Agios Pharmaceuticals, Inc.

Good morning, and welcome to AGO's second quarter 2021 conference call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session at the end. Please be advised that this call is being recorded at AGO's request. I would now like to turn the call over to Jessica Renningkamp, Director of Corporate Communications.

Thank you, Operator. Good morning, everyone, and welcome to AGO's second quarter 2021 conference call. You can access slides for today's call by going to the Investors section of our website, adios.com. With me on the call today with prepared remarks are Dr. Jackie Faust, our Chief Executive Officer, Dr. Chris Bowden, our Chief Medical Officer, Darren Miles, our Chief Commercial Officer, Jonathan Biller, our Chief Financial Officer and Head of Legal and Corporate Affairs, and Dr. Bruce Carr, our Chief Scientific Officer, who 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.

Thanks, Jessie. Good morning, everyone, and thanks for joining our second quarter 2021 financial results call. We are pleased to report another quarter of strong progress at AGIOS, the first full quarter since the close of the sale of our oncology business to Servier. The team is focused, energized, and excited for the future as we continue to advance our pipeline in genetically defined diseases led by Medipivet across its three initial indications in hemolytic anemias. We achieved significant recent milestones with the submission of our NDA for Medipivet in adults with pyruvate kinase deficiency in June, as well as with the submission of our MAA to the EMA the same month. We look forward to working with the FDA and EMA as they complete their reviews. With these two filings, we are one step closer to delivering the first potentially disease-modifying therapy for people with pyruvate kinase deficiency. These regulatory submissions are supported by strong Phase III data from the ACTIVATE and ACTIVATE-T studies. Full results from both were recently presented at the European Hematology Association, or EHA, virtual congress in June. Our preparations for the commercial launch of MediPIVAT in PK deficiency continue to advance, and we remain on track for anticipated approval and launch in 2022. In addition, we would like to extend our congratulations to the Pyruvate Kinase Deficiency Foundation and the Thrive with Pyruvate Kinase Deficiency Organization both of which recently launched as the first two U.S.-based advocacy organizations dedicated to PK deficiency. Both organizations are patient-led, and it's very exciting to see how this community has coalesced and the momentum they are gaining in raising awareness and advocating for those living with this disease. Beyond PK deficiency, we are also making excellent progress with the late stage development of midipivate and thalassemia and sickle cell disease. At EHA, we presented positive results from our phase two open label study of midipivate in adults with non-transfusion dependent alpha or beta thalassemia. These data continue to validate the potential of PK activation as an entirely new mechanism for treating thalassemia and represent the first clinical data generated in alpha thalassemia patients. We remain on track to initiate our two registrational phase three trials, ENERGYZE and ENERGYZE-T, in not regularly transfused and regularly transfused adults with thalassemia, respectively, this year. In sickle cell disease, we also remain on track to initiate a pivotal phase two, three trial of Minipivet by the end of the year. Beyond MediPIVAT, we are building on our expertise in PK activation and cellular metabolism and are advancing our earlier stage research programs in genetically defined diseases to position us for sustainable growth and momentum. In the fourth quarter, we plan to host an investor day to share more information about our commercial launch planning for MediPIVAT and PK deficiency and talk more in detail about our research and development pipeline. Before I turn the call over to Chris to provide an update on our clinical development programs, I wanted to take a moment to share that Chris has decided to retire from his role as Chief Medical Officer at Adios after a terrific seven years on our leadership team. After a transition period to his successor over the coming months, I'm very pleased that Chris will remain part of our team as a strategic advisor through at least the end of 2022. We are excited for him as he enters this new chapter of his life and want to thank him for his leadership and many years of service at Agios. Among his many accomplishments and contributions, he oversaw the build-out of our medical and clinical development organizations, acted as Agios' lead medical representative internally and externally, navigated complex regulatory interactions in order to bring important drugs to patients, and played a key role in the evolution of our organization and culture. He's been an integral part of our team, and his work will continue impacting the lives of patients for many years to come. On behalf of everyone at AGIOS, I wish Chris all the best in the future. I'm equally excited to announce that Dr. Sarah Guins, who has up to now served as our head of clinical development for genetically defined diseases, will assume the role of Chief Medical Officer effective September 1st. Sarah has been with AGIOS for almost two years and has been an impactful and energizing leader across the organization during her tenure. Among Sarah's most significant accomplishments at AGIOS, she played an integral role in the work associated with the PK deficiency filings and the design and strategy for our sickle cell disease pivotal programs. She knows all aspects of our programs inside and out and has a genuine passion for serving people with genetically defined diseases. Prior to Agios, Sarah held roles of increasing responsibility at Biogen in safety and risk management, medical affairs, and clinical development, and she is a neurologist by training. We look forward to continuing to see great things from her as she takes on this new level of responsibility. With that, I will now turn the call over to Chris.