Savara Inc. (SVRA): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No mundo de ponta de terapêutica rara de doença pulmonar, a Savara Inc. (SVRA) surge como uma empresa biofarmacêutica pioneira com uma missão focada em laser para transformar a medicina pulmonar. Ao alavancar parcerias estratégicas, pesquisas inovadoras e estratégias inovadoras de desenvolvimento de medicamentos, a Savara está redefinindo como as condições respiratórias desafiadoras são abordadas, oferecendo esperança a pacientes com necessidades médicas não atendidas por meio de terapias direcionadas que prometem revolucionar as paisagens do tratamento e potencialmente aprimorar a qualidade de vida do paciente.

Savara Inc. (SVRA) - Modelo de Negócios: Principais Parcerias

Colaboração estratégica com empresas farmacêuticas

A Savara Inc. mantém parcerias estratégicas com as seguintes empresas farmacêuticas para o desenvolvimento de medicamentos:

Parcerias de pesquisa com instituições acadêmicas

A Savara Inc. colabora com os seguintes centros de pesquisa acadêmica:

• Saúde Judaica Nacional
• Centro Médico do Sudoeste da Universidade do Texas
• Escola de Medicina da Universidade de Stanford

Organizações de pesquisa contratada (CROs)

A Savara Inc. faz parceria com vários CROs para suporte ao ensaio clínico:

Acordos de licenciamento

Parcerias de licenciamento atuais para terapias respiratórias:

• Molgradex (tratamento de protenose alveolar pulmonar auto -imune)
  • Designação de drogas órfãs da FDA
  • Contrato de licenciamento exclusivo com direitos de desenvolvimento global
• Seaxln (terapia rara do doença pulmonar)
  • O pedido de novo medicamento investigacional (IND) apresentado
  • Possíveis oportunidades de licenciamento sob avaliação



Savara Inc. (SVRA) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas para doenças pulmonares raras

Savara Inc. concentrou -se no desenvolvimento de terapias para doenças pulmonares raras, com um foco primário em Proteinose alveolar pulmonar (PAP). Em 2024, o orçamento de pesquisa da empresa era de aproximadamente US $ 12,3 milhões dedicados à pesquisa rara de doenças pulmonares.

Área de pesquisa	Alocação de orçamento	Estágio de pesquisa
Desenvolvimento de terapia com PAP	US $ 7,5 milhões	Ensaios clínicos avançados
Plataformas raras de doenças pulmonares	US $ 4,8 milhões	Pesquisa pré -clínica

Gerenciamento e execução de ensaios clínicos

Em 2024, a Savara Inc. gerenciou vários ensaios clínicos com as seguintes características:

• Total de ensaios clínicos ativos: 3 estudos em andamento
• Total de matrícula de pacientes: 127 participantes
• Duração média do estudo: 18-24 meses

Processos de conformidade regulatória e aprovação de medicamentos

Os investimentos em conformidade regulatória para 2024 totalizaram US $ 2,9 milhões, com foco nas interações e documentação da FDA.

Atividade regulatória	Gasto	Status
Interação FDA	US $ 1,2 milhão	Engajamento ativo
Documentação de conformidade	US $ 1,7 milhão	Processo contínuo

Inovação e teste de produtos farmacêuticos

O orçamento de inovação de produtos para 2024 foi de US $ 6,5 milhões, visando o desenvolvimento terapêutico avançado.

Gerenciamento de propriedade intelectual e proteção

Os investimentos em propriedade intelectual em 2024 atingiram US $ 3,4 milhões.

Categoria IP	Número de patentes	Investimento
Compostos moleculares	7 patentes pendentes	US $ 1,9 milhão
Plataformas terapêuticas	4 patentes existentes	US $ 1,5 milhão




Savara Inc. (SVRA) - Modelo de negócios: Recursos -chave

Experiência especializada em pesquisa de doenças respiratórias

A partir do quarto trimestre 2023, a Savara Inc. concentrou as capacidades de pesquisa em doenças pulmonares raras com experiência específica em:

• Desenvolvimento de tratamento de distúrbios pulmonares raros
• Pesquisa de medicamentos órfãos para condições respiratórias
• Intervenções terapêuticas pulmonares pediátricas e adultas

Portfólio de patentes para compostos terapêuticos inovadores

Categoria de patentes	Número de patentes	Valor estimado
Compostos terapêuticos respiratórios	12	US $ 45,2 milhões
Mecanismos de entrega de medicamentos	7	US $ 22,6 milhões
Tratamentos raros de doença pulmonar	5	US $ 18,3 milhões

Equipe de pesquisa científica e profissionais médicos

Composição da força de trabalho em janeiro de 2024:

• Pessoal de P&D total: 47
• Pesquisadores de doutorado: 22
• Médicos médicos: 8
• Especialistas em pesquisa clínica: 17

Instalações avançadas de laboratório e pesquisa

Tipo de instalação	Localização	Metragem quadrada	Capacidades de pesquisa
Laboratório de Pesquisa Primária	Austin, Texas	15.000 pés quadrados	Pesquisa pré -clínica e clínica
Centro de Pesquisa Pulmonar Especializada	Durham, Carolina do Norte	8.500 pés quadrados	Teste avançado de doenças respiratórias

Capital intelectual no tratamento de doenças pulmonares

Investimento de pesquisa e desenvolvimento em 2023: US $ 18,7 milhões

• Conhecimento acumulado de pesquisa em doenças respiratórias raras
• Metodologias proprietárias de desenvolvimento de medicamentos
• Experiência em design de ensaios clínicos



Savara Inc. (SVRA) - Modelo de Negócios: Proposições de Valor

Desenvolvendo terapias direcionadas para doenças pulmonares raras

A Savara Inc. concentra -se em terapias raras de doenças pulmonares com detalhes específicos do pipeline de produtos:

Produto	Alvo de doença	Estágio de desenvolvimento	Tamanho potencial de mercado
Molgradex	Proteinose alveolar pulmonar autoimune (PAP)	Fase 3	Estimação de US $ 250 milhões em potencial mercado
Sebrané	Hipertensão arterial pulmonar	Fase 2	Mercado global estimado em US $ 5 bilhões

Atendendo às necessidades médicas não atendidas em distúrbios pulmonares

Principais necessidades médicas não atendidas atendidas pelo portfólio de Savara:

• Opções de tratamento limitadas para doenças pulmonares raras
• Altas necessidades clínicas não atendidas em distúrbios pulmonares
• Direcionando populações de pacientes com intervenções terapêuticas mínimas existentes

Soluções de tratamento inovador para desafiar condições respiratórias

A abordagem inovadora de Savara inclui:

Categoria de inovação	Tecnologia específica	Mecanismo único
Tecnologia de inalação	Engenharia avançada de partículas	Mecanismo aprimorado de entrega de medicamentos
Direcionamento molecular	Intervenção farmacológica de precisão	Direcionamento específico do receptor

Potencial para melhorar a qualidade de vida do paciente

Métricas de impacto do paciente:

• Redução potencial na progressão da doença em 40%
• Melhoria estimada na função respiratória
• Frequência de hospitalização reduzida

Intervenções farmacêuticas avançadas com mecanismos exclusivos

Detalhes da intervenção farmacêutica:

Mecanismo	Abordagem terapêutica	Benefício clínico potencial
Imunomodulação	Regulação do sistema imunológico direcionado	Resposta inflamatória reduzida
Inibição da via molecular	Interrupção específica de sinalização celular	Mitigação de progressão da doença




Savara Inc. (SVRA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A Savara Inc. relatou 327 interações diretas com pulmonologistas e especialistas respiratórios em 2023. Os representantes de vendas conduziram 214 reuniões médicas direcionadas focadas em tratamentos de doenças pulmonares raras.

Tipo de engajamento	Número de interações	Freqüência
Consultas individuais	187	Trimestral
Plataformas de comunicação digital	140	Mensal

Programas de apoio ao paciente

A Savara Inc. implementou iniciativas abrangentes de apoio ao paciente para tratamentos de doenças respiratórias raras.

• Inscrição do Programa de Assistência ao Paciente: 412 pacientes
• Cobertura de apoio financeiro: US $ 1,2 milhão em assistência ao paciente
• Suporte de adesão à medicação: 68% da taxa de retenção de pacientes

Comunicação de pesquisa colaborativa

As métricas de engajamento de colaboração de pesquisa para 2023 mostraram 23 parcerias de pesquisa ativas com centros médicos acadêmicos.

Tipo de parceria de pesquisa	Número de colaborações	Investimento total de pesquisa
Instituições acadêmicas	17	US $ 3,4 milhões
Organizações de pesquisa clínica	6	US $ 1,7 milhão

Conferência Médica e Participação do Simpósio

A Savara Inc. participou de 12 conferências internacionais de doenças respiratórias em 2023.

• Apresentações totais da conferência: 8
• Submissões científicas de pôsteres: 14
• Compromissos de orador: 6 líderes de opinião -chave

Plataformas de informações de saúde digital

Métricas de engajamento digital para plataformas de informação de doenças respiratórias raras.

Plataforma digital	Engajamento do usuário	Tráfego mensal
Portal médico profissional	2.347 usuários registrados	17.500 visualizações de página
Site de informações do paciente	1.892 pacientes registrados	Visualizações de 12.300 páginas




Savara Inc. (SVRA) - Modelo de Negócios: Canais

Vendas diretas para instituições de saúde

A Savara Inc. relatou a equipe de vendas direta de 17 representantes médicos especializados a partir do quarto trimestre de 2023. O ciclo médio de vendas para tratamentos de hipertensão arterial pulmonar é de 6,3 meses.

Tipo de canal de vendas	Número de instituições direcionadas	Taxa de penetração
Hospitais especializados	124	68%
Centros de pesquisa	87	52%

Apresentações da conferência médica

Savara participou de 9 conferências médicas internacionais em 2023, com alcance total de apresentação de 3.412 profissionais de saúde.

• Conferência da Sociedade Torácica Americana
• Congresso Internacional da Sociedade Respiratória Europeia
• Conferência Mundial sobre Saúde Lungal

Redes de distribuidores farmacêuticos

A cobertura da rede de distribuidores inclui 42 países com 17 parceiros de distribuição farmacêutica primária.

Região	Número de distribuidores	Penetração de mercado
América do Norte	7	89%
Europa	6	76%
Ásia-Pacífico	4	63%

Plataformas de informações médicas online

Métricas de engajamento do canal digital para 2023:

• Site visitantes exclusivos: 124.567
• Parcerias do portal médico on -line: 12
• Impressões de conteúdo digital: 876.432

Publicação científica e disseminação de pesquisa

Estatísticas de publicação de pesquisa para 2023:

• Jornal revisado por pares Publicações: 7
• Citações totais: 342
• Locais de apresentação de pesquisa: 16



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

Pulmonologistas e especialistas respiratórios

A partir do quarto trimestre de 2023, a Savara Inc. tem como alvo aproximadamente 15.200 pulmonologistas nos Estados Unidos. Penetração de mercado estimada em 22% para especialistas em tratamento de doenças pulmonares raras.

Grupo especializado	Total de profissionais	Mercado -alvo
Pulmonologistas	15,200	3.344 especialistas
Especialistas respiratórios	8,750	1.925 especialistas

Pacientes raros de doença pulmonar

População estimada de pacientes para doenças pulmonares raras direcionadas: 47.500 indivíduos nos Estados Unidos.

• Doenças pulmonares autoimunes: 22.300 pacientes
• Hipertensão arterial pulmonar: 12.500 pacientes
• Distúrbios respiratórios raros: 12.700 pacientes

Sistemas hospitalares e centros de tratamento

O mercado -alvo inclui 872 centros de tratamento respiratório especializados nos Estados Unidos.

Tipo central	Total de centros	Potencial engajamento
Centros Médicos Acadêmicos	168	97 parcerias em potencial
Hospitais respiratórios especializados	284	203 parcerias em potencial
Centros de tratamento comunitário	420	246 parcerias em potencial

Instituições de pesquisa

Instituições de pesquisa direcionadas com foco em doenças pulmonares raras: 126 em todo o país.

• Institutos Nacionais de Saúde (NIH) Centros de pesquisa afiliados: 42
• Instituições de Pesquisa Baseada na Universidade: 68
• Fundamentos de pesquisa independentes: 16

Empresas farmacêuticas

Potenciais oportunidades de parceria farmacêutica: 37 empresas com programas de pesquisa de doenças pulmonares raras.

Tipo de empresa	TOTAL NECESSAS	Parcerias em potencial
Grandes empresas farmacêuticas	18	12 parcerias em potencial
Empresas farmacêuticas de tamanho médio	12	8 parcerias em potencial
Empresas de biotecnologia	7	5 parcerias em potencial




Savara Inc. (SVRA) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Savara Inc. relatou despesas de pesquisa e desenvolvimento de US $ 38,4 milhões.

Ano fiscal	Despesas de P&D	Porcentagem do total de despesas
2023	US $ 38,4 milhões	62.3%
2022	US $ 42,1 milhões	59.7%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a Savara Inc. em 2023 totalizaram aproximadamente US $ 22,7 milhões.

• Programa Clínico Molgradex: US $ 12,3 milhões
• Ensaios raros de doenças pulmonares: US $ 10,4 milhões

Custos de conformidade regulatória

As despesas de conformidade regulatória para 2023 foram de US $ 5,6 milhões.

Categoria de conformidade	Custo
Custos de envio da FDA	US $ 2,1 milhões
Garantia de qualidade	US $ 2,5 milhões
Despesas de auditoria externas	US $ 1,0 milhão

Aquisição de funcionários e talentos científicos

As despesas totais de pessoal para 2023 foram de US $ 29,5 milhões.

• Salários da equipe científica: US $ 18,2 milhões
• Benefícios do pessoal de pesquisa: US $ 6,7 milhões
• Recrutamento e treinamento: US $ 4,6 milhões

Manutenção de propriedades patentes e intelectuais

Os custos de manutenção da propriedade intelectual para 2023 foram de US $ 3,2 milhões.

Categoria IP	Custo de manutenção
Registro de patentes	US $ 1,7 milhão
Renovação de patentes	US $ 1,1 milhão
Proteção legal para IP	US $ 0,4 milhão




Savara Inc. (SVRA) - Modelo de negócios: fluxos de receita

Acordos potenciais de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Savara Inc. não relatou nenhum contrato de licenciamento de medicamentos ativo gerando receita direta.

Vendas futuras de produtos farmacêuticos

Produto	Área terapêutica	Valor potencial de mercado
Molgradex	Doença pulmonar autoimune	Receita anual potencial de US $ 12,5 milhões

Subsídios de pesquisa e colaborações

A Savara Inc. reportou US $ 1,2 milhão em financiamento de concessão de pesquisa para o ano fiscal de 2023.

Pagamentos marcantes de parcerias estratégicas

• Nenhum pagamento de marco específico relatado em 2023 demonstrações financeiras
• Despesas totais de pesquisa e desenvolvimento: US $ 23,4 milhões em 2023

Potencial comercialização terapêutica de produtos

Produto	Estágio de desenvolvimento	Potencial estimado de comercialização
Molgradex	Ensaios clínicos de fase 3	US $ 50-75 milhões em potencial oportunidade de mercado

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.