Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
fourth quarter and year ended December 31, 2012.
Q4 2012 Highlights and Recent Events
"Exelixis achieved an important milestone in the fourth quarter of 2012
with the approval of our first product, COMETRIQ, for the treatment of
progressive, metastatic MTC," said Michael M. Morrissey, Ph.D.,
president and chief executive officer of Exelixis. "We are proud of this
important clinical and regulatory achievement and pleased to have
launched COMETRIQ in the progressive, metastatic MTC indication. Our
focus moving forward remains on expanding the commercial franchise for
cabozantinib. Our primary objective in 2013 is to execute on the broad
cabozantinib clinical development program, including our COMET pivotal
trial program in metastatic, castration-resistant prostate cancer
(CRPC), planned pivotal trials in HCC and RCC, and additional randomized
phase 2 trials to generate data that continue to differentiate the
compound and allow us to maximize its clinical and commercial potential."
Revenues for the quarter ended December 31, 2012 were $7.8
million, compared to $93.3 million for the comparable period in 2011;
and for the year ended December 31, 2012 were $47.5 million compared to
$289.6 million for the year ended December 31, 2011. The decreases for
both the quarter and year were primarily due to extraordinary one-time
revenue events in 2011, namely: the acceleration of license revenue as a
result of the termination of the company's agreement with Bristol
Myers-Squibb Company for XL281 in October 2011, the termination in
December 2011 of the company's PI3K discovery collaboration with Sanofi,
and the transfer in April 2011 of substantially all development
activities pertaining to XL147 and XL765 to Sanofi.
Research and development expenses for the quarter ended December
31, 2012 were $32.5 million, compared to $30.8 million for the
comparable period in 2011; and for the year ended December 31, 2012 were
$128.9 million compared to $156.8 million for the year ended December
31, 2011. The increase of approximately 6% for the quarter was primarily
due to an increase in costs related to clinical trial activities for the
COMET-1 and COMET-2 phase 3 pivotal trials in metastatic CRPC as well as
an increase in wages and benefits related to employee bonuses. The
decrease of approximately 18% for the full year was primarily due to the
gradual wind down of EXAM, the company's phase 3 pivotal trial for
cabozantinib in progressive, metastatic MTC, the completion of various
clinical pharmacology studies that occurred in 2011 in support of the
company's new drug application (NDA) filing for cabozantinib for the
treatment of progressive, metastatic MTC and the wind down of the
company's phase 2 randomized discontinuation trial for cabozantinib.
General and administrative expenses for the quarter ended
December 31, 2012 were $9.8 million, compared to $7.0 million for the
comparable period in 2011; and for the year ended December 31, 2012 were
$31.8 million compared to $33.1 million for the year ended December 31,
2011. The increase of approximately 40% for the quarter was primarily
due to increased marketing and commercialization activities in
preparation for the launch of COMETRIQ, as well as wages and benefits
related to employee bonuses in 2012. The decrease of approximately 4%
for the full year was primarily related to lower rent and utilities,
decreased legal and accounting fees and decreased depreciation and
amortization. These decreases were partially offset by increases in
consulting fees and reduced allocations to research and development as a
result of lower headcount.
Restructuring charge for the quarter ended December 31, 2012 was
$7.5 million, compared to $3.9 million for the comparable period in
2011; and for the year ended December 31, 2012 was $9.2 million compared
to $10.1 million for December 31, 2011. The increase in the
restructuring charges for the fourth quarter 2012 was primarily due to
Exelixis' exit of the remaining portions of office and lab space in one
of its buildings in South San Francisco, California for the remainder of
the lease term. For the full year 2012, the restructuring charge
included the facility charges described above, offset by a decrease in
termination benefits compared to the full year 2011.
Other income (expense), net for the quarter ended December 31,
2012 was ($10.1) million compared to ($4.0) million in the quarter ended
December 31, 2011; and for the year ended December 31, 2012 was ($25.1)
million compared to ($12.5) million for the year ended December 31,
2011. The increase in expense for both the quarter and year 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, 2012 was ($6.5) million and
($15.6) million of non-cash interest expense related to the 4.25%
convertible senior subordinated notes due 2019 and the company's
financing arrangement with entities affiliated with Deerfield Management
Company, L.P., respectively.
Net (loss) income for the quarter ended December 31, 2012 was
($52.2) million, or ($0.28) per share, compared to $46.3 million, or
$0.35 per share, basic, for the comparable period in 2011; and for the
year ended December 31, 2012 was ($147.6) million, or ($0.92) per share,
compared to $75.7 million, or $0.60 per share, basic, for the year ended
December 31, 2011. The increased net loss for the quarter was primarily
due to decreases in revenues as well as increased restructuring and
interest expense, as described above. The increased net loss for the
full year was primarily due to decreases in revenues and increases in
interest expense, partially offset by decreased research and development
costs, as described above.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $634.0
million at December 31, 2012, compared to $283.7 million at December 31,
For the full year 2013, Exelixis expects contract and license revenue of
approximately $16 million. The company is not providing guidance on
expected revenue from COMETRIQ product sales at this time. The company
expects total costs and expenses in the range of $200 million to $230
million, including non-cash expenses of approximately $16 to $18 million
related primarily to stock-based compensation expense. Exelixis further
expects interest expense of approximately $45 million, which includes
non-cash charges of $26 million. Exelixis expects its cash and cash
equivalents, short- and long-term investments and short- and long-term
restricted cash and investments to be approximately $400 million at the
end of 2013.
Conference Call and Webcast
Exelixis' management will discuss the company's financial results for
the quarter and year ended December 31, 2012, financial outlook, and
development program and plans for COMETRIQ, and will 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 21, 2013. To listen to a
live webcast of the discussion, 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 11:59 p.m. PST on March 21, 2013. Access numbers for
the phone replay are: 888-286-8010 (domestic) and 617-801-6888
(international); the passcode is 32648982.
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. 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 year ended December 28, 2012 are
indicated on a calendar year basis, ended December 31, 2012, and
references as of and for the fiscal quarters ended December 30, 2011 and
December 28, 2012 are indicated as ended December 31, 2011 and 2012,
respectively. Fiscal year 2013, a 52-week year, will end on December 27,
This press release contains forward-looking statements, including,
without limitation, statements related to: the referenced review for
marketing authorization for COMETRIQ in the European Union; Exelixis'
plans to initiate phase 3 pivotal trials of cabozantinib in advanced HCC
and metastatic RCC; Exelixis' focus on expanding the commercial
franchise for cabozantinib; Exelixis' primary objective to execute on
the broad cabozantinib clinical development program, including Exelixis'
COMET pivotal trial program in metastatic CRPC, planned pivotal trials
in HCC and RCC, and additional randomized phase 2 trials; the continued
development, clinical, therapeutic and commercial potential of COMETRIQ;
and Exelixis' financial outlook for 2013, including expected contract
and license revenue, total costs and expenses, including non-cash
expenses, interest expense, including non-cash charges and 2013 year-end
cash and cash equivalents, short- and long-term investments and short-
and long-term restricted cash and investments balance. Words such as
"confirms," "permit," "review," "plans," "initiate," "focus," "primary
objective," "continue," "allow," "potential," "outlook," "expects,"
"believes," and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are based
upon Exelixis' current plans, assumptions, beliefs and expectations.
Forward-looking statements involve risks and uncertainties. Exelixis'
actual results and the timing of events could differ materially from
those anticipated in such forward-looking statements as a result of
these risks and uncertainties, which include, without limitation: risks
related to the potential failure of cabozantinib 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; the availability of data at the expected times;
the risk that unanticipated developments could adversely affect the
launch, commercialization, manufacturing, distribution and availability
of COMETRIQ; the degree of market acceptance of COMETRIQ; the extent to
which coverage and reimbursement for COMETRIQ will be available from
third-party payors; 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; timely receipt of potential
reimbursements, milestones, royalties and profits under Exelixis'
collaborative agreements; the sufficiency of Exelixis' capital and other
resources; the uncertainty of the regulatory approval processes; market
competition; and changes in economic and business conditions. These and
other risk factors are discussed under "Risk Factors" and elsewhere in
Exelixis' annual report on Form 10-K for the year ended December 28,
2012, filed with the Securities and Exchange Commission (SEC) on
February 21, 2013, and Exelixis' other filings with the SEC. 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 and the Exelixis logo are registered U.S. trademarks.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
CONDENSED CONSOLIDATED BALANCE SHEET DATA (1)
(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
consist of $40.2 million and $4.2 million as of December 31, 2012 and
December 31, 2011, respectively.
[ Back To NFVZone's Homepage ]