ARIAD Reports Third Quarter 2005 Results; Further Strengthening of Senior Management Team Positions ARIAD to Achieve Future Milestones.CAMBRIDGE, Mass. -- ARIAD ARIAD Allison Research Index of Art and Design Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced financial results for the quarter ended September 30, 2005 and provided an update on progress towards achievement of 2005 goals, including revision of its guidance for cash used in operations for 2005. "Earlier this year, we highlighted ARIAD's next set of critical objectives: readiness to launch AP23573 in the U.S. ourselves, a partnership to commercialize AP23573 outside the U.S., and execution of the initial AP23573 registration trial in patients with soft-tissue and bone sarcomas Sarcomas Definition A sarcoma is a bone tumor that contains cancer (malignant) cells. A benign bone tumor is an abnormal growth of noncancerous cells. Description A primary bone tumor originates in or near a bone. ," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "To help meet these goals, we recently announced the addition of three new members of our senior management team: Rich Pascoe as chief commercial officer, John Loewy as vice president, biostatistics biostatistics /bio·sta·tis·tics/ (-stah-tis´tiks) biometry. bi·o·sta·tis·tics n. The science of statistics applied to the analysis of biological or medical data. and outcomes research, and Shirish Harani as vice president, development operations and planning. These experienced pharmaceutical and biotechnology executives broaden and deepen our management team by adding substantial leadership strength and indispensable skill sets to advance our efforts towards achieving our previously stated objectives." ARIAD has also continued to advance the clinical development of AP23573, its lead oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. product candidate. AP23573 - a novel, potent mTOR inhibitor discovered by ARIAD scientists - is currently in Phase 2 and Phase 1b trials for the treatment of various solid tumors and hematologic malignancies hematologic malignancy Hematologic cancer Hematology Any CA of blood-forming tissues, BM, or lymph nodes–eg, leukemia and lymphoma . Dr. Berger further commented, "The Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. for AP23573 in the treatment of advanced sarcomas, our lead indication, has exceeded enrollment expectations and is progressing according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. plan. We look forward to the opportunity to update the market and the clinical community on our progress in several areas of our global clinical development program for AP23573 in the coming weeks." Financial Highlights For the quarter ended September 30, 2005, the Company reported a net loss of $14.6 million, or $0.25 per share, as compared to $9.4 million, or $0.18 per share, for the quarter ended September 30, 2004. The increase in net loss for the quarter is due primarily to higher R&D expenses resulting from execution of the global development plan for its lead cancer product candidate, AP23573. During the quarter ended September 30, 2005, the Company raised $62.1 million in gross proceeds from the sale of 8,625,000 shares of its common stock in an underwritten secondary offering. The Company ended third quarter 2005 with $95.8 million in cash, cash equivalents, and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has , compared with $75.5 million at the end of 2004. For the nine months ended September 30, 2005, cash used in operations was $31.8 million. As a result of continued progress in implementation of its global development plan for AP23573, including faster than anticipated enrollment of several key clinical trials and early planning for our initial registration trial, the Company has revised its guidance for cash used in operations in 2005 from a range of $39 to $42 million, to approximately $46 million. Upcoming Scientific Meetings Clinical investigators A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under from major cancer centers will be presenting Phase 2 and Phase 1 data on AP23573 at the following meetings: --AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. : Discovery, Biology, and Clinical Applications, Philadelphia, Pennsylvania, November 14-18, 2005. --Connective Tissue Oncology Society 11th Annual Meeting, Boca Raton, Florida Boca Raton ("bōkə rə-tōn") is a city in Palm Beach County, Florida incorporated in May 1925. As of the 2000 census, the city had a total population of 74,764; the 2006 population recorded by the U.S. Census Bureau was 86,396. , November 19-21, 2005. --American Society of Hematology hematology Branch of medicine concerned with the nature, function, and diseases of the blood. It covers the cellular and serum composition of blood, the coagulation process, blood-cell formation, hemoglobin synthesis, and disorders of all these. 47th Annual Meeting and Exposition, Atlanta, Georgia, December 10-13, 2005. Upcoming Investor Meetings ARIAD management will present updated overviews of the Company's progress and plans at several investor conferences - all to be webcast - including the following: --Rodman & Renshaw Techvest 7th Annual Healthcare Conference, New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , New York, November 7, 2005. --SG Cowen 6th Annual Global Health Care Conference, Barcelona, Spain, November 10, 2005. --Lazard Capital Markets Life Sciences Conference, New York, New York, November 30, 2005. 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 Investor relations The process by which the corporation communicates with its investors. section of the Company's website at http://www.ariad.com/investor. The call can also be accessed by dialing 1-800-237-9752 (domestic) or 617-847-8706 (international) five minutes prior to the start time and providing the passcode 41537436. 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 disease by regulating cell signaling Cell signaling is part of a complex system of communication that governs basic cellular activities and coordinates cell actions. The ability of cells to perceive and correctly respond to their microenvironment is the basis of development, tissue repair, and immunity as well as 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 angioplasty (ăn`jēōplăs'tē), any surgical repair of a blood vessel, especially balloon angioplasty or percutaneous transluminal coronary angioplasty, a treatment of coronary artery disease. . ARIAD has an exclusive license to pioneering technology and patents related to certain NF-(kappa Kappa Used in regression analysis, Kappa represents the ratio of the dollar price change in the price of an option to a 1% change in the expected price volatility. Notes: Remember, the price of the option increases simultaneously with the volatility. )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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. and clinical development and manufacture of our product candidates, including the timing and costs related to the global development plan for AP23573 described in this release, the adequacy of our capital resources and the availability of additional funding, risks and uncertainties regarding our or our collaborator's ability to manufacture our product candidates on a commercial scale or to supply our product candidates to collaborators, risks and uncertainties regarding our ability to successfully enroll and conduct preclinical and clinical studies of product candidates, including our product candidate to treat various cancers described in this release and our collaborator's medical device product candidate to treat vascular disease, 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 collaborator's product candidates, risks and uncertainties of third-party intellectual property claims relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc our and any collaborator's product candidates, and risks and uncertainties relating to regulatory oversight, the timing, scope, cost and outcome of legal proceedings All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. , including litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. concerning our NF-(kappa)B patent portfolio, future capital needs, key employees, dependence on collaborators and manufacturers, markets, economic conditions, products, services, prices, reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , as amended, for the fiscal year ended December 31, 2004. 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 Nine Months Ended
per share data September 30, September 30,
------------------------- -------------------------
2005 2004 2005 2004
(Unaudited) (Unaudited)
Total license
revenue $ 321 $ 185 $ 975 $ 563
----------- ----------- ----------- -----------
Operating expenses:
Research and
development 12,381 7,401 35,128 18,836
General and
administrative 2,892 2,386 7,808 7,169
----------- ----------- ----------- -----------
Total
operating
expenses 15,273 9,787 42,936 26,005
----------- ----------- ----------- -----------
Other income, net 358 233 938 583
----------- ----------- ----------- -----------
Net loss $ (14,594) $ (9,379) $ (41,023) $ (24,859)
=========== =========== =========== ===========
Net loss per
common share
(basic and
diluted) $ (.25) $ (.18) $ (.75) $ (.49)
=========== =========== =========== ===========
Weighted average
number of shares
of common stock
outstanding
(basic and
diluted) 57,662,708 52,544,234 54,474,950 50,840,247
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
September 30, December 31,
In thousands 2005 2004
------------- -------------
(Unaudited)
Cash, cash equivalents and marketable
securities $ 95,826 $ 75,506
Total assets $ 110,216 $ 87,189
Total liabilities $ 24,670 $ 19,749
Stockholders' equity $ 85,546 $ 67,440
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