the year.
“We are pleased with our U.S. approval in advanced prostate
cancer and continued sales growth for Rubraca year over year in the
U.S. and Europe, particularly in the face of evident headwinds from
COVID-19. Second-quarter revenues were negatively affected, largely
due to fewer new patient starts, as oncology practices and patients
adjusted to the impact of the virus in the U.S. and Europe,” said
Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We
continue to believe that Rubraca has significant advantages as a
maintenance option in ovarian cancer and a treatment option for
prostate cancer in an environment in which physicians are trying to
reduce patient visits to their clinics, and will continue our
efforts to engage with clinicians during this period, which is
ongoing as resurgences of the virus continue in large U.S. markets.
I am pleased that we successfully completed target enrollment in
the 1000 patient Phase 3 ATHENA study in front-line, newly
diagnosed advanced ovarian cancer maintenance in June in less than
two years. We are also particularly enthusiastic to be moving
FAP-2286 into the clinic with planned imaging and therapeutic INDs
in the fourth quarter.”
Second Quarter 2020 Financial Results
Clovis reported net product revenue for Rubraca of $39.9 million
for the second quarter of 2020, which included U.S. product revenue
of $36.7 million and ex-U.S. product revenue of $3.2 million,
compared to net product revenue for Q2 2019 of $33.0 million, which
included U.S. net product revenue of $32.7 million and ex-U.S. net
product revenue of $0.3 million. U.S. product revenues increased 12
percent in Q2 2020 compared to Q2 2019 and ex-U.S. product revenue
increased meaningfully from the first reported ex-U.S. sales in Q2
2019.
Clovis reported net product revenue for Rubraca of $82.5 million
for the six months ended June 30, 2020, which included U.S. product
revenue of $76.0 million and ex-U.S. product revenue of $6.5
million, compared to net product revenue for same period in 2019 of
$66.1 million, which included U.S. net product revenue of $64.6
million and ex-U.S. net product revenue of $1.5 million.
Net product revenue decreased six percent sequentially from Q1
2020 to Q2 2020 principally due to reduced new patient starts which
we believe is the result of the effects of COVID-19 in the U.S. and
Europe during the quarter. The effects of COVID-19 on future sales
are difficult to predict, especially with the increase in COVID-19
cases in the U.S. and Europe.
Clovis had $261.4 million in cash and cash equivalents as of
June 30, 2020, including $82.8 million in net proceeds in an equity
offering of 11.1 million shares of common stock in May 2020.
The Company has reduced its total outstanding convertible debt
by $145.1 million in outstanding principal amount from December 31,
2019 through June 30, 2020.
As of June 30, 2020, the Company had drawn approximately $68
million under the TPG ATHENA clinical trial financing and had up to
$107 million available to draw under the agreement to fund the
expenses of the ATHENA trial through Q3 2022.
Based on the Company’s anticipated revenues, spending, available
financing sources and existing cash and cash equivalents, the
Company believes it has sufficient cash and cash equivalents to
fund its operating plan into early 2022, after taking into account
any cash repayment (unless refinanced earlier) of the remaining
$64.42 million aggregate principal amount of the 2.50% convertible
notes, at their maturity in September 2021.
Net cash used in operating activities was significantly lower at
$59.9 million for the second quarter of 2020, compared with $98.0
million for the second quarter of 2019. Similarly, net cash used in
operating activities for the first half of 2020 was $142.4 million,
compared with $196.5 million for the first half of 2019.
Borrowings under the TPG ATHENA financing provided $17.7 million
in cash in Q2 2020, and we paid a milestone payment to Pfizer of
$8.0 million for the U.S. mCRPC approval. Cash burn in Q2 2020 was
$50.1 million, which represents a 25 percent decline from the Q1
2020 cash burn of $66.9 million. Cash burn in the first half of
2020 was $117.0 million.
Clovis reported a net loss for the second quarter of 2020 of
$92.2 million, or ($1.15) per share, and a net loss of $191.6
million, or ($2.52) per share, for the first half of 2020. Net loss
for Q2 2019 was $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 and the first half of 2020 included
share-based compensation expense of $13.3 million and $26.3
million, compared to $14.1 million and $27.8 million for the
comparable periods of 2019.
Research and development expenses totaled $69.9 million for Q2
2020 and $138.1 million for the first half of 2020, compared to
$70.7 million and $132.8 million for the comparable periods in
2019. Research and development expenses remained relatively flat
for the second quarter and increased slightly for the first half of
2020 compared to the same period in the prior year. We expect
research and development expenses to be lower in the full year 2021
compared to full year 2020.
Selling, general and administrative expenses totaled $41.9
million for Q2 2020 and $84.5 million for the first half of 2020,
compared to $48.0 million and $95.8 million for the comparable
periods in 2019. Selling, general and administrative expenses
decreased during the second quarter and first half of 2020 compared
to the same period in the prior year with savings due to the
COVID-19 situation globally and overall cost reduction efforts.
U.S. Approval and Label Expansion for Rubraca now includes
BRCA1/2-mutant mCRPC
On May 15, 2020, the U.S. FDA approved Rubraca for the treatment
of adult patients with a deleterious BRCA mutation (germline and/or
somatic)-associated metastatic castrate-resistant prostate cancer
who have been treated with androgen receptor-directed therapy and a
taxane-based chemotherapy. The FDA approved this indication under
accelerated approval based on objective response rate and duration
of response data from the multi-center, single arm TRITON2 clinical
trial.
In late May, the National Comprehensive Cancer Network® (NCCN)
updated its Clinical Practice Guidelines in Oncology for Prostate
Cancer to include new recommendations for Rubraca. In addition to
its ovarian cancer recommendations, Rubraca is now recommended in
the NCCN Guidelines® for the treatment of patients with BRCA-mutant
tumors with mCRPC under second-line treatment and subsequent
therapy as a Category 2A recommendation inclusive of the
following:
Rucaparib is a treatment option for patients with mCRPC and a
pathogenic BRCA1 or BRCA2 mutation (germline and/or somatic) who
have been treated with androgen receptor-directed therapy and a
taxane-based chemotherapy. If the patient is not fit for
chemotherapy, rucaparib can be considered even if taxane-based
therapy has not been given.
Target Enrollment Completed in the Phase 3 ATHENA
Study
In June, the Company announced the completion of target
enrollment of 1000 patients in the Clovis-sponsored Phase 3 ATHENA
trial evaluating Rubraca as monotherapy and the combination of
Rubraca and Opdivo as front-line maintenance treatment of
newly-diagnosed advanced ovarian cancer. ATHENA is the first
front-line switch maintenance study designed to evaluate PARP
monotherapy and PARP/PD-1 combination therapy in one study design.
Target enrollment of 1000 patients in the ATHENA study was achieved
in less than two years with the support and involvement of the
Gynecologic Oncology Group (GOG) and the European Network for
Gynecological Oncological Trials (ENGOT), two of the largest
cooperative groups in the U.S. and Europe dedicated to the
treatment of gynecological cancers.
In addition, three abstracts describing data from rucaparib
monotherapy or combination clinical trials were accepted for
e-poster presentation at the 2020 ESMO Virtual Congress in
September.
Lucitanib Combination Studies Underway
Two Clovis-sponsored early Phase 1b/2 lucitanib combination
studies are currently underway: LIO-1, evaluating lucitanib and
Opdivo in combination in advanced solid tumors (Phase 1b) and
gynecologic cancers (Phase 2); and lucitanib in combination with
rucaparib in advanced solid tumors (Phase 1b) and ovarian cancer
(Phase 2) as an arm of the SEASTAR study. An abstract describing
the initial Phase 1b clinical experience of lucitanib in
combination with Opdivo (LIO-1) has been accepted as an e-poster
for the 2020 European Society of Medical Oncology (ESMO) Virtual
Congress to be held in September. In addition, the Phase 2 portion
of LIO-1 recently opened for enrollment and treated the first
patient in the trial, and a Trials-In-Progress e-poster describing
the trial design was also accepted for the 2020 ESMO Virtual
Congress.
FAP-2286 and Peptide-Targeted Radiotherapy Development
Program
The Company’s peptide-targeted radiopharmaceutical therapy
development program includes lead compound FAP-2286 and three
additional unnamed preclinical targets. An abstract describing the
first presentation of FAP-2286 preclinical data in animal models
has been accepted for the 2020 ESMO Virtual Congress, and during Q4
2020, Clovis intends to submit two Investigational New Drug (IND)
applications for FAP-2286 for use as imaging and treatment agents
respectively. Upon activation of the INDs by the U.S. FDA, Clovis
will initiate a Phase 1 study to determine the dose and
tolerability of the FAP-targeting therapeutic agent, with expansion
cohorts planned in multiple tumor types. The FAP-targeting imaging
agent will be utilized to identify tumors that contain FAP for
treatment in the Phase 1 study.
Conference Call Details
Clovis will hold a conference call to discuss Q2 2020 results
this afternoon, August 6, at 4:30pm ET. The conference call will be
simultaneously webcast on the Clovis Oncology web site
www.clovisoncology.com, and archived for future review. Dial-in
numbers for the conference call are as follows: US participants
(877) 698-7048, International participants (647) 689-5448,
conference ID: 7155799.
About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 being developed multiple tumor types, including ovarian and
prostate cancers, as monotherapy and in combination with other
anti-cancer agents. Exploratory studies in other tumor types are
also underway. 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. Additionally, Rubraca is approved in the U.S. for the
treatment of adult patients with a deleterious BRCA mutation
(germline and/or somatic)-associated metastatic
castration-resistant prostate cancer (mCRPC) who have been treated
with androgen receptor-directed therapy and a taxane-based
chemotherapy. Patients should be selected for treatment with
Rubraca based on the presence of a deleterious BRCA mutation
(germline and/or somatic). This indication is approved under
accelerated approval based on objective response rate and duration
of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trials. The TRITON3 clinical trial is expected to
serve as the confirmatory study for the Rubraca accelerated
approval in mCRPC.
In Europe, 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.
Rubraca is also approved in Europe 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
Europe.
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 may reverse this
immunosuppression and augment response to immunotherapy.
Lucitanib is an unlicensed medical product.
About FAP-2286
FAP-2286 is a preclinical candidate discovered by 3B
Pharmaceuticals under investigation as a peptide-targeted
radionuclide therapy (PTRT) and imaging agent targeting fibroblast
activation protein alpha (FAP). FAP is highly expressed in many
epithelial cancers, including more than 90 percent of breast, lung,
colorectal and pancreatic carcinomas. Clovis is planning to submit
an investigational new drug application (IND) for FAP-2286 in the
second half of 2020. Clovis will conduct the global clinical trials
and holds U.S. and global rights, excluding Europe.
FAP-2286 is an unlicensed medical product.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical second focused on
acquiring, developing and commercializing innovative anti-cancer
agents in the U.S., Europe and additional international markets.
Clovis Oncology targets development programs at specific subsets of
cancer populations, and simultaneously develops, with partners, for
those indications that require them, diagnostic tools intended to
direct a compound in development to the population that is most
likely to benefit from its use. Clovis Oncology is headquartered in
Boulder, Colorado, with additional office locations in the U.S. and
Europe. Please visit www.clovisoncology.com for more
information.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management. Examples of forward-looking
statements contained in this press release include, among others,
statements regarding our future financial and operating
performance, business plans or prospects, including expectations
concerning our future cash position, our expectations regarding the
impact of COVID-19 on our business operations and results,
including future revenues, supply and distribution of our clinical
trial supplies and commercial product supplies, our expectations
regarding our ability to maintain the enrollment and conduct of our
clinical trials and other development activities, expectations
concerning future regulatory activities, our plans for commercial
launch in expanded indications in the United States, our plans for
commercial launch in additional countries, expectations for
submission of regulatory filings, our plans to present final or
interim data on ongoing clinical trials, our plans to submit
additional data to, or meet with, the FDA with respect to the
status of or plans for ongoing or planned trials, the timing and
pace of commencement of enrollment in and conduct of our clinical
trials and the cost of certain trials, including those being
considered, planned or conducted in collaboration with partners,
our plans for commencement of additional planned trials, the
potential results of such clinical trials, changes in drug supply
timing and costs and other expenses and statements regarding our
expectations of the supply of free drug distributed to eligible
patients and our expectations regarding the funding that may be
available to us under the agreement with TPG Sixth Street Partners.
Such forward-looking statements involve substantial risks and
uncertainties that could cause our future results, performance or
achievements to differ significantly from that expressed or implied
by the forward-looking statements. Such risks and uncertainties
include, among others, the impacts of the COVID-19 pandemic and
disruption related to efforts to mitigate its spread on our
business, results of operations or financial condition, including
impacts on the vendors or distribution channels in our supply
chain, impacts on our contract manufacturers’ ability to continue
to manufacture our products, impacts on our ability to continue our
development activities, impacts on the conduct of our clinical
trials, including with respect to enrollment rates, availability of
investigators and clinical trial sites or monitoring of data and
impact on the ability and timing of our field personnel to conduct
their activities with health care providers, the uncertainties
inherent in the effect our future revenues or expenses may have on
our cash position, the market potential of our approved drug,
including the performance of our sales and marketing efforts and
the success of competing drugs and therapeutic approaches, changes
in gross-to-net or free drug provided through our patient
assistance program, the availability of reimbursement and insurance
coverage, the performance of our third-party manufacturers, whether
our clinical development programs for our drug candidates and those
of our partners can be completed on time or at all, whether future
study results will be consistent with study findings to date and
whether future study results will support continued development or
regulatory approval, the corresponding development pathways of our
companion diagnostics, the timing of availability of data from our
clinical trials and the results, the initiation, enrollment, timing
and results of our planned clinical trials, the risk that final
results of ongoing trials may differ from initial or interim
results as a result of factors such as final results from a larger
patient population may be different from initial or interim results
from a smaller patient population, actions by the FDA, the EMA or
other regulatory authorities regarding data required to support
drug applications and whether to accept or approve drug
applications that may be filed, their interpretations of our data
and agreement with our regulatory approval strategies or components
of our filings, including our clinical trial designs, conduct and
methodologies, as well as their decisions regarding drug labeling,
reimbursement and pricing, and other matters that could affect the
development, approval, availability or commercial potential of our
drug candidates or companion diagnostics. Clovis Oncology does not
undertake to update or revise any forward-looking statements. A
further description of risks and uncertainties can be found in
Clovis Oncology’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K and its
reports on Form 10-Q and Form 8-K.
CLOVIS ONCOLOGY, INC CONSOLIDATED FINANCIAL RESULTS
(Unaudited, in thousands, except per share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2020
2019
2020
2019
Revenues: Product revenue
$
39,887
$
32,978
$
82,451
$
66,096
Operating expenses: Cost of sales - product
9,120
6,445
18,216
13,851
Cost of sales - intangible asset amortization
1,280
1,217
2,492
2,337
Research and development
69,878
70,746
138,099
132,777
Selling, general and administrative
41,902
48,029
84,500
95,791
Other operating expenses
355
-
3,805
-
Total expenses
122,535
126,437
247,112
244,756
Operating loss
(82,648
)
(93,459
)
(164,661
)
(178,660
)
Other income (expense): Interest expense
(6,739
)
(3,817
)
(16,300
)
(7,407
)
Foreign currency loss
142
(226
)
(735
)
(419
)
Loss on convertible notes conversion
-
-
(7,791
)
-
Loss on extinguishment of debt
(3,277
)
-
(3,277
)
-
Legal settlement loss
-
(25,000
)
-
(25,000
)
Other income
239
1,899
1,081
4,300
Other income (expense), net
(9,635
)
(27,144
)
(27,022
)
(28,526
)
Loss before income taxes
(92,283
)
(120,603
)
(191,683
)
(207,186
)
Income tax benefit
36
176
104
336
Net loss
$
(92,247
)
$
(120,427
)
$
(191,579
)
$
(206,850
)
Basic and diluted net loss per common share
$
(1.15
)
$
(2.27
)
$
(2.52
)
$
(3.91
)
Basic and diluted weighted-average common shares
80,453
53,028
76,057
52,960
CONSOLIDATED BALANCE SHEET DATA (Unaudited, in
thousands)
June 30, 2020
Dec 31, 2019
Cash and cash equivalents
$
261,436
$
161,833
Available-for-sale securities
-
134,826
Working capital
210,254
233,384
Total assets
628,209
669,604
Convertible senior notes
504,680
644,751
Common stock and additional paid-in capital
2,382,632
2,114,123
Total stockholders' deficit
(97,375
)
(174,257
)
Other Data (Unaudited, in thousands)
Six Months Ended June
30,
2020
2019
Net cash used in operating activities
(142,351
)
(196,488
)
Share Based Compensation Expense
26,274
27,769
RECONCILIATION OF NET CASH USED IN
OPERATING ACTIVITIES TO CASH BURN (Unaudited, in
thousands)
Three Months
Ended June 30,
2020
Six Months
Ended June 30,
2020
Net cash used in operating activities
$
(59,857
)
$
(142,351
)
Adjustments: Acquired in-process research and development -
milestone payment
(8,000
)
(8,000
)
Proceeds from borrowings under financing agreement
17,730
33,322
Cash burn
$
(50,127
)
$
(117,029
)
Net cash provided by investing activities
$
56,800
$
126,607
Net cash provided by financing activities
$
101,007
$
115,651
To supplement our financial statements prepared in
accordance with U.S. GAAP, we monitor and consider cash burn, which
is a non-U.S. GAAP financial measure. This non-U.S. GAAP financial
measure is not based on any standardized methodology prescribed by
U.S. GAAP and is not necessarily comparable to similarly-titled
measures presented by other companies. We define cash burn as net
cash used in operating activities plus acquired in-process research
and development - milestone payments less proceeds from borrowings
under financing agreement with TPG specifically related to our
Phase 3 ATHENA trial. We believe cash burn to be a liquidity
measure that provides useful information to management and
investors about the amount of cash consumed by the operations of
the business including milestone payments and proceeds from
borrowings under the TPG financing agreement, which specifically
offsets the costs of our ATHENA trial. A limitation of using this
non-U.S. GAAP measure is that cash burn does not represent the
total change in cash and cash equivalents for the period because it
excludes all other cash provided by or used for other investing and
financing activities. We account for this limitation by providing
information about our investing and financing activities in the
statements of cash flows in our financial statements and by
presenting cash flows from investing and financing activities in
our reconciliation of cash burn. In addition, it is important to
note that other companies, including companies in our industry, may
not use cash burn, may calculate cash burn in a different manner
than we do or may use other financial measures to evaluate their
performance, all of which could reduce the usefulness of cash burn
as a comparative measure. Because of these limitations, cash burn
should not be considered in isolation from, or as a substitute for,
financial information prepared in accordance with U.S. GAAP.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200806005922/en/
Breanna Burkart 303.625.5023 bburkart@clovisoncology.com
Anna Sussman 303.625.5022 asussman@clovisoncology.com
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