Agios Pharmaceuticals, Inc.

Good morning and welcome to AGO's second quarter 2025 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 AGO. Please go ahead.

Thank you, operator. Good morning, everyone. I'm Morgan Sanford, vice president of Investor at AGO. Thank you for joining us to discuss AGO's pharmaceuticals second quarter 2025 financial results and business highlights. You can access the slides for today's call by going to the investor section of our website, AGO.com. Please move to the next slide. Today we'll be making certain forward-looking statements. Actual events and results could differ materially from those expressed or implied by any forward-looking statements. Because 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. Next slide, please. On the call with me today from AGO are Brian Goff, chief executive officer, Cecilia Jones, chief financial officer, Sveta Milanova, chief commercial officer, and Dr. Sarah Hewens, chief medical officer and head of research and development. Following prepared remarks, we will open the call for questions. With that, please move to the next slide and I am pleased to turn the call over to Brian.

Thanks, Morgan. Good morning, everyone, and thank you for joining us on today's call. Next slide, please. 2025 is shaping up to be a breakout year for AGOs and we believe we have a clear path to deliver sustainable growth and unlock long-term shareholder value. First, we have a TK activator, Pyrokin. Second, momentum is building as we approach multiple near-term high-value catalysts. We hope to add thalassemia as the second approved indication for Pyrokin in the U.S. pending FDA approval and we are now less than 40 days from our September 7th PDUFA goal date. We expect to read out the Rise Up Phase 3 trial for Pyrokin in sickle cell disease before the end of the year and early next year anticipate Phase 2b data for Tebapibed, our more potent PK activator in patients with anemia due to lower risk myelodysplastic syndromes. And third, we are well capitalized to develop and launch Pyrokin in thalassemia and sickle cell disease and to continue to advance our existing development programs as well as look opportunistically to expand our pipeline through internal efforts and business development activities. Please move to the next slide. In the second quarter, we reported $12.5 million in net revenue reflecting the strong value proposition of Pyrokin. We entered into an agreement with Avancinite Bioscience to commercialize and distribute Pyrokin in Europe. This is a capital efficient deal allowing us to focus our investment on commercial launches in the U.S. We exited the second quarter with approximately $1.3 billion in cash, cash equivalents, and marketable securities and intend to be disciplined in our investment behind the commercial buildout of Pyrokin and advancement of our pipeline. In the second quarter, we dosed the first patient in the phase two trial of Teva-Pivot and sickle cell disease and received IND clearance for AG236, our siRNA targeting Tempor6, intended for the treatment of polycythemia vira. We are at an important turning point in our growth story. Near term, we have the potential to transform the treatment of thalassemia and sickle cell disease with Pyrokin. And beyond, we have the opportunity to deliver additional medicines to rare disease patients waiting and in urgent need of innovative treatment options. Please move to the next slide and I'll turn the call over to Cecilia to provide additional commentary on our second quarter performance and the future trajectory for Pyrokin.