South San Francisco, California
February 19, 2003
Exelixis, Inc. (Nasdaq:
EXEL) today reported financial results for the quarter and year
ended December 31, 2002.
For the quarter ended December
31, 2002, the company reported a pro forma net loss of
approximately $19.8 million, or $0.34 per share, excluding the
restructuring charge and non-cash charges for stock compensation
and amortization of intangibles. For the quarter ended December
31, 2001, the comparable pro forma net loss was approximately
$12.7 million, or $0.26 per share. Including the restructuring
charge and non-cash charges, under generally accepted accounting
principles, the company reported a net loss of $20.9 million, or
$0.36 per share, for the quarter ended
December 31, 2002, compared to a net loss of $18.3 million, or
$0.38 per share, for the quarter ended December 31, 2001.
For the year ended December 31,
2002, the company reported a pro forma net loss of approximately
$81.0 million, or $1.43 per share, excluding discontinued
operations, the restructuring charge and non-cash charges for
stock compensation and amortization of intangibles. For the year
ended December 31, 2001, the comparable pro forma net loss was
approximately $49.4 million, or $1.06 per share. Including
discontinued operations, the restructuring charge and non-cash
charges, under generally accepted accounting principles, the
company reported a net loss of $86.1 million, or $1.52 per
share, for the year ended December 31, 2002, compared to a net
loss of $71.2 million, or $1.53 per share, for the year ended
December 31, 2001.
Our cash burn for 2002 was $39.3
million. At December 31, 2002, cash, cash equivalents,
short-term investments and restricted cash totaled approximately
$222.0 million compared to $227.7 million at December 31, 2001.
For the quarter ended December
31, 2002, total revenues were approximately $12.5 million,
compared to $12.8 million for the same period of 2001. The
decrease in revenues for the quarter from the 2001 levels was
driven primarily by the reduction of revenue from Pharmacia due
to the February 2002 conclusion of our collaboration. This
decrease was largely offset by revenue from our new
collaboration with GlaxoSmithKline and from compound deliveries
under our chemistry collaborations established with
Cytokinetics, Inc., Scios Inc. and Schering Plough Research
Institute, Inc. to jointly design custom high-throughput
screening compound libraries.
For the year ended December 31,
2002, total revenues were approximately $44.3 million, compared
to $41.0 million for the same period of 2001. The increase in
revenues from the 2001 levels was driven primarily by the impact
of our corporate collaborations with GlaxoSmithKline,
Bristol-Myers Squibb and Protein Design Labs and from compound
deliveries under our chemistry collaborations established with
Cytokinetics, Elan Pharmaceuticals, Scios and Schering-Plough
Research Institute. This increase was partially offset by
reduction of revenue from Pharmacia due to the February 2002
conclusion of our
collaboration.
Research and development expenses
for the quarter ended December 31, 2002 were $27.5 million,
excluding stock compensation expense of $200,000, compared to
$21.8 million, excluding stock compensation $1.1 million, for
the equivalent period of 2001. Research and development expenses
for 2002 totaled approximately $110.5 million, excluding stock
compensation expense of $1.6 million, compared to $77.7 million,
excluding stock compensation expense of $5.0 million, for 2001.
The increase in both periods was driven primarily by personnel
costs and related lab supplies expenses to support new
collaborative arrangements and Exelixis' internal proprietary
research efforts and licenses and consulting expenses. The
increase in consulting costs is associated with the
manufacturing of the rebeccamycin analog to ensure adequate
clinical supply, costs associated with data analysis of the
ongoing NCI-sponsored phase II trials and planning for the
implementation of pivotal trials in the first half of 2003. Also
contributing to R&D expenses were costs associated with
advancing XL 784, the company's lead IND candidate, through
preclinical toxicology testing in anticipation of filing an IND
early in 2003.
General and administrative
expenses for the quarter ended December 31, 2002 were $4.9
million, excluding a reversal of previously recorded stock
compensation expense of $50,000 due to the Company's lower stock
price, compared to $4.1 million, excluding stock compensation
$400,000,
for the equivalent period of 2001. General and administrative
expenses for 2002 totaled approximately $17.9 million, excluding
stock compensation expense of $900,000 compared to $16.8
million, excluding stock compensation expense of $2.4 million,
for 2001. The increase in both periods was driven primarily by
costs associated with personnel and facilities to support
expansion in our research and development operations.
During the fourth quarter of 2002
Exelixis implemented a restructuring plan, which resulted in a
reduction in force of approximately 8% of the company's North
American operations. Accordingly, the company recorded a
restructuring charge of $700,000, comprised primarily of
involuntary termination benefits. The restructuring plan was
implemented in order to facilitate the company's evolution into
a fully integrated drug discovery company and reallocation of
resources to permit greater focus on building the company's
expanding portfolio of development programs.
"In 2002, we executed well
against all of our strategic, financial and product-related
goals and delivered a very strong performance for the year,"
said George A. Scangos, Ph.D., president and chief executive
officer. "We are on track to initiate next development steps
leading to registration with our rebeccamycin analogue around
mid-year, pending discussions with the FDA concerning trial
design. We are confident that clinical supplies of the compound
will be adequate for conducting our clinical program as well as
continuing to support the NCI's ongoing Phase II program. Our
proprietary compound, XL 784, continues to progress through
regulatory toxicology studies and we are on track to file that
IND near the end of the first quarter. We are also making
progress in moving other promising preclinical programs forward.
Continued Dr. Scangos: "Exelixis
excelled in the area of managing and building strategic
alliances in 2002. We met or exceeded all of our goals with
existing partners including Bayer, Bristol-Myers Squibb, Protein
Design Labs and Dow AgroSciences, and we renewed our mechanism
of action
collaboration with BMS for an additional two years. Early in the
year, we established a fifth combinatorial chemistry
collaboration when we finalized our deal with Merck.
In the agrochemicals arena, through
Agrinomics, our joint venture with Bayer CropScience, we
established an exciting collaboration with Renessen to improve
the seed oil content of commercially important crops.
Clearly, the major accomplishment of the year was our landmark
discovery and
development collaboration with GlaxoSmithKline. The deliverables
in this innovative collaboration are Phase IIa compounds,
deriving from Exelixis' own discovery and development efforts,
which GSK can elect to take through late-stage development,
registration and commercialization. Not only does the
GSK relationship provide strong validation for our gene-to-drug
capabilities and substantial committed funding, milestones and
royalties, it has profound strategic importance, enabling us to
fuel our pipeline growth for years to come and at a
significantly faster pace than we could have achieved
independently."
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 December 31, 2002.
With respect to financial
expectations for 2003, we have assumed the closing of one or two
new collaborations during the year and an increase in clinical
expenses by approximately $10 million in 2003. As a result, we
anticipate that revenues will increase in the range of 30 to 40%
from 2002,
and that operating expenses excluding non-cash charges will
increase in the range of 18 to 25%. For 2003, our anticipated
cash burn is expected to be in the range of $80 to 84 million,
including approximately $13 to 18 million in capital
expenditures worldwide. The increase in cash burn is principally
related to advancing our rebeccamycin analogue into our own
studies and the preparation for and filing of an IND for XL 784
and another small molecule candidate, as well as investments in
drug discovery, clinical development and manufacturing and
facilities expansion. The Company's cash and investments balance
at the end of 2003 is expected to exceed $165 million, not
including the proceeds of any loans under our facility with
GlaxoSmithKline. Stock compensation expense for the year is
anticipated to total approximately $1 million.
With respect to financial
expectations for the first quarter of 2003, we expect our
revenues to remain relatively flat, and our operating expenses,
excluding non-cash charges, to increase by 12 to 19% from fourth
quarter 2002 levels.
For reference, "cash burn" is the
sum of the net cash used in operating activities; plus purchases
of property and equipment, net of proceeds from sale-leaseback
of equipment and bank obligations; plus principal payments on
capital lease obligations, notes payable and bank obligations,
as derived from
our Consolidated Statements of Cash Flows.
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 SmithKlineBeecham (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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