- Conference Call and Webcast Today at 5:00 PM Eastern Time -
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 10, 2015--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
third quarter of 2015 and provided an update on progress toward
delivering upon its key 2015 corporate objectives and clinical
development milestones.
Key Priorities and Corporate Updates
Following release of positive results from the pivotal METEOR trial,
Exelixis is focused on expediting its regulatory submissions and
augmenting its commercial infrastructure to support the potential launch
of its lead compound, cabozantinib, in advanced renal cell carcinoma
(RCC) in the United States. At the same time, in support of its
collaboration partner, Genentech, a member of the Roche Group, Exelixis
is rolling out its portion of the U.S. sales force promoting COTELLICTM
(cobimetinib), a second Exelixis-discovered compound, following recent
regulatory approvals for the compound in combination with vemurafenib
for the treatment of BRAF V600 mutation-positive unresectable or
metastatic melanoma in the United States and Switzerland.
Cabozantinib Highlights
METEOR Trial Delivers Positive Results in Advanced RCC; Cabozantinib
Granted Breakthrough Therapy Designation. In July 2015, Exelixis
announced that METEOR met its primary endpoint, demonstrating a
statistically significant improvement in progression-free survival (PFS)
for cabozantinib versus everolimus in a population of patients with
advanced RCC who have experienced disease progression following
treatment with at least one prior VEGFR tyrosine kinase inhibitor. Based
on these data, the FDA granted Breakthrough Therapy Designation to
cabozantinib as a potential treatment for patients with advanced RCC who
have received one prior therapy. In September 2015, detailed data from
METEOR were published in The New England Journal of Medicine and
also presented during the Presidential Session I at the European Cancer
Congress in Vienna, Austria.
Progress on U.S. and EU Regulatory Filings for Cabozantinib in
Advanced RCC. Based on the data from the METEOR trial, in October
2015, Exelixis initiated the rolling submission of its New Drug
Application (NDA) in the United States. Exelixis expects to complete the
U.S. filing before the end of 2015. In the European Union, the European
Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)
has granted accelerated assessment to cabozantinib for advanced RCC. As
a result, when filed, the company’s Marketing Authorization may be
eligible for a 150-day review, versus the standard 210 days (excluding
clock stops when written or oral information is requested from CHMP).
Exelixis expects to complete the EU filing in early 2016.
Results from a Randomized Phase 2 Trial in First-Line RCC Expected in
the First Half 2016. The randomized phase 2 trial comparing
cabozantinb versus sunitinib in the treatment of first-line intermediate
or poor risk RCC patients, CABOSUN, completed enrollment in early 2015
and results for the primary endpoint of PFS are now expected in the
first half of 2016. 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).
Trial Underway Evaluating Cabozantinib with Immunotherapies. In July
2015, Exelixis’ collaborators at NCI-CTEP initiated a phase 1 trial of
cabozantinib in combination with nivolumab alone, or in combination with
nivolumab plus ipilimumab, in patients with genitourinary tumors,
including bladder cancer and RCC. The primary endpoint of the trial is
the determination of dose-limiting toxicities and a recommended phase 2
dose for the combinations. Exelixis believes that there is a strong
rationale for combining cabozantinib with immunotherapies, including
clinical evidence of cabozantinib’s ability to create a more
immune-permissive environment, as well as preclinical data suggesting
cabozantinib increases T-cell infiltration into tumors. Data from this
trial could have relevance in other disease settings, including
non-small cell lung cancer (NSCLC).
Cobimetinib Highlights
Regulatory Progress for COTELLIC in Europe, Including Approval in
Switzerland and Positive Opinion Issued by the European Medicines
Agency’s CHMP. On August 27, 2015, Exelixis announced that
Swissmedic, the Swiss licensing and supervisory authority, approved
COTELLIC for use in combination with vemurafenib as a treatment for
patients with advanced melanoma. In September 2015, the European
Medicines Agency’s CHMP adopted a positive opinion of Roche’s Marketing
Authorization Application for COTELLIC in combination with vemurafenib
for the treatment of BRAF V600 mutation-positive unresectable or
metastatic melanoma. The European Commission is expected to release its
final opinion by the end of 2015. Under the terms of the collaboration
agreement with Roche and Genentech, Exelixis will receive royalties on
sales of COTELLIC outside of the United States.
Positive Overall Survival Data for Cobimetinib in Combination with
Vemurafenib in Advanced Melanoma. In October 2015, Exelixis
announced that the phase 3 coBRIM trial of cobimetinib in combination
with vemurafenib met its secondary endpoint of demonstrating a
statistically significant and clinically meaningful increase in overall
survival for patients with unresectable locally advanced or metastatic
melanoma carrying the BRAF V600 mutation. These data will be the subject
of a presentation at the Society for Melanoma Research 2015 Congress
taking place in San Francisco, November 18-21, 2015.
Regulatory Approval for COTELLIC in the United States. Today,
Exelixis announced that the U.S. FDA approved cobimetinib for use in
combination with vemurafenib as a treatment for patients with BRAF V600
mutation-positive advanced melanoma. COTELLIC is expected to be
available within two weeks. Exelixis is entitled to an initial equal
share of U.S. profits and losses, which will decrease as sales increase,
and shares in the U.S. sales and marketing costs, including co-promoting
COTELLIC in the U.S.
Corporate Highlights
Key Hires in Medical Affairs, Sales, and Marketing. In September
2015, the company announced three high-level appointments to support the
commercialization of cabozantinib and cobimetinib: William Berg, M.D.
joined the company as Senior Vice President of Medical Affairs, Jonathan
Berndt as Vice President of Sales, and Gregg Bernier as Vice President
of Marketing.
Public Offering of Stock Raises Net Proceeds of Approximately $145.6
Million. In late July 2015, Exelixis launched and completed a
public offering of common stock. The company issued 28,750,000 shares,
including 3,750,000 shares issued under the underwriters’ 30-day option
to buy shares, at a price to the public of $5.40 per share, receiving
approximately $145.6 million in net proceeds after deducting the
underwriting discount and other estimated offering expenses payable
by Exelixis. Exelixis currently expects to use the net proceeds from the
offering for general corporate purposes, including for clinical trials,
build-out of commercial infrastructure, research and development,
capital expenditures and working capital.
“Over the last few months, we have made significant strides with our
lead development program, cabozantinib in advanced RCC, including
receiving Breakthrough Therapy Designation from the FDA, initiating our
rolling NDA submission and obtaining accelerated assessment status from
the European Medicines Agency’s CHMP,” said Michael M. Morrissey, Ph.D.,
president and chief executive officer of Exelixis. “At the same time, we
have significantly strengthened our organization’s capabilities,
including the addition of high-level personnel in medical affairs,
sales, and marketing in advance of the potential commercialization of
cabozantinib in advanced RCC.”
Dr. Morrissey continued: “Moreover, after the third quarter closed,
Exelixis achieved a major milestone when COTELLIC became the second
medicine to emerge from our research and development organization that
has received FDA approval. We are excited to embark on the launch of
COTELLIC in the U.S., working closely with our partners Genentech and
Roche to commercialize the product, including fielding one quarter of
the U.S. sales force.”
2015 Financial Guidance. The company is refining its operating
expense guidance for the second six months of 2015. We expect second
half operating expenses to be at the upper end of the previously
indicated $80 million to $90 million range including approximately $10
million of incremental non-cash stock-based compensation expense related
to the vesting of performance stock options tied to the read-out of
METEOR top-line results. As a result, we anticipate that our full year
2015 operating expenses will be near the upper end of the
previously-indicated $150 million to $160 million range.
Third Quarter 2015 Financial Results
Net revenues for the quarter ended September 30, 2015 were $9.9
million, compared to $6.3 million for the comparable period in 2014. Net
revenues for the third quarter of 2015 consisted of $6.9 million net
product revenue related to the sale of COMETRIQ and $3.0 million of
contract revenues for a milestone payment received from Merck related to
their worldwide license of our PI3K-delta program.
Research and development expenses for the quarter ended
September 30, 2015 were $26.1 million, compared to $43.6 million for the
comparable period in 2014. The decrease was primarily related to a net
decrease in clinical trial costs related to COMET and METEOR, the
company’s phase 3 trials in metastatic castration-resistant prostate
cancer and advanced RCC, and to a lesser degree, decreases in personnel
related expenses resulting from an overall reduction in headcount. Those
decreases were partially offset by an increase in stock-based
compensation expense due to performance-based stock-options that vested
as a result of the positive top-line data received from METEOR.
Selling, general and administrative expenses for the quarter
ended September 30, 2015 were $17.8 million, compared to $9.9 million
for the comparable period in 2014. The increase was primarily related to
stock-based compensation expense due to the vesting of performance-based
stock-options as a result of the positive top-line data received from
the METEOR trial and higher marketing expenses, including expenses for
cobimetinib under the company’s collaboration agreement with Genentech.
Those increases were partially offset by a decrease in facilities costs
and consulting and outside services.
Other income (expense), net for the quarter ended September 30,
2015 was a net expense of ($11.8) million compared to ($11.0) million
for the comparable period in 2014. The net expense is comprised
primarily of interest expense which includes $6.9 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 the Deerfield Notes for the quarter ended
September 30, 2015, as compared to $7.5 million for the comparable
period in 2014.
Net loss for the quarter ended September 30, 2015 was ($47.6)
million, or ($0.22) per share, basic, compared to ($62.6) million, or
($0.32) per share, basic, for the comparable period in 2014. The
decreased net loss for the quarter was primarily due to decreases in
research and development expenses and an increase in net revenues,
partially offset by an increase in selling, general and administrative
expenses.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $282.1
million at September 30, 2015 compared to $242.8 million at December 31,
2014.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the
second quarter of 2015 and provide a general business update during a
conference call beginning at 5:00 p.m. EST/2:00 p.m. PST today,
November 10, 2015. 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
62011541 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. EST on November 12, 2015. Access numbers for the phone replay are:
(855) 859-2056 (domestic) and (404) 537-3406 (international); the
passcode is 62011541.
About Exelixis
Exelixis, Inc. is a biopharmaceutical company committed to developing
small molecule therapies for the treatment of cancer. Exelixis is
focusing its development and commercialization efforts primarily on
cabozantinib, its wholly owned inhibitor of multiple receptor tyrosine
kinases. Positive results were recently announced for a phase 3 pivotal
trial of cabozantinib in patients with advanced renal cell carcinoma who
received at least one prior VEGF receptor tyrosine kinase inhibitor, and
Exelixis expects to complete regulatory filings in the U.S. and European
Union in late 2015 and early 2016, respectively. Another
Exelixis-discovered compound, COTELLICTM, a selective
inhibitor of MEK, received its first regulatory approvals in Switzerland
and the United States, and is being evaluated by Roche and Genentech (a
member of the Roche Group) in a broad development program under a
collaboration with Exelixis. For more information, please visit the
company’s website at www.exelixis.com.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: Exelixis’ key 2015 corporate
objectives and clinical development milestones; Exelixis’ focus on
expediting regulatory submissions for cabozantinib for the treatment of
advanced RCC and augmenting its commercial infrastructure to support the
potential launch of advanced RCC; Exelixis’ continued support of
Genentech, including fielding 25% of the U.S. sales force promoting
COTELLIC; Exelixis’ plan to complete regulatory filings for cabozantinib
for the treatment of advanced RCC in the U.S. before the end of 2015 and
in the EU in early 2016; the likelihood of expedited approval of
cabozantinib for advanced RCC as a result Breakthrough Technology
Designation in the U.S. and accelerated assessment status in the EU; the
availability of results from the CABOSUN trial in the first half of
2016; Exelixis’ belief that there is a strong rationale for combining
cabozantinib with immunotherapies and that data from the phase 1 trial
evaluating this approach in patients with genitourinary tumors could
have relevance in other disease settings; the timing of a possible
approval of cobimetinib in the EU; timing of the presentation of
positive overall survival data from the coBRIM trial; the financial
terms of Exelixis’ collaboration with Genentech if cobimetinib
successfully reaches the market, including Exelixis’ entitlement to an
initial equal share of U.S. profits and losses, with Exelixis’ share
decreasing as sales increase; the parties' plan to share equally in the
U.S. sales and marketing costs and Exelixis’ entitlement to receive
royalties on sales of cobimetinib outside of the U.S.; Exelixis’ plans
for use of the net proceeds from the July 2015 public offering; and
Exelixis’ financial outlook for the second six months of 2015. Words
such as “progress toward,” “objectives,” “priority,” “expedite,”
“augment,” “potential,” “rolling out,” “expects,” “may be,” “initiate,”
“believes,” “suggesting,” “could,” “continues,” “potential,” “will be,”
“plan,” “priority,” “committed,” “entitled,” “trend,” “embark” 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. Exelixis’ 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 uncertainties of FDA and EMA regulatory review
and approval processes and Exelixis’ compliance with applicable legal
and regulatory requirements; 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;
Exelixis’ ability to roll out its portion of the U.S. sales force
promoting COTELLIC; Exelixis’ dependence on its relationship with
Genentech/Roche with respect to cobimetinib and Exelixis’ ability to
maintain its rights under the collaboration; the availability of
clinical trial data at the expected times; risks related to the
potential failure of cabozantinib or cobimetinib to demonstrate safety
and efficacy in clinical testing; the clinical, therapeutic and
commercial value of cabozantinib and cobimetinib; the sufficiency of
Exelixis’ capital and other resources; the accuracy of Exelixis’
financial guidance; the uncertain timing and level of expenses
associated with the development of cabozantinib; Exelixis’ ability to
enter into new collaborations on acceptable terms; the risk that
unanticipated developments could adversely affect the commercialization
of Exelixis products; the degree of market acceptance of Exelixis
products and the availability of coverage and reimbursement for them;
Exelixis’ dependence on third-party vendors; 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 November 10,
2015 and in Exelixis’ other filings with the SEC. 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.
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EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
$
|
6,854
|
|
|
$
|
6,291
|
|
|
$
|
24,234
|
|
|
$
|
17,758
|
|
Contract revenues
|
|
3,000
|
|
|
—
|
|
|
3,000
|
|
|
—
|
|
Total revenues
|
|
9,854
|
|
|
6,291
|
|
|
27,234
|
|
|
17,758
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
1,420
|
|
|
573
|
|
|
2,872
|
|
|
1,359
|
|
Research and development
|
|
26,091
|
|
|
43,628
|
|
|
72,879
|
|
|
149,451
|
|
Selling, general and administrative
|
|
17,842
|
|
|
9,906
|
|
|
40,162
|
|
|
41,063
|
|
Restructuring charge
|
|
282
|
|
|
3,758
|
|
|
1,142
|
|
|
4,135
|
|
Total operating expenses
|
|
45,635
|
|
|
57,865
|
|
|
117,055
|
|
|
196,008
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(35,781
|
)
|
|
(51,574
|
)
|
|
(89,821
|
)
|
|
(178,250
|
)
|
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
Interest income and other, net
|
|
276
|
|
|
1,296
|
|
|
146
|
|
|
3,786
|
|
Interest expense
|
|
(12,059
|
)
|
|
(12,282
|
)
|
|
(36,421
|
)
|
|
(36,125
|
)
|
Total other income (expense), net
|
|
(11,783
|
)
|
|
(10,986
|
)
|
|
(36,275
|
)
|
|
(32,339
|
)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(47,564
|
)
|
|
$
|
(62,560
|
)
|
|
$
|
(126,096
|
)
|
|
$
|
(210,589
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$
|
(0.22
|
)
|
|
$
|
(0.32
|
)
|
|
$
|
(0.62
|
)
|
|
$
|
(1.09
|
)
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
217,587
|
|
|
195,126
|
|
|
203,153
|
|
|
193,855
|
|
|
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
|
|
|
|
September 30, 2015
|
|
December 31, 2014 (1)
|
|
|
(unaudited)
|
|
Cash and investments (2)
|
|
$
|
282,061
|
|
|
$
|
242,760
|
|
|
|
|
|
|
Working capital (deficit)
|
|
$
|
151,429
|
|
|
$
|
(4,619
|
)
|
|
|
|
|
|
Total assets
|
|
$
|
363,241
|
|
|
$
|
327,960
|
|
|
|
|
|
|
Total stockholders’ deficit
|
|
$
|
(74,228
|
)
|
|
$
|
(114,829
|
)
|
_______________________________________
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(1)
|
Derived from the audited consolidated financial statements.
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(2)
|
Cash and investments include cash and cash equivalents, short- and
long-term investments and short- and long-term restricted cash and
investments. Long-term restricted cash and investments totaled
$2.7 million as of September 30, 2015. Short- and long-term
restricted cash and investments totaled $16.9 million as of
December 31, 2014.
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View source version on businesswire.com: http://www.businesswire.com/news/home/20151110006958/en/
Source: Exelixis, Inc.
Exelixis, Inc.
Chris Senner, 650-837-7240
Chief
Financial Officer
csenner@exelixis.com
or
Susan
Hubbard, 650-837-8194
Investor Relations & Corporate
Communications
shubbard@exelixis.com