SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug. 6, 2013--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
quarter ended June 30, 2013.
Q2 2013 Highlights and Recent Events
-
Reported net product revenue for COMETRIQ® (cabozantinib) of $4.0
million in the second quarter of 2013.
-
Expanded the sales force to 14 representatives.
-
Initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to
everolimus in patients with metastatic renal cell carcinoma (RCC) who
have experienced disease progression following treatment with at least
one prior VEGFR tyrosine kinase inhibitor (TKI). The trial is expected
to enroll 650 patients, and the primary endpoint is progression-free
survival (PFS). The secondary endpoint is overall survival (OS) and no
cross-over will be allowed between the study arms.
-
Cabozantinib was the subject of nine presentations at the American
Society of Clinical Oncology (ASCO) 2013 Annual Meeting in June,
including an oral presentation of data from the EXAM study, Exelixis'
phase 3 pivotal trial in progressive, metastatic medullary thyroid
cancer (MTC), as well as a poster discussion presentation of overall
survival data from patients with metastatic castration-resistant
prostate cancer (CRPC) in a non-randomized expansion (NRE) cohort of
Exelixis' phase 2 randomized discontinuation trial. Additional
presentations covered cabozantinib's potential activity in
investigational studies of advanced urothelial carcinoma, metastatic
uveal melanoma, and CRPC metastatic to the bone.
“We gained significant momentum in both commercial and development
activities in the second quarter of 2013,” said Michael M. Morrissey,
Ph.D., president and chief executive officer of Exelixis. “While
continuing to focus on enrollment of the COMET phase 3 pivotal trials as
our top priority, we initiated the METEOR phase 3 pivotal trial in
metastatic RCC and finalized planning for our phase 3 pivotal trial in
metastatic hepatocellular carcinoma (HCC). In addition, the overall
survival and post-hoc analyses from the phase 2 NRE metastatic CRPC
cohort were presented at the ASCO Annual Meeting and those data continue
to support the rationale for the COMET pivotal trials in metastatic
CRPC, for which we continue to expect top-line data in 2014."
Net revenues for the quarter ended June 30, 2013 were $11.9
million, compared to $7.8 million for the comparable period in 2012. The
increase for the quarter was due to $4.0 million of net product revenue
resulting from the sale of COMETRIQ, which became commercially available
in the United States for the treatment of progressive, metastatic MTC in
January 2013.
Research and development expenses for the quarter ended June 30,
2013 were $49.1 million, compared to $32.6 million for the comparable
period in 2012. The increases were primarily due to increased clinical
trial costs. The increase in clinical trial costs was primarily related
to clinical trial activities for COMET-1, the phase 3 pivotal trial with
the primary endpoint of overall survival in metastatic CRPC, as well as
start-up costs incurred for the phase 3 pivotal trials for metastatic
RCC and metastatic HCC.
Selling, general and administrative expenses for the quarter
ended June 30, 2013 were $13.2 million, compared to $6.8 million for the
comparable period in 2012. The increase was primarily due to an increase
in expenses related to the sale of COMETRIQ, predominantly for
consulting and outside services, as well as marketing expenses.
Other income (expense), net for the quarter ended June 30, 2013
was a net expense of ($10.9) million compared to ($3.8) million in the
quarter ended June 30, 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 June 30, 2013 was ($6.5) 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 June 30, 2013 was ($62.2) million,
or ($0.34) per share, basic, compared to ($36.5) million, or ($0.25) per
share, basic, for the comparable period in 2012. The net loss was
primarily due to increases in research and development, selling, general
and administrative and interest expenses, slightly offset by increased
revenues, as described above, and lower restructuring charges.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $524.3
million at June 30, 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 June 30, 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, August 6, 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 September 6, 2013. Access numbers
for the phone replay are: 888-286-8010 (domestic) and 617-801-6888
(international); the passcode is 71509629.
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 ended
June 29, 2012 and June 28, 2013, and as of the fiscal year ended
December 28, 2012, are indicated as ended June 30, 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 continued development and
clinical, therapeutic and commercial potential of, and opportunities
for, cabozantinib; the design, plans and goals for the recently
initiated phase 3 pivotal trial of cabozantinib in metastatic RCC;
planning for the phase 3 pivotal trial of cabozantinib in metastatic
HCC; the belief that Exelixis gained significant momentum in the second
quarter of 2013; the continued focus on enrollment of the COMET pivotal
trials in metastatic CRPC as Exelixis' top priority; the belief that the
overall survival and post-hoc analyses from the phase 2 NRE metastatic
CRPC cohort presented at the ASCO Annual Meeting continue to support the
rationale for the COMET pivotal trials; and the continued expectation
that top-line data for the COMET pivotal trials will be available in
2014. Words such as “expect,” “will,” “potential,” “activity,”
“momentum,” “continue,” “focus,” “priority,” “planning,” “support,”
“rationale,” 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
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; risks and uncertainties related to Exelixis' compliance with
applicable regulatory requirements, including healthcare fraud and abuse
laws; the sufficiency of Exelixis' capital and other resources; the
uncertainty of the regulatory approval process; 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 June 28, 2013, filed with the Securities
and Exchange Commission (SEC) on August 6, 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, the Exelixis logo, and COMETRIQ are registered U.S.
trademarks.
|
EXELIXIS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
Revenues:
|
|
|
|
|
|
|
|
|
License and contract revenues
|
|
$
|
7,813
|
|
|
$
|
7,813
|
|
|
$
|
15,626
|
|
|
$
|
26,323
|
|
Net product revenues
|
|
4,043
|
|
|
—
|
|
|
5,899
|
|
|
—
|
|
Total revenues
|
|
11,856
|
|
|
7,813
|
|
|
21,525
|
|
|
26,323
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
285
|
|
|
—
|
|
|
565
|
|
|
—
|
|
Research and development
|
|
49,077
|
|
|
32,610
|
|
|
81,812
|
|
|
65,706
|
|
Selling, general and administrative
|
|
13,180
|
|
|
6,760
|
|
|
23,725
|
|
|
14,665
|
|
Restructuring charge
|
|
609
|
|
|
1,166
|
|
|
728
|
|
|
971
|
|
Total operating expenses
|
|
63,151
|
|
|
40,536
|
|
|
106,830
|
|
|
81,342
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(51,295
|
)
|
|
(32,723
|
)
|
|
(85,305
|
)
|
|
(55,019
|
)
|
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
Interest income and other, net
|
|
373
|
|
|
340
|
|
|
711
|
|
|
500
|
|
Interest expense
|
|
(11,239
|
)
|
|
(4,092
|
)
|
|
(22,296
|
)
|
|
(8,096
|
)
|
Total other income (expense), net
|
|
(10,866
|
)
|
|
(3,752
|
)
|
|
(21,585
|
)
|
|
(7,596
|
)
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
(62,161
|
)
|
|
(36,475
|
)
|
|
(106,890
|
)
|
|
(62,615
|
)
|
Income tax provision
|
|
—
|
|
|
12
|
|
|
—
|
|
|
23
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(62,161
|
)
|
|
$
|
(36,487
|
)
|
|
$
|
(106,890
|
)
|
|
$
|
(62,638
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$
|
(0.34
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
(0.43
|
)
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
183,981
|
|
|
148,654
|
|
|
183,861
|
|
|
145,297
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
2013
|
|
2012 (1)
|
|
|
(unaudited)
|
|
|
Cash and investments (2)
|
|
$
|
524,267
|
|
|
$
|
633,961
|
|
|
|
|
|
Working capital
|
|
$
|
300,356
|
|
|
$
|
350,837
|
|
|
|
|
|
Total assets
|
|
$
|
612,084
|
|
|
$
|
721,097
|
|
|
|
|
|
Total stockholders' equity
|
|
$
|
196,332
|
|
|
$
|
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 $34.2 million and $40.2 million as of June 30, 2013 and
December 31, 2012, respectively.
Source: Exelixis, Inc.
Exelixis, Inc.
Frank Karbe, 650-837-7565
Chief
Financial Officer
fkarbe@exelixis.com
or
Exelixis,
Inc.
Charles Butler, 650-837-7277
Vice President
Investor
Relations
& Corporate Communications
cbutler@exelixis.com