Exhibit 99.1
ARIAD Reports First Quarter 2006 Results;
Management to Discuss Recent Favorable Verdict in Lilly NF-(kappa)B
Patent Case and Provide Update on AP23573 Clinical Development Program
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 9, 2006--ARIAD
Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced financial results
for the quarter ended March 31, 2006 and provided an update on
progress towards achievement of 2006 goals.
"We are extremely pleased with the recent jury verdict supporting
our assertions regarding Lilly's infringement of our NF-(kappa)B
patent and the validity of this pioneering patent," said Harvey J.
Berger, M.D., chairman and chief executive officer of ARIAD. "In
addition to this achievement, our lead product candidate, the potent
mTOR inhibitor AP23573, continues its rapid progression through
clinical trials toward launch of the pivotal Phase 3 trial needed for
product registration. We have completed enrollment and initial follow
up of patients in our Phase 2 clinical trial of AP23573 in advanced
sarcomas, and we expect to present extensive data from this trial to
the oncology community at the American Society of Clinical Oncology
(ASCO) annual meeting in June."
Financial Highlights
For the quarter ended March 31, 2006, the Company reported a net
loss of $15.4 million, or $0.25 per share, as compared to $12.3
million, or $0.23 per share, for the quarter ended March 31, 2005. The
increase in net loss for the quarter is due primarily to higher
operating expenses resulting from continued development of its lead
cancer product candidate, AP23573, professional fees related to
ongoing patent litigation and the impact of adoption of the new
accounting requirements regarding expensing stock options and other
share-based payments. Cash used in operations for the quarter was
$13.9 million, which is consistent with the Company's guidance for
2006 of $53 million to $56 million.
The Company ended the first quarter 2006 with $68.1 million in
cash, cash equivalents, and marketable securities, compared with $81.5
million at the end of 2005.
Corporate and Development Highlights
Thus far, this year, the Company has made substantial progress
toward achievement of its corporate goals for 2006. Key
accomplishments include:
-- Received favorable verdict from the jury in the United States
District Court for the District of Massachusetts in lawsuit
against Eli Lilly and Company alleging infringement of
pioneering U.S. patent covering methods of treating human
disease by regulating NF-(kappa)B cell-signaling activity. The
jury ruled unanimously in favor of ARIAD and co-plaintiffs in
finding that the claims of the NF-(kappa)B patent asserted in
the lawsuit are valid and infringed by Lilly with respect to
Lilly's osteoporosis drug, Evista(R), and Lilly's septic shock
drug, Xigris(R). The jury awarded damages to the plaintiffs in
the amount of approximately $65.2 million, based on the jury's
determination of a reasonable royalty rate of 2.3% to be paid
by Lilly to the plaintiffs based on U.S. sales of Evista and
Xigris from filing of the lawsuit on June 25, 2002 through
February 28, 2006. The jury awarded further damages on an
ongoing basis, in amounts to be determined, equal to 2.3% of
U.S. sales of Evista and Xigris through the year 2019, when
the patent expires.
-- Initiated enrollment of advanced cancer patients in a Phase Ib
clinical trial of AP23573 in combination with doxorubicin - a
chemotherapeutic agent used widely in soft-tissue sarcomas as
part of first-line regimens, as well as in breast, ovarian and
endometrial cancers and certain hematologic malignancies.
-- Completed enrollment in a Phase 2 clinical trial of AP23573 as
a single agent in advanced prostate cancer patients who have
become refractory to standard hormone therapy and have
progressed after taxane chemotherapy; follow-up evaluation of
patients is ongoing.
-- Continued enrollment in a Phase 2 clinical trial of AP23573 as
a single agent in patients with recurrent or persistent
endometrial cancer and disease progression; patient enrollment
is on schedule.
-- Updated the international sarcoma community on the AP23573
clinical development program at the EORTC Soft Tissue and Bone
Sarcoma Group (STBSG) Scientific Symposium & Spring Meeting on
Sarcomas in Mannheim, Germany. Expanded data, originally
disclosed at the 17th AACR-NCI-EORTC International Conference
on "Molecular Targets and Cancer Therapeutics" in
Philadelphia, were presented by Professor Jean-Yves Blay, one
of the lead European clinical investigators in the AP23573
clinical trials and chairman of the EORTC-STBSG.
-- Presented data from several preclinical studies on ARIAD's
pipeline product candidates at the American Association for
Cancer Research (AACR) annual meeting. These studies
demonstrated broad anti-cancer activity and the potential of
ARIAD's oncogenic kinase inhibitors and bone-targeted mTOR
inhibitors - new molecularly targeted oncology therapies.
Upcoming Medical and Partnering Meetings
Current data on AP23573 will be presented at the following
meetings:
-- 2006 American Society of Clinical Oncology (ASCO) Annual
Meeting, Atlanta, Georgia, June 2 to 6, 2006
-- Windhover Therapeutic Alliances Series: Oncology, Atlanta,
Georgia, June 6 to 7, 2006
Upcoming Investor Meetings
ARIAD management will present updated overviews of the Company's
progress and plans at several investor conferences, all of which will
be webcast:
-- Banc of America Health Care Conference 2006, Las Vegas,
Nevada, May 16 to 18, 2006
-- Bear Stearns Boston Biotech Confab, Boston, Massachusetts, May
31, 2006
-- Pacific Growth Equities Third Annual Life Sciences Growth
Conference, San Francisco, California, June 12 to 14, 2006
-- Needham & Company Fifth Annual Biotechnology and Medical
Technology Conference, New York, New York, June 14 to 15, 2006
Today's Conference Call Reminder
ARIAD will hold a live webcast of its quarterly conference call
today at 8:30 a.m. (ET). The live webcast can be accessed by visiting
the investor relations section of the Company's website at
http://www.ariad.com/investor. The call can be accessed by dialing
1-800-291-5365 (domestic) or 617-614-3922 (international) five minutes
prior to the start time and providing the passcode 40346992. A replay
of the call will be available on the ARIAD website approximately two
hours after completion of the call and will be archived for two weeks.
About ARIAD
ARIAD is engaged in the discovery and development of breakthrough
medicines to treat cancer by regulating cell signaling with small
molecules. The Company is developing a comprehensive approach to
patients with cancer that addresses the greatest medical need -
aggressive and advanced-stage cancers for which current treatments are
inadequate. Medinol Ltd. also is developing stents and other medical
devices that deliver ARIAD's lead cancer product candidate to prevent
reblockage at sites of vascular injury following stent-assisted
angioplasty. ARIAD has an exclusive license to pioneering technology
and patents related to certain NF-(kappa)B treatment methods, and the
discovery and development of drugs to regulate NF-(kappa)B
cell-signaling activity, which may be useful in treating certain
diseases. Additional information about ARIAD can be found on the web
at http://www.ariad.com.
Some of the matters discussed herein are "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements are identified by the use of words
such as "anticipate," "estimate," "expect," "project," "intend,"
"plan," "believe," and other words and terms of similar meaning in
connection with any discussion of future operating or financial
performance. Such statements are based on management's current
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events, timing
and performance to differ materially from those expressed or implied
by such forward-looking statements. These risks include, but are not
limited to, risks and uncertainties regarding our ability to
accurately estimate the timing and actual R&D expenses and other costs
associated with the preclinical and clinical development and
manufacture of our product candidates, the adequacy of our capital
resources and the availability of additional funding, risks and
uncertainties regarding our ability to manufacture or have
manufactured our product candidates on a commercial scale, risks and
uncertainties regarding our ability to successfully enroll and conduct
clinical studies of product candidates, risks and uncertainties that
clinical trial results at any phase of development may be adverse or
may not be predictive of future results or lead to regulatory approval
of any of our or any partner's product candidates, risks and
uncertainties of third-party intellectual property claims relating to
our and any partner's product candidates, and risks and uncertainties
relating to regulatory oversight, the timing, scope, cost and outcome
of legal proceedings, including judicial determinations still pending
before the judge in the U.S. District Court litigation, litigation
initiated by Amgen Inc. in the U.S. District Court in Delaware, a
possible appeal by Eli Lilly in such litigation, and reexamination
proceedings in the U.S. Patent and Trademark Office concerning our
NF-(kappa)B patent portfolio, future capital needs, key employees,
dependence on collaborators and manufacturers, markets, economic
conditions, products, services, prices, reimbursement rates,
competition and other factors detailed in the Company's public filings
with the Securities and Exchange Commission, including ARIAD's Annual
Report on Form 10-K for the fiscal year ended December 31, 2005. The
information contained in this document is believed to be current as of
the date of original issue. The Company does not intend to update any
of the forward-looking statements after the date of this document to
conform these statements to actual results or to changes in the
Company's expectations, except as required by law.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
In thousands, except share and Three Months Ended
per share data March 31,
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2006 2005
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(Unaudited)
Total revenue $ 229 $ 304
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Operating expenses:
Research and development 11,674 10,654
General and administrative 4,456 2,316
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Total operating expenses 16,130 12,970
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Other income, net 543 320
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Net loss $ (15,358) $ (12,346)
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Net loss per share $ (.25) $ (.23)
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Weighted average number of
shares of common stock outstanding 61,728,913 52,807,513
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
In thousands March 31, December 31,
2006 2005
--------- -----------
(Unaudited)
Cash, cash equivalents and marketable securities $68,055 $81,516
Total assets $82,112 $96,174
Total liabilities $23,929 $24,796
Stockholders' equity $58,183 $71,378
CONTACT: ARIAD Pharmaceuticals, Inc.
Edward Fitzgerald (Investors), 617-621-2345
or
Pure Communications
Sheryl Seapy (Media), 949-608-0841