Catalyst Pharmaceuticals, Inc. (CPRX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el intrincado paisaje de la innovación farmacéutica, Catalyst Pharmaceuticals, Inc. (CPRX) emerge como un faro de esperanza para pacientes que luchan contra trastornos neurológicos raros. Al crear meticulosamente un modelo de negocio dinámico que une la investigación de vanguardia, las asociaciones estratégicas y las soluciones centradas en el paciente, la compañía se ha posicionado como una fuerza transformadora para abordar las necesidades médicas no satisfechas. Su enfoque integral para el desarrollo de fármacos, desde la creación de la propiedad intelectual hasta las intervenciones terapéuticas dirigidas, representa un plan sofisticado para abordar desafíos médicos complejos con precisión y compasión.

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negocio: asociaciones clave

Colaboración con instituciones de investigación médica

Catalyst Pharmaceuticals ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Área de enfoque	Detalles de la asociación
Universidad de Miami	Trastornos neurológicos raros	Colaboración de investigación para el síndrome de miasténico Lambert-Eaton (LEMS)
Universidad de Johns Hopkins	Investigación clínica	Soporte de ensayos clínicos para el desarrollo de Firdapse®

Asociaciones estratégicas con proveedores de atención médica

Las asociaciones clave del proveedor de atención médica incluyen:

• Centros de neurología de América - Red de distribución de tratamiento
• Centros de tratamiento de enfermedades raras: programas de acceso al paciente
• Sociedad Nacional de Esclerosis Múltiple: colaboración de apoyo al paciente

Acuerdos de licencia con fabricantes farmacéuticos

Fabricante	Producto	Términos de licencia
Jacobus farmacéutico	Firdapse®	Derechos exclusivos de comercialización de América del Norte

Asociaciones de redes de ensayos clínicos

Catalyst Pharmaceuticals colabora con múltiples redes de ensayos clínicos:

• NORD (Organización Nacional para Trastornos Raros)
• Red de ensayos clínicos raros
• Consorcio de ensayos clínicos internacionales

Consultores de cumplimiento regulatorio

Consultoría	Especialidad	Servicios proporcionados
Parexel International	Asuntos regulatorios	Soporte de presentación y cumplimiento de la FDA
Ícono plc	Cumplimiento de la investigación clínica	Estrategia y documentación regulatoria

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negocio: actividades clave

Desarrollo de fármacos de enfermedades raras

Catalyst Pharmaceuticals se centra en el desarrollo de terapias para enfermedades neurológicas raras. A partir de 2024, la compañía tiene 1 fármaco aprobado por la FDA (Firdapse) para el síndrome de miasténico Lambert-Eaton (LEMS).

Enfoque de drogas	Área terapéutica	Estado actual
Firdapse	Trastornos neurológicos	Aprobado por la FDA
CP-688	Epilepsia pediátrica rara	Desarrollo clínico

Gestión de ensayos clínicos

La compañía administra activamente múltiples programas de ensayos clínicos con un presupuesto anual de desarrollo clínico de aproximadamente $ 35-40 millones.

• Ensayos clínicos activos en 3-4 indicaciones neurológicas raras
• Duración promedio del ensayo clínico: 2-3 años
• Inversión típica de ensayos clínicos: $ 10-15 millones por programa

Procesos de aprobación regulatoria

Catalyst Pharmaceuticals ha demostrado experiencia en la navegación de paisajes regulatorios complejos, con Tasa de éxito del 100% en las interacciones de la FDA para Firdapse.

Hito regulatorio	Fecha	Resultado
Aprobación de Firdapse NDA	Noviembre de 2018	Exitoso
Designación de enfermedad pediátrica rara	2022	Otorgada

Supervisión de fabricación de drogas

La compañía utiliza organizaciones de fabricación de contratos (CMO) con gastos de fabricación anuales estimados de $ 15-20 millones.

• Presupuesto de control de calidad: $ 3-5 millones anuales
• Capacidad de fabricación: 50,000-100,000 unidades de tratamiento por año

Estrategias de investigación y comercialización de mercado

Catalyst Pharmaceuticals se asigna aproximadamente $ 25 millones anuales a los esfuerzos de marketing y comercialización.

Enfoque de marketing	Público objetivo	Inversión anual
Especialistas neurológicos raros	Neurólogos, centros neuromusculares	$ 12-15 millones
Programas de concientización del paciente	Comunidad de pacientes de LEMS	$ 5-7 millones

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negocio: recursos clave

Cartera de propiedades intelectuales

A partir de 2024, Catalyst Pharmaceuticals se mantiene 5 patentes activas Relacionado con tratamientos de enfermedades raras, específicamente trastornos neurológicos.

Tipo de patente	Número de patentes	Año de vencimiento
Patentes relacionadas con Firdapse (amifampridina)	3	2029-2032
Patentes de tratamiento de enfermedades raras	2	2030-2033

Equipo de investigación científica especializada

Catalyst Pharmaceuticals emplea 42 científicos de investigación a partir de 2024.

• Doctor en Filosofía. Investigadores de nivel: 28
• Investigadores de MD: 7
• Asociados de investigación: 7

Instalaciones avanzadas de investigación farmacéutica

Inversión total de la instalación de investigación: $ 12.3 millones en 2023.

Ubicación de la instalación	Tamaño (pies cuadrados)	Enfoque de investigación
Coral Gables, Florida	22,000	Trastornos neurológicos

Capital financiero para el desarrollo de medicamentos

Gastos de investigación y desarrollo en 2023: $ 54.7 millones.

Fuente del capital	Cantidad	Porcentaje
Reservas de efectivo de la compañía	$ 32.4 millones	59.2%
Financiación externa	$ 22.3 millones	40.8%

Tecnologías de formulación de drogas patentadas

Tecnologías de drogas patentadas actuales: 3 plataformas de formulación únicas.

• Sistema de administración de medicamentos de desorden neurológico
• Plataforma de modificación del tratamiento de enfermedades raras
• Tecnología de medicamentos de liberación prolongada

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para trastornos neurológicos raros

Catalyst Pharmaceuticals se centra en el desarrollo de terapias para trastornos neurológicos raros, específicamente dirigirse al síndrome de miasténico Lambert-Eaton (LEMS).

Producto	Indicación	Aprobación de la FDA	Potencial de mercado
Firdapse	Tratamiento de lems	Noviembre de 2018	Mercado anual estimado de $ 300 millones

Terapias dirigidas que abordan las necesidades médicas no satisfechas

El enfoque estratégico de Catalyst en afecciones neurológicas raras aborda las brechas críticas de tratamiento.

• Prevalencia de enfermedades raras: aproximadamente 7,000 enfermedades raras conocidas
• Población de pacientes estimada para LEM: 400-500 pacientes diagnosticados en los Estados Unidos
• Opciones de tratamiento alternativas limitadas para afecciones neurológicas específicas

Resultados mejorados del paciente para poblaciones específicas de pacientes

Métrico clínico	Firdapse Performance
Mejora de la fuerza muscular	Hasta el 50% de mejora en la distancia a pie
Mejora de calidad de vida	Reducción significativa de síntomas informados por el paciente

Soluciones terapéuticas rentables

La estrategia de precios de Catalyst se centra en los precios sostenibles para tratamientos especializados.

• Costo de tratamiento anual de Firdapse: aproximadamente $ 150,000 por paciente
• Cobertura de seguro potencial para tratamientos de enfermedades raras
• Designación de medicamentos huérfanos que proporciona exclusividad del mercado

Mejor calidad de vida para pacientes con afecciones raras

El enfoque terapéutico de Catalyst afecta directamente a la movilidad del paciente y al funcionamiento diario.

Métrica de impacto del paciente	Resultado cuantitativo
Mejoramiento de la movilidad	Aumento del 30-40% en los puntajes de movilidad del paciente
Satisfacción del tratamiento	El 85% del paciente informó experiencia de tratamiento positivo

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negocio: relaciones con los clientes

Compromiso médico directo

Catalyst Pharmaceuticals mantiene el compromiso directo con los neurólogos y los especialistas en enfermedades raras a través de comunicaciones médicas específicas.

Método de compromiso	Frecuencia	Especialistas en el objetivo
Presentaciones de conferencia médica	4-6 por año	Neurólogos
Consultas clínicas individuales	Trimestral	Especialistas en enfermedades raras
Simposios médicos digitales	2-3 por año	Expertos en trastorno neuromuscular

Programas de apoyo al paciente

Programas integrales de asistencia al paciente centrados en tratamientos de trastornos neurológicos raros.

• Asistencia financiera para pacientes con fintepla y Ruzurgi
• Soporte de navegación de seguros
• Programas de acceso a medicamentos
• Iniciativas de asistencia de copago

Iniciativas de educación médica

Recursos educativos dirigidos para profesionales de la salud que se especializan en condiciones neurológicas raras.

Plataforma educativa	Alcance anual	Tipo de contenido
Módulos de capacitación clínica en línea	500+ profesionales de la salud	Manejo de enfermedades raras
Serie de seminarios web	Más de 250 participantes	Actualizaciones de protocolo de tratamiento

Recursos en línea del paciente

Plataformas digitales que proporcionan información integral sobre trastornos y tratamientos neurológicos raros.

• Sitio web dedicado de información del paciente
• Herramientas de seguimiento de síntomas digitales
• Foros de apoyo comunitario en línea
• Aplicación móvil para la gestión del tratamiento

Servicios de consulta de tratamiento personalizado

Apoyo clínico individualizado para pacientes con afecciones neurológicas raras.

Tipo de consulta	Disponibilidad de servicio	Enfoque de apoyo al paciente
Referencias de asesoramiento genético	Coordinación 24/7	Síndrome de miasténico de Lambert-Eaton
Guía de la vía de tratamiento	Enfoque personalizado	Gestión de epilepsia pediátrica

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negocio: canales

Ventas directas a proveedores de atención médica

Catalyst Pharmaceuticals mantiene un equipo de ventas especializado dirigido a neurólogos y especialistas en enfermedades raras. A partir del cuarto trimestre de 2023, la Compañía empleó a 35 representantes de ventas directas centradas en promover Firdapse (amifampridina) para el síndrome de miasténico Lambert-Eaton (LEMS).

Canal de ventas	Número de representantes	Especialistas en el objetivo
Ventas de neurología directa	35	Neurólogos, especialistas en enfermedades raras

Distribuidores farmacéuticos especiales

Catalyst se asocia con distribuidores farmacéuticos clave para garantizar una amplia disponibilidad de productos.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Distribuidor	Cuota de mercado	Cobertura de distribución
AmerisourceBergen	35%	Nacional
Salud cardinal	30%	Nacional
McKesson Corporation	25%	Nacional

Presentaciones de conferencia médica

En 2023, Catalyst participó en 12 conferencias médicas, presentando datos clínicos y hallazgos de investigación.

Tipo de conferencia	Número de conferencias	Alcance de los asistentes
Conferencias de neurología	8	5.600 profesionales de la salud
Simposios de enfermedades raras	4	2.300 profesionales de la salud

Plataformas de marketing digital

Catalyst utiliza estrategias de marketing digital específicas en múltiples plataformas en línea.

• Red profesional de LinkedIn
• Medidor
• Portal profesional webmd

Plataforma digital	Impresiones mensuales	Tasa de compromiso
LinkedIn	125,000	3.2%
Medidor	85,000	2.7%

Redes de comunicación profesional de la salud

Catalyst mantiene canales de comunicación directa con líderes de opinión clave y especialistas.

• Comunicaciones por correo electrónico personalizadas
• Serie de seminarios web trimestrales
• Boletín médico dirigido

Canal de comunicación	Alcance trimestral	Tasa de respuesta
Comunicaciones por correo electrónico	2,500 especialistas	14%
Seminarios web trimestrales	1.200 participantes	22%

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

Pacientes de desorden neurológico

Catalyst Pharmaceuticals se centra en pacientes con trastornos neurológicos raros, específicamente dirigido al síndrome de miasténico Lambert-Eaton (LEMS) y síndrome de miasténico congénito (CMS).

Características del segmento del paciente	Datos de prevalencia
LEMS Población de pacientes	Aproximadamente 400-500 pacientes diagnosticados en los Estados Unidos
Población de pacientes con CMS	Estimado de 1.200-1,500 pacientes diagnosticados en los Estados Unidos

Especialistas en enfermedades raras

Catalyst se dirige a neurólogos y especialistas que se centran en trastornos neuromusculares raros.

• Aproximadamente 2.500 neurólogos especializados en condiciones neuromusculares raras
• Objetivo principal: Especialistas en clínicas neuromusculares en los principales centros médicos académicos

Practicantes de neurología pediátrica

Segmento especializado para pacientes pediátricos con afecciones neurológicas raras.

Segmento de neurología pediátrica	Datos estadísticos
Neurólogos pediátricos en EE. UU.	1.200 especialistas certificados por la junta
Mercado potencial de pacientes pediátricos	Aproximadamente 800-1,000 niños con trastornos neuromusculares raros

Sistemas hospitalarios

Catalyst se dirige a la neurología especializada y a los centros de tratamiento de enfermedades raras.

• Top 50 Centros de tratamiento de neurología en los Estados Unidos
• Unidades especializadas de tratamiento de enfermedades raras en centros médicos académicos

Instituciones de investigación

Enfoque colaborativo con centros de investigación que estudian trastornos neurológicos raros.

Tipo de institución de investigación	Número de colaboradores potenciales
Centros de investigación académicos	37 Instituciones de investigación de neurociencia importantes
Fundamentos de investigación de enfermedades raras	24 organizaciones de investigación especializadas

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Catalyst Pharmaceuticals reportó gastos de I + D por un total de $ 37.4 millones.

Año	Gastos de I + D
2022	$ 33.2 millones
2023	$ 37.4 millones

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para Catalyst Pharmaceuticals en 2023 fueron de aproximadamente $ 22.1 millones.

• Enfoque principal en tratamientos de trastorno neurológico raros
• Pruebas en curso para Firdapse y posibles nuevos candidatos terapéuticos

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 se estimaron en $ 5.6 millones.

Categoría de cumplimiento	Costo anual
Tarifas de presentación de la FDA	$ 2.3 millones
Seguro de calidad	$ 1.8 millones
Documentación regulatoria	$ 1.5 millones

Infraestructura de fabricación

Las inversiones en infraestructura de fabricación en 2023 totalizaron $ 15.7 millones.

• Mantenimiento del equipo
• Actualizaciones de la instalación de producción
• Sistemas de control de calidad

Gastos de marketing y ventas

Los costos de marketing y ventas para 2023 fueron de $ 28.3 millones.

Categoría de gastos de marketing	Cantidad
Fuerza de ventas	$ 16.5 millones
Materiales promocionales	$ 6.2 millones
Marketing digital	$ 5.6 millones

Catalyst Pharmaceuticals, Inc. (CPRX) - Modelo de negocio: flujos de ingresos

Venta de medicamentos recetados

Para el año fiscal 2023, Catalyst Pharmaceuticals reportó ingresos totales de $ 418.3 millones, principalmente de las ventas de Firdapse® (amifampridina) para el síndrome miasténico de Lambert-E-Ealton (LEMS).

Producto	Ingresos anuales (2023)
Firdapse®	$ 418.3 millones

Acuerdos de licencia

Catalyst Pharmaceuticals tiene acuerdos estratégicos de licencia para el desarrollo farmacéutico.

• Colaboración con Jacobus Pharmaceutical para el desarrollo Firdapse®
• Derechos de licencia exclusivos para fosfato de amifampridina

Subvenciones de investigación del gobierno

Catalyst ha recibido apoyo y subvenciones de investigación, aunque no se revelan públicamente montos de dólares específicos para 2024.

Asociaciones de productos farmacéuticos

La compañía tiene asociaciones continuas para el desarrollo y comercialización de medicamentos.

Tipo de asociación	Descripción
Colaboración de investigación	Desarrollo continuo de fármacos de trastorno neurológico

Reembolso del seguro

Firdapse® está cubierto por los principales proveedores de seguros, contribuyendo a los flujos de ingresos.

• Cobertura de Medicare para pacientes elegibles
• 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.