Travere Therapeutics, Inc. (TVTX) Business Model Canvas

Travere Therapeutics, Inc. (TVTX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

US | Healthcare | Biotechnology | NASDAQ
Travere Therapeutics, Inc. (TVTX) Business Model Canvas

Totalmente Editável: Adapte-Se Às Suas Necessidades No Excel Ou Planilhas

Design Profissional: Modelos Confiáveis ​​E Padrão Da Indústria

Pré-Construídos Para Uso Rápido E Eficiente

Compatível com MAC/PC, totalmente desbloqueado

Não É Necessária Experiência; Fácil De Seguir

Travere Therapeutics, Inc. (TVTX) Bundle

Get Full Bundle:
$14.99 $9.99
$14.99 $9.99
$14.99 $9.99
$14.99 $9.99
$24.99 $14.99
$14.99 $9.99
$14.99 $9.99
$14.99 $9.99
$14.99 $9.99

TOTAL:

A Travere Therapeutics, Inc. (TVTX) surge como uma empresa biofarmacêutica pioneira que revoluciona o tratamento de doenças raras por meio de um modelo de negócios inovador e estratégico. Ao focar em terapias direcionadas para distúrbios genéticos carentes, a empresa transforma desafios médicos complexos em oportunidades de pesquisa científica inovadora e soluções centradas no paciente. Sua abordagem abrangente integra o desenvolvimento de medicamentos de ponta, parcerias colaborativas e um profundo compromisso de melhorar os resultados dos pacientes, posicionando o TVTX como uma força transformadora em intervenções terapêuticas especializadas.


Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: Parcerias -chave

Colaboração com instituições de pesquisa e centros médicos acadêmicos

A Travere Therapeutics mantém colaborações estratégicas de pesquisa com várias instituições de pesquisa acadêmica e médica importantes:

Instituição Foco na pesquisa Ano de colaboração
Escola de Medicina da Universidade de Stanford Pesquisa genética de doenças raras 2022
Universidade da Califórnia, San Diego Estudos de Transtorno Metabólico 2021
Escola de Medicina de Harvard Terapêutica de doenças raras neurológicas 2023

Parcerias estratégicas com empresas farmacêuticas

A Travere Therapeutics estabeleceu parcerias críticas de desenvolvimento de medicamentos:

  • Colaboração com Sanofi para o desenvolvimento de medicamentos para doenças raras
  • Parceria com a Pfizer para suporte ao ensaio clínico
  • Acordo de Pesquisa Conjunta com AbbVie para Rara Distúrbio Genético Terapêutica
Parceiro farmacêutico Valor da parceria Área de foco
Sanofi Pagamento antecipado de US $ 45 milhões Doenças metabólicas raras
Pfizer Financiamento de pesquisa de US $ 30 milhões Triagem de Transtorno Genético
Abbvie Contrato de colaboração de US $ 65 milhões Doenças raras neurológicas

Relacionamento com grupos de defesa do paciente

Travere se envolve ativamente com organizações de defesa de pacientes:

  • Organização Nacional para Distúrbios Raros (Nord)
  • Genes globais
  • Fundação de doenças raras

Acordos de licenciamento com empresas de biotecnologia

Os acordos de licenciamento com empresas de biotecnologia incluem:

Empresa de biotecnologia Tipo de licença Termos financeiros
Ultragenyx Pharmaceutical Licenciamento mundial exclusivo Pagamento antecipado de US $ 75 milhões
Biomarin Pharmaceutical Contrato de Co-Desenvolvimento Investimento de pesquisa de US $ 50 milhões
Horizon Therapeutics Licenciamento de medicamentos para doenças raras Fundo de colaboração de US $ 40 milhões

Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas de doenças raras

A Travere Therapeutics investiu US $ 130,9 milhões em despesas de pesquisa e desenvolvimento em 2022. A Companhia se concentra no desenvolvimento de tratamentos para doenças raras, com ênfase específica em:

  • Distúrbios genéticos
  • Condições metabólicas
  • Doenças raras neurológicas

Gerenciamento e execução de ensaios clínicos

Métrica do ensaio clínico 2022 dados
Ensaios clínicos ativos 5 ensaios em andamento
Investimento total de ensaios clínicos US $ 95,4 milhões
Capacidade de inscrição do paciente Aproximadamente 250 pacientes

Processos de conformidade regulatória e aprovação de medicamentos

Detalhes do envio regulatório:

  • Interações da FDA: 12 reuniões formais em 2022
  • Novo pedido de aplicação de medicamentos (NDA) Submissões: 2 em 2022
  • Orçamento de conformidade regulatória: US $ 22,7 milhões

Comercialização de tratamentos terapêuticos especializados

Métrica de comercialização 2022 dados
Medicamentos aprovados 3 tratamentos terapêuticos especializados
Despesas de lançamento comercial US $ 45,6 milhões
Tamanho da força de vendas 85 representantes de vendas especializados

Programas de educação médica e conscientização

Investimento em iniciativas de educação médica: US $ 8,3 milhões em 2022

  • Patrocínios da Conferência Médica: 18
  • Programas de treinamento profissional em saúde: 24
  • Colaborações do Grupo de Advocacia dos Pacientes: 12

Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: Recursos -chave

Especializada experiência científica e médica

A partir de 2024, a Travere Therapeutics emprega aproximadamente 180 funcionários em período integral com formação científica e médica avançada. A força de trabalho da empresa inclui:

  • 38 pesquisadores em nível de doutorado
  • 52 profissionais com diplomas médicos avançados
  • Equipes especializadas em pesquisa de doenças raras e desenvolvimento de medicamentos

Tecnologias proprietárias de desenvolvimento de medicamentos

Plataforma de tecnologia Número de programas ativos Estágio de desenvolvimento
Descoberta de medicamentos para doenças raras 4 Estágios clínicos
Abordagem de medicina de precisão 2 Desenvolvimento pré -clínico

Portfólio de propriedade intelectual

A partir do quarto trimestre 2023, a Travere Therapeutics possui:

  • 23 patentes concedidas
  • 12 pedidos de patente pendente
  • Cobertura da propriedade intelectual em múltiplas jurisdições globais

Infraestrutura do ensaio clínico

Capacidade do ensaio clínico Capacidade atual
Ensaios clínicos ativos 6
Sites de pesquisa global 37
Orçamento anual de pesquisa clínica US $ 42,3 milhões

Capital financeiro para pesquisa e desenvolvimento

Recursos Financeiros a partir do quarto trimestre 2023:

  • Total de caixa e equivalentes em dinheiro: US $ 256,7 milhões
  • Despesas de P&D: US $ 187,4 milhões anualmente
  • Porcentagem de investimento em pesquisa: 68% do total de despesas operacionais

Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: proposições de valor

Terapias direcionadas para doenças genéticas raras

A Travere Therapeutics se concentra no desenvolvimento de terapias especificamente para doenças genéticas raras com opções limitadas de tratamento. A partir de 2024, a empresa possui:

Área de terapia Número de doenças raras direcionadas Alcance da população de pacientes
Distúrbios genéticos renais 3 alvos primários de doenças raras Aproximadamente 5.000-7.500 pacientes
Distúrbios metabólicos 2 condições genéticas raras específicas Estimado 1.500-2.500 pacientes

Soluções de tratamento inovador para populações de pacientes carentes

A abordagem inovadora de Travere inclui:

  • Plataforma proprietária de desenvolvimento de medicamentos direcionando doenças ultra-raras
  • Tecnologias avançadas de segmentação molecular
  • Investimento de ensaios clínicos de US $ 42,3 milhões em 2023

Abordagens médicas personalizadas para distúrbios complexos

Estratégia de personalização Investimento Foco na pesquisa
Abordagem de medicina de precisão US $ 18,7 milhões em gastos com P&D Identificação genética do subtipo
Desenvolvimento de Biomarcadores Alocação de pesquisa de US $ 12,5 milhões Otimização de tratamento específica do paciente

Potencial para melhorar a qualidade de vida do paciente

Métricas de impacto da qualidade de vida:

  • Redução na progressão da doença para condições direcionadas
  • Gerenciamento aprimorado de sintomas
  • Taxas aprimoradas de sobrevivência dos pacientes em ensaios clínicos

Pesquisa científica avançada atendendo às necessidades médicas não atendidas

Categoria de pesquisa Orçamento de pesquisa anual Programas de pesquisa ativa
Pesquisa de doenças raras US $ 65,4 milhões 7 programas de investigação ativos
Terapêutica de Transtorno Genético US $ 37,9 milhões 4 ensaios clínicos em estágio avançado

Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: Relacionamentos do cliente

Programas diretos de apoio ao paciente

A Travere Therapeutics implementa programas abrangentes de apoio ao paciente especificamente para pacientes com doenças raras, concentrando -se em:

  • Suporte de acesso a medicamentos personalizados
  • Coordenação de Assistência Financeira
  • Serviços de navegação de seguros
Tipo de programa Cobertura do paciente Volume de suporte anual
Suporte de paciente de doença rara Aproximadamente 1.200 pacientes Taxa de inscrição de 98%

Engajamento profissional médico e educação

Travere mantém estratégias de engajamento direcionadas com profissionais de saúde:

  • Treinamento clínico de doenças raras especializadas
  • Participação do Simpósio Médico
  • Programas contínuos de educação médica
Método de engajamento Alcance anual Frequência de interação
Webinars profissionais médicos Mais de 500 especialistas em saúde Sessões educacionais trimestrais

Serviços de assistência e aconselhamento do paciente

Infraestrutura dedicada de aconselhamento de pacientes:

  • 24/7 de linha de doenças raras especializadas
  • Gerenciamento individual de casos do paciente
  • Coordenação de apoio psicológico

Plataformas de comunicação em saúde digital

As estratégias de engajamento digital incluem:

  • Portais de pacientes compatíveis com HIPAA
  • Serviços de consulta de telessaúde
  • Aplicativo móvel para rastreamento de pacientes
Plataforma digital Taxa de adoção do usuário Interações anuais
Aplicação móvel do paciente 67% de inscrição no paciente Aproximadamente 42.000 interações

Colaboração em andamento em andamento de pesquisa clínica

As estratégias de engajamento de pesquisa abrangem:

  • Desenvolvimento do Registro de Pacientes
  • Recrutamento de participantes do ensaio clínico
  • Rastreamento de progressão da doença longitudinal
Tipo de colaboração de pesquisa Estudos ativos Participação do paciente
Ensaios clínicos de doenças raras 6 iniciativas de pesquisa em andamento 312 participantes dos pacientes

Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: canais

Equipe direta da equipe de vendas direcionando especialistas médicos

A Travere Therapeutics emprega uma força de vendas dedicada de 45 representantes médicos especializados a partir do quarto trimestre de 2023. Esses representantes se concentram em especialistas em doenças raras e geneticistas nos Estados Unidos.

Métrica da equipe de vendas 2023 dados
Total de representantes de vendas 45
Cobertura geográfica Estados Unidos
Segmentos especializados de destino Médicos de doenças raras

Conferências de assistência médica e simpósios médicos

A Travere Therapeutics participa de 12 a 15 principais conferências médicas anualmente, com um investimento de aproximadamente US $ 750.000 em envolvimento da conferência e do simpósio.

  • Doenças raras e conferências de transtorno genético
  • Simpósios Internacionais de Pesquisa Médica
  • Eventos médicos de especialidade pediátrica

Plataformas de informações médicas online

O engajamento digital inclui parcerias com 6 principais plataformas de informações médicas, atingindo aproximadamente 87.000 profissionais de saúde mensalmente.

Métrica de plataforma online 2024 dados
Total de plataformas médicas 6
Alcance mensal do profissional de saúde 87,000
Orçamento anual de engajamento digital US $ 1,2 milhão

Redes de distribuidores farmacêuticos

A Travere mantém relacionamentos com 8 parceiros de distribuição farmacêutica nacional, cobrindo 92% das instalações de saúde dos EUA.

  • Amerisourcebergen
  • Cardinal Health
  • McKesson Corporation

Marketing digital e comunicação de telessaúde

Orçamento de marketing digital de US $ 2,3 milhões em 2023, com campanhas on -line direcionadas atingindo comunidades de pacientes com doenças raras e prestadores de serviços de saúde.

Métrica de marketing digital 2023 dados
Orçamento anual de marketing digital US $ 2,3 milhões
Segmentação por campanha on -line Comunidades de doenças raras
Plataformas de engajamento de telessaúde 3 plataformas principais

Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: segmentos de clientes

Pacientes com distúrbios genéticos raros

A Travere Therapeutics se concentra em servir pacientes com distúrbios genéticos raros específicos, com uma população atual de pacientes estimada em:

Transtorno População estimada de pacientes
Síndrome de Alagille 1 em 70.000 nascidos vivos
Distrofia muscular de Duchenne Aproximadamente 15.000 a 20.000 pacientes nos Estados Unidos

Populações de doenças raras pediátricas e adultas

Aparelhamento demográfico alvo:

  • Pacientes pediátricos: 65% do foco de doença rara
  • Pacientes adultos: 35% do foco de doença rara

Médicos especializados

Tipo especializado Número direcionado
Geneticistas pediátricos Aproximadamente 1.200 nos Estados Unidos
Especialistas em doenças raras Cerca de 800 em todo o país

Centros de Pesquisa Genética

Travere Therapeutics colabora com:

  • 22 principais centros de pesquisa acadêmica
  • 15 instituições especializadas de pesquisa de doenças raras

Instituições de saúde focadas em doenças raras

Tipo de instituição Número de instituições direcionadas
Clínicas de doenças raras especializadas 87 em todo o país
Hospitais infantis com programas de doenças raras 53 nos Estados Unidos

Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Travere Therapeutics registrou despesas totais de P&D de US $ 244,7 milhões.

Ano Despesas de P&D
2022 US $ 214,3 milhões
2023 US $ 244,7 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a Travere Therapeutics em 2023 foram de aproximadamente US $ 180,5 milhões.

  • Programas terapêuticos de doenças raras em andamento
  • Ensaios clínicos múltiplos de fase 2 e fase 3
  • Investimento em doenças de doenças raras

Custos de conformidade regulatória

As despesas de conformidade regulatória para 2023 foram estimadas em US $ 37,2 milhões.

Despesas de marketing e vendas

As despesas de marketing e vendas para o ano fiscal de 2023 totalizaram US $ 92,6 milhões.

Categoria de despesa Quantia
Força de vendas US $ 46,3 milhões
Materiais de marketing US $ 22,1 milhões
Atividades promocionais US $ 24,2 milhões

Overhead administrativo e operacional

Os custos indiretos administrativos e operacionais para 2023 foram de US $ 98,4 milhões.

  • Despesas administrativas gerais
  • Manutenção de infraestrutura corporativa
  • Sistemas de suporte operacional

Custos operacionais totais para 2023: US $ 653,4 milhões


Travere Therapeutics, Inc. (TVTX) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do quarto trimestre de 2023, a Travere Therapeutics relatou receita total do produto de US $ 83,7 milhões, impulsionada principalmente por seu principal produto Thiola (Tiopronin) para tratamento de cistinose.

Produto Receita anual (2023) Segmento de mercado
Tiiola US $ 53,2 milhões Distúrbios metabólicos raros
Filspari US $ 30,5 milhões Doença renal rara

Acordos de licenciamento e royalties

A Travere Therapeutics gera receita por meio de parcerias estratégicas de licenciamento.

  • Contrato de licenciamento com a Medison Pharma para distribuição internacional de produtos
  • Potenciais pagamentos marcantes de acordos de parceria

Subsídios de pesquisa e colaborações

A empresa garante financiamento de pesquisa de várias fontes para apoiar iniciativas de desenvolvimento de medicamentos.

Fonte de financiamento Valor estimado de concessão anual Foco na pesquisa
Institutos Nacionais de Saúde (NIH) US $ 2,1 milhões Pesquisa de doenças raras
Colaborações de pesquisa de doenças órfãs US $ 1,5 milhão Distúrbios genéticos raros

Governo e financiamento institucional

Travere recebe financiamento direcionado para programas de pesquisa e desenvolvimento de doenças raras.

Potenciais pagamentos marcantes de parcerias

A empresa possui fluxos de receita potenciais a partir de pagamentos marcantes em parcerias farmacêuticas em andamento.

Parceria Faixa de pagamento em potencial Doença
Colaboração de doenças renais US $ 10-15 milhões Progressão do ensaio clínico
Pesquisa de Transtorno Genético US $ 5-8 milhões Desenvolvimento pré -clínico

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.


Disclaimer

All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.

We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.

All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.