0001157523-12-005833.txt : 20121107 0001157523-12-005833.hdr.sgml : 20121107 20121107074553 ACCESSION NUMBER: 0001157523-12-005833 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20121107 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: 20121107 DATE AS OF CHANGE: 20121107 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: 121184758 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 a50468859.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 7, 2012

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.

In a press release dated November 7, 2012, ARIAD Pharmaceuticals, Inc. (the “Company”) announced financial results for the third quarter and nine months ended September 30, 2012.  A copy of the press release is attached hereto as Exhibit 99.1.  The information under the headings “Financial Highlights from the Third Quarter of 2012” and “Today’s Conference Call Reminder” and the condensed consolidated financial information 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 November 7, 2012, the Company also provided information on upcoming medical and investor meetings.  The information set forth under the headings “Upcoming Medical Meeting” and “Upcoming Investor Meetings” 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 November 7, 2012, the Company also provided an update on its ponatinib and AP26113 programs.  The second paragraph of the press release and the information set forth under the headings “Ponatinib Clinical Development Progress,” “Ready for U.S. Commercialization of Ponatinib” and “Advancing AP26113 Through Clinical Development” together with the forward-looking statement disclaimer at the end of the press release, are 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 November 7, 2012.

 The press release contains hypertext links to information on our website.  The information on our website is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.

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.

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

Executive Vice President, Chief Financial Officer

 

Date:

November 7, 2012

3

EX-99.1 2 a50468859ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

ARIAD Reports Third Quarter 2012 Financial Results and Development Progress

~ Ponatinib Regulatory Filings Under Review in the U.S. and E.U.

~Ready for Commercialization of Ponatinib in the U.S.

~ AP26113 Advancing Following First Clinical Presentation

CAMBRIDGE, Mass.--(BUSINESS WIRE)--November 7, 2012--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter and nine months ended September 30, 2012 and provided an update on corporate developments.

“We are advancing the clinical development of ponatinib with the initiation of the global, Phase 3 EPIC trial in patients with newly diagnosed chronic myeloid leukemia (CML) and the start of a Phase 1/2 trial in Japan,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We also presented positive clinical proof-of-concept data on AP26113 and continue to advance its development. Importantly, we are now commercial-ready in the U.S. for the potential approval of ponatinib in the first quarter of 2013 and are building our infrastructure in Europe for anticipated ponatinib approval in the third quarter of next year.”

Ponatinib Clinical Development Progress

  • The U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) of ponatinib in patients with resistant or intolerant CML or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The FDA granted ARIAD’s request for Priority Review of ponatinib and established an action date of March 27, 2013 under the Prescription Drug User Fee Act (PDUFA). The Company anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013.
  • ARIAD also submitted a Marketing Authorization Application (MAA) for ponatinib to the European Medicines Agency (EMA). ARIAD is seeking marketing approval in the European Union of ponatinib in adult patients with resistant or intolerant CML or Ph+ ALL. The Committee for Medicinal Products for Human Use (CHMP) granted ARIAD’s request for accelerated assessment of the MAA, potentially decreasing the regulatory review time. ARIAD anticipates approval of ponatinib in the E.U. in the third quarter of 2013.
  • Approximately 100 patients with CML or Ph+ALL at 23 centers in the U.S. are now receiving ponatinib through an expanded access protocol. Forty of these patients are in the chronic-phase of the disease. Patients on this expanded access protocol could be eligible to transition to commercial use of ponatinib following its anticipated approval early next year. These U.S. patients are part of a broad, global expanded access program that includes more than 400 patients, some of whom are receiving ponatinib through compassionate-use programs.
  • ARIAD will present follow-up data from the pivotal Phase 2 PACE trial at the upcoming American Society of Hematology (ASH) Annual Meeting that will be held in Atlanta, GA, December 8 to 11, 2012. The ASH presentation will include 12 months of available response rate and duration of response data from the patients enrolled in the trial.
  • Patient enrollment is underway in the global, Phase 3 EPIC trial of ponatinib in patients with newly diagnosed CML. This trial compares ponatinib to imatinib and has a primary endpoint of major molecular response at 12 months. ARIAD anticipates full patient enrollment in the trial by end of 2013, and the study includes an interim analysis of the primary endpoint 12 months after half of the approximately 500 patients in the trial have been enrolled.

Ready for U.S. Commercialization of Ponatinib

  • ARIAD is commercially ready in the U.S. with all account executives now hired and trained. In addition to the account executives, the U.S. commercial team consists of regional business directors, corporate account managers, global marketing and distribution leaders, managed markets and payer reimbursement experts, with support from medical affairs and medical information personnel.
  • In Europe, ARIAD has made major strides in executing on its commercial plan with the initiation of early-access programs and implementation of pricing and reimbursement activities. The European supply chain has been established, and key hires for the European leadership team have been made. ARIAD is committed to being commercial-ready in Europe on July 1, 2013.

Advancing AP26113 Through Clinical Development

  • Dosing continues in the ongoing Phase 1/2 clinical trial of AP26113, ARIAD’s investigational dual inhibitor of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). AP26113 is now being administered at a once-daily oral dose of 300 mg. Clinical investigators are enrolling patients at seven sites in the U.S., and additional sites will be opened shortly in Europe. Patients with non-small cell lung cancer (NSCLC) are now exclusively being enrolled in the trial.
  • Phase 1 data presented at the recent European Society of Medical Oncology meeting provided compelling clinical evidence of the anti-tumor activity of AP26113 at multiple dose levels in patients with ALK-positive NSCLC and initial clinical evidence of anti-tumor activity in patients with EGFR-mutant NSCLC. Importantly, AP26113 showed activity in ALK-positive patients with brain metastases.
  • Planning is actively underway for pivotal trial(s) of AP26113 to start in 2013 in ALK-positive NSCLC patients. ARIAD will also plan to begin a pivotal trial in patients with EGFR-mutant NSCLC who have failed prior EGFR inhibitor therapy, dependent on the clinical findings from the Phase 2 portion of the currently ongoing Phase 1/2 trial.

Financial Highlights from the Third Quarter of 2012

Cash Position

At September 30, 2012, cash, cash equivalents and marketable securities totaled $206.7 million, compared to $306.3 million at December 31, 2011.

Net Income/Loss

Net loss for the quarter ended September 30, 2012, was $53.2 million, or $0.32 per share, compared to net income of $13.9 million, or $0.10 per share, for the same period in 2011. For the nine month period ended September 30, 2012, net loss was $160.4 million, or $0.98 per share, compared to a net loss of $71.8 million, or $0.55 per share, for the same period in 2011.

Research and development expenses increased by $19.1 million from the third quarter of 2011 to the third quarter of 2012 and by $54.0 million from the nine months ended September 30, 2011 to the nine months ended September 30, 2012 reflecting expansion of development activities for ponatinib and AP26113, including an increase in personnel expenses to support those activities.

General and administrative expenses increased by $8.2 million from the third quarter of 2011 to the third quarter of 2012 and by $20.7 million from the nine month ended September 30, 2011 to the nine months ended September 30, 2012 due to growth in commercial operations and supporting activities in anticipation of potential regulatory approval and commercial launch of ponatinib.

Our net loss for the nine months of 2012 also reflects a charge of $15.9 million, taken in the first quarter of 2012, related to the revaluation of our warrant liability, compared to a charge of $26.6 million for the nine months of 2011, due to the impact of increases in the market price of our common stock on the warrant liability during those periods. All warrants that remained outstanding at December 31, 2011 were exercised in the first quarter of 2012 for proceeds to the Company of $12.5 million.

Upcoming Medical Meeting

  • American Society of Hematology 54th Annual Meeting, Atlanta, GA, December 8 to 11, 2012.

Upcoming Investor Meetings

ARIAD management will be making corporate presentations at the following investor conferences:

  • Lazard Capital Market’s 9th Annual Healthcare Conference, New York, NY, November 13 to 14, 2012.
  • Deutsche Bank BioFEST, Boston, MA, December 3 to 4, 2012.
  • 31st Annual J.P. Morgan Healthcare Conference, San Francisco, CA, January 7 to 10, 2013.

Today’s Conference Call Reminder

ARIAD will hold a live webcast of its quarterly conference call today, November 7, 2012, 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://investor.ariad.com. The call can be accessed by dialing 800-435-1398 (domestic) or 617-614-4078 (international) five minutes prior to the start time and providing the pass code 56319418. 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 three weeks.

About ARIAD

ARIAD Pharmaceuticals, Inc. is an emerging global oncology company focused on the discovery, development and commercialization of medicines to transform the lives of cancer patients. ARIAD’s approach to structure-based drug design has led to several internally discovered, molecularly targeted product candidates for drug-resistant or difficult-to-treat cancers, including chronic myeloid leukemia and certain forms of non-small cell lung cancer. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).

This press release contains “forward-looking statements” including, but not limited to, updates on clinical, preclinical and regulatory developments and commercialization plans for our product candidates. 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, 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 per share data

Three Months Ended
September 30,

Nine Months Ended
September 30,

2012 2011 2012 2011
(Unaudited) (Unaudited)
Total revenue $ 85 $ 25,101 $ 484 $ 25,222
Operating expenses:
Research and development 38,822 19,692 107,021 53,020
General and administrative 14,482 6,329 37,994 17,334
Total operating expenses 53,304 26,021 145,015 70,354
Revaluation of warrant liability --- 14,846 (15,924 ) (26,629 )
Other 6 (16 ) 36 (40 )
Other income (expense), net 6 14,830 (15,888 ) (26,669 )
Net income (loss) $ (53,213 ) $ 13,910 $ (160,419 ) $ (71,801 )
Net income (loss) per common share:
-- basic $ (0.32 ) $ 0.10 $ (0.98 ) $ (0.55 )
-- diluted $ (0.32 ) $ 0.10 $ (0.98 ) $ (0.55 )
Weighted average number of shares of common stock outstanding:
-- basic 166,296 132,587 164,378 131,215
-- diluted 166,296 137,480 164,378 131,215
 

CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION

       
In thousands

September 30,
2012

December 31,
2011

(Unaudited)
Cash, cash equivalents and marketable securities $ 206,660 $ 306,256
Total assets $ 222,997 $ 320,712
Working capital $ 171,571 $ 282,195
Total liabilities $ 58,334 $ 100,571
Stockholders’ equity $ 164,663 $ 220,141
 

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION

         
In thousands

Nine Months Ended
September 30,

2012 2011
(Unaudited) (Unaudited)
Net cash used in operating activities $ (112,590 ) $ (30,598 )
Net cash used in investing activities (69,024 ) (1,710 )
Net cash provided by financing activities 16,977 14,995
 
Net decrease in cash and cash equivalents $ (164,637 ) $ (17,313 )

CONTACT:
ARIAD Pharmaceuticals, Inc.
For Investors
Kendra Adams, 617-503-7028
Kendra.adams@ariad.com
or
For Media
Liza Heapes, 617-621-2315
Liza.heapes@ariad.com