South San Francisco, California
May 6, 2003
Exelixis, Inc. (Nasdaq:
EXEL) today reported financial results for the quarter ended
March 31, 2003.
For the quarter ended March 31,
2003, the company reported a net loss of approximately $23.1
million, or $0.39 per share, under generally accepted accounting
principles (GAAP), compared to a net loss of $18.4 million, or
$0.33 per share, for the quarter ended March 31, 2002. For the
quarter ended
March 31, 2003, the company reported a non-GAAP net loss of
approximately $22.4 million, or $0.38 per share, excluding
discontinued operations and non-cash charges for stock
compensation and amortization of intangibles. For the quarter
ended March 31, 2002, the comparable non-GAAP net loss was
approximately $17.0 million, or $0.31 per share. A
reconciliation of GAAP net loss to non-GAAP net loss is set
forth at the end of this press release. At March 31, 2003, cash,
cash equivalents, short-term investments and restricted cash
totaled approximately $203.9 million compared to $222.0 million
at December 31, 2002.
For the quarter ended March 31,
2003, total revenues were approximately $12.3 million, compared
to $11.5 million for the same period of 2002. The increase from
2002 to 2003 was driven primarily by revenue from our October
2002 corporate collaboration with SmithKlineBeecham Corporation
(GlaxoSmithKline) partially offset by the reduction in revenue
from the conclusion of our Pharmacia relationship in February
2002.
Research and development expenses
for the quarter ended March 31, 2003 were $30.3 million,
including stock compensation expense of $0.2 million, compared
to $26.2 million, including stock compensation $0.5 million, for
the equivalent period of 2002. The increase in the quarter from
the 2002 levels was driven primarily by an increase in personnel
costs and activities related to advancing our clinical and
preclinical development programs. These activities included:
completing regulatory toxicology testing of XL784 and
successfully filing the IND application at the end of the
quarter; advancing a new series of development candidates and
back-up compounds into preclinical testing in anticipation of
filing additional IND applications; manufacturing of those
compounds to support preclinical studies; building additional
infrastructure in clinical development to support an expanding
clinical pipeline; and completion of the manufacturing of XL119,
our rebeccamycin analogue, to support initiation of registration
trials later in 2003. General and administrative expenses for
the quarter ended March 31, 2003 were $5.2 million, including
stock compensation expense of $0.2 million, compared to $4.7
million, including stock compensation of $0.3 million, for the
equivalent period of 2002.
"We delivered a strong and
productive quarter with respect to our financial and research
and development goals," said George A. Scangos, PhD., president
and chief executive officer. "The highlight of the quarter was
the successful filing of our company's first IND application for
a proprietary
compound, XL784. We believe that this was an important step in
our maturation and evolution into a product-focused company. We
believe that XL784 will be the first of many promising compounds
to emerge from our gene-to-drug discovery platform that advance
into the clinic, enabling us to fuel our
pipeline growth and fulfill our obligations to our partners as
well as our internal development goals. We currently have an
active IND application, and we plan to initiate Phase 1
first-in-man studies in healthy volunteers in the second quarter
of 2003."
Continued Dr. Scangos: "During
the quarter, we also made significant progress in planning the
registration program for XL119, our rebeccamycin analogue, as a
potential treatment for hepatobiliary tumors. We remain on track
to initiate registration trials later this year, pending
conclusion of
discussions with the FDA concerning trial design. We believe we
continued to perform well in all other operational areas of the
company, and all of our corporate alliances are also on track.
In short, we believe we are making good progress toward meeting
our development, strategic and financial management goals for
the year."
Outlook
The following statements are
based on current expectations. These statements are
forward-looking, and actual results may differ materially.
Except as expressly set forth below, these statements do not
include the potential impact of any mergers, acquisitions or
other business combinations that may be closed or entered into
after March 31, 2003. With respect to financial expectations for
the second quarter of 2003 compared to the first quarter, we
expect our revenues to increase in the range
of 3 to 8%. We expect our operating expenses, excluding non-cash
charges, to increase by 6 to 11% as we continue to focus our
efforts on preclinical and clinical activities including:
initiating Phase 1 safety trials for XL784; advancing
development candidates through preclinical testing with the goal
of
filing additional INDs; advancing XL119, our rebeccamycin
analogue, into registration trials; and as we continue to
support our existing collaborations.
The split-out of our German
subsidiary, Artemis Pharmaceuticals GmbH, continues to progress
and we expect to complete a transaction in the second quarter.
Approximately $1.0 million of expenses originally expected to be
incurred in the first quarter of 2003 related to the split-out
of Artemis
activities, is expected to be incurred in the second quarter due
to the timing of efforts to finalize the split-out. In addition
to these activities, we will continue to review our worldwide
operating expenses throughout the remainder of the year
considering both our research and development goals and meeting
our cash burn objectives for the year.
Exelixis, Inc. is a leading
genomics-based drug discovery company dedicated to the discovery
and development of novel therapeutics. The company is leveraging
its fully integrated gene-to-drug platform to fuel the growth of
its proprietary drug pipeline. Exelixis has established broad
corporate alliances with major pharmaceutical and biotechnology
companies, including GlaxoSmithKline, Bristol-Myers Squibb, and
Protein Design Labs. The company has
also established agricultural research collaborations with Bayer
CropScience, Dow Agrosciences and Renessen. Other
partners include Merck, Schering-Plough Research Institute,
Cytokinetics, Elan and Scios.
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