Alexion Pharmaceuticals Inc. (ALXN)
Q2 2011 Earnings Call
July 21, 2011 10:00 am ET
Lenny Bell – CEO
Tom Dubin – SVP and Chief Legal Officer
Vikas Sinha – SVP and CFO
David Hallal – SVP, Global Commercial Operations
Steve Squinto – EVP and Head of Research & Development
Rachel McMinn – Bank of America-Merrill Lynch
David Friedman – Morgan Stanley
Eric Schmidt – Cowen & Company
Salveen Richter – Collins Stewart
Brian Abrahams – Wells Fargo Securities
Geoff Porges – Bernstein
Ian Somaiya – Piper Jaffray
Matt Roden – UBS
Howard Liang – Leerink Swann
Mark Monane – Needham & Company
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
» Alexion Pharmaceuticals, Inc. Q1 2008 Earnings Call Transcript
Thank you, operator. Good morning. Thank you for joining us on today’s call to discuss Alexion’s performance for the second quarter of 2011. I’m joined today by other 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 Alexion team working around the world. Vikas, David and Steve will join me on today’s call to report on our financial, commercial and clinical accomplishments in the second quarter and to discuss our strategic initiatives and accelerated execution plans for the remainder of 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 in PNH, aHUS, transplant and other indications in the U.S. and other territories, plans for clinical trials with Soliris in aHUS, transplant, STEC-HUS and other indications, as well as development plans for other products, 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 for various indications, 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 in other diseases, the risk that third parties won’t agree to license any necessary intellectual property to us on their 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 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 March 31, 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 US GAAP except in three respects. First, our non-GAAP number excludes share-based compensation. Second, we exclude non-cash tax expense associated with using our U.S. net operating losses. Third, with completion of two acquisitions during Q1, we now also exclude amortization of acquired intangible assets and costs associated with the acquisitions. A reconciliation of our GAAP and non-GAAP results are included in the press release we issued this morning. As a further reminder, earnings per share discussed in today’s call reflected two-for-one stock split effected during the second quarter. Thank you. Lenny?
Thank you, Tom. In the second quarter of 2011, Alexion made strong progress on our core clinical and commercial objectives on behalf of patients with severe life threatening and ultra rare disorders. We significantly advanced our key pipeline projects and achieved strong operating results.
On today’s call we would like to highlight four areas of our progress during the quarter. First, we grew our PNH operations robustly in Q2, as we again served an increasing number of new patients with PNH in the United States and Western Europe as well as in Japan.
Second, following the FDA decision during Q2 to grant priority review to our sBLA, we advanced our preparations for our potential US launch of Soliris in aHUS in the fourth quarter of this year.
Third, we progress key development programs with eculizumab and our other highly innovative compound and what is now the most robust pipeline in the Alexion history.
And fourth, during Q2, we played a significant leadership role in responding to the unprecedented STEC-HUS public health crisis in Germany. First, by providing access to eculizumab through one of the largest compassionate used programs ever conducted in a developed country. And more recently, in collaboration with the German regulatory authorities and leading physicians, we have commenced clinical study to evaluate eculizumab as a potential future treatment for patients with STEC-HUS.
To begin I’d like to briefly review our PNH operations in core territories. Q2 marks the start of the fifth year in which we have consistently provided the clinical benefits of Soliris to a growing number of patients each quarter in the United States and Western Europe, and now most recently in Japan. Since the US new launch of the Soliris in 2007, we have understood that majority of patients with PNH typically waited years before attending a correct diagnosis, and that’s where high risk from a progressive and life threatening manifestation of the disorder.