-----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, HSxgQj+QMf2N3BIAtRkAde049vG697f12FaPFImUEqQJau7r2fuvhtkNtEUQaImV qUN24E3XO68pYIPCb43RIA== 0001157523-09-007711.txt : 20091105 0001157523-09-007711.hdr.sgml : 20091105 20091105074517 ACCESSION NUMBER: 0001157523-09-007711 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20091105 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091105 DATE AS OF CHANGE: 20091105 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: 091159459 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 a6092370.htm 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): November 5, 2009

ARIAD Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)

Delaware

0-21696

22-3106987

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

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 5, 2009, ARIAD Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter and nine months ended September 30, 2009, and an update on corporate developments. The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.  Except for the information set forth under the headings “Upcoming Medical Meetings” and “Upcoming Investor and Partnering Meetings,” the information contained in the press release shall be considered “filed” under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall be incorporated by reference into filings of the Company under the Securities Act of 1933, as amended (the “Securities Act”).

ITEM 7.01     Regulation FD Disclosure.

In the press release dated November 5, 2009 attached hereto as Exhibit 99.1, the Company provided information on upcoming medical and investor and partnering meetings.  The information set forth under the headings “Upcoming Medical Meetings” and “Upcoming Investor and Partnering Meetings” in the press release attached hereto as Exhibit 99.1 is being furnished pursuant to this Item 7.01 of this Current Report on Form 8-K, and shall not be incorporated by reference in any filing under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

ITEM 9.01     Financial Statements and Exhibits.

(d)       Exhibits.

Exhibit
Number

Description

 
99.1 Press Release dated November 5, 2009 regarding the Company’s earnings as of and for the three and nine month periods ended September 30, 2009.

Except for the information set forth under the headings “Upcoming Medical Meetings” and “Upcoming Investor and Partnering Meetings,” the information contained in Exhibit 99.1 shall be considered “filed” under the Exchange Act and shall be incorporated by reference into filings of the Company under the Securities Act. The information set forth under the headings “Upcoming Medical Meetings” and “Upcoming Investor and Partnering Meetings” in Exhibit 99.1 is being furnished and shall not be incorporated by reference in any filing under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

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, Chief Financial Officer

 
 

Date:

November 5, 2009

3

EX-99.1 2 a6092370ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

ARIAD Reports Third Quarter 2009 Development Progress and Financial Results

~ SUCCEED Trial Full Patient Enrollment On Track for Year-end 2009

~ Proof-of-Concept Clinical Data of AP24534 to be Presented at ASH

CAMBRIDGE, Mass.--(BUSINESS WIRE)--November 5, 2009--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter and nine months ended September 30, 2009 and provided an update on corporate developments.

SUCCEED Trial Full Enrollment Expected at Year-End

ARIAD reaffirmed that the global, Phase 3 SUCCEED trial of oral ridaforolimus in patients with metastatic soft tissue and bone sarcomas remains on track for full enrollment around year-end 2009.

The independent Data Monitoring Committee (DMC) of the SUCCEED trial completed the first interim efficacy analysis as specified by the study protocol in September of this year and recommended that this randomized, placebo-controlled trial continue to full patient enrollment and completion. The DMC made this recommendation after reviewing the pre-specified statistical analyses and available data on the safety and efficacy of oral ridaforolimus. The DMC indicated that the safety data from the first interim analysis are consistent with the known safety profile of ridaforolimus, and no modifications to the study protocol were recommended.

The report of the second interim efficacy analysis, which will be based on approximately two-thirds of the total number of progression-free survival (PFS) events in the trial, is expected around the end of the first quarter of 2010, as previously announced. The final analysis of all PFS events is expected at approximately the end of the third quarter of 2010. The complete SUCCEED trial is 90 percent powered to show a 33 percent improvement in median PFS comparing the drug-treated and placebo arms of the trial.

“The recommendation by the DMC to continue the SUCCEED trial to completion was an important step in the development of oral ridaforolimus as a potential new treatment option for patients with metastatic sarcomas, and we are very pleased to be on schedule for full enrollment around the end of the year,” stated Harvey J. Berger, M.D. chairman and chief executive officer of ARIAD.


AP24534 Clinical Data to be Presented at ASH

Leading cancer investigators will present Phase 1 clinical proof-of-concept data on ARIAD’s investigational, pan-BCR-ABL inhibitor, AP24534, in patients with drug-resistant and refractory chronic myeloid leukemia (CML) and other hematological cancers at the upcoming American Society of Hematology annual meeting in December. Preliminary trial results on AP24534 that were announced earlier this quarter provide initial clinical evidence of hematologic, cytogenetic and molecular responses and anti-cancer activity of AP24534 in heavily pretreated patients with resistant and refractory CML and Philadelphia-positive acute lymphoblastic leukemia, including those with the T315I mutant variant of the target protein, BCR-ABL.

More than 40 patients have been enrolled in the trial to date at five medical centers in the United States. All CML patients have been previously treated with the currently available first- and second-generation targeted therapies for CML and, in most instances, other investigational agents as well. Pending further analysis of the results of this trial and discussions with regulatory authorities, ARIAD believes that it will be able to proceed to a registration trial of this product candidate in 2010.

Other Development Progress

In addition to the SUCCEED trial, ARIAD and its ridaforolimus partner, Merck & Co., Inc., are making steady progress in other clinical trials, including:

  • Complete enrollment in the Phase 2 clinical trial of oral ridaforolimus in combination with trastuzumab (Herceptin®) in patients with Her-2 positive, resistant and refractory metastatic breast cancer. Preliminary data from this study were announced earlier this quarter, and updated findings will be presented at the San Antonio Breast Cancer Symposium in December.
  • Continuing Phase 2 clinical trials of oral ridaforolimus in patients with advanced endometrial, prostate and non-small cell lung cancers.
  • Continuing enrollment in the Phase 1 study of MK-0646, Merck’s IGF-1R human monoclonal antibody, in combination with oral ridaforolimus.

Financial Highlights

For the quarter ended September 30, 2009, ARIAD reported a net loss of $20.8 million, or $0.21 per share, compared to a net loss of $20.0 million, or $0.29 per share, for the same period in 2008. For the nine-month period ended September 30, 2009, ARIAD reported a net loss of $62.0 million, or $0.70 per share, compared to a net loss of $54.3 million, or $0.78 per share for the nine-month period ended September 30, 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 ARIAD’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.

On August 7, 2009, ARIAD raised net proceeds of $35.6 million in an underwritten offering of 21.85 million shares of its common stock. The purchase price in this offering was $1.75 per share. This offering, along with ARIAD’s offering in February 2009, has resulted in a total of $58.4 million of funding raised this year to support its product development progress.

For the nine-month period ended September 30, 2009, cash used in operations was $36.0 million, compared to $36.4 million for the same period in 2008. ARIAD ended the third quarter of 2009 with cash, cash equivalents and marketable securities of $57.5 million, compared to $39.1 million at December 31, 2008.

Upcoming Medical Meetings

Clinical data will be presented at the following upcoming medical meetings:

  • American Society of Hematology annual meeting in New Orleans, LA, December 7, 2009 - Phase 1 clinical proof-of-concept data on AP24534.
  • San Antonio Breast Cancer Symposium, San Antonio, TX, December 11, 2009 - Phase 2 clinical data on ridaforolimus in combination with trastuzumab in patients with Her-2 positive metastatic breast cancer.

Upcoming Investor and Partnering Meetings

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

  • Lazard Capital Markets 6th Annual Healthcare Conference, New York, NY, November 17, 2009.
  • Windhover’s Therapeutic Area Partnerships Conference, Boston, MA, November 18, 2009
  • J.P. Morgan Annual Healthcare Conference, San Francisco, CA, January 11-14, 2010.

Today’s Conference Call Reminder

ARIAD will hold a live webcast of its quarterly conference call today, November 5, at 8:30 a.m. (EST). 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 866-783-2146 (domestic) or 857-350-1605 (international) five minutes prior to the start time and providing the pass code 97543712. 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 product candidate, AP24534, is an investigational multi-targeted kinase inhibitor in Phase 1 clinical development in patients with hematological cancers. 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 enrollment in, and timing of, the interim analyses of the SUCCEED trial, enrollment in other clinical trials of ridaforolimus, reporting of clinical proof-of-concept data for AP24534, and expectations related to the initiation of a registration trial for AP24534. 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 costs associated with our research, development, manufacturing and other activities, the conduct, timing and results of pre-clinical and clinical studies of our product candidates, the adequacy of our capital resources and the availability of additional funding, the timing, scope, cost and outcome of legal and patent office proceedings concerning our 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.

Herceptin® is a registered trademark of Genentech, Inc., a member of the Roche Group.


ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

     

In thousands, except share and per share
data

Three Months Ended
September 30,

Nine Months Ended
September 30,

2009

2008

2009

2008

(Unaudited)

(Unaudited)

License and collaboration revenue $ 2,155 $ 1,536 $ 6,148 $ 4,481
Operating expenses:
Research and development 14,384 13,365 47,939 36,067
General and administrative 3,472 8,255 12,412 23,431
Total operating expenses 17,856 21,620 60,351 59,498
Other income (expense), net (5,108 ) 91 (7,797 ) 747
Net loss $ (20,809 ) $ (19,993 )

 

$

(62,000 ) $ (54,270 )

Net loss per common share

$ (.21 ) $ (.29 )

 

$

(.70 ) $ (.78 )
 
Weighted average number of shares of

common stock outstanding

100,274,893 69,429,185 88,119,741 69,369,602

CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION

       
In thousands

September 30,
2009

December 31,
2008

 
(Unaudited)
Cash, cash equivalents and marketable securities $ 57,473 $ 39,068
Total assets $ 85,233 $ 68,188
Working capital $ 37,083 $ 14,174
Deferred revenue, total $ 113,616 $ 97,264
Total liabilities $ 157,542 $ 137,386
Stockholders’ deficit $ (72,309 ) $ (69,198 )

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION

       
In thousands

Nine Months Ended
September 30,

2009 2008
(Unaudited) (Unaudited)
Net cash used in operating activities $ (36,018 ) $ (36,386 )
Net cash provided by (used in) investing activities 11,588 (6,120 )
Net cash provided by financing activities 57,660 9,776
 
Net increase (decrease) in cash and cash equivalents $ 33,230 $ (32,730 )

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

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