-----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, P+9eVq5DDvHsntkHVbEffWa71Sd8662cT6frTU+aMPqIpRo8UpoCRzk3Fw3anEl1 gejArjR3d/o1jF2rg1Fwog== 0001157523-06-004867.txt : 20060509 0001157523-06-004867.hdr.sgml : 20060509 20060509093349 ACCESSION NUMBER: 0001157523-06-004867 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060508 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060509 DATE AS OF CHANGE: 20060509 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: 06818908 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 a5143698.txt ARIAD PHARMACEUTICALS 8K 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 9, 2006 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 9, 2006, ARIAD Pharmaceuticals, Inc. (the "Company") announced financial results for the quarter ended March 31, 2006 and provided an update on progress towards achievement of 2006 goals. 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 May 9, 2006, the Company provided a summary of progress toward achievement of its corporate goals for 2006 under the heading "Corporate and Development Highlights" and information regarding upcoming scientific and investor meetings under the headings "Upcoming Medical and Partnering 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 May 9, 2006. 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: May 9, 2006 3 EXHIBIT INDEX Exhibit Number Description 99.1 Press release dated May 9, 2006. 4 EX-99.1 2 a5143698ex991.txt EXHIBIT 99.1 Exhibit 99.1 ARIAD Reports First Quarter 2006 Results; Management to Discuss Recent Favorable Verdict in Lilly NF-(kappa)B Patent Case and Provide Update on AP23573 Clinical Development Program CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 9, 2006--ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced financial results for the quarter ended March 31, 2006 and provided an update on progress towards achievement of 2006 goals. "We are extremely pleased with the recent jury verdict supporting our assertions regarding Lilly's infringement of our NF-(kappa)B patent and the validity of this pioneering patent," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "In addition to this achievement, our lead product candidate, the potent mTOR inhibitor AP23573, continues its rapid progression through clinical trials toward launch of the pivotal Phase 3 trial needed for product registration. We have completed enrollment and initial follow up of patients in our Phase 2 clinical trial of AP23573 in advanced sarcomas, and we expect to present extensive data from this trial to the oncology community at the American Society of Clinical Oncology (ASCO) annual meeting in June." Financial Highlights For the quarter ended March 31, 2006, the Company reported a net loss of $15.4 million, or $0.25 per share, as compared to $12.3 million, or $0.23 per share, for the quarter ended March 31, 2005. The increase in net loss for the quarter is due primarily to higher operating expenses resulting from continued development of its lead cancer product candidate, AP23573, professional fees related to ongoing patent litigation and the impact of adoption of the new accounting requirements regarding expensing stock options and other share-based payments. Cash used in operations for the quarter was $13.9 million, which is consistent with the Company's guidance for 2006 of $53 million to $56 million. The Company ended the first quarter 2006 with $68.1 million in cash, cash equivalents, and marketable securities, compared with $81.5 million at the end of 2005. Corporate and Development Highlights Thus far, this year, the Company has made substantial progress toward achievement of its corporate goals for 2006. Key accomplishments include: -- Received favorable verdict from the jury in the United States District Court for the District of Massachusetts in lawsuit against Eli Lilly and Company alleging infringement of pioneering U.S. patent covering methods of treating human disease by regulating NF-(kappa)B cell-signaling activity. The jury ruled unanimously in favor of ARIAD and co-plaintiffs in finding that the claims of the NF-(kappa)B patent asserted in the lawsuit are valid and infringed by Lilly with respect to Lilly's osteoporosis drug, Evista(R), and Lilly's septic shock drug, Xigris(R). The jury awarded damages to the plaintiffs in the amount of approximately $65.2 million, based on the jury's determination of a reasonable royalty rate of 2.3% to be paid by Lilly to the plaintiffs based on U.S. sales of Evista and Xigris from filing of the lawsuit on June 25, 2002 through February 28, 2006. The jury awarded further damages on an ongoing basis, in amounts to be determined, equal to 2.3% of U.S. sales of Evista and Xigris through the year 2019, when the patent expires. -- Initiated enrollment of advanced cancer patients in a Phase Ib clinical trial of AP23573 in combination with doxorubicin - a chemotherapeutic agent used widely in soft-tissue sarcomas as part of first-line regimens, as well as in breast, ovarian and endometrial cancers and certain hematologic malignancies. -- Completed enrollment in a Phase 2 clinical trial of AP23573 as a single agent in advanced prostate cancer patients who have become refractory to standard hormone therapy and have progressed after taxane chemotherapy; follow-up evaluation of patients is ongoing. -- Continued enrollment in a Phase 2 clinical trial of AP23573 as a single agent in patients with recurrent or persistent endometrial cancer and disease progression; patient enrollment is on schedule. -- Updated the international sarcoma community on the AP23573 clinical development program at the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) Scientific Symposium & Spring Meeting on Sarcomas in Mannheim, Germany. Expanded data, originally disclosed at the 17th AACR-NCI-EORTC International Conference on "Molecular Targets and Cancer Therapeutics" in Philadelphia, were presented by Professor Jean-Yves Blay, one of the lead European clinical investigators in the AP23573 clinical trials and chairman of the EORTC-STBSG. -- Presented data from several preclinical studies on ARIAD's pipeline product candidates at the American Association for Cancer Research (AACR) annual meeting. These studies demonstrated broad anti-cancer activity and the potential of ARIAD's oncogenic kinase inhibitors and bone-targeted mTOR inhibitors - new molecularly targeted oncology therapies. Upcoming Medical and Partnering Meetings Current data on AP23573 will be presented at the following meetings: -- 2006 American Society of Clinical Oncology (ASCO) Annual Meeting, Atlanta, Georgia, June 2 to 6, 2006 -- Windhover Therapeutic Alliances Series: Oncology, Atlanta, Georgia, June 6 to 7, 2006 Upcoming Investor Meetings ARIAD management will present updated overviews of the Company's progress and plans at several investor conferences, all of which will be webcast: -- Banc of America Health Care Conference 2006, Las Vegas, Nevada, May 16 to 18, 2006 -- Bear Stearns Boston Biotech Confab, Boston, Massachusetts, May 31, 2006 -- Pacific Growth Equities Third Annual Life Sciences Growth Conference, San Francisco, California, June 12 to 14, 2006 -- Needham & Company Fifth Annual Biotechnology and Medical Technology Conference, New York, New York, June 14 to 15, 2006 Today's 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 be accessed by dialing 1-800-291-5365 (domestic) or 617-614-3922 (international) five minutes prior to the start time and providing the passcode 40346992. 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 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 our ability to accurately estimate the timing and actual R&D 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 or have manufactured our product candidates on a commercial scale, risks and uncertainties regarding our ability to successfully enroll and conduct clinical studies of product candidates, 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 partner's product candidates, risks and uncertainties of third-party intellectual property claims relating to our and any partner's product candidates, and risks and uncertainties relating to regulatory oversight, the timing, scope, cost and outcome of legal proceedings, including judicial determinations still pending before the judge in the U.S. District Court litigation, litigation initiated by Amgen Inc. in the U.S. District Court in Delaware, a possible appeal by Eli Lilly in such litigation, and reexamination proceedings in the U.S. Patent and Trademark Office 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 factors 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, 2005. 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, -------------------------- 2006 2005 ----------- ------------ (Unaudited) Total revenue $ 229 $ 304 ----------- ----------- Operating expenses: Research and development 11,674 10,654 General and administrative 4,456 2,316 ----------- ----------- Total operating expenses 16,130 12,970 ----------- ----------- Other income, net 543 320 ----------- ----------- Net loss $ (15,358) $ (12,346) =========== =========== Net loss per share $ (.25) $ (.23) =========== =========== Weighted average number of shares of common stock outstanding 61,728,913 52,807,513 CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION In thousands March 31, December 31, 2006 2005 --------- ----------- (Unaudited) Cash, cash equivalents and marketable securities $68,055 $81,516 Total assets $82,112 $96,174 Total liabilities $23,929 $24,796 Stockholders' equity $58,183 $71,378 CONTACT: ARIAD Pharmaceuticals, Inc. Edward Fitzgerald (Investors), 617-621-2345 or Pure Communications Sheryl Seapy (Media), 949-608-0841 -----END PRIVACY-ENHANCED MESSAGE-----