SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 30, 2013--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
quarter ended September 30, 2013.
Q3 2013 Highlights and Recent Events
-
Reported net product revenue for COMETRIQ® (cabozantinib) of $4.8
million in the third quarter of 2013.
-
Reached the enrollment target of 960 patients for COMET-1, the phase 3
pivotal trial of cabozantinib in patients with metastatic
castration-resistant prostate cancer (mCRPC). The primary endpoint of
COMET-1 is overall survival (OS). Top-line data from COMET-1 and a
second pivotal trial in mCRPC, COMET-2, with the primary endpoint of
pain response in patients with bone pain associated with bone
metastases, are expected in 2014.
-
Initiated CELESTIAL, a phase 3 pivotal trial comparing cabozantinib to
placebo in patients with advanced hepatocellular carcinoma (HCC) who
have previously been treated with sorafenib. The trial is expected to
enroll 760 patients at up to 200 sites globally in up to 30 countries.
The primary endpoint is OS, and the secondary endpoints include
objective response rate (ORR) and progression-free survival (PFS).
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Announced updated results from BRIM7, an ongoing phase 1b clinical
trial conducted by Roche and Genentech, Exelixis' collaborator and a
member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) at the European
Cancer Congress 2013. The study is evaluating the BRAF inhibitor
(BRAFi) vemurafenib in combination with the MEK inhibitor cobimetinib
(GDC-0973/XL518) in patients with locally advanced/unresectable or
metastatic melanoma carrying a BRAFV600 mutation. The ORR
(comprising complete or partial responses) was 85% in the cohort of
BRAFi-naïve patients. As previously announced, Genentech is conducting
a phase 3 pivotal trial evaluating vemurafenib alone or in combination
with cobimetinib in previously untreated patients with malignant
melanoma and the BRAFV600 mutation, for which data are
expected in 2014.
"The continued progress of our clinical development program is
illustrated by the five ongoing pivotal trials investigating
cabozantinib in multiple indications, including the METEOR trial in
metastatic renal cell cancer (RCC) and the CELESTIAL trial in advanced
HCC," said Michael M. Morrissey, Ph.D., president and chief executive
officer of Exelixis. "Top-line data from COMET-1 and COMET-2 and the
overall survival analysis for EXAM are expected in 2014. Additionally,
the phase 3 pivotal trial of vemurafenib alone or in combination with
cobimetinib is also expected to report data in 2014. Thus, we believe
2014 will be an important year for Exelixis with the potential read out
of a total of four phase 3 pivotal trials for the Exelixis-discovered
compounds cabozantinib and cobimetinib."
Net revenues for the quarter ended September 30, 2013 were $5.5
million, compared to $13.3 million for the comparable period in 2012.
Revenues for the quarter included net product revenues of $4.8 million
from the sale of COMETRIQ, which became commercially available in late
January 2013. The overall decrease in revenues during the quarter as
compared to the same period in 2012 was due to a decrease in contract
and license revenue relating to the depletion of deferred revenues from
Bristol-Myers Squibb and a $5.5 million milestone payment received from
Daiichi Sankyo in August 2012.
Research and development expenses for the quarter ended
September 30, 2013 were $47.4 million, compared to $30.7 million for the
comparable period in 2012. The increases were predominantly driven by
clinical trial costs, primarily related to clinical trial activities for
COMET-1 as well as costs incurred in connection with the start-up of the
METEOR phase 3 pivotal trial in metastatic RCC and the CELESTIAL phase 3
pivotal trial in advanced HCC.
Selling, general and administrative expenses for the quarter
ended September 30, 2013 were $13.6 million, compared to $7.3 million
for the comparable period in 2012. Approximately half of the increase
was a result of an increase in expenses related to consulting and
outside services provided by our U.S. sales force and our European
distribution partner for the sale of COMETRIQ. The remaining increase
was related to legal and accounting fees, wages and benefits, employee
stock-based compensation expense, and patent costs. These increases were
partially offset by decreases in facilities costs.
Other income (expense), net for the quarter ended September 30,
2013 was a net expense of $(11.2) million compared to $(7.4) million for
the comparable period in 2012. The increase in expense 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 September 30, 2013 was $6.7 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 financing arrangement with
Deerfield Management Company, L.P.
Net loss for the quarter ended September 30, 2013 was $(67.1)
million, or $(0.36) per share, basic, compared to $(32.8) million, or
$(0.20) per share, basic, for the comparable period in 2012. The
increased net loss 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 $464.7
million at September 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 September 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, Wednesday, October 30, 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. PST on November 30, 2013. Access numbers
for the phone replay are: 888-286-8010 (domestic) and 617-801-6888
(international); the passcode is 62077154.
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
September 28, 2012 and September 27, 2013, and as of the fiscal year
ended December 28, 2012, are indicated as ended September 30, 2012,
September 30, 2013, and 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 and cobimetinib (GDC-0973/XL518); the designs, plans
and goals for the COMET-1 and COMET-2 trials of cabozantinib in mCRPC,
and the timing (including for the readout of top-line data) thereof; the
design, plans and goals for the CELESTIAL trial of cabozantinib in
advanced HCC; the design, plans and goals for the phase 3 pivotal trial
of cobimetinib in locally advanced/unresectable or metastatic melanoma,
and the timing (including for the readout of top-line data) thereof; the
continued progress of Exelixis’ development program; and the expectation
that 2014 will be an important year for Exelixis, with the potential
read out of a total of four phase 3 pivotal trials for cabozantinib and
cobimetinib. Words such as “expected,” “endpoint,” “continued,”
“progress,” “believe,” “will,” “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: risks related to the potential failure of
cabozantinib or cobimetinib (GDC-0973/XL518) 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; Exelixis'
dependence on its relationship with Genentech/Roche for the development
of cobimetinib (GDC-0973/XL518) and Exelixis’ ability to maintain its
rights under the collaboration; the uncertainty of regulatory approval
processes; 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; 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 September 27, 2013, filed with the Securities and
Exchange Commission (SEC) on October 30, 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.
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EXELIXIS, INC.
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CONSOLIDATED STATEMENTS OF OPERATIONS
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(in thousands, except per share data)
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(unaudited)
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Three Months Ended September 30,
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Nine Months Ended September 30,
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2013
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2012
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2013
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2012
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Revenues:
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License and contract revenues
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$
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695
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$
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13,313
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$
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16,321
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$
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39,636
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Net product revenues
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4,771
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—
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10,670
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—
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Total revenues
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5,466
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13,313
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26,991
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39,636
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Operating expenses:
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Cost of goods sold
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290
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—
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855
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—
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Research and development
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47,354
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30,680
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129,166
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96,386
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Selling, general and administrative
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13,598
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7,343
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37,323
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22,008
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Restructuring charge
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137
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733
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865
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1,704
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Total operating expenses
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61,379
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38,756
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168,209
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120,098
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Loss from operations
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(55,913
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)
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(25,443
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)
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(141,218
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)
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(80,462
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)
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Other income (expense), net:
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Interest income and other, net
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219
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|
318
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|
930
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818
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Interest expense
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(11,430
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)
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(7,679
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)
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(33,726
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)
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(15,775
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)
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Total other income (expense), net
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(11,211
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)
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(7,361
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)
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(32,796
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)
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(14,957
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)
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Loss before income taxes
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(67,124
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)
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(32,804
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)
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(174,014
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)
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(95,419
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)
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Income tax provision
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—
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10
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—
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33
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Net loss
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$
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(67,124
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)
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$
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(32,814
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)
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$
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(174,014
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)
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$
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(95,452
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)
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Net loss per share, basic and diluted
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$
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(0.36
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)
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$
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(0.20
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)
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$
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(0.95
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)
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$
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(0.63
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)
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Shares used in computing basic and diluted net loss per share
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184,149
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166,354
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183,957
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152,316
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EXELIXIS, INC.
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CONDENSED CONSOLIDATED BALANCE SHEET DATA
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(in thousands)
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September 30, 2013
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December 31, 2012 (1)
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(unaudited)
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Cash and investments (2)
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$
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464,721
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|
$
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633,961
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|
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Working capital
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$
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228,284
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|
$
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350,837
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|
|
|
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Total assets
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$
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555,959
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$
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721,097
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Total stockholders' equity
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$
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132,763
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$
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296,434
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(1)
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Derived from the audited consolidated financial statements.
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(2)
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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 $28.1 million and $40.2 million as of September 30, 2013 and
December 31, 2012, respectively.
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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
