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4/29/2026
joining us to discuss Augeos Pharmaceuticals first quarter 2026 financial results and business highlights. You can access the slides for today's call by going to the investor section of our website, Augeos.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 AGO are Brian Goff, 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. Next slide, please. At the start of the year, we outlined our 2026 strategic priorities, which are designed to drive both near-term execution and long-term value creation. We are off to a strong start entering another catalyst-rich year with clear momentum across these priorities. Turning to first quarter highlights on the next slide, we delivered $20.7 million in net revenues representing 138% growth year over year. The first quarter marks the US commercial launch of Acvesme and Thalassemia with the REMS fully operational as of the end of January. And already we have shown strong initial demand. We continue to expect 2026 operating expenses to be approximately flat versus 2025 and we ended the quarter with a strong balance sheet, including over $1 billion in cash, cash equivalents, and marketable securities. Importantly, we've advanced two priorities that are key to our growth inflection. First, the U.S. commercial launch of Acvesme in thalassemia is off to a strong start, with 242 prescriptions written as of March 31st by REM-certified physicians building significantly on the 44 prescriptions we reported as of the end of January. This early progress reflects solid execution as the launch continues to broaden. Sveta will provide additional details shortly, but the early momentum highlights the strong work and rare disease capabilities of the AGIOS commercial team. Second, following our pre-FMDA meeting with the FDA in the first quarter, We now plan to submit an SNDA for mitopivet in sickle cell disease in the second quarter under the U.S. accelerated approval pathway, marking an important step toward expanding our PK activation franchise into a significantly larger indication. I also want to underscore the caliber of our team, whose ability to respond rapidly and rigorously to FDA feedback reflects the deep regulatory and scientific expertise we've built at Agios. Next slide, please. Stepping back, our strategy is to build a sustainable rare disease company anchored by a foundation in rare hematology. In the near term, our focus is on executing the ACVSME U.S. commercial launch in thalassemia and advancing the mid-pivot SMDA filing in sickle cell disease. In parallel, we are preparing for important midterm catalysts, including phase two top-line data for tepipivet, our next generation more potent PK activator in both lower risk MDS and sickle cell disease this year. And over the longer term, we continue to advance our early stage clinical programs and selectively evaluate expansion into other rare disease hematology, rare hematology diseases rather, to support our sustained growth. With that, please advance to the next slide, and I'll turn the call over to Cecilia to discuss financials. Cecilia?
Thank you, Brian. The next slide summarizes our first quarter financial results. As we have previously shared, we will report MetaPivot net revenues with U.S. and S.U.S. components. In the first quarter, we delivered $20.7 million in worldwide MetaPivot net revenues. with $18.8 million from sales generated in the U.S., driven by the recent launch of Acvesme in Thalassemia. Outside of the U.S., we reported $1.9 million in sales, reflecting expected quarterly fluctuations. We reported $81 million in R&D expense in the first quarter, an increase of roughly $8 million from prior year, due to workforce-related expenses supporting pipeline advancement efforts, as well as increased meta-pivot process development expenses. We also reported $48 million in SG&A spend, up approximately $7 million from the prior year, due to an increase in activities to support the U.S. commercial launch of Advesme in thalassemia, as well as an increase in stock compensation expense. We ended the quarter with over $1 billion in cash, cash equivalents, and marketable securities, positioning us well to remain disciplined as we invest to maximize portfolio value and build a pipeline for long-term growth. Turning to our approach to capital allocation on the next slide, our priorities remain clear. First, we will continue to maximize the U.S. commercial launch of Agvesme and Thalassemia. Second, we are managing operating expenses in a way that is aligned with our long-term value creation. Based on our current plans and accounting for the meta-pivot confirmatory clinical trial in sickle cell disease, we anticipate 2026 operating expenses to be approximately flat compared to 2025. Finally, we will continue to diversify our pipeline, leveraging both internal capabilities and external innovation as we continue to execute our 2026 priorities with a disciplined approach to long-term growth. Please advance to the next slide, and I'll turn it over to Sveta to cover commercial highlights and early aggressive use of thalassemia launch dynamics.
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