- Conference Call and Webcast Today at 5:00 PM Eastern Time -
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 1, 2014--
Exelixis, Inc. (Nasdaq:EXEL) today reported financial results for the
quarter ended March 31, 2014.
Q1 2014 Highlights and Recent Events
-
The European Commission approved COMETRIQ® (cabozantinib)
for the treatment of adult patients with progressive, unresectable
locally advanced or metastatic medullary thyroid cancer in January
2014. Additionally, the Committee for Orphan Medicinal Products
recommended maintenance of orphan drug designation at the time of
marketing authorization.
-
The Independent Data Monitoring Committee (IDMC) for COMET-1, the
phase 3 pivotal trial of cabozantinib in advanced metastatic
castration-resistant prostate cancer (mCRPC) with the primary endpoint
of overall survival, completed its planned interim analysis and
recommended the trial proceed to its final analysis. Exelixis
anticipates top-line results from COMET-1 in 2014.
-
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.
-
Net product revenue from COMETRIQ sales was $4.9 million for the first
quarter of 2014.
-
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.
“For Exelixis, 2014 is a year focused on anticipated top-line results
from four pivotal trials of cabozantinib and cobimetinib. Positive data
from COMET-1 and COMET-2 could support future regulatory filings and
help position cabozantinib as a differentiated treatment option for
patients with mCRPC,” said Michael M. Morrissey, Ph.D., president and
chief executive officer of Exelixis. “Concurrently, our partners Roche
and Genentech, a member of the Roche Group, are advancing cobimetinib,
an Exelixis-discovered MEK inhibitor that is under evaluation in a phase
3 pivotal trial with top-line results expected in 2014. We believe that,
together, cabozantinib and cobimetinib have the potential to benefit a
significant number of patients, and we look forward to the continued
maturing datasets from studies exploring the use of these compounds as
we progress through the year.”
First Quarter 2014 Financial Results
Net revenues for the quarter ended March 31, 2014 were $4.9
million, consisting entirely of product revenue related to the sale of
COMETRIQ, compared to $9.7 million for the comparable period in 2013,
consisting of $1.9 million of product revenue related to the sale of
COMETRIQ and $7.8 million of license and contract revenue. The increase
in product revenue reflects the ramp up in sales of COMETRIQ following
its commercial launch in the United States in January 2013. The decrease
in contract and license revenue was the result of having fully
recognized all revenues from the company’s collaboration agreements with
Bristol-Myers Squibb Company in the prior period.
Research and development expenses for the quarter ended March 31,
2014 were $54.8 million, compared to $32.7 million for the comparable
period in 2013. The increase was primarily due to higher clinical trial
costs but also reflects higher personnel related expenses in support of
the company's four phase 3 pivotal trials for cabozantinib. The increase
in clinical trial costs related predominantly to clinical trial
activities for METEOR, the company's phase 3 pivotal trial in metastatic
renal cell cancer and to a lesser degree COMET-1, the company's phase 3
pivotal trial in mCRPC, as well as start-up costs incurred in connection
with CELESTIAL, the company's phase 3 pivotal trial in advanced
hepatocellular cancer. Clinical trial costs for METEOR included a $7.5
million comparator drug purchase during the quarter ended March 31,
2014. The increases in costs for those trials was partially offset by
lower clinical trial expenses as a result of the continued wind down of
various studies for cabozantinib, most notably the company's randomized
discontinuation trial and EXAM, the company's phase 3 pivotal trial in
medullary thyroid cancer.
Selling, general and administrative expenses for the quarter
ended March 31, 2014 were $14.7 million, compared to $10.5 million for
the comparable period in 2013. Approximately half of the increase was
the result of increased personnel expenses, as compared to the
comparable period in 2013, the majority of which reflects the expansion
of the company's U.S. sales force. The remaining increases relate
predominantly to marketing expenses, stock based compensation expenses
as well as an increase in expenses for cobimetinib under the company's
collaboration agreement with Roche and Genentech.
Other income (expense), net for the quarter ended March 31, 2014
was a net expense of ($9.6) million compared to ($10.7) million for the
comparable period in 2013. Included in interest expense for the quarter
ended March 31, 2014 was $7.0 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, as compared to $6.3 million for the comparable period in
2013. The overall decrease in other income (expense), net was due in
part to a $1.7 million unrealized gain on warrants issued to Deerfield
in connection with the January 2014 amendment to the company's financing
arrangement.
Net loss for the quarter ended March 31, 2014 was ($74.6)
million, or ($0.39) per share, basic, compared to ($44.7) million, or
($0.24) per share, basic, for the comparable period in 2013. The
increased net loss was primarily due to a decrease in license and
contract revenues, which was partially offset by an increase in product
revenues, and increases in research and development expenses and
selling, general and administrative expenses.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $407.7
million at March 31, 2014, compared to $415.9 million at December 31,
2013.
Conference Call and Webcast
Exelixis management will discuss the company's financial results for the
quarter ended March 31, 2014 and provide a general business update
during a conference call beginning at 5:00 p.m. EDT/2:00 p.m. PDT today,
Thursday, May 1, 2014. To join the call, participants may dial
866-202-3048 (domestic) or 617-213-8843 (international) and use passcode
28848437. 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 conference call 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 1, 2014. Access numbers for
the phone replay are: 888-286-8010 (domestic) and 617-801-6888
(international); the passcode is 74388407.
About Exelixis
Exelixis, Inc. is a biopharmaceutical company committed to developing
small molecule therapies for the treatment of cancer. Exelixis is
focusing its development and commercialization efforts primarily on
COMETRIQ® (cabozantinib), its wholly-owned inhibitor of multiple
receptor tyrosine kinases. Another Exelixis-discovered compound,
cobimetinib, a highly selective inhibitor of MEK, is being evaluated by
Roche and Genentech, Inc. (a member of the Roche Group) in a broad
development program under a collaboration with Exelixis. 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 29,
2013 and March 28, 2014, and as of the fiscal year ended December 27,
2013, are indicated as ended March 31, 2013, March 31, 2014, and
December 31, 2013, 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; anticipated developments in, and the
expected timing of, various trials, including expected top-line results
from four pivotal trials in 2014; and future potential regulatory
filings. Words such as “anticipates,” “focused,” “could,” “support,”
“future,” “help,” “position,” “option,” “advancing,” “expected,”
“believe,” “potential,” “look forward,” “continued,” “maturing,”
“exploring,” “progress,” 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’
quarterly report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on May 1, 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.
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands, except per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2014
|
|
|
2013
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
|
$
|
4,905
|
|
|
|
$
|
1,856
|
|
License and contract revenues
|
|
|
—
|
|
|
|
7,813
|
|
Total revenues
|
|
|
4,905
|
|
|
|
9,669
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
|
309
|
|
|
|
280
|
|
Research and development
|
|
|
54,847
|
|
|
|
32,735
|
|
Selling, general and administrative
|
|
|
14,691
|
|
|
|
10,545
|
|
Restructuring charge
|
|
|
46
|
|
|
|
119
|
|
Total operating expenses
|
|
|
69,893
|
|
|
|
43,679
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(64,988
|
)
|
|
|
(34,010
|
)
|
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
Interest income and other, net
|
|
|
2,131
|
|
|
|
338
|
|
Interest expense
|
|
|
(11,762
|
)
|
|
|
(11,057
|
)
|
Total other income (expense), net
|
|
|
(9,631
|
)
|
|
|
(10,719
|
)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
$
|
(74,619
|
)
|
|
|
$
|
(44,729
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
|
$
|
(0.39
|
)
|
|
|
$
|
(0.24
|
)
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
191,699
|
|
|
|
183,742
|
|
|
|
|
|
|
|
|
|
|
EXELIXIS, INC.
|
CONDENSED CONSOLIDATED BALANCE SHEET DATA
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2014
|
|
|
December 31, 2013 (1)
|
|
|
|
(unaudited)
|
|
|
Cash and investments (2)
|
|
|
$
|
407,749
|
|
|
|
$
|
415,862
|
|
|
|
|
|
|
|
|
Working capital
|
|
|
$
|
227,253
|
|
|
|
$
|
178,756
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
$
|
497,565
|
|
|
|
$
|
503,287
|
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
$
|
71,482
|
|
|
|
$
|
66,238
|
(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 $23.0 million and $29.1 million as of March 31, 2014 and
December 31, 2013, respectively.
|
Source: Exelixis, Inc.
Exelixis, Inc.
Frank Karbe, 650-837-7565
Chief
Financial Officer
fkarbe@exelixis.com
Susan
Hubbard, 650-837-8194
Investor Relations & Corporate
Communications
shubbard@exelixis.com