Axsome Therapeutics, Inc. (AXSM): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da inovação farmacêutica, a Axome Therapeutics surge como uma empresa de neurociência pioneira que remodelava como abordamos distúrbios neurológicos complexos. Ao aproveitar estrategicamente uma tela sofisticada do modelo de negócios, essa organização de ponta é pioneira em tratamentos inovadores que prometem transformar o atendimento ao paciente em depressão, ansiedade e tratamento da dor. Sua abordagem única combina pesquisas científicas rigorosas, desenvolvimento terapêutico direcionado e uma estratégia visionária que os posiciona na vanguarda da inovação farmacêutica neurológica.

Axsome Therapeutics, Inc. (AXSM) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa farmacêutica e redes de ensaios clínicos

A Axsome Therapeutics colabora com várias instituições de pesquisa para desenvolvimento de medicamentos e ensaios clínicos.

Parceiro de pesquisa	Foco de colaboração	Ano de parceria
Institutos Nacionais de Saúde (NIH)	Pesquisa de depressão AXS-05	2019
Duke University Medical Center	Coordenação do ensaio clínico	2020

Organizações de fabricação contratada (CMOs)

A Axsome trabalha com CMOs especializados para produção de medicamentos e gerenciamento da cadeia de suprimentos.

• Pathon Pharmaceuticals (Subsidiária Científica Thermo Fisher)
• Lonza Group AG
• Soluções farmacêuticas catalentas

Centros Médicos Acadêmicos para Desenvolvimento de Medicamentos

Centro Médico	Programa de Pesquisa	Estágio de desenvolvimento de medicamentos
Escola de Medicina de Harvard	Pesquisa em neurociência	Pré -clínico
Centro Médico da Universidade de Stanford	Pesquisa de enxaqueca AXS-07	Ensaios clínicos

Parceiros de licenciamento estratégico

A Axsome estabeleceu acordos estratégicos de licenciamento para expandir seu portfólio de medicamentos.

• CORIUM International: Contrato de Licenciamento para Entrega Transdermal AXS-05
• Pharmaceuticals de jazz: colaboração potencial para terapêutica de neurociência

Axsome Therapeutics, Inc. (AXSM) - Modelo de negócios: Atividades -chave

Pesquisa de medicamentos para neurociência e sistema nervoso central

A Axsome Therapeutics se concentra no desenvolvimento de novas terapias para distúrbios do sistema nervoso central (SNC). A partir de 2024, a empresa investiu US $ 45,2 milhões em despesas de pesquisa e desenvolvimento.

Áreas de foco de pesquisa	Status do pipeline atual
Transtorno depressivo maior	3 candidatos a drogas ativas
Agitação de Alzheimer	1 Tratamento aprovado pela FDA (Auvelity)
Narcolepsia	1 composto de estágio clínico

Desenvolvimento e gerenciamento de ensaios clínicos

A Axsome conduz vários ensaios clínicos simultaneamente em várias áreas terapêuticas.

• Ensaios clínicos ativos totais: 7
• Duração média do ensaio clínico: 36 meses
• Investimento total de ensaios clínicos em 2023: US $ 32,7 milhões

Processos de envio e aprovação regulatórios

A empresa navegou com sucesso nas vias regulatórias da FDA para vários candidatos a medicamentos.

Marco regulatório	Número de realizações
FDA novas aplicações de drogas	2
Aprovações da FDA	1 (Auvelity em 2022)

Formulação e inovação de drogas

A Axsome é especializada em mecanismos inovadores de administração de medicamentos e estratégias de reformulação.

• Plataformas proprietárias de entrega de medicamentos: 3
• Pedidos de patente arquivados: 12
• Tamanho da equipe de P&D: 45 pesquisadores

Comercialização de tratamentos farmacêuticos especializados

A empresa se concentra na comercialização de tratamentos do SNC com potencial de mercado significativo.

Produto	Receita anual (2023)	Potencial de mercado
Auvelity	US $ 47,3 milhões	Mercado de Transtornos Depressivos Maiores
AXS-05	US $ 12,6 milhões	Depressão resistente ao tratamento

Axsome Therapeutics, Inc. (AXSM) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa e desenvolvimento de neurociência

A partir do quarto trimestre de 2023, a Axome Therapeutics empregava 133 funcionários em período integral, com aproximadamente 70% dedicados à pesquisa e desenvolvimento.

Categoria de funcionários	Número de funcionários	Percentagem
Total de funcionários	133	100%
Equipe de P&D	93	70%

Portfólio de propriedade intelectual

Axsome mantém 14 patentes concedidas e 24 pedidos de patente pendente em dezembro de 2023.

• Cobertura de patente através das principais formulações de drogas
• Propriedade intelectual protegendo novas tecnologias de tratamento neurológico
• Datas de vencimento da patente que variam de 2030-2040

Dados de ensaios clínicos e insights de pesquisa

Métrica do ensaio clínico	2023 dados
Ensaios clínicos ativos	6
Investimento total de ensaios clínicos	US $ 42,3 milhões

Capital financeiro

Recursos Financeiros a partir do quarto trimestre 2023:

• Caixa e equivalentes em dinheiro: US $ 362,4 milhões
• Despesas totais de pesquisa e desenvolvimento: US $ 184,2 milhões
• Capital de giro: US $ 276,5 milhões

Infraestrutura de pesquisa farmacêutica avançada

Métrica da instalação de pesquisa	2023 Detalhes
Instalações de pesquisa	2 centros de pesquisa primários
Investimento de equipamentos de laboratório	US $ 17,6 milhões
Plataformas de tecnologia de pesquisa	4 plataformas especializadas de pesquisa neurológica

Axsome Therapeutics, Inc. (AXSM) - Modelo de negócios: proposições de valor

Tratamentos inovadores para distúrbios neurológicos complexos

A Axsome Therapeutics se concentra no desenvolvimento de novas soluções farmacêuticas com posicionamento específico de mercado:

Candidato a drogas	Área terapêutica	Mecanismo único	Potencial de mercado
AXS-05	Transtorno depressivo maior	Antagonista do receptor NMDA	Mercado potencial de US $ 7,1 bilhões
AXS-07	Tratamento da enxaqueca	Mecanismo multimodal	Mercado potencial de US $ 4,8 bilhões
AXS-12	Narcolepsia	Inibidor seletivo da recaptação de norepinefrina	Mercado potencial de US $ 1,2 bilhão

Novas soluções farmacêuticas com mecanismo de ação exclusivo

Principais estratégias de desenvolvimento farmacêutico diferenciador:

• Tecnologias proprietárias de formulação de medicamentos
• Abordagens farmacológicas multi-alvo
• Desenvolvimento neurológico avançado de medicamentos

Terapias direcionadas atendendo a necessidades médicas não atendidas

Necessidades médicas não atendidas específicas direcionadas pela Axome Therapeutics:

Condição médica	Necessidade não atendida	Solução AxSa
Depressão resistente ao tratamento	Tratamentos eficazes limitados	AXS-05 com novo mecanismo
Enxaqueca aguda	Necessidade de alívio mais rápido	Formulação AXS-07 de ação rápida

Potenciais tratamentos inovadores

Áreas de foco de desenvolvimento de tratamento inovador:

• Gerenciamento de depressão
• Intervenções de transtorno de ansiedade
• Gerenciamento da dor crônica

Resultados aprimorados do paciente

Medicamento	Eficácia do ensaio clínico	Métricas de melhoria do paciente
AXS-05	Taxa de resposta de 48%	Redução significativa dos sintomas de depressão
AXS-07	62% de alívio da enxaqueca	Início mais rápido da ação

Axsome Therapeutics, Inc. (AXSM) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais de saúde

A Axsome Therapeutics implementa uma abordagem direcionada ao engajamento profissional de saúde:

Método de engajamento	Freqüência	Público -alvo
Apresentações da conferência médica	4-6 Conferências anualmente	Psiquiatras, neurologistas
Consultas clínicas individuais	Aproximadamente 250-300 interações por trimestre	Líderes de opinião -chave

Programas de apoio ao paciente e educação

Estratégias abrangentes de apoio ao paciente incluem:

• Programa de Assistência ao Paciente Auvelyx ™
• Recursos educacionais digitais
• Materiais de apoio à adesão ao tratamento

Equipes de ligação de ciências médicas

Estrutura de ligação científica médica de Axsome:

Composição da equipe	Áreas terapêuticas	Cobertura geográfica
8-10 ligações médicas especializadas	Distúrbios neurológicos, transtorno depressivo maior	Estados Unidos em todo o país

Plataformas de informações de saúde digital

Métricas de engajamento digital:

• Tráfego do site: aproximadamente 35.000 visitantes únicos mensalmente
• Interações portal de médicos online: 2.500 compromissos mensais
• Informações do paciente Downloads: 1.200 mensais

Estratégias de comunicação de tratamento personalizado

Abordagem de comunicação direcionada:

Canal de comunicação	Nível de personalização	Alcançar
Integração eletrônica de registro de saúde	Alto	Mais de 5.000 prestadores de serviços de saúde
Orientação de tratamento personalizada	Médio	Específico para pacientes Auvelyx ™ e Sunosi®

Axsome Therapeutics, Inc. (AXSM) - Modelo de negócios: Canais

Força de vendas direta direcionando neurologistas e psiquiatras

A Axsome Therapeutics mantém uma equipe de vendas especializada de 45 representantes focados em neurologistas e psiquiatras a partir do quarto trimestre 2023. A força de vendas cobre aproximadamente 3.200 médicos de prescrição -chave nos Estados Unidos.

Métrica da força de vendas	2024 dados
Total de representantes de vendas	45
Especialidades do médico -alvo	Neurologistas, psiquiatras
Cobertura geográfica	Estados Unidos (em todo o país)

Apresentações da Conferência de Saúde

Axsome apresentou -se em 12 principais conferências médicas em 2023, incluindo a Reunião Anual da American Psychiatric Association e a American Neurological Association.

Tipo de conferência	Número de apresentações
Conferências psiquiátricas	7
Conferências neurológicas	5

Publicações de revistas médicas

Em 2023, Axome publicou 8 artigos revisados ​​por pares em periódicos como Neuropsicofarmacologia e Jornal de Psiquiatria Clínica.

Plataformas de informações médicas online

• Portal Profissional do WebMD
• Rede de Médicos Medscape
• Banco de dados de pesquisa central do PubMed
• Ensaios clínicos.

Redes de distribuidores farmacêuticos

A Axsome colabora com 3 principais distribuidores farmacêuticos: Amerisourcebergen, Cardinal Health e McKesson Corporation.

Distribuidor	Quota de mercado
Amerisourcebergen	35%
Cardinal Health	30%
McKesson Corporation	35%

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

Neurologistas e profissionais de psiquiatria

A partir do quarto trimestre 2023, a Axsome Therapeutics tem como alvo aproximadamente 52.000 neurologistas licenciados e 48.500 psiquiatras nos Estados Unidos.

Categoria profissional	Número total	Penetração potencial de mercado
Neurologistas	52,000	37% de envolvimento potencial
Psiquiatras	48,500	42% de envolvimento potencial

Pacientes com distúrbios neurológicos resistentes ao tratamento

Demografia da população de pacientes alvo para 2024:

• Transtorno depressivo maior: 16,1 milhões de adultos
• Depressão resistente ao tratamento: 2,8 milhões de pacientes
• Agitação de Alzheimer: 1,5 milhão de pacientes em potencial

Instituições de saúde e hospitais

Tipo de instituição	Número total	Cobertura potencial de mercado
Hospitais psiquiátricos	573	48% de envolvimento potencial
Centros de tratamento de neurologia	1,245	55% de envolvimento potencial

Prestadores de cuidados especializados

Aparelhamento do prestador de cuidados especializados para 2024:

• Clínicas de especialidade neurológica: 2.100
• Centros de tratamento de saúde mental: 3.750
• Instalações de cuidados geriátricos: 4.500

Pesquisadores e médicos farmacêuticos

Categoria de pesquisa	Total de profissionais	Potencial interesse da pesquisa
Pesquisa neurológica	7,800	62% de colaboração potencial
Desenvolvimento de medicamentos psiquiátricos	5,600	55% de colaboração potencial

Axsome Therapeutics, Inc. (AXSM) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, a Axome Therapeutics registrou despesas de P&D de US $ 127,6 milhões. As despesas de P&D da empresa aumentaram de US $ 86,5 milhões em 2021.

Ano	Despesas de P&D ($ M)
2021	86.5
2022	127.6

Investimentos de ensaios clínicos

A Axsome investiu aproximadamente US $ 93,2 milhões em atividades de ensaios clínicos durante 2022, com foco em candidatos a medicamentos-chave como AXS-05, AXS-07 e AXS-14.

Custos de conformidade regulatória

A empresa gastou aproximadamente US $ 15,4 milhões em processos de conformidade e envio regulatórios em 2022.

Despesas de fabricação e produção

Categoria	Despesa ($ m)
Manufatura de sobrecarga	22.7
Equipamento de produção	8.3
Controle de qualidade	5.9

Despesas de vendas e marketing

Para o ano fiscal de 2022, a Axome Therapeutics registrou despesas de vendas e marketing de US $ 41,3 milhões.

• Compensação da força de vendas: US $ 18,6 milhões
• Materiais de marketing: US $ 7,2 milhões
• Eventos promocionais: US $ 5,5 milhões
• Marketing Digital: US $ 10 milhões

Despesas operacionais totais para 2022: US $ 306,2 milhões

Axsome Therapeutics, Inc. (AXSM) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do quarto trimestre 2023, a Axome Therapeutics gerou receita principalmente de:

• Auvelyx (AXS-05) para transtorno depressivo maior: US $ 28,7 milhões em vendas líquidas de produtos para 2023
• Sunosi para sonolência diurna excessiva: US $ 43,2 milhões em vendas líquidas de produtos para 2023

Acordos de licenciamento para tecnologias de medicamentos

Detalhes específicos da receita de licenciamento para 2024:

Tecnologia de drogas	Parceiro de licenciamento	Receita estimada
AXS-05	Corium International	US $ 5,2 milhões
Auvelyx	Acordos colaborativos pendentes	Não divulgado

Pagamentos marcantes de parcerias estratégicas

Possíveis pagamentos em potencial para 2024:

• AXS-07 Milestone de tratamento de enxaqueca de migras: US $ 15 milhões
• AXS-12 Narcolepsy Treatment Potencial Milestone: US $ 10 milhões

Royalties da comercialização de drogas

Receita de royalties Fluxos para 2024:

Medicamento	Porcentagem de royalties	Royalty anual estimada
Sunosi	12-15%	US $ 6,5 milhões
Auvelyx	10-12%	US $ 4,3 milhões

Subsídios de pesquisa e financiamento colaborativo

Pesquise fontes de financiamento para 2024:

• Grant do National Institutes of Health (NIH): US $ 2,1 milhões
• Financiamento da pesquisa do Departamento de Defesa: US $ 1,5 milhão

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.