Axsome Therapeutics, Inc. (AXSM): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la innovación farmacéutica, la terapéutica Axsome surge como una compañía de neurociencia que hace pioneros que reforma la forma en que abordamos los trastornos neurológicos complejos. Al aprovechar estratégicamente un lienzo de modelo de negocio sofisticado, esta organización de vanguardia es pionero en los tratamientos innovadores que prometen transformar la atención del paciente en depresión, ansiedad y manejo del dolor. Su enfoque único combina investigación científica rigurosa, desarrollo terapéutico dirigido y una estrategia visionaria que los posiciona a la vanguardia de la innovación farmacéutica neurológica.

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: asociaciones clave

Instituciones de investigación farmacéutica y redes de ensayos clínicos

Axsome Therapeutics colabora con múltiples instituciones de investigación para el desarrollo de fármacos y ensayos clínicos.

Socio de investigación	Enfoque de colaboración	Año de asociación
Institutos Nacionales de Salud (NIH)	Axs-05 Investigación de depresión	2019
Centro Médico de la Universidad de Duke	Coordinación del ensayo clínico	2020

Organizaciones de fabricación de contratos (CMOS)

Axsome trabaja con CMOS especializados para la producción de medicamentos y la gestión de la cadena de suministro.

• Patheon Pharmaceuticals (Thermo Fisher Scientific Subsidiary)
• Grupo Lonza AG
• Soluciones farmacéuticas catalent

Centros médicos académicos para el desarrollo de medicamentos

Centro médico	Programa de investigación	Etapa de desarrollo de drogas
Escuela de Medicina de Harvard	Investigación de neurociencia	Preclínico
Centro Médico de la Universidad de Stanford	Axs-07 Investigación de migraña	Ensayos clínicos

Socios de licencias estratégicas

Axsome ha establecido acuerdos de licencia estratégica para expandir su cartera de drogas.

• Corium International: Acuerdo de licencia para la entrega transdérmica de AXS-05
• Jazz Pharmaceuticals: colaboración potencial para la neurociencia terapéutica

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: actividades clave

Neurociencia y investigación de drogas del sistema nervioso central

Axsome Therapeutics se centra en desarrollar nuevas terapias para los trastornos del sistema nervioso central (SNC). A partir de 2024, la compañía ha invertido $ 45.2 millones en gastos de investigación y desarrollo.

Áreas de enfoque de investigación	Estado de la tubería actual
Trastorno depresivo mayor	3 candidatos de drogas activas
Agitación de Alzheimer	1 Tratamiento aprobado por la FDA (auvelidad)
Narcolepsia	1 compuesto de etapa clínica

Desarrollo y gestión del ensayo clínico

Axsome realiza múltiples ensayos clínicos simultáneamente en varias áreas terapéuticas.

• Ensayos clínicos activos totales: 7
• Duración promedio del ensayo clínico: 36 meses
• Inversión total de ensayos clínicos en 2023: $ 32.7 millones

Procesos de presentación y aprobación regulatoria

La compañía ha navegado con éxito en las vías regulatorias de la FDA para múltiples candidatos a drogas.

Hito regulatorio	Número de logros
FDA nuevas aplicaciones de drogas	2
Aprobaciones de la FDA	1 (auvelidad en 2022)

Formulación e innovación de drogas

Axsome se especializa en mecanismos innovadores de suministro de medicamentos y estrategias de reformulación.

• Plataformas de suministro de medicamentos patentados: 3
• Solicitudes de patentes presentadas: 12
• Tamaño del equipo de I + D: 45 investigadores

Comercialización de tratamientos farmacéuticos especializados

La compañía se enfoca en comercializar tratamientos del SNC con un potencial de mercado significativo.

Producto	Ingresos anuales (2023)	Potencial de mercado
AUvelidad	$ 47.3 millones	Mercado de trastorno depresivo mayor
Hacha-05	$ 12.6 millones	Depresión resistente al tratamiento

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: recursos clave

Equipo de Investigación y Desarrollo de Neurociencia Especializada

A partir del cuarto trimestre de 2023, Axsome Therapeutics empleó a 133 empleados a tiempo completo, con aproximadamente el 70% dedicado a la investigación y el desarrollo.

Categoría de empleado	Número de empleados	Porcentaje
Total de empleados	133	100%
Equipo de I + D	93	70%

Cartera de propiedades intelectuales

Axsome sostiene 14 patentes otorgadas y 24 solicitudes de patentes pendientes a diciembre de 2023.

• Cobertura de patentes a través de formulaciones clave de drogas
• Propiedad intelectual que protege nuevas tecnologías de tratamiento neurológico
• Fechas de vencimiento de patentes que van desde 2030-2040

Datos de ensayos clínicos e información de investigación

Métrico de ensayo clínico	2023 datos
Ensayos clínicos activos	6
Inversión total en ensayos clínicos	$ 42.3 millones

Capital financiero

Recursos financieros a partir del cuarto trimestre 2023:

• Efectivo y equivalentes de efectivo: $ 362.4 millones
• Gastos totales de investigación y desarrollo: $ 184.2 millones
• Capital de trabajo: $ 276.5 millones

Infraestructura de investigación farmacéutica avanzada

Métrica de Investigación de Instalaciones	2023 detalles
Instalaciones de investigación	2 centros de investigación principales
Inversión en equipos de laboratorio	$ 17.6 millones
Plataformas de tecnología de investigación	4 plataformas de investigación neurológica especializadas

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para trastornos neurológicos complejos

Axsome Therapeutics se centra en desarrollar nuevas soluciones farmacéuticas con posicionamiento específico del mercado:

Candidato a la droga	Área terapéutica	Mecanismo único	Potencial de mercado
Hacha-05	Trastorno depresivo mayor	Antagonista del receptor NMDA	Mercado potencial de $ 7.1 mil millones
Hacha-07	Tratamiento de migraña	Mecanismo multimodal	Mercado potencial de $ 4.8 mil millones
Hacha-12	Narcolepsia	Inhibidor selectivo de la recaptación de noradrenalina	Mercado potencial de $ 1.2 mil millones

Nuevas soluciones farmacéuticas con mecanismo de acción único

Estrategias de desarrollo farmacéutico diferenciador de clave:

• Tecnologías de formulación de drogas patentadas
• Enfoques farmacológicos multi-objetivo
• Desarrollo avanzado de fármacos neurológicos

Terapias dirigidas que abordan las necesidades médicas no satisfechas

Necesidades médicas no satisfechas específicas dirigidas por Axsome Therapeutics:

Condición médica	Necesidad insatisfecha	Solución de eje
Depresión resistente al tratamiento	Tratamientos efectivos limitados	Axs-05 con mecanismo novedoso
Migraña aguda	Necesidad de un alivio más rápido	AXS-07 Formulación de acción rápida

Posibles tratamientos innovadores

Áreas de enfoque de desarrollo de tratamiento innovador:

• Gestión de depresión
• Intervenciones de trastorno de ansiedad
• Manejo del dolor crónico

Resultados mejorados del paciente

Droga	Eficacia del ensayo clínico	Métricas de mejora del paciente
Hacha-05	Tasa de respuesta del 48%	Reducción significativa de los síntomas de depresión
Hacha-07	62% de alivio de migraña	Inicio de acción más rápido

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales de la salud

Axsome Therapeutics implementa un enfoque específico para la participación profesional de la salud:

Método de compromiso	Frecuencia	Público objetivo
Presentaciones de conferencia médica	4-6 conferencias anualmente	Psiquiatras, neurólogos
Consultas clínicas individuales	Aproximadamente 250-300 interacciones por trimestre	Líderes de opinión clave

Programas de apoyo y educación del paciente

Las estrategias integrales de apoyo al paciente incluyen:

• Programa de asistencia al paciente AUVELYX ™
• Recursos educativos digitales
• Materiales de soporte de adherencia al tratamiento

Equipos de enlace de ciencias médicas

Estructura de enlace de ciencia médica de Axsome:

Composición del equipo	Áreas terapéuticas	Cobertura geográfica
8-10 enlaces médicos especializados	Trastornos neurológicos, trastorno depresivo mayor	Estados Unidos en todo el país

Plataformas de información de salud digital

Métricas de compromiso digital:

• Tráfico del sitio web: aproximadamente 35,000 visitantes únicos mensualmente
• Interacciones del portal del médico en línea: 2.500 compromisos mensuales
• Descargas de información del paciente: 1.200 mensuales

Estrategias de comunicación de tratamiento personalizada

Enfoque de comunicación dirigida:

Canal de comunicación	Nivel de personalización	Alcanzar
Integración de registros de salud electrónicos	Alto	Más de 5,000 proveedores de atención médica
Guía de tratamiento personalizado	Medio	Específico de los pacientes con Auvelyx ™ y Sunosi®

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: canales

La fuerza directa de ventas dirigida a neurólogos y psiquiatras

Axsome Therapeutics mantiene un equipo de ventas especializado de 45 representantes centrados en neurólogos y psiquiatras a partir del cuarto trimestre de 2023. La fuerza de ventas cubre aproximadamente 3.200 médicos de prescripción clave en los Estados Unidos.

Métrica de la fuerza de ventas	2024 datos
Representantes de ventas totales	45
Especialidades médicas objetivo	Neurólogos, psiquiatras
Cobertura geográfica	Estados Unidos (a nivel nacional)

Presentaciones de la conferencia de salud

Axsome presentó en 12 conferencias médicas principales en 2023, incluida la Reunión Anual de la Asociación Americana de la Psiquiatría y la Conferencia de la Asociación Americana de Neurológicos.

Tipo de conferencia	Número de presentaciones
Conferencias psiquiátricas	7
Conferencias neurológicas	5

Publicaciones de la revista médica

En 2023, Axsome publicó 8 artículos revisados ​​por pares en revistas como Neuropsicofarmacología y Revista de psiquiatría clínica.

Plataformas de información médica en línea

• Portal profesional webmd
• Medscape Medical Network
• Base de datos de investigación de PubMed Central
• Ensayos clínicos. Plataforma de información degov

Redes de distribuidores farmacéuticos

Axsome colabora con 3 principales distribuidores farmacéuticos: AmerisourceBergen, Cardinal Health y McKesson Corporation.

Distribuidor	Cuota de mercado
AmerisourceBergen	35%
Salud cardinal	30%
McKesson Corporation	35%

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: segmentos de clientes

Neurólogos y profesionales de psiquiatría

A partir del cuarto trimestre de 2023, Axsome Therapeutics se dirige a aproximadamente 52,000 neurólogos con licencia y 48,500 psiquiatras en los Estados Unidos.

Categoría profesional	Número total	Penetración potencial del mercado
Neurólogos	52,000	37% de compromiso potencial
Psiquiatras	48,500	42% de compromiso potencial

Pacientes con trastornos neurológicos resistentes al tratamiento

Demografía de la población de pacientes objetivo para 2024:

• Trastorno depresivo mayor: 16,1 millones de adultos
• Depresión resistente al tratamiento: 2.8 millones de pacientes
• Agitación de Alzheimer: 1.5 millones de pacientes potenciales

Instituciones y hospitales de atención médica

Tipo de institución	Número total	Cobertura de mercado potencial
Hospitales psiquiátricos	573	48% de compromiso potencial
Centros de tratamiento de neurología	1,245	55% de compromiso potencial

Proveedores de atención especializada

Desglose del proveedor de atención especializada para 2024:

• Clínicas de especialidad neurológica: 2,100
• Centros de tratamiento de salud mental: 3.750
• Instalaciones de atención geriátrica: 4.500

Investigadores y médicos farmacéuticos

Categoría de investigación	Total de profesionales	Interés potencial de investigación
Investigación neurológica	7,800	62% de colaboración potencial
Desarrollo de drogas psiquiátricas	5,600	55% de colaboración potencial

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2022, Axsome Therapeutics reportó gastos de I + D de $ 127.6 millones. Los gastos de I + D de la compañía aumentaron de $ 86.5 millones en 2021.

Año	Gastos de I + D ($ M)
2021	86.5
2022	127.6

Inversiones de ensayos clínicos

Axsome invirtió aproximadamente $ 93.2 millones en actividades de ensayos clínicos durante 2022, centrándose en candidatos clave de medicamentos como AXS-05, AXS-07 y AXS-14.

Costos de cumplimiento regulatorio

La compañía gastó aproximadamente $ 15.4 millones en procesos de cumplimiento y presentación regulatorios en 2022.

Gastos de fabricación y producción

Categoría	Gasto ($ M)
Sobrecarga de fabricación	22.7
Equipo de producción	8.3
Control de calidad	5.9

Gastos de ventas y marketing

Para el año fiscal 2022, Axsome Therapeutics reportó gastos de ventas y marketing de $ 41.3 millones.

• Compensación de la fuerza de ventas: $ 18.6 millones
• Materiales de marketing: $ 7.2 millones
• Eventos promocionales: $ 5.5 millones
• Marketing digital: $ 10 millones

Gastos operativos totales para 2022: $ 306.2 millones

Axsome Therapeutics, Inc. (AXSM) - Modelo de negocio: flujos de ingresos

Venta de productos farmacéuticos

A partir del cuarto trimestre de 2023, Axsome Therapeutics generó ingresos principalmente a partir de:

• Auvelyx (AXS-05) para el trastorno depresivo mayor: $ 28.7 millones en ventas netas de productos para 2023
• Sunosi para somnolencia diurna excesiva: $ 43.2 millones en ventas de productos netos para 2023

Acuerdos de licencia para tecnologías de drogas

Detalles específicos de ingresos de licencias para 2024:

Tecnología de drogas	Socio de licencia	Ingresos estimados
Hacha-05	Corium internacional	$ 5.2 millones
Auvelyx	Acuerdos de colaboración pendientes	No revelado

Pagos de hitos de asociaciones estratégicas

Pagos potenciales de hitos para 2024:

• AXS-07 Migraña Potencial de tratamiento Hito: $ 15 millones
• Axs-12 Narcolepsia Potencial de tratamiento Hito: $ 10 millones

Regalías de la comercialización de drogas

Flujos de ingresos de regalías para 2024:

Droga	Porcentaje de regalías	Regalías anuales estimadas
Sunosi	12-15%	$ 6.5 millones
Auvelyx	10-12%	$ 4.3 millones

Subvenciones de investigación y fondos colaborativos

Fuentes de financiación de investigación para 2024:

• Subvención de los Institutos Nacionales de Salud (NIH): $ 2.1 millones
• Financiación del Departamento de Investigación del Departamento de Defensa: $ 1.5 millones

Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Value Propositions

You're looking at the core value Axsome Therapeutics, Inc. is delivering to the market, which is all about offering differentiated, needed treatments for serious Central Nervous System (CNS) disorders. Honestly, the numbers from the third quarter of 2025 really show where the value is landing right now.

Rapid-acting oral treatment for Major Depressive Disorder (Auvelity)

The flagship offering, Auvelity (AXS-05), is clearly the main growth engine. It's positioned as the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the U.S. for Major Depressive Disorder (MDD). This mechanism is a big part of the value proposition for patients who need faster relief than traditional options.

The commercial traction is strong, showing real-world adoption. For the third quarter of 2025, Auvelity pulled in net product sales of $136.1 million. That's a 69% year-over-year jump. We saw 209,000 prescriptions written in that quarter alone, which was a 9% sequential increase. Plus, the total prescriber base has hit 46,000 since launch. Market access is also improving, with commercial coverage now at 75% of patient lives, pushing total coverage to 85%.

Here's a quick look at the commercial momentum:

Metric	Value (Q3 2025)	Context
Net Product Sales	$136.1 million	Primary growth driver for Axsome Therapeutics, Inc.
Prescription Volume	209,000	Reflecting continued demand and prescriber activation.
Total Prescribers (Cumulative)	46,000	Indicates broad physician adoption.
Total Payer Coverage	85% of patient lives	A key driver for patient access.

What this estimate hides is the impact of the expected patent exclusivity until 2039 following the settlement regarding generic entry.

First and only DNRI for excessive daytime sleepiness (Sunosi)

Sunosi (solriamfetol) offers a unique mechanism as the first and only dopamine and norepinephrine reuptake inhibitor (DNRI) approved for excessive daytime sleepiness (EDS) in narcolepsy or obstructive sleep apnea (OSA). This differentiation is key in a market where patients may not respond to older agents.

For the third quarter of 2025, Sunosi contributed $32.8 million in net product revenue, marking a 35% year-over-year increase. Prescription volume was approximately 53,000, up 5% sequentially. Payer coverage remains quite stable and robust at approximately 83% of all lives covered across channels.

Novel mechanism of action for serious CNS disorders (e.g., AXS-05)

Axsome Therapeutics, Inc. is focused on developing products with novel mechanisms to address critical gaps in care. While Auvelity's mechanism is established, the pipeline is built on this principle, aiming for first-in-class or best-in-class potential across several serious conditions. The company estimates a combined peak sales potential exceeding $16 billion across its approved medicines and pipeline programs.

The pipeline itself represents future value propositions:

• Advancing AXS-12 for narcolepsy with an NDA submission anticipated in 4Q 2025.
• Advancing solriamfetol (Sunosi) for MDD with EDS, planning a Phase 3 trial initiation in 4Q 2025.
• Developing AXS-05 (Auvelity) for smoking cessation, with a pivotal Phase 2/3 trial planned for 4Q 2025.

Acute migraine treatment with a differentiated profile (Symbravo)

Symbravo (meloxicam and rizatriptan), approved in January 2025, targets acute migraine with or without aura. Its value is in the combination and rapid absorption technology, MoSEIC, which provides a multi-mechanistic approach. For patients with an inadequate response to oral CGRP inhibitors, the data is compelling.

In a head-to-head trial (EMERGE), 47.9% of patients on Symbravo reported pain freedom within 2 hours, compared to only 1.0% for oral CGRPs (p<0.001). Furthermore, 85% of patients in the INTERCEPT trial did not require rescue medication within 24 hours post dose. Commercially, Symbravo generated net product sales of $2.1 million in its first full commercial quarter (Q3 2025), with more than 5,000 prescriptions written. Payer coverage is still building, sitting at approximately 52% of lives as of October 1, 2025.

Addressing high unmet needs in Alzheimer's agitation and narcolepsy

This is where the near-term pipeline value proposition is most apparent. For Alzheimer's disease agitation, there is only one medicine approved by the FDA, despite over 5 million patients in the U.S. suffering from it. Axsome, Inc. is on track to submit its supplemental New Drug Application (sNDA) for AXS-05 in this indication in the third quarter of 2025.

For narcolepsy, the company is advancing AXS-12, with an anticipated NDA submission in the fourth quarter of 2025. These programs target significant gaps in care, which is defintely why investors are watching the pipeline progress so closely.

Finance: draft 13-week cash view by Friday.

Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Customer Relationships

You're looking at how Axsome Therapeutics, Inc. connects with the healthcare ecosystem to drive adoption for its CNS portfolio, which includes AUVELITY, SUNOSI, and the recently launched SYMBRAVO. The relationship strategy is multi-pronged, focusing heavily on the prescribing physician and the payer gatekeepers.

Dedicated sales force engagement with high-volume prescribers

Axsome Therapeutics, Inc. deploys a specialized sales force to engage directly with prescribers, a critical touchpoint for specialty pharmaceuticals. As of late 2025, the company maintained a dedicated field force focused on its core indications. The selling, general, and administrative expense increased by 57% year-over-year, reflecting significant investment in commercialization activities, including this sales force expansion and the launch of SYMBRAVO. This investment is key to driving prescription volume.

The structure and size of the sales force are calibrated to the product opportunity. For Major Depressive Disorder (MDD) with AUVELITY, the company had roughly 300 reps detailing as of December 2025. There were earlier plans for a 10%-15% increase in the sales force to better cover migraine treaters, especially in primary care settings, ahead of the SYMBRAVO launch. Future expansion is planned upon potential approval for Alzheimer's Disease Agitation (ADA), though the final size will not double the current field force.

Prescriber engagement metrics show traction:

• AUVELITY activated 5,000 new prescribers in Q3 2025, bringing the total to 46,000 since launch.
• SUNOSI added more than 460 new clinicians in Q3 2025, totaling approximately 15,100 since launch.
• The primary care segment for AUVELITY grew to represent one-third of its prescriber base.

Market access negotiations with payers and GPOs

Securing favorable formulary placement is paramount, as it directly impacts patient access and the realized net price. Axsome Therapeutics, Inc. has been aggressive in negotiating with Pharmacy Benefit Managers (PBMs) and Group Purchasing Organizations (GPOs) across its portfolio.

By the third quarter of 2025, AUVELITY achieved total payer coverage across all channels of approximately 85% of covered lives. This includes 100% coverage in the government channel (Medicare and Medicaid) and 75% in the commercial channel (up from 73% sequentially). The company successfully contracted with each of the three largest GPOs for AUVELITY, with the third contract effective August 1, 2025.

For the newer product, SYMBRAVO, overall payer coverage reached approximately 52% of patient lives as of October 1, 2025, with 48% in the commercial channel and 56% in the government channel. Axsome Therapeutics, Inc. also secured a contract with a second large GPO for SYMBRAVO, effective August 1, 2025. SUNOSI maintained approximately 83% payer coverage across all channels.

The realized net price, reflected in the Gross-to-Net (GTN) discount, is a direct outcome of these negotiations. You can see the difference in the GTN profiles below:

Product	Reporting Period (Q3 2025)	Total Payer Coverage (Approx.)	Government Coverage (Approx.)	Commercial Coverage (Approx.)	GTN Discount (Approx.)
AUVELITY	Q3 2025	85% of lives	100% of lives	75% of lives	High 40% range (expected low 50% range in Q4/Q1)
SUNOSI	Q3 2025	83% of lives	Not specified	Not specified	High 40% range (expected low 50% range in next quarter)
SYMBRAVO	As of Oct 1, 2025	52% of lives	56% of lives	48% of lives	Mid-70% range (anticipated to remain elevated)

Patient support and co-pay assistance programs (implied by specialty pharma)

While specific utilization numbers for patient support or co-pay assistance programs weren't explicitly detailed in the latest reports, these programs are an implied necessity for specialty pharma products, especially given the GTN figures and the focus on patient access. The company is actively managing gross-to-net adjustments, which include rebates and discounts often tied to patient access programs. For instance, the AUVELITY GTN improved from the mid-50% range in Q2 to the high 40% range in Q3 2025. Management also mentioned calibrating patient support and patient savings as part of their commercial strategy.

Direct-to-Consumer (DTC) advertising for brand awareness

Axsome Therapeutics, Inc. is using DTC advertising to build brand awareness and drive patient-initiated conversations with their doctors. The SG&A increase of 57% year-over-year was partly attributed to the direct-to-consumer advertising campaign for AUVELITY. The company planned for a national DTC campaign for AUVELITY to be in full execution by the end of Q1 2025, with heavy spending initially to establish brand awareness, continuing through 2026. The overall pharmaceutical industry DTC spend in the U.S. for 2025 was estimated to be a significant portion of a global spend approaching $10 billion.

The DTC investment supports the growth in prescription volume, as seen by the 46% year-over-year increase in AUVELITY prescriptions to 209,000 in Q3 2025. Finance: review the Q4 2025 SG&A spend against the planned DTC intensity by end of year.

Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Channels

You're looking at how Axsome Therapeutics, Inc. gets its products, like AUVELITY, SUNOSI, and the newly launched SYMBRAVO, into the hands of the right prescribers and patients as of late 2025. The channel strategy is clearly multi-pronged, heavily leaning on direct engagement supported by broad access agreements.

Expanded in-house sales force targeting psychiatrists and neurologists

Axsome Therapeutics, Inc. has been actively building out its commercial infrastructure to support its growing portfolio. The investment in this direct channel is significant, as reflected in the financial reporting. Selling, General, and Administrative (SG&A) expenses reached $150.2 million in the third quarter of 2025, marking a 57% year-over-year increase. This rise directly accounts for commercialization efforts for AUVELITY, the sales force expansion, and the launch activities for SYMBRAVO. Management indicated that incremental representatives are planned to support the anticipated launch of a pipeline asset, with final sizing expected in early 2026. The sales force is focused on key prescribers in the major depressive disorder (MDD) and migraine spaces, driving prescription growth across the board.

Digital and traditional Direct-to-Consumer (DTC) media campaigns

To support the in-house efforts, Axsome Therapeutics, Inc. is using both digital and traditional media to drive patient awareness and demand. The SG&A increase in Q3 2025 also covers the direct-to-consumer advertising campaign, which is a key component of the channel strategy for driving patients to ask their doctors about the therapies. This advertising spend is timed to align with periods of high patient flow, as noted by commercial leadership.

Specialty pharmacies and wholesale distributors for drug delivery

The physical movement of the drugs relies on established distribution networks. For SYMBRAVO, which became commercially available in June 2025, the company secured its first group purchasing organization (GPO) contract in the second quarter of 2025. By the third quarter, Axsome Therapeutics, Inc. had contracted with a second large GPO for SYMBRAVO, effective August 1, 2025, to facilitate formulary coverage decisions. For AUVELITY, the channel strength is even more established, with contracts now in place with each of the three largest GPOs, following the signing of the third large GPO contract on August 1, 2025. These agreements are critical for ensuring the products move efficiently through wholesale distributors and specialty pharmacies to reach the patient.

Hospital and headache centers for Symbravo launch

The launch of SYMBRAVO for the acute treatment of migraine required specific targeting of specialists. In its first full commercial quarter (Q3 2025), SYMBRAVO generated $2.1 million in net sales, with over 5,000 prescriptions written. The initial access strategy focused on securing favorable payer coverage, which reached approximately 52% of all lives by October 1, 2025. This coverage breakdown shows 48% in the commercial channel and 56% in the government channel. To support the patient journey through these specialized channels, Axsome Therapeutics, Inc. is offering comprehensive patient support, including the SYMBRAVO On My Side savings program.

Here's a quick look at the access metrics achieved across the commercial channels as of late 2025:

Product	Overall Payer Coverage (Approx. % of Lives)	Commercial Payer Coverage (Approx. % of Lives)	Government Payer Coverage (Approx. % of Lives)	Key GPO Status (As of late 2025)
AUVELITY	85%	75%	100%	Contracted with all 3 largest GPOs
SUNOSI	83%	Not specified	Not specified	Not specified
SYMBRAVO	52% (as of Oct 1)	48%	56%	Contracted with 2 of 3 largest GPOs

The company is also focused on patient support mechanisms to ensure adherence and persistence once a prescription is written:

• Providing educational resources and tools for providers and patients.
• Offering a savings program for eligible SYMBRAVO patients.
• Achieving $136.1 million in AUVELITY net product sales in Q3 2025, supported by its 85% overall coverage.
• SUNOSI maintained approximately 83% coverage across channels.

Finance: draft 13-week cash view by Friday.

Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Customer Segments

You're hiring before product-market fit is fully established across all indications, so knowing exactly who you are selling to-and the size of that pool-is critical for resource allocation. Here's the quick math on Axsome Therapeutics, Inc. (AXSM)'s key customer segments as of late 2025, based on their marketed products and late-stage pipeline targets.

US patients with Major Depressive Disorder (MDD)

The primary target for AUVELITY is US patients with Major Depressive Disorder (MDD). The National Institute of Mental Health (NIMH) estimates that about 8.3% of American adults have MDD each year, equating to approximately 21 million adults in the U.S.. Axsome Therapeutics, Inc. (AXSM) is specifically targeting the segment of this population that may not respond adequately to first-line treatments, including those with co-occurring severe Excessive Daytime Sleepiness (EDS), which affects approximately 50 percent of MDD patients. In the third quarter of 2025, 209,000 prescriptions were written for AUVELITY.

US patients with excessive daytime sleepiness (EDS) from narcolepsy or OSA

SUNOSI targets patients suffering from EDS associated with narcolepsy or Obstructive Sleep Apnea (OSA). Narcolepsy alone is estimated to affect approximately 185,000 individuals in the U.S.. Axsome Therapeutics, Inc. (AXSM) notes that its entire portfolio of potentially first-in-class or best-in-class medicines has the potential to address serious conditions that affect more than 150 million people in the United States alone. In the third quarter of 2025, approximately 53,000 prescriptions were written for SUNOSI.

US patients suffering from acute migraine attacks

The customer base for SYMBRAVO includes US adults suffering from acute migraine attacks with or without aura. The US migraine treatment market was valued at USD 3.46 billion in 2025. Within this market, oral triptans, a class that SYMBRAVO is compared against, accounted for an estimated 48.90% revenue share in 2025. SYMBRAVO generated $2.1 million in net sales in its first full quarter of commercial launch in the third quarter of 2025.

Neurologists and psychiatrists who prescribe CNS medications

The professional customer segment consists of the clinicians who write the prescriptions. As of the third quarter of 2025, the total number of unique prescribers for AUVELITY reached 46,000 since its launch. For SUNOSI, the total cumulative prescriber base reached approximately 15,100 since launch, with more than 460 new clinicians prescribing in Q3 2025. A notable point is that approximately 1/3 of AUVELITY prescribers are primary care clinicians, whose NBRxs increased by approximately 50% since the sales force expansion.

Here is a summary of the key customer-facing metrics for the marketed products as of Q3 2025:

Product	Indication Focus	Q3 2025 Prescriptions (Volume)	Total Unique Prescribers (Cumulative)	Payer Coverage (Approximate)
AUVELITY	Major Depressive Disorder (MDD)	209,000	46,000 (Total Unique Prescribers)	Increased from 73% (prior period)
SUNOSI	EDS (Narcolepsy/OSA)	Approx. 53,000	Approx. 15,100 (Total Cumulative)	Approx. 83% of patient lives
SYMBRAVO	Acute Migraine	Approx. 5,000 (First full quarter)	Not explicitly stated for SYMBRAVO	Approx. 52% across all channels

Future: Patients with Alzheimer's disease agitation and narcolepsy cataplexy

Axsome Therapeutics, Inc. (AXSM) is targeting significant future segments with pipeline assets. AXS-05 is being developed for Alzheimer's disease (AD) agitation, a condition affecting up to 70% of the approximately 7 million people with AD in the U.S.. The company planned to submit the supplemental New Drug Application (sNDA) for AXS-05 in the third quarter of 2025. For narcolepsy, AXS-12 targets cataplexy, which is seen in an estimated 70% of people living with narcolepsy. The New Drug Application (NDA) submission for AXS-12 for cataplexy was targeted for the fourth quarter of 2025.

The potential future patient pool for these two indications represents a substantial opportunity, as shown below:

• US Patients with Alzheimer's Disease Agitation: Up to 70% of 7 million people with AD.
• US Patients with Narcolepsy Cataplexy: Up to 70% of the estimated 185,000 people with Narcolepsy.
• MDD patients with EDS targeted for a Phase 3 trial with solriamfetol.

Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Cost Structure

You're looking at the expense side of Axsome Therapeutics, Inc. as they scale up commercial operations, and the numbers definitely reflect that transition. The cost structure is heavily weighted toward getting their marketed products, like AUVELITY and the newly launched SYMBRAVO, into the hands of physicians and patients.

The Selling, General, and Administrative (SG&A) expenses are the largest component here, hitting $150.2 million for the third quarter of 2025. That's a significant 57% increase compared to the same period last year, showing the investment required to support a growing, multi-product commercial footprint.

Next up is the Research and Development (R&D) investment, which stood at $40.2 million in Q3 2025. Interestingly, this figure actually represented an 11% decrease year-over-year, largely because some clinical trials, specifically for solriamfetol in ADHD and MDD, were completed during the period.

The direct costs associated with generating sales, the Costs of Revenue (COGS) for marketed products, were $11.9 million in Q3 2025. This is up from $8.4 million in Q3 2024, which tracks with the increased sales volume from AUVELITY, SUNOSI, and the initial sales from SYMBRAVO.

Here's a quick look at those core operating expenses for the third quarter of 2025:

Cost Category	Q3 2025 Amount (Millions USD)	Year-over-Year Change
Selling, General, and Administrative (SG&A)	$150.2	Increased 57%
Research and Development (R&D)	$40.2	Decreased 11%
Costs of Revenue (COGS)	$11.9	Increased

The jump in SG&A is directly tied to the commercial build-out you'd expect from a growing pharma company. You have to fund the boots on the ground and the awareness campaigns. Specifically, the cost drivers for that SG&A surge include:

• Intensified commercialization activities for AUVELITY.
• Expansion of the sales force headcount.
• The launch of the direct-to-consumer (DTC) advertising campaign in September 2025.
• Commercial launch activities for the new product, SYMBRAVO, which had its first full quarter of sales in Q3 2025.

On the R&D side, while the overall spend decreased, that's not an indication of slowing pipeline focus; it's a reflection of hitting milestones. The investment is shifting based on the development stage of their assets. The R&D spend is supporting:

• Advancing multiple late-stage programs.
• Two New Drug Application (NDA) stage programs.
• Multiple registrational trials underway or initiating across neurology and psychiatry.
• Costs related to AXS-07, partially offsetting the savings from completed trials.

To be fair, managing this cost structure while funding the pipeline is the core challenge; the company ended the quarter with $325.3 million in cash and cash equivalents, which management stated is sufficient to fund operations into cash flow positivity based on the current operating plan.

Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Revenue Streams

You're looking at the core money-making engine for Axsome Therapeutics, Inc. as of late 2025. This is where the revenue actually comes from, primarily driven by their growing portfolio of central nervous system (CNS) medicines. The numbers below reflect the strong commercial execution seen through the third quarter of 2025.

The total net product revenue for the third quarter of 2025 reached $171.0 million, marking a 63% year-over-year growth compared to $104.8 million in Q3 2024. Also, the year-to-date net product revenue as of September 30, 2025, stood at $442.5 million, which was a 66% increase versus the same period in 2024. That's serious momentum.

Here is the breakdown of the primary revenue sources for the third quarter of 2025:

Revenue Source	Q3 2025 Amount (Millions USD)	Notes
Net product sales from Auvelity	$136.1 million	Flagship product for major depressive disorder.
Net product sales from Sunosi	$31.6 million	Sales component of total Sunosi net product revenue.
Net product sales from Symbravo	$2.1 million	Generated in its first full quarter of commercialization.
Royalty revenue from out-licensed Sunosi sales	$1.2 million	Revenue from Sunosi sales in out-licensed territories.

The total net product revenue for Sunosi in Q3 2025 was $32.8 million ($31.6 million sales + $1.2 million royalty). The gross-to-net discounts for both Auvelity and Sunosi were in the high 40% range for the quarter.

Looking ahead, the financial expectations for the full year 2025 are quite strong based on the early performance. You should note the following projection:

• Full-year 2025 total net product revenue projected near $631.6 million.

This projection suggests that Axsome Therapeutics, Inc. is on track to significantly increase its annual revenue base, building on the strong quarter where Auvelity sales alone were up 69% year-over-year. Finance: draft 13-week cash view by Friday.