Alexion Pharmaceuticals, Inc. (ALXN)

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Alexion Pharmaceuticals (ALXN)

Q3 2012 Earnings Call

October 24, 2012 10:00 am ET


Irving Adler - Senior Director of Corporate Communications

Leonard Bell - Co-Founder, Chief Executive Officer, Treasurer, Secretary 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, Head of Research & Development and Executive Vice President


Sara Slifka

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

Brian Corey Abrahams - Wells Fargo Securities, LLC, Research Division

Ying Huang - Barclays Capital, Research Division

Matthew Roden - UBS Investment Bank, Research Division

Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division

M. Ian Somaiya - Piper Jaffray Companies, Research Division

John S. Sonnier - William Blair & Company L.L.C., Research Division

Howard Liang - Leerink Swann LLC, Research Division

Robyn Karnauskas - Deutsche Bank AG, Research Division



Good day, everyone, and welcome to the Alexion Pharmaceuticals Third Quarter 2012 Conference Call. Today's conference is being recorded. And now, your host for today's call, the Executive Director for Corporate Communications, Mr. Irving Adler. Mr. Adler, please go ahead, sir.

Irving Adler

Thank you, operator, and good morning. Thank you for joining us on today's call to discuss Alexion's performance for the third quarter of 2012 and our outlook for the remainder of 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 R&D; 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 the call, we may make forward-looking statements such as expected financial results, medical benefits, regulatory milestones and commercial potential of Soliris, asfotase alfa and our other product candidates globally; plans for development and clinical trials of Soliris, asfotase alfa and our other product candidates; and operations, reimbursement, price approval and funding processes in different countries.

Forward-looking statements are subject to factors that may cause our results and plans to differ from those expected, including decisions of regulatory authorities regarding approval or limitations on the marketing of Soliris and our product candidates for various indications, the possibility that results of clinical trials are not predictive of the safety and efficacy of Soliris or our product candidates in broader populations in the disease studied or in other diseases, the possibility that initial results of commercialization are not predictive of future results, the risk that third-party payors will not or will not continue to reimburse for the use of Soliris at acceptable rates or at all, and a variety of other risks set forth from time to time in our filings with the SEC, including our 10-Q for the 3 months ended June 30, 2012. We do not intend to update any of these forward-looking statements after this call, except when a duty arises under law.

I'd also like to remind you that our reported non-GAAP operating results conform to our U.S. GAAP operating results except for certain adjustments that we 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?

Leonard Bell

Thank you, Irving. During the third quarter, we continued to successfully execute on our mission to develop and deliver life-transforming therapies for patients with severe and life-threatening, ultra-rare disorders.

In Q3, our growing global team continued to make significant progress across 3 key initiatives: first, we again provided Soliris with a substantial number of new patients with PNH, with a steady addition of new patients in Q3, similar to Q2; second, we continue to be encouraged by the steady quarter-on-quarter addition of new aHUS patients in the early stages of the U.S. launch; and finally, we are encouraged by the recent presentation of eculizumab clinical data in patients with severe and relapsing neuromyelitis optica or NMO.

Other development highlights of the quarter include important progress in our asfotase alfa and cPMP programs. Due to our solid performance in this past quarter, we announced this morning that we are increasing our revenue forecast and significantly increasing our earnings guidance, despite the ongoing macroeconomic headwinds, particularly in Europe.

Turning to the quarter, I'd like to start with our growing PNH operations in the United States. In Q3, as in prior quarters, our U.S. team helped to optimize patient care, as our growing presence among hematologists again resulted in a significant number of new patients starting on Soliris. As in prior quarters, the positive impact of our disease awareness programs and diagnostic initiatives resulted in more patients being tested for PNH, as well as more newly diagnosed patients with PNH being started on Soliris. These dynamics reflect the increasing understanding among physicians of the progressive life-threatening complications of PNH and the transformative clinical benefits of Soliris.

In our PNH operations beyond the United States in Q3, we again observed a steady addition of new patients in our core countries in Europe and Japan. Beyond these core territories, we continue to expand our global operations into emerging markets, most recently into Turkey and Brazil. As expected, following the small initial bolis of PNH patients in Turkey and Brazil in Q2, in Q3, and in line with our plans for continuing long-term growth, the rate of new patient additions in these countries returned to a more steady pace.

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