- Conference Call and Webcast Today at 5:00 PM Eastern Time -
SOUTH SAN FRANCISCO--(BUSINESS WIRE)--May 4, 2016--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
first quarter of 2016 and provided an update on progress toward
delivering upon its key 2016 corporate objectives and clinical
development milestones.
Corporate Updates and Key Priorities for 2016
On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved
CABOMETYX™ (cabozantinib) tablets as a treatment for patients with
advanced renal cell carcinoma (RCC) who have received prior
anti-angiogenic therapy. With approval granted, Exelixis is highly
focused on the U.S. commercial launch for CABOMETYX. CABOMETYX was
shipped to wholesalers and pharmacies within three days of approval,
with the first prescription filled on April 28, 2016. The European
Medicines Agency (EMA) is reviewing the company’s Marketing
Authorization Application (MAA) for cabozantinib for advanced RCC;
assuming approval, the product would be marketed in the EU by the
company’s corporate partner, Ipsen Pharma SAS (Ipsen).
Exelixis continues to work with its partner Genentech, a member of the
Roche Group, to co-promote COTELLIC™ (cobimetinib) in the United States
as a treatment for patients with BRAF V600E or V600K mutation-positive
advanced melanoma, in combination with vemurafenib, also known as
Zelboraf®. COTELLIC is also approved in multiple other
territories including the EU and Canada.
Corporate Highlights
Exclusive Licensing Agreement with Ipsen for Cabozantinib in Regions
Outside the United States, Canada and Japan. On February 29, 2016,
Exelixis announced an exclusive licensing agreement with Ipsen for the
commercialization and further development of cabozantinib for its
current and potential future indications, including COMETRIQ® (cabozantinib)
capsules, outside the United States, Canada and Japan. Pursuant to the
parties’ agreement, Exelixis received an upfront payment from Ipsen of
$200.0 million in the first quarter of 2016. The company is also
eligible to receive regulatory milestones, including $60.0 million upon
the approval of cabozantinib in Europe for advanced RCC and $50.0
million upon the filing and approval of cabozantinib in Europe for
advanced hepatocellular carcinoma (HCC), as well as additional
development and regulatory milestones for potential further indications.
The agreement includes up to $545.0 million of potential commercial
milestones and provides for Exelixis to receive tiered royalties up to
26% on Ipsen’s net sales of cabozantinib in its territories. Exelixis
and Ipsen have agreed to collaborate on the global development of
cabozantinib for current and potential future indications as well.
Cabozantinib Highlights
FDA Approval of CABOMETYX, the Third Approved Medicine to Have Been
Discovered by Exelixis. 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) for patients with advanced RCC.
The CABOMETYX label includes data from the second interim analysis of
the METEOR trial’s OS secondary endpoint. In February 2016, Exelixis
announced that CABOMETYX demonstrated a highly statistically significant
and clinically meaningful improvement in OS as compared to everolimus.
These results have been accepted as an oral presentation at the American
Society of Clinical Oncology’s (ASCO) 2016 Annual Meeting, June 3-7, in
Chicago, and will be presented in detail on Sunday, June 5, during the
Oral Abstract Session: Genitourinary (Nonprostate) Cancer, 10:12 - 10:24
a.m.
Progress on EU Regulatory Filing for Cabozantinib in Advanced RCC. In
January 2016, Exelixis submitted, and the EMA subsequently validated,
the company’s regulatory application for cabozantinib as a treatment for
patients with advanced RCC who have received one prior therapy. In
validating the MAA, the EMA granted accelerated assessment, making the
application eligible for a shortened 150-day review excluding
clock-stops when information is requested from Exelixis. Exelixis
intends to transfer the MAA to Ipsen later this year.
Continued Enrollment in CELESTIAL; Data Anticipated in 2017.
Exelixis continues to make progress with enrollment of 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
continues to anticipate top-line results from CELESTIAL in 2017. At this
time, there is no approved treatment for HCC patients who progress
following sorafenib treatment, the current standard of care.
Broad 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 National Cancer Institute’s
Cancer Therapy Evaluation Program (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, non-small cell lung
cancer, and endometrial cancer.
Cabozantinib, Cobimetinib and XL888 Data Presentations at ASCO 2016. Exelixis-discovered
compounds will be the subject of 18 presentations at the meeting. In
addition to the OS results from the METEOR study in advanced RCC, there
will be a poster presentation from the same trial on outcomes based on
prior therapy. Additional presentations will highlight results from
early and mid-stage trials of cabozantinib in other disease settings,
including metastatic colorectal cancer, endometrial cancer and
metastatic urothelial carcinomas. Cobimetinib data will include updates
on combination trials of the compound in metastatic melanoma,
triple-negative breast cancer, and colorectal cancer. Exelixis will also
host an investor/analyst briefing at the meeting on Sunday, June 5,
2016; see the Investors & Media section of www.exelixis.com
for more details when available.
Cobimetinib Highlights
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. As previously announced, in February
2016Health Canada approved COTELLIC in combination with Zelboraf for
the treatment of patients with unresectable or metastatic melanoma with
a BRAF V600 mutation.
2016 Financial Guidance
The Company is maintaining its guidance that operating expenses for the
full year 2016 will be between $240 million and $270 million, including
approximately $30 million of non-cash items primarily related to
stock-based compensation expense.
“The first quarter of 2016, and the time period following it, was marked
by important advances not only for our company, but for the patients we
serve,” said Michael M. Morrissey, Ph.D., president and chief executive
officer of Exelixis. “Most notably, just a little over a week ago we
announced that the FDA approved CABOMETYX for advanced RCC, a major
milestone for the company. We are especially pleased that the label
includes the robust overall survival data from the METEOR trial.
CABOMETYX is now the first and only therapy to have demonstrated
improvements in the three key efficacy parameters in a phase 3 trial of
advanced renal cell carcinoma, one of the most common forms of cancer
for men and women in the United States. We are moving quickly to
introduce this new and important medicine to the medical community, with
our experienced U.S. commercial team already in the field and meeting
with healthcare providers. With our partner Ipsen, we are also well
positioned to advance the process of seeking approval and potentially
commercializing CABOMETYX in markets beyond the U.S., Canada and Japan.”
First Quarter 2016 Financial Results
Net revenues for the quarter ended March 31, 2016 were $15.4
million, compared to $9.4 million for the comparable period in 2015. Net
revenues for the first quarter of 2016 consisted of $9.1 million of net
product revenue related to the sale of COMETRIQ, $5.0 million of
contract revenues for a milestone earned from Merck in the first quarter
of 2016 related to their worldwide license of our PI3K-delta program and
$1.2 million of license revenues recognized from the upfront payment we
received from Ipsen under our collaboration and license agreement.
Research and development expenses for the quarter ended March 31,
2016 were $28.9 million, compared to $22.3 million for the comparable
period in 2015. The increase was primarily related to an increase in
stock-based compensation expense for performance-based stock-options and
an annual bonus to our employees in the form of fully-vested restricted
stock units, an increase in personnel related expenses resulting from an
increase in headcount and an increase in consulting and outside services
for medical affairs and drug safety.
Selling, general and administrative expenses for the quarter
ended March 31, 2016 were $34.9 million, compared to $9.5 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, higher marketing expenses which includes a portion of
commercialization expenses from COTELLIC under our collaboration
agreement with Genentech, consulting and outside services expenses which
includes an accrual for the estimated termination fee due to Sobi, and
stock-based compensation expense for performance-based stock-options and
an annual bonus to our employees in the form of fully-vested restricted
stock units.
Other income (expense), net for the quarter ended March 31, 2016
was a net expense of ($12.2) million compared to ($12.4) million for the
comparable period in 2015. The net expense is comprised primarily of
interest expense which includes $7.2 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 June 2018 held by entities associated with
Deerfield for the quarter ended March 31, 2016, as compared to $7.7
million for the comparable period in 2015.
Net loss for the quarter ended March 31, 2016 was ($61.3)
million, or ($0.27) per share, basic, compared to ($35.2) million, or
($0.18) per share, basic, for the comparable period in 2015. The
increased net loss for the quarter was primarily due to increases in
selling, general and administrative expenses and research and
development expenses, partially offset by an increase in net revenues.
Cash and cash equivalents, short- and long-term investments and
long-term restricted cash and investments totaled $407.6 million at
March 31, 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 April 1,
2016, January 1, 2016 and March 28, 2015 are indicated as being as of
and for the periods ended March 31, 2016, December 31, 2015
and March 31, 2015, respectively.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the
first 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, May 4, 2016. To listen to a live webcast of the conference
call, visit the Event Calendar page under Investors & Media at www.exelixis.com.
Alternatively, participants may dial (855) 793-2457 (domestic) or (631)
485-4921 (international) and provide the conference call passcode
82069908 to join by phone.
An archived replay of the webcast will be available on the Event
Calendar page under Investors & Media at www.exelixis.com
for one year. An audio-only phone replay will be available until 11:59
p.m. EDT on May 6, 2016. Access numbers for the phone replay are: (855)
859-2056 (domestic) and (404) 537-3406 (international); the passcode is
82069908.
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.
commercial launch for CABOMETYX; the plan that, assuming approval of
cabozantinib for advanced RCC by the EMA, the product would be marketed
in the EU by Ipsen; Exelixis’ plan to continue to work with its partner
Genentech to co-promote COTELLIC in the United States; the business and
financial terms of the collaboration agreement for cabozantinib with
Ipsen, including, the division of commercialization rights, development
plans and Exelixis’ eligibility to receive regulatory and commercial
milestones and royalties; future data presentations for cabozantinib,
cobimetinib and XL888 at the ASCO 2016 Annual Meeting; the eligibility
for an expedited review of Exelixis’ MAA for cabozantinib in advanced
RCC by the EMA; Exelixis’ intention to transfer the MAA to Ipsen later
this year; the status of enrollment progress for and the timing of
anticipated top-line results from CELESTIAL; the continued development
of cabozantinib through Exelixis’ collaboration with NCI-CTEP and its
ongoing IST program; Exelixis’ anticipated operating expenses for 2016,
including non-cash items; Exelixis’ belief that the company is
well-positioned to advance the process of seeking approval and
potentially commercializing CABOMETYX in markets beyond the U.S., Canada
and Japan; 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,” “assuming,” “would,” “eligible,” “potential,” “future,”
“will,” “intend,” “continues,” “anticipate,” “planned,” “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; Exelixis’ ability
to judge the proper size and level of experience of the
commercialization teams required to support the launch of cabozantinib
for advanced RCC in the U.S.; 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
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; the sufficiency of Exelixis’ resources; the risk that
unanticipated developments could adversely affect the commercialization
of CABOMETYX or COMETRIQ; 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’
annual report on Form 10-K filed with the Securities and Exchange
Commission (SEC) on February 29, 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 May 4, 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 and COMETRIQ are registered U.S.
trademarks, and CABOMETYX and COTELLIC are U.S. trademarks.
|
EXELIXIS, INC.
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands, except per share data)
|
(unaudited)
|
|
|
|
Three Months Ended March 31,
|
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
Net product revenues
|
|
$
|
9,099
|
|
|
$
|
9,388
|
|
License and contract revenues
|
|
6,328
|
|
|
—
|
|
Total revenues
|
|
15,427
|
|
|
9,388
|
|
Operating expenses:
|
|
|
|
|
Cost of goods sold
|
|
685
|
|
|
766
|
|
Research and development
|
|
28,926
|
|
|
22,282
|
|
Selling, general and administrative
|
|
34,857
|
|
|
9,531
|
|
Restructuring charge
|
|
94
|
|
|
(431
|
)
|
Total operating expenses
|
|
64,562
|
|
|
32,148
|
|
Loss from operations
|
|
(49,135
|
)
|
|
(22,760
|
)
|
Other income (expense), net:
|
|
|
|
|
Interest income and other, net
|
|
202
|
|
|
(7
|
)
|
Interest expense
|
|
(12,414
|
)
|
|
(12,403
|
)
|
Total other income (expense), net
|
|
(12,212
|
)
|
|
(12,410
|
)
|
Net loss
|
|
$
|
(61,347
|
)
|
|
$
|
(35,170
|
)
|
Net loss per share, basic and diluted
|
|
$
|
(0.27
|
)
|
|
$
|
(0.18
|
)
|
Shares used in computing basic and diluted net loss per share
|
|
228,304
|
|
|
195,904
|
|
|
EXELIXIS, INC.
|
CONDENSED CONSOLIDATED BALANCE SHEET DATA
|
(in thousands)
|
|
|
|
March 31, 2016
|
|
December 31, 2015 (1)
|
|
|
(unaudited)
|
|
Cash and investments (2)
|
|
$
|
407,617
|
|
|
$
|
253,310
|
|
Working capital
|
|
$
|
238,401
|
|
|
$
|
126,414
|
|
Total assets
|
|
$
|
492,533
|
|
|
$
|
332,342
|
|
Total stockholders’ deficit
|
|
$
|
(155,954
|
)
|
|
$
|
(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 $2.7 million as of
March 31, 2016 and December 31, 2015.
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160504006718/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