Alexion Pharmaceuticals, Inc. (ALXN)
Q4 2011 Earnings Call
February 9, 2012 10:00 am ET
Leonard Bell – Chief Executive Officer
Thomas Dubin – Senior Vice President and Chief Legal Officer
Vikas Sinha – Senior Vice President and Chief Financial Officer
David Hallal – Senior Vice President, Global Commercial Operations
Stephen Squinto – Executive Vice President and Head of Research & Development
Rachel McMinn – Bank of America-Merrill Lynch
Eric Schmidt – Cowen and Company
Geoff Meacham – JPMorgan
Yogesh Ahuja – Goldman Sachs & Co.
David Friedman – Morgan Stanley
Salveen Richter – Collins Stewart Llc
Geoffrey Porges – Sanford C. Bernstein & Co. LLC
Matt M. Roden – UBS Securities LLC
Brian Abrahams – Wells Fargo Securities
M Ian Somaiya – Piper Jaffray
Howard Liang – Leerink Swann Llc
Bret Holley – Oppenheimer & Co.
Previous Statements by ALXN
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I’d now like to introduce Dr. Leonard Bell. Please proceed, sir.
Thank you, Alisha. Good morning. Thank you for joining us on today’s call to discuss Alexion’s performance for the fourth quarter and full year 2011.
I’m joined by members of Alexion management, Steve Squinto, Executive Vice President and Head of R&D; Vikas Sinha, Senior Vice President and Chief Financial Officer; David Hallal, Senior Vice President, Global Commercial Operations; and Tom Dubin, Senior Vice President and Chief Legal Officer.
We also welcome our entire Alexion team working around the world including our new colleagues in Cambridge and Montreal who have joined us just this week from Enobia. Vikas, David, and Steve will join me on today's call to report on our financial, commercial, and R&D accomplishments in the fourth quarter and the year and to discuss our strategic initiatives and accelerated execution plans for 2011.
Before we begin, Tom will apprise you of our potential to make forward-looking statements. Tom?
Thanks, Lenny. During this 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 in the U.S. and other territories. Plans for development and clinical trials of Soliris, Asfotase Alfa in our other product candidates and operations, 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 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 patient populations in the disease studied or other diseases; the risks that third parties won’t agree to license any necessary intellectual property to us on reasonable terms or at all, the possibility that initial results of commercialization are not predictive of future results, the risk that third party payers 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 quarter ended September 30, 2011. We do not intend to update any of these forward-looking statements after this call, except when a duty arises under law.
I'd like to remind you that our reported non-GAAP numbers conform to U.S. GAAP except in three respects. First, our non-GAAP numbers exclude share-based compensation. Second, we exclude non-cash tax adjustments associated with utilization of our U.S. net operating losses, and third with completion of three recent acquisitions, we also exclude amortization of acquired intangible assets and costs associated with acquisitions. A reconciliation of our GAAP to non-GAAP results is included in the press release we issued this morning. Thanks, very much. Lenny?
Thanks, Tom. In the fourth quarter and full-year 2011 Alexion exceeded its objectives and significantly advanced our mission to provide life transforming therapies for patients with severe, ultra-rare and life-threatening disorders. Our continued progress expand three major growth initiatives. First, during Q4 we continued the strong Soliris growth trajectory, serving a substantial number of new patients with PNH, primarily in our core territories of United States, Western Europe and Japan.
Second, we significantly progress our mission to serve patients with aHUS. In late September, following FDA approval, we began to serve initial patients with aHUS in United States. And in November Soliris received European commission approval for patients with aHUS. With these regulatory steps now completed, we look forward to transforming the lives in the increasing number of patients with this life-threatening ultra-rare disorder in 2012 and beyond.
And third, as we expand our initiative to serve more patients with more disorders that are severe and ultra-rare, we have progressed our lead development programs, which now include four other highly innovative compounds in addition to Soliris. In all, our five novel compounds are currently being investigated across eight severe and ultra-rare disorders in addition to PNH and aHUS.
As we enter 2012, Alexion has the widest commercial operation and the deepest development pipeline in the company’s history. Importantly, as we expand our commercial and clinical initiatives, with a focus on sustainable long-term growth, we remain tightly focused in areas that we know well and do well.