Q2 2024 Agios Pharmaceuticals Inc Earnings Call Transcript
Key Points
- Agios Pharmaceuticals Inc (AGIO) reported positive momentum in Q2 with multiple key milestones, including the Phase 3 ENERGIZE-T study of mitapivat meeting both primary and secondary endpoints in adults with transfusion-dependent alpha or beta-thalassemia.
- The company plans to submit an sNDA for mitapivat in thalassemia by the end of 2024, seeking a label that covers all subtypes of thalassemia.
- Agios Pharmaceuticals Inc (AGIO) announced a significant financial agreement with Royalty Pharma, which will provide an upfront payment of $905 million upon FDA approval of vorasidenib.
- The company reported strong cash reserves, ending the second quarter with approximately $645 million in cash and investments.
- Agios Pharmaceuticals Inc (AGIO) has completed enrollment in the ACTIVATE-kids study and looks forward to top-line readout in 2025, indicating progress in their pediatric studies.
- The Phase 3 ACTIVATE-kids T study of mitapivat did not meet the prespecified statistical criterion for the primary endpoint using Bayesian methodology.
- There were adverse events reported in the mitapivat arm of the ENERGIZE-T study, with 5.8% of patients experiencing an AE that led to discontinuation compared to 1.2% in the placebo arm.
- The company expects more muted growth going forward and quarter-over-quarter variability in PKD revenues as they pivot focus to thalassemia launch preparedness.
- R&D expenses increased by $8.5 million year-over-year, primarily due to costs associated with the TMPRSS6 program in-licensed from siRNA.
- SG&A expenses also saw an increase of $5.1 million compared to the same quarter in 2023, attributed to commercial-related activities in preparation for the potential approval of PYRUKYND in thalassemia.
Good morning and welcome to Agios' second quarter 2024 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 Chris Taylor, VP, Investor Relations and Corporate Communications for Agios.
Thank you, operator. Good morning, everyone, and welcome to Agios' conference call and webcast to discuss second quarter 2024 financial results and recent business highlights. You can access slides for today's call by going to the Investors section of our website, agios.com. On today's call, I'm joined by our Chief Executive Officer, Brian Goff; Dr. Sarah Gheuens, Chief Medical Officer and Head of Research and Development; Tsveta Milanova, our Chief Commercial Officer; and Cecilia Jones, our Chief Financial Officer.
Before we get started, I'd like to remind
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