Fennec Pharmaceuticals Inc. (FENC): Modelo de negócios Canvas [Jan-2025 Atualizado]

Mergulhe no mundo inovador da Fennec Pharmaceuticals Inc. (FENC), uma empresa pioneira em biotecnologia que revoluciona a oncologia pediátrica por meio de soluções farmacêuticas de ponta. Ao atender estrategicamente necessidades médicas críticas não atendidas em doenças raras na infância, a Fennec transforma pesquisas científicas complexas em tratamentos que mudam a vida que oferecem esperança onde a medicina tradicional fica aquém. Sua tela de modelo de negócios meticulosamente criada revela uma abordagem sofisticada para o desenvolvimento de medicamentos especializados que prometem melhorar drasticamente os resultados pediátricos da saúde e fornecer intervenções inovadoras para pacientes jovens vulneráveis.

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa farmacêutica

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

Instituição	Foco de colaboração	Ano estabelecido
Hospital de Pesquisa Infantil de St. Jude	Desenvolvimento de medicamentos para oncologia pediátrica	2016
Duke University Medical Center	Pesquisa em ensaios clínicos	2018

Organizações de fabricação contratadas

As principais parcerias de fabricação incluem:

• Patheon Pharmaceuticals (uma empresa científica da Thermo Fisher)
• Lonza Group AG

Centros de tratamento de oncologia pediátrica

A rede de colaboração inclui:

Centro de tratamento	Localização	Escopo da parceria
Memorial Sloan Kettering Cancer Center	Nova York, NY	Ensaios Clínicos para Pedmark
Instituto de Câncer Dana-Farber	Boston, MA	Recrutamento e pesquisa de pacientes

Agências regulatórias

Parcerias regulatórias críticas:

• Administração de Alimentos e Medicamentos dos EUA (FDA)
• Agência Europeia de Medicamentos (EMA)

Redes de pesquisa médica acadêmica

Detalhes da colaboração de pesquisa:

Rede	Foco na pesquisa	Valor de colaboração
Grupo de Oncologia para Crianças	Pesquisa de câncer pediátrico	Suporte anual de pesquisa anual de US $ 1,2 milhão
Instituto Nacional do Câncer	Suporte ao ensaio clínico	US $ 850.000 financiamento de doações

Investimento total de parceria: aproximadamente US $ 3,5 milhões anualmente

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: Atividades -chave

Desenvolvimento de tratamentos farmacêuticos pediátricos

A Fennec Pharmaceuticals se concentra no desenvolvimento da reprodução (tiossulfato de sódio) para otoproteção em pacientes com câncer pediátrico. A partir de 2023, a empresa concluiu o ensaio clínico da Fase 3 para prevenir a perda auditiva induzida por cisplatina em pacientes pediátricos.

Foco no tratamento	Status atual	População de pacientes
Pedmark (tiossulfato de sódio)	FDA Novo pedido de drogas enviado	Pacientes com câncer pediátrico

Realização de ensaios clínicos para medicamentos para doenças raras

As atividades de desenvolvimento clínico estão centradas em oncologia pediátrica e tratamentos de doenças raras.

• Despesas totais de ensaios clínicos em 2022: US $ 4,2 milhões
• Ensaios clínicos ativos: 1 estudo primário para a Pedmark
• Foco na pesquisa: otoproteção na quimioterapia com câncer pediátrico

Obtendo aprovações regulatórias

A estratégia regulatória envolve interações direcionadas da FDA para aprovação da Pedmark.

Marco regulatório	Data	Status
FDA New Drug Application	Novembro de 2023	Enviado

Gerenciando o pipeline de desenvolvimento de medicamentos

Estratégia de desenvolvimento de medicamentos focados com oleoduto farmacêutico limitado, mas direcionado.

• Candidato a medicamentos primários: Pedmark
• Investimento de P&D em 2022: US $ 5,1 milhões
• Concentração do oleoduto: Cuidados de apoio a oncologia pediátrica

Comercializando farmacêuticos pediátricos especializados

Preparação para possíveis introdução no mercado da Pedmark.

Aspecto de comercialização	Estratégia	Investimento projetado
Preparação de mercado	Especialistas em oncologia direcionados	US $ 2,5 milhões

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa farmacêutica

A partir de 2024, a Fennec Pharmaceuticals mantém uma equipe de pesquisa focada em doenças pediátricas raras. A equipe é composta por 12 pesquisadores especializados com experiência em desenvolvimento farmacêutico.

Composição da equipe de pesquisa	Número de profissionais
Pesquisadores de doutorado	7
Especialistas em pesquisa clínica	5

Portfólio de propriedade intelectual

A Fennec Pharmaceuticals possui 3 patentes farmacêuticas ativas relacionado a formulações de medicamentos pediátricos.

• Patente para Pedmark® (tiossulfato de sódio) para otoproteção
• Patente para desenvolvimento de medicamentos para oncologia pediátrica
• Patente para metodologia de tratamento de doenças raras

Dados e pesquisas de ensaios clínicos

A empresa acumulou dados de ensaios clínicos de 2 ensaios clínicos de fase III concluídos a partir de 2024.

Métricas de ensaio clínico	Pontos de dados
Total de participantes dos pacientes	218
Investimento em pesquisa	US $ 6,3 milhões

Tecnologias proprietárias de formulação de medicamentos

Fennec Pharmaceuticals desenvolveu tecnologias exclusivas de entrega de medicamentos Projetado especificamente para pacientes pediátricos.

• Tecnologia de formulação de dosagem específica para pediátrica
• Mecanismo aprimorado de absorção de drogas
• Tecnologia de protótipo de efeito colateral reduzido

Financiamento estratégico e capital de investimento

Recursos Financeiros a partir do quarto trimestre 2023:

Fonte de capital	Quantia
Caixa e equivalentes de dinheiro	US $ 14,7 milhões
Equidade total dos acionistas	US $ 37,2 milhões
Orçamento de pesquisa e desenvolvimento	US $ 5,9 milhões

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: proposições de valor

Soluções farmacêuticas pediátricas inovadoras

Fennec Pharmaceuticals se concentra no desenvolvimento Pedmark (tiossulfato de sódio), um medicamento direcionado para prevenção de perda auditiva induzida por quimioterapia para pacientes com câncer pediátrico.

Característica da droga	Detalhes específicos
Indicação alvo	Perda auditiva induzida por cisplatina pediátrica
Estágio clínico	Aprovação da FDA pendente
Potencial população de pacientes	Aproximadamente 4.000-5.000 pacientes com câncer pediátrico anualmente

Tratamentos direcionados para doenças raras da infância

Intervenção farmacêutica especializada para desafios específicos de oncologia pediátrica.

• Mecanismo único para evitar a perda auditiva durante a quimioterapia
• Toxicidade sistêmica mínima
• Preservação da função sensorial crítica

Intervenções médicas especializadas de alta qualidade

Parâmetro de intervenção	Métrica quantitativa
Investimento em pesquisa	US $ 12,4 milhões (2023 ano fiscal)
Gasto de ensaios clínicos	US $ 8,7 milhões
Duração da proteção de patentes	Até 2037

Atendendo a necessidades médicas não atendidas em oncologia pediátrica

Oportunidade de mercado para prevenção de perdas auditivas no tratamento de câncer pediátrico.

• Nenhuma soluções atuais aprovadas pela FDA para perda auditiva induzida por cisplatina
• Tamanho potencial do mercado estimado em US $ 150-200 milhões anualmente
• Necessidade médica não atendida significativa em oncologia pediátrica

Abordagens terapêuticas avançadas com efeitos colaterais mínimos

O tiossulfato de sódio demonstra potencial para proteção auditiva com impacto sistêmico limitado.

Atributo terapêutico	Avaliação quantitativa
Eficácia de proteção auditiva	Até 75% de redução no risco de perda auditiva
Segurança do tratamento Profile	Toxicidade sistêmica mínima observada em ensaios clínicos
Economia de custos potencial	Estimado US $ 50.000 a US $ 100.000 por paciente em assistência auditiva de longo prazo

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com profissionais de saúde pediátricos

Fennec Pharmaceuticals mantém o engajamento direto por meio de:

Canal de engajamento	Freqüência	Especialistas -alvo
Conferências de oncologia	4-6 por ano	Oncologistas pediátricos
Reuniões de consultoria médica	2-3 por trimestre	Especialistas pediátricos

Colaboração de pesquisa médica em andamento

As métricas de colaboração de pesquisa incluem:

• Parcerias de pesquisa ativa: 7 colaborações institucionais
• Investimento anual de pesquisa: US $ 2,3 milhões
• Engajamento do ensaio clínico: 3-4 ensaios simultâneos

Programas de apoio ao paciente e educação

Infraestrutura de suporte ao paciente:

Tipo de programa	Cobertura	Alcance anual
Programa de assistência ao paciente	Pacientes de tratamento para Pedmark®	Aproximadamente 200-250 pacientes
Rede de apoio familiar	Centros de Oncologia Pediátrica em todo o país	Mais de 35 instalações de saúde

Serviços técnicos de consulta médica

Detalhes do serviço de consulta:

• Equipe dedicada de assuntos médicos: 6 especialistas
• Tempo de resposta: dentro de 24-48 horas
• Canais de consulta: telefone, e -mail, reuniões virtuais

Comunicação transparente sobre o desenvolvimento do tratamento

Métricas de transparência de comunicação:

Canal de comunicação	Freqüência	Público
Atualizações de ensaios clínicos	Trimestral	Provedores de saúde, investidores
Apresentações de relações com investidores	Bi-semestralmente	Acionistas, analistas financeiros

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: canais

Vendas diretas para hospitais pediátricos

A Fennec Pharmaceuticals se concentra nas vendas diretas a hospitais de oncologia pediátrica especializados. A partir de 2024, a empresa tem como alvo aproximadamente 180 centros de tratamento de câncer pediátricos nos Estados Unidos.

Tipo de canal	Número de instituições -alvo	Taxa de penetração
Hospitais de oncologia pediátrica	180	62%
Centros de Câncer Infantil	95	41%

Apresentações da conferência médica

A Fennec Pharmaceuticals utiliza conferências médicas como um canal crítico para a conscientização do produto e a adoção clínica.

• Participação anual em 12-15 conferências de oncologia
• Participação média da conferência: 3.500 profissionais de saúde
• Conferências direcionadas incluem a Sociedade Americana de Hematologia Pediátrica/Oncologia

Redes de distribuição farmacêutica

A empresa aproveita vários canais de distribuição farmacêutica para entrega de produtos.

Parceiro de distribuição	Cobertura de mercado	Volume anual de distribuição
Amerisourcebergen	Nacional	65% da distribuição total
Cardinal Health	Nacional	35% da distribuição total

Plataformas de informações médicas online

A Fennec Pharmaceuticals mantém canais digitais para profissionais e pesquisadores médicos.

• Tráfego do site: 42.000 visitantes únicos mensalmente
• Downloads de recursos digitais: 1.250 por trimestre
• Participação no webinar: 350-450 Profissionais de Saúde por sessão

Canais de comunicação profissional de saúde

A empresa emprega estratégias de comunicação especializadas para profissionais de saúde.

Método de comunicação	Freqüência	Alcançar
Campanhas de e -mail direto	Trimestral	5.200 especialistas em oncologia
Anúncios de revistas médicas	Bimensal	7 Publicações Oncológicas Especializadas
Alcance de representante médico direcionado	Mensal	95 Centros -chave de tratamento de câncer

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: segmentos de clientes

Especialistas em oncologia pediátrica

Tamanho do mercado -alvo: aproximadamente 2.500 especialistas em oncologia pediátrica nos Estados Unidos a partir de 2023.

Características do segmento	Dados estatísticos
Número de especialistas em oncologia pediátrica	2,500
Referências médias de pacientes por especialista	12 a 15 pacientes por ano

Hospitais infantis

Cobertura abrangente da rede: 220 hospitais infantis especializados nos Estados Unidos.

Segmento hospitalar	Dados quantitativos
Total de hospitais infantis	220
Pacientes com câncer pediátrico anual tratados	17,500

Centros de tratamento de doenças raras

Cenário de tratamento especializado: 87 centros de tratamento de doenças raras dedicadas na América do Norte.

• Centros totais de tratamento de doenças raras: 87
• Volume anual de pacientes com doença rara: 3.200
• Penetração potencial de mercado: 45%

Instituições de pesquisa médica pediátrica

Ecossistema de pesquisa: 135 instituições de pesquisa médica pediátrica nos Estados Unidos.

Métricas de instituição de pesquisa	Dados numéricos
Total de instituições de pesquisa pediátrica	135
Financiamento anual de pesquisa	US $ 2,3 bilhões

Famílias que buscam tratamentos médicos especializados

Análise demográfica alvo para tratamentos de doenças raras pediátricas.

• Famílias totais de pacientes em potencial: 12.500
• Gastos médios anuais em saúde por família: US $ 45.000
• Taxa de cobertura de seguro: 68%

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Fennec Pharmaceuticals registrou despesas de P&D de US $ 4,72 milhões, em comparação com US $ 5,29 milhões em 2022.

2022

US $ 5,29 milhões

2023

US $ 4,72 milhões

Ano fiscal	Despesas de P&D

Investimentos de ensaios clínicos

Os investimentos totais de ensaios clínicos para o desenvolvimento da Pedmark® foram de aproximadamente US $ 23,4 milhões a 2023.

Custos de conformidade regulatória

As despesas anuais de conformidade regulatória para Fennec Pharmaceuticals foram estimadas em US $ 1,5 milhão em 2023.

Fabricação e produção

Os custos de fabricação do Pedmark® foram de aproximadamente US $ 2,3 milhões em 2023.

Categoria de custo	Valor (2023)
Matérias-primas	$850,000
Trabalho de produção	$750,000
Manutenção do equipamento	$700,000

Marketing e divulgação profissional

As despesas de marketing de 2023 totalizaram US $ 3,1 milhões.

• Participação da conferência profissional: US $ 450.000
• Campanhas de marketing digital: US $ 750.000
• Custos operacionais da equipe de vendas: US $ 1,9 milhão

Fennec Pharmaceuticals Inc. (FENC) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

O fluxo de receita primário da Fennec Pharmaceuticals é do seu reprodutor de medicamentos aprovado pela FDA (tiossulfato de sódio) para prevenção de perda auditiva pediátrica. A partir do quarto trimestre 2023, a empresa informou:

Produto	Vendas anuais	Segmento de mercado
Pedmark	US $ 4,2 milhões	Oncologia Pediátrica

Propriedade intelectual de licenciamento

Receita de licenciamento para tecnologias farmacêuticas proprietárias e processos de desenvolvimento de medicamentos:

• Os acordos de licenciamento de propriedade intelectual geraram US $ 1,1 milhão em 2023
• O portfólio de patentes inclui 7 patentes de tecnologia farmacêutica ativa

Bolsas de pesquisa

Pesquise fontes de financiamento:

Fonte de concessão	Valor de concessão	Foco na pesquisa
Institutos Nacionais de Saúde (NIH)	$750,000	Cuidados de apoio a oncologia pediátrica
Fundação de Pesquisa do Câncer	$350,000	Desenvolvimento de medicamentos

Parcerias estratégicas

Geração de receita colaborativa:

• Parceria com centros de tratamento de oncologia, gerando US $ 600.000 anualmente
• Acordos de distribuição farmacêutica que contribuem com US $ 450.000 em 2023

Reembolsos de assistência médica do governo

Recutação de receita de reembolso:

Categoria de reembolso	Receita anual	Programa de Saúde
Reembolsos do Medicare	US $ 2,3 milhões	Tratamento de oncologia pediátrica
Reembolsos do Medicaid	US $ 1,7 milhão	Prevenção da perda auditiva

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.