- $38.1M in Rubraca® (rucaparib) global net product revenues for
Q1 2021, down 11% vs. Q1 2020, due to continued headwinds from
COVID-19 in the US and Europe
- Maintained US market share as US PARP inhibitor market impacted
by COVID-19
- Imaging and treatment INDs cleared by FDA for FAP-2286, a novel
peptide-targeted radionuclide therapy (PTRT)
- Phase 1/2 LuMIERE study of FAP-2286 expected to open for
enrollment this quarter
- Top-line data from Phase 3 ATHENA trial of Rubraca as
first-line maintenance treatment for ovarian cancer monotherapy
anticipated 2H 2021
- $190.9M in cash and cash equivalents and $61.4M in available
funding under the ATHENA financing at March 31, 2021, anticipated
to fund the Company’s operating plan into early 2023 based on
current revenue and expense forecasts
- $28.1M reduction in R&D and SG&A expense and 25%
reduction in net cash used in operating activities compared to Q1
2020
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended March 31, 2021, and provided an update on the
Company’s clinical development programs and regulatory and
commercial outlook for the rest of the year.
“The second quarter of 2021 marks an important moment in our
commitment to targeted radionuclide therapies, as the FDA clearance
of our INDs for FAP-2286 enables us to initiate the Phase 1 portion
of the LuMIERE study this quarter as planned. We are increasingly
enthusiastic about FAP-2286 and its potential to treat patients
with solid tumors, and about targeted radiotherapeutics as a
class,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “While continuing headwinds from COVID-19 impacted
Rubraca sales this quarter, we believe this effect will lessen over
the course of this year. Importantly, since each approved PARP
inhibitor faced some impact from COVID-19 in the US market in Q1
2021 compared to Q4 2020, we believe we maintained market share in
the US. Finally, we are not far from top-line ATHENA monotherapy
data as a front-line maintenance treatment for women with advanced
ovarian cancer, expected in the second half of this year, which
will be the most important indication for Rubraca.”
First Quarter 2021 Financial Results
Clovis reported global net product revenues for Rubraca of $38.1
million for Q1 2021, which included US product revenues of $31.7
million and ex-US product revenues of $6.4 million, respectively.
This represents an 11% decrease year-over-year, compared to Q1 2020
net product revenues of $42.6 million, which included US net
product revenues of $39.3 million and ex-US net product revenues of
$3.3 million. The decrease was primarily due to fewer diagnoses and
fewer patient starts, substantially due to the ongoing COVID-19
pandemic. In addition, first quarter 2020 was the Company’s
strongest quarter of US Rubraca sales to date, and the COVID-19
pandemic had limited, if any, effect on Q1 2020 net revenues.
Research and development expenses totaled $52.8 million for Q1
2021, down 23% compared to $68.2 million for the comparable period
in 2020, due primarily to lower spending on Rubraca clinical
trials. As previously discussed, the Company expects research and
development expenses to be lower in the full year 2021 compared to
2020.
Selling, general and administrative expenses totaled $29.9
million for Q1 2021, down 30% compared to $42.6 million for the
comparable period in 2020, due to the COVID-19 situation globally
and overall cost reduction efforts. Clovis continues to expect
selling, general and administrative expenses to decrease in the
full year 2021 compared to 2020.
Clovis reported a net loss for Q1 2021 of $66.3 million, or
($0.64) per share, compared to a net loss for Q1 2020 of $99.3
million, or ($1.39) per share. Net loss for Q1 2021 included
share-based compensation expense of $4.0 million, compared to $13.0
million for the comparable period of 2020.
Clovis had $190.9 million in cash and cash equivalents as of
March 31, 2021, which together with the ATHENA clinical trial
financing, is expected to fund the Company’s operating plan into
early 2023 based on current revenue and expense forecasts.
As of March 31, 2021, the Company had drawn $113.6 million under
the Sixth Street Partners, LLC (SSP) ATHENA clinical trial
financing and had up to $61.4 million available to draw under the
agreement to fund the expenses of the ATHENA trial.
Net cash used in operating activities was $61.9 million for Q1
2021, down from $82.5 million reported in Q1 2020. Cash burn in Q1
2021 was $48.1 million, down 28% from $66.9 million in Q1 2020. We
expect this trend of lower cash burn to continue in 2021.
Clovis Oncology Pipeline Highlights
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 upon the occurrence of the protocol-specified
progression-free survival (PFS) events. Data from the combination
arm of Rubraca plus Opdivo® (nivolumab) 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 in
1H 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 is the lead candidate in the Company’s PTRT
development program. With FDA clearance of each of the treatment
and imaging IND applications for FAP-2286, Clovis expects to open
for enrollment the Phase 1/2 LuMIERE clinical study this quarter.
The Phase 1 portion of the LuMIERE study will evaluate the safety
of the FAP-targeting investigational therapeutic agent and identify
the recommended Phase 2 dose and schedule of lutetium-177 labeled
FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68
(68Ga-FAP-2286) will be utilized as an investigational imaging
agent to identify patients with FAP-positive tumors appropriate for
treatment with the therapeutic agent. Once the Phase 2 dose is
determined, Phase 2 expansion cohorts are planned in multiple tumor
types.
Interim LIO-1 Data of Lucitanib and Opdivo in Combination
Expected in 2021
Clovis Oncology’s Phase 1b/2 LIO-1 study is evaluating the
combination of lucitanib and Opdivo in gynecologic cancers, and the
Phase 2 portion is enrolling patients into four expansion cohorts:
non-clear cell ovarian; non-clear cell endometrial; cervical; and
clear-cell ovarian and endometrial cancers. Interim data from the
non-clear-cell ovarian cancer expansion cohort have been accepted
as a poster presentation at ASCO in early June, and while evidence
of clinical activity has been observed, Clovis does not believe
that the efficacy data support further development in
non-clear-cell ovarian cancer. Enrollment continues in the three
other expansion cohorts, and the Company continues to plan to
submit an abstract to a medical meeting later this year describing
the interim endometrial cohort data.
Conference Call Details
Clovis will hold a conference call to discuss Q1 2021 results
this morning, May 5, at 8:30am ET. The conference call will be
simultaneously webcast on the Clovis Oncology website
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: 3219208.
About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 being developed in 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 US 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 the US and
Europe.
About FAP-2286
FAP-2286 is a clinical candidate under investigation as a
peptide-targeted radionuclide therapy (PTRT) and imaging agent
targeting fibroblast activation protein (FAP). FAP-2286 consists of
two functional elements; a targeting peptide that binds to FAP and
a site that can be used to attach radioactive isotopes for imaging
and therapeutic use. FAP is highly expressed on cancer-associated
fibroblasts (CAFs) in many epithelial cancers, including more than
90% of breast, lung, colorectal, and pancreatic carcinomas.i Clovis
holds US and global rights for FAP-2286 excluding Europe, Russia,
Turkey, and Israel.
FAP-2286 is an unlicensed medical product.
About Targeted Radionuclide Therapy
Targeted radionuclide therapy is an emerging class of cancer
therapeutics, which seeks to deliver radiation directly to the
tumor while minimizing delivery of radiation to normal tissue.
Targeted radionuclides are created by linking radioactive isotopes,
also known as radionuclides, to targeting molecules (e.g.,
peptides, antibodies, small molecules) that can bind specifically
to tumor cells or other cells in the tumor environment. Based on
the radioactive isotope selected, the resulting agent can be used
to image and/or treat certain types of cancer. Agents that can be
adapted for both therapeutic and imaging use are known as
“theranostics.” Clovis is developing a pipeline of novel, targeted
radiotherapies for cancer treatment and imaging, including its lead
candidate, FAP-2286, an investigational peptide-targeted
radionuclide therapeutic (PTRT) and imaging agent, as well as three
additional discovery-stage compounds.
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 Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing, and commercializing innovative anti-cancer
agents in the US, 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 US 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 timing and extent
of recovery from the impact of COVID-19, 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.
___________________________ i Rettig WJ et al. Regulation and
Heteromeric Structure of the Fibroblast Activation Protein in
Normal and Transformed Cells of Mesenchymal and Neuroectodermal
Origin. Cancer Res. 1993;53:3327–3335.
CLOVIS ONCOLOGY, INC CONSOLIDATED
FINANCIAL RESULTS (Unaudited, in thousands, except per
share amounts)
Three Months Ended March 31,
2021
2020
Revenues: Product revenue
$
38,053
$
42,564
Operating expenses: Cost of sales - product
8,268
9,096
Cost of sales - intangible asset amortization
1,343
1,212
Research and development
52,805
68,221
Selling, general and administrative
29,941
42,598
Other operating expenses
3,707
3,449
Total expenses
96,064
124,576
Operating loss
(58,011
)
(82,012
)
Other income (expense): Interest expense
(8,037
)
(9,561
)
Foreign currency loss
(546
)
(877
)
Loss on convertible senior notes conversion
-
(7,791
)
Other income
183
841
Other income (expense), net
(8,400
)
(17,388
)
Loss before income taxes
(66,411
)
(99,400
)
Income tax benefit
134
68
Net loss
$
(66,277
)
$
(99,332
)
Basic and diluted net loss per common share
$
(0.64
)
$
(1.39
)
Basic and diluted weighted-average common shares
104,246
71,662
CONSOLIDATED BALANCE SHEET DATA (In thousands)
March 31, 2021 (Unaudited) December 31,
2020 Cash and cash equivalents
$
190,922
$
240,229
Working capital
79,277
125,901
Total assets
548,838
605,554
Convertible senior notes
499,625
499,044
Common stock and additional paid-in capital
2,502,349
2,498,283
Total stockholders' deficit
(221,039
)
(158,748
)
Other Data (Unaudited, in thousands)
Three
Months Ended March 31,
2021
2020
Net cash used in operating activities
$
(61,890
)
(82,494
)
Share Based Compensation Expense
4,039
12,961
RECONCILIATION OF NET CASH USED IN OPERATING
ACTIVITIES TO CASH BURN (Unaudited, in
thousands)
Three Months Ended March 31,
2021
2020
Net cash used in operating activities
$
(61,890
)
$
(82,494
)
Adjustments: Proceeds from borrowings under financing agreement
13,802
15,592
Cash burn
$
(48,088
)
$
(66,902
)
Net cash (used in) provided by investing activities
$
(118
)
$
69,807
Net cash provided by financing activities
$
13,376
$
14,644
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 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 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/20210505005172/en/
Breanna Burkart (303) 625-5023 bburkart@clovisoncology.com
Anna Sussman (303) 625-5022 asussman@clovisoncology.com
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