We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ariad Pharmaceuticals, Inc. | NASDAQ:ARIA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 23.99 | 23.80 | 22.88 | 0 | 01:00:00 |
~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
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 WARNINGWARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITYSee 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
In thousands, except per share dataThree Months EndedMarch 31,
2016 2015Revenue:
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 73,689Other 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 thousandsMarch 31,2016
December 31,2015
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 thousandsThree Months EndedMarch 31,
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)
(Unaudited)
In thousands, except per share dataThree Months EndedMarch 31,
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 EndedMarch 31,
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160510005888/en/
For InvestorsMaria Cantor, 617-621-2208Maria.cantor@ariad.comorFor MediaLiza Heapes, 617-621-2315Liza.heapes@ariad.com
1 Year Ariad Chart |
1 Month Ariad Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions