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): August
6, 2014
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
001-36172 |
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 August 6, 2014, ARIAD Pharmaceuticals, Inc.
(the “Company”) announced financial results for the second quarter ended
June 30, 2014 and provided an update on corporate developments. A copy
of the press release is attached hereto as Exhibit 99.1. The information
under the headings “2014 Second Quarter 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 August 6, 2014, the Company also provided
updated financial guidance and information regarding upcoming medical
and investor meetings. The information set forth under the headings
“Financial Guidance for 2014,” “Upcoming Medical Meeting” 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 August 6, 2014, the Company also provided an
update on its Iclusig® and AP26113 programs. The second
paragraph of the press release and the information set forth under the
heading “Recent Progress on 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 |
Description |
|
99.1 | Press release dated August 6, 2014. |
The press release contains hypertext links to information on our websites. The information on our websites 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 such item. The remaining portions of the press release dated August 6, 2014 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 Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall they 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: |
August 6, 2014 |
Exhibit 99.1
ARIAD Reports Second Quarter 2014 Financial Results and Development Progress
Conference Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--August 6, 2014--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the second quarter of 2014, including revenue from sales of Iclusig® (ponatinib). The Company also provided an update on corporate developments.
“We made steady progress in the second quarter on Iclusig sales in both the U.S. and Europe, and expect this momentum to build in the second half of the year,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We are also focused on initiating a new randomized dose-ranging trial for Iclusig aimed at further improving the benefit/risk profile of this approved medicine and accelerating patient enrollment in the ALTA clinical trial of AP26113 in patients with ALK-positive non-small cell lung cancer.”
2014 Second Quarter Financial Results
Revenues
Total revenue for the quarter ended June 30, 2014 was $12.1 million, which includes product revenue from sales of Iclusig and license revenue.
Net product revenues from sales of Iclusig were $11.9 million for the quarter ended June 30, 2014. Net product revenues for the quarter include Iclusig revenues of $7.9 million in the U.S. and $4.0 million in Europe. Net revenues reported exclude $3.6 million related to the following items:
Net Income/Loss
Net loss for the quarter ended June 30, 2014 was $56.9 million, or $0.30 per share, compared to net loss of $69.0 million, or $0.37 per share, for the same period in 2013.
Research and development expenses decreased by $8.9 million, or 22%, from the second quarter of 2013 to the second quarter of 2014, predominantly reflecting a decrease in clinical trial costs, as well as decreased manufacturing and other supporting costs related to Iclusig clinical trials, and decreased personnel and related costs reflecting the impact of the Company’s reduction in workforce effected in the fourth quarter of 2013. These decreases were offset, in part, by increases in clinical-trial and related costs for AP26113 due to the initiation of the pivotal Phase 2 ALTA trial.
Selling, general and administrative expenses decreased by $7.9 million, or 19%, from the second quarter of 2013 to the second quarter of 2014, reflecting a decrease in personnel expenses in the U.S. as a result of the reduction in workforce in the fourth quarter of 2013 and a decrease in expenses related to sales and marketing initiatives and other consulting services in support of the initial commercial launch of Iclusig in the U.S. in 2013. These decreases were offset, in part, by an increase in personnel and other expenses in Europe due to the launch of Iclusig in various European countries in the second half of 2013.
Cash Position
In June, the Company completed a private placement of convertible senior notes due 2019, resulting in $177.3 million in net proceeds to ARIAD, after expenses and the cost of related bond hedge and warrant transactions. Also in June, the Company paid off the remaining $8.0 million balance of its outstanding bank term loan.
As of June 30, 2014, cash and cash equivalents totaled $310.0 million, compared to $183.0 million at March 31, 2014.
Financial Guidance for 2014
We anticipate cash used in operations in 2014 to range from $165 million to $175 million, unchanged from prior guidance.
We now expect that our cash, cash equivalents and marketable securities at December 31, 2014 will range from $230 million to $235 million, sufficient to fund operations into the second half of 2016. This does not take into account any commercial agreements for Iclusig that may be entered into during this period.
Recent Progress on Key Objectives
Commercialization of Iclusig
Iclusig Clinical Development
Advancing AP26113
Upcoming Medical Meeting
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 first quarter 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 888-771-4371 (domestic) or 847-585-4405 (international) five minutes prior to the start time and providing the pass code 37600188. 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 Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
Important U.S. Safety Information for Iclusig® (ponatinib)
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
See full U.S. prescribing information for complete boxed warning
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.
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).
Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc.
This press release contains “forward-looking statements” including, but not limited to, updates on clinical and regulatory developments and commercialization plans for our products and product candidates and financial guidance for 2014. 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, difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; our ability to successfully commercialize and generate profits from sales of Iclusig; competition from alternative therapies, our reliance on the performance of third-party manufacturers and specialty pharmacies for the distribution of Iclusig; the occurrence of adverse safety events with our products and product candidates; our ability to meet anticipated clinical trial commencement and completion dates; delays in or failure of obtaining regulatory clearance for resumption of clinical trials; 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; the adequacy of our capital resources and the availability of additional funding; patent protection and third-party intellectual property claims; 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.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(Unaudited) |
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In thousands, except per share data |
Three Months Ended
June 30, |
Six Months Ended
June 30, |
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2014 | 2013 | 2014 | 2013 | |||||||||||||||||||||
Total revenue | $ | 12,114 | $ | 14,011 | $ | 23,895 | $ | 20,476 | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Cost of product revenue | 2,395 | 228 | 3,683 | 497 | ||||||||||||||||||||
Research and development | 31,794 | 40,668 | 60,348 | 81,931 | ||||||||||||||||||||
Selling, general and administrative | 34,199 | 42,101 | 65,790 | 71,583 | ||||||||||||||||||||
Total operating expenses | 68,388 | 82,997 | 129,821 | 154,011 | ||||||||||||||||||||
Other income (expense), net | (541 | ) | 87 | (592 | ) | 25 | ||||||||||||||||||
Provision for income taxes | 106 | 86 | 225 | 145 | ||||||||||||||||||||
Net loss | $ | (56,921 | ) | $ | (68,985 | ) | $ | (106,743 | ) | $ | (133,655 | ) | ||||||||||||
Net loss per common share: | ||||||||||||||||||||||||
-- basic and diluted | $ | (0.30 | ) | $ | (0.37 | ) | $ | (0.57 | ) | $ | (0.74 | ) | ||||||||||||
Weighted-average number of shares of common stock outstanding: | ||||||||||||||||||||||||
-- basic and diluted | 186,815 | 184,726 | 186,535 | 181,651 | ||||||||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION |
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(Unaudited) |
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In thousands |
June 30,
2014 |
December 31,
2013 |
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Cash and cash equivalents | $ | 310,039 | $ | 237,179 | ||||||
Total assets | $ | 492,810 | $ | 370,894 | ||||||
Total liabilities | $ | 370,046 | $ | 185,377 | ||||||
Stockholders’ equity | $ | 122,764 | $ | 185,517 | ||||||
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION |
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(Unaudited) |
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In thousands |
Six Months Ended
June 30, |
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2014 | 2013 | |||||||||
Net cash used in operating activities | $ | (95,016 |
) |
|
$ | (114,144 |
) |
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Net cash provided by (used in) investing activities | (2,010 | ) | 17,118 | |||||||
Net cash provided by (used in) financing activities | 169,885 | 309,563 | ||||||||
Effect of exchange rates on cash | 1 | (25 | ) | |||||||
Net increase in cash and cash equivalents | $ | 72,860 | $ | 212,512 |
CONTACT:
For Investors
Kendra Adams, 617-503-7028
Kendra.adams@ariad.com
or
For
Media
Liza Heapes, 617-621-2315
Liza.heapes@ariad.com