Exelixis, Inc. (ticker: EXEL, exchange: NASDAQ Global Market (.O))
News Release -
9-May-2005
Exelixis Announces First Quarter 2005 Financial ResultsSOUTH SAN FRANCISCO, Calif., May 9, 2005 /PRNewswire-FirstCall via COMTEX/ -- Exelixis,
Inc. (Nasdaq: EXEL) today reported financial results for the quarter ended
March 31, 2005.
Net loss, under generally accepted accounting principles (GAAP), was
approximately $27.4 million, or $0.36 per share, compared to $28.8 million, or
$0.40 per share, for the first quarter of 2004. Non-GAAP net loss, which
excludes non-cash charges for stock compensation, restructuring and
amortization of intangibles, was $27.2 million, or $0.36 per share, compared
to approximately $28.1 million, or $0.39 per share for the first quarter of
2004. A reconciliation of GAAP net loss to non-GAAP net loss is set forth at
the end of this press release.
Cash, cash equivalents, short-term investments and restricted cash totaled
approximately $139.1 million at March 31, 2005, and $171.2 million at December
31, 2004.
Revenues were approximately $12.9 million compared to $11.9 million for
the same period in 2004. The increase from 2004 to 2005 was primarily a
result of a $1.9 million increase in research and development funding from our
collaboration with GlaxoSmithKline (GSK) and a $1.0 million increase in
research and development funding from our collaboration with Sankyo Co., Ltd.
The increase is also attributable to $0.7 million recognized as revenue from a
$2.2 million premium GSK paid as part of its acquisition of 1.0 million shares
of our common stock in January 2005. These increases were partially offset by
a $1.4 million decrease in revenues related to the expiration of one of our
Bristol-Myers Squibb collaborations during July 2004 and a $0.8 million
decrease in revenues related to the termination of our combinatorial chemistry
collaborations effective as of December 31, 2004.
Research and development expenses were approximately $33.3 million
compared to $34.2 million for the comparable period in 2004. The decrease
from 2004 to 2005 was primarily related to a decrease in lab supplies as a
result of the termination of most of our combinatorial chemistry
collaborations. The decrease was partially offset by increased expenses
associated with further advancing and expanding our clinical and preclinical
development activities, which we expect to continue to increase in future
periods.
General and administrative expenses were approximately $6.2 million
compared to $5.6 million for the comparable period in 2004. The increase from
2004 to 2005 was primarily a result of higher legal, insurance and facility
expenses to support our growing clinical and preclinical development
activities.
First Quarter 2005 Business Highlights
-- Exelixis announced an amendment to its GSK collaboration in January,
which clarifies the scope of the collaboration, provides accelerated milestone
payments to Exelixis in 2005 and allows third-party funding of certain
programs so that all compounds discovered under the collaboration can be moved
forward aggressively.
-- In March, Exelixis initiated a Phase I clinical trial for XL880, which
is the third oncology compound generated from the Company's internal discovery
efforts to enter clinical trials within nine months.
-- Exelixis agreed with Bayer Crop Sciences to amend its collaboration
with Genoptera resulting in a termination of the Company's research efforts
effective March 31, 2005. The amendment keeps Exelixis whole from a financial
perspective and allows the Company to shift resources to its clinical and
preclinical pipeline of compounds.
-- XL647 and XL999 continued to progress in ongoing Phase I clinical
trials and the Phase III clinical trial for XL119 continued to enroll patients
as planned.
For additional details on our compounds please visit our website at
www.exelixis.com under the heading "Pipeline."
"In the first quarter we continued our productivity by initiating the
Phase I trial for XL880 and taking the necessary steps to appropriately focus
the business on our rapidly growing pharmaceutical pipeline," said George A.
Scangos, Ph.D., president and chief executive officer of Exelixis. "Our pace
of productivity is continuing. We've submitted two additional INDs in April
and could have eight compounds in clinical trials from Phase I through III in
the second half of 2005."
Conference Call and Webcast
Exelixis' management will discuss the company's first quarter 2005
financial results as well as other business developments during a conference
call beginning at 2:00 p.m. PDT / 5:00 p.m. EDT today, Monday, May 9, 2005.
To listen to the discussion, visit the Webcast section under Investor
Information on the Exelixis website at www.exelixis.com.
About Exelixis
Exelixis, Inc. is a leading genomics-based drug discovery company
dedicated to the discovery and development of novel therapeutics across
various disease areas. The company is leveraging its fully integrated
gene-to-drug platform to fuel the growth of its proprietary drug pipeline.
Exelixis' development pipeline covers cancer and metabolism and is comprised
of the following compounds: XL119 (becatecarin), for which a multinational
Phase III clinical trial has been initiated in patients with bile duct tumors;
XL784, initially an anticancer compound, which completed a Phase I clinical
trial and is being developed as a treatment for renal disease; XL647, XL999
and XL880, anticancer compounds currently in Phase I clinical trials; XL820
and XL844 for which investigational new drug (IND) applications have been
filed; and XL184, a potential IND candidate for the treatment of cancer; and
multiple compounds in preclinical development for diseases including cancer
and various metabolic and cardiovascular disorders. Exelixis has established
broad corporate alliances with major pharmaceutical and biotechnology
companies including GlaxoSmithKline (GSK) and Bristol-Myers Squibb Company.
Pursuant to a product development and commercialization agreement between
Exelixis and GSK, GSK has the option, after completion of Phase IIa clinical
trials, to elect to develop a certain number of compounds in Exelixis' product
pipeline, which may include the cancer compounds identified in this press
release (other than XL119), thus potentially triggering milestone payments and
royalties from GSK and co-promotion rights by Exelixis. For more information,
please visit the company's web site at www.exelixis.com.
This press release contains forward-looking statements, including without
limitation statements related to our ability to enter into new collaborations,
continue existing collaborations and receive milestones and royalties derived
from future products developed from research efforts under collaborative
agreements; the rate of growth, if any, in license and contract revenues; the
timing and level of expenses associated with the growth of proprietary
programs and the GSK collaboration. Words such as "believes," "anticipates,"
"plans," "expects," "intends," "will," "slated," "goal" and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon Exelixis' current 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 potential failure of
Exelixis' product candidates to demonstrate safety and efficacy in clinical
testing; the ability of Exelixis to file IND applications and initiate
clinical trials at the referenced times; the ability of Exelixis to conduct
the Phase III clinical trial of XL119 sufficient to achieve FDA approval;
plans to initiate and conduct additional studies for XL784 in 2005, the
ability to conduct Phase I clinical trials of XL647, XL999, XL880, XL820 and
XL844 sufficient to achieve a positive completion; the ability of Exelixis to
successfully advance and develop additional compounds including XL184; the
ability to develop drug candidates and/or INDs as part of the metabolism
program; the ability of the company to advance additional preclinical
compounds into clinical development; the uncertainty of the FDA approval
process; and the therapeutic and commercial value of the company's compounds.
These and other risk factors are discussed under "Risk Factors" and elsewhere
in our annual report on Form 10-K for the year ended December 31, 2004 and
other filings with the Securities and Exchange Commission. The company
expressly disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained herein to
reflect any change in the company's expectations with regard thereto or any
change in events, conditions or circumstances on which any such statements are
based.
NOTE: Exelixis and the Exelixis logo are registered U.S. trademarks.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended March 31,
2005 2004
Revenues:
Contract $10,090 $8,764
License 2,784 3,128
Total revenues 12,874 11,892
Operating expenses:
Research and development 33,321 34,224
General and administrative 6,242 5,576
Restructuring charge -- 537
Amortization of intangibles 272 166
Total operating expenses 39,835 40,503
Loss from operations (26,961) (28,611)
Other income (expense):
Interest income 928 916
Interest expense (1,552) (1,233)
Other income (expense), net 174 85
Total other income (expense) (450) (232)
Net loss $(27,411) $(28,843)
Net loss per share, basic and diluted $(0.36) $(0.40)
Shares used in computing basic and
diluted net loss per share 75,918 71,512
EXELIXIS, INC.
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP NET LOSS (1)
(in thousands, except per share data)
(unaudited)
Three Months Ended March 31,
2005 2004
GAAP net loss $(27,411) $(28,843)
Add:
Restructuring charges -- 537
Non-cash charges for amortization of
intangibles 272 166
Non-cash charges for stock compensation
expense (reversals) (16) 34
Non-GAAP net loss $(27,155) $ (28,106)
Non-GAAP net loss per share, basic and diluted $(0.36) $(0.39)
Shares used in computing basic and diluted
Non-GAAP net loss per share 75,918 71,512
(1) These non-GAAP amounts are intended to illustrate the company's
results from operations excluding restructuring charges and certain
non-cash charges, including (a) stock-based compensation expense and
(b) amortization of purchased intangibles related to business
combinations. Management of the company believes the non-GAAP
results are a useful measure of the company's results from continuing
operations, excluding the non-cash charges, which, in management's
view, are not necessarily reflective of or directly attributable to
operations. These non-GAAP results are not in accordance with, or an
alternative for, generally accepted accounting principles and may be
different from non-GAAP measures used by other companies.
EXELIXIS, INC.
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
March 31, December 31,
2005 2004 (1)
(unaudited)
Cash, cash equivalents and short-term
investments, (including
restricted cash of $15.5 million and
$16.0 million, respectively) $139,053 $171,223
Working capital 73,982 100,161
Total assets 269,753 291,340
Stockholders' equity 33,108 50,671
(1) Derived from the audited consolidated financial statements
SOURCE Exelixis, Inc.
Frank Karbe, Chief Financial Officer, +1-650-837-7565, or fkarbe@exelixis.com, or
Charles Butler, Associate Director, Corporate Communications, +1-650-837-7277, or
cbutler@exelixis.com, both of Exelixis, Inc.
http://www.prnewswire.com
|