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): February
25, 2013
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 February 25, 2013, ARIAD Pharmaceuticals, Inc. (the “Company”) announced financial results for the fourth quarter and year ended December 31, 2012 and provided financial guidance for 2013, a summary of business highlights from 2012 and a summary of recent progress and key objectives for 2013. A copy of the press release is attached hereto as Exhibit 99.1. The information under the headings “2012 Fourth Quarter and Full-Year Financial Results” and “Today’s Conference Call at 8:30 a.m. ET” 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 February 25, 2013, the Company provided information regarding key objectives and financial guidance for 2013 as well as upcoming investor meetings. The information set forth under the headings “Financial Guidance for 2013” and “Upcoming Investor Meetings” in the press release are 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 February 25, 2013, 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 “Key Highlights from 2012” and “Recent Progress and Key Objectives” 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 February 25, 2013. |
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: |
February 25, 2013 |
3
Exhibit 99.1
ARIAD Reports 2012 Financial Results and Outlines Key Objectives for 2013
Commercial Oncology Company Established Following U.S. Approval of IclusigTM (ponatinib)
Conference Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 25, 2013--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the fourth quarter and full year ended December 31, 2012 and provided an update on corporate developments.
“Last year was clearly a landmark period for ARIAD as we transformed into a commercial oncology company,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We received U.S. approval of Iclusig™ (ponatinib), established a commercial organization in the U.S. and hired our European leadership team. We advanced the development of AP26113 and presented positive clinical proof-of-concept data showing the great promise of AP26113 as our next internally discovered tyrosine kinase inhibitor that overcomes drug resistance. We are now a sustainable, fully integrated global oncology company with the highly differentiated capability to discover, develop and deliver innovative cancer medicines.”
Key Highlights from 2012
Recent Progress and Key Objectives
Global Commercialization of Iclusig
Broadening Iclusig Clinical Development
Advancing AP26113 Through Clinical Development
2012 Fourth Quarter and Full-Year Financial Results
Net Income/Loss
Quarter Ended December 31, 2012
Net loss for the fourth quarter ended December 31, 2012 was $60.5 million, or $0.36 per share, compared to a net loss of $51.8 million, or $0.38 per share, for the same period in 2011. The increase in net loss is primarily due to an increase in operating expenses of $28.8 million, reflecting our preparations for commercial launch of Iclusig, including the hiring of sales personnel and other professional staff, as well as continued development of our product candidates, and a decrease of $20.1 million in the non-cash charge related to the revaluation of our warrant liability.
Year Ended December 31, 2012
Net loss for the full year 2012 was $220.9 million, or $1.34 per share, compared to a net loss of $123.6 million, or $0.93 per share, for the full year 2011.
These results show an increase in operating expenses of $103.5 million in 2012 as compared to 2011 reflecting ongoing development of our product candidates and planning and preparations for commercial launch of Iclusig. Our results also include a decrease of $30.8 million in the non-cash charge related to the revaluation of our warrant liability in 2012 as compared to 2011.
Cash Position
As of December 31, 2012, cash, cash equivalents and marketable securities totaled $164.4 million, compared to $306.3 million at December 31, 2011. Subsequently, in January 2013, we raised net proceeds of $310 million in an underwritten public offering and sale of approximately 16.5 million shares of our common stock.
Financial Guidance for 2013
We anticipate cash used in operations in 2013 to range from $255 million to $265 million. Our guidance includes:
We expect that our cash, cash equivalents and marketable securities at December 31, 2013 will range from $195 million to $205 million, sufficient to advance the Company’s programs into the fourth quarter of 2014.
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following investor conferences:
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our fourth quarter/year-end 2012 financial results this morning 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 866-831-6272 (domestic) or 617-213-8859 (international) five minutes prior to the start time and providing the pass code 59632303. 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 IclusigTM (ponatinib) tablets
Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.
Important Safety Information for IclusigTM (ponatinib)
WARNING: ARTERIAL THROMBOSIS and HEPATOTOXICITY
Arterial Thrombosis: Cardiovascular, cerebrovascular, and peripheral vascular thrombosis, including fatal myocardial infarction and stroke have occurred in Iclusig-treated patients. In clinical trials, serious arterial thrombosis occurred in eight percent of Iclusig-treated patients. Interrupt and consider discontinuation of Iclusig in patients who develop arterial thrombotic events.
Hepatotoxicity: Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Iclusig for hepatotoxicity.
Please visit www.iclusig.com for full prescribing information, including boxed warning.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. 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 and financial guidance for 2013. 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, our ability to successfully launch, commercialize and generate profits from sales of Iclusig; competition from alternative therapies, our ability to obtain approval for Iclusig outside of the United States and in additional indications; our reliance on third-party manufacturers, and on specialty pharmacies for the distribution of Iclusig; 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 and results of preclinical and clinical studies of our product candidates; difficulties or delays in obtaining regulatory approvals to market products; the adequacy of our capital resources and the availability of additional funding; patent protection and third-party intellectual property claims; our failure to comply with extensive regulatory requirements; the occurrence of serious adverse events in patients being treated with Iclusig or our product candidates; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk 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.
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ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES |
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Three Months Ended |
Year Ended |
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In thousands, except per share data |
December 31, |
December 31, |
||||||||||||||
2012 |
2011 |
2012 |
2011 |
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(Unaudited) |
(Unaudited) |
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Total revenue | $ | 74 | $ | 78 | $ | 558 | $ | 25,300 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 37,689 | 24,723 | 144,709 | 77,743 | ||||||||||||
General and administrative | 22,915 | 7,046 | 60,909 | 24,380 | ||||||||||||
Total operating expenses | 60,604 | 31,769 | 205,618 | 102,123 | ||||||||||||
Revaluation of warrant liability | --- | (20,086 | ) | (15,924 | ) | (46,715 | ) | |||||||||
Other | 77 | (25 | ) | 112 | (65 | ) | ||||||||||
Other income (expense), net | 77 | (20,111 | ) | (15,812 | ) | (46,780 | ) | |||||||||
Net income (loss) | $ | (60,453 | ) | $ | (51,802 | ) |
|
$ |
(220,872 | ) | $ | (123,603 | ) | |||
Net income (loss) per common share: | ||||||||||||||||
- basic | $ | (0.36 | ) | $ | (0.38 | ) | $ | (1.34 | ) | $ | (0.93 | ) | ||||
- diluted | $ | (0.36 | ) | $ | (0.38 | ) | $ | (1.34 | ) | $ | (0.93 | ) | ||||
Weighted average number of shares of
common stock outstanding: |
||||||||||||||||
- basic | 166,707 | 135,816 | 164,964 | 132,375 | ||||||||||||
- diluted | 166,707 | 135,816 | 164,964 | 132,375 | ||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION |
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In thousands | December 31, | December 31, | ||||
2012 | 2011 | |||||
Cash, cash equivalents and marketable securities | $ | 164,414 | $ | 306,256 | ||
Total assets | $ | 180,193 | $ | 320,712 | ||
Working capital | $ | 119,484 | $ | 282,195 | ||
Deferred revenue, total | $ | 769 | $ | 999 | ||
Total liabilities | $ | 67,342 | $ | 100,571 | ||
Stockholders’ equity | $ | 112,851 | $ | 220,141 | ||
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION |
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In thousands |
Year Ended December 31, |
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2012 | 2011 | ||||||||
Net cash used in operating activities | $ | (153,681 | ) | $ | (53,262 | ) | |||
Net cash used in investing activities | (50,400 | ) | (2,123 | ) | |||||
Net cash provided by financing activities | 17,204 | 258,001 | |||||||
Net increase (decrease) in cash and cash equivalents | $ | (186,877 | ) | $ | 202,626 | ||||
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