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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 first quarter of 2015, including revenue from sales of Iclusig® (ponatinib). The Company also provided an update on corporate developments.
“Iclusig demonstrated strong performance in both the U.S. and European markets during the first quarter driven by steady underlying demand,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We continue to expand the global commercial opportunity for Iclusig, most recently through additional marketing approvals in Israel and Canada. Additionally, we are on track to initiate three new randomized Iclusig clinical trials during 2015 and to achieve full patient enrollment in the brigatinib pivotal trial in the third quarter.”
2015 First Quarter Financial Results
Revenues
Net Loss
Cash Position
Recent Progress and Key Objectives
Commercialization of Iclusig®
Iclusig Clinical Development
Advancing Brigatinib
Upcoming Medical Meetings
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our first 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 888-771-4371 (domestic) or 847-585-4405 (international) five minutes prior to the start time and providing the pass code 39467029. 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 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 first quarter 2015 financial results; our progress against our 2015 financial and business objectives; 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; the expected timing for commencing and completing clinical trials and for clinical trial data presentations and regulatory filings for our products and product candidates; the expected timing for Iclusig’s commercial launch in Israel; and the duration of our U.S. composition-of-matter patent for brigatinib and the status of additional patent applications covering brigatinib, 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 for our products and product candidates and to move new development candidates into the clinic; our ability to secure a partnership for AP26113; 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, 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; 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 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 data Three Months EndedMarch 31,
2015 2014 Revenue: Product revenue, net $ 23,901 $ 7,992 License and other revenue 90 3,790 Total revenue 23,991 11,782 Operating expenses: Cost of product revenue 695 1,288 Research and development 39,444 28,554 Selling, general and administrative 33,550 31,591 Total operating expenses 73,689 61,433 Other income (expense), net (2,764 ) (52 ) Provision for income taxes 214 119 Net loss $ (52,676 ) $ (49,822)
Net loss per common share: -- basic and diluted $ (0.28 ) $ (0.27
)
Weighted-average number of shares of common stock outstanding:
-- basic and diluted 187,837 186,252CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
In thousands March 31,2015
December 31,2014
Cash and cash equivalents $ 304,016 $ 352,688 Total assets $ 580,451 $ 603,870 Total liabilities $ 542,388 $ 523,069 Stockholders’ equity $ 38,063 $ 80,801CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION
In thousands Three Months EndedMarch 31,
2015 2014 Net cash used in operating activities $ (50,194) $ (52,409 ) Net cash used in investing activities (754) (1,706) Net cash provided by (used in) financing activities 2,051 (90) Effect of exchange rates on cash 225 (1) Net decrease in cash and cash equivalents $ (48,672) $ (54,206)
ARIAD Pharmaceuticals, Inc.For InvestorsKendra Adams, 617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes, 617-621-2315Liza.heapes@ariad.com
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