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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 |
Conference Call Scheduled Today at 8:30 a.m. ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter of 2015, including revenue from sales of Iclusig® (ponatinib). The Company also provided an update on key corporate initiatives and clinical-trial plans.
“We are on track to achieve our product revenue guidance of $130 to $140 million for 2015, with important contributions coming from European and U.S. sales and anticipated successful resolution of pricing negotiations for Iclusig in France,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “Each of the major clinical initiatives – outlined at the beginning of 2015 as part of our three-year strategic operating plan – is progressing as projected. These include full patient enrollment in the ALTA pivotal trial of brigatinib, ongoing enrollment of patients in the dose-ranging OPTIC trial of Iclusig and anticipated initiation before year-end of the second-line trial of Iclusig. We expect that results from these randomized trials, if positive, will form the basis for expanded utilization of Iclusig and initial approval of brigatinib. We are also moving ahead with another randomized trial – a comparison of brigatinib and crizotinib in front-line non-small cell lung cancer – which we anticipate beginning in the first half of next year.”
2015 Third Quarter Financial Results
Revenues
Operating Expenses
Net Loss
Cash Position
Recent Progress and Key Objectives
Commercialization of Iclusig®
Iclusig Clinical Development
Brigatinib Clinical Development
Advancing the Pipeline
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our third quarter 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 55634805. 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 unaudited expected third quarter 2015 financial results; progress against our 2015 financial and business objectives, including our 2015 revenue guidance; the expected timing for recording revenue for cumulative shipments of Iclusig to patients in France; the therapeutic and commercial potential of Iclusig and our other product candidates, including brigatinib and AP32788; the expected timing for commencing and completing clinical trials and for clinical trial data presentations, regulatory filings, and commercial launches of our products and product candidates; and PDL’s obligation to pay us $50 million in July 2016, 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 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 ability to successfully commercialize and generate profits from sales of Iclusig or our other product candidates, including brigatinib, if approved; 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; the costs associated with our research, development, manufacturing and other activities; the conduct 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; 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 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 SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited)
In thousands, except per share dataThree Months EndedSeptember 30,
Nine Months EndedSeptember 30,
2015 2014 2015 2014 Revenue: Product revenue, net $ 27,543 $ 14,499 $ 79,262 $ 34,371 License and other revenue 1,527 183 3,038 4,206 Total revenue 29,070 14,682 82,300 38,577 Operating expenses: Cost of product revenue 483 594 1,666 4,277 Research and development 48,219 27,600 126,401 87,948 Selling, general and administrative 36,744 33,622 118,916 99,411 Total operating expenses 85,446 61,816 246,983 191,636 Other income (expense), net (4,917) (2,820 ) (11,930) (3,413) Benefit from (provision for) income taxes 5,842 (154 ) 5,328 (379)
Net loss $ (55,451) $ (50,108 ) $ (171,285) $ (156,851 ) Net loss per common share: -- basic and diluted $ (0.29) $ (0.27 ) $ (0.91) $ (0.84 ) Weighted-average number of shares of common stock outstanding: -- basic and diluted 188,921 187,034 188,456 186,703CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION(Unaudited)
In thousands
September 30,2015
December 31,2014
Cash and cash equivalents $ 282,187 $ 352,688 Total assets $ 576,139 $ 603,116 Total liabilities $ 625,789 $ 522,315 Stockholders’ equity (deficit) $ (49,650) $ 80,801CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION(Unaudited)
In thousands
Nine Months EndedSeptember 30,
2015 2014 Net cash used in operating activities $ (119,523) $ (131,930 ) Net cash provided by (used in) investing activities (4,446) (2,475) Net cash provided by financing activities 53,643 170,524 Effect of exchange rates on cash (175) 153 Net increase in cash and cash equivalents $ (70,501) $ 36,272
View source version on businesswire.com: http://www.businesswire.com/news/home/20151103005174/en/
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams, 617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes, 617-621-2315Liza.heapes@ariad.com
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