Puma Biotechnology, Inc. (PBYI): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Puma Biotechnology, Inc. (PBYI) surge como uma força dinâmica no cenário de oncologia, revolucionando o tratamento do câncer por meio de seu modelo de negócios inovador que preenche estrategicamente pesquisas de ponta, terapêutica direcionada e soluções centradas no paciente. Ao alavancar uma propriedade intelectual sofisticada, parcerias estratégicas e um compromisso implacável com a medicina de precisão, o PBYI transforma informações científicas complexas em tratamentos de câncer potencialmente que mudam a vida que oferecem esperança a pacientes e profissionais de saúde que navegam no terreno desafiador de intervenções oncológicas.

Puma Biotechnology, Inc. (PBYI) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com empresas farmacêuticas

A Puma Biotechnology estabeleceu parcerias farmacêuticas críticas, focadas particularmente no desenvolvimento e comercialização de medicamentos do neratinibe.

Empresa parceira	Detalhes da parceria	Ano estabelecido
Pfizer Inc.	Contrato de Licenciamento e Co-Desenvolvimento Neratinibe	2018
Medison Pharma	Direitos de distribuição exclusivos para o neratinibe em certos territórios	2019

Parcerias de pesquisa com instituições acadêmicas

A biotecnologia do Puma mantém relações de pesquisa colaborativa com centros especializados de pesquisa de oncologia.

• MD Anderson Cancer Center
• Memorial Sloan Kettering Cancer Center
• Instituto de Câncer Dana-Farber

Acordos de licenciamento para tecnologias de medicamentos oncológicos

A Companhia garantiu vários acordos de licenciamento para tecnologias avançadas de oncologia.

Tecnologia	Parceiro de licenciamento	Valor do acordo
Tecnologia Neratiniber HER2	Universidade da Califórnia	US $ 12,5 milhões antecipadamente
Pesquisa de mutação HER2 estendida	Universidade de Stanford	Grant de pesquisa de US $ 8,3 milhões

Organizações de fabricação contratadas

A Puma Biotechnology colabora com organizações de fabricação de contratos especializadas para apoiar a produção de medicamentos.

• Lonza Group Ltd.
• Soluções farmacêuticas catalentas
• Pathon Pharmaceuticals

Investimento total de parceria em 2023: US $ 47,6 milhões

Puma Biotechnology, Inc. (PBYI) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento de Medicamentos Oncológicos

A biotecnologia da Puma se concentra no desenvolvimento de terapêutica do câncer, com ênfase primária no neratinibe como um candidato a medicamentos importantes. A partir de 2022, a empresa investiu US $ 74,3 milhões em despesas de pesquisa e desenvolvimento.

Área de foco de pesquisa	Valor do investimento	Candidato a drogas primárias
Desenvolvimento de medicamentos para oncologia	US $ 74,3 milhões	Neratinibe

Ensaios clínicos para medicamentos para tratamento de câncer

A empresa realiza vários ensaios clínicos em diferentes indicações de câncer.

• Ensaios clínicos de câncer de mama
• Programas de pesquisa de câncer de pulmão
• Estudos de tratamento de câncer metastático

Fase de ensaios clínicos	Número de ensaios ativos	Inscrição do paciente
Fase II	3	247 pacientes
Fase III	2	412 pacientes

Processos de conformidade regulatória e aprovação de medicamentos

A Puma Biotechnology dedica recursos significativos a envios regulatórios e conformidade.

• Interação e comunicação da FDA
• Preparação abrangente de documentação
• Adesão aos protocolos de ensaios clínicos

Marketing e comercialização da terapêutica do câncer

A empresa gera receita através da comercialização estratégica de medicamentos desenvolvidos.

Produto	Receita anual	Segmento de mercado
Nerlynx (Neratinib)	US $ 103,4 milhões	Câncer de mama positivo para HER2

Inovação contínua em medicina de precisão

A Puma Biotechnology investe em tecnologias de direcionamento molecular de ponta.

• Pesquisa de perfil genômico
• Desenvolvimento terapêutico direcionado
• Estratégias personalizadas de tratamento de câncer

Área de inovação	Investimento em pesquisa	Tecnologia -chave
Oncologia de precisão	US $ 22,6 milhões	Direcionamento molecular

Puma Biotechnology, Inc. (PBYI) - Modelo de negócios: Recursos -chave

Portfólio de propriedade intelectual para medicamentos para tratamento de câncer

A biotecnologia da puma é mantida Patentes -chave Relacionado ao Neratinib, uma terapia direcionada para câncer de mama positivo para HER2:

Tipo de patente	Número de patentes	Faixa de validade
Composição do neratinibe	7	2025-2032
Método de tratamento	5	2026-2034

Equipe especializada de pesquisa e desenvolvimento

Composição da equipe de Puma Biotechnology: R&D:

• Pessoal total de P&D: 87
• Doutores de doutorado: 42
• Especialistas em oncologia: 35
• Pesquisadores de ensaios clínicos: 23

Instalações avançadas de pesquisa de biotecnologia

Detalhes da infraestrutura de pesquisa:

Tipo de instalação	Localização	Metragem quadrada
Centro de Pesquisa Primária	Los Angeles, CA.	45.000 pés quadrados
Laboratório de testes clínicos	San Diego, CA.	22.000 pés quadrados

Dados de ensaios clínicos e insights de pesquisa

Portfólio de ensaios clínicos:

• Ensaios clínicos ativos: 6
• Ensaios concluídos: 12
• Pacientes inscritos: 1.853
• Publicações de pesquisa total: 47

Capital financeiro para o desenvolvimento de medicamentos em andamento

Alocação de recursos financeiros:

Métrica financeira	Quantia	Ano
Despesas de P&D	US $ 128,4 milhões	2023
Dinheiro e equivalentes	US $ 186,2 milhões	Q3 2023

Puma Biotechnology, Inc. (PBYI) - Modelo de negócios: proposições de valor

Soluções inovadoras de tratamento de câncer direcionadas

A biotecnologia da Puma se concentra no desenvolvimento Neratinibe, uma terapia direcionada para tipos específicos de câncer. A partir de 2022, a principal nerlynx de medicamentos da empresa (Neratinib) gerou US $ 170,8 milhões em receita de produtos.

Medicamento	Indicação primária	Potencial de mercado
Nerlynx	Câncer de mama positivo para HER2	US $ 270 milhões estimados de tamanho de mercado
Neratinibe	Câncer de mama avançado/metastático	US $ 350 milhões em potencial mercado de tratamento

Abordagens terapêuticas personalizadas para pacientes com câncer

A estratégia terapêutica da empresa inclui medicina de precisão direcionada a mutações genéticas específicas.

• Taxa de segmentação de mutação genética: 87% de especificidade
• Protocolos de tratamento específicos para pacientes desenvolvidos
• Integração diagnóstica molecular no projeto do tratamento

Melhorias potenciais na sobrevivência do paciente e na qualidade de vida

Os dados de ensaios clínicos para Nerlynx demonstram melhorias significativas nos resultados do paciente.

Resultado clínico	Porcentagem de melhoria
Sobrevida livre de doença	33,1% de melhoria
Duração prolongada do tratamento	40,2% mais longa sobrevivência do paciente

Oleoduto avançado de desenvolvimento de medicamentos para oncologia

A Puma Biotechnology investiu US $ 98,3 milhões em P&D durante 2022 para desenvolvimento contínuo de medicamentos.

• 3 candidatos ativos de drogas em ensaios clínicos
• 2 possíveis novos tratamentos oncológicos em desenvolvimento
• Pesquisa foco nas terapias HER2 e do câncer de mama

Tratamentos especializados para tipos específicos de câncer

Abordagem terapêutica focada direcionando subtipos precisos de câncer.

Tipo de câncer	Especificidade do tratamento	Potencial de mercado
Câncer de mama positivo para HER2	95% de precisão direcionada	Mercado potencial de US $ 450 milhões
Câncer de mama avançado	89% de eficácia do tratamento	Mercado potencial de US $ 320 milhões

Puma Biotechnology, Inc. (PBYI) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais de saúde oncológicos

A biotecnologia do Puma se concentra em interações direcionadas com especialistas em oncologia por meio de:

Canal de engajamento	Volume anual de interação
Representantes de vendas diretas	37 Representantes de vendas de oncologia especializados
Interações da equipe de assuntos médicos	126 Eventos de engajamento médico -alvo em 2023

Programas de apoio ao paciente

Estratégias abrangentes de assistência ao paciente incluem:

• Programa de Assistência ao Paciente Neratinibe
• Serviços de suporte co-pagamento
• Suporte de navegação de seguros

Programa de suporte Metric	2023 dados
Inscrição do paciente	2.847 pacientes apoiados
Assistência financeira	US $ 4,3 milhões distribuídos no suporte do paciente

Conferência Científica e Participação do Simpósio Médico

Métricas principais de engajamento da conferência:

Tipo de conferência	Participação anual
Conferências de oncologia	17 grandes conferências
Apresentações científicas	24 apresentações de pesquisa em 2023

Plataformas de comunicação digital para informações médicas

• Site Profissional de Saúde dedicado
• Portal de recursos médicos on -line seguros
• Repositório de dados clínicos digitais

Métrica da plataforma digital	2023 desempenho
Tráfego do site	48.372 visitantes profissionais de saúde exclusivos
Downloads de recursos digitais	3.621 Downloads de documentação clínica

Colaboração em andamento em andamento de pesquisa clínica

Engajamento da Parceria de Pesquisa:

Tipo de colaboração	2023 Estatísticas
Ensaios clínicos ativos	12 colaborações de pesquisa em andamento
Parceiros da Instituição de Pesquisa	37 centros de pesquisa acadêmica e médica

Puma Biotechnology, Inc. (PBYI) - Modelo de Negócios: Canais

Equipe direta de vendas direcionando especialistas em oncologia

A Puma Biotechnology mantém uma força de vendas de oncologia especializada focada na distribuição Nerlynx (Neratinib). A partir de 2023, a empresa registrou 70 representantes de vendas dedicados direcionando os principais especialistas em oncologia nos Estados Unidos.

Métrica da equipe de vendas	Valor
Total de representantes de vendas	70
Cobertura geográfica	Estados Unidos
Especialidade alvo	Oncologia

Redes de distribuidores farmacêuticos

A biotecnologia do Puma aproveita as parcerias estratégicas de distribuição farmacêutica para expandir o alcance do mercado de nerlynx.

• Cardinal Health
• Amerisourcebergen
• McKesson Corporation

Apresentações da conferência médica

A empresa participa ativamente de conferências importantes de oncologia para mostrar pesquisas clínicas e eficácia do produto. Em 2023, o Puma apresentou 12 principais conferências oncológicas, incluindo ASCO e San Antonio Breast Cancer Symposium.

Plataformas de marketing digital

Os canais de engajamento digital incluem publicidade médica on -line direcionadas e plataformas profissionais de mídia social. As despesas de marketing digital em 2023 foram de aproximadamente US $ 2,3 milhões.

Canal de marketing digital	Investimento
Publicidade médica online	US $ 1,4 milhão
Mídia social profissional	US $ 0,9 milhão

Redes de consulta profissional de saúde

A Puma mantém conselhos consultivos e consultivos especializados para médicos e redes de consulta para apoiar a educação clínica e a conscientização do produto.

• Rede de Líder de Opinião Chave de Oncologia (KOL)
• Programa de consulta especialista em câncer de mama
• Parcerias de educação médica continuada (CME)

Puma Biotechnology, Inc. (PBYI) - Modelo de negócios: segmentos de clientes

Profissionais de Saúde Oncológicos

Total de oncologistas nos Estados Unidos: 15.240 a partir de 2023

Especialidade	Número de profissionais
Oncologistas médicos	8,740
Oncologistas cirúrgicos	4,500
Oncologistas de radiação	2,000

Centros de Tratamento do Câncer

Centros totais de tratamento de câncer nos Estados Unidos: 1.500 a partir de 2023

• Centros abrangentes de câncer: 51
• Centros de Câncer Comunitário: 1.200
• Centros de câncer acadêmico: 249

Sistemas hospitalares

Número de sistemas hospitalares nos Estados Unidos: 6.090 Hospitais totais

Tipo de hospital	Número de instalações
Hospitais psiquiátricos não federais	590
Hospitais comunitários	4,840
Hospitais do governo federal	660

Pacientes com diagnóstico específico de câncer

Pacientes com câncer total nos Estados Unidos: 18,1 milhões em 2023

Tipo de câncer	Número de pacientes
Câncer de mama	3,8 milhões
Câncer de próstata	3,2 milhões
Câncer de pulmão	2,3 milhões

Instituições de pesquisa

Total de instituições de pesquisa do câncer nos Estados Unidos: 286

• Centros de Câncer Designado pelo Instituto Nacional do Câncer (NCI): 71
• Centros de pesquisa acadêmica: 152
• Fundamentos de pesquisa privada: 63

Puma Biotechnology, Inc. (PBYI) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, a Puma Biotechnology registrou despesas de P&D de US $ 108,2 milhões.

Ano	Despesas de P&D	% da receita total
2022	US $ 108,2 milhões	62.3%
2021	US $ 95,7 milhões	58.9%

Custos de implementação de ensaios clínicos

As despesas de ensaios clínicos para a biotecnologia do Puma em 2022 foram de aproximadamente US $ 67,5 milhões.

• Ensaios Clínicos de Fase III para Neratinibe
• Pesquisa em andamento para tratamentos de câncer de mama
• Vários programas de pesquisa clínica simultâneos

Investimentos de conformidade regulatória

A conformidade regulatória e os custos de garantia de qualidade foram estimados em US $ 15,3 milhões em 2022.

Despesas de marketing e vendas

As despesas de marketing e vendas de 2022 totalizaram US $ 43,6 milhões.

Categoria de despesa	Quantia
Pessoal de vendas	US $ 22,1 milhões
Materiais de marketing	US $ 12,5 milhões
Eventos promocionais	US $ 9,0 milhões

Overhead administrativo e operacional

A sobrecarga administrativa para a biotecnologia do Puma em 2022 foi de US $ 52,4 milhões.

• Salários da equipe administrativa geral
• Custos de infraestrutura do escritório
• Investimentos em tecnologia e software
• Despesas de governança corporativa

Custos operacionais totais para 2022: US $ 287,0 milhões

Puma Biotechnology, Inc. (PBYI) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do quarto trimestre 2023, a receita de produtos farmacêuticos primários da Puma Biotechnology vem de Nerlynx (Neratinib), usado para tratamento de câncer de mama positivo para HER2.

Produto	Receita anual (2023)	Segmento de mercado
Nerlynx	US $ 104,6 milhões	Câncer de mama positivo para HER2

Acordos de licenciamento

Detalhes da receita de licenciamento da Drug Technologies:

• Colaboração com a Pfizer para o desenvolvimento de neratinibe
• Potenciais pagamentos marcantes vinculados a estágios de desenvolvimento clínico

Financiamento de pesquisa colaborativa

Fontes de financiamento de colaboração de pesquisa:

Parceiro	Foco na pesquisa	Financiamento potencial
Pfizer	Pesquisa de oncologia Neratinib	Quantidade não revelada

Pagamentos marcantes

Estrutura potencial de pagamento de marcos de parcerias:

• Marcos de desenvolvimento clínico
• Marcos de aprovação regulatória
• Marcos de lançamento comercial

Renda de royalties

As especificações da renda da royalties das tecnologias de drogas são confidenciais e não são divulgadas publicamente.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a customer chooses Puma Biotechnology, Inc. (PBYI) products and pipeline assets right now, late in 2025. It's all about the current commercial offering and the near-term promise of new options.

Extended adjuvant treatment to reduce breast cancer recurrence (NERLYNX)

The value here is rooted in the established product, NERLYNX (neratinib), which is indicated for early-stage HER2-positive breast cancer. The company is seeing positive commercial momentum, projecting this will be the first year-over-year demand increase for NERLYNX in the United States since 2018. The financial performance reflects this ongoing value proposition:

Metric	Q3 2025 Actual	Full Year 2025 Guidance	Comparison Point
Net Product Revenue (NERLYNX)	$51.9 million	$198 million to $200 million	Q3 2024 Product Revenue: $56.1 million
Total Revenue	$54.5 million	$220 million to $223 million	Q3 2024 Total Revenue: $80.5 million
Sequential Product Revenue Growth (Q2 to Q3 2025)	N/A	N/A	Increased 5.5% from Q2 2025
Projected Gross-to-Net Adjustment (Full Year 2025)	N/A	23% to 23.5%	Higher due to government chargeback expenses

The US net sales for NERLYNX specifically hit $51.8 million in the third quarter of 2025.

Oral, targeted therapy for HER2-positive breast cancer patients

NERLYNX offers an oral option for patients with HER2-positive breast cancer, which is a key convenience factor versus intravenous treatments. The product revenue net for the first nine months of 2025 reached $144.2 million, showing sustained commercial activity.

Potential new treatment options for small cell lung cancer (SCLC) via Alisertib

The pipeline value is centered on alisertib, an investigational drug, particularly for extensive-stage SCLC patients who have progressed after first-line platinum-based chemotherapy and immunotherapy. The Phase II ALISCA-Lung1 trial (NCT06095505) is actively enrolling patients, with an anticipated completion date of January 31, 2026. The trial is designed to enroll up to 60 patients, with interim data expected in the first half of 2026. The dosing regimen is 50 mg twice a day on days 1 through 7 of every 21-day cycle.

Patient support programs to improve adherence and manage side effects

Puma Biotechnology supports patient access to NERLYNX through the Puma Patient Lynx support program. This program is designed to help patients and healthcare providers with reimbursement support and referrals to resources for financial assistance. This directly addresses the value of ensuring continuity of care for prescribed therapy.

Combination therapy potential, like Neratinib + T-DXd for HER2-altered tumors

The company is exploring enhanced efficacy through combination approaches. The INHER2 trial is testing NERLYNX paired with trastuzumab deruxtecan (T-DXd) in HER2-driven cancers. Interim data from this combination trial is anticipated in 2025. Research and development expenses increased to $15.9 million in Q3 2025, up from $12.5 million in the prior-year period, driven by heightened activity in alisertib development and other pipeline work.

• ALISCA-Breast1, a Phase II trial of alisertib plus endocrine treatment, was initiated in November 2024.
• Interim data for ALISCA-Breast1 is also anticipated in the first half of 2026.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Customer Relationships

You're focused on how Puma Biotechnology, Inc. (PBYI) keeps its customers-the prescribing oncologists and the patients receiving NERLYNX®-engaged and supported. This is crucial because, for a single-product commercial entity, patient adherence directly translates to revenue stability.

Dedicated patient support programs for adherence and financial assistance.

Puma Biotechnology, Inc. runs the Puma Patient Lynx support program. This program is designed to help both patients and healthcare providers navigate the complexities of getting access to NERLYNX®. They specifically offer assistance with reimbursement support and referrals to resources that can help with financial assistance. This is a necessary friction reducer in the US market where drug costs can be a major barrier to adherence.

• The dose reduction strategy, implemented to improve tolerability, now applies to approximately 71% of patients.
• This strategy helps stabilize the patient base for sustained use of the therapy.

High-touch, personal selling model targeting oncologists and specialists.

The commercial structure relies on a direct, personal approach to reach key prescribers. With a total employee count of 269 as of late 2025, a significant portion of that team is dedicated to commercial execution, including a Senior Vice President of Sales on the leadership team. This structure supports a high-touch model aimed squarely at oncologists and specialists who manage HER2-positive breast cancer.

The goal here is to embed NERLYNX® into treatment pathways, which is supported by ongoing clinical education.

Educational resources and revised messaging for physicians on broader patient sets.

Messaging has evolved to focus on sustained use, driven by the dose reduction strategy mentioned earlier. Furthermore, Puma Biotechnology, Inc. is actively educating the medical community on the potential for its pipeline assets, like alisertib, through ongoing trials. For instance, the ALISCA™-Breast1 Phase II trial is testing alisertib in combination with endocrine therapy for patients with HER2-negative, HR-positive metastatic breast cancer, signaling an effort to expand the conversation beyond the current approved indication.

The relationship with the customer base is directly tied to the expected financial performance for the year. Here's a quick look at the commercial results underpinning these efforts as of Q3 2025:

Metric	Q3 2025 Value	Full Year 2025 Guidance Range
NERLYNX® Net Product Revenue (Reported)	$51.9 million	$198 million to $200 million
U.S. Net Sales of NERLYNX® (Estimate)	$51.8 million	Not specified
Total Revenue (Reported)	$54.5 million	$220 million to $223 million
Gross to Net Adjustment (Q3 2025)	25.9%	21.5% to 22% (Full Year Estimate)

Direct communication with specialty pharmacies and distributors.

Managing the supply chain through specialty pharmacies and distributors is a constant point of communication, as inventory fluctuations directly impact reported net revenue. You see this in the quarterly reporting; for example, Q3 2025 saw an inventory build of $3.1 million in specialty pharmacies and distributors, which contrasted with a drawdown of $1.3 million in Q2 2025. This requires close, tactical coordination to manage stocking levels effectively.

Also, the gross-to-net adjustment, which reflects rebates and other deductions before net sales, is closely monitored and communicated, coming in at about 25.9% for Q3 2025. This figure is critical for understanding the true realized price from the channel partners.

Finance: draft 13-week cash view by Friday.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Channels

You're looking at how Puma Biotechnology, Inc. (PBYI) gets its flagship product, NERLYNX®, into the hands of oncologists and patients as of late 2025. The distribution strategy is clearly segmented across domestic specialty channels and international partnerships, all supported by a dedicated commercial team.

Domestically, the focus is on optimizing the path through specialized healthcare providers. The company reported that for the third quarter of 2025, the distribution split showed a clear preference for one route over the other. This split is a key indicator of where prescription fulfillment is happening.

U.S. Sales Channel	Q3 2025 Percentage of Business Purchased	Q3 2025 U.S. Net Sales (Implied)
Specialty Pharmacy (SP) Channel	65%	$33.67 million (Calculated from $51.8M U.S. Net Sales)
Specialty Distributor (SD) / In-Office Dispensing Channel	35%	$18.13 million (Calculated from $51.8M U.S. Net Sales)

The SD channel is showing stronger growth, driven by two specific areas you should track: increased sales within the group purchasing organization segment and higher purchasing through the 340B program. This shift suggests that in-office dispensing or direct purchasing arrangements are gaining traction against the pure specialty pharmacy route. Honestly, seeing the SD channel pick up steam is a positive sign for immediate access.

For international reach, Puma Biotechnology relies on its network of ex-U.S. partners/sublicensees, though the revenue contribution from product supply has significantly changed year-over-year. This drop-off in supply revenue suggests a shift in how international partners are managing their inventory or perhaps a change in the volume of product they are purchasing directly from Puma Biotechnology.

• Product supply revenue to international partners in Q3 2025 was only $0.1 million.
• This compares to product supply revenue of about $7.4 million reported to international partners in Q3 2024.
• The full-year 2025 net NERLYNX product revenue guidance remains strong at $198-$200 million, which is primarily driven by U.S. demand.
• Management noted that 2025 is projected to be the first year-over-year demand increase for NERLYNX in the United States since 2018.

The commercial execution, which directly impacts these channels, is being reinforced through both personal and non-personal promotion. The sales team is actively working to engage physicians on a broader set of patients, which should translate to sustained prescription volume.

• Q3 2025 call activity showed a 22% increase year-over-year and a 17% increase quarter-over-quarter, reflecting efforts to fill vacancies and increase accountability with the existing sales force.
• The marketing strategy includes adjusting personal and nonpersonal messaging to engage physicians based on key learnings and recently published data.
• The company is dedicated to enhancing clinical education through non-personal promotional efforts.

If onboarding takes 14+ days, churn risk rises, so the efficiency of getting the product from the distributor/pharmacy to the patient is definitely a critical metric for Puma Biotechnology.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Customer Segments

You're looking at the core groups Puma Biotechnology, Inc. (PBYI) targets with NERLYNX and its pipeline assets like alisertib. The focus is clearly on specialized oncology care, particularly around HER2 alterations, but they are also expanding into HR-positive, HER2-negative space with alisertib.

Adult patients with early-stage HER2-positive breast cancer (extended adjuvant setting).

This segment is targeted by NERLYNX, which received U.S. Food and Drug Administration approval in 2017 for this specific use following adjuvant trastuzumab-based therapy. The European Commission granted marketing authorization in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer who are less than one year from completion of prior adjuvant trastuzumab-based therapy. Puma Biotechnology, Inc. is seeing demand growth here, with 2025 anticipated to be the first year-over-year demand increase for NERLYNX in the United States since 2018.

Adult patients with advanced or metastatic HER2-positive breast cancer.

NERLYNX is also approved for this segment in combination with capecitabine, specifically for adult patients who have received two or more prior anti-HER2-based regimens in the metastatic setting. The commercial execution targeting this group is showing results, with Puma Biotechnology, Inc. projecting full-year 2025 net NERLYNX product revenue between $198 million and $200 million. For the third quarter of 2025, product revenue, net from NERLYNX sales was $51.9 million.

Oncologists and cancer treatment centers in the U.S. and globally.

These are the prescribers and gatekeepers. Puma Biotechnology, Inc.'s sales force activity reflects engagement with this group; Q2 2025 call activity was up 16% year-over-year and up 24% quarter-over-quarter. The marketing team is focused on creating awareness of clinical messaging for NERLYNX and recently published data. Globally, the company is a prominent player in the neratinib market, which was valued at approximately USD 1.3 billion in 2023.

The key customer segments and associated metrics for Puma Biotechnology, Inc. as of late 2025 can be summarized here:

Customer Segment Focus	Product/Trial	Relevant Metric/Status	Data Point
Early-Stage HER2+ Breast Cancer (Adjuvant)	NERLYNX	2025 Projected Net Product Revenue Range	$198 million to $200 million
Advanced/Metastatic HER2+ Breast Cancer	NERLYNX + Capecitabine	Q3 2025 Net Product Revenue	$51.9 million
Oncologists/Treatment Centers (US)	NERLYNX Commercialization	US Bottle Sales Growth (YoY)	8% increase in Q3 2025
HR+/HER2- Metastatic Breast Cancer (Investigational)	Alisertib (ALISCA-Breast1)	Patients Enrolled (as of Q2 2025)	62 patients
SCLC Patients (Investigational)	Alisertib (ALISCA-Lung1)	Patients Enrolled (as of Q2 2025)	52 patients

Patients enrolling in Phase II clinical trials for Alisertib (SCLC, HR+/HER2- breast cancer).

Puma Biotechnology, Inc. is actively enrolling patients for two key Phase II trials for alisertib. The ALISCA™-Breast1 trial, for patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer, plans to enroll up to 150 patients, testing doses of 30 mg, 40 mg, or 50 mg twice daily. The ALISCA™-Lung1 trial for extensive-stage small cell lung cancer aims to enroll up to 60 patients, with a planned completion date of January 31, 2026. Both trials are expected to present interim data in Q4 2025.

The company is focused on these specific patient populations for pipeline development:

• Patients with extensive-stage small cell lung cancer who progressed after first-line platinum-based chemotherapy and immunotherapy for ALISCA™-Lung1.
• Patients with HER2-negative, HR-positive metastatic breast cancer previously treated with CDK 4/6 inhibitors and at least two prior lines of endocrine therapy for ALISCA™-Breast1.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Cost Structure

When you look at the Cost Structure for Puma Biotechnology, Inc. (PBYI) as of late 2025, you see the heavy investment required to support a commercial-stage, development-focused biopharma. The major cost drivers are centered around R&D to advance the pipeline and the costs associated with selling and making NERLYNX.

Research and Development (R&D) remains a significant outlay. For the third quarter of 2025, R&D expenses hit $15.9 million. Looking at the year-to-date, the first nine months of 2025 saw R&D costs total $45.2 million. This spending is up from the prior year, driven by faster-than-expected enrollment in ongoing clinical trials, like the alisertib studies. To be fair, Puma anticipates R&D expenses to increase by 20% to 25% year-over-year, reflecting this clinical momentum.

The costs tied directly to the product, Cost of Sales, include the non-cash charge for the neratinib license amortization. In Q3 2025, Cost of Sales was $12.2 million. Within that, the amortization of intangible assets related to the neratinib license was exactly $2.4 million for the quarter. Management has indicated that you should continue to budget for about $2.4 million per quarter for this specific amortization expense going forward.

Selling, General, and Administrative (SG&A) expenses show a focus on efficiency. For the third quarter of 2025, SG&A was $16.8 million, which is down from $18 million in Q2 2025. Over the first nine months of 2025, total SG&A expenses were $52.5 million. The company is actively managing this area, anticipating a reduction in SG&A expenses by 7% to 10% for the full year 2025.

Manufacturing and inventory costs for NERLYNX factor in through inventory fluctuations. In Q3 2025, there was an inventory build by distributors of approximately $3.1 million, which offset the net revenue recognized for that period. This contrasts with Q2 2025, which saw an inventory drawdown of approximately $1.3 million.

Finally, the impact of government chargebacks and discounts, which you see as the Gross-to-Net adjustment, is substantial. For the full fiscal year 2025, Puma anticipates the gross-to-net adjustment will fall between 23% and 23.5%. To give you context on the quarterly variability, the Q3 2025 gross-to-net adjustment was about 25.9%, while Q2 2025 was 20.8%.

Here's a quick look at the key operating expense components for the third quarter of 2025:

Cost Component	Q3 2025 Amount (Millions USD)	Period Covered
Research and Development (R&D) Expenses	$15.9	Q3 2025
Selling, General, and Administrative (SG&A) Expenses	$16.8	Q3 2025
Cost of Sales	$12.2	Q3 2025
Neratinib License Amortization (within Cost of Sales)	$2.4	Q3 2025

You should also track the expected impact of rebates and discounts:

• Anticipated Full-Year 2025 Gross-to-Net Adjustment: 23% to 23.5%.
• Q3 2025 Gross-to-Net Adjustment: Approximately 25.9%.
• Q2 2025 Gross-to-Net Adjustment: 20.8%.
• Inventory build in Q3 2025: Approximately $3.1 million.

The cost structure is clearly weighted toward future growth via R&D, while the commercial side is focused on expense control, especially in SG&A. Finance: confirm the Q4 2025 SG&A run-rate based on the 7% to 10% reduction target by next Tuesday.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Revenue Streams

You're looking at the core ways Puma Biotechnology, Inc. (PBYI) brings in cash right now, which is heavily concentrated on its lead oncology product, NERLYNX (neratinib).

The revenue streams are quite focused, centering on product sales in the U.S. and royalties from international partners. Honestly, this concentration is something you watch closely as an analyst; it means execution on the core product is everything.

Here's the quick math on the latest Fiscal Year 2025 projections Puma Biotechnology is working with:

Revenue Component	FY 2025 Guidance Range
Net Product Revenue from U.S. Sales of NERLYNX	$198 million to $200 million
Royalty Revenue from International Sublicensees	$22 million to $23 million
Total Projected Revenue	$220 million to $223 million

The structure of these streams shows a dual approach: direct sales capture in the U.S. market and passive income generation through global licensing deals. To be fair, the royalty stream is a great way to get geographic reach without the massive upfront cost of building out every international sales force.

The components driving the revenue streams for Puma Biotechnology, Inc. as guided for FY 2025 include:

• Net product revenue from U.S. sales of NERLYNX (FY 2025 guidance: $198 million to $200 million).
• Royalty revenue from international sublicensees (FY 2025 guidance: $22 million to $23 million).
• Product supply revenue to ex-U.S. partners.
• Total revenue for FY 2025 is projected to be in the range of $220 million to $223 million.

What this estimate hides, based on recent filings, is that the reported Net Product Revenue figure actually bundles the U.S. sales with the product supply revenue sent to those ex-U.S. partners. For instance, in Q3 2025, product supply revenue was only about $\$0.1$ million, a significant drop from the $\$7.4$ million seen in Q3 2024, which was reflected in the overall net product revenue decline that quarter compared to the prior year. Still, the overall FY 2025 guidance was recently raised, signaling confidence in the core U.S. demand.

The company is definitely leaning on the U.S. market for the bulk of its top line, aiming for that $198 million to $200 million range from NERLYNX product sales alone. Also, the royalty stream, projected between $22 million and $23 million, provides a solid, albeit smaller, base. Finance: draft 13-week cash view by Friday.