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
23, 2016
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 February 23, 2016, ARIAD Pharmaceuticals, Inc. (the “Company”) announced financial results for the fourth quarter and full year ended December 31, 2015 and issued 2016 product revenue guidance. Additionally, the Company provided an update on corporate developments and key objectives for 2016. A copy of the press release is attached hereto as Exhibit 99.1. The information under the headings “2015 Fourth Quarter and Full-Year Financial Results,” “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 23, 2016, the Company also provided product revenue guidance for 2016, as well as upcoming investor meetings. The information set forth under the headings “2016 Product Revenue Guidance” 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 23, 2016, the Company also provided an update on its Iclusig®, brigatinib and pipeline programs. The second paragraph of the press release and the information set forth under the heading “Research and Development 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 |
Description |
|
99.1 | Press release dated February 23, 2016. |
The press release may contain 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 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. |
|||||
|
|
By: |
/s/ Edward M. Fitzgerald |
||
Edward M. Fitzgerald |
|||||
Executive Vice President, Chief Financial Officer |
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Date: |
February 23, 2016 |
Exhibit List.
Exhibit |
Description |
|
99.1 | Press release dated February 23, 2016. |
Exhibit 99.1
ARIAD Reports 2015 Financial Results, Provides 2016 Product Revenue Guidance and Outlines Company Progress
Iclusig Net Product Revenue Guidance for 2016 in the Range of $190 Million to $200 Million
Filing for U.S. Marketing Approval of Brigatinib Expected This Year
Conference Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 23, 2016--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the fourth quarter and full year ended December 31, 2015 and issued 2016 product revenue guidance. Additionally, the Company provided an update on corporate developments and key objectives for 2016.
”We had a strong fourth quarter of sales for Iclusig and 102 percent growth year over year,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “This is a very important year for ARIAD as we work to complete our ongoing review of strategic initiatives to deliver patient and shareholder value. In addition to maximizing top-line growth of Iclusig, a key event this year will be the presentation of pivotal, registration data on brigatinib at ASCO, along with our planned filing for marketing approval of brigatinib in the U.S.”
2015 Fourth Quarter and Full-Year Financial Results
Revenues
Net Loss
Quarter Ended December 31, 2015
Year Ended December 31, 2015
Cash Position
2016 Product Revenue Guidance
Research and Development Progress and Key Objectives
Iclusig Clinical Development
Brigatinib Clinical Development
Advancing the Pipeline
Upcoming Investor Meetings
ARIAD management will be participating 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 2015 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 888-311-8173 (domestic) or 330-863-3376 (international) five minutes prior to the start time and providing the pass code 38796876. 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.
Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for the:
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
See full 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).
Forward-Looking Statements
This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any statements contained herein which do not describe historical facts, including, but not limited to, statements regarding: our plans to complete our ongoing review of strategic initiatives to deliver patient and shareholder value; our efforts to maximize top-line growth of Iclusig; our plans to present pivotal, registration data on brigatinib at ASCO and file for marketing approval of brigatinib in the U.S.; the receipt of additional funding from PDL; our 2016 product revenue guidance and the assumptions used in developing that guidance; our plans for the OPTIC and OPTIC-2L clinical trials of Iclusig and expected regulatory approval in Japan; our plans to commence a front-line trial of brigatinib; and our plans to commence a Phase 1/2 clinical trial of AP32788, are forward-looking statements that 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 factors, risks and uncertainties include, but are not limited to, our ongoing strategic review, our ability to successfully commercialize and generate profits from sales of Iclusig and our product candidates, if approved; competition from alternative therapies; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for our products and product candidates and to move new development candidates into the clinic; our ability to execute on our key corporate initiatives; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; our reliance on the performance of third-party manufacturers and specialty pharmacies for the supply and distribution of our products and product candidates; the occurrence of adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing, commercialization and other activities; the conduct, timing and results of preclinical and clinical studies of our products and product candidates, including that preclinical data and early-stage clinical data may not be replicated in later-stage clinical studies; the adequacy of our capital resources and the availability of additional funding; the ability to satisfy our contractual obligations, including under our leases, convertible debt and royalty financing agreements; patent protection and third-party intellectual property claims; litigation; our operations in foreign countries; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) |
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In thousands, except per share data |
Three Months Ended
December 31, |
Twelve Months Ended
December 31, |
|||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Revenue: | |||||||||||||||
Product revenue, net | $ | 33,266 | $ | 21,349 | $ | 112,527 | $ | 55,720 | |||||||
License and other revenue | 3,239 |
|
45,486 | 6,277 |
|
49,692 | |||||||||
Total revenue | 36,505 | 66,835 | 118,804 | 105,412 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of product revenue | 449 | 947 | 2,114 | 5,224 | |||||||||||
Research and development | 44,814 | 32,645 | 171,216 | 120,593 | |||||||||||
Selling, general and administrative | 43,834 | 40,379 | 162,750 | 139,790 | |||||||||||
Total operating expenses | 89,097 | 73,971 | 336,080 | 265,607 | |||||||||||
Other income (expense), net | (5,344) | 1,636 | (17,274) | (1,777) | |||||||||||
Benefit from (provision for) income taxes | (1,935) | (251 | ) | 3,394 | (630 | ) | |||||||||
Net loss | $ | (59,871) | $ | (5,751 | ) | $ | (231,156) | $ | (162,602 | ) | |||||
Net loss per common share: | |||||||||||||||
-- basic and diluted | $ | (0.32) | $ | (0.03 | ) | $ | (1.23) | $ | (0.87 | ) | |||||
Weighted-average number of shares of common stock outstanding: | |||||||||||||||
-- basic and diluted | 189,299 | 187,226 | 188,669 | 186,835 | |||||||||||
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION (Unaudited) |
|||||||
In thousands |
December 31,
|
December 31,
|
|||||
Cash, cash equivalents and marketable securities | $ | 242,295 | $ | 352,688 | |||
Total assets | $ | 546,692 | $ | 603,116 | |||
Total liabilities | $ | 649,833 | $ | 522,315 | |||
Stockholders’ equity (deficit) | $ | (103,141) | $ | 80,801 | |||
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION (Unaudited) |
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|
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In thousands |
Twelve Months Ended |
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2015 | 2014 | ||||||
Net cash used in operating activities | $ | (159,245) | $ | (57,794) | |||
Net cash provided by (used in) investing activities | (17,205) | 1,981 | |||||
Net cash provided by financing activities | 54,257 | 171,060 | |||||
Effect of exchange rates on cash | 393 | 262 | |||||
Net increase (decrease) in cash and cash equivalents | $ | (121,800) | $ | 115,509 | |||
CONTACT:
For Investors
Maria Cantor, 617-621-2208
Maria.Cantor@ariad.com
or
For
Media
Liza Heapes, 617- 621-2315
Liza.heapes@ariad.com