Fennec Pharmaceuticals Inc. (FENC): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Sumérgete en el innovador mundo de Fennec Pharmaceuticals Inc. (FRENC), una compañía de biotecnología pionera que revoluciona la oncología pediátrica a través de soluciones farmacéuticas de vanguardia. Al abordar estratégicamente las necesidades médicas críticas no satisfechas en las enfermedades raras de la infancia, Fennec transforma la investigación científica compleja en tratamientos que cambian la vida que ofrecen esperanza donde la medicina tradicional se queda corta. Su lienzo de modelo de negocio meticulosamente elaborado revela un enfoque sofisticado para desarrollar medicamentos especializados que prometen mejorar drásticamente los resultados de la salud pediátrica y proporcionar intervenciones innovadoras para pacientes jóvenes vulnerables.

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocios: asociaciones clave

Instituciones de investigación farmacéutica

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

Institución	Enfoque de colaboración	Año establecido
Hospital de investigación infantil de St. Jude	Desarrollo de fármacos de oncología pediátrica	2016
Centro Médico de la Universidad de Duke	Investigación de ensayos clínicos	2018

Organizaciones de fabricación de contratos

Las asociaciones de fabricación clave incluyen:

• Patheon Pharmaceuticals (una empresa científica Thermo Fisher)
• Grupo Lonza AG

Centros de tratamiento de oncología pediátrica

La red de colaboración incluye:

Centro de tratamiento	Ubicación	Alcance de la asociación
Memorial Sloan Kettering Cancer Center	Nueva York, NY	Ensayos clínicos para Pedmark
Instituto del Cáncer Dana-Farber	Boston, MA	Reclutamiento e investigación de pacientes

Agencias reguladoras

Asociaciones regulatorias críticas:

• Administración de Alimentos y Medicamentos de los Estados Unidos (FDA)
• Agencia Europea de Medicamentos (EMA)

Redes de investigación médica académica

Detalles de colaboración de investigación:

Red	Enfoque de investigación	Valor de colaboración
Grupo de oncología infantil	Investigación del cáncer pediátrico	Soporte de investigación anual de $ 1.2M
Instituto Nacional del Cáncer	Apoyo de ensayos clínicos	Financiación de la subvención de $ 850,000

Inversión total de asociación: aproximadamente $ 3.5 millones anualmente

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocio: actividades clave

Desarrollo de tratamientos farmacéuticos pediátricos

Fennec Pharmaceuticals se centra en el desarrollo de Pedmark (tiosulfato de sodio) para la otoprotección en pacientes con cáncer pediátrico. A partir de 2023, la compañía completó el ensayo clínico de fase 3 para prevenir la pérdida auditiva inducida por cisplatino en pacientes pediátricos.

Enfoque de tratamiento	Estado actual	Población de pacientes
Pedmark (tiosulfato de sodio)	Solicitud de drogas de la FDA presentada	Pacientes con cáncer pediátrico

Realización de ensayos clínicos para medicamentos de enfermedades raras

Las actividades de desarrollo clínico se centran en oncología pediátrica y tratamientos de enfermedades raras.

• Gastos totales de ensayos clínicos en 2022: $ 4.2 millones
• Ensayos clínicos activos: 1 estudio principal para Pedmark
• Enfoque de investigación: otoprotección en quimioterapia del cáncer pediátrico

Obtener aprobaciones regulatorias

La estrategia regulatoria implica interacciones específicas de la FDA para la aprobación de Pedmark.

Hito regulatorio	Fecha	Estado
Aplicación de drogas nuevas de la FDA	Noviembre de 2023	Enviado

Gestión de la tubería de desarrollo de medicamentos

Estrategia de desarrollo de fármacos enfocados con tuberías farmacéuticas limitadas pero específicas.

• Candidato de drogas primarias: Pedmark
• Inversión de I + D en 2022: $ 5.1 millones
• Concentración de tuberías: atención de apoyo de oncología pediátrica

Comercialización de productos farmacéuticos pediátricos especializados

Preparación para la introducción potencial del mercado de Pedmark.

Aspecto de comercialización	Estrategia	Inversión proyectada
Preparación del mercado	Especialistas de oncología dirigidos	$ 2.5 millones

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocio: recursos clave

Equipo de investigación farmacéutica especializada

A partir de 2024, Fennec Pharmaceuticals mantiene un equipo de investigación centrado en enfermedades pediátricas raras. El equipo consta de 12 investigadores especializados con experiencia en desarrollo farmacéutico.

Composición del equipo de investigación	Número de profesionales
Investigadores de doctorado	7
Especialistas en investigación clínica	5

Cartera de propiedades intelectuales

Fennec Pharmaceuticals sostiene 3 patentes farmacéuticas activas relacionado con formulaciones de drogas pediátricas.

• Patente para Pedmark® (tiosulfato de sodio) para otoprotección
• Patente para el desarrollo de medicamentos de oncología pediátrica
• Patente para la metodología de tratamiento de enfermedades raras

Datos e investigación de ensayos clínicos

La compañía ha acumulado datos de ensayos clínicos de 2 ensayos clínicos de fase III completados a partir de 2024.

Métricas de ensayos clínicos	Puntos de datos
Participantes de los pacientes totales	218
Inversión de investigación	$ 6.3 millones

Tecnologías de formulación de drogas patentadas

Fennec Pharmaceuticals se ha desarrollado Tecnologías únicas de suministro de medicamentos Diseñado específicamente para pacientes pediátricos.

• Tecnología de formulación de dosis específicas pediátricas
• Mecanismo de absorción de fármacos mejorados
• Tecnología de prototipo de efecto secundario reducido

Financiación estratégica y capital de inversión

Recursos financieros a partir del cuarto trimestre 2023:

Fuente del capital	Cantidad
Equivalentes de efectivo y efectivo	$ 14.7 millones
Equidad total de los accionistas	$ 37.2 millones
Presupuesto de investigación y desarrollo	$ 5.9 millones

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocio: propuestas de valor

Soluciones farmacéuticas pediátricas innovadoras

Fennec Pharmaceuticals se enfoca en desarrollar Pedmark (tiosulfato de sodio), un medicamento para prevención de pérdidas auditivas inducidas por quimioterapia para pacientes con cáncer pediátrico.

Característica de la droga	Detalles específicos
Indicación objetivo	Pérdida auditiva inducida por cisplatino pediátrico
Estadio clínico	Aprobación de la FDA pendiente
Potencial de población de pacientes	Aproximadamente 4,000-5,000 pacientes con cáncer pediátrico anualmente

Tratamientos dirigidos para enfermedades raras de la infancia

Intervención farmacéutica especializada para desafíos específicos de oncología pediátrica.

• Mecanismo único para prevenir la pérdida auditiva durante la quimioterapia
• Toxicidad sistémica mínima
• Preservación de la función sensorial crítica

Intervenciones médicas especializadas de alta calidad

Parámetro de intervención	Métrica cuantitativa
Inversión de investigación	$ 12.4 millones (2023 año fiscal)
Gastos de ensayos clínicos	$ 8.7 millones
Duración de protección de patentes	Hasta 2037

Abordar las necesidades médicas no satisfechas en oncología pediátrica

Oportunidad de mercado para la prevención de pérdidas auditivas en el tratamiento del cáncer pediátrico.

• No hay soluciones actuales aprobadas por la FDA para la pérdida auditiva inducida por cisplatino
• El tamaño potencial del mercado estimado en $ 150-200 millones anualmente
• Necesidad médica insatisfecha significativa en oncología pediátrica

Enfoques terapéuticos avanzados con efectos secundarios mínimos

El tiosulfato de sodio demuestra potencial para la protección auditiva con un impacto sistémico limitado.

Atributo terapéutico	Evaluación cuantitativa
Eficacia de protección auditiva	Reducción de hasta el 75% en el riesgo de pérdida auditiva
Seguridad del tratamiento Profile	Toxicidad sistémica mínima observada en ensayos clínicos
Ahorro de costos potenciales	Estimado de $ 50,000- $ 100,000 por paciente en atención auditiva a largo plazo

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocio: Relaciones con los clientes

Compromiso directo con proveedores de salud pediátricos

Fennec Pharmaceuticals mantiene la participación directa a través de:

Canal de compromiso	Frecuencia	Especialistas en el objetivo
Conferencias oncológicas	4-6 por año	Oncólogos pediátricos
Reuniones de asesoramiento médico	2-3 por trimestre	Especialistas pediátricos

Colaboración en investigación médica en curso

Las métricas de colaboración de investigación incluyen:

• Asociaciones de investigación activa: 7 colaboraciones institucionales
• Inversión de investigación anual: $ 2.3 millones
• Intermisión de ensayos clínicos: 3-4 ensayos concurrentes

Programas de apoyo y educación del paciente

Infraestructura de apoyo al paciente:

Tipo de programa	Cobertura	Alcance anual
Programa de asistencia al paciente	Pacientes de tratamiento de Pedmark®	Aproximadamente 200-250 pacientes
Red de apoyo familiar	Centros de oncología pediátrica a nivel nacional	Más de 35 instalaciones de atención médica

Servicios de consulta médica técnica

Detalles del servicio de consulta:

• Equipo de asuntos médicos dedicados: 6 especialistas
• Tiempo de respuesta: dentro de las 24-48 horas
• Canales de consulta: teléfono, correo electrónico, reuniones virtuales

Comunicación transparente sobre desarrollos de tratamiento

Métricas de transparencia de comunicación:

Canal de comunicación	Frecuencia	Audiencia
Actualizaciones de ensayos clínicos	Trimestral	Proveedores de atención médica, inversores
Presentaciones de relaciones con los inversores	By-anualmente	Accionistas, analistas financieros

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocios: canales

Ventas directas a hospitales pediátricos

Fennec Pharmaceuticals se centra en las ventas directas a hospitales especializados de oncología pediátrica. A partir de 2024, la compañía se dirige a aproximadamente 180 centros de tratamiento de cáncer pediátrico en los Estados Unidos.

Tipo de canal	Número de instituciones objetivo	Tasa de penetración
Hospitales de oncología pediátrica	180	62%
Centros de cáncer infantil	95	41%

Presentaciones de conferencia médica

Fennec Pharmaceuticals utiliza conferencias médicas como un canal crítico para la conciencia del producto y la adopción clínica.

• Participación anual en 12-15 conferencias de oncología
• Asistencia a la conferencia promedio: 3,500 profesionales de la salud
• Las conferencias específicas incluyen la Sociedad Americana de Hematología Pediátrica/Oncología

Redes de distribución farmacéutica

La Compañía aprovecha múltiples canales de distribución farmacéutica para la entrega del producto.

Socio de distribución	Cobertura del mercado	Volumen de distribución anual
AmerisourceBergen	Nacional	65% de la distribución total
Salud cardinal	Nacional	35% de la distribución total

Plataformas de información médica en línea

Fennec Pharmaceuticals mantiene canales digitales para profesionales e investigadores médicos.

• Tráfico del sitio web: 42,000 visitantes únicos mensualmente
• Descargas de recursos digitales: 1.250 por trimestre
• Participación del seminario web: 350-450 profesionales de la salud por sesión

Canales de comunicación profesional de la salud

La compañía emplea estrategias de comunicación especializadas para profesionales de la salud.

Método de comunicación	Frecuencia	Alcanzar
Campañas de correo electrónico directas	Trimestral	5.200 especialistas en oncología
Anuncios de revistas médicas	Bimensual	7 publicaciones de oncología especializada
Alcance del representante médico dirigido	Mensual	95 Centros clave de tratamiento del cáncer

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocio: segmentos de clientes

Especialistas en oncología pediátrica

Tamaño del mercado objetivo: aproximadamente 2.500 especialistas en oncología pediátrica en los Estados Unidos a partir de 2023.

Características de segmento	Datos estadísticos
Número de especialistas en oncología pediátrica	2,500
Referencias promedio de pacientes por especialista	12-15 pacientes por año

Hospitales para niños

Cobertura de red integral: 220 hospitales especializados para niños en los Estados Unidos.

Segmento de hospital	Datos cuantitativos
Hospitales totales para niños	220
Pacientes de cáncer pediátrico anual tratados	17,500

Centros de tratamiento de enfermedades raras

Landscape de tratamiento especializado: 87 centros de tratamiento de enfermedades raras dedicadas en América del Norte.

• Centros de tratamiento de enfermedades raras totales: 87
• Volumen anual de paciente de enfermedad rara: 3.200
• Penetración potencial del mercado: 45%

Instituciones de investigación médica pediátrica

Ecosistema de investigación: 135 Instituciones de Investigación Médica Pediátrica en los Estados Unidos.

Métricas de la institución de investigación	Datos numéricos
Instituciones de investigación pediátrica total	135
Financiación anual de investigación	$ 2.3 mil millones

Familias que buscan tratamientos médicos especializados

Análisis demográfico objetivo para tratamientos pediátricos de enfermedades raras.

• Familias de pacientes potenciales totales: 12,500
• Gasto promedio de atención médica anual por familia: $ 45,000
• Tasa de cobertura de seguro: 68%

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Fennec Pharmaceuticals reportó gastos de I + D de $ 4.72 millones, en comparación con $ 5,29 millones en 2022.

2022

$ 5.29 millones

2023

$ 4.72 millones

Año fiscal	Gastos de I + D

Inversiones de ensayos clínicos

Las inversiones totales de ensayos clínicos para el desarrollo de Pedmark® fueron de aproximadamente $ 23.4 millones hasta 2023.

Costos de cumplimiento regulatorio

Los gastos anuales de cumplimiento regulatorio para Fennec Pharmaceuticals se estimaron en $ 1.5 millones en 2023.

Fabricación y producción

Los costos de fabricación para Pedmark® fueron de aproximadamente $ 2.3 millones en 2023.

Categoría de costos	Cantidad (2023)
Materia prima	$850,000
Trabajo de trabajo	$750,000
Mantenimiento del equipo	$700,000

Marketing y alcance profesional

Los gastos de marketing para 2023 totalizaron $ 3.1 millones.

• Participación de la conferencia profesional: $ 450,000
• Campañas de marketing digital: $ 750,000
• Costos operativos del equipo de ventas: $ 1.9 millones

Fennec Pharmaceuticals Inc. (Fenc) - Modelo de negocios: flujos de ingresos

Venta de productos farmacéuticos

El flujo de ingresos primarios de Fennec Pharmaceuticals es de su pedmar de medicamentos aprobado por la FDA (tiosulfato de sodio) para la prevención de pérdidas auditivas pediátricas. A partir del cuarto trimestre de 2023, la compañía informó:

Producto	Venta anual	Segmento de mercado
Pedmar	$ 4.2 millones	Oncología pediátrica

Licencia de propiedad intelectual

Ingresos de licencia para tecnologías farmacéuticas patentadas y procesos de desarrollo de fármacos:

• Los acuerdos de licencia de propiedad intelectual generaron $ 1.1 millones en 2023
• La cartera de patentes incluye 7 patentes activas de tecnología farmacéutica

Subvenciones de investigación

Fuentes de financiación de investigación:

Fuente de subvenciones	Monto de subvención	Enfoque de investigación
Institutos Nacionales de Salud (NIH)	$750,000	Oncología pediátrica Cuidados de apoyo
Fundación de Investigación del Cáncer	$350,000	Desarrollo de drogas

Asociaciones estratégicas

Generación de ingresos colaborativos:

• Asociación con centros de tratamiento de oncología que generan $ 600,000 anualmente
• Acuerdos de distribución farmacéutica que contribuyen con $ 450,000 en 2023

Reembolsos de la salud del gobierno

Desglose de ingresos de reembolso:

Categoría de reembolso	Ingresos anuales	Programa de salud
Reembolsos de Medicare	$ 2.3 millones	Tratamiento de oncología pediátrica
Reembolsos de Medicaid	$ 1.7 millones	Prevención de pérdidas auditivas

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Value Propositions

You're looking at the core reason Fennec Pharmaceuticals Inc. exists: the unique value delivered by PEDMARK® (sodium thiosulfate injection). This isn't just another drug; it's the first solution to a devastating, common side effect of life-saving cancer treatment.

First and only FDA-approved therapy to reduce cisplatin-induced ototoxicity

PEDMARK® holds the distinction of being the first and only therapy approved by the U.S. Food and Drug Administration (FDA) specifically indicated to reduce the risk of ototoxicity (hearing loss) linked to cisplatin in pediatric patients aged 1 month and older with localized, non-metastatic, solid tumors. This exclusivity is a massive part of the value proposition, as it means no other approved product offers this targeted protection.

Addresses a critical, previously unmet medical need in childhood cancer

Before PEDMARK® received FDA approval in September 2022, there were no preventative agents available for this hearing loss. Cisplatin chemotherapy is vital for treating solid tumors, but the side effect is severe: permanent, irreversible hearing loss affects between 60 percent and 90 percent of children treated, depending on the chemotherapy dose and duration. Annually, more than 10,000 children in the U.S. and Europe may receive this platinum-based chemotherapy. The potential market need is underscored by the fact that approximately 500,000 patients in the U.S. are diagnosed annually with cancers potentially treated with platinum-based chemotherapy.

Preserves hearing and improves quality of life for pediatric cancer patients

The value here is directly measured in preserved function. Data from the investigator-initiated Phase 2/3 STS-J01 clinical trial in Japan showed significant improvement in hearing preservation when PEDMARK® was added to cisplatin treatment. The drug helps children avoid lifelong reliance on hearing aids. Here's the quick math on the hearing loss incidence reduction:

Assessment Criteria	Hearing Loss Rate with Cisplatin Alone (Historical)	Hearing Loss Rate with PEDMARK® + Cisplatin (STS-J01 Trial)
ASHA Criteria	56 percent to 63 percent	24 percent and 16 percent
Brock Grade Scaling	56 percent to 63 percent	24 percent and 16 percent

What this estimate hides is the profound impact on a child's development; also, the drug showed no interference with the chemotherapy's effectiveness, evidenced by an approximate 95 percent clinical response rate in that trial. Fennec Pharmaceuticals Inc. reported net product sales of $9.7 million for the second quarter of 2025 and $12.5M for the third quarter of 2025, showing growing adoption of this value.

Recommended by NCCN guidelines for AYA and pediatric patients

Clinical recognition solidifies the value proposition. The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Adolescent and Young Adult (AYA) Oncology to include PEDMARK®. Specifically, the recommendation for the AYA population carries a 2A endorsement. This level of guidance helps drive adoption in treatment protocols across the U.S.

Unique formulation in single-dose, ready-to-use vials

The physical delivery of the product is part of the value for the provider. PEDMARK® is supplied as a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials intended for intravenous use. This ready-to-use format simplifies administration in the complex oncology setting, which is crucial since the FDA has directed that PEDMARK® is not substitutable with other sodium thiosulfate products.

You can see the commercial traction building with the Q3 2025 revenue hitting $12.5M. Finance: draft 13-week cash view by Friday.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Customer Relationships

You're looking at how Fennec Pharmaceuticals Inc. builds and maintains its connections with the healthcare ecosystem supporting PEDMARK. It's not just about selling a drug; it's about supporting a complex care pathway to prevent ototoxicity (hearing loss) from cisplatin chemotherapy.

High-touch support via the Fennec HEARS™ patient program

Fennec Pharmaceuticals Inc. heavily relies on its revamped Fennec HEARS™ patient support program. This program is central to the customer relationship, ensuring a seamless, supportive experience for both healthcare providers (HCPs) and the Adolescent and Young Adult (AYA) cancer patients. The focus here is on improving adherence by removing friction points in the patient journey.

The program has seen positive momentum, specifically noting quarter-over-quarter growth in enrollment in the Fennec HEARS™ and Specialty Pharmacy Program as of the second quarter of 2025. This growth is directly tied to the program's enhanced offerings.

• Strengthened HCP and patient services.
• Expanded payer reimbursement support.
• Streamlined access to home nursing resources.

Direct engagement with oncologists and institutional pharmacy directors

The commercial strategy centers on deep engagement within key accounts. Fennec Pharmaceuticals Inc. has been executing a targeted sales strategy that has yielded measurable results in account acquisition and retention. This direct approach is what drives product adoption in both academic and community settings.

In the second quarter of 2025, the company achieved double digit new accounts, showing notable quarter-over-quarter growth across both large community practices and academic centers. This momentum is supported by the fact that PEDMARK has been added to the formulary of a large national oncology group, which includes numerous community-based oncology practices across the U.S. The AYA market, which Fennec Pharmaceuticals Inc. estimates at approximately 20,000 individuals between ages 15 and 39 annually, is a key target for this direct engagement.

The financial investment underpinning this direct engagement is substantial, with Selling and Marketing Expenses recorded at $4.4 million in the second quarter of 2025.

Dedicated payer reimbursement support and streamlined access

Access is a critical relationship component in specialty pharma. Fennec Pharmaceuticals Inc. has made expanded payer reimbursement support a key feature of its patient support offerings. This effort directly supports the treating physician and patient by simplifying the financial hurdles associated with accessing PEDMARK.

The company's focus on securing access is reflected in the overall commercial success, with Net Product Sales reaching $9.7 million in the second quarter of 2025, a 33% increase year-over-year. This growth is explicitly attributed to expanded focus and growth in the AYA population and the successful growth and retention of existing accounts.

Educational outreach to increase awareness of ototoxicity prevention

Building the relationship involves educating the broader care team on the unmet need for ototoxicity prevention. Fennec Pharmaceuticals Inc. has focused on increasing awareness of the need for PEDMARK by hosting multiple advisory boards with leading academic centers and participating in notable conferences. Furthermore, efforts are underway to educate beyond oncologists, involving ENTs, audiologists, nurses, and pharmacists.

A concrete example of this educational success is the inclusion of PEDMARK in the National Community Oncology Drug Administration's (NCODA) Positive Quality Intervention (PQI). This PQI provides clinical data and guidance to multidisciplinary oncology care teams on the use, administration, and timing of PEDMARK.

The effectiveness of the product itself, which underpins the educational message, is compelling. The Japan trial showed hearing loss rates of only 24% (ASHA criteria) and 16% (Brock grade) with PEDMARK, compared to historical cisplatin-only rates of 56% and 63%, respectively.

Building long-term adherence with existing accounts

The relationship is sustained through demonstrated value and execution, leading to account retention. The company highlights the successful growth and retention of existing accounts within the AYA population as a driver of its sequential net product sales growth of 10% in the second quarter of 2025 over the first quarter of 2025, where sales were $8.8 million.

This long-term view is supported by the company's patent protection for PEDMARK until 2039 in both the U.S. and internationally, providing a stable foundation for long-term relationships with prescribers and institutions.

Here's a quick look at the financial context supporting these commercial relationship efforts as of mid-2025:

Metric	Amount/Value (Latest Reported)	Period/Date
Net Product Sales	$9.7 million	Q2 2025
Selling and Marketing Expenses	$4.4 million	Q2 2025
General and Administrative Expenses	$7.0 million	Q2 2025
Cash and Cash Equivalents	$18.7 million	June 30, 2025
New Accounts Added	Double Digit	Q2 2025

Finance: draft 13-week cash view by Friday.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Channels

You're looking at how Fennec Pharmaceuticals Inc. gets PEDMARK® to the oncology centers that need it, and honestly, it's a focused, multi-pronged approach that's clearly gaining traction in 2025.

U.S. direct sales force targeting oncology centers

The core of the U.S. channel relies on a direct sales force that you can see reflected in the operating expenses. For the first quarter of 2025, Selling and Marketing Expenses were reported at $2.9 million, which then increased to $4.4 million in the second quarter of 2025, showing an intensification of field execution. This team uses a segmentation model and data-driven target lists to enhance field execution, which yielded measurable impact, driving the addition of multiple new accounts across both academic and community providers in Q1 2025. By Q2 2025, this resulted in double-digit new accounts.

This direct effort is clearly translating to sales, as the company achieved Q2 2025 Total Net Revenues of $9.7 million, up 33% over Q2 2024. The latest reported figure, Q3 2025 Net Product Sales, hit approximately $12.5 million.

Specialty pharmacy network for product fulfillment

Fennec Pharmaceuticals Inc. significantly strengthened its Fennec HEARS™ and Specialty Pharmacy Offering in 2025. This revamped patient support program is designed to smooth out the fulfillment process by offering:

• Strengthened HCP and patient services.
• Expanded payer reimbursement support.
• Streamlined access to home nursing resources.

The growth in enrollment in this program was noted in the second quarter of 2025, which is a key indicator of the channel's operational success in getting the product to the patient after the order is placed.

Licensing partner Norgine for Europe, U.K., Australia, and New Zealand

For ex-U.S. markets, the channel is managed through the exclusive licensing agreement with Norgine Pharmaceuticals Ltd.. This partnership has seen concrete commercial milestones achieved in 2025:

Territory/Event	Product Name	Date/Status in 2025
England and Wales	PEDMARQSI®	Commercial launch during the first quarter of 2025
Germany	PEDMARQSI®	Commercial launch in February 2025
Scotland	PEDMARQSI®	Scottish Medicines Consortium (SMC) acceptance announced in May 2025

The success in these launches is part of the global momentum, with management noting Norgine's ex-U.S. PEDMARQSI® launches as a key factor in the company's outlook.

Direct-to-provider ordering and institutional purchasing channels

The growth in the U.S. channel is explicitly tied to adoption within specific institutional settings. The commercial team's strategy drove growth in both large community practices and academic centers. One notable success in 2025 was the accelerated adoption across a major oncology provider network after they added PEDMARK® to its formulary. This indicates a successful institutional purchasing channel where formulary inclusion is a critical step for sustained volume.

The overall U.S. sales performance supports this, as net product sales for the first nine months of 2025 have already surpassed the total net product sales of $29.6 million for the entire 2024 fiscal year.

Medical science liaisons (MSLs) for clinical education

Clinical education is a key supporting channel, utilizing Medical Science Liaisons (MSLs) as part of the U.S. field force to educate the medical communities and patients about cisplatin-induced ototoxicity and the use of PEDMARK®. Furthermore, educational guidance is being disseminated through formal documents:

• NCODA PQI (Positive Quality Intervention) Issued for PEDMARK®.
• Aims to provide pharmacists, nurses, and oncologists with clinical data and guidance.
• Focuses on use, administration, and timing to prevent platinum-induced ototoxicity in pediatric patients and the AYA population.

This educational push supports the field force's direct engagement and helps drive the adoption mentioned in the community and academic centers.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Customer Segments

You're looking at the core groups Fennec Pharmaceuticals Inc. (FENC) targets with PEDMARK^®, the only FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity (CIO). The customer segments are defined by the patient population receiving the chemotherapy and the institutions/payers that facilitate and fund that care.

Pediatric cancer patients (1 month+) receiving cisplatin chemotherapy

This segment represents the initial, FDA-approved indication for PEDMARK^®. The patient pool is defined by localized, non-metastatic solid tumors requiring cisplatin. The risk of hearing loss in this group is substantial, historically ranging from 40% to 60% in pediatric cancer patients. You see the protective effect clearly in the data from the investigator-initiated trial in Japan, where hearing loss rates dropped to 16% (Brock grade) and 24% (ASHA criteria) when PEDMARK^® was used alongside cisplatin. The overall tumor response rate remained approximately 95%, confirming no interference with the chemotherapy's anti-cancer effects.

Adolescent and Young Adult (AYA) cancer patients on cisplatin regimens

This is a significant growth vector for Fennec Pharmaceuticals Inc., as noted by management. The AYA segment (ages 15-39) is a high-value target, with over 20,000 patients annually in the U.S. and Europe receiving cisplatin-based regimens. This market is estimated to represent a $200+ million addressable opportunity. The National Comprehensive Cancer Network (NCCN) gives PEDMARK^® a 2A endorsement for this population, signaling strong clinical guidance for adoption. Fennec Pharmaceuticals Inc. reported surpassing greater than 90% reimbursement for PEDMARK^® in the AYA population as of Q3 2024, which is crucial for access in this group, often treated in community settings.

Academic and large community oncology treatment centers

These centers are the primary points of care where cisplatin is administered and where prescribing decisions for supportive care are made. Fennec Pharmaceuticals Inc. has focused its commercial execution on Tier 1-5 accounts, which collectively account for over 60% of U.S. cisplatin prescriptions. The company's Q1 2025 results showed growth across both academic and community providers, with early wins cited at institutions like Tampa General Hospital, Rady Children's Hospital, and Huntsman Cancer Institute. The European launch of PEDMARQSI^®, handled by Norgine, also saw commercial availability in Germany in February 2025, and in the U.K. and Wales during Q1 2025.

Institutional payers and government healthcare programs (CMS)

Market acceptance and sales depend heavily on securing coverage and adequate reimbursement from these entities. The company has actively worked to strengthen its Fennec HEARS™ patient support program to include expanded payer reimbursement support. The success in the AYA segment is directly tied to payer coverage, as evidenced by the reported 90% reimbursement achievement in Q3 2024. Uncertainty related to third-party coverage and reimbursement is a noted risk in filings, making this segment critical for revenue realization. The company's strong gross profit margins, reported at 93%, suggest favorable unit economics once access is secured.

Oncologists and pediatric oncologists who defintely prescribe cisplatin

These are the prescribers whose behavior Fennec Pharmaceuticals Inc. seeks to influence through education and support programs like Fennec HEARS™. The total addressable population is large; approximately 500,000 patients annually in the U.S. are diagnosed with cancers that could be treated with a platinum-based chemotherapy. The target prescribers are those managing the high-volume cisplatin patients in the pediatric and AYA segments. The company's recent financial performance reflects engagement with these prescribers, with Q3 2025 net product sales reaching a record high of approximately $12.5 million, up from $7.0 million in Q3 2024, showing four consecutive quarters of double-digit growth.

Here's a quick look at the patient incidence and the demonstrated protective effect:

Patient Group / Metric	Relevant Number / Rate	Context / Data Source
Annual U.S. & Europe AYA Cisplatin Patients	20,000+	Patients aged 15-39 receiving cisplatin-based regimens.
Historical Pediatric Ototoxicity Rate (Cisplatin Alone)	56% (ASHA) / 63% (Brock)	Historical rates from pivotal Phase 3 trials (ACCL0431/SIOPEL 6).
Ototoxicity Rate with PEDMARK® (Japan Study)	16% (Brock) / 24% (ASHA)	Topline results from STS-J01 investigator-initiated trial.
Tumor Response Rate with PEDMARK®	Approx. 95%	Demonstrates no attenuation of cisplatin antitumor activity.
Q3 2025 Net Product Sales	Approx. $12.5 million	Highest quarterly net product sales in Fennec Pharmaceuticals Inc.'s history.

The commercial focus is clearly on driving adoption within these defined patient pathways, which is translating to financial results, with the company reporting its first profitable quarter from operations as of Q3 2025. The company's market capitalization was $296M as of November 18, 2025, with a stock price of $8.66.

Finance: draft 13-week cash view by Friday.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Cost Structure

You're looking at the expenses driving Fennec Pharmaceuticals Inc.'s commercial stage, especially as they push PEDMARK® adoption in the U.S. The cost structure is heavily weighted toward commercialization and maintaining the regulatory foundation for their product.

The primary cost drivers for Fennec Pharmaceuticals Inc. in the third quarter of 2025 reflect the ongoing investment required to support the U.S. launch and maintenance of PEDMARK®. Here's a snapshot of the key figures from the period ended September 30, 2025.

Cost Category	Q3 2025 Amount	Comparison Point (Q3 2024)
Selling and Marketing Expenses	$5.2 million	$4.6 million
General and Administrative (G&A) Expenses	$6.8 million	$6.1 million
Net Product Sales (Revenue Context)	$12.5 million	$7.0 million

That Selling and Marketing spend of $5.2 million in Q3 2025 shows the commitment to the U.S. launch; it was up from $4.4 million the prior quarter and $4.6 million year-over-year. That's where the money goes when you're building out a specialized commercial presence.

General and Administrative (G&A) costs were $6.8 million for the quarter. This line item bundles necessary overhead, including the costs associated with protecting and maintaining your intellectual property portfolio. What this estimate hides is the exact split between IP defense, routine overhead, and executive functions.

Manufacturing and Cost of Goods Sold (COGS) for PEDMARK are a direct cost against the $12.5 million in Q3 2025 net product sales. While the specific COGS number isn't broken out in the latest release, it's the variable cost directly tied to producing the drug that generated those sales. The company is focused on commercialization, so these costs scale with adoption.

Clinical development and regulatory maintenance costs are ongoing expenses necessary to support the product post-approval and explore new territories. You see this reflected in the overall operating expenses, even as the focus shifts to commercial execution. For instance, preliminary results from the investigator-initiated clinical trial (STS-J01) evaluating PEDMARK® in Japan are expected in the fourth quarter of 2025, which implies continued associated costs.

Personnel and compensation for the specialized commercial team are embedded within the Selling and Marketing and G&A figures. You can see how compensation components fluctuate:

• G&A expenses in Q1 2025 increased quarter-over-quarter primarily due to non-cash stock-based compensation.
• Looking back at fiscal 2023, non-cash expenses associated with equity remuneration increased by $1.4 million over 2022.
• Also in fiscal 2023, payroll and benefits related expenses rose by $1.1 million compared to 2022.
• The cash position as of September 30, 2025, stood at $21.9 million, which must cover these operating outlays.

Finance: draft 13-week cash view by Friday.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Revenue Streams

Fennec Pharmaceuticals Inc.'s revenue streams as of late 2025 are heavily anchored in the commercial success of its U.S. product, PEDMARK, supplemented by significant non-recurring and recurring income from its international partnership.

The primary driver for current operational revenue is the direct sale of the U.S. product, PEDMARK. You saw the latest quarterly performance:

• Net product sales of PEDMARK in the U.S. for Q3 2025 reached approximately $12.5 million.
• This Q3 2025 figure represented a 79% year-over-year growth for the quarter.

Looking at the cumulative performance for the year through the third quarter, the total net product sales were approximately $31.0 million for the first nine months of 2025. This total is derived from the reported quarterly sales:

• Q1 2025 Net Product Sales: approximately $8.8 million.
• Q2 2025 Net Product Sales: approximately $9.7 million.
• Q3 2025 Net Product Sales: approximately $12.5 million.

The second major component of the revenue stream comes from the exclusive licensing agreement with Norgine for PEDMARQSI in Europe, Australia, and New Zealand. This deal provides both immediate cash and future potential earnings.

The upfront and milestone payments structure is quite substantial:

Payment Type	Amount (EUR)	Amount (USD Equivalent)
Upfront Consideration	€40 million	$44 million or $43.6 million
Additional Milestones (Max)	Up to €210 million	Up to $229 million

Also, Fennec Pharmaceuticals Inc. is set to receive double-digit tiered royalties on PEDMARQSI net sales from Norgine in those licensed territories, with the tiers going up to the mid-twenties percent. This is recurring revenue tied directly to Norgine's commercial success in Europe, Australia, and New Zealand.

Finally, there is potential for future licensing revenue tied to ongoing clinical work outside the Norgine territories. Specifically, you're watching the results from Japan:

• Preliminary results from the investigator-initiated clinical trial (STS-J01) evaluating PEDMARK in Japan were expected in Q4 2025.

If those results are positive, it opens the door for potential future licensing revenue from new territories like Japan, which would represent another distinct revenue stream for Fennec Pharmaceuticals Inc.