Catalyst Pharmaceuticals, Inc. (CPRX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na intrincada paisagem da inovação farmacêutica, a Catalyst Pharmaceuticals, Inc. (CPRX) surge como um farol de esperança para pacientes que combatem distúrbios neurológicos raros. Ao criar meticulosamente um modelo de negócios dinâmico que preenche a pesquisa de ponta, parcerias estratégicas e soluções centradas no paciente, a empresa se posicionou como uma força transformadora no atendimento de necessidades médicas não atendidas. Sua abordagem abrangente para o desenvolvimento de medicamentos - distribuindo da criação da propriedade intelectual a intervenções terapêuticas direcionadas - representa um plano sofisticado para enfrentar desafios médicos complexos com precisão e compaixão.

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negócios: Parcerias -chave

Colaboração com instituições de pesquisa médica

A Catalyst Pharmaceuticals estabeleceu parcerias com as seguintes instituições de pesquisa:

Instituição	Área de foco	Detalhes da parceria
Universidade de Miami	Distúrbios neurológicos raros	Colaboração de pesquisa para a síndrome miostênica de Lambert-Eaton (LEMS)
Universidade Johns Hopkins	Pesquisa clínica	Apoio aos ensaios clínicos para o desenvolvimento do Firdaps®

Parcerias estratégicas com prestadores de serviços de saúde

Principais parcerias dos prestadores de serviços de saúde incluem:

• Centros de neurologia da América - Rede de distribuição de tratamento
• Centros de tratamento de doenças raras - Programas de acesso ao paciente
• Sociedade Nacional de Esclerose Múltipla - Colaboração de Apoio ao Paciente

Acordos de licenciamento com fabricantes farmacêuticos

Fabricante	Produto	Termos de licenciamento
Jacobus Pharmaceutical	Firdaps®	Direitos de comercialização norte -americanos exclusivos

Parcerias de rede de ensaios clínicos

A Catalyst Pharmaceuticals colabora com várias redes de ensaios clínicos:

• Nord (Organização Nacional para Distúrbios Raros)
• Rede de ensaios clínicos raros
• Consórcio Internacional de Ensaios Clínicos

Consultores de conformidade regulatória

Empresa de consultoria	Especialidade	Serviços prestados
Parexel International	Assuntos regulatórios	Submissão da FDA e suporte de conformidade
Icon plc	Conformidade da pesquisa clínica	Estratégia e documentação regulatória

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negócios: Atividades -chave

Desenvolvimento de medicamentos para doenças raras

Os farmacêuticos catalisadores se concentram no desenvolvimento de terapias para doenças neurológicas raras. A partir de 2024, a empresa tem 1 medicamento aprovado pela FDA (Firdaps) para a síndrome miostênica de Lambert-Eaton (LEMS).

Foco na droga	Área terapêutica	Status atual
Firdapso	Distúrbios neurológicos	FDA aprovado
CP-688	Epilepsia pediátrica rara	Desenvolvimento Clínico

Gerenciamento de ensaios clínicos

A empresa gerencia ativamente vários programas de ensaios clínicos com um orçamento anual de desenvolvimento clínico de aproximadamente US $ 35-40 milhões.

• Ensaios clínicos ativos em 3-4 indicações neurológicas raras
• Duração média do ensaio clínico: 2-3 anos
• Investimento típico de ensaio clínico: US $ 10-15 milhões por programa

Processos de aprovação regulatória

Catalyst Pharmaceuticals demonstrou experiência na navegação de paisagens regulatórias complexas, com Taxa de sucesso de 100% nas interações FDA para o Firdaps.

Marco regulatório	Data	Resultado
Aprovação do NDA de Firdaps	Novembro de 2018	Bem-sucedido
Designação rara de doença pediátrica	2022	Garantido

Supervisão de fabricação de medicamentos

A Companhia utiliza organizações de fabricação de contratos (CMOs) com despesas anuais estimadas de fabricação de US $ 15-20 milhões.

• Orçamento de controle de qualidade: US $ 3-5 milhões anualmente
• Capacidade de fabricação: 50.000 a 100.000 unidades de tratamento por ano

Pesquisa de mercado e estratégias de comercialização

Catalyst Pharmaceuticals aloca aproximadamente US $ 25 milhões anualmente para os esforços de marketing e comercialização.

Foco de marketing	Público -alvo	Investimento anual
Especialistas neurológicos raros	Neurologistas, centros neuromusculares	US $ 12-15 milhões
Programas de conscientização sobre pacientes	Lems Comunidade de pacientes	US $ 5-7 milhões

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negócios: Recursos -chave

Portfólio de propriedade intelectual

A partir de 2024, os produtos farmacêuticos catalisadores 5 patentes ativas Relacionado a tratamentos de doenças raras, especificamente distúrbios neurológicos.

Tipo de patente	Número de patentes	Ano de validade
Patentes relacionadas a Firdaps (Amifampridina)	3	2029-2032
Patentes de tratamento de doenças raras	2	2030-2033

Equipe de pesquisa científica especializada

A Catalyst Pharmaceuticals emprega 42 cientistas de pesquisa a partir de 2024.

• Ph.D. Pesquisadores de nível: 28
• Pesquisadores de MD: 7
• Associados de pesquisa: 7

Instalações avançadas de pesquisa farmacêutica

Investimento total da instalação de pesquisa: US $ 12,3 milhões em 2023.

Localização da instalação	Tamanho (Sq. Ft.)	Foco na pesquisa
Coral Gables, Flórida	22,000	Distúrbios neurológicos

Capital financeiro para o desenvolvimento de medicamentos

Despesas de pesquisa e desenvolvimento em 2023: US $ 54,7 milhões.

Fonte de capital	Quantia	Percentagem
Reservas de caixa da empresa	US $ 32,4 milhões	59.2%
Financiamento externo	US $ 22,3 milhões	40.8%

Tecnologias proprietárias de formulação de medicamentos

Tecnologias de medicamentos proprietários atuais: 3 plataformas de formulação exclusivas.

• Sistema de administração de medicamentos para transtorno neurológico
• Plataforma de modificação de tratamento de doenças raras
• Tecnologia de medicamentos de liberação estendida

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negócios: proposições de valor

Tratamentos inovadores para distúrbios neurológicos raros

Os produtos farmacêuticos catalisadores se concentram no desenvolvimento de terapias para distúrbios neurológicos raros, direcionando especificamente a síndrome miastenica de Lambert-Eaton (LEMS).

Produto	Indicação	Aprovação da FDA	Potencial de mercado
Firdapso	Tratamento de Lems	Novembro de 2018	Mercado anual estimado em US $ 300 milhões

Terapias direcionadas atendendo a necessidades médicas não atendidas

O foco estratégico do catalisador em condições neurológicas raras aborda lacunas críticas de tratamento.

• Prevalência de doenças raras: aproximadamente 7.000 doenças raras conhecidas
• População estimada de pacientes para LEMS: 400-500 Pacientes diagnosticados nos Estados Unidos
• Opções de tratamento alternativas limitadas para condições neurológicas específicas

Melhores resultados dos pacientes para populações específicas de pacientes

Métrica clínica	Desempenho de firgapse
Melhoria da força muscular	Até 50% de melhoria na curta distância
Melhoramento da qualidade de vida	Redução significativa de sintomas relatados pelo paciente

Soluções terapêuticas econômicas

A estratégia de preços do Catalyst se concentra nos preços sustentáveis ​​para tratamentos especializados.

• Custo anual de tratamento de Firdaps: aproximadamente US $ 150.000 por paciente
• Cobertura de seguro potencial para tratamentos de doenças raras
• Designação de medicamentos órfãos que fornecem exclusividade do mercado

Qualidade de vida aprimorada para pacientes com condições raras

A abordagem terapêutica do catalisador afeta diretamente a mobilidade do paciente e o funcionamento diário.

Métrica de impacto do paciente	Resultado quantitativo
Melhoria da mobilidade	Aumento de 30 a 40% nas pontuações de mobilidade dos pacientes
Satisfação do tratamento	85% do paciente relataram experiência de tratamento positivo

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto do médico

Os produtos farmacêuticos catalisadores mantêm o envolvimento direto com neurologistas e especialistas em doenças raras por meio de comunicações médicas direcionadas.

Método de engajamento	Freqüência	Especialistas -alvo
Apresentações da conferência médica	4-6 por ano	Neurologistas
Consultas clínicas individuais	Trimestral	Especialistas em doenças raras
Simpósios médicos digitais	2-3 por ano	Especialistas neuromusculares de transtorno

Programas de apoio ao paciente

Programas abrangentes de assistência ao paciente focados em tratamentos raros de transtorno neurológico.

• Assistência financeira para pacientes com fintepla e ruzurgi
• Suporte de navegação de seguros
• Programas de acesso a medicamentos
• Iniciativas de assistência à copay

Iniciativas de educação médica

Recursos educacionais direcionados para profissionais de saúde especializados em condições neurológicas raras.

Plataforma educacional	Alcance anual	Tipo de conteúdo
Módulos de treinamento clínico online	500 mais de profissionais de saúde	Gerenciamento de doenças raras
Série de webinar	250 mais de participantes	Atualizações do protocolo de tratamento

Recursos on -line do paciente

Plataformas digitais que fornecem informações abrangentes sobre distúrbios e tratamentos neurológicos raros.

• Site de Informação do Paciente dedicada
• Ferramentas de rastreamento de sintomas digitais
• Fóruns de suporte comunitário online
• Aplicativo móvel para gerenciamento de tratamento

Serviços de consulta de tratamento personalizado

Suporte clínico individualizado para pacientes com condições neurológicas raras.

Tipo de consulta	Disponibilidade de serviço	Foco de apoio ao paciente
Referências de aconselhamento genético	Coordenação 24/7	Síndrome miastenica de Lambert-Eaton
Orientação da via de tratamento	Abordagem personalizada	Gerenciamento de epilepsia pediátrica

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de Negócios: Canais

Vendas diretas para profissionais de saúde

A Catalyst Pharmaceuticals mantém uma equipe de vendas especializada direcionada a neurologistas e especialistas em doenças raras. A partir do quarto trimestre de 2023, a empresa empregou 35 representantes de vendas diretas focadas na promoção do FIRDAPHSE (Amifampridina) para a síndrome miastênica de Lambert-Eaton (LEMS).

Canal de vendas	Número de representantes	Especialistas -alvo
Vendas diretas de neurologia	35	Neurologistas, especialistas em doenças raras

Distribuidores farmacêuticos especializados

A Catalyst faz parceria com os principais distribuidores farmacêuticos para garantir ampla disponibilidade de produtos.

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Distribuidor	Quota de mercado	Cobertura de distribuição
Amerisourcebergen	35%	Nacional
Cardinal Health	30%	Nacional
McKesson Corporation	25%	Nacional

Apresentações da conferência médica

Em 2023, o Catalyst participou de 12 conferências médicas, apresentando dados clínicos e resultados da pesquisa.

Tipo de conferência	Número de conferências	Retenção dos participantes
Conferências de neurologia	8	5.600 profissionais de saúde
Simpósios de doenças raras	4	2.300 profissionais de saúde

Plataformas de marketing digital

O Catalyst utiliza estratégias de marketing digital direcionadas em várias plataformas on -line.

• Rede Profissional do LinkedIn
• Medscape
• Portal Profissional do WebMD

Plataforma digital	Impressões mensais	Taxa de engajamento
LinkedIn	125,000	3.2%
Medscape	85,000	2.7%

Redes de comunicação profissional de saúde

O Catalyst mantém canais de comunicação direta com os principais líderes de opinião e especialistas.

• Comunicações de email personalizadas
• Série de webinar trimestral
• Newsletter médico direcionado

Canal de comunicação	Alcance trimestral	Taxa de resposta
Comunicações por e -mail	2.500 especialistas	14%
Quartos on -line trimestrais	1.200 participantes	22%

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negócios: segmentos de clientes

Pacientes com transtorno neurológico

Os produtos farmacêuticos catalisadores se concentram em pacientes com distúrbios neurológicos raros, direcionando especificamente a síndrome miostênica de Lambert-Eaton (LEMS) e a síndrome miastênica congênita (CMS).

Características do segmento de pacientes	Dados de prevalência
População de pacientes em LEMS	Aproximadamente 400-500 pacientes diagnosticados nos Estados Unidos
População de pacientes com CMS	Estimado 1.200-1.500 pacientes diagnosticados nos Estados Unidos

Especialistas em doenças raras

O catalisador tem como alvo neurologistas e especialistas que se concentram em distúrbios neuromusculares raros.

• Aproximadamente 2.500 neurologistas especializados em condições neuromusculares raras
• Alvo primário: Especialistas em clínicas neuromusculares em principais centros médicos acadêmicos

Praticantes de neurologia pediátrica

Segmento especializado para pacientes pediátricos com condições neurológicas raras.

Segmento de neurologia pediátrica	Dados estatísticos
Neurologistas pediátricos em nós	1.200 especialistas certificados pela placa
Potencial mercado de pacientes pediátricos	Aproximadamente 800-1.000 crianças com distúrbios neuromusculares raros

Sistemas hospitalares

O catalisador tem como alvo neurologia especializada e centros de tratamento de doenças raras.

• 50 principais centros de tratamento de neurologia Nos Estados Unidos
• Unidades especializadas de tratamento de doenças raras em centros médicos acadêmicos

Instituições de pesquisa

Abordagem colaborativa com centros de pesquisa que estudam distúrbios neurológicos raros.

Tipo de instituição de pesquisa	Número de potenciais colaboradores
Centros de pesquisa acadêmica	37 Principais instituições de pesquisa em neurociência
Fundamentos de pesquisa de doenças raras	24 organizações de pesquisa especializadas

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Catalyst Pharmaceuticals relatou despesas de P&D totalizando US $ 37,4 milhões.

Ano	Despesas de P&D
2022	US $ 33,2 milhões
2023	US $ 37,4 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para produtos farmacêuticos de catalisadores em 2023 foram de aproximadamente US $ 22,1 milhões.

• Foco primário em tratamentos raros de transtorno neurológico
• Ensaios em andamento para Firdaps e potenciais novos candidatos terapêuticos

Custos de conformidade regulatória

Os gastos com conformidade regulatória para 2023 foram estimados em US $ 5,6 milhões.

Categoria de conformidade	Custo anual
Taxas de envio da FDA	US $ 2,3 milhões
Garantia de qualidade	US $ 1,8 milhão
Documentação regulatória	US $ 1,5 milhão

Infraestrutura de fabricação

Os investimentos em infraestrutura de fabricação em 2023 totalizaram US $ 15,7 milhões.

• Manutenção do equipamento
• Atualizações da instalação de produção
• Sistemas de controle de qualidade

Despesas de marketing e vendas

Os custos de marketing e vendas para 2023 foram de US $ 28,3 milhões.

Categoria de despesa de marketing	Quantia
Força de vendas	US $ 16,5 milhões
Materiais promocionais	US $ 6,2 milhões
Marketing digital	US $ 5,6 milhões

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negócios: fluxos de receita

Vendas de medicamentos prescritos

Para o ano fiscal de 2023, a Catalyst Pharmaceuticals relatou receita total de US $ 418,3 milhões, principalmente das vendas do Firdaps® (Amifampridina) para a síndrome miostênica de Lambert-Eaton (LEMS).

Produto	Receita anual (2023)
Firdaps®	US $ 418,3 milhões

Acordos de licenciamento

A Catalyst Pharmaceuticals possui acordos de licenciamento estratégico para o desenvolvimento farmacêutico.

• Colaboração com Jacobus Pharmaceutical for Firdaps® Development
• Direitos de licenciamento exclusivos para fosfato de amifampridina

Subsídios de pesquisa do governo

O Catalyst recebeu apoio e subsídios de pesquisa, embora valores em dólares específicos para 2024 não sejam divulgados publicamente.

Parcerias de produtos farmacêuticos

A empresa possui parcerias em andamento para desenvolvimento e comercialização de medicamentos.

Tipo de parceria	Descrição
Colaboração de pesquisa	Desenvolvimento de drogas neurológico em andamento

Reembolso de seguros

O Firdaps® é coberto pelos principais provedores de seguros, contribuindo para os fluxos de receita.

• Cobertura do Medicare para pacientes elegíveis
• Mecanismos de reembolso de seguro privado

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Value Propositions

The value propositions for Catalyst Pharmaceuticals, Inc. center on providing specialized, approved treatments for rare, chronic, and debilitating neuromuscular and neurological diseases, supported by robust patient access infrastructure.

FIRDAPSE: Only FDA-approved treatment for Lambert-Eaton Myasthenic Syndrome (LEMS)

• FIRDAPSE generated net product revenue of $92.2 million in Q3 2025, a 16.2% increase over Q3 2024 net product revenue.
• First-half 2025 net product revenue for FIRDAPSE was $168.6 million, representing a 16.9% increase year-over-year.
• Full-year 2025 net product revenue guidance for FIRDAPSE is reaffirmed between $355 million and $360 million.
• Orphan exclusivity ended in November 2025, but method-of-use and dosing patents extend to 2037.
• A patent settlement with Teva/Lupin effectively blocks generic entry until February 2035.
• Catalyst Pharmaceuticals estimates the total U.S. adult LEMS patient population at 3,000, with approximately 1,500 definitively identified in claims data as the immediate addressable market.

AGAMREE: Differentiated, novel corticosteroid for Duchenne Muscular Dystrophy (DMD)

• AGAMREE achieved net product revenue of $32.4 million in Q3 2025, rising 115% Year/Year.
• Q2 2025 net product revenue was $27.4 million, up 212.9% year-over-year since its mid-March 2024 launch.
• First-half 2025 net product revenue for AGAMREE was $49.4 million, a 398.0% increase year-over-year.
• Full-year 2025 net product revenue guidance for AGAMREE was raised to between $105 million and $115 million.
• Management stated that all top 45 DMD centers have at least one AGAMREE patient.

FYCOMPA: Established anti-epileptic drug for partial-onset and primary generalized seizures

• FYCOMPA Q3 2025 net product revenue was $23.8 million, a 25.8% decrease compared to Q3 2024 net product revenue.
• Q2 2025 net product revenue was $34.3 million, reflecting a 6.0% year-over-year decrease due to generic entry.
• Full-year 2025 net product revenue guidance for FYCOMPA was raised to between $100 million and $110 million.
• Exclusivity protection for tablets expired on May 23, 2025, with oral suspension exclusivity set to expire on December 15, 2025.

Treatment options for chronic, debilitating neuromuscular and neurological rare diseases

The portfolio delivers multiple therapies across distinct rare disease areas, contributing to overall company performance:

Metric	Q3 2025 Amount	Year-over-Year Change (Q3)	Full-Year 2025 Guidance Range
Total Product Revenue, Net	$148.4 million	17.4% increase	$565 million to $585 million (Total Revenue)
FIRDAPSE Net Product Revenue	$92.2 million	16.2% increase	$355 million to $360 million
AGAMREE Net Product Revenue	$32.4 million	More than doubled	$105 million to $115 million
FYCOMPA Net Product Revenue	$23.8 million	25.8% decrease	$100 million to $110 million

Comprehensive patient access and financial support via Catalyst Pathways®

Catalyst Pathways® offers multiple layers of support to ensure patients can access and afford their medication:

• Catalyst Copay Assistance: Lowers out-of-pocket costs to $0/month for patients with commercial insurance.
• Catalyst Bridge Program: Offers up to 60 days of free medication if insurance coverage verification is delayed.
• Patient Assistance Program (PAP): Provides free medicine to those who qualify based on financial and other program-specific criteria.
• The program can direct patients to nonprofit organizations for Third-Party Foundation Assistance to help pay for care costs.
• The program was last updated on 09/12/2025.
• For assistance or information, the dedicated line is 1-833-422-8259, available Monday to Friday, 7AM to 7PM CT.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Customer Relationships

You're looking at how Catalyst Pharmaceuticals, Inc. keeps its specialized patient base engaged and on therapy. It's all about high-touch support, especially for rare disease treatments where the journey from diagnosis to effective dose can be tough.

High-touch, dedicated support through the Catalyst Pathways® program

The Catalyst Pathways® program is the single source for personalized treatment support for FIRDAPSE®. This service guides patients through the tricky dosing and titration regimen until they reach an effective therapeutic dose. It's also the access point for the free bridge medication for patients transitioning or facing insurer complications. Catalyst Pharmaceuticals believes this program enhances access and contributes to medication compliance and persistence. The distribution model uses a very small group of exclusive specialty pharmacies, which is standard for ultra-orphan disease products, aiming to make navigating the healthcare system easier for the patient community.

Specialized field teams for physician and center of excellence engagement

Catalyst Pharmaceuticals strategically refined its commercial outreach in early 2025 by splitting its field-based force into two distinct units. One unit focuses expressly on the marketing of FIRDAPSE®, and the other is expressly focused on the marketing of AGAMREE®. This division allows for better focus on the specific market dynamics of each product. For AGAMREE®, the company is focused on securing uptake in Duchenne muscular dystrophy (DMD) centers of excellence, with Q3 2025 net product revenue reaching $32.4 million.

Direct-to-patient and direct-to-physician educational outreach (e.g., NCCN guidelines)

Physician education is closely tied to clinical guidelines, which drive physician behavior in complex fields like oncology. Catalyst's approach included efforts to update the NCCN guidelines, which is a key part of the education opportunity paired with changes in care pathways. The company also continues to make available at no-cost a LEMS voltage gated calcium channel antibody diagnostic testing program for physicians suspecting LEMS.

Maintaining high prescription approval rates, consistently above 90%

While the exact approval rate for late 2025 isn't explicitly stated as a single figure in the latest reports, the focus on the Catalyst Pathways® program and bridge medication suggests a strong commitment to overcoming payer hurdles. The company's overall financial performance reflects strong product uptake. For example, FIRDAPSE® net product revenue in Q3 2025 was $92.2 million, reflecting sustained organic growth from new patients and enhanced dosing.

Long-term patient adherence focus to ensure persistence (discontinuation rate below 20% annualized)

Ensuring patients stay on therapy is critical, and the Catalyst Pathways® program is explicitly linked to compliance and persistence. A concrete metric reflecting patient continuation for AGAMREE® shows a retention rate of 85% when sourcing patients from existing corticosteroid users. This focus on persistence contributes to the overall revenue picture, with Catalyst raising its full-year 2025 total revenue guidance to between $565 million and $585 million.

Here's a quick look at the revenue performance that underpins the commercial relationship success through Q3 2025:

Product	Q3 2025 Net Product Revenue	FY 2025 Guidance Range (Total Revenue)
FIRDAPSE®	$92.2 million	$355 million to $360 million (Product Revenue Guidance)
AGAMREE®	$32.4 million	$100 million to $110 million (Product Revenue Guidance)
Total Net Product Revenue (Implied)	$148.4 million (Total Revenue Q3 2025)	$565 million to $585 million (Total Revenue Guidance)

The commitment to patient support is further demonstrated by the resources allocated to the commercial structure:

• Commercial field-based force split into two units by early Q2 2025.
• AGAMREE® patient sourcing strategy targets a retention rate of 85%.
• FIRDAPSE® patent protection extends until February 2035.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Channels

You're looking at how Catalyst Pharmaceuticals, Inc. (CPRX) gets its specialized, high-cost medicines from the lab bench to the patient's bedside in late 2025. It's a focused approach, built around rare disease specialists and direct support.

The primary mechanism for delivering its portfolio, which includes FIRDAPSE®, AGAMREE®, and FYCOMPA®, relies heavily on specialized distribution networks, which is typical for controlled, high-cost drug delivery. This ensures proper handling and access for these niche therapies.

Dedicated U.S. Field Sales Force

Catalyst Pharmaceuticals maintains a dedicated U.S. field sales force aimed squarely at neurologists and rare disease specialists. This direct engagement is crucial for educating prescribers on therapies for conditions like Lambert-Eaton myasthenic syndrome (LEMS) and Duchenne muscular dystrophy (DMD). The company's total employee count as of October 2025 was approximately 182 employees.

The commercial execution is clearly driving results; for the third quarter of 2025, Catalyst Pharmaceuticals reported net product revenues of $148.4 million. This channel is supported by the company's confidence, leading to a raised full-year 2025 total revenue guidance between $565 million and $585 million.

Canadian Commercial Channel via Exclusive Partner

For Canada, Catalyst Pharmaceuticals uses an exclusive partner, KYE Pharmaceuticals, Inc. KYE handles the commercialization, importation, and distribution there. This partnership is key for expanding the footprint beyond the U.S. market. For instance, KYE markets FIRDAPSE® in Canada. Furthermore, as of April 2025, Health Canada accepted the New Drug Submission for AGAMREE® via KYE with Priority Review, aiming for potential marketing authorization before the end of 2025.

Direct-to-Patient Support Services (Catalyst Pathways®)

A critical component supporting prescription fulfillment and persistence is the direct-to-patient support offered through the Catalyst Pathways® program. This personalized treatment support program serves as a single source for education and guidance for patients taking FIRDAPSE® and AGAMREE®. The company explicitly states this program enhances access and contributes to medication compliance and persistence.

Scientific and Medical Conferences for Data Dissemination

Disseminating clinical data is managed through scientific and medical conferences. Catalyst Pharmaceuticals was scheduled to participate in the Citi Annual Global Healthcare Conference in December 2025 and the Bank of America CNS Therapeutics Virtual Conference in November 2025. This activity supports the ongoing adoption of their products, such as AGAMREE®, which achieved net product revenue of $32.4 million in Q3 2025.

Here's a quick look at the financial performance underpinning these channel activities for the third quarter of 2025:

Product	Q3 2025 Net Product Revenue	FY 2025 Net Product Revenue Guidance
FIRDAPSE®	$92.2 million	$355 million to $360 million
AGAMREE®	$32.4 million	$105 million to $115 million
FYCOMPA®	$23.8 million	$100 million to $110 million

The company's strong financial footing supports these channel investments. As of the end of Q3 2025, Catalyst Pharmaceuticals ended with a cash position of $689.9 million and no debt. This strength allowed the Board to authorize a new share repurchase program of up to $200 million between October 1, 2025, and December 31, 2026.

The specialized nature of the market means the sales force targets specific, small populations, such as the estimated 400-500 diagnosed LEMS patients in the U.S.. For the oncology expansion of FIRDAPSE®, management noted that potentially 90% of cancer-associated LEMS patients remain undiagnosed, representing a significant opportunity.

The primary channels used by Catalyst Pharmaceuticals, Inc. include:

• Specialty pharmacies and distributors for controlled, high-cost drug delivery.
• A dedicated U.S. field sales force targeting neurologists and rare disease specialists.
• The Canadian commercial channel managed exclusively by KYE Pharmaceuticals.
• Direct-to-patient support services via the Catalyst Pathways® program.
• Scientific and medical conferences for ongoing data dissemination.

Finance: draft 13-week cash view by Friday.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Customer Segments

You're hiring before product-market fit... well, Catalyst Pharmaceuticals, Inc. (CPRX) has definitely found its fit in the rare disease space, and you need to know who is buying their products as of late 2025.

The customer segments for Catalyst Pharmaceuticals, Inc. (CPRX) are highly specialized, centering on patients with rare, often debilitating, neuromuscular and neurological conditions, as well as the healthcare professionals who treat them.

Patients with Lambert-Eaton Myasthenic Syndrome (LEMS)

This segment is served primarily by FIRDAPSE, which has a strong market position, especially after the Teva settlement secured exclusivity until February 2035.

• Estimated 400 cases of LEMS in the United States at any given time.
• The global prevalence of LEMS is estimated at about 2.8 people per million worldwide or 3.67 cases per million worldwide.
• The Total Addressable Market (TAM) for LEMS is estimated by Catalyst Pharmaceuticals, Inc. (CPRX) to be over $1 billion.
• FIRDAPSE net product revenue for Q3 2025 reached $92.2 million, showing a 16.2% year-over-year increase.
• Full-year 2025 net product revenue guidance for FIRDAPSE is reaffirmed at $355 million to $360 million.

Pediatric Patients with Duchenne Muscular Dystrophy (DMD)

AGAMREE targets this segment, showing significant growth in adoption, especially in specialized centers.

• DMD affects about 1 in every 5,000 males aged 5-9 years.
• Parent Project Muscular Dystrophy (PPMD) estimates about 15,000 young men living with Duchenne in the United States.
• AGAMREE net product revenue for Q3 2025 was $32.4 million, representing a 115.2% year-over-year increase.
• Full-year 2025 net product revenue guidance for AGAMREE was raised to $105 million to $115 million.
• AGAMREE generated $46 million in net product revenue in its first 10 months of 2024.

Patients with Epilepsy (FYCOMPA)

This segment provides revenue diversification, though facing generic headwinds in 2025.

• FYCOMPA generated net product revenues of $34.3 million in Q2 2025.
• FYCOMPA revenue for Q3 2025 was $23.8 million.
• The full-year 2025 net product revenue guidance for FYCOMPA was raised to $100 million to $110 million.
• Tablet generics for FYCOMPA began hitting the market in late May 2025, with the oral suspension remaining exclusive until mid-December 2025.

Healthcare Professionals and Centers

These are the gatekeepers and decision-makers who prescribe FIRDAPSE and AGAMREE. The company is focused on education for these groups, noting that potentially 90% of cancer-associated LEMS patients remain undiagnosed.

Customer Type	Estimated US Population/Count (Late 2025)	Relevance/Context
Practicing Neurologists (US)	Roughly 16,000 to 18,000	Treat LEMS and Epilepsy patients; a projected 19% shortfall exists by 2025.
DMD Centers of Excellence	Specific number not found; AGAMREE is seeing penetration into nearly all of them	Key prescribers for AGAMREE for DMD patients.
Neuromuscular Specialists	Subset of the total neurologist population	Primary prescribers for FIRDAPSE (LEMS).

Global Rare Disease Patient Populations via Licensing Partners

Catalyst Pharmaceuticals, Inc. (CPRX) maintains a U.S. commercial strategy but continuously evaluates opportunities to expand its global footprint, often through partners.

• A licensing partner, KYE Pharmaceuticals, Inc., received Health Canada approval for AGAMREE on October 2, 2025, marking the first therapy approved to treat DMD in Canada.
• The company is committed to in-licensing, developing, and commercializing novel medicines for people living with rare and difficult-to-treat diseases globally.

Overall, the commercial portfolio is expected to generate total revenues between $565 million and $585 million for the full year 2025.

Finance: draft 13-week cash view by Friday.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Cost Structure

You're looking at the expenses Catalyst Pharmaceuticals, Inc. incurred to support its commercial and pipeline activities as of late 2025. Honestly, for a specialty pharma company like this, the cost structure is heavily weighted toward getting the existing drugs to market and supporting patients.

The primary cost buckets for Catalyst Pharmaceuticals, Inc. in the third quarter of 2025 are clearly defined in their financial reporting. These figures show where the money went to keep FIRDAPSE®, AGAMREE®, and FYCOMPA® running and to fund future work.

Cost Category	Q3 2025 Amount (Millions USD)	Primary Driver/Context
Sales, General, and Administrative (SG&A) expenses	\$47.5 million	Reflecting, in part, an increase in cancer-associated LEMS activities.
Cost of Goods Sold (COGS)	\$22.7 million	Consisted principally of royalties, including a 5% royalty on net sales up to $100 million for 2025.
Research and Development (R&D) expenses	\$2.7 million	Costs mainly supported the two ongoing AGAMREE studies.

The SG&A figure is the one that bundles most of the commercialization and marketing spend. You can see the scale of the commercial effort when you look at the product revenues that this cost base supports; for instance, FIRDAPSE® generated net product revenue of \$92.2 million in the quarter. That's a significant operational cost to maintain.

Here's a breakdown of the implied and contextual costs related to your outline points:

• Commercialization and marketing costs for three key products: These are embedded within the \$47.5 million SG&A expense for Q3 2025.
• Activities supporting AGAMREE® commercial uptake: This is a key driver of the SG&A increase year-over-year.
• Costs associated with in-licensing and business development activities: While management actively evaluates opportunities (reportedly mulled over ~100 BD assessments), the direct Q3 2025 expense for this wasn't itemized separately from SG&A.
• License and other revenue offset: This was minimal in Q3 2025 at \$27,000, compared to \$2.3 million in Q3 2024.

The quick math shows that the core operational costs (COGS + SG&A + R&D) totaled \$72.9 million for the quarter, against total revenues of \$148.4 million. The company is definitely focused on keeping R&D lean while driving commercial execution.

Finance: draft 13-week cash view by Friday.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Revenue Streams

You're looking at the core money-makers for Catalyst Pharmaceuticals, Inc. as of late 2025. The business model is heavily weighted on product sales, but those licensing deals are starting to generate secondary income streams, which is key for long-term stability.

The primary revenue drivers are the net product sales from the commercial portfolio. Management has set a clear expectation for the full fiscal year 2025, which you can see broken down here:

Product	2025 Net Product Sales Guidance Range
FIRDAPSE	\$355 million to \$360 million
AGAMREE	\$105 million to \$115 million
FYCOMPA	\$100 million to \$110 million

When you add those up, the total 2025 revenue guidance is between \$565 million and \$585 million. This reflects the company's confidence, especially after raising the outlook following strong Q3 performance. Honestly, the growth in AGAMREE is a big part of why they felt comfortable bumping that total guidance up.

The revenue streams aren't just about what Catalyst sells directly in the U.S. The international licensing agreements bring in important, often less predictable, income:

• Royalties and milestone payments from international licensing agreements.
• Specific to AGAMREE, Catalyst pays Santhera sales-based milestones up to \$105 million plus up to low-teen percentage royalties on North American sales.
• The royalty structure for AGAMREE dictates that royalty percentages increase once net sales exceed \$100 million annually.
• For FYCOMPA, royalties owed to Eisai commence after the loss of patent protection, which started with the tablet form in May 2025.
• FYCOMPA royalties to Eisai before generic entry were tiered: 12% on net sales greater than \$10 million and less than \$100 million, 17% on net sales between \$100 million and \$125 million, and 22% on net sales greater than \$125 million.
• Post-generic entry for FYCOMPA, those royalty tiers drop to 6%, 8.5%, and 11%, respectively.
• The agreement with KYE Pharmaceuticals for AGAMREE in Canada makes Catalyst eligible to receive further reimbursement, sales milestones, and sales royalties.

To be fair, the royalty stream from AGAMREE is already partially monetized; a portion of those net royalties from Catalyst to Santhera was subject to a monetization agreement secured in 2024. That's the kind of financial engineering that keeps capital flowing for near-term growth initiatives.