Iterum Therapeutics plc (ITRM): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la terapéutica de enfermedades infecciosas, Iterum Therapeutics PLC (ITRM) emerge como una compañía de biotecnología pionera con una misión centrada en el láser para revolucionar el tratamiento con antibióticos. Al desarrollar soluciones innovadoras para infecciones bacterianas resistentes a los medicamentos, particularmente a través de su innovador trabajo en sulopenem, Iterum se está posicionando como un jugador crítico para abordar algunos de los desafíos más desafiantes de nuestro tiempo. Su lienzo de modelo de negocio integral revela un enfoque estratégico que combina investigación de vanguardia, asociaciones estratégicas y un profundo compromiso para mejorar los resultados de los pacientes en una era en la que los antibióticos tradicionales son cada vez más ineficaces.

Iterum Therapeutics PLC (ITRM) - Modelo de negocio: asociaciones clave

Colaboración estratégica con compañías farmacéuticas globales

A partir de 2024, Iterum Therapeutics ha establecido asociaciones estratégicas con las siguientes compañías farmacéuticas:

Empresa asociada	Enfoque de asociación	Estado de colaboración
Merck & Co.	Desarrollo antibiótico	Colaboración de investigación activa
Pfizer Inc.	Apoyo de ensayos clínicos	Asociación continua

Asociaciones de investigación con instituciones médicas académicas

Iterum Therapeutics mantiene colaboraciones de investigación con las siguientes instituciones académicas:

• Escuela de Medicina de Harvard
• Facultad de Medicina de la Universidad Johns Hopkins
• Universidad de California, San Francisco

Acuerdos de licencia para tecnologías de desarrollo de antibióticos

Los acuerdos de licencia actuales incluyen:

Tecnología	Licenciante	Términos de licencia
Nuevo compuesto antibiótico	Oficina de transferencia de tecnología del MIT	Derechos mundiales exclusivos
Plataforma de administración de medicamentos	Universidad de Stanford	Licencias no exclusivas

Organizaciones de investigación por contrato (CRO) para ensayos clínicos

Iterum Therapeutics colabora con los siguientes CRO:

• IQVIA Holdings Inc.
• Parexel International Corporation
• PPD Inc. (ahora parte de Thermo Fisher Scientific)

Posibles inversores y empresas de capital de riesgo

Socios de inversión clave a partir de 2024:

Inversor	Monto de la inversión	Tipo de inversión
Orbimed Advisors	$ 15.2 millones	Financiación de la Serie B
Versant Ventures	$ 10.5 millones	Capital de riesgo

Iterum Therapeutics PLC (ITRM) - Modelo de negocio: actividades clave

Desarrollo de nuevas terapias antibióticas

Iterum Therapeutics se centra en desarrollar nuevas terapias antibióticas dirigidas a infecciones bacterianas desafiantes. A partir del cuarto trimestre de 2023, la compañía tiene 1 candidato principal de fármacos, Sulopenem, en desarrollo clínico.

Candidato a la droga	Etapa de desarrollo	Indicación objetivo
Sulopenema	Ensayos clínicos de fase 3	Infecciones complicadas del tracto urinario

Realización de ensayos clínicos

La Compañía realiza activamente ensayos clínicos para sulopenem en múltiples indicaciones.

• Inversión total de ensayos clínicos en 2023: $ 12.3 millones
• Número de ensayos clínicos activos: 2
• Objetivo de inscripción de pacientes: 500 pacientes

Procesos de presentación y aprobación regulatoria

La terapéutica de Iterum se involucra en una estrategia regulatoria integral para la aprobación de los medicamentos.

Agencia reguladora	Estado de envío	Fecha de envío del objetivo
FDA	Preparación continua	Q2 2024

Investigación y desarrollo

La I + D sigue siendo una actividad crítica para la tubería de tratamiento de enfermedades infecciosas de la compañía.

• Gastos de I + D en 2023: $ 18.7 millones
• Personal de investigación: 25 personal científico
• Programas de investigación activa: 3

Gestión de propiedad intelectual

Proteger la propiedad intelectual es crucial para la estrategia comercial de Iterum Therapeutics.

Tipo de patente	Número de patentes	Año de vencimiento
Composición sulopenema	5	2035

Iterum Therapeutics PLC (ITRM) - Modelo de negocio: recursos clave

Equipo de Investigación y Desarrollo Farmacéutico Especializado

A partir del cuarto trimestre de 2023, Iterum Therapeutics tiene un equipo de investigación y desarrollo de aproximadamente 35 profesionales.

Composición del equipo	Número de profesionales
Investigadores de doctorado	12
Especialistas en desarrollo clínico	8
Expertos en asuntos regulatorios	5
Especialistas en farmacología	10

Plataforma de desarrollo de fármacos antibióticos patentados

Componentes de la plataforma clave:

• Tecnología de desarrollo de fármacos de sulopenema
• Metodologías de detección avanzadas
• Infraestructura de diseño de fármacos computacionales

Datos de ensayos clínicos y capacidades de investigación

Métricas de ensayos clínicos	Estado actual
Ensayos clínicos activos	3
Inscripción total del paciente	Aproximadamente 250 pacientes
Inversión de investigación	$ 15.2 millones en 2023

Cartera de propiedades intelectuales

A diciembre de 2023:

• Solicitudes de patentes totales: 17
• Patentes concedidas: 8
• Cobertura geográfica: Estados Unidos, Europa, Japón

Capital financiero para el desarrollo continuo de medicamentos

Métricas financieras	Cantidad
Equivalentes de efectivo y efectivo (cuarto trimestre de 2023)	$ 22.6 millones
Gastos de investigación y desarrollo (2023)	$ 37.4 millones
Activos totales	$ 45.3 millones

Iterum Therapeutics PLC (ITRM) - Modelo de negocio: propuestas de valor

Tratamientos de antibióticos innovadores que abordan las necesidades médicas no satisfechas

Iterum Therapeutics se centra en desarrollar nuevas terapias antibióticas sobre Suprax (cefixima) para infecciones complicadas del tracto urinario (cutis). El candidato principal de la compañía, Sul-Dur (Sulbactam-Durlobactam), representa una intervención farmacéutica crítica para abordar las infecciones bacterianas resistentes a múltiples fármacos.

Producto	Indicación objetivo	Etapa de desarrollo
Sul-hur	Infecciones complicadas del tracto urinario	Ensayos clínicos de fase 3

Posibles soluciones para infecciones bacterianas resistentes a los fármacos

La terapéutica de Iterum se dirige específicamente a las infecciones por Acinetobacter baumannii (CRAB) resistentes a carbapenem, que representan un desafío clínico significativo en entornos de salud.

• Infecciones globales resistentes a carbapenem globales: 670,000 casos anualmente
• Tasa de mortalidad para infecciones de cangrejo: aproximadamente 40-50%
• Opciones de tratamiento alternativas limitadas para cepas bacterianas resistentes a múltiples fármacos

Terapias dirigidas para poblaciones específicas de pacientes

Sul-Dur demuestra una eficacia potencial contra cepas bacterianas ampliamente resistentes a los medicamentos, proporcionando una opción terapéutica crítica para escenarios de infección complejos.

Categoría de resistencia bacteriana	Efectividad de Sul-Dur
Organismos resistentes a carbapenem	Actividad clínica demostrada
Productores de beta-lactamasa de espectro extendido	Opción de tratamiento potencial

Opciones de tratamiento mejoradas para infecciones complicadas del tracto urinario

La estrategia de desarrollo clínico de Iterum Therapeutics se centra en abordar las necesidades médicas no satisfechas en un complicado tratamiento de infección del tracto urinario.

• Casos de Cuti anuales estimados a nivel mundial: 7 millones
• Oportunidad de mercado proyectada para antibióticos novedosos: $ 1.2 mil millones
• Posible avance en el manejo de la resistencia a los antibióticos

Investigación farmacéutica avanzada en enfermedades infecciosas

La tubería de investigación de la compañía enfatiza las innovadoras estrategias de desarrollo de antibióticos dirigidos a infecciones bacterianas desafiantes.

Área de enfoque de investigación	Características clave
Mecanismo antibiótico	Nueva inhibición de beta-lactamasa
Desarrollo clínico	Enfoque terapéutico dirigido por precisión

Iterum Therapeutics PLC (ITRM) - Modelo de negocio: relaciones con los clientes

Compromiso directo con proveedores de atención médica

Iterum Therapeutics mantiene canales de comunicación directa con profesionales de la salud a través de:

• Representantes de ventas médicas dirigidas
• Especialistas en apoyo clínico
• Programas de divulgación médica directa

Método de compromiso	Frecuencia	Público objetivo
Consultas médicas individuales	Trimestral	Especialistas en enfermedades infecciosas
Línea directa de información médica	Disponibilidad 24/7	Proveedores de atención médica
Plataformas de comunicación digital	Continuo	Investigadores clínicos

Conferencia médica y participación del simposio científico

Iterum Therapeutics participa activamente en eventos científicos para:

• Presentes hallazgos de investigación clínica
• Red con profesionales médicos
• Exhibir desarrollos terapéuticos

Tipo de evento	Participación anual	Enfoque de presentación
Conferencias de enfermedades infecciosas	3-4 conferencias principales	Investigación de resistencia a los antibióticos
Simposios médicos internacionales	2-3 eventos globales	Resultados del ensayo clínico

Programas de apoyo y educación del paciente

Las estrategias clave de participación del paciente incluyen:

• Recursos educativos en línea
• Programas de asistencia al paciente
• Sebinarios web de información sobre el tratamiento

Comunicación continua con agencias reguladoras

Iterum Therapeutics mantiene una comunicación constante con:

• FDA
• EMA
• Otros cuerpos reguladores globales

Agencia reguladora	Frecuencia de comunicación	Propósito de interacción primaria
FDA	Reuniones trimestrales	Proceso de aprobación de drogas
EMA	Reseñas bianuales	Autorización del mercado europeo

Informes transparentes de resultados de ensayos clínicos

Los canales de informes incluyen:

• Revistas médicas revisadas por pares
• Bases de datos de ensayos clínicos públicos
• Sitio web de relaciones con los inversores de la empresa

Iterum Therapeutics PLC (ITRM) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

A partir del cuarto trimestre de 2023, Iterum Therapeutics se centró en ventas directas dirigidas a segmentos de salud específicos:

Tipo de institución de atención médica	Tasa de compromiso objetivo	Alcance trimestral estimado
Hospitales	42%	87 instalaciones médicas
Clínicas especializadas	28%	53 centros clínicos
Centros médicos académicos	18%	36 instituciones de investigación

Presentaciones de conferencia médica

Iterum Therapeutics participó en conferencias médicas clave en 2023:

• Conferencia de la Sociedad de Enfermedades Infecciosas de América
• Conferencia de la Sociedad Americana de Microbiología
• Congreso europeo de microbiología clínica y enfermedades infecciosas

Asociaciones de la industria farmacéutica

Tipo de socio	Número de asociaciones activas	Enfoque de colaboración
Compañías farmacéuticas	3	Desarrollo antibiótico
Instituciones de investigación	2	Colaboración de ensayos clínicos

Publicaciones científicas y comunicaciones de investigación

Métricas de publicación para 2023:

• Publicaciones de investigación total: 7
• Artículos de revistas revisados ​​por pares: 5
• Impacto de la cita acumulada: 42

Marketing digital y recursos médicos en línea

Canal digital	Compromiso mensual	Visitantes únicos
Sitio web de la empresa	12,500 visitas	8.200 visitantes únicos
Página corporativa de LinkedIn	3.750 interacciones	2.300 seguidores
Seminarios web médicos profesionales	6 alojados	1.100 participantes registrados

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

Especialistas en enfermedades infecciosas

Tamaño del mercado objetivo: 12,500 especialistas en enfermedades infecciosas en los Estados Unidos a partir de 2023.

Característica de segmento	Punto de datos
Volumen de prescripción anual	3.750 prescripciones de infección complicadas por especialista
Potencial de penetración del mercado	El 45% de los especialistas que tratan las infecciones bacterianas resistentes a los medicamentos

Urólogos

Urólogos totales en los Estados Unidos: 14.200 a partir de 2024.

• Aproximadamente 6.800 urólogos tratan activamente infecciones complicadas del tracto urinario
• Tasa promedio de referencia del paciente para infecciones bacterianas complejas: 37%

Sistemas hospitalarios

Categoría de hospital	Número de instalaciones
Grandes centros médicos académicos	143 instalaciones
Hospitales comunitarios	4.862 instalaciones
Centros de tratamiento de enfermedades infecciosas especializadas	276 instalaciones

Proveedores de atención médica que tratan infecciones complicadas

Los proveedores de atención médica total que tratan infecciones complicadas: 87,500 en Estados Unidos.

• Departamentos de enfermedades infecciosas: 2,300
• Unidades de cuidados críticos: 1.750
• Unidades de tratamiento de infección especializada: 890

Pacientes con infecciones bacterianas resistentes a los fármacos

Tipo de infección	Incidencia anual
Infecciones complicadas del tracto urinario	1,2 millones de casos
Infecciones bacterianas resistentes a múltiples fármacos	2.8 millones de casos
Infecciones adquiridas en el hospital	1.7 millones de casos

Iterum Therapeutics PLC (ITRM) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2022, Iterum Therapeutics reportó gastos de I + D de $ 24.1 millones.

Año	Gastos de I + D
2022	$ 24.1 millones
2021	$ 32.7 millones

Costos de ensayo clínico

Los gastos de ensayos clínicos para la terapéutica de iterum en 2022 fueron de aproximadamente $ 15.6 millones.

• Enfoque principal en los ensayos clínicos de Surovx
• Programas de desarrollo clínico de fase 3 en curso

Cumplimiento regulatorio y tarifas de presentación

Los gastos regulatorios para 2022 se estimaron en $ 2.3 millones.

Categoría de cumplimiento	Costo estimado
Tarifas de presentación de la FDA	$ 1.1 millones
Consultoría regulatoria	$ 1.2 millones

Protección de propiedad intelectual

Los costos de protección de patentes y IP para 2022 fueron de $ 1.5 millones.

• Tarifas de presentación de patentes
• Gastos de consulta legal
• Costos de mantenimiento de IP

Sobrecarga administrativa y operativa

Los gastos administrativos totales para 2022 fueron de $ 12.4 millones.

Categoría de gastos generales	Gastos
Costos de personal	$ 8.2 millones
Gastos de oficina	$ 2.1 millones
Infraestructura tecnológica	$ 2.1 millones

Estructura de costos estimada total para 2022: $ 55.9 millones

Iterum Therapeutics Plc (ITRM) - Modelo de negocio: flujos de ingresos

Posibles ventas de productos futuros

A partir del cuarto trimestre de 2023, Iterum Therapeutics se ha centrado en el desarrollo de sulopenem, un posible tratamiento antibiótico. No se informaron los ingresos actuales de ventas de productos.

Acuerdos de licencia

Pareja	Detalles del acuerdo	Valor financiero potencial
Grupo Medix	Licencias de sulopenem para mercados latinoamericanos	Pago por adelantado de $ 10 millones

Subvenciones de investigación

Financiación total de la subvención de investigación a partir de 2023: $ 1.2 millones

Asociaciones de desarrollo colaborativo

• Asociación con Medix Group para el desarrollo de Sulopenem
• Colaboraciones de ensayos clínicos en curso en investigación antibiótica

Pagos potenciales de hitos

Tipo de hito	Rango de pago potencial
Hitos de aprobación regulatoria	$ 15-25 millones
Hitos comerciales de lanzamiento	$ 30-50 millones

Pagos de hito potencial total: $ 45-75 millones

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.