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ARIAD Reports Third Quarter 2014 Financial Results and Development ProgressCAMBRIDGE, Mass. --(Business Wire)-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter of 2014, including revenue from sales of Iclusig® (ponatinib). The Company also provided an update on corporate developments. "Our third quarter results show solid growth in U.S. sales of Iclusig and continued commercial progress in Europe," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "The EMA (News - Alert) has adopted its final opinion on Iclusig following the Article 20 review in Europe, leaving the Iclusig indications unchanged, and we are now focused on obtaining pricing and reimbursement in all key European markets. As we head into the end of the year, we are also finalizing the details of the new randomized dose-ranging trial for Iclusig aimed at further improving the benefit-risk profile of Iclusig and accelerating patient enrollment in the ALTA trial of AP26113 in patients with ALK+ non-small cell lung cancer, which we expect will be the basis for our initial registration of AP26113." 2014 Third Quarter Financial Results Revenues Total revenue for the quarter ended September 30, 2014 increased 21% to $14.7 million, versus the second quarter of 2014. Total revenue includes product revenue from sales of Iclusig and license revenue. Net product revenues from sales of Iclusig were $14.5 million for the quarter ended September 30, 2014, an increase of 22% from the second quarter of 2014. Net product revenues for the quarter include Iclusig revenues of $10.5 million in the U.S. and $4.0 million in Europe. Net revenues reported do not include $2.9 million related to deferred revenue of $1.2 million in the U.S., representing Iclusig inventory on hand at our specialty pharmacy as of September 30, 2014 and shipment of $1.7 million of Iclusig to patients in France during the quarter ($17.3 million cumulatively through September 30, 2014). We will record revenue related to cumulative shipments in France upon completion of pricing and reimbursement negotiations, net of any amounts that will be refunded to the French health authorities as a result of such negotiations, which we anticipate will be completed in mid-2015. Net Income/Loss Net loss for the quarter ended September 30, 2014 was $50.1 million, or $0.27 per share, compared to net loss of $66.3 million, or $0.36 per share, for the same period in 2013. Research and development expenses decreased by $17.5 million, or 39%, from the third quarter of 2013 to the third quarter of 2014, predominantly reflecting a decrease in clinical-trial costs, as well as decreased manufacturing and other supporting costs related to Iclusig clinical trials, and decreased personnel and related costs reflecting the impact of the Company's reduction in workforce effected in the fourth quarter of 2013. These decreases were offset, in part, by increases in clinical-trial and related costs for our investigational anaplastic lymphoma kinase positive (ALK+) inhibitor, AP26113, due to the initiation of the pivotal Phase 2 ALTA trial. Selling, general and administrative expenses decreased by $3.8 million, or 10%, from the third quarter of 2013 to the third quarter of 2014, reflecting a decrease in personnel expenses in the U.S. as a result of the reduction in workforce in the fourth quarter of 2013 and a decrease in expenses related to sales and marketing initiatives and other consulting services in support of the initial commercial launch of Iclusig in the U.S. in 2013. These decreases were offset, in part, by an increase in personnel and other expenses in Europe due to the launch of Iclusig in various European countries in the second half of 2013.
Cash Position As of September 30, 2014, cash and cash equivalents totaled $273.5 million, compared to $310.0 million at June 30, 2014. Financial Guidance for 2014 We now expect research and development expenses of $125 million to $130 million, compared to our previous guidance of $140 million to $150 million for 2014. The decrease in research and development spend is driven by the cost of clinical trials, manufacturing and other activities. We anticipate cash used in operations in 2014 will now range from $150 million to $155 million, compared to our previous guidance of $165 million to $175 million. As a result, we expect that our cash, cash equivalents and marketable securities at December 31, 2014 will range from $250 million to $255 million, sufficient to fund operations into the second half of 2016. This does not take into account any distributorship or partnership agreements that may be entered into during this period. Recent Progress on Key Objectives Commercialization of Iclusig
Iclusig Clinical Development
Advancing AP26113
Upcoming Medical Meeting
Upcoming Investor Meeting ARIAD management will be making corporate presentations at the following investor conference:
Today's Conference Call at 8:30 a.m. ET We will hold a live webcast and conference call of our first quarter 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 38094306. 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. Important U.S. Safety Information for Iclusig® (ponatinib) WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY See full U.S. 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 (News - Alert) (@ARIADPharm). Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc. This press release contains "forward-looking statements" including, but not limited to, updates on clinical and regulatory developments and commercialization plans for our products and product candidates and financial guidance for 2014. Forward-looking statements 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 risks and uncertainties include, but are not limited to, 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; 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; our ability to meet anticipated clinical trial commencement and completion dates; delays in or failure of obtaining regulatory clearance for resumption of clinical trials; 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 the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.
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