Syndax Pharmaceuticals Inc Q2 2025 Earnings Call Transcript

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

Question: Anupam Rama - JPMorgan Chase & Co - Analyst : Hey guys, thanks so much for taking the question. Just wanted to ask a question about this path to profitability. Keith, I know you mentioned operating expenses staying stable over the next couple of years. But what are you assuming in terms of the top line, in terms of treatment settings for Revuforj and Niktimvo? Can you get to profitability on sort of the refractory settings alone? Is there some sort of assumptions on frontline expansion baked into getting to profitability? How should we be thinking about that?

Question: Anupam Rama - JPMorgan Chase & Co - Analyst : Thanks so much for taking the question.

Question: Kevin Strang - Goldman Sachs Group Inc - Analyst : This is Kevin Strang on for Corinne. I had a quick question on the patients moving on to transplant. After how many cycles is that typically occurring? And for patients that are going back on drug, you said that it was about 1/3 of patients so far. What are your expectations for the ultimate proportion of patients that will move on to maintenance therapy? And is this something you'll report quarterly?

Question: Philip Nadeau - Cowen and Company LLC - Analyst : Good afternoon. Congrats on the two successful launches. A couple of questions from us. First, on the KMT2A launch for Revuforj. You suggested, I think that 25% of patients with KMT2A for one year have initiated therapy in the second quarter, which suggests in the incident population the penetration is probably quite high. Can you give us a sense of where you think the penetration is in the incident KMT2A population here today in Q2 of 2025? And kind of where could that go at peak? I guess we're trying to understand how much growth could be left over the next couple of quarters before the label expansion? And then second, on the NPM1 label expansion, any update on inclusion of NPM1 in the NCCN guidelines?

Question: Philip Nadeau - Cowen and Company LLC - Analyst : Great. Can I just follow up on the first one? So with the 2,000 patients in the year, it's reasonable to assume 1,000 patients in six months. It's been six months since launch; 500 patients have started therapy. So that's 50%. You're suggesting 50% of the identified population by the end of the year. Obviously, more and more patients will go on over time, but this is a very sick population, so some are going to fall off. So are you kind of at peak penetration now and therefore, revenue growth over -- in the KMT2A population specifically, revenue growth over the next six to 12 months will be basically dependent on patients living longer and the duration of therapy increasing?

Question: Peter Lawson - Barclays Services Corp - Analyst : Thank you so much. Congratulations on the quarter. Just as we think about the looming FDA approval, what can you tell us around any remaining open items or feedback you've got from the FDA and anything that kind of helps add around the confidence around the FDA approval?

Question: Peter Lawson - Barclays Services Corp - Analyst : Maybe I could circle back on the first question just around the FDA. I know there's always a level of uncertainty, and it seems to be a heightened level of uncertainty. Have you seen any changes in that dialogue, any moving targets? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 04, 2025 / 8:30PM, SNDX.OQ - Q2 2025 Syndax Pharmaceuticals Inc Earnings Call

Question: Peter Lawson - Barclays Services Corp - Analyst : Perfect. Thank you so much. Thanks.

Question: Paul Jeng, Ph.D. - Guggenheim Securities LLC - Analyst : This is Paul on for Michael. I have two on the frontline combo opportunities. So first on the recent EHA updates from BEAT AML. It seems pretty clear that revumenib is enhancing the CR and MRD compared to ven/aza alone. But would love to get your thoughts on the degree of OS improvement you're seeing and whether or not you plan to provide another survival update in the study with additional follow-up? And then secondly, just looking ahead to the intensive chemo combo, can you sort of talk about how we should think about key CR and MRD benchmarks for that combo and sort of what to expect for the update later this year?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Hey, Michael and team, thank you. On the 1/3 of the patients that have restarted after the transplant and then the 2/3 that don't, could you just clarify, so of those 2/3, are they not expected to restart? Or is it simply that they're not ready to restart and the expectation is that most of them, in fact, will restart?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. And then just can you clarify on the mechanics? Do they need to get a reimbursement approval again when they come back after the transplant? Or is it seamless and they just start Revuforj again without a second need to request the reimbursement? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 04, 2025 / 8:30PM, SNDX.OQ - Q2 2025 Syndax Pharmaceuticals Inc Earnings Call

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Okay. And then lastly, I'm just curious if you could speak in a little more detail about this first wave of the real-world evidence that you're going to have at the end of the year? Can you just expand on that a little, please?

Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst : Thanks.

Question: Salim Syed - Mizuho Securities Asia Ltd - Analyst : Congrats on the quarter. Mike, Keith, maybe just a couple from us. One on Niktimvo. So -- and I apologize, this is going to be another math question. But when I look at 2026, consensus currently, I think, is around $240 million or so on the end user sales number. And just kind of like looking at some of the numbers that have been released between yourselves and Incyte, there were $45 million of sales, I think, or so ex inventory, that's our number, I think, 4,500 infusions. I think they mentioned that on their call. I know you guys are saying over 4,000, but they said 4,500. So it looks at about $10,000 net price per infusion, assuming the trial duration of 10.3 months. You start to get to this price of $225,000 for the 22 infusions that would take place, so assuming they talked about having 1,000 patients at the end of this year, perhaps. So you start to get to these numbers of $225,000. And again, that's using the 10.3, not the 12-month duration, no additional inventory impact, no additional penetration, no growth. Is it just me? Or is that number just incredibly light, the [26] Niktimvo end-user sales number just based on that math? Is there something I'm missing?

Question: Salim Syed - Mizuho Securities Asia Ltd - Analyst : Okay. Yes. I mean they did talk about the [$1,000 million] sort of at the end of the year from the current [$700 million] or so. That's sort of the basis for the math. But I understand your point. And just quickly, I guess, on your slides, it looks like you updated your EPi data for the NPM1 from 3,000 to 4,500 just to 4,500. Is there something you guys did on the Epi to make you more confident around the upper end of that range? The one that's $5 billion TAM? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 04, 2025 / 8:30PM, SNDX.OQ - Q2 2025 Syndax Pharmaceuticals Inc Earnings Call

Question: Salim Syed - Mizuho Securities Asia Ltd - Analyst : Yeah, it was meant to be conservative.

Question: Salim Syed - Mizuho Securities Asia Ltd - Analyst : Very good point. Yeah, fair enough. Thanks, so much guys, appreciate it.

Question: David Dai - UBS AG - Analyst : Congrats on the quarter. A couple for me. One, just on the $28 million of Revuforj revenue, could you talk about the percentage of revenue is inventory? And also, how much of that is coming from new patient start versus refill?

Question: David Dai - UBS AG - Analyst : Got it. Okay. And then just another question on the patients on the stem cell transplant. And right now, you have about 33%, 1/4 of it or 1/3. I'm just curious, do you expect this to increase given that you have 50% of patients currently treated in the second line? So how should we think about this going forward in terms of the increase in stem cell transplantation?.

Question: David Dai - UBS AG - Analyst : I think it's something in my questions.

Question: Jason Zemansky - Bofa Merrill Lynch Asset Holdings Inc - Analyst : A couple from us, if we may, based on your earlier comments. But first being, of the 2,000 or so relapsed/refractory KMT2A patients, can you give us any color on your assumptions regarding the overall peak penetration here? And then similarly, given the comments regarding the overall opportunity in relapsed/refractory, at least as far as your cash runway goes, any color on your insights or assumptions as far as the competitive split in the NPM1 population look like? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 04, 2025 / 8:30PM, SNDX.OQ - Q2 2025 Syndax Pharmaceuticals Inc Earnings Call

Question: Jason Zemansky - Bofa Merrill Lynch Asset Holdings Inc - Analyst : Fair enough, appreciate the color thanks guys.

Question: Mayank Mamtani - B. Riley Securities Holdings Inc - Analyst : Congrats on the progress. Could you just clarify, and sorry if I missed that, if there's any real-world evidence you're planning to generate as you strengthen the case for Revuforj use as maintenance therapy post-transplant? And what's your expectation for duration of therapy there, say,

Question: Mayank Mamtani - B. Riley Securities Holdings Inc - Analyst : Very helpful. And then on Niktimvo, can you just remind us what development milestones to look out for as you think about the therapy moving into earlier line GVHD? I believe the label is third line, fourth line, but the uptake is in earlier lines. But I was curious if any additional clinical data milestones we should be on the lookout for?

Question: Mayank Mamtani - B. Riley Securities Holdings Inc - Analyst : Thank you.