Neurocrine Biosciences Inc Q2 2026 Earnings Call

Hello, welcome everyone joining today's Neurocrine Biosciences Reports Q2 2026 earnings 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. To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded, and we are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Todd Tushla, Vice President of Investor Relations. Please go ahead. Happy Thursday, everyone.

Welcome to Neurocrine Biosciences' second quarter 2026 earnings call. With me today on the call are Kyle Gano, Chief Executive Officer, Matt Abernethy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, Sanjay Keswani, Chief Medical Officer, and in his well-deserved new role as Chief Business Officer, Samir Siddhanti. During today's 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. In addition, some of the information discussed today includes non-GAAP financial measures that have not been calculated in accordance with U.S. GAAP. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has been posted on the investor relations page of Neurocrine's website.

After prepared remarks, we'll jump into Q&A. Now I'll hand the call off to Kyle.

Thanks, Todd. Good afternoon, everyone. Neurocrine's second quarter performance demonstrates the power of a diversified growth strategy built to compound over time. Our commercial portfolio of first-in-class medicines, INGREZZA, CRENESSITY, and VYKAT XR, delivered another record quarter with net product sales exceeding $950 million, enabling more patients to benefit from our innovative medicines. This durable commercial performance provides the financial strength to continue investing in innovation, advance our industry-leading pipeline, and pursue strategic opportunities that further strengthen Neurocrine for long-term growth. Our strategy remains clear: execute our commercial portfolio to bring our medicines to patients, advance our innovation engine, and deploy capital with discipline. This quarter demonstrated meaningful progress across all three of these priorities. The commercial business continues to generate durable growth.

The pipeline is advancing with one of the industry's strongest mid to late-stage portfolios. Disciplined capital deployment was demonstrated through the successful acquisition and integration of VYKAT XR. Together, these efforts further strengthen our position in rare disease while building on our leadership in endocrinology. More importantly, these results reflected the continued evolution of Neurocrine. Just a few years ago, we were largely viewed as a single-product company. Today, we have multiple commercial growth drivers, an expanding pipeline across all phases of development, and the financial strength to invest through innovation cycles. Together, these strengths position us to create long-term value for patients, physicians, employees, and shareholders alike. Looking ahead, we remain on track to deliver multiple important clinical milestones in 2027, including phase III data readouts for osavampator in major depressive disorder and direclidine in schizophrenia.

Together with the continuing integration of VYKAT XR, these milestones represent the next chapter in Neurocrine's growth and reinforce our confidence in the opportunity ahead. Before I turn the call to Matt, I'd like to recognize Samir Siddhanti on his recent promotion to Chief Business Officer. Since joining Neurocrine in 2017, Samir has played an integral role in shaping our corporate strategy and business development efforts. As a member of our executive leadership team, he will help guide the next phase of Neurocrine's growth and evolution. Samir, congratulations. We are excited for what's ahead. With that, I'll turn the call over to Matt.

Good afternoon, everyone. For the second quarter, we delivered over $950 million of total revenue, representing nearly 40% year-over-year growth. This reflects full quarter contributions from INGREZZA and CRENESSITY, along with a partial quarter contribution from VYKAT XR following the close of the Soleno acquisition. This revenue performance demonstrates accelerating top-line growth, delivering a financial profile with non-GAAP EPS of $2.85 per share. Starting with INGREZZA, second quarter net sales were $716 million, up 15% year-over-year, driven by another quarter of record new patient additions and sustained underlying demand. Given this performance, we are raising full year INGREZZA guidance from $2.7 billion-$2.8 billion to a new range of $2.825 billion-$2.875 billion.

At the midpoint, this represents approximately 13% year-over-year growth. CRENESSITY second quarter net sales were $184 million, reflecting continued strong launch execution, consistent new patient starts, and expanding prescriber adoption. Approximately 15% of the estimated diagnosed patient population has now been prescribed CRENESSITY, reinforcing our confidence in the significant runway for growth. Turning to VYKAT XR, second quarter pro forma net sales were $94 million, with $54 million recognized by Neurocrine from May 18th, the closing date of the Soleno acquisition. Integration has progressed well and expect to drive sequential quarterly growth exiting 2026. New patient demand remained fairly consistent with the first quarter, while discontinuation rates tracked in line with our expectations following the initial launch bolus in 2025.

We have more work to do in developing this market and remain optimistic in the opportunity to help many more patients with PWS over the years ahead. Pro forma total revenues were $998 million for the second quarter 2026, when including full quarter VYKAT XR sales. This performance underscores the strength and increasing scale of our commercial portfolio across three highly differentiated products. Turning to our financials. With the Soleno acquisition now complete, I'd like to briefly discuss the financial impact of the transaction, including the purchase accounting and the GAAP and non-GAAP adjustments reflected in our earnings release. We acquired Soleno for approximately $2.9 billion and financed the transaction with cash on hand. We ended the second quarter with approximately $500 million in cash and no debt. Strategically and financially, this is a highly attractive acquisition.

VYKAT XR adds another differentiated durable growth product to our portfolio and is immediately accretive to non-GAAP earnings. Accordingly, we updated operating expense guidance to include the Soleno operating expenses, transaction and integration costs, and the expected purchase accounting intangible and inventory fair value amortization impacts for the remainder of 2026. We expect approximately $150 million of acquisition-related costs, of which $130 million was recognized in the second quarter. Our GAAP second quarter results also include non-cash purchase accounting amortization of acquired intangible assets and inventory fair value step-up of approximately $20 million. Overall, our commercial portfolio continues to perform exceptionally well, generating close to $1 billion in pro forma quarterly sales, providing substantial financial flexibility to invest consistent with our capital allocation priorities to drive revenue growth, advance our expanding pipeline, and pursue additional strategic business development opportunities.

With growing sales, an improving financial profile, and meaningful data catalysts ahead, we feel quite fortunate to find ourselves in a position to continue to build a leading global biotech company. With that, I will now hand the call over to Eric Benevich, our chief commercial officer. Eric. Thanks, Matt. Just five years ago, Neurocrine was a single-product commercial stage company celebrating INGREZZA achieving blockbuster status, surpassing $1 billion in annual sales.

Today, our commercial portfolio includes three first-in-class medicines with combined quarterly sales approaching $1 billion and annualizing to approximately $4 billion. This transformation reflects the successful execution of our long-term growth strategy. Starting with INGREZZA, second quarter performance was outstanding, with record sales of $716 million, driven by another quarter of all-time highs in both new patient starts and total prescriptions. Based on our increased full-year guidance, we expect to help more patients than ever before who are living with tardive dyskinesia or chorea associated with Huntington's disease. CRENESSITY also delivered another excellent sales quarter, generating $184 million. The launch continues to follow a very consistent pattern: steady pace of new patient starts, high persistence and compliance, and favorable reimbursement.

Adoption remains balanced across both adult and pediatric patients, male and female patients, and across the business segments of CAH Centers of Excellence, pediatric endocrinologists, and community adult endocrinologists. Importantly, our prescriber base has nearly tripled compared to 1 year ago, providing a strong foundation for continued growth. Turning to VYKAT XR, while still very early in the integration of this franchise into our commercial platform, we were encouraged by second quarter trends. New patient starts remained steady on a sequential basis, the prescriber base continued to expand, and discontinuations tracked in line with expectations following the initial bolus of patients who began therapy last year. As with any acquisition, it will take a few quarters to get fully integrated, and we're excited to introduce Neurocrine's commercial, medical, and patient support capabilities to the VYKAT team and the PWS community.

We remain confident in driving sequential growth as we exit 2026 and continue our conviction that VYKAT XR has the potential to become the third blockbuster in our portfolio. Before I wrap, I'd like to extend a special thank you to our commercial and medical teams in neuropsychiatry and rare endocrinology, our internal cross-functional colleagues, and the VYKAT XR team from Soleno. Q2 was a quarter of significant transformative change for Neurocrine, where we both expanded our existing commercial footprint to better meet the needs of healthcare providers and patients, while we also began the integration of VYKAT XR into our company. We executed all these significant structural changes without missing a beat in terms of our mission to help more patients. My hat is literally off to our teams for pulling off such a tremendous transformation while simultaneously delivering such a strong quarter.

I'll turn the call over to our Chief Medical Officer, Dr. Sanjay Keswani Thanks, Eric, good afternoon, everyone.

I'll begin today with highlights from ENDO 2026, where we presented important new data for both CRENESSITY and VYKAT XR. Starting with CRENESSITY, we presented 2-year data from the ongoing CATALYST open label studies in pediatric and adult patients with classic congenital adrenal hyperplasia. These results demonstrated meaningful and durable improvements across multiple aspects of health, including cardiometabolic outcomes, bone health, quality of life, and pediatric growth, while continuing to reinforce CRENESSITY's favorable long-term safety profile. For VYKAT XR, we presented 3-year HQ-CT and Prader-Willi syndrome profile data comparing treated patients with a natural history cohort. These analyses demonstrated significant and sustained reductions in hyperphagia across all evaluated time points, supporting the durability of treatment benefit. Additional data also showed meaningful improvements when patients who had previously discontinued therapy restarted treatment, underscoring the importance of continued treatment in maintaining long-term outcomes.

Collectively, these data strengthen the growing body of evidence supporting both CRENESSITY and VYKAT XR and highlight the meaningful impact these medicines are having for patients and the endocrinology community. Turning to the pipeline, we continue to make steady progress. Notably, we remain on track to report phase III top-line data for osavampator in major depressive disorder in the second half of 2027. We also remain on track to report the first phase III readout for direclidine in schizophrenia in the second half of 2027 and for the second phase III study in 2028. Looking ahead, we look forward to hosting our neurology and immunology webinar in early December, where we will provide an update on our strategy and highlight key programs across both therapeutic areas. With that, I'll hand the call back to Todd.

Excellent. Chloe, let's jump into Q&A.

Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. We'll take our first question from Paul Matteis with Stifel. Your line is open. Great.

Thanks a lot, guys, and congrats on the execution and the great quarter. As it relates to INGREZZA, I was wondering at this point in the year, how much visibility do you have on pricing dynamics next year and any feedback you're getting or any insight you're getting into access dynamics, with the NASHP MFP being enacted? Thank you so much. Hey, Paul.

This is Kyle. Thanks for the question. Maybe just to start where we are with 2026, great access this year with about 70% of all Medicare lives covered under the contracting that we executed last year. We expect that pricing to remain relatively consistent year-to-year as we think about the second half of 2026. In terms of 2027, obviously our discussions with payers are ongoing now. We should get a read on that later this year. I think where we are right now is we do see a process and a path moving forward. It's not just us, but others, that there'll be a place for MFP adjacent products for Medicare beneficiaries.

If you couple that with the fact that we're the market leader in the VMAT2 category, there's going to be ample opportunity for us to have the same access that we have here, moving forward, strong access through 2027 and 2028. Right now it's all leveraging what we can with our team. I would be remiss by not calling out that this market overall continues to grow double digit year-to-year. There's a lot of room left in this market. We'll continue to focus there.

Kyle, any thought on how much additional costs maintaining this access might be next year or beyond?

No, I think it's too early to make a call on that, Paul. We'll have more to comment on that later in the year. Right now it's been a great first half. We'll continue to build on the momentum that we've seen.

Okay. Thanks very much. We'll take our next question from Phil Nadeau with TD Cowen.

Your line is open. Good afternoon.

Thanks for taking our question. Ours is on CRENESSITY, really strong quarter with revenue up 20% quarter-over-quarter. It sounds from the prepared remarks like everything was steady as she goes. Steady patient adds, good reimbursement, no bolus. I'm curious whether that interpretation is correct. Were there any one-time issues in Q2 that made it particularly strong that we shouldn't extrapolate into the back half of the year? Or is this pace of revenue growth reasonable for the next couple quarters? Thanks. Yeah, I think characterizing Q2 as really an extension of what we've seen earlier in the launch, a very steady and consistent pattern of new patient adds.

We continue to see adoption across all the segments that we're focused on, the pediatric endocrinologists, the adult community endocrinologists, and those centers of excellence. Really pleased with the fact that we estimate now that we've got about 15% of the addressable patient population on treatment and certainly expect to see continued strong momentum as we move forward.

That's very helpful. Thank you.

We'll move next to Tazeen Ahmad with Bank of America. Your line is open. Hi.

Thanks for taking my question. Mine's on VYKAT. This quarter's results of $94 million, it's roughly flat sequentially. You just took over this franchise. Can you maybe just talk to us about some of the things that you're doing in order to accelerate the launch trajectory now that the franchise is fully under your control? Maybe just give some specifics about some of the things that you're doing now that you think could have an effect in a quarter or two. Thanks. Yeah. Hi, Tazeen. First of all, I'll say that the results that we saw in Q2 were aligned with our expectations coming out of diligence.

Certainly, I think we're still learning a lot about the hyperphagia market opportunity. What we've learned so far just reaffirms our convictions about the potential for this medicine to be a blockbuster. We're still deep in the midst of our integration process here. Ultimately, I think the fundamentals are what matters. Continuing to find patients, to introduce VYKAT XR to the providers that care for them, primarily in endocrinology. Then provide good education and guidance around how to select appropriate patients, how to help them through the titration process, and to achieve good outcomes. I feel very good about the opportunity with VYKAT.

Everything that I've heard from the physicians that have experience with it is very positive and certainly look forward to continuing to drive the launch of this product that's still very early in its commercial ramp.

Tazeen, this is Kyle. I'm just reminded as we talk about VYKAT XR, this is our first earnings call post-close where we've had a discussion on this. I do want to bring up the merits of the acquisition and the product itself. There's great strategic and financial fit here for us. VYKAT XR is a first-in-class, first-in-disease medicine for Prader-Willi syndrome, very much of the same category that we've seen for INGREZZA and CRENESSITY upon their launch. We're really excited about the strategic fit there. Obviously, we're able to expand on our endocrinology franchise moving forward.

As a product that comes under the Neurocrine umbrella earlier in its launch, not only do we get to treat many thousands of patients under Neurocrine, which is exciting, we also get to reap the financial reward of maximizing all the revenue growth that gets added to our top line as well as diversification. There's a lot of financial fit there as well. Not to mention that we believe the IP estate goes out to the mid-2040s, so it's durable as well. Overall, we're really excited about what we have here. I think Eric called out some of the points that we're looking at now, and we're excited to bring this into the same blockbuster category that we see for CRENESSITY and INGREZZA moving forward.

The only thing I'd add is this was very much in line with our internal expectations. We knew what we were buying, and this has a tremendous amount of opportunity to help many more patients. We have a ton of confidence in the team, the product, and the opportunity to help many more patients with PWS. We're encouraged as we think forward.

We'll move next to Brian Skorney with Baird. Your line is open. Hey, afternoon, guys.

Congrats on a great quarter. To jump in with a question on VYKAT as well. I think during the Soleno days, there was a lot of debate on sort of the differences between new start boluses and sort of dropouts and as you're sort of getting your head around things right now. Maybe you can just kind of characterize what you're seeing out there in terms of how much of initial bolus numbers are really kind of affecting the dropout rate that we see right now, and when do you think that there's an upwards equilibrium of new starts and dropout rates to think about in the coming quarters?

Yeah, no, I appreciate the question. This is Kyle. I think what we've seen on a new patient start basis is a pretty steady flow of new patient starts over the past couple quarters. That's good. That's right along the lines of the expectation we had after completing diligence on the company. In terms of discontinuations, obviously, with a bolus of patients at the launch, we do see some of those discontinuations being pulled through as time has gone along. We expect to see the ultimate rate settling into what we would see with other orphan medicines in the 25%-30% range. That's what we'll be looking at moving forward. Ultimately, our goal here is you'll see sequential growth as we exit 2026 and looking at that in future years. We're right where we need to be right now.

I think more importantly, I'm really excited to see our team bring its resources and the support to the Soleno team now under the Neurocrine brand, take all of our learnings collectively and make this particular medicine be the best it can be moving forward.

Great. Thanks, Kyle. We'll move next to Mohit Bansal with Wells Fargo.

Your line is open. Great.

Thank you very much for taking my question, and congrats on a great quarter. Just wanted to understand your VYKAT XR commentary a little bit better for next few quarters. You're saying that the new patient start, you expect it to be steady. Are you saying that the sales could be choppy a little bit? Again, what you are saying is that as you exit 2026, you can see you are confidently driving sequential growth. Just wondering that how would you characterize the next few quarters as you integrate the business into your own business? Thank you. Yeah. As we move from Q3 to Q4, we would anticipate seeing some sequential growth.

As you think about going into next year, it's really about that momentum. As we've talked about, it's that mix of new patient additions and being offset by the discontinuations, and we feel like we'll be through the bolus of the discontinuations here in this quarter. We would expect to be sequential growers, as we've said, in Q4 and beyond.

Hasbullah, thank you. We'll take our next question from Anupam Rama with J.P.

Morgan. Your line is open.

Hey, guys. Thanks so much for taking the question. Just wondering what some of the physician feedback has been on some of the two-year CRENESSITY data in both adults and peds, and how these data could impact uptake of the product. Thanks so much. Thanks, Anupam.

Yeah, we're really pleased about the feedback we're getting from the physicians with respect to our two-year data that were recently presented at Endo. Of note, this included both adult and pediatric data. Indicated long-term benefits with respect to both androgen reduction and also glucocorticoid steroid reduction as well. Really excited by that feedback. Also, this is in the context of a really nice safety tolerability profile. Of note, at this point, we have well over 35,000 patient weeks of exposure. Again, very important, bearing in mind the breadth of the population that we're treating with CRENESSITY.

We'll move next to Cory Kasimov with Evercore. Your line is open. Hey, good afternoon, guys.

Thank you for taking the question. Given the recent acquisition of potential future competitor, CAH, can you just talk a little bit about the clinical plan and anticipated timelines for your next gen CRENESSITY assets to the extent that they're needed to help defend the franchise in the future? Thank you. Yeah, thanks for the question.

We do have our next generation medicine going through clinical development right now. That's NBIP-1435. This is a protein-based therapeutic, a peptide that we're developing that would be a once weekly or less frequent dosed medicine for patients wanting that particular option of not having to worry about taking a medicine on a day-to-day basis. It may offer additional advantages above that, in addition to that, because of the PK profile. We have great phase I data that's come out of the program thus far, and we look forward to starting a phase II study shortly, and bringing that to patients as quickly as we can. I will say, going back to CRENESSITY just for a moment, that it set a really high bar.

It's got great efficacy, great safety, great tolerability, and what an outstanding label that we're able to get from the clinical program. We've got multiple formulations, a wide spectrum of age ranges that are applied to the medicine, and now, as Sanjay just mentioned, multiple years of clinical data that we'll be able to lean on in a multiple year head start. I say this because, this high bar not only makes it more difficult for our competitors, but even our own programs in our clinical portfolio. We're really excited about the position that we have right now with CRENESSITY. A lot of room still to grow. We got about 15% of the market currently under CRENESSITY's care, and we're going to continue growing that out over time to become that standard of care for patients.

Appreciate that perspective, Kyle. We'll move next to Jay Olson with Oppenheimer.

Your line is open. Hey, guys.

Congrats on the quarter, and congrats to Samir. Our question is related to the future of your psychiatry franchise with data readouts for osavampator and direclidine expected next year. Do you have the commercial infrastructure that you would like to have to launch those two products? How are you thinking about building out that organization? Thank you. Thanks, Jay. The way I would characterize it is that we have a really good foundation for a future infrastructure that would be required for either osavampator or direclidine or both.

As you know, we have a substantial footprint today in psychiatry, as well as in long-term care, and a very strong reputation with those provider communities. If you look at the profile of either of those two medicines, it might require us to bolster our teams or to do some reorganization work. I think that we're in a very good place in terms of being able to leverage our existing foundation.

You may recall that when we were talking about the planned expansion of our INGREZZA team last fall, we said that the value of that expansion was not only to accelerate the growth of our INGREZZA business, but also to set us up nicely for future launches of our phase III psychiatry assets. I don't anticipate any near-term changes to our footprint. Certainly, I think we're well-positioned to accelerate those adjustments to our commercial platform on the other side of positive phase III data.

I think that'd be a great day if Osa in particular is a positive as you think about going into primary care to be able to help those with major depressive disorder. That would require a step up in overall investment within SG&A in 2028, 2029 timeframe. I think you'd agree with me, that would be something we'd all enjoy to have the privilege of doing. In the near term, I think we're focused on executing, as Eric said, with INGREZZA and continuing to expand the impact we're having across the psychiatry community today. Great. Thank you. We'll take our next question from Akash Tewari with Jefferies.

Your line is open. Hey, thanks so much.

A few questions on your obesity efforts. For 2118, the CRF2 asset, what do you expect for monotherapy weight loss and muscle preservation in your phase I trial when you get into obese patients? For 1968, your triple G, is that already in the clinic? I'm surprised you're able to start a combo trial with the CRF2 this year without any monotherapy data. Finally, when we think about the combo, any sense on when we'd be able to get the first full cut of data there? Thank you. Thanks so much for the questions.

With respect to our CRF2 agonist, obviously, we're very excited about this molecule. This is our first obesity molecule in the clinic. We're currently accumulating phase I data, and we're due to have a signal-seeking study readout next year with respect to both weight loss and also lean mass preservation. That's really exciting for us. Clearly, we're looking for a robust effect, not just in weight loss, as I said, but also muscle mass preservation. We have other molecules behind CRF2 with respect to our obesity portfolio, which will be shortly entering the clinic.

We'll move next to Josh Schimmer with Cantor. Your line is open. Great.

Thanks for taking my question. How are you thinking about the ability to smooth top and bottom-line growth through the 2029 INGREZZA IRA implementation year? Does the answer to that question depend on your phase III readouts next year? How do you expect that to play out under various pipeline scenarios? Thank you. Thanks, Josh. This is Kyle.

Obviously, we're keeping an eye on our MFP to IRA outcome. Those discussions will start next year, certainly we'll keep everyone updated once we know our MFP that would be applied to INGREZZA in 2029. I think overarching what we see in the evolution of our commercial portfolio are medicines that are growing over that timeframe as well. We think we'll end up being in a good position there to see continued top-line revenue growth through the end of this decade and beyond. On the earnings side, or I should say on the income or expense side of the equation, we also have phase III trials that will be sunsetting over that same timeframe as well, our pipeline switches more to an early to mid-stage type on our pipeline, excuse me.

I think that's going to be a more or less a view into our steady-state portfolio as we get to the end of this decade. It all goes back to what we shared at the beginning of this year in terms of expectations around new phase I, phase II, and phase III starts. I like what we have in terms of the company and how we set it up. We'll keep people informed over the next couple of years as we get closer to 2029.

Yeah. EPS variability is really going to be based upon, as you said, the impact of the IRA implementation in 2029. On the expense side, as I said earlier, is if osavampator is positive, we will spend in advance of sales to build up that sales force in that market. I think you'll have episodic investments that may lead to some earnings variability, but our North Star is to grow revenue over the long term. I think from those investments, we'll have very nice earnings growth as you look into the 2030s.

We'll move next to Brian Abrahams with RBC Capital Markets. Your line is open. Hey, guys.

Thanks so much for taking my question. It seems like you're seeing really nice growth in the prescriber base for CRENESSITY. I guess I'm curious, what proportion of your target practices are still not using CRENESSITY at all? At this point, what are some of the barriers for them here at this stage of the launch, and how might you expect to overcome them? Thanks. Yeah, it's an interesting question.

I think the way I'd characterize it is that we're seeing really nice expansion of new prescribers each quarter. At this stage, we're still, I'd call it early in the overall commercial ramp. There's a long way to go. The reason I sort of qualified my comments a little bit is that as we learn more about this market and with our patient-finding opportunity, there is some movement in and out of our target list over time. Overall, the feedback's been very positive. Most of the physicians that have tried CRENESSITY have only treated one patient so far, and I think that's a function of two things. One is the flow of patients into their practices. Especially in the adult setting, patients only come in maybe once a year.

It takes time, if they have more than one patient, to see them. The second thing is really this, what we call the long tail of this market. There's really not that many practices that have more than a handful of patients, and there's a lot of physician practices that have only one or two. Ultimately, feel really good about the growth that we've seen, and we talked about this very steady and consistent pace that we're on. I think that's mostly a testament to the patient-finding efforts and of course, the execution by our team.

Thanks. We'll move next to Sean Layman with Morgan Stanley.

Your line is open. Good afternoon, Kyle and team.

Hope everyone's well. My question's on the launch trajectory of CRENESSITY. You keep handily beating our numbers.

I'm just wondering how the drug performs against your own internal expectations. Is it falling in line? If so, when will you be comfortable giving us guidance? If it's beating your expectations internally, what are some of the key areas that it's doing that?

I would say it's quite close to what our internal expectations have been. With that said, we're learning a tremendous amount each quarter. I'd say from the beginning of launch, we've been very encouraged by the feedback that we're getting by clinicians. Also, the high rates of persistency have been quite strong. We're seeing a lot of the benefits and hearing those back from clinicians in regards to the longer-term outcomes and the benefit there. We're still really quite early in launch, only six quarters in. It's premature for us to start thinking about giving a more formal guide. I would say our internal models are getting closer to the numbers that we're delivering.

Still, I'd say to the team, "Keep over-delivering." They've done an incredible job developing a new product that's in the market for the first time in over 70 years. A lot of learning going on and a lot of excitement. Kudos to the team. Well done. We'll address the guidance piece to your question as we get later in the year to next year.

Thank you, Carl. We'll move next to Marc Goodman with Leerink Partners.

Your line is open. Yeah, on VYKAT, I just want to make sure I understand, Matt, what you're saying.

Are you saying that we should expect sales to be roughly about the same in 3Q as 2Q, then 4Q should show some incremental growth versus 3Q, and the reason is because of this gating issue of timing issue, whatever you want to call it, of patients discontinuing from the bolus that occurred so-called 6 months ago or so, something like that? Just if I could, just another question. Just curious what the R&D team thinks about any learnings from the MapLight Therapeutics data that reported earlier this week. Thanks. Yeah, regarding VYKAT. I think you said it correctly, but I would go back and just say we've only had the product for 6 weeks, and it's a market that we're incredibly excited about.

We're hearing great feedback from clinicians alike. As you said, this is more of a function of getting through some of the bolus of discontinuations and then implementing some of the things that Eric laid out in terms of driving additional patients to being helped with their PWS. From an expectation perspective, I think what you said aligns with what I was trying to describe. I'll take the MapLight Therapeutics question. Maybe just to start with where Matt left off on VYKAT.

Just want to make sure everyone appreciates that we are going through an integration of the company, and obviously that can be a little noisy as you work through that, just as a sales force expansion can be. But as you know, we are quite skilled in the art of sales force expansions across INGREZZA and CRENESSITY, and we've all come out on the other side much stronger, and we believe that will be the case for VYKAT. In terms of MapLight Therapeutics, we did see their data come out here the past couple of days. I think it's a good data point for further validating the orthosteric approach for using a muscarinic agonist. Their approach is entirely different than our own, and it's worth calling out those differences here. Very similar to COBENFY, the approved medicine that utilizes the muscarinic mechanism.

The MapLight approach also requires an add back muscarinic antagonist to manage side effects. Our approach with direclidine is the only approach, a first-in-class approach, using a selective M4 agonist that works just fine by itself. It doesn't require anything to add back for mitigating side effects. We know at the end of the day, efficacy gets your foot in the door. It's really what you do on the other factors that allow you to win. Things like safety and tolerability, things like ease of administration, and that's where direclidine is really going to shine. What we saw in our phase II trial, very clean GI profile, no weight gain, no food effect, once-a-day, no titration. That's how we're going to win here, just as we've seen with other antipsychotics across the spectrum from low to high efficacy.

They all win on safety, tolerability, and ease of administration.

Thanks. We'll move next to David Amsellem with Piper Sandler.

Your line is open. Thanks.

A VYKAT question. Can you clarify how much of your discontinuations are from edema? Regarding the management of edema, what are you going to be doing to sort of help patients and practitioners manage through that so as to minimize discontinuations due to fluid retention? Thanks. This is Carl. I don't think we're going to get into the nature of the discontinuations, I will say, just like any medicine, especially one that you're inheriting, acquiring, is that there's always the opportunity to improve messaging and education.

I know that's going to be a big part of what our team looks at. The messaging in education is the same, again, across all medicines that we look at for caregivers, for patients, and for physicians. When it comes to VYKAT XR, obviously, you look at even something as simple as a dosing regimen. It's a titration schedule that's required through a weight-based mechanism. That's unique. Making sure that you can educate across that appropriately. Also setting the right expectations in terms of efficacy.

This is not like a pain medicine where you see relief the same day you take the medicine. It can take months for the hyperphagia to improve. These are all things that we're working through right now, we'll continue to work with the team to get in a really good spot as we look to fully bring the Soleno team on board here to Neurocrine, and leverage the learnings on both sides to do what's best for patients here.

We'll take our next question from Ash Verma with UBS. Your line is open. Hey, guys.

Thanks for taking my question. Maybe just on the perspective of CRENESSITY, I wanted to get your thoughts on the competitive dynamic here. For Tumulin, which Vertex acquired, they did note that there were seven LFT elevation cases versus the prior disclosure by Crinetics, which was two cases. They still ended up paying a pretty hefty premium. I just want to understand from your perspective, what do you think drove that? Is that something that ultimately signals to you that CAH can be very big market? Is it possible that the LFT elevation is actually a non-issue? Thanks. Thanks, Ash, for the question.

It's really hard for us to comment on the competitor or any competitors in the spaces that we work in. All I can share with you is the excitement that we have around our own medicine. I'll go back to the CATALYST data that we have. Two-year data, 35,000 patient weeks of exposure, and accumulating over time where we're able to show 70% of patients at the 2-year period were on a physiological dose of a GC and 70% of patients were at a physiological concentration of their androgens. That's a pretty good area to be in for CAH and really for any medicine. We'll continue to hopefully accumulate more data of that kind and type as time moves along to show the real benefits for patients.

We'll take our next question from Myles Minter with William Blair. Your line is open. Hey.

Congrats on the quarter, thanks for taking the question. I just wanted to hear your thoughts on the CRENESSITY sort of peak opportunity here. Are you still describing that drug as a blockbuster opportunity? I only ask because recent acquisition seems to put your competitor saying that that might be a $3 billion market or greater, and you're, on an annualized basis, the best part of three-quarters of a billion dollars already. Eric, you said you're really, really early on in the launch. I'm just wondering whether a blockbuster drug is the right way to think about this, or like that multi-billion-dollar sort of claim that the competitive acquisition made, is more relevant here. Thanks very much. We're going to take this to the highest number that we can and help as many patients as possible, Myles.

I think you said it quite well. The trajectory so far has been very, very strong, very nice, and I think it reflects the great need in the market, the great product we have, and also the great team. When you look back over time at other rare disease launches like this, you can see peak penetration between 30% and 50% for chronic-type medicines. When you look at what the peak opportunity is, that's the ZIP code. I know that's a pretty broad range, we're going to work to getting to as high up in that range as possible. Yeah, you can get to a really nice figure quite quickly.

It really comes, at the end of the day, a focus on helping as many patients as possible for their CAH.

Makes sense. Thanks, Matt. We'll move next to Rudy Li with Wolfe Research.

Your line is open. Hey, thanks.

Want to take my question. I have a question for the pipeline, just a quick follow-up. Given the trajectory of COBENFY and the feedback, I'm just curious on your thoughts on the muscarinics opportunity and maybe just talk about your overall strategy building a muscarinic franchise as you have multiple products maybe targeting different indications. Thanks. Hi. Thanks, Rudy. This is Samir here.

I really appreciate the question on the muscarinic. We've got four shots on goal here with our muscarinic franchise. direclidine NBI-568, that's in phase III right now for the treatment of schizophrenia and phase II bipolar. A phase II study right now ongoing in bipolar mania. All studies remain on track timeline-wise there. Our next generation, NBI-570, that's an M4-preferring M1/M4 dual. Right now that's in a phase II study for the treatment of schizophrenia. Where we see opportunity there is the potential for a long-acting injectable. This is a class of medicines that has generated significant commercial sales for other companies here, and we view this as the one and only potential LAI within the muscarinic space. NBI-569, that's earlier right now. It's an M1/M4 dual as well that we're studying in an early study in Alzheimer's disease.

The view there is to take that into Alzheimer's disease psychosis. We've got a fourth compound, NBI-567, that will be soon starting a phase II study in Alzheimer's cognition. Overall, we feel like we have a best-in-class muscarinic franchise here. Really looking forward to getting the direclidine data next year and going from there.

The only thing I would add to that, these are all orthosteric agonists that don't require any add back to block side effects. They are selective on M1 and M4, they're unique in that regard and puts us in a really unique space in the muscarinic category.

Very helpful. Thank you. We'll take our next question from Sumant Kulkarni with Canaccord.

Your line is open. Good afternoon.

Thanks for taking our question. This is a bit of a strategic one that has long-term financial implications. With each commercial product you now have, there's typically been an aspect of pioneering commercialization with the first approvals for the respective indications. Your pipeline includes candidates in large markets where not only do several products exist, but the competitors are typically much larger organizations as well. Could you share any targets for what a steady state longer-term operating margin target might look like for Neurocrine as you yourself grow a lot larger?

I'll let Kyle talk about the strategic aspect of how we're going to compete against larger guys in these markets. I also would comment that Eric and team have done a heck of a job in developing markets and feel like we can compete quite well with medicines like the muscarinics and also the osavampator. We're not going to give long-term operating margin guidance, but you can see we're becoming quite a profitable company, where our operating income on a non-GAAP basis is over 30%. I think our focus right now is invest on SG&A to grow sales as much as possible, also to advance the pipeline and be able to get to these opportunities where we can compete in some of the larger markets where we believe that we can win in.

Maybe just to add to that, this is Kyle. From the strategic perspective, what we're doing is setting up the pipeline to have a portfolio of not only first, but best-in-class medicines across neurology, psychiatry, and endocrinology, as well as immunology. These are areas that we think we can compete in in a number of ways, either through the molecules that we design or ultimately in ownership of particular mechanisms that are unique to Neurocrine. We've talked about obesity on this call as an example, we're leading in this category, we believe, with a CRF2 agonist, which is quite novel. Of course, we know a lot about the biology, this being the founding biology of the company. Ultimately, what we do by using this approach is diversifying risk across different therapeutic areas.

We appreciate all the psychiatry programs that we have, and we believe we have all winners there. We also know that the full profile of those assets are not fully known until the other side of phase III. We balance that by actually being in some of these larger disease states, like obesity, where we have biomarkers, objective endpoints, and the ability to see data in phase I-B studies. Overall, I think what we have done is we have really leveled out the portfolio and ability to play for some big wins on some larger opportunities, as well as stay within our wheelhouse of more traditional neuropsych programs as well, that you are used to seeing. Overall, it is going to set the company quite well up over the long term.

We will take our next question from Danielle Brill with Truist. Your line is open. Hi, guys.

Good afternoon. Thanks so much for the question. A follow-up on CRENESSITY. You guys highlighted really strong growth in your prescriber base, but can you comment on trends in repeat prescribing? I think you noted roughly two-thirds of prescribers have only written a single prescription on your prior call. Are you seeing existing prescribers begin to treat more patients, or is growth still being driven primarily by adding new prescribers? And then, as you look forward, where do you see the bigger opportunity expanding prescriber breadth or penetration from the existing base? Thank you. I guess the way that I would characterize that, it is a little bit of both in terms of depth versus breadth.

We still are adding a substantial number of new prescribers each quarter. And to date, most of the prescribers that have tried CRENESSITY have only treated one or two patients. Now, this is a market that is an inch deep and a mile wide in the sense that there is a limited number of practices that have more than a handful of classic CAH patients. And then there is a lot of CAH patients that are out there in the community, and a lot of the physicians that treat them might only have one patient. I think that we will continue to see this dynamic of a lot of physicians having only one or two patients under treatment.

At this stage of the launch, only about a year and a half into it, essentially, we're still seeing a lot of adoption by new prescribers, and we think there's a ways to go in terms of building that prescriber base over time.

We'll move next to Yigal Nochomovitz with Citi. Your line is open. Hi.

Great, thank you for taking the questions, and Adma, congrats on a strong quarter. I had a curious question on CRENESSITY regarding the rarer subtypes, specifically the 11-beta-hydroxylase patients. What's the status in terms of progress getting the payers to cover that subtype? I'd be curious there. Quickly on VYKAT, do you have any comments with respect to ex-U.S. strategy, and where does that fit in terms of your relative prioritization with regard to the asset? Thank you. Hi, I just want to reinforce that the coverage and reimbursement for CRENESSITY has been excellent and has really exceeded our expectations from the very beginning of the launch.

From a coverage perspective, typically what's required, this is a specialty medicine, and the physician has to fill out a prior authorization.

Typically, they're required to attest that the patient has classic CAH, usually not defining what particular genetic subtype they have, that they're four years of age or older, and that they're currently on glucocorticoids. For the vast majority of patients, those are the coverage criteria. We've seen really high claim approval rates. We've seen that claims tend to get approved pretty quickly, and that it's very affordable for patients, with the majority of patients, actually over 90%, paying $10 or less per month. Really good on the reimbursement side.

Yeah, in terms of VYKAT XR in ex-U.S., our first priority right now is to fully integrate the team and make sure that we're doing everything that we can to help the patients here in the U.S. with the approval. As you may recall, Soleno did withdraw the EMA filing for review during the closing process of the transaction. I think once we get our hands around the integration and complete that and move the medicine forward here, we'll go back and revisit the opportunity in territories outside the U.S. In the meantime, for Europe, all patients that are currently on VYKAT XR will continue on their treatment, and we'll look at some named patient program types of vehicles to help other patients that may want to have access in that region.

Thank you. We'll move next to Delma Caiati with Guggenheim.

Your line is open. Hi, good afternoon, and thank you for taking my question.

On Friedreich's ataxia program, what shall we expect from the 2027 phase I readout? More in details. Which tissue compartments will you report for ataxia in protein levels from buccal cells, skin, or muscle? What would you view as a proof of mechanism? Will you report also clinical results together with the biomarker data? Thank you. No, I appreciate the question.

We're excited about the Friedreich's ataxia gene therapy program here at Neurocrine. We'll be looking at starting clinical development later this year. Once we get that study up and running, we'll look for actual data in patients towards the end of next year. The nature of what we'll be sharing, I think, we'll determine that over the next couple of months into the beginning of the year. Hopefully, we'll have some more commentary around our R&D day in December.

We'll move next to David Huang with Deutsche Bank. Your line is open. Hi there.

Congrats on the quarter, thanks for taking my question. Was curious to get any feedback that you guys may have or your latest thoughts on the competitive dynamic and threat from your competitor in the VMAT inhibitor space. I think your competitor also printed a very strong quarter. They have talked about $3 billion in peak sales and a continued uptake of the AUSTEDO XR product. As you look over the next few years, recognizing there's some pricing dynamics there, just what's your, I guess, thoughts on how the market share may play out between two products and if the pie will continue to keep growing in PD or there'll be any share shifts between products. Thanks a lot. Yeah, I'll just start off by saying that almost 10 years into the launch of INGREZZA, the TD market continues to grow very rapidly.

We see that there's still a substantial number of untreated patients and even undiagnosed patients out there. Our focus remains on driving awareness, driving diagnosis, and then obviously, being able to educate providers on the unique benefits of INGREZZA. Obviously also continuing to provide strong reimbursement support. The results speak for themselves. INGREZZA has been the most preferred and the most prescribed VMAT2 inhibitor since day one and continues to do so. Even looking at the most current quarter, with strong market growth for VMAT2s, INGREZZA outgrew the market. We can expect to continue to see that momentum carry forward through the balance of this year.

As Kyle said earlier, from a coverage and reimbursement perspective, we expect to have good coverage in 2027 and 2028 that will enable continued strong growth in terms of adoption. Overall, just very pleased with our performance, and we'll let the results speak for themselves.

We'll take our next question from Evan Seigerman with BMO Capital Markets. Your line is open. Hi, guys.

Thank you so much for taking my question. I want to touch on osavampator. MDD is clearly a large market. You're very enthusiastic about it. Just walk us through kind of what you're solving for that the existing antidepressant strategies really don't do well. What do you need to show in a phase III for this truly to be viewed as differentiated rather than incremental? Thank you. Thanks for the question.

Just for context, osavampator is an AMPA potentiator. We think provides unique advantages from a differentiation point of view from the existing standard of care. With respect to efficacy, we're expecting greater efficacy, particularly in individuals who have already been unresponsive or not so responsive to a whole slew of other antidepressants with different methods of action. Secondly, and also just as importantly, a really nice safety tolerability profile. That was one of the most impressive things, actually, with respect to our phase II SAVITRI data was the safety tolerability, and the implication is long-term compliance with this medication.

That does conclude the question and answer portion of today's call. I'd now like to turn it back to Kyle Gano for any additional or closing remarks.

Thanks, everyone, for joining us today. We appreciate your time and thoughtful questions. We look forward to continuing the conversation with many of you, certainly at the investor conferences and meetings throughout the remainder of the year. Until then, thanks again for your support and interest, and have a great afternoon, and goodbye for now.

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation.