Alexion Pharmaceuticals, Inc. (ALXN)

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Alexion Pharmaceuticals, Inc. (ALXN)

Q2 FY08 Earnings Call

July 29, 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, M.B.A., C.A. - Sr. VP and CFO


Michael Aberman - Credit Suisse

Rachel McMinn - Cowen and Company

Sapna Srivasatava - Morgan Stanley

Meg Malloy - Goldman Sachs

Salveen Kochnover - Collins Stewart

Eun Yang - Jefferies and Company



Good day and welcome everyone to the Alexion Pharmaceuticals, Inc. Second 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, sir.

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

Thank you, operator. Good morning. Thank you for joining us on today's conference call to discuss Alexion's financial results and corporate developments for the second quarter of 2008. I am joined by members of Alexion management, including David Keiser, President and Chief Operating Officer; Vikas Sinha, Senior Vice President and Chief Financial Officer; Dave 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 Alexion team working at our headquarters and those in Connecticut, our manufacturing facility in Rhode Island, our field teams across the United States and our local operations in the field in countries across Europe. After a review of Alexion's second quarter performance, we will have time for several questions. Before we begin, Mr. Dubin will apprize you of our potential to make forward-looking statements. Tom?

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

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

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 reimburse for the use of Soliris at acceptable rates or at all, the risk 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 period ended March 31, 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. During the second quarter of 2008, we marked the first anniversary of the launch of Soliris. This has truly been a remarkable period for patients living with a rare debilitating and life-threatening disease PNH. On this call, I will focus my discussion on three areas of accomplishment in the second quarter.

First, we provided a life changing clinical benefit of Soliris to an increasing number of patients with in the United States and in a growing number of European countries. In all territories, newly identified PNH patients represented the majority of patients who began Soliris therapy in the quarter.

Second, we made notable progress in our development programs to expand the use of our first-in-class complement inhibitor Soliris to provide much needed treatments for patients with other rare, severe and life threatening disorders in hematology, translocation and neurology.

And third, we have broadened our product pipeline with important strives in our lead oncology program, with the initial dosing our novel anti-CD200 antibody in patients with chronic lymphocytic leukemia or CLL.

PNH is a devastating disease in which one-third of patients die within five years of diagnosis. Prior to Soliris, physicians had little to offer their PNH patients beyond supportive care with blood transfusion, and in a limited number of cases high risk bone marrow transplant.

In addition to the risk of death, the chronic hemolysis of PNH often resulted in years of severe morbidity, including repeated life threatening blood clots, organ damage and failure, severe pain and developing fatigue. The introduction of Soliris provides a safe and effective means to reduce hemolysis, their primary manifestation of PNH. Indeed, Soliris has transformed the life of patients affected with this rare disease.

Of course, after only one year, our work on behalf of patients with PNH is still just beginning, both in the countries where Soliris is currently available, and on an increasingly global basis.

Reviewing our progress by territory, the number of new patient starts in the U.S. in Q2 were similar to our experience in Q1, a steady rate of growth that reflects the patient-centered efforts of our team of professional representative across the country. In order to help more patients with PNH optimal care, as with other rare diseases, requires accurate and efficient patient diagnosis.

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