Alexion Pharmaceuticals, Inc. (ALXN)
Q2 2012 Earnings Call
July 25, 2012 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 and Development
Geoff Meacham – JP Morgan
Rachel McMinn – Bank of America/Merrill Lynch
Eric Schmidt – Cowen & Company
David Friedman – Morgan Stanley
Shane – Wells Fargo
Salveen Richter – Canaccord
Geoffrey Porges – Bernstein
Navdeep Singh – Deutsche Bank
Ying Huang – Barclays
Ian Somaiya – Piper Jaffray
Matt Roden – UBS
Howard Liang – Leerink Swann
Chris Raymond – Robert Baird
Good day, ladies and gentlemen, and welcome to the Second Quarter 2012 Alexion Pharmaceuticals Earnings Conference Call.
I would now like to turn the presentation over to your host for today, Dr. Bell. Please proceed, sir.
Thank you, operator, and good morning. Thank you for joining us on today’s call to discuss Alexion’s performance for the second quarter of 2012.
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With me on the call this morning are 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.
Vikas, David and Steve will join me on today’s call to report on our progress in the second quarter, and to provide an update on our outlook for the second half of this year.
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 globally; plans for development and clinical trials of Soliris, asfotase alfa and our other product candidates; and operations reimbursement, price approval and funding processes in different countries.
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 from 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 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 three months March 31, 2012.
We do not intend to update any of these forward-looking statements after this call, except when the 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 numbers exclude share-based compensation. Second, we adjust for tax items associated with utilization of our US net operating losses and the Q2 tax expense related to acquisition structuring. And third, we also exclude costs associated with acquisitions. A reconciliation of our GAAP to non-GAAP results is included in the press release we issued this morning.
Thank you. Lenny?
Thank you very much, Tom. During the second quarter, we made steady progress across our strategic objectives for the year, as we continue to expand our initiatives to develop and deliver life-transforming therapies for patients with severe and ultra-rare disorders.
Our development and commercial teams performed solidly in three key areas during the quarter. First, we again provided Soliris to a substantial number of new patients with PNH. Second, we are very pleased with the ongoing launch in aHUS as we continue to serve an increasing number of patients with Soliris. And finally, we continue to advance our eight lead development programs, comprising the most robust pipeline in our company’s history.
I’d like to start with a review of our operations in the United States. With regard to aHUS during Q2, we made significant progress in serving an increasing number of patients. Our field team continued to expand our aHUS disease education programs to both hematologists and nephrologists, resulting in a meaningful increase in the number of aHUS patients who initiated treatment with Soliris.
Although we expect the uptake of Soliris in aHUS to continue to be limited by the relatively low prevalence to the disease, we are nonetheless encouraged by the progress that we are making as we identify and serve an increasing number children and adults with this severe and life-threatening disorder.
Turning to PNH. Our expanded presence among hematologists again resulted in a growing positive impact on patient care. We continued to observe that as more patients are being tested, those who are diagnosed with PNH are also starting on Soliris rapidly, reflecting their physician’s understanding of the life-threatening severity of PNH and the role of Soliris to transform their patient’s lives. In our PNH operations beyond the United States, our quarter-on-quarter growth reflects the addition of a steady number of new Soliris patients with PNH in our core country Southern Europe, as well as in Japan.
Looking beyond these core territories, and as noted in previous calls, we have been building our operations in two additional major countries, Turkey and Brazil. As a result of initial deployment of our field teams, during Q2 Soliris treatment was initiated in a significant number of previously diagnosed PNH patients who had been awaiting therapy with a subsequent one-time positive impact on our results.