10/29/2020

speaker
Operator

Ladies and gentlemen, thank you for standing by, and welcome to Alexion Pharmaceuticals' third quarter 2020 results conference call. At this time, all participant lines are in listen-only mode, so if you require operator assistance, please press star, then zero. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star, then one. Please be advised that today's conference may be recorded. I'd now like to hand the conference over to your host today, Mr. Chris Devo, Head of Investor Relations. Please go ahead.

speaker
Chris Devo
Head of Investor Relations

Thank you, Operator. Good morning. Thank you for joining us on today's call to discuss Alexion's performance for the third quarter 2020. As has been our practice recently, we are practicing physical distancing and are each doing the call from home. Today's call will be led by... Ludwig will be joined by Rodney Serin, our Chief Financial Officer, John Orloff, our Global Head of R&D, and Brian Goff, our Chief Commercial and Global Operations Officer. We will begin the call with a brief presentation and will reserve the rest of the time for your questions. You can access the webcast slides that will be presented on this call and other earnings materials by going to the Events section of our Investor Relations page on our website. Before we begin, I would like to point out that we will be making forward-looking statements, and these statements involve certain risks and uncertainties that could cause our actual results to differ materially. Please take a look at the risk factors discussed in our SEC filings for additional detail. These forward-looking statements apply only as of today, and we undertake no duty to update any of the statements after the call except as required by law. I'd also like to remind you that we'll be using non-GAAP financial measures, which we believe provide useful information for the understanding of our ongoing business performance. Reconciliations of our financial results and financial guidance are included in our press release. These non-GAAP financial measures should be considered in addition to, but not a substitute for, our GAAP results. Thank you. And with that, it's my pleasure to give you our CEO. Ludwig?

speaker
Ludwig Hantson
Chief Executive Officer

Thank you, Chris, and good morning, everyone. I'm pleased to share our third quarter performance today. COVID-19 continues to test the global community, healthcare systems, and families worldwide. Our ability to successfully navigate through this challenging time is a testament to the strength of our business and the resilience of our global organization. Alexion's patient-centric culture and focused rare disease infrastructure continues to shine in this new environment. I would like to thank our employees worldwide for their hard work and commitment to our mission of transforming the lives of people with rare diseases and devastating conditions. Despite the challenges posed by COVID-19, the election team has continued to deliver. Third quarter financial results were strong, with 26% revenue growth and 16% non-GAAP EPS growth year-over-year. As a result, we're increasing our full-year financial guidance to reflect the momentum of the business. We continue to progress our revised capital allocation strategy and are well on track to achieve our 2020 commitment to return capital to shareholders of $500 million. to $550 million in share repurchases this year. Our commercial execution remains resilient across the portfolio. With Ultramarys, we have now achieved our ambition of greater than 70% conversion across each of our top markets in P&H. We remain on track to achieve the same ambition in atypical HUS. Our first quarter with Indexa was strong. with integration efforts underway and approximately $39 million in sales within the quarter. We look forward to continuing to drive this momentum as the integration progresses. Finally, progress continues in our R&D portfolio. During the quarter, we received approval for the Ultramers 100 mg per ml high-concentration formulation in the U.S., and Ultramir's approval for atypical HUS in Japan. We continue to advance our pipeline, including near-completion of enrollment in our Phase III Ultramir's GMG trial and our partner Kalem's initiation of the Phase III Kalem 101 programs in AL amyloidosis. As we have shared before, we have a multi-year strategy for value creation against which we continue to execute. It is our ambition to continue to lead and expand in our C5 business. Ultramarist is now established as the market leader for P&H across our top markets, with atypical HUS on track to achieve a similar outcome within two years of launch. The expansion of our C5 business began with Neurology, which is now the largest franchise in the U.S. in terms of both revenues and patient volumes. We continue to build upon this success with additional Ultramers development programs and a third generation C5 inhibitor, 1720. Finally, diversify. As we shared earlier this month, we have significant opportunity in our Factor D and FCRN platforms and high value potential in our innovative assets such as Kalem 101 and 1840. Our acquisition of Portolia earlier this year has brought us Indexa, which allows us to expand upon our critical care presence to address this unmet need in the Factor 10a markets. Collectively, these three components will drive a sustainable and growing C5 business, while also driving new growth opportunities beyond. We have made great progress on our journey thus far, and have a strong foundation upon which to drive future growth. Finally, turning to slide eight, I'd like to reiterate some of the key messages from our investor day earlier this month. Over the last three years, we have transformed this company, establishing a strong foundation for sustainable long-term growth and delivering significant value for patients and shareholders. Driven by a long-term value creation strategy, we see sustainable growth ahead and a clear path to revenues of $9 to $10 billion by 2025 and continues best-in-class operating margins. Beyond this, we see even greater value within our current pipeline of more than $10 billion in peak sales potential. As a biotech company, Alexion is uniquely positioned within the industry with a unique set of rare disease-tailored capabilities. Over the next several years, we have a number of pivotal data readouts and an ambition for more than five novel IND filings by 2025. Anchored by three novel platforms and a number of promising individual assets, we have built a diversified development portfolio with the potential for seven blockbuster franchises to drive continued growth well into the future. Our commitment and ongoing success as a company comes down to the hard work done by our employees, and we'd like to thank our teams all over the world for their continued dedication. With that, I will now turn the call over to Radna to discuss our financial results.

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