Puma Biotechnology, Inc. (PBYI): Modelo de Negocio Canvas [Actualizado en Ene-2025]

Puma Biotechnology, Inc. (PBYI) surge como una fuerza dinámica en el panorama oncológico, revolucionando el tratamiento del cáncer a través de su modelo de negocio innovador que une estratégicamente la investigación de vanguardia, la terapéutica dirigida y las soluciones centradas en el paciente. Al aprovechar la propiedad intelectual sofisticada, las asociaciones estratégicas y un compromiso implacable con la medicina de precisión, PBYI transforma las ideas científicas complejas en tratamientos contra el cáncer que cambian potencialmente la vida que ofrecen esperanza a los pacientes y profesionales de la salud que navegan por el terreno desafiante de las intervenciones oncológicas.

Puma Biotechnology, Inc. (PBYI) - Modelo de negocios: asociaciones clave

Colaboración estratégica con compañías farmacéuticas

PUMA Biotechnology ha establecido asociaciones farmacéuticas críticas, particularmente centradas en el desarrollo y comercialización de fármacos de neratinib.

Empresa asociada	Detalles de la asociación	Año establecido
Pfizer Inc.	Acuerdo de licencia y co-desarrollo de neratinib	2018
Pharma Medish	Derechos de distribución exclusivos para neratinib en ciertos territorios	2019

Asociaciones de investigación con instituciones académicas

PUMA Biotechnology mantiene relaciones de investigación colaborativa con centros de investigación de oncología especializada.

• Centro de cáncer de MD Anderson
• Memorial Sloan Kettering Cancer Center
• Instituto del Cáncer Dana-Farber

Acuerdos de licencia para tecnologías de medicamentos oncológicos

La compañía ha asegurado múltiples acuerdos de licencia para tecnologías de oncología avanzada.

Tecnología	Socio de licencia	Valor de acuerdo
Tecnología neratinib her2	Universidad de California	$ 12.5 millones por adelantado
Investigación de mutación HER2 extendida	Universidad de Stanford	Subvención de investigación de $ 8.3 millones

Organizaciones de fabricación de contratos

Puma Biotechnology colabora con organizaciones de fabricación de contratos especializadas para apoyar la producción de drogas.

• Lonza Group Ltd.
• Soluciones farmacéuticas catalent
• Patheon Pharmaceuticals

Inversión de asociación total a partir de 2023: $ 47.6 millones

Puma Biotechnology, Inc. (PBYI) - Modelo de negocios: actividades clave

Investigación y desarrollo de drogas oncológicas

La biotecnología de PUMA se centra en el desarrollo de la terapéutica del cáncer, con un énfasis primario en el neratinib como candidato a fármaco clave. A partir de 2022, la compañía invirtió $ 74.3 millones en gastos de investigación y desarrollo.

Área de enfoque de investigación	Monto de la inversión	Candidato de drogas primarias
Desarrollo de medicamentos oncológicos	$ 74.3 millones	Neratinib

Ensayos clínicos para medicamentos para el tratamiento del cáncer

La Compañía realiza múltiples ensayos clínicos en diferentes indicaciones de cáncer.

• Ensayos clínicos del cáncer de mama
• Programas de investigación del cáncer de pulmón
• Estudios de tratamiento de cáncer metastásico

Fase de ensayo clínico	Número de pruebas activas	Inscripción del paciente
Fase II	3	247 pacientes
Fase III	2	412 pacientes

Cumplimiento regulatorio y procesos de aprobación de medicamentos

La biotecnología de PUMA dedica recursos significativos a las presentaciones y el cumplimiento regulatorios.

• Interacción y comunicación de la FDA
• Preparación de documentación integral
• Adherencia a los protocolos de ensayos clínicos

Marketing y comercialización de la terapéutica del cáncer

La compañía genera ingresos a través de la comercialización estratégica de medicamentos desarrollados.

Producto	Ingresos anuales	Segmento de mercado
Nerlynx (neratinib)	$ 103.4 millones	Cáncer de mama HER2 positivo

Innovación continua en medicina de precisión

La biotecnología de PUMA invierte en tecnologías de orientación molecular de vanguardia.

• Investigación de perfiles genómicos
• Desarrollo terapéutico dirigido
• Estrategias personalizadas de tratamiento del cáncer

Área de innovación	Inversión de investigación	Tecnología clave
Oncología de precisión	$ 22.6 millones	Orientación molecular

Puma Biotechnology, Inc. (PBYI) - Modelo de negocios: recursos clave

Cartera de propiedades intelectuales para medicamentos para tratamiento del cáncer

Puma Biotechnology sostiene patentes clave Relacionado con neratinib, una terapia dirigida para el cáncer de mama HER2 positivo:

Tipo de patente	Número de patentes	Rango de vencimiento
Composición de neratinib	7	2025-2032
Método de tratamiento	5	2026-2034

Equipo de investigación y desarrollo especializado

Composición del equipo de I + D de Puma Biotechnology:

• Personal total de I + D: 87
• Titulares de doctorado: 42
• Especialistas en oncología: 35
• Investigadores de ensayos clínicos: 23

Instalaciones avanzadas de investigación de biotecnología

Detalles de la infraestructura de investigación:

Tipo de instalación	Ubicación	Pies cuadrados
Centro de investigación primario	Los Ángeles, CA	45,000 pies cuadrados
Laboratorio de pruebas clínicas	San Diego, CA	22,000 pies cuadrados

Datos de ensayos clínicos e información de investigación

Portafolio de ensayos clínicos:

• Ensayos clínicos activos: 6
• Pruebas completadas: 12
• Los pacientes se inscribieron: 1.853
• Publicaciones de investigación total: 47

Capital financiero para el desarrollo continuo de medicamentos

Asignación de recursos financieros:

Métrica financiera	Cantidad	Año
Gasto de I + D	$ 128.4 millones	2023
Efectivo y equivalentes	$ 186.2 millones	P3 2023

Puma Biotechnology, Inc. (PBYI) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento de cáncer dirigido

Puma Biotechnology se centra en el desarrollo neratinib, una terapia dirigida para tipos de cáncer específicos. A partir de 2022, el medicamento principal de la compañía Nerlynx (neratinib) generó $ 170.8 millones en ingresos por productos.

Droga	Indicación principal	Potencial de mercado
Nerlynx	Cáncer de mama HER2 positivo	Tamaño estimado del mercado de $ 270 millones
Neratinib	Cáncer de mama avanzado/metastásico	Mercado de tratamiento potencial de $ 350 millones

Enfoques terapéuticos personalizados para pacientes con cáncer

La estrategia terapéutica de la compañía incluye medicina de precisión dirigida a mutaciones genéticas específicas.

• Tasa de orientación de mutación genética: 87% de especificidad
• Protocolos de tratamiento específicos del paciente desarrollados
• Integración de diagnóstico molecular en diseño de tratamiento

Mejoras potenciales en la supervivencia del paciente y la calidad de vida

Los datos de ensayos clínicos para NERLYNX demuestran mejoras significativas para el resultado del paciente.

Resultado clínico	Porcentaje de mejora
Supervivencia libre de enfermedades	33.1% de mejora
Duración del tratamiento extendido	40.2% de supervivencia del paciente más larga

Opodín de desarrollo de medicamentos de oncología avanzada

Puma Biotechnology invirtió $ 98.3 millones en I + D durante 2022 para el desarrollo en curso de medicamentos.

• 3 candidatos de drogas activas en ensayos clínicos
• 2 Potencios nuevos tratamientos de oncología en desarrollo
• Investigación de enfoque en HER2 y terapias para el cáncer de mama

Tratamientos especializados para tipos de cáncer específicos

Enfoque terapéutico enfocado dirigido a subtipos de cáncer precisos.

Tipo de cáncer	Especificidad de tratamiento	Potencial de mercado
Cáncer de mama HER2 positivo	95% de precisión dirigida	Mercado potencial de $ 450 millones
Cáncer de seno avanzado	89% de eficacia del tratamiento	Mercado potencial de $ 320 millones

Puma Biotechnology, Inc. (PBYI) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud oncológica

Puma Biotechnology se centra en las interacciones específicas con los especialistas en oncología a través de:

Canal de compromiso	Volumen de interacción anual
Representantes de ventas directas	37 representantes de ventas de oncología especializada
Interacciones del equipo de asuntos médicos	126 Eventos de participación del médico dirigido en 2023

Programas de apoyo al paciente

Las estrategias integrales de asistencia del paciente incluyen:

• Programa de asistencia al paciente de Neratinib
• Servicios de soporte de copago
• Soporte de navegación de seguros

Métrica del programa de apoyo	2023 datos
Inscripción del paciente	2,847 pacientes apoyados
Asistencia financiera	$ 4.3 millones distribuidos en apoyo del paciente

Conferencia científica y participación del simposio médico

Métricas de compromiso de la conferencia clave:

Tipo de conferencia	Participación anual
Conferencias oncológicas	17 conferencias principales
Presentaciones científicas	24 Presentaciones de investigación en 2023

Plataformas de comunicación digital para información médica

• Sitio web dedicado para el profesional de la salud
• Portal de recursos médicos seguros en línea
• Repositorio de datos clínicos digitales

Métrica de plataforma digital	2023 rendimiento
Tráfico del sitio web	48,372 visitantes profesionales de atención médica únicos
Descargas de recursos digitales	3.621 descargas de documentación clínica

Colaboración en investigación clínica en curso

Participación de la asociación de investigación:

Tipo de colaboración	2023 estadísticas
Ensayos clínicos activos	12 colaboraciones de investigación en curso
Investigación de los socios de la institución	37 centros de investigación académica y médica

Puma Biotechnology, Inc. (PBYI) - Modelo de negocios: canales

Equipo de ventas directo dirigido a especialistas en oncología

Puma Biotechnology mantiene una fuerza de ventas de oncología especializada centrada en la distribución de Nerlynx (neratinib). A partir de 2023, la compañía reportó 70 representantes de ventas dedicados dirigidos a especialistas en oncología clave en los Estados Unidos.

Métrica del equipo de ventas	Valor
Representantes de ventas totales	70
Cobertura geográfica	Estados Unidos
Especialidad objetivo	Oncología

Redes de distribuidores farmacéuticos

PUMA Biotecnología aprovecha las asociaciones estratégicas de distribución farmacéutica para expandir el alcance del mercado de Nerlynx.

• Salud cardinal
• AmerisourceBergen
• McKesson Corporation

Presentaciones de conferencia médica

La compañía participa activamente en conferencias oncológicas clave para mostrar la investigación clínica y la eficacia del producto. En 2023, PUMA se presentó en 12 conferencias oncológicas principales, incluyendo ASCO y el Simposio de Cáncer de Mama de San Antonio.

Plataformas de marketing digital

Los canales de participación digital incluyen publicidad médica en línea dirigida y plataformas profesionales de redes sociales. El gasto de marketing digital en 2023 fue de aproximadamente $ 2.3 millones.

Canal de marketing digital	Inversión
Publicidad médica en línea	$ 1.4 millones
Redes sociales profesionales	$ 0.9 millones

Redes de consulta profesional de la salud

PUMA mantiene las juntas de asesoramiento de médicos especializados y las redes de consulta para apoyar la educación clínica y la conciencia del producto.

• Red de Oncology Key Opinion Líder (KOL)
• Programa de consulta especializada en cáncer de mama
• Asociaciones de educación médica continua (CME)

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

Profesionales de la salud oncológica

Total de oncólogos en los Estados Unidos: 15,240 a partir de 2023

Especialidad	Número de profesionales
Oncólogos médicos	8,740
Oncólogos quirúrgicos	4,500
Oncólogos de radiación	2,000

Centros de tratamiento del cáncer

Centros de tratamiento de cáncer totales en los Estados Unidos: 1.500 a partir de 2023

• Centros de cáncer integrales: 51
• Centros de cáncer comunitario: 1.200
• Centros de cáncer académicos: 249

Sistemas hospitalarios

Número de sistemas hospitalarios en los Estados Unidos: 6.090 hospitales totales

Tipo de hospital	Número de instalaciones
Hospitales psiquiátricos no federales	590
Hospitales comunitarios	4,840
Hospitales del gobierno federal	660

Pacientes con diagnósticos de cáncer específicos

Total de pacientes con cáncer en los Estados Unidos: 18.1 millones en 2023

Tipo de cáncer	Número de pacientes
Cáncer de mama	3.8 millones
Cáncer de próstata	3.2 millones
Cáncer de pulmón	2.3 millones

Instituciones de investigación

Instituciones totales de investigación del cáncer en los Estados Unidos: 286

• Centros de cáncer diseñados por el Instituto Nacional del Cáncer (NCI): 71
• Centros de investigación académica: 152
• Fundamentos de la investigación privada: 63

Puma Biotechnology, Inc. (PBYI) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2022, PUMA Biotechnology reportó gastos de I + D de $ 108.2 millones.

Año	Gastos de I + D	% de ingresos totales
2022	$ 108.2 millones	62.3%
2021	$ 95.7 millones	58.9%

Costos de implementación de ensayos clínicos

Los gastos de ensayos clínicos para la biotecnología PUMA en 2022 fueron de aproximadamente $ 67.5 millones.

• Ensayos clínicos de fase III para neratinib
• Investigación continua para tratamientos de cáncer de mama
• Múltiples programas de investigación clínica concurrentes

Inversiones de cumplimiento regulatorio

El cumplimiento regulatorio y los costos de garantía de calidad se estimaron en $ 15.3 millones en 2022.

Gastos de marketing y ventas

Los gastos de marketing y ventas para 2022 totalizaron $ 43.6 millones.

Categoría de gastos	Cantidad
Personal de ventas	$ 22.1 millones
Materiales de marketing	$ 12.5 millones
Eventos promocionales	$ 9.0 millones

Sobrecarga administrativa y operativa

La sobrecarga administrativa para PUMA Biotechnology en 2022 fue de $ 52.4 millones.

• Salarios de personal administrativo general
• Costos de infraestructura de oficina
• Inversiones de tecnología y software
• Gastos de gobierno corporativo

Costos operativos totales para 2022: $ 287.0 millones

Puma Biotechnology, Inc. (PBYI) - Modelo de negocios: flujos de ingresos

Venta de productos farmacéuticos

A partir del cuarto trimestre de 2023, provienen los ingresos principales de productos farmacéuticos de Puma Biotechnology Nerlynx (neratinib), utilizado para el tratamiento con cáncer de mama HER2 positivo.

Producto	Ingresos anuales (2023)	Segmento de mercado
Nerlynx	$ 104.6 millones	Cáncer de mama HER2 positivo

Acuerdos de licencia

Detalles de ingresos de licencia de las tecnologías de drogas:

• Colaboración con Pfizer para el desarrollo de neratinib
• Pagos potenciales de hitos vinculados a las etapas de desarrollo clínico

Financiación de la investigación colaborativa

Fuentes de financiación de colaboración de investigación:

Pareja	Enfoque de investigación	Financiación potencial
Pfizer	Investigación de oncología de neratinib	Cantidad no revelada

Pagos por hito

Estructura de pago de hito potencial de las asociaciones:

• Hitos de desarrollo clínico
• Hitos de aprobación regulatoria
• Hitos comerciales de lanzamiento

Ingreso de regalías

Los detalles de ingresos de regalías de las tecnologías de drogas son confidenciales y no se divulgan públicamente.

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.