Alexion Pharmaceuticals, Inc. (ALXN)
Q4 2008 Earnings Call
February 12, 2009 10:00 AM ET
Leonard Bell, M.D. - Chief Executive Officer, Secretary and Treasurer
Thomas I.H. Dubin, J.D. - Senior Vice President and General Counsel
Vikas Sinha, M.B.A., C.A. - Senior Vice President and Chief Financial Officer
David L. Hallal - Senior Vice President of Commercial Operations, Americas
Stephen P. Squinto, Ph.D. - Executive Vice President and Head of Research & Development
Rachel McMinn - Cowen and Company
Michael Aberman - Credit Suisse
Salveen Kochnover - Collins Stewart
David Friedman - Morgan Stanley
John Sonnier - William Blair
Stephen Willey - Thomas Weisel Partners
Lucy Lu - Citigroup
Eun Yang - Jefferies & Company
Mark Monane - Needham & Company
Previous Statements by ALXN
» Alexion Pharmaceuticals Inc. Q3 2008 Earnings Conference Call Transcript
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» Alexion Pharmaceuticals, Inc. Q1 2008 Earnings Call Transcript
Leonard Bell, M.D.
Thank you very much operator. Good morning. Thank you for joining us on today's call to discuss Alexion's performance for the fourth quarter of 2008.
I am joined by members of Alexion's management including Steve Squinto, Executive Vice President and Head of R&D; Vikas Sinha, Senior Vice President and Chief Financial Officer; David Hallal, Senior Vice President and Head of Commercial Operations for the Americas; and Tom Dubin, Senior Vice President and General Counsel.
We also welcome the entire global Alexion team working in United States, Europe, Japan and Australia. Before we begin now, Mr. Dubin, will apprise you our potential and make forward-looking statements. Tom?
Thomas I.H. Dubin, J.D.
Yeah thanks Lenny. During this call we may make forward-looking statements such as expected 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 approvals or limitations on the marketing of Soliris, the possibility of the results of clinical trials are not predictive of the safety and efficacy of Soliris in broader patient populations, in the disease study or other diseases, the possibility that initial results of commercialization are not predictive of future results, the risk that third party payers will not or not continue to reimburse for these and Soliris at acceptable rates 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 quarter ended December 30, 2008.
We do not intend to update any of these forward-looking statements after this call, except where a duty arises under law. Thanks. Lenny?
Leonard Bell, M.D.
Thanks, Tom. In 2008, at our first full year of commercial operation Alexion completed a transformation into a commercially successful global biopharmaceutical company with operations in United States and Europe an initial commercial presence now in Japan and a regional headquarters in Australia.
Underlying our expanding commercial operations is a growing research and development pipeline that is more robust than at anytime in the company's history. Vikas, David and Steve will join me on today's call, discussing some detail, our financial results, commercial initiatives and then pipeline programs as a review 2008 and look ahead to 2009.
In the fourth quarter, we again delivered strong results through execution of our commercial initiatives in United States and Europe with significant additions of new patients in both territories. We also continue to observe higher rates of retention and compliance among existing patients. Few commercial milestones is particular enabled us to achieve our fourth quarter and full year 2008 results and also pointing towards continued growth in 2009 and beyond.
First, in the United States during the fourth quarter we again saw an increasing impact from our PNH diagnostic initiatives. With a further increase in diagnostic testing and identification of newly diagnosed patients. Importantly in Q4 we observe that a meaningful proportion of patients newly started on Soliris were also newly diagnosed. This observation and others indicate that our diagnostic initiatives are positively influencing the entire cycle of care from a patient newly diagnosed with PNH to a patient newly started on Soliris.
Our U.S. commercial team is now rapidly expanding our diagnostic initiatives throughout the country and we expect these programs will have a continued and growing impact to optimize the treatment of patients with PNH.
Our second key milestone of 2008 was the successful completion of pricing and reimbursement processes for launch in the top 5 European markets of France, Germany, Italy, Spain and United Kingdom; the results of each of our European country teams having successfully explained the benefits of Soliris.
We appreciate that various European governments have recognize the value of Soliris for their citizens with this debilitating and life threatening disease.
During Q4 these core countries again contributed significant numbers of new patient starts. We expect patient growth in England to further increase beginning Q2 since as we have previously discussed the English government will began funding principally all eligible patients starting April.
Based upon individual country operations, we built a strong platform for healthy patients with PNH in each of the five largest EU countries. This year these teams are focusing their efforts on increasing patient identification through implementation of the diagnostic pathways while also generating demand in part through fully rolling out the new disease awareness initiatives describing the progressive and debilitating nature of PNH.