- $36.8M in Rubraca® (rucaparib) global net product revenues for
Q2 2021, down 8% vs. Q2 2020, due to continuing impact of
COVID-19
- Phase 1/2 LuMIERE clinical study of FAP-2286 open for
enrollment, first peptide-targeted radionuclide therapeutic
candidate targeting FAP in clinical development
- Three top-line Phase 3 data read-outs for Rubraca anticipated
over the next six to 18 months with potential to address larger
ovarian and prostate cancer patient populations in earlier lines of
therapy
- $72.5M in net proceeds raised through “at-the-market” equity
offering program in Q2 2021
- $230.2M in cash and cash equivalents and $48.1M in available
funding under the ATHENA financing at June 30, 2021
- $33.1M or 30% reduction in R&D and SG&A expense and 22%
reduction in net cash used in operating activities compared to Q2
2020
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended June 30, 2021, and provided an update on the
Company’s clinical development programs and regulatory and
commercial outlook for the rest of the year.
“While these are obviously complicated times, I’m encouraged
that, based on the data available to us, we have maintained our US
market share for Rubraca and achieved meaningful growth in Europe
in the second-line maintenance ovarian cancer setting, and
significantly advanced our development and pipeline programs during
the quarter,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “Importantly, in the next six to 18 months, we expect
three Phase 3 data read-outs for Rubraca, potentially expanding the
number of ovarian and prostate cancer patients eligible for Rubraca
treatment in the US and Europe, which we anticipate will drive
growth in sales. In addition, we achieved a significant milestone
in the second quarter with the initiation of our Phase 1/2 LuMIERE
clinical study of FAP-2286, the first peptide-targeted radionuclide
therapeutic targeting FAP in clinical development. This represents
the first of multiple anticipated milestones in our strategy to
develop innovative precision-targeted radiotherapies for a broad
range of tumors.”
Second Quarter 2021 Financial Results
Clovis reported global net product revenues for Rubraca of $36.8
million for Q2 2021, which included US product revenues of $27.7
million and ex-US product revenues of $9.1 million, respectively.
This represents an 8% decrease year-over-year, compared to Q2 2020
net product revenues of $39.9 million, which included US net
product revenues of $36.7 million and ex-US net product revenues of
$3.2 million. The decrease was primarily due to fewer diagnoses and
fewer patient starts, due to the ongoing COVID-19 pandemic.
Clovis reported net product revenue for Rubraca of $74.9 million
for the six months ended June 30, 2021, which included US product
revenue of $59.4 million and ex-U.S. product revenue of $15.5
million, compared to net product revenue for same period in 2020 of
$82.5 million, which included US net product revenue of $76.0
million and ex-US net product revenue of $6.5 million.
Research and development expenses totaled $45.8 million for Q2
2021, down 35% compared to $69.9 million for the comparable period
in 2020, due primarily to lower spending on Rubraca clinical
trials. For the six months ended June 30, 2021, research and
development expenses totaled $98.6 million, down 29% compared to
$138.1 million for the comparable period in 2020. 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 $32.9
million for Q2 2021, down 21% compared to $41.9 million for the
comparable period in 2020, due to overall cost reduction efforts.
For the six months ended June 30, 2021, selling, general and
administrative expenses totaled $62.9 million, down 26% compared to
$84.5 million for the comparable period in 2020. 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 Q2 2021 of $66.4 million, or
($0.61) per share, compared to a net loss for Q2 2020 of $92.2
million, or ($1.15) per share. Net loss for Q2 2021 included
share-based compensation expense of $7.4 million, compared to $13.3
million for the comparable period of 2020.
Clovis had $230.2 million in cash and cash equivalents as of
June 30, 2021. During Q2 2021, the Company raised $72.5 million in
net proceeds through its “at-the-market” equity offering
program.
As of June 30, 2021, the Company had drawn $126.9 million under
the Sixth Street Partners, LLC (SSP) ATHENA clinical trial
financing and had up to $48.1 million available to draw under the
agreement to fund the expenses of the ATHENA trial.
Net cash used in operating activities was $46.8 million for Q2
2021, down 22% from the $59.9 million reported in Q2 2020. Net cash
used in operating activities for the first six months of 2021 was
$108.6 million, down 24% from the same period in 2020.
Cash burn in Q2 2021 was $33.4 million, down 33% from $50.1
million in Q2 2020. Cash burn for the first six months of 2021 was
$81.5 million, down 30% from $117.0 million in the first six months
of 2020.
Clovis Oncology Pipeline Highlights
Three Anticipated Rubraca Phase 3 Read-outs in Next 6 to 18
Months
Top-line data from the ATHENA Phase 3 study in first-line
maintenance treatment ovarian cancer setting evaluating Rubraca
monotherapy versus placebo are now expected in the first quarter of
2022 based on event-based projections. Data from the combination
arm of Rubraca plus Opdivo® (nivolumab) versus Rubraca monotherapy
are expected in the second half of 2022 based on protocol-defined
assumptions.
Top-line data from the TRITON3 trial, which is expected to serve
as the confirmatory study for Rubraca’s approval in metastatic
castration-resistant prostate cancer (mCRPC) as well as a potential
second-line label expansion, are expected in the second quarter of
2022. TRITON3 is a Phase 3 study evaluating Rubraca versus
physician’s choice of chemotherapy or second-line androgen
deprivation therapy in patients with mCRPC with BRCA and ATM
mutations.
The three anticipated data readouts, ATHENA monotherapy, ATHENA
combination and TRITON3, provide the potential to reach larger
patient populations in earlier lines of therapy for ovarian and
prostate cancers, in which Rubraca is currently approved in
later-line indications. The timing for each data readout is
contingent upon the occurrence of the protocol-specified
progression-free survival (PFS) events.
LuMIERE Phase 1/2 Study of FAP-2286 Now Opened for
Enrollment
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 TRT
development program. Following FDA clearance of each of the
treatment and imaging IND applications for FAP-2286, Clovis opened
enrollment for the Phase 1/2 LuMIERE clinical study. 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 used as an investigational imaging agent to
identify patients with FAP-positive tumors appropriate for
treatment in LuMIERE. Once the Phase 2 dose is determined, Phase 2
expansion cohorts are planned in multiple tumor types.
Conference Call Details
Clovis will hold a conference call this morning, August 4, at
8:30 a.m. ET to discuss Q2 2021 results and provide an update on
the Company’s clinical development programs and regulatory and
commercial outlook for the rest of the year. The conference call
will be simultaneously webcast on the Clovis Oncology website at
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:
3887398.
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 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 June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Revenues: Product revenue
$
36,820
$
39,887
$
74,873
$
82,451
Operating expenses:
Cost of sales - product
8,294
9,120
16,562
18,216
Cost of sales - intangible asset amortization
1,343
1,280
2,686
2,492
Research and development
45,759
69,878
98,564
138,099
Selling, general and administrative
32,918
41,902
62,859
84,500
Acquired in-process research and development
2,204
-
2,204
-
Other operating expenses
3,884
355
7,591
3,805
Total expenses
94,402
122,535
190,466
247,112
Operating loss
(57,582
)
(82,648
)
(115,593
)
(164,661
)
Other income (expense):
Interest expense
(8,770
)
(6,739
)
(16,807
)
(16,300
)
Foreign currency (loss) gain
(206
)
142
(752
)
(735
)
Loss on convertible notes conversion
-
-
-
(7,791
)
Loss on extinguishment of debt
-
(3,277
)
-
(3,277
)
Other income
107
239
290
1,081
Other income (expense), net
(8,869
)
(9,635
)
(17,269
)
(27,022
)
Loss before income taxes
(66,451
)
(92,283
)
(132,862
)
(191,683
)
Income tax (expense) benefit
3
36
137
104
Net loss
$
(66,448
)
$
(92,247
)
$
(132,725
)
$
(191,579
)
Basic and diluted net loss per
common share
$
(0.61
)
$
(1.15
)
$
(1.25
)
$
(2.52
)
Basic and diluted
weighted-average common shares
108,481
80,453
106,375
76,057
CONSOLIDATED BALANCE SHEET DATA (Unaudited, in thousands)
June 30, 2021 Dec 31,
2020 Cash and cash equivalents
$
230,204
$
240,229
Working capital
122,474
125,901
Total assets
572,229
605,554
Convertible senior notes
500,112
499,044
Common stock and additional paid-in capital
2,582,839
2,498,283
Total stockholders' deficit
(206,983
)
(158,748
)
Other Data
(Unaudited, in thousands)
Six Months Ended June 30,
2021
2020
Net cash used in operating activities
$
(108,645
)
$
(142,351
)
Share Based Compensation Expense
$
11,401
$
26,274
RECONCILIATION OF NET CASH USED IN OPERATING ACTIVITIED TO CASH
BURN (Unaudited, in thousands)
Three Months Ended June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Net cash used in operating
activities
$
(46,755
)
$
(59,857
)
$
(108,645
)
$
(142,351
)
Adjustments: Acquired in-process
research and development - milestone payment
-
(8,000
)
-
(8,000
)
Proceeds from borrowings under financing agreement
13,351
17,730
27,154
33,322
Cash burn
$
(33,404
)
$
(50,127
)
$
(81,491
)
$
(117,029
)
Net cash (used in) provided by
investing activities
$
(36
)
$
56,800
$
(154
)
$
126,607
Net cash provided by financing
activities
$
85,940
$
101,007
$
99,316
$
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 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/20210804005226/en/
Breanna Burkart (303) 625-5023 bburkart@clovisoncology.com
Anna Sussman (303) 625-5022 asussman@clovisoncology.com
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