SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Feb. 20, 2014--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
fourth quarter and year ended December 31, 2013.
Q4 2013 Highlights and Recent Events
-
Completed enrollment in COMET-1, the phase 3 study of cabozantinib
versus prednisone with the primary endpoint of overall survival in
patients with advanced metastatic castration-resistant prostate cancer
(CRPC). The study reached its enrollment target of 960 patients in
September 2013 and the enrollment was closed in November 2013.
-
Received a positive opinion from the European Committee for Medicinal
Products for Human Use (CHMP) on the Marketing Authorization
Application (MAA) for COMETRIQ® (cabozantinib) for the treatment of
adult patients with progressive, unresectable locally advanced or
metastatic medullary thyroid cancer (MTC). The opinion is now being
reviewed by the European Commission, which has the authority to
approve medicines for the European Union.
-
Initiated a phase 2 clinical trial comparing cabozantinib plus
abiraterone and prednisone versus abiraterone/prednisone in patients
with CRPC who have bone metastases and have not been previously
treated with chemotherapy. The primary endpoint for the randomized,
open-label trial is radiographic progression-free survival (PFS). The
company believes that the results of this trial could provide
important insight into the role that cabozantinib might play in
earlier lines of therapy, including patients who have not yet received
chemotherapy.
-
Entered into an amendment to the company's financing arrangement with
Deerfield Private Design Fund, L.P. and Deerfield Private Design
International, L.P. (collectively, Deerfield) in January 2014 to
provide the company with an option to extend to July 1, 2018 from July
1, 2015 the maturity date of the indebtedness incurred by the company
under the financing arrangement.
-
Completed an underwritten public offering of 10,000,000 shares of
common stock in January 2014, raising net proceeds of approximately
$75.6 million after deducting the underwriting discount and estimated
offering expenses.
-
Reported net product revenue for COMETRIQ (cabozantinib) of $4.3
million in the fourth quarter of 2013.
-
Appointed Jeffrey J. Hessekiel, J.D. as executive vice president and
general counsel. Mr. Hessekiel is a veteran legal professional with
more than a decade of corporate and commercial experience specific to
the biopharmaceutical industry, most of it gained in senior roles at
Gilead Sciences.
“We made significant progress in 2013 by launching COMETRIQ in MTC in
the U.S. and substantially advancing our cabozantinib clinical
development efforts by completing enrollment in COMET-1 and initiating
pivotal trials in metastatic renal cell cancer (RCC) and advanced
hepatocellular cancer (HCC). Building off that success, 2014 has the
potential to be a transformational year in advancing our mission to help
patients with cancer. We started the year with two internally-discovered
compounds in six ongoing pivotal trials, with four of these trials
expected to deliver top-line data in 2014,” said Michael M. Morrissey,
Ph.D., the company’s president and chief executive officer. “These
include the COMET-1 and COMET-2 trials for cabozantinib in metastatic
CRPC, and a pivotal trial of cobimetinib conducted by Roche and
Genentech in patients with malignant melanoma, in addition to the
overall survival readout for EXAM in MTC. While we look forward to these
results, we continue to advance the other components of our global
clinical development program, which is focused on identifying additional
opportunities for cabozantinib to expand its clinical and commercial
potential.”
Net revenues for the quarter ended December 31, 2013 were $4.3
million, compared to $7.8 million for the comparable period in 2012; and
for the year ended December 31, 2013 were $31.3 million compared to
$47.5 million for the year ended December 31, 2012. Revenues included
net product revenues of $4.3 million and $15.0 million for the quarter
and year ended December 31, 2013, respectively, from the sale of
COMETRIQ, which became commercially available in late January 2013. The
overall decrease in revenues during both the quarter and the year as
compared to the same periods in 2012 was due to a decrease in contract
and license revenue as a result of having fully recognized all revenues
from the company’s collaboration agreements with Bristol-Myers Squibb
Company. The decrease in revenues during the year was also due to $10.7
million in license revenue recognized in 2012 resulting from the
completion of the technology transfer under the company’s December 2011
license agreement with Merck for the company’s PI3K-delta program, and a
$5.5 million milestone payment received in August 2012 under the
company’s collaboration agreement with Daiichi Sankyo for XL550.
Research and development expenses for the quarter ended
December 31, 2013 were $49.6 million, compared to $32.5 million for the
comparable period in 2012; and for the year ended December 31, 2013 were
$178.8 million compared to $128.9 million for the year ended December
31, 2012. The increase during both the quarter and the year was
predominantly driven by clinical trial costs, primarily related to
clinical trial activities for COMET-1 and METEOR, the company’s phase 3
pivotal trials in metastatic CRPC and metastatic RCC, respectively, as
well as costs incurred in connection with the start-up of the CELESTIAL
phase 3 pivotal trial in advanced HCC. For the year, the increases in
costs for those trials were partially offset by lower clinical trial
costs related to the continued wind down of various phase 2 studies for
cabozantinib, most notably the randomized discontinuation trial, as well
as the EXAM trial for cabozantinib in patients with MTC.
Selling, general and administrative expenses for the quarter
ended December 31, 2013 were $13.6 million, compared to $9.8 million for
the comparable period in 2012; and for the year ended December 31, 2013
were $51.0 million compared to $31.8 million for the year ended December
31, 2012. The increase during both the quarter and the year was
primarily a result of an increase in expenses related to the company’s
U.S. sales force and the company’s European distribution partner for the
sale of COMETRIQ, personnel expenses and employee stock-based
compensation expense. The increase during the year was also due to
increases in legal and accounting fees, patent costs, and lower overhead
allocations to research and development, which were partially offset by
a decrease in facilities costs.
Other income (expense), net for the quarter ended December 31,
2013 was a net expense of ($11.3) million compared to ($10.1) million
for the comparable period in 2012; and for the year ended December 31,
2013 was ($44.1) million compared to ($25.1) million for the year ended
December 31, 2012. The increase in expense for the quarter was primarily
related to the gain on sale of excess property and equipment in 2012 and
for the year end was primarily due to interest expense in connection
with the $287.5 million aggregate principal amount of 4.25% Convertible
Senior Subordinated Notes due 2019 issued in August 2012. Included in
interest expense for the quarter and year ended December 31, 2013 was
$6.8 million and $26.3 million, respectively, 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 financing
arrangement with Deerfield.
Net loss for the quarter ended December 31, 2013 was ($70.7)
million, or ($0.38) per share, basic, compared to ($52.2) million, or
($0.28) per share, basic, for the comparable period in 2012; and for the
year ended December 31, 2013 was ($244.8) million, or ($1.33) per share,
compared to ($147.6) million, or ($0.92) per share, basic, for the year
ended December 31, 2012. The increased net loss during both the quarter
and the year was primarily due to increases in research and development
expenses, selling, general and administrative expenses and decreases in
license and contract revenues, which were slightly offset by increases
in product revenues, as described above.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $415.9
million at December 31, 2013, compared to $634.0 million at December 31,
2012.
Financial Outlook
For the full year 2014, Exelixis does not expect any significant
contract and license revenue in 2014 and is not providing guidance on
expected revenue from COMETRIQ product sales at this time. Exelixis
expects total costs and expenses in the range of $250 million to $280
million, including non-cash expenses of approximately $16 million to $18
million related primarily to stock-based compensation expense. Exelixis
further expects interest expense of approximately $47 million, which
includes non-cash charges of $28 million. Exelixis expects its cash and
cash equivalents, short- and long-term investments and short- and
long-term restricted cash and investments to be greater than $200
million at the end of 2014.
Conference Call and Webcast
Exelixis' management will discuss the company's financial results for
the quarter ended December 31, 2013, financial outlook and development
program and plans for cabozantinib, and also provide a general business
update, during a conference call beginning at 5:00 p.m. EST/2:00 p.m.
PST today, Thursday, February 20, 2014. To listen to a live webcast of
the conference call, visit the Event Calendar page under Investors &
Media at www.exelixis.com.
An archived replay of the webcast will be available on the Event
Calendar page under Investors & Media at www.exelixis.com
and via phone until 8:59 p.m. PST on March 20, 2014. Access numbers for
the phone replay are: 888-286-8010 (domestic) and 617-801-6888
(international); the passcode is 59600043.
About Exelixis
Exelixis, Inc. is a biotechnology company committed to developing small
molecule therapies for the treatment of cancer. Exelixis is focusing its
proprietary resources and development efforts exclusively on its lead
product, COMETRIQ® (cabozantinib). Exelixis has also established a
portfolio of other novel compounds that it believes have the potential
to address serious unmet medical needs, many of which are being advanced
by partners as part of collaborations. For more information, please
visit the company's web site at www.exelixis.com.
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 quarters and years ended
December 28, 2012 and December 27, 2013 are indicated as ended
December 31, 2012 and December 31, 2013, respectively.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: the review by the European
Commission of the CHMP’s referenced positive opinion on the MAA for
COMETRIQ® (cabozantinib); the belief that the referenced phase 2
clinical trial of cabozantinib in combination with other agents in
patients with CRPC could provide insight into the role cabozantinib
might play in earlier lines of therapy; the potential for 2014 to be a
transformational year for Exelixis; the expected timing of various
trials, including expected top-line data from four pivotal trials in
2014; the continued development and clinical, therapeutic and commercial
potential of, and opportunities for, cabozantinib; and Exelixis'
financial outlook for 2014, including expected contract and license
revenue, total costs and expenses, including non-cash expenses, interest
expense, including non-cash charges, and 2014 year-end cash and cash
equivalents, short- and long-term investments and short- and long-term
restricted cash and investments balance. Words such as “being,”
“believes,” “could,” “provide,” “might,” “potential,”
“transformational,” “expect,” “look forward,” “continue,” “advance,”
“focused,” “opportunities,” “expand,” “outlook,” 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 availability of data at the expected times;
risks related to the potential failure of cabozantinib or cobimetinib to
demonstrate safety and efficacy in clinical testing; the uncertain
timing and level of expenses associated with the development of
cabozantinib; Exelixis' ability to conduct clinical trials of
cabozantinib sufficient to achieve a positive completion; Exelixis'
dependence on its relationship with Genentech/Roche for the development
of cobimetinib and Exelixis’ ability to maintain its rights; the
uncertainty of regulatory approval processes; the risk that
unanticipated developments could adversely affect the commercialization
of COMETRIQ® (cabozantinib); the degree of market acceptance of COMETRIQ
and the availability of coverage and reimbursement for COMETRIQ; risks
and uncertainties related to Exelixis' compliance with applicable
regulatory requirements, including healthcare fraud and abuse laws and
post-marketing requirements; Exelixis' dependence on third-party
vendors; the sufficiency of Exelixis' capital and other resources;
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 20, 2014 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.
|
EXELIXIS, INC.
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands, except per share data)
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
Year Ended December 31,
|
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
|
(Unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
License and contract revenues
|
|
$
|
—
|
|
|
$
|
7,814
|
|
|
$
|
16,321
|
|
|
$
|
47,450
|
|
Net product revenues
|
|
4,347
|
|
|
—
|
|
|
15,017
|
|
|
—
|
|
Total revenues
|
|
4,347
|
|
|
7,814
|
|
|
31,338
|
|
|
47,450
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
263
|
|
|
—
|
|
|
1,118
|
|
|
—
|
|
Research and development
|
|
49,597
|
|
|
32,492
|
|
|
178,763
|
|
|
128,878
|
|
Selling, general and administrative
|
|
13,635
|
|
|
9,829
|
|
|
50,958
|
|
|
31,837
|
|
Restructuring charge
|
|
366
|
|
|
7,467
|
|
|
1,231
|
|
|
9,171
|
|
Total operating expenses
|
|
63,861
|
|
|
49,788
|
|
|
232,070
|
|
|
169,886
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(59,514
|
)
|
|
(41,974
|
)
|
|
(200,732
|
)
|
|
(122,436
|
)
|
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
Interest income and other, net
|
|
293
|
|
|
1,168
|
|
|
1,223
|
|
|
1,986
|
|
Interest expense
|
|
(11,621
|
)
|
|
(11,313
|
)
|
|
(45,347
|
)
|
|
(27,088
|
)
|
Total other income (expense), net
|
|
(11,328
|
)
|
|
(10,145
|
)
|
|
(44,124
|
)
|
|
(25,102
|
)
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
(70,842
|
)
|
|
(52,119
|
)
|
|
(244,856
|
)
|
|
(147,538
|
)
|
Income tax (benefit) provision
|
|
(96
|
)
|
|
74
|
|
|
(96
|
)
|
|
107
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(70,746
|
)
|
|
$
|
(52,193
|
)
|
|
$
|
(244,760
|
)
|
|
$
|
(147,645
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$
|
(0.38
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(1.33
|
)
|
|
$
|
(0.92
|
)
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
184,376
|
|
|
183,605
|
|
|
184,062
|
|
|
160,138
|
|
|
|
EXELIXIS, INC.
|
CONDENSED CONSOLIDATED BALANCE SHEET DATA (1)
|
(in thousands)
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
2013
|
|
2012
|
Cash and investments (2)
|
|
$
|
415,862
|
|
|
$
|
633,961
|
|
|
|
|
|
Working capital
|
|
$
|
178,756
|
|
|
$
|
350,837
|
|
|
|
|
|
Total assets
|
|
$
|
503,287
|
|
|
$
|
721,097
|
|
|
|
|
|
Total stockholders' equity
|
|
$
|
66,238
|
|
|
$
|
296,434
|
|
(1)
|
|
Derived from the audited consolidated financial statements.
|
(2)
|
|
Cash and investments include cash and cash equivalents, short- and
long-term investments and short- and long-term restricted cash and
investments. Short- and long-term restricted cash and investments
totaled $29.1 million and $40.2 million as of December 31, 2013 and
2012, respectively.
|
Source: Exelixis, Inc.
Exelixis, Inc.
Frank Karbe, 650-837-7565
Chief
Financial Officer
fkarbe@exelixis.com
Charles
Butler, 650-837-7277
Vice President
Investor
Relations & Corporate Communications
cbutler@exelixis.com