SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May. 7, 2009--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
first quarter ended March 31, 2009.
Revenues for the quarter ended March 31, 2009 were $25.3 million,
compared to $27.9 million for the comparable period in 2008. The
decrease from 2008 to 2009 primarily reflects the decrease in revenue
due to the conclusion of various collaboration agreements partially
offset by revenues associated with the license fee payments under the
new cancer collaboration with Bristol-Myers Squibb Company for XL184 and
XL281.
Research and development expenses for the quarter ended March 31,
2009 were $55.3 million, compared to $66.0 million for the comparable
period in 2008. The decrease from 2008 to 2009 primarily reflects the
wind down of development expenses for XL647, decreased personnel costs
due to our November 2008 restructuring and the impact from other cost
containment measures initiated in 2008 which were partially offset by
increased development activities related to XL184 and XL281.
General and administrative expenses for the quarter ended March
31, 2009 were $8.5 million, compared to $8.7 million for the comparable
period in 2008. The decrease from 2008 to 2009 was primarily due to
decreased personnel costs due to our November 2008 restructuring,
partially offset by an increase in facilities costs.
Collaboration cost-sharing for the quarter ended March 31, 2009
was $1.8 million and reflects the net impact of reimbursement due to
Exelixis under the agreement with Bristol-Myers Squibb Company for XL281
offset by expenses incurred by Bristol-Myers Squibb Company on XL184.
Net loss attributable to Exelixis, Inc. for the quarter ended
March 31, 2009 was $36.2 million, or $0.34 per share, compared to $41.3
million, or $0.39 per share, for the comparable period in 2008. The
decrease in net loss attributable to Exelixis, Inc. from 2008 to 2009
was primarily due to decreased expenses described above.
Cash and cash equivalents, short-term and long-term marketable
securities, investments held by Symphony Evolution, Inc. (a consolidated
clinical development financing vehicle) and restricted cash and
investments totaled $237.7 million at March 31, 2009, compared to $284.2
million at December 31, 2008.
Q1 2009 Highlights and Recent Developments:
-
Announced that seven abstracts have been accepted for presentation at
the American Society of Clinical Oncology Annual Meeting, which will
be held May 29 to June 2, 2009 in Orlando, Florida. Interim data from
an ongoing phase 2 clinical trial of XL184 in patients with
progressive glioblastoma multiforme in first or second relapse will be
described in three poster presentations. Interim data from ongoing
phase 1 clinical trials of XL147, XL281 and XL765 in patients with
advanced solid tumors and XL228 in patients with advanced solid tumors
or hematologic malignancies will be described in four separate oral
presentations.
-
Established an exclusive, worldwide collaboration with Boehringer
Ingelheim with the aim to discover, develop and commercialize
autoimmune disease therapies. The collaboration is focused on the
discovery of sphingosine-1-phosphate type 1 receptor (S1P1) agonists.
Exelixis will receive a $15 million upfront payment. In addition,
Exelixis will potentially receive up to $339 million in milestone
payments dependent on the successful achievement of development,
regulatory and commercial program goals and royalties on sales of
potential products commercialized under the collaboration.
“We have continued our significant momentum across all aspects of our
business in the first quarter while maintaining a manageable cost base,”
said George A. Scangos, Ph.D., president and chief executive officer of
Exelixis. “We continue to be encouraged by the data from the XL184 trial
in glioblastoma, and we look forward to sharing data in seven
presentations covering XL184, XL281, XL228, XL147 and XL765 at ASCO at
the end of May. Our compounds are moving forward well, and our ongoing
partnership discussions are progressing as anticipated. We ended the
quarter with over $230 million in cash and investments, providing us
with a solid financial base on which to continue building our business,”
continued Dr. Scangos.
Conference Call and Webcast
Exelixis’ management will discuss the company’s first quarter ended
March 31, 2009 financial results and provide a general business update
during a conference call beginning at 2:00 p.m. PDT/ 5:00 p.m. EDT
today, Thursday, May 7, 2009. To listen to a webcast of the discussion,
visit the Event Calendar page under Investors at www.exelixis.com.
About Exelixis
Exelixis, Inc. is a development-stage biotechnology company dedicated to
the discovery and development of novel small molecule therapeutics for
the treatment of cancer and other serious diseases. The company is
leveraging its fully integrated drug discovery platform to fuel the
growth of its development pipeline, which is primarily focused on
cancer. Currently, Exelixis’ broad product pipeline includes
investigational compounds in phase 3, phase 2, and phase 1 clinical
development. Exelixis has established strategic corporate alliances with
major pharmaceutical and biotechnology companies, including
Bristol-Myers Squibb, GlaxoSmithKline, Genentech, Boehringer Ingelheim,
Wyeth Pharmaceuticals, and Daiichi-Sankyo. For more information, please
visit the company’s web site at www.exelixis.com.
Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that ends on the
Friday closest to December 31st. For convenience,
references in this press release as of and for the fiscal year ended
January 2, 2009 are indicated on a calendar year basis, ended
December 31, 2008 and as of and for the fiscal quarters ended March 28,
2008 and April 3, 2009 are indicated as ended March 31, 2008 and 2009,
respectively.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to Exelixis’ receipt of upfront,
milestone and royalty payments from Boehringer Ingelheim under the
parties’ collaboration to discover, develop and commercialize autoimmune
disease therapies, Exelixis’ belief that it has a solid financial base
on which to continue building its business, Exelixis’ expectations with
respect to its ongoing partnership discussions, the future development
and potential efficacy of Exelixis’ compounds and the release of new
data in seven presentations covering five compounds at the upcoming
American Society of Clinical Oncology Annual Meeting. Words such as
“will,” “potentially,” “goals,” “anticipate,” “continue” and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon our 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: Exelixis’
dependence on its relationship with Bristol-Myers Squibb Company; the
potential failure of Exelixis’ compounds to demonstrate safety and
efficacy in clinical testing; the therapeutic and commercial value of
Exelixis’ compounds; the ability to conduct clinical trials for
Exelixis’ compounds sufficient to achieve a positive completion; the
timing and level of expenses associated with the development of
Exelixis’ programs; Exelixis’ ability to enter into new partnerships and
collaborations; Exelixis’ ability to execute upon its objectives; the
timely receipt of potential license payments, research funding,
milestones and royalties under Exelixis’ collaborative agreements; 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 quarter ended April 3, 2009, and
other filings with the Securities and Exchange Commission. 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 and the Exelixis logo are registered U.S. trademarks.
EXELIXIS, INC.
CONSOLIDATED STATEMENT OF OPERATIONS DATA
(in thousands, except per share data)
(unaudited)
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2009
|
|
|
|
2008
|
|
Revenues:
|
|
|
|
|
Contract
|
|
$
|
6,706
|
|
|
$
|
18,626
|
|
License
|
|
|
18,596
|
|
|
|
9,318
|
|
Total revenues
|
|
|
25,302
|
|
|
|
27,944
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
|
55,344
|
|
|
|
65,973
|
|
General and administrative
|
|
|
8,529
|
|
|
|
8,691
|
|
Collaboration cost-sharing
|
|
|
(1,797
|
)
|
|
|
-
|
|
Total operating expenses
|
|
|
62,076
|
|
|
|
74,664
|
|
|
|
|
|
|
Loss from operations
|
|
|
(36,774
|
)
|
|
|
(46,720
|
)
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
Interest income and other, net
|
|
|
554
|
|
|
|
2,511
|
|
Interest expense
|
|
|
(2,116
|
)
|
|
|
(961
|
)
|
Total other income
|
|
|
(1,562
|
)
|
|
|
1,550
|
|
|
|
|
|
|
Consolidated net loss
|
|
|
(38,336
|
)
|
|
|
(45,170
|
)
|
|
|
|
|
|
Loss attributable to noncontrolling interest
|
|
|
2,156
|
|
|
|
3,896
|
|
|
|
|
|
|
Net loss attributable to Exelixis, Inc.
|
|
$
|
(36,180
|
)
|
|
$
|
(41,274
|
)
|
|
|
|
|
|
Net loss per share, basic and diluted, attributable to Exelixis, Inc.
|
|
$
|
(0.34
|
)
|
|
$
|
(0.39
|
)
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
attributable to Exelixis, Inc.
|
|
|
106,383
|
|
|
|
104,993
|
|
EXELIXIS, INC.
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
2009
|
|
|
2008 (1)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
Cash and cash equivalents and short-term and long-term marketable
securities (2)
|
|
$
|
237,733
|
|
|
$
|
284,185
|
|
|
|
|
|
|
Working capital
|
|
$
|
53,757
|
|
|
$
|
82,028
|
|
|
|
|
|
|
Total assets
|
|
$
|
355,105
|
|
|
$
|
401,622
|
|
|
|
|
|
|
Stockholders' equity
|
|
$
|
(88,948
|
)
|
|
$
|
(56,975
|
)
|
|
|
|
|
|
|
|
|
|
(1) Derived from the audited consolidated financial statements
|
(2) These amounts include investments held by Symphony Evolution,
Inc. of $12.6 million and $14.7 million and restricted cash and
investments of $4.9 million and $4.0 million as of March 31, 2009
and December 31, 2008, respectively.
|
Source: Exelixis, Inc.
Exelixis, Inc.
Frank Karbe, 650-837-7565
Chief
Financial Officer
fkarbe@exelixis.com
or
Exelixis,
Inc.
Charles Butler, 650-837-7277
Executive
Director
Corporate Communications & Investor Relations
cbutler@exelixis.com