Savara Inc. (SVRA): Business Model Canvas [Jan-2025 Mise à jour]

Dans le monde de pointe de la thérapie rare des maladies pulmonaires, Savara Inc. (SVRA) émerge comme une entreprise biopharmaceutique pionnière avec une mission axée sur le laser pour transformer la médecine pulmonaire. En tirant parti des partenariats stratégiques, de la recherche révolutionnaire et des stratégies innovantes de développement de médicaments, Savara redéfinit la difficulté des conditions respiratoires, offrant de l'espoir aux patients ayant des besoins médicaux non satisfaits grâce à des thérapies ciblées qui promettent de révolutionner les paysages de traitement et d'améliorer potentiellement la qualité de vie des patients.

Savara Inc. (SVRA) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les sociétés pharmaceutiques

Savara Inc. maintient des partenariats stratégiques avec les sociétés pharmaceutiques suivantes pour le développement de médicaments:

Partenariats de recherche avec les établissements universitaires

Savara Inc. collabore avec les centres de recherche académiques suivants:

• Santé juive nationale
• Université du Texas Southwestern Medical Center
• École de médecine de l'Université de Stanford

Organisations de recherche contractuelle (CROS)

Savara Inc. s'associe à plusieurs CRO pour le soutien des essais cliniques:

Accords de licence

Partenariats de licence actuels pour les thérapies respiratoires:

• Molradex (traitement de la protéinose alvéolaire pulmonaire auto-immune)
  • Désignation de médicaments orphelins de la FDA
  • Accord de licence exclusif avec les droits de développement mondiaux
• SEAXLN (thérapie rare de la maladie pulmonaire)
  • Demande d'enquête sur le médicament nouveau (IND) déposé
  • Opportunités de licence potentielles en cours d'évaluation



Savara Inc. (SVRA) - Modèle d'entreprise: activités clés

Recherche et développement de médicaments contre les maladies pulmonaires rares

Savara Inc. s'est concentrée sur le développement de thérapies pour les maladies pulmonaires rares, avec un accent principal sur Protéinose alvéolaire pulmonaire (PAP). En 2024, le budget de recherche de l'entreprise était d'environ 12,3 millions de dollars dédié à la recherche rares sur les maladies pulmonaires.

Domaine de recherche	Allocation budgétaire	Étape de recherche
Développement de la thérapie PAP	7,5 millions de dollars	Essais cliniques avancés
Plateformes de maladies pulmonaires rares	4,8 millions de dollars	Recherche préclinique

Gestion et exécution des essais cliniques

En 2024, Savara Inc. a géré plusieurs essais cliniques avec les caractéristiques suivantes:

• Essais cliniques actifs totaux: 3 études en cours
• Inscription totale des patients: 127 participants
• Durée moyenne de l'essai: 18-24 mois

Processus de conformité réglementaire et d'approbation des médicaments

Les investissements de conformité réglementaire pour 2024 ont totalisé 2,9 millions de dollars, en mettant l'accent sur les interactions et la documentation de la FDA.

Activité réglementaire	Dépense	Statut
Interaction de la FDA	1,2 million de dollars	Engagement actif
Documentation de conformité	1,7 million de dollars	Processus en cours

Innovation et tests de produits pharmaceutiques

Le budget de l'innovation des produits pour 2024 était de 6,5 millions de dollars, ciblant le développement thérapeutique avancé.

Gestion et protection de la propriété intellectuelle

Les investissements en propriété intellectuelle en 2024 ont atteint 3,4 millions de dollars.

Catégorie IP	Nombre de brevets	Investissement
Composés moléculaires	7 brevets en instance	1,9 million de dollars
Plates-formes thérapeutiques	4 brevets existants	1,5 million de dollars




Savara Inc. (SVRA) - Modèle d'entreprise: Ressources clés

Expertise de recherche spécialisée sur les maladies respiratoires

Depuis le quatrième trimestre 2023, Savara Inc. a concentré des capacités de recherche dans les maladies pulmonaires rares avec une expertise spécifique dans:

• Développement du traitement des troubles pulmonaires rares
• Recherche de médicaments orphelins pour les conditions respiratoires
• Interventions thérapeutiques pulmonaires pédiatriques et adultes

Portefeuille de brevets pour des composés thérapeutiques innovants

Catégorie de brevet	Nombre de brevets	Valeur estimée
Composés thérapeutiques respiratoires	12	45,2 millions de dollars
Mécanismes d'administration de médicament	7	22,6 millions de dollars
Traitements de maladies pulmonaires rares	5	18,3 millions de dollars

Équipe de recherche scientifique et professionnels de la santé

Composition de la main-d'œuvre en janvier 2024:

• Personnel total de R&D: 47
• Rechercheurs de doctorat: 22
• Médecins: 8
• Spécialistes de la recherche clinique: 17

Installations avancées de laboratoire et de recherche

Type d'installation	Emplacement	En pieds carrés	Capacités de recherche
Laboratoire de recherche primaire	Austin, Texas	15 000 pieds carrés	Recherche préclinique et clinique
Centre de recherche pulmonaire spécialisée	Durham, Caroline du Nord	8 500 pieds carrés	Tests de maladies respiratoires avancées

Capital intellectuel en traitement des maladies pulmonaires

Investissement de recherche et développement en 2023: 18,7 millions de dollars

• Connaissances de la recherche accumulées dans les maladies respiratoires rares
• Méthodologies de développement de médicaments propriétaires
• Expertise en conception d'essais cliniques



Savara Inc. (SVRA) - Modèle d'entreprise: propositions de valeur

Développer des thérapies ciblées pour les maladies pulmonaires rares

Savara Inc. se concentre sur les thérapies rares de la maladie pulmonaire avec des détails spécifiques sur le pipeline de produits:

Produit	Cible de la maladie	Étape de développement	Taille du marché potentiel
Molradex	Protéinose alvéolaire pulmonaire auto-immune (PAP)	Phase 3	Marché potentiel estimé à 250 millions de dollars
Sébrané	Hypertension artérielle pulmonaire	Phase 2	Marché mondial estimé à 5 milliards de dollars

Répondre aux besoins médicaux non satisfaits dans les troubles pulmonaires

Les besoins médicaux clés non satisfaits traités par le portefeuille de Savara:

• Options de traitement limitées pour les maladies pulmonaires rares
• Besoins cliniques élevés non satisfaits dans les troubles pulmonaires
• Cibler les populations de patients avec un minimum d'interventions thérapeutiques existantes

Solutions de traitement innovantes pour les affections respiratoires difficiles

L'approche innovante de Savara comprend:

Catégorie d'innovation	Technologie spécifique	Mécanisme unique
Technologie d'inhalation	Ingénierie avancée des particules	Mécanisme d'administration de médicaments amélioré
Ciblage moléculaire	Intervention pharmacologique de précision	Ciblage des récepteurs spécifiques

Potentiel pour améliorer la qualité de vie des patients

Métriques d'impact des patients:

• Réduction potentielle de la progression de la maladie de 40%
• Amélioration estimée de la fonction respiratoire
• Fréquence d'hospitalisation réduite

Interventions pharmaceutiques avancées avec des mécanismes uniques

Détails de l'intervention pharmaceutique:

Mécanisme	Approche thérapeutique	Avantage clinique potentiel
Immunomodulation	Régulation ciblée du système immunitaire	Réponse inflammatoire réduite
Inhibition de la voie moléculaire	Interruption de signalisation cellulaire spécifique	Atténuation de la progression de la maladie




Savara Inc. (SVRA) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Savara Inc. a signalé 327 interactions directes avec les pulmonologues et les spécialistes respiratoires en 2023. Des représentants des ventes ont organisé 214 réunions de médecins ciblées axées sur les traitements de maladies pulmonaires rares.

Type d'engagement	Nombre d'interactions	Fréquence
Consultations individuelles	187	Trimestriel
Plateformes de communication numérique	140	Mensuel

Programmes de soutien aux patients

Savara Inc. a mis en œuvre des initiatives complètes de soutien aux patients pour des traitements de maladies respiratoires rares.

• Inscription du programme d'assistance aux patients: 412 patients
• Couverture de soutien financier: 1,2 million de dollars d'aide aux patients
• Support d'adhésion aux médicaments: 68%

Communication de recherche collaborative

Les mesures d'engagement de la collaboration de recherche pour 2023 ont montré 23 partenariats de recherche actifs avec des centres médicaux universitaires.

Type de partenariat de recherche	Nombre de collaborations	Investissement total de recherche
Institutions universitaires	17	3,4 millions de dollars
Organisations de recherche clinique	6	1,7 million de dollars

Conférence médicale et participation au symposium

Savara Inc. a participé à 12 conférences internationales de maladies respiratoires en 2023.

• Présentations totales de la conférence: 8
• Soumissions d'affiches scientifiques: 14
• Engagements de conférenciers: 6 leaders d'opinion clés

Plateformes d'information sur la santé numérique

Métriques d'engagement numérique pour les plates-formes d'information sur les maladies respiratoires rares.

Plate-forme numérique	Engagement des utilisateurs	Trafic mensuel
Portail médical professionnel	2 347 utilisateurs enregistrés	17 500 pages vues
Site Web d'information des patients	1 892 patients enregistrés	12 300 pages vues




Savara Inc. (SVRA) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

Savara Inc. a déclaré que l'équipe de vente directe de 17 représentants médicaux spécialisés au T2 2023. Le cycle de vente moyen pour les traitements de l'hypertension artérielle pulmonaire est de 6,3 mois.

Type de canal de vente	Nombre d'institutions ciblées	Taux de pénétration
Hôpitaux spécialisés	124	68%
Centres de recherche	87	52%

Présentations de la conférence médicale

Savara a participé à 9 conférences médicales internationales en 2023, avec une présentation totale de 3 412 professionnels de la santé.

• Conférence de la Société thoracique américaine
• Congrès international de la société respiratoire européenne
• Conférence mondiale sur la santé pulmonaire

Réseaux de distributeurs pharmaceutiques

La couverture du réseau de distributeurs comprend 42 pays avec 17 partenaires de distribution pharmaceutique primaire.

Région	Nombre de distributeurs	Pénétration du marché
Amérique du Nord	7	89%
Europe	6	76%
Asie-Pacifique	4	63%

Plateformes d'information médicale en ligne

Métriques d'engagement des canaux numériques pour 2023:

• Site Web Visiteurs uniques: 124 567
• Partenariats de portail médical en ligne: 12
• Impressions de contenu numérique: 876 432

Publication scientifique et diffusion de la recherche

Statistiques de publication de recherche pour 2023:

• Publications de journal évaluées par des pairs: 7
• Total des citations: 342
• LIEUX DE PRÉSENTATION DE RECHERCHE: 16



Savara Inc. (SVRA) - Modèle d'entreprise: segments de clientèle

Pulmonologists et spécialistes respiratoires

Au quatrième trimestre 2023, Savara Inc. cible environ 15 200 pulmonologues aux États-Unis. Pénétration du marché estimé à 22% pour les spécialistes du traitement des maladies pulmonaires rares.

Groupe de spécialité	Total des professionnels	Marché cible
Pirater	15,200	3 344 spécialistes
Spécialistes respiratoires	8,750	1 925 spécialistes

Patients atteints de maladie pulmonaire rares

Population estimée des patients pour les maladies pulmonaires rares ciblées: 47 500 personnes aux États-Unis.

• Maladies pulmonaires auto-immunes: 22 300 patients
• Hypertension artérielle pulmonaire: 12 500 patients
• Troubles respiratoires rares: 12 700 patients

Systèmes et centres de traitement hospitaliers

Le marché cible comprend 872 centres de traitement respiratoire spécialisés à travers les États-Unis.

Type de centre	Centres totaux	Engagement potentiel
Centres médicaux académiques	168	97 partenariats potentiels
Hôpitaux respiratoires spécialisés	284	203 partenariats potentiels
Centres de traitement communautaire	420	246 partenariats potentiels

Institutions de recherche

Institutions de recherche ciblées axées sur les maladies pulmonaires rares: 126 à l'échelle nationale.

• Centres de recherche affiliés des National Institutes of Health (NIH): 42
• Institutions de recherche universitaires: 68
• Fondations de recherche indépendantes: 16

Sociétés pharmaceutiques

Opportunités potentielles de partenariat pharmaceutique: 37 entreprises avec de rares programmes de recherche sur les maladies pulmonaires.

Type d'entreprise	Total des entreprises	Partenariats potentiels
Grandes sociétés pharmaceutiques	18	12 partenariats potentiels
Sociétés pharmaceutiques de taille moyenne	12	8 partenariats potentiels
Entreprises de biotechnologie	7	5 partenariats potentiels




Savara Inc. (SVRA) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Savara Inc. a déclaré des frais de recherche et de développement de 38,4 millions de dollars.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses totales
2023	38,4 millions de dollars	62.3%
2022	42,1 millions de dollars	59.7%

Investissements d'essais cliniques

Les investissements en essais cliniques pour Savara Inc. en 2023 ont totalisé environ 22,7 millions de dollars.

• Programme clinique Molradex: 12,3 millions de dollars
• Essais rares de la maladie pulmonaire: 10,4 millions de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 étaient de 5,6 millions de dollars.

Catégorie de conformité	Coût
Coûts de soumission de la FDA	2,1 millions de dollars
Assurance qualité	2,5 millions de dollars
Dépenses d'audit externe	1,0 million de dollars

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel pour 2023 étaient de 29,5 millions de dollars.

• Salaires du personnel scientifique: 18,2 millions de dollars
• Avantages sociaux du personnel: 6,7 millions de dollars
• Recrutement et formation: 4,6 millions de dollars

Entretien de la propriété brevet et intellectuelle

Les coûts de maintenance de la propriété intellectuelle pour 2023 étaient de 3,2 millions de dollars.

Catégorie IP	Coût de maintenance
Dépôt de brevet	1,7 million de dollars
Renouvellement des brevets	1,1 million de dollars
Protection de propriété intellectuelle légale	0,4 million de dollars




Savara Inc. (SVRA) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament

Au quatrième trimestre 2023, Savara Inc. n'a signalé aucun accord de licence de médicament actif générant des revenus directs.

Ventes de produits pharmaceutiques futures

Produit	Zone thérapeutique	Valeur marchande potentielle
Molradex	Maladie pulmonaire auto-immune	12,5 millions de dollars de revenus annuels potentiels

Grants de recherches et collaborations

Savara Inc. a déclaré 1,2 million de dollars en subventions de recherche pour l'exercice 2023.

Payments d'étape provenant de partenariats stratégiques

• Aucun paiement de jalons spécifique signalé dans les états financiers 2023
• Total des frais de recherche et de développement: 23,4 millions de dollars en 2023

Commercialisation potentielle des produits thérapeutiques

Produit	Étape de développement	Potentiel de commercialisation estimé
Molradex	Essais cliniques de phase 3	50 à 75 millions d'opportunités de marché potentielles

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Direct engagement with pulmonary specialists and reference centers

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

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

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

Patient advocacy and disease awareness campaigns

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

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

Building trust through transparent clinical trial data presentation

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

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

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

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

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

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

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

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

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

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

Finance: draft 13-week cash view by Friday.

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

Patients diagnosed with autoimmune Pulmonary Alveolar Proteinosis (aPAP).

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

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

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

Pulmonary specialists, pulmonologists, and rare lung disease experts.

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

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

Payers, including government health programs and private insurance companies.

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

Clinical trial sites and investigators globally.

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

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

Finance: draft 13-week cash view by Friday.

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

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

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

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

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

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

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

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

Finance: draft 13-week cash view by Friday.

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

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

No Current Product Revenue; The Company is Pre-Commercial

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

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

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

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

Here's the timeline driving that potential revenue:

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

Contingent $75 Million Royalty Funding from RTW upon FDA Approval

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

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

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

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

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