Alexion Pharmaceuticals, Inc. (ALXN)

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Alexion Pharmaceuticals, Inc. (ALXN)

Q3 FY08 Earnings Call

October 23, 2008, 10:00 AM ET


Leonard Bell, M.D. - CEO, Secretary, and Treasurer

Thomas I.H. Dubin, J.D. - Sr. VP and General Counsel

David W. Keiser - President and COO

Vikas Sinha - Sr. VP and CFO

Stephen P. Squinto, Ph.D. - EVP and Head of Research

David L. Hallal - Sr. VP, United States of Commercial Operations


Michael Aberman - Credit Suisse

Rachel McMinn - Cowen

Meg Malloy - Goldman Sachs

Katherine Kim - Banc of America Securities

Salveen Kochnover - Collins Stewart

John Sonnier - William Blair

Eun Yang - Jefferies & Company



Good day everyone and welcome to the Alexion Pharmaceuticals, Incorporated Third Quarter Financial Results Conference Call. Today's call is being recorded. At this time for opening remarks and introductions I would like to turn the call over to Dr. Leonard Bell. Please go ahead doctor.

Leonard Bell, M.D. - Chief Executive Officer, Secretary, and Treasurer

Thanks operator and good morning. Thank you for joining us on today's conference call to discuss Alexion's operating performance and financial results for the third quarter of 2008.

I am joined by members of Alexion's management including David Keiser, President and Chief Operating Officer; Vikas Sinha, Senior Vice President and Chief Financial Officer; Steve Squinto, Executive Vice President and Head of R&D; David Hallal, Senior Vice President and Head of U.S. Commercial Operations; and Tom Dubin, Senior Vice President and General Counsel.

We also welcome the entire and growing global Alexion team working in United States, Europe, Japan and Asia Pacific. Before we begin Mr. Dubin, will apprise you of our potential to make forward-looking statements. Tom?

Thomas I.H. Dubin, J.D. - Senior Vice President and General Counsel

Thanks Lenny. During this conference call we may make forward-looking statements, including statements related to expected 2008 financial results. Medical benefits and commercial potential of Soliris and PNH and other diseases, commercial and regulatory milestones for Soliris in different territories, commercialization strategies, diagnostic techniques, plans for clinical trials of Soliris and other products, and reimbursement, price approval, and funding processes in different territories.

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 marketing approvals or material limitations on the marketing of Soliris. The possibility that results of clinical trials are not predictive of the safety and efficacy of Soliris in broader patient populations, in the disease studied or other diseases.

The possibility that initial results of commercialization are not predictive of future results, the risk that third parties won't agree to license any necessary intellectual property to us on reasonable terms, the risk that third party payors will not or not continue to reimburse for the use of Soliris at acceptable rates at all, the risks that estimates regarding the number of people living with PNH are inaccurate and a variety of other risks set forth from time-to-time in our filings with the SEC, including our 10-Q for the quarter ended June 30, 2008.

We do not intend to update any of these forward-looking statements after this call, except when a duty arises under law. Thank you. Lenny?

Leonard Bell, M.D. - Chief Executive Officer, Secretary, and Treasurer

Thanks, Tom. In the third quarter of 2008, Alexion continued outstanding execution of our commercial initiative to again deliver robust results with Soliris in the United States and in Europe. Our performance was driven by the strong addition of new patients with PHN in existing markets, the expansion in their growing number of countries in Europe. At the same time during the quarter, our drug development groups advanced Alexion's research programs in three key areas. First, broadening the understanding of PNH and enhancing the critical value proposition of Soliris. Next, investigating the potential of Soliris as a life changing treatment for patients with other rare and severe disorders. And finally, advancing oncology program with our anti-CD200 antibody in patients with CLL.

Each quarter brings new stories of patients with PNH whose lives have been transformed by Soliris. Stories that continually renew our agreement to our objective that every patients with PNH who can benefit from Soliris will have access to Soliris. The growing number of successful patient experiences now stands more than six years. These include the transformation of a young English woman from a spiraling downward critical course of progressive blood clots, organ damage and severe disability too with Soliris have an active and normal life. Recently, a patient with PNH in United States who has been unable to work because of the severity of her disease, with no access to health insurance, the Alexion Complement Foundation responded to the patient's needs and provided Soliris to her free of charge. Her health improved rapidly, and so dramatically that she now holds a fulltime job with health coverage for herself and for her family.

Because PNH is an ultra rare disorder awareness of the disorder and the understanding of its natural history have been very limited. Further, accurate and early diagnosis is essential, especially in light of the progressive and serious nature of the disease. A growing number of U.S. physicians are implementing standardized diagnostic pathways for appropriate patients. Those with a greater likelihood of having PNH, including patients with aplastic anemia, myelodysplastic syndrome, and unexplained blood clots.

In Q3 as in Q2, we saw a strong uptake in the use of high quality diagnostic testing in the United States as these diagnostic pathways were more widely embraced by the oncology and hematology communities. In the United States during Q3 we observed that the number of new patients started on Soliris were similar to the number in Q1 and Q2 of this year. As in prior quarters most new patients started on drug in Q3 were newly identified to us during the quarter.

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