- $38.8M in Rubraca® (rucaparib) global sales for Q3 2020; net
product revenue up 3% over Q3 2019
- Global net product revenue guidance provided for Q4 2020 in a
range of $38M to $40M
- Restructuring U.S. commercial organization to adopt hybrid
strategy elevating digital programming and peer-to-peer
interactions
- Oncology pipeline, inclusive of Rubraca, lucitanib and
FAP-2286, expected to result in multiple key clinical, development
and regulatory milestones during 2021
- $224.7M in cash and cash equivalents at September 30, 2020,
which is anticipated to fund the Company’s operating plan into
early 2022
- Assuming completion of the offering of $50M of convertible
notes announced today, the additional cash proceeds are anticipated
to fund the Company’s operating plan into early 2023
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended September 30, 2020, and provided an update on
the Company’s clinical development programs and regulatory and
commercial outlook for the rest of the year.
“We are pleased that third quarter revenues for Rubraca grew
slightly over the same period in 2019, despite a very challenging
sales environment caused by COVID-19, which has severely limited
oncology patient visits and cancer diagnoses. In addition, oncology
practices have substantially limited traditional in-person sales
calls – a trend that we see accelerating – and physicians
increasingly prefer digital communications and virtual peer-to-peer
interactions. In response to this evolving U.S. oncology market, we
are shifting to a hybrid commercial strategy to support these
preferences. This new strategy incorporates more targeted in-person
promotion, online resources for prescribers customized to their
practices and new approaches to peer-to-peer interactions. We
believe this hybrid strategy will increase awareness and interest
in Rubraca. We have undertaken this change with the goal of
returning to growth as rapidly as we can, despite cancer diagnoses
and cancer patient visits currently remaining lower than
pre-COVID-19,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology.
“We also remain focused on our growing pipeline activities and
in 2021, we anticipate multiple meaningful clinical, development
and regulatory milestones. For Rubraca, we anticipate data from the
ATHENA monotherapy arm, and pending data, a potential sNDA filing
for the LODESTAR pan-tumor study in the second half of 2021.
Interim updates from the LIO-1 study of Rubraca and Opdivo in
combination are anticipated in 2021. Following allowance of the IND
filings for our peptide-targeted radiotherapeutic candidate,
FAP-2286, planned for submission this quarter, we plan to initiate
a robust clinical development program in early 2021,” Mr. Mahaffy
continued.
Third Quarter 2020 Financial Results
Clovis reported net product revenue for Rubraca of $38.8 million
for the third quarter of 2020, which included U.S. product revenue
of $33.9 million and ex-U.S. product revenue of $4.9 million,
compared to net product revenue for Q3 2019 of $37.6 million, which
included U.S. net product revenue of $36.5 million and ex-U.S. net
product revenue of $1.1 million.
Clovis reported net product revenue for Rubraca of $121.2
million for the nine months ended September 30, 2020, which
included U.S. product revenue of $109.8 million and ex-U.S. product
revenue of $11.4 million, compared to net product revenue for same
period in 2019 of $103.7 million, which included U.S. net product
revenue of $101.1 million and ex-U.S. net product revenue of $2.6
million.
Clovis Oncology expects global net product revenue for the
fourth quarter 2020 to be in a range of $38 million to $40 million.
The effects of COVID-19 on future sales are difficult to predict,
especially with the increase in COVID-19 cases in the U.S. and
Europe.
Research and development expenses totaled $62.9 million for Q3
2020 and $201.0 million for the first nine months of 2020, compared
to $77.9 million and $210.7 million for the comparable periods in
2019. Research and development expenses decreased for the third
quarter and the first nine months of 2020 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 full year
2020.
Selling, general and administrative expenses totaled $38.6
million for Q3 2020 and $123.1 million for the first nine months of
2020, compared to $41.8 million and $137.6 million for the
comparable periods in 2019. Selling, general and administrative
expenses decreased during the third quarter and first nine months
of 2020 compared to the same period in the prior year with savings
due to the COVID-19 situation globally and overall cost reduction
efforts.
Clovis reported a net loss for the third quarter of 2020 of
$78.7 million, or ($0.89) per share, and a net loss of $270.3
million, or ($3.37) per share, for the first nine months of 2020.
Net loss for Q3 2019 was $94.1 million, or ($1.72) per share, and
$300.9 million, or a net loss of ($5.62) per share, for the first
nine months of 2019. Net loss for Q3 and the first nine months of
2020 included share-based compensation expense of $12.5 million and
$38.8 million, compared to $14.0 million and $41.7 million for the
comparable periods of 2019.
Clovis had $224.7 million in cash and cash equivalents as of
September 30, 2020.
As of September 30, 2020, the Company had drawn approximately
$85 million under the TPG ATHENA clinical trial financing and had
up to $90 million available to draw under the agreement to fund the
expenses of the ATHENA trial through Q3 2022.
Based on the Company’s anticipated revenues, spending, available
financing sources and existing cash and cash equivalents, the
Company believes it has sufficient cash and cash equivalents to
fund its operating plan into early 2022, after taking into account
any cash repayment (unless refinanced earlier) of the remaining
$64.42 million aggregate principal amount of the 2.50% convertible
notes, at their maturity in September 2021. Assuming the completion
of the offering of $50 million of convertible notes announced
today, the additional cash proceeds are anticipated to fund the
Company’s operating plan into early 2023.
Net cash used in operating activities was $54.3 million for the
third quarter of 2020, down from $57.0 million reported in the
third quarter of 2019. Similarly, net cash used in operating
activities for the first nine months of 2020 was $196.7 million,
compared with $253.5 million for the first nine months of 2019.
Cash burn in Q3 2020 was $37.7 million, which represents a 25
percent sequential decrease from the Q2 2020 cash burn of $50.1
million. Borrowings under the TPG ATHENA financing provided $16.6
million in cash in Q3 2020. Cash burn in the first nine months of
2020 was $154.7 million.
Restructured U.S. Commercial Organization
The COVID-19 pandemic has accelerated a preference by oncology
practices for more digital programming, including digital
peer-to-peer interactions and reduced in-person promotion. In order
to meet these changing preferences, the Company is adopting a
hybrid commercial strategy combining increased digital promotional
activities, greater online resources and more peer-to-peer
interactions with reduced and more targeted in-person promotion.
Accordingly, new tools and performance indicators based on this
hybrid approach are being rolled out during the fourth quarter, and
the U.S. commercial organization has been reduced in size by
approximately 45 employees. Despite increased investment in digital
promotion, we anticipate an effect of adopting this hybrid model
will result in annual cost-savings of approximately $10 million.
The Company is adopting this strategy in order to better reach
customers in the way they want to be reached with the goal of
returning to growth, especially as the ongoing impact of COVID-19
is reduced.
FDA-approved Companion Diagnostic to Identify Eligible mCRPC
Patients Added to Rubraca U.S. Label
In late August, the U.S. FDA approved the FoundationOne® Liquid
CDx, Foundation Medicine’s comprehensive liquid biopsy test for all
solid tumors with multiple companion diagnostic indications,
including for Rubraca. It is intended to be used as a companion
diagnostic to identify patients who may benefit from treatment with
specific FDA-approved targeted therapies, including Rubraca. In
early October, the companion diagnostic for Rubraca in mCRPC was
added to the Rubraca U.S. label.
These events follow the U.S. FDA’s May 2020 approval of Rubraca
for the treatment of adult patients with a deleterious BRCA
mutation (germline and/or somatic)-associated mCRPC who have been
treated with androgen receptor-directed therapy and a taxane-based
chemotherapy. The FDA approved this indication under accelerated
approval based on objective response rate and duration of response
data from the multi-center, single arm TRITON2 clinical trial.
Data from the TRITON2 study of Rubraca for the treatment of
mCRPC harboring BRCA1/2 mutations were published online in the
Journal of Clinical Oncology during the quarter. These results
supported the May approval and provide additional detail for
physicians about the study and about Rubraca as a treatment option
for eligible men with mCRPC and a deleterious BRCA1/2 mutation.
Initial Presentations for Lucitanib and Rucaparib
Combinations and Preclinical Data for FAP-2286 at Medical
Meetings
Six e-posters for Clovis’ three portfolio compounds were
presented at the European Society for Medical Oncology (ESMO)
Virtual Congress 2020 in September. These included the
following:
- Initial data from the Phase 1b part of the LIO-1 trial of
lucitanib combined with Opdivo® (nivolumab) in advanced metastatic
solid tumors which identified a recommended Phase 2 dose and showed
promising signs of antitumor activity; also, a Trials In Progress
e-poster describing the Phase 2 study currently enrolling
patients.
- The first presentation of preclinical data for FAP-2286, a
novel peptide-targeted radionuclide therapy (PTRT), showed the
compound potently and selectively binds fibroblast activation
protein (FAP); in addition, compelling anti-tumor activity was
observed in FAP-expressing tumor models.
- New data analyses from pivotal Rubraca studies ARIEL3 and
TRITON2 further characterized its safety profile in recurrent
ovarian cancer and metastatic castration-resistant prostate cancer
(mCRPC), respectively.
- Encouraging initial data from the SEASTAR study evaluating
Rubraca in combination with Trodelvy™ (sacituzumab
govitecan-hziy).
In addition, in an oral plenary session at the International
Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting in
September, data from an exploratory analysis of the ARIEL3 clinical
study evaluating Rubraca as maintenance treatment in recurrent
ovarian cancer were presented. The findings demonstrate that
rucaparib maintenance treatment can lead to a clinically meaningful
delay in starting subsequent therapy and lasting clinical benefits
in patients with BRCA1- or BRCA2-mutant ovarian cancer.
The data described here are available online at
www.clovisoncology.com/pipeline/scientificpresentations.
Lucitanib Combination Studies Underway
The Phase 2 portion of LIO-1 trial evaluating lucitanib and
Opdivo in combination in advanced solid tumors (Phase 1b) and
gynecologic cancers (Phase 2) is open for enrollment and the first
patient was treated in August. Clovis intends to submit updated
interim data from the LIO-1 study for presentation at a 2021
medical meeting.
FAP-2286 and Radionuclide Therapy Development Program
Clovis intends to submit two Investigational New Drug (IND)
applications for FAP-2286 for use as imaging and treatment agents
respectively. Following allowance of the INDs by the U.S. FDA,
Clovis will initiate a Phase 1 study to determine the dose and
tolerability of the FAP-targeting therapeutic agent, with expansion
cohorts planned in multiple tumor types. The FAP-targeting imaging
agent will be utilized to identify tumors that contain FAP for
treatment in the Phase 1 study.
Conference Call Details
Clovis will hold a conference call to discuss Q3 2020 results
this morning, November 5, 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: 2999168.
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 a 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 alpha (FAP). 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.
FAP-2286 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 U.S., Europe and additional international markets.
Clovis Oncology targets development programs at specific subsets of
cancer populations, and simultaneously develops, with partners, for
those indications that require them, diagnostic tools intended to
direct a compound in development to the population that is most
likely to benefit from its use. Clovis Oncology is headquartered in
Boulder, Colorado, with additional office locations in the U.S. and
Europe. Please visit www.clovisoncology.com for more
information.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management. Examples of forward-looking
statements contained in this press release include, among others,
statements regarding our future financial and operating
performance, business plans or prospects, including expectations
concerning our future cash position and future revenue expectations
from the sale of Rubraca, 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 TPG Sixth Street Partners. Such
forward-looking statements involve substantial risks and
uncertainties that could cause our future results, performance or
achievements to differ significantly from that expressed or implied
by the forward-looking statements. Such risks and uncertainties
include, among others, the impacts of the COVID-19 pandemic and
disruption related to efforts to mitigate its spread on our
business, results of operations or financial condition, including
impacts on the vendors or distribution channels in our supply
chain, impacts on our contract manufacturers’ ability to continue
to manufacture our products, impacts on our ability to continue our
development activities, impacts on the conduct of our clinical
trials, including with respect to enrollment rates, availability of
investigators and clinical trial sites or monitoring of data and
impact on the ability and timing of our field personnel to conduct
their activities with health care providers, the uncertainties
inherent in the effect our future revenues or expenses may have on
our cash position, the market potential of our approved drug,
including the performance of our sales and marketing efforts and
the success of competing drugs and therapeutic approaches, changes
in gross-to-net or free drug provided through our patient
assistance program, the availability of reimbursement and insurance
coverage, the performance of our third-party manufacturers, whether
our clinical development programs for our drug candidates and those
of our partners can be completed on time or at all, whether future
study results will be consistent with study findings to date and
whether future study results will support continued development or
regulatory approval, the corresponding development pathways of our
companion diagnostics, the timing of availability of data from our
clinical trials and the results, the initiation, enrollment, timing
and results of our planned clinical trials, the risk that final
results of ongoing trials may differ from initial or interim
results as a result of factors such as final results from a larger
patient population may be different from initial or interim results
from a smaller patient population, actions by the FDA, the EMA or
other regulatory authorities regarding data required to support
drug applications and whether to accept or approve drug
applications that may be filed, their interpretations of our data
and agreement with our regulatory approval strategies or components
of our filings, including our clinical trial designs, conduct and
methodologies, as well as their decisions regarding drug labeling,
reimbursement and pricing, and other matters that could affect the
development, approval, availability or commercial potential of our
drug candidates or companion diagnostics. Clovis Oncology does not
undertake to update or revise any forward-looking statements. A
further description of risks and uncertainties can be found in
Clovis Oncology’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K and its
reports on Form 10-Q and Form 8-K.
CLOVIS ONCOLOGY, INC CONSOLIDATED FINANCIAL RESULTS
(Unaudited, in thousands, except per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2020
2019
2020
2019
Revenues: Product revenue
$
38,772
$
37,603
$
121,223
$
103,699
Operating expenses: Cost of sales - product
8,438
8,134
26,654
21,984
Cost of sales - intangible asset amortization
1,343
1,212
3,834
3,549
Research and development
62,902
77,896
201,000
210,674
Selling, general and administrative
38,636
41,811
123,136
137,601
Acquired in-process research and development
-
9,440
-
9,440
Other operating expenses
-
5,539
3,805
5,539
Total expenses
111,319
144,032
358,429
388,787
Operating loss
(72,547
)
(106,429
)
(237,206
)
(285,088
)
Other income (expense): Interest expense
(6,859
)
(5,278
)
(23,160
)
(12,684
)
Foreign currency gain (loss)
633
(229
)
(102
)
(648
)
Gain on extinguishment of debt
-
18,480
-
18,480
Loss on convertible senior notes conversion
-
-
(7,791
)
-
Loss on extinguishment of debt
-
-
(3,277
)
-
Legal settlement loss
-
(1,750
)
-
(26,750
)
Other income
79
781
1,160
5,081
Other income (expense), net
(6,147
)
12,004
(33,170
)
(16,521
)
Loss before income taxes
(78,694
)
(94,425
)
(270,376
)
(301,609
)
Income tax benefit
18
350
122
686
Net loss
$
(78,676
)
$
(94,075
)
$
(270,254
)
$
(300,923
)
Basic and diluted net loss per common share
$
(0.89
)
$
(1.72
)
$
(3.37
)
$
(5.62
)
Basic and diluted weighted-average common shares
88,255
54,707
80,153
53,549
CONSOLIDATED BALANCE SHEET DATA (Unaudited, in thousands)
September 30, 2020 Dec 31, 2019 Cash
and cash equivalents
$
224,702
$
161,833
Available-for-sale securities
-
134,826
Working capital
165,321
233,384
Total assets
593,057
669,604
Convertible senior notes
505,278
644,751
Common stock and additional paid-in capital
2,395,063
2,114,123
Total stockholders' deficit
(163,366
)
(174,257
)
Other Data (Unaudited, in thousands)
Nine Months
Ended September 30,
2020
2019
Net cash used in operating activities
(196,675
)
(253,468
)
Share Based Compensation Expense
38,765
41,748
RECONCILIATION OF NET CASH USED IN OPERATING ACTIVITIES
TO CASH BURN (Unaudited, in thousands)
Three Months Ended September
30, 2020
Nine Months Ended September
30, 2020
Net cash used in operating activities
$
(54,324
)
$
(196,675
)
Adjustments: Acquired in-process research and development -
milestone payment
-
(8,000
)
Proceeds from borrowings under financing agreement
16,641
49,963
Cash burn
$
(37,683
)
$
(154,712
)
Net cash (used in) provided by investing activities
$
(19
)
$
126,588
Net cash provided by financing activities
$
16,157
$
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 plus acquired in-process research and
development - milestone payments less proceeds from borrowings
under financing agreement with TPG specifically related to our
Phase 3 ATHENA trial. We believe cash burn to be a liquidity
measure that provides useful information to management and
investors about the amount of cash consumed by the operations of
the business including milestone payments and proceeds from
borrowings under the TPG financing agreement, which specifically
offsets the costs of our ATHENA trial. A limitation of using this
non-U.S. GAAP measure is that cash burn does not represent the
total change in cash and cash equivalents for the period because it
excludes all other cash provided by or used for other investing and
financing activities. We account for this limitation by providing
information about our investing and financing activities in the
statements of cash flows in our financial statements and by
presenting cash flows from investing and financing activities in
our reconciliation of cash burn. In addition, it is important to
note that other companies, including companies in our industry, may
not use cash burn, may calculate cash burn in a different manner
than we do or may use other financial measures to evaluate their
performance, all of which could reduce the usefulness of cash burn
as a comparative measure. Because of these limitations, cash burn
should not be considered in isolation from, or as a substitute for,
financial information prepared in accordance with U.S. GAAP.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201105005168/en/
Breanna Burkart 303.625.5023 bburkart@clovisoncology.com
Anna Sussman 303.625.5022 asussman@clovisoncology.com
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