Agios Pharmaceuticals Inc Q2 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Eric Schmidt - Cantor Fitzgerald - Analyst : Hi, good morning, everyone. This is [Imogen] on for Eric. I think in the past, you've said that you would update investors on any change to mitapivat safety profile, including any cases of liver toxicity outside of thalassemia. Is there anything new that you have to report there?

Question: Eric Schmidt - Cantor Fitzgerald - Analyst : Okay. Great. And then one quick follow-up. On the GCC approval date, is there any more color you could share on that? Are you expecting it maybe just after the US approval?

Question: Eric Schmidt - Cantor Fitzgerald - Analyst : Okay, great. Thanks very much.

Question: Marc Frahm - Cowen and Company LLC - Analyst : Hey, thanks for taking my questions. Maybe just with the thal review ongoing, are you able to comment on if you're maybe in labeling discussions yet? And obviously, safety information is going to need to be at least somewhat updated just to account for the fact that thalassemia is now hopefully going to become an approved indication. So what's the latest thoughts on kind of how you're anticipating that part of the label to read? And then I'll probably have a follow-up question.

Question: Marc Frahm - Cowen and Company LLC - Analyst : Okay. That's helpful. And then this is more for Tsveta and Cecilia. Just the SG&A spend has been ticking up, obviously, as you build out and prepare for that thalassemia launch. Should we view this as fully built out now and this is kind of the run rate? Or are there still kind of meaningful step-ups that we should be expecting going forward as the launch actually starts?

Question: Marc Frahm - Cowen and Company LLC - Analyst : Great, thank you.

Question: Salveen Richter - Goldman Sachs Group Inc - Analyst : Good morning. Thanks for taking my question. As you look to the upcoming PDUFA here for thal and focus on the launch, could you just help us understand the initial target patient population that you'll be addressing or just be targeting here initially?

Question: Andrew Berens - Leerink Partners LLC - Analyst : Congrats on all the progress. This is a follow-up to Marc's earlier question. Has anything changed in the sickle cell trial protocol since you identified risks in liver injury at ASH 2024. Interested in whether the consent forms and the monitoring requirements have changed. And then I have one on tebapivat. We noticed that the tebapivat trial is using markedly lower doses than the MDS Phase IIb trials being conducted. Can you discuss the dosing protocol in this trial and the rationale for going lower in the sickle cell trial? Are there data at the relevant doses in MDS and sickle cell that you can share with us? Hello? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JULY 31, 2025 / 12:00PM, AGIO.OQ - Q2 2025 Agios Pharmaceuticals Inc Earnings Call

Question: Andrew Berens - Leerink Partners LLC - Analyst : Thank you, Sarah.

Question: Tessa Romero - JPMorgan - Analyst : Good morning, Brian and team. Thanks for taking our question. So to double-click back on a few of the earlier questions on the call. Is it still reasonable to assume that the potential risk of hepatocellular injury will sit in the warnings and precautions section of the label as is currently reflected today? And relatedly, when do you expect to present your open-label extension data that you have collected in this population that may be of interest to physicians and institutions as they begin to prescribe in thalassemia? Thank you.

Question: Greg Harrison - Scotiabank - Analyst : This is Theresa on for Greg. Just wanted to see ahead of the launch -- potential launch in thalassemia, if you could provide any additional color on the prescriber base for your initial launch focus and how you're planning to address any variability in care between academic centers and community hematologists.