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Alexion Pharmaceuticals, Inc. (ALXN)
Q4 2012 Earnings Call
February 14, 2013 10:00 AM ET
Irving Adler – Executive Director, Corporate Communications
Lenny Bell – CEO
Vikas Sinha – EVP and CFO
David Hallal – EVP and Chief Commercial Officer
Steve Squinto – EVP and Head, Research and Development
Eric Schmidt – Cowen & Company
Rachel McMinn – Bank of America Merrill Lynch
Geoff Meacham – JPMorgan
Salveen Richter – Canaccord Genuity
David Friedman – Morgan Stanley
Brian Abraham – Wells Fargo Securities
Ying Huang – Barclays
Matth Roden – UBS
Robyn Karnauskas – Deutsche Bank
Terence Flynn – Goldman Sachs
Previous Statements by ALXN
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Thank you, operator. Good morning and thank you for joining us on today’s call to discuss Alexion’s performance for the fourth quarter and full year 2012 and our outlook for 2013.
Today’s call will be led by Dr. Leonard Bell, our Chief Executive Officer. Lenny will be joined by members of Alexion management – Dr. Steve Squinto, Executive Vice President and Head of R&D; Vikas Sinha, Executive Vice President and Chief Financial Officer; and David Hallal, Executive Vice President and Chief Commercial Officer.
Before we begin, I’d like to note that during the call we will make forward-looking statements, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause our actual results to differ materially from these statements.
A description of these risks can be found in our most recent 10-Q and 10-K reports on file with the SEC. Any forward-looking statements speak only as of today’s date, and we undertake no duty to update any of these statements after this call.
I’d also like to remind you that our reported non-GAAP operating results conform to our U.S. GAAP operating results except for certain adjustments that were described in our press release issued this morning. A reconciliation of our GAAP to non-GAAP results is included in the release.
Thank you. Lenny?
Thank you, Irving. In the fourth quarter, we continued the high level of execution that we had achieved throughout 2012 in our mission to develop and deliver therapies that transform the lives of patients whose disorders are severe, life-threatening and also ultra-rare.
During the quarter, we again reached key milestones across our three primary strategic growth initiatives. First, in Q4, our global rollout in PNH proceeded with a steady addition of patients commencing Soliris therapy. In 2013, deeper penetration in existing and new countries positions us to continue to strongly grow our PNH operations.
Second, we are very pleased with aHUS launch in the United States, as we continue to observe a steady addition of new patients during Q4. In 2013, we look forward to serving more patients with aHUS in the United States as well as beginning to serve patients in a growing number of countries in the Western Europe.
Third, during Q4, we continued to advance our lead development programs in severe and ultra-rare disorders with Soliris and four additional highly innovative therapeutics. Steve will highlight the significant 2013 news flow and our pipeline programs, including registration trial commencements, registration dossier submissions and key data publications.
Our accomplishments in 2012 position us for continued strong growth in 2013, as indicated by this morning’s guidance. In addition to our anticipated strong financial performance, we also expect 2013 to be pivotal year across both our commercial operations and development pipeline.
With our operations in place to serve patients in 50 countries, we expect increasing global leverage in 2013, 2014 and future years in PNH and also in aHUS. Beyond our current Soliris indications in PNH and aHUS, we except that development milestones in each of our pipeline programs in 2013 will lead to a series of regulatory approvals starting in 2014 resulting in product launches across this expanded global infrastructure.
Looking more closely at PNH. In Q4, a significant number of new patients again commenced Soliris therapy in our core territories of United States, Western Europe and Japan. This steady addition of new patients reflect the ongoing positive impact of our disease awareness programs and diagnostic initiatives, which continues to result in consistent identification of new patients with PNH.
I would now like to look beyond our core countries at several of the larger countries that are in the earlier stages of our global introduction of Soliris and PNH. In Q4, as expected from our last call, we, again, added PNH patients in Turkey and Brazil at a steady rate. We anticipate steady growth in these countries in 2013, 2014, and future years.
Turning to Russia, as a result of initial deployment of our field teams, Soliris treatment was initiated in a significant number of previously diagnosed PNH patients, who have been awaiting therapy with a onetime positive impact on our Q4 results. We now expect a steady rate of patient identification and treatment initiation in Russia throughout 2013, which should further increase in 2014.
We also expect initial contributions from Korea commencing later in 2013. Likewise, commencing later this year, we anticipate adding new patients with PNH in multiple countries in Latin America, growing further in 2014. As we build on our global platform, we remain acutely aware that on a global basis the majority of patients with PNH have not yet received an accurate diagnosis let alone commence appropriate treatment.