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Conference · 2026-09-15

Neurocrine Biosciences Inc (NBIX) September 15, 2026 Conference Transcript

Concluded Sep 15, 2026 Audio replay
Sep 15, 2026 36:04 36 turns
Period
2026-09-15
Runtime
36:04
Sources
2 artifacts

Transcript & audio

36:04 Audio
Sean Larman Analyst — Morgan Stanley

Good morning, everyone. I'm Sean Larman, Head of US Mid-Cap Biotech Equity Research here at Morgan Stanley. Before we commence, to make you aware of some important disclosures, see those disclosures at the Morgan Stanley Research Disclosure website at www.morganstanley.com forward slash research disclosures. And if you do have any questions, please reach out and ask your Morgan Stanley sales representative. With that said, we have the pleasure of welcoming from Neurocrin Biosciences, their CEO, Kyle Garno, and from IR, Todd Tushar. Welcome, gentlemen, and thank you both for your time today. Thank you. Maybe just to kick off proceedings before we get into the heart of Neurocrin, just a question, just a few general questions on the macro side of the equation for biotech. How is the rise of China-originated innovation changing, if at all, your competitive outlook, and does it influence your BD and R&D playbook?

That's a great question, very timely at Neurocrin, I know, industry-wide. You know, my view of China is that they are a competitive force, but at the same time, they represent an important source of innovation. And I think that those views, I think, at a high level seem to be diametrically approached. But a lot of us, I think, would share that same sentiment. And even on the competitive side of the equation, competition can be a good thing. It can bring out the best in all countries, parties involved. I've seen that at Nurekren over the years, in particular when it comes to things that we're developing in competitive spaces or commercially. And I'm confident that the United States will do well to compete in this area. But coming back to China, what I've seen over the course of the past decade, a lot of changes in the region. The speed, the quality, the breadth of the science has really improved. And I think that's something that we appreciate. The competitive bar has been risen, in particular in areas of validated biology. And for us, that really expands the universe of innovation that Neurocrin and other companies can access. And we have done that in the past couple of years. We have been in China and been successful in bringing in mainly earlier stage assets that are not material for the organization at a high level. But we have used some of the work that they've done to help us accelerate some of our interest in research. But how does that change things at Neurocrin today? I would say fundamentally it doesn't change our view on the mix of internal R&D versus business development. It does change in one important way, and that is the importance of speed and selectivity. Selectivity, I mean by that, what you choose to invest in. For validated biology, being right about the science is no longer the most important thing. It's really developing a compelling and efficient drug development plan that allows you to be first to market, or nearly so, and also having that same plan be one that shines a light on all your points of differentiation throughout each point of development. And that's something that you have to keep in mind now as China opens up access to a new source of assets and technologies for companies in the sector. The other thing I would call out that I think we'll see more and more of, perhaps even at Neurocrin, is leaning into the Chinese ecosystem to help accelerate development. And this can occur in one of two ways, either directly through a more CRO type of relationship or, from what I'm seeing out there, companies striking collaborations on the same assets and technologies that I just referred to, but allowing their Chinese partner to develop the asset that comes from that collaboration, say, through the end of phase one. And then the company here in the U.S. catches that program as it comes over the ocean and finishes the development plan here in the U.S. and then commercializes it. The benefits, again, speed allows the company to look at that as a multiplier in terms of programs that they can bring into the portfolio per unit of time. it usually comes at a less of a cost which is a benefit as well so they can do more with their r&d dollars and i think it goes back to an earlier remark it's also a remark it's also done with very high quality so for neurocrine that doesn't mean we're moving our r&d to china but it does put china squarely in the global community of what we want to access to make neurocrine better and faster for drug development great answer thank you carl and the next question on on ai so are

Sean Larman Analyst — Morgan Stanley

you're implementing AI across your business? And can you give an example where it might have changed a decision, a cost outcome, or even a POS?

Yeah, no, I think it's another great question. For AI and machine learning technologies, it's been something that we've been very deliberate and intentional incorporating through our organizations. Actually, in our corporate goals now, there's an element of that last year and this year as well. We have brought in over a year ago i'd say in 2025 open ai and that's certainly a tool that's used broadly across the organization now we also have anthropic through claude that we're using across the organization now so both of those are available for our employees i would separate productivity gains from claims about ai suddenly changing or transforming research and development and i would like to touch on the productivity games piece first and i'll come back to R&D, but on the productivity gain side of the equation, there's a lot of near-term opportunity I see for NeuroGren. The employees have adopted it in several different ways, but I can see it accelerating some of their workflow. I've seen it being used in areas of the company that interrogate large data sets. They're able to move through that more quickly. There's a lot of redundant tasks that are just very tedious in nature that have been minimized. And just generally, information and knowledge that individual groups might have has been made much more accessible across the organization. That's benefited us as well. So I've seen it in medicinal chemistry, chemical development, chemistry broadly, translational science, clinical development, clinical trial execution. And I would expect that to continue as we look at the next year or so. The challenge, I think, where most of us run into problems is how do you monetize or see if you're making improvements across your organization with the technology and for us it's all about outcomes and kpis standards that we can attach to specific problems and in every organization there are just repetitive decisions that come up and for us using ai can we make those decisions faster when it comes to repetitive tasks or activities can we get through those more quickly or in a more cost-effective manner? When it comes to clinical trials, can we enroll our trials more quickly with AI tools? Ultimately, what it's going to come down to when we think about an organization in its entirety, can you move through more science without having to proportionally increase the size of your organization? So I know we often talk about increases in headcount or decreases in headcount for AI. I think in the near term, the opportunity is, can you minimize your growth using AI based on some of the outcomes I just described? So those are the areas that we'll look for improvements and how we'll look to measure them over the next couple of years. I do want to come back to the R&D side of the equation. I think right now it's still early days and how we think about improving probabilities of technical success across the R&D portfolio. And the reason for that is, you know, the whole idea of machine learning, AI, is that you need to have data populate your project in order for it to get reasonable outputs. But if you're working in novel areas of biology, it's very unreasonable to expect what you get from that project or from that programming, if you will, is going to be helpful in improving your probability of technical success. So that's a more mid to longer term view right now. I think there's a lot of near term opportunities for us.

Sean Larman Analyst — Morgan Stanley

Wonderful. Thank you, Colin. And last question before we dig into the specifics of Neurocrin, but which policy variable, FTA, Medicare negotiations, MFN, tariffs, or global pricing matters most to your economics? And what have you changed, if anything, because of it?

Well, we just had our first 101 here before this meeting, and I can tell you it all goes back to Ingressa and our Medicare negotiation. So this is our version of the Inflation Reduction Act. For Ingreza, we're exposed in a couple different ways. Two specifically. Directly, we have our IRA moment where our MFP, our maximum fair price, is implemented in 2029. But indirectly, we're in a two-product category, and our competitor in this space has their IRA moment two years before our own. So there's an unintended consequence, if you will, for MFP and MFP-adjacent products that we work through. So I think that's something that is tangible to Neurocrine. unique to Newark and we spend a lot of time talking to you all about that and it's probably worth maybe another question on how that looks for us but for me when I think about policy I'd like to separate policy on a singular product like Congreza and policy and how it might affect our long-term strategy and at Newark and we're not building the company to predict what comes out of Washington that's that's a slippery slope but we are trying to make the company as strong and as resilient and each and every day make it better across those two metrics. And for us, that means diversifying the source of our growth and the durability of our growth opportunities. So Ingresa is a great medicine. You know, we've guided a 2.825 to 2.875 billion this year. The market continues to grow double digit each year. We have patent life out to 2038, but it's not just the growth opportunity through Ingresa. We have now Cronicity, a medicine for congenital adrenal hyperplasia that's on an annual run rate of 750 million now. So that's another piece of our growth story. And more recently, we acquired BicatXR, which we're about a little more than a year into launch, and we're about a 400 million run rate right now. So a lot of growth across our commercial portfolio. And when it comes to the durability of our growth, it really focuses our attention on the pipeline. So we've got an industry-leading muscarinic and depression pipeline now with Osef Amplitor and Direcladine that will read out phase threes next year. We see that as a near-term opportunity for growth. And then we've shown our ability to have a sustainable R&D engine, putting new programs into the clinic each and every year. So ultimately, the best hedge against policy for us is multiple growing products, a deep diversified portfolio, a good cash position, and the financial capacity to keep investing despite what happens externally.

Sean Larman Analyst — Morgan Stanley

Sure, great answer. I mean, if you go back 18 to 24 months, you know, Neuroquin was largely in Greza's story, but now you've got, you know, three commercial products. You've got pretty catalyst-rich sort of six to 18 months coming up. You've got two major phase three readouts next year in Ausebampertour and DirectLadine. You know, how would you characterize the outlook for the business, you know, through 2027? happen?

Yeah, we've really been focusing on building the business, not just inside our commercial portfolio, but outside across our portfolio as well. And that means adding new programs to phase one and advancing those programs that were in early stage to mid-stage and then, of course, phase three. But maybe just to start from the top, and I won't go through all the programs in detail here, but three first-in-class medicines in Q2 generated almost a billion in net sales and we think about neurocrine you know one of the one of the messages i'd like to leave with you all is that the company's really evolved into a diversified multi-product biopharmaceutical company so when we talk about the three first-in-class medicines you got ingressa continuously delivering on a commercial from a commercial perspective you've got a great launch with chronicity and now we're integrating vicat xr diversification is obvious they're now 25 percent of our revenue in Q2 came from Cronicity and BicatXR. It used to be just an aggressive story, and as I mentioned, we've got other commercial products now to talk about. And then when it comes to those medicines delivering for us, they generate a ton of cash flow, and that's able to help fund our late-stage pipeline and also our emerging early-stage pipeline and continuously giving us the flexibility for business development. So it really sets the stage quite well for what we want to do for the company moving forward. It does go back to executing on the clinical trials that we set in motion a couple of years ago. If we do those well, then that's when the data readouts come next year. Sure. Those of Ampitor directly in phase three readouts starting the second half of next year into early 2028. We have phase two readouts with our next generation VMAT two inhibitor, which is NBI 890, as well as another muscarinic program is schizophrenia in early 28, and the list still goes on and on. The idea is that the data catalyst that we have next year will be more the norm, and that will set the company up quite nicely to hopefully deliver a new medicine every couple of years.

Sean Larman Analyst — Morgan Stanley

Wonderful. Thank you. And maybe just to hone in on Ingressa, so the re-acceleration and the growth, we've got an upgrade for this year. What's driving that?

Well, we've learned a lot since we've launched the medicine in 2017. I think through trial and error, if you will, the two things that really accelerate growth or magnify our investments is having the right share of voice out there. So that means the right-sized Salesforce. And we did go through a Salesforce expansion this year. It was concluded in Q1. We saw the benefits of that already earlier in the year, and we expect that to continue to compound as we get through the remainder of the year. So share of voice, Salesforce sizing, That's very important, and also having strong access, and we've got that as well. With Ingressa today, we cover about 70% of all Medicare beneficiary lives, and that puts us in a good spot to get access for the patients that need the medicine. Those are the two main drivers on that. And, of course, messaging the data generation that we've had over time, we've shown good data on quality of life with our validated instrument. We've shown good remission data. 60% of patients on Ingressa are symptom-free. and we've also shown recently good pet data which shows target occupancy that's superior to our competitor in the space all that gets to get pushed through that sales force sure and that's a very compelling story uh for us out there awesome i've got a couple of ingress of pricing questions so net price i believe was expected to decline four to five percent this year is that still the right framework heading into 2027. So for us, the headwinds on the 4% to 5% price delta this year really comes from the contracting that we did last year. So the 45% is relative to last year. This year, our price prescript, our revenue prescript has been relatively consistent throughout the year, and we expect that to be the case as we think about the remainder of this year. Of course, in 2027, our competitor in this space is going through the first year where their MFP is implemented, and we do expect some price concessions with the plans, the payers that we're currently on contract with to maintain that same level of access for 27. That will be pretty nominal, but I would also point out that we do have an increase in the statutory rebate that we pay for sales that go through Medicare Part D, in particular the catastrophic phase, that phase in that all companies that have the same exemption of us, the specified small manufacturer exemption, that statutory rebate will go from 2% this year to 5% next year, and that's on the WAC.

Sean Larman Analyst — Morgan Stanley

Thinking longer terms, I just answered my next two pricing questions, but how do you maintain a stable growth on the top and bottom line through 29 implementation year, and how much does that answer depend on Cronesty continuing to outperform?

Well, in terms of Ingresa, it's worth repeating that we continuously see double-digit volume growth out there each year. The market is incredibly robust. We've got about 10% of the 800,000 patients or so under the care of a VMAT-2 inhibitor. So there's plenty of room to grow in this marketplace still. And even despite the price concessions that we pay next year, 27, 28 are going to be revenue growth years as well as volume growth years for us, of course. So in 2029, we do have our IRA moment there, our MFP, our maximum fair price would be implemented. We start those negotiations next year, and recall, because we had the small biotech exemption, we know that's going to be within a band of about a 25% to 34% discount off of this non-FAMP number. This is the federal average manufacturing price. It's a little bit nuanced on this, but ultimately, it's a number that you're discounting from a 2026 value that comes into our negotiations. We would expect revenue to dip in 2029. So what it means for overall enterprise-wide revenue is going to be a function of how well Crenestine by CatXR grows. I'm certainly happy and glad that we had these two medicines in our portfolio because they will be growing over this time frame. We also have the opportunity to potentially see Osev Ampitor and Direcledine pay off over this time frame and be commercial products in that 2029 time frame as well. They probably won't offset coming out of the launch necessarily the revenue that we'd want to see for two blockbuster medicines like those two, which we believe they will be. But we have a lot of financial capacity to continue looking externally as well if we need to.

Sean Larman Analyst — Morgan Stanley

Sure. Thank you. Thank you. Moving on to Cronesty, you know, very strong Q2 numbers, more than tripled what you did in revenue like a year ago. I think you're now 15%. Yeah, that's right. Yeah, 15%. So six quarters in, you know, what do you need to see before we'll be able to get some revenue guidance?

Todd Tushla Head of Investor Relations

Yeah, this comes up now and again in investor one-on-ones. What I would say is, like you said, we're only six quarters in, and the launch has been great, but we're still learning a lot about the marketplace, learning a lot about the endocrinology community, the patients, where, when, and who they seek treatment from. So it took us four years before we gave Ingraza guidance. I suspect we're going to end this year with some strong momentum with chronicity, and that's something we're going to have to revisit ahead of the Q4 call next year.

Sean Larman Analyst — Morgan Stanley

Yeah, thank you.

Todd Tushla Head of Investor Relations

But I understand and you probably wanted it.

Sean Larman Analyst — Morgan Stanley

Yeah, we do. We want everything. Still on Crenessi, is the next leg of growth like adding prescribers or is it deepening the number of patients per prescriber?

Todd Tushla Head of Investor Relations

Yeah, I would say it's a little bit of both. As a reference point, there's really three sources of where patients seek treatment. There's the Centers of Excellence. There's about 20 of those. That covers about 15% of the 20,000 or so patients who have classic congenital adrenal hyperplasia. There's pediatric endocrinologists. There's about a thousand of those. And then you have the community-based endocrinologists, which is about 8,000. And one of the nice things about the launch that was surprising to us in a good way was we're seeing utilization across all three sources of that business. And so, as you would expect, the Centers of Excellence, although we're not fully penetrated there by a long shot, have more prescriptions on a per MD basis. Whereas on the community endocrinology, they may have one or two patients. And so I think what's going to happen over time as chronicity becomes the standard of care, there's going to be a network effect that's going to help those community endocrinologists who aren't yet treating a patient to treat their one or two patients and for the folks that are treating to go deeper. So I think the answer is a little bit of both is where growth is going to come from.

Sean Larman Analyst — Morgan Stanley

Sure. Thank you, Todd. And you also initiated a phase two in children from three months to under four years. How commercially meaningful is that youngest cohort?

Todd Tushla Head of Investor Relations

Yeah, it's super meaningful. There's about a third of the patient population is pediatric, and we're approved for age four and up right now. The phase two that you reference is three months to four years old. And what we know is that with chronicity, we have a chance to interdict and change the trajectory of especially a pediatric patient's life. Because, you know, steroids are bad for the brain, bad for the blood, bad for the bone. We can have an overall impact on changing the course of overall height for these pediatric kids. And so treating earlier has a more profound impact over time. and so we'll get that data sometime in the 2028 time frame.

Sean Larman Analyst — Morgan Stanley

Wonderful, thank you. And last question on Cronesti. So looking down the path to Vertex slash Cronetics, how do you compare...

Todd Tushla Head of Investor Relations

Yeah, that was a big acquisition price. We're already validating that there is a market there in classic CAH, but now you have Vertex further validating it.

Sean Larman Analyst — Morgan Stanley

Sure, yeah, I'm with you on that one, Todd. So how do you compare CRF1 inhibition with ACTH receptor antagonism, and can the market support both?

Todd Tushla Head of Investor Relations

Yeah, what I would say on that is we work upstream in the HPA axis, and they're further downstream. Instead of diving too much into the competitive aspects here, they're still several years away from coming to market on the adult front, even further on peds. Meanwhile, we're at 15 percent, market share six quarters in. we're becoming the standard of care treatment and we're making it difficult not just for a competitor with Crenicity's label which has got uncompromised efficacy but also uncompromised safety and tolerability so setting a high bar with Crenicity for others including ourselves with our follow-on peptide that's in development is going to be tough to displace a standard of care kind of treatment that we're seeing evolve with chronicity and time will tell if the competitor product comes to market, but we like how we're positioned right now.

Sean Larman Analyst — Morgan Stanley

Great, thank you. Moving on to VicatXR, so there was a joint statement in early August from the Foundation for Prada-Willy which flagged some deaths and adverse events and there have been 800 plus patients prescribed since launch. What's your read on those data and what is the process, if anything, from here with the FDA?

Yeah, no, I think it's a good reminder just to level set on the Prader-Willi disease state. These are patients that are, it's a very serious and complicated disease, and these patients have many comorbidities. You know, high level mortality is multiples above the general population. The mortality rate increases for each decade of life. Life expectancy is in the mid to late 40s, at least based on what you can find in the literature today. So I think it's a view that needs to be shared, and I think the physicians that came out and shared this letter was shining a light on the complexities of this disease state and also the benefit risk profile of ICAT-XR, in particular with patients that are very severe in terms of their symptoms. So at a high level, we largely agree with a lot of the things that were pointed out in the letter that came out during the course of our diligence and actually was the emphasis, has been the emphasis of our educational efforts that we had planned on and are doing now post-close of the acquisition. So right now it's really a function of making sure that we're doing all we can with real-time data. Everything that you mentioned that came out in the Ferris database or the AIMS now is really information that we solicit using our specialty pharmacy. And when you're first in disease, these things do become visible for the first time in patients' physicians' lives. They haven't seen this in a registry type of format. So we have a lot of work ahead of us in terms of patient education, in particular on the side of physicians, helping them identify the ideal patient, and also how to manage and monitor adverse events. And that's going to be done in a hands-on way with Neurocrin with the help of our specialty pharmacy. But today, just as a reminder to help get us all on the same page, we have over 1,400 patient years of experience now with BICAT-XR. We have patients that have been on the medicine for more than seven years and benefiting quite well. So I know it's hard to look at the news and get drawn into the safety pieces of the disease of BICAT-XR, but there are a lot of patients that are benefiting as well, and that came out through the course of our diligence that there is a compelling benefit-risk profile for BICAT-XR and the Prader-Willi patient syndrome, patient population. It's really on us now to make sure that we have all the tools in place for physicians and families and patients to do well in the medicine, and I know we're up for the challenge.

Todd Tushla Head of Investor Relations

I think what was interesting following that letter, there were a number of KOL calls to ask about the letter, and largely all of them that I read were, the response was, this is nothing new. We knew all about this. And it's part of the awareness campaign that we're going to drive forward.

Sean Larman Analyst — Morgan Stanley

Got you. Thank you, Todd. That's interesting. I guess sort of commercially on Biocat, what are you watching most closely to evaluate? I mean, I know you've already done the evaluation, but to evaluate the longer-term outlook. Is it new starts, discontinuations, or persistence?

Well, I'm going to lean on what Todd said about Cronesty. It's probably a function of all those things. I will say that we're starting in a good position from the perspective that new patient starts, enrollment forms, however you want to look at it, have been relatively steady over the past couple of quarters. What we've been looking at is the discontinuation rate over time. I think initially what you would see in any orphan disease or any first-in disease medicine is that there is a bolus of patients that come in. They're excited about having a new treatment option, and they get on the medicine and they try it for the first time. The most severe patients, and by that the most severe I mean the ones where the hyperphagia is quite severe, were the ones that are coming into the real-world setting with prescription of ICAT-XR, and that's where some complications were having in those particular patients in terms of the adverse events that were seen just in that patient population were given rise to the concerns that we've seen in the physician community. that's a long way of saying that what we saw were discontinuations that exceeded what we saw in the phase three setting and we have the ability to see when patients start medicine in a given month and we can track them over time from one month to the next next month and so forth and what we can see now with about a year's worth of data is that the discontinuation rate as it turns into one year is about 20 percent, 25 percent. So what we see is a good steady state number for us is to have a discontinuation rate in the 25 to 30 percent number. That includes persistence of going in one year to the next. And once you get that into a steady state position with the steady enrollments that we've seen, we do expect to have sequential growth as we exit this year into 2027. So it's all about the education piece that I mentioned before in making sure that we've identified the right patients. Physicians know what to look for in terms of AEs. They know how to manage it. And I think we'll be in a much better place.

Sean Larman Analyst — Morgan Stanley

Wonderful. Thank you. Maybe to move on to some pipeline questions now. So, you know, we look at direct Ladeen. We look at the Cabemphi launch, which has been slower than what most would have anticipated. What do you believe Neurocrin needs to show with direct Ladeen to give investors confidence that you've got a good commercial story here?

Well, I think for the antipsychotics in general, I'll put Colbemphi into that category because I think we're seeing the same thing, is that everyone knows that you get your foot in the door in this therapeutic category in general by moving into schizophrenia. It's a patient population that has continuously the highest unmet need. It sets a price point for you to branch out into other indication. It's the most straightforward development pathway to commercialization. So what we've seen from Combenfee, at least in my view, in our view, is something very consistent with other antipsychotics. The trajectory is pretty much in line with what we thought we would see. But to really get to the larger numbers in terms of valuation, revenue, if you will, you really have to branch out to other indications. And we've seen that through, you know, complied most recently, went from schizophrenia to bipolar to MDD. you can look at that same trajectory as the other antipsychotics. To really do well with muscarinics, you have to move outside of schizophrenia. And I think that's something that BMS appreciates. That's why they're in ADP and bipolar. That's why we have gone into bipolar mania as a second indication, nearly in parallel with our efforts in schizophrenia. So we're excited about what we have, but we're also realistic in appreciating that the numbers that we're all wanting to see in terms of revenue are going to be achieved by branching out in other indications. And that's something that we'll be looking at moving forward.

Sean Larman Analyst — Morgan Stanley

Sure. Thank you, Kyle. And moving on, Ozavampator, maybe a very, for investors, you know, a quick snapshot and overview of the program. When do we expect the phase three readouts? And, you know, how should investors think about differentiation versus esketamine?

Sure. So this differentiation is quite easy. It's an oral tablet that you can take from the convenience of your own home, just like any other antidepressant. Great safety, great tolerability. There's no monitoring required. There's no device that's required to administer the product through an inhalation type of delivery mechanism. So very simple, easy to use, and very much consistent with how patients take their medicines today. So I think that's the real take-home there in terms of differentiation. In terms of the program itself, we have three replicate Phase III trials that are ongoing. Each trial is 200 subjects in sample size. It's a one-to-one ratio of active to placebo, so 50-50, that we believe will be helpful in terms of minimizing the placebo response. It's testing the one milligram dose that we saw good results in Phase II versus placebo, and we're looking at the Madras at day 56. So that's the plan in terms of the placebo-controlled trials. Those patients roll over to an open-label study. We also have a randomized withdrawal study that's running in parallel with this as well. So if everything goes well in terms of recruitment, what we're talking about is phase three data the second half of next year. And then if those are positive, we would play out the open-label safety data. Recall we need at least 100 patients out to one year. That's part of the ICH guidelines for submitting an NDA. All that wrapped up, we'll be able to put an NDA in the hands of the FDA preview somewhere in 2028 with a launch possible somewhere in 2029.

Sean Larman Analyst — Morgan Stanley

Amazing. Thank you. Still moving on, just in the interest of time, I do have more questions on that one, but I want to get to the SERIF-2 and the VST program. So 2118, so once-weekly SERIF-2 agonist that ended phase one in May, signal-seeking next year, and what we thought was interesting is that Roche's Genetech acquired an asset from Hanmai. I think they paid $190 million up front, $2.3 billion in milestones, sort of doubling down and validating the area, we think. But how do you interpret that transaction in the context of 2118? And does it increase your confidence in the industry that the industry is converging around CRF2 as a differentiated mechanism for preserving or improving lean mass during weight loss?

Yeah, no, I think that was a pretty big deal by Roche to invest almost $200 million in phase one. And, of course, all the hard milestones that come with that, that's a pretty significant deal. So I'm guessing they saw something there. CRF and CRF2 is something near and dear to Neurocrin's heart. And for me personally, I in-licensed one of the very first CRF2 agonists from the Salk Institute about 25 years ago and took that forward into some phase one and phase two trials for a very acute heart failure indication. We had signs that we were on to something very special back then. Unfortunately, for those that know the Nurocrin story, we couldn't develop everything that we wanted to back then and had to discontinue the effort. But for those that were around at that time and are still at Nurocrin today, we always knew that we wanted to revisit this biology. And fortunately, we brought in some folks from Eli Lilly that worked in the same space on around the time that we did, including our chief scientific officer, Jude Onia. And we re-engineered peptides in this space to be longer acting. Our first molecule that we had, it had a half-life of about 15 minutes. Now we're out to one week. So these are things that you can do now with all the tools that are available to us. But ultimately the idea is to get to, it comes with an appreciation that obesity is a disease of the CNS. You start there, CRF2 is in the brain. We like leveraging the things that we know about CNS drug development, about CRF biology. It seems like a perfect match for us. And what we've seen after engineering some of the molecules that we have, very good weight loss data in the DIO model in the mouse that shows weight loss comparable to what we see from the incretins. But to your point, and similar to what Hami and others have demonstrated, And the weight loss is on the fat side of the equation, not on the muscle. And we've also seen other cardiac and renal benefits, as we've seen over time with our work in R2. We also see a differential tolerability profile. It's not going through the GLP pathway. So we don't expect to see nausea, vomiting, those types of things that you would see with the medicines that are available today. Other than pointing out those kind of differentiation attributes of CRP2, there's another reason why we like this type of approach. In psychiatry, we all know that we're dealing with subjective endpoints, and you don't know definitively what you have until you've completed your phase three. The only thing that's guaranteed is your expense. And I'm joking a little bit. But we appreciate that there's challenges with psychiatry that you can mitigate by being in endocrinology, specifically in obesity. You get biomarkers in phase one. You're dealing with objective endpoints instead of subjective endpoints. You can actually pick winners, the molecules you want to take into phase two, as early as phase 1b. And that's really refreshing for neuroendocrine. We can get a nice balance in the portfolio about risk-benefit and probabilities of technical success. And, of course, I give some benefit to us having a rich history in CRF to win here. So I'm excited about what we have.

Sean Larman Analyst — Morgan Stanley

Well, we're just out of time. So thank you, gentlemen, for your time today. Pleasure to host you. Thanks so much. Appreciate it.

Analyst Q&A · 1 question
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