NBIX

Krystal Biotech KRYS reported second-quarter 2026 earnings per share (EPS) of $1.79, which surpassed the Zacks Consensus Estimate of $1.70. The company recorded an EPS of $1.29 in the year-ago quarter. Revenues of $119.2 million rose 24.14% year over year in the reported quarter, marginally beating the Zacks Consensus Estimate of $119 million. Revenues came in solely from Vyjuvek sales. The FDA approved Krystal’s lead drug, Vyjuvek, the first-ever revocable gene therapy, in 2023 for the treatment of patients aged six months or older with dystrophic epidermolysis bullosa (DEB), a rare and severe monogenic disease that affects the skin and mucosal tissues. The drug has been approved by the FDA for the treatment of DEB patients from birth, with authorization for at-home administration by patients or their caregivers. The company secured more than 730 reimbursement approvals for Vyjuvek in the United States, supporting nationwide access. Internationally, robust patient demand continues to drive steady uptake following the launches in Germany, France and Japan, with more than 180 patients prescribed the therapy across these markets. In May, Vyjuvek got approval in the United Kingdom for the treatment of DEB patients since birth. Despite earnings beat, shares of KRYS were down nearly 8.4% on Monday. Year to date, shares of KRYS have risen 26.8% compared with the industry’s 2.8% growth. Image Source: Zacks Investment Research The top line comprises product revenues from Krystal’s only marketed drug, Vyjuvek. Krystal generated $119.2 million in product revenues from Vyjuvek, up from $96 million in the year-ago quarter, driven by strong patient uptake. The gross margin in the reported quarter was 95%. Research and development (R&D) expenses were approximately $14.5 million, including stock-based compensation, roughly consistent with the prior-year quarter. Selling, general and administrative (SG&A) expenses totaled $39.9 million, including stock-based compensation, up 13.6% from the year-ago level. This increase was primarily due to increased headcount and marketing costs to support the global launches of Vyjuvek. As of June 30, 2026, cash, cash equivalents and investments totaled $1.1 billion compared with approximately $1 billion as of March 31, 2026. Krystal reiterated its non-GAAP combined R&D and SG&A expense guidance of $175 million to $195 million for full-year 2026. For Vyjuvek, the company is advancing pricing and reimbursement negotiations across Europe, targeting commercial launches in Italy and Spain by the end of 2026. Krystal is also advancing a robust clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics. On the respiratory front, the company has two candidates in its pipeline, KB407 and KB408. The company is evaluating KB407 for the treatment of cystic fibrosis (CF). Based on its discussions with the FDA, Krystal has initiated an open-label study to test repeat-dose KB407 in CF patients who cannot use or benefit from existing therapies. Patient enrollment is ongoing, and initial study data are anticipated by the end of the year. Concurrently, Krystal is collaborating with the FDA and the Cystic Fibrosis Foundation on an innovative registrational study design that may use real-world patient data to support evaluation of KB407’s treatment effect. It plans to finalize and share the study design following FDA alignment in the fourth quarter of 2026, with the registrational study expected to begin in 2027. KB408 is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease. Enrollment is ongoing in repeat-dose Cohort 2B of the SERPENTINE-1 study, with interim results expected in 2027. In the ophthalmology space, another candidate, KB803, is being evaluated in IOLITE, a phase III randomized, placebo-controlled crossover study for the treatment and prevention of corneal abrasions in DEB patients. Patient enrollment has been completed, with top-line data anticipated in the fourth quarter of 2026. Krystal is also evaluating KB801 for the treatment of patients with neurotrophic keratitis (NK). A registrational, randomized, double-masked, placebo-controlled study, EMERALD-1, is evaluating the safety and tolerability of topical ocular administration of KB801 in patients with NK. Patient enrollment is ongoing. On the oncology front, Krystal has a promising candidate, KB707, which is being developed for the treatment of non-small cell lung cancer (NSCLC). Krystal is evaluating inhaled KB707 as monotherapy and in combination with other therapies in patients with advanced NSCLC. In May, the company announced interim data from a dose-expansion cohort of its phase I/II KYANITE-1 study, which showed that KB707 combined with Keytruda (pembrolizumab) was well tolerated and demonstrated encouraging anti-tumor activity, while earlier monotherapy data also showed promising efficacy. The company is on track to complete patient enrollment in the final dose-expansion cohort of the KYANITE-1 study, evaluating KB707 in combination with chemotherapy by the end of 2026. Updated interim clinical data, along with potential registrational study plans, are expected in the first half of 2027. In the aesthetics space, the company’s wholly owned subsidiary, Jeune Aesthetics, is currently developing KB304 for the treatment of wrinkles of the décolleté. The company expects to initiate a mid-stage study in 2027. Krystal Biotech, Inc. price-consensus-eps-surprise-chart | Krystal Biotech, Inc. Quote Krystal currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy) and Neurocrine Biosciences NBIX, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 90 days, earnings per share estimates for Harmony Biosciences have decreased from $3.34 to $3.30 for 2026. Over the same period, estimates for earnings per share increased from $3.79 to $3.87 for 2027. HRMY shares have lost 4.9% year to date. Harmony Biosciences missed on earnings in each of the trailing four quarters, delivering an average negative surprise of 25.16%. Over the past 90 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $5.31 from $2.91. LQDA shares have gained 143.1% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8.04 to $9.09. Over the same period, EPS estimates for 2027 have increased from $9.54 to $10.81. NBIX shares have gained 17.2% year to date. Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 13.57%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Thursday, July 30, 2026 at 4:30 p.m. ET Vice President of Investor Relations - Todd Tushla Chief Executive Officer - Kyle W. Gano Chief Financial Officer - Matthew Abernethy Chief Commercial Officer - Eric S. Benevich Chief Medical Officer - Sanjay Keswani Chief Business Officer - Samir Siddhanti Need a quote from a Motley Fool analyst? Email [email protected] Operator: Thank you for your continued patience. Your meeting will begin shortly. Star zero, and a member of our team will be happy to help you. You for your continued patience. Your meeting will begin shortly. And a member of our team will be happy to help you. Hello and welcome everyone to join today's Neurocrine Biosciences Reports Q2 26 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 1 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. Todd Tushla: Happy Thursday, everyone. Welcome to Neurocrine Biosciences second quarter 26 earnings call. With me today on the call are Kyle W. Gano, chief executive officer Matthew Abernathy, chief financial officer Eric S. 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 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 US 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 will jump into Q&A. Now I will hand the call off to Kyle. Kyle W. Gano: 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 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 on our commercial portfolio to bring our medicines to patients, advance our innovation engine, deploy capital with discipline. This quarter demonstrated meaningful progress across all 3 of these priorities. The commercial business continues to generate durable growth, The pipeline is advancing as 1 of the industry's strongest mid to late stage portfolios. And 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 and 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 3 data readouts for osavampator in major depressive disorder, and dereclidine in schizophrenia. Together with the continued 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 Matthew, I would 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 is ahead. With that, I will turn the call over to Matthew. Matthew C. Abernethy: 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 the partial-quarter contribution from VYKAT XR following the close of the Sileno 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 our full-year INGREZZA guidance from $2.7 billion to $2.8 billion to a new range of $2.825 billion to $2.875 billion At the midpoint, this represents approximately 13% year over year growth. Chronicity's 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 18. 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 form a total revenues were $998 million for the second quarter 26 when including full quarter VYKAT XR sales. This performance underscores the strength and increasing scale of our commercial across 3 highly differentiated products. Turning to our financials. With the Soleno acquisition now complete, I would like to briefly discuss the financial impact of the transaction. Including the purchase accounting and the GAAP to non adjustments reflected in our earnings release. We acquired So 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. Strategic 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 So operating expenses, transaction and integration costs, and the expected purchase accounting intangible and in 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 noncash 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, 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 S. Benevich. Eric S. Benevich: Our chief commercial officer. Eric. Thanks, Matthew. Just 5 years ago, Neurocrine was a single, product commercial stage company celebrating INGREZZA achieving blockbuster status. Surpassing $1 billion in annual sales. Todd, our commercial portfolio includes 3 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. So 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. Basma 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 a $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, but 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 are 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 would 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 health care 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. Now I will turn the call over to our Chief Medical Officer, Dr. Sanjay Keswani. Sanjay Keswani MBBS: Thanks, Eric, and good afternoon, everyone. I will begin today with highlights from ENDO 26. Where we presented important new data for both Crinesity 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 H 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 3 top line data for osavampator in major depressive disorder in the second half of 27. We also remain on track to report the first phase 3 readout for dereclidine in schizophrenia in the second half of 27 and for the second phase 3 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 will hand the call back to Todd. Todd Tushla: Excellent. Chloe, let's jump into Q&A. Operator: Thank you. Star 2. Take our first question from Paul Matteis with Stifel. Your line is open. Paul Matteis: Great. Thanks a lot, guys, and congrats on the execution on 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 are getting or any insight you are getting into Access Dynamics with the AUSTEDO MSP being enacted? Thank you so much. Kyle W. Gano: 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. Matthew C. Abernethy: Under the contracting that we executed last year, and we expect that pricing to remain relatively consistent year to year as we think about the second half of 26. In terms of 2027, obviously, our discussions with payers are ongoing now, and we should get a read on that later this year. Kyle W. Gano: But I think where we are right now is we do see a process and a path moving forward. it is not just us, but others, that there will be a place for MFP adjacent products for Medicare beneficiaries. And if you couple that with the fact that we are the market leader, in the CMAT2 category, there is gonna be ample opportunity for us to have the same access that we have here, moving forward strong access through 2027 and 2028. So right now, it is all leveraging what we can with our team. I would remiss be remiss by not calling out that this market overall continues to grow double digit year to year, so there is a lot of room left in this market. We will continue to focus there. Paul Matteis: Kyle, any thought on how much additional costs maintaining this access might be next year or beyond? Kyle W. Gano: No. I think it is too early to make a call on that, Paul. We will have more to comment on that later in the year. Right now, it is it is been a great first half and we will continue to build on the momentum that we have seen. Okay. Very much. Operator: We will take our next question from Philip Nadeau with TD Cowen. Your line is open. Philip Nadeau: Good afternoon. Thanks for taking our question. Ours is on Crinesity. A really good quarter with revenue up 20% quarter over quarter. It sounds from the prepared remarks, like everything was steady-as-she-goes. So steady patient adds, good reimbursement, no bolus, I am curious whether that interpretation is correct. Were there any onetime issues in Q2 that made it particularly strong that we should not extrapolate into the back half of the year? Or is this pace of revenue growth reasonable for the next couple of quarters? Thanks. Eric S. Benevich: Yeah. I think characterizing Q2 is really an extension of what we have seen earlier in the launch, very steady and consistent pattern of, new patient adds. You know, we continue to, see adoption across all the segments that we are focused on: the pediatric endocrinologist, the adult community endocrinologist, and those centers of excellence. You know, really pleased with the fact that, you know, we estimate now that we have got about 15% of the addressable patient population on treatment. And know, certainly expect to see continued strong momentum as we move forward. that is very helpful. Thank you. Operator: We will move next to Tazeen Ahmad with Bank of America. Your line is open. Tazeen Ahmad: Hi. Thanks for taking my question. Mine is on VYKAT. So this quarter's results of $94 million it is roughly flat sequentially. You just took over this franchise. So can you maybe talk to us about some of the things that you are doing in order to accelerate the launch trajectory now that the franchise is fully under your control? And maybe just give some specifics about some of the things that you are doing now that you think could have an effect you know, in a quarter or 2. Thanks. Eric S. Benevich: Yeah, hi, Tazeen. So, first of all I will say that the results that we saw in Q2 were aligned with our expectations coming out of diligence. Certainly, I think we are still learning a lot, about the hyperphagia market opportunity. but what we have learned so far it just reaffirms our convictions about the potential for this medicine to be a blockbuster. And, you know, we are still in the you know, deep in the midst of our integration process here. But, you know, ultimately, I think the fundamentals are what matters. You know, continuing to find patients, to introduce VYKAT XR to the providers that care for them primarily in endocrinology. And then, you know, provide good education and guidance around how to select appropriate patients, how to help them through the titration process, and to achieve good outcomes. So I feel very good about the opportunity with VICAT. Everything that I have 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 is still very early in its in its commercial ramp. Kyle W. Gano: And, Tazeen, this is Kyle. I am just reminded as we talk about VYKAT XR. This is our first earnings call post close where we have had a discussion on this. So I do wanna bring up, the merits of the acquisition and the product itself. there is a great strategic and financial fit here for us. VYKAT XR is a first in class, first in disease for Prader Willi syndrome, very much of the same category that we have seen for INGREZZA and Crinesity upon their launch. So we are really excited about this strategic fit there. Obviously, we are able to expand on our endocrinology franchise moving forward. But 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 is 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 is durable as well. So overall, we are really excited about what we have here. I think Eric called out some of the points that we are looking at now, and, we are excited to bring this into the same blockbuster category that we see for Crinesity and INGREZZA moving forward. Matthew C. Abernethy: The only thing I would add is this was very much in line with our internal expectations. Knew what we were buying. And this has a tremendous amount of opportunity to help many more patients. So we have a ton of confidence in the team, the product, and the opportunity to help many more patients with PWS. So we are encouraged as we think forward. Operator: We will move next to Brian Skorney with Baird. Your line is open. Brian Skorney: Congrats on a great quarter. Maybe to jump with a question on VYKAT as well. I think during the Selena days, there is lot of debate on sort of the differences between sort of new-start boluses and sort of dropouts and, you know, as you are sort of getting your head around things. Right now. Maybe you could just kind of characterize what you are seeing out there in terms of like how much of initial, bolus numbers are really kind of affecting things, the dropout rate that we see right now. And when do we, you know, you think that there is an upwards equilibrium of new starts dropout rates to think about in the coming quarters. Kyle W. Gano: Yeah. No. I appreciate the question. This is Kyle. I think what we have seen on a new patient start basis is a pretty steady flow of new patient starts over the past couple quarters. So that is good. that is right along the lines of the expectation we had after, after completing diligence on the company. In terms of discontinuations, obviously, with the bolus of patients, at the launch, we do see some of those discontinuations being pulled through. As time has gone along, but we expect to see the ultimate rate settling into what we would see with other orphan medicines in the 25 to 30 percent range. So that is what we will be looking at moving forward. But, ultimately, you know, our goal here is you will see sequential growth as we exit 2026 and looking at that in future years. So we are right where we need to be right now. I think more importantly, I am really excited to see our team bring its resources and the support, to the So team now under the Neurocrine brand. And take all of our learnings collectively and, make this particular medicine be the best it can be moving forward. Great. Thanks, Kyle. Operator: We will move next to Mohit Bansal with Wells Fargo. Your line is open. Mohit Bansal: Great. Thank you very much for taking my question and congrats on the great quarter. So just wanted to understand VYKAT a little bit better for next few quarters. So you are saying that the patient or a patient in patient new patient start, you expect it to be steady. So wondering that so are you saying that the sales could be choppy a little bit? But, again, what you are saying is that as you exit 2026, you can see you are confirming driving sequential growth. I am just wondering that how will you characterize the next few quarters? As you integrate the business into your own business? Thank you. Matthew C. Abernethy: Yeah. So as we move from Q3 to Q4 we would anticipate seeing some sequential growth. And then as you think about going into next year, it is really about that momentum. But as we have talked about, it is that mix of new patient additions and being offset by the discontinuations, and we feel like we will be through the bolus of the discontinuations here this quarter. So we would expect to be sequential growers, as we have said. In Q4 and beyond. Helpful. Thank you. Operator: We will take our next question from Anupam Rama with JPMorgan. Your line is open. Anupam Rama: Just wondering what some of the physician feedback has been on some of the 2 year CRENESSITY data both adults and peds, and how these data could impact kind of uptake of the product? Thanks so much. Sanjay Keswani MBBS: Thanks, Anupam. Yeah, we are really pleased about the feedback we are getting from the physicians with respect to our 2-year data. That we recently presented at ENDO. Of note, this included both adult and pediatric data and indicated long term benefits with respect to both antigen reduction and also glucocorticoid steroid reduction as well. So really, really excited by that feedback. Also, this is in the context of a really nice safety profile. So note at this point, we have well over 35 thousand patient-weeks of exposure Again, very important, bearing in mind the breadth of the population that we are treating with chronicity. Operator: We will move next to Cory Kasimov with Evercore. Your line is open. Cory Kasimov: Hey. Good afternoon, guys. Thank you for taking the question. So given the recent acquisition of potential future competitor in 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 are needed to help defend the franchise in the future? Thank you. Kyle W. Gano: Yeah. Thanks for the question. We do have our next generation medicine going through clinical development right now. that is NBI-112 thousand. This is a protein based therapeutic of peptide that we are 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. So we have great phase 1 data that is come out of the program thus far. We look forward to starting a phase 2 study shortly. And bringing that to, you know, 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 is got great efficacy, great safety, great tolerability, and what an outstanding label that we are able to get from the clinical program. We have 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 will 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. So we are really excited about the position that we have right now with Crinesity. A lot of room still to grow. We got about 15% of the market currently under Crinesity's care. We are gonna continue growing that out over time. To become that standard of care for patients. Appreciate that perspective, Kyle. Operator: We will move next to Jay Olson with Oppenheimer. Your line is open. Jay Olson: 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 dereclidine expected next year. Do you have the commercial infrastructure that you would like to have to launch those 2 products? Or, I guess, how are you thinking about building out that organization? Thank you. Eric S. Benevich: Thanks, Jay. So, 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 dereclidine 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 that provider communities. You know, if you look at the profile of either of those 2 medicines, it might require us to, bolster our teams or to, do some reorganization work. But I think that we are in a very good place in terms of being able to leverage our existing foundation. And 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 3 psychiatry assets. So I do not anticipate any near term changes to our footprint. But, certainly, I think we are well positioned, you know, to accelerate you know, those adjustments to our commercial platform. On the other side of positive Phase 3 data. Matthew C. Abernethy: I think that would be a great day if OSA, in particular, is 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 and A, and 2028-2020 timeframe, but I think you would agree with me that would be something we would all enjoy to have the privilege of doing. But in the near term, you know, I think we are focused on executing, as Eric said, with INGREZZA and continuing to expand the impact we are having across the psychiatry community today. Kyle W. Gano: Great. Thank you. Operator: We will take our next question from Akash Tewari with Jefferies. Your line is open. Analyst: Hey. Thanks so much. Just okay. A few questions on your obesity efforts. So for 2.12 thousand the CRF2 asset, what do you expect for monotherapy weight loss and muscle preservation in your phase 1 trial when you get into obese patients? And then for 1.97 thousand your triple g, is that already in the clinic? I am surprised you are able to start a combo trial with the CRF2 this year without any monotherapy data. And then finally, when we think about the combo, any sense on when we would be able to get the first full of cut first full cut of data there? Thank you. Sanjay Keswani MBBS: Thanks so much for the questions. With respect to our CRF agonist, obviously, we are very excited about this molecule. This is our first molecule in the clinic. We are currently accumulating a phase 1 data and we are due to have a signal seeking study readout next year with respect to both weight loss and also lean mass preservation. So that is really exciting for us. I am not sure if I will comment specifically on the exact bar we are looking at, but clearly, we are 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 the clinic. Operator: We will move next to Josh Schimmer with Cantor Your line is open. Analyst: Thanks for taking the question. How are you thinking about the ability to smooth top and bottom line growth through the 2029 INGREZZA IRA implementation year? And does the answer to that question depend on your Phase III readouts next year? How do you expect that play out under various pipeline scenarios? Thank you. Kyle W. Gano: Thanks, Josh. This is Kyle. Obviously, we are keeping an eye on our MFP to IRA outcome Those discussions will start next year, and, certainly, we will keep everyone updated once we know our MFP that would be applied to INGREZZA in 2029. But I think overarching, what we see in the evolution of our commercial portfolio are medicines that are growing over that time frame as well. So we will think we will we will 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 an expense side of the equation, we also have phase 3 trials that will be sunsetting over that same time frame as well. Our pipeline switches more to an early to mid stage pipeline, excuse me, And I think that is going to be more or less a view into our steady state portfolio as we get to the end of this decade. And it all goes back to what we shared at the beginning of this year, in terms of expectations around new phase 1, phase 2, and phase 3 starts. So I like what we have in terms of the company and how we set it up. And we will keep people informed over the next couple, of years as we get closer to 2029. Matthew C. Abernethy: Yeah. EPS variability is really going to be based upon, as you said, the impact of the IRA implementation in 2029. But on the expense side, as said earlier, is if osavampator is positive, we will spend in advance of sales to build up that sales force in that market. So I think you will have episodic investments that, you know, may lead to some earnings variability, but our north star is to grow revenue over the long term. And I think from those investments, we will have very nice earnings growth as you look into the 20 thirties. Operator: We will move next to Brian Abrahams with RBC Capital Markets. Your line is open. Brian Abrahams: Hey, guys. Thanks so much for taking my question. It seems like you are seeing really nice growth in the prescriber base for CRENESSITY. I guess I am curious what proportion of your target practices are still not using Crinesity at all? What are this point, what are some of the barriers for them here in at this stage of the launch? And how might you, expect to overcome them? Thanks. Eric S. Benevich: Yes. it is an interesting question. Think the way I would characterize it is that, you know, we are seeing really nice expansion of new prescribers each quarter. And at this stage, you know, we are still I would call it early in the overall commercial ramp. And so there is there is 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. But overall, the feedback's been very positive. Most of the physicians that have tried CRENESSITY have only treated 1 patient so far, and I think that is a function of 2 things. 1 is the flow of patients. Into their practices, especially in the adult setting. Patients only come in maybe once a year. So it takes time, if they have more than 1 patient to see them. And then the second thing is really this what we call the long tail of this of this market. there is really not that many practices that have more than a handful of patients, and there is a lot of lot of physician practices that have only 1 or 2. So, ultimately, you know, feel really good about the growth that we are that we are that we have seen, and we talked about this very steady and consistent pace that we are on. I think that is mostly, a testament to the patient finding efforts and, of course, the execution by our team. Thanks. Operator: We will move to Sean Lehmann with Morgan Stanley. Your line is open. Analyst: Good afternoon, Kyle and team. Hope everyone is well. My question is on the launch trajectory of CRENESSITY. You keep handily beating our numbers. I am just wondering how the drug performs against your own internal expectations. Is it falling in line? And if so, when do you when will you be comfortable giving us guidance? If it is beating your expectations internally, what are some of the key areas that it is it is doing that? Matthew C. Abernethy: I would say it is quite close to what our internal expectations have been. But with that said, we are learning a tremendous amount each quarter. I would say from the beginning of launch, we have been very encouraged by the feedback that we are getting by clinicians and then also the high rates of persistency have been quite strong. And we are we are seeing a lot of the benefits and hearing those back from clinicians in regards to the longer term outcomes and the benefit there. So we are still really quite early in launch, only 6 quarters in. it is premature for us to start thinking about giving a more formal guide. But I would say our internal models are getting closer to the numbers that we are delivering, but still, I would say to the team, keep over delivering. They have done an incredible job developing a new product that is in the market for the first time in over 70 years. And a lot of learning going on and a lot of excitement. So kudos to the team Well done, and we will address the guidance piece to your question as we get later in the year to next year. Kyle W. Gano: Thank you, Carl. Operator: We will move next to Marc Goodman with Leerink Partners. Your line is open. Marc Goodman: Yes. On VICAT, I just want to make sure I understand, Matthew, what you are saying. Are you saying that we should expect sales to be roughly about the same in 3Q as 2Q? And then 4Q should show some incremental growth versus 3q. And the reason is because of this gating issue of timing issue, whatever you wanna call it, of patients discontinuing from the bolus that occurred you know, so called 6 months ago or so, something like that. And then just if I could, just another question. Just curious what the R and D team thinks about any learnings from the Maplight data reported earlier this week. Thanks. Matthew C. Abernethy: Yeah. Regarding VICAT, you know, I think you said it correctly, but I would go back and just say we have only had the product for 6 weeks. And it is a market that we have, we are incredibly excited about. We are 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. So from an expectation perspective, I think what you said aligns with what I was trying to describe. Kyle W. Gano: And I will take the, the map like question. Maybe just to start with where Matthew left off on. BICAT. Just wanna make sure everyone appreciates that we are going through an organ integration of company. And, obviously, that can be a little noisy, as you work through that just as a Salesforce expansion can be. But as you know, we are quite skilled in the art of Salesforce expansions across INGREZZA and Cranesedy, and we have all come out on the other side much stronger, and we believe that will be the case for VICAT. In terms of map light, we did see their data come out here the past couple days. I think it is a good data point for further validating the orthosteric approach for using a muscarinic agonist. Although their approach is entirely different than our own. it is 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 dereclidine is the only approach, a first in class approach, using a selective M4 agonist that works just alright by all fine by itself. It does not require anything to add back for mitigating side effects. But we know at the end of the day, efficacy gets your foot in the door, it is 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 is where dereclidine's really gonna shine. What we saw in our phase 2 trial very clean GI profile, no weight gain, no food effect, once a day, no titration. that is how we are gonna win here just as we have seen with other antipsychotics across the spectrum. From low to high efficacy. They all went on safety, tolerability, and ease of administration. Thanks. Operator: We will move next to David Amsellem with Piper Sandler. Your line is open. David Amsellem: Thanks. A VICAT question. Can you clarify how much of your discontinuations are from edema? And 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 discontinuation due to fluid retention? Thanks. Kyle W. Gano: Yeah. This is Scott. I do not think we are gonna get into the nature of the discontinuations. But I will say, just like any medicine, especially 1 that you are inheriting, acquiring, is that there is always, the opportunity to improve messaging and education. I know that is gonna be a big part of what our team looks at. And the messaging education is the same, again, across all medicines that we look at for caregivers, for patients, and for physicians. And when it comes to, Bicat XR, obviously, you look at even something as simple as a dosing regimen. it is a titration schedule that is required through a weight based mechanism. that is unique. So 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. So these are all things that we are working through right now. And we will continue to work with the team to get in a really good spot as we look to fully bring the Soleno team onboard here to Neurocrine. And leverage the learnings on both sides to do what is best for patients here. Operator: We will take our next question from Ashwani Varma with UBS. Your line is open. Analyst: Hey, guys. Thanks for taking my question. So maybe send the perspective of CRENESSITY, I wanted to get your thoughts on the competitor dynamic here. So for 2 minutes, would they acquired, they did note that, there were 7 LFT cases versus the prior disclosure by Kinetics, which was 2 cases. But they still end up paying a pretty hefty premium I just wanted 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 or is it possible that the LFT elevation is actually a nonissue? Thanks. Kyle W. Gano: Yeah. Thanks, Josh, for the for the question. it is really hard for us to comment on the competitor or any competitors. And in the spaces that, we work in. All I can share with you is the excitement that we have around our own medicine. I will go back to the catalyst data that we have 2 year data, 35 thousand patient weeks of exposure. And accumulating over time where we are able to show 70 percent of patients, at the 2 year period were on a physiologic dose of a GC, and 70 percent of patients were at a physiological concentration of their androgens. that is a pretty good air to be in, for CH and really for any medicine. And we will continue to hopefully accumulate more data of that kind in type as time moves along to show the real benefits for patients. Operator: We will take our next from Myles Minter with William Blair. Your line is open. Myles Minter: Hi. Congrats on the quarter and thanks for taking the question. I just wanted to hear your thoughts on the Chronicity sort of peak opportunity here. Are you still describing that drug as a blockbuster opportunity? I only ask because recent acquisition seems to your competitors saying that might be a $3 billion market or greater and your on an annualized basis, the best part of $750 million already. And, Eric, you said you are really, really early on in the launch. I am just wondering whether a blockbuster drug is the right way to think about this or, like, that multi dollar sort of claim that the competitive acquisition made is more relevant here? Thanks very much. Matthew C. Abernethy: We are gonna take this to the highest number that 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 3.05 thousand% for chronic type medicines. So you know, when you look at what the peak opportunity is, that is the ZIP code. I know that is a pretty broad range. And we are gonna work to getting to as high up in that range as possible. But, yeah, you can get to a really nice figure quite quickly But it really comes at the end of the day a focus on helping as many patients with possible for their for their CAH. Myles sense. Thanks, Matthew. Operator: We will move next to Rudy Lee with Wylie Research. Your line is open. Analyst: Hi, thanks for taking my question. I have a question for the pipeline, just a quick follow-up. Given the trajectory of coblimbi and the feedback I am just curious on your thoughts. On the opportunity and maybe just talk about your overall strategy during the Muscarini franchise as you have multiple products maybe targeting different indications. Thanks. Hi. Thanks, Rudy. This is Samuel here. Really appreciate the question on the muscarinic. So, you know, we have got 4 shots on goal here with our muscarinic franchise directly in 68. that is in Phase 3 right now for the treatment of schizophrenia and phase 2 bipolar, so phase 2 study right now ongoing in bipolar mania. All studies remain on track timeline wise there. Next generation NBI 75, that is an m 4 preferring m 1 m 4 dual. Right now, that is in a phase 2 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 1 and only potential LAI within the muscarinic space. NBI 9, that is earlier right now. it is an m 4 dual as well that we are studying in an early study in Alzheimer's disease. The view there is to take that into Alzheimer's disease psychosis, and then we have got a fourth compound, NBI 7, that will be soon starting a phase 2 study in Alzheimer's cognition. Overall, we feel like we have a best in class muscarinic franchise here. Really looking forward to getting the direct leading data next year and going from there. Kyle W. Gano: The only thing I would add to that, these are all these are all, orthosteric agonists that do not require any add back to block side effects. They are selective on m 1 and m 4. They are unique in that regard and puts us in a really unique space in the muscarinic category. Very helpful. Thank you. Operator: We will take our next question from Sumant Kulkarni with Canaccord. Your line is open. Sumant Kulkarni: This is a bit of strategic 1 that has long term financial implications. With each commercial product you now have, there is typically been an aspect of pioneering commercialization with the first approvals for the respective indications. But your pipeline indicates includes candidates in large markets where not only do several product exist, but the competitors are typically much larger organizations as well. So could you share any targets for what a steady state longer term operating margin target might look like for Neurocrine as it you yourself grow a lot larger? Matthew C. Abernethy: Yeah. I will let Kyle talk about the Subir or sorry, the strategic, aspect of how we are gonna compete against larger guys in these markets, but 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 muscarinic and also osavampator. Not gonna give long term operating margin guidance, but you can see we are becoming quite a profitable company. We are operating income on a non GAAP basis is over 30%. So I think our focus right now is invest on the SG&A to grow sales much as possible and then 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. Kyle W. Gano: And maybe just to add to that. This is Kyle From a strategic perspective, what we are doing is setting up the pipeline to have a portfolio of not only first but best in class medicines, a neurology, psychiatry, and endocrinology as well as immunology. These are areas that, we think we can compete in a number of ways, either through the merit of the molecules that we design or ultimately in ownership of particular mechanisms that are unique to Neurocrine. You know, we have talked about obesity on this call as an example. We are leading in this category, we believe, with a CRF2 agonist, which is quite novel. And, of course, we know a lot about the biology being this being or this being the founding biology of the company. So, 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. But we also know that the full profile of those assets are fully known until the other side of phase threes. 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 1 b studies. So 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 with within a wheelhouse of more traditional neuropsych programs as well. That you are used to seeing. But overall, it is gonna set the company quite well. Up over the long term. Operator: We will take our next question from Danielle Brill with Truist. Your line is open. Danielle Brill Bongero: Hi, guys. Good afternoon. Thanks so much for the question. A follow-up on Crinesity. So you guys highlighted really strong growth in your prescriber base, but can you comment on trends in repeat prescribing? I think you noted roughly 2 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. Eric S. Benevich: So the I guess the way that I would characterize that, it is a little bit of both in terms of depth versus breadth. You know, we still are adding a substantial number of new prescribers each quarter. And to date, most of the prescribers that have tried have only treated 1 or 2 patients. Now this is a market that is an inch deep and a mile wide in the sense that, you know, there is a limited number of practices that have more than a handful of classic CAH patients. And then there is a lot of CH patients that are out there. In the in the community, and a lot of the physicians that treat them might only have 1 patient. So I think that, you know, we will continue to see this dynamic of a lot of physicians having only 1 or 2 patients under treatment. But, you know, at this stage of the launch, only about a year and a half into it, essentially, we are still seeing a lot of adoption by new prescribers, and we think there is a ways to go in terms of building that prescriber base over time. Operator: We will move next to Igole Nochomovitz with Citi. Your line is open. Yigal Nochomovitz: Hi, great. Thank you for taking the questions and my congrats on a strong quarter. My question, I had a quick question on Crinesity. Regarding the rarer subtypes, specifically the 11 beta hydroxylase patients, what is the status in terms of progress getting the payers to cover that subtype I am curious there. And then quickly on VICAT, do you have any comments with respect to ex US strategy, and where does that fit in terms of your relative prioritization, with regard to that? The asset? Thank you. Eric S. Benevich: Hi. I just wanna, reinforce that the coverage and reimbursement for Cranesity has been excellent. And has really exceeded our expectations from the very beginning of the launch. You know, from a coverage perspective, typically what is required, this is a specialty medicine, and the physician has to fill out a prior authorization, typically, they are required to attest that the patient has classic CAH, usually, not defining what particular subtype. Genetic subtype they have. That they are 4 years of age or older and that they are currently on glucocorticoids. For the vast majority of patients, those are the coverage criteria. And we have seen really high claim approval rates, but we have seen that claims tend to get approved pretty quickly. And that it is very affordable for patients with the majority of patients. Actually, over 90% paying $10 or less per month. So really good on the reimbursement side. Kyle W. Gano: Yeah. In terms of, VICAD XR and ex US, our first priority right now is fully integrate the team and make sure that we are doing everything that we can, to help the patients here in The US 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 will go back and revisit the in territories outside The US. In the meantime, for Europe, all patients that are currently on VYKAT XR will continue to continue on their treatment, and we will look at some named patient program types of vehicles to help other patients that may wanna have access in that region. Thank you. Operator: We will move next to Basma Chayati with Guggenheim. Your line is open. Analyst: Hi, good afternoon. Thank you for taking my question. So on the Friedreich's ataxia program, what should we expect from the 2027 Phase I readout? More in details. Which tissue compartment will you report for taxing protein levels from buccal cells, skin, or muscle? And what would you view as a proof of mechanism? And also, will you report also clinical results together with the biomarker data? Thank you. Kyle W. Gano: No, I appreciate the question. We are excited about the Friedreich's ataxia gene therapy program here at Neurocrine. We will be looking at starting clinical development later this year. Then once we get that study up and running, we will look forward for actual data in patients towards the end of next year. The nature of what we will be sharing, I think, will determine that over the next couple months into the beginning of the year. And, hopefully, we will have some more commentary around our R&D Day in December. Operator: We will move next to David Hoang with Deutsche Bank. Your line is open. David Hoang: Hi, there. Congrats on the quarter and thanks for taking my question. So I was curious to get any feedback that you guys may have or your latest thoughts on the competitive dynamic and threat from competitor in the VMAT inhibitor space. So I think your competitor also printed a very strong quarter. They have talked about $3 billion in peak sales, and continued uptake of the AUSTEDO XR product. And so as you look over the next few years, recognizing there is some pricing dynamics there, just what is your, I guess, thoughts on how the market share may play out 2 products and if the pie will continue to keep growing in TD, or will there be any share shifts between products. Thanks a lot. Eric S. Benevich: Yeah. I will just start off by saying that the, you know, 10 years, almost 10 years into the launch of INGREZZA, the TD market continues to grow very rapidly. You know, we see that there is still a substantial number of untreated patients and even undiagnosed patients out there. And so our focus remains on driving awareness, driving diagnosis, and then, obviously, being able to educate providers on the unique benefits of INGREZZA. And I think that and obviously also, you know, continuing to provide strong reimbursement support. And the results speak for themselves. INGREZZA has been the most preferred and the most prescribed VMAT2 inhibitor since day 1 and continues to do so. And even looking at the most current quarter, you know, with strong market growth for VMAT2s, INGREZZA outgrew the market. And so, you know, we can expect to continue to see that momentum carry forward through the balance of this year. And as Kyle said earlier, from a coverage reimbursement perspective, you know, we expect to have good coverage in 2027 and 2028 that would enable continued strong growth in terms of adoption. Kyle W. Gano: So overall, just very pleased with our performance. And we will let the results speak for themselves. Analyst: We will take our next question from Evan Seigerman with BMO Capital Markets. Your line is open. Evan Seigerman: Hi, Thank you so much for taking my question. I wanna touch on osavampator MDD is clearly a large market. You are very enthusiastic about it. Just walk us through kind of what you are solving for that the existing antidepressant strategies really do not do well. What do you need to show in a phase 3 for this truly to be viewed as differentiated rather than incremental. Thank you. Sanjay Keswani MBBS: Yeah. Thanks for the question. So just for context, osavampator is an AMPA potentiator, and we think provides unique advantages from a differentiation point of view from the existing standard of care. With respect to efficacy, we are expecting greater efficacy, in individuals who have already been unresponsive or not so responsive to a whole slew of other antidepressants with different mechanisms. But secondly, and also just as important, a really nice safety and tolerability profile That was 1 of the most impressive things actually with respect to our phase 2 SAVITRI data. Was the safety and tolerability, and the implication is long term compliance with this medication. Operator: And that does conclude the question and answer portion of today's call. I would now like to turn it back to Kyle W. Gano for any additional or closing remarks. Kyle W. Gano: 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. Operator: Thank you. This brings us to the end of today's meeting. Appreciate your time and participation. You may now disconnect. Before you buy stock in Neurocrine Biosciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Neurocrine Biosciences wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool recommends Neurocrine Biosciences. The Motley Fool has a disclosure policy. Neurocrine (NBIX) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

In the second quarter of 2026, Neurocrine Biosciences reported revenue of US$959.0 million and net income of US$144.4 million, sharply higher than a year earlier and ahead of analyst expectations, with INGREZZA, CRENESSITY, and newly acquired VYKAT XR leading record sales. The company also raised its full-year INGREZZA sales guidance and reinforced its leadership bench with new senior appointments, underscoring an ambition to build a broader, multi-product neuroscience business backed by one of the sector’s larger late-stage pipelines. We’ll now examine how this earnings beat and increased INGREZZA guidance may influence Neurocrine Biosciences’ longer-term investment narrative. This technology could replace computers: discover 26 stocks that are working to make quantum computing a reality. To own Neurocrine Biosciences, you need to believe it can turn INGREZZA, CRENESSITY, and VYKAT XR into a durable, multi-product neuroscience franchise while broadening its late-stage pipeline. The latest earnings beat and higher INGREZZA guidance reinforce that story but do not remove the key near term tension between pricing and access, particularly around Medicare, or the portfolio concentration risk that still comes from relying heavily on a few products. The recent appointment of a new Chief Business Officer, charged with driving business development and maximizing the value of Neurocrine’s expanding pipeline, looks especially relevant as the company integrates VYKAT XR and prepares for Phase 3 readouts in 2027. Earnings strength gives management more room to execute on this agenda, but it does not eliminate the risk that late stage trials or future reimbursement decisions could still reshape the story. Yet behind the strong quarter, investors should also be aware that pricing pressure and payer scrutiny could eventually... Read the full narrative on Neurocrine Biosciences (it's free!) Neurocrine Biosciences' narrative projects $5.1 billion revenue and $1.5 billion earnings by 2029. Uncover how Neurocrine Biosciences' forecasts yield a $192.88 fair value, a 16% upside to its current price. Some of the most optimistic analysts were already assuming revenue near US$6.4 billion and earnings around US$2.7 billion by 2029, while also highlighting heavier INGREZZA dependence and rising regulatory hurdles, so this quarter’s beat could either reinforce that upbeat view or prompt a rethink of how much risk you are willing to accept around pricing and access. Explore 3 other fair value estimates on Neurocrine Biosciences - why the stock might be worth over 3x more than the current price! Disagree with existing narratives? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Neurocrine Biosciences research is our analysis highlighting 4 key rewards that could impact your investment decision. Our free Neurocrine Biosciences research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Neurocrine Biosciences' overall financial health at a glance. Right now could be the best entry point. These picks are fresh from our daily scans. Don't delay: Outshine the giants: these 16 early-stage AI stocks could fund your retirement. Find 55 companies with promising cash flow potential yet trading below their fair value. Uncover the next big thing with 21 elite penny stocks that balance risk and reward. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NBIX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Interested in Neurocrine Biosciences, Inc.? Here are five stocks we like better. Neurocrine’s second-quarter revenue exceeded $950 million, up nearly 40% year over year, driven by growth in INGREZZA and CRENESSITY and a partial-quarter contribution from VYKAT XR. INGREZZA sales rose 15% to $716 million, prompting the company to raise its 2026 sales guidance to $2.825 billion–$2.875 billion. CRENESSITY sales reached $184 million, with approximately 15% of diagnosed classic CAH patients prescribed the treatment. Neurocrine is integrating VYKAT XR following its $2.9 billion Soleno acquisition and expects sequential growth as it exits 2026, while key Phase III pipeline readouts for osavampator and direclidine are scheduled for the second half of 2027. 3 Biotech Stocks to Watch: Iovance, Neurocrine & Viking Neurocrine Biosciences (NASDAQ:NBIX) reported second-quarter 2026 revenue of more than $950 million, nearly 40% higher than a year earlier, as sales of INGREZZA and CRENESSITY continued to grow and the company added a partial-quarter contribution from VYKAT XR following its acquisition of Soleno Therapeutics. Chief Executive Officer Kyle Gano said the company’s three-product commercial portfolio generated record quarterly net product sales exceeding $950 million. He said the performance supports continued investment in the company’s pipeline and strategic business-development opportunities. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now Bristol Myers Squibb’s big buys: $18.1 billion in 2 biotech deals “Just a few years ago, we were largely viewed as a single-product company,” Gano said. “Today, we have multiple commercial growth drivers, an expanding pipeline across all phases of development, and the financial strength to invest through innovation cycles.” INGREZZA recorded second-quarter net sales of $716 million, up 15% from the prior-year period. Chief Financial Officer Matt Abernethy attributed the increase to record new patient additions and sustained demand for the treatment. → Microsoft Just Flipped the AI Spending Narrative Overnight Is Mid-Cap Neurocrine Biosciences A Buy After Blowout Q3 Report? Based on the performance, Neurocrine raised its full-year 2026 INGREZZA sales guidance to a range of $2.825 billion to $2.875 billion, from its previous range of $2.7 billion to $2.8 billion. The midpoint of the updated range represents approximately 13% year-over-year growth, according to the company. Gano said approximately 70% of Medicare lives have coverage under contracting completed last year. He said pricing is expected to remain relatively consistent through the second half of 2026, while discussions with payers regarding 2027 access are ongoing. → Carrier Earnings Could Send the Stock to a New All-Time High The company expects continued access for INGREZZA in 2027 and 2028, Gano said, citing its leadership in the VMAT2 inhibitor category and the continued double-digit growth of the broader market for tardive dyskinesia treatments. CRENESSITY generated $184 million in second-quarter net sales. Neurocrine said approximately 15% of the estimated diagnosed patient population with classic congenital adrenal hyperplasia, or CAH, has now been prescribed the medicine. Chief Commercial Officer Eric Benevich said the launch continued to show steady new patient starts, high persistence and compliance, favorable reimbursement, and balanced adoption across adult and pediatric patients. The product’s prescriber base has nearly tripled over the past year, he said. Management said growth has been supported by both new prescribers and additional patient treatment within the existing prescriber base. Benevich noted, however, that many physician practices treat only a small number of CAH patients, making the market “an inch deep and a mile wide.” At ENDO 2026, Neurocrine presented two-year data from its ongoing CATALYST open-label studies in pediatric and adult patients with classic CAH. Chief Medical Officer Sanjay Keswani said the data showed durable improvements in cardiometabolic outcomes, bone health, quality of life and pediatric growth, along with a favorable long-term safety profile. Keswani said the company has accumulated more than 35,000 patient-weeks of CRENESSITY exposure. Gano added that the company’s data showed 70% of patients at two years were receiving a physiological dose of glucocorticoids and had physiological androgen concentrations. VYKAT XR, which Neurocrine acquired through its approximately $2.9 billion cash acquisition of Soleno, generated pro forma second-quarter net sales of $94 million. Neurocrine recognized $54 million of those sales from May 18, the date the transaction closed. Abernethy said new patient demand remained relatively consistent with the first quarter, while discontinuation rates were in line with expectations after an initial group of patients began treatment in 2025. The company expects sequential quarterly growth as it exits 2026 and said it anticipates growth from the fourth quarter and beyond. Gano said Neurocrine expects discontinuation rates to eventually settle in a range of 25% to 30%, comparable with other orphan-drug products. The company is working to integrate its commercial, medical and patient-support capabilities with the VYKAT XR team and to educate physicians, caregivers and patients on treatment selection, dosing titration and expectations for treatment response. Neurocrine said it ended the quarter with about $500 million in cash and no debt after financing the Soleno acquisition with cash on hand. The company expects roughly $150 million of acquisition-related costs, including $130 million recognized during the second quarter. GAAP results also included about $20 million in non-cash purchase-accounting amortization and inventory fair-value step-up expenses. Neurocrine reiterated that it expects to report top-line Phase III data for osavampator in major depressive disorder during the second half of 2027. The company also expects the first Phase III readout for direclidine in schizophrenia in the second half of 2027, followed by results from a second Phase III study in 2028. Keswani described osavampator as an AMPA potentiator that the company believes could offer differentiated efficacy for patients who have not responded adequately to other antidepressants, alongside favorable safety and tolerability. For direclidine, Gano said the company’s selective M4 agonist approach does not require an add-back therapy to mitigate side effects. Chief Business Officer Samir Siddhanti said Neurocrine has four programs in its muscarinic franchise. In addition to direclidine, the portfolio includes NBI-570 in a Phase II schizophrenia study, NBI-569 in an early Alzheimer’s disease study, and NBI-567, which is expected to enter a Phase II study in Alzheimer’s cognition. The company also said it expects a signal-seeking Phase I study readout next year for its CRF2 agonist obesity program, including data on weight loss and lean-mass preservation. Neurocrine plans to host a neurology and immunology webinar in early December to provide additional pipeline updates. Neurocrine Biosciences (NASDAQ: NBIX) is a biopharmaceutical company based in San Diego, California, focused on developing treatments for neurological, endocrine and neuropsychiatric disorders. Since its founding in 1992, the company has pursued a research‐driven strategy aimed at addressing unmet medical needs in movement disorders, reproductive health and central nervous system conditions. Neurocrine's operations encompass drug discovery, clinical development and commercialization activities. The company's lead marketed product, Ingrezza™ (valbenazine), is indicated for the treatment of tardive dyskinesia, a movement disorder associated with long-term antipsychotic use. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Neurocrine Biosciences Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

Agios Pharmaceuticals AGIO reported a loss of $1.69 per share for the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of $1.86. In the year-ago quarter, the company had incurred a loss of $1.93 per share. Total revenues for the quarter came in at $44.7 million, significantly beating the Zacks Consensus Estimate of $23 million. Revenues surged 259.3% year over year, primarily driven by continued strong growth in Pyrukynd sales and robust demand for Aqvesme since the U.S. commercial launch in January this year. The company’s lead drug, mitapivat, is marketed under two brand names in the United States, Pyrukynd and Aqvesme. While Pyrukynd is approved for the treatment of hemolytic anemia in adult patients with pyruvate kinase (PK) deficiency, Aqvesme is approved to treat anemia in adults with alpha- or beta-thalassemia. Aqvesme received approval in the United States in December 2025 and was subsequently launched in January 2026, following the implementation of its Risk Evaluation and Mitigation Strategy program. Agios reported a strong initial uptake, with 442 prescriptions written as of June 30, 2026. Outside the United States, mitapivat continues to be marketed as Pyrukynd for PK deficiency and thalassemia indications. In May, Pyrukynd received approval for thalassemia in the European Union. Agios’ partner, Avanzanite Bioscience B.V., will commercialize and distribute Pyrukynd across the European Economic Area, the United Kingdom and Switzerland. The top line entirely comprises product revenues from Pyrukynd and Aqvesme. Agios generated $40.9 million of product revenues in the United States, up 235.2% year over year, driven by strong early momentum of the U.S. commercial launch of Aqvesme for thalassemia. The company added $3.8 million from ex-U.S. territories, driven by anticipated demand for Pyrukynd following its approval for thalassemia in Europe, as well as continued steady early demand across the Gulf Cooperation Council countries. Research and development expenses increased by approximately 9.6% year over year to $100.8 million in the quarter. The increase was primarily driven by the $25.0 million upfront payment related to the licensing agreement with Oscotec for cevidoplenib. Selling, general and administrative expenses totaled $51.5 million, up around 12.4% year over year, driven by higher spending associated with the commercial launch of Aqvesme. As of June 30, 2026, cash, cash equivalents and marketable securities totaled $964.8 million compared with $1.0 billion as of March 31, 2026. Management expects its existing cash balance, together with anticipated product revenues, to be sufficient to support the potential launch of mitapivat in sickle cell disease (SCD) if approved and advance its clinical pipeline. For full-year 2026, Agios expects to generate $45 million to $50 million in U.S. sales from Pyrukynd for PK deficiency.The company reiterated that full-year operating expenses are expected to remain approximately flat compared with 2025, excluding the $25 million upfront payment related to the cevidoplenib in-licensing agreement recognized in the second quarter. Beyond the marketed indications, Agios is also developing mitapivat for sickle cell disease (SCD). Earlier this month, the FDA accepted its supplemental new drug application (sNDA) seeking approval for mitapivat in SCD. The sNDA was submitted under the FDA’s accelerated approval pathway in May. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on Nov. 1, 2026. If approved, mitapivat is likely to become the first oral PK activator to be approved for patients with SCD. Agios had been developing another candidate, tebapivat, a novel PK activator, for the treatment of lower-risk myelodysplastic syndromes (LR-MDS) and SCD in separate mid-stage studies. However, the company has discontinued the development of tebapivat across all indications following setbacks in the clinical programs. In June, the company halted the candidate's development for LR-MDS after a phase II dose-finding study failed to demonstrate sufficient clinical benefit, despite showing biological activity and a favorable safety profile. Subsequently, in July, Agios also discontinued the SCD program after phase II data failed to demonstrate meaningful clinical differentiation from existing PK activators. These decisions marked the complete termination of the tebapivat development program. Despite the earnings beat, shares of AGIO were down 6.4% on Thursday, likely due to investor concern about the loss of tebapivat as a pipeline asset, which narrowed the company's growth prospects and increased its reliance on mitapivat, with its upcoming FDA decision now serving as the key catalyst. Image Source: Zacks Investment Research Year to date, the stock has risen 20.4% compared with the industry’s 3.6% growth. In early June, the company entered into an agreement with Oscotec, a South Korea-based biotech to in-license exclusive global rights to develop and commercialize cevidoplenib for immune thrombocytopenia (ITP). Cevidoplenib is a next-generation, late-stage, highly selective oral spleen tyrosine kinase inhibitor being developed for the treatment of patients with ITP, a rare autoimmune disorder characterized by low platelet counts and an elevated risk of bleeding. The agreement expands and diversifies Agios’ rare hematology portfolio by adding a potential treatment for ITP, with an estimated peak annual U.S. sales potential of up to $1 billion. Agios intends to advance cevidoplenib into a phase III study for ITP, with initiation expected in the first half of 2028. Per the agreement, Agios will fund all future development and commercialization costs associated with cevidoplenib. Agios Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Agios Pharmaceuticals, Inc. Quote Agios currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy) and Neurocrine Biosciences NBIX, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 90 days, earnings per share estimates for Harmony Biosciences have decreased from $3.34 to $3.30 for 2026. Over the same period, estimates for earnings per share increased from $3.79 to $3.87 for 2027. HRMY shares have lost 4.2% year to date. Harmony Biosciences missed on earnings in each of the trailing four quarters, delivering an average negative surprise of 25.16%. Over the past 90 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $5.31 from $2.91. LQDA shares have gained 151.7% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8.00 to $9.09. Over the same period, EPS estimates for 2027 have increased from $9.48 to $10.81. NBIX shares have gained 30.8% year to date. Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agios Pharmaceuticals, Inc. (AGIO) : Free Stock Analysis Report Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Neurocrine Biosciences, Inc. NBIX highlighted the continued expansion of its commercial portfolio during its second-quarter 2026 earnings call, with management emphasizing growth from INGREZZA, CRENESSITY and the newly acquired VYKAT XR. The company also outlined upcoming clinical catalysts and its strategy to diversify beyond its established franchises. The company reported non-GAAP earnings of $2.85 per share, beating the Zacks Consensus Estimate of $2.26. Revenues were $959 million, surpassing the estimate of $901.5 million. Management focused on commercial execution, pipeline advancement and disciplined business development following the Soleno Therapeutics acquisition. Neurocrine Biosciences, Inc. price-consensus-eps-surprise-chart | Neurocrine Biosciences, Inc. Quote Neurocrine said that its second-quarter results reflected progress toward becoming a diversified biotechnology company rather than a single-product business. CEO Kyle Gano noted that the company’s commercial portfolio generated more than $950 million in quarterly net product sales. INGREZZA remained the largest contributor, with second-quarter net sales of $716 million, up 15% year over year. Management attributed the performance to record patient additions, prescription growth, and sustained demand in tardive dyskinesia and Huntington’s disease chorea. Chief commercial officer Eric Benevich said that INGREZZA continued to benefit from market expansion, with the VMAT2 category growing and the company maintaining its position as the most prescribed VMAT2 inhibitor. CRENESSITY continued to gain adoption in classic congenital adrenal hyperplasia (CAH). The therapy generated second-quarter sales of $184 million compared with $53 million in the prior-year period, supported by patient demand and expanding physician adoption. Benevich said that the launch trajectory remained consistent, with steady patient additions, favorable reimbursement and increasing prescriber engagement. Approximately 15% of the estimated diagnosed patient population has now been prescribed CRENESSITY. During Q&A, a TD Cowen analyst asked whether the quarter benefited from unusual factors. Benevich responded that results reflected the ongoing launch pattern rather than a one-time boost, with continued adoption across pediatric endocrinologists, adult endocrinologists and CAH Centers of Excellence. The acquisition of Soleno Therapeutics added VYKAT XR to Neurocrine’s portfolio, expanding its rare disease and endocrinology presence. The transaction closed in May 2026 for $2.9 billion. VYKAT XR generated $54 million in recognized second-quarter sales following the acquisition close, while pro-forma full-quarter sales were $94 million. Management said that integration efforts are progressing and expects sequential quarterly growth exiting 2026. During Q&A, a BofA Securities analyst questioned the near-term launch trajectory. Benevich said that the company remains confident in VYKAT XR’s long-term potential, with priorities centered on identifying patients, educating providers and improving treatment adoption in Prader-Willi syndrome. Management highlighted several late-stage programs expected to provide growth opportunities. Chief medical officer Sanjay Keswani said that the company remains on track for Phase III data readouts for osavampator in major depressive disorder and direclidine in schizophrenia in 2027. The company is also advancing its muscarinic franchise, with multiple programs targeting neurological and psychiatric conditions. Chief business officer Samir Siddhanti said that the pipeline includes four muscarinic programs spanning schizophrenia, bipolar mania and Alzheimer’s disease-related indications. Management also discussed its obesity research efforts, noting that its CRF2 agonist program is progressing through Phase I development with future studies focused on weight loss and lean mass preservation. NBIX increased investment across research and commercial infrastructure while integrating VYKAT XR. Second-quarter GAAP research and development expenses rose to $327 million from $244 million a year earlier, while GAAP selling, general and administrative expenses increased to $440 million from $286 million. The company raised its 2026 INGREZZA sales guidance to $2.83-$2.88 billion from the previous $2.7-$2.8 billion. Management also updated the expense guidance to reflect expanded commercial activities and acquisition-related costs. Chief financial officer Matthew Abernethy said that the company ended the quarter with approximately $500 million in cash and no debt after completing the Soleno acquisition. Neurocrine emphasized a strategy built around commercial execution, pipeline development and selective business development. Management said that the company’s expanded portfolio provides greater flexibility to invest through innovation cycles. The company continues to focus on advancing first-in-class and potentially best-in-class medicines across neuroscience, psychiatry, endocrinology and immunology. Upcoming clinical milestones remain central to management’s long-term growth plans. NBIX carries a Zacks Rank #2 (Buy) at present. The Zacks Rank reflects earnings estimate revision trends and can change as analysts update their expectations following new company developments and the quarterly results. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The stock has a Value Score of B, a Growth Score of A, a Momentum Score of F and a VGM Score of B. Zacks Style Scores evaluate value, growth and momentum characteristics, with stronger grades representing more favorable relative attributes. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Total Revenue: Over $950 million in Q2 2026, representing nearly 40% year-over-year growth. Non-GAAP EPS: $2.85 per share for the second quarter. INGREZZA Net Sales: $716 million in Q2, up 15% year-over-year, driven by record new patient additions. CRENESSITY Net Sales: $184 million in Q2, reflecting strong launch execution and expanding prescriber adoption. VYKAT XR Net Sales: $94 million pro forma for Q2, with $54 million recognized by Neurocrine from the May 18 acquisition closing date. Pro Forma Total Revenues: $998 million for Q2 2026, including full quarter VYKAT XR sales. INGREZZA Full-Year Guidance: Raised from $2.7 billion-$2.8 billion to a new range of $2.825 billion-$2.875 billion, representing approximately 13% year-over-year growth at the midpoint. Acquisition Costs: Approximately $150 million expected, with $130 million recognized in Q2. Purchase Accounting Amortization: Non-cash amortization of acquired intangibles and inventory fair value step-up of approximately $20 million in Q2. Cash Position: Approximately $500 million in cash and no debt at the end of Q2. Warning! GuruFocus has detected 6 Warning Signs with NBIX. Is NBIX fairly valued? Test your thesis with our free DCF calculator. Release Date: July 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record Q2 2026 total revenue of over $950 million, up nearly 40% year-over-year, driven by strong performance across INGREZZA, CRENESSITY, and VYKAT XR. INGREZZA delivered record quarterly sales of $716 million, up 15% year-over-year, with all-time highs in new patient starts and total prescriptions, leading to raised full-year guidance to $2.825-$2.875 billion. CRENESSITY continued its strong launch with $184 million in Q2 sales, steady new patient starts, high persistence, and a prescriber base that has nearly tripled year-over-year, with only 15% of the diagnosed patient population treated. VYKAT XR, acquired via Soleno, contributed $54 million in Q2 (pro forma $94 million), with integration progressing well and expectations for sequential growth exiting 2026, positioning it as a potential third blockbuster. Pipeline progress remains on track with Phase III readouts for osavampator (MDD) and direclidine (schizophrenia) expected in 2027, and a strong muscarinic franchise with multiple assets in development. The company ended Q2 with approximately $500 million in cash and no debt, providing financial flexibility for continued investment and strategic opportunities. Positive long-term data presented at ENDO 2026 for CRENESSITY (2-year) and VYKAT XR (3-year) reinforce durability and safety, supporting continued growth. INGREZZA continues to outgrow the VMAT2 market, maintaining leadership with strong access (70% of Medicare lives covered) and expectations for continued growth through 2027-2028. VYKAT XR sales were roughly flat sequentially, with discontinuations from the initial launch bolus expected to impact Q3, and growth only anticipated to resume in Q4 2026. The company faces potential pricing and access pressures from the IRA implementation in 2029, with uncertainty around the impact on INGREZZA's revenue and earnings. CRENESSITY's growth is limited by a fragmented market with many prescribers treating only one or two patients, and the company is not yet ready to provide formal guidance. The Soleno acquisition incurred approximately $150 million in acquisition-related costs, including $130 million recognized in Q2, impacting near-term GAAP earnings. VYKAT XR's ex-US strategy is on hold, with the EMA filing withdrawn, and international expansion is deprioritized until US integration is complete. The company faces competitive threats in the CAH market, with a potential competitor's acquisition signaling a large market opportunity, but Neurocrine must defend its position. Future launches in large markets (e.g., MDD, schizophrenia) will require significant SG&A investment, potentially leading to earnings variability in 2028-2029. The company is still learning about the VYKAT XR market, including managing discontinuations due to edema and other factors, which could impact long-term growth. Q: As it relates to INGREZZA, how much visibility do you have on pricing dynamics next year, and any insight into access dynamics with the NASHP MFP being enacted?A: Kyle Gano (CEO) stated that 2026 access is strong with about 70% of Medicare lives covered under existing contracts, and pricing is expected to remain consistent through the second half of 2026. For 2027, discussions with payers are ongoing, and he sees a path for MFP-adjacent products, expecting strong access through 2027 and 2028 given Neurocrine's market leadership in the VMAT2 category. He also noted the market continues to grow double-digit year-over-year. Q: On CRENESSITY, the quarter was strong with revenue up 20% quarter-over-quarter. Were there any one-time issues in Q2 that made it particularly strong, or is this pace of revenue growth reasonable for the next couple of quarters?A: Eric Benevich (Chief Commercial Officer) characterized Q2 as an extension of the steady and consistent pattern of new patient adds seen earlier in the launch. Adoption continues across all segments, including pediatric endocrinologists, adult community endocrinologists, and centers of excellence. He noted that approximately 15% of the addressable patient population is now on treatment, and the company expects continued strong momentum. Q: On VYKAT, the $94 million in sales is roughly flat sequentially. What are you doing to accelerate the launch trajectory now that the franchise is fully under your control?A: Eric Benevich (Chief Commercial Officer) said Q2 results aligned with expectations from diligence. The company is still learning about the hyperphagia market opportunity, which reaffirms conviction in the product's blockbuster potential. Kyle Gano (CEO) added that VYKAT XR is a first-in-class, first-in-disease medicine for Prader-Willi syndrome with a durable IP estate extending to the mid-2040s, and the acquisition provides both strategic and financial fit, expanding the endocrinology franchise. Q: Can you clarify how much of VYKAT's discontinuations are from edema, and what are you doing to help patients and practitioners manage through that to minimize discontinuations?A: Kyle Gano (CEO) declined to break down discontinuations by cause but emphasized the opportunity to improve messaging and education for caregivers, patients, and physicians. He highlighted the unique weight-based titration schedule and the need to set appropriate expectations, noting that unlike pain medicines, hyperphagia improvement can take months. The company is working through these educational efforts as it integrates the Soleno team. Q: Given the recent acquisition of a potential future competitor in CAH, can you talk about the clinical plan and timelines for your next-gen CRENESSITY assets?A: Kyle Gano (CEO) discussed NBIP-1435, a next-generation peptide therapeutic that could be dosed once weekly or less frequently. Phase I data has been positive, and a Phase II study is expected to start shortly. He emphasized that CRENESSITY has set a high bar with strong efficacy, safety, and a broad label, making it difficult for competitors and even their own pipeline programs to surpass. Q: With data readouts for osavampator and direclidine expected next year, do you have the commercial infrastructure to launch those products, and how are you thinking about building out that organization?A: Eric Benevich (Chief Commercial Officer) said the company has a strong foundation in psychiatry and long-term care, and the recent INGREZZA sales force expansion was designed to set up for future launches. Kyle Gano (CEO) added that a positive osavampator readout would require a step-up in SG&A investment in 2028-2029, particularly for primary care expansion, but near-term focus remains on executing with INGREZZA. Q: For your obesity efforts, what do you expect for monotherapy weight loss and muscle preservation for the CRF2 asset in Phase I, and when will we get the first full data cut?A: Sanjay Keswani (Chief Medical Officer) said the CRF2 agonist is the first obesity molecule in the clinic, with Phase I data accumulating. A signal-seeking study readout is expected next year, focusing on both weight loss and lean mass preservation. Additional molecules in the obesity portfolio are expected to enter the clinic shortly. Q: How are you thinking about smoothing top and bottom-line growth through the 2029 INGREZZA IRA implementation year, and does that depend on Phase III readouts next year?A: Kyle Gano (CEO) said MFP discussions will start next year, but the company expects continued top-line revenue growth through the end of the decade driven by other growing portfolio medicines. Matt Abernethy (CFO) noted EPS variability will depend on IRA implementation and potential pre-launch investments for osavampator, but the North Star is long-term revenue growth with strong earnings growth expected into the 2030s. Q: On CRENESSITY, what proportion of target practices are still not using the drug, and what are the barriers at this stage of the launch?A: Eric Benevich (Chief Commercial Officer) said the market is "an inch deep and a mile wide," with most prescribers having treated only one or two patients. The company is still seeing substantial new prescriber adoption each quarter, and the long tail of the market means many practices have only a handful of patients. Growth is driven by both expanding prescriber breadth and increasing depth from existing prescribers. Q: On VYKAT, should we expect sales to be roughly the same in Q3 as Q2, then show incremental growth in Q4?A: Matt Abernethy (CFO) confirmed that Q3 sales are expected to be roughly flat, with sequential growth anticipated in Q4 and beyond. This is a function of getting through the bolus of discontinuations from the initial launch and implementing strategies to drive additional patient adoption. Kyle Gano (CEO) added that the integration process can be noisy, but the company has a strong track record of successful sales force expansions. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management highlighted the company's transformation from a single-product entity to a diversified commercial leader with three first-in-class medicines annualizing at approximately $4 billion in sales. INGREZZA performance was driven by record new patient additions and sustained underlying demand, leading to a raised full-year guidance midpoint reflecting 13% year-over-year growth. CRENESSITY's launch success is attributed to steady new patient starts and high persistence, with management noting that 15% of the diagnosed classic CAH population has already been prescribed the therapy. The acquisition of Soleno and VYKAT XR was framed as a strategic fit that immediately accreted to non-GAAP earnings while extending the company's rare disease and endocrinology footprint. Operational strength and disciplined capital deployment have provided the financial flexibility to invest in a pipeline that management describes as one of the industry's strongest mid-to-late stage portfolios. The company emphasized its leadership in the VMAT2 category, noting that INGREZZA continues to outgrow the broader market despite competitive dynamics. Management expects sequential quarterly growth for VYKAT XR exiting 2026 as the company integrates Soleno's operations and moves past the initial launch bolus of patient discontinuations. Multiple Phase 3 clinical catalysts are scheduled for 2027, including data readouts for osavampator in major depressive disorder and dereclidine in schizophrenia. The company anticipates maintaining strong Medicare access for INGREZZA through 2027 and 2028, though specific pricing impacts from the IRA implementation in 2029 remain under evaluation. Strategic R&D focus is shifting toward a 'best-in-class' muscarinic franchise, with four distinct programs targeting schizophrenia, bipolar mania, and Alzheimer's disease. Future SG&A investment levels will be contingent on Phase 3 readouts, particularly for osavampator, which would require a significant primary care sales force expansion if successful. The $2.9 billion Soleno acquisition was financed entirely with cash on hand, leaving the company with $500 million in cash and no debt at quarter-end. GAAP results included $130 million in acquisition-related costs and $20 million in non-cash purchase accounting amortization for the second quarter. Management acknowledged a 'noisy' integration period for VYKAT XR, noting that discontinuation rates are expected to settle into a standard orphan medicine range of 25% to 30%. The company flagged potential EPS variability in the late 2020s due to episodic investments required for large-market launches and the sunsetting of current Phase 3 trials. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that current flat sequential sales were due to a bolus of discontinuations from the initial 2025 launch, which they expect to clear by Q3. They reaffirmed confidence in VYKAT XR becoming a third blockbuster, citing steady new patient starts and a durable IP estate extending into the mid-2040s. Management distinguished dereclidine as a selective M4 orthosteric agonist that does not require an 'add-back' antagonist to manage side effects, unlike competitors. They emphasized that while efficacy gets products in the door, dereclidine will compete on safety, tolerability, and ease of administration (once-daily, no titration). The prescriber base has nearly tripled year-over-year, though most physicians currently only have one or two patients on therapy due to the 'inch deep, mile wide' nature of the CAH market. Management noted that 70% of patients in long-term studies achieved physiologic steroid doses, which they believe sets a high bar for future competitors. Neurocrine is prioritizing its CRF2 agonist for obesity, targeting both weight loss and muscle mass preservation, with a signal-seeking readout expected next year. The company views obesity as a way to diversify risk, utilizing objective biomarkers in early phases to balance the longer-cycle neuropsychiatry programs.

Image source: The Motley Fool. Thursday, July 30, 2026 at 4:30 p.m. ET Vice President of Investor Relations - Todd Tushla Chief Executive Officer - Kyle W. Gano Chief Financial Officer - Matthew Abernethy Chief Commercial Officer - Eric S. Benevich Chief Medical Officer - Sanjay Keswani Chief Business Officer - Samir Siddhanti Need a quote from a Motley Fool analyst? Email [email protected] Operator: Thank you for your continued patience. Your meeting will begin shortly. Star zero, and a member of our team will be happy to help you. You for your continued patience. Your meeting will begin shortly. And a member of our team will be happy to help you. Hello and welcome everyone to join today's Neurocrine Biosciences Reports Q2 26 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 1 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. Todd Tushla: Happy Thursday, everyone. Welcome to Neurocrine Biosciences second quarter 26 earnings call. With me today on the call are Kyle W. Gano, chief executive officer Matthew Abernathy, chief financial officer Eric S. 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 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 US 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 will jump into Q&A. Now I will hand the call off to Kyle. Kyle W. Gano: 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 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 on our commercial portfolio to bring our medicines to patients, advance our innovation engine, deploy capital with discipline. This quarter demonstrated meaningful progress across all 3 of these priorities. The commercial business continues to generate durable growth, The pipeline is advancing as 1 of the industry's strongest mid to late stage portfolios. And 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 and 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 3 data readouts for osavampator in major depressive disorder, and dereclidine in schizophrenia. Together with the continued 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 Matthew, I would 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 is ahead. With that, I will turn the call over to Matthew. Matthew C. Abernethy: 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 the partial-quarter contribution from VYKAT XR following the close of the Sileno 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 our full-year INGREZZA guidance from $2.7 billion to $2.8 billion to a new range of $2.825 billion to $2.875 billion At the midpoint, this represents approximately 13% year over year growth. Chronicity's 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 18. 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 form a total revenues were $998 million for the second quarter 26 when including full quarter VYKAT XR sales. This performance underscores the strength and increasing scale of our commercial across 3 highly differentiated products. Turning to our financials. With the Soleno acquisition now complete, I would like to briefly discuss the financial impact of the transaction. Including the purchase accounting and the GAAP to non adjustments reflected in our earnings release. We acquired So 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. Strategic 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 So operating expenses, transaction and integration costs, and the expected purchase accounting intangible and in 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 noncash 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, 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 S. Benevich. Eric S. Benevich: Our chief commercial officer. Eric. Thanks, Matthew. Just 5 years ago, Neurocrine was a single, product commercial stage company celebrating INGREZZA achieving blockbuster status. Surpassing $1 billion in annual sales. Todd, our commercial portfolio includes 3 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. So 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. Basma 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 a $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, but 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 are 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 would 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 health care 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. Now I will turn the call over to our Chief Medical Officer, Dr. Sanjay Keswani. Sanjay Keswani MBBS: Thanks, Eric, and good afternoon, everyone. I will begin today with highlights from ENDO 26. Where we presented important new data for both Crinesity 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 H 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 3 top line data for osavampator in major depressive disorder in the second half of 27. We also remain on track to report the first phase 3 readout for dereclidine in schizophrenia in the second half of 27 and for the second phase 3 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 will hand the call back to Todd. Todd Tushla: Excellent. Chloe, let's jump into Q&A. Operator: Thank you. Star 2. Take our first question from Paul Matteis with Stifel. Your line is open. Paul Matteis: Great. Thanks a lot, guys, and congrats on the execution on 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 are getting or any insight you are getting into Access Dynamics with the AUSTEDO MSP being enacted? Thank you so much. Kyle W. Gano: 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. Matthew C. Abernethy: Under the contracting that we executed last year, and we expect that pricing to remain relatively consistent year to year as we think about the second half of 26. In terms of 2027, obviously, our discussions with payers are ongoing now, and we should get a read on that later this year. Kyle W. Gano: But I think where we are right now is we do see a process and a path moving forward. it is not just us, but others, that there will be a place for MFP adjacent products for Medicare beneficiaries. And if you couple that with the fact that we are the market leader, in the CMAT2 category, there is gonna be ample opportunity for us to have the same access that we have here, moving forward strong access through 2027 and 2028. So right now, it is all leveraging what we can with our team. I would remiss be remiss by not calling out that this market overall continues to grow double digit year to year, so there is a lot of room left in this market. We will continue to focus there. Paul Matteis: Kyle, any thought on how much additional costs maintaining this access might be next year or beyond? Kyle W. Gano: No. I think it is too early to make a call on that, Paul. We will have more to comment on that later in the year. Right now, it is it is been a great first half and we will continue to build on the momentum that we have seen. Okay. Very much. Operator: We will take our next question from Philip Nadeau with TD Cowen. Your line is open. Philip Nadeau: Good afternoon. Thanks for taking our question. Ours is on Crinesity. A really good quarter with revenue up 20% quarter over quarter. It sounds from the prepared remarks, like everything was steady-as-she-goes. So steady patient adds, good reimbursement, no bolus, I am curious whether that interpretation is correct. Were there any onetime issues in Q2 that made it particularly strong that we should not extrapolate into the back half of the year? Or is this pace of revenue growth reasonable for the next couple of quarters? Thanks. Eric S. Benevich: Yeah. I think characterizing Q2 is really an extension of what we have seen earlier in the launch, very steady and consistent pattern of, new patient adds. You know, we continue to, see adoption across all the segments that we are focused on: the pediatric endocrinologist, the adult community endocrinologist, and those centers of excellence. You know, really pleased with the fact that, you know, we estimate now that we have got about 15% of the addressable patient population on treatment. And know, certainly expect to see continued strong momentum as we move forward. that is very helpful. Thank you. Operator: We will move next to Tazeen Ahmad with Bank of America. Your line is open. Tazeen Ahmad: Hi. Thanks for taking my question. Mine is on VYKAT. So this quarter's results of $94 million it is roughly flat sequentially. You just took over this franchise. So can you maybe talk to us about some of the things that you are doing in order to accelerate the launch trajectory now that the franchise is fully under your control? And maybe just give some specifics about some of the things that you are doing now that you think could have an effect you know, in a quarter or 2. Thanks. Eric S. Benevich: Yeah, hi, Tazeen. So, first of all I will say that the results that we saw in Q2 were aligned with our expectations coming out of diligence. Certainly, I think we are still learning a lot, about the hyperphagia market opportunity. but what we have learned so far it just reaffirms our convictions about the potential for this medicine to be a blockbuster. And, you know, we are still in the you know, deep in the midst of our integration process here. But, you know, ultimately, I think the fundamentals are what matters. You know, continuing to find patients, to introduce VYKAT XR to the providers that care for them primarily in endocrinology. And then, you know, provide good education and guidance around how to select appropriate patients, how to help them through the titration process, and to achieve good outcomes. So I feel very good about the opportunity with VICAT. Everything that I have 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 is still very early in its in its commercial ramp. Kyle W. Gano: And, Tazeen, this is Kyle. I am just reminded as we talk about VYKAT XR. This is our first earnings call post close where we have had a discussion on this. So I do wanna bring up, the merits of the acquisition and the product itself. there is a great strategic and financial fit here for us. VYKAT XR is a first in class, first in disease for Prader Willi syndrome, very much of the same category that we have seen for INGREZZA and Crinesity upon their launch. So we are really excited about this strategic fit there. Obviously, we are able to expand on our endocrinology franchise moving forward. But 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 is 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 is durable as well. So overall, we are really excited about what we have here. I think Eric called out some of the points that we are looking at now, and, we are excited to bring this into the same blockbuster category that we see for Crinesity and INGREZZA moving forward. Matthew C. Abernethy: The only thing I would add is this was very much in line with our internal expectations. Knew what we were buying. And this has a tremendous amount of opportunity to help many more patients. So we have a ton of confidence in the team, the product, and the opportunity to help many more patients with PWS. So we are encouraged as we think forward. Operator: We will move next to Brian Skorney with Baird. Your line is open. Brian Skorney: Congrats on a great quarter. Maybe to jump with a question on VYKAT as well. I think during the Selena days, there is lot of debate on sort of the differences between sort of new-start boluses and sort of dropouts and, you know, as you are sort of getting your head around things. Right now. Maybe you could just kind of characterize what you are seeing out there in terms of like how much of initial, bolus numbers are really kind of affecting things, the dropout rate that we see right now. And when do we, you know, you think that there is an upwards equilibrium of new starts dropout rates to think about in the coming quarters. Kyle W. Gano: Yeah. No. I appreciate the question. This is Kyle. I think what we have seen on a new patient start basis is a pretty steady flow of new patient starts over the past couple quarters. So that is good. that is right along the lines of the expectation we had after, after completing diligence on the company. In terms of discontinuations, obviously, with the bolus of patients, at the launch, we do see some of those discontinuations being pulled through. As time has gone along, but we expect to see the ultimate rate settling into what we would see with other orphan medicines in the 25 to 30 percent range. So that is what we will be looking at moving forward. But, ultimately, you know, our goal here is you will see sequential growth as we exit 2026 and looking at that in future years. So we are right where we need to be right now. I think more importantly, I am really excited to see our team bring its resources and the support, to the So team now under the Neurocrine brand. And take all of our learnings collectively and, make this particular medicine be the best it can be moving forward. Great. Thanks, Kyle. Operator: We will move next to Mohit Bansal with Wells Fargo. Your line is open. Mohit Bansal: Great. Thank you very much for taking my question and congrats on the great quarter. So just wanted to understand VYKAT a little bit better for next few quarters. So you are saying that the patient or a patient in patient new patient start, you expect it to be steady. So wondering that so are you saying that the sales could be choppy a little bit? But, again, what you are saying is that as you exit 2026, you can see you are confirming driving sequential growth. I am just wondering that how will you characterize the next few quarters? As you integrate the business into your own business? Thank you. Matthew C. Abernethy: Yeah. So as we move from Q3 to Q4 we would anticipate seeing some sequential growth. And then as you think about going into next year, it is really about that momentum. But as we have talked about, it is that mix of new patient additions and being offset by the discontinuations, and we feel like we will be through the bolus of the discontinuations here this quarter. So we would expect to be sequential growers, as we have said. In Q4 and beyond. Helpful. Thank you. Operator: We will take our next question from Anupam Rama with JPMorgan. Your line is open. Anupam Rama: Just wondering what some of the physician feedback has been on some of the 2 year CRENESSITY data both adults and peds, and how these data could impact kind of uptake of the product? Thanks so much. Sanjay Keswani MBBS: Thanks, Anupam. Yeah, we are really pleased about the feedback we are getting from the physicians with respect to our 2-year data. That we recently presented at ENDO. Of note, this included both adult and pediatric data and indicated long term benefits with respect to both antigen reduction and also glucocorticoid steroid reduction as well. So really, really excited by that feedback. Also, this is in the context of a really nice safety profile. So note at this point, we have well over 35 thousand patient-weeks of exposure Again, very important, bearing in mind the breadth of the population that we are treating with chronicity. Operator: We will move next to Cory Kasimov with Evercore. Your line is open. Cory Kasimov: Hey. Good afternoon, guys. Thank you for taking the question. So given the recent acquisition of potential future competitor in 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 are needed to help defend the franchise in the future? Thank you. Kyle W. Gano: Yeah. Thanks for the question. We do have our next generation medicine going through clinical development right now. that is NBI-112 thousand. This is a protein based therapeutic of peptide that we are 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. So we have great phase 1 data that is come out of the program thus far. We look forward to starting a phase 2 study shortly. And bringing that to, you know, 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 is got great efficacy, great safety, great tolerability, and what an outstanding label that we are able to get from the clinical program. We have 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 will 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. So we are really excited about the position that we have right now with Crinesity. A lot of room still to grow. We got about 15% of the market currently under Crinesity's care. We are gonna continue growing that out over time. To become that standard of care for patients. Appreciate that perspective, Kyle. Operator: We will move next to Jay Olson with Oppenheimer. Your line is open. Jay Olson: 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 dereclidine expected next year. Do you have the commercial infrastructure that you would like to have to launch those 2 products? Or, I guess, how are you thinking about building out that organization? Thank you. Eric S. Benevich: Thanks, Jay. So, 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 dereclidine 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 that provider communities. You know, if you look at the profile of either of those 2 medicines, it might require us to, bolster our teams or to, do some reorganization work. But I think that we are in a very good place in terms of being able to leverage our existing foundation. And 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 3 psychiatry assets. So I do not anticipate any near term changes to our footprint. But, certainly, I think we are well positioned, you know, to accelerate you know, those adjustments to our commercial platform. On the other side of positive Phase 3 data. Matthew C. Abernethy: I think that would be a great day if OSA, in particular, is 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 and A, and 2028-2020 timeframe, but I think you would agree with me that would be something we would all enjoy to have the privilege of doing. But in the near term, you know, I think we are focused on executing, as Eric said, with INGREZZA and continuing to expand the impact we are having across the psychiatry community today. Kyle W. Gano: Great. Thank you. Operator: We will take our next question from Akash Tewari with Jefferies. Your line is open. Analyst: Hey. Thanks so much. Just okay. A few questions on your obesity efforts. So for 2.12 thousand the CRF2 asset, what do you expect for monotherapy weight loss and muscle preservation in your phase 1 trial when you get into obese patients? And then for 1.97 thousand your triple g, is that already in the clinic? I am surprised you are able to start a combo trial with the CRF2 this year without any monotherapy data. And then finally, when we think about the combo, any sense on when we would be able to get the first full of cut first full cut of data there? Thank you. Sanjay Keswani MBBS: Thanks so much for the questions. With respect to our CRF agonist, obviously, we are very excited about this molecule. This is our first molecule in the clinic. We are currently accumulating a phase 1 data and we are due to have a signal seeking study readout next year with respect to both weight loss and also lean mass preservation. So that is really exciting for us. I am not sure if I will comment specifically on the exact bar we are looking at, but clearly, we are 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 the clinic. Operator: We will move next to Josh Schimmer with Cantor Your line is open. Analyst: Thanks for taking the question. How are you thinking about the ability to smooth top and bottom line growth through the 2029 INGREZZA IRA implementation year? And does the answer to that question depend on your Phase III readouts next year? How do you expect that play out under various pipeline scenarios? Thank you. Kyle W. Gano: Thanks, Josh. This is Kyle. Obviously, we are keeping an eye on our MFP to IRA outcome Those discussions will start next year, and, certainly, we will keep everyone updated once we know our MFP that would be applied to INGREZZA in 2029. But I think overarching, what we see in the evolution of our commercial portfolio are medicines that are growing over that time frame as well. So we will think we will we will 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 an expense side of the equation, we also have phase 3 trials that will be sunsetting over that same time frame as well. Our pipeline switches more to an early to mid stage pipeline, excuse me, And I think that is going to be more or less a view into our steady state portfolio as we get to the end of this decade. And it all goes back to what we shared at the beginning of this year, in terms of expectations around new phase 1, phase 2, and phase 3 starts. So I like what we have in terms of the company and how we set it up. And we will keep people informed over the next couple, of years as we get closer to 2029. Matthew C. Abernethy: Yeah. EPS variability is really going to be based upon, as you said, the impact of the IRA implementation in 2029. But on the expense side, as said earlier, is if osavampator is positive, we will spend in advance of sales to build up that sales force in that market. So I think you will have episodic investments that, you know, may lead to some earnings variability, but our north star is to grow revenue over the long term. And I think from those investments, we will have very nice earnings growth as you look into the 20 thirties. Operator: We will move next to Brian Abrahams with RBC Capital Markets. Your line is open. Brian Abrahams: Hey, guys. Thanks so much for taking my question. It seems like you are seeing really nice growth in the prescriber base for CRENESSITY. I guess I am curious what proportion of your target practices are still not using Crinesity at all? What are this point, what are some of the barriers for them here in at this stage of the launch? And how might you, expect to overcome them? Thanks. Eric S. Benevich: Yes. it is an interesting question. Think the way I would characterize it is that, you know, we are seeing really nice expansion of new prescribers each quarter. And at this stage, you know, we are still I would call it early in the overall commercial ramp. And so there is there is 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. But overall, the feedback's been very positive. Most of the physicians that have tried CRENESSITY have only treated 1 patient so far, and I think that is a function of 2 things. 1 is the flow of patients. Into their practices, especially in the adult setting. Patients only come in maybe once a year. So it takes time, if they have more than 1 patient to see them. And then the second thing is really this what we call the long tail of this of this market. there is really not that many practices that have more than a handful of patients, and there is a lot of lot of physician practices that have only 1 or 2. So, ultimately, you know, feel really good about the growth that we are that we are that we have seen, and we talked about this very steady and consistent pace that we are on. I think that is mostly, a testament to the patient finding efforts and, of course, the execution by our team. Thanks. Operator: We will move to Sean Lehmann with Morgan Stanley. Your line is open. Analyst: Good afternoon, Kyle and team. Hope everyone is well. My question is on the launch trajectory of CRENESSITY. You keep handily beating our numbers. I am just wondering how the drug performs against your own internal expectations. Is it falling in line? And if so, when do you when will you be comfortable giving us guidance? If it is beating your expectations internally, what are some of the key areas that it is it is doing that? Matthew C. Abernethy: I would say it is quite close to what our internal expectations have been. But with that said, we are learning a tremendous amount each quarter. I would say from the beginning of launch, we have been very encouraged by the feedback that we are getting by clinicians and then also the high rates of persistency have been quite strong. And we are we are seeing a lot of the benefits and hearing those back from clinicians in regards to the longer term outcomes and the benefit there. So we are still really quite early in launch, only 6 quarters in. it is premature for us to start thinking about giving a more formal guide. But I would say our internal models are getting closer to the numbers that we are delivering, but still, I would say to the team, keep over delivering. They have done an incredible job developing a new product that is in the market for the first time in over 70 years. And a lot of learning going on and a lot of excitement. So kudos to the team Well done, and we will address the guidance piece to your question as we get later in the year to next year. Kyle W. Gano: Thank you, Carl. Operator: We will move next to Marc Goodman with Leerink Partners. Your line is open. Marc Goodman: Yes. On VICAT, I just want to make sure I understand, Matthew, what you are saying. Are you saying that we should expect sales to be roughly about the same in 3Q as 2Q? And then 4Q should show some incremental growth versus 3q. And the reason is because of this gating issue of timing issue, whatever you wanna call it, of patients discontinuing from the bolus that occurred you know, so called 6 months ago or so, something like that. And then just if I could, just another question. Just curious what the R and D team thinks about any learnings from the Maplight data reported earlier this week. Thanks. Matthew C. Abernethy: Yeah. Regarding VICAT, you know, I think you said it correctly, but I would go back and just say we have only had the product for 6 weeks. And it is a market that we have, we are incredibly excited about. We are 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. So from an expectation perspective, I think what you said aligns with what I was trying to describe. Kyle W. Gano: And I will take the, the map like question. Maybe just to start with where Matthew left off on. BICAT. Just wanna make sure everyone appreciates that we are going through an organ integration of company. And, obviously, that can be a little noisy, as you work through that just as a Salesforce expansion can be. But as you know, we are quite skilled in the art of Salesforce expansions across INGREZZA and Cranesedy, and we have all come out on the other side much stronger, and we believe that will be the case for VICAT. In terms of map light, we did see their data come out here the past couple days. I think it is a good data point for further validating the orthosteric approach for using a muscarinic agonist. Although their approach is entirely different than our own. it is 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 dereclidine is the only approach, a first in class approach, using a selective M4 agonist that works just alright by all fine by itself. It does not require anything to add back for mitigating side effects. But we know at the end of the day, efficacy gets your foot in the door, it is 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 is where dereclidine's really gonna shine. What we saw in our phase 2 trial very clean GI profile, no weight gain, no food effect, once a day, no titration. that is how we are gonna win here just as we have seen with other antipsychotics across the spectrum. From low to high efficacy. They all went on safety, tolerability, and ease of administration. Thanks. Operator: We will move next to David Amsellem with Piper Sandler. Your line is open. David Amsellem: Thanks. A VICAT question. Can you clarify how much of your discontinuations are from edema? And 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 discontinuation due to fluid retention? Thanks. Kyle W. Gano: Yeah. This is Scott. I do not think we are gonna get into the nature of the discontinuations. But I will say, just like any medicine, especially 1 that you are inheriting, acquiring, is that there is always, the opportunity to improve messaging and education. I know that is gonna be a big part of what our team looks at. And the messaging education is the same, again, across all medicines that we look at for caregivers, for patients, and for physicians. And when it comes to, Bicat XR, obviously, you look at even something as simple as a dosing regimen. it is a titration schedule that is required through a weight based mechanism. that is unique. So 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. So these are all things that we are working through right now. And we will continue to work with the team to get in a really good spot as we look to fully bring the Soleno team onboard here to Neurocrine. And leverage the learnings on both sides to do what is best for patients here. Operator: We will take our next question from Ashwani Varma with UBS. Your line is open. Analyst: Hey, guys. Thanks for taking my question. So maybe send the perspective of CRENESSITY, I wanted to get your thoughts on the competitor dynamic here. So for 2 minutes, would they acquired, they did note that, there were 7 LFT cases versus the prior disclosure by Kinetics, which was 2 cases. But they still end up paying a pretty hefty premium I just wanted 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 or is it possible that the LFT elevation is actually a nonissue? Thanks. Kyle W. Gano: Yeah. Thanks, Josh, for the for the question. it is really hard for us to comment on the competitor or any competitors. And in the spaces that, we work in. All I can share with you is the excitement that we have around our own medicine. I will go back to the catalyst data that we have 2 year data, 35 thousand patient weeks of exposure. And accumulating over time where we are able to show 70 percent of patients, at the 2 year period were on a physiologic dose of a GC, and 70 percent of patients were at a physiological concentration of their androgens. that is a pretty good air to be in, for CH and really for any medicine. And we will continue to hopefully accumulate more data of that kind in type as time moves along to show the real benefits for patients. Operator: We will take our next from Myles Minter with William Blair. Your line is open. Myles Minter: Hi. Congrats on the quarter and thanks for taking the question. I just wanted to hear your thoughts on the Chronicity sort of peak opportunity here. Are you still describing that drug as a blockbuster opportunity? I only ask because recent acquisition seems to your competitors saying that might be a $3 billion market or greater and your on an annualized basis, the best part of $750 million already. And, Eric, you said you are really, really early on in the launch. I am just wondering whether a blockbuster drug is the right way to think about this or, like, that multi dollar sort of claim that the competitive acquisition made is more relevant here? Thanks very much. Matthew C. Abernethy: We are gonna take this to the highest number that 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 3.05 thousand% for chronic type medicines. So you know, when you look at what the peak opportunity is, that is the ZIP code. I know that is a pretty broad range. And we are gonna work to getting to as high up in that range as possible. But, yeah, you can get to a really nice figure quite quickly But it really comes at the end of the day a focus on helping as many patients with possible for their for their CAH. Myles sense. Thanks, Matthew. Operator: We will move next to Rudy Lee with Wylie Research. Your line is open. Analyst: Hi, thanks for taking my question. I have a question for the pipeline, just a quick follow-up. Given the trajectory of coblimbi and the feedback I am just curious on your thoughts. On the opportunity and maybe just talk about your overall strategy during the Muscarini franchise as you have multiple products maybe targeting different indications. Thanks. Hi. Thanks, Rudy. This is Samuel here. Really appreciate the question on the muscarinic. So, you know, we have got 4 shots on goal here with our muscarinic franchise directly in 68. that is in Phase 3 right now for the treatment of schizophrenia and phase 2 bipolar, so phase 2 study right now ongoing in bipolar mania. All studies remain on track timeline wise there. Next generation NBI 75, that is an m 4 preferring m 1 m 4 dual. Right now, that is in a phase 2 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 1 and only potential LAI within the muscarinic space. NBI 9, that is earlier right now. it is an m 4 dual as well that we are studying in an early study in Alzheimer's disease. The view there is to take that into Alzheimer's disease psychosis, and then we have got a fourth compound, NBI 7, that will be soon starting a phase 2 study in Alzheimer's cognition. Overall, we feel like we have a best in class muscarinic franchise here. Really looking forward to getting the direct leading data next year and going from there. Kyle W. Gano: The only thing I would add to that, these are all these are all, orthosteric agonists that do not require any add back to block side effects. They are selective on m 1 and m 4. They are unique in that regard and puts us in a really unique space in the muscarinic category. Very helpful. Thank you. Operator: We will take our next question from Sumant Kulkarni with Canaccord. Your line is open. Sumant Kulkarni: This is a bit of strategic 1 that has long term financial implications. With each commercial product you now have, there is typically been an aspect of pioneering commercialization with the first approvals for the respective indications. But your pipeline indicates includes candidates in large markets where not only do several product exist, but the competitors are typically much larger organizations as well. So could you share any targets for what a steady state longer term operating margin target might look like for Neurocrine as it you yourself grow a lot larger? Matthew C. Abernethy: Yeah. I will let Kyle talk about the Subir or sorry, the strategic, aspect of how we are gonna compete against larger guys in these markets, but 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 muscarinic and also osavampator. Not gonna give long term operating margin guidance, but you can see we are becoming quite a profitable company. We are operating income on a non GAAP basis is over 30%. So I think our focus right now is invest on the SG&A to grow sales much as possible and then 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. Kyle W. Gano: And maybe just to add to that. This is Kyle From a strategic perspective, what we are doing is setting up the pipeline to have a portfolio of not only first but best in class medicines, a neurology, psychiatry, and endocrinology as well as immunology. These are areas that, we think we can compete in a number of ways, either through the merit of the molecules that we design or ultimately in ownership of particular mechanisms that are unique to Neurocrine. You know, we have talked about obesity on this call as an example. We are leading in this category, we believe, with a CRF2 agonist, which is quite novel. And, of course, we know a lot about the biology being this being or this being the founding biology of the company. So, 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. But we also know that the full profile of those assets are fully known until the other side of phase threes. 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 1 b studies. So 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 with within a wheelhouse of more traditional neuropsych programs as well. That you are used to seeing. But overall, it is gonna set the company quite well. Up over the long term. Operator: We will take our next question from Danielle Brill with Truist. Your line is open. Danielle Brill Bongero: Hi, guys. Good afternoon. Thanks so much for the question. A follow-up on Crinesity. So you guys highlighted really strong growth in your prescriber base, but can you comment on trends in repeat prescribing? I think you noted roughly 2 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. Eric S. Benevich: So the I guess the way that I would characterize that, it is a little bit of both in terms of depth versus breadth. You know, we still are adding a substantial number of new prescribers each quarter. And to date, most of the prescribers that have tried have only treated 1 or 2 patients. Now this is a market that is an inch deep and a mile wide in the sense that, you know, there is a limited number of practices that have more than a handful of classic CAH patients. And then there is a lot of CH patients that are out there. In the in the community, and a lot of the physicians that treat them might only have 1 patient. So I think that, you know, we will continue to see this dynamic of a lot of physicians having only 1 or 2 patients under treatment. But, you know, at this stage of the launch, only about a year and a half into it, essentially, we are still seeing a lot of adoption by new prescribers, and we think there is a ways to go in terms of building that prescriber base over time. Operator: We will move next to Igole Nochomovitz with Citi. Your line is open. Yigal Nochomovitz: Hi, great. Thank you for taking the questions and my congrats on a strong quarter. My question, I had a quick question on Crinesity. Regarding the rarer subtypes, specifically the 11 beta hydroxylase patients, what is the status in terms of progress getting the payers to cover that subtype I am curious there. And then quickly on VICAT, do you have any comments with respect to ex US strategy, and where does that fit in terms of your relative prioritization, with regard to that? The asset? Thank you. Eric S. Benevich: Hi. I just wanna, reinforce that the coverage and reimbursement for Cranesity has been excellent. And has really exceeded our expectations from the very beginning of the launch. You know, from a coverage perspective, typically what is required, this is a specialty medicine, and the physician has to fill out a prior authorization, typically, they are required to attest that the patient has classic CAH, usually, not defining what particular subtype. Genetic subtype they have. That they are 4 years of age or older and that they are currently on glucocorticoids. For the vast majority of patients, those are the coverage criteria. And we have seen really high claim approval rates, but we have seen that claims tend to get approved pretty quickly. And that it is very affordable for patients with the majority of patients. Actually, over 90% paying $10 or less per month. So really good on the reimbursement side. Kyle W. Gano: Yeah. In terms of, VICAD XR and ex US, our first priority right now is fully integrate the team and make sure that we are doing everything that we can, to help the patients here in The US 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 will go back and revisit the in territories outside The US. In the meantime, for Europe, all patients that are currently on VYKAT XR will continue to continue on their treatment, and we will look at some named patient program types of vehicles to help other patients that may wanna have access in that region. Thank you. Operator: We will move next to Basma Chayati with Guggenheim. Your line is open. Analyst: Hi, good afternoon. Thank you for taking my question. So on the Friedreich's ataxia program, what should we expect from the 2027 Phase I readout? More in details. Which tissue compartment will you report for taxing protein levels from buccal cells, skin, or muscle? And what would you view as a proof of mechanism? And also, will you report also clinical results together with the biomarker data? Thank you. Kyle W. Gano: No, I appreciate the question. We are excited about the Friedreich's ataxia gene therapy program here at Neurocrine. We will be looking at starting clinical development later this year. Then once we get that study up and running, we will look forward for actual data in patients towards the end of next year. The nature of what we will be sharing, I think, will determine that over the next couple months into the beginning of the year. And, hopefully, we will have some more commentary around our R&D Day in December. Operator: We will move next to David Hoang with Deutsche Bank. Your line is open. David Hoang: Hi, there. Congrats on the quarter and thanks for taking my question. So I was curious to get any feedback that you guys may have or your latest thoughts on the competitive dynamic and threat from competitor in the VMAT inhibitor space. So I think your competitor also printed a very strong quarter. They have talked about $3 billion in peak sales, and continued uptake of the AUSTEDO XR product. And so as you look over the next few years, recognizing there is some pricing dynamics there, just what is your, I guess, thoughts on how the market share may play out 2 products and if the pie will continue to keep growing in TD, or will there be any share shifts between products. Thanks a lot. Eric S. Benevich: Yeah. I will just start off by saying that the, you know, 10 years, almost 10 years into the launch of INGREZZA, the TD market continues to grow very rapidly. You know, we see that there is still a substantial number of untreated patients and even undiagnosed patients out there. And so our focus remains on driving awareness, driving diagnosis, and then, obviously, being able to educate providers on the unique benefits of INGREZZA. And I think that and obviously also, you know, continuing to provide strong reimbursement support. And the results speak for themselves. INGREZZA has been the most preferred and the most prescribed VMAT2 inhibitor since day 1 and continues to do so. And even looking at the most current quarter, you know, with strong market growth for VMAT2s, INGREZZA outgrew the market. And so, you know, we can expect to continue to see that momentum carry forward through the balance of this year. And as Kyle said earlier, from a coverage reimbursement perspective, you know, we expect to have good coverage in 2027 and 2028 that would enable continued strong growth in terms of adoption. Kyle W. Gano: So overall, just very pleased with our performance. And we will let the results speak for themselves. Analyst: We will take our next question from Evan Seigerman with BMO Capital Markets. Your line is open. Evan Seigerman: Hi, Thank you so much for taking my question. I wanna touch on osavampator MDD is clearly a large market. You are very enthusiastic about it. Just walk us through kind of what you are solving for that the existing antidepressant strategies really do not do well. What do you need to show in a phase 3 for this truly to be viewed as differentiated rather than incremental. Thank you. Sanjay Keswani MBBS: Yeah. Thanks for the question. So just for context, osavampator is an AMPA potentiator, and we think provides unique advantages from a differentiation point of view from the existing standard of care. With respect to efficacy, we are expecting greater efficacy, in individuals who have already been unresponsive or not so responsive to a whole slew of other antidepressants with different mechanisms. But secondly, and also just as important, a really nice safety and tolerability profile That was 1 of the most impressive things actually with respect to our phase 2 SAVITRI data. Was the safety and tolerability, and the implication is long term compliance with this medication. Operator: And that does conclude the question and answer portion of today's call. I would now like to turn it back to Kyle W. Gano for any additional or closing remarks. Kyle W. Gano: 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. Operator: Thank you. This brings us to the end of today's meeting. Appreciate your time and participation. You may now disconnect. Before you buy stock in Neurocrine Biosciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Neurocrine Biosciences wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool recommends Neurocrine Biosciences. The Motley Fool has a disclosure policy. Neurocrine (NBIX) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Corcept Therapeutics CORT reported second-quarter 2026 earnings of 36 cents per share, beating the Zacks Consensus Estimate of a loss of 4 cents. In the year-ago quarter, the company had reported earnings of 29 cents. Second-quarter revenues rose nearly 32% year over year to $256.1 million and surpassed the Zacks Consensus Estimate of $216 million. Growth was driven by higher Korlym sales and the first-quarter contribution from newly launched ovarian cancer drug Lifyorli (relacorilant). Year to date, shares of Corcept have surged 167.1% against the industry’s 2.4% decline. Image Source: Zacks Investment Research Corcept’s top line consisted of product sales from Cushing’s syndrome drug Korlym and newly launched ovarian cancer drug Lifyorli. In the second quarter of 2026, product revenues from Korlym were $208.6 million, up 7.3% year over year. However, the metric missed our model estimate of $212.2 million. In March 2026, the FDA approved Lifyorli, Corcept’s selective glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adult patients with platinum-resistant ovarian cancer. Lifyorli generated $47.6 million in its first quarter of commercial availability. The reported figure surpassed our model estimate of $2 million. More than 1,300 patients started treatment by the earnings update, while more than 1,000 physicians prescribed the drug. Management attributed uptake to Lifyorli’s efficacy and safety profile, oral administration and lack of a biomarker requirement. The regimen was listed as a preferred option in the NCCN Guidelines shortly after approval. Second-quarter operating expenses increased 28.1% year over year to $214.8 million. The rise reflected spending related to the Lifyorli launch and continued investment in the company’s Cushing’s syndrome business. Selling, general and administrative expenses surged 51.1% to $156.9 million. Research and development expenses declined 10.9% to $53.9 million. Corcept ended the quarter with cash and investments of $544.6 million, up from $515.4 million as of March 31, 2026. Corcept raised its 2026 revenue guidance to $1.1-$1.2 billion from the previous $950 million to $1.05 billion. Management said that the revised outlook reflects strength across the endocrinology and oncology businesses. The Zacks Consensus Estimate for revenues is pegged at $986.45 million. Corcept continued to make meaningful progress across its late-stage pipeline. The company resubmitted the new drug application (NDA) for relacorilant for the treatment of patients with hypercortisolism (Cushing's syndrome) to the FDA in June 2026. The FDA accepted the application and assigned a target action date of Dec. 17, 2026. The NDA filing is supported by positive data from the GRACE study, confirmatory evidence from the phase III GRADIENT study, long-term extension studies and a phase II study in hypercortisolism. Corcept is evaluating relacorilant plus nab-paclitaxel and bevacizumab in the phase II BELLA study in patients with platinum-resistant ovarian cancer to understand whether combining relacorilant with two medicines offers patients an additional treatment option or not. Top-line data are expected by the end of 2026. Additional studies investigating relacorilant across platinum-sensitive ovarian, endometrial, cervical and pancreatic cancers remain on track to report results by the end of 2027. Patient enrollment is ongoing in the mid-stage prostate cancer study. Corcept has submitted a marketing authorization application to the European Medicines Agency, seeking approval for relacorilant plus nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer. A final decision in Europe is expected by the end of 2026. Beyond relacorilant, Corcept continues to advance its broader pipeline. Corcept is developing its other pipeline candidates, dazucorilant and miricorilant, in separate studies for treating amyotrophic lateral sclerosis (ALS) and biopsy-confirmed or presumed metabolic dysfunction-associated steatohepatitis, respectively. The phase IIb MONARCH study of miricorilant in patients with metabolic dysfunction-associated steatohepatitis has completed enrollment. Results are expected by the end of this year. Corcept is also conducting a dose-titration study of dazucorilant in ALS to improve gastrointestinal tolerability. The findings are expected to guide a planned phase III study after phase II DAZALS analyses showed substantial reductions in mortality risk at the 300-milligram dose. Corcept Therapeutics Incorporated price-consensus-eps-surprise-chart | Corcept Therapeutics Incorporated Quote Corcept currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy), and Neurocrine Biosciences NBIX, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 90 days, earnings per share estimates for Harmony Biosciences have decreased from $3.34 to $3.30 for 2026. Over the same period, estimates for earnings per share increased from $3.79 to $3.87 for 2027. HRMY shares have lost 4.2% year to date. Harmony Biosciences missed on earnings in each of the trailing four quarters, delivering an average negative surprise of 25.16%. Over the past 90 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $5.31 from $2.91. LQDA shares have gained 151.7% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 54.40%. Over the past 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8 to $9.09. Over the same period, EPS estimates for 2027 have increased from $9.48 to $10.81. NBIX shares have gained 27.5% year to date. Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Corcept Therapeutics Incorporated (CORT) : Free Stock Analysis Report Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Total Second-Quarter 2026 Revenue Grew 39% Year-Over-Year to $959 Million INGREZZA® (valbenazine) 2026 Net Sales Guidance Raised to $2.825 to $2.875 Billion Acquisition of Soleno Therapeutics Completed in May 2026 SAN DIEGO, July 30, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the second quarter ended June 30, 2026. "Our second quarter performance demonstrates the power of a strategy designed to compound over time," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "As our commercial portfolio of first-in-class medicines continues to grow, so does our capacity to reinvest in innovation, advance a differentiated late-stage pipeline and pursue strategic opportunities that strengthen the company for the long term. With multiple important clinical milestones in 2027, including Phase 3 readouts for osavampator in major depressive disorder and direclidine in schizophrenia, we are building an enduring company poised to deliver meaningful value for patients and shareholders for years to come." Total Revenue Highlights Total revenues for the second quarter 2026 were $959 million, compared with $688 million in the prior-year period representing 39% year-over-year growth. Unaudited pro-forma total revenues were $998 million for the second quarter 2026 when including full quarter VYKAT XR net product sales. INGREZZA second-quarter 2026 net product sales were $716 million, representing 15% growth year-over-year. Results reflected double-digit prescription volume growth in TRx and record NRx driven by strong patient demand. INGREZZA full year 2026 guidance was increased from a range of $2.7 billion to $2.8 billion up to $2.825 billion to $2.875 billion. CRENESSITY second-quarter 2026 net product sales were $184 million, driven by strong patient demand with approximately 80% reimbursement for dispensed prescriptions in the second quarter 2026. VYKAT XR second-quarter 2026 net product sales were $54 million from May 18, 2026, the closing date of the Soleno acquisition. Unaudited pro-forma full quarter net product sales were $94 million. Recent Clinical and Corporate Developments In May 2026, acquired Soleno Therapeutics for $53.00 per share in cash, representing a total transaction equity value of $2.9 billion. The addition of VYKAT XR, a first-in-class therapy to treat hyperphagia in Prader-Willi syndrome (PWS), expands Neurocrine's portfolio of innovative medicines and strengthens its leadership position in endocrinology and rare disease. In May 2026, the Company entered into a $1.0 billion senior secured revolving credit facility to provide an additional source of liquidity for general corporate purposes. As of June 30, 2026, available borrowing capacity was $1.0 billion. Announced new two-year data from the Phase 3 CAHtalyst® Pediatric study showing positive growth outcomes in children and adolescents with classic congenital adrenal hyperplasia treated with CRENESSITY. Announced new two-year data from the Phase 3 CAHtalyst® Adult study demonstrating improved cardiometabolic outcomes alongside sustained glucocorticoid dose reduction through up to two years of treatment with CRENESSITY for classic congenital adrenal hyperplasia. Announced publication of expert recommendations for glucocorticoid dose reduction after initiating CRENESSITY for the treatment of classic congenital adrenal hyperplasia. Presented new VYKAT XR data demonstrating meaningful and durable improvements in hyperphagia and behavioral symptoms in Prader-Willi syndrome following randomized withdrawal period. Announced new post-hoc data from the KINECT® 4 clinical trial demonstrating that adults with tardive dyskinesia treated with INGREZZA capsules experienced clinically meaningful and robust improvements in involuntary movement severity, including those who did not meet the stringent symptomatic remission threshold. Initiated Phase 2 clinical study to assess the safety and tolerability of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia. Promoted Samir Siddhanti to the executive management team as Chief Business Officer where he will lead the Company's business development, corporate strategy, and R&D portfolio management functions helping guide Neurocrine's continued evolution into a leading, global biotechnology company. Second-Quarter 2026 Financial Results Second-quarter 2026 GAAP net income and earnings per share were $144 million and $1.39, respectively, compared with $108 million and $1.06, respectively, for second-quarter 2025. Second-quarter 2026 Non-GAAP net income and earnings per share were $297 million and $2.85, respectively, compared with $166 million and $1.65, respectively, for second-quarter 2025. A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 at the end of this press release. Second-quarter 2026 GAAP and Non-GAAP net income compared with second-quarter 2025 were primarily driven by: At June 30, 2026, the Company had cash, cash equivalents, and marketable securities totaling approximately $482 million. Full Year 2026 Financial Guidance INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. R&D guidance reflects the continued advancement of the Company's pre-clinical and clinical portfolio including the Phase 3 programs for osavampator in MDD and direclidine in schizophrenia, and includes approximately $25 million of expense for development milestones related to our in-licensed product candidates. Development milestones are included in R&D guidance once achieved or deemed probable to achieve. Non-GAAP guidance has been adjusted to exclude estimated non-cash stock-based compensation expense of approximately $115 million in R&D and $170 million in SG&A, including approximately $58 million related to the acceleration of vesting of equity awards for Soleno employees which vested in full upon the closing of the transaction, and acquisition, integration and divestiture-related expenses of approximately $95 million. Non-cash stock-based compensation expense for performance-based equity awards is included in guidance once the predefined performance-based criteria for vesting is achieved or deemed probable to achieve. IPR&D guidance represents completed collaboration and licensing arrangements. SG&A guidance reflects expense for ongoing commercial initiatives, including the recent expansion of our sales teams in Q1 2026, supporting INGREZZA growth and the launch of CRENESSITY and VYKAT XR. In connection with the acquisition of Soleno, the Company recorded approximately $2.2 billion of intellectual property related to VYKAT XR to the balance sheet, which will be amortized over an expected life of 16 years. Conference Call and Webcast Today at 4:30 PM Eastern TimeNeurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-347-6865 (US) or 203-518-9757 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 4:30 p.m. Eastern Time on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine BiosciencesNeurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc. VYKAT is a registered trademark of Soleno Therapeutics, Inc. Non-GAAP Financial MeasuresIn addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following Non-GAAP financial measures: Non-GAAP cost of revenues, Non-GAAP R&D expense, Non-GAAP SG&A expense, Non-GAAP other income (expense), net, Non-GAAP net income and earnings per share. When preparing the Non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these Non-GAAP financial measures exclude: non-cash stock-based compensation expense, amortization expense related to acquired intangible assets, amortization expense related to acquisition-date inventory fair value step-up, stock based compensation expense related to the acceleration of vesting of equity awards for Soleno employees, changes in fair value of equity investments, acquisition-related transaction and integration costs, gains on sales of businesses, net of transaction costs, other divestiture-related transaction costs, changes in foreign currency exchange rates and certain adjustments to income tax expense. These Non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these Non-GAAP financial measures are useful to investors because they help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these Non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a Non-GAAP basis. A reconciliation of these GAAP financial results to Non-GAAP financial results is included in the attached financial information. In connection with the Soleno acquisition, this press release also includes unaudited pro forma full quarter VYKAT XR net product sales and total revenue, Non-GAAP financial measures, which management uses, and believes is useful to investors, to provide supplemental information regarding VYKAT XR net product sales for the full second quarter of 2026, including the period from April 1, 2026 through May 17, 2026, prior to the closing of the acquisition on May 18, 2026. Forward-Looking StatementsIn addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our business strategy, objectives, and future development plans; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; successfully commercializing CRENESSITY and VYKAT XR; our financial and operating performance, including our future revenues, expenses, or profits; our full year 2026 financial guidance; our acquisition of Soleno Therapeutics, including the prospective benefits of the acquisition, and our strategy, plans, objectives, expectations (financial or otherwise) and intentions with respect to our future financial results, growth potential and anticipated product portfolio in connection with the acquisition; our collaborative partnerships; clinical and scientific data updates for our products and product candidates, including observations regarding clinical outcomes, safety, and tolerability; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements, include but are not limited to the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general; risks and uncertainties associated with the commercialization of our products; risks related to our ability to realize the anticipated benefits of the acquisition of Soleno Therapeutics, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period and that we will not be able to integrate Soleno Therapeutics' business successfully or that such integration may be more difficult, time-consuming or costly than expected, disruption from the acquisition, making it more difficult to conduct business as usual or maintain relationships with employees, customers, suppliers, other business partners or governmental entities, unknown or inestimable liabilities, the risk of litigation and/or regulatory actions related to the acquisition, and the degree and pace of market uptake of VYKAT XR; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-second-quarter-2026-financial-results-302839431.html