-----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, Tn+pJa5H0pRNTmmJnDP23ek7fVsiEFMDEEfvsgP8KnTbgHxqFmTUXeJun4QVm2KH 9qRiSvJ7dwOYI9MX2JmsAw== 0001157523-06-008120.txt : 20060808 0001157523-06-008120.hdr.sgml : 20060808 20060808091841 ACCESSION NUMBER: 0001157523-06-008120 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060808 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060808 DATE AS OF CHANGE: 20060808 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: 061011079 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 a5204643.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): August 8, 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 August 8, 2006, ARIAD Pharmaceuticals, Inc. (the "Company") announced financial results for the quarter ended June 30, 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 August 8, 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 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 August 8, 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: August 8, 2006 3 EXHIBIT INDEX Exhibit Number Description - ------- ----------- 99.1 Press release dated August 8, 2006. 4 EX-99.1 2 a5204643ex99-1.txt EXHIBIT 99.1 EXHIBIT 99.1 ------------ ARIAD Reports Second Quarter 2006 Results; Key Milestones Achieved in First Half of Year CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 8, 2006--ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced financial results for the quarter ended June 30, 2006 and provided an update on progress towards achievement of 2006 goals. "Based on the positive Phase 2 efficacy data announced earlier this year, our lead product candidate, the potent mTOR inhibitor, AP23573, is set to enter a global Phase 3 clinical trial in patients with advanced sarcomas," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We have chosen a clinical setting for this trial in which patients will receive AP23573 after a favorable response to first or second-line chemotherapy - a period during which patients generally do not receive any treatment. Our registration strategy is designed to achieve early market entry and a broad clinical indication for AP23573 in soft-tissue and bone sarcomas by addressing a major unmet medical need. This protocol will evaluate a new treatment paradigm for oncologists - maintenance therapy with AP23573, which may also be applicable to many other difficult-to-treat solid tumors." Financial Highlights For the quarter ended June 30, 2006, the Company reported a net loss of $17.0 million, or $0.27 per share, as compared to $14.1 million, or $0.27 per share, for the quarter ended June 30, 2005. The increase in net loss for the quarter is due primarily to higher expenses resulting from the Company's litigation against Eli Lilly and Company, which resulted in a favorable jury verdict for the Company in May 2006, and the adoption of new accounting requirements related to stock options and other share-based payments. For the six months ended June 30, 2006, cash used in operations was $27.4 million, consistent with the Company's guidance for 2006 of $53 million to $56 million. The Company ended the second quarter 2006 with $54.3 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: -- Announced positive efficacy data on AP23573 in soft-tissue and bone sarcomas at the American Society of Clinical Oncology meeting in June. AP23573 demonstrated efficacy and was well tolerated as a single agent in a multi-center Phase 2 trial in metastatic and/or unresectable soft-tissue and bone sarcomas. The primary end-point of the trial - evidenced by clinical-benefit response rates - was achieved in the three most prevalent types of sarcoma. Treatment with AP23573 more than doubled progression-free survival when compared to historical control data published by the European Organization for Research and Treatment of Cancer (EORTC). -- Provided an overview of plans for the randomized, worldwide Phase 3 clinical trial to be used for global registration of oral AP23573 in patients with advanced sarcomas. The Phase 3 trial design is based on the promising results achieved in the Phase 2 trial, and the goal will be to prolong progression-free survival and overall survival for these patients. The Company expects to provide additional details regarding the trial design and to launch the trial in 4Q06, and to begin patient enrollment at multiple leading sarcoma centers in 1Q07. -- Completed patient enrollment in the first stage of the two-stage Phase 2 clinical trial of AP23573 as a single agent in patients with recurrent or persistent endometrial cancer and disease progression. -- Received a favorable verdict in May from the jury in the United States District Court (the "Court") for the District of Massachusetts in the lawsuit against Eli Lilly and Company ("Lilly"), alleging infringement of our pioneering U.S. patent covering methods of treating human disease by regulating NF-(kappa)B cell-signaling activity. A separate trial, or bench trial, commenced before the judge on August 7, 2006 on certain defenses asserted by Lilly relating to the validity and enforceability of the claims of the patent, which must be addressed before the Court enters a final judgment in this lawsuit. -- Presented data from several studies on preclinical product candidates at the American Association for Cancer Research annual meeting. These studies demonstrated broad anti-cancer activity of ARIAD's oncogenic kinase inhibitors and bone-targeted mTOR inhibitors - promising, new molecularly targeted oncology therapies. The Company expects to designate its next development candidate from these programs later this year. Dr. Berger added, "We have achieved all of our key milestones so far this year, while prudently managing our financial resources. This progress positions us well to deliver on our remaining objectives in the second half of 2006 and beyond and to complete an ex-U.S. partnership for AP23573 - our highest business priority. We are particularly gratified by the jury verdict we received this quarter in the NF-(kappa)B trial against Lilly, and while Lilly has the right to challenge the verdict in the trial court and on appeal, we are confident that we will prevail." Upcoming Scientific Meetings ARIAD expects to have presentations at the following meetings: -- 5th International Congress on Targeted Therapies in Cancer, New York, New York, August 25 to 27, 2006. -- 4th Annual Symposium on Anti-angiogenesis: New Frontiers in Therapeutic Development, Boston, Massachusetts, October 16 to 17, 2006. -- 12th Annual Connective Tissue Oncology Society (CTOS) Meeting, Venice, Italy, November 2 to 4, 2006. -- 18th EORTC-NCI-AACR (ANE) Symposium on Molecular Targets and Cancer Therapeutics, Prague, Czech Republic, November 7 to 10, 2006. -- 48th American Society of Hematology Annual Meeting, Orlando, Florida, December 9 to 12, 2006. Upcoming Investor Meetings ARIAD management will present updated overviews of the Company's progress and plans at several investor conferences, including the following: -- Bear Stearns 19th Annual Healthcare Conference, New York, New York, September 11 to 12, 2006. -- ThinkEquity Partners 4th Annual Growth Conference, San Francisco, California, September 11 to 14, 2006. -- Credit Suisse 2006 Healthcare Conference, Phoenix, Arizona, November 15 to 17, 2006. -- Lazard Capital Markets 3rd Annual Life Sciences Conference, New York, New York, November 28 to 29, 2006. Today's Conference Call Reminder ARIAD will hold a live webcast of its quarterly conference call today at 7:30 a.m. (ET). The live webcast can be accessed by visiting the investor relations section of the Company's Web site at http://www.ariad.com/investor. The call can be accessed by dialing 866-356-4281 (domestic) or 617-597-5395 (international) five minutes prior to the start time and providing the passcode 96641869. A replay of the call will be available on the ARIAD Web site 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 "may," "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 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 recruit centers, enroll patients and conduct clinical studies of product candidates, including the Phase 3 pivotal trial described in this press release, risks and uncertainties that clinical trial results at any phase of development, including the results of the Phase 2 trial in advanced sarcomas described in this press release, 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 and patent office proceedings, litigation, prosecution and re-examination proceedings 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 per share data Three Months Ended Six Months Ended June 30, June 30, ------------------------ ------------------------ 2006 2005 2006 2005 ----------- ----------- ----------- ----------- (Unaudited) (Unaudited) Total license revenue $ 229 $ 350 $ 458 $ 654 ----------- ----------- ----------- ----------- Operating expenses: Research and development 10,144 12,093 21,818 22,747 General and administrative 7,531 2,600 11,987 4,916 ----------- ----------- ----------- ----------- Total operating expenses 17,675 14,693 33,805 27,663 ----------- ----------- ----------- ----------- Other income, net 450 260 993 580 ----------- ----------- ----------- ----------- Net loss $ (16,996) $ (14,083) $ (32,354) $ (26,429) ----------- ----------- ----------- ----------- ----------- ----------- ----------- ----------- Net loss per common share (basic and diluted) $ (.27) $ (.27) $ (.52) $ (.50) ----------- ----------- ----------- ----------- ----------- ----------- ----------- ----------- Weighted average number of shares of common stock outstanding (basic and diluted) 62,093,353 52,901,275 61,827,494 52,854,653 CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION In thousands June 30 December 31, 2006 2005 ------------ ------------ (Unaudited) Cash, cash equivalents and marketable securities $ 54,329 $ 81,516 Total assets $ 68,538 $ 96,174 Total liabilities $ 25,883 $ 24,796 Stockholders' equity $ 42,655 $ 71,378 CONTACT: ARIAD Pharmaceuticals, Inc. Edward Fitzgerald (Investors) 617-621-2345 or Andrea Johnston (Media) Pure Communications 910-616-5858 -----END PRIVACY-ENHANCED MESSAGE-----