Iterum Therapeutics PLC (ITRM): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da terapêutica de doenças infecciosas, o Iterum Therapeutics PLC (ITRM) surge como uma empresa pioneira em biotecnologia com uma missão focada em laser para revolucionar o tratamento com antibióticos. Ao desenvolver soluções inovadoras para infecções bacterianas resistentes a drogas, particularmente através de seu trabalho inovador no Sulopenem, o Iterum está se posicionando como um jogador crítico ao abordar alguns dos desafios médicos mais desafiadores de nosso tempo. Seu modelo abrangente de modelo de negócios revela uma abordagem estratégica que combina pesquisas de ponta, parcerias estratégicas e um profundo compromisso de melhorar os resultados dos pacientes em uma época em que os antibióticos tradicionais são cada vez mais ineficazes.

Iterum Therapeutics PLC (ITRM) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com empresas farmacêuticas globais

A partir de 2024, a Iterum Therapeutics estabeleceu parcerias estratégicas com as seguintes empresas farmacêuticas:

Empresa parceira	Foco em parceria	Status de colaboração
Merck & Co.	Desenvolvimento de Antibióticos	Colaboração de pesquisa ativa
Pfizer Inc.	Suporte ao ensaio clínico	Parceria em andamento

Parcerias de pesquisa com instituições médicas acadêmicas

O Iterum Therapeutics mantém colaborações de pesquisa com as seguintes instituições acadêmicas:

• Escola de Medicina de Harvard
• Johns Hopkins University School of Medicine
• Universidade da Califórnia, São Francisco

Acordos de licenciamento para tecnologias de desenvolvimento de antibióticos

Os contratos de licenciamento atuais incluem:

Tecnologia	Licenciante	Termos de licenciamento
Novo composto antibiótico	MIT Technology Transfer Office	Direitos mundiais exclusivos
Plataforma de entrega de medicamentos	Universidade de Stanford	Licenciamento não exclusivo

Organizações de pesquisa contratada (CROs) para ensaios clínicos

O Iterum Therapeutics colabora com os seguintes CROs:

• Iqvia Holdings Inc.
• Parexel International Corporation
• PPD Inc. (agora parte do Thermo Fisher Scientific)

Potenciais investidores e empresas de capital de risco

Principais parceiros de investimento em 2024:

Investidor	Valor do investimento	Tipo de investimento
Consultores orbimed	US $ 15,2 milhões	Financiamento da série B.
Ventuos versantes	US $ 10,5 milhões	Capital de risco

Iterum Therapeutics PLC (ITRM) - Modelo de negócios: Atividades -chave

Desenvolvimento de novas terapias antibióticas

O Iterum Therapeutics se concentra no desenvolvimento de novas terapias antibióticas direcionadas a infecções bacterianas desafiadoras. A partir do quarto trimestre de 2023, a empresa possui 1 candidato a medicamentos primários, Sulopenem, no desenvolvimento clínico.

Candidato a drogas	Estágio de desenvolvimento	Indicação alvo
Sulopenem	Ensaios clínicos de fase 3	Infecções complicadas do trato urinário

Conduzindo ensaios clínicos

A Companhia conduz ativamente ensaios clínicos para o sulopenem em múltiplas indicações.

• Investimento total de ensaios clínicos em 2023: US $ 12,3 milhões
• Número de ensaios clínicos ativos: 2
• Alvo de inscrição do paciente: 500 pacientes

Processos de envio e aprovação regulatórios

O Iterum Therapeutics se envolve em uma estratégia regulatória abrangente para aprovação de medicamentos.

Agência regulatória	Status de envio	Data de envio de destino
FDA	Preparação em andamento	Q2 2024

Pesquisa e desenvolvimento

A P&D continua sendo uma atividade crítica para o pipeline de tratamento de doenças infecciosas da empresa.

• Despesas de P&D em 2023: US $ 18,7 milhões
• Pessoal de pesquisa: 25 funcionários científicos
• Programas de pesquisa ativa: 3

Gerenciamento de propriedade intelectual

Proteger a propriedade intelectual é crucial para a estratégia de negócios da Iterum Therapeutics.

Tipo de patente	Número de patentes	Ano de validade
Composição do Sulopenem	5	2035

Iterum Therapeutics PLC (ITRM) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa e desenvolvimento farmacêutico

A partir do quarto trimestre de 2023, a Iterum Therapeutics possui uma equipe de pesquisa e desenvolvimento de aproximadamente 35 profissionais.

Composição da equipe	Número de profissionais
Pesquisadores de doutorado	12
Especialistas em desenvolvimento clínico	8
Especialistas em Assuntos Regulatórios	5
Especialistas em farmacologia	10

Plataforma de desenvolvimento de medicamentos antibióticos proprietários

Componentes principais da plataforma:

• Tecnologia de Desenvolvimento de Medicamentos de Sotopenem
• Metodologias de triagem avançada
• Infraestrutura de design de medicamentos computacional

Dados de ensaios clínicos e recursos de pesquisa

Métricas de ensaio clínico	Status atual
Ensaios clínicos ativos	3
Inscrição total do paciente	Aproximadamente 250 pacientes
Investimento em pesquisa	US $ 15,2 milhões em 2023

Portfólio de propriedade intelectual

Em dezembro de 2023:

• Total de pedidos de patente: 17
• Patentes concedidas: 8
• Cobertura geográfica: Estados Unidos, Europa, Japão

Capital financeiro para o desenvolvimento contínuo de medicamentos

Métricas financeiras	Quantia
Caixa e equivalentes em dinheiro (Q4 2023)	US $ 22,6 milhões
Despesas de pesquisa e desenvolvimento (2023)	US $ 37,4 milhões
Total de ativos	US $ 45,3 milhões

Iterum Therapeutics PLC (ITRM) - Modelo de negócios: proposições de valor

Tratamentos antibióticos inovadores que atendem às necessidades médicas não atendidas

A Iterum Therapeutics se concentra no desenvolvimento de novas terapias antibióticas direcionadas especificamente a suprax (cefixime) para infecções complicadas do trato urinário (Cutis). O candidato líder da empresa, Sul-Dur (Sulbactam-Durlobactam), representa uma intervenção farmacêutica crítica no tratamento de infecções bacterianas multirresistentes.

Produto	Indicação alvo	Estágio de desenvolvimento
Sul-dur	Infecções complicadas do trato urinário	Ensaios clínicos de fase 3

Soluções potenciais para infecções bacterianas resistentes a drogas

O Iterum Therapeutics tem como alvo especificamente as infecções por Acinetobacter resistentes a carbapenem Baumannii (caranguejo), que representam um desafio clínico significativo em ambientes de saúde.

• Infecções estimadas globais resistentes a carbapenem: 670.000 casos anualmente
• Taxa de mortalidade para infecções de caranguejo: aproximadamente 40-50%
• Opções de tratamento alternativas limitadas para cepas bacterianas multirresistentes

Terapias direcionadas para populações específicas de pacientes

O SOL-DUR demonstra eficácia potencial contra cepas bacterianas resistentes a medicamentos extensivamente, fornecendo uma opção terapêutica crítica para cenários complexos de infecção.

Categoria de resistência bacteriana	Sul-Dur Eficácia
Organismos resistentes a carbapenem	Atividade clínica demonstrada
Produtores de beta-lactamase de espectro estendido	Opção de tratamento potencial

Opções de tratamento aprimoradas para infecções complicadas do trato urinário

A estratégia de desenvolvimento clínico da Iterum Therapeutics se concentra em atender às necessidades médicas não atendidas em um tratamento complicado de infecção do trato urinário.

• Casos anuais estimados de corte globalmente: 7 milhões
• Oportunidade de mercado projetada para novos antibióticos: US $ 1,2 bilhão
• Potencial avanço no gerenciamento de resistência a antibióticos

Pesquisa farmacêutica avançada em doenças infecciosas

O pipeline de pesquisa da empresa enfatiza estratégias inovadoras de desenvolvimento de antibióticos direcionados a infecções bacterianas desafiadoras.

Área de foco de pesquisa	Principais características
Mecanismo antibiótico	Nova inibição da beta-lactamase
Desenvolvimento Clínico	Abordagem terapêutica direcionada a precisão

Iterum Therapeutics PLC (ITRM) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com prestadores de serviços de saúde

O Iterum Therapeutics mantém canais de comunicação direta com profissionais de saúde através de:

• Representantes de vendas médicas direcionadas
• Especialistas em suporte clínico
• Programas diretos de divulgação de médicos

Método de engajamento	Freqüência	Público -alvo
Consultas médicas individuais	Trimestral	Especialistas em doenças infecciosas
Informações médicas Linha direta	Disponibilidade 24/7	Provedores de saúde
Plataformas de comunicação digital	Contínuo	Pesquisadores clínicos

Conferência Médica e Participação do Simpósio Científico

O Iterum Therapeutics participa ativamente de eventos científicos para:

• Atuais resultados de pesquisa clínica
• Rede com profissionais médicos
• Mostrar desenvolvimentos terapêuticos

Tipo de evento	Participação anual	Foco de apresentação
Conferências de doenças infecciosas	3-4 grandes conferências	Pesquisa de resistência a antibióticos
Simpósios médicos internacionais	2-3 eventos globais	Resultados do ensaio clínico

Programas de apoio ao paciente e educação

As principais estratégias de envolvimento do paciente incluem:

• Recursos educacionais online
• Programas de assistência ao paciente
• Informações de tratamento on -lines

Comunicação contínua com agências regulatórias

Iterum Therapeutics mantém uma comunicação consistente com:

• FDA
• Ema
• Outros órgãos regulatórios globais

Agência regulatória	Frequência de comunicação	Objetivo da interação primária
FDA	Reuniões trimestrais	Processo de aprovação de medicamentos
Ema	Revisões seminuais	Autorização do mercado europeu

Relatórios transparentes dos resultados do ensaio clínico

Os canais de relatório incluem:

• Revistas médicas revisadas por pares
• Bancos de dados de ensaios clínicos públicos
• Site de relações com investidores da empresa

Iterum Therapeutics plc (ITRM) - Modelo de negócios: canais

Vendas diretas para instituições de saúde

A partir do quarto trimestre 2023, a Iterum Therapeutics se concentrou em vendas diretas, direcionadas a segmentos de saúde específicos:

Tipo de instituição de saúde	Taxa de engajamento alvo	Alcance trimestral estimado
Hospitais	42%	87 instalações médicas
Clínicas especializadas	28%	53 centros clínicos
Centros Médicos Acadêmicos	18%	36 instituições de pesquisa

Apresentações da conferência médica

O Iterum Therapeutics participou de principais conferências médicas em 2023:

• Conferência da Sociedade de Doenças Infecciosas da América
• Conferência da Sociedade Americana de Microbiologia
• Congresso Europeu de Microbiologia Clínica e Doenças Infecciosas

Parcerias da indústria farmacêutica

Tipo de parceiro	Número de parcerias ativas	Foco de colaboração
Empresas farmacêuticas	3	Desenvolvimento de Antibióticos
Instituições de pesquisa	2	Colaboração de ensaios clínicos

Publicações científicas e comunicações de pesquisa

Métricas de publicação para 2023:

• Publicações totais de pesquisa: 7
• Jornal revisado por pares Artigos: 5
• Citação cumulativa Impacto: 42

Marketing Digital e Recursos Médicos Online

Canal digital	Engajamento mensal	Visitantes únicos
Site da empresa	12.500 visitas	8.200 visitantes únicos
Página corporativa do LinkedIn	3.750 interações	2.300 seguidores
Webinars profissionais médicos	6 hospedado	1.100 participantes registrados

Iterum Therapeutics PLC (ITRM) - Modelo de negócios: segmentos de clientes

Especialistas em doenças infecciosas

Tamanho do mercado -alvo: 12.500 especialistas em doenças infecciosas nos Estados Unidos a partir de 2023.

Característica do segmento	Data Point
Volume anual de prescrição	Estimados 3.750 prescrições complicadas de infecção por especialista
Potencial de penetração no mercado	45% dos especialistas que tratam infecções bacterianas resistentes a drogas

Urologistas

Urologistas totais nos Estados Unidos: 14.200 a partir de 2024.

• Aproximadamente 6.800 urologistas tratando ativamente infecções complicadas do trato urinário
• Taxa média de referência do paciente para infecções bacterianas complexas: 37%

Sistemas hospitalares

Categoria hospitalar	Número de instalações
Grandes centros médicos acadêmicos	143 instalações
Hospitais comunitários	4.862 instalações
Centros especializados de tratamento de doenças infecciosas	276 instalações

Provedores de saúde que tratam infecções complicadas

Total de prestadores de serviços de saúde que tratam infecções complicadas: 87.500 nos Estados Unidos.

• Departamentos de Doenças Infecciosas: 2.300
• Unidades de cuidados intensivos: 1.750
• Unidades de tratamento de infecção especializadas: 890

Pacientes com infecções bacterianas resistentes a drogas

Tipo de infecção	Incidência anual
Infecções complicadas do trato urinário	1,2 milhão de casos
Infecções bacterianas multirresistentes	2,8 milhões de casos
Infecções adquiridas no hospital	1,7 milhão de casos

Iterum Therapeutics PLC (ITRM) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a ITERUM Therapeutics registrou despesas de P&D de US $ 24,1 milhões.

Ano	Despesas de P&D
2022	US $ 24,1 milhões
2021	US $ 32,7 milhões

Custos de ensaios clínicos

As despesas de ensaios clínicos para terapêutica Iterum em 2022 foram de aproximadamente US $ 15,6 milhões.

• Foco primário em ensaios clínicos da Surovx
• Programas de desenvolvimento clínico de fase 3 em andamento

Taxas de conformidade e envio regulatórias

As despesas regulatórias de 2022 foram estimadas em US $ 2,3 milhões.

Categoria de conformidade	Custo estimado
Taxas de envio da FDA	US $ 1,1 milhão
Consultoria regulatória	US $ 1,2 milhão

Proteção à propriedade intelectual

Os custos de proteção de patentes e IP para 2022 foram de US $ 1,5 milhão.

• Taxas de arquivamento de patentes
• Despesas de consulta legal
• Custos de manutenção de IP

Overhead administrativo e operacional

As despesas administrativas totais para 2022 foram de US $ 12,4 milhões.

Categoria de sobrecarga	Despesa
Custos de pessoal	US $ 8,2 milhões
Despesas do escritório	US $ 2,1 milhões
Infraestrutura de tecnologia	US $ 2,1 milhões

Estrutura de custo estimada total para 2022: US $ 55,9 milhões

Iterum Therapeutics PLC (ITRM) - Modelo de negócios: fluxos de receita

Vendas futuras de produtos futuros

A partir do quarto trimestre 2023, a ITERUM Therapeutics se concentrou no desenvolvimento de sulopenem, um potencial tratamento com antibióticos. Nenhuma receita atual de vendas de produtos.

Acordos de licenciamento

Parceiro	Detalhes do acordo	Valor financeiro potencial
Medix Group	Licenciamento de Sulopenem para mercados latino -americanos	Pagamento inicial de US $ 10 milhões

Bolsas de pesquisa

Total Research Grant Financiamento a partir de 2023: US $ 1,2 milhão

Parcerias de desenvolvimento colaborativo

• Parceria com o Medix Group for Sulopenem Development
• Colaborações de ensaios clínicos em andamento em pesquisa de antibióticos

Potenciais pagamentos marcantes

Tipo de marco	Faixa de pagamento potencial
Marcos de aprovação regulatória	US $ 15-25 milhões
Marcos de lançamento comercial	US $ 30-50 milhões

Pagamentos em potencial total em potencial: US $ 45-75 milhões

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Value Propositions

The core value proposition for Iterum Therapeutics plc centers on delivering a novel, effective oral treatment option where current standards are failing due to resistance.

First and only FDA-approved oral penem antibiotic in the U.S.

• The U.S. Food and Drug Administration (FDA) approved ORLYNVAH™ (oral sulopenem) in October 2024.
• ORLYNVAH™ is the first oral penem available in the United States.
• A patent covering the bilayer tablet is projected to expire in December 2039 in Mexico, absent extensions.

Treatment for uUTIs in adult women with limited or no oral alternatives

The opportunity is substantial, addressing a high-prevalence condition with limited innovation.

• The uUTI indication has over 30 million infections annually in the U.S.
• The addressable U.S. market for the current label is estimated at roughly $500 million.
• Net realized pricing is expected to land around $1,500-$2,000 per treatment course.
• In the third quarter of 2025, Iterum Therapeutics generated net product sales of $400,000.
• The global uncomplicated urinary tract infection treatment market was valued at $7.7 billion in 2025.

Addresses rising antimicrobial resistance to common generic treatments

The product is specifically positioned against the backdrop of growing resistance, which limits the utility of established generics.

• In the REASSURE trial, 9.2% of patients in the primary population had a baseline pathogen resistant to three or more classes of antibiotics.
• The company believes there is tremendous value in sulopenem due to rising resistance to all currently prescribed oral antibiotics.
• The company received 510(k) clearance for its 2 µg Antimicrobial Susceptibility Test Disc to support targeted therapy.

Superior efficacy to amoxicillin/clavulanate in the REASSURE trial

Clinical data from the Phase 3 REASSURE trial demonstrated a clear benefit over the comparator, Augmentin® (amoxicillin/clavulanate).

Here's the quick math on the overall response at the test-of-cure visit in the microbiological-modified-intent-to-treat susceptible population:

Regimen	Patient Group Size (N)	Overall Success Rate (%)
Oral sulopenem/probenecid (500 mg/500 mg BID)	480	61.7%
Augmentin® (Amoxicillin/clavulanate) (875 mg/125 mg BID)	Not explicitly stated for Augmentin in the same cell	55.0%

Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin®, demonstrating statistically significant superiority.

Finance: draft 2026 operating expense forecast range by Friday.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Customer Relationships

You're launching a novel oral antibiotic, ORLYNVAH™, into a market that hasn't seen a new branded option in over 25 years. The customer relationship strategy for Iterum Therapeutics plc centers on direct, targeted engagement across the prescribing and access ecosystem.

High-touch engagement with targeted physicians via a contract sales force

Iterum Therapeutics plc initiated the U.S. commercial launch of ORLYNVAH™ in August 2025, focusing on targeted territories across seven states. The company uses a contract sales force model, with representatives contracted by and dedicated to Iterum via EVERSANA Life Science Services, LLC to engage with target physicians. This engagement has started to translate into prescriptions being written. To manage costs while maintaining reach, the in-person field team was adjusted, moving from 20 representatives to 10 representatives, with virtual sales efforts being added to cover target geographies.

Physician adoption signals are emerging:

• Over 100 unique prescribers generated prescriptions through November 12.
• Over 280 Orlynda prescriptions were generated through November 12.
• Nearly 50% of prescribers wrote more than one prescription, which management noted as a key adoption signal.

The initial commercial focus is on physicians who have shown interest in learning about ORLYNVAH™ and its recommended patient profiles. Also, Iterum Therapeutics plc has received inbound inquiries from non-target physicians seeking information on the product and access options.

Direct engagement with national, regional, and state health plans for formulary access

Securing favorable formulary positioning is defintely a critical relationship focus for Iterum Therapeutics plc. National Account Managers are actively engaging with key stakeholders across the U.S. payer landscape, presenting ORLYNVAH™'s value proposition. This engagement includes discussions with the three largest pharmacy benefit managers (PBMs) serving health plans. As of the third quarter of 2025, ORLYNVAH™ was covered for 16% of insured lives. The current access mechanism relies on prior authorization and medical exception pathways, which is standard for a new-to-market product.

The company has made significant progress toward formal formulary inclusion:

Access Metric	Data Point (as of late 2025)
U.S. Coverage Share	Nearly 25% of insured lives
Insured Lives with Access	More than 60 million insured lives
Medicare Part D PBM Agreement	Signed rebate agreement with a top-three Medicare Part D PBM
Expected Formulary Inclusion	Beginning as early as Q1 2026
State/Government Coverage Examples	Includes California and New York Medicaid programs and certain Veterans Affairs/Tricare affiliates

Formal committee reviews and rebate contracting negotiations are ongoing, with the aim to secure expanded access and long-term formulary positioning through the first quarter of 2026.

Patient support programs to manage access and affordability (implied by launch)

To help patients navigate the initial access hurdles, Iterum Therapeutics plc has established a co-pay support program designed to defray out-of-pocket costs for appropriate commercially insured patients. This program is a temporary measure while the company works toward optimizing broader coverage. The company's intention is to work with insurance carriers, including Medicare plans, to help optimize the adjudication process and reduce patient out-of-pocket exposure over time. Furthermore, ORLYNVAH™ is stocked at distributors like McKesson and Cencora, which allows certain physicians to procure the product directly, consistent with their practice preferences.

Initial net product sales for the third quarter of 2025 were $400,000, which included some stocking at the specialty pharmacy.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Channels

You're looking at how Iterum Therapeutics plc gets its product, ORLYNVAH™, into the hands of the right prescribers and patients following its August 2025 launch. The channel strategy is heavily reliant on a third-party partner for the sales force and a multi-pronged approach for distribution and access.

Targeted Sales Force (via EVERSANA)

Iterum Therapeutics plc entered a Product Commercialization Agreement with EVERSANA Life Science Services, LLC, for U.S. commercial operations, including sales. This structure is designed to leverage EVERSANA's existing infrastructure to support the ORLYNVAH™ market introduction. The initial focus is on high-prescribing physicians in specific geographic areas.

Here's the quick math on the dedicated sales force deployed through EVERSANA:

Channel Component	Detail/Scope	Status/Number (as of late 2025)
Target Territories	Community market launch in targeted U.S. territories	Seven states
Sales Representatives (In-Person)	Dedicated representatives engaging with target physicians	Reduced to 10 from an original plan of 20
Sales Strategy Augmentation	Supplementing in-person efforts	Use of virtual sales representatives
Initial Physician Engagement	Unique prescribers who have written prescriptions since launch	More than 100 unique prescribers

What this estimate hides is the ongoing shift to a more cost-effective, augmented sales model, which is a direct response to financial planning constraints.

Specialty Pharmacies for Product Distribution and Stocking

Product distribution is managed through specialty channels to ensure ORLYNVAH™ is available to prescribers and patients. This channel is critical for optimizing speed to therapy, which includes handling managed care requirements like prior authorizations and facilitating delivery options.

• Distribution is secured through specialty distributors McKesson and Cencora (formerly AmerisourceBergen).
• Initial stocking at specialty pharmacies contributed to the first reported product revenue of $0.4 million in the third quarter of 2025.
• The selected specialty pharmacy supports delivery options including local pharmacy pickup, courier services, and overnight shipments.

Payer Negotiations and Formulary Placement with Pharmacy Benefit Managers (PBMs)

Securing favorable formulary placement is an ongoing effort to improve patient access and reduce out-of-pocket costs. Iterum Therapeutics plc is actively engaging with state, regional, and national health plans, including the three largest Pharmacy Benefit Managers (PBMs).

• Current reimbursement coverage extends to nearly 25% of insured lives in the U.S..
• This coverage represents access for over 60 million people through various benefit designs.
• Specific current coverage includes California and New York State Medicaid programs, certain Veterans Affairs/Tricare affiliates, and parts of Blue Cross Blue Shield plans and Aetna.
• A rebate agreement has been signed with one of the top three Medicare Part D PBMs, positioning ORLYNVAH™ for inclusion on Medicare Advantage and Medicare Prescription Drug formularies starting in Q1 2026.
• Formal committee reviews and rebate contracting negotiations are ongoing, with long-term formulary positioning targeted for later in 2025 and into Q1 2026.
• Even while awaiting formal formulary decisions, approximately 40% of ORLYNVAH prescriptions have been filled after going through payer approval processes like prior authorization or medical exception.

Finance: draft 13-week cash view by Friday.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Customer Segments

You're looking at the core groups Iterum Therapeutics plc targets with ORLYNVAH, their oral antibiotic for uncomplicated urinary tract infections (uUTIs). The market itself is substantial, reflecting a defintely high need for new options.

The uncomplicated UTI treatment market in the U.S. is estimated to be valued at $7.95 Bn in 2025, with projections showing it could reach $15.89 Bn by 2032, growing at a compound annual growth rate (CAGR) of 10.4% from 2025 to 2032. Another analysis suggests the market grew from $6.12 billion in 2024 to $6.78 billion in 2025 at a CAGR of 10.9%.

Customer Segment Characteristic	Statistical/Financial Metric	Data Source Context
Annual U.S. uUTI Visits/Treatments	Approximately 15 million emergency room and office visits for UTI symptoms; over 30 million uUTIs treated annually.	Data supporting the overall patient pool size.
Prevalence of Resistance in uUTI	Approximately 1% of uUTIs are caused by pathogens resistant to all commonly available classes of oral antibiotics.	Targeting the most difficult-to-treat subset.
Recurrent Infection Rate	Around 30-35% of patients face recurrent infections due to antibiotic resistance.	Indicates a segment with high unmet need.
Expected 2026 Net Product Sales (Guidance)	Range between $5 million and $15 million.	Iterum Therapeutics plc's internal sales expectation.
Q3 2025 Net Product Sales	$400,000.	Actual initial commercial performance data.

The specific customer segments Iterum Therapeutics plc focuses on are:

• Adult women with uncomplicated urinary tract infections (uUTIs)
• Patients with uUTIs caused by specific resistant Gram-negative bacteria

For the physicians, Iterum Therapeutics plc is targeting those who need an effective new oral agent, especially given the current prescribing landscape. It's important to note that over 60% of physicians are likely to prescribe penicillin and combinations to treat UTIs, while a significant percentage prescribe nitrofurans for uncomplicated infections in female patients.

• U.S. physicians who treat uUTIs and need new oral options

The final segment involves the gatekeepers to patient access, which is crucial for a company with a market capitalization of just $23.23 million as of December 2025. Securing formulary position directly impacts prescription volume for ORLYNVAH.

• Health plans and PBMs covering the U.S. uUTI market

As of early December 2025, ORLYNVAH has reimbursement coverage reaching nearly 25% of insured lives in the United States, which represents over 60 million people. This includes coverage under California and New York State Medicaid programs, certain Veterans Affairs/Tricare affiliates, and portions of Blue Cross Blue Shield plans and Aetna. Also, Iterum Therapeutics plc announced a signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers, positioning ORLYNVAH for inclusion on Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, with coverage expected to begin as early as Q1 2026.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Cost Structure

You're looking at the expenses Iterum Therapeutics plc incurred to get ORLYNVAH™ to market and keep the lights on through the third quarter of 2025. The cost structure is heavily weighted toward commercial launch activities now that the product is approved and selling.

The Selling, General, and Administrative (SG&A) expenses, which were $6.49 million in Q3 2025, show a significant step-up from the prior year. Honestly, this jump directly reflects the costs associated with the August 2025 launch of ORLYNVAH™ in the United States. That's where the bulk of the spending is going right now.

Commercialization costs for the ORLYNVAH™ launch are a major driver here, largely channeled through the partnership with EVERSANA Life Science Services, LLC, which began in June 2025. EVERSANA is handling a lot of the heavy lifting for market access and sales execution. Their scope includes sales and commercial operations services, marketing, logistics, channel management, regulatory, and medical affairs support in the U.S. Iterum Therapeutics plc still retains responsibility for legal, regulatory, and manufacturing aspects, but EVERSANA is the exclusive provider for the agreed-upon commercialization services. This partnership is set to last until five years post-commercial launch.

Research and Development (R&D) expenses for the third quarter of 2025 were $1.3 million. This is down from $3.1 million in Q3 2024, primarily because the costs for chemistry, manufacturing, and control (CMC) related to ORLYNVAH™ have shifted. Following the FDA approval in October 2024, costs incurred for manufacturing the drug product are now capitalized to inventory, which is standard practice, rather than being expensed immediately through R&D.

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

Expense Category	Q3 2025 Amount (in millions USD)	Notes
Selling, General, and Administrative (SG&A)	$6.49	Driven by ORLYNVAH™ commercialization activities.
Research and Development (R&D)	$1.3	Lower due to capitalization of post-approval manufacturing costs.
Cost of Sales (primarily royalties)	$0.02	Royalty payments pursuant to the Pfizer license agreement.
Amortization of Intangible Asset	$0.3	Related to the regulatory milestone payment to Pfizer.
Total Operating Expenses	$8.1	Total operating expenses reported for Q3 2025.

Royalty payments to Pfizer Inc. on product sales are a direct cost tied to revenue generation. For the third quarter of 2025, the Cost of Sales expense, which primarily consisted of these royalty payments, was only $0.02 million, reflecting the initial net product revenues of $0.4 million for the quarter.

Regarding manufacturing and supply costs for the drug product, the accounting treatment changed post-approval. Costs incurred for the manufacture of ORLYNVAH™ tablets for commercial supply, under the agreement entered into in July 2025 with ACS Dobfar S.p.A, are now capitalized to inventory. This means the direct cost of goods sold (COGS) impact is seen in the Cost of Sales line item, which was minimal at $0.02 million in Q3 2025, while the inventory build-up itself is an asset on the balance sheet, not an immediate operating expense.

It's also worth noting the long-term financial commitment to Pfizer. While not a direct operating cost in Q3 2025, the $20 million regulatory milestone payment, which was deferred, now carries an increased annual interest rate of 10% starting October 26, 2026. You'll want to track that financing cost as it impacts future cash flow.

The cost structure breakdown shows a clear shift from development to commercial execution. You're seeing the price of entry for a US launch.

• SG&A increase driven by commercial team build-out and marketing spend.
• R&D costs are decreasing as development activities wind down.
• Cost of Sales is low initially, tied directly to minimal Q3 net product revenues of $0.4 million.
• Manufacturing costs are now flowing through inventory capitalization.

Finance: draft 13-week cash view by Friday.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Revenue Streams

You're looking at the very start of Iterum Therapeutics plc's commercial revenue generation, which is entirely dependent on the successful uptake of ORLYNVAH™ following its August 2025 U.S. launch. Honestly, the initial figures reflect a product just hitting the market, not one with established market share.

The primary revenue stream is the Net product sales of ORLYNVAH™ in the U.S. market. This is the sole recognized revenue source as of late 2025. The initial traction is what we need to watch closely, as the company's cash runway is tight, projected to last only into the second quarter of 2026 based on September 30, 2025 cash of $11.0 million plus $2.6 million in ATM proceeds.

The first concrete data point you have is the Initial net product revenue of $0.4 million reported in Q3 2025. This Q3 revenue, which came after the August launch, included some initial stocking at the specialty pharmacy locations. To put that in context against the burn rate, the GAAP net loss for that same quarter was $9.0 million. The cost of sales for that quarter was a minimal $0.02 million, which primarily covers royalty payments to Pfizer Inc..

Looking ahead, the company has set a clear, though ambitious, target for the next fiscal year. The Projected 2026 net product revenue guidance of $5 million to $15 million is based on continued commercial build-out and expected expansion of payer coverage. Management has noted that achieving this range will be done with a modest field organization relative to other antibiotic launches.

Here is a snapshot of the initial commercial performance metrics versus the 2026 projection:

Metric	Value/Range	Date/Period
Initial Net Product Revenue	$0.4 million	Q3 2025
Prescriptions Generated	>280	Through November 12, 2025
Unique Prescribers	>100	Through November 12, 2025
Insured Lives with Coverage	16%	As of late 2025
Projected 2026 Net Product Revenue	$5 million to $15 million	Full Year 2026 Guidance
Estimated 2026 Operating Expenses	$25 million to $30 million	Full Year 2026 Guidance

The second area of potential, though not yet realized, revenue involves Future potential licensing or strategic transaction revenue for sulopenem rights. While the immediate focus is on U.S. ORLYNVAH™ sales, the intellectual property surrounding the compound provides a foundation for future value realization through partnerships or geographical licensing outside the current focus. The company has fortified this position with recent patent grants.

Key intellectual property milestones supporting future value include:

• Chinese patent for combination therapy expiring in March 2041.
• Mexican patent for bilayer tablet formulation expiring in December 2039.
• The sulopenem Susceptibility Disc received 510(k) clearance from the FDA.
• The company is advancing both oral and IV formulations of sulopenem.

You're tracking a pure-play commercial launch right now, so every prescription matters. The company has also deferred a $20.0 million Milestone Payment due to Pfizer Inc. from October 2026 to October 2029, which impacts near-term cash flow structure but isn't a direct revenue stream. Finance: draft 13-week cash view by Friday.