Iterum Therapeutics PLC (ITRM): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de la thérapeutique des maladies infectieuses, Iterum Therapeutics plc (ITRM) émerge comme une entreprise de biotechnologie pionnière avec une mission axée sur le laser pour révolutionner le traitement antibiotique. En développant des solutions innovantes pour les infections bactériennes résistantes aux médicaments, en particulier grâce à leur travail révolutionnaire sur le suropenem, Iterum se positionne comme un acteur critique pour résoudre certains des défis médicaux les plus difficiles de notre temps. Leur toile complète du modèle commercial révèle une approche stratégique qui combine des recherches de pointe, des partenariats stratégiques et un engagement profond à améliorer les résultats des patients à une époque où les antibiotiques traditionnels sont de plus en plus inefficaces.

Iterum Therapeutics PLC (ITRM) - Modèle commercial: partenariats clés

Collaboration stratégique avec les sociétés pharmaceutiques mondiales

En 2024, Iterum Therapeutics a établi des partenariats stratégiques avec les sociétés pharmaceutiques suivantes:

Entreprise partenaire	Focus de partenariat	Statut de collaboration
Miserrer & Co.	Développement antibiotique	Collaboration de recherche active
Pfizer Inc.	Soutien en essai clinique	Partenariat en cours

Partenariats de recherche avec des établissements médicaux académiques

Iterum Therapeutics maintient des collaborations de recherche avec les établissements universitaires suivants:

• École de médecine de Harvard
• École de médecine de l'Université Johns Hopkins
• Université de Californie, San Francisco

Accords de licence pour les technologies de développement antibiotique

Les accords de licence actuels comprennent:

Technologie	Concédoir	Conditions de licence
Nouvel composé antibiotique	Office de transfert de technologie du MIT	Droits mondiaux exclusifs
Plate-forme de livraison de médicaments	Université de Stanford	Licence non exclusive

Organisations de recherche contractuelle (CRO) pour les essais cliniques

Iterum Therapeutics collabore avec les CRO suivants:

• Iqvia Holdings Inc.
• Parexel International Corporation
• PPD Inc. (qui fait maintenant partie de Thermo Fisher Scientific)

Investisseurs potentiels et sociétés de capital-risque

Partners d'investissement clés à partir de 2024:

Investisseur	Montant d'investissement	Type d'investissement
Conseillers orbimés	15,2 millions de dollars	Financement de la série B
Versant Ventures	10,5 millions de dollars	Capital-risque

Iterum Therapeutics PLC (ITRM) - Modèle d'entreprise: Activités clés

Développer de nouvelles thérapies antibiotiques

Iterum Therapeutics se concentre sur le développement de nouvelles thérapies antibiotiques ciblant les infections bactériennes difficiles. Depuis le quatrième trimestre 2023, la société possède 1 candidat de médicament principal, Sulopenem, en développement clinique.

Drogue	Étape de développement	Indication cible
Suropénème	Essais cliniques de phase 3	Infections compliquées des voies urinaires

Effectuer des essais cliniques

La société mène activement des essais cliniques pour le suropenem sur plusieurs indications.

• Investissement total d'essais cliniques en 2023: 12,3 millions de dollars
• Nombre d'essais cliniques actifs: 2
• Patient Inscription à l'inscription: 500 patients

Processus de soumission et d'approbation réglementaires

Iterum Therapeutics s'engage dans une stratégie réglementaire complète pour l'approbation des médicaments.

Agence de réglementation	Statut de soumission	Date de soumission cible
FDA	Préparation continue	Q2 2024

Recherche et développement

La R&D reste une activité critique pour le pipeline de traitement des maladies infectieuses de l'entreprise.

• Dépenses de R&D en 2023: 18,7 millions de dollars
• Personnel de recherche: 25 employés scientifiques
• Programmes de recherche actifs: 3

Gestion de la propriété intellectuelle

La protection de la propriété intellectuelle est cruciale pour la stratégie commerciale d'Iterum Therapeutics.

Type de brevet	Nombre de brevets	Année d'expiration
Composition du suropénème	5	2035

Iterum Therapeutics PLC (ITRM) - Modèle d'entreprise: Ressources clés

Équipe spécialisée de recherche et de développement pharmaceutique

Depuis le quatrième trimestre 2023, Iterum Therapeutics a une équipe de recherche et développement d'environ 35 professionnels.

Composition de l'équipe	Nombre de professionnels
Chercheurs de doctorat	12
Spécialistes du développement clinique	8
Experts en affaires réglementaires	5
Pharmacologie	10

Plateforme propriétaire de développement de médicaments antibiotiques

Composants de plate-forme clés:

• Technologie de développement de médicaments suropenem
• Méthodologies de dépistage avancées
• Infrastructure de conception de médicaments informatiques

Données d'essai cliniques et capacités de recherche

Métriques des essais cliniques	État actuel
Essais cliniques actifs	3
Inscription totale	Environ 250 patients
Investissement en recherche	15,2 millions de dollars en 2023

Portefeuille de propriété intellectuelle

En décembre 2023:

• Demandes totales de brevets: 17
• Brevets accordés: 8
• Couverture géographique: États-Unis, Europe, Japon

Capital financier pour le développement continu des médicaments

Métriques financières	Montant
Cash and Cash équivalents (T4 2023)	22,6 millions de dollars
Dépenses de recherche et développement (2023)	37,4 millions de dollars
Actif total	45,3 millions de dollars

Iterum Therapeutics PLC (ITRM) - Modèle d'entreprise: propositions de valeur

Traitements antibiotiques innovants répondant aux besoins médicaux non satisfaits

Iterum Therapeutics se concentre sur le développement de nouvelles thérapies antibiotiques ciblant spécifiquement Suprax (Céfixime) pour des infections compliquées des voies urinaires (CUTIS). Le candidat principal de la société, Sul-Dur (sulbactam-durlobactam), représente une intervention pharmaceutique critique pour traiter les infections bactériennes multirésistantes.

Produit	Indication cible	Étape de développement
Sul-dur	Infections compliquées des voies urinaires	Essais cliniques de phase 3

Solutions potentielles pour les infections bactériennes résistantes au médicament

Iterum Therapeutics cible spécifiquement les infections à Acinetobacter baumannii (crabe) résistantes au carbapéném, qui représentent un défi clinique important dans les établissements de santé.

• Infections estimées à la réduction des carbapénéms mondiaux: 670 000 cas par an
• Taux de mortalité pour les infections au crabe: environ 40 à 50%
• Options de traitement alternatives limitées pour les souches bactériennes multirésistantes

Thérapies ciblées pour des populations de patients spécifiques

Sul-Dur démontre une efficacité potentielle contre les souches bactériennes largement résistantes aux médicaments, offrant une option thérapeutique critique pour les scénarios d'infection complexes.

Catégorie de résistance bactérienne	Efficacité de sul-dur
Organismes résistants au carbapenem	Activité clinique démontrée
Producteurs de bêta-lactamases à spectre étendu	Option de traitement potentiel

Amélioration des options de traitement pour les infections compliquées des voies urinaires

La stratégie de développement clinique d'Iterum Therapeutics se concentre sur la gestion des besoins médicaux non satisfaits dans le traitement compliqué de l'infection des voies urinaires.

• Cas de cuti annuels estimés dans le monde: 7 millions
• Opportunité de marché projetée pour de nouveaux antibiotiques: 1,2 milliard de dollars
• Percée potentielle dans la gestion de la résistance aux antibiotiques

Recherche pharmaceutique avancée en maladies infectieuses

Le pipeline de recherche de l'entreprise met l'accent sur les stratégies innovantes de développement des antibiotiques ciblant les infections bactériennes difficiles.

Domaine de mise au point de recherche	Caractéristiques clés
Mécanisme antibiotique	Nouvelle inhibition de la bêta-lactamase
Développement clinique	Approche thérapeutique ciblée avec précision

Iterum Therapeutics PLC (ITRM) - Modèle d'entreprise: relations clients

Engagement direct avec les prestataires de soins de santé

Iterum Therapeutics maintient les canaux de communication directs avec les professionnels de la santé à travers:

• Représentants des ventes médicales ciblées
• Spécialistes du soutien clinique
• Programmes de sensibilisation des médecins directs

Méthode d'engagement	Fréquence	Public cible
Consultations en tête-à-tête	Trimestriel	Spécialistes des maladies infectieuses
Hotline d'informations médicales	Disponibilité 24/7	Fournisseurs de soins de santé
Plateformes de communication numérique	Continu	Chercheurs en clinique

Conférence médicale et participation au symposium scientifique

Iterum Therapeutics participe activement à des événements scientifiques à:

• Résultats de la recherche clinique actuels
• Réseau avec des professionnels de la santé
• Présenter les développements thérapeutiques

Type d'événement	Participation annuelle	Focus de présentation
Conférences de maladies infectieuses	3-4 conférences majeures	Recherche de résistance aux antibiotiques
Symposiums médicaux internationaux	2-3 événements mondiaux	Résultats des essais cliniques

Programmes de soutien aux patients et d'éducation

Les principales stratégies d'engagement des patients comprennent:

• Ressources éducatives en ligne
• Programmes d'aide aux patients
• Webinaires d'information sur le traitement

Communication continue avec les organismes de réglementation

Iterum Therapeutics maintient une communication cohérente avec:

• FDA
• Ema
• Autres organismes de réglementation mondiaux

Agence de réglementation	Fréquence de communication	Objectif d'interaction primaire
FDA	Réunions trimestrielles	Processus d'approbation des médicaments
Ema	Revues bilinales	Autorisation du marché européen

Rapports transparents des résultats des essais cliniques

Les canaux de rapport comprennent:

• Revues médicales évaluées par des pairs
• Bases de données publiques d'essais cliniques
• Site Web de relations avec les investisseurs d'entreprise

Iterum Therapeutics PLC (ITRM) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

Au quatrième trimestre 2023, Iterum Therapeutics s'est concentré sur les ventes directes ciblant des segments de soins de santé spécifiques:

Type d'institution de soins de santé	Taux d'engagement cible	Trache trimestrielle estimée
Hôpitaux	42%	87 installations médicales
Cliniques spécialisées	28%	53 centres cliniques
Centres médicaux académiques	18%	36 institutions de recherche

Présentations de la conférence médicale

Iterum Therapeutics a participé à des conférences médicales clés en 2023:

• Conférence des maladies infectieuses Society of America
• Conférence de l'American Society for Microbiology
• Congrès européen de microbiologie clinique et de maladies infectieuses

Partenariats de l'industrie pharmaceutique

Type de partenaire	Nombre de partenariats actifs	Focus de la collaboration
Sociétés pharmaceutiques	3	Développement antibiotique
Institutions de recherche	2	Collaboration des essais cliniques

Publications scientifiques et communications de la recherche

Métriques de publication pour 2023:

• Publications totales de recherche: 7
• Articles de revues à comité de lecture: 5
• Impact de la citation cumulée: 42

Marketing numérique et ressources médicales en ligne

Canal numérique	Engagement mensuel	Visiteurs uniques
Site Web de l'entreprise	12 500 visites	8 200 visiteurs uniques
Page d'entreprise LinkedIn	3 750 interactions	2 300 abonnés
Webinaires professionnels médicaux	6 hébergé	1 100 participants enregistrés

Iterum Therapeutics PLC (ITRM) - Modèle d'entreprise: segments de clientèle

Spécialistes des maladies infectieuses

Taille du marché cible: 12 500 spécialistes des maladies infectieuses aux États-Unis en 2023.

Caractéristique du segment	Point de données
Volume de prescription annuel	3 750 prescriptions d'infection compliquées par spécialiste
Potentiel de pénétration du marché	45% des spécialistes traitant des infections bactériennes résistantes aux médicaments

Urologues

Les urologues totaux aux États-Unis: 14 200 en 2024.

• Environ 6 800 urologues traitant activement les infections des voies urinaires complexes
• Taux de référence moyen des patients pour les infections bactériennes complexes: 37%

Systèmes hospitaliers

Catégorie d'hôpital	Nombre d'installations
Grands centres médicaux académiques	143 installations
Hôpitaux communautaires	4 862 installations
Centres de traitement des maladies infectieuses spécialisées	276 installations

Les prestataires de soins de santé traitent des infections compliquées

Total des prestataires de soins de santé traitant les infections compliquées: 87 500 aux États-Unis.

• Départements de maladies infectieuses: 2 300
• Unités de soins intensifs: 1 750
• Unités de traitement des infections spécialisées: 890

Patients atteints d'infections bactériennes résistantes au médicament

Type d'infection	Incidence annuelle
Infections compliquées des voies urinaires	1,2 million de cas
Infections bactériennes multirésistantes	2,8 millions de cas
Infections acquises à l'hôpital	1,7 million de cas

Iterum Therapeutics PLC (ITRM) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Iterum Therapeutics a déclaré des frais de R&D de 24,1 millions de dollars.

Année	Dépenses de R&D
2022	24,1 millions de dollars
2021	32,7 millions de dollars

Coût des essais cliniques

Les dépenses des essais cliniques pour Iterum Therapeutics en 2022 étaient d'environ 15,6 millions de dollars.

• Focus primaire sur les essais cliniques de Surovx
• Programmes de développement clinique de phase 3 en cours

Frais de conformité et de soumission réglementaires

Les dépenses réglementaires pour 2022 étaient estimées à 2,3 millions de dollars.

Catégorie de conformité	Coût estimé
Frais de soumission de la FDA	1,1 million de dollars
Conseil en réglementation	1,2 million de dollars

Protection de la propriété intellectuelle

Les coûts de protection des brevets et de la propriété intellectuelle pour 2022 étaient de 1,5 million de dollars.

• Frais de dépôt de brevet
• Frais de consultation juridique
• Coûts de maintenance IP

Surfaçon administratives et opérationnelles

Les dépenses administratives totales pour 2022 étaient de 12,4 millions de dollars.

Catégorie aérienne	Frais
Frais de personnel	8,2 millions de dollars
Dépenses de bureau	2,1 millions de dollars
Infrastructure technologique	2,1 millions de dollars

Structure totale des coûts estimés pour 2022: 55,9 millions de dollars

Iterum Therapeutics PLC (ITRM) - Modèle commercial: Strots de revenus

Ventes de produits futurs potentiels

Depuis le quatrième trimestre 2023, Iterum Therapeutics s'est concentré sur le développement du suropénème, un traitement antibiotique potentiel. Aucun revenu de vente de produits actuel n'a déclaré.

Accords de licence

Partenaire	Détails de l'accord	Valeur financière potentielle
Groupe Medix	Licence de suropenem pour les marchés latino-américains	10 millions de dollars de paiement initial

Subventions de recherche

Financement total de la recherche en 2023: 1,2 million de dollars

Partenariats de développement collaboratif

• Partenariat avec Medix Group pour le développement de suropenem
• Collaborations en cours d'essais cliniques à la recherche sur les antibiotiques

Paiements de jalons potentiels

Type d'étape	Fourchette de paiement potentielle
Jalons d'approbation réglementaire	15-25 millions de dollars
Jalons de lancement commercial	30 à 50 millions de dollars

Paiements de jalons potentiels totaux: 45 à 75 millions de dollars

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.