7/30/2026

speaker
Operator
Conference Operator

Good morning, and welcome to RGO's Pharmaceuticals Second Quarter 2026 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 RGO's request. I would now like to turn the call over to Morgan Sanford, Head of Investor Relations at RGO's. Thank you, operator.

speaker
Morgan Sanford
Head of Investor Relations, RGO's Pharmaceuticals

Good morning, everyone. Thank you for joining us to discuss Agios Pharmaceuticals' second quarter 2026 financial results and business highlights. You can access the slides for today's call by going to the Investors 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 Goff, Chief Executive Officer, Cecilia Jones, Chief Financial Officer, Sveta Milanova, Chief Commercial Officer, and Dr. Sarah Gheuens, 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.

speaker
Brian Goff
Chief Executive Officer

Thanks, Morgan. Good morning, everyone, and thank you for joining us. Before we review our second quarter results, I'd like to take a step back and highlight the strong position from which Agios is executing as we continue advancing toward our goal of building a multi-billion-dollar rare disease business. We are executing against multiple drivers of value creation, including the launch of Akvesme and thalassemia, the potential expansion of midipivet into sickle cell disease, and a pipeline that continues to grow through both internal innovation and disciplined business development. During the quarter, we further strengthened our portfolio with the addition of sevadoclinib, a next generation, highly selective oral stick inhibitor that expands our rare hematology franchise into immune thrombocytopenia, or ITP. We also advanced AG236, into an operationally seamless Phase 2-3 program in polycythemia vera, adding another potential growth driver within hematology. Beyond hematology, AG1A1 continues to progress, and we expect Phase 1B proof of mechanism data in phenylketonuria patients in the second half of the year. We also continue to apply a disciplined approach to portfolio management, Making Focused Investment Decisions and Directing Resources Toward Opportunities with the Greatest Potential to Create Value for Patients and Shareholders. As you'll hear throughout today's call, our progress this quarter reflects the strength of that strategy, combining commercial execution, pipeline advancement, disciplined capital allocation, and strategic business development to position RGOs for sustainable long-term growth. Turning to our second quarter highlights on the next slide, we delivered a quarter marked by strong commercial performance, meaningful pipeline progress, and continued portfolio discipline. First, we delivered sustained commercial momentum with $44.7 million in total net revenue, including $40.9 million in the U.S. and 442 cumulative Akvesme prescriptions for REM-certified physicians. Second, we further diversified our pipeline through the in-licensing of sevadoplinib, a next-generation highly-selective oral sick inhibitor for ITP, progressing toward Phase III and strengthening our rare hematology pipeline. Third, we advanced Minipivet toward a potential new indication in sickle cell disease, During the quarter, we received FDA acceptance of our SNDA with priority review and were assigned a Purdue faculty of November 1st, bringing us one step closer to delivering a first-in-class medicine in an area of significant unmet need. And finally, we ended the quarter with approximately $1 billion in cash, cash equivalents, and marketable securities. providing financial flexibility to support both commercial growth and pipeline progression. Overall, we entered the second half of 2026 with strong commercial delivery, a more diversified pipeline, an important near-term regulatory catalyst, and the capital position to execute on our strategy. With that, please advance to the next slide and I'll turn the call over to Cecilia to discuss financials.

Disclaimer

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