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Alexion Pharmaceuticals Inc. (ALXN)
Q1 FY08 Earnings Call
April 30, 2008, 10:00 AM ET
Leonard Bell - CEO, Secretary, and Treasurer
David W. Keiser - President and COO
Vikas Sinha - Sr. VP and CFO
Stephen P. Squinto - EVP and Head of Research
David L. Hallal - Sr. VP, United States Commercial Operations
Thomas I.H. Dubin, J.D. - Sr. VP and General Counsel
Michael Aberman - Credit Suisse
Rachel McMinn - Cowen and Company
David Veal - Morgan Stanley
Meg Malloy - Goldman Sachs
John Sonnier - William Blair & Company
George Farmer - Wachovia Capital Markets Llc
Previous Statements by ALXN
» Alexion Pharmaceuticals Q4 2008 Earnings Call Transcript
» Alexion Pharmaceuticals Inc. Q3 2008 Earnings Conference Call Transcript
» Alexion Pharmaceuticals, Inc. Q2 2008 Earnings Call
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 - Chief Executive Officer, Secretary and Treasurer
Thank you, Operator. Good morning. Thank you for joining us on this morning’s conference call to discuss Alexion’s financial results and corporate developments for the first 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; Dr. Stephen Squinto, Executive Vice President and Head of R&D, Dave Hallal, Senior Vice President and Head of US Commercial Operations; and Thomas Dubin, Senior Vice President and General Counsel.
We also welcome the entire Alexion team here at our headquarters in Connecticut, at our manufacturing facility in Rhode Island, and in countries across Europe. After a review of the quarter, we will have time for several questions. 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
Yeah, 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 at Soliris and other products, reimbursement, price approval and funding processes in Europe, and completion and regulatory approval to manufacture at our Rhode Island manufacturing facility.
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 approval 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. The possibility that initial results of commercialization are not predictive of future rates of adoption. The risk that third parties won’t agree to license any necessary intellectual property to us on reasonable terms or that litigation maybe resolved adversely
The risk that third party payors will not reimburse for the use of Soliris at acceptable rates or at all, the risks of the 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-K for the quarter ended December 31, 2007. We do not intend to update any of these forward-looking statements to reflect events or circumstances after this call, except where duty arises under law. As a reminder for when we discuss non-GAAP results in this call, our non-GAAP results conform to GAAP in all respects except only for the exclusion of expense under section 123R.
Thank you, Lenny.
Leonard Bell - Chief Executive Officer, Secretary and Treasurer
Thanks very much Tom. The first quarter of 2008 was a landmark quarter for Alexion. As we announced the company’s first reporting period of profitability on a non-GAAP basis. We expect that this will represent an historic inflexion point for Alexion’s future operating performance. The introduction of Soliris has tested and proven our scientific, medical, commercial, and financial skills. The non-GAAP profitability is a key measure of our success so far, more importantly it strengthens our mission to bring the Soliris to patient with PNH and to expand the Soliris franchise for the potential treatment of patients with other rare diseases.
I would like to highlight four additional first quarter accomplishments. First, we continue to deliver the hope of Soliris to more patients in the United States and in Europe resulting in a 35% increase in net product sales compared to the fourth quarter. This reflects the growing awareness and strong demand among physicians and patients in marketed territories. Second, we lay the ground work, for expanding our global PNH business by achieving initial sales in more than 10 countries and completing enrollment in our Japanese registration study.
Third, we took important steps to begin to expand our Soliris franchise with developing milestones in Myasthenia gravis and kidney transplantation. Additionally, we have reversed our oncology platform with normal anti-CD200 antibody for patients with CLL. Fourth, we are paying these important commercial and product development accomplishments, while maintaining rigorous financial discipline.
I would like to discuss each of these areas in more detail, beginning with the ongoing success of the global Soliris launch. Net product sales of Soliris were $45.5 million in the first quarter compared to $33.9 million in the prior quarter, Q4 of 2007. This brings total Soliris net product sales in the first 12 months of commercial availability to $111 million. These results place Soliris among the most successful ultra orphan drug launches in both the United States and European markets.
In the first quarter and in line with our expectation substantial numbers of newly identified patients were added to our growing base of patients on Soliris treatment in both the United States and Europe. As in our earlier experience, we are finding that these newly identified patients represented the majority of patients started on therapy in Q1. We are particularly encouraged by a strong increase and performance of new patient additions in United States, which is partly related to the implementation our field force expansion towards the end of 2007.