Syndax Pharmaceuticals, Inc. (SNDX) Earnings Call Transcript & Summary

Good afternoon, everyone. Thanks for joining us here at the Goldman Sachs Annual Healthcare Conference. Thrilled to be joined by the team from Syndax. Maybe I'll kick it off. I'll let you guys introduce yourselves and then introduce the company.

Sure. Good -- good to see you, Corinne. Thank you. I'm Michael Metzger, I'm the CEO of Syndax, and I've been with the company about 10 years. And to my left, Steve?

Yes, Steve Closter, Chief Commercial Officer at Syndax. Corinne, thanks for having us here. Looking forward to the discussion.

All right. So let's do an overview of the business.

Look, I think exciting time for the company. I couldn't be more excited to be here and to tell you about it. We have 2 approved products, addressing very large markets, first-mover advantage, capital to execute. So we're funded through profitability and profile on both of our drugs is sort of best-in-class. So we feel fantastic about our position as we go into the early -- this is early launch time. So we started with approvals last year and launching the drug late last year with Revuforj, which is our drug for acute AML and ALL and subtypes of those diseases. And then with Niktimvo, which is for chronic GVHD in third-line plus patients. And so both of those drugs are now launched. We're in the early phases of that, and things are proceeding very, very well. We've had some early sales data, which we put out, and we expect tremendous growth from here.

Great. I think we'll start with revumenib. Revuforj is the brand name, obviously. It was recently approved, as you said, in a subset of acute leukemia, KMT2A translocations, adults pediatrics. Maybe you could just like talk to us about the population and the opportunity there and also help us understand like the clinical data that led to that approval.

Sure. So this is an area of very high unmet medical need where patients have a very poor prognosis. KMT2A acute leukemia affects about 10% of AML and ALL. So it's a significant portion and an identifiable portion. So the patients are tested for KMT2A because they have a poor prognosis, the standard of care treatments that really help them. So we are the first with a menin inhibitor to be approved. We have really significant profile across the board. The data speaks for itself. I think physicians are excited about the fact that 2/3 of the patients in our trial got to a response. What that means is they've wiped their tumor, really cleared their tumor and that allows for these patients [Technical Difficulty] in our trial, these 35 years of age. So younger patient population affects a lot of pediatric patients. We do have, as you mentioned, an indication for adults pediatrics, AML and ALL. So it's agnostic across the board indication one of its kind. So we really cover all of the different populations, which is really, really important. Going back to the data, 2/3 of the patients get to a response. Many of those patients go on to get a stem cell transplant, which is the goal of treatment for these patients. And the ability to actually get a transplant and then go back on a maintenance treatment in the relapsed/refractory setting is exactly what physicians want to do with this drug. And it is exactly what they're starting to do in the commercial setting. We saw it in the pivotal trial and to be able to transplant 25% to 50%, maybe more percent of the patients that we see, that is a game changer for these patients. And so we are well on our way to achieving that, and it's a really exciting time.

Yes. Like at the early stages of the launch. You, I think, had $7.7 million in the fourth quarter. That was only a couple of weeks, $20 million in the first quarter. Maybe you could characterize the demographics driving the early launch with respect to the prescribing population and like the patients that are coming into therapy.

Yes, absolutely. I think any good launch starts with great execution that starts with the people. So we hired a great team. Our customer-facing team is some of the best in the industry, a lot of experience at launches working at biotechs like this. They know their customers on the HCP side. Payer side, no different. We've been in market for 1.5 years talking to payers and building up a great trade team. I think all that's paid off. So when we think about fundamentals of a launch, you need an active and growing user base. We have that. We've given some markers over time. We have these Tier 1 and Tier 2 institutions, a couple of hundred of the largest academic centers in the country. They represent about 2/3 of the opportunity. We've got more than 50% of that group prescribing. There's also prescribers at smaller academic centers as well as community oncology. So that's great. On the payer side, we were getting claims paid very early on even before formulary coverage was being established. That's obviously advanced. Our formulary coverage now is well north of 90%, which is pretty good 6, 7 months into launch. And the last piece is a very effective trade team and some great specialty pharmacy partners. These patients are very sick, as Michael said, days matter. So our goal and what we've been able to achieve is patients on drug on average less than 5 days. It will all lead to better treatment progression. And when you look at those markers, those metrics targeted AML therapy that we can look at that has numbers as good as that. And I say that because off to a good start, we expect very good things in the near term, midterm and even the long term, we've got to make sure we're executing.

I think on a like week -- adjusted per week basis, sales were somewhat flattish, a little up in the first quarter, but I imagine there were some dynamics going on the early launch. Can you tell us about anything inventory bolus, patients transferring over from clinical studies, like what drove some of those early launch dynamics?

Sure. In terms of the growth, we believe there is growth from quarter-to-quarter. I think some of that explanation is simply in inventory. So that first quarter of 7.7, fully 1/3 of it was stocking. So that stocks the channel. We're not going to give exact guidance on inventory changes by quarter, but you can expect it to be in the 2- to 3-week range. So the inventory component of Q2 was very small. I think how you have to think about the market, and Michael laid this out really within the clinical data. There are roughly 3 different pathways of patients. You need to understand each one to see how that evolves and then how does that ultimately contribute to sales. The first is the goal of treatment, right? These are very sick patients, best chance for them for a cure, if they're fit is to get to transplant. So that patient will be on treatment for some period of time, go to transplant. There's roughly a 90-day window on average. We'll call that a drug holiday where patients are off treatment, so the engraftment can take place and then they're back on treatment, right? And we believe that's a patient that will be on drug for a very long period of time. That second set of patients are ones that may not be fit, they will get some benefit from the drug. They will be on for some period of time. And the last piece of the patients that may not respond, and that's always going to happen. When we think about the dynamics of a launch like this, there are patients in market -- and when a new drug comes out, there's a lot of excitement. It lasts maybe the first 6, 8, 10 weeks or so where a lot of different patients are put on drug. So you've got patients at first relapse, which is where the drug is indicated for. That's where physicians tell us they want to use it. And then you've got patients all the way out to very later line, which are like the ones in the trials, we'll call these hospice patients. So it's a mix. Over time, it's going to move earlier. So better quality patient, better chance of them really [ going ] to transplant and ultimately maintenance, and that's how it's evolving.

So as you think about what's going to drive revenue here, is it going to be about -- like how -- to what extent is duration versus new patient growth drive sort of like the opportunity?

Great question, and it's both. You can't have one without the other. We've shown that we can find KMT2A relapsed/refractory patients. We'll expect by end of the year, we'll be above 50% of penetration in that market. That would be a great number. Each month, there are more patients coming in for treatment, which is great. So that's one component. That will continue to grow. The second piece is the duration piece. So I'd think about it this way. In part, where we are in the year, the quality of patient, as mentioned, it will go earlier. So you'll have more success in that patient. But we would expect duration of treatment roughly in the 4- to 6-month range in this year, and that's a blended rate of all patients. And that will move out. Over time, as more patients go to transplant, maintenance, it will move closer to 9.

4 to 6 months this year, like over time, what did you see in the trial? Or like how are you thinking about what should guide us -- guide our expectations for duration over time?

The trials really suggested 9 overall. And that is, again, that mix of patients, transplant maintenance, those having some effect, but may not go to transplant and those that didn't have a benefit from the drug.

I think just to add on here, I think the efficacy profile of the drug really suggests that they're going to use this as early as possible in treating KMT2A and also with NPM1. And I think that will drive the utilization longer. More patients will get to transplant if you treat them earlier, more patients will go back on therapy post-transplant. I think this really changes the dynamic with a great efficacy profile where you've really distinguished yourself from others. You can get patients on, you can keep them on. That's really the...

In that maintenance setting, the post-transplant, they've come back on, what triggers like people staying on therapy versus coming off therapy? Is there a stopping mechanism?

No. I mean it's up to the individual treating physician and the physician -- the patient. I mean this is a drug that's really well tolerated. And physicians typically look at it, this is the drug that got the patient to a response and clear their tumor. In difficult diseases, that's really critical, and they want to keep that response in check. So they look to put the patient back on that therapy in a post maintenance or in a maintenance setting in order to maintain that response. And so physicians are -- with a drug that is well tolerated, there's really no reason not to do it. There's only upside. And so that's how they think about it.

Is there additional data that they would like to see or that you would like to generate that would help physicians understand how to use this drug in a maintenance setting?

As Michael said, they want to do this, and this is what they've done with other agents. We were just at ASCO. It was a great opportunity to meet with customers. We conducted an advisory board. We had 10 mostly hemes, some transplanters, top institutions around the country, and this is what they want to do. So in terms of is there more data, we'll generate more data over time. Some of it's going to be real-world data. It doesn't take -- we talk about competitive immunity and where do you create the muscle memory to use the drug. It tends to be about 2 to 3 patients. And we're getting there amongst many of our bigger treaters. So they'll gain experience, and we'll provide it with supplemental data over time.

Yes, there will be a lot of data that will continue to roll out over time as we look at. We've also published some data already in the maintenance setting, which has been helpful to physicians think about that.

Understood. Maybe we should talk about NPM1 AML. You've reported the registrational data here. The supplementary NDA is currently under review. Maybe like talk to us about how this gets to market because it's not necessarily strictly about the regulatory process. So talk to us about how you get this to patients.

Right. So the key is getting it to patients, and we are excited. Obviously, we're the only menin inhibitor approved. We have KMT2A, and that affords us the opportunity to publish the data and then submit it to guidelines, which we've done. And so our expectation is that we'll have guideline coverage very soon, hopefully, and we expect that before approval. The drug has been, as you noted, submitted as an sNDA for this -- for the NPM1 indication, and that will be -- we'll have our PDUFA date soon. So we expect under priority review, we'll be able to have that drug approved in October. So the steps here, getting into guidelines, getting the drug approved this year, both should happen, and that is the most expedited way to get the product to patients. So that's good.

So you have obviously, the registrational data. There's a competitor that's shared registrational data as well. Could you review the data that you've shared with a focus on what some of like the key metrics are and how those compare to the others?

Look, we're thrilled. We came out of ASCO. We finally saw some competitor data in their NPM1 pivotal trial. I think it's very clear that our efficacy profile is the best there is, best-in-class on all measures. And I would say a couple of things stand out. First of all, overall response rate, which is the measure of clearing your tumor, this is what physicians want to see. They want to see the tumor go away, right? And so in about 48% of our patients, that is -- that was the case. And that compares to our competitors about 1/3 of their patients. So very different overall response rate. And then you think about CR/CRh, which is the regulatory endpoint, were 26% -- they were 23%. It doesn't seem numerically different, so numerically different, but it is superior for sure. And I would say overall survival is a big measure of this as well. In our patient population, we are at 23 months, not only in the patients who reached the CR/CRh, but the overall response rate. So in the 48% that I mentioned before, that overall survival -- median overall survival is out to 23 months compared to our competitor at 16 months, about a 50% difference. So we're talking about the most efficacious drug. This is an efficacy-driven market. Physicians are most concerned with that. If you have a loved one, you want to get rid of the tumor first. Drug is very well tolerated across the board, ours is. I would say our competitor showed some additional side effects such as pruritus, which is pretty significant that's itching. When you remove the drug, it doesn't go away. So this is a potentially an ongoing side effect for them to have to deal with. So our profile in terms of safety, tolerability, risk benefit and the best efficacy, which is what physicians are really driven by, that's what stands out for us.

Obviously, whenever we're comparing trials, there's significant caveats. Anything in particular you'd highlight from a baseline patient characteristics perspective or like the way the trial was executed, where it was executed, anything that we should be keeping in mind as we think about comparing these 2?

No, I would say just in our patient population, the vast majority of patients, about 3/4 of the patients were treated with prior venetoclax, which is a very difficult regimen to treat after. We showed excellent efficacy in the patients that were treated in the trial. So that -- you often sort of look at that as a comparison. But overall, I would say this is an international trial. So we did enroll patients all over the world, a lot of them in the U.S., a lot of in Europe and so forth. So it's a -- what we say is a representative patient population, third line.

Okay. One of the things that we've heard spoken about is the QTc prolongation. Maybe you could address that just like how -- I'll just lob it to you with that.

Non-issue. QT is a side effect that a lot of drugs in AML encounter, including our competitor who had QT, grade 3 QT. So it's more of a class effect, I would say, of these drugs. In our case, easily identifiable, monitorable. It goes away. If you get to a certain level, Grade 3, we dose adjust. Patient doesn't come off drug, they continue. It's very easy for the physician, you give an EKG to assess this. They're not walking around with QT on an extended basis. So nonissue, really easily managed for physicians and...

What about monitoring? What are the monitoring requirements?

So by label, it's once a week for the first month and then monthly thereafter. So there's pretty liberal based on what the physician feels is the right thing. These are patients who are in the office, they're getting EKGs. They're getting EKGs for any number of drugs that they may be taking. So this is standard practice, not an onerous practice at all for physicians and everybody knows how to do.

Okay. On the October time line for approval, but guidelines could come any time. Do we have any sense when the guideline changes will happen? And how quickly does new guidelines get implemented in AML practices?

Yes. I mean I think one analog is simply the Revuforj initial indication as well as Niktimvo for chronic GVHD. And those were off cycle and in the guidelines. And Niktimvo, I believe, was 2 weeks. Revuforj was under 4 weeks. So it can happen at any time. For these particular guidelines, the manuscript came out in May. We immediately submitted to the NCCN guidelines. They did have a meeting on May 19. We're not sure. They don't confirm what they talked about at their meetings. But I would -- we would expect it to happen any time, could be this month. And certainly, as I think Michael said earlier, before the approval comes. It will come within this window.

And so then once they get on guidelines in terms of reimbursement, is that sufficient? And in terms of like physicians changing their practice, would you expect to kind of that to be the trigger for doctors to start using this?

I would say it's another trigger. It's another driver. It's already being used to a smaller extent in NPM1 and other off-label indications. Payers are paying claims. We believe from what we can tell, they are paying even for off-label claims. That's not uncommon. The guidelines themselves would be a driver, so that will -- for payers and for physicians. The larger medium-sized academic centers, I mean, NPM1 patients relapsed/refractory is as severe a patient to treat as a KMT2A are relapsed/refractory as they really have nothing. So physicians over time have used drugs because they've had to. Revuforj [Audio Gap] in terms of education on NPM1 data as an organization, you can tap into the SIUU guidelines, which are FDA guidelines on medical affairs sharing information with interested clinicians. So that's something that you need a peer-review journal, which we have. We have a sizable MSL team with great relationships. So that will start and that will impact as well.

Okay. There's obviously been a number of drugs approved in AML and different kind of genetics subsides. So what are the like precedent launches in other areas of AML tell you about what to expect from a launch perspective as well as like how much does first-to-market advantage matter?

I'd say -- I mean I did mention some of the analogs earlier, penetration into the marketplace, formulary coverage, getting patients on drug quickly. So those were all ahead of. The obvious question you get a new patient and duration. So we've kind of already covered that. We feel like we're in a really good place. In terms of first-mover advantage, this isn't a concept, obviously, we've made up. That's what the marketplace dictates. I did mention a couple of questions ago, how long does it take for a physician to gain experience with the drug. And the muscle memory they create, it's for the physician, it's the nursing staff, it's the path lab, it's formulary. It's all those aspects of any institution that has to get educated on the drug. So there are hurdles to utilization. We've gone over many of them with a large part of our customer base. That will continue. It takes 2 to 3 patients to really gain some experience. And that's very long lasting. So question is when another similar drug comes out, would I use it? I think as Michael laid out, we've got a drug that will have 2 indications, much broader population, adult pediatrics down age 1. The drug is easy to use, easy to dose. It's a high hurdle for -- and the payer side as well is it makes it challenging. So they need a reason to use any new drug. And from what we can tell based on their data set, there's just not a lot of reasons.

Yes. And I would add, if it's the most efficacious drug, it's even better, right? Added to what Steve said, I think that is the key point. That's what they're going to reach for.

Okay. In terms of overlap between the prescriber population that's already using the drug in KMT2A versus NPM1, like you talked about tiering the patients for -- you heard me. So why don't you just tell me a little bit more about like the overlap there and how that will advantage your early launch in NPM1?

There's complete overlap. It's the same treatment centers. You may see a little more interest and willingness to prescribe for NPM1 patients in the community and smaller academic centers. They just see these patients more. And at first diagnosis, there -- it's a positive prognosis and then eventually, it's not. So they have some additional experience. What we've done is we sized the team and focused the team on the full audience really at our initial launch in November, knowing that we were going to eventually get an indication. So we're covering the full audience, same treaters. Nothing else really changes. So we're already in the places we need to be for the future launch.

Steve says we're everywhere, right?

I think you guys have said -- like described the opportunity between the 2 is about $2 billion per year estimate. I guess what does that embed in terms of duration of treatment, annual cost, penetration, et cetera? How should we think about those estimates around the size of this market opportunity?

Right. So $2 billion is both KMT2A and NPM1. That's a TAM that assumes a $40,000 a month price and roughly 5,000 patients or more, a little bit more, 2,000 KMT2A, 3,000 to 4,000 NPM1, duration of treatment somewhere in the 9-month range as we talked about earlier. So that is -- and the difference is between the amount of patients going into transplant, and then how long maintenance goes on for KMT2A versus a component of patients who are going to go to maintenance for NPM1 after their transplant. That's -- those are some of the variables that will drive it perhaps even beyond that number, but I think it's a fair estimate based on the [ epi data ] we have.

Okay. So duration, are they the same in both populations, KMT2A?

Duration, Roughly, I mean, we think about it in terms of time on treatment. It takes a little bit longer to get to a response for NPM1, KMT2A. So the KMT2A patients respond within about a cycle, 1.5 cycle or 2, and it's about an extra month for the NPM1 patients. And then you have to measure duration of response. Duration of response in our KMT2A trial was 6.4 months. NPM1 trial was 4.8 months.

So the net of this and...

Net of it is similar, very similar.

One of the things that could expand this market from there is just a frontline opportunity. So talk to us about the development priorities as you look to go into earlier lines of therapy.

So the highest unmet need is the area that we're starting first, which is ven/aza in the unfit population. We're doing a combination trial. We actually have data at EHA that's being presented this week in that patient population in the Beat AML trial. But this is an important population where the unmet medical need is high. The opportunity to add to ven in that setting, we will be the first to get to the front line in that setting based on the fact that we started our trial. We've enrolled patients, and we have the most data presented to date by a long shot in that population. So we're quite keen to move ahead there. And then the other population, of course, is the unfit population where 7+3 is used, and we're finishing up our Phase I. We'll take the dose that we confirm in that trial and start 2 Phase III trials this year, later this year to get at NPM1 and KMT2A separately. And those are, of course, that's the other half of the frontline population together. We should have trials, 3 registration trials going on before the end of this year, covering the broad landscape. But the priority is to get this to as many patients as possible as quickly as we can. I think we've been able to demonstrate the combinations are first in with ven and ven/aza, quite well tolerated efficacy and we can add to the standard of care. Now we're seeing that in our Beat AML trial. We've incorporated things like complete response as an accelerated approval endpoint in our protocol in order to get to that important point as quickly as possible and then confirm it with OS. So these are the right designs in order to get to the...

So speaking of the Beat AML data at EHA, I guess, what are the things we should be paying attention to in terms of those results?

Right. Great results. We're thrilled by what we're seeing in that combination. I think the investigators are really excited about it. We believe it will help drive enrollment in our pivotal trial. I would pay attention to the CR rate and the MRD rate. So CR is in our trial as of now in 43 patients is 67%. I'll just draw your attention to VIALE-A, which is the approval trial for ven/aza. The CR rate was 37%. So quite big delta between what we're seeing and what was reported again cross-trial comparison, but I think that gives us an indication. MRD in our trial was 100%. In the VIALE-A was 23%, so very different. And those endpoints tend to correlate with survival. So that's why you can use CR as an accelerated approval endpoint. So that gives us a lot of confidence that we're going to see a very nice margin of improvement in that trial. So I would pay attention to those things. We do report on a very early basis, overall survival. In the VIALE-A trial, they looked at it at 20 months, and they were at 14.7 months of overall survival. I think when you look at our 7-month cut, which will, of course, we'll do additional cuts that the investigators will, we're beyond what they showed in VIALE-A, we're 15.5 months. So early cut gives us a lot of confidence. We know that CR and MRD correlate with OS. So that's the idea. So we expect to really improve on that.

What does the registrational program look like or a registrational trial look like in that patient population? How many patients in control arm?

Right. So it's the control is ven/aza. We do -- we add to that. So it's a triplet. It's a 410-patient trial. CR is the accelerated endpoint and then OS is the confirmatory primary endpoint. So these are dual primaries. We'll enroll very quickly, we expect based on the data we have in hand, people are excited about this trial. So we expect to be there in the next handful of years ahead of competition, and then we'll confirm it with [indiscernible].

Okay. Maybe -- I think you've described an overall $4 billion opportunity once you start layering in these. As you think about like what we're going to unlock with each one, can you help us understand like proportionality between the different populations you're going into registrations for and what like are kind of the most important?

Right. So the highest unmet need is what I mentioned is the unfit population. These are older patients. They are patients that don't have the fitness to get chemotherapy. So they need treatment, and they need to stay on therapy for an extended period of time. The tolerability is also very important. Safety is very important. We've been able to demonstrate that we don't add any liabilities to the ven/aza regimen. So we're in a great position. It covers about half the market. So that's -- again, that's a very high priority for us. When it goes to the fit population, we're segmenting out KMT2A versus NPM1. KMT2A, again, very high risk. NPM1 segments into high-risk, medium risk and lower-risk population. So there's a mix of patients with different prognosis. So we'll be able to get at that with our trials. So I wouldn't say there's one area of priority versus the other. I would say the highest unmet medical need is in the unfit population. That happens to be where we're deploying our resources first, but it's closely followed by these other 2 very important populations.

You said this, but I would like for you to just double-click on it. In terms of overlapping tolerability, any concerns as you start to think about combinations of ven/aza or some of the other drugs that you're looking at?

No. I mean we've seen ven/aza in the relapsed/refractory setting. We've seen ven and Cobi, which is another hypomethylating agent, really not adding toxicity to what you see with ven alone or ven/aza or ven and Cobi, for instance. So we feel great about that. Patients are able to stay on drug, low rates of discontinuation and really drive very high efficacy. So we feel really great about that. With chemotherapy, we tested in the relapsed/refractory setting, and now we're doing frontline newly diagnosed patients with 7+3. In the relapsed/refractory setting, we did FLAG-IDA, which is another regimen of chemo. And drug is really well tolerated, saw, again, excellent efficacy across the board. So we expect to see the same sort of risk benefit on all of these combinations, really not adding significant tox in any particular area.

Great. Maybe we can spend a few minutes on Niktimvo. I know we don't have a ton of time left, but let's just start with a bit of background and talk about like the launch came in August, so we can do a bit of background on how the launch is going.

So I'll just give a little background, and then Steve can talk about the launch. The product is a CSF-1R antibody, which we in-licensed several years ago from UCB and have directed it to third-line GVHD. So the approval came. It's a new mechanism of action, and the product is really going after fibrosis and inflammation. So it's a new paradigm for these patients who really have to deal with intractable disease over many years. In our trial, we saw patients who had been on drug an average of 4 years. And so resolution of symptoms is key for these patients in areas such as the lung and skin where they just can't get relief. And so we were able to see it quickly with these patients. They respond quickly. They stay on drug. But I think it's just so remarkable and what we're seeing is patients are not staying on this for months. They're staying on it for years, seeing it through our trial, a very high percentage of patients still taking the drug from our trials. It's rather amazing multiple years. I expect this drug to really expand the category. We're talking about 6,500 patients in the third line plus, talking about 15,000 patients in the U.S. frontline and later. It's not an insignificant patient population. But if you could take a very significant share and extend this for years, I think multiple myeloma, things like that. I mean it's really an underappreciated market opportunity. So we're thrilled with how the drug is performing. Steve can talk a little bit about the launch, but it's really exciting.

Yes, I can certainly talk for our partners is Incyte on this product. So they've really pretty much created the chronic GVHD space. So running start to this. And then the drug was approved in August, but didn't hit the market until late January to [indiscernible]. So it's really been just a stub quarter. So net sales were about $13.6 million. But like I said earlier, in terms of execution, you look at user base, the transplant audience is small. It's very focused in the country, maybe 150 transplant centers that capture 90-plus percent of the transplants. All of them, I would say, at this point have prescribed, many have reordered. What we're hearing early is what we saw in the clinical data, early response, a durable response. I mentioned we were just at ASCO, and folks were coming up to our booth and Niktimvo booth actually sits with an Incyte. But even at our booth, which was Revuforj, physicians came up unsolicited and started talking about what they're seeing in patients. It's an insidious disease. Patients have really suffered through leukemia. They've gone through transplant. And then they have this long-lasting highly symptomatic condition that questions they will to live, honestly. So the ability to treat patients early has been great. The feedback has been excellent. Payers are paying for the drug. So a very, very encouraging start. REZUROCK is often the drug we use as the analog. It's a $0.5 billion brand and growing. And we did in 2 months, which took them about 6 months to do in terms of activating the user base. So really good stuff.

Maybe we can spend a minute on like cash flow, balance sheet. I think you guys have said that you're confident that you're funded to profitability. Can you help us understand the path to profitability? Like what point do you flip to being cash flow positive?

Yes. Look, I think we control our own destiny. We say we're going to be profitable in the next few years, and I think that's a really solid statement. The products that are contributing are twofold, right? So we have Niktimvo, which is a very high-margin product, basically profitable in the first 2 months. We think that will meaningfully contribute to the profitability of this company. And Revuforj also ramping quickly. And we know that those expenses are kind of fully loaded in the P&L at this point over the next handful of years. So we don't expect expansion of expenses. We don't expect expansion of SG&A expense, R&D expense, SG&A. So we're kind of where we are today, and we feel very good that with expanding product revenue and very good margins that we'll have contribution from both and get to profitability in that time.

Probably goes without saying, but does that include the Phase III programs that you guys have talked about?

It Includes everything. Includes everything, absolutely.

Given that, how would you think about bringing in additional assets from here? Is that something you guys are interested in? And what kind of criteria?

Yes. Look, I think we could probably talk about new assets in the future. I think we are so focused on driving value with these 2 franchises. We're in a very unique situation where we have 2 approved products that are best-in-class and really differentiated in their markets. And our job is to bring it to as many patients as possible and drive value for Syndax shareholders. So I think we can do that successfully with these 2 products in a way that other companies can't. So all of our energy, all of our resources are really going into achieving that. So new products, we'll talk about that maybe some time later.

Lots to do. Lots to do in the existing portfolio. Wonderful. Well, thank you guys so much for joining us. Thanks to everyone who joined us here and online and really appreciate the time this afternoon. Thanks so much.

Thanks so much.

Thanks.