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4/29/2021
Conference call. At this time, all participants are in listen-only mode. There will be a question-and-answer session at the end. Please be advised that this call is being recorded at RGS's request. I would now like to turn the call over to Holly Manning, Senior Director of Investor Relations.
Thank you, Operator. Good morning, everyone, and welcome to AGIOS's first quarter 2021 conference call. You can access slides for today's call by going to the investor section of our website, AGIOS.com. With me on the call today with prepared remarks are Dr. Jackie South, our Chief Executive Officer, Dr. Chris Bowden, our Chief Medical Officer, Darren Miles, our Chief Commercial Officer, and Jonathan Biller, our Chief Financial Officer and Head of Legal and Corporate Affairs. Dr. Bruce Carr, our Chief Scientific Officer, will join for Q&A. Before we get started, I would like to remind everyone that some of the statements we make on this call will include forward-looking statements. Actual events and results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC. With that, I will turn the call over to Jackie.
Thank you, Holly. Good morning, everyone, and thanks for joining our first quarter 2021 results call. The first three months of this year were extremely productive. We closed the sale of our oncology business, accelerated our late-stage clinical programs for Medipivet, and prepared for our first regulatory filings and subsequent commercial launch in pyruvate kinase deficiency. Back in December, we announced our strategy to focus on genetically defined diseases, including accelerating and unlocking the full potential of midipivate across its three initial indications in hemolytic anemias, as well as leveraging our overall expertise in PK activation and our other research programs. To enable this focus, we also announced the decision to sell our oncology programs to Servier to facilitate and fund this strategy. Since that time, nearly a third of our organization has been actively involved in the important and complex process of ensuring a smooth transition of our assets and people to Servier. The transaction was approved by Ajo shareholders on March 25th, and on April 1st, we announced the closing of the sale. To each and every oncology employee who helped create truly meaningful, differentiated therapies for patients over the past decade, We are grateful for your impassioned work at Agios, and we look forward to watching these programs flourish with Servier. As we look ahead, Agios is poised for a bright and focused future that will build on the important progress we are making now in Q2. This includes finalizing our global regulatory filings for minipivet and pyruvate kinase deficiency, preparing to initiate two Phase III trials of minipivet and thalassemia, and a Phase 2-3 trial of Medipivat in sickle cell disease, advancing our patient identification efforts and launch preparations ahead of the potential approval of Medipivat in PK deficiency next year, and finally, initiating the thoughtful execution of up to $1.2 billion in share repurchases that Jonathan will describe in more detail. At the heart of this work is our continued commitment to making a significant difference in the lives of the patients we serve. And I would like to take a moment to recognize some of the important efforts we have been pursuing on behalf of patients over recent months. First, we are excited to announce a collaboration with 23andMe that led to the launch of its very first PK deficiency carrier status report, which is a significant step forward in educating the broader population about PK deficiency. Second, we announced our sponsorship of citizen scientists Unpacking the Science of Sickle Cell Disease, an initiative developed by the Sickle Cell Community Consortium to promote health literacy for sickle cell patients. Within the Citizen Scientist Initiative, we were also the founding sponsor of a new series of episodes on Cheat Codes, a sickle cell podcast. The podcast series brings world-renowned physicians together with patients and caregivers to have real conversations about new sickle cell research emerging from major medical and scientific congresses. The goal is to provide the sickle cell community with access to critical information about better ways to manage their health and innovative new treatments in development. The inaugural episodes focused on the presentations from the 2020 ASH Annual Meeting and can be accessed by searching for cheat codes wherever you stream your podcasts. And third, in honor of Rare Disease Day, we hosted a discussion about thalassemia with Dr. Sujit Sheth, who runs the New York Comprehensive Thalassemia Center, and his patient, Sam, who's been treated for thalassemia for over 20 years and has a unique perspective on living with the disease. These educational and patient-focused efforts underscore our commitment to making a positive difference in the lives of the people we serve. With that, I will now turn the call over to Chris. Thanks, Jackie.
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