Q2 2025 Neurocrine Biosciences Inc Earnings Call

Speaker 4: Thank you.

Operator: Please stand by. Your program is about to begin. If you need assistance during your conference today, please press star zero. Good day, everyone, and welcome to today's Neurocrine Biosciences Second Quarter 2025 Results Conference. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star one on your telephone keypad. You may withdraw yourself from the queue by pressing star two. Please note this call may be recorded, and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla. Please go ahead, sir.

Please stand by. Your program is about to begin. If you need assistance during your conference today, please press *0.

Good day, everyone, and welcome to today's Neurocrine Biosciences second quarter 2025 results conference.

At this time, all participants are in a listen-only mode.

Later, you will have the opportunity to ask questions during the question and answer session.

You may register to ask a question at any time by pressing star 1 on your telephone keypad.

You may withdraw yourself from the queue by pressing star 2.

Please note, this call may be recorded, and I will be standing by if you should need any assistance.

Todd Tushla: Thank you, and happy Wednesday, everyone. Welcome to Neurocrine Biosciences Second Quarter 2025 Earnings Call. With me today are Kyle Gano, Chief Executive Officer; Matt Abernethy, Chief Financial Officer; Eric Benevich, Chief Commercial Officer; Ivory Roberts; and for one first time as Chief Medical Officer, Sanjay Keswani. During today's call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. After prepared remarks, we will jump into Q&A. I now turn the call over to Kyle.

It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla. Please go ahead, sir.

Thank you, and happy Wednesday, everyone. Welcome to Neurocrine Biosciences' second quarter 2025 earnings call.

With me today are Kyle Go Chief Executive Officer. Matt Abernathy Chief Financial Officer, Eric bennov Chief commercial officer, Ivory Roberts, and for 1 first time as chief medical officer Sanjay quani,

Kyle Gano: Thank you, Todd. Good afternoon, everyone. We were especially pleased with our standout second quarter that delivered high double-digit growth, which showcased our diversified revenue profile and highlighted the organization's ongoing evolution. From a commercial perspective, our Ingreza-based business continues to post solid growth, and we are excited by the strong early performance of Kernecity. For Ingrezza, our strategic investments to enhance payer access led to another record of new patient starts and TRX for the quarter, further strengthening our leadership in the VMed2 class. We remain confident that these market access initiatives will continue to drive long-term growth for the Ingreza franchise. For Kernecity, we once again outperformed internal expectations. Today, Kernecity has been well received by both patients and prescribers, underscoring the significant unmet needs within the classical congenital adrenal hyperplasia community.

During today's call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. After prepared remarks, we will jump into Q&A. I now turn the call over to Kyle.

Thank you, Todd. Good afternoon, everyone. We were especially pleased with our standout second quarter, that delivered High double digit growth, which showcased our Diversified Revenue profile. And highlighted the organization's ongoing Evolution from a commercial perspective. Our ingresa based business continues to post solid growth and we are excited by the strong early performance of kity.

Foreign gressa, our strategic Investments to enhance payer access led to another record of new patients, starts, and TRX for the quarter for their strengthening. Our leadership in the bmat 2 class, we remain confident that these Market access initiatives will continue to drive long-term growth for the ingreso franchise.

Kyle Gano: With a strong product profile across efficacy, safety, and tolerability, we believe Kernecity is well positioned to become the standard of care for patients with classical CH and has all the attributes to be Neurocrine's second commercial blockbuster. Coming off a successful Endo conference this month, I'm reminded of how far we've come. In fact, it was back in March of 2015 at Endo that we first presented proof of concept data in CH with a CRF receptor antagonist. This year, over a decade later, I had the opportunity to meet directly with clinicians in the field, which gave me an even deeper appreciation for the impact we are making for CH patients and for the importance of the work we do every day at Neurocrine. Putting patients at the center isn't just a guiding principle; it's what drives meaningful progress.

Essity has been well received by both patients and prescribers, underscoring the significant unmet needs within the classical congenital adrenal hyperplasia community.

With a strong product profile across efficacy safety. And tolerability, we believe kesti is well positioned to become the standard of care for patients with classical CH and is all the attributes to be neurocrine. Second commercial Blockbuster

Coming off a successful endoc conference this month. I'm reminded how far we've come. In fact, it was back in March of 2015 at Endo that we first presented proof of concept data in ch with a CRF receptor antagonist.

This year, over a decade later, I had the opportunity to meet directly with clinicians in the field, which gave me an even deeper appreciation for the impact. We are making for CH patients and for the importance of the work we do every day at neurocrine.

Kyle Gano: It goes without saying we're deeply grateful to the patients, their caregivers, and families, and investigators who made this progress possible in partnership with the Neurocrine team. We look forward to our continued collaboration. Turning to the clinical pipeline, we believe we have one of the industry's deepest diversified neuroscience-focused pipelines. I would like to welcome Sanjay Keswani, who officially joined us in June as our Chief Medical Officer. He joins Neurocrine at an exciting time as we have initiated multiple phase III programs within a single calendar year, with both OSOVAMPATOR and MBA-568 enrolling patients in registrational studies. At our upcoming R&D day on December 16th, we look forward to sharing additional data from both programs, as well as our perspective on the psychiatry portfolio and progress in our R&D transformation.

Putting patients at the center isn't just the guiding principle; it's what drives meaningful progress.

It goes without saying we're deeply grateful to the patients, their caregivers and families and investigators who made this progress possible in partnership with the neurocrine team.

We look forward to our continued collaboration.

Turning to the clinical pipeline, we believe we have one of the industry's deepest diversified neuroscience-focused pipelines. I would like to welcome Sanjay Keswani, who officially joined us in June as our Chief Medical Officer. He joins Neurocrine at an exciting time as we have initiated multiple Phase 1 programs within a single calendar year with both ATO and NBA 568.

Enrolling patients and registrational studies.

Kyle Gano: On the preclinical front, our R&D engine, led by Chief Scientific Officer Jude Onya, is advancing internally discovered biologics candidates towards the clinic, which further diversifies our mechanistic approach to address a broad range of diseases aligned with our expertise and strategic focus. Overall, I'm pleased with our performance in the first half of the year. Looking ahead, sustained revenue contribution from both Ingreza and now Kernecity will enable us to further invest in advancing and expanding our pipeline, and importantly, helping more patients than ever before in solidifying Neurocrine's position as a leading neurology-focused enterprise. With that, I will turn the call over to Matt.

At our upcoming R&D day on December 16th, we look forward to sharing additional data from both programs as well as our prospective on the Psychiatry portfolio and progress in our R&D transformation.

On the preclinical front, our R&D engine, led by Chief Scientific Officer Jude On, is advancing internally discovered biologics candidates towards the clinic, which further diversifies our mechanistic approach to address a broad range of diseases, aligned with our expertise and strategic focus.

Overall, I'm pleased with our performance in the first half of the Year, looking at sustained Revenue contribution, from both ingresa. And now, kessie will enable us to further invest in advancing and expanding our pipeline in importantly, helping more patients than ever before and solidifying their reference position. As a leading neurology focused, Enterprise with that. I will turn the call over to Matt.

Matt Abernethy: Thank you, Kyle, and good afternoon, everyone. Neurocrine's evolution into a multi-product growth company was underscored by $682 million in net product sales during the second quarter, representing 17% year-over-year growth. We expect the profile of both Kernecity and Ingreza to drive meaningful revenue growth and generate significant cash flow over the coming years, positioning Neurocrine to become a leading CNS company. Kernecity grew sequentially from $15 million in Q1 2025 to $53 million in Q2 2025, reflecting strong early adoption by CH patients and clinicians eager for better treatment options. Although only six months into launch, we are quite encouraged by what we're seeing in terms of steady new patient starts, greater than 75% of all dispensed prescriptions being reimbursed, and overall positive anecdotal feedback on product performance. As Eric says, so far, so great, and kudos to everyone involved in this launch.

Thank you, Kyle, and good afternoon everyone. Neurocrine Evolution into a multi-product growth company was underscored by 682 million dollars in net product sales. During the second quarter representing 17% year-over-year, growth,

We expect the profile of both kecetit and ingresa to drive meaningful Revenue, growth and generate significant cash flow over the coming years. Positioning, neurocrine, to become a leading CNS company.

Facity grew sequentially from 15 million dollars in q1, 2025 to 53 million in Q2 2025, reflecting strong, early adoption by CH patients in clinicians. Eager for better treatment options.

Although only six months into launch, we are quite encouraged by what we're seeing. In terms of studying new patient starts,

Greater than 75% of all dispense. Prescriptions being reimbursed and overall positive anecdotal feedback on product performance.

Matt Abernethy: Shifting to Ingrezza, we delivered $624 million in second quarter sales, including another record number of new patient starts, reflecting the fruits of the salesforce expansion, our DTC campaign, and early positive signs from our investment in expanded access. Importantly, on both NRX and TRX front, we are seeing prescription market share gains in the first half of 2025. While we expect to gain volume share for the remainder of 2025, dollar share will be impacted in the near term due to contracting. These are intentional investments that position Ingreza for continued volume and sales growth, as well as market share gains over the coming years. Given current performance and considering market access investments for the remainder of the year, we've refined the Ingreza net sales guidance range to $2.5 to $2.55 billion, which accounts for anticipated double-digit volume gains, partially offset by higher near-term growth to net impact.

As Eric says, "So far, so great," and kudos to everyone involved in this launch.

Shifting to ingresa, we delivered 624 million. In second quarter sales, including another record number of new patient, starts reflecting the fruits of the sales force expansion.

Our DTC campaign and early positive signs from our investment and expanded access.

Importantly on both annorax and TRX front. We are seeing prescription market share gains in the first half of 2025.

While we expect to gain, volume, share for the remainder of 2025 dollar share will be impacted in the near-term due to Contracting.

These are intentional Investments at positioning aggressive for continued volume and sales growth as well as market share gains over the coming years.

Matt Abernethy: Overall, Ingreza is well positioned for continued growth heading into 2026. A few financial comments. Our capital allocation priorities remained intact to drive revenue growth, advance our R&D programs, enable business development, and return capital to shareholders. Our progress in the first half of 2025 reflects these priorities with the strong launch of Kernecity, continued Ingreza growth, and the initiation of our two phase III programs for OSOVAMPATOR and MDD and muscarinic schizophrenia trials. We have increased SG&A GAAP and non-GAAP operating expense guidance by $25 million to support continued Kernecity and Ingreza sales growth, and we expect SG&A leverage throughout the second half of 2025. With $1.8 billion in cash and a strong balance sheet, we are well positioned to support our commercial and clinical development strategies for continued growth. With that, I'll now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?

Given current performance and considering Market access Investments for the remainder of the year, we've refined the ingresa, net sales guidance range. The 2.5 to 2.55 billion dollars, which accounts for anticipated, double digit volume gains, partially offset by higher near-term growth. In net impact.

Overall Andres was well positioned for continued growth heading into 2026.

Revenue growth Advance, our R&D programs enable Business Development and return Capital to shareholders.

Our progress in the first half of 2025 reflects these priorities with a strong launch of Kecetit, continued great growth, and the initiation of our two Phase 3 programs for OSA, vampire, MDD, and muscarinic schizophrenia trials.

We have increased SG&A, GAAP and non-GAAP operating expenses guidance by $25 million to support continued chronicity and Ingrezza sales growth. We expect SG&A leverage throughout the second half of 2025.

With $1.8 billion in cash and a strong balance sheet, we are well positioned to support our commercial and clinical development strategies for continued growth.

Eric Benevich: Thanks, Matt. Q2 was a quarter of continued strong execution of our Ingreza growth strategy. Our strategic investments in the Ingreza franchise over the past year are yielding tangible results. These investments, such as last year's salesforce expansion, enhanced marketing initiatives, and increased contracting for Medicare formulary coverage, combined with strong efforts from our commercial and medical teams, led to a record number of new patient starts and total prescriptions for the quarter. In fact, this was the second quarter in a row of all-time high new patient starts. Q2 sales of $624 million represented 15% sequential growth and year-over-year sales growth of 8%. In addition, we saw continued prescription VMed2 market share gains in Q2. In Q2 and again in early Q3, as Matt noted, we contracted to further expand Medicare formulary coverage for Ingrezza.

With that, I'll now hand the call over to Eric bennov our chief commercial officer. Eric

thanks, Matt Q2 was a quarter of continued strong, execution of our ingresa growth strategy.

Our strategic investments in the ingresa franchise over the past year are yielding tangible results.

These investments, such as last year's sales force expansion, enhanced marketing initiatives, and increased contracting for Medicare formulary coverage, combined with strong efforts from our commercial and medical teams, led to a record number of new patient starts and total prescriptions for the quarter. In fact, this was the second quarter in a row.

Of all-time high new patient starts.

Q2 sales of 624 million represented, 15% sequential growth and year-over-year sales growth of 8%.

In addition, we saw continued prescription. Vmat2 market share gains in Q2.

Eric Benevich: We now have formulary coverage for approximately 70% of Medicare beneficiary lives in the TD market. These incremental rebate agreements were mid-year adds to key formularies outside of the regular bid cycle. They substantially improve our coverage and will make it easier for patients and providers to start or reinitiate Ingrezza therapy going forward. The formulary adds in Q2 and Q3 represent approximately a 25-point increase in coverage in just two quarters and embody the stellar work done by our market access team. We acknowledge that these rebate agreements encompass prescriptions for all current Ingrezza patients insured under those plans, not just the new incremental patients. So we saw an impact on our gross to net, which somewhat offset our strong volume growth. However, we believe that over time, these Medicare formulary investments will allow us to grow our volume and share faster than we otherwise would.

In Q2 and again in early Q3, as Matt noted, we contracted to further expand Medicare formulary recovery for Ingrezza.

We now have formula recovery for approximately 7% of Medicare beneficiary lives in the TD market.

These incremental rebate agreements were mid-year ads to keep formularies outside of the regular bid cycle.

They substantially improve our coverage and will make it easier for patients and providers to start or reinitiate Reset Therapy going forward.

The formulary ads in Q2 and Q3 represent approximately a 25-point increase in coverage in just 2 quarters and embody the stellar work done by our Market Access team.

We acknowledge that these rebate agreements Encompass, prescriptions for all current and reservations insured under those plans. Not just the new incremental patients so we saw an impact on our gross to net which somewhat offset our strong volume growth.

Eric Benevich: With less than half of the estimated 800,000 TD patients as yet diagnosed and approximately 13 more years of exclusivity, we believe these sales, marketing, and access investments position the Ingrezza franchise well for growth in the years to come. Now, turning to Kernecity, the launch is off to a strong start with early results surpassing our internal expectations. In Q2, we received 664 new treatment forms, and over 1,000 have come in since we launched in late December. This was an important milestone for our franchise. Q2 net sales were $53 million, more than triple our Q1 sales, and over 75% of all dispensed prescriptions in the quarter were reimbursed. Clearly, we're building strong momentum with this launch. To date, we've seen widespread adoption across both pediatric and adult patients, with a slight trend towards pediatrics after two full quarters on the market.

However, we believe that over time, these Medicare formulary investments will allow us to grow our volume and share faster than we otherwise would.

With less than half of the estimated 800,000 TD patients as yet diagnosed and approximately 13, more years of exclusivity.

we believe these sales marketing and access Investments position, the ingressive franchise well for growth, in the years to come,

Now, turning to chronicity, the launch is off to a strong. Start with early results, surpassing our internal expectations in Q2. We received 664, new treatment forms and over a thousand have come in since we launched in late December. This was an important milestone for our franchise.

CO2, net sales were 53 million more than triple our q1 sales.

And over 75% of all dispense prescriptions in the quarter were reimbursed.

Clearly, we're building strong momentum with this launch.

Eric Benevich: Furthermore, we've seen prescriptions written by a range of CH healthcare providers, including those practicing at multidisciplinary centers of excellence, pediatric endocrinologists, and community-based adult endocrinologists. Given the early stage of the launch, most individual prescribers have only initiated treatment for one or two patients so far, which is to be expected. Now, let me share a little color on the launch. Earlier in July, our commercial and medical teams had a strong showing at the Endocrine Society annual meeting in San Francisco, where we presented 16 posters, including long-term Kernecity efficacy and tolerability data and weight-related outcomes. Attendance at our commercial and medical booths, as well as our sponsored symposia, was very good. Feedback from endocrinologists who have already treated patients with Kernecity was quite positive, and the interest level was high amongst those who haven't yet had a chance to prescribe.

To date, we've seen widespread adoption across both pediatric and adult patients, with a slight trend towards pediatrics. After two full quarters on the market,

Furthermore, we've seen prescriptions written by a range of healthcare providers, including those practicing at multi-disciplinary centers of excellence, pediatric endocrinologists, and community-based adult endocrinologists.

Given the early stage of the launch, most individual prescribers have only initiated treatment for 1 or 2 patients so far, which is to be expected.

Now, let me share a little color on the launched. Earlier in July, our commercial and medical teams have a strong showing at the endocrine Society, annual meeting in San Francisco, where we presented, 16, posters including long-term, chronicity efficacy, and tolerability data and weight, related outcomes,

attendance at our commercial and medical booths as well as our sponsored symposia was very good.

Eric Benevich: With two full quarters complete, Kernecity's performance continues to trend very positively. We have all the right ingredients here for a future blockbuster: high unmet need, strong efficacy and safety data, a broad and favorable label, and highly dedicated teams who put CH patients' needs first. Once again, I'd like to thank our commercial and medical teams for driving strong results for both Ingrezza and Kernecity in Q2. And with that, for the first time ever, I'll hand the call over to my new colleague, Dr. Sanjay Keswani, our Chief Medical Officer.

Feedback from the chronologists who have already treated patients with chronicity was quite positive, and the interest level was high amongst those who haven't yet had a chance to prescribe.

Creds performance continues to Trend very positively, we have all the right ingredients here for a future Blockbuster. High-end met need strong efficacy and safety data abroad, and favorable label, and highly, dedicated teams who put cah patients needs first.

Once again, I'd like to thank our Commercial and Medical Teams for driving strong results for both Ingrezza and Kecentryn in Q2.

And with that, for the first time ever, I'll hand the call over to my new colleague, Dr. Sanjay keswani our chief medical officer.

Dr. Sanjay Keswani: Thanks, Eric, and good afternoon, everyone. Before I begin, I want to express how enthusiastic I am to join Kyle, the Neurocrine team, as Chief Medical Officer. I'd also like to acknowledge my predecessor, Dr. Ivory Roberts, for her remarkable leadership and the significant clinical advancements accomplished during her tenure. I'm grateful that Ivory will continue to support us as a strategic advisor through the end of next year. Now on to the clinical update. The registrational studies for both OSOVAMPATOR and Major Depressive Disorder and MBI-568 in schizophrenia are progressing well. Indeed, we have just screened the first patient in our second phase III study in schizophrenia for 568. Hence, all the phase III studies, as well as the open-label studies for 568 and OSOVAMPATOR, are up and running. And we anticipate top-line data readouts for OSOVAMPATOR in 2027 and a bit later for 568 in the 2027-2028 timeframe.

Uh, thanks Eric and good afternoon everyone before I begin, I want to express how enthusiastic I am to join K. The neurocrine team as chief medical officer. I would also like technology my predecessor, Dr. I Roberts for her remarkable leadership and the significant clinical advancements accomplished during her tenure

I'm grateful that our will continue to support us as a strategic adviser through the end of next year.

Now, on to the clinical update, the registrational studies for both OSAP amitur and major depressive disorder.

And nvi 568 in schizophrenia are progressing. Well,

Indeed, we are just screened the first patient in our second. Phase 3, study in schizophrenia 4568, hence all the phase 3 studies as well as the open label studies.

For 568 and the USA, Vampire are up and running. And we anticipate topline data readouts for us of Ampi Tour in 2012.

Dr. Sanjay Keswani: Regarding data readouts this year, we disclosed in May that for the adjunctive treatment of schizophrenia, barbenazine did not meet the primary endpoint of improvement in the positive and negative syndrome scale, or PANS. Recall, this study was designed as a learning opportunity for our next-generation VMed2 follow-on programs and has indeed provided valuable insights. Notably, we observed numerical separation and improvements in the valbenazine arm compared to placebo, as well as statistically significant improvement in positive symptoms. We look forward to sharing the full study results at an upcoming scientific meeting. Continuing with valbenazine, top-line results from our phase III study for the treatment of dyskinetic cerebral palsy will read out in Q4 of this year. In addition, the phase II proof of concept and dose-finding study for MBI-770, our NMDA and R2B negative allosteric modulator will also read out top-line data in Q4.

And a bit later for $568 million in the 2027–2028 timeframe.

Regarding data readouts this year, we disclosed in May that for the adjunctive treatment of schizophrenia, our benzene did not meet the primary endpoint of improvement in the Positive and Negative Syndrome Scale, or PANSS.

Recall, this study was designed as a learning opportunity for our next generation VMAT2 follow-on programs and has indeed provided valuable insights.

notably, we observed numerical separation and improvements in the valbenazine arm compared to Placebo, as well as statistically significant Improvement in positive symptoms,

We look forward to sharing the full study results at an upcoming scientific meeting.

Continuing with our Behnaz topline results from our Phase 3 study for the treatment of Bell's palsy, we will read out in Q4 of this year.

Dr. Sanjay Keswani: With a positive readout, these data could pave the way for a confirmatory phase II study or the initiation of a phase III trial. Turning to our new programs, last month we announced the initiation of the phase I study for MBIP-1435, a long-acting corticotropin-releasing factor I receptor antagonist administered subcutaneously for the potential treatment of congenital adrenal hyperplasia. This program marks the first investigational peptide from our internal pipeline to advance into the clinic. It's also the first of what we anticipate to be many biological compounds advancing from Chief Scientific Officer Jude Onya's research division. Regarding our early-stage muscarinic programs, we remain on track to initiate the phase II study of MBI-570, our dual M1/M4 selective agonist for the treatment of schizophrenia. We also expect to report phase I results later this year for both MBI-567, our M1 preferring dual agonist, and MBI-569, our M4 preferring dual agonist.

In addition, the Phase 2 proof of concept and dose-finding study for NBI 770, an NMDA NR2B negative allosteric modulator, were also read out with topline data in Q4.

With a positive readout these data could pave the way for a confirmatory, Phase, 2 study, or the initiation of a phase 3 trial.

Turning to our new programs. Last month, we announced the initiation of the phase 1 study for nvi 1435 a long-acting, corticotropin releasing Factor 1 receptor antagonist, administered subcutaneously for the potential treatment of congenital adrenal hyperplasia.

This program lasts the first investigational peptide from our internal pipeline to advance into the clinic.

There's also the first of what we anticipate to be many biological compounds.

Advancing from Chief Scientific Officer, Jude Ona's research division.

Regarding our early stage masculine programs. We remain on track to initiate the phase 2 study of NBI 570. Our dual M1 M4 selective Agonist for the treatment of schizophrenia.

Dr. Sanjay Keswani: I look forward to engaging with many of you over the coming months ahead in advance of our R&D day at Neurocrine's campus in San Diego on December 16th. With that, I'll hand the call back to Kyle.

We also expect to report Phase 1 results later this year for both NBI 567 rm1 preferring dual, Agonist and NBI 569 are M4. Preferring dual Agonist

I look forward to engaging with many of you over the coming months ahead of our R&D Day at Neurocrine campus in San Diego on December 16th.

With that, I'll hand the call back to Kyle.

Kyle Gano: Thanks, Sanjay. I think we're ready for questions now.

Thanks, Andre. I think we're ready for uh, questions now.

Operator: Thank you. At this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. We ask that you limit yourself to one question so that we may take as many questions as possible. Once again, that is star one to ask your question. We will pause for a moment to allow questions to queue. And our first question comes from Tizin Ahmad with Bank of America.

Thank you at this time. If you would like to ask a question, please press *1 on your telephone keypad.

You may remove yourself from the Queue at any time by pressing star 2.

We ask that you limit yourself to 1 question so that we may take as many questions as possible.

Once again, that is star 1 to ask a question, we will pause for a moment to allow questions to queue.

In our first question comes from tazeen, Ahmad with Bank of America.

Speaker 10: Hi, guys. Good afternoon. Thanks for taking my question. So mine, I think, is going to be for Matt. Matt, we know that you're super detail-oriented, but taking that into account, you're narrowing the top end of guidance by $50 million, and we've still got half of the year left. And you know I fully appreciate the comments that you made about having mid-year adds and improving access on Medicare. But I guess how are you triangulating that level of certainty, and is that number potentially up for future adjustment as the year progresses? Thanks.

Matt Abernethy: Yeah, thanks Tizin. It really comes down to the contracting and where net price was coming into the year. As you mentioned, I am detail-oriented, and so I never like to have anything changed throughout the year, but that's not the case of our business. It's very dynamic. And on the price on the contracting in place, but throughout this year, we've been able to pull forward actually some major programs in contracting from 2026 into 2025. So from a pricing perspective, we went from flattish pricing expectations to call it negative 5% price decline for the year. And so I think that that should help triangulate where the guidance range is at. From a volume perspective, kudos to the team. Record numbers of TRX, record numbers of new patients, double-digit volume growth. So on the volume side, everything is going well for us as well as in the marketplace.

Um, Matt, we know that you're super detail oriented. Uh, but taking that into account, your narrowing the top end of guidance by 50 million and we've still got half of the year left. And, you know, I fully appreciate the comments that you made about having midyear ads and improving, um, access on Medicare. But I guess, how are you triangulating that level of certainty? And is that number potentially up for future adjustment as the year progresses. Thanks,

Matt Abernethy: This adjustment down on the top end really comes back to a change in assumption around pricing.

Yeah, thanks to Zen it really comes down to the Contracting and we're net price was coming into the year, as you mentioned. I am detail oriented. And so I never like to have anything uh changed throughout the year, but that's not the case of our business. It's very Dynamic and on the price on the Contracting in place, but throughout this year, we've been able to pull forward, actually some major Pro uh programs uh from uh in Contracting from 2026 into 2025. So from a pricing perspective went from flattish pricing expectations to um, call it negative 5%, uh, price decline for the year. And so I think that that should help triangulate where the guidance range is at, from a volume perspective, kudos to the team record numbers of TRX, record numbers of of of new patients, double digit, volume growth. So, on the volume side, everything is going well for us as well, as in the marketplace.

This adjustment down on the top end. Really comes back to a change in Assumption around pricing.

Operator: We'll move to our next question from Phil Nadu with TD Cowan.

We'll move to our next question. From Phil Nadu with TD Cowen.

Ivory Roberts: Good morning or good afternoon. Thanks for taking our question. Congrats on the Kernecity number. It does seem to be launching much more quickly than most of us had anticipated. Can you talk about the dynamics you're encountering at the clinics? In particular, were there any boluses of patients added to Kernecity during the quarter? Any reason why we shouldn't extrapolate the growth we saw in Q2 to future quarters? Or any other dynamics that we should consider as we try to digest the big number you just put up and what that portends for future quarters? Thanks.

Good morning or good afternoon. Thanks for taking our question. Uh, congrats on the car number does seem to be launching much more quickly than most of us had anticipated. Can you talk about the Dynamics here? Encountering at the the clinics, um, in particular were there any boluses of patients, um, added to chronicity during the quarter? Any reason why we shouldn't extrapolate the growth? We saw

In Q2 to to, to Future quarters or any other dynamics that we should consider, as we try to digest the big number, you just put up and and what that portends for future quarters, thanks.

Eric Benevich: Yeah, hi, Phil. So you know I'll comment, and maybe Ivory has some additional commentary here. But you know before the launch and you know after Q1, we had sort of guided towards what we called a measured launch. And the reasons for that were primarily around patient flow through the practices. We know that adult patients usually only see their endocrinologists once, maybe twice a year, pediatric patients two or three times a year. And endocrinologists had indicated to us that they intended to offer Kernecity treatment as patients flow through. Those dynamics haven't really changed. We're still seeing that patients are being initiated subsequent to an in-person visit. That being said, you know we have seen strong adoption, obviously. We feel really good about the pace of patient starts, and it's building over time.

Yeah. Hi Phil. So, you know, I'll comment and maybe Ivory has some additional, uh, commentary here. But, you know, before the launch and, you know, and after q1, we had sort of guided towards what we call the measured launch, and the reasons for that were primarily around patient flow through the practices. We know that uh, adult patients usually only see their endocrinologists once maybe twice a year at the Pediatric patients 2 or 3 times a year and um endocrinologists had indicated to us that the intended to offer Chestatee treatment as patients flow through those Dynamics haven't really changed. We're still

Eric Benevich: Certainly, I think it's a function of our ability to reach the endocrinologists and to get the word out within the patient and family communities. So you know kind of getting back to this concept of a bolus, no, it's not really a bolus or you know patients that were necessarily waiting for Kernecity because for the most part, people weren't aware of it prior to its approval. But we have seen what I would describe as very steady and consistent adoption. And certainly, we view the activity that we had at Endo as sort of another booster for us in terms of being able to accelerate that awareness within the endocrinology community.

Seeing that patients are being initiated subsequent to a to an in-person visit. That being said, you know, we have seen, um, strong adoption, obviously. We feel really good about the, the pace of of patient starts. Um, and and it's building over time, uh, certainly I think it's a function of our ability to reach the endocrinologists and to get the word out within the patient and family communities.

So um you know kind of getting back to this concept of a bolus know. It's it's not really a bolus or um, you know, patients that were necessarily waiting uh for chronicity because for the most part people were aware of it prior to its approval. Um but we have seen what I would describe as very steady and consistent adoption in. Certainly, uh, we view the um, activity that we had at Endo is sort of another booster for us in terms of being able to um accelerate that awareness within the Endocrinology community.

Dr. Sanjay Keswani: Hi, Phil. Thanks. The only thing I'd add there is, I mean, I do think we have a lot of interest and excitement out there in the community, and we certainly felt that during our participation in Endo. And that comes from both the clinicians and also the patients. We heard from several of the clinicians that we work with on the medical side that they were receiving a lot of questions from patients and requests from patients to get in and get the opportunity to talk about Kernecity. Certainly, the other place you'd think of a bolus is if there was one coming from the clinical trial environment. And as you know, we signaled that we were shutting down the adult open-label trial, and those patients are steadily moving on to commercial Kernecity. So it isn't a bolus effect there either.

I feel, um, thanks. The only thing I’d add there is, uh, I mean, I do think we have a lot of interest and excitement out there in the community, and we certainly felt that during our, um, participation in Endo. That comes from both the clinicians and also the patients. We heard from several of the clinicians that we work with on the medical side that they were receiving a lot of questions from patients and requests from patients to get in and get the opportunity to talk about current, uh, chronicity. Uh, certainly the other place you’d think of a bolus is if.

Dr. Sanjay Keswani: And obviously, we still have our pediatric open-label extension trial going, which is going to provide us with longer-term clinical data that we think will be very important.

Technical data that we think will be very important.

Operator: We will move next to Paul Matthias with Stifel.

We will move an extra Pilatus with Stifel.

Ivory Roberts: Hey, congrats on the great progress with Kernecity and thanks for taking my question. I was wondering if you can share any data or metrics or at least qualitative poll on how concentrated prescribing has been at this point. You know if we look at some other rare disease launches that have had a great start but you know maybe tapered off after a bit, it feels like there can be this sort of COE academic dynamic, and then the patient acquisition effort increases over time as you have to go to the community. So how do you think CH stacks up with these sort of treatment dynamics and what you're seeing with Kernecity? Thank you.

Hey, congrats on the great progress with pests in the adventure, taking my question. Um, I was wondering if you could share any data or metrics or or at least qualitative caller and have concentrated prescribing has been at this point. Um, you know, if we look at some other rare disease launches that have had a great start but you know, maybe tapered off after a bit. It feels like there can be this sort of Coe academic Dynamic and then the patient acquisition effort increases over time as you have to go to the community. So how do you think CH Stacks up with these sort of treatment Dynamics and what you're seeing with PR? Thank you.

Eric Benevich: Yeah, Paul. So you know certainly, we're very excited about you know the adoption that we're seeing. And you know prior to the launch and subsequently, you know our estimate has been that you know if you think about sort of three segments of endocrinology prescribers, you know we've got our centers of excellence that are accredited, and then there are others that are not accredited by the CARES Foundation. Overall, you know we estimate that around 15% or so of the total CH patient population flows through a small number of those centers. Let's call it 20 or less. And then you know an important segment is also the pediatric endocrinologists. There's a little over 1,000 of them out there. They care you know for all of these pediatric patients and even some of the young adults.

Yeah, Paul. So you know, certainly we're we're very excited about um you know, the adoption that we're seeing and you know, prior to the launch and and subsequently, you know, our estimate has been that, you know, if you think about sort of 3, segments, of of Endocrinology prescribers, uh, you know we've got our, our centers of excellence uh that are accredited and then there are others that are not accredited by uh the cares Foundation overall. You know we we estimate that around 15% or so of the total uh CH patient population flows through a small number of those centers. Let's call it a 20 or less and then um you know an important segment is also the Pediatric endocrinologist. Uh, there's a little over, a thousand of them out there. Um, they care. You know, for all these Pediatric,

Eric Benevich: And then there's the community endocrinologists, and that's where, you know as we say, the tail gets long. Ultimately, though, this isn't a super concentrated patient population. You know somewhere north of 20,000, we estimate in the US. And most of the adult community endocrinologists, if they have CH in their practice, they have one or two patients. And so in my prepared remarks, I commented that most of the prescribers so far have written for one or two patients, and in some instances, that's all they have. But certainly, we see a lot of HCPs that have yet to prescribe, and in those centers of excellence, there's still a lot of room for growth in terms of adoption. So it's still early days yet. We're two quarters in. We're pleased with the trajectory of the launch.

Patients, and even some of the young adults,

Eric Benevich: But you know for the most part, this isn't a super concentrated patient population.

Dr. Sanjay Keswani: Hi, Paul. The only thing I'd add there is that I think we are hearing that given the breadth of the label and the efficacy and tolerability data that was generated for Kernecity, that the ease of starting the therapy is helping ensure that it isn't something that is requiring that center of excellence presence in order to be able to get patients onto the medication.

And then, um, there's the community endocrinologists. And that's where, you know, as we say that the tail gets long. Um, ultimately, though this isn't a super concentrated patient population, you know, somewhere north of 20,000, we estimate in the US and most of the, um, Adult Community endocrinologists. Uh, if they have ch in their practice, they have 1 or 2 patients. And so, in my prepared remarks, a comment that that most of the prescribers so far have written for 1 or 2 patients, and in some instances, that's all they have. Uh, but certainly, we see, uh, a lot of hcps that have yet to prescribe, and in those centers of excellence. There's still a lot of room for growth in terms of adoption. So, it's still early days yet. We're 2 quarters in. Uh, we're pleased with the, uh, the trajectory of the launch. Um, but you know, for the most part, this isn't a super concentrated patient population.

Hi Paul. The only thing I'd add there is that I think we are hearing that uh given the breadth of the label and the efficacy and tolerability data, that was generated for kecetit that the ease of starting the therapy is helping ensure that it isn't something that is requiring that Center of Excellence presence. In order to be able to get patients onto the medication.

Matt Abernethy: Sorry. This is an exciting launch, so the last ad here from the team. When you look at how steady the new patient additions were throughout the quarter, I mean, it was very consistent within a pretty tight range week by week. So I think if we would have had some inflection or some bolus effect, I don't think you'd see the steadiness in terms of overall adoption and new scripts written each week. So kudos to the team for finding these patients and getting them help, and then also for the reimbursement team to be able to have above 75% of scripts reimbursed at this point. Just quite an accomplishment.

Sorry, uh, this is an exciting launch. So, the last idea from the team, uh, when you look at how steady, uh, the new patient editions were without throughout the quarter. I mean, it was very consistent within a pretty tight range week by week. So, I think if, if we would have had some inflection or some bolus effect, I don't think you'd see the steadiness in terms of overall adoption and, uh, new scripts written each week. So, kudos to the team, uh, for uh, for finding these patients and getting them help. And then also for, uh, the reimbursement team to be able to have above 75% of scripts. Reimbursed, at this point, uh, just quite a, uh, accomplishment.

Operator: We'll go next to Cory Kasma with Evercore.

We'll go next to Corey Kasma with Evercore.

Ivory Roberts: Hey, good afternoon, guys. Thanks for taking the question. Wanted to follow up on Ivory's earlier comment on the adult OLE program and patients rolling from that over to commercial product. Are you able to provide any more granularity there in terms of percentage of patients that have moved over and whether you would expect the rest to follow suit? Are there any nuances in this process that would perhaps prevent them from doing so? Thank you.

Hey, hey, good afternoon, you guys. Thanks for taking the question. Wanted to.

Follow up on Iris earlier, comment on the adult Olli program and patience rolling from that over to commercial product. Are you able to provide any more granularity there in terms of percentage of patients that have moved over? And and whether you would expect a rest to follow suit? Are there any nuances in this in this process? That would perhaps perhaps um prevent them from doing so? Thank you.

Matt Abernethy: Hi, Cory. So we're talking about less than 40 patients here. And you're going to see some of those, we saw some fall into Q2 and some fall into Q3. So in the context of over 600 patient starts in the quarter, you know pretty de minimis in terms of the overall landscape of what we're seeing with Kernecity.

Hi Corey. Um, so we're talking about less than 40 patients here and uh you're you're going to see some of those. We saw some fall into Q2 and some fall into Q3. So in the context of over, 600 patients starts in the quarter, you know, pretty de minimis in terms of the overall, uh, you know, landscape of what we're seeing with chronicity,

Operator: We'll go next to Jay Olson with Oppenheimer.

We'll go next to Jay, Olsson with Oppenheimer.

Matt Abernethy: Oh, hey. Congrats on the Kernecity launch success, and thank you for providing this update. I wanted to thank Ivory for her substantial contributions and wish her all the best. And I also wanted to welcome Sanjay. So congratulations on joining the team. And could you please share with us some of the key findings that you learned from your due diligence that attracted you to Neurocrine? Thank you.

Oh, hey. Congrats on the chronicity launch success. And thank you for providing this update. I wanted to thank irie for her substantial contributions and wish her all the best.

And could you please share with us some of the key findings that you learned from your due diligence that attracted you to Neurocrine? Thank you.

Dr. Sanjay Keswani: Nice to meet you, Jay. Yeah, I'm super excited to join Kyle and the Neurocrine team. And yeah, I'd also like to acknowledge Ivory, who's sitting just beside me, for her terrific leadership. Yeah, in terms of some of the reasons I joined, I thought the company was really at a transformational stage, evolving from primarily a small molecule to product company to potentially a multiple-modality company targeting multiple therapeutic areas with multiple products. So the potential here to positively impact the lives of many patients and their families who are suffering with unmet need is a major source of motivation for me. With respect to the portfolio, my perspective is that the late-phase psychiatry portfolio has a high probability of success because they're essentially validated targets.

Uh nice to meet you Jay uh yeah I'm super excited to join Kyle and the neurocrine team. And yeah I'd also like to acknowledge irie. Uh who's sitting just beside me for her terrific uh leadership. Yeah. In terms of some of the reasons I joined, I thought the company was really at a transformational stage evolving from primarily a small molecule to Products Company to potentially multiple modality company targeting, multiple therapeutic areas with multiple products. Uh, so the potential here to positively impact the lives of many patients and their families, who are suffering with unmet, need is a major source of motivation for me.

Dr. Sanjay Keswani: And I'm also really excited by our large early-phase portfolio, which largely comprises large molecules such as bispecifics, antibody drug conjugates, and peptides, with many of these programs having transformational potential. And as Kyle mentioned, we'll discuss some of this at our R&D day later this year. So I think that Neurocrine has walked the talk with respect to substantial R&D investment. So thank you for the question.

I would respect to the portfolio. My perspective is that the late face Psychiatry portfolio has a high probability of success because they're essentially validated targets and I'm also really excited by our large early phase. Uh portfolio, which largely comprises large molecules such as by specifics antibody drug conjugates and peptides with many of these programs having transformational potential. Uh and as Kyle mentioned, we'll discuss uh some of this at our R&D day later this year. So I think that neuro-id has walked the talk with respect to substantial R&D investment

Um, so thank you for the question.

Operator: We'll go next to Brian Abrams with RBC Capital Markets.

We'll go next to Brian Abrams with RBC.

Ivory Roberts: Hey, good afternoon. Thanks for taking my question. I'm curious if we could talk about what steered your decision to contract Ingreza mid-year. How long these contracts, we should think about these contracts generally being in place for, and should we not expect now additional contracting shortly after the new IRA price is established for your competitor? Thanks.

Hey, good afternoon.

Taking, uh, my question. Um, I'm curious if you could talk about, what steered your decision to contract ingresa midyear how long these contracts, uh, we should think about these contracts generally being in place for and, and should we not expect now additional Contracting shortly after the new Ira price is established for your competitor. Thanks.

Kyle Gano: Hi, Brian. This is Kyle. You probably heard from me when I stepped into the role a lot more conversation about looking at maximizing access for patients. I think it's something that is important to me and the company, and it's always been a north star for us to do that for patients. We think that's in their best interests in terms of offering options for their care. I also think it provides a great deal of flexibility for us moving into the new era of IRA that starts next year with the first round of 10 that go through their price negotiation. So as you know, with the contracting process, this starts well in advance of the year that you're looking to actually observe your new price, if you will.

Kyle Gano: And our contracting efforts that we've outlined here were actually started, initiated with the mindset that we'd begin in 2026. And obviously, when you start the year in these discussions, you don't know where they're going to go, but we got them to a good place for '26 and the opportunity to accelerate or pull them forward into 2025. So you saw some of the efforts there result into an advantage for us starting in Q2, and then another one that has played out for the start here in Q3. So that's where we are today on this. I think that's part and parcel of where we landed on narrowing the band of our guidance to 2.5 to 2.55 billion. But I do want to go back to a point that Matt started earlier in the call.

Hi Brian. This is Kyle. Um, You probably heard from me when I stepped into the role. Uh a lot more conversation about looking at maximizing, um, access for patients. I think it's something that it's important to me in the company and it's always been a Northstar for us to do that for patients, we think that's in their best interests in terms of offering options for their care. I also think it provides a great deal of flexibility for us, uh, moving into the new era of Ira that starts next year, with the first round of 10 uh, that go through their their price negotiation. So as you know, with the Contracting process, this starts, well, advance of the year that you're looking to actually observe your, your new price, if you will, and our Contracting efforts that we've outlined here. We're actually started initiated with, um, the mindset that that we begin in 2026. And uh, obviously when you start the year in these discussions, you don't know where they're going to go. Uh, but we got them to a good.

Place for 26 in the opportunity to accelerate or pull them forward into 2025.

So you saw uh some of the efforts there result into an advantage for us, starting in Q2.

And then another 1 that has played out for the start here in Q3.

Kyle Gano: What we saw here in Q2 was a second quarter of new record new prescriptions as well as total prescriptions, and that led to a market share increase in need of RAM prescriptions as well as total prescriptions. That doesn't happen by chance eight years into commercialization. It really is a function of sound business fundamentals, and this is across our Salesforce expansion that started later or late last year through the marketing initiatives that we outlined for this year and the market access advantages that we now have. So you pair those together with very strong demand in the patient segment within TD, and we're seeing the uptick in the volume that we think is very important for our business this year in terms of new patient starts, but even more important in 2026.

Kyle Gano: We're going to start off on day one on a good foot and really have a strong year. So I think that gives you a nice feel for our contracting process and thoughts here for this year in '26.

So that's where we are today on this. I think that's, uh, part and parcel of where we landed on narrowing, the band of our guidance to 2.5 to 2.55 billion. But I do want to go back to a point that Matt started earlier in the call. What we saw here in Q2, uh, was, uh, uh, a second quarter of new, uh, record, uh, new prescriptions, as well as total prescriptions, and that led led to a market share increase in new to Brand prescriptions, as well, as total prescriptions that doesn't happen by chance. 8 years in the commercialization, it really is a function of Sound business fundamentals. And this is across our sales force expansion, that started a later or late last year through the marketing initiatives that we outlined for this year and the market access advantages that we now have. So, you pair those together with, uh, very strong demand in the patient segments, within TD. And we're seeing the, the uptick in the volume that we think is very important for our business. This year, in terms of new patients starts, but even more important in 2020,

6. We're going to start off on day 1 on a good foot and really have a strong year. So I think that gives you a nice feel for our Contracting process and thoughts, uh, here for this year in 26.

Operator: We'll move next to Etienne Rama. I'm sorry. Please go ahead.

Matt Abernethy: Yeah, I think, Brian, you were also wanting some clarification around any additional contracting that we would expect to take place, and just do want to build on what Kyle said in that you know we believe this sets us up really well for 2026. So sitting here right now, do not expect or believe there's going to be any major contract sign that would degradate pricing further from how we're exiting 2025. So sitting here right now, we would expect very similar pricing into 2026 based upon the amount of coverage that we have. But we'll, of course, update everybody if that were to change.

Home of next year. I'm sorry. Please go ahead.

Contract sign that would aggregate, uh, pricing further from how we're exiting 2025. So, sitting here, right now, we, we would expect very similar pricing, uh, into 2026 based upon the amount of coverage that we have. But we'll of course update everybody if that were to change,

Operator: We'll go next to Anupam Rama with JP Morgan.

we'll go next and

Ivory Roberts: Hey, guys. Thanks so much for taking the question, and congrats on the Kernecity launch. Quickly on the valbenazine schizophrenia update, what are you learning from that study on VMed2 mechanism and schizophrenia target population considerations or trial design considerations as you look to the next-gen VMed2? Thanks so much.

hey guys, thanks so much for taking the question and, uh, congrats on the launch um, quickly on the valve benzine. Schizophrenia update, what are you learning from that study on? Vet 2 mechanisms, and schizophrenia Target, population, considerations or trial, design, considerations, as you look to the NextGen vmat 2. Thanks so much.

Dr. Sanjay Keswani: Yeah, I think it's, as you mentioned, important to understand that that study in ATS was a learning opportunity for us, specifically for our VMed2 follow-on programs. So what we saw was essentially some positive efficacy signal in the positive scale within the PANS score. And so I think that will be very helpful in terms of understanding the target patient population for the other programs that are following valbenazine. But I don't know, Ivory, if you want to mention some more things. Yeah, no, happy to. Nice to talk to you, Anupam. I think the first thing to say was it was a well-designed, a well-controlled, large study. So actually, I think we were very pleased with the level of the data and information we were able to get out of the study. So that was a good thing.

Yeah I think it's as you mentioned important to understand that that study in ATS was a learning opportunity for us specifically for our vmat to follow on programs. Uh so um, what we saw was essentially um some positive efficacy signal in the positive uh scale within the pan score. And so I think that will be very helpful in terms of understanding uh the target patient population for the other programs that are following. Um valbenazine. But I don't know I if you want to

Dr. Sanjay Keswani: Secondly, I think it's really helpful that it confirmed in a larger population of 400 patients the safety and tolerability profile that we knew was there for valbenazine, but it's good to see it in these more acutely unwell individuals. We obviously, beyond the PANS positive score and the PANS total score, were able to look at a whole series of the sub-scores and additional quality of life functional measures and other things of that sort. And what I'll say is that there were some interesting signals in there across the sub-scores that we will intend to publish on in due course over the next few months. And we'll obviously use that knowledge as well to inform the next generation of VMed2 inhibitors in terms of choice of patient population, indications, and other elements.

Mentioned some more things. Yeah, no, happy to, uh, nice to talk to Pam. Um, I think the first thing to say was, uh, it was a, a well-designed, a well-controlled, large study. So actually, uh I think we were very pleased with the uh level of the data and information. We were able to get out of the study so that was a good thing. Secondly, I think it's really helpful that it confirmed in a larger population of of 400 patients. Uh, the safety and tolerability profile that that we knew was there for Val banaz. But it's good to see it in these, uh, more acutely unwell individuals. Um, we obviously beyond the um, the Pan's positive score on the Pan's total score. We're able to look at a whole series of, um, the you know, the sub scores, um and additional uh uh quality of life, functional measures and other things of that sort. And what I'll say is that there were some interesting signals in there across the sub scores that we will intend to um publish on in due course over the next of

The next few months uh and will obviously use that knowledge as well to inform the next uh, generation of vmat2 Inhibitors. In terms of choice of patient, population, indications and other uh, elements.

Operator: We'll move next to Brian Scorney with Baird.

Hello ma'am. Next to Brian scy with beard.

Ivory Roberts: Hey, good afternoon, everyone, and thank you for taking the question. Also, on Kernecity, congrats on a really strong quarter. Something you could maybe give us a little more detail on the derivation of that figure. Is there any inventory dynamic in this quarter? And can you disclose the number of filled prescriptions represented here? It just seems hard to calculate more than like 2,000 TRX in the quarter, given the patient start forms and reimbursement numbers you gave us, which puts the net TRX somewhere in the high 20,000 range. I guess, are we in the right ballpark with those numbers? And how do you think about pricing going forward, both on sort of gross to net and a mix of adult and pediatrics? Thanks.

Hey, good afternoon everyone, and thank you for taking the question. Um, also on CAR, uh, congrats on a really strong quarter. I was hoping you could, um, maybe give us a little more detail on the derivation of that figure. Is there any inventory dynamic in this quarter? And can you disclose the number of build prescriptions represented? Um, it just seems hard to calculate more than like 2,000 TRX in the quarter, given the patient's heart forms and reimbursement numbers you gave us, which puts the net TRX somewhere in the, you know, high 20,000 range. I guess, are we in the right ballpark with those numbers? And how do you think about pricing going forward, both on sort of gross to net and the mix of adults and pediatrics? Thanks.

Matt Abernethy: Yeah, Brian. On the inventory front, because I've seen some notes on this, but on the inventory front, what we had in the quarter was a build of around $5 million. So that's just reflective of growth in the channel as the scripts continue to grow. You know, as we've said before, very consistent demand throughout the quarter. Very good job from our pharmacy getting patients ultimately on therapy. And gross to net so far has largely been on the heels of copay assistance as well as some distribution fees and costs. And like we've said, I haven't been at a place of contracting yet. So good job to the team so far.

Yeah, Brian on the inventory front uh, because I I've seen some notes on this but uh, on the inventory front. Uh, what we had in the quarter was a build up of around 5 million dollars so that's just reflective of growth um in the channel as as the scripts continue to to grow. Um you know as we've said before very consistent uh demand throughout the quarter. Uh very uh good job from our Pharmacy, getting patients, ultimately on therapy and gross in it. Uh so far has largely been on the heels of of co-pay uh, assistance as well as some distribution fees and costs and

Like we've said, I haven't been at a place of Contracting yet, so uh, good job to the team so far.

Operator: We'll go next to Yatin Sinija with Guggenheim Partners.

Okay, with Guggenheim partners.

Ivory Roberts: Hey, guys. Thank you for taking my question. I have a question regarding the IRA implication. If you can just maybe talk about how do you envision the access to shake out? I mean, what would be the end goal? Will you seek access at parity once we know the negotiated price? I'm just curious if you can outline that dynamic for us the best you can, and also your expectations on how whether one drug will be mandated versus the other. Thank you so much.

Hey guys. Uh, thank you for taking my question. Um, I have a question regarding the, the IRA implication, if you can just maybe talk about what, how do you envision the, the access to shake out? I mean, what would be the end goal? Would you seek access at Clarity? Once, we know the negotiated price, it just curious, you know, if you can outline that Dynamic for us, the best you can and also, you know, your expectations on how uh, you know, whether 1 drug will be mandated versus the other. Thank you so much.

Kyle Gano: Hi, yes. This is Kyle. I'll start a response here, and I'll ask Eric to fill in any holes in my answer here. I think for IRA, I mean, there's a couple of pieces here that I would point you to. There's our own IRA moment in 2029. That's when our negotiated price is enacted. And then there's our competitor in this space with theoretic tetrabenazine in 2027. And if you want to just speak to the near-term event with our competitor, I think we start with we acknowledge we don't have all the answers what's going to happen during an IRA. I don't think anyone does. So I think we all acknowledge that piece. It's a good place to land on. In 2025, we're going to see what happens with other brands in the same categories where medicines are negotiated. So I think we'll have some learnings there.

Kyle Gano: And then the third piece I'd point out is our goal here is to maximize the number of patients on Ingrezza. That's part of our maximizing our access strategy here. And I think that's important to point out because Ingrezza is incredibly sticky. Patients, when they start Ingrezza, they tend to stay on it. So when it comes to 2027 and the years between that and our own IP moment in 2029, we are talking about the new patients primarily. And we think that we're on a good footing here with the differentiation that we offer for Ingrezza relative to our competitor in this space when they go through their IP moments. Maybe I'll stop there. Eric, anything to add?

Uh a response here and I'll I'll ask Eric uh to fill in any uh holes in my. Um my answer here. I think for Ira I mean there's a couple pieces here that I would point you to there's our own Ira moment in 2029 that's when our negotiated price is enacted. And then there's our competitor in the space with deuterated, tetrabenazine in 2027. And if you want to just speak to the near-term, um, event, uh, with our competitor, I think we start with, we acknowledge, we don't have all the answers. What's going to happen do during an IRA, I don't think anyone does. So I think we all acknowledge that piece. It's a good place to to land on, uh, in 2025, we're going to see what happens with other brands in the same categories where medicines uh, are negotiated. So I think we'll have some learnings there and then the therapy side point out is, you know, our goal here is to maximize the number of patients on ingresa. That's part of our uh, maximizing, our access strategy here and I think that's important to point out.

Matt Abernethy: Yeah, I just want to reinforce that I think we're all going to learn together in 2026 in terms of how health plans are managing various classes where there's one or more negotiated products. And certainly, our overall strategy from an access perspective is to have broad access and parity. And over time, we've been very successful with that. Obviously, you know we commented that in 2024, we started to see some tightening of access in terms of health plans starting to reject more claims and so on. This wasn't specific to Ingrezza. This was more of a broader industry trend, and that's carried forward into 2025. Frankly, that's one of the reasons that we've invested in access because we believe it's very important to make it as easy as possible for providers and patients to get on product.

Because, uh, ingresa is incredibly sticky patients. When they start in graza, they tend to stay on it. So when it comes to 2027 in the Years between that and our own IPA moment in 2029, we are talking about the new patients, uh, primarily. And we think that we're on a good footing here with the differentiation that we offer. For him, graza relative to our competitor in this space, uh, when they go through their IP moments, maybe I'll stop there. Eric, anything to add?

Yeah, I just want to re uh reinforce that I think we're all going to learn together in 2026, in terms of uh, how health plans are managing various classes, where there's 1 or more, uh, negotiated products. And certainly our our, um, overall strategy from from an access perspective is to have broad access, and, and parity.

Matt Abernethy: And certainly, these increased investments that have led to a higher proportion of covered lives in Medicare sets us up well for 2026 and beyond. So you know we're going to very carefully monitor the environment, but ultimately, the goals don't change. We want to help patients. We want to make it available. And how we go about doing that is probably going to evolve over time.

And um over time we've been very successful with that. Obviously, you know, we commented that in 2024 uh we started to see some tightening of of access in terms of health plans starting to reject more claims and so on, this wasn't specific to ingresa, this was more of a broader industry Trend and that's, you know, carried forward into 2025, uh, frankly that's 1 of the reasons that we've invested in Access because, you know, we believe it's, it's very important to make it as easy as possible for, uh, providers and patients to get on on product. And, uh, certainly this, uh, these increased Investments that have led to a higher proportion of of covered lives in Medicare, uh, sets us up well, for 2026 and Beyond so, you know, we're we're going to, uh, very carefully monitor the environment, but ultimately, the goals don't change. We want to help patients. We want to make it available and how we go about doing that is probably going to evolve over time.

Button.

Speaker 10: Hey, Jess, are you there? I think.

Hey, just are you there? Hey, Amy.

Ivory Roberts: Hi, Ami.

Speaker 10: Hi.

Ivory Roberts: Okay, great. Thanks for taking my question. A question on Kernecity. Can you give us a sense of the penetration across the different segments of the market from a physician perspective that you've talked about? And you mentioned that at present, mostly physicians have one or two patients on treatment, and that is likely to evolve over time. How long do you anticipate physicians sort of limit to maybe a handful of patients before they feel like they have enough experience with the treatment to start to expand that? Thank you.

Okay great. Um thanks for taking my question. Uh, a question on. Uh, can you give us a sense of the penetration across

um, the different segments of the market, from a physician perspective that you've talked about, and you mentioned that at, at present

Mostly Physicians have 1 or 2 patients on treatment and that is likely to evolve over time. How long do you anticipate Physicians?

You know sort of limit to maybe you know, a handful of patients before they feel like they have enough experience with the treatment to start to expand that.

Thank you.

Matt Abernethy: Yeah, so I'll kind of go back to some of my prepared remarks. You know we recently crossed an important threshold of having over 1,000 NRXs submitted, treatment forms submitted into our patient hub. And most endocrinologists that have treated have only treated one or two patients so far. And the reality is, and as I mentioned earlier, this is sort of a thinly spread population. Most of the adult endocrinologists, if they have any classic CH patients in their practice, they might have one or two. So in some instances, they've treated all the patients that they have. However, you know especially within pediatric endocrinology and in those centers of excellence, there's still a lot of untreated patients. And so we have a long way to go, frankly, in terms of adoption. It's still two quarters into a launch.

Yeah, so I'll I'll kind of go back to some of my prepared remarks. You know, we we recently across an important threshold of having over a thousand uh anaxes submitted a treatment form submitted into our into our patient Hub. Uh and most uh endocrinologists have only

Matt Abernethy: And there's certainly endocrinologists that we have yet to meet with and to walk through the clinical data and the labeling. So I would say, you know if you want to try and back calculate how many prescribers there are, certainly looking at the number of treatment forms coming in and sort of that ratio where most have only one or two, you can get a sense that it's less than that total number. But ultimately, you know I think that we'll see how things evolve as we move further into the launch and we continue to raise the awareness of not only the availability but of the benefits of Kernecity.

Launch and um, there's certainly endocrinologists have yet that we have yet to meet with and to walk through the clinical data and the labeling. So um, I would say, you know, if you want to try and back back calculate how many prescribers there are, there are, um, certainly looking at the number of treatment forms coming in and and sort of that ratio where most of only 1 or 2, uh, you can get a sense that it's less than that total number. Uh, but ultimately, you know, I think that we'll see how things evolve as we move further into the launch and we continue to raise the awareness of uh, not only the availability, but of the benefits of chronicity

Operator: We'll go next to Corinne Johnson with Goldman Sachs.

We'll go next to Karen Johnson. With Goldman Sachs.

Speaker 10: Good afternoon, everyone. I wanted to ask on the reimbursement process from here. When you anticipate transitioning to more of a formulary-driven process, then how do you anticipate that could impact net pricing on Kernecity?

Good afternoon everyone. Um, I wanted to ask on the reimbursement process from here when you anticipate transitioning to more of a formulary driven process and how do you anticipate that could impact? Um, net pricing on kity.

Eric Benevich: Yeah, let me tackle that. So at launch, Kernecity was a non-formulary drug everywhere. And our expectation is that in some instances, health plans will decide to do a formulary review, and you know often they'll add it to formulary. But given that it's a class of one, it's more likely that in many instances, they won't bother to do a formulary review. And it will remain as a non-formulary product. That doesn't mean that it's not covered. And certainly, we're very pleased with the rate of reimbursement that we're seeing. Our expectation coming out of the gate with the approval was that in most instances, patients would need to go on to our free goods program for a month or possibly longer before getting their prescription claim approved and then transitioning over to a commercially reimbursed product.

Yeah, let me, let me let me tackle that. Um, so at launch kecetit was a, um, a non formulary drug everywhere. And um, our expectation is that in some instances Health Plans, will decide to do a formulary review and, you know, and often they'll add it to formulary but given that it's a class of 1, it's more likely that in many instances. Uh, they won't bother to do a formulary review and it will remain as a non formulary.

Eric Benevich: The reality is that we've been pleasantly surprised at the fast rate of approvals for these claims. Most patients don't need to go on free goods. And thus, the statistic that over three quarters of all the dispenses, both in Q1 and in Q2, have been reimbursed product. So just to set expectations, I don't know that we're ever going to be in a place where we'll provide formulary coverage statistics because in many instances, health plans will continue to reimburse as a non-formulary product given the size and scope of this category.

Product, that doesn't mean that it's not covered. And certainly, uh, we're very pleased with the, uh, the rate of reimbursement that we're seeing our expectation, uh, coming out of the gate with the approval. Was that in most instances patients, would need to go on to our free Goods program for a month or possibly longer before getting their, um, prescription claim approved. And then transitioning over to commercial, uh, re commercially reimbursed product.

Uh, the reality is that um, we've been pleasantly surprised that the, uh, fast rate of approvals for these claims most patients don't need to go on free goods. And thus the, uh, statistic that over 3, quarters of all the dispenses, both in q1 and in Q2 have been reimbursed product. So, um, just to set expectations, I don't know that we're ever going to be in a place where, you know, we'll provide, uh, formulary coverage statistics because, uh, in many instances, Health Plans will continue to reimburse as a non formulary product, um, given the size and scope of this category.

Operator: We'll go next to Danielle Breaux with Truist.

We'll go next to Danielle, bro, with truist.

Speaker 10: Hi, guys. Good afternoon. Thanks for the question. You mentioned some of the data that you presented at Endo, and I was just curious about some of the feedback that you received there from the prescribing community, specifically as it relates to the change in glucocorticoid dose at one year remaining relatively flat versus 24 weeks and how we should think about that. And then same thing on the insulin resistance data that you presented. It seemed like we don't see further benefits beyond 12 months. Is there anything to read into there or why might that be? And then at any point in time, will we see any additional clinical data such as bone age data or other benefits from lowering steroid doses? Thank you.

Hey guys, uh, good afternoon, thanks for the question. Uh, you mentioned some of the, uh, data that you presented at endo. And I was just curious about some of the feedback that you received their from the prescribing Community specifically, as it relates to like the change in Google, corticoide dose at 1 year, remaining relatively full

At verse 24 weeks and how we should think about that. And then same thing on the insulin resistance data that you presented. It seemed like we don't see further benefits Beyond 12 months.

Um, is there anything to read into there or why might that be? And then at any point in time, will we see any additional clinical data such as donij data um or other benefits from lowering steroid? Doses?

Dr. Sanjay Keswani: Hi. Hi, it's Ivory here. I'll address the last bit first. Yes, we do have ongoing open-label trials for Kernecity, both in adults and pediatrics, the adult patients being outside the United States, pediatrics being worldwide. And our intent is to continue to publish over the long haul from those studies because we do believe that those longer-term clinical data are absolutely critical. Just as a reminder, this was the first time that we had presented one-year data from our registrational program and the first time we'd really been able to concentrate on those clinical outcomes that are so important to patients and to clinicians. And just again, by means of kind of reminding everyone, you know the impact of Kernesifont directly, Kernecity, is to have a direct impact in lowering androgens.

Dr. Sanjay Keswani: And so we're interested in understanding the long-term impact of controlling those androgens over a 12-month period and even beyond. And then secondly, as a result of that reduction in 17OHP, ACTH, and androgen levels that we're able to achieve directly with Kernecity, we are able to reduce the steroid dosing in these patients from the superphysiologic doses that are required to control the disease in the absence of Kernecity. Going into the release of data from this program, we had said, and this was supported broadly, that any reduction in steroid dose was.Beneficial

Thank you, hi, hi, sorry here. Um, I'll address the last bit first. Uh yes. Um we do have ongoing open-label, trials, for chronicity both in adults and Pediatrics. The adult patients being outside the United States, Pediatrics being worldwide and our intent is to continue to publish, um, over the Long Haul from those studies because we do believe that those longer term clinical data are absolutely critical. Um, just as a reminder, this was the first time that we had presented 1 year uh data from our registration or program. Um, and the first time we'd really been able to concentrate on those clinical outcomes that are so important to patients and to clinicians. Um and and just uh Again by uh means of kind of um reminding everyone, you know, the the impact of caress. The font directly kecetit is to have a direct impact in lowering androgens. And so we're interested in understanding the long-term impact of controlling the

Operator: to patients over a lifetime. And I think that is, in fact, what is playing out. What we saw in the one-year data was a consistent, small, modest effect, but a consistent effect across many metabolic parameters, including weight, Homer IR, the insulin resistance that you referred to. And you know that is a clinically beneficial change that we saw there that results in a potential for improved outcomes over a lifetime for those patients. So it's extremely important. We also saw changes in scores such as hirsutism scores in females, which are important in terms of looking at the direct androgen effect. So with the release of all of those data, I will say that the response from the community was actually very positive. Clinicians were very interested and excited in the data, looking forward to obviously continuing to follow those data over time.

Operator: But it's a really good start from our point of view in terms of how we're able to serve patients.

Was supported broadly. That any reduction in steroid dose was beneficial to patients over a lifetime and I think that is, in fact, what is playing out? Uh, what we saw in the 1 year data was a consistent, uh, small modest effect. But a consistent effect across Many metabolic parameters, including weight homeri, the insulin resistance that you referred to. And you know, that is a clinically beneficial change that we saw there that results in a, a, an a potential for improved outcomes, over a lifetime for those patients. So, it's extremely important. We also saw changes in schools such as her to her suit, ISM scores in uh, in females which are important in terms of looking at the direct Androgen effect. So in with the release of all of those data, I will say that the um, the response from the community was actually very positive, uh, clinicians were very interested in excited in the data. Looking forward to obviously continuing to follow those uh data over time. Uh but it's a really good start.

From our point of view, in terms of how we're able to serve patients.

Coordinator: We'll go next to Mohit Bansal with Wells Fargo.

We'll go next to mohead banzo with Wells Fargo.

Jess: Your line is open. Please go ahead or check your mute button.

Your line is open, please go ahead or check your mute button.

Speaker 4: I guess we'll catch Mohit on the flip side. Can we go to the next one, Jess?

I guess we'll catch mohead on the flip side when we go to the next 1, Jess.

Jess: We will go next to Ash Verma with UBS.

We will go next to Ash Verma with UBS.

Todd Tushla: Hi. Thanks for bringing my question. Just a quick one on the chronicity formulary commentary that you made. So are a lot of these reimbursements for a six-month or one-year basis? And then when chronicity is up for reauthorization for these patients, would that require a steroid dose reduction based on what you can tell right now? Thanks.

Um, hi. Thanks for taking my question. Uh, just a quick 1 on current city formulary commentary that you made. So are a lot of these reimbursement for a 6 million or 6 month or 1 year basis and then, when city is up for reauthorization, for these patients, would that require uh, steroid dose reduction based on what you can tell right now,

Thanks.

Kyle Gano: Yeah. So if I understand your question correctly, it's related to reauthorization. You know, what are we seeing in terms of the authorized number of fills and timing for reauthorization and what kind of criteria are required? For the most part, you know what we're seeing is patients either getting six prescription fills authorized initially or 12. That seems to be the pattern generally. And for the most part, plans have that if they have published their approval criteria, they haven't necessarily published reauthorization criteria. But typically, what we're seeing now is sort of that first early cohort of patients that might have gotten onto commercial product early in the launch that are getting reauthorized. Generally, it's the provider affirming that they're benefiting from treatment.

Yeah, so if I understand your question correctly, it's related to reauthorization. Um, you know, what are we seeing in terms of the authorized number of bills and and timing for the authorization and what kind of criteria are required? Uh for the most part you know what we're seeing is um patients either getting an author, a 6 prescriptions uh Phil's authorized initially or 12. Uh that seems to be the pattern generally

And, um, for the most part plans, have that if they have published their, um, approval criteria. Um, they haven't necessarily published uh, reauthorization criteria. But, uh, typically what, what we're seeing now was sort of that first. Early cohort of patients that might have gotten onto commercial product, early in the launch that are getting reauthorized. Um, generally, it's the, uh, it's the provider. Um,

Kyle Gano: So we're not seeing any hard and fast thresholds of GC dose or GC dose change or needing to provide labs related to the ACTH or the androgens. So for the most part, the reauthorization process has been going about as smoothly as the initial authorization process.

Uh, affirming that they're benefiting from treatment. So we're not seeing any uh, hard and fast, um, thresholds of of uh GC dose or GC dose change or um, you know, needing to provide Labs related to the act, or the androgens. Uh, so for the most part, um, the reauthorization process has been going about as smoothly as the initial authorization process,

Jess: We'll go next to David Amzalin with Piper Sandler.

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

Matt Abernethy: Thanks. So I had a question on the muscarinics in the pipeline, particularly the M1/M4 agonists, 570s. I'm sure you're watching Bristol's work with Coventi with significant interest. And what I wanted to ask is, to the extent that the ADEPT2 study in Alzheimer's psychosis reads out favorably later this year, how does that play into your development plans potentially to get more aggressive with the advancement of 570, say, in AD psychosis or potentially other indications? I know you have the schizophrenia study in rolling, but how are you thinking about that more expansively, just given its mechanism and that it's precedented by another M1/M4 that's on the market? Thank you.

Um, thanks. So, I had a question on the muscarinic, particularly the M1 M4 agonist, um, 5770. So, I'm sure you're watching, uh, Bristol's work with queente, uh, with significant interest. What I wanted to ask is, to the extent that the Adept 2 study in Alzheimer's psychosis reads out favorably later this year, how does that play into your development plans, potent?

Potentially to get more aggressive with the advancement of 570 say in 80 psych or potentially other indications. I know you have the schizophrenia study enrolling but how are you thinking about that more expansively just given its mechanism and that it's precedented by another M1 M4? That's on the market. Thank you.

Eric Benevich: Great. Yeah. So we are watching Coventi's data with interest. Of note, we have quite a robust muscarinic portfolio. So we have a number of M1 preferring as well as M4 preferring agonists, and as you mentioned, a dual M1/M4 570. So we have a number of choices in terms of which ones we take to various indications. Indeed, AD psychosis is a really important indication for the field. And we are interested in that. It may be with 570, but we have other muscarinic agonists which actually may be better suited for that rather elderly population because potentially there's a superior safety profile associated with it. Are there any more questions? Any more?

uh, indeed 80 psychosis is a really important indication for the field and we are interested in that uh, it may be with 570, but we have other

Uh, muscarinic Agonist, which actually may be better suited for that rather elderly population because potentially, uh, there's a superior safety profile associated with it. Um,

Operator: No, I think that was well said. And just to pick up on what Sanjay said at the end there, I think one of the things that obviously we're watching the Coventi data very closely. But you know we do believe that the direct agonist approach here without the need for an add-back, particularly in that older population, could provide an opportunity for differentiation if we were to go forward.

any more questions if any more? No, I think that was, well said, and I just to pick up on what Sanjay said at the end, I think, um, 1 of the things that obviously, we're watching the co empty data very closely, uh, but uh, you know, we do believe that the direct Agonist approach here without the need, for an ad back, particularly in that older population. Uh, could provide an opportunity for differentiation, if we were to go forward.

Jess: We'll go next to Mark Goodman with Lee Rink Partners.

We'll go next to Mark Goodman with Lee rank partners.

Dr. Sanjay Keswani: Yeah, Matt. Just to confirm this negative 5% ingress at ASP comment for the year, is this a full-year impact? Because I'm kind of assuming that the second half is lower than the first half for ASP. So when you say there's no change for ASP in 2026, are you referring to the full-year ASP, or are you referring to where you actually are kind of ending the year, which is lower than kind of the average for the year, if you understand my question? Thanks.

Kyle Gano: Yeah. Regarding the 2026 trajectory, it's a trajectory comment. How we're exiting the year in 2025 would be what you would expect to continue into 2026. So I appreciate that clarification. In addition to that, on the net price comment for the year for 2025, the negative 5% price, as you mentioned, it's more concentrated in the second half of the year. So that was a full-year commentary. So it is safe to assume that the price headwind is a bit more in the second half as compared to the first half. But with that said, I think you take a step back and you look at the volume gains that we expect to have, and it's just an incredible market and feel like we're really well positioned with these formularies to continue to grow and build the market.

Yeah, Matt just to confirm this uh, negative 5% aggressive ASP comment for the year. Is this a full year impact? Because I'm kind of assuming that the second half is lower than the first half for ASP. So when you say there's no change for ASP in 2026, so you're referring to the full year ASP. Or are you falling to where you actually are kind of ending the year, which is lower than kind of the average for the year? If you understand my question, thanks.

Yeah, regarding the 2026 trajectory. It's a trajectory comment. How we're exiting the year in 2025, would be what you would expect to continue into 2026. So appreciate that clarification, in addition to that on the the net price comment for the year for 2025, uh, the negative 5%, uh, price. Uh, as you mentioned, it's more concentrated in the second half of the year. So that was a full year uh, commentary. So it is safe to assume that the the price headwind is a bit more in the second half as compared to, uh, the first half. But with that said, I think you take a step back and you look at the volume gains that we expect to have and uh, it's just an incredible market and feel like we're really well positioned with these formularies to, uh, continue to grow and build the market.

Jess: We'll go next to Miles Mentor with William Blair.

we'll go next to Mi Mentor with William, Blair,

Speaker 10: Hi. Thanks for checking the question. Can you just remind us of the discontinuation rates for chronicity and the one-year open label extensions for the pediatric and the adult studies? And is that still probably the best proxy we have for the annualized retention rates on chronicity in the real world, or are there other key factors we have to consider for retention basis? Thanks very much.

Operator: Yeah. Hi, Miles. I think the first thing to say is that we were very favorably surprised, I guess, at how well tolerated and how safe chronicity was across the adult and pediatric populations. That's the first thing to say. We had just a very small number of patients discontinue during the course of the program, and more than 95% of the patients rollover from both the pediatric and the adult program into the open label extension. Many of those patients have now been on study for greater than three years, and we still continue to see very low discontinuation rates and the continued improvement in the outcome for those patients.

Uh, hi. Thanks for, uh, checking the question. Can you just remind us if the, uh, the discontinuation rates for City and the 1 year at the label extensions for the Pediatric, in the adult studies and is that still probably the best proxy we have for the annualized? Retention rate? So I'm I'm finishing in the real world or are there other key factors we have to consider for potential devices. Thanks very much.

Kyle Gano: So it's still early in the launch cycle for chronicity, and we're watching that, of course, over these first six months. But that's a key variable as we think about what's the long-term potential of chronicity. And that's something I think we're going to know a lot more here in the second half of this year as well as then into the first half of next year as you see patients getting the blood draws and understanding glucocorticoid titration. But from a safety and tolerability perspective, as Iri said, three years of patients on therapy, we have a lot to believe in in terms of high levels of adherence. Yeah. One last point to make, you know, in terms of the difference between real world and clinical trial experiences, you know, typically in the real world with the medicine, affordability and coverage can impact persistency.

Yeah. I'm, uh, hi miles. I think the first thing to say is that, um, we were very favorably, um, surprised I guess and at how, well tolerated and how safe he was AC the, uh, dealt and pediatric population. That's the first thing to say, we had just a very small number of patients discontinued during the course of the program and more than 95% of the patients roll over from both the Pediatric and the adult program into the open label extension, many of those patients have now been on study for greater than 3 years. And, uh, we still continue to see very low discontinuation rates, uh, and the continued Improvement. In, in, in the outcome, for those patients,

So it's still early in the launch cycle uh for kecetit and we're watching that of course, over these first 6 months, but that it's a, a key variable as we think about what's the long-term potential of kecetit and that's something I think we're going to know a lot more here in the second half of this year as well as then into the first half of next year. As you see patients getting the blood draws and understanding uh glucocorticoid uh titration. Um, but from a safety and tolerability perspective, as I already said, 3 years of patients on therapy, uh, we have a lot, uh, to, to believe in in terms of high levels of adherence.

Kyle Gano: We're seeing really, really good coverage, and we believe that chronicity is very affordable for patients, you know, between the copay buy down and the other programs that we have. So we don't expect insurance to be a barrier to persistency.

Yeah, 1 1 last, uh, point to make, you know, in terms of the difference between real world and and clinical trial experience is, you know, typically and in the real world, with a medicine, um, affordability and coverage can impact persistency, um, we're seeing really, really good, uh, coverage. And, um, we and we, you know, believe that chronicity is very affordable for patients, you know, between, uh, the, uh, co-pay by down and the other programs that we have. So we don't expect, uh, Insurance to be a barrier to persistency

Jess: We'll go next to David Huang with Deutsche Bank.

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

Speaker 10: Hi there. Congrats on the quarter, and thanks for taking my questions. So first, I just wanted to ask in terms of Ingrezza. So a competitor, so Teva, reported this morning, I believe they raised their guidance for their product, Steto, for the year. Is there anything to maybe read into that as it pertains to the relative growth of Ingrezza versus your competitor this past quarter and market share in terms of dollars? And then just quickly on CAH, I think you talked about 20K prevalent patients in the US. Do we have a sense of what percentage is regularly followed in clinics, maybe from things like medical claims data? Thanks a lot.

Uh, in terms of increases. So, so a competitor. So to have a reported this morning, I believe they raised their guidance for their product. Uh, Stow for the year. Is there anything to, uh, maybe read into that as pertains to the relative growth of ingresa versus uh, your competitor, this past quarter and, and market share in terms of dollars, and then just quickly on cah. I think you talked about 20K, uh, prevalent patients in the US. Do we have a sense of what percentage is regularly followed in clinics? Maybe from things like medical claims data. Uh, thanks a lot.

Dr. Sanjay Keswani: Yeah. This is Kyle. I'll take your first question. When it comes to our competitor in this space, you know, we don't really speak to the dynamics of their marketplace and what they're looking at. I think from the perspective of Ingrezza, I'm extremely encouraged by the volume growth that we saw this quarter. And I do want to reiterate, we increased our market share on both new to brand as well as total prescriptions. And so I think that we're really happy with the performance in the first half of this year. You combine that with our initiatives that we put in place starting the year with our additional market access, and we are looking forward to a strong second half as well. So I think I'll leave that there for the time being.

Dr. Sanjay Keswani: And then on the chronicity side of things, Eric, do you want to comment on that?

Yeah, this is Kyle. I'll take your first question. Um, when it comes to our competitor in the space, you know, we don't really speak to the dynamics of their marketplace and what they're looking at. I think from the perspective of Andresa, I'm extremely encouraged by the volume growth that we saw this quarter. And I do want to reiterate, we increased our market share on both new-to-brand as well as total prescriptions, and uh, so I think that we're really happy with the performance in the first half of this year. You combine that with our initiatives that we put in place starting the year with our additional market access, and we are looking forward to a strong second half as well. So I think I'll leave that uh there for the time being. And then on the Kecetit side of things, uh Eric, do you want to comment on that?

Kyle Gano: Yeah. I just want to reiterate that our estimate is greater than 20,000 patients in the US. And the reason that it's an estimate and not a firm number is that some of these patients, first of all, there is no specific ICD-10 diagnosis code for classic CAH. There is a CAH diagnosis code that encompasses both classic and non-classic patients. And if you look at the medical literature, for every classic CAH patient, there's three or possibly four non-classic patients. So you know we have had to triangulate, you know, doing a thorough medical literature review, looking at claims data and so on to get at that number. Some of these patients don't have the CAH diagnosis code at all for various reasons. And so you know we feel like that 20,000 number in the US is a good estimate for the overall prevalent population.

Yeah, I just want to reiterate that that our estimate is greater than 20,000 patients in the US and the reason that it's an estimate and and not a a a a, a firm number is that um some of these patients, their first of all, there is no specific icd10 diagnosis code for classic cah. There is a cah diagnosis code but that encompasses both classic and non-classic patients. And if you look at the medical literature for every class C patients, there's 3 or possibly 4, Non patients.

Kyle Gano: It's a subset of them that are more easily findable, I guess, is the way I would put it. And certainly, there are, you know, that are under the care of an endocrinologist, for example. But there are certainly a cohort of classic CAH patients that are not under the care of an endocrinologist, and they're probably being seen by internal medicine, family medicine, or even OB/GYN. So you know we will learn more about this market as we get deeper into the launch.

So, um, you know, we have had to triangulate, you know, doing a thorough medical literature review, looking at claims data, and so on to, to get at that number, some of these patients don't have the, the CH diagnosis code at all, uh, for various reasons. And so, um, you know, we feel like that 20,000 number in the US is, is a good estimate for the overall prevalence subset of them that are, uh, more easily findable, I guess is the way I would put it. And certainly there are, you know, that are under the care of an endocrinologist. For example, but there are are certainly a cohort of classic CH patients that are not under the care of an endocrinologist. And they're probably being seen by Internal Medicine, family medicine or even OBGYN. So, uh, it, you know, we we will learn more about this Market as we get deeper into the launch.

Jess: We'll go next to Sumanth Kulkarni with Canaccord.

Speaker 10: Jasmine, thanks for taking my question, which is science-based but could have significant strategic and stock implications. You have several years of internal experience in CRF1 receptor antagonists. Corticotropin is involved in stress response, and there's some intriguing external preclinical data on binge eating and this approach. Now that you've presented one-year data on weight-related effects of chronicity at endo, what are your thoughts on using this approach specifically for weight loss, especially as you have a longer-acting version in the works which could help in compliance in that setting?

Kearney with canaccord.

Definitely, thanks for taking my question, which is science based. But could have significant study, you can stop stop implications, or you have several years of internal experience in crf100 data, on weight related effects of chity, at Endo. What are your thoughts on using this approach specifically for weight loss? Especially as you have a longer acting version in the works, which could help in compliance in that setting?

Operator: Yeah. We're clearly very encouraged by the data that we saw from the one-year readout recently at endo for chronicity. And as you can probably imagine, we have a wealth of knowledge about CRF1 antagonism and CRF biology here at Neurocrine. So as we go forward, we'll be considering a broad range of potential indications. And also, obviously, we have a breadth of other research projects in our pipeline that may well seek to address some of those challenging disease areas moving forward.

Yeah, we're clearly very encouraged by the data that we saw from the 1-year readout recently at Endo for chronicity. And as you can probably imagine, we have a wealth of knowledge about.

Jess: We'll go next to Sean Lehman with Morgan Stanley.

We'll go next to Sean Layman with Morgan Stanley.

Ivory Roberts: Hi. This is Michael Riyad on for Sean Lehman. Thank you for taking our question. For Ingrezza, could you comment on the current volume split between the neurology, psychiatry, and long-term care channel? And regarding the double-digit volume growth you expect this year, could you provide any more color on respective contributions to that volume growth from the respective channels? Thank you.

Kyle Gano: Yeah. I mean, what we saw was strong growth really across all three of the business segments. You know, overall, psychiatry accounts for about 60 or so percent of our volume and 65% maybe. And then the balance is split between the other two segments pretty evenly. But all of them are growing at approximately the same rate. So we're really pleased with the overall growth trajectory for the franchise.

Hi. This is Michael Riyad on for Sean Loman. Thank you for taking our questions. Um, for grea, could you comment on the current volume split between the neurology Psychiatry and long-term care Channel, and regarding the double digit volume growth, you expect this year, could you provide any more caller on respective contributions to that? Volume growth from the respective channels. Thank you.

Yeah, I mean, we saw it was strong growth, really across all 3 of the business segments, you know, overall, uh, Psychiatry accounts for about 60 or so percent of our volume and and, and 65% maybe. And and then the balance is split, you know, between the other 2 um segments pretty evenly, but all of them are growing at approximately the same rate. So we're really pleased with the overall growth trajectory for the franchise.

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

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

Ivory Roberts: Thanks very much for taking the question. On chronicity, I wanted to dive into a little bit more about the cadence of prescribing and kind of just clarifying, one, have the majority of patients transitioned from studies to paid script status at this point? And two, as we're thinking about increasing breadth of prescribing, I guess, is there kind of an upper limit as to how many patients physicians are going to be able to manage on chronicity? I guess, is there any capacity constraints that you can share? Thank you.

Thanks very much for taking the question on kassity. I wanted to dive into a little bit more about the the Cadence of prescribing and kind of just clarifying 1 um, have the majority of patients transition from studies to paid script status at this point. And as to, as we're thinking about um, increasing breadth of prescribing, I guess is there kind of an upper limit as to how many patients Physicians are going to be able to manage on taciti, I guess, is there any capacity constraints that you can share? Thank you.

Kyle Gano: Yeah. We don't see any capacity constraints in terms of managing patients on chronicity. It fits right into how they're already being cared for. And we have a really good pharmacy partner to help with that. And so I'll leave it there.

Yeah, we don't see any capacity constraints in terms of of managing patients on kecetit. If it's right in to how they're already being cared for and we have a really good Pharmacy partner to help with that um and and so I I'll I'll leave it there.

Ivory Roberts: And we'll take our final.

Kyle Gano: Sorry. Laura, I forgot to mention. In regards to clinical trial patients, as I said earlier on the call, it's less than 40 patients, and you could assume half of them came on board in Q2, and the other half are going to come on board in Q3. So it's pretty de minimis in terms of overall new patients that are being added to therapy.

We'll take our final, I'm sorry. Um, Laura Laura, I I I forgot to mention, um, in regards to uh, clinical trial patients, as I said earlier, on the call, uh, it's less than 40 patients and you could assume half of them came on board in in Q2 and and the other half were going to come on board and and Q3 so it's pretty dim Minimus. In terms of overall, um, new patients that are being added to therapy

Jess: And we'll move to our final question from Evan Seegerman with BMO Capital Markets.

Speaker 12: Hi, guys. Thank you so much for taking my question. I wanted to touch on some of the thinking behind moving five, six, eight, excuse me, into phase three. I know the phase three trial against CA dose response. Can you walk me through what you were able to look you get in the data to give you confidence in moving to this larger phase three program? Thank you so much.

And we'll move to our final question from Evan's sermon with BMO Capital Markets.

Hi guys, thank you so much for taking my question. I wanted to talk on some of the thinking behind moving 58 568. Excuse me into 53. You know, I know the the phase 2 trial agency a dose response. Let me walk me through what you were able to look. You, get in the data to give you confidence in moving to this larger phase through program. Thank you so much.

Speaker 13: Well, I think we've discussed the merits of moving five, six, eight into phase three. I will mention here we do have an INN name. So I wanted to do a shout out to the team for putting that together for us for this meeting. It's DirectLedin. So stay tuned on that. We'll be able to put that in future correspondence and releases out there. I think, again, I'll refer back to our phase two commentary around the totality of the data that we have. All doses worked in our phase two, and for the dose that we selected for phase three, we hit the primary endpoint, all the secondary endpoints as well. Very attractive profile overall from an efficacy, safety, and tolerability profile. We think that will differentiate quite nicely if we're able to reproduce those results in phase three relative to Coventi out there today.

Well, I think we've uh discussed the the merits of moving 5668 in the phase 3. I I will mention here, we do have an in name. So I wanted to do a shout out to the team for uh putting that together for us for this meeting that's direct leading. So stay tuned on that. We'll be able to put that in future uh correspondence and releases uh out there. I think again, I'll refer back to our Phase 2, commentary around, the totality of the data that we have all doses worked in our Phase 2 and for the dose that we selected for phase 3. We hit the primary endpoint, is all the secondary endpoints as well. Uh, very attractive profile overall from an efficacy safety and tolerability profile. We think that will differentiate quite nicely if we're able to reproduce those results in Phase 3 relative to a comfy out there today.

Jess: And that will conclude the Q&A session for today. I'll turn the program back to Kyle Gano for any additional or closing remarks.

Speaker 13: Thanks, Jess. Thank you all for your thoughtful questions and engaging discussion this afternoon. We covered a lot of ground, in particular across our commercial portfolio and our pipeline. And I hope you're seeing a transition of the company to one defined by both revenue growth and diversity. I should say revenue diversity moving forward with both Ingrezza and Chronicity. Look forward to connecting at upcoming healthcare conferences and certainly at our R&D day on December 16th. So thanks again for joining. Talk to you soon.

And that will conclude the Q&A session for today. I'll turn the program back to Kyle Gano for any additional or closing remarks.

Thanks, Jess. Uh, thank you all for your thoughtful questions and engaging discussion. This afternoon, we covered a lot of ground, uh, in particular across our commercial portfolio and our pipeline. I hope you're seeing a transition of the company to one defined by both revenue growth and revenue diversity, uh, moving forward with both Ingrezza and Grasscity. I look forward to connecting at upcoming healthcare conferences and certainly in our R&D day on December 16th. So, thanks again for joining. Talk to you soon.

Jess: Thank you, ladies and gentlemen. That will conclude today's call. We thank you for your participation. You may disconnect at this time.

Thank you, ladies and gentlemen; that will conclude today's call. We thank you for your participation. You may disconnect at this time.