SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May. 7, 2013--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
quarter ended March 31, 2013.
Q1 2013 Highlights and Recent Events
-
Commercial launch of COMETRIQ™ (cabozantinib) in the United States on
January 24, 2013 for the treatment of progressive, metastatic
medullary thyroid cancer (MTC).
-
Reported net product revenue for COMETRIQ of $1.9 million in the first
quarter of 2013.
-
Announced in February 2013 a three-year agreement with Swedish Orphan
Biovitrum (Sobi) to support the distribution and commercialization of
COMETRIQ for metastatic MTC primarily in the European Union and
potentially other countries, initially under a Named Patient Use
Program and then more broadly only if approved by the European
Medicines Agency.
-
Presentation of data at the American Association for Cancer Research
Annual Meeting 2013 detailing the mechanism of action of cabozantinib
in a preclinical castration-resistant prostate cancer (CRPC) bone
metastasis model. Treatment of animals with cabozantinib resulted in
substantial inhibition of tumor growth, induction of tumor cell death,
and blockade of cancer-induced bone remodeling as determined by
bioluminescence imaging, MRI, micro-CT, and histological analyses. In
addition, imaging studies showed that early reductions in the uptake
of the bone scan tracer 99Tc-MDP were associated with the
anti-tumor activity of cabozantinib in mice.
-
Announced that nine abstracts have been accepted for presentation at
the 2013 Annual Meeting of the American Society of Clinical Oncology
(ASCO) this June in Chicago, Illinois. At the meeting, investigators
will present updates from clinical trials of cabozantinib in MTC,
CRPC, uveal melanoma, and bladder cancer, among other tumor types.
-
Received notice from Genentech, Exelixis' collaborator in the
development of cobimetinib (GDC-0973/XL518) and a member of the Roche
Group, in January 2013 that the first patient was dosed in a phase 3
pivotal trial evaluating the BRAF inhibitor Zelboraf (vemurafenib)
alone or in combination with cobimetinib (GDC-0973/XL518) in
previously untreated patients with malignant melanoma harboring the
BRAF V600 mutation.
“The first quarter of 2013 began on a significant note with the
successful U.S. launch of COMETRIQ for the treatment of progressive,
metastatic MTC. We are gratified to provide an important new treatment
option for patients with this disease,” said Michael M. Morrissey,
Ph.D., president and chief executive officer of Exelixis. “While we
continue to execute on the commercial launch, we remain focused on
advancing the cabozantinib clinical development program. The majority of
sites for the COMET program, consisting of two pivotal trials in CRPC,
are now open, and we continue to expect top-line data in 2014. Beyond
prostate cancer, we expect to start additional pivotal trials in
metastatic renal cell carcinoma (RCC) and metastatic hepatocellular
carcinoma (HCC) in the third quarter 2013. In addition, we have a broad
and expanding program of earlier stage trials, and updates on some of
these trials will be provided at the ASCO Annual Meeting in June.”
Net revenues for the quarter ended March 31, 2013 were $9.7
million, compared to $18.5 million for the comparable period in 2012.
Net revenues for the quarter included $1.9 million resulting from the
sale of COMETRIQ, which became commercially available on January 24,
2013. The quarterly decrease in non-product revenues, when compared to
the same period in 2012, is primarily due to $10.7 million in revenue
recognized in 2012 resulting from the completion of the technology
transfer under Exelixis'December 2011 license agreement with Merck for
Exelixis' PI3K-delta program.
Research and development expenses for the quarter ended March 31,
2013 were $32.7 million, compared to $33.1 million for the comparable
period in 2012. The decrease was primarily due to lower personnel
expenses, lower allocations of general corporate costs to research and
development and lower depreciation and amortization expenses. These
decreases were largely offset by increased clinical trial costs as well
as increased expenses for consulting and outside services. The increase
in clinical trial costs was primarily related to clinical trial
activities for COMET-1 and COMET-2, Exelixis' phase 3 pivotal trials in
CRPC, as well as costs incurred in preparation for phase 3 trials for
metastatic HCC and metastatic RCC. These increases are largely offset by
lower costs related to the continued wind down of Exelixis' phase 2
randomized discontinuation trial, EXAM, Exelixis' phase 3 pivotal trial
for cabozantinib in progressive, metastatic MTC, as well as a decrease
in chemistry, manufacturing and control expenses.
Selling, general and administrative expenses for the quarter
ended March 31, 2013 were $10.5 million, compared to $7.9 million for
the comparable period in 2012. The increase was primarily due to an
increase in expenses for consulting and outside services related to both
the sale of COMETRIQ in the United States and the preparation for making
COMETRIQ available to patients primarily in the European Union and
potentially other countries, as well as an increase in marketing expense
and lower allocations of general corporate costs to research and
development.
Other income (expense), net for the quarter ended March 31, 2013
was a net expense of ($10.7) million compared to ($3.8) million in the
quarter ended March 31, 2012. The increase in expense in 2013 compared
to 2012 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 ended March 31, 2012 was ($6.3) million of
non-cash expense related to the accretion of the discount on both the
4.25% convertible senior subordinated notes due 2019 and the company's
financing arrangement with Deerfield Management Company, L.P.
Net loss for the quarter ended March 31, 2013 was ($44.7)
million, or ($0.24) per share, compared to ($26.2) million, or ($0.18)
per share, basic, for the comparable period in 2012. The net loss was
primarily due to decreases in revenues, increases in selling, general
and administrative expenses and increased interest expenses as described
above.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $566.8
million at March 31, 2013, compared to $634.0 million at December 31,
2012.
Conference Call and Webcast
Exelixis' management will discuss the company's financial results for
the quarter ended March 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. EDT/2:00 p.m.
PDT today, Tuesday, May 7, 2013. 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 11:59 p.m. PDT on June 7, 2013. Access numbers for
the phone replay are: 888-286-8010 (domestic) and 617-801-6888
(international); the passcode is 84660665.
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™. 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 ended
March 30, 2012 and March 29, 2013, and as of the fiscal year ended
December 28, 2012, are indicated as ended March 31, 2012 and 2013, and
as ended December 31, 2012, respectively.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: the referenced distribution
and commercialization of COMETRIQ in the European Union and potentially
other countries, initially under a Named Patient Use Program and then
more broadly only if approved by the European Medicines Agency; expected
data presentations from clinical trials of cabozantinib in MTC, CRPC,
uveal melanoma and bladder cancer at the 2013 ASCO Annual Meeting;
Exelixis' continued execution on the commercial launch of COMETRIQ;
Exelixis' focus on advancing the cabozantinib clinical development
program; Exelixis' continued expectation for top-line data for the COMET
program in 2014; Exelixis' plans to initiate phase 3 pivotal trials of
cabozantinib in metastatic RCC and metastatic HCC in the third quarter
2013; Exelixis' expanding cabozantinib development program of earlier
stage trials and updated data presentations on such trials at the 2013
ASCO Annual Meeting; and the continued development and clinical,
therapeutic and commercial potential of, and opportunities for,
cabozantinib. Words such as “support,” “potentially,” “will,”
“continue,” “remain,” “focused,” “expect,” “expanding,” “believes,”
“potential” 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: the
uncertainty of the regulatory approval processes; the availability of
data at the expected times; 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 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; market competition; and changes in economic and business
conditions. These and other risk factors are discussed under “Risk
Factors” and elsewhere in Exelixis' quarterly report on Form 10-Q for
the three months ended March 29, 2013, filed with the Securities and
Exchange Commission (SEC) on May 7, 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.
|
EXELIXIS, INC.
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands, except per share data)
|
(unaudited)
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2013
|
|
|
2012
|
|
Revenues:
|
|
|
|
|
License and contract revenues
|
|
$
|
7,813
|
|
|
$
|
18,510
|
|
Net product revenues
|
|
1,856
|
|
|
—
|
|
Total revenues
|
|
9,669
|
|
|
18,510
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
Cost of goods sold
|
|
280
|
|
|
—
|
|
Research and development
|
|
32,735
|
|
|
33,096
|
|
Selling, general and administrative
|
|
10,545
|
|
|
7,905
|
|
Restructuring charge (credit)
|
|
119
|
|
|
(195
|
)
|
Total operating expenses
|
|
43,679
|
|
|
40,806
|
|
|
|
|
|
|
Loss from operations
|
|
(34,010
|
)
|
|
(22,296
|
)
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
Interest income and other, net
|
|
338
|
|
|
160
|
|
Interest expense
|
|
(11,057
|
)
|
|
(4,004
|
)
|
Total other income (expense), net
|
|
(10,719
|
)
|
|
(3,844
|
)
|
|
|
|
|
|
Loss before income taxes
|
|
(44,729
|
)
|
|
(26,140
|
)
|
Income tax provision
|
|
—
|
|
|
11
|
|
|
|
|
|
|
Net loss
|
|
$
|
(44,729
|
)
|
|
$
|
(26,151
|
)
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$
|
(0.24
|
)
|
|
$
|
(0.18
|
)
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
183,742
|
|
|
141,940
|
|
|
|
|
|
|
|
|
|
EXELIXIS, INC.
|
CONDENSED CONSOLIDATED BALANCE SHEET DATA
|
(in thousands)
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
2013
|
|
2012 (1)
|
|
|
(unaudited)
|
|
|
Cash and investments (2)
|
|
$
|
566,757
|
|
|
$
|
633,961
|
|
|
|
|
|
Working capital
|
|
$
|
316,146
|
|
|
$
|
350,837
|
|
|
|
|
|
Total assets
|
|
$
|
659,527
|
|
|
$
|
721,097
|
|
|
|
|
|
Total stockholders' equity
|
|
$
|
254,852
|
|
|
$
|
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
consist of $34.1 million and $40.2 million as of March 31, 2013 and
December 31, 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