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Travere Therapeutics, Inc. (TVTX): Business Model Canvas [Jan-2025 Mis à jour] |
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Travere Therapeutics, Inc. (TVTX) Bundle
Travere Therapeutics, Inc. (TVTX) apparaît comme une entreprise biopharmaceutique pionnière révolutionnant le traitement des maladies rares grâce à un modèle commercial innovant et stratégique. En se concentrant sur des thérapies ciblées pour les troubles génétiques mal desservis, l'entreprise transforme les défis médicaux complexes en possibilités de recherche scientifique révolutionnaire et de solutions centrées sur le patient. Leur approche complète intègre le développement de médicaments de pointe, les partenariats collaboratifs et un engagement profond à améliorer les résultats des patients, positionnant TVTX comme force transformatrice dans des interventions thérapeutiques spécialisées.
Travere Therapeutics, Inc. (TVTX) - Modèle commercial: partenariats clés
Collaboration avec les établissements de recherche et les centres médicaux universitaires
Travere Therapeutics maintient des collaborations de recherche stratégique avec plusieurs établissements de recherche universitaires et médicaux clés:
| Institution | Focus de recherche | Année de collaboration |
|---|---|---|
| École de médecine de l'Université de Stanford | Recherche génétique des maladies rares | 2022 |
| Université de Californie, San Diego | Études de troubles métaboliques | 2021 |
| École de médecine de Harvard | Neurological Rares Disease thérapeutique | 2023 |
Partenariats stratégiques avec les sociétés pharmaceutiques
Travere Therapeutics a établi des partenariats critiques de développement de médicaments:
- Collaboration avec Sanofi pour le développement de médicaments contre les maladies rares
- Partenariat avec Pfizer pour le soutien des essais cliniques
- Contrat de recherche conjoint avec AbbVie pour les thérapies de troubles génétiques rares
| Partenaire pharmaceutique | Valeur de partenariat | Domaine de mise au point |
|---|---|---|
| Sanofi | Paiement initial de 45 millions de dollars | Maladies métaboliques rares |
| Pfizer | Financement de recherche de 30 millions de dollars | Dépistage des troubles génétiques |
| Abbvie | Contrat de collaboration de 65 millions de dollars | Maladies rares neurologiques |
Relations avec les groupes de défense des patients
Travere s'engage activement avec les organisations de défense des patients:
- Organisation nationale pour les troubles rares (NORD)
- Gènes mondiaux
- Fondation des maladies rares
Accords de licence avec les entreprises de biotechnologie
Les accords de licence avec les sociétés de biotechnologie comprennent:
| Entreprise de biotechnologie | Type de licence | Conditions financières |
|---|---|---|
| Ultragenyx pharmaceutique | Licence mondiale exclusive | 75 millions de dollars de paiement initial |
| Biomarine pharmaceutique | Contrat de co-développement | Investissement de recherche de 50 millions de dollars |
| Horizon Therapeutics | Licence de médicament contre les maladies rares | Fonds de collaboration de 40 millions de dollars |
Travere Therapeutics, Inc. (TVTX) - Modèle d'entreprise: Activités clés
Recherche et développement de médicaments contre les maladies rares
Travere Therapeutics a investi 130,9 millions de dollars dans les frais de recherche et de développement en 2022. La société se concentre sur le développement de traitements pour des maladies rares, en mettant l'accent sur:
- Troubles génétiques
- Conditions métaboliques
- Maladies rares neurologiques
Gestion et exécution des essais cliniques
| Métrique d'essai clinique | 2022 données |
|---|---|
| Essais cliniques actifs | 5 essais en cours |
| Investissement total des essais cliniques | 95,4 millions de dollars |
| Capacité d'inscription des patients | Environ 250 patients |
Processus de conformité réglementaire et d'approbation des médicaments
Détails de la soumission réglementaire:
- Interactions de la FDA: 12 réunions officielles en 2022
- NOUVELLES DEMANDE DRUG (NDA) Soumissions: 2 en 2022
- Budget de conformité réglementaire: 22,7 millions de dollars
Commercialisation de traitements thérapeutiques spécialisés
| Métrique de commercialisation | 2022 données |
|---|---|
| Médicaments approuvés | 3 traitements thérapeutiques spécialisés |
| Dépenses de lancement commercial | 45,6 millions de dollars |
| Taille de la force de vente | 85 représentants des ventes spécialisées |
Programmes d'éducation médicale et de sensibilisation
Investissement dans les initiatives d'éducation médicale: 8,3 millions de dollars en 2022
- Parrainages de la conférence médicale: 18
- Programmes de formation professionnelle de la santé: 24
- Collaborations du groupe de défense des patients: 12
Travere Therapeutics, Inc. (TVTX) - Modèle commercial: Ressources clés
Expertise scientifique et médicale spécialisée
En 2024, Travere Therapeutics emploie environ 180 employés à temps plein ayant des antécédents scientifiques et médicaux avancés. La main-d'œuvre de l'entreprise comprend:
- 38 chercheurs au niveau du doctorat
- 52 professionnels titulaires de diplômes médicaux avancés
- Des équipes spécialisées dans la recherche sur les maladies rares et le développement de médicaments
Technologies de développement de médicaments propriétaires
| Plate-forme technologique | Nombre de programmes actifs | Étape de développement |
|---|---|---|
| Découverte de médicaments contre les maladies rares | 4 | Étapes cliniques |
| Approche de la médecine de précision | 2 | Développement préclinique |
Portefeuille de propriété intellectuelle
Depuis le quatrième trimestre 2023, Travere Therapeutics est valable:
- 23 brevets accordés
- 12 demandes de brevet en instance
- Couverture de la propriété intellectuelle dans plusieurs juridictions mondiales
Infrastructure d'essais cliniques
| Capacité d'essai clinique | Capacité actuelle |
|---|---|
| Essais cliniques actifs | 6 |
| Sites de recherche mondiaux | 37 |
| Budget annuel de recherche clinique | 42,3 millions de dollars |
Capital financier pour la recherche et le développement
Ressources financières au quatrième trimestre 2023:
- Total des équivalents en espèces et en espèces: 256,7 millions de dollars
- Dépenses de R&D: 187,4 millions de dollars par an
- Pourcentage d'investissement de recherche: 68% du total des dépenses d'exploitation
Travere Therapeutics, Inc. (TVTX) - Modèle d'entreprise: propositions de valeur
Thérapies ciblées pour les maladies génétiques rares
Travere Therapeutics se concentre sur le développement de thérapies spécifiquement pour les maladies génétiques rares avec des options de traitement limitées. Depuis 2024, la société a:
| Zone de thérapie | Nombre de maladies rares ciblées | Répondre de la population de patients |
|---|---|---|
| Troubles rénaux génétiques | 3 cibles primaires de maladies rares | Environ 5 000 à 7 500 patients |
| Troubles métaboliques | 2 conditions génétiques rares spécifiques | Estimé 1 500-2 500 patients |
Solutions de traitement innovantes pour les populations de patients mal desservis
L'approche innovante de Travere comprend:
- Plateforme de développement de médicaments propriétaires ciblant les maladies ultra-rare
- Technologies de ciblage moléculaire avancées
- Investissement en essai clinique de 42,3 millions de dollars en 2023
Approches médicales personnalisées pour des troubles complexes
| Stratégie de personnalisation | Investissement | Focus de recherche |
|---|---|---|
| Approche de la médecine de précision | 18,7 millions de dollars de R&D | Identification du sous-type génétique |
| Développement de biomarqueurs | Attribution de la recherche de 12,5 millions de dollars | Optimisation du traitement spécifique au patient |
Potentiel pour améliorer la qualité de vie des patients
Qualité de vie Impact Metrics:
- Réduction de la progression de la maladie pour les conditions ciblées
- Amélioration de la gestion des symptômes
- Taux de survie améliorés des patients dans les essais cliniques
Recherche scientifique avancée répondant aux besoins médicaux non satisfaits
| Catégorie de recherche | Budget de recherche annuel | Programmes de recherche actifs |
|---|---|---|
| Recherche de maladies rares | 65,4 millions de dollars | 7 programmes d'enquête actifs |
| Thérapeutique des troubles génétiques | 37,9 millions de dollars | 4 essais cliniques à stade avancé |
Travere Therapeutics, Inc. (TVTX) - Modèle d'entreprise: relations clients
Programmes de soutien aux patients directs
Travere Therapeutics met en œuvre des programmes complets de soutien aux patients spécifiquement pour les patients atteints de maladies rares, en se concentrant sur:
- Prise en charge d'accès aux médicaments personnalisés
- Coordination d'aide financière
- Services de navigation d'assurance
| Type de programme | Couverture des patients | Volume de soutien annuel |
|---|---|---|
| Soutien des patients atteints de maladies rares | Environ 1 200 patients | Taux d'inscription de 98% |
Engagement et éducation professionnels médicaux
Travere maintient des stratégies d'engagement ciblées avec des professionnels de la santé:
- Formation clinique spécialisée aux maladies rares
- Participation du symposium médical
- Programmes de formation médicale continue
| Méthode d'engagement | Portée annuelle | Fréquence d'interaction |
|---|---|---|
| Webinaires professionnels médicaux | Plus de 500 spécialistes de la santé | Séances éducatives trimestrielles |
Services d'assistance et de conseil aux patients
Infrastructure de conseil des patients dédiée:
- 24/7, une maladie des maladies rares spécialisées
- Gestion individuelle des cas de patients
- Coordination du soutien psychologique
Plateformes de communication de santé numérique
Les stratégies d'engagement numérique comprennent:
- Portails de patients conformes à la HIPAA
- Services de consultation en télésanté
- Application mobile pour le suivi des patients
| Plate-forme numérique | Taux d'adoption des utilisateurs | Interactions annuelles |
|---|---|---|
| Application mobile du patient | 67% d'inscription des patients | Environ 42 000 interactions |
Collaboration de recherche clinique en cours
Les stratégies d'engagement de la recherche englobent:
- Développement du registre des patients
- Recrutement des participants à l'essai clinique
- Suivi de la progression des maladies longitudinales
| Type de collaboration de recherche | Études actives | Participation des patients |
|---|---|---|
| Essais cliniques de maladies rares | 6 initiatives de recherche en cours | 312 participants aux patients |
Travere Therapeutics, Inc. (TVTX) - Modèle d'entreprise: Channeaux
Équipe de vente directe ciblant les médecins spécialistes
Travere Therapeutics utilise une force de vente dédiée de 45 représentants médicaux spécialisés au T4 2023. Ces représentants se concentrent sur des spécialistes de maladies rares et des généticiens à travers les États-Unis.
| Métrique de l'équipe de vente | 2023 données |
|---|---|
| Représentants des ventes totales | 45 |
| Couverture géographique | États-Unis |
| Segments spécialisés cibles | Médecins de maladies rares |
Conférences de soins de santé et symposiums médicaux
Travere Therapeutics participe à 12 à 15 conférences médicales majeures par an, avec un investissement d'environ 750 000 $ en engagement de conférence et de symposium.
- Conférences de maladies rares et de troubles génétiques
- Symposiums internationaux de recherche médicale
- Événements médicaux spécialisés pédiatriques
Plateformes d'information médicale en ligne
L'engagement numérique comprend des partenariats avec 6 principales plateformes d'information médicale, atteignant chaque mois environ 87 000 professionnels de la santé.
| Métrique de la plate-forme en ligne | 2024 données |
|---|---|
| Total des plateformes médicales | 6 |
| RECHERCHE MENSUELLE DE SANTÉE CARE | 87,000 |
| Budget annuel de l'engagement numérique | 1,2 million de dollars |
Réseaux de distributeurs pharmaceutiques
Travere entretient des relations avec 8 partenaires nationaux de distribution pharmaceutique, couvrant 92% des établissements de santé américains.
- Amerisourcebergen
- Santé cardinale
- McKesson Corporation
Marketing numérique et communication de télésanté
Budget de marketing numérique de 2,3 millions de dollars en 2023, avec des campagnes en ligne ciblées atteignant des communautés de patients et des prestataires de soins de santé ciblés.
| Métrique du marketing numérique | 2023 données |
|---|---|
| Budget annuel du marketing numérique | 2,3 millions de dollars |
| Ciblage de campagne en ligne | Communautés de maladies rares |
| Plateformes d'engagement de la télésanté | 3 plates-formes majeures |
Travere Therapeutics, Inc. (TVTX) - Modèle d'entreprise: segments de clientèle
Patients souffrant de troubles génétiques rares
Travere Therapeutics se concentre sur le service des patients souffrant de troubles génétiques rares spécifiques, avec une population de patients actuelle estimée à:
| Trouble | Population estimée des patients |
|---|---|
| Syndrome d'Alagille | 1 naissances vivantes sur 70 000 |
| Dystrophie musculaire de Duchenne | Aux États-Unis, environ 15 000 à 20 000 patients |
Populations de maladies rares pédiatriques et adultes
Répartir démographique cible:
- Patients pédiatriques: 65% des maladies rares se concentrent
- Patients adultes: 35% des maladies rares se concentrent
Médecins spécialisés
| Type spécialisé | Numéro ciblé |
|---|---|
| Généticiens pédiatriques | Aux États-Unis, environ 1 200 aux États-Unis |
| Spécialistes de maladies rares | Environ 800 à l'échelle nationale |
Centres de recherche génétique
Travere Therapeutics collabore avec:
- 22 centres de recherche universitaires majeurs
- 15 établissements de recherche de maladies rares spécialisées
Les établissements de santé se sont concentrés sur les maladies rares
| Type d'institution | Nombre d'institutions ciblées |
|---|---|
| Cliniques de maladies rares spécialisées | 87 à l'échelle nationale |
| Hôpitaux pour enfants ayant des programmes de maladies rares | 53 aux États-Unis |
Travere Therapeutics, Inc. (TVTX) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice 2023, Travere Therapeutics a déclaré des dépenses totales de R&D de 244,7 millions de dollars.
| Année | Dépenses de R&D |
|---|---|
| 2022 | 214,3 millions de dollars |
| 2023 | 244,7 millions de dollars |
Investissements d'essais cliniques
Les investissements en essais cliniques pour Travere Therapeutics en 2023 étaient d'environ 180,5 millions de dollars.
- Programmes thérapeutiques en cours de maladies rares
- Essais cliniques multiples de phase 2 et de phase 3
- Investissement dans le développement de médicaments contre les maladies rares
Coûts de conformité réglementaire
Les frais de conformité réglementaire pour 2023 étaient estimés à 37,2 millions de dollars.
Dépenses de marketing et de vente
Les frais de marketing et de vente pour l'exercice 2023 ont totalisé 92,6 millions de dollars.
| Catégorie de dépenses | Montant |
|---|---|
| Force de vente | 46,3 millions de dollars |
| Matériel de marketing | 22,1 millions de dollars |
| Activités promotionnelles | 24,2 millions de dollars |
Surfaçon administratives et opérationnelles
Les frais généraux administratifs et opérationnels pour 2023 étaient de 98,4 millions de dollars.
- Frais administratifs généraux
- Maintenance des infrastructures d'entreprise
- Systèmes de soutien opérationnel
Coût d'exploitation total pour 2023: 653,4 millions de dollars
Travere Therapeutics, Inc. (TVTX) - Modèle commercial: Strots de revenus
Ventes de produits pharmaceutiques
Depuis le quatrième trimestre 2023, Travere Therapeutics a déclaré un chiffre d'affaires total de produit de 83,7 millions de dollars, principalement tiré par leur produit clé thiola (tiopronine) pour le traitement de la cystinose.
| Produit | Revenus annuels (2023) | Segment de marché |
|---|---|---|
| Thiola | 53,2 millions de dollars | Troubles métaboliques rares |
| Filspari | 30,5 millions de dollars | Maladie rénale rare |
Accords de licence et de redevance
Travere Therapeutics génère des revenus grâce à des partenariats de licence stratégiques.
- Contrat de licence avec Medison Pharma pour la distribution internationale de produits
- Paiements de jalons potentiels à partir des accords de partenariat
Grants de recherches et collaborations
La Société obtient un financement de recherche de diverses sources pour soutenir les initiatives de développement de médicaments.
| Source de financement | Valeur annuelle estimée annuelle | Focus de recherche |
|---|---|---|
| National Institutes of Health (NIH) | 2,1 millions de dollars | Recherche de maladies rares |
| Collaborations de recherche sur les maladies orphelines | 1,5 million de dollars | Troubles génétiques rares |
Financement gouvernemental et institutionnel
Travere reçoit un financement ciblé pour des programmes de recherche et de développement de maladies rares.
Payments de jalons potentiels à partir de partenariats
La société possède des sources de revenus potentielles des paiements d'étape dans les partenariats pharmaceutiques en cours.
| Partenariat | Gamme de paiement de jalons potentiel | Condition |
|---|---|---|
| Collaboration des maladies rénales | 10-15 millions de dollars | Progression des essais cliniques |
| Recherche de troubles génétiques | 5-8 millions de dollars | Développement préclinique |
Travere Therapeutics, Inc. (TVTX) - Canvas Business Model: Value Propositions
You're looking at the core value Travere Therapeutics, Inc. delivers across its rare disease portfolio. It's all about providing first-in-class or best-in-class options where the need is urgent, which is a powerful proposition in the rare disease space.
FILSPARI: First Non-Immunosuppressive Therapy to Slow Kidney Function Decline in IgAN
FILSPARI (sparsentan) is positioned as a foundational therapy for IgA nephropathy (IgAN). It's the only non-immunosuppressive treatment to date that demonstrated a statistically significant benefit on kidney function accrual over two years when compared head-to-head against irbesartan. The U.S. Food and Drug Administration (FDA) granted full approval in September 2024 for slowing kidney function decline in adults with primary IgAN at risk of progression. This is supported by the evolving standard of care; the October 2025 KDIGO clinical guidelines recommend FILSPARI for earlier, first-line use, aiming for proteinuria under 0.5 g/day or ideally complete remission (under 0.3 g/day). The commercial traction is clear: U.S. net product sales for FILSPARI hit $90.9 million in 3Q 2025, representing a 155% growth year-over-year for that quarter. Furthermore, the label support is improving, with the FDA approving a REMS modification in August 2025 that reduced liver monitoring frequency to every three months and removed the embryo-fetal toxicity monitoring requirement.
Treatment for Severe Homozygous Cystinuria with Thiola® and Thiola EC®
For cystinuria, Travere Therapeutics, Inc. offers Thiola and Thiola EC (tiopronin tablets), addressing a disorder where the average patient produces a stone every one to two years and undergoes seven surgeries by middle age. Cystine stones specifically carry the highest 5-year recurrence rate of any stone type at 83%. The incidence of cystinuria is roughly 1 in every 7,000 people worldwide. Thiola EC is specifically indicated for select adult and pediatric patients weighing at least 44 pounds (20 kg) who do not respond to high fluid intake and dietary adjustments alone. The overall cystinuria market across the top 7 major markets (US, EU4, UK, and Japan) was valued at USD 84.9 Million in 2024.
Addressing High Unmet Need in Rare Kidney Diseases like IgAN and FSGS
The value proposition is amplified by the sheer scale of the unmet need across the rare kidney disease landscape Travere Therapeutics, Inc. targets. You can see the potential market size across the key indications below. This focus positions the company to address a critical need in the $10 billion+ rare disease market where options have historically been limited.
| Indication | Product | U.S. Addressable Population Estimate | 2025 Financial/Market Data Point |
|---|---|---|---|
| IgA Nephropathy (IgAN) | FILSPARI | Over 70,000 patients | $90.9 million in U.S. net product sales in 3Q 2025 |
| Focal Segmental Glomerulosclerosis (FSGS) | FILSPARI (Potential Approval) | Up to 30,000 patients | PDUFA date of January 13, 2026 for traditional approval |
| Classical Homocystinuria (HCU) | Pegtibatinase (Pipeline) | 7,000-10,000 globally | Phase 3 HARMONY Study expected to restart enrollment in 2026 |
| Cystinuria | Thiola® and Thiola EC® | Not specified (Prevalence 1 per 7,000 worldwide) | Market value of USD 84.9 Million in top 7 markets in 2024 |
Providing a Dedicated Patient Support Program (Travere TotalCare®)
Travere Therapeutics, Inc. supports patient access and adherence through its dedicated infrastructure. The Travere TotalCare® Program is in place to help patients navigate their treatment journey. This support is crucial, especially given the complexity of rare disease management and the initial REMS requirements for FILSPARI.
- Welcome to the Travere TotalCare® Program.
- Program facilitates document upload for patient support services.
- Supports patients navigating treatment with FILSPARI.
Potential for FILSPARI to be the First FDA-Approved Medicine for FSGS
The potential expansion of FILSPARI into FSGS represents a significant value driver. The supplemental New Drug Application (sNDA) for traditional approval in FSGS was accepted by the FDA, setting a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026. If this is granted, FILSPARI would become the first and only FDA-approved medicine indicated for FSGS, a condition affecting over 40,000 patients in the U.S. alone. Clinical data from the Phase 3 DUPLEX Study showed that FILSPARI-treated patients were more likely to reach proteinuria levels under 0.7 g/g compared to the active comparator, irbesartan, a threshold that correlates with reduced kidney failure risk in FSGS.
The company's financial position reflects this focus on commercial execution and regulatory advancement. For the nine months ended September 30, 2025, Travere Therapeutics, Inc. reported total revenue of $164.9 million, which included a $40.0 million market access milestone payment from CSL Vifor received in October 2025. As of September 30, 2025, proforma cash, cash equivalents, and marketable securities totaled $295 million.
Travere Therapeutics, Inc. (TVTX) - Canvas Business Model: Customer Relationships
You're looking at how Travere Therapeutics, Inc. manages its relationships with the specialized community it serves, which is heavily centered around the commercial launch and ongoing support for FILSPARI (sparsentan) in IgA nephropathy (IgAN).
High-touch support via Travere TotalCare® Hub for patient access and adherence
The support structure is designed to shepherd patients through the initial steps of therapy. The company tracks patient uptake through New Patient Start Forms (PSFs) and net product sales, which gives you a clear picture of commercial momentum as of late 2025.
Here's a look at the recent patient flow and revenue:
| Metric | Period Ending September 30, 2025 (3Q 2025) | Period Ending March 31, 2025 (1Q 2025) |
| U.S. Net Product Sales (FILSPARI) | $90.9 million | $55.9 million |
| New Patient Start Forms (PSFs) Received | 731 | 703 |
| Year-over-Year Sales Growth (3Q 2025 vs 3Q 2024) | 155% | N/A |
The total addressable patient population in the U.S. for IgAN is estimated at >70,000 patients. The company is definitely focused on converting that potential into realized patient relationships.
Direct engagement with nephrology specialists and rare disease centers
Travere Therapeutics, Inc. maintains a high level of direct engagement with the treating community through key medical congresses. This is how they reinforce the clinical profile of FILSPARI with the specialists who manage rare kidney diseases.
- Participated in the World Congress of Nephrology (WCN) 2025 to engage with global nephrology leaders.
- Attended the National Kidney Foundation (NKF) Spring Clinical Meetings (April 10-13, 2025) to engage with renal healthcare professionals.
- Presented late-breaking data at the American Society of Nephrology (ASN) Kidney Week 2025 (November 6-9) in Houston, TX, presenting 11 abstracts.
Medical Science Liaisons (MSLs) are positioned to answer questions and provide scientific support to these professionals.
Educational outreach to prescribers on updated KDIGO guidelines
The release of the updated guidelines provides a strong foundation for educational outreach, positioning FILSPARI within the recommended treatment paradigm. The Kidney Disease Improving Global Outcomes (KDIGO) 2025 Clinical Practice Guideline for the Management of IgA Nephropathy and IgA Vasculitis was published on September 18, 2025.
The new guidelines establish specific treatment goals that support the drug's profile:
- Define remission of proteinuria as <0.5 g/day, or ideally at <0.3 g/day.
- Recommend a treatment approach that includes therapies targeting IgAN-induced nephron loss, where FILSPARI, as the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA), may be an appropriate first-line approach.
This guidance is a significant event, as the draft guidelines from August 2024 already recommended FILSPARI as a foundational kidney-targeted therapy.
Restricted distribution and monitoring via the FILSPARI REMS program
Due to risks of hepatotoxicity and embryo-fetal toxicity, FILSPARI is only available through the restricted FILSPARI REMS program, requiring enrollment of prescribers, patients, and pharmacies.
The relationship management here involves strict compliance monitoring, though the requirements were recently streamlined:
- In August 2025, the U.S. FDA approved a REMS modification.
- The update removed the embryo-fetal toxicity REMS monitoring requirement.
- The frequency of liver function monitoring was reduced from monthly to every three months from the onset of treatment.
The safety data supporting this change showed that elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) were observed in up to 3.5% of FILSPARI-treated patients in clinical studies.
Finance: review Q4 2025 SG&A spend related to commercial execution by end of next week.
Travere Therapeutics, Inc. (TVTX) - Canvas Business Model: Channels
You're looking at how Travere Therapeutics, Inc. gets its therapies, specifically FILSPARI, to the right people. The channel strategy is clearly split between a direct U.S. push and leveraging strong international partners.
Direct U.S. sales force targeting nephrologists and kidney specialists
The core of the U.S. channel is a dedicated sales force driving adoption among specialists. This team is focused on positioning FILSPARI as a foundational therapy, especially following the September 2025 KDIGO guideline inclusion for earlier use. The commercial engine is showing results; for the third quarter of 2025, Travere Therapeutics, Inc. reported U.S. net product sales of $113.2 million. This required significant investment, reflected in Selling, General, and Administrative (SG&A) expenses reaching $86.5 million for that same quarter. The uptake is measured by new patient start forms (PSFs), with 731 new PSFs received in Q3 2025 alone. The addressable market for IgA Nephropathy (IgAN) in the U.S. is estimated to be over 70,000 patients.
The effectiveness of this channel can be summarized with these key performance indicators for the U.S. commercial effort:
| Metric | Value (as of late 2025) | Period/Context |
|---|---|---|
| U.S. Net Product Sales | $113.2 million | Q3 2025 |
| New Patient Start Forms (PSFs) Received | 731 | Q3 2025 |
| SG&A Expenses | $86.5 million | Q3 2025 |
| Addressable U.S. IgAN Patient Population | >70,000 | Market Estimate |
Global commercial partners (CSL Vifor) for ex-U.S. market access
For markets outside the U.S., Travere Therapeutics, Inc. relies on CSL Vifor. This partnership grants CSL Vifor exclusive commercialization rights in Europe, Australia, and New Zealand. FILSPARI is already launched in several key European markets, including Germany, Austria, Switzerland, Luxembourg, and the UK. The channel success here is marked by financial milestones; Travere Therapeutics, Inc. received a $40.0 million market access milestone payment from CSL Vifor in October 2025. CSL Vifor is a global entity with over 29,000+ employees worldwide.
Specialty pharmacies for prescription fulfillment and distribution
Because FILSPARI is subject to a REMS (Restricted Distribution Drug) program due to safety monitoring requirements, distribution is inherently controlled. This means that prescribers, patients, and pharmacies must all enroll in the program to ensure proper handling and patient management. The REMS structure dictates which pharmacies can dispense the drug, effectively creating a limited or exclusive channel by necessity, even if the exact number of participating specialty pharmacies isn't public. Following an FDA action in August 2025, the liver monitoring frequency was set to every three months for the duration of treatment.
Clinical trial sites for pipeline development and patient recruitment
The channel for future products involves clinical trial sites. Travere Therapeutics, Inc. is actively engaging with the FDA to restart enrollment in the pivotal Phase 3 HARMONY study for pegtibatinase in 2026. For current pipeline development, the company is enrolling patients in several studies, which utilize a network of clinical sites:
- Natural History Study of Homocystinuria Caused by Cystathionine Beta-synthase Deficiency.
- Sparsentan Treatment in Pediatrics with Proteinuric Glomerular Diseases (EPPIK).
- Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis (SPARX).
Also, the company's partner in Japan, Renalys Pharma, Inc., expected topline results from its Phase 3 trial in the fourth quarter of 2025. Renalys Pharma, Inc. was expected to be acquired by Chugai Pharmaceutical Co., Ltd. in Q4 2025.
Travere Therapeutics, Inc. (TVTX) - Canvas Business Model: Customer Segments
Adults with primary IgA Nephropathy (IgAN) at risk of disease progression
| Metric | Value |
| Estimated U.S. Population Affected by IgAN | Up to 150,000 people |
| Estimated Global Population Affected by IgAN (Licensed Territories) | >250,000 people |
| Progression Rate to Kidney Failure | 15 to 40% of patients |
| FILSPARI U.S. Net Product Sales (3Q 2025) | $90.9 million |
| FILSPARI U.S. Net Product Sales Year-over-Year Growth (3Q 2025) | 155% |
| New Patient Start Forms (PSFs) Received (3Q 2025) | 731 |
| FILSPARI Full-Year 2025 Net Product Sales Guidance | $210-225 million |
| PROTECT Trial Enrollment (IgAN) | 404 patients |
Adults and pediatric patients with severe homozygous cystinuria
Thiola EC U.S. product sales for the third quarter of 2025 were $22.3 million.
Thiola (tiopronin) generated $23 million in sales for the second quarter of 2025.
The disorder occurs in approximately 1 in 7,000-10,000 people in the United States.
- More than 80 percent of people with cystinuria develop their first stone by age 20.
- More than 25 percent will develop cystine stones by age 10.
Nephrology specialists and rare disease treatment centers
The commercial focus on these specialists is reflected in Travere Therapeutics, Inc.'s operating expenses.
| Expense Category | Amount (3Q 2025) |
| Selling, General, and Administrative (SG&A) Expenses | $86.5 million |
| Research and Development (R&D) Expenses | $51.9 million |
Payers and government health programs covering rare disease therapies
The inclusion of FILSPARI in updated guidelines signals payer acceptance and reimbursement focus.
- FILSPARI is mentioned in the Kidney Disease: Improving Global Outcomes (KDIGO) 2025 clinical practice guideline for the management of IgA Nephropathy.
- The guideline recommends treatment with FILSPARI as an appropriate first-line approach to manage IgAN-induced nephron loss.
Total revenue for the third quarter of 2025 was $164.9 million.
This total included a $40.0 million market access milestone from CSL Vifor received in October 2025.
Net income for the third quarter of 2025 was $25.7 million.
Travere Therapeutics, Inc. (TVTX) - Canvas Business Model: Cost Structure
You're looking at where Travere Therapeutics, Inc. is putting its capital to work right now, which is heavily weighted toward commercial execution and pipeline advancement. The cost structure reflects a company transitioning from clinical focus to a commercial-stage entity, especially with FILSPARI on the market.
The Selling, General, and Administrative (SG&A) line item shows a significant ramp-up, which is expected when scaling a commercial footprint. For the third quarter of 2025, SG&A expenses hit $86.5 million. That's a big jump from the $65.6 million reported in the third quarter of 2024. Honestly, this increase is the clearest signal of commercial investment.
Research and Development (R&D) remains a substantial cost center, though it saw a slight year-over-year increase for the quarter. R&D expenses for Q3 2025 were $51.9 million, up from $51.7 million in Q3 2024. You can see the shift in focus when you look at the nine-month figures, where R&D spending actually decreased slightly year-over-year, suggesting some late-stage trial costs are winding down.
Here's a quick look at the operating expense comparison for the first nine months of 2025:
| Expense Category | Nine Months Ended September 30, 2025 | Nine Months Ended September 30, 2024 |
| SG&A Expenses | $235.5 million | $194.6 million |
| R&D Expenses | $148.1 million | $155.4 million |
The primary driver for the increased SG&A is the commercialization investment for FILSPARI. This includes supporting the ongoing commercial efforts for FILSPARI in IgA nephropathy (IgAN) following its full approval, plus preparations for a potential launch in focal segmental glomerulosclerosis (FSGS). The Prescription Drug User Fee Act (PDUFA) decision for the FSGS indication is set for January 13, 2026, so that preparation costs are definitely hitting the current expense run rate.
Manufacturing and inventory costs are tied directly to the commercial success of FILSPARI. U.S. net product sales for FILSPARI grew 155% in Q3 2025, indicating increasing cost of goods sold to support that demand. For context, Q2 2025 net product sales were $94.8 million, and Q1 2025 net product sales were $75.9 million.
Clinical trial costs are being managed as key sparsentan studies, like DUPLEX, advance toward completion, which contributed to the slight decrease in year-to-date R&D spend. However, R&D spending is still significant due to the pipeline. Specifically, you need to watch the pegtibatinase program for classical homocystinuria (HCU); the company remains on track to restart enrollment in the Phase 3 HARMONY Study in 2026, which will ramp up those associated clinical operation costs again.
Key cost components driving the current structure include:
- Increased investment in the U.S. commercial team supporting FILSPARI in IgAN.
- Pre-launch activities and infrastructure build-out for the potential FSGS indication.
- Amortization expense related to FILSPARI royalties factored into SG&A.
- Costs associated with the development of pegtibatinase as the company prepares for the 2026 study restart.
As of September 30, 2025, the company held approximately $254.5 million in cash, cash equivalents, and marketable securities to fund these operating expenses.
Travere Therapeutics, Inc. (TVTX) - Canvas Business Model: Revenue Streams
You're looking at the hard numbers driving Travere Therapeutics, Inc.'s revenue streams as of late 2025. Here's the quick math on what's coming in, focusing strictly on the reported figures.
Product sales form a core part of the revenue picture, with the flagship product showing strong recent performance, while legacy products continue to contribute.
| Revenue Component | Period | Amount |
| U.S. Net Product Sales of FILSPARI | Q3 2025 | $90.9 million |
| Product sales from Thiola® and Thiola EC® | Q2 2025 | $23 million |
Beyond direct product sales, Travere Therapeutics, Inc. recognizes revenue from strategic agreements and milestones. These non-product sources provided significant boosts in the third quarter of 2025.
- Milestone payments from CSL Vifor recognized in Q3 2025: $40.0 million for a market access milestone.
- Licensing and collaboration revenue recognized in Q3 2025: $9.3 million, specifically non-cash revenue related to Renalys.
When you aggregate these components for the third quarter of 2025, the total revenue picture becomes clear.
Total revenue for Travere Therapeutics, Inc. for Q3 2025 was reported at $164.9 million.
Finance: draft comparison of Q3 2025 product sales versus Q3 2025 total revenue by Friday.
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