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.
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. |
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|
|
By: |
/s/ Edward M. Fitzgerald |
||
Edward M. Fitzgerald |
|||||
Executive Vice President, Chief Financial Officer |
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Date: |
November 7, 2012 |
3
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
Ready for U.S. Commercialization of Ponatinib
Advancing AP26113 Through Clinical Development
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
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following investor conferences:
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 |
Nine Months Ended |
||||||||||||
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, |
December 31, |
||||||
(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 |
||||||||||
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