Llamada de resultados de Alkermes (ALKS) del T3 de 2026: $480.1M en ingresos y catalizadores de orexina

Conclusiones clave

• Alkermes generó unos ingresos totales de 480,1 millones de dólares en el tercer trimestre de 2026, incluidos 417,3 millones de dólares procedentes de productos propios, lo que supone un aumento del 31% interanual tras la incorporación de LUMRYZ y el constante crecimiento de la demanda en toda la cartera consolidada.
• El beneficio neto GAAP del tercer trimestre fue de 16,3 millones de dólares, el EBITDA alcanzó los 63,0 millones de dólares y el EBITDA ajustado se situó en 120,1 millones de dólares. El efectivo y las inversiones totales cerraron el trimestre en 787,6 millones de dólares.
• Las ventas netas de LUMRYZ alcanzaron los 89,9 millones de dólares, con aproximadamente 4.100 pacientes en tratamiento al cierre del trimestre. Las ventas incluyeron una reducción de inventario de aproximadamente 7 millones de dólares acumulado en el segundo trimestre.
• La dirección reiteró todas las previsiones financieras para 2026 presentadas en julio. Se prevé que la cartera de productos propios genere casi 1.600 millones de dólares en ventas netas en 2026, con un pronóstico de ventas para el cuarto trimestre de 400 a 420 millones de dólares.
• Alkermes prevé publicar los resultados de seis estudios de su cartera de orexina durante el próximo año, comenzando a finales de 2026 o principios de 2027 con los datos del ensayo de Fase II Vibrance-3 sobre alixorextón en hipersomnia idiopática.
• Los gastos en I+D aumentaron a 121,1 millones de dólares frente a los 81,7 millones de dólares, lo que refleja la inversión en los estudios de Fase III de alixorextón y el desarrollo clínico de ALKS 7290 y ALKS 4510.

Datos financieros clave

Rendimiento operativo y del negocio

VIVITROL: Las ventas netas del T3 fueron de 127,6 millones de dólares, impulsadas por la demanda para la dependencia del alcohol y aproximadamente 8 millones de dólares en ajustes positivos de bruto a neto, procedentes principalmente del perfil de pacientes.

ARISTADA: Las ventas netas de la familia de productos alcanzaron los 103,9 millones de dólares. La dirección atribuyó el crecimiento de la demanda a una mayor adopción por parte de los profesionales sanitarios, mientras que la evolución favorable del bruto a neto y de los inventarios aportó aproximadamente 7 millones de dólares.

LYBALVI: Las ventas netas fueron de 95,9 millones de dólares, incluyendo un beneficio de inventario de aproximadamente 2 millones de dólares. Las recetas totales crecieron un 18% interanual, respaldadas por nuevos inicios de pacientes y una mayor adopción prescriptora. El número de vidas cubiertas alcanzó aproximadamente el 80% tras la ampliación del acceso por parte de los pagadores, mientras que los ajustes de bruto a neto del T3 se situaron en torno al 42%.

LUMRYZ: Las ventas netas sumaron 89,9 millones de dólares, con aproximadamente 4.100 pacientes en tratamiento. La dirección señaló que el aumento de pacientes reflejó nuevos registros, conversiones y la continuidad del tratamiento. La fijación de precios y el acceso al mercado se mantuvieron dentro de las expectativas de la empresa.

El estudio positivo de Fase III REVITALYZ respaldará la presentación de una sNDA para LUMRYZ en hipersomnia idiopática. De ser aprobada, Alkermes afirmó que la comercialización no comenzaría antes del 1 de marzo de 2028.

Catalizadores clínicos y de la cartera de desarrollo

Los estudios de Fase III Brilliance de alixorextón en narcolepsia tipo 1 y tipo 2 están en curso, y se prevé que los resultados principales comiencen a conocerse a mediados de 2027.

El estudio de Fase II Vibrance-3 inscribió a unos 130 participantes con hipersomnia idiopática. El ensayo evalúa la administración una vez al día y en dosis divididas, utilizando la Escala de Somnolencia de Epworth como criterio de valoración principal y la Escala de Severidad de la Hipersomnia Idiopática como criterio secundario. Se esperan los resultados principales hacia finales de 2026 o principios de 2027.

ALKS 7290 produjo mejoras dependientes de la dosis con respecto a la línea de base en las medidas exploratorias de TDAH en un ensayo de Fase Ib con 50 sujetos, y en general fue bien tolerado, sin acontecimientos adversos graves derivados del tratamiento ni interrupciones del mismo entre los participantes. El estudio de Fase II en TDAH controlado con placebo evalúa la pauta de una dosis diaria frente a la dosis dividida, y se esperan datos en la segunda mitad de 2027.

Alkermes también inició un estudio de Fase II con 150 pacientes para evaluar ALKS 7290 como coadyuvante de los antidepresivos en el trastorno depresivo mayor. El estudio incluye un subgrupo preespecificado con somnolencia diurna excesiva y evaluará los síntomas depresivos durante seis semanas.

La empresa planea un estudio de Fase II con ALKS 4510 para la fatiga asociada a la esclerosis múltiple o la enfermedad de Parkinson. Se esperan datos de prueba de concepto hacia finales de 2027.

Previsiones de la dirección

Para 2027, la dirección prevé unos ajustes de bruto a neto para LYBALVI de aproximadamente el 45% y un crecimiento del volumen de prescripciones cercano al 20% interanual, al que debería seguir un crecimiento aún mayor de las ventas netas. Más allá de 2027, la empresa espera que el crecimiento del volumen y de las ventas netas se alineen con mayor precisión.

Alkermes prevé que el coste de los productos vendidos disminuya en 2027, dado que la mayor parte del ajuste al valor razonable sin salida de efectivo del inventario de LUMRYZ se contabiliza en 2026. Excluyendo los costes de la transacción de principios de 2026, se espera que los gastos generales, de venta y administrativos (SG&A) se mantengan en niveles muy similares, mientras que la inversión en I+D aumentará en paralelo a una mayor actividad clínica. La dirección anticipa una sólida generación de efectivo y un buen rendimiento del EBITDA ajustado en 2027, aunque presentará sus estimaciones completas en febrero.

Riesgos y factores a vigilar

• La entrada comercial del agonista del receptor de orexina 2 de Takeda podría afectar a los nuevos inicios con oxibatos. La dirección prevé que el impacto inicial sobre los oxibatos sea marginal, pero reconoció que la dinámica del mercado dependerá en parte de la estrategia de precios de Takeda.
• La ampliación del acceso de LYBALVI por parte de los pagadores incrementa la presión a corto plazo sobre la relación bruto-neto, y se espera que los ajustes aumenten desde aproximadamente el 42% en el T3 de 2026 hasta alrededor del 45% en 2027.
• El avance de alixorextón hacia los estudios de Fase III en hipersomnia idiopática dependerá de la señal de eficacia y seguridad de Vibrance-3, así como de las conversaciones con los organismos reguladores. La dirección identificó la fecha de la reunión con la agencia regulatoria como un posible factor determinante en los plazos.
• El estudio de Fase Ib sobre ALKS 7290 en TDAH se diseñó principalmente para evaluar la seguridad y la dosis, no para comparar la eficacia frente a placebo. El ensayo de Fase II en curso tiene como objetivo determinar el efecto del tratamiento en comparación con placebo.
• Los beneficios potenciales de combinar agonistas de orexina con oxibatos aún requieren evidencia clínica. Alkermes prevé realizar estudios de combinación en etapas posteriores del desarrollo para no poner en riesgo el programa principal de registro.

Puntos destacados de las preguntas y respuestas con analistas

Estrategia en hipersomnia idiopática: La dirección espera que el estudio Vibrance-3 permita aclarar la selección de dosis, la utilidad de la dosis dividida, los criterios de valoración y las respuestas en durmientes de larga duración, que representan aproximadamente el 25% de la población general con hipersomnia idiopática. Un estudio de Fase III podría tener un tamaño similar al del programa de narcolepsia tipo 2, sujeto a los resultados de la Fase II y al asesoramiento regulatorio.

Posicionamiento en TDAH: La dirección sostuvo que ALKS 7290 no necesita alcanzar una eficacia al nivel de los estimulantes para tener relevancia comercial si ofrece una respuesta más amplia y un perfil de seguridad favorable. El ensayo de Fase II determinará la magnitud del beneficio y comparará la dosis única diaria con la pauta dividida.

Fundamentación en el trastorno depresivo mayor: Alkermes afirmó que el agonismo de orexina busca actuar directamente sobre las vías cerebrales vinculadas al estado de ánimo, a diferencia de un enfoque con antagonistas de orexina enfocado en mejorar el insomnio. La empresa tiene como objetivo evaluar la eficacia general en el TDM y si los pacientes con somnolencia diurna excesiva presentan una respuesta más acentuada.

Uso de orexina y oxibato: La dirección considera que los agonistas de orexina diurnos y los oxibatos nocturnos son potencialmente complementarios. Alkermes planea obtener datos de la combinación más adelante en el programa de registro y señaló que LUMRYZ sería el oxibato utilizado en dicho estudio.

Sostenibilidad de LUMRYZ: La dirección anticipa cierta transición inicial de pacientes con la entrada de nuevas terapias de orexina en el mercado de la narcolepsia, pero destacó que los pacientes estables con oxibatos suelen continuar con su tratamiento. En hipersomnia idiopática, la empresa prevé que LUMRYZ compita tanto por nuevos tratamientos como por transiciones de pacientes si llega a ser aprobado.

Transcripción completa de la conferencia de resultados

Transcripción completa de la conferencia de resultados

Comentarios de la dirección

Operator

Greetings, and welcome to the Alkermes Third Quarter 2026 Financial Results Conference Call. My name is Dylan, and I will be your operator for today's call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may now begin.

Sandra Coombs

Welcome to the Alkermes plc conference call to discuss our financial results and business update for the quarter ended September 30, 2026. With me today are Blair Jackson, our Chief Executive Officer; Todd Nichols, our Chief Commercial Officer; and Joshua Reed, our Chief Financial Officer. A slide presentation, along with our press release, related financial tables and reconciliations of the GAAP to non-GAAP financial measures that we'll discuss today are available on the Investors section of alkermes.com. We believe the non-GAAP financial results in conjunction with the GAAP results are useful in understanding the ongoing economics of our business.

Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see Slide 2 of the accompanying presentation, our press release issued this morning and our most recent annual report filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements.

We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we'll open the call for Q&A. And now I'll turn the call over to Blair for some opening remarks.

Blair Jackson

Thank you, Sandy. Good morning, everyone. On my first quarterly call as CEO of Alkermes, I'd like to start with a few thoughts on the opportunity ahead and the priorities that will guide us. We have a clear strategy and a strong foundation. Our focus now is on execution. That means advancing our pipeline with rigor and urgency, driving strong commercial and financial performance and allocating capital thoughtfully to our highest value opportunities.

Our commercial business is an important element of our strategy and provides a strong financial foundation to invest in innovation. Our greatest opportunity for growth and value creation lies in our pipeline, particularly our leadership in orexin research and the potential of our orexin development portfolio to yield important new treatment options in neuropsychiatry. I'll discuss the significant momentum across our development pipeline in more detail following the discussion of the quarterly results. The combination of commercial strength, financial performance and a differentiated pipeline positions Alkermes well for its next chapter and the potential for meaningful long-term value creation for shareholders. I'm incredibly proud and honored to lead Alkermes at this important point in its evolution, and I'm confident in our strategy, our people and the opportunities ahead. With that, let's turn to the quarter, Todd.

Todd Nichols

Thank you, Blair. Good morning, everyone. I'm pleased to report that we delivered strong performance across our commercial portfolio in the third quarter, reflecting contributions across addiction, psychiatry and sleep medicine. Our teams remain focused on driving demand, broadening patient access and building on the opportunities across our 4 proprietary products.

In the third quarter, net sales from our proprietary product portfolio increased 31% year-over-year to $417.3 million, reflecting the addition of LUMRYZ and continued demand growth across our established commercial portfolio. Starting with VIVITROL. Net sales in the third quarter were $127.6 million. VIVITROL continued to see strong demand driven by penetration in the alcohol dependence market.

Net sales also benefited from approximately $8 million in gross to net favorability, primarily driven by favorable patient mix. For the full year, we continue to expect VIVITROL net sales in the range of $460 million to $480 million. We remain confident in the strength and durability of our VIVITROL business and look forward to continuing our impact with this important medicine.

Turning to our psychiatry franchise. Third quarter net sales for ARISTADA product family were $103.9 million. ARISTADA continued to see demand growth driven by expansion in HCP adoption. Net sales also benefited from approximately $7 million of gross to net and inventory favorability. We are encouraged by ARISTADA's continued strong performance within this category.

For the full year, we continue to expect ARISTADA net sales in the range of $365 million to $385 million. LYBALVI net sales were $95.9 million in the third quarter with underlying TRx growth of 18% year-over-year, supported by new patient starts and broader prescriber adoption. Net sales also reflected approximately $2 million of inventory benefit. Last quarter, we implemented a strategic expansion of the LYBALVI market access profile that we believe will position LYBALVI for long-term growth. Access now stands at approximately 80% of covered lives. And as a result, we have already seen positive trends on volume demand and prescription fulfillment. As expected, gross to net adjustments were approximately 42% during the third quarter.

For the full year, we continue to expect LYBALVI net sales in the range of $380 million to $400 million. Looking ahead to next year, we expect gross to net adjustments for LYBALVI to be in the 45% range. We expect the benefits of expanded payer access to be reflected first in prescription volume, which we expect will continue to grow nearly 20% year-over-year with an acceleration in net sales growth expected to follow.

Beyond 2027, we expect volume growth and net sales growth to track more closely together again. Turning to our sleep franchise. LUMRYZ net sales were $89.9 million in the third quarter. We reached approximately 4,100 patients on therapy at quarter end, reflecting strong underlying demand, broader prescriber adoption and increased use among existing prescribers.

Net sales also reflected the drawdown of approximately $7 million of inventory build that we highlighted in our second quarter results. Last month, we presented results from the positive Phase III REVITALYZ study of LUMRYZ in idiopathic hypersomnia at the Sleep Europe meeting.

IH is a fast-growing segment for the oxybate market. The revitalized data will serve as the foundation for the sNDA submission for IH with a potential launch in March 2028, if approved. IH represents an important potential growth opportunity for LUMRYZ, and we look forward to updating you on our progress. For the full year, we continue to expect total LUMRYZ net sales of $350 million to $370 million, of which Alkermes expects to record $315 million to $335 million, reflecting the mid-February close of the Avadel transaction.

Supporting LUMRYZ, we have an established sleep medicine platform that includes an experienced commercial and medical organization with a deep understanding of the market dynamics in HCP and patient journeys. This platform provides a strong foundation to support the potential launch of alixorexton and our broader ambition to become leaders in sleep medicine across multiple treatment modalities.

Across our proprietary portfolio, we expect net sales to be in the range of $400 million to $420 million in the fourth quarter. We are pleased with what we have accomplished so far this year and remain focused on delivering against our 2026 objectives. As we enter the final quarter, our priorities remain clear. Drive demand for our medicines, expand patient access and position our brands for continued growth. With that, I will pass the call to Joshua to review the financial results for the quarter.

Joshua Reed

Thank you, Todd. We delivered solid financial results in the third quarter, supported by the strength of our commercial portfolio and disciplined management of the business. Through the first 9 months of the year, our financial position has provided the flexibility to advance our strategic priorities and invest in key opportunities that we believe will support our future growth. During the quarter, we generated total revenues of $480.1 million. As Todd outlined, our portfolio of proprietary products generated net sales of $417.3 million. These results reflect contributions from all 4 of our proprietary products and positive underlying demand trends across the commercial business.

Manufacturing and royalty revenues were $62.9 million for the quarter, including $29.5 million from VUMERITY and $26.4 million from the long-acting INVEGA products. Turning to expenses. Cost of goods sold in the third quarter was $94.2 million, which includes the purchase price fair value accounting of LUMRYZ inventory that we described last quarter. This compared to $51.6 million in Q3 of the prior year. R&D expenses in the quarter were $121.1 million compared to $81.7 million in Q3 of the prior year, reflecting continued investment in our orexin development portfolio.

Of note, our development activities during the quarter included the alixorexton Phase III studies initiated earlier this year and clinical development activities to advance ALKS 7290 in ADHD and MDD as well as ALKS 4510 in fatigue associated with Parkinson's disease or multiple sclerosis. SG&A expenses were $208.5 million for the quarter compared to $171.8 million in Q3 of the prior year, with the addition of the Avadel commercial infrastructure as the primary driver of the year-over-year change.

During the quarter, we also recorded amortization of acquired intangible assets of $19.7 million and net interest expense of $21.1 million. In Q3, we recorded GAAP net income of $16.3 million and EBITDA of $63 million. Adjusted EBITDA was $120.1 million, which we believe provides a useful measure of the underlying cash-generating performance of the business during the quarter.

From a balance sheet perspective, we ended the third quarter in a strong position with approximately $787.6 million in cash and total investments. For the year, we are reiterating our 2026 financial expectations provided in July across all line items. Our performance through the first 9 months of the year positions us well to deliver against these expectations.

Our 2026 financial performance and operating expenses reflect a number of Avadel transaction-related costs. As we look ahead to our 2027 operating expense profile, there are a few important dynamics to keep in mind, beginning with cost of goods sold. With the vast majority of the noncash LUMRYZ inventory fair value step-up associated with the Avadel acquisition being recognized in 2026, we expect cost of goods sold to be lower in 2027, reflective of more normalized patterns.

For SG&A, excluding the transaction-related costs recorded in early 2026, we expect a broadly similar expense profile for 2027. For R&D, our 2027 investment will reflect the growing number of programs across the portfolio and the broader level of clinical activity planned.

Importantly, we expect to deliver strong cash generation and adjusted EBITDA performance in 2027 while continuing to invest in the significant opportunities across our pipeline. We believe this balance demonstrates our ability to fund future growth drivers while maintaining financial discipline. We'll provide our full 2027 expectations on our February call. With that, I'll now hand the call to Blair.

Blair Jackson

As you've heard from Todd and Joshua, our commercial business continues to perform well with the proprietary product portfolio expected to deliver net sales of nearly $1.6 billion in 2026. That foundation allows us to advance an increasingly broad pipeline led by our portfolio of orexin 2 receptor agonists.

We are in the early stages of understanding the full therapeutic potential of orexin biology. Over the past several years, we've been generating a substantial body of clinical evidence across central disorders of hypersomnolence, and we are now generating our first clinical datasets from our orexin portfolio in broader areas of neuroscience.

Starting with alixorexton, our most advanced orexin candidate, we reached several important milestones across the development program during the quarter. Our Phase III Brillance Studies in narcolepsy type 1 and narcolepsy type 2 are underway, and we are pleased with enrollment progress across the program. We continue to expect top line results from these studies beginning in mid-2027.

In idiopathic hypersomnia, we completed enrollment in the Vibrance-3 Phase II study, which enrolled approximately 130 participants and will represent the first multi-week clinical dataset of an oral orexin 2 receptor agonist in IH. The study is evaluating wakefulness and IH symptom severity with the Epworth Sleepiness Scale and idiopathic hypersomnia severity scale as primary and secondary endpoints, respectively.

Beyond evaluating the safety, tolerability and efficacy of alixorexton in patients with IH, we expect the study to provide important insights to inform a potential registration program, including dose selection, dosing regimen and endpoint strategy. The study also includes our first evaluation of split dosing in a hypersomnolence disorder, which we believe could provide additional flexibility to address the diverse needs of patients.

We expect top line results around year-end or in early 2027 and look forward to sharing those data. Hypersomnolence disorders represent a significant market opportunity. And this month, the first orexin 2 receptor agonist is expected to become commercially available for the subset of patients with narcolepsy type 1. As this new therapeutic category enters the commercial landscape, we believe that if approved, alixorexton's wide therapeutic range, dosing optionality and broad anticipated utility across narcolepsy types 1 and 2 and potentially IH will support a differentiated profile with the potential to provide an important new treatment option to providers and patients. While the commercial opportunity begins to take shape in hypersomnolence disorders, we are advancing our strategy to develop orexin 2 receptor agonist for a range of neuropsychiatric and neurodegenerative disorders.

Last month, we reported the first clinical results for ALKS 7290 in adults with ADHD. This was a 50-subject Phase Ib proof-of-concept study designed primarily to evaluate safety and tolerability and to generate initial data characterizing the effects of ALKS 7290 across a range of established clinical scales for ADHD, CNS biomarkers and objective cognitive performance tests.

In the study, ALKS 7290 was generally well tolerated with no serious treatment-emergent adverse events and no treatment discontinuations among participants who received ALKS 7290. Most treatment-emergent adverse events were mild and largely consistent with on-target effects for orexin 2 receptor agonists.

Across the 2 doses evaluated, ALKS 7290 demonstrated dose-dependent clinically meaningful improvements from baseline on exploratory endpoints evaluating established measures of ADHD symptoms and disease severity. We were pleased to observe improvements across both the inattentive and the hyperactivity impulsivity subscales of the adult ADHD Investigator Symptom Rating Scale, or AISRS, with effects emerging as early as the first assessment on day 6.

ALKS 7290 also demonstrated clinically meaningful improvements from baseline in overall ADHD disease severity as measured on the CGI-S scale. In addition, we observed treatment effects across objective measures related to processing speed, information processing, working memory and attention. These findings provide the first clinical evidence of the effects of an orexin 2 receptor agonist in the treatment of adults with ADHD and further support the dose range selected for the ongoing Phase II study. That Phase II study is already enrolling adults with ADHD and is designed to evaluate once-daily and split dose regimens of ALKS 7290 with change from baseline in AISRS total score compared with placebo at week 4 as the primary endpoint.

We expect the ADHD Phase II data in the second half of 2027. Building our momentum in diseases outside of hypersomnolence, last week, we announced the expansion of the ALKS 7290 development program into major depressive disorder, or MDD, with the initiation of a 150-patient Phase II study evaluating ALKS 7290 as an adjunct to antidepressant treatment in adults with MDD who have had a partial response to standard antidepressant therapy. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of ALKS 7290 over 6 weeks while also assessing its effects on depressive symptoms as measured by change from baseline on the MADRS or CGI-S compared to placebo at week 6.

The study will enroll adults with and without excessive daytime sleepiness, which will allow us to evaluate the potential effects of ALKS 7290 in the overall MDD population as well as in this important subgroup. Turning to orexin biology and neurodegenerative disorders. We plan to initiate a randomized, double-blind, placebo-controlled Phase II study evaluating ALKS 4510 in people with fatigue associated with multiple sclerosis or Parkinson's disease.

Fatigue is one of the most common and consequential symptoms across a broad range of neurological and systemic diseases, yet effective treatment options remain limited. Fatigue associated with multiple sclerosis or Parkinson's disease are compelling initial areas for development with clearly defined patient populations, significant unmet need and established clinical scales focused on fatigue.

We believe these disease areas offer a tractable development pathway for establishing clinical proof of concept for orexin 2 receptor agonism in fatigue while also representing meaningful commercial opportunities in these patient populations.

Importantly, this study is intended not only to evaluate the potential of ALKS 4510 in these specific disorders, but also to deepen our understanding of the role of orexin biology in fatigue more broadly. We believe these insights generated could help establish a foundation for evaluating additional disease areas where fatigue remains a significant source of patient burden and unmet need.

Alixorexton in hypersomnolence disorders, ALKS 7290 in broader neuropsychiatric disorders and ALKS 4510 in fatigue are components of our broader orexin portfolio development strategy that allows us to evaluate these distinct molecules across a range of patient populations and disease settings. As we advance and expand these development programs, we're also continuing to advance additional orexin compounds through preclinical development.

We're just beginning to explore the potential clinical utility of orexin compounds, and Alkermes is at the leading edge of research for this emerging therapeutic class. Our focus will remain in neuroscience applications, but with the potential to reach across a broad range of disorders, we believe the opportunity for this class is vast and will be the focus of significant research and development for years to come.

Looking ahead, the next year will be a pivotal and data-rich period for Alkermes with 6 important studies expected to read out across our orexin portfolio. We start with anticipated data from the Vibrance-3 Phase II study of alixorexton in idiopathic hypersomnia in the coming months, followed by top line results from all 3 Brilliance Phase III studies in narcolepsy beginning in mid-2027.

For ALKS 7290, we expect Phase II data in ADHD next fall and for ALKS 4510 Phase II proof-of-concept data in fatigue toward the end of the year. Taken together, these studies have the potential to significantly expand our understanding of where orexin-based therapies can make a meaningful difference for patients.

Our focus remains on executing with urgency and discipline, generating the clinical evidence needed to unlock the potential of this novel class and building what we believe can become a leading franchise, addressing some of the most significant unmet needs across sleep, neuropsychiatric and neurological disorders. We plan to pursue these opportunities while continuing to deliver strong commercial performance and investing thoughtfully to support long-term growth and value creation. With that, I'll turn the call back to Sandy for the Q&A.

Sandra Coombs

Thanks, sir. We'll now open the call for Q&A.

Operator

[Operator Instructions] Our first question comes from Leonid Timashev with RBC Capital Markets.

Preguntas y respuestas

Leonid Timashev

Just wanted to ask one on IH and how you're thinking about what to expect there. Maybe can you talk us through when you see that data, how you'll think about moving forward with the split dose, maybe with the once-daily doses and maybe how you're thinking about what you could see on the relative magnitude between those?

Blair Jackson

Sure. It's Blair. I think when we look at the IH dataset that's coming out, there's a wealth of information that we're going to be getting from that trial. As you alluded to, first and foremost, we're going to be getting the once-daily dosing for that program. And as we've spoken before, we see the IH population as somewhat similar to the NT2 population in that it's highly variable. These patients have a range of disease and different responses to orexin agonism. So we would expect something similar to that NT2 dataset. The main difference, though, being that with IH population, they do have one separate population, which is the long sleepers. And those long sleepers, we have less experience with.

We expect that we'll have a similar response within them, but this dataset will tell us more on that piece. With regards to the split dosing, the split dosing, as you know, is an important component of our overall program in that it provides both flexibility for patients across NT1, NT2 and IH, but also could provide some additional efficacy for those patients who need it in the later afternoon. And so this will be the first opportunity we'll be able to see that split dataset as part of a patient program. So all this data will be coming out towards the end of the year, and we're pretty excited to see it.

Operator

Our next question comes from Paul Matteis with Stifel.

Unknown Analyst

This is [ Emily ] on for Paul. We were just wondering where do you think Takeda may price? And like if there was a chance that they price on the lower end, do you think that you have the possibility to kind of like adjust there with the different doses you plan to have available across the disorders?

Blair Jackson

This is Blair. I think that Takeda is going to be pricing imminently, and we'll see that in the next few weeks. And obviously, that will set the range for the overall market. As you alluded to in your question, though, we have a lot of flexibility on our pricing moving forward. So we'll see where they price and we'll adjust accordingly.

Operator

Our next question comes from Graig Suvannavejh with Mizuho Securities.

Graig Suvannavejh

Congrats on the progress in the quarter. Just on the pipeline and obviously, on the orexin franchise, I was intrigued by the movement into major depressive disorder and psychiatry. Could you give us perhaps a little bit more of the rationale there? And can you give us maybe a sense of if there are other psychiatric indications beyond MDD that you think an orexin might make sense?

Blair Jackson

Yes, we looked extensively at other areas outside of hypersomnolence where you could apply orexin agonism. And we did some comprehensive preclinical work, really looking at the basic biology behind orexin agonism and identified a number of different domains where you could apply this, some of them being cognition, fatigue, mood, wakefulness, all these different areas. And so as part of that, we did some translational work in many of these areas. And within mood, some of the things we noticed is that we saw a really strong synergistic increase in serotonin in the prefrontal cortex when orexin agonism was given with SSRIs or SNRIs and so synergistically. And I think that's really telling that there's a benefit you could have here by having adjunctive therapy with orexin agonism.

We also did use the highly translational model as part of that early research, which is the chronic social defeat test, which is really a way of establishing rodents who have really a depressive phenotype and then providing them with therapy and seeing how they respond to treatment. And what we found is we found similar effects to what you'd see if those animals were dosed with ketamine or with fluoxetine.

So we feel -- we felt pretty strongly that there's a potential signal here. And so the desire to move into a patient population is something we've had for some time. And so part of this study that we're looking at is exploratory in that we'll be looking at not only the full MDD population, but we'll also be looking at a subgroup of the population who also have some excessive daytime sleepiness. So that gives us an opportunity to really learn a lot as part of this program and really design our program going forward.

To the first part of your question regarding other things, yes, we have a number of other areas that we're looking at within neuroscience, both neurodegenerative and neuropsychiatry. And we'll talk about those as we get closer to additional activity.

Operator

Our next question comes from Akash Tewari with Jefferies.

Unknown Analyst

This is [ Albert ] on for Akash. Given that your ADHD program will likely need to demonstrate efficacy comparable to existing stimulants to be competitive, can you discuss the rationale for not modifying the trial design to target a specific patient type? And what gives you confidence that the current trial design can demonstrate a clinical meaningful treatment benefit?

Blair Jackson

So first, I would like to correct a little bit of what you said there. I think there's a wide range of efficacy outcomes that are commercially attractive for a new entrant in the ADHD space, especially an entrant like an orexin agonist, which could bring broader response profiles over and above what you see with existing therapies that are there. So I think for us, the goal moving forward is to establish that efficacy level, flush out some of those broader domains that we started to see in the Phase Ib study and show and demonstrate that this is a safe profile within this patient area.

And I think the early data that we saw in our Phase Ib program support all of those goals. One of the key things that we looked at through that Phase Ib study was our dosage range, making sure we were at the right region of targeting those receptors and engaging that circuitry. And what we found was exactly that, that yes, we're right in the range. We don't need to lower or raise our dose. We can use the doses that we have. We also found that we were seeing a really robust response early within treatment. And so I think there is no requirement for us to modify the study in any way nor would it benefit from us based on what we've seen to look at individual subtypes.

Operator

Our next question comes from Rudy Li with Wolfe Research.

Rudy Li

Just a quick follow-up question on 7290's MDD study. So J&J showed good efficacy data in MDD for its orexin antagonist, but in patients with insomnia. Can you maybe talk about the rationale for orexin agonist for MDD? I mean, what will be the key difference in the study population, the trial design versus J&J and what will be the key differentiator versus current standard of care?

Blair Jackson

And I think it's important to recognize that using orexin agonism is a fundamentally different approach than using orexin antagonism. And orexin antagonism, what J&J was trying to do there was sort of address the sleep disorder and hoping it would have a knock-on effect on potential mood.

This is very different what we're doing. We believe that we directly impact centers of mood within the brain, and we're actually looking at treating the depressive symptoms directly. Now because we are using a subgroup who has excessive daytime sleepiness because we think we might be able to drive additional signal through that group. But this is a fundamentally different view than what J&J did with their orexin antagonist.

Operator

Our next question comes from David Amsellem with Piper Sandler.

David Amsellem

Got a couple of LUMRYZ questions. So regarding the launch of Takeda's oveporexton, do you perceive any potential impact to LUMRYZ in terms of new starts next year in NT1. So that's number one. And then looking longer term with the IH launch for LUMRYZ in '28, how are you envisioning uptake? Do you think there's going to be a sizable switch market from XYWAV to LUMRYZ? Do you think you'll be able to expand the overall oxybate footprint in IH? Or is it a little bit of both?

Todd Nichols

Yes. David, this is Todd. I appreciate the questions on LUMRYZ. Yes, we're really, really excited and pleased with the performance of LUMRYZ this year and specifically in Q2, strong net sales, really strong patient demand up to 4,100 patients. We are watching very closely and thinking very deeply about the impact of orexin. As you know, we're big believers in the mechanisms. We actually believe they're complementary, and we hear that pretty consistently from HCPs around the belief and the desire to use both mechanisms. So we think there's a long-term durability in the oxybate market and a lot of excitement with orexins.

Initially, we're going to have to see how this plays out with Takeda's product entering the market. We think initially, that will be a switch population for earlier lines of therapy, patients looking to switch. But we hear pretty consistently from HCPs that patients that are on oxybate, specifically LUMRYZ and that are stable, like to stay on the product overall. So we do believe that there will be an impact on oxybate, but we think it will be somewhat marginal at the beginning, and we think the category overall will be durable.

In terms of IH, yes, this is something we're really excited about. We did present the data recently at Sleep Europe. There's a lot of anticipation on the IH launch. If it's approved, we will be commercializing no sooner than March 1, 2028. And there's a lot of anticipation there. This will be the second product potentially approved in the market. We think it's underpenetrated at this point right now. We think that LUMRYZ actually will compete for new starts in IH, but also there will be a switch market and that LUMRYZ will compete in that switch market.

Operator

Our next question comes from Jessica Fye with JPMorgan.

Unknown Analyst

[indiscernible] Jess. Any feedback from physicians regarding the ADHD dataset? I wonder if you could tell us when -- how the placebo group did in the recent study or when we could see more detailed data, including placebo response rates.

Blair Jackson

Yes. So we've had a lot of discussions with physicians with regards to the ADHD data. And I think there's a lot of excitement about the fact that we're able to move a number of these different tools using orexin agonism. And I think, in particular, folks were interested in the fact that you were seeing consistent response across these measures. And so not only the internal consistency between patient-reported outcomes, but also physician-reported outcomes as well as objective measures.

And just as a reminder, the study itself was a safety study that was designed to look at the wide therapeutic potential that we could have and the therapeutic window we would have with an orexin agonist. And I think that read out really, really well. As such, it's not really appropriate to have a placebo comparison. So what we rely on for that is the objective measures and the subjective measures that we included in that study that we shared in our press release.

Operator

Our next question comes from David Hoang with Deutsche Bank.

David Hoang

I wanted to ask, once you are post Vibrance-3 data in IH, either year-end or early '27, once that data is in hand, how quickly would you look to move into a Phase III program for IH? And what would that study design potentially look like?

Blair Jackson

I think we're going to want to move as quick as we can. Obviously, our goal is to get into the Phase III following that dataset. What we would like to do, though, is meet with the agency first. And so that actually will probably be a rate-limiting step as making sure we get that meeting. And we'll obviously hope that they'll be very responsive because this is an important patient population. As for the size, our expectation is it's probably going to be a similar size to the NT2 study, but that will obviously depend on the signal that we see in the Phase II program. And so that will help set that. But ballpark-wise, think of the Phase IIs for planning purposes -- sorry, think of NT2 for planning purposes.

Operator

Our next question comes from Marc Goodman with Leerink Partners.

Marc Goodman

Just back on oxybate. Could you just give us a little sense behind the scenes what you thought happened in the quarter as far as was it a normal quarter of just new patient starts, discontinuations, the pricing, just how the market dynamics have just shaping up since you've owned the asset? Is it generally kind of consistent with what you thought, any major changes in the quarter?

Todd Nichols

Yes, absolutely, Marc. This is Todd. I'll take that. Yes, again, we were pleased with the quarter. We were assuming some seasonality, which you typically would during Q3. And I think we saw a little bit of seasonal dynamics. But overall, the growth in LUMRYZ was really driven by patient demand.

We saw nice increases in overall patients for narcolepsy, 4,100 patients. That was driven by some of the submetrics that we watch very closely, which are new enrollments, conversions and actually patient persistency. So all 3 of those dynamics, we believe, really contributed to the nice patient growth, which -- and then also contributed to the net sales growth, which was 16% year-over-year.

Marc Goodman

And then pricing?

Todd Nichols

Yes. We didn't see any significant pressures on pricing overall. The pricing was within our range of expectations. And as we've said before, historically, LUMRYZ has a really strong market access profile. We didn't see any changing dynamics there as well, and we're not anticipating any strong changing dynamics as we head into the last part of the year.

Operator

Our next question comes from Joseph Thome with TD Cowen.

Unknown Analyst

This is [ Jacob ] on the line for Joe. On the MDD study for 7290, I was actually just curious if we might expect any kind of prespecified subgroup analysis by excessive daytime sleepiness or like stratification by excessive daytime sleepiness and whether we might expect powering to be sufficient to determine any differences between those patient populations or whether we could have an endpoint like ESS where we could see if the effects on move were being mediated by sleepiness?

Blair Jackson

Yes, as I said in the prepared remarks, actually, we do have a prespecified subgroup, which is a group that has excessive daytime sleepiness. And our goal here is to look at the 2 populations, both the all-comers MDD versus the group that has the excessive daytime sleepiness. And one of the goals there is to see do we see an enriched signal within that group.

And you may expect to see that because as you look at the MADRS scale, for example, there's some questions there that specify or are highly related to sleep or the anhedonia associated or lack of urgency and things like that, that people get. So we want to see that and we want to test that in the study. And then that will allow us to then determine our development path moving forward.

Operator

Our next question comes from Alex Nackenoff with Truist Securities.

Alex Nackenoff

Another one on ADHD. For the Phase Ib portion, could you explain your rationale why you utilized an inpatient setting and possibly how that may have impacted, if at all, baseline characteristics? And if those baseline factors or the inpatient setting may have led to an outsized or suppressed treatment response. I'm just curious if you think you had a representative ADHD population where you believe the results will translate in future clinical studies.

Blair Jackson

So as we look at the ADHD program, we had 2 programs that are studies that we're running at the same time. We have, first and foremost, our large Phase II outpatient study that we're running that is placebo-controlled, multiple doses, et cetera. What we wanted to do in the Phase Ib study was to ensure that we had some information that we would inform on, one, what are some of the types of signals that we would see and two, whether we were in the right dosage range overall. In order to do that, what we needed to do is learn a lot about how patients respond to orexin agonism. Because remember, this is actually the first asset of this mechanism that's ever been tested outside of hypersomnia indications.

And so we needed to learn what we're doing, and that meant we had to put a lot of different tools within the Phase I program. And in order to do that, if you try to do that in an outpatient type setting, that would be exhaustive for the patients. It would be very hard for you to operationalize that. So that's why we chose an inpatient setting. What it allows us to do is put those patients in a clinic, look at those different outcomes in a more staggered pace that's appropriate for the patients.

And we don't think that has any change on the overall baseline characteristics. I think overall, when we looked at the incoming baseline characteristics, that's consistent with what we see with other ADHD studies. I think where it would where inpatient settings tend to have an impact on some things is on your safety outcomes because sometimes what you tend to see in inpatient settings is those patients talking about their side effects, and that can sometimes amplify side effects here and there.

Again, we saw a very good AE profile from this program. So I think all in all, we got exactly what we wanted from this study. I think it validates the approach. And as we've always said, the Phase II study that's ongoing is going to be the one that's going to determine what's the characteristics or what's the signal size related to this drug treatment in this population.

Operator

Our next question comes from Umer Raffat with Evercore ISI.

Umer Raffat

I wanted to touch upon 7290 as well and a couple of points. First, I saw you guys used split dosing when conducting the inpatient ADHD trial. Do you think split dosing could be driving placebo response? And are you intending to continue using split dosing only in your ongoing outpatient ADHD as well as the MDD trial? And then secondly, the fact that you used up to 50-milligram dose of 7290, what does that tell us about the potency relative to your narcolepsy program?

Blair Jackson

I think on the first question on the split dosing. So as we went into the ADHD study, one of the things we wanted to do as we're trying to learn on the signals is we didn't want to confound some of the PK differences of single-day dosing versus split dosing. We wanted to take that out of the equation.

So we use split dosing just because it's a more -- it just allowed us to standardize. I think as you look at our ongoing Phase II study, we're actually using both once daily and split dosing. And I think that's important because, as you know, in the ADHD population, it is a bit of a lifestyle drug in some respects in that it -- patients have different needs according to what -- whether they're working, whether they're student, what's happening in the evening, what happens in the morning, et cetera.

And so I would envision that we'll probably introduce other dosing types, maybe PRN and other things in the future after original registration. But we're going to do both moving forward, single-day dosing as well as split dosing through the development program. With regards to the upper dose of 7290, it's actually -- you can't really use that to relate to narcolepsy. This is fundamentally a different drug. It has a different potency, has different pharmacological characteristics.

And then also keep in mind that the pharmacologic dose level that you need to activate the ADHD circuit may be different than what you need to activate, say, a wakefulness circuit. And so there's a lot of dynamics that are going on there that don't really allow you to make that comparison.

Operator

Our next question comes from Ash Verma with UBS.

So Youn Shim

This is So Youn on for Ash. For the IH study, is it fair to assume that the baseline ESS scores are similar to what you had in the NT2 study? Or so is it fair to assume that the placebo arm in this IH study could closely resemble how the placebo did in the NT2 study?

Blair Jackson

Yes. I mean, look, we've established very similar entrance criteria as in IH versus NT2. Now who ends up enrolling in the study depends on the study and which patients show up. So we'll know that as we look at the data moving forward. I think as we look at this area overall, I think we feel pretty good that we're controlling placebo. Obviously, with wakefulness, one of the things to keep in mind is you don't tend to see such a big placebo response that you see in neuropsychiatric indications.

So you tend to actually -- it really depends more on the treatment arm than it depends on the placebo arm. But again, we do what we can to control that. And we've done that in this program by really trying to standardize how we do the tests, really making sure we have high-quality control on our clinical sites.

So Youn Shim

Got it. And if I may have a follow-up. I think you alluded to the long-form IH patients earlier. Can you talk about roughly what percentage of your IH patients would be the long-form IH?

Blair Jackson

So in our study, we haven't disclosed what that is. I think as we look at the general population, though, within IH, typically, you see something in the order of around 25% of patients can be deemed long sleepers.

Operator

Our next question comes from Amy Fabia with Needham & Company.

Ami Fadia

With regards to the upcoming IH study readout, I'm trying to understand what -- how you're sort of thinking about the outcome of the results, especially in the split dosing arm. As we think about the trade-off between efficacy of having split dose and then maybe potentially implications on safety, are there any guardrails in terms of those trade-offs beyond which you may decide not to pursue a split dosing? And then secondly, is there some process within the study of determining which patients may be best suited for a split dosing versus not that could inform your next clinical trial?

Blair Jackson

I think with the split dosing, there's -- we have a wide therapeutic range with this drug. So you remember, when we went into our programs before, we studied in the NT2 trial up to 18 milligrams. And we have an ability to go higher if we want to. So split dosing, we don't see sort of a safety question as to what's going to determine whether we move to split dosing.

Now obviously, the data will tell us that. When we look at the NT2 data, if we see something unexpected, we'll adapt accordingly. But a priori, we don't anticipate that being a gating factor. What we're really looking for with the split dosing is really a comparison to the once-daily dosing. And in the subset of patients who require additional efficacy in the afternoon, do we see a difference. And if we do see that difference, that's going to add additional flexibility for physicians to provide that dosage option to the patients.

And remember, in our NT2 study, we normalized, I would say, about 70% of the patients on the ESS scale using the once-daily dosing. So we anticipate even in IH that we're going to see a good response on both dosage forms. But we want to have that added flexibility and that added efficacy for patients and that added flexibility that split dosing would provide.

What the second question was what again, sorry?

Ami Fadia

What I was trying to ask is, is there a way to learn from the study as to a priori, which patients may be best suited for a split dosing?

Blair Jackson

Yes. No... So it's interesting. It's a priori. What we don't know when patients come into the study is would you be better on a split dose? Or would you be better on a single dose? And patients, obviously, in our study are going to be randomized randomly into that -- into those categories.

We'll see if we learn anything from this study of whether or not there are any patient characteristics that drive that. I think it would be surprising. I think one of the challenges when you get into NT2 and IH populations is the science underlying the etiology of the disease is a little unclear. And so in many ways, it's hard to -- you can't just use a standard biomarker to say a patient is going to be responsive or nonresponsive or need an afternoon split dose.

So again, we'll learn in the NT2 study. And it may just be that after this study, doctors are going to have to empirically decide to see how their patients respond to the once-daily dose and then move them on to split dose if it's required. But the data will tell us, and we'll adapt from there.

Operator

Our next question comes from Andrea Newkirk with Goldman Sachs.

Unknown Analyst

This is [ Morgan ] on for Andrea Newkirk. For ALKS 7290 in MDD, given antidepressants typically fail to address residual fatigue and anhedonia, what magnitude of difference on MADRS do you consider clinically meaningful for this novel mechanism?

Blair Jackson

Yes. It's interesting that as you look at the MADRS scores and you look at things that are out there, I mean, I think typically, people see a change versus placebo of somewhere between 2 and 5 as being a meaningful difference on MADRS. And in fact, the drug that's out now, AUVELITY, which only had a 3-point change, 3.5 point change or so relative to placebo has strong uptake because it has unique characteristics. And so it has, A, a different mechanism; and B, it has a rapid onset.

And I think as you look at the MDD space, there's a number of areas where you can provide improvement, cognition, anhedonia, fatigue, as you alluded to. And we've seen things like cognition and fatigue benefits in some of our other trials. And so I think you -- I think the goal for us is to be able to show a statistical difference between placebo as part of MADRS, understand the domains of where we see response -- and if we can show something that's different that provides a different -- a broader profile than you see with the SSRIs, SNRIs, I think there's a lot of opportunity there. Because remember, this is adjunctive therapy. About 40% of these patients have an inadequate response. I think there's a lot of room for improvement for these patients.

Operator

Our next question comes from Jason Gerberry with Bank of America.

Unknown Analyst

This is [ Chi ] on for Jason. I have a follow-up on the expectation for Vibrance-3. What do you expect to see from the data for advancing the program to Phase III? Is it driven by whether the study meeting the primary endpoint? And what do you want to see as differentiator relative to our market offerings such as oxybate? Do you want to see sort of magnitude of benefit on ESS or IHSS for the IH study? And just quickly as a follow-up, on your earlier commentary around expecting to see a similar response as in the Vibrance-2 study, is that commentary related to QD dosing in ESS scale as we think about the overlapping elements between Vibrance -2 and Vibrance-3?

Blair Jackson

Yes. I mean there's a lot in your question there. I think as you look at the Vibrance-3 study, as you look at it, obviously, our endpoints are ESS and IHSS. And we want to be able to show a benefit within there. And for us, the Phase II study, remember, is about trying to ensure and understand your signal, just trying to understand your signal relative to your safety profile. And can you design your Phase III trial in order to get over the line, show the statistical significance, show a benefit to those patients.

Obviously, we want to hit statistical significance as part of our Phase II study if we can. If we were to fall a little bit short, does that mean we would stop the program? No. As long as we feel that we have an appropriate signal that trial design would be able to overcome. That being said, when we look at our early treatment within this patient population, remember, we had a once-daily dosing, similar to what we did with the NT2 population. We saw a similar effect size between NT2 and IH.

So our hope is that we see something similar. We hope that we'll provide additional benefit through the split dosing and that we'll be able to then design our Phase III meet with the agency and then move that into our Phase III program. So with regards to my previous comment with regards to Vibrance-2 versus Vibrance-3, what I'm really just trying to say is that there's a lot of heterogeneity in the patient populations, both in NT2 and IH. There's also a lot of overlap between diagnosis.

Patients move between an NT2 diagnosis in an IH diagnosis sometimes frequently. So I would expect that there's an overlap of population there. And that if you have a similar population that the once-daily drug would perform similarly with the caveats that I mentioned earlier that you have this other patient group in there that we're going to be learning about the long sleepers. So again, what I'm hoping is that we've designed the study in a way where we can learn what we need to from this program and move forward quickly into Phase III.

Operator

Our next question comes from Luke Herrmann with Baird.

Luke Herrmann

So just a follow-up on the orexin and oxybate dynamic. Given the view that orexin and oxybates can be complementary by HCPs and that's intuitively sound that they can be complementary. But I guess what is your early thinking on payer dynamics if a set of patients could theoretically be in a position to step up from 1 to 2 branded therapeutics?

Todd Nichols

Yes. Luke, this is Todd. I'll take that. Yes, we're spending a lot of time right now talking to payers overall. As you know, the access profile for oxybates and for LUMRYZ is quite strong at north of 80%. And we don't see that changing over time. There's a significant value to HCPs and to patients. I think a lot will be determined pretty quickly here when we see what the pricing dynamic looks like for the Takeda product overall. As you know, there's a lot that goes into pricing.

And one of the considerations that we will be thinking through is not only just the overall value of alixorexton with a very broad label and how we plan to differentiate, but also making sure we take into consideration what the reimbursement profile looks like. So our expectation is that we will put forward a profile in a pricing dynamic that will allow broad access to both products.

Operator

Our next question comes from Douglas Tsao with H.C. Wainwright.

Douglas Tsao

Just on 7290 into MDD, I was just curious, it sounds like you were looking into the drug's effect on sort of some of the specific domains of the MADRS. I'm just curious, are you looking at things like SHAPS -- because I think there is a rationale to think that orexin could have an effect on anhedonia. And obviously, that's sort of a more refined measure of looking at that specific aspect of the disease.

Blair Jackson

Yes. I mean I think as we move forward in the program, we're going to be looking at a lot of different things. I think for the ongoing study right now, our primary is really on the MADRS. We're really -- yes, are we looking at the individual domains? Of course, we do, but we're designed to look at the overall response overall. So our goal here is to really show whether or not we see an overall effect size, understand the patient population. And then as we move into the next phase of the program, we'll dive deeper into some of the areas that we see.

Operator

Our last question comes from Ben Burnett with Wells Fargo.

Orfeas Sfyrlas

This is Orfeas on for Ben. Congrats on the progress. I had another question on oxybate plus orexin. It is complementary, and we've also heard similar feedback from KOLs. With that in mind, would you remind us of your plans to generate data of an orexin agonist in combination with an oxybate? And if you do run such a study, would your oxybate of choice be LUMRYZ or valiloxybate?

Blair Jackson

And actually, we do want to generate a lot of data with oxybates and orexins together because just like you're hearing, we're hearing from our patients that, that would be a desirable to be able to have a nighttime treatment with an oxybate and a daytime treatment with an orexin. And we want to be able to support that. We want to support patients and doctors in how to use it, how to use it safely and also for payers to support it and show those benefits. That being said, what we want to make sure is that we do those studies as we're further along in the registration program. We don't want to put our core registration program at risk. So it will take a little time, and we will move to that. And of course, we will use LUMRYZ as the comparator. We think that's the dominant drug moving forward, and that's what we'll want to show.

Operator

We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Sandra Coombs for closing comments.

Sandra Coombs

All right. Thanks, everyone, for joining us on the call today. If you have any follow-up questions, please don't hesitate to reach out to us at the company. Thank you.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.