-----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, QXB99Vi5HiXFwZW9ru2+t6o7h/DM96WdLBcHrKLsg9mpcg14NtjEmnQeZRY0t4yV Lu+PlTQoaOcn4BrLTGMpUQ== 0001157523-05-009525.txt : 20051102 0001157523-05-009525.hdr.sgml : 20051102 20051102094547 ACCESSION NUMBER: 0001157523-05-009525 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051102 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051102 DATE AS OF CHANGE: 20051102 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: 051171667 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 a5009861.txt ARIAD PHARMACEUTICALS, INC. 8-K 5 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): November 2, 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 November 2, 2005, ARIAD Pharmaceuticals, Inc. announced its consolidated financial results for the three and nine months ended September 30, 2005. A copy of the press release is being 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 November 2, 2005, ARIAD Pharmaceuticals, Inc. provided an update on additions to the senior management team and on progress regarding the clinical development of its lead product candidate in the second, third and fourth paragraphs of the press release and under the headings "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) Exhibit Number Description ------ ----------- 99.1 Press release dated November 2, 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, Finance and Corporate Operations, Chief Financial Officer Date: November 2, 2005 3 EXHIBIT INDEX ------------- Exhibit Number Description - ------ ----------- 99.1 Press release dated November 2, 2005. 4 EX-99.1 2 a5009861ex99-1.txt EXHIBIT 99.1 Exhibit 99.1 ARIAD Reports Third Quarter 2005 Results; Further Strengthening of Senior Management Team Positions ARIAD to Achieve Future Milestones CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2005--ARIAD 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," 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 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 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. Dr. Berger further commented, "The Phase 2 clinical trial for AP23573 in the treatment of advanced sarcomas, our lead indication, has exceeded enrollment expectations and is progressing according to 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, 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 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: Discovery, Biology, and Clinical Applications, Philadelphia, Pennsylvania, November 14-18, 2005. -- Connective Tissue Oncology Society 11th Annual Meeting, Boca Raton, Florida, November 19-21, 2005. -- American Society of Hematology 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, 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 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 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, 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 our and any 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 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 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 CONTACT: Investors: ARIAD Pharmaceuticals, Inc. Ed Fitzgerald, 617-621-2345 or Media: Pure Communications Andrea Johnston, 910-681-1088 -----END PRIVACY-ENHANCED MESSAGE-----