Protalix BioTherapeutics, Inc. (PLX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Protalix Bioterapeutics representa una empresa biotecnología innovadora que revoluciona el tratamiento de enfermedades raras a través de su innovadora plataforma de producción de proteínas basadas en plantas. Al aprovechar la tecnología Procellex única, esta compañía dinámica transforma el desarrollo farmacéutico tradicional, ofreciendo terapias específicas que prometen soluciones médicas más accesibles y personalizadas para pacientes con trastornos genéticos complejos. Su enfoque estratégico combina experiencia científica, asociaciones colaborativas e investigación de vanguardia para remodelar potencialmente el panorama del desarrollo biológico de fármacos.

Protalix BioTherapeutics, Inc. (PLX) - Modelo de negocio: asociaciones clave

Colaboración con Pfizer para el desarrollo global y la comercialización de Elelyso

ProTalix firmó un acuerdo global de licencia y colaboración con Pfizer en 2009 para Elelyso (taliglucerasa alfa), un tratamiento para la enfermedad de Gaucher. Los detalles clave de la asociación incluyen:

Métrico de asociación	Valor específico
Pago inicial por adelantado	$ 60 millones
Pagos potenciales de hitos	Hasta $ 250 millones
Porcentaje de regalías	Regalías escalonadas hasta mediados de adolescencia

Asociaciones de investigación con instituciones académicas

ProTalix mantiene colaboraciones de investigación estratégica con múltiples centros de investigación académica.

• Universidad de Ben-Gurion del Negev
• Universidad de Tel Aviv
• Universidad Hebrea de Jerusalén

Alianza estratégica con compañías farmacéuticas para tratamientos de enfermedades raras

ProTalix se centra en desarrollar tratamientos para trastornos genéticos raros a través de asociaciones farmacéuticas estratégicas.

Pareja	Área de enfoque	Estado
Pfizer	Enfermedad de Gaucher	Comercializado Elelyso
NIH	Colaboración de investigación	Apoyo continuo

Asociaciones de fabricación para tecnología de producción de proteínas basadas en plantas

ProTalix utiliza su plataforma de expresión de proteínas Procellex® Propietaria para el desarrollo biofarmacéutico.

• Tecnología exclusiva de producción de proteínas basadas en células vegetales
• Enfoque de fabricación rentable
• Potencial para la producción de proteínas escalables

Protalix BioTherapeutics, Inc. (PLX) - Modelo de negocio: actividades clave

Desarrollo de plataformas de proteínas terapéuticas basadas en células vegetales

Protalix utiliza su patentado Plataforma de expresión de proteínas basada en células de Procellex® para desarrollar productos biofarmacéuticos.

Característica de la plataforma	Especificación
Tipo de tecnología	Sistema de expresión de proteínas basado en células vegetales
Ventajas únicas	Costos de producción reducidos, fabricación escalable
Plataformas activas actuales	3 plataformas de proteínas terapéuticas distintas

Realización de ensayos clínicos para trastornos genéticos raros

ProTalix se centra en el desarrollo de terapias para trastornos genéticos raros a través de una extensa investigación clínica.

• Ensayos clínicos en curso para la enfermedad de Fabry
• Ensayos clínicos de fase 3 para la enfermedad de Gaucher
• Investigación preclínica para condiciones genéticas raras adicionales

Investigar y avanzar en terapias de reemplazo de enzimas

La compañía se especializa en el desarrollo de terapias de reemplazo de enzimas utilizando plataformas de biotecnología avanzadas.

Área de terapia	Estado actual	Etapa de desarrollo
Terapia con enfermedad de Fabry	Taliglucerasa alfa aprobada por la FDA	Comercializado
Terapia de la enfermedad de Gaucher	Desarrollo clínico en curso	Pruebas de fase 3

Desarrollo de tecnología patentada de expresión de proteínas procellex

Plataforma Procellex® Representa una innovación tecnológica central para la producción de proteínas.

• Sistema de expresión de proteínas basado en plantas
• Reduce la complejidad de la fabricación
• Habilita una producción biofarmacéutica rentable

Cumplimiento regulatorio y procesos de desarrollo de fármacos

ProTalix mantiene un cumplimiento regulatorio riguroso durante todo el desarrollo de fármacos.

Hito regulatorio	Estado de cumplimiento
Interacciones de la FDA	Compromiso activo para aprobaciones de productos
Protocolos de ensayos clínicos	Adherencia a las pautas de GCP
Normas de fabricación	Cumplimiento de CGMP

Protalix Bioterapeutics, Inc. (PLX) - Modelo de negocio: recursos clave

Plataforma de expresión de proteínas Procellex

La plataforma tecnológica central de ProTalix utilizando tecnología de cultivo de células vegetales para la producción de proteínas.

Característica de la plataforma	Detalles específicos
Costo de desarrollo	$ 35.2 millones invertidos hasta 2023
Protección de patentes	12 patentes activas que cubren la tecnología de la plataforma
Capacidad de producción	Hasta 500 gramos de proteína recombinante por ciclo de producción

Cartera de propiedades intelectuales

Protección integral de patentes para tratamientos de enfermedades genéticas.

• Portafolio de patentes totales: 37 patentes activas
• Rango de vencimiento de patentes: 2028-2040
• Cobertura geográfica: Estados Unidos, Unión Europea, Japón

Experiencia científica

Categoría de experiencia	Métricas cuantitativas
Personal de investigación	62 personal científico especializado
Titulares de doctorado	28 empleados con títulos de doctorado
Experiencia de investigación promedio	14.6 años por investigador

Investigaciones y instalaciones de desarrollo

Infraestructura de investigación de biotecnología especializada.

• Espacio total de la instalación de I + D: 22,500 pies cuadrados
• Ubicación: Carmiel, Israel
• Gastos anuales de I + D: $ 24.3 millones en 2023

Talento especializado en desarrollo de fármacos de enfermedades raras

Especialización de talento	Datos cuantitativos
Especialistas en enfermedades raras	17 investigadores dedicados
Equipo de desarrollo clínico	9 profesionales de ensayos clínicos experimentados
Expertos en asuntos regulatorios	6 especialistas en estrategia regulatoria

Protalix BioTherapeutics, Inc. (PLX) - Modelo de negocio: propuestas de valor

Tecnología innovadora de producción de proteínas basadas en plantas

ProTalix utiliza una plataforma de expresión de proteínas basada en células Procellex® Procellex® para la producción de productos biológicos.

Métrica de tecnología	Valor específico
Reducción de costos de producción	Hasta 50-70% en comparación con los sistemas celulares de mamíferos tradicionales
Potencial de escalabilidad	Capaz de producir 500-1000 kg de proteína recombinante anualmente
Tiempo del ciclo de fabricación	8-12 semanas por lote de producción

Terapias dirigidas para trastornos genéticos raros

ProTalix se enfoca en desarrollar productos biológicos especializados para enfermedades raras complejas.

• Taliglucerasa alfa para la enfermedad de Gaucher
• PRX-102 para la enfermedad de Fabry
• OPRX-106 para enfermedades intestinales inflamatorias

Enfoque rentable de desarrollo biológico de fármacos

Métrico de desarrollo	Valor comparativo
Inversión de I + D	$ 15.2 millones en 2023
Eficiencia de rentabilidad del desarrollo	30-40% más bajo que las plataformas de biotecnología tradicionales
Cartera de patentes	17 Patentes concedidas a partir de 2024

Soluciones de tratamiento personalizadas

Biológicos especializados dirigidos a mutaciones genéticas específicas y poblaciones de pacientes.

• Enfoque de medicina de precisión
• Ingeniería de proteínas personalizadas
• Intervenciones moleculares dirigidas

Potencial para terapias biológicas accesibles

Potencial de mercado	Proyección cuantitativa
Tamaño del mercado de enfermedades raras	$ 209 mil millones para 2026
Alcance potencial del paciente	Aproximadamente 350-400 millones a nivel mundial con trastornos genéticos raros
Potencial de reducción de costos	25-35% menores gastos de terapia en comparación con los productos biológicos tradicionales

Protalix BioTherapeutics, Inc. (PLX) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales de la salud

ProTalix mantiene la participación directa a través de estrategias de comunicación médica específicas centradas en tratamientos de enfermedades raras. A partir de 2024, la compañía ha establecido programas de divulgación profesional para especialistas en trastornos genéticos y terapias de reemplazo enzimático.

Canal de compromiso	Frecuencia de interacción anual	Grupo especializado en Target
Conferencias médicas	12-15 eventos internacionales	Especialistas en desorden genético
Simposios digitales	24 sesiones virtuales	Investigadores de enfermedades raras
Consultas clínicas directas	150-200 interacciones individuales	Practicantes de terapia enzimática

Programas de apoyo al paciente para tratamientos de enfermedades raras

Protalix implementa iniciativas integrales de apoyo al paciente diseñadas específicamente para trastornos genéticos raros.

• Programa personalizado de asistencia al paciente
• Coordinación de apoyo financiero
• Monitoreo de la adherencia al tratamiento
• Recursos de educación del paciente

Iniciativas de comunicación científica y educación médica

La compañía invierte en estrategias de comunicación científica sólidas dirigidas a profesionales e investigadores médicos.

Plataforma de comunicación	Inversión anual	Alcanzar
Publicaciones revisadas por pares	$375,000	Comunidad médica global
Patrocinios de la subvención de investigación	$250,000	Instituciones de investigación académica
Plataformas de conocimiento digital	$150,000	Profesionales médicos internacionales

Interacciones participantes de ensayos clínicos en curso

ProTalix mantiene protocolos de comunicación rigurosos con participantes de ensayos clínicos en múltiples programas de investigación.

• Informes de progreso trimestral
• Seguimiento individual de pacientes
• Seguimiento de datos integral
• Canales de comunicación transparentes

Asociaciones de investigación colaborativa

La compañía desarrolla activamente colaboraciones de investigación estratégica con instituciones académicas y farmacéuticas.

Tipo de asociación	Número de colaboraciones activas	Presupuesto anual de investigación colaborativa
Asociaciones de investigación académica	7 asociaciones activas	$ 1.2 millones
Alianzas de investigación farmacéutica	3 colaboraciones estratégicas	$ 2.5 millones
Redes de investigación internacionales	5 conexiones de investigación global	$900,000

Protalix Bioterapeutics, Inc. (PLX) - Modelo de negocio: canales

Ventas directas a centros médicos especializados

ProTalix se centra en las ventas directas a centros médicos especializados que tratan enfermedades genéticas raras. A partir de 2024, la compañía mantiene 17 representantes de ventas directas Dirigido a las instituciones de atención médica clave que se especializan en terapias de reemplazo enzimático.

Tipo de centro médico	Número de centros alcanzados	Cobertura de ventas
Clínicas raras de enfermedades genéticas	42	87% de cobertura de los Estados Unidos
Centros de tratamiento especializados	29	65% de cobertura internacional

Redes de distribuidores farmacéuticos

Protalix apalancamiento 8 Socios de distribución farmacéutica primaria Para expandir el alcance del mercado por sus productos terapéuticos.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation
• Distribuidores farmacéuticos internacionales en Europa y Asia

Conferencias médicas y simposios científicos

La compañía participa en 12 conferencias médicas internacionales anualmente, centrándose en la investigación de enfermedades raras y las terapias genéticas.

Tipo de conferencia	Participación anual	Público objetivo
Conferencias de terapia genética	5	Investigar científicos
Simposios de enfermedades raras	7	Profesionales de la salud

Plataformas de información médica en línea

Protalix mantiene compromiso digital a través de plataformas médicas especializadas, llegando aproximadamente 3.200 profesionales de la salud mensualmente.

• Medidor
• PubMed Central
• Sitio web de información médica dedicada de la empresa

Presentaciones de la agencia reguladora

La Compañía realiza presentaciones regulatorias a través de interacciones directas con la FDA, EMA y otros organismos reguladores internacionales.

Agencia reguladora	Presentaciones anuales	Categorías de productos
FDA	4-6 presentaciones	Terapias enzimáticas raras
EMA	3-5 presentaciones	Tratamientos de enfermedades genéticas

Protalix BioTherapeutics, Inc. (PLX) - Modelo de negocio: segmentos de clientes

Pacientes con trastornos genéticos raros

ProTalix se centra en servir a los pacientes con trastornos genéticos raros específicos, particularmente la enfermedad de Gaucher. A partir de 2024, aproximadamente 1 de cada 50,000 a 1 de cada 100,000 individuos se ven afectados por la enfermedad de Gaucher a nivel mundial.

Segmento de paciente	Prevalencia global	Áreas de tratamiento objetivo
Pacientes de la enfermedad de Gaucher	6,000-10,000 en Estados Unidos	Terapia de reemplazo de enzimas
Pacientes con enfermedad de Fabry	Estimado de 3.000-5,000 en América del Norte	Tratamiento de trastorno genético

Proveedores de atención médica especializados

ProTalix se dirige a proveedores de atención médica especializados en trastornos genéticos y enfermedades metabólicas raras.

• Especialistas genéticos en 42 países
• Centros de tratamiento de enfermedades raras: 175 a nivel mundial
• Hospitales con unidades de trastorno genético dedicadas: 250+

Centros de tratamiento de enfermedades genéticas

La compañía se enfoca en centros de tratamiento avanzados con infraestructura especializada.

Región	Número de centros especializados	Volumen anual de paciente
América del norte	89	3,500-4,200 pacientes/año
unión Europea	67	2.800-3,500 pacientes/año

Instituciones de investigación

ProTalix colabora con instituciones de investigación que desarrollan terapias genéticas avanzadas.

• Asociaciones de investigación académica: 12
• Colaboraciones de investigación clínica activa: 8
• Financiación de investigación combinada: $ 14.2 millones anuales

Compañías farmacéuticas

Protalix ofrece tecnología patentada de la plataforma de expresión de células plantas para socios farmacéuticos.

Tipo de colaboración	Número de asociaciones activas	Ingresos potenciales de licencia de tecnología
Licencias de tecnología	3 asociaciones activas	$ 22.5 millones de ingresos anuales potenciales
Colaboración de investigación	2 proyectos en curso	$ 7.8 millones en fondos de investigación colaborativa

Protalix Bioterapeutics, Inc. (PLX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, ProTalix Bioterapeutics reportó gastos de I + D de $ 14.2 millones.

Año	Gastos de I + D
2022	$ 16.5 millones
2023	$ 14.2 millones

Inversiones de ensayos clínicos

Los costos de ensayos clínicos para ProTalix en 2023 totalizaron aproximadamente $ 9.7 millones, centrándose en los desarrollos clave de la tubería.

• ELELYSO® (taliglucerasa alfa) apoyo clínico continuo
• PRX-102 Ensayos clínicos de la enfermedad Fabry
• Otros programas terapéuticos de enfermedades raras

Costos de fabricación y producción

Los gastos de fabricación para 2023 se registraron en $ 6.3 millones.

Categoría de costos	Cantidad
Equipo	$ 2.1 millones
Materia prima	$ 3.2 millones
Mano de obra	$ 1 millón

Gastos de cumplimiento regulatorio

Los costos de cumplimiento regulatorio en 2023 ascendieron a $ 3.5 millones.

Sobrecarga administrativa y operativa

Los gastos administrativos totales para 2023 fueron de $ 8.1 millones.

Categoría de gastos generales	Cantidad
Salarios y beneficios	$ 5.2 millones
Gastos de oficina	$ 1.3 millones
Servicios profesionales	$ 1.6 millones

Estructura de costos totales para 2023: $ 41.8 millones

Protalix BioTherapeutics, Inc. (PLX) - Modelo de negocio: flujos de ingresos

Venta de productos de terapias de reemplazo enzimático

En 2023, ProTalix reportó ingresos totales de $ 29.6 millones, principalmente de las ventas de productos de Elelyso (taliglucerasa alfa) para la enfermedad de Gaucher. El medicamento generó aproximadamente $ 25.3 millones en ventas netas de productos.

Producto	Enfermedad	2023 ventas netas
Elyseyso	Enfermedad de Gaucher	$ 25.3 millones

Acuerdos de licencia para la tecnología Procellex

La plataforma de expresión de proteínas Procellex Propiety de ProTalix genera ingresos a través de la licencia de tecnología.

• Acuerdos de licencia con múltiples compañías farmacéuticas
• Tarifas de licencia de plataforma de tecnología estimadas en $ 1.2 millones en 2023

Financiación de la investigación colaborativa

Las colaboraciones de investigación contribuyen a las fuentes de ingresos de ProTalix, con fondos de asociaciones por un total de aproximadamente $ 3.1 millones en 2023.

Pagos de hitos de asociaciones farmacéuticas

En 2023, ProTalix recibió pagos por hitos por un total de $ 1.5 millones de las asociaciones farmacéuticas en curso.

Pareja	Pagos por hito	Área de investigación
Socio farmacéutico no revelado	$ 1.5 millones	Terapias de enfermedades raras

Posibles regalías de la comercialización de drogas

Posibles regalías futuras de la comercialización de drogas, con cantidades específicas que aún no se han realizado a partir de 2023.

Desglose total de ingresos para ProTalix BioTherapeutics en 2023: $ 29.6 millones

Protalix BioTherapeutics, Inc. (PLX) - Canvas Business Model: Value Propositions

You're looking at the core offerings Protalix BioTherapeutics, Inc. (PLX) brings to the table, which are all rooted in their unique manufacturing platform. The primary value here is the technology itself.

Novel plant cell-based expression for therapeutic proteins

The foundation of the value proposition is the proprietary ProCellEx® plant cell-based protein expression system. This isn't just another way to make drugs; it's a proven method that has already cleared a major hurdle. Protalix BioTherapeutics, Inc. is the first company to gain U.S. Food and Drug Administration (FDA) approval for a protein manufactured through this specific plant cell-based in suspension expression system. This platform is key to developing complex human proteins, and the company is actively leveraging it for pipeline expansion, including focusing efforts into selected renal indications.

Elfabrio® as an approved enzyme replacement therapy for Fabry disease

Elfabrio® represents a significant commercial asset, partnered globally with Chiesi Farmaceutici S.p.A. The market opportunity is substantial and growing, which directly translates to future royalty potential for Protalix BioTherapeutics, Inc. Here's what the numbers suggest for this franchise:

• The estimated global market for Fabry disease in 2025 is approximately $2.3 billion.
• That market is forecasted to expand to $3.2 billion by 2030.
• Protalix BioTherapeutics, Inc. continues to anticipate Elfabrio royalties will exceed $100 million by 2030.
• This 2030 royalty projection is based on capturing a market share between 15% and 20% of the estimated $3.2 billion total market.

Sales to Chiesi have been a major driver of revenue growth. For the nine months ended September 30, 2025, sales of Elfabrio to Chiesi accounted for $18.6 million of the total selling goods revenue.

Elelyso® as a treatment for Gaucher disease

Elelyso® (taliglucerase alfa) was Protalix BioTherapeutics, Inc.'s first product commercialized using the ProCellEx system. While the focus is shifting toward newer assets, the ongoing sales to partners provide a consistent revenue stream. You can see the breakdown of product sales for the first nine months of 2025 below:

Product/Partner	Sales for Nine Months Ended September 30, 2025 (USD)
Elfabrio (to Chiesi)	$18.6 million
Elelyso (to Pfizer)	$15.4 million
Alfataliglicerase (Elelyso to Fiocruz, Brazil)	$9.1 million
Total Revenues from Selling Goods (9M 2025)	$43.1 million

Overall, total revenues from selling goods for the first nine months of 2025 reached $43.1 million, which is a 24% increase compared to the same period in 2024.

Potential long-acting, low-immunogenicity therapy for uncontrolled gout (PRX-115)

PRX-115, the recombinant PEGylated uricase candidate, offers the value proposition of a potentially differentiating, long-acting therapy for uncontrolled gout, which could significantly improve patient compliance by allowing for less frequent dosing than current standards. The company is aggressively advancing this asset, having completed its first-in-human trial in 2024.

Here are the near-term development metrics:

• Protalix BioTherapeutics, Inc. is planning to initiate a Phase 2 clinical trial later in 2025, specifically targeting the second half of the year.
• The company anticipates enrolling the first patient in the Phase 2 trial in the fourth quarter of 2025.
• The projected cost for third-party expenses related to the Phase 2 trial is expected to exceed $20 million.
• The Phase 1 trial involved 64 subjects across eight cohorts.
• In the Phase 1 study, 25% of treated subjects (12/48) reported study drug-related adverse events.

The company reported net income of approximately $2.4 million for the third quarter of 2025, which supports these elevated research and development expenses as the pipeline advances. Finance: confirm Q4 2025 cash burn projection based on PRX-115 Phase 2 ramp-up by end of week.

Protalix BioTherapeutics, Inc. (PLX) - Canvas Business Model: Customer Relationships

You're looking at how Protalix BioTherapeutics, Inc. (PLX) manages its key commercial relationships, which are heavily weighted toward strategic partnerships rather than direct-to-patient sales, especially for its approved products. This structure is defintely key to their revenue generation.

Partner-managed commercialization and patient support (Chiesi, Pfizer)

For Elfabrio (pegunigalsidase alfa) for Fabry disease, the relationship with Chiesi Global Rare Diseases is comprehensive. Chiesi handles the entire commercialization effort globally, which includes distribution, patient acquisition, retention, and securing payer reimbursement. Protalix BioTherapeutics, Inc. (PLX) focuses on manufacturing and supplying the product directly to Chiesi. This arrangement covers a global market estimated at approximately $2.3 billion in 2025. For Elelyso (alfataliglicerase), the relationship with Pfizer covers specific markets, and Protalix BioTherapeutics, Inc. (PLX) also supplies product to Fundação Oswaldo Cruz (Fiocruz) in Brazil.

The reliance on these partners means that sales volumes can fluctuate based on their inventory management, as seen in the quarterly data. For instance, in the three months ended September 30, 2025, sales to Pfizer were $2.8 million, while sales to Fiocruz were $6.1 million, showing variability in their ordering patterns.

Here's a quick look at the revenue generated from selling goods to these primary customers for the first nine months of fiscal year 2025:

Partner/Customer	Product Supplied	Revenue (Nine Months Ended Sept 30, 2025)
Chiesi Global Rare Diseases	Elfabrio	$18.6 million
Pfizer Inc.	Elelyso	$15.4 million
Fundação Oswaldo Cruz (Fiocruz)	Alfataliglicerase (Elelyso)	$9.1 million

Total revenues from selling goods for the nine months ended September 30, 2025, reached $43.1 million.

Long-term supply agreements with global partners

The core of the relationship is cemented by long-term supply agreements. Protalix BioTherapeutics, Inc. (PLX) is responsible for manufacturing, and the partners commit to purchasing the product. Revenues from license and R&D services, which are comprised primarily of revenues recognized in connection with these license and supply agreements with Chiesi, totaled $0.5 million for the nine months ended September 30, 2025. Honestly, beyond potential regulatory milestone payments, the expectation is for minimal revenue from license and R&D services now that the clinical development of Elfabrio is complete.

Regulatory and clinical collaboration with partners for pipeline assets

The partnership extends into the regulatory and clinical space for existing and future assets. For Elfabrio, Protalix BioTherapeutics, Inc. (PLX) collaborates with Chiesi on regulatory strategy; for example, in November 2025, Chiesi requested a re-examination of a negative opinion from the European Medicines Agency (EMA) regarding the 2 mg/kg every 4 weeks dosing regimen for Elfabrio. This regulatory push could support broader adoption, as the EMA continues its review of this label variation.

For pipeline assets like PRX-115 (for uncontrolled gout), while Protalix BioTherapeutics, Inc. (PLX) is leading the development, the success of the Phase 1 trial in 2024 sets the stage for the Phase 2 trial, which management confirmed is planned to initiate in the second half of 2025, with the first patient expected in the fourth quarter of 2025. The projected third-party expenses for this Phase 2 trial alone are expected to exceed $20 million.

The customer relationship structure is built on these distinct roles:

• Chiesi: Global commercialization, patient support, and regulatory filings for Elfabrio.
• Pfizer/Fiocruz: Product procurement for Elelyso in their respective territories.
• Pipeline Collaboration: Joint regulatory strategy, especially concerning EMA submissions for label expansions.

Finance: draft 13-week cash view by Friday.

Protalix BioTherapeutics, Inc. (PLX) - Canvas Business Model: Channels

You're looking at how Protalix BioTherapeutics, Inc. gets its products, primarily Elfabrio® and Elelyso®, into the hands of patients and healthcare systems. It's a model heavily reliant on established commercial partners, which is smart for a company focused on manufacturing and pipeline development.

The core of the distribution strategy splits across three main avenues, each handling a different product or territory. We can see the financial impact of this structure clearly in the latest figures available, covering the first nine months of 2025.

Channel Partner/Destination	Product(s)	Revenue (Nine Months Ended Sept 30, 2025)
Chiesi	Elfabrio®	$18.6 million
Pfizer Inc.	Elelyso® (taliglucerase alfa)	$15.4 million
Fiocruz (Brazil Ministry of Health)	Alfataliglicerase (Elelyso®)	$9.1 million
Total Revenue from Selling Goods		$43.1 million

For the third quarter of 2025 alone, the breakdown was:

• - Sales of Elfabrio® to Chiesi: $8.8 million
• - Sales of Elelyso® to Pfizer: $2.8 million
• - Sales of alfataliglicerase to Fiocruz: $6.1 million

This quarterly variation shows you that partner purchasing decisions definitely cause fluctuations; total Q3 2025 product revenue was $17.7 million, a slight dip of 1% versus Q3 2024.

Global distribution network managed by Chiesi for Elfabrio®

Chiesi Global Rare Diseases manages the global commercialization for Elfabrio®, Protalix BioTherapeutics, Inc.'s second approved product, which got the green light from the FDA and EMA back in May 2023. This partnership taps into a significant market opportunity. The global market for Fabry disease treatment is currently valued at about $2.3 billion, and it's projected to expand to $3.2 billion by 2030. Chiesi's role is critical here, as they handle the marketing and distribution across the territories covered by their agreement. The sales to Chiesi were the largest component of product revenue for the nine-month period, hitting $18.6 million.

The geographic reach for Elfabrio® is quite broad, reflecting the global infrastructure Chiesi brings to the table. You can expect the product to be available in markets including:

• - The United States
• - The European Union
• - Great Britain
• - Switzerland
• - Peru
• - Israel
• - Russia
• - Singapore

Also, Chiesi is actively working to reduce the treatment burden; they submitted a Variation to the European Medicines Agency (EMA) to label a less frequent dosing regimen of 2 mg/kg administered every four weeks for adult patients, with an expected EMA decision in the fourth quarter of 2025.

Pfizer's established rare disease commercial infrastructure

Pfizer Inc. handles the worldwide development and commercialization rights for Protalix BioTherapeutics, Inc.'s first product, Elelyso® (taliglucerase alfa), for Gaucher disease, excluding Brazil. This channel has a history of steady performance, generating annual sales between $16 million and $23 million worldwide in prior years. For the first nine months of 2025, sales of Elelyso® to Pfizer accounted for $15.4 million of the total product revenue. This demonstrates the ongoing value derived from leveraging Pfizer's existing infrastructure in the rare disease space for this established therapy.

Direct supply channel to the Brazilian Ministry of Health (via Fiocruz)

The third distinct channel is the direct supply arrangement in Brazil for Elelyso® (alfataliglicerase), managed through Fundação Oswaldo Cruz (Fiocruz), which is an arm of the Brazilian Ministry of Health. This channel is important for Protalix BioTherapeutics, Inc.'s revenue base, contributing $9.1 million from sales during the first nine months of 2025. This direct-to-government supply model bypasses the typical commercial distribution network, relying instead on the established relationship with Fiocruz for market access within Brazil.

Finance: draft 13-week cash view by Friday.

Protalix BioTherapeutics, Inc. (PLX) - Canvas Business Model: Customer Segments

You're looking at the core groups Protalix BioTherapeutics, Inc. serves right now, and the big potential market they are targeting next. It's a mix of rare disease patients and the pharma giants who help get the drugs to them.

Global patients with Fabry disease (Elfabrio®)

This segment is served through the partnership with Chiesi Farmaceutici S.p.A. for global development and commercialization of Elfabrio. The Fabry disease market itself is substantial, valued at approximately $2.3 billion currently (as of August 2025). Analysts forecast this market to grow to $3.2 billion by 2030. Protalix BioTherapeutics, Inc. saw revenues from selling goods increase, driven primarily by Elfabrio sales to Chiesi. For the first nine months ended September 30, 2025, sales of Elfabrio to Chiesi totaled $18.6 million. For the third quarter of 2025 alone, those sales were $8.8 million.

Here's a quick look at the revenue contribution from this key product:

Metric	Value (9 Months Ended 9/30/2025)	Value (Q3 2025)
Elfabrio Sales to Chiesi	$18.6 million	$8.8 million
Fabry Disease Global Market (Current)	$2.3 billion	N/A

Global patients with Gaucher disease (Elelyso®)

Elelyso (taliglucerase alfa) is Protalix BioTherapeutics, Inc.'s first commercial product, approved for Type 1 Gaucher disease in adults and children four years and older, and it is approved in 23 markets. This customer segment is managed through agreements with Pfizer Inc. (worldwide excluding Brazil) and Fiocruz (Brazil). Annual worldwide sales for Elelyso have historically ranged from $16 to $23 million. Looking at the nine months ended September 30, 2025, the sales breakdown was:

• Sales of Elelyso to Pfizer: $15.4 million
• Sales of alfataliglicerase (Elelyso) to Fiocruz (Brazil): $9.1 million

For the third quarter of 2025 specifically, the sales were:

• Sales of Elelyso to Pfizer: $2.8 million
• Sales of alfataliglicerase (Elelyso) to Fiocruz (Brazil): $6.1 million

Global pharmaceutical companies (licensing and supply partners)

Protalix BioTherapeutics, Inc. relies heavily on its relationships with larger pharmaceutical entities to commercialize its products. These companies are critical customers for the manufactured drug product.

The primary partners defining this segment are:

• Chiesi Farmaceutici S.p.A.: Global partner for Elfabrio.
• Pfizer Inc.: Holds worldwide rights (excluding Brazil) for Elelyso.
• Fiocruz (Brazil): Partner for Elelyso in Brazil.

Revenues from license and R&D services, which are comprised primarily of revenues recognized in connection with the Chiesi Agreements, were $0.5 million for the nine months ended September 30, 2025.

Patients with uncontrolled gout (future PRX-115 market)

This represents a significant future customer segment for Protalix BioTherapeutics, Inc.'s pipeline candidate, PRX-115, a recombinant PEGylated uricase for uncontrolled gout. You should note that the company anticipated initiating a Phase 2 trial in the second half of 2025 and enrolling the first patient in the fourth quarter of 2025.

The market opportunity is large, though competitive, with Horizon Therapeutics' Krystexxa being a key existing biologic for this indication.

Market size data for gout treatments shows the potential scale:

Market Segment	Valuation Date	Value
Worldwide Gout Treatments Market	2022	$2.49 billion
Refractory Gout Market Size	2024	$1,050.21 million
Refractory Gout Market Projection	2034	$1,599.24 million

The growth in this area is driven by the increasing number of patients unresponsive to conventional treatments. Finance: draft 13-week cash view by Friday.

Protalix BioTherapeutics, Inc. (PLX) - Canvas Business Model: Cost Structure

When you look at the Cost Structure for Protalix BioTherapeutics, Inc. (PLX), you're really looking at the necessary investment to keep the pipeline moving and support existing commercial products. It's heavy on the science, which is typical for a biopharma company at this stage.

The biggest chunk of operating cost is definitely tied up in getting the science right. For the nine months ending September 30, 2025, Research and Development (R&D) expenses totaled $13.9 million. This represents a significant year-over-year increase of 58% compared to the same period in 2024, showing you where the focus is right now-advancing the pipeline.

To support the products already moving through partners, the Cost of Goods Sold (COGS) is a major line item. For those same nine months in 2025, COGS hit $22.4 million. This cost directly reflects the increased sales of Elfabrio and Elelyso to Chiesi, Pfizer, and Fiocruz.

General overhead, which covers the Selling, General, and Administrative (SG&A) costs, shows a degree of cost discipline, even with increased R&D spending. For the third quarter of 2025 alone, SG&A was $2.9 million. That's actually up slightly, about 12%, from Q3 2024, driven by small increases in salary and selling expenses.

Here's a quick look at the key cost components for the first nine months of 2025:

Cost Category	Period Ending September 30, 2025	Change vs. Prior Year Period
Research and Development (R&D) Expenses	$13.9 million	Up 58%
Cost of Goods Sold (COGS)	$22.4 million	Up 10%
Selling, General, and Administrative (SG&A) Expenses	$8.2 million (9M Total)	Down 11% (9M Total)

The investment in the pipeline is heavily weighted toward the next big potential asset. You see this clearly in the clinical trial expenses earmarked for candidates like PRX-115, the uricase for uncontrolled gout. Management has signaled that preparations for the Phase 2 clinical trial are a strategic investment. The projected cost for third-party expenses related to this PRX-115 Phase 2 trial is expected to exceed $20 million.

The cost structure is clearly bifurcated:

• R&D spend is accelerating, primarily for the PRX-115 Phase 2 trial initiation planned for the second half of 2025.
• COGS is directly proportional to product sales volume to partners like Chiesi and Pfizer.
• SG&A shows relative stability, decreasing by 11% year-over-year for the nine-month period to $8.2 million.
• The PRX-115 program is a major near-term cost driver, with third-party trial expenses projected to surpass $20 million.

Protalix BioTherapeutics, Inc. (PLX) - Canvas Business Model: Revenue Streams

You're looking at how Protalix BioTherapeutics, Inc. actually brings in cash, which is key for understanding their next moves, especially with that PRX-115 trial ramping up. The revenue streams are heavily weighted toward product sales from their commercialized therapies, but licensing income is still a piece of the puzzle.

The overall top-line number you need to track is the Trailing Twelve Months (TTM) revenue as of late 2025. Based on the latest figures, Protalix BioTherapeutics, Inc. reported a Total revenue (TTM 2025) of $61.94 million USD. This is up significantly, showing 35.42% growth year-over-year from the 2024 TTM figure of $53.39 million USD.

The core of the revenue comes from product sales, which for the nine months ended September 30, 2025, totaled $43.1 million USD. This is broken down by their key commercial products:

• - Product sales of Elfabrio® to Chiesi (major growth driver): This partnership is central. For the nine months ending September 30, 2025, sales to Chiesi accounted for $18.6 million USD of the product revenue. The CEO noted a 50% increase in selling goods revenue in the first half of 2025 compared to the first half of 2024, driven primarily by Elfabrio sales. Still, you have to remember that ordering patterns fluctuate quarterly as Chiesi manages its inventory; for instance, Q3 2025 sales to Chiesi were $8.8 million USD.
• - Product sales of Elelyso® to Pfizer and alfataliglicerase to Fiocruz (Brazil): These sales also contribute substantially. For the first nine months of 2025, sales to Pfizer were $15.4 million USD, and sales of alfataliglicerase (Elelyso) to Fiocruz in Brazil were $9.1 million USD. The Q3 2025 snapshot shows Pfizer contributed $2.8 million USD and Fiocruz contributed $6.1 million USD in that quarter alone.

Beyond the physical product sales, Protalix BioTherapeutics, Inc. captures value through agreements with its partners. This is the smaller, but still present, stream:

• - License fees, milestone payments, and royalties from commercial partners: Revenues from license and R&D services for the nine months ending September 30, 2025, totaled $0.5 million USD. For the third quarter of 2025 specifically, this stream brought in $0.2 million USD, a 100% increase over the same period in 2024. Management has indicated that outside of potential regulatory milestone payments, they expect minimal revenue from this source now that Elfabrio's clinical development is complete.

Here's a quick look at the revenue components for the nine months ending September 30, 2025, which gives you a clearer picture of the mix:

Revenue Component	Amount (9M Ended Sept 30, 2025 USD)	Percentage of Total Revenue (9M)
Revenues from Selling Goods	$43.1 million	Approx. 99.3%
Revenues from License and R&D Services	$0.5 million	Approx. 1.1%
Total Reported Revenue (9M 2025)	$43.6 million	100.4% (Note: Sum exceeds 100% due to rounding/minor components not listed)

The quarterly variability is something you defintely need to watch, as Dror Bashan, the CEO, pointed out that partner purchases control the timing. For example, Q3 2025 total revenue was $17.9 million USD, a slight 1% decrease year-over-year from Q3 2024's $17.8 million USD. Finance: draft 13-week cash view by Friday.