-----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, PDKmPGtslDVgqwB3ltjDeK7Y62ACDAvlv4VvKD5Xo/PTxqRP2UzgREEXC0Lh2DE9 f2LnaWaTdIUZ+S7PlQcUyQ== 0001157523-10-001578.txt : 20100316 0001157523-10-001578.hdr.sgml : 20100316 20100316075334 ACCESSION NUMBER: 0001157523-10-001578 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100316 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100316 DATE AS OF CHANGE: 20100316 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: 10683695 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 a6215930.htm ARIAD PHARMACEUTICALS, INC.

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):  March 16, 2010

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.

In a press release dated March 16, 2010, ARIAD Pharmaceuticals, Inc. (the “Company”) announced financial results for the fourth quarter and year ended December 31, 2009.  A copy of the press release is attached hereto as Exhibit 99.1.  The information under the headings “Financial Highlights” and “Today’s Conference Call Reminder” and the condensed consolidated financial statements included in the press release are incorporated by reference into this Item 2.02 of this Current Report on Form 8-K.

ITEM 7.01     Regulation FD Disclosure.

In the press release dated March 16, 2010, the Company also provided information on upcoming medical and investor meetings. The information set forth under the headings “Upcoming Medical Meeting” and “Upcoming Investor Meeting” in the press release is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.

ITEM 8.01     Other Events.

In the press release dated March 16, 2010, the Company also provided information on the status and expected timing of its SUCCEED trial, progress in its AP24534 program and negotiations with Merck regarding revisions to the parties’ collaboration agreement.  The information set forth under the headings “Phase 3 Sarcoma Data in 2010,” “Advancing AP24534 to a Pivotal Trial,” “AP24534 Data Highlights from ASH” and “Progress in Negotiations with Merck” is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.

ITEM 9.01     Financial Statements and Exhibits.

(d)       Exhibits.

Exhibit  

Number

Description

 
99.1 Press release dated March 16, 2010.

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 Items 2.02 and 7.01 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (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, as amended, or the Exchange Act except as shall be 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 hereunto duly authorized.

  ARIAD Pharmaceuticals, Inc.
 
 
By: /s/ Edward M. Fitzgerald
Edward M. Fitzgerald
Senior Vice President, Chief Financial Officer

Date:     March 16, 2010

EX-99.1 2 a6215930ex_991.htm EXHIBIT 99.1

Exhibit 99.1

ARIAD Reports Development Progress and Fourth Quarter and Year-End 2009 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 16, 2010--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the fourth quarter and full year ended December 31, 2009 and provided an update on corporate developments.

Phase 3 Sarcoma Data in 2010

ARIAD expects to have results this year from the Phase 3 SUCCEED trial of oral ridaforolimus -- its investigational mTOR inhibitor -- in patients with metastatic soft tissue and bone sarcomas, who have had a favorable response to chemotherapy. Patient enrollment in the 650-patient, randomized, placebo-controlled study was completed in the fourth quarter of 2009. Two-thirds of the progression-free survival (PFS) events in the trial occurred earlier in the first quarter of 2010, triggering initiation of the study’s second interim efficacy analysis. The independent Data Monitoring Committee of the SUCCEED trial is expected to complete the second interim analysis as specified by the study protocol and statistical analysis plan in the second quarter of 2010. The final analysis of the PFS data is expected in the fourth quarter of 2010.

The SUCCEED trial is 90 percent powered to show a 33 percent improvement in median PFS comparing the ridaforolimus and placebo arms of the trial. Pending review of the results of the SUCCEED trial and other ongoing development activities, ARIAD and its ridaforolimus development partner, Merck & Co, Inc., anticipate filing for marketing approval of oral ridaforolimus in patients with metastatic sarcomas in late 2010 or in 2011. The timing of the filing will be based primarily on whether the interim or final analysis is used to determine the safety and efficacy of oral ridaforolimus in the potential sarcoma indication. There has been no new therapy approved for patients with soft-tissue or bone sarcoma in the U.S. for more than 20 years and, depending on the results of the SUCCEED trial and regulatory review, ridaforolimus could be the first targeted agent to be approved for this patient population.

Advancing AP24534 to a Pivotal Trial

ARIAD is rapidly advancing the clinical development of its second internally discovered product candidate -- its investigational pan-BCR-ABL inhibitor -- AP24534, in patients with advanced hematological cancers. Preliminary clinical proof-of-concept data on AP24534 were presented at the annual meeting of the American Society of Hematology (ASH) last December. Pending further analysis of the results from the ongoing Phase 1 trial and continued interactions with regulatory authorities, ARIAD plans to advance AP24534 into a pivotal registration trial in the second half of 2010.

Fifty-seven patients at five medical centers have been enrolled in the study, and a new, 45 mg/day dosing cohort has been enrolling patients since last December. ARIAD expects to finalize dose selection for the pivotal trial in the second quarter of 2010. Updated results from the Phase 1 study of AP24534, including data on durability of hematologic and cytogenetic responses and the new dosing cohort, have been submitted for presentation at a major oncology meeting this spring.

AP24534 Data Highlights from ASH

Preliminary safety data presented at ASH show AP24534 to be well tolerated with a dose-limiting toxicity (DLT) observed at 60 mg/day and no DLTs in any of the five lower dosing cohorts studied (2, 4, 6, 15, and 30 mg administered orally once daily).

Preliminary clinical data presented at ASH provide strong evidence of hematologic, cytogenetic and molecular anti-leukemic activity of AP24534 in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML), including those with the T315I mutation of the target protein, BCR-ABL. More than 80 percent of the patients treated in this study had failed at least three prior tyrosine kinase inhibitors before enrolling in the study. Importantly, major cytogenetic response data on AP24534 in chronic phase CML patients compare favorably with published Phase 1 data from current second-line CML therapies.


Progress in Negotiations with Merck

ARIAD is engaged in advanced negotiations with Merck regarding the terms of a revised collaboration agreement for the development and commercialization of ridaforolimus.

“We have made excellent progress in these negotiations and anticipate that a revised agreement will be finalized and executed in the second quarter of 2010,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “Although we cannot assure that such agreement will be reached, we have seen a strong commitment from Merck to bringing this process to fruition.”

“A revised collaboration agreement, including the annual global development plan and associated budget, will provide important clarity on the available funding resources and potential scope of development for ridaforolimus,” he added.

Financial Highlights

For the fourth quarter ended December 31, 2009, ARIAD reported a net loss of $18.0 million, or $0.17 per share, compared to a net loss of $16.8 million, or $0.24 per share, for the same period in 2008. For the full year ended December 31, 2009, ARIAD reported a net loss of $80.0 million, or $0.86 per share, compared to a net loss of $71.1 million, or $1.02 per share for the same period in 2008. These results reflect increases in research and development expenses in 2009 compared to 2008 due to the continued advancement of ARIAD’s development programs for its lead investigational product candidates, ridaforolimus and AP24534, as well as non-cash charges related to revaluation of the Company’s warrant liability. These increases and non-cash charges were offset in large part by decreases in general and administrative expenses in 2009 compared to 2008, due to reduction in activities and costs related to corporate and commercial development initiatives and patent litigation.

For the year ended December 31, 2009, cash used in operations was $51.9 million, compared to cash used in operations of $48.3 million for the same period in 2008. ARIAD ended 2009 with cash, cash equivalents and marketable securities of $40.4 million, compared to $38.4 million at December 31, 2008. In the Company’s annual report on Form 10-K to be filed today, the report of its independent auditors expresses an unqualified opinion on the consolidated financial statements as of December 31, 2009 and includes a going-concern explanatory paragraph.

“We anticipate providing financial guidance for 2010 once we reach final agreement with our partner Merck on the terms of a revised collaboration agreement, including the scope of ridaforolimus development activities and the associated budget and funding,” said Edward M. Fitzgerald, senior vice president and chief financial officer of ARIAD.

“We are also pursuing partnering opportunities for our other product candidates, which could provide up-front and milestone payments, as well as funding of development costs and other licensing possibilities. In the event that we are unable to revise the Merck agreement, we would seek to raise additional capital or pursue other strategic options,” he said.

Upcoming Medical Meeting

Six scientific abstracts representing each of our three of ARIAD’s investigational agents have been accepted for presentation at the 101st Annual Meeting of the American Association for Cancer Research taking place April 17-21, 2010 in Washington, D.C.


Upcoming Investor Meeting

ARIAD will make a corporate presentation at the following upcoming investor conferences:

  • Barclays Capital Global Healthcare Conference, Miami Beach, FL, March 23, 2010

Today’s Conference Call Reminder

ARIAD will hold a live webcast of its quarterly and year-end earnings conference call today, March 16, 2010 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 866-383-8003 (domestic) or 617-597-5330 (international) five minutes prior to the start time and providing the pass code 51909292. 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’s vision is to transform the lives of cancer patients with breakthrough medicines. The Company’s mission is to discover, develop and commercialize small-molecule drugs to treat cancer in patients with the greatest and most urgent unmet medical need – aggressive cancers where current therapies are inadequate. ARIAD’s lead product candidate, ridaforolimus, is an investigational mTOR inhibitor in Phase 3 clinical development in patients with advanced sarcomas and is being developed in collaboration with Merck & Co., Inc. ARIAD’s second internally discovered product candidate, AP24534, is an investigational pan-BCR-ABL inhibitor completing Phase 1 clinical development in patients with hematological cancers, notably chronic myeloid leukemia. ARIAD has an exclusive license to pioneering technology and patents related to certain NF-κB cell-signaling activity, which may be useful in treating certain diseases. For additional information about the Company, please visit http://www.ariad.com.

This press release contains “forward-looking statements” including, but not limited to, statements relating to the timing of the second interim analysis and final results of the SUCCEED trial and filing for marketing approval of oral ridaforolimus in patients with metastatic sarcomas, the potential for ridaforolimus to be the first agent approved for patients with soft-tissue or bone sarcomas, the potential to advance AP24534 into a pivotal registration trial in patients with CML and the expected timing for finalizing dose selection and initiation of such a trial, the status of the Company’s negotiations with Merck regarding the terms of a revised collaboration agreement and the expected timing for entering into such agreement, the Company’s plans to raise additional capital necessary to funds its operations and reduce operating expenses if it does not reach a revised agreement with Merck, the Company’s plans for providing financial guidance for 2010, and the Company’s pursuit of partnering opportunities for its other product candidates as a potential source of funding. Forward-looking 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 statements. These risks and uncertainties include, but are not limited to, preclinical data and early-stage clinical data that may not be replicated in later-stage clinical studies; the outcome of negotiations with Merck regarding revisions to the parties’ collaboration agreement; the costs associated with the Company’s research, development, manufacturing and other activities; the conduct, timing and results of pre-clinical and clinical studies of the Company’s product candidates and its ability to advance them into later stage and pivotal trials on the timelines it anticipates; the adequacy of the Company’s capital resources and the availability of additional funding; the timing, scope, cost and outcome of legal and patent office proceedings concerning the Company’s NF-κB patent portfolio; and other factors detailed in the Company’s public filings with the U.S. Securities and Exchange Commission. The information contained in this press release 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

December 31,

   

Year Ended

December 31,

2009

   

2008

2009

   

2008

 
License and collaboration revenue $ 2,154   $ 2,601   $ 8,302   $ 7,082  
Operating expenses:
Research and development 16,020 14,774 63,447 50,841
General and administrative   4,476     4,661     16,888     28,092  
Total operating expenses   20,496     19,435     80,335     78,933  
Other income (expense), net   (178 )   52     (7,975 )   799  
Net loss $ (18,520 ) $ (16,782 )

$

(80,008

)

$ (71,052 )

Net loss per common share

$ (.17 ) $ (.24 )

$

(.86

)

$ (1.02 )
 

Weighted average number of shares of common stock outstanding

108,792,101 71,045,173 93,330,308 69,790,784
 

CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION

 
In thousands    

December 31,

2009

   

December 31,

2008

 
Cash, cash equivalents and marketable securities $ 40,362 $ 38,369
Total assets $ 65,010 $ 68,188
Deferred revenue, total $ 111,611 $ 97,264
Total liabilities $ 154,026 $ 137,386
Stockholders’ deficit $ (89,016 )

$

(69,198 )
 

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION

 
In thousands    

Year Ended

December 31,

2009     2008
 
Net cash used in operating activities $ (51,904 ) $ (48,251 )
Net cash provided by (used in) investing activities 11,271 (4,837 )
Net cash provided by financing activities   57,451     9467  
 
Net increase (decrease) in cash and cash equivalents $ 16,818   $ (43,621 )

CONTACT:
ARIAD Pharmaceuticals, Inc.
Maria E. Cantor, 617-621-2208

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