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Alexion Pharmaceuticals (ALXN)
Q1 2013 Earnings Call
April 25, 2013 10:00 am ET
Irving Adler - Executive Director of Corporate Communications
Leonard Bell - Co-Founder, Chief Executive Officer, Treasurer and Director
Vikas Sinha - Chief Financial Officer and Executive Vice President
David L. Hallal - Chief Commercial Officer and Executive Vice President
Stephen P. Squinto - Co-Founder, Chief Global Operations Officer and Executive Vice President
Eric Schmidt - Cowen and Company, LLC, Research Division
Rachel L. McMinn - BofA Merrill Lynch, Research Division
Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division
Salveen J. Richter - Canaccord Genuity, Research Division
David Friedman - Morgan Stanley, Research Division
Robyn Karnauskas - Deutsche Bank AG, Research Division
Shin Kang - Wells Fargo Securities, LLC, Research Division
Matthew Roden - UBS Investment Bank, Research Division
Terence C. Flynn - Goldman Sachs Group Inc., Research Division
Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division
Joshua Schimmer - Lazard Capital Markets LLC, Research Division
Stephen D. Willey - Stifel, Nicolaus & Co., Inc., Research Division
Good morning, and welcome to the Alexion Pharmaceuticals, Inc. First Quarter 2013 Results Conference Call. Today's call is being recorded.
Previous Statements by ALXN
» Alexion Pharmaceuticals' Management Presents at Barclays Global Healthcare Conference (Transcript)
» Alexion Pharmaceuticals' CEO Discusses Q4 2012 Results - Earnings Call Transcript
» Alexion Pharmaceuticals Management Discusses Q3 2012 Results - Earnings Call Transcript
Thank you, operator, and good morning. Thank you for joining us on today's call to discuss Alexion's performance for the first quarter of 2013 and our outlook for the year.
Today's call will be led by Dr. Leonard Bell, our Chief Executive Officer. Lenny will be joined by members of Alexion management: Dr. Steve Squinto, Executive Vice President and Head of Research and Development; Vikas Sinha, Executive Vice President and Chief Financial Officer; and David Hallal, Executive Vice President and Chief Commercial Officer.
Before we begin, I'd like to note that during this call, we will make forward-looking statements, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause our actual results to differ materially from these statements. A description of these risks can be found in our most recent 10-Q and 10-K reports on file with the SEC. Any forward-looking statements speak only as of today's date and we undertake no duty to update any of these statements after this call.
I'd also like to remind you that our reported non-GAAP operating results are adjusted from our U.S. GAAP operating results for certain adjustments that were described in our press release issued this morning. A reconciliation of our GAAP to non-GAAP results is included in the release. Thank you. Lenny?
Thank you, Irving. In the first quarter of 2013, Alexion maintained our strong momentum in our mission to develop and deliver life-transforming therapies for patients with severe and life-threatening disorders that are also ultra-rare. During the quarter, we also received a warning letter from the FDA, which I will briefly address later in my remarks. In his section of the call, Steve will provide a comprehensive review of the letter, our submitted response and our ongoing actions.
During Q1, we significantly progressed our 3 primary commercial and product development initiatives. First, our global rollout in PNH proceeded with a steady addition of new patients commencing Soliris therapy across our nearly 50-patient global commercial platform. Second, we continue to observe a steady addition of new patients with aHUS receiving Soliris therapy in the United States and have now started to increase our operations to serve an increasing number of patients in Western Europe. Third, Q1 was an especially noteworthy quarter across the breadth of our R&D pipeline.
I am pleased to announce that we completed enrollment in the multinational deceased donor kidney transplant trial ahead of schedule, recently agreed with regulators on conducting a single pivotal registration trial in myasthenia gravis, completed enrollment in the natural history study of hypophosphatasia in infants, initiated a retrospective clinical study of cPMP and MoCD and following positive discussions with regulators, are now also planning to initiate the first study with our newly manufactured synthetic cPMP.
Looking more closely at PNH, in Q1, a significant number of new patients, again, commenced Soliris therapy in our core territories in the United Estates, Western Europe and Japan, augmented by steady contributions from Turkey, Brazil and Russia and other countries across our global operations.
Turning to aHUS. In the United States, during Q1, we again observed a steady increase in the number of patients commencing Soliris therapy. Our aHUS performance in Q1 continued to reinforce our belief that over time, we have the opportunity to serve a similar or greater number of aHUS patients compared to PNH across our nearly 50-country platform.
In our aHUS operations in Western Europe, we continue to progress the reimbursement processes in key countries and anticipate additional commercial launches in the second half of this year. In England, the government has very recently clarified to Alexion and patient groups its process for providing access to Soliris for patients with aHUS. To begin, it will now fund Soliris for any newly arising case of aHUS. NHS England will subsequently develop our policies specific to aHUS, which in turn will be expected to be operative until the NICE recommendation.
Turning to our increased 2013 guidance. With continued strength in serving a growing number of patients with PNH globally, together with the newly increased visibility to serve additional aHUS patients in the latter part of this year, we announced today that we have raised our revenue and earnings forecast for the year.
I would now like to briefly discuss the warning letter from the FDA that we received in March regarding compliance with current GMPs for Soliris in our Rhode Island manufacturing facility. Earlier this month, we submitted our comprehensive response to the FDA. I would also remind you that in his section of the call, Steve will provide a comprehensive review of the letter, our submitted response and our ongoing actions.