Exhibit 99.1
[GRAPHIC OMITTED] News Release
FOR IMMEDIATE RELEASE CONTACT: Kelly Lindenboom
(617) 621-2345
ARIAD REPORTS FOURTH QUARTER AND YEAR-END 2004 RESULTS
Clinical and Financial Guidance for 2005 Provided
Cambridge, MA, February 1, 2005 -- ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA)
today announced consolidated financial results for the quarter and the year
ended December 31, 2004 and provided product development and financial guidance
for 2005.
"Based on the encouraging anti-cancer responses seen with our mTOR inhibitor,
AP23573, in a spectrum of patients with various solid tumors and hematologic
cancers, we initiated several multicenter clinical studies during 2004 - a major
step towards our goal of building a commercially successful bio-oncology
business," said Harvey J. Berger, M.D., chairman and chief executive officer of
ARIAD. "We expect 2005 to be a transforming year for the Company. We started by
establishing our first AP23573 drug-delivery stent collaboration with Medinol
Ltd. We also plan to roll out the evolving clinical data on AP23573, begin to
put in place the infrastructure needed to commercialize AP23573 in the United
States, and progress partnering discussions for markets outside the U.S."
Financial Highlights
For the year ended December 31, 2004, the Company reported a net loss of $35.6
million, or $0.69 per share, as compared to $19.7 million, or $0.51 per share,
for the year ended December 31, 2003. For the quarter ended December 31, 2004,
the Company reported a net loss of $10.7 million, or $0.20 per share, compared
to a net loss of $5.7 million, or $0.13 per share, for the same period in 2003.
The increase in net loss for the full year and quarter are due primarily to
higher R&D expenses resulting from execution of the clinical development plan
for its lead cancer product candidate, AP23573.
The Company ended the year 2004 with $75.5 million in cash, cash equivalents,
and marketable securities, compared with $66.7 million at the end of 2003. For
the year 2004, the Company reported cash used in operations of $31.6 million,
which is below the guidance of $34 million it had provided.
Key Milestones for 2005
The Company is committed to achieve the following clinical and financial goals
during 2005:
o Begin patient enrollment in AP23573 Phase 2 multicenter clinical trials in
various solid tumors, including endometrial and prostate cancer, in 1H05.
o Begin patient enrollment in Phase 1b clinical trials of AP23573 in
combination with other anti-cancer therapies in 1H05.
o File an Investigational New Drug (IND) application for the oral dosage form
of AP23573 in 1H05 and initiate clinical trials.
o Achieve significant progress in the clinical development of AP23573 in 2H05,
including potential use of mTOR-pathway biomarkers, allowing initial
definition of the registration path for AP23573 in solid tumors and
hematologic malignancies.
o Facilitate development of AP23573 drug-delivery stents for prevention of
coronary artery re-blockage by partner Medinol Ltd.
o Advance NF-(kappa)B patent litigation with Eli Lilly and be prepared for
trial in 2H05, subject to setting of a trial date at the Court's discretion.
o Achieve target for annual cash used in operations of $39 to $42 million.
"In conjunction with our key clinical investigators, we will continue to submit
data from our AP23573 clinical trials to major and subspecialty oncology and
hematology meetings in the U.S. and abroad and anticipate being able to present
these clinical data at various forums during the year," said Camille L.
Bedrosian, M.D., vice president and chief medical officer of ARIAD.
"We are continuing to make excellent progress in our preclinical programs and
will provide further details and guidance on these product candidates as we
approach IND filings," said Tim Clackson, Ph.D., senior vice president and chief
scientific officer of ARIAD.
Upcoming Events
ARIAD management will be presenting updated overviews of the Company's progress
and plans at investor conferences - all to be webcast - including the following:
o SunTrust Robinson Humphrey "Off the Cuff" Therapeutics Conference, March 1,
2005 at the Le Parker Meridien, New York, New York.
o JMP Securities Fourth Annual Growth Conference, March 2, 2005 at the Ritz
Carlton Hotel, San Francisco, California.
o Lehman Brothers Eighth Annual Global Healthcare Conference, March 30 - April
1, 2005 at the Loews Hotel, Miami Beach, Florida.
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 the Company's
ability to accurately estimate the timing and actual research and development
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 our product candidates on a
commercial scale or to supply our product candidates to our collaborator for use
in its product candidates, risks and uncertainties regarding our and our
collaborator's ability to successfully enroll and conduct preclinical and
clinical studies of product candidates, including our product candidates to
treat cancers described in this release and our collaborator's medical device
product candidates to treat vascular disease, risks and uncertainties that
clinical trial results at any phase of development including those described in
this release may be adverse or may not be predictive of future results or lead
to regulatory approval of any of our or our collaborator's product candidates,
risks and uncertainties of third-party intellectual property claims relating to
our and our collaborator's product candidates, and risks and uncertainties
relating to regulatory oversight, the timing, scope, cost and outcome of legal
proceedings, including litigation concerning our NF-(kappa)B patent portfolio,
future capital needs, key employees, dependence on our collaborators and
manufacturers, markets, economic conditions, products, services, prices,
reimbursement rates, competition and other risks 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, 2003. 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 per share
data
Three Months Ended Twelve Months Ended
December 31, December 31,
---------------------------- ----------------------------
2004 2003 2004 2003
------------- ------------- ------------- -------------
(Unaudited) (Unaudited)
Total license revenue $ 179 $ 191 $ 742 $ 660
------------- ------------- ------------- -------------
Operating expenses:
Research and
development 8,875 3,850 27,711 14,889
General and
administrative 2,273 2,133 9,442 5,547
------------- ------------- ------------- -------------
Total operating
expenses 11,148 5,983 37,153 20,436
------------- ------------- ------------- -------------
Other income
(expense), net 255 81 838 50
------------- ------------- ------------- -------------
Net loss $ (10,714) $ (5,711) $ (35,573) $ (19,726)
============= ============= ============= =============
Net loss per common
share (basic and
diluted) $ (.20) $ (.13) $ (.69) $ (.51)
============= ============= ============= =============
Weighted average of
common stock
outstanding (basic
and diluted) 52,646,030 45,417,428 51,294,160 39,036,073
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
In thousands December 31, December 31,
2004 2003
------------- -------------
(Unaudited)
Cash, cash equivalents and marketable securities $ 75,506 $ 66,740
Total assets $ 87,189 $ 74,284
Working capital $ 68,874 $ 61,587
Total liabilities $ 19,748 $ 14,958
Stockholders' equity $ 67,440 $ 59,326
###