Agios Pharmaceuticals, Inc.

Good morning and welcome to Agios Pharmaceuticals' fourth quarter and full year 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 Agios' request. I would now like to turn the call over to Morgan Sanford, head of investor relations at Agios. Please go ahead.

Thank you, operator. Good morning, everyone. Thank you for joining us to discuss Agios Pharmaceuticals' fourth quarter and full year 2025 financial results and business highlights. You can access the slides for today's call by going to the investor section of our website, agios.com. Please note, we'll be making certain forward-looking statements today. 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. On the call with me today from Agios are Brian Gough, Chief Executive Officer, Cecilia Jones, Chief Financial Officer, Sveta Milanova, Chief Commercial Officer, and Dr. Sarah Huynh, Chief Medical Officer and Head of Research and Development. Following prepared remarks, we will open the call for questions. With that, 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. Just last month, we outlined our 2026 strategic priorities, which are focused on delivering long-term shareholder value. First, we're focused on executing a high-impact launch of Acvesme for the treatment of thalassemia in the U.S. We see meaningful opportunity to expand our PK activation franchise into additional high-value indications, including sickle cell disease and lower-risk myelobusplastic syndrome, with key catalysts this year for both opportunities. Third, through the advancement of our early-stage pipeline with AG236 and AG181, we have the potential to unlock future value in hematologic and other rare diseases. And finally, we remain committed to long-term sustainability, supported by disciplined capital allocation and continued operational efficiency. Building on those priorities, the next slide maps key pipeline catalysts in 2026 across multiple high-value indication opportunities. The Akvesny launch in thalassemia is underway in the U.S., and we look forward to the potential to expand our PK activation franchise into sickle cell disease and lower-risk MDS. These milestones and continued progress in our early-stage pipeline position the portfolio for growth and long-term value creation. Next slide, please. We exited 2025 with solid momentum across the business, commercial execution, pipeline progress, and continued focus on financial discipline, which together provide a strong foundation to deliver on our 2026 strategic priorities. Starting with commercial performance, Piratine delivered $20 million in net revenue in the fourth quarter. bringing full-year 2025 revenue to $54 million, reflecting robust year-on-year growth. In the fourth quarter, we reported top-line data from the Rise Up Phase III trial, and we'll meet with the FDA this quarter as anticipated for our pre-FNDA meeting to determine the regulatory path forward. Importantly, just before the end of the year, we received FDA approval for Acvesme, and the US thalassemia launch is underway. Finally, we recently completed enrollment in the phase two sickle cell disease trial of Tevapivac, with top line results expected in the second half of this year. Importantly, we continue to operate from a position of strength, ending the year with approximately $1.2 billion in cash, providing flexibility to maximize the Akvesny, Thalassemia, and US launch, pursue the path forward for Midipivac in sickle cell disease, and continue to advance our pipeline programs. Please move to the next slide, and I'll turn the call over to Cecilia to provide additional details on our 2025 fourth quarter and full-year performance, as well as our 2026 outlook.