- $164.5M in Rubraca® (rucaparib) global net product revenues for
2020, up 15% over 2019; $43.3M in Rubraca global net product
revenues for Q4 2020, up 10% over Q4 2019
- Phase 1/2 LuMIERE study of FAP-2286, a targeted radiotherapy,
planned to begin 1H 2021
- Top-line data from Phase 3 ATHENA trial of Rubraca as
first-line maintenance ovarian cancer monotherapy anticipated 2H
2021
- Interim data from Phase 2 cohorts of LIO-1 study of lucitanib
in combination with Opdivo® (nivolumab) in gynecologic cancers
anticipated at 2021 medical meetings
- Net cash used in operating activities significantly lower in
2020 compared to 2019
- $240.2M in cash and cash equivalents at December 31, 2020,
which is anticipated to fund the Company’s operating plan into
early 2023 based on current revenue and expense forecasts
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter and year ended December 31, 2020, and provided an
update on the Company’s clinical development programs and
regulatory and commercial outlook for 2021.
“Despite the evident COVID-related challenges of 2020, we are
pleased with our overall sales performance and pipeline progress,”
said Patrick J. Mahaffy, President and CEO of Clovis Oncology.
“Most importantly, we advanced our development programs in 2020,
positioning them for important potential achievements in 2021,
including the initiation of clinical development for FAP-2286 in
the first half of the year, top-line ATHENA monotherapy data in the
second half of the year and initial efficacy data for the LIO-1
lucitanib and Opdivo combination trial at medical meetings later
this year. While early, we are increasingly enthusiastic about
FAP-2286 and our commitment to becoming a leader in the emerging
field of targeted radionuclide therapy.”
Fourth Quarter and Year-End 2020 Financial Results
Clovis reported global net product revenues for Rubraca of $43.3
million for the fourth quarter of 2020, which included U.S. product
revenues of $36.4 million and ex-U.S. product revenues of $6.9
million, respectively. This represents a 10 percent increase
year-over-year compared to Q4 2019 net product revenues of $39.3
million, which included U.S. net product revenues of $36.1 million
and ex-U.S. net product revenues of $3.2 million.
Rubraca global net product revenues for 2020 were $164.5
million, which included $146.3 million in the U.S. and $18.2
million in ex-U.S. product revenues, respectively. This represents
a 15 percent increase year-over-year compared to 2020 net product
revenues of $143.0 million, which included $137.2 million in the
U.S. and ex-U.S. net product revenues of $5.8 million.
Research and development expenses totaled $56.7 million for Q4
2020 and $257.7 million for FY 2020, down 22 percent and 9 percent,
respectively, compared to $72.5 million and $283.1 million for the
comparable periods in 2019. Research and development expenses
decreased for the quarter and year compared to the same periods in
the prior year due primarily to lower spending on Rubraca clinical
trials. We expect research and development expenses to be lower in
the full year 2021 compared to 2020.
Selling, general and administrative expenses totaled $40.8
million for Q4 2020 and $163.9 million for FY 2020, both down 10
percent compared to $45.2 million and $182.8 million for the
comparable periods in 2019. Selling, general and administrative
expenses decreased during the quarter and year compared to the same
periods in the prior year with savings due to the COVID-19
situation globally and overall cost reduction efforts. We expect
selling, general and administrative expenses to decrease in the
full year 2021 compared to 2020.
Clovis reported a net loss for the fourth quarter of 2020 of
$99.0 million, or ($1.02) per share, and a net loss of $369.2
million, or ($4.38) per share, for FY 2020. Net loss for Q4 2019
was $99.5 million, or ($1.81) per share, and $400.4 million, or a
net loss of ($7.43) per share, for FY 2019. Net loss for Q4 and FY
2020 included share-based compensation expense of $12.0 million and
$50.8 million, compared to $12.6 million and $54.3 million for the
comparable periods of 2019.
Clovis had $240.2 million in cash and cash equivalents as of
December 31, 2020, which is expected to fund the Company’s
operating plan into early 2023 based on current revenue and expense
forecasts.
As of December 31, 2020, the Company had drawn approximately
$100 million under the Sixth Street Partners, LLC ATHENA clinical
trial financing and had up to $75 million available to draw under
the agreement to fund the expenses of the ATHENA trial.
Net cash used in operating activities was $56.1 million for the
fourth quarter of 2020, down from $70.1 million reported in the
fourth quarter of 2019. Similarly, net cash used in operating
activities for FY 2020 was $252.7 million, compared with $323.6
million for FY 2019. Cash burn in Q4 2020 was $40.9 million, down
27 percent from the Q4 2019 quarter cash burn of $56.3 million.
Cash burn for the twelve months ended December 31, 2020 was $195.6M
million, down 36 percent from the twelve months ended 2019 cash
burn of $304.7 million. We expect this trend of lower cash burn to
continue in 2021.
Clovis Oncology Pipeline Highlights
Rubraca ARIEL4 Study Met Primary Endpoint of Improved PFS
Compared to Chemotherapy
In December, Clovis announced the top line results of the ARIEL4
randomized Phase 3 study of Rubraca versus standard-of-care
chemotherapy, in which Rubraca met the primary endpoint of
significantly improving progression-free survival (PFS) in
later-line ovarian cancer patients with a BRCA mutation. The safety
observed in the study was highly consistent with both the U.S. and
European labels. These results were submitted as a late-breaking
abstract and accepted as an oral presentation at the upcoming
Society for Gynecologic Oncology Virtual Annual Meeting in March.
Completion of ARIEL4 is a post-marketing commitment in the U.S. and
Europe.
Anticipated Rubraca Pipeline Events in 2021
Top-line data from the ATHENA Phase 3 study in first-line
maintenance treatment ovarian cancer setting evaluating Rubraca
monotherapy versus placebo are expected in the second-half of 2021,
contingent on achieving sufficient PFS events. Data from the
combination arm of Rubraca plus Opdivo versus Rubraca monotherapy
are expected a year or more later.
LODESTAR, the Company’s Phase 2 trial of Rubraca in patients
with solid tumors with deleterious mutations in homologous
recombination repair (HRR) genes is currently enrolling. This study
may be registration-enabling with a potential regulatory filing by
the end of 2021 or first-half 2022.
LuMIERE Phase 1/2 Study of FAP-2286 Expected to Begin 1H
2021
FAP-2286 is Clovis Oncology’s peptide-targeted radionuclide
therapy (PTRT) and imaging agent targeting fibroblast activation
protein (FAP) and represents its lead candidate in the PTRT
development program. Clovis intends to initiate the Phase 1/2
LuMIERE clinical study of lutetium-177 labeled FAP-2286
(177Lu-FAP-2286) to determine the dose and tolerability of the
FAP-targeting therapeutic agent (Phase 1), with expansion cohorts
planned in multiple tumor types (Phase 2). FAP-2286 labelled with
gallium-68 (68Ga-FAP-2286) will be utilized as a diagnostic to
identify patients with FAP-positive tumors appropriate for
treatment with the therapeutic agent. The LuMIERE study is expected
to begin in the first half of 2021, pending acceptance by the FDA
of gallium-68 CMC data from clinical sites. Other studies of
FAP-2286 linked to an alpha-particle emitting radionuclide and
combination studies are also being planned.
Interim LIO-1 data of Lucitanib and Opdivo in Combination
Expected in 2021
The Phase 2 part of the LIO-1 study of lucitanib in combination
with Opdivo continues to enroll patients with gynecologic cancers,
and Clovis Oncology intends to present initial data at 2021 medical
meetings, which are expected to include interim results from the
ovarian and endometrial cancer expansion cohorts.
Conference Call Details
Clovis will hold a conference call to discuss Q4/FY 2020 results
this morning, February 23, 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: 5869256.
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. Select patients for therapy based on an FDA-approved
companion diagnostic for Rubraca. 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 investigational angiogenesis inhibitor, which
inhibits 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. Clovis
holds global rights for lucitanib excluding China.
Lucitanib is an unlicensed medical product.
About FAP-2286
FAP-2286 is a preclinical candidate under investigation as a
peptide-targeted radionuclide therapy (PTRT) and imaging agent
targeting fibroblast activation protein (FAP). FAP-2286 consists of
two parts; a peptide that binds to FAP and a linker and site that
can be used to attach radiation for imaging and therapeutic use.
FAP is highly expressed in many epithelial cancers, including more
than 90 percent of breast, lung, colorectal and pancreatic
carcinomas. Clovis holds U.S. and global rights for FAP-2286
excluding Europe, Russia, Turkey, and Israel.
FAP-2286 is an unlicensed medical product.
About Peptide-Targeted Radionuclide Therapy
Peptide-targeted radionuclide therapy (PTRT) is a form of
targeted radiotherapy that is emerging as a new treatment option
for patients with cancer. These therapies consist of a small amount
of a radioactive isotope, known as a radionuclide, linked to a
cell-targeting peptide that binds to a cancer specific protein
which selectively directs the radionuclide to tumors. Following
binding, the radionuclide warhead emits ionizing radiation causing
DNA damage and cell death to neighboring tumor cells.
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, 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, 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, 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 Sixth Street Partners,
LLC. 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 December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
Revenues: Product revenue
$ 43,299
$ 39,307
$ 164,522
$ 143,006
Operating expenses: Cost of sales - product
9,474
7,942
36,128
29,926
Cost of sales - intangible asset amortization
1,342
1,211
5,177
4,760
Research and development
56,706
72,473
257,707
283,146
Selling, general and administrative
40,758
45,168
163,894
182,769
Acquired in-process research and development
-
-
-
9,440
Other operating expenses
-
4,172
3,804
9,711
Total expenses
108,280
130,966
466,710
519,752
Operating loss
(64,981
)
(91,659
)
(302,188
)
(376,746
)
Other income (expense): Interest expense
(7,349
)
(6,720
)
(30,508
)
(19,405
)
Foreign currency gain (loss)
30
100
(72
)
(547
)
(Loss) gain on extinguishment of debt
-
-
(3,277
)
18,480
Loss on convertible senior notes conversion
(27,284
)
-
(35,075
)
-
Legal settlement loss
-
-
-
(26,750
)
Other income
202
1,262
1,361
6,342
Other income (expense), net
(34,401
)
(5,358
)
(67,571
)
(21,880
)
Loss before income taxes
(99,382
)
(97,017
)
(369,759
)
(398,626
)
Income tax benefit (expense)
425
(2,484
)
547
(1,798
)
Net loss
$ (98,957
)
$ (99,501
)
$ (369,212
)
$ (400,424
)
Basic and diluted net loss per common share
$ (1.02
)
$ (1.81
)
$ (4.38
)
$ (7.43
)
Basic and diluted weighted-average common shares
96,681
54,834
84,307
53,873
CONSOLIDATED BALANCE SHEET DATA (Unaudited, in thousands)
December 31, 2020 December
31, 2019 Cash and cash equivalents
$ 240,229
$ 161,833
Available-for-sale securities
-
134,826
Working capital
125,901
233,384
Total assets
605,554
669,604
Convertible senior notes
499,044
644,751
Common stock and additional paid-in capital
2,498,283
2,114,123
Total stockholders' deficit
(158,748
)
(174,257
)
Other Data (Unaudited, in thousands)
Twelve Months Ended December
31,
2020
2019
Net cash used in operating activities
(252,728
)
(323,615
)
Share Based Compensation Expense
50,794
54,304
RECONCILIATION OF NET CASH USED IN OPERATING ACTIVITIES
TO CASH BURN (Unaudited, in thousands)
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
Net cash used in operating activities
$ (56,053
)
$ (70,147
)
$ (252,728
)
$ (323,615
)
Adjustments: Acquired in-process research and development -
milestone payment
-
-
(8,000
)
(15,750
)
Proceeds from borrowings under financing agreement
15,156
13,828
65,119
34,636
Cash burn
$ (40,897
)
$ (56,319
)
$ (195,609
)
$ (304,729
)
Net cash (used in) provided by investing activities
$ (260
)
$ 16,767
$ 126,328
$ 143,398
Net cash provided by financing activities
$ 71,836
$ 13,206
$ 203,644
$ 119,888
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 Sixth Street 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 Sixth Street 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/20210223005296/en/
Breanna Burkart 303.625.5023 bburkart@clovisoncology.com
Anna Sussman 303.625.5022 asussman@clovisoncology.com
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