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): May
10, 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 May 10, 2016, ARIAD Pharmaceuticals, Inc. (the “Company”) announced financial results for the first quarter ended March 31, 2016, issued 2016 financial guidance, and provided an update on corporate developments and its ongoing strategic review. A copy of the press release is attached hereto as Exhibit 99.1. The information under the headings “2016 First Quarter Financial Results” (other than the information under “2016 Financial Guidance”), “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 May 10, 2016, the Company also provided 2016 financial guidance, as well as information on upcoming meetings. The information set forth under the headings “2016 Financial Guidance” and “Upcoming 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 May 10, 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 “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 |
Description |
|
99.1 | Press release dated May 10, 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/ Manmeet S. Soni |
||
Manmeet S. Soni |
|||||
Executive Vice President, Chief Financial Officer |
|||||
Date: |
May 10, 2016 |
Exhibit List.
Exhibit |
Description |
99.1 |
Press release dated May 10, 2016 |
4
Exhibit 99.1
ARIAD Reports First Quarter 2016 Financial Results and Progress on Strategic Review
~Recorded Net Product Revenue of $33.6 million for the first quarter of 2016; growth of 41% from prior year
~Provides guidance for 2016, including strengthened year-end cash position, following announced Incyte transaction:
~Conference Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 10, 2016--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the first quarter of 2016, including revenue from sales of Iclusig® (ponatinib). The Company also provided an update on corporate developments and its ongoing strategic review and provided financial guidance following its announced transaction with Incyte Corporation.
“Iclusig demonstrated strong performance in both the U.S. and European markets during the first quarter of 2016 compared to the prior year period, primarily driven by increasing demand and new patient growth,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “Following our major announcement yesterday with Incyte regarding our agreement to divest our European operations and license the commercial rights to Iclusig in Europe, we are on track to complete our strategic review this quarter aimed at delivering patient and shareholder value. We also look forward to the presentation of pivotal, registration data on brigatinib at ASCO, along with our planned filing for marketing approval of brigatinib in the U.S. in the third quarter of this year.”
2016 First Quarter Financial Results
Revenues
GAAP and Non-GAAP Net Loss
GAAP net loss for the quarter ended March 31, 2016 was $53.8 million, or $0.28 loss per share, compared to GAAP net loss of $52.7 million, or $0.28 loss per share, for the quarter ended March 31, 2015.
Non-GAAP net loss for the quarter ended March 31, 2016 was $44.1 million, or $0.23 loss per share, compared to non-GAAP net loss of $44.2 million, or $0.24 per share for the quarter ended March 31, 2015.
Non-GAAP net loss excludes stock-based compensation and restructuring charges. See “Use of Non-GAAP Financial Measures” below for a description of non-GAAP financial measures and the reconciliation between GAAP and non-GAAP measures at the end of this press release.
Operating Expenses
Cash Position
2016 Financial Guidance
This new 2016 expense guidance reflects an expected reduction in expenses of approximately $30 million from the planned divesture of our European business to Incyte.
Recent Progress and Key Objectives
Iclusig Clinical Development
Brigatinib Clinical Development
Advancing the Pipeline
AP32788 targets tumors driven by EGFR or HER2 kinases and was designed to achieve selective inhibition of exon 20 mutations in these kinases. ARIAD estimates that there are approximately 6,000 patients in the United States living with EGFR exon 20 or HER2 point mutations.
Upcoming Meetings
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our first quarter 2016 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 84030796. 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:
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 orphan 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 orphan 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).
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including costs and expenses and other expenses adjusted to exclude certain cash and non-cash expenses. These measures are not in accordance with, or an alternative to, generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures used by other companies. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are: (i) employee-related non-cash expenses, including stock-based compensation expense, which may fluctuate from period to period based on factors including the timing and accounting of grants for stock options, restricted stock units and performance- based stock units and changes in the Company’s stock price which impacts the fair value of these awards, and (ii) restructuring charge expenses associated with employee workforce reductions. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to our financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of our ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating operational performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.
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 the statements related to our financial and operational guidance, the closing of our transaction with Incyte, including the anticipated benefits of the transaction and impact on our results of operations and financial position, our proposed presentation of clinical data from the Phase 2 ALTA trial of brigatinib at ASCO in June 2016, the expected timing for filing of approval for brigatinib in the U.S., and the clinical development plans for our product candidates, along with the statements made by our Chief Executive Officer, 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 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(Unaudited) |
||||||||
In thousands, except per share data |
Three Months Ended |
|||||||
2016 | 2015 | |||||||
Revenue: |
||||||||
Product revenue, net | $ | 33,633 | $ | 23,901 | ||||
License and other revenue | 1,964 | 90 | ||||||
Total revenue | 35,597 | 23,991 | ||||||
Operating expenses: | ||||||||
Cost of product revenue | 486 | 695 | ||||||
Research and development | 44,079 | 39,444 | ||||||
Selling, general and administrative | 35,977 | 33,550 | ||||||
Restructuring charges | 2,918 | --- | ||||||
Total operating expenses | 83,460 | 73,689 |
|
|||||
Other expense, net | (5,672) | (2,764) | ||||||
Provision for income taxes | 252 | 214 | ||||||
Net loss | $ | (53,787 | ) | $ | (52,676 | ) | ||
Net loss per common share: | ||||||||
-- basic and diluted | $ | (0.28) | $ | (0.28 | ) | |||
Weighted-average number of shares of common stock outstanding: | ||||||||
-- basic and diluted | 190,304 | 187,837 | ||||||
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION |
||||||||
(Unaudited) |
||||||||
In thousands |
March 31, |
December 31, |
||||||
Cash, cash equivalents and marketable securities | $ | 168,348 | $ | 242,295 | ||||
Total assets | $ | 502,549 | $ | 546,692 | ||||
Total liabilities | $ | 656,561 | $ | 649,833 | ||||
Stockholders’ deficit | $ | (154,012) | $ | (103,141) | ||||
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION |
|||||||||
(Unaudited) |
|||||||||
In thousands |
Three Months Ended |
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2016 | 2015 | ||||||||
Net cash used in operating activities | $ | (65,095) | $ | (50,194 | ) | ||||
Net cash used in investing activities | (15,300) | (754) | |||||||
Net cash provided by financing activities | 10,478 | 2,051 | |||||||
Effect of exchange rates on cash | (44) | 225 | |||||||
Net decrease in cash and cash equivalents | $ | (69,961) | $ | (48,672) | |||||
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1) |
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(Unaudited) |
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In thousands, except per share data |
Three Months Ended |
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2016 | 2015 | ||||||||||||||||
Reconciliation of GAAP to non-GAAP Net loss: | |||||||||||||||||
GAAP Net loss | $ | (53,787) | $ | (52,676) | |||||||||||||
Add: Stock-based compensation (2) | 6,719 | 8,434 | |||||||||||||||
Add: Restructuring charges (3) | 2,918 | - | |||||||||||||||
Non-GAAP Net loss | $ | (44,150) | $ | (44,242) |
Three Months Ended |
||||||
2016 | 2015 | |||||
Reconciliation of GAAP to non-GAAP Net loss per share: | ||||||
GAAP Net loss per share | $ | (0.28) | $ | (0.28) | ||
Add: Stock-based compensation (2) | 0.03 | 0.04 | ||||
Add: Restructuring charges (3) | 0.02 | - | ||||
Non-GAAP Net loss per share | $ | (0.23) | $ | (0.24) |
(1) This presentation includes non-GAAP measures. The Company’s non-GAAP measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read only in conjunction with its financial statements prepared in accordance with GAAP.
(2) All stock-based compensation expenses were excluded for the non-GAAP analysis.
(3) Restructuring charges associated with employee workforce reductions were excluded for the non-GAAP analysis.
CONTACT:
For Investors
Maria Cantor, 617-621-2208
Maria.cantor@ariad.com
or
For
Media
Liza Heapes, 617-621-2315
Liza.heapes@ariad.com