Exhibit 99.1
ARIAD Reports First Quarter 2007 Results and
Provides Update on Corporate Developments
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 8, 2007--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced financial results
for the quarter ended March 31, 2007 and provided an update on
corporate developments.
"We are rapidly approaching achievement of three of our key
objectives towards becoming a fully integrated oncology company.
First, we expect to execute a partnership agreement with a major
pharmaceutical company this quarter to help develop and commercialize
our lead product candidate - the mTOR inhibitor, AP23573 - in a broad
range of cancers. Second, we plan to initiate patient enrollment next
quarter in our Phase 3 pivotal trial of oral AP23573 in metastatic
sarcoma. Lastly, we are on track to file an investigational new drug
application in the second half of this year for our next product
candidate - the multi-targeted kinase inhibitor, AP24534 - initially
for use in patients with drug-resistant chronic myeloid leukemia,"
said Harvey J. Berger, M.D., chairman and chief executive officer of
ARIAD.
Financial Highlights
For the quarter ended March 31, 2007, the Company reported a net
loss of $15.0 million, or $0.23 per share, as compared to a net loss
of $15.4 million, or $0.25 per share, for the quarter ended March 31,
2006. The decrease in net loss for the quarter is due primarily to
lower manufacturing and clinical-trial costs related to the Company's
lead cancer product candidate, AP23573, and lower costs related to the
NF-(kappa)B patent infringement litigation, offset in part by higher
costs resulting from preclinical, manufacturing and toxicology studies
related to the Company's second product candidate, AP24534. Cash used
in operations for the quarter ended March 31, 2007 was $12.6 million.
The Company ended the first quarter 2007 with $39.1 million in
cash, cash equivalents, and marketable securities, compared with $39.8
million at the end of 2006.
Corporate and Development Highlights
The Company has made substantial progress this year on multiple
fronts, including:
Novel mTOR Inhibitor - AP23573
-- Phase 3 Pivotal Trial in Sarcomas. Based on feedback from the
U.S. Food and Drug Administration, ARIAD plans to launch its
randomized Phase 3 trial of oral AP23573 in metastatic sarcoma
patients following a favorable response to chemotherapy;
overall survival will be the primary endpoint and
progression-free survival will be a key secondary endpoint.
The Company expects to initiate patient enrollment in the
third quarter of 2007.
-- Investor Day Featuring Leading Sarcoma Experts. In February,
ARIAD hosted its first-ever Investor & Analyst Day, at which
it provided a detailed update on the status of AP23573. ARIAD
management was joined by a panel of leading sarcoma experts to
discuss their clinical experience with AP23573, an overview of
the Phase 3 trial, current treatment paradigms in sarcomas and
the significant unmet medical need in both adult and pediatric
populations.
-- Commercial Update. As part of its Investor & Analyst Day,
ARIAD management discussed the $48 billion global oncology
market and the expected drivers of market growth - namely
targeted therapeutics, such as AP23573. The Company outlined
its market entry and market expansion strategies for AP23573,
including potential estimated peak U.S. revenues of $300
million for AP23573 in sarcomas and potential total peak
revenues for AP23573 in the U.S. of over $1 billion assuming
successful development and approval of AP23573 in multiple
indications.
-- Partnering Update. ARIAD is completing negotiation of the
definitive agreements for its collaboration with a major
pharmaceutical company to help develop and commercialize
AP23573 in a broad range of oncology indications. The Company
expects to execute the agreements with the partner in the
second quarter of 2007.
Novel Bcr-Abl Inhibitor for Drug-Resistant CML - AP24534
-- Investor Day Update on AP24534. The Company provided an
overview of its next oncology product candidate - the
multi-targeted kinase inhibitor, AP24534, which was designed
to treat drug-resistant chronic myeloid leukemia (CML).
AP24534 has demonstrated broad activity against the common
mutant forms of Bcr-Abl including the T315I mutant, as well as
the un-mutated form of this oncogenic enzyme. The Company
highlighted results of studies from well-established animal
models showing dose-dependant tumor shrinkage and increased
survival due to oral AP24534. ARIAD plans to file an
investigational new drug application for AP24534 in the second
half of 2007. Initial clinical trials of AP24534 are being
planned for patients with drug-resistant CML.
Corporate Activities
-- ARGENT(TM) License Agreement. The Company entered into a
non-exclusive, royalty-bearing license agreement to its ARGENT
cell-signaling regulation technology with CellNexus, LLC to
develop and commercialize new cancer therapies. The initial
CellNexus product candidate is a novel cell therapy to prevent
and treat anemia in cancer patients, while potentially
eliminating stimulation of tumor growth and angiogenesis that
may be caused by recombinant forms of erythropoietin.
-- NF-(kappa)B. The Company and its co-plaintiffs filed an action
against Amgen Inc. and certain affiliated entities (Amgen) and
Wyeth alleging infringement of ARIAD's pioneering U.S. patent
covering methods of treating human disease by regulating
NF-(kappa)B cell-signaling activity. The claim was filed in
response to a lawsuit filed by Amgen against ARIAD in the
United States District Court for the District of Delaware in
April 2006 seeking declaratory judgment that the claims of
U.S. Patent No. 6,410,516 are invalid and that Amgen has not
infringed any of the claims of the patent based on activities
related to Enbrel(R) (etanercept) and Kineret(R) (anakinra).
-- Financing. The Company entered into a common stock purchase
agreement with Azimuth Opportunity, Ltd., which provides for
the sale and issuance of up to $50 million in equity financing
by ARIAD to Azimuth from time to time, in ARIAD's discretion.
In the first quarter 2007, Azimuth purchased 3,072,393 shares
of common stock from ARIAD at an aggregate purchase price of
$12.5 million, or net proceeds of approximately $12.3 million
after deducting expenses.
Upcoming Medical Meetings
Clinical data on AP23573 will be presented at the following
meeting:
-- American Society of Clinical Oncology Annual Meeting, Chicago,
Illinois,
June 1 to 5, 2007.
Upcoming Investor Meetings
ARIAD management will present updated overviews of the Company's
progress and plans at several investor conferences:
-- BIO 2007 International Convention, Boston, Massachusetts, May
9, 2007.
-- Bank of America 2007 Healthcare Conference, Las Vegas, Nevada,
May 31, 2007.
-- Bear Stearns Boston Biotech Confab, Boston, Massachusetts,
June 7, 2007.
-- Needham & Company Sixth Annual Biotechnology and Medical
Technology Conference, New York, New York, June 13 to 14,
2007.
Today's Conference Call Reminder
ARIAD will hold a live webcast of its quarterly conference call
today at 8:00 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
1-800-561-2731 (domestic) or 617-614-3528 (international) five minutes
prior to the start time and providing the passcode 95004873. 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, including our plans to execute a
partnership for AP23573 in the second quarter of 2007, initiate
enrollment in a Phase 3 clinical trial of AP23573 in metastatic
sarcoma in the third quarter of 2007 and file an IND with the FDA for
AP24534 in the second half of 2007, 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 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, 2006. 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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2007 2006
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(Unaudited)
Total revenue $ 190 $ 229
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Operating expenses:
Research and development 11,023 11,674
General and administrative 4,403 4,456
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Total operating expenses 15,426 16,130
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Other income, net 285 543
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Net loss $ (14,951) $ (15,358)
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Net loss per share $ (.23) $ (.25)
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Weighted average number of
shares of common stock outstanding 65,625,902 61,728,913
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
In thousands March 31, December 31,
2007 2006
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(Unaudited)
Cash, cash equivalents and marketable
securities $ 39,074 $ 39,804
Total assets $ 50,595 $ 51,043
Total liabilities $ 21,452 $ 20,781
Stockholders' equity $ 29,143 $ 30,262
CONTACT: ARIAD Pharmaceuticals, Inc.
Edward Fitzgerald, 617-621-2345
or
Pure Communications
Andrea L. Johnston, 910-616-5858