Neurocrine Biosciences, Inc.

Good day, everyone, and welcome to today's Neurocrine Biosciences third quarter 2025 results call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone keypad. Please note this call is being recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla.

Hi, everybody, and a very pleasant good afternoon to you, wherever you may be. Welcome to Neurocurrent Biosciences' third quarter 2025 earnings call. I'm joined today by Kyle Gaino, Chief Executive Officer, Matt Abernathy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, and Sanjay Kaswani, Chief Medical Officer. During our call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. After prepared remarks and as is our standard practice, we will try to address all your questions. With that, I turn the call over to Kyle. Thank you, Todd.

Good afternoon, everyone. Our third quarter results reflect Neurocrin's exceptional execution and the strength of our enterprise-wide momentum as we continue to deliver across our commercial, clinical, and operational objectives. From a commercial perspective, for Ingresa, the recent investments to expand our sales force and improve patient access drove yet another record quarter for both new patient starts and total prescriptions, highlighting the persistent unmet need for patients with tardive dyskinesia in Huntington's, Korea. With chronicity, the strong launch highlights its role as a first-in-class therapy, redefining the standard of care for patients with classical congenital adrenal hyperplasia, or CH. While there is still much to learn, we are encouraged by the early response from the CH community and the potential to make a lasting impact for patients. Momentum for both Ingresa and Chronicity is strong, and we believe continued targeted investments in these commercial assets will accelerate growth into 2026 and beyond. In our clinical portfolio, I am pleased with the steady enrollment progress in our Phase III studies of Osteoamphator and major depressive disorder and directly dealing with schizophrenia. We remain on track to meet our enrollment objectives for the year. Beyond these late-stage programs, we continue to advance a robust early- and mid-stage that is expanding through high-quality preclinical programs emerging from Neurocrin's internal discovery efforts. To this end, I'm also happy to report that we are on track to achieve our R&D productivity goals for the year, specifically four new Phase I study initiations and two new Phase II initiations. Advancing two potentially standard of care changing medicines until their final phase of development, while simultaneously driving early and mid-stage innovation, represents a record level of productivity for us and positions Neurocrine exceptionally well for the future. As I reflect on my more than 20 years at Neurocrine and just over one year as CEO, I'm deeply proud of how far we've come. Yet, as we continue to evolve, I'm even more inspired by what lies ahead. Neurocrin is poised into our new chapter of sustained long-term growth driven by our science, our people, and our unwavering commitment to the patients we serve and the investors who support our mission. With that, I'll turn the call over to Matt.

Thank you, Kyle, and good afternoon, everyone. The third quarter was strong across the board for Neurocrin with $790 million in net product sales reflecting 28% year-over-year growth. driven by continued progress both from Chronicity and Ingreza. Congrats to all involved in the performance of these two medicines. Chronicity grew sequentially from $53 million in Q2 to $98 million in Q3, reflecting strong early adoption and persistency rates. In addition, 80% of dispensed prescriptions are now being reimbursed. Feedback from patients in KOLs remains quite favorable in terms of chronicity's efficacy, safety, and tolerability profile. We look forward to continuing to add patients to therapy and to further establishing chronicity as a standard of care treatment for patients with CAH. Momentum for Ingresa also continues to build with our third consecutive quarter of record new patient additions in Q3, resulting in net sales of $687 million. Of note, as you consider modeling Q4, the third quarter benefited from a 14th ordering week. Outside of this ordering dynamic, the combination of improved access and our Salesforce expansion are resulting in double-digit TRX growth, record NRX, and market share gains through the first nine months of the year. On the heels of this momentum and strength of the TD market, we have decided to pursue an additional Salesforce expansion with three goals in mind. First, accelerate the development of the TD market between now and 2029, strengthening our position as we navigate potential impacts of the Inflation Reduction Act. Second is to maximize INGRESA patient share during this window of time. And third, set the foundation of an expanded psychiatry portfolio, anticipating one or more of our late-stage clinical programs will have successful top-line data in 2027. From a financial perspective, the expanded investment in both INGRESA and chronicity will result in an SG&A expense increase of around $150 million in 2026. We will, of course, provide a fuller financial picture for Nurocrine in February next year, but wanted to give you this insight for now. To close, our capital allocation priorities remain intact. Number one, drive revenue growth. Number two, advance our R&D programs. Number three, enable business development. And number four, return capital to shareholders. Our top-line growth and financial profile of over $2.1 billion in cash is the foundation for continued investment in our internal pipeline, which will position Neurocrine for sustained growth and enable us to deliver new, innovative therapies to patients with unmet needs in the years ahead. With that, I will now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric.

Thanks, Matt. Q3 was another banner quarter for our brands. Our commercial and medical teams continued to deliver with a record quarter for both Ingresa and Chronicity, with combined net sales of 785 million. Starting with Ingresa, performance through the first nine months of 2025 has been exceptional, reflecting both the strong clinical profile and the continued significant unmet need for people living with tardive dyskinesia or Huntington's chorea. Past strategic investments to expand the sales force and improve access have been positive, yielding a third consecutive quarter of record new patient starts and total prescriptions. Today, of a population exceeding 800,000, we estimate only about half of those living with TD have received a diagnosis for their uncontrolled movements, and only about 10% are currently being treated with a VMAT2 inhibitor. With exclusivity out to 2038, there remains significant organic growth opportunity ahead. Our ingressive prescriber base continues to expand, particularly in psychiatry, where advanced practice providers such as nurse practitioners and physician associates now account for the majority of psychiatric patient care in the United States. As an example, our ingressive prescriber base is 30% larger today than it was two years ago at this time. In addition, TD prevalence continues to increase in conjunction with broader use of antipsychotic medications. In light of our strong momentum and the significant growth opportunity, we've made the decision to further scale up our Ingressor sales force to meet this growing demand. Going forward, we will be expanding and restructuring our Ingressor sales organization to create two dedicated teams, one combined neuropsych team and our existing long-term care team. Both the neuropsych and LTC teams will be expanded to enable us to engage more VMAT2 prescribers than ever before and deepen relationships across our current base of prescribers. Consistent with prior expansions, success will be measured by growth in new patient starts and total prescriptions, metrics which typically show the full impact of field expansion several quarters after deployment. The expansion of the sales teams sets Ingresa up well for 2026 and beyond. and will also help position us for the anticipated launches of our next wave of investigational psychiatric medicines currently in phase three development. Now turning to chronicity, our launch mantra of so far so great remains well-deserved with Q3 net sales reaching 98 million in just the third full quarter on the market. During the third quarter, 540 new patients initiated therapy, bringing the total number of classic CEH patients on therapy since launch to more than 1,600. As we said from the outset, this is a new market we are building, and therefore, this is a learning launch. With Chronicity representing the first therapy developed and approved specifically for patients with classic CEH, we continue to gain important insights into prescriber behavior, patient dynamics, and potential seasonality trends. We continue to see steady adoption, and while the pace of new patient starts may vary from quarter to quarter, the strong persistence and adherence rates observed to date give us confidence in continued volume growth going forward. In the third quarter, patient demand modestly favored the pediatric population versus adults and skewed towards female patients. Prescriptions continue to be written by a range of endocrinology providers, including those practicing in multidisciplinary centers of excellence, pediatric endocrinologists, and community-based adult endocrinologists. On the payer front, we continue to see strong reimbursement. Launched to date, 9 out of 10 people taking Chronicity have received approval through their insurance. And Chronicity is affordable, with 9 out of 10 people paying $10 or less per month out of pocket. Most pay zero. So far, insurance reimbursement has not been a barrier to treatment. As the first and only FDA-approved treatment specifically for classic CAH, Chronicity delivers a compelling combination of efficacy, safety, and tolerability. Our ongoing open-label extension studies continue to generate valuable data on quality of life, long-term safety, and differentiating outcomes, which will further strengthen an already robust data set. We estimate approximately 20,000 people in the U.S. live with classic CAH. Based on the very favorable receptivity from the CEH community and the opportunity to bring relief to more people with CEH, we've made the decision to also expand our chronicity sales team. As I said in my opening comments, we're executing very well from a commercial perspective. Both our products are fast-growing, innovative, first-in-disease medicines. Given the significant growth potential for each, it was a straightforward decision to expand both the Ingresa and Chronicity sales teams. This is an investment in growth and an investment in our future. Both sales team expansions will be fully completed by the end of Q1, and we can give further color on our progress as we get into 2026. These are very exciting times here at Nurocrin as we make good on our promise to deliver brave science. So with that, I'll hand the call over to Dr. Sanjay Keswani, our Chief Medical Officer.

Thanks, Eric, and good afternoon to everyone. My prepared remarks for today will be brief as we remain on track for all our clinical programs. We anticipate top-line results in the fourth quarter for valbenazine in dyskinetic cerebral palsy, as well as for the phase two proof of concept and dose-finding study of NBI-770, that's our NR2B-NAM, as an adjunctive treatment in major depressive disorder. As a reminder, positive results from NBI-770 could support a confirmatory Phase II study or the initiation of a Phase III trial in MDD. As Carl mentioned earlier, the Phase III studies for osofampetor in major depressive disorder and direclidine, or NBI-568 in schizophrenia, continue to enroll well, alongside solid progress for the rest of our early to mid-stage pipeline studies. You've heard us talk about our upcoming R&D day throughout today's call. As my colleagues alluded to, we are excited to welcome the Wall Street community to our San Diego campus, where we'll have an opportunity to provide greater detail into our long-term vision, much of which stems from enthusiasm around our clinical and early stage programs, plans, and recent progress. To provide a bit more detail on the agenda, I will provide an overview of our neuropsychiatry programs, with a spotlight on osofampitor and our broad muscarinic agonist portfolio. Following my presentation, Dr. John Crystal, a leading psychiatrist from Yale University, will join me for a moderated Q&A session. Afterwards, Jude Onyer, our chief scientific officer, will discuss Neurocrin's ongoing R&D transformation efforts and preview a few of the next generation programs expected to enter clinical development. We look forward to seeing many of you there as we unveil the foundation for Neurocrine's next chapter. With that, I will hand the call back to Kyle.

Thanks, Angela. I think we're ready to take questions now.

Certainly. At this time, if you would like to ask a question, please press star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star 1 to ask a question. We'll take our first question from Phil Nadeau with T.D. Cowan. Your line is open. Please go ahead.

Good afternoon. Congratulations on a really strong quarter and great commercial performance. We wanted to just ask about the patient dynamics and patient starts for chronicity. It did seem like enrollment forms were a little bit lower in Q3 than Q2. Was this seasonality or a sign of maybe an early launch bonus? I guess any insights you can give us on those trends would be helpful as we look to model the next several quarters of chronicity. Thanks.

Yeah. Hi, Phil. This is Eric. So, obviously, we're really pleased with the overall adoption of chronicity launch to date and with 540 new treatment forms in Q3. You know, we saw that as a continuation to the strong adoption that we saw earlier in the year in the first half. You know, we said at the beginning we expected this to be a steady or measured launch, and so far it really has borne out that way. The weekly adoption has been really consistent over the course of the summer. We don't think that there's necessarily a... any kind of quarterly dynamics going on or seasonality. You know, we are still early in the launch and we'll have to see, you know, how things bear out after we've gone through a few cycles. But ultimately, you know, we're really pleased with the enrollment and with over 1600 treatment forms through Q3, we're really optimistic and expect to see, you know, this accumulation of patients as we go forward.

That's really helpful. Thank you. Phil, thanks for setting the tone also and asking just one question. So, just hygiene purposes, we'll stick to the answering the first question that gets asked.

Thanks, Matt.

And we'll go next to Paul Matys with Stifel.

Hey, thanks so much, and let me add my congrats on the quarter. I wanted to ask a question, I guess, about the IRA, and I hope you bear with me as it has two subparts to this. I swear to God, it's really only one question. Just can you help us set up how you guys are thinking about the upcoming Ostato price that we'll learn about, and just what are the sort of implications for Nurocurrent? And then for Ingresa, given the increased discounting, and now that we're looking at a gross net that's getting up into the mid to high 30s, Should we think that the worst case scenario for you has now changed, given that the small biotech exemption taps the discounting to a level that is actually potentially going to be below where your gross net ends up? Thanks so much.

Thanks, Paul. A lot to unpack there. Maybe I'll start with the first question and see how far we get on that. I think when it comes to Stetto, you know, our view of this is that we'll learn of its pricing across both the current and immediate release and XR formulations in November. We should hear from CMS late November, if not sooner than that. But that's what we're planning on currently. In terms of our expectations of how it might affect Ingresia, I think where we stand right now is we're trying to understand, you know, what the plans might do in reaction to the Ostetos pricing. You know, our view at this point is both the health plans and the PBMs will use a variety of strategies for medicines that go through the IRA as well as those medicines that are not going through an IRA type of moment. And for us, there are things that we know and don't know. And ultimately, where we stand right now is that Ingreza is an incredibly sticky medicine. Once patients start Ingreza, they tend to stay on it, which really means we're looking at new patient starts during a two-year period of 27 to 29 when we reach our own IRA year. So we'll look to contract here over the next, say, 12 to 14 months as we approach 2027. We'll look to maximize the number of patients that are on Greza between now and the end of 26, and that will help us negate any headwinds on NRXs, which to date is only about 5% of our total TRX. On a quarterly basis, that number is quite small. We'll look also to see if there's any learnings from those medicines that are negotiated and become implemented next year. And then I think most importantly here, we'll control what we can across Ingresa, but across the portfolio, we'll look to build the company as strong as we can.

Hey, Paul, this is Eric. I just want to chime in and kind of reinforce a couple of points. One is that we do believe that there's room on formularies for MFP-adjacent products. We think that PBMs and health plans will behave differently. There's not going to be sort of a uniform approach that they take. And kind of tying in with our prepared remarks, you know, it's really important that we maximize patient share going into 27 and beyond, and currently that's what we're doing, and that's part of the rationale for the Salesforce expansion for Ingresa.

And we'll take our next question from Tazeen Ahmad with Bank of America.

Hi, guys. Good afternoon. Thanks for taking my question. Mine's going to be on chronicity. So is it too early to know this, but are payers already looking for a certain level of steroid papering in order to continue covering therapy? And just in terms of number of days in 3Q versus 4Q, we're heading into holiday season, so how should we be thinking about the potential for seasonal impact for chronicity sales and 4Q. Thanks.

Thanks for the question. This is Matt. We're not really anticipating seasonality outside of just the pace and cadence of patient visits into the clinician's office, so nothing on the seasonality front. In terms of reimbursement, it really has not been a requirement for patients to titrate down steroids to a specific extent. It's really looking at do they have the underlying disease and do they have treatment with hydrocortisone. And if that's the case, reimbursement has been quite smooth. And I'd just give a shout-out to the team working on this, advocating on behalf of patients. And I'd say the insurance providers can understand the benefit of this new medicine for these patients.

And we'll go next to Akash Tiwari with Jefferies.

Hi, this is Phoebe on for Akash. Thank you for taking our question. On Ingresa, given that you've seen sort of Oxido XR is already much more expensive than regular Oxido, is there any changes in payer preferences you've seen thus far? And then just in terms of the IRA negotiated pricing upcoming, how were you able to lock in Ingresa's pricing through 2026 ahead of this announcement? Thank you.

Yeah, no, thank you for the question. So I think the health plans are seeing that, you know, part of what Teva is doing is trying to push patients to higher dose strengths of both the BID and the XR formulation of deuterated tetrabenazine. And since that product has a per milligram pricing structure, higher doses mean more revenue per patient. Health plans are catching on to that. And we have seen examples of health plans that would, for example, cover the BID formulation, but not the XR. So I think that the fact that we've seen this dose creep dynamic and or patients transitioning to the XR formulation being more expensive to the plan, that they've been more willing to engage with us. And I think it partly explains the ability that we've had this year mid-year to expand our formulary coverage. The coverage that we have now, we expect to carry through 2026. And so in terms of expectation setting for next year, we should expect at least the same level of formulary coverage that we have now.

But in most instances, we're seeing we're at parity from a formulary perspective. And that's always been our goal is to take an approach to give clinicians a choice as to what medicine they prefer. And that's going to be our strategy also going forward.

Got it. Thank you so much. We'll go next to Mohit Bansal with Wells Fargo.

Great. Thank you very much for taking my question. And I would love to touch upon the 10Q filing and the talks about DOJ investigation. Any color you can provide on that, and how should we think about the next timeline for this one? Thank you.

Hi, Mohit. This is Kyle. I appreciate the question here on this. In August, we received a CID, a civil investigative demand from the DOJ requesting certain documents and information attached to the sales, marketing, and promotion of Impreza. Of course, we're fully cooperating with the DOJ, and I think right now there's not much more to say on that. We'd certainly keep the external community updated when there's material information to share on that. The only piece I would conclude with is that we have an extremely robust compliance program here at NERC, and we take compliance seriously and the responsibility that comes with that. And as we move forward here, we'll continue business as usual because we think that's the right thing to do. Again, we'll keep folks updated as we learn more.

Thank you.

We'll go next to Corey Kasimov with Evercore.

Hey, good afternoon, guys. Thanks for taking the question. Mine's on chronicity. I guess I'm wondering if you can speak to where you are with getting chronicity up and running at this point at the centers of excellence and then the progress that's also being made in the community setting where docs see far fewer patients. Are you more or less at every COE at this point? And do you see that opportunity in the community level? Thank you.

Yeah, and just to recap, we estimate there's around 20 centers of excellence out there that care for roughly 15% of the classic CEH patient community. Yeah, I mean, all of the COEs have now started adopting, though I would say at different pace. And I think that reflects sort of the different ways that they work, the level of bureaucracy, the level of access, et cetera. But for the most part, you know, our view is that the rate of adoption that we're seeing in the COEs is mostly a function of the rate at which patients are flowing through. We've also been surprised, very pleasantly surprised, I think, by the rate of adoption with community endocrinologists that treat the adults. Most of these practices, as you rightly call out, only have one or two patients. And so that's where you get into a much wider pool of HCPs to reach. And kind of tying back to our prepared comments as part of the rationale for expanding our field sales team to go a little bit deeper into our call universe, and to be able to reach some of these practices that we haven't yet tapped into.

Very helpful. Thank you.

We'll go next to Anupam Raba with J.P. Morgan.

Hey, guys. Thanks so much for taking the question. Congrats on the quarter. Could you provide a little bit more color and maybe some quantification around the Salesforce expansion for both products in terms of the segments that are going to be targeted here for Ingresa? Is it psychiatry, neurology, long-term, or for Kinesity, is it general endos versus pediatric endos? Thanks so much, Chris.

Yeah, so in terms of scale, I would characterize it as about a 30% increase in terms of our overall sales footprint across both products. Obviously, Ingresa is a bigger product, so most of the incremental headcount are going to be going to Ingresa. I said in my prepared remarks that we were going to be both restructuring and expanding. And what we're doing with Ingresa is essentially combining our existing psychiatry and neurology teams and then expanding the headcount there because what we've seen is that We could do a better job, I think, of covering our psychiatry and neurology customers who, in many ways, are more similar than they are different by having a cohesive team versus having multiple different teams with different reporting structures. So I think that this simplifies things substantially for us going forward. We're going to keep the LTC team separate, and we are expanding that group as well. That's been a continuing... fast growing segment for us. So we're excited about increasing our coverage of high potential psych providers and neurology providers with the neuropsych team and then adding more headcount into LTC. The expansion with chronicity is obviously smaller in scale. You know, our existing team is less than 50. So, you know, this is going to be a relatively smaller expansion, but it does allow us to go deeper especially in those community endocrinology practices and ultimately to accelerate adoption in classic CEH and help more patients faster.

This is, you know, really a reflection of our belief in the TD market and the opportunity that we have ahead. Eric's track record here, this is probably our fourth expansion. Every time we've done it, we've seen a tremendous response and the team has done a great job driving more patients onto therapy. So I would look at this investment as clearly being to accelerate the market development and to maximize the number of patients on therapy. And we feel fortunate to have two great medicines to do this with.

And we'll go next to Jay Olson with Oppenheimer.

Oh, hey, congrats on the quarter. We have a pipeline question related to direclidine. As you look at potential indications beyond schizophrenia and bipolar, are you considering Alzheimer's psychosis? And are there any particular lessons you expect to learn from the Coventry Phase III study in Alzheimer's when that study reads out and any potential read-across to direclidine? Thank you.

Yeah, thank you so much for the question. So as you mentioned, with 568 or Directladine, we're targeting our phase three program, schizophrenia. We have initiated a phase two bipolar mania study. That's this year. We're also very interested in Alzheimer's disease psychosis. You know, we do have a pretty robust muscarinic portfolio and indeed we'll unveil that at R&D Day in December. But we have a lot of options in terms of which molecule we use, M1 preferring, M4 preferring dual agonists for various indications. So at the moment, we're thinking about AD psychosis for one of our follow-on molecules, which has particular advantages with respect to safety considerations in the elderly. Yeah, we'll be watching BMS's co-BENFI data very closely. Our understanding is that their ADEPT phase 3 study will be reading out relatively soon. They're going to be lessons learned, I think, for the whole field.

Great. Thank you.

We'll go next to David Amselem with Piper Sandler.

Hey, thanks. So I wanted to come back to the Salesforce expansion for Ingressa. So you've had a number of Salesforce expansions over the years, over the commercial life of a product. So I guess with that in mind, at what point do you think the commercial organization is going to be right sized? And also, at what point do you think the level of DTC spend is going to be right sized? In other words, when do we start to see more aggressive margin expansion associated with the product? Thank you.

So on the margin expansion, we've made tremendous progress over the last five years. Being in the low 50% range all the way down to this year, we should be in the low 40% range. And growing revenue to almost $800 million this quarter is just a testament to the investments as well as the markets that we're playing in. So when will we be 100% right-sized? We always invest as much as we can to pull as much revenue forward. in any of these situations, and we're learning a lot as we go with the TD market. But overall, from a margin expansion perspective, you know, we look into the last part of this decade as being in a place where we'll continue to drive leverage, albeit maybe not as much as what had been anticipated in 26, but it's really with an eye to maximize the number of patients on therapy heading into the 27 to 29 window.

Maybe I'll just add there, too, that I think we touched on this already, but the Ingresa market as it relates to the TD is an incredibly robust growth engine for the company. And as much as we lean on the performance of the medicine, we're still only treating 10% of the 800,000 patients that are out there. And that was with the backdrop of the TD prevalence continuing to increase at the rate of growth of the antipsychotics, which is 3% to 4% per year, which is three to four times greater than the general population. You put all those pieces together, the number of prescribers increases year to year as well. It's increasing faster than we've expanded the sales force over the years. In fact, I believe the past two years, the prescriber base has increased by 30%. So as much as we have looked at ways of reaching all these patients and prescribers over time, the current structure of our sales organization is actually smaller than some of the companies out there with products just within schizophrenia. So we like where we're headed to right now, but it's still an organization that is right-sized for tardive dyskinesia, not so much for some of these larger psychiatry indications. And I think this is a step that not only helps us with Ingresa, But as Eric said in his open remarks, sets the stage quite well for us as we look at Osa Vampator and Regladine in phase three and their potential launch the second half of this decade.

We'll go next to Brian Scorny with Baird.

Hey guys, this is Luke on for Brian. On the upcoming 770 readout, can you talk about your expectations for the data And what type of result, in your view, would support a confirmatory phase two as compared to moving right into pivotal?

Yep, so we're expecting the results of the phase two study for 770 that's on RNR2B-NAM this quarter. Just for context, the phase two is a relatively small signal finding study, so 72 patients total with three active arms as well as placebo. So I think the likelihood is that we would go into confirmatory phase 2B if the results we see are encouraging, but we won't discount going to phase 3 at this moment. In terms of, frankly, what we'd like to see, we would like to see esketamine-like efficacy, not to do similar from Spravato, but without the baggage of some of the dissociative side effects which mandate a two-hour period. in-house observation period post-dose. But I guess we'll see what we see later this quarter.

All right. Thank you.

We'll go next to Brian Abrams with RBC Capital Market.

Hey, guys. Congrats on the quarter. Thanks so much for taking my question. I was wondering if you could talk a little bit more about chronicity persistence just now that, you know, you're several quarters in. Can you be any more specific in terms of what you're seeing there And then just the overall KOL feedback around patients who started on the drug early in the launch and the glucocorticoid equilibration at this point now that patients have been on drug for many months.

Thanks.

Yeah, I mean, the way that I would characterize it is that chronicity's persistence and compliance has been really strong. And certainly, you know, we were hopeful going into the launch that we would see this kind of overall adherence to medication based on our experience in the double-blind studies and the open-label extensions. But, you know, the vast majority of people that are starting treatment are in the earlier parts of the year are still on treatment. In terms of the feedback on, you know, the reduction of GCs, you know, obviously you all have done your doc calls. You're probably hearing the same kind of thing that we're hearing. Patients, you know, are on treatment for a period of time. Doctors want to see how they can reduce the androgens, and then they start the process of tapering down the GCs, and it varies a little bit. from provider to provider and also I think is dependent on the particular situation of the patient. But overall, you know, we're seeing really good feedback in terms of both disease control with the androgen reductions and also the opportunity to really bring down those GCs to more physiologic or near physiologic levels.

Thank you.

We'll go next to Mark Goodman with Lyric Partners.

Yeah, Matt, at the beginning of the year, you were pretty conservative with respect to the chronicity launch. I think your main issue, if I remember, was just reimbursement concerns and how quickly that would be adopted. Obviously, that's been adopted way better than anybody could have expected, I suppose. So how do we think about gross tenets now? I mean, they clearly have come down a lot just, you know, working through the numbers. Are we continuing to move lower quite a bit outside of maybe the first quarter? next year just because first quarters are, you know, unusual. But, you know, if you think about the next three, four quarters, are they just going to continue to come down and ramp down to more normalized levels for what we, you know, consider a, you know, an orphan product like this?

Thanks. Mark, that's quite fair. In terms of a guide for gross to net, I would just characterize it as being less than a 20% gross to net discount. And that's something that in the foreseeable future, that's something we would be anticipating. Part of the gross net dynamics has to do with the nature of the patients. They're primarily commercial, but we also have a base of Medicaid patients, so you do pay the statutory rebate. But overall, the rate of reimbursement, as you mentioned, it's above 80%. As Eric said, 9 out of 10 patients have ultimately ended up with an adjudicated claim. So feel quite strong with where we're at and reaching a pretty darn good level in terms of how we think about the future.

Thanks. We'll go next to Sean Lamond with Morgan Stanley.

Thank you. And hi, Kyle and team. Hope everyone's well. Maybe just circling back on Ingresa, but can you comment on neurology versus the psych split and is it a focus on psych to the expense of neurology? You know, I think I've heard Esteto had a strong uptake in neurology, especially during COVID and what are your plans for neurology? Thanks.

Yeah, neurology represents about 15% of our total volume. You know, obviously, all of the business segments, neurology, psychiatry, and LTC have been growing like gangbusters this year in particular. But on a relative basis, it's now the smallest segment that we have. And, you know, we view it as important, but It doesn't have the same kind of patient potential that we see in psychiatry. As I said in my prepared remarks, the fastest growing segment is really advanced practice providers that are in behavioral health. And so this reorganization and kind of combining our teams across psychiatry and neurology sort of puts our resources where we see the highest growth potential. And behaviorally, the psychiatry segment and the neurology segment are more similar to each other than psychiatry. And so we're keeping LTC separate, expanding that team. We're combining our psych and neurology teams and then expanding that team. And ultimately, we want to make sure that we can keep up with the pace of this market that's very fast growing and continue to drive new patient starts. You know, this is an investment in growth, as we said, and we really like the trajectory that we're on now.

Maybe just to add to that real quickly on the neuro piece, just keep in mind a lot of interest has come from the side of the Korea side of the indication opportunity with Ingresa. For HD Korea, There are about 30,000 patients in the U.S. About 90% have FREA. So that 20,000 number is about a 40 to 1 ratio to the TD patients that we see out there today. So I think that speaks to some of the volume flow that we see across the neuro and psych piece, and that's something that we keep in mind as we look at further investments down the road.

Thank you.

We'll go next to Yagal Nochemovitz with Citi.

Hi, great. Thank you very much for taking the question. I had one on capital management. You mentioned, obviously, the increase in SG&A of about $150 million to expand both sales forces. So with that in mind, I'm just curious, how are you thinking about the continuation of the buyback at the pace of that buyback related to the new $500 million buyback allocation? Thank you.

Yeah, so we have $2.1 billion in cash right now, no debt, we're profitable. Where we're putting the capital right now is prioritizing top line growth as well as investing in R&D at 35% is what our target range is. We, of course, have flexibility to do share buyback, but I would say that our bias is to utilize our capital for business development activities, but right now focused on driving our own internal initiatives.

Thank you.

We'll go next to Corrine Johnson with Goldman Sachs. Good afternoon, guys.

Maybe a question for us. Can you talk about where you stand with respect to share of new to category or new to class patients with Ingresa versus Osteto, and where do you think that could go? Maybe contextualize that versus where we were a year ago and where you think we could go with the expanded sales force over kind of the next year. Thanks.

Yeah, as Matt mentioned, new patient starts or NRX in any given week or month are single-digit percent of total TRX. But they're critically important, you know, because of the persistency and compliance that these patients have on Ingresa that, you know, they represent a significant number of likely refills. And what we've seen really since the beginning of the year with the prior expansion of our field sales team and then the investment that we've made in increasing formulary coverage, particularly in the Medicare segment, is that we're getting the majority of new patient starts, and that's really what's driving increased total market share from a patient perspective. And that's really an important part of our strategy going forward, this momentum that we're carrying through 25 into 26. We want to make sure that we continue that into that critical time period of 27 and beyond. So the way I would look at it is, you know, we're gaining the majority of new patient starts now, and we intend to continue doing that going forward.

Thanks.

We'll go next to Ash Verma with UBS.

Hi, thanks for taking our questions. I'm just trying to understand the medium-term growth outlook for Ingresa given the Salesforce investment and the contract that you've done. For the years before IRA impact, do you believe that you can grow at a higher pace versus where you've guided to this year? Thank you.

Yeah, I guess the way that I would characterize that is that, you know, this year the VMAT2 market is experiencing double-digit growth, and our brand is growing faster than the market. So we're really pleased with the growth trajectory that we're on. In fact, you know, as we mentioned earlier, for Q3, that represented 12% year-over-year growth. So the goal is to continue and carry that forward into 2026 and beyond. and to maximize our patient share. You know, we'll be able to give more color as we get closer to our Q4 earnings call and talk about the projections for 2026. But, you know, at this point, it looks like we'll be able to see a continuing, strong, robust, growing market for VMAT2s, and in Greza in particular, next year and beyond.

We'll go next to Ami Fadia with Needham.

Hi, good afternoon. Thanks for taking my question. It's on NBI 770. Given that this study is not necessarily powered for statistical significance, just on an absolute basis, what is, you know, the level of change in the primary endpoint that you're looking to see as you think about some of the other drugs such as Provato or other psychedelics in the space? Eventually, are you thinking of studying this in PRD or NDD?

Just sort of current thoughts. Thank you.

Hi, Ami. Yeah, really good question.

So yeah, it's a relatively small study. So I'm hesitant to to give an effect size that, frankly, we would be considered as successful versus not, because I think there's a huge amount of unmet need in this population. As you mentioned, there are potentially two populations that we could target with 770. One is adjunctive treatment in MDD, which is currently where the program is headed. But we clearly could go down this bravado route with respect to TRD as well with this mechanism. So we have a couple of options. We will decide that, I think, based on the data that we'll receive later this quarter.

Thank you.

We'll go next to Samant Kulkarni with Canaccord.

Good afternoon. Thanks for taking my question. As the Inflation Reduction Act kicks in for your competitors, Could you comment on where you might see the most impact on Ingresa, either in terms of profile of patient or by prescriber type? And on the neuropsych side specifically, what might be the maximum number of products that you might be able to leverage this iteration of your expanded neuropsych sales team?

Yeah, let me take the second part of your question here. You know, we'd love to have the challenge of... having three products into psychiatry and long-term care at the same time. Obviously, we're really excited about the late-stage pipeline with both DirectLidene and Osobampitor in phase three trials. And as Kyle said in his prepared remarks, data and potential launches later in the latter half of this decade. This expansion that we're in the midst of now I think sets us up well for being able to move and launch with either of those two products or potentially both. So I would say that it's not sufficient, meaning, for example, if we end up having the opportunity to launch Osovampitor, we won't have the coverage of the primary care, future primary care prescribers that we would need to reach. So this gets us partly the way there, but not fully. And so I do think it reduces the amount of changes that we would have to make to prepare for either of those two launches down the road.

In terms of impact from the IRA and the negotiation, you know, our view is that patients or existing patients are ultimately going to stay on therapy during this window of time. So you're thinking about a two-year window when you're dealing with new patients and where do they go. So a lot of what we're doing right now is maximize the number of patients on therapy between now and 2027. And we're going to control every single thing that we can to maximize that number. And we think we'll be successful during that window of time. But we will learn more in terms of what the MFP is for us, as well as payer behavior over the coming months. But for what we can control, we're doing everything we can possible. We have a great market with a great medicine here.

And we'll go next to Yatin Suniha with Guggenheim.

Thank you for taking my question. Matt, one clarification. The 14-week dynamic or one extra week dynamic, that is just specific to Ingresa. And then if you can just comment also on the inventory, if you can, for Kernesity. Thank you.

Yeah, Kernesity inventory billed was about $7 million for the quarter. And then as it relates to the 14-week, that does pertain to Ingresa primarily. and you can assume that was almost a full week of impact on the quarter. So when you want to normalize Q3 to think about trajectory into Q4, I think it's safe to assume remove the week, and then you can grow off of that base from there.

And we'll go next to Miles Minter with William Blair.

Hey, thanks for taking the question. This one's just on Chronicity New Starts. I think in the second quarter you had 664, you got 540 this quarter. Is there some sort of warehousing effect that's bleeding out of those patients? Can we expect that sort of trajectory for the next quarter and maybe a return to growth when you get that Salesforce expansion hitting in the new year? Thanks very much.

Yeah, the way I would characterize the adoption in Q3 was that, you know, very consistent and steady. You know, we said this would be a measured launch, and so far it has played out that way. Although the overall rate of adoption, I think, since day one has been a little bit quicker than what we anticipated prior to the launch. We were helped out a little bit in Q2 by the wind down of the adults. open label study. And so there were some patients that transitioned towards the end of Q2 to commercial drug that bumped up the numbers a little bit. But overall, I'd say that the rate of weekly enrollments has been pretty consistent across both Q2 and Q3.

And maybe I'll just add here quickly, you know, the launch continues to exceed our expectations, and that's across the board. Enrollment forms, persistence, compliance, And that's played out here ultimately as time moves along, the combination of the study adoption of chronicity as well as the is going to stack volume over time and gives us all the confidence that we have and need for this to be our next blockbuster here.

Awesome. Thanks, guys.

We'll go next to Danielle Brill with Truist.

Hey, guys. This is Alex on for Danielle. Thanks for taking the question. Another one on Kinesity. Just curious if you're seeing any new, any shifts in the new prescription breakdown between pediatrics and adults, and additionally, any trends in the usage of the pre-drug program. Thanks.

No major shifts from the demographic perspective. It still is skewing towards younger patients and primarily towards female patients. That pattern kind of kicked in you know, after about a quarter or so on the market, and it's been pretty steady ever since. And then, what was the second half of your question? I'm sorry.

I was on, yeah.

Yeah, it's actually, you know, continues to be less than what we had anticipated it would be. You know, the idea being that if insurance hadn't approved the claim after about a week, that we would be able to offer a month's supply of chronicity to get someone started pretty quickly. And, you know, as I mentioned earlier, nine out of ten patients that are on Prunicity have gotten their prescription approved with their insurance. And so not that many people end up on the free drug program, to be honest with you. All right.

Thanks so much.

We'll go next to Laura Chico with Wedbush Securities.

Good afternoon. Thanks very much. One on the pipeline with respect to valbenazine and dyskinetic cerebral palsy. The data coming up here, can you talk a little bit more about what would constitute a meaningful change in Korea score in a CP population? But also, I guess, against the backdrop of the Ingresa field forest expansion, how should we think about the size of the opportunity and overlap with existing Ingresa prescribers? Thank you.

Yeah, I'll do the first question really quickly.

I'm going to head on for the second. So this population dysgenic cerebral palsy doesn't have an a priori validated scale. So essentially, we're borrowing from the UHDRS Huntington's scale. That's a total maximal career scale. Our assumption is that a statistically significant effect in that would be meaningful enough. Clearly, we'll be seeing the totality of the data later this quarter.

And maybe this, Kyle, just to add to Nick's steps on this, we would take a data set, you know, if it was robust to the agency and ensure that there's a path forward for an NDA submission. And with the current size and composition of the sales force, we would be covered there in case that was an SNDA.

Laura, last thing, I'll chime in here. The DCP population is larger than the Huntington's Korea population, but still substantially smaller than the TD population. And The expanded sales team, if this turned into an indication down the road, would be able to cover all the potential prescribers.

Thanks very much. We'll go next to David Huang with Deutsche Bank.

Hi there. Thanks for fitting me in and taking my question. So, again, congrats on strong quarter. I saw, you know, you have reiterated but not raised guidance. So I guess, you know, you mentioned the extra week in Q3 for ordering. But if we think about the, you know, what the Q4 number may look like, I think the guidance implies something to, like, down, you know, a mid-single digit to flattish. Anything else to think about in there in terms of maybe whether you envision seasonal dynamics or perhaps there's some degree of embedded conservatism?

Yeah, if you back out the 14th week, I think it gets you into a place to grow off of. And then sequentially what you've seen over the last handful of years is the fourth quarter typically will have a range of 15 to $20 million of sequential growth. So my recommendation, David, is to, you know, normalize Q3 to 13 week and then think about that type of a growth trajectory. Price should be pretty consistent. It was down 6% to 7% year over year in the third quarter. That should be something that you would experience in Q4 as well. So nothing abnormal on the pricing side.

And our final question comes from Evan Siegerman with BMO Capital Markets.

Hi, guys. Thank you so much for taking my question. In your 10-kilogram file today, there was a disclosure about the Make America Healthy Again Commission issuing warning letters regarding DTC advertisements. You indicated that you got one for Ingresa. Can you talk about what was in that letter and what you might need to correct, given that that is pretty important when it comes to the commercial plan for that asset? Thank you very much.

Yeah, I'll take this question. This is Kyle. I think many of us in the industry received a similar letter with similar types of contents in there. I think what a good view to have on this is as a pharma member is we're committed to conducting responsible advertising for us. It is an important part of our business. We think it's a good opportunity for us to reach patients and also educate out there. We'll continue to look at that as an opportunity, but rest assured we continue to do this in a responsible way. We'll look to continue doing that moving forward.

And this does conclude today's question and answer session.

I will now turn the call over to Kyle Gano for any additional or closing remarks.

Thank you, and thanks, everyone, for the good discussion and call this afternoon. Looking ahead, we're confident in the company's direction and momentum. We hope you can see here today that we're executing with clarity and discipline, expanding two commercial franchises in Ingresa and Chronicity, advancing a robust and growing pipeline. We talked about some of our mid to late stage assets today and investing in the next generation of innovation. This is what Neurocrime is about today and in the future. It goes without saying we look forward to meeting with many of you at the upcoming and remaining conferences this year and certainly at our R&D day on December 16th. Thanks again.

This does conclude today's program. Thank you for your participation. You may disconnect at any time.