Syndax Pharmaceuticals Inc Q4 2024 Earnings Call Transcript

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

Question: Anupam Rama - JPMorgan - Analyst : Congrats on all the launch progress here in the early innings. Just quick one for me. I know in the press release, you talked about, about a third of the 4Q Revuforj sales were inventory. Just wondering how we should be thinking about inventory levels throughout 2025. And then I know also that you said you're about a third penetrated into your Tier 1, Tier 2 accounts. How -- have you any trends on repeat prescribers from some of the docs given the aggressive nature of KMT2A?

Question: Bradley Canino - Stifel Financial Corp. - Analyst : Nice first commercial quarter. Two part-er for me. For the 66% of Tier 1, Tier 2 accounts that have not yet ordered, what do you expect for the cadence and extent of activation over the next 10 months? And then second, now with a few months of commercial experience under the belt, how do you see Revuforj tracking with some of the historic AML targeted therapy launches?

Question: Peter Lawson - Barclays Investment Bank - Analyst : I guess firstly around Revuforj, like how that's being used, if you're seeing off label use, how much for NPM1 and if you're seeing it being used in combination? And then just regarding the expanded access program, just maybe a clarification for me. You kind of talked about a rapid transition, I think you mentioned less than 10 patients transitioned. Just kind of how many patients are left on that extended access program?

Question: Peter Lawson - Barclays Investment Bank - Analyst : Just maybe a final question, how's momentum going in the first couple of months of '25?

Question: Chris Shibutani - Goldman Sachs - Analyst : Congratulations on great progress with the initiative part of the commercial launch. Many questions have been asked there. Perhaps if I could ask a little bit more of an intermediate or longer-term strategic question. Certainly, company has gotten to this point finding assets, developing them successfully, now commercializing. What are your thoughts on what's next? What does this company look like in 2023? Many arguments for saying that if you're making these investments in a fully integrated company that we'd be soon turning to what else is in the pipeline based upon your experience, capabilities, now commercial presence. Do you have a vision to that? Are you going to share that? If not, why not? When might you? And are you and the Board aligned?

Question: Kelly Shi - Jefferies - Analyst : Congrats on a great quarter. Although it's still like early days, but curious for patients bearing co-mutations such as FLT3, how physicians sequence therapies? And what would be the reason that a physician prioritize Revuforj? And also curious on safety front, could you share about the physician's feedback on their real-world experience?

Question: Michael Schmidt - Guggenheim Securities - Analyst : I had a couple more on the Revuforj launch. Keith, perhaps, could you comment on early trends in gross to net adjustment as well as potential use of a free drug program, et cetera? And then in terms of early feedback from the market, what have you heard about or seen around transplant dynamics perhaps relative --

Question: Yigal Nochomovitz - Citigroup - Analyst : Congrats on the first quarter revenues. I have three quick ones, if I may. First, by my math, it seems like you have about 125 to 130 patients on drug net of the inventory, which is about 6% share. Could you just comment on that? Second, if you could be a little more specific regarding how you're defining Tier 1 versus Tier 2 centers? And then third, for Neil perhaps, you mentioned some of the FLT3 dynamics. I'm just curious if you could be a little bit more granular as far as how those Phase III trials could look. As I could imagine, four studies, a KMT2A study for those with a FLT3 and those without, similarly NPM1 for those within FLT3 and those without. This would be in the fit population. So would you have a seven, three plus the FLT3 control arm in those studies respectively?

Question: David Dai - UBS - Analyst : And also want to congrats on the great quarter. So two from me as well. So the first one just around the relapsed/refractory NPM1 pivotal data, you're planning to submit for NCCN Guidelines end quarter this year. Could you maybe talk about the timing of the inclusion of Revuforj for NPM1 in the NCCN Guideline? Do we think about the inclusion of the NCCN before the approval in second half this year? And then second question just around the frontline additional trial in the unfit AML where you said that you were planning to meet with the regulators to use MRD negativity as a set of endpoint. Can just talk a little bit more about the timing around that? And how should we think about your engagement with the regulators on the timing for MRD negativity CR?

Question: Justin Zelin - BTIG - Analyst : Congrats on the strong commercial start here. Michael, maybe just a follow-up on the prior question. Can you speak to your confidence of a broad recommendation by NCCN in the second quarter? And then any color on payer discussions regarding reimbursement of patients with NPM mutations with support of a broad NCCN Guideline recommendation ahead of the formal potential FDA label expansion later this year?

Question: Justin Zelin - BTIG - Analyst : That makes sense to me. And Steve, if I could just ask a quick follow-up. Could you just talk to, in your opinion, the importance of being first in a competitive marketplace like this, the importance of having first to market?

Question: George Farmer - Scotiabank - Analyst : A couple from me. Regarding the strategy for attaining compendia listing in the NPM1 population, can you point to other AML drugs in the space that have secured compendia listing based on a similar dataset than what you have -- with what you have today? And then as a follow-up regarding your strategy in the intensive chemo fit patient population, this data that could come in the second half in combination. Can you talk about what do you think the optimal dose is in combination with IC?

Question: Jason Zemansky - Bank of America - Analyst : Congratulations on the launch progress. Two, if I may, somewhat of a follow-up, but regarding the HOVON led trial in the unfit population, there's something in the protocol that could support a potential path to accelerated approval and what would the timelines look like for that? And then maybe from a broader strategic perspective, how are you prioritizing first line fit versus unfit? What's the more important opportunity for Revu, especially considering the evolving competitive landscape?