EX-99.1 2 a4811653ex991.txt ARIAD PHARMACEUTICALS, INC. EXHIBIT 99.1 Exhibit 99.1 ARIAD Reports Fourth Quarter and Year-End 2004 Results; Clinical and Financial Guidance for 2005 Provided CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 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: -- Begin patient enrollment in AP23573 Phase 2 multicenter clinical trials in various solid tumors, including endometrial and prostate cancer, in 1H05. -- Begin patient enrollment in Phase 1b clinical trials of AP23573 in combination with other anti-cancer therapies in 1H05. -- File an Investigational New Drug (IND) application for the oral dosage form of AP23573 in 1H05 and initiate clinical trials. -- 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. -- Facilitate development of AP23573 drug-delivery stents for prevention of coronary artery re-blockage by partner Medinol Ltd. -- 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. -- 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: -- SunTrust Robinson Humphrey "Off the Cuff" Therapeutics Conference, March 1, 2005 at the Le Parker Meridien, New York, New York. -- JMP Securities Fourth Annual Growth Conference, March 2, 2005 at the Ritz Carlton Hotel, San Francisco, California. -- 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 225 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 CONTACT: ARIAD Pharmaceuticals, Inc. Kelly Lindenboom, 617-621-2345