-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Qre7JJdVQHfOO5qNX52NmSLh/br0EfFrycG18W1m2jgqwb/V1ww4rW3LiOw2awSO Ghnj4gkOLuDVAfhywxjRSw== 0001157523-03-001841.txt : 20030513 0001157523-03-001841.hdr.sgml : 20030513 20030513092057 ACCESSION NUMBER: 0001157523-03-001841 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030513 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030513 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARIAD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000884731 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 223106987 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-76486 FILM NUMBER: 03694026 BUSINESS ADDRESS: STREET 1: 26 LANDSDOWNE ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174940400 MAIL ADDRESS: STREET 1: 26 LANDSDOWNE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 a4394819.txt ARIAD PHARMACEUTICALS 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): May 13, 2003 ARIAD PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 0-21696 22-3106987 -------- ------- ---------- (State or Other Jurisdiction (Commission File Number) (I.R.S. Employer of Incorporation) Identification No.) 26 LANDSDOWNE STREET CAMBRIDGE, MASSACHUSETTS 02139 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (617) 494-0400 ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS. (c) Exhibits. 99.1 The Registrant's Press Release dated May 13, 2003. ITEM 9. REGULATION FD DISCLOSURE (INFORMATION FURNISHED PURSUANT TO ITEM 12, "DISCLOSURE OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION") On May 13, 2003, ARIAD Pharmaceuticals, Inc. announced its financial results for the three months ended March 31, 2003 and the results of studies supporting the use of its product candidate, AP23464, to treat advanced and drug-resistant cancers. The earnings release for the interim period is attached hereto as an exhibit to this current report on Form 8-K and is being furnished pursuant to Item 12 of Form 8-K. In accordance with the procedural guidance in SEC Release No. 33-8216, the information in this Form 8-K and the exhibit attached to this Form 8-K are being furnished under "Item 9. Regulation FD Disclosure" in satisfaction of the requirements of "Item 12. Disclosure of Results of Operations and Financial Condition." The information shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing. Signatures Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. ARIAD PHARMACEUTICALS, INC. By: /s/ Edward M. Fitzgerald -------------------------------- Edward M. Fitzgerald Senior Vice President and Chief Financial Officer Date: May 13, 2003 EXHIBIT INDEX ------------- Exhibit Number Description Sequential Page Number - ------- ----------- ---------------------- 99.1 The Registrant's Press 4 Release dated May 13, 2003. EX-99 3 a4394819_ex991.txt ARIAD PHARMACEUTICALS EXHIBIT 99.1 Exhibit 99.1 ARIAD Reports First Quarter 2003 Results Latest Studies Supporting Use of Product Candidate, AP23464, to Treat Advanced and Drug-Resistant Cancers Announced CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 13, 2003--ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced results for the first quarter ended March 31, 2003. Financial Highlights For the three months ended March 31, 2003, the Company reported a net loss of $5.3 million, or $0.15 per share (diluted), compared to a net loss of $6.2 million, or $0.19 per share (diluted), for the same period of 2002. This decrease in net loss is due primarily to lower R&D expenses as a result of the Company's decision to focus its efforts primarily on its lead anti-cancer small-molecule product candidates and reduce or defer its efforts in certain other programs. The Company expects that its net cash burn for the full year 2003 will be approximately $18 million (compared to $26.5 million for the year ended December 31, 2002), including funding for the ongoing clinical trials of AP23573. The Company ended the first quarter of 2003 with $21.4 million in cash and cash equivalents, which compares to cash and cash equivalents of $26.9 million at year-end 2002. Product Development Updates Because of the postponement of the American Association of Cancer Research (AACR) annual meeting in Toronto, Canada due to the SARS outbreak, scientists from ARIAD and their collaborators from the Beatson Institute of Cancer Research, University of Glasgow, were unable to present the results of on-going preclinical studies on AP23464, one of the Company's lead cancer product candidates. These studies, published in part in the annual meeting proceedings, support the potential use of AP23464 in two major oncology indications: the treatment and prevention of the spread of cancer (metastases) and the treatment of certain drug-resistant forms of leukemia. ARIAD's small-molecule drug was designed to have broad clinical applications in largely untreatable cancer patients by inhibiting two medically important and closely related proteins, known as Src and Abl, that play key roles in these malignancies. Metastatic spread, the migration of tumor cells from primary to distant sites, is critically dependent on the activity of the Src protein, which is over-activated in tumors prone to spread (such as colon cancer) and is potently inhibited by AP23464. Approximately 500,000 patients are expected to die from cancer this year in the United States; in over half of them, the cause of death is expected to be due to the consequences of metastases, rather than the primary tumor. There are no drugs which are currently available to specifically prevent or treat a broad spectrum of cancer metastases. AP23464 also blocks the activity of the abnormal proteins responsible for the malignant transformation in bone marrow cells that leads to certain forms of leukemia. Therefore, this product candidate may allow treatment of patients who no longer respond to currently available drugs, such as imatinib (known as Gleevec(R)) - the major challenge facing hematologists treating patients with this life-threatening bone marrow cancer. These leukemias appear to be dependent on both Abl and Src activity, both of which are potently inhibited by AP23464. This product candidate targets the market currently dominated by imatinib, which had over $700 million of sales in 2002. Additional results will be presented at the AACR meeting which has been rescheduled for July 2003 in Washington, D.C. The Company also recently began enrollment of cancer patients at major cancer centers in two phase 1 clinical studies of AP23573, its lead cancer product candidate. The AP23573 class of cancer drugs inhibits the protein mTOR and shrinks tumors by a novel mode of action - - cancer-cell starvation (metabolic arrest) through inhibition of nutrient uptake to tumor cells, as well as inhibition of growth factor stimulation. ARIAD is engaged in the discovery and development of breakthrough medicines that regulate cell signaling with small molecules. The Company is developing a comprehensive approach to the treatment of cancer and is primarily focused on a series of product candidates for targeted oncology indications. ARIAD also has an exclusive license to pioneering technology and patents related to the discovery, development and use of drugs that regulate NF-(kappa)B cell-signaling activity, which has been implicated in many major 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 conduct preclinical and clinical studies of its product candidates and the results of such studies, regulatory oversight, intellectual property claims, the timing, scope, cost and outcome of legal proceedings, future capital needs, key employees, dependence on the Company's 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, 2002. 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, 2003 2002 (Unaudited) Total research revenue $ 126 Operating expenses: Research and development (a) $ 4,541 $ 5,099 General and administrative 885 1,184 Total operating expenses 5,426 6,283 Interest income (expense), net (12) 116 Net loss $ (5,312) $ (6,167) Net loss per common share basic and diluted $ (.15) $ (.19) Weighted average number of shares of common stock outstanding basic and diluted 34,849,405 32,317,924 (a) Includes non-cash stock-based compensation expense (income) $ (3) $ 22 ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION March 31, December 31, In thousands 2003 2002 Cash, cash equivalents and marketable securities $ 21,414 $ 26,850 Total assets $ 29,439 $ 35,104 Total liabilities $ 12,850 $ 13,252 Stockholders' equity $ 16,589 $ 21,852 CONTACT: ARIAD Pharmaceuticals, Inc. Tom Pearson, 610/407-9260 or Kathy Lawton, 617/621-2345 -----END PRIVACY-ENHANCED MESSAGE-----