The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Gregory Renza - RBC Capital Markets - Analyst
: Great, thanks. Hey, good morning, Brian and team. Congratulations on the progress and thanks for taking my questions.
Question: Gregory Renza - RBC Capital Markets - Analyst
: Thank you. Brian, we certainly appreciate more precision and timing for the ENERGIZE-T data. I'm just curious that -- just narrowing it at least from
midyear to second quarter, can you just comment a bit on the relevance factors now, what needs to be done and maybe some of the influences
around just getting it to that narrower earlier timeframe on the second quarter? And maybe related to that, just remind us just the mechanics on
patients rolling over to the open-label extension. Thanks so much.
Question: Gregory Renza - RBC Capital Markets - Analyst
: That's great, Brian. Thank you very much. Maybe just a follow-up, just broadly on the landscape, certainly with PK activation competition with
etavopivat from Novo maybe having some timelines now established. What do you make of that? How do you think about the landscape longer
term? You're certainly moving fast, but as you think about the [jockeying] between the two offerings for patients ultimately. Thanks again.
Question: Divya Rao - TD Cowen - Analyst
: Good morning. This is Divya on for Mark. Thanks for taking our question. One on the thalassemia, the transfusion-dependent thalassemia trial
coming up. Can you walk us through the powering assumptions for the primary endpoint? And then I have a follow-up.
Question: Divya Rao - TD Cowen - Analyst
: Got it. And then just quickly as a follow-up, for AG-946, do we still expect to see the full data from the Phase 2a trial sometime this year?
Question: Divya Rao - TD Cowen - Analyst
: Okay, thank you.
Question: Eric Schmidt - Cantor Fitzgerald & Co. - Analyst
: Good morning, everyone. Thanks for taking my question and congrats on all the progress. Maybe just two quick ones, first, for Brian and Sarah on
this thalassemia filing. One, I guess can you confirm whether it's going to be an NDA filing? It sounds like you're already preparing that filing. Just
to be very specific, if for some reason, the TDT study falls short, you'd still be filing for non patients. Is that correct?
Question: Eric Schmidt - Cantor Fitzgerald & Co. - Analyst
: Okay. Thanks for the clarification, Sarah. And just a second question on the sickle cell Phase 3 study that's enrolling. Can you provide any kind of
color on how that's going and what percent of the study is already on board or maybe a finer insight into your timelines for next year? Thanks.
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MAY 02, 2024 / 12:00PM, AGIO.OQ - Q1 2024 Agios Pharmaceuticals Inc Earnings Call
Question: Eric Schmidt - Cantor Fitzgerald & Co. - Analyst
: Thanks very much. Congrats again.
Question: Alec Stranahan - BofA Global Research - Analyst
: Hey, guys, thanks for taking our questions. Just a couple from us. First, a commercial question. Assuming both transfusion and non-transfusion
end up on the label, any reason to think you'd need to maybe tailor your sales strategy differently between these two patient groups? Or will it be
more or less the same, given they're likely seeing the same prescribers? And then l've got a follow-up.
Question: Alec Stranahan - BofA Global Research - Analyst
: Okay, perfect. And then just one question on the ex-US opportunity. I know you've said that the plan would likely be to partner in ex-US geographies.
But any additional color you can provide around timing or scope of the ex-US opportunity, just from a modeling perspective for us? Thank you.
Question: Alec Stranahan - BofA Global Research - Analyst
: Great. Thanks again for the question.
Question: Tess Romero - J.P. Morgan Securities, LLC - Analyst
: Hi, good morning, Brian and team. Thanks so much for taking our question.
Question: Tess Romero - J.P. Morgan Securities, LLC - Analyst
: Question for Cecilia here. I mean, just curious, can you walk us through the pushes and pulls on your balance sheet and how you think about means
to potentially extend that runway and what your latest thinking is there? We noticed you included in your release today, how interested specifically
are you in potentially a royalty monetization for vorasidenib?
And then on the partnering side outside of the US, just to clarity Tsveta's comments here, could that occur this year? Thanks.
Question: Danielle Brill - Raymond James & Associates, Inc. - Analyst
: Hi, guys. Good morning. Thanks so much for taking my questions. First, I wanted to ask a question about the expected placebo response for
ENERGIZE-T. In luspatercept's trial, I believe the placebo response rate, as you defined it for your primary, was around 6%. Curious your thoughts
on how the placebo population is able to achieve that level of reduction. And are you expecting a similar outcome in ENERGIZE-T?
And then as a quick follow-up, I'm just curious how you plan to announce the data. Will this be a top0line PR or is it possible that you'll present it
at EHA? Thank you.
Question: Danielle Brill - Raymond James & Associates, Inc. - Analyst
: Understood. Thanks so much.
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