- Launch of CABOMETYX Results in Cabozantinib Franchise Sales of
$31.6 Million -
- Conference Call and Webcast Today at 5:00 PM Eastern Time -
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug. 3, 2016--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
second quarter of 2016 and provided an update on progress toward
delivering upon its key 2016 corporate objectives, as well as commercial
and clinical development milestones.
Exelixis is focused on executing the U.S. launch of CABOMETYX™
(cabozantinib) tablets as a treatment for patients with advanced renal
cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
The first prescriptions for CABOMETYX were filled within three days of
approval by the U.S. FDA on April 25. CABOMETYX generated $17.6 million
in net product revenue during the remaining nine weeks of the second
quarter of 2016. Net product revenues for the second quarter of 2016,
including sales of COMETRIQ® (cabozantinib) capsules, were
$31.6 million.
“The Exelixis team has worked tirelessly to prepare for and execute on
the U.S. launch of CABOMETYX in order to bring this important new
therapeutic option for advanced kidney cancer to prescribing clinicians
and the patients they serve,” said Michael M. Morrissey, Ph.D.,
president and chief executive officer of Exelixis. “We are encouraged by
the initial uptake in May and June and are steadfast in our efforts to
support the launch by educating the treatment community on the data in
the CABOMETYX label, which differentiate this medicine from others
available for patients with previously-treated advanced renal cell
carcinoma.”
Cabozantinib Highlights
CABOMETYX Approved by U.S. FDA. On April 25, 2016, the U.S. FDA
approved CABOMETYX for the treatment of patients with advanced RCC who
have received prior anti-angiogenic therapy. CABOMETYX is the first
therapy to demonstrate robust and clinically meaningful improvements in
all three key efficacy parameters - overall survival (OS),
progression-free survival (PFS) and objective response rate (ORR) - in a
phase 3 trial (METEOR) of patients with advanced RCC. Approximately
17,000 patients with advanced RCC in the U.S. and 37,000 globally
require second-line or later treatment.1
Positive Top-Line Results from CABOSUN Randomized Phase 2 Trial. On
May 23, 2016, Exelixis announced that CABOSUN, the independent
randomized phase 2 trial of cabozantinib in patients with previously
untreated advanced RCC, met its primary endpoint, demonstrating a
statistically significant and clinically meaningful improvement in PFS
compared with sunitinib in patients with advanced intermediate- or
poor-risk RCC. CABOSUN is being conducted by The Alliance for Clinical
Trials in Oncology as part of Exelixis’ collaboration with the National
Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).
Presentation of the CABOSUN results is planned for an upcoming medical
meeting. Exelixis is discussing the results with regulatory authorities
and evaluating potential next steps in the development and submission
strategy for cabozantinib as a first-line treatment for patients with
advanced RCC.
European CHMP Adopts Positive Opinion for Cabozantinib for the
Treatment of Advanced RCC. On July 22, 2016, the European Medicines
Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a
positive opinion of the Marketing Authorization Application (MAA) for
cabozantinib for the treatment of adult patients with advanced RCC who
have received at least one prior VEGF receptor tyrosine kinase inhibitor
therapy. The CHMP's positive opinion will now be reviewed by the
European Commission (EC), which has the authority to approve medicines
for the European Union. Exelixis and Ipsen, its partner for the
development and commercialization of cabozantinib outside of the United
States, Canada and Japan, anticipate a decision from the EC before the
end of this year.
CELESTIAL Second-line Hepatocellular Carcinoma (HCC) Data Anticipated
in 2017. Enrollment continues for CELESTIAL, the phase 3 pivotal
trial comparing cabozantinib to placebo in patients with advanced HCC
who have previously been treated with sorafenib. Initiated in September
2013, the trial is designed to enroll 760 patients at approximately 200
sites. Patients are being randomized 2:1 to receive 60 mg of
cabozantinib daily or placebo. The primary endpoint for CELESTIAL is OS,
and the secondary endpoints include PFS and ORR. Exelixis anticipates
results from this trial in 2017. New treatment options are needed for
HCC patients who progress following sorafenib, the current standard of
care.
Other Cabozantinib Development Program Updates. While Exelixis
pursues cabozantinib’s late-stage development in advanced RCC and
advanced HCC, earlier-stage investigation of the compound continues
through the company’s collaboration with the NCI-CTEP, and its ongoing
Investigator-Sponsored Trial (IST) program. Through these two programs,
there are more than 45 ongoing or planned studies including trials in
advanced RCC, bladder cancer, colorectal cancer (CRC), non-small cell
lung cancer, and endometrial cancer. Data from several studies,
including CABOSUN and a phase 1b study evaluating the combination of
cabozantinib with nivolumab or nivolumab and ipilimumab, are expected to
be presented in the second half of 2016.
Cobimetinib Highlights
Initiation of COTEZO Phase 3 Pivotal Trial in Advanced CRC. In
June 2016, Exelixis’ partner Genentech (a member of the Roche Group)
announced the initiation of COTEZO, the phase 3 pivotal trial of the
combination of cobimetinib, the Exelixis-discovered MEK inhibitor, and
atezolizumab, an anti-PD-L1 antibody, in unresectable locally advanced
or metastatic CRC. COTEZO is designed to enroll 360 patients who have
received at least two prior chemotherapies in the metastatic disease
setting, and the primary endpoint of the trial is OS. The decision to
start COTEZO was informed by results from the ongoing phase 1b trial of
the combination in advanced solid tumors, and results from CRC patients
enrolled in this trial were presented during an oral presentation at the
Annual Meeting of the American Society of Clinical Oncology (ASCO) in
June 2016.
Additional Regulatory Approvals for COTELLIC®.
In April and May 2016, Australia’s Therapeutic Goods Administration and
Brazil’s ANVISA, respectively, approved COTELLIC for use in combination
with Zelboraf for the treatment of patients with unresectable or
metastatic melanoma with a BRAF V600 mutation.
Corporate Highlights
Cabozantinib, Cobimetinib and XL888 Data Presentations at ASCO 2016. Exelixis-discovered
compounds were the subject of 18 presentations at the meeting, including
an oral presentation of the OS results from the METEOR study in advanced
RCC, as well as a poster presentation from the same trial on outcomes
based on prior therapy or presence of bone metastases. Additional
presentations highlighted results from early and mid-stage trials of
cabozantinib in other disease settings, including metastatic CRC,
endometrial cancer and metastatic urothelial carcinomas. Cobimetinib
data included updates on combination trials of the compound in
metastatic melanoma, triple-negative breast cancer, and CRC. On Sunday,
June 5, 2016, Exelixis hosted an investor/analyst briefing at the
meeting. The event featured a Q&A session with METEOR’s principal
investigator, Dr. Toni Choueiri of the Dana-Farber Cancer Institute and
Dr. Thomas Hutson of Baylor University Medical Center. An archive of the
briefing is available on the Event Calendar page under Investors & Media
at www.exelixis.com.
Dr. Morrissey continued, “Our clinical development and regulatory
efforts were highly productive during the second quarter. The positive
top-line results for the CABOSUN trial sponsored by our collaborators at
NCI-CTEP suggest that cabozantinib has potential as a treatment for
previously-untreated patients with advanced RCC, and we are discussing
potential next steps with regulators. The second half of 2016 will be
eventful for Exelixis, as we will continue to advance the U.S. launch of
CABOMETYX, while awaiting with our partner Ipsen the EC’s decision in
the European Union. We look forward to the presentation of the CABOSUN
data later this year and ongoing enrollment of patients in CELESTIAL
with potential results in 2017. And finally, we continue to monitor the
progress of our partner, Genentech, with the cobimetinib development
program, including COTEZO, the recently initiated second pivotal trial
of this Exelixis-discovered compound in combination with atezolizumab in
refractory CRC.”
2016 Financial Guidance
The company is refining its guidance that operating expenses for the
full year 2016 will be between $250 million and $270 million, including
approximately $30 million of non-cash items primarily related to
stock-based compensation expense.
Second Quarter 2016 Financial Results
Net revenues for the quarter ended June 30, 2016 were $36.3
million, compared to $8.0 million for the comparable period in 2015. Net
revenues for the second quarter of 2016 include $31.6 million of net
product revenue compared to $8.0 million for the comparable period in
2015. The increase in net product revenues for the three months ended
June 30, 2016, as compared to the same period in 2015, reflects the
impact of the commercial launch of CABOMETYX in late April 2016, as well
as an increase in COMETRIQ revenues. Net product revenues for CABOMETYX
and COMETRIQ were $17.6 million and $14.0 million respectively. Product
revenues for CABOMETYX and COMETRIQ are both recognized using the
“sell-in” method of revenue recognition. Product revenues during the
quarter ended June 30, 2016 were impacted by the build of channel
inventory related to the initial launch period for CABOMETYX. Net
revenues also includes $3.6 million of license revenues recognized from
the $200 million upfront payment we received in February 2016 from Ipsen
under our collaboration and license agreement and $1.0 million of
royalties on ex-U.S. net sales of COTELLIC. There was no such royalty or
license revenue during the comparable period in 2015.
Research and development expenses for the quarter ended June 30,
2016 were $23.0 million, compared to $24.5 million for the comparable
period in 2015. The decrease was primarily related to a decrease in
clinical trial costs and the allocation of general corporate costs;
those decreases were partially offset by increases in personnel related
expenses resulting from an increase in headcount predominantly
associated with the build-out of our Medical Science Liaison
organization and an increase in consulting and outside services.
Selling, general and administrative expenses for the quarter
ended June 30, 2016 were $35.8 million, compared to $12.8 million for
the comparable period in 2015. The increase was primarily related to an
increase in personnel related expenses resulting from an increase in
headcount, predominantly connected to the expansion of our U.S. sales
force and outside services expenses supporting the commercialization and
launch of CABOMETYX.
Other income (expense), net for the quarter ended June 30, 2016
was a net expense of ($11.9) million compared to ($12.1) million for the
comparable period in 2015. The net expense is comprised primarily of
interest expense which includes $7.4 million of non-cash expense related
to the accretion of the discounts on both the 4.25% Convertible Senior
Subordinated Notes due 2019 and the company’s indebtedness under our
Secured Convertible Notes due 2018 held by entities associated with
Deerfield for the quarter ended June 30, 2016, as compared to $7.2
million for the comparable period in 2015.
Net loss for the quarter ended June 30, 2016 was ($37.0) million,
or ($0.16) per share, basic, compared to ($43.4) million, or ($0.22) per
share, basic, for the comparable period in 2015. The decreased net loss
for the quarter was primarily due to an increase in net revenues and a
decrease in research and development expenses, which were partially
offset by an increase in selling, general and administrative expenses.
Cash and cash equivalents, short- and long-term investments and
long-term restricted cash and investments totaled $384.0 million at
June 30, 2016, which increased from $253.3 million at December 31, 2015
as a result of the $200.0 million upfront payment we received from Ipsen
in connection with our February 29, 2016 licensing agreement.
Basis of Presentation
Exelixis adopted a 52- or 53-week fiscal year that generally ends on the
Friday closest to December 31st. For convenience, references
in this press release as of and for the fiscal periods ended July 1,
2016, January 1, 2016 and July 3, 2015 are indicated as being as of and
for the periods ended June 30, 2016, December 31, 2015 and June 30,
2015, respectively.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the
second quarter of 2016 and provide a general business update during a
conference call beginning at 5:00 p.m. EDT/2:00 p.m. PDT today,
Wednesday, August 3, 2016.
To access the webcast link, log onto www.exelixis.com
and proceed to the Event Calendar page under Investors & Media. Please
connect to the company’s website at least 15 minutes prior to the
conference call to ensure adequate time for any software download that
may be required to listen to the webcast. Alternatively, please call
(855) 793-2457 (domestic) or (631) 485-4921 (international) and provide
the conference call passcode 43700006 to join by phone.
A telephone replay will be available until 11:59 p.m. EDT on August 5,
2016. Access numbers for the telephone replay are: 855-859-2056
(domestic) and 404-537-3406 (international); the passcode is 43700006. A
webcast replay will also be archived on www.exelixis.com
for one year.
About Exelixis
Exelixis, Inc. (Nasdaq: EXEL) is a biopharmaceutical company committed
to the discovery, development and commercialization of new medicines
with the potential to improve care and outcomes for people with cancer.
Since its founding in 1994, three medicines discovered at Exelixis have
progressed through clinical development to receive regulatory approval.
Currently, Exelixis is focused on advancing cabozantinib, an inhibitor
of multiple tyrosine kinases including MET, AXL and VEGF receptors,
which has shown clinical anti-tumor activity in more than 20 forms of
cancer and is the subject of a broad clinical development program. Two
separate formulations of cabozantinib have received regulatory approval
to treat certain forms of kidney and thyroid cancer and are marketed for
those purposes as CABOMETYX™ tablets (U.S.) and COMETRIQ® capsules
(U.S. and EU), respectively. Another Exelixis-discovered compound,
COTELLIC® (cobimetinib), a selective inhibitor of MEK, has
been approved in major territories including the United States and
European Union, and is being evaluated for further potential indications
by Roche and Genentech (a member of the Roche Group) under a
collaboration with Exelixis. For more information on Exelixis, please
visit www.exelixis.com
or follow @ExelixisInc on Twitter.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: Exelixis’ focus on the U.S.
launch for CABOMETYX as a treatment for patients with advanced RCC; the
initial uptake of CABOMETYX and Exelixis’ efforts to support the launch;
the planned data presentation of the CABOSUN results at an upcoming
medical meeting; the potential next steps in the development and
submission strategy for cabozantinib as a first-line treatment for
patients with advanced RCC; the review by the EC of the CHMP’s positive
opinion of the MAA for cabozantinib for the treatment of adult patients
with advanced RCC and an anticipated decision from the EC before the end
of this year; the status of enrollment progress for and the timing of
anticipated top-line results from CELESTIAL; the continued late-stage
development of cabozantinib pursued by Exelixis and earlier-stage
investigation through Exelixis’ collaboration with NCI-CTEP and its
ongoing IST program; the expected timing of data results from CABOSUN
and a phase 1b study evaluating the combination of cabozantinib with
nivolumab or nivolumab and ipilimumab; the potential for cabozantinib as
a treatment for previously-untreated patients with advanced RCC; an
eventful second half of 2016 for Exelixis, including, the continued
advancement of the U.S. launch of CABOMETYX, while awaiting the EC’s
decision in the European Union; Exelixis’ continued monitoring of the
progress of Genentech with the cobimetinib development program;
Exelixis’ refined guidance for 2016 operating expenses, including
non-cash items; Exelixis' commitment to the discovery, development and
commercialization of new medicines with the potential to improve care
and outcomes for people with cancer; Exelixis’ focus on advancing
cabozantinib; and the continued development of cobimetinib. Words such
as “focused,” “encouraged,” “planned,” “potential,” “strategy,” “will,”
“anticipate,” “continues,” “expected,” “look forward,” “guidance,”
“committed,” or other similar expressions identify forward-looking
statements, but the absence of these words does not necessarily mean
that a statement is not forward-looking. In addition, any statements
that refer to expectations, projections or other characterizations of
future events or circumstances are forward-looking statements. These
forward-looking statements are based upon Exelixis’ current plans,
assumptions, beliefs, expectations, estimates and projections.
Forward-looking statements involve risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in the forward-looking statements as a result of these risks
and uncertainties, which include, without limitation: the degree of
market acceptance of CABOMETYX and COMETRIQ and the availability of
coverage and reimbursement for CABOMETYX and COMETRIQ; the risk that
unanticipated developments could adversely affect the commercialization
of CABOMETYX or COMETRIQ; Exelixis’ dependence on its relationship
with Ipsen, including, the level of Ipsen’s investment in the resources
necessary to successfully commercialize cabozantinib in the territories
where it is approved; the availability of data at the referenced times;
risks and uncertainties related to regulatory review and approval
processes and Exelixis’ compliance with applicable legal and regulatory
requirements; Exelixis’ ability to conduct clinical trials
of cabozantinib sufficient to achieve a positive completion; risks
related to the potential failure of cabozantinib to demonstrate safety
and efficacy in clinical testing; the sufficiency of Exelixis’
resources; costs associated with Exelixis’ commercialization, research
and development and other activities; Exelixis’ dependence on its
relationship with Genentech/Roche with respect to cobimetinib and
Exelixis’ ability to maintain its rights under the collaboration;
Exelixis’ dependence on third-party vendors; Exelixis’ ability to
protect the company’s intellectual property rights; market competition;
changes in economic and business conditions, and other factors discussed
under the caption “Risk Factors” in Exelixis’ quarterly report on Form
10-Q filed with the Securities and Exchange Commission (SEC) on May 4,
2016, and in Exelixis’ future filings with the SEC, including, without
limitation, Exelixis’ quarterly report on Form 10-Q expected to be filed
with the SEC on August 3, 2016. The forward-looking statements made in
this press release speak only as of the date of this press
release. Exelixis expressly disclaims any duty, obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in
Exelixis’ expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
Exelixis, the Exelixis logo, COMETRIQ and COTELLIC are registered
U.S. trademarks, and CABOMETYX is a U.S. trademark.
1. Decision Resources Report: Renal Cell Carcinoma. October 2014
(internal data on file).
|
|
|
|
|
EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
$
|
31,618
|
|
|
$
|
7,992
|
|
|
$
|
40,717
|
|
|
$
|
17,380
|
|
Royalty, license and contract revenues
|
|
4,634
|
|
|
—
|
|
|
10,962
|
|
|
—
|
|
Total revenues
|
|
36,252
|
|
|
7,992
|
|
|
51,679
|
|
|
17,380
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
1,560
|
|
|
686
|
|
|
2,245
|
|
|
1,452
|
|
Research and development
|
|
22,984
|
|
|
24,506
|
|
|
51,910
|
|
|
46,788
|
|
Selling, general and administrative
|
|
35,823
|
|
|
12,789
|
|
|
70,680
|
|
|
22,320
|
|
Restructuring charge
|
|
1,021
|
|
|
1,291
|
|
|
1,115
|
|
|
860
|
|
Total operating expenses
|
|
61,388
|
|
|
39,272
|
|
|
125,950
|
|
|
71,420
|
|
Loss from operations
|
|
(25,136
|
)
|
|
(31,280
|
)
|
|
(74,271
|
)
|
|
(54,040
|
)
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
Interest income and other, net
|
|
749
|
|
|
(123
|
)
|
|
951
|
|
|
(130
|
)
|
Interest expense
|
|
(12,628
|
)
|
|
(11,959
|
)
|
|
(25,042
|
)
|
|
(24,362
|
)
|
Total other income (expense), net
|
|
(11,879
|
)
|
|
(12,082
|
)
|
|
(24,091
|
)
|
|
(24,492
|
)
|
Net loss
|
|
$
|
(37,015
|
)
|
|
$
|
(43,362
|
)
|
|
$
|
(98,362
|
)
|
|
$
|
(78,532
|
)
|
Net loss per share, basic and diluted
|
|
$
|
(0.16
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.43
|
)
|
|
$
|
(0.40
|
)
|
Shares used in computing basic and diluted net loss per share
|
|
229,310
|
|
|
196,201
|
|
|
228,860
|
|
|
196,052
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
|
|
|
|
|
|
June 30, 2016
|
|
December 31, 2015 (1)
|
|
(unaudited)
|
|
Cash and investments (2)
|
$
|
383,996
|
|
|
$
|
253,310
|
|
Working capital
|
$
|
160,588
|
|
|
$
|
126,414
|
|
Total assets
|
$
|
477,136
|
|
|
$
|
332,342
|
|
Total stockholders’ deficit
|
$
|
(186,134
|
)
|
|
$
|
(104,304
|
)
|
_______________________________________
(1)
|
|
|
Derived from the audited consolidated financial statements.
|
(2)
|
|
|
Cash and investments include cash and cash equivalents, short- and
long-term investments and long-term restricted cash and investments.
Long-term restricted cash and investments totaled $4.2 million and
$2.7 million as of June 30, 2016 and December 31, 2015, respectively.
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View source version on businesswire.com: http://www.businesswire.com/news/home/20160803006648/en/
Source: Exelixis, Inc.
Exelixis, Inc.
Chris Senner, 650-837-7240
Chief
Financial Officer
csenner@exelixis.com
Susan
Hubbard, 650-837-8194
Investor Relations & Corporate
Communications
shubbard@exelixis.com