Ariad Pharmaceuticals (ARIA)
Q3 2012 Earnings Call
November 07, 2012 8:30 am ET
Maria E. Cantor - Senior Vice President of Corporate Affairs
Harvey J. Berger - Principal Founder, Chairman of the Board, Chief Executive Officer, President and Chairman of Executive Committee
Edward M. Fitzgerald - Chief Financial Officer, Principal Accounting Officer, Executive Vice President and Treasurer
Martin J. Duvall - Senior Vice President of Commercial Operations
Matthew Harrison - UBS Investment Bank, Research Division
Karen E. Jay - JP Morgan Chase & Co, Research Division
Philip Nadeau - Cowen and Company, LLC, Research Division
Howard Liang - Leerink Swann LLC, Research Division
Rachel L. McMinn - BofA Merrill Lynch, Research Division
Michael J. Yee - RBC Capital Markets, LLC, Research Division
Filippo Petti - William Blair & Company L.L.C., Research Division
Ying Huang - Barclays Capital, Research Division
Jim Birchenough - BMO Capital Markets U.S.
Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division
Ryan Martins - Lazard Capital Markets LLC, Research Division
Ling Wang - Summer Street Research Partners
Jonathan Eckard - Leerink Swann LLC, Research Division
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Maria E. Cantor
Good morning, everyone, and thank you for joining us. This morning, we report on financial results and corporate developments for the third quarter of 2012. Joining me this morning are Dr. Harvey Berger, our Chairman and Chief Executive Officer; Mr. Ed Fitzgerald, our Executive Vice President and Chief Financial Officer; and Mr. Marty Duvall, our Senior Vice President of Commercial Operations.
During this call, we'll be making forward-looking statements. These statements are subject to factors, risks and uncertainties, including those detailed in our Form 10-K for the year ended December 31, 2011, and other SEC filings that may cause actual results to differ materially from the results expressed or implied by such statements.
Now let me turn the call over to Dr. Berger for our opening remarks.
Harvey J. Berger
Thanks very much, Maria. I'll be very brief at the beginning. 2012 has been a very busy year for ARIAD, and the third quarter was no exception, as I think everyone's quite aware. The global Phase III EPIC trial of ponatinib in patients with newly diagnosed CML, as well as the Phase I/II trial of ponatinib in Japan are underway. As well positive clinical proof-of-concept data on 113 has been presented and we continue to advance its development. Importantly, we're now ready to commercialize ponatinib in the U.S. and we expect to be ready in Europe by the third quarter of next year. We have several updates to share with you this morning, but first, let me have Ed Fitzgerald run through our financial results for the quarter.
Edward M. Fitzgerald
Thank you, Harvey, and good morning, everyone. As noted in our press release this morning, our net loss for the third quarter was $53.2 million or $0.32 per share compared to net income of $13.9 million or $0.10 per share for the same period in 2011. Our R&D expenses increased by $19.1 million from the third quarter of 2011 to the third quarter of 2012, reflecting expansion of development activities for ponatinib and AP26113, including an increase in personnel and personnel-related expenses to support those activities. Our G&A expenses increased by $8.2 million from the third quarter of 2011 to the third quarter of 2012 due to growth in commercial operations and the supporting activities to prepare for potential regulatory approval and commercialization of ponatinib. Finally, as of September 30, 2012, we reported cash, cash equivalents and marketable securities of $206.7 million compared to $306.3 million at December 31, 2011.
Let me now turn the call back over to Harvey.
Harvey J. Berger
Thanks very much, Ed. Our focus this year has been on flawless execution throughout the company. We are transforming ARIAD from an innovative drug discovery and development enterprise into a fully integrated global oncology business. At our recent Investor and Analyst Day, we shared with you some of the processes and some of the steps that we've been taking, and I'm delighted to report on our progress in achieving these important goals.
So let's start with ponatinib. First, our NDA for ponatinib in patients with resistant or intolerant CML or Philadelphia-chromosome positive ALL has been accepted for filing by the FDA. Additionally, the FDA granted our request for priority review of ponatinib and has established an action date of March 27, 2013. As a reminder, we anticipate approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013.
Second, in Europe, we submitted an MAA, seeking marketing approval for ponatinib in patients with resistant or intolerant CML or Philadelphia-positive ALL. The CHMP granted our request for accelerated assessment of the MAA, potentially decreasing the regulatory review time for us. And we anticipate approval of ponatinib in the EU in the third quarter of 2013. Patient enrollment is underway in our global Phase III EPIC trial of ponatinib in patients with newly diagnosed CML. The EPIC trial compares ponatinib to the standard of imatinib and as a primary endpoint of major molecular response at 12 months. We anticipate full patient enrollment in the trial by the end of next year. The study includes an interim analysis of the primary endpoint, 12 months after half of the approximately 500 patients in the trial have been enrolled. Depending on the results of this interim analysis, it may allow us to file for regulatory approval of ponatinib in the newly diagnosed clinical indication approximately 6 months earlier than otherwise.