- $37.9M in Rubraca® (rucaparib) global net product revenues for
Q3 2021, up 3% over Q2 2021 and down 2% from Q3 2020
- Three top-line Phase 3 data read-outs for Rubraca expected in
2022 with potential to address larger ovarian and prostate cancer
patient populations in earlier lines of therapy
- Phase 1 LuMIERE study of targeted radiotherapy candidate
FAP-2286 ongoing; initial Phase 1 data expected at medical meeting
in 2022, as well as initiation of Phase 2 expansion cohorts in
multiple tumor types
- Retired final $64.4M in principal amount of 2021 notes and
raised net proceeds of $41.5M through ATM equity offering program
in Q3 2021, complementing ongoing focus on cost control
- $171.9M in cash and cash equivalents and $37.5M in available
funding under the ATHENA financing at September 30, 2021
- Reduction in R&D and SG&A expense of $23.1M, or 23%,
and reduction in net cash used in operating activities of $8.3M, or
15%, each as compared to Q3 2020
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended September 30, 2021, and provided an update on
the Company’s clinical development programs and regulatory and
commercial outlook.
“While COVID-19 continues to impact our revenues, as fewer
patients have been diagnosed and treated for ovarian cancer during
the pandemic, it has not affected our development programs. We
remain on track for an eventful 2022, with three data readouts from
Phase 3 ATHENA and TRITON3 studies of Rubraca with label expansion
potential, as well as initial data from the ongoing Phase 1 LuMIERE
study of our first targeted radiotherapy candidate FAP-2286
anticipated during 2022,” said Patrick J. Mahaffy, President and
CEO of Clovis Oncology. “With the additional capital raised in the
quarter and recent repayment of the remaining 2021 notes, we have
made further progress on improving our balance sheet and remain
focused on our three core strategies: expand the Rubraca label to
drive revenue growth, emerge as a leader in targeted radionuclide
therapy, and achieve long-term financial stability.”
Third Quarter 2021 Financial Results
Clovis reported global net product revenues for Rubraca of $37.9
million for Q3 2021, which included US product revenues of $28.7
million and ex-US product revenues of $9.2 million, respectively.
This represents a sequential 3% increase over Q2 2021 and a 2%
decrease year-over-year, compared to Q3 2020 net product revenues
of $38.8 million, which included US net product revenues of $33.9
million and ex-US net product revenues of $4.9 million. The
decrease in year-over-year revenues was primarily due to fewer
ovarian cancer diagnoses and fewer patients treated in the US
related to the ongoing impact of COVID-19.
Clovis reported net product revenue for Rubraca of $112.8
million for the nine months ended September 30, 2021, which
included US product revenue of $88.1 million and ex-US product
revenue of $24.7 million, compared to net product revenue for same
period in 2020 of $121.2 million, which included US net product
revenue of $109.8 million and ex-US net product revenue of $11.4
million.
Research and development expenses totaled $46.2 million for Q3
2021, down 27% compared to $62.9 million for the comparable period
in 2020, due primarily to lower spending on Rubraca clinical
trials. For the nine months ended September 30, 2021, research and
development expenses totaled $144.8 million, down 28% compared to
$201.0 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 $32.2
million for Q3 2021, down 17% compared to $38.6 million for the
comparable period in 2020, due to overall cost reduction efforts.
For the nine months ended September 30, 2021, selling, general and
administrative expenses totaled $95.1 million, down 23% compared to
$123.1 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 Q3 2021 of $67.4 million, or
($0.56) per share, compared to a net loss for Q3 2020 of $78.7
million, or ($0.89) per share. Net loss for Q3 2021 included
share-based compensation expense of $7.0 million, compared to $12.5
million for the comparable period of 2020.
Clovis had $171.9 million in cash and cash equivalents as of
September 30, 2021. During Q3 2021, the Company established an
“at-the-market” equity offering program (ATM) with the capacity to
issue up to $125 million of shares of common stock. During Q3, the
Company raised $41.5 million in net proceeds through this ATM.
Clovis also paid off in full at maturity, the remaining $64.4
million in principal amount outstanding of its 2.50% convertible
senior notes due 2021. The Company’s next convertible debt maturity
is August 1, 2024 and has a conversion price of $7.29 for a
portion, and a conversion price of $6.24 for the remainder.
As of September 30, 2021, the Company had drawn $137.5 million
under the Sixth Street Partners, LLC (SSP) ATHENA clinical trial
financing and had up to $37.5 million available to draw under the
agreement to fund the expenses of the ATHENA trial.
Net cash used in operating activities was $46.1 million for Q3
2021, down 15% from the $54.3 million reported in Q3 2020. Net cash
used in operating activities for the first nine months of 2021 was
$154.7 million, down 21% from the same period in 2020.
Cash burn in Q3 2021 was $35.5 million, down 6% from $37.7
million in Q3 2020. Cash burn for the first nine months of 2021 was
$117.0 million, down 24% from $154.7 million in the first nine
months of 2020.
Clovis Oncology Pipeline Highlights
Three Anticipated Rubraca Phase 3 studies on Track for 2022
Readouts
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 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 full data release is
contingent upon the occurrence of the protocol-specified
progression-free survival (PFS) events.
LuMIERE Phase 1/2 Study of FAP-2286 Enrolling Patients with
FAP-Positive Solid Tumors into Phase 1; Initial Phase 1 LuMIERE
Data Expected in 2022
FAP-2286 is the first peptide-targeted radionuclide therapy
(PTRT) and imaging agent targeting fibroblast activation protein
(FAP) to enter clinical development and is the lead candidate in
Clovis Oncology’s TRT development program. The ongoing Phase 1
portion of the LuMIERE study, for which enrollment in the second
dose cohort is expected to initiate in Q4 2021, is evaluating the
safety of the FAP-targeting investigational therapeutic agent and
will 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. The first presentations of
Phase 1 data from LuMIERE are expected at medical meetings in 2022.
Once the Phase 2 dose is determined, Phase 2 expansion cohorts are
planned in multiple tumor types and are expected to initiate in
2022.
Nonclinical data evaluating FAP expression across a variety of
solid tumor types were presented at AACR-NCI-EORTC in October. High
FAP expression was observed in multiple indications, including
pancreatic ductal adenocarcinoma, salivary gland, mesothelioma,
colon, bladder, sarcoma, squamous NSCLC, and head and neck cancers
as well as in cancers of unknown primary. In these tumor types,
high FAP expression was detected in both primary and metastatic
tumor samples and was independent of tumor stage or grade. The
analysis also demonstrated that in most tumor types, FAP expression
was predominantly localized to cancer-associated fibroblasts (CAFs)
surrounding the tumor cells and integrated into the tumor
microenvironment. In addition, in cancers of mesenchymal origin
including sarcoma and mesothelioma, expression was observed in
tumor cells in addition to CAFs. These data support the
investigation of FAP-2286 in multiple tumor types in the planned
Phase 2 expansion cohorts of LuMIERE. Additional presentations of
nonclinical data are anticipated at medical meetings over the next
few quarters.
In addition, Clovis and ITM Isotope Technologies Munich SE
recently announced the signing of a clinical supply agreement that
provides Clovis with ITM’s therapeutic radioisotope
no-carrier-added lutetium-177 (n.c.a. 177Lu), EndolucinBeta®, for
use in the clinical development of FAP-2286 for the next five
years.
For more information about FAP-2286, targeted radionuclide
therapy (TRT), or Clovis’ TRT development program, click here.
Conference Call Details
Clovis will hold a conference call this morning, November 3, at
8:30am ET, to discuss Q3 2021 results and provide an update on the
Company’s clinical development programs and regulatory and
commercial outlook. 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 (888) 440-4615, International
participants (646) 960-0682, conference ID: 2259685.
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. High FAP expression has been shown in
pancreatic ductal adenocarcinoma, salivary gland, mesothelioma,
colon, bladder, sarcoma, squamous non-small cell lung, squamous
head and neck cancers, and cancers of unknown primary. High FAP
expression was detected in both primary and metastatic tumor
samples and was independent of tumor stage or grade. 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 made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
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 those 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.
CLOVIS ONCOLOGY, INC
CONSOLIDATED FINANCIAL RESULTS (Unaudited, in thousands,
except per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Revenues: Product revenue
$
37,916
$
38,772
$
112,789
$
121,223
Operating expenses: Cost of sales - product
8,506
8,438
25,068
26,654
Cost of sales - intangible asset amortization
1,343
1,343
4,028
3,834
Research and development
46,222
62,902
144,786
201,000
Selling, general and administrative
32,196
38,636
95,055
123,136
Acquired in-process research and development
3,272
-
5,477
-
Other operating expenses
3,841
-
11,431
3,805
Total expenses
95,380
111,319
285,845
358,429
Operating loss
(57,464
)
(72,547
)
(173,056
)
(237,206
)
Other income (expense): Interest expense
(8,786
)
(6,859
)
(25,593
)
(23,160
)
Foreign currency (loss) gain
(1,248
)
633
(2,001
)
(102
)
Loss on convertible notes conversion
-
-
-
(7,791
)
Loss on extinguishment of debt
-
-
-
(3,277
)
Other income
101
79
392
1,160
Other income (expense), net
(9,933
)
(6,147
)
(27,202
)
(33,170
)
Loss before income taxes
(67,397
)
(78,694
)
(200,258
)
(270,376
)
Income tax (expense) benefit
(13
)
18
125
122
Net loss
$
(67,410
)
$
(78,676
)
$
(200,133
)
$
(270,254
)
Basic and diluted net loss per common share
$
(0.56
)
$
(0.89
)
$
(1.80
)
$
(3.37
)
Basic and diluted weighted-average common shares
121,217
88,255
111,377
80,153
CONSOLIDATED BALANCE SHEET DATA (Unaudited, in thousands)
September 30, 2021 Dec 31, 2020 Cash
and cash equivalents
$
171,949
$
240,229
Working capital
117,973
125,901
Total assets
507,997
605,554
Convertible senior notes
436,263
499,044
Common stock and additional paid-in capital
2,631,356
2,498,283
Total stockholders' deficit
(225,461
)
(158,748
)
Other Data (Unaudited, in thousands)
Nine Months Ended September
30,
2021
2020
Net cash used in operating activities
$
(154,714
)
$
(196,675
)
Share Based Compensation Expense
$
18,402
$
38,765
RECONCILIATION OF NET CASH USED IN OPERATING ACTIVITIES TO CASH
BURN (Unaudited, in thousands)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Net cash used in operating activities
$ (46,069
)
$ (54,324
)
$ (154,714
)
$ (196,675
)
Adjustments: Acquired in-process research and development -
milestone payment
-
-
-
(8,000
)
Proceeds from borrowings under financing agreement
10,576
16,641
37,730
49,963
Cash burn
$ (35,493
)
$ (37,683
)
$ (116,984
)
$ (154,712
)
Net cash (used in) provided by investing activities
$ (89
)
$ (19
)
$ (243
)
$ 126,588
Net cash (used in) provided by financing activities
$ (12,326
)
$ 16,157
$ 86,990
$ 131,808
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/20211103005189/en/
Breanna Burkart (303) 625-5023 bburkart@clovisoncology.com
Anna Sussman (303) 625-5022 asussman@clovisoncology.com
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