Savara Inc. (SVRA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo de vanguardia de la terapéutica de enfermedad pulmonar rara, Savara Inc. (SVRA) emerge como una compañía biofarmacéutica pionera con una misión centrada en el láser para transformar la medicina pulmonar. Al aprovechar las asociaciones estratégicas, la investigación innovadora y las estrategias innovadoras de desarrollo de fármacos, Savara redefine cómo se abordan las condiciones respiratorias desafiantes, ofreciendo esperanza a pacientes con necesidades médicas no satisfechas a través de terapias específicas que prometen revolucionar los paisajes de tratamiento y potencialmente mejorar la calidad de la vida de los pacientes.

Savara Inc. (SVRA) - Modelo de negocios: asociaciones clave

Colaboración estratégica con compañías farmacéuticas

Savara Inc. mantiene asociaciones estratégicas con las siguientes compañías farmacéuticas para el desarrollo de medicamentos:

Asociaciones de investigación con instituciones académicas

Savara Inc. colabora con los siguientes centros de investigación académicos:

• Salud judía nacional
• Centro Médico Southwestern de la Universidad de Texas
• Facultad de Medicina de la Universidad de Stanford

Organizaciones de investigación por contrato (CRO)

Savara Inc. se asocia con múltiples CRO para apoyo de ensayos clínicos:

Acuerdos de licencia

Asociaciones actuales de licencia para terapias respiratorias:

• Molgradex (tratamiento de proteinosis alveolar pulmonar autoinmune)
  • Designación de medicamentos huérfanos de la FDA
  • Acuerdo de licencia exclusivo con Derechos de Desarrollo Global
• Seaxln (terapia de enfermedad pulmonar rara)
  • Solicitud de investigación de nueva droga de investigación (IND) presentada
  • Oportunidades potenciales de licencia bajo evaluación



Savara Inc. (SVRA) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas de enfermedad pulmonar rara

Savara Inc. se centró en el desarrollo de terapias para enfermedades pulmonares raras, con un enfoque principal en Proteinosis alveolar pulmonar (PAP). A partir de 2024, el presupuesto de investigación de la compañía era de aproximadamente $ 12.3 millones dedicado a la investigación de enfermedades pulmonares raras.

Área de investigación	Asignación de presupuesto	Etapa de investigación
Desarrollo de la terapia PAP	$ 7.5 millones	Ensayos clínicos avanzados
Plataformas raras de enfermedades pulmonares	$ 4.8 millones	Investigación preclínica

Gestión y ejecución del ensayo clínico

En 2024, Savara Inc. gestionó múltiples ensayos clínicos con las siguientes características:

• Ensayos clínicos activos totales: 3 estudios en curso
• Inscripción total del paciente: 127 participantes
• Duración promedio de prueba: 18-24 meses

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Las inversiones de cumplimiento regulatorio para 2024 totalizaron $ 2.9 millones, con enfoque en las interacciones y la documentación de la FDA.

Actividad regulatoria	Gasto	Estado
Interacción de la FDA	$ 1.2 millones	Compromiso activo
Documentación de cumplimiento	$ 1.7 millones	Proceso continuo

Innovación y prueba de productos farmacéuticos

El presupuesto de innovación de productos para 2024 fue de $ 6.5 millones, dirigido a un desarrollo terapéutico avanzado.

Gestión y protección de la propiedad intelectual

Las inversiones de propiedad intelectual en 2024 alcanzaron $ 3.4 millones.

Categoría de IP	Número de patentes	Inversión
Compuestos moleculares	7 patentes pendientes	$ 1.9 millones
Plataformas terapéuticas	4 patentes existentes	$ 1.5 millones




Savara Inc. (SVRA) - Modelo de negocio: recursos clave

Experiencia de investigación de enfermedades respiratorias especializadas

A partir del cuarto trimestre de 2023, Savara Inc. ha centrado capacidades de investigación en enfermedades pulmonares raras con experiencia específica en:

• Desarrollo de tratamiento de trastornos pulmonares raros
• Investigación de drogas huérfanas para afecciones respiratorias
• Intervenciones terapéuticas pulmonares pediátricas y adultas

Portafolio de patentes para compuestos terapéuticos innovadores

Categoría de patente	Número de patentes	Valor estimado
Compuestos terapéuticos respiratorios	12	$ 45.2 millones
Mecanismos de administración de medicamentos	7	$ 22.6 millones
Tratamientos raros de enfermedad pulmonar	5	$ 18.3 millones

Equipo de investigación científica y profesionales médicos

Composición de la fuerza laboral a partir de enero de 2024:

• Personal total de I + D: 47
• Investigadores de doctorado: 22
• Médicos: 8
• Especialistas en investigación clínica: 17

Instalaciones avanzadas de laboratorio e investigación

Tipo de instalación	Ubicación	Pies cuadrados	Capacidades de investigación
Laboratorio de investigación primaria	Austin, Texas	15,000 pies cuadrados	Investigación preclínica y clínica
Centro de investigación pulmonar especializada	Durham, Carolina del Norte	8,500 pies cuadrados	Prueba avanzada de enfermedades respiratorias

Capital intelectual en el tratamiento de la enfermedad pulmonar

Inversión en investigación y desarrollo en 2023: $ 18.7 millones

• Conocimiento de investigación acumulado en enfermedades respiratorias raras
• Metodologías de desarrollo de fármacos patentados
• Experiencia de diseño de ensayos clínicos



Savara Inc. (SVRA) - Modelo de negocio: propuestas de valor

Desarrollo de terapias dirigidas para enfermedades pulmonares raras

Savara Inc. se centra en terapias raras de la enfermedad pulmonar con detalles específicos de la tubería de productos:

Producto	Objetivo de enfermedad	Etapa de desarrollo	Tamaño potencial del mercado
Molgradex	Proteinosis alveolar pulmonar autoinmune (PAP)	Fase 3	Mercado potencial estimado de $ 250 millones
Sebrané	Hipertensión arterial pulmonar	Fase 2	Mercado global estimado de $ 5 mil millones

Abordar las necesidades médicas no satisfechas en los trastornos pulmonares

Necesidades médicas no satisfechas clave abordadas por la cartera de Savara:

• Opciones de tratamiento limitadas para enfermedades pulmonares raras
• Altas necesidades clínicas no satisfechas en los trastornos pulmonares
• Dirigirse a las poblaciones de pacientes con intervenciones terapéuticas existentes mínimas

Soluciones de tratamiento innovadoras para afecciones respiratorias desafiantes

El enfoque innovador de Savara incluye:

Categoría de innovación	Tecnología específica	Mecanismo único
Tecnología de inhalación	Ingeniería de partículas avanzadas	Mecanismo mejorado de suministro de medicamentos
Orientación molecular	Intervención farmacológica de precisión	Orientación del receptor específico

Potencial para mejorar la calidad de vida del paciente

Métricas de impacto del paciente:

• Reducción potencial en la progresión de la enfermedad en un 40%
• Mejora estimada en la función respiratoria
• Frecuencia de hospitalización reducida

Intervenciones farmacéuticas avanzadas con mecanismos únicos

Detalles de intervención farmacéutica:

Mecanismo	Enfoque terapéutico	Beneficio clínico potencial
Inmunomodulación	Regulación del sistema inmunitario dirigido	Respuesta inflamatoria reducida
Inhibición de la vía molecular	Interrupción de señalización celular específica	Mitigación de progresión de la enfermedad




Savara Inc. (SVRA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

Savara Inc. informó 327 interacciones directas con pulmonólogos y especialistas respiratorios en 2023. Los representantes de ventas realizaron 214 reuniones médicas dirigidas centradas en tratamientos raros de enfermedades pulmonares.

Tipo de compromiso	Número de interacciones	Frecuencia
Consultas individuales	187	Trimestral
Plataformas de comunicación digital	140	Mensual

Programas de apoyo al paciente

Savara Inc. implementó iniciativas integrales de apoyo al paciente para tratamientos de enfermedades respiratorias raras.

• Inscripción del programa de asistencia al paciente: 412 pacientes
• Cobertura de apoyo financiero: $ 1.2 millones en asistencia del paciente
• Apoyo de adherencia a la medicación: 68% de tasa de retención del paciente

Comunicación de investigación colaborativa

Las métricas de participación de la colaboración de investigación para 2023 mostraron 23 asociaciones de investigación activas con centros médicos académicos.

Tipo de asociación de investigación	Número de colaboraciones	Inversión total de investigación
Instituciones académicas	17	$ 3.4 millones
Organizaciones de investigación clínica	6	$ 1.7 millones

Conferencia médica y participación del simposio

Savara Inc. participó en 12 conferencias internacionales de enfermedades respiratorias en 2023.

• Presentaciones de conferencia totales: 8
• Presentaciones de póster científicos: 14
• Compromisos del orador: 6 líderes de opinión clave

Plataformas de información de salud digital

Métricas de participación digital para plataformas de información de enfermedades respiratorias raras.

Plataforma digital	Compromiso de usuario	Tráfico mensual
Portal médico profesional	2.347 usuarios registrados	17.500 vistas de página
Sitio web de información del paciente	1.892 pacientes registrados	12.300 vistas de la página




Savara Inc. (SVRA) - Modelo de negocios: canales

Ventas directas a instituciones de atención médica

Savara Inc. informó que el equipo de ventas directas de 17 representantes médicos especializados a partir del cuarto trimestre de 2023. El ciclo de ventas promedio para los tratamientos de hipertensión arterial pulmonar es de 6.3 meses.

Tipo de canal de ventas	Número de instituciones específicas	Tasa de penetración
Hospitales especializados	124	68%
Centros de investigación	87	52%

Presentaciones de conferencia médica

Savara participó en 9 conferencias médicas internacionales en 2023, con un alcance total de presentación de 3.412 profesionales de la salud.

• Conferencia de la American Thoracic Society
• Congreso internacional de la Sociedad Respiratoria Europea
• Conferencia mundial sobre salud pulmonar

Redes de distribuidores farmacéuticos

La cobertura de la red de distribuidores incluye 42 países con 17 socios de distribución farmacéutica primaria.

Región	Número de distribuidores	Penetración del mercado
América del norte	7	89%
Europa	6	76%
Asia-Pacífico	4	63%

Plataformas de información médica en línea

Métricas de participación del canal digital para 2023:

• Sitio web Visitantes únicos: 124,567
• Asociaciones de portal médico en línea: 12
• Impresiones de contenido digital: 876,432

Publicación científica y difusión de investigación

Estadísticas de publicación de investigación para 2023:

• Publicaciones de revistas revisadas por pares: 7
• Citas totales: 342
• Lugares de presentación de investigación: 16



Savara Inc. (SVRA) - Modelo de negocios: segmentos de clientes

Pulmonólogos y especialistas respiratorios

A partir del cuarto trimestre de 2023, Savara Inc. se dirige a aproximadamente 15.200 pulmonólogos en los Estados Unidos. Penetración del mercado estimada en 22% para especialistas en tratamiento de enfermedad pulmonar raras.

Grupo especializado	Total de profesionales	Mercado objetivo
Pulmonólogos	15,200	3.344 especialistas
Especialistas respiratorios	8,750	1.925 especialistas

Pacientes de enfermedad pulmonar rara

Población de pacientes estimada para enfermedades pulmonares raras dirigidas: 47,500 individuos en los Estados Unidos.

• Enfermedades pulmonares autoinmunes: 22,300 pacientes
• Hipertensión arterial pulmonar: 12,500 pacientes
• Trastornos respiratorios raros: 12,700 pacientes

Sistemas hospitalarios y centros de tratamiento

El mercado objetivo incluye 872 centros de tratamiento respiratorio especializados en los Estados Unidos.

Tipo central	Centros totales	Compromiso potencial
Centros médicos académicos	168	97 asociaciones potenciales
Hospitales respiratorios especializados	284	203 asociaciones potenciales
Centros de tratamiento comunitario	420	246 asociaciones potenciales

Instituciones de investigación

Instituciones de investigación específicas que se centran en enfermedades pulmonares raras: 126 en todo el país.

• Centros de investigación afiliados a los Institutos Nacionales de Salud (NIH): 42
• Instituciones de investigación basadas en la universidad: 68
• Fundamentos de investigación independientes: 16

Compañías farmacéuticas

Oportunidades potenciales de asociación farmacéutica: 37 empresas con programas raros de investigación de enfermedades pulmonares.

Tipo de empresa	Total de empresas	Posibles asociaciones
Grandes corporaciones farmacéuticas	18	12 asociaciones potenciales
Compañías farmacéuticas de tamaño mediano	12	8 posibles asociaciones
Empresas de biotecnología	7	5 asociaciones potenciales




Savara Inc. (SVRA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Savara Inc. reportó gastos de investigación y desarrollo de $ 38.4 millones.

Año fiscal	Gastos de I + D	Porcentaje de gastos totales
2023	$ 38.4 millones	62.3%
2022	$ 42.1 millones	59.7%

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para Savara Inc. en 2023 totalizaron aproximadamente $ 22.7 millones.

• Programa clínico de Molgradex: $ 12.3 millones
• Ensayos raros de enfermedad pulmonar: $ 10.4 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 fueron de $ 5.6 millones.

Categoría de cumplimiento	Costo
Costos de envío de la FDA	$ 2.1 millones
Seguro de calidad	$ 2.5 millones
Gastos de auditoría externa	$ 1.0 millones

Adquisición de personal y talento científico

Los gastos totales de personal para 2023 fueron de $ 29.5 millones.

• Salarios del personal científico: $ 18.2 millones
• Beneficios del personal de investigación: $ 6.7 millones
• Reclutamiento y capacitación: $ 4.6 millones

Mantenimiento de patentes e propiedad intelectual

Los costos de mantenimiento de la propiedad intelectual para 2023 fueron de $ 3.2 millones.

Categoría de IP	Costo de mantenimiento
Presentación de patentes	$ 1.7 millones
Renovación de patente	$ 1.1 millones
Protección legal de IP	$ 0.4 millones




Savara Inc. (SVRA) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de drogas

A partir del cuarto trimestre de 2023, Savara Inc. no ha informado ningún acuerdos activos de licencia de medicamentos que generen ingresos directos.

Ventas de productos farmacéuticos futuros

Producto	Área terapéutica	Valor de mercado potencial
Molgradex	Enfermedad pulmonar autoinmune	$ 12.5 millones de ingresos anuales potenciales

Subvenciones y colaboraciones de investigación

Savara Inc. reportó $ 1.2 millones en fondos de subvenciones de investigación para el año fiscal 2023.

Pagos de hitos de asociaciones estratégicas

• No se informaron pagos de hitos específicos en 2023 estados financieros
• Gastos totales de investigación y desarrollo: $ 23.4 millones en 2023

Comercialización potencial de productos terapéuticos

Producto	Etapa de desarrollo	Potencial de comercialización estimado
Molgradex	Ensayos clínicos de fase 3	Oportunidad de mercado potencial de $ 50-75 millones

Savara Inc. (SVRA) - Canvas Business Model: Value Propositions

You're looking at the core reason Savara Inc. (SVRA) exists: to offer the first and only pharmacologic treatment for autoimmune PAP (aPAP) in the U.S. and Europe. This is a massive value driver, considering that as of late 2025, Japan remains the only country with an approved therapy for aPAP. The autoimmune PAP segment itself dominates the global PAP drug market, accounting for 62.3% of revenue share in 2025.

The product, molgramostim inhalation solution (Molbreevi), directly addresses the core cause of aPAP by working as a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). It is designed to restore GM-CSF signaling, which re-establishes alveolar macrophage function to facilitate surfactant clearance. This mechanism is key because, without it, the abnormal buildup of surfactant clogs the air sacs, leading to impaired gas transfer.

The value proposition is heavily supported by the Phase 3 IMPALA-2 trial results, which Savara Inc. presented data from at CHEST 2025 and ERS Congress 2025. The clinical evidence shows significant improvements across multiple patient-centric measures:

• Significantly improves pulmonary gas transfer, measured by DLco%.
• Significantly improves respiratory health-related quality of life (HRQoL).
• Significantly improves patient functionality, measured by exercise capacity (METs).
• Reduces pulmonary surfactant burden, as seen on high-resolution computed tomography scans.

The magnitude of these improvements is concrete. For instance, the mean improvement in DLco% from baseline was 9.8% at Week 24 and 11.6% at Week 48. Honestly, that 11.6% improvement at 48 weeks is similar to the minimal clinically meaningful difference (MCID) of 10% reported for pulmonary fibrosis. For quality of life, the St. George's Respiratory Questionnaire (SGRQ) Total score saw a mean reduction of -11.5 points versus placebo's -5.9 points at Week 24.

This therapeutic effect has a direct impact on the current standard of care. The data suggests a potential to reduce the need for invasive Whole Lung Lavages (WLLs). To give you a sense of the current burden, one patient testimonial mentioned needing a WLL every 8 months due to surfactant buildup, which causes significant anxiety. The IMPALA-2 poster presentation specifically noted that Molgramostim reduces the number of WLL procedures in aPAP patients.

The delivery method is also a core value point: it is inhaled, non-invasive delivery via a specialized nebulizer. Molgramostim is delivered via a proprietary investigational eFlow® Nebulizer System developed by PARI Pharma GmbH specifically for this large molecule. This contrasts with systemic treatments, offering localized delivery and minimal systemic effects, which physicians favor for long-term management.

Here's a quick look at the patient population Savara Inc. is targeting, which underscores the unmet need:

The company is actively working to bring this value to market. Despite an FDA Refusal to File (RTF) letter in March 2025, Savara Inc. plans to resubmit the Biologics License Application (BLA) in December 2025, with regulatory approval anticipated in mid-2026. Furthermore, they expect to submit the Marketing Authorization Applications (MAA) to the EMA and MHRA by the first quarter of 2026. The company strengthened its balance sheet with approximately $149.5 million in equity financing, adding about $140 million to their cash position as of September 30, 2025, to support this potential launch.

Savara Inc. (SVRA) - Canvas Business Model: Customer Relationships

You're looking at how Savara Inc. plans to connect with and support the small, specific group of patients needing MOLBREEVI, which is crucial given its orphan indication status.

High-touch, specialized support programs for rare disease patients (post-approval)

Savara Inc. is developing the MyMolbreevi program specifically to cut down on access hurdles for appropriate patients once MOLBREEVI is approved. This program is designed around patient services and clinical education.

• Clinical education components include Pharmacist calls, Device training, Nurse educators, and Adherence support.
• Financial assistance planned includes a Commercial co-pay program and Free drug for eligible patients.
• Access will be facilitated through an Exclusive Specialty Pharmacy with Integrated Patient Services, which will service all patients with direct shipments and ongoing support.

The investment in this infrastructure is supported by recent financing activity. As of September 30, 2025, Savara Inc. reported cash, cash equivalents, and short-term investments of approximately $124.4 million, and they announced a $75 million Royalty Funding Agreement to support the potential MOLBREEVI launch. The net loss for the third quarter ending September 30, 2025, was $29.6 million.

Direct engagement with pulmonary specialists and reference centers

Engagement is focused on the specialized community treating Autoimmune Pulmonary Alveolar Proteinosis (aPAP). Savara Inc.'s management team brings significant experience in rare respiratory diseases and pulmonary medicine. The company has identified 8 Autoimmune PAP Centers of Excellence in its planning materials. Furthermore, the company is working with Fujifilm Biotechnologies as the Drug Substance Manufacturer for the Biologics License Application (BLA) resubmission planned for December 2025, indicating a key partnership for manufacturing quality assurance that supports specialist confidence.

Continuous data sharing and education via medical conferences (CHEST 2025)

Savara Inc. actively engages the medical community through presentations at major meetings. At CHEST 2025 (October 19-22), Savara was scheduled for an oral presentation on the Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis (aPAP). They also had 2 abstracts accepted for poster presentation, including one detailing the relationship between pulmonary gas transfer, respiratory health-related quality of life (HRQoL), exercise capacity, and surfactant burden in aPAP patients. The company also hosted a Learning Theatre open to all registered conference attendees.

Patient advocacy and disease awareness campaigns

Commercial launch planning involves a multi-channel disease awareness campaign targeting both healthcare professionals and patients. This effort includes several specific channels for outreach.

The company is also evolving its GM-CSF autoantibody testing platform with an eye toward long-term market expansion, which directly impacts patient identification.

Building trust through transparent clinical trial data presentation

Trust is built by making pivotal data accessible and peer-reviewed. Results from the Phase 3 IMPALA-2 clinical trial of molgramostim were published online in the New England Journal of Medicine on August 21, 2025. The data showed that molgramostim significantly improved lung diffusing capacity, with results showing a DLco% increase of 11.6% versus 4.7% for placebo at Week 48. The trial was the largest and longest randomized, double-blind, placebo-controlled study in autoimmune PAP, enrolling 62 patients in the open-label extension across 15 IMPALA-2 sites in the EU, UK, and Turkey.

Savara Inc. (SVRA) - Canvas Business Model: Channels

You're looking at how Savara Inc. plans to get MOLBREEVI, their inhaled biologic for autoimmune PAP, to the patients who need it, assuming regulatory hurdles clear. This is all about execution now that they've hit major submission milestones.

The regulatory pathway is the most immediate channel focus. Savara Inc. completed the initial Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for MOLBREEVI in the first quarter of 2025, requesting Priority Review, which could shorten the review to six months from the standard ten months. However, on May 27, 2025, the Company received a Refusal to File (RTF) letter from the FDA, which requested additional data related to Chemistry, Manufacturing, and Controls (CMC). Savara Inc. is now on track to resubmit the BLA in December 2025, again requesting Priority Review. If granted, this targets a PDUFA date by the end of 2025, setting up a potential U.S. commercial launch in early 2026. For Europe and the U.K., Savara Inc. anticipates submitting the Marketing Authorization Applications (MAA) to the EMA and MHRA in 1Q 2026. The target patient population, Autoimmune PAP, has approximately 3,600 diagnosed aPAP patients in the U.S.

For specialty pharmacy and distribution networks, the focus is on preparing for the commercial launch, which requires significant investment channels. While specific network contracts aren't public, the financial commitment shows this channel is being built out. Savara Inc. announced a $75 million Royalty Funding Agreement specifically to support the potential MOLBREEVI launch. The company believes its current cash position, bolstered by recent financing, is sufficient into 2H 2027, which covers the initial launch phase.

The direct sales force targeting pulmonary and critical care physicians is being staffed as part of the commercial build-up. General and administrative expenses for the third quarter ending September 30, 2025, reached $9.6 million, an increase of 60.1% year-over-year. This expense increase was primarily driven by strategic addition of personnel and related costs of $2.9 million for the quarter, alongside certain commercial activities of $0.2 million in the same period. This spending directly fuels the channel infrastructure, including the sales team build.

Medical publications and conference presentations serve as a critical channel for disseminating clinical data to prescribers and key opinion leaders. Savara Inc. presented new data analyses from the pivotal IMPALA-2 trial at this year's European Respiratory Society meeting. Furthermore, data from the Phase 3 IMPALA-2 trial was presented at the ATS International Conference 2025 in San Francisco, running from May 16-21, 2025.

Digital and patient-focused disease education platforms are part of the broader commercial investment, evidenced by the rising General and administrative expenses. The company stated it is accelerating investment in preparing for potential commercialization, which includes these non-personal promotion channels. The Q3 2025 G&A spend of $9.6 million reflects this preparatory work.

Here's a quick look at the key channel-related financial and regulatory milestones as of late 2025:

The scientific communication channel included presenting IMPALA-2 data at the ATS International Conference 2025 (May 16-21, 2025) and the European Respiratory Society meeting.

Finance: draft 13-week cash view by Friday.

Savara Inc. (SVRA) - Canvas Business Model: Customer Segments

Patients diagnosed with autoimmune Pulmonary Alveolar Proteinosis (aPAP).

The core segment is patients with autoimmune aPAP, a rare lung disease characterized by abnormal surfactant build-up in the alveoli. The addressable patient pool is concentrated in developed markets, though diagnosis rates are accelerating.

• U.S. estimated diagnosed prevalence (updated September 2025): ~5,500 autoimmune PAP patients.
• U.S. estimated diagnosed prevalence (previous 2023 analysis): ~3,600 patients.
• 7MM (Seven Major Markets) U.S. prevalent cases: about 8,300 cases.
• Germany diagnosed prevalent cases (2024): about 580 cases.
• Japan stage-specific (DSS-3, 4, and 5) aPAP cases (2024): about 780 cases.
• The largest diagnosed cohort is adults aged 41-55 years.

For these patients, the current standard of care without a pharmacologic option is whole lung lavage (WLL), an invasive procedure. In the IMPALA-2 trial, molgramostim reduced the need for WLL: 7.4% (6 patients) in the molgramostim group versus 13.3% (11 patients) in the placebo group required WLL during the 48-week treatment period.

Pulmonary specialists, pulmonologists, and rare lung disease experts.

This segment includes the physicians who diagnose and manage aPAP. Savara Inc. targets these experts through scientific exchange and awareness efforts. The company's management team possesses significant experience in rare respiratory diseases and pulmonary medicine.

• Savara Inc. presented pivotal Phase 3 IMPALA-2 trial data at the American Thoracic Society (ATS) International Conference in May 2025.
• Poster presentations, including data relevant to treatment efficacy, were accepted for CHEST 2025 in October.
• The Chief Commercial Officer was hired in September 2025 to prepare for potential launch.

Payers, including government health programs and private insurance companies.

Payers are critical for establishing access and reimbursement for molgramostim, which is anticipated to be the first and only pharmacologic treatment for aPAP in the U.S. and Europe.

Clinical trial sites and investigators globally.

This segment comprises the academic and clinical institutions necessary for generating the pivotal data supporting regulatory submissions and future post-marketing studies. Sites are located across the U.S. and internationally, supporting the global development plan.

• The pivotal Phase 3 IMPALA-2 trial data was presented by investigators from institutions including the University of Cincinnati College of Medicine and University College Dublin, Ireland, at ATS 2025.
• Marketing Authorization Applications (MAA) are expected to be submitted to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in Q1 2026.

Finance: draft 13-week cash view by Friday.

Savara Inc. (SVRA) - Canvas Business Model: Cost Structure

You're looking at the operating expenses for Savara Inc. as they push toward potential commercialization for MOLBREEVI. The cost structure is heavily weighted toward advancing the science and preparing the infrastructure for market entry, which is typical for a clinical-stage biopharma at this stage.

The Dominant Research and Development (R&D) expenses for the third quarter ending September 30, 2025, totaled $20.6 million. This figure reflects the ongoing commitment to the MOLBREEVI program, which is central to the company's value proposition. To be fair, this R&D spend is where the bulk of the cash burn is happening right now.

General and Administrative (G&A) costs are also climbing as the company gears up. G&A expenses for Q3 2025 reached $9.6 million. This increase, up from $6.0 million in the prior year period, is directly tied to commercial preparation activities and building out the necessary operational backbone.

Here's a quick look at the major drivers within those operating expenses for the third quarter of 2025:

Digging deeper into the R&D spend for that quarter, you see specific costs related to getting the drug ready for potential approval and launch. These are the costs that help secure the regulatory pathway:

• Chemistry, Manufacturing, and Controls (CMC) costs: approximately $0.3 million, mainly for establishing the primary drug substance manufacturer.
• Regulatory filing and quality assurance costs: $0.9 million.
• Clinical costs saw a decrease of $1.5 million compared to the prior year period.

The jump in G&A is largely explained by staffing up. The increase was primarily attributable to the strategic addition of personnel and related costs of $2.9 million for the three months ended September 30, 2025. Other departmental overhead accounted for $0.5 million, and certain commercial activities added $0.2 million to the G&A total. Honestly, this spending pattern shows you they are serious about the December BLA resubmission and the expected MAA submissions in early 2026.

Finance: draft 13-week cash view by Friday.

Savara Inc. (SVRA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Savara Inc. (SVRA) as of late 2025, and honestly, it's all about what's coming next, not what's here today. As a pre-commercial company, the current revenue line is flat, but the potential future streams are what matter for valuation right now.

No Current Product Revenue; The Company is Pre-Commercial

Savara Inc. is still in the development and regulatory preparation phase for its lead candidate, MOLBREEVI. This means, as of the third quarter ending September 30, 2025, the company reported $0 in revenue for the 2025 fiscal year. This is reflected in the analyst consensus revenue forecast for 2025Q4 being $0.000. The financial reality is captured by the net loss reported for Q3 2025, which was $29.6 million.

The company's near-term financial strength is being bolstered by non-sales related financing activities, which are critical to bridge the gap until potential product launch. You can see the structure of these financing events below:

Future Net Sales of MOLBREEVI for aPAP (Post-Approval)

The primary future revenue stream is the commercial sale of MOLBREEVI for Autoimmune Pulmonary Alveolar Proteinosis (aPAP) in the U.S. and Europe. Analysts project the worldwide peak sales potential for MOLBREEVI to reach approximately $1.2 billion.

Here's the timeline driving that potential revenue:

• Targeting potential U.S. launch in 2027.
• Planned submission of Marketing Authorization Applications (MAA) to the EMA and MHRA in 1Q 2026.
• BLA resubmission to the FDA planned for December 2025.

Contingent $75 Million Royalty Funding from RTW upon FDA Approval

This is a near-term cash infusion, not sales revenue, but it's directly tied to the product's success. Savara Inc. secured a $75 million royalty funding agreement with RTW Investments. This money becomes available only upon FDA approval of MOLBREEVI on or before March 31, 2027. In exchange, RTW receives a true sale of assigned interests, including tiered U.S. Net Sales royalties on MOLBREEVI ranging from 7.0% to 1.0%. To be fair, there's a step-up provision where the royalty rate could rise to 9.5% if prior year net sales fall below a specified level. The obligation terminates when RTW has received up to $187.5 million in total payments.

Potential Non-Dilutive Debt Financing Drawdowns (Up to $200 Million Facility)

Savara has a loan and security agreement with Hercules Capital for up to $200 million. This facility is structured in tranches based on milestones:

• Initial advance of $30 million funded at closing to refinance the existing $26.5 million debt facility.
• An additional $100 million becomes available upon FDA approval of MOLBREEVI and certain other milestones.
• The final $70 million tranche may be made available upon the Company's request and at Hercules Capital's discretion.

The loan has a five-year maturity, with a 36-month interest-only period, extendable to 60 months upon MOLBREEVI's FDA approval.