ARIAD Reports First Quarter 2013 Financial Results and Development Progress
$6.4 Million of Iclusig® (ponatinib) Net Sales in Launch Quarter
Conference Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May. 7, 2013-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the first quarter, including revenue from its first cancer medicine, Iclusig® (ponatinib), which was approved last December by the U.S. Food & Drug Administration. The Company also provided an update on corporate developments.
“Today, we report Iclusig revenues for the first time,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “The first quarter shows a very strong launch for Iclusig, which demonstrates early adoption of Iclusig in all lines of treatment for adult patients with CML or Ph+ALL that is resistant or intolerant to prior TKI therapy and impressive market penetration into both the community and academic physician settings. Our commercial team has shown that it can compete effectively in this market, and we will build on this momentum as we move forward through the year. Ensuring that Iclusig is available to all resistant or intolerant Ph+ leukemia adult patients in need of this new treatment option – independent of their ability to pay – is our priority.”
2013 First Quarter Financial Results
Net sales of Iclusig were $6.4 million for the quarter ended March 31, 2013.
We currently use the sell-through method for recognition of product revenues. As of March 31, 2013, we deferred revenue of $3.3 million in the U.S., representing Iclusig inventory at specialty pharmacies and distributors, which had not yet shipped to the end customer by the end of the quarter.
In addition, we shipped $2.1 million of Iclusig to patients in France through Autorisation Temporaire d’Utilisation (ATU), or Temporary Authorization for Use. Previously, in 2012, we also shipped $1.1 million of Iclusig to patients through the ATU. Shipments under the French ATU will be recorded as revenue when the list price in France is determined. We anticipate this determination to occur later this year.
Net loss for the quarter ended March 31, 2013 was $64.7 million, or $0.36 per share, compared to net loss of $55.9 million, or $0.35 per share, for the same period in 2012.
Research and development expenses increased by $12.5 million from the first quarter of 2012 to the first quarter of 2013, predominantly reflecting further expansion of clinical development and manufacturing activities for Iclusig and AP26113.
Selling, general and administrative expenses increased by $18.2 million from the first quarter of 2012 to the first quarter of 2013, reflecting investment in the commercial launch of Iclusig in the U.S., preparations for anticipated commercial launch of Iclusig in Europe and related activities.
As of March 31, 2013, cash, cash equivalents and marketable securities totaled $398.3 million, compared to $164.4 million at December 31, 2012. In January 2013, we raised net proceeds of $310 million in an underwritten public offering and sale of approximately 16.5 million shares of our common stock.
Recent Progress on Key Objectives
Global Commercialization of Iclusig
Broadening Iclusig Clinical Development
Advancing AP26113 Through Clinical Development
Upcoming Medical Meeting and Investor Briefing
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following investor conferences:
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 866-515-2914 (domestic) or 617-399-5128 (international) five minutes prior to the start time and providing the pass code 43738421. 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 indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.
Important Safety Information for Iclusig® (ponatinib)
WARNING: ARTERIAL THROMBOSIS and HEPATOTOXICITY
Arterial Thrombosis: Cardiovascular, cerebrovascular, and peripheral vascular thrombosis, including fatal myocardial infarction and stroke have occurred in Iclusig-treated patients. In clinical trials, serious arterial thrombosis occurred in eight percent of Iclusig-treated patients. Interrupt and consider discontinuation of Iclusig in patients who develop arterial thrombotic events.
Hepatotoxicity: Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Iclusig for hepatotoxicity.
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).
This press release contains “forward-looking statements” including, but not limited to, updates on clinical, preclinical and regulatory developments and commercialization plans for our product candidates and financial guidance for 2013. 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, our ability to successfully launch, commercialize and generate profits from sales of Iclusig; competition from alternative therapies, our ability to obtain approval for Iclusig outside of the United States and in additional indications; our reliance on third-party manufacturers, and on specialty pharmacies for the distribution of Iclusig; 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; difficulties or delays in obtaining regulatory approvals to market products; the adequacy of our capital resources and the availability of additional funding; patent protection and third-party intellectual property claims; our failure to comply with extensive regulatory requirements; the occurrence of serious adverse events in patients being treated with Iclusig or our product candidates; 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.
Source: ARIAD Pharmaceuticals, Inc.
Berry & Company Public Relations, LLC
57 E 11th Street
New York, NY 10003
T: 212 253-8881 F: 212 253-8241
MassBio Membership gives you:
Purchasing power-MassBio negotiates a broad-based collection of services on behalf of member companies and passes the savings on to its members.
Networking and professional development-MassBio organizes and executes numerous conferences, committee meetings, and networking events throughout the year.
MassBio Signature Events-Attend our Investors Forum, Innovator Roundtables, Pharma Days, our Golf Classic Fundraiser, Policy Leadership Breakfast, and many others.
Public policy & Advocacy-As the state's leading advocate for our life science super cluster, we fight for public policy initiatives and tax incentives in Massachusetts and Washington, D.C., that will enable biotechnology companies to do their best work.
Economic development-MassBio provides expert advice and guidance to help companies find suitable locations and resources as they move to and grow in the Bay State. We make Massachusetts a better place for your business.
Visibility/Resources-Members are listed on a searchable directory that includes a profile and link to the company's website. We highlight your company's latest news by posting to our MassBio member news page. In addition, members can post job openings on our website free!
Educational incentives-We promote education, workforce development and lifelong learning through the MassBioEd Foundation. The foundation customizes training programs for companies and educational institutions and promotes science in the classroom through BioTeach. MassBio members receive a discount on courses offered by the foundation.