-----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, OTTP4DKWS6moc/1x4YzETsDjN6AVF6DUo4iR0DSMDrMqC+NK8bfDlOja0EkN4dh7 PGESiX0hjfdvG9jgD/DANw== 0001157523-05-004236.txt : 20050504 0001157523-05-004236.hdr.sgml : 20050504 20050504081648 ACCESSION NUMBER: 0001157523-05-004236 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050504 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050504 DATE AS OF CHANGE: 20050504 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: 000-21696 FILM NUMBER: 05796966 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 a4879760.txt ARIAD PHARMACEUTICALS, INC. 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 4, 2005 ARIAD Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 0-21696 22-3106987 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.) 26 Landsdowne Street, Cambridge, Massachusetts 02139 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (617) 494-0400 Not Applicable (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) ITEM 2.02 Results of Operations and Financial Condition On May 4, 2005, ARIAD Pharmaceuticals, Inc. announced consolidated financial results for the quarter ended March 31, 2005. A copy of the press release is furnished pursuant to this Item 2.02 as Exhibit 99.1 to this Current Report on Form 8-K. ITEM 8.01 Other Events. In its press release dated May 4, 2005, ARIAD Pharmaceuticals, Inc. provided an update on progress towards achievement of 2005 goals under the headings "Sarcoma Market Highlights", "Upcoming Scientific Meetings" and "Upcoming Investor Meetings". The Company hereby incorporates such information by reference into this Item 8.01 of this Current Report on Form 8-K. ITEM 9.01 Financial Statements and Exhibits. (c) Exhibits Exhibit Number Description ------ ----------- 99.1 Press release dated May 4, 2005. The portions of the Press Release incorporated by reference into Item 8.01 of this Current Report on Form 8-K are being filed pursuant to Item 8.01. The remaining portions of the Press Release are being furnished pursuant to Item 2.02 of this Current Report on Form 8-K and 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. 2 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 hereunto duly authorized. ARIAD Pharmaceuticals, Inc. By: /s/ Edward M. Fitzgerald ------------------------------------------- Edward M. Fitzgerald Senior Vice President and Chief Financial Officer Date: May 4, 2005 3 EXHIBIT INDEX ------------- Exhibit Number Description - ------ ----------- 99.1 Press release dated May 4, 2005. 4 EX-99.1 2 a4879760ex99.txt EXHIBIT 99.1 PRESS RELEASE EXHIBIT 99.1 ------------ ARIAD Reports First Quarter 2005 Results; Sarcoma Market Highlights CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 4, 2005--ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced financial results for the quarter ended March 31, 2005 and provided an update on progress towards achievement of 2005 goals. "We recently chose the treatment of soft-tissue and bone sarcomas as the initial registration path for our novel mTOR inhibitor, AP23573, which was designated a fast-track product by the U.S. Food and Drug Administration (FDA) for this indication. We also initiated several additional clinical trials of AP23573: Phase 2 studies in patients with hormone-refractory prostate cancer and Phase 1b studies combining AP23573 with two chemotherapeutic agents in patients with various solid tumors. Finally, the Investigational New Drug (IND) application for the oral dosage form of AP23573 became effective, and we expect to begin enrollment in this clinical trial shortly," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We are clearly on track to achieve all of our key product-development milestones for 2005 on or ahead of schedule." Financial Highlights For the quarter ended March 31, 2005, the Company reported a net loss of $12.3 million, or $0.23 per share, as compared to $6.2 million, or $0.13 per share, for the quarter ended March 31, 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. Cash used in operations for the quarter was $10.1 million, consistent with the Company's guidance for 2005 of $39 million to $42 million. The Company ended the first quarter 2005 with $63.4 million in cash, cash equivalents, and marketable securities, compared with $75.5 million at the end of 2004. Sarcoma Market Highlights Urgent Unmet Medical Need. Fast-track designation by the FDA is granted only when there is an urgent need for a new treatment. Patients with soft-tissue and bone sarcomas have a serious and life-threatening condition for which treatment options are limited or non-existent. There are no effective therapies currently available for advanced soft-tissue sarcomas or metastatic refractory sarcomas in general. The Numbers. In the U.S. alone, public health authorities estimate current sarcoma prevalence and incidence of new cases and deaths as follows(1,2). - -0- *T Sarcoma Type Prevalence New Cases Sarcoma Deaths Soft Tissue 71,343 9,420 3,490 Bone and Joint 27,684 2,570 1,210 *T To put these numbers in perspective: -- They are exclusive of Europe, Japan, China and the rest of the world. -- The prevalence of all sarcomas is more than five times higher than the prevalence of chronic myelogenous leukemia (CML) - the initial indication for imatinib (Gleevec(R)). Types of Sarcoma. Sarcomas are malignant tumors associated with one of the various connective tissues that hold the body together, such as muscles, nerves, bones, fat, tendons, cartilage, blood vessel or deep skin tissues. Sarcomas can develop in any part of the body. Half of them develop in the arms or legs; the rest arise in the trunk, head and neck area, internal organs, or the back of the abdominal cavity. Sarcomas are generally divided into two broad classes: soft-tissue sarcomas and bone sarcomas. Soft-tissue Sarcomas. Soft-tissue sarcomas are the most frequent form of the disease. Since many patients with soft-tissue sarcoma are not diagnosed until the disease is far advanced, the 5-year survival rate of those patients with distant metastases is only 10% to 15%. Primary Bone Sarcomas. The three most common kinds of primary bone sarcomas are: osteosarcoma (35%), chondrosarcoma (30%) and the Ewing's family of tumors (16%). Osteosarcoma primarily affects adolescents and young adults and is almost always a highly aggressive tumor with either detectable or subclinical metastases. References. (1) Jemal A, et al. Cancer Statistics, 2005. CA: A Cancer Journal for Clinicians 55(1): 10-30(2005). (2) Statistical Research and Applications Branch National Cancer Institue. Website: http://seer.cancer.gov/canques/. Accessed April 19, 2005. Upcoming Scientific Meetings Clinical investigators from major cancer centers will be presenting Phase 2 and Phase 1 data on AP23573 at the: -- American Society of Clinical Oncology Annual Meeting, Orlando, Florida, May 13-17, 2005. Upcoming Investor Meetings ARIAD management will be presenting updated overviews of the Company's progress and plans at investor conferences - all to be webcast - including the following: -- Bank of America Healthcare Conference at the Four Seasons Hotel in Las Vegas, Nevada, May 18, 2005 -- Fourth Annual Needham Biotechnology Conference at the New York Palace Hotel in New York, New York, May 25-26, 2005 About AP23573 The small-molecule drug, AP23573, starves cancer cells and shrinks tumors by inhibiting the critical cell-signaling protein, mTOR, which regulates the response of tumor cells to nutrients and growth factors, and controls tumor blood supply and angiogenesis through effects on Vascular Endothelial Growth Factor (VEGF) in tumor and endothelial cells. AP23573 also blocks the proliferation and migration of vascular smooth muscle cells, the primary cause of narrowing and reblockage of injured arteries, and is an analog of sirolimus, another mTOR inhibitor that has been approved for use in drug-eluting stents. AP23573 is currently in Phase 1 and 2 clinical trials in patients with solid tumors and hematologic cancers. AP23573 has been designated a fast-track product by the U.S. Food and Drug Administration for the treatment of soft tissue and bone sarcomas. About ARIAD ARIAD is engaged in the discovery and development of breakthrough medicines to treat disease 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. Gleevec is a trademark of Novartis AG. 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, including those costs related to the global development plan for AP23573, 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 candidate to treat cancer 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 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, 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 per share data March 31, ----------------------- 2005 2004 ----------------------- (Unaudited) Total revenue $ 304 $ 190 ---------- ---------- Operating expenses: Research and development 10,654 4,333 General and administrative 2,316 2,218 ---------- ---------- Total operating expenses 12,970 6,551 ---------- ---------- Other income, net 320 126 ---------- ---------- Net loss $ (12,346) $ (6,235) ========== ========== Net loss per share $ (.23) $ (.13) ========== ========== Weighted average number of shares of common stock outstanding 52,807,513 47,540,854 CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION March 31, December 31, In thousands 2005 2004 ------- ------- (Unaudited) Cash, cash equivalents and marketable securities $63,370 $75,506 Total assets $76,332 $87,189 Total liabilities $20,852 $19,749 Stockholders' equity $55,480 $67,440 CONTACT: ARIAD Pharmaceuticals, Inc. (Investors) Tom Pearson, 617-621-2345 or (Media) Pure Communications Sheryl Seapy, 949-608-0841 -----END PRIVACY-ENHANCED MESSAGE-----