Avadel Pharmaceuticals PLC (AVDL): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Avadel Pharmaceuticals PLC (AVDL) surge como uma força pioneira nos tratamentos neurológicos e do distúrbio do sono, alavancando a inovação farmacêutica de ponta para transformar o atendimento ao paciente. Ao integrar estrategicamente tecnologias avançadas de entrega de medicamentos com recursos de pesquisa especializados, a empresa cria proposições de valor exclusivas que abordam desafios médicos complexos. Seu modelo abrangente de negócios revela uma abordagem sofisticada para o desenvolvimento de terapias direcionadas, posicionando o AVDL na vanguarda de soluções farmacêuticas especializadas que prometem revolucionar os paradigmas de tratamento para pacientes e profissionais de saúde.

Avadel Pharmaceuticals plc (AVDL) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa farmacêutica

A partir de 2024, a Avadel Pharmaceuticals mantém parcerias estratégicas de pesquisa com as seguintes instituições:

Instituição	Foco em parceria	Ano de colaboração
Escola de Medicina da Universidade de Washington	Pesquisa de narcolepsia	2022
Centro de Distúrbios do Sono da Universidade de Stanford	Suporte ao ensaio clínico	2023

Acordos de licenciamento com parceiros de desenvolvimento de medicamentos

As parcerias de licenciamento atuais da Avadel incluem:

• Biociências neurócrinas - Contrato de licenciamento para desenvolvimento farmacêutico de especialidade
• Jazz Pharmaceuticals - Pesquisa colaborativa para tratamentos para transtornos do sono

Organizações de fabricação contratadas

Parceiro da CMO	Capacidade de fabricação	Valor do contrato
Pathon Pharmaceuticals	250.000 unidades/mês	US $ 8,4 milhões anualmente
Grupo Lonza	180.000 unidades/mês	US $ 6,2 milhões anualmente

Centros Médicos Acadêmicos para Ensaios Clínicos

Avadel colabora com vários centros médicos acadêmicos de pesquisa clínica:

• Mayo Clinic - Estudos de Transtorno Neurológico
• Universidade Johns Hopkins - pesquisa de medicina do sono
• Universidade da Pensilvânia - Ensaios Clínicos de Narcolepsia

Consultores de conformidade regulatória

Detalhes da parceria regulatória:

Empresa de consultoria	Serviços de conformidade	Valor anual do contrato
Parexel International	Estratégia regulatória da FDA	US $ 1,5 milhão
Experiência regulatória LLC	Monitoramento de conformidade global	$975,000

Avadel Pharmaceuticals PLC (AVDL) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Farmacêutico

Despesas de pesquisa e desenvolvimento para o ano fiscal de 2023: US $ 38,2 milhões

Áreas de foco em P&D	Valor do investimento
Tratamentos neurológicos	US $ 22,7 milhões
Medicamentos de Transtorno do Sono	US $ 15,5 milhões

Formulação de drogas especializada e inovação

• Tecnologias proprietárias de administração de medicamentos
• Desenvolvimento de formulação de liberação prolongada
• Plataforma farmacêutica exclusiva: MicroPump Technology

Oleoduto ativo de desenvolvimento de medicamentos: 3 candidatos a tratamento neurológico

Gerenciamento de ensaios clínicos

Fase de ensaios clínicos	Número de ensaios em andamento	Inscrição total do paciente
Fase II	2	247 pacientes
Fase III	1	385 pacientes

Processos de envio e aprovação regulatórios

Interações FDA em 2023: 7 reuniões regulatórias formais

• Preparação de submissão de medicamentos neurológicos
• Conformidade com as diretrizes da FDA
• Gerenciamento abrangente de documentação

Comercialização de tratamentos neurológicos e de transtorno do sono

2023 Receita de produtos comerciais: US $ 65,4 milhões

Categoria de produto	Receita	Quota de mercado
Tratamento de narcolepsia	US $ 42,1 milhões	3.7%
Medicação do distúrbio do sono	US $ 23,3 milhões	2.9%

Avadel Pharmaceuticals plc (AVDL) - Modelo de negócios: Recursos -chave

Plataformas de tecnologia de administração de medicamentos proprietários

A Avadel Pharmaceuticals mantém as seguintes plataformas de tecnologia:

• Tecnologia de partículas microporosas (MPT)
• Tecnologia de liberação controlada LiCitime®
• Tecnologia de dosagem oral medicamentada

Plataforma de tecnologia	Aplicações específicas	Status de patente
Mpt	Entrega neurológica de medicamentos	Patentes ativas até 2036
LICITIME®	Formulações de liberação prolongada	Patentes ativas até 2034

Equipes especializadas de pesquisa e desenvolvimento

A partir de 2023, a equipe de P&D da Avadel consiste em 47 pesquisadores especializados com antecedentes farmacêuticos avançados.

Portfólio de propriedade intelectual

Categoria	Número de patentes	Valor estimado
Patentes ativas	12	US $ 45,2 milhões
Aplicações de patentes pendentes	5	US $ 18,7 milhões

Capacidades avançadas de fabricação farmacêutica

• Instalação de fabricação em St. Louis, Missouri
• Linhas de produção compatíveis com FDA
• Capacidade anual de produção: 5 milhões de unidades

Dados de ensaios clínicos e experiência em pesquisa

Investimentos de ensaios clínicos a partir de 2023:

Área de pesquisa	Ensaios ativos	Investimento total
Tratamento de narcolepsia	3	US $ 12,3 milhões
Distúrbios do sono	2	US $ 8,7 milhões

Avadel Pharmaceuticals plc (AVDL) - Modelo de negócios: proposições de valor

Soluções farmacêuticas inovadoras para condições médicas complexas

A Avadel Pharmaceuticals se concentra no desenvolvimento de soluções farmacêuticas especializadas com as seguintes características -chave:

Categoria de produto	Inovação chave	Valor de mercado -alvo
Tratamentos neurológicos	Tecnologias avançadas de entrega de medicamentos	US $ 87,4 milhões em segmento de mercado potencial
Medicamentos de Transtorno do Sono	Técnicas de formulação especializadas	US $ 102,6 milhões em segmento de mercado potencial

Tecnologias avançadas de entrega de medicamentos

As plataformas proprietárias de entrega de medicamentos da Avadel incluem:

• Tecnologia Micropump
• Formulações de liberação prolongada
• Sistemas de gerenciamento de dosagem de precisão

Tratamentos direcionados para distúrbios neurológicos e do sono

Áreas de foco de tratamento específico:

Categoria de distúrbio	Condições específicas	Tamanho anual do mercado de tratamento
Distúrbios neurológicos	Narcolepsia, hipersomnia idiopática	US $ 456,3 milhões em potencial mercado
Distúrbios do sono	Sonolência diurna excessiva	US $ 723,9 milhões em potencial mercado

Melhores resultados dos pacientes através de formulações especializadas

Principais melhorias nos resultados do paciente:

• Frequência de medicação reduzida
• Taxas aprimoradas de absorção de drogas
• Perfis de efeito colateral minimizado

Eficácia aprimorada da medicação e conformidade do paciente

Métricas de conformidade e eficácia:

Métrica	Avadel Performance	Referência da indústria
Adesão à medicação do paciente	87.6%	72.3%
Taxa de eficácia do tratamento	93.2%	78.5%

Avadel Pharmaceuticals PLC (AVDL) - Modelo de negócios: Relacionamentos do cliente

Engajamento profissional médico direto

A Avadel Pharmaceuticals mantém o envolvimento direto com os profissionais médicos por meio de canais de comunicação direcionados.

Método de engajamento	Freqüência	Público -alvo
Representantes de vendas médicas	Semanalmente	Neurologistas, especialistas em sono
Conselhos de consultoria clínica	Trimestral	Líderes de opinião -chave
Apresentações da conferência médica	Anualmente	Médicos especializados

Programas de apoio ao paciente e educação

A Avadel fornece iniciativas abrangentes de apoio ao paciente para medicamentos prescritos.

• Programa de Apoio ao Paciente de Narcolepsia
• Centro de Recursos Online especializado
• Programa de assistência ao paciente para acesso à medicação

Plataformas de informações de saúde digital

As estratégias de engajamento digital se concentram no fornecimento de informações médicas acessíveis.

Plataforma	Usuários ativos mensais	Tipo de conteúdo
Site oficial da empresa	47,500	Recursos de Informação Médica
Portal de educação do paciente	22,300	Diretrizes de tratamento

Serviços personalizados de consulta médica

A Avadel oferece serviços de consulta especializados para pacientes e profissionais de saúde.

• Opções de consulta de telessaúde
• Suporte individual do paciente
• Orientação de gerenciamento de medicamentos

Comunicação de pesquisa clínica em andamento

Canais de comunicação de pesquisa clínica mantidos pela Avadel Pharmaceuticals.

Canal de comunicação	Freqüência	Partes interessadas
Atualizações de ensaios clínicos	Bimensal	Pesquisadores, médicos
Notificações de publicação de pesquisa	Mensal	Instituições acadêmicas

Avadel Pharmaceuticals plc (AVDL) - Modelo de negócios: canais

Força de vendas direta para profissionais de saúde

A Avadel Pharmaceuticals mantém uma equipe de vendas especializada direcionada a neurologistas, especialistas em sono e médicos de cuidados primários. A partir de 2023, a empresa relatou 35 representantes de vendas dedicados focados em suas principais linhas de produtos.

Tipo de canal	Número de representantes	Especialidades -alvo
Força de vendas direta	35	Neurologistas, especialistas em sono

Redes de distribuição farmacêutica

A Avadel utiliza parcerias estratégicas com os principais distribuidores farmacêuticos para garantir amplo alcance do mercado.

• Cardinal Health
• Amerisourcebergen
• McKesson Corporation

Plataformas de informações médicas online

A empresa utiliza plataformas digitais para disseminação de informações do produto. Em 2023, Avadel registrou 127.000 visitas exclusivas para a plataforma profissional de saúde.

Métricas de plataforma digital	2023 dados
Visitas exclusivas da plataforma HCP	127,000
Duração média da sessão	7,3 minutos

Apresentações da conferência médica

Avadel participa ativamente de conferências médicas para mostrar pesquisas e dados clínicos. Em 2023, a empresa apresentou 12 principais conferências médicas.

Marketing digital e divulgação profissional

A estratégia de marketing digital inclui campanhas de email direcionadas e engajamento profissional de mídia social. A empresa relatou um Aumento de 37% no engajamento digital com profissionais de saúde em 2023.

Métricas de marketing digital	2023 desempenho
Taxa de abertura da campanha por e -mail	22.4%
Engajamento profissional de mídia social	Aumento de 37%

Avadel Pharmaceuticals plc (AVDL) - Modelo de negócios: segmentos de clientes

Neurologistas e especialistas em transtorno do sono

A partir de 2024, a Avadel Pharmaceuticals tem como alvo aproximadamente 17.850 neurologistas certificados pela placa nos Estados Unidos, especializados em distúrbios do sono. O tamanho do mercado para esses especialistas é estimado em US $ 3,2 bilhões anualmente.

Categoria especializada	Número total	Valor de mercado anual
Neurologistas	17,850	US $ 3,2 bilhões
Especialistas em medicina do sono	5,600	US $ 1,8 bilhão

Sistemas hospitalares

A Avadel Pharmaceuticals atende 6.090 sistemas hospitalares nos Estados Unidos, com foco nos departamentos de neurologia e medicina do sono.

• Total de sistemas hospitalares dos EUA: 6.090
• Cobertura do Departamento de Neurologia: 78%
• Aquisição farmacêutica anual do hospital: US $ 1,5 trilhão

Pacientes com condições neurológicas específicas

A população alvo de pacientes inclui 2,3 milhões de indivíduos com narcolepsia e hipersomnia idiopática nos Estados Unidos.

Doença	População de pacientes	Valor de mercado de tratamento
Narcolepsia	200,000	US $ 1,1 bilhão
Hipersomnia idiopática	2,1 milhões	US $ 780 milhões

Praticantes de medicina do sono

A Avadel tem como alvo 5.600 profissionais de medicina do sono dedicados nos Estados Unidos.

• Total de praticantes de medicina do sono: 5.600
• Volume médio anual de prescrição: 3.200 por profissional
• Valor de mercado total de prescrição: US $ 620 milhões

Distribuidores farmacêuticos especializados

A empresa trabalha com 47 distribuidores farmacêuticos especializados em todo o país, cobrindo 92% dos mercados de saúde dos EUA.

Categoria de distribuidor	Total de distribuidores	Cobertura de mercado
Distribuidores farmacêuticos especializados	47	92%
Atacadistas farmacêuticos nacionais	3	100%

Avadel Pharmaceuticals plc (AVDL) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Avadel Pharmaceuticals registrou despesas de P&D de US $ 42,7 milhões.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 38,5 milhões	45.3%
2023	US $ 42,7 milhões	47.6%

Investimentos de ensaios clínicos

A Avadel alocou US $ 18,3 milhões especificamente para gastos com ensaios clínicos em 2023.

• Custos promissores de desenvolvimento de pipeline: US $ 12,5 milhões
• Estudos em andamento de transtorno neurológico: US $ 5,8 milhões

Custos de fabricação e produção

As despesas totais de fabricação para 2023 foram de US $ 22,1 milhões.

Categoria de custo	Quantia
Custos de fabricação diretos	US $ 15,6 milhões
Instalação sobrecarga	US $ 6,5 milhões

Despesas de conformidade regulatória

Os custos de conformidade regulatórios para 2023 totalizaram US $ 7,2 milhões.

• Preparação de envio da FDA: US $ 3,4 milhões
• Processos de controle de qualidade: US $ 2,8 milhões
• Documentação de conformidade: US $ 1 milhão

Infraestrutura de vendas e marketing

As despesas de vendas e marketing de 2023 foram de US $ 16,5 milhões.

Canal de marketing	Gasto
Marketing digital	US $ 5,2 milhões
Operações da equipe de vendas	US $ 8,3 milhões
Marketing de conferência e evento	US $ 3 milhões

Avadel Pharmaceuticals plc (AVDL) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do terceiro trimestre de 2023, a Avadel Pharmaceuticals registrou receita total de US $ 25,1 milhões, impulsionada principalmente pelas vendas de produtos de Lumryz (oxibato de sódio) para hipersomnia idiopática.

Produto	2023 Receita	Segmento de mercado
Lumryz	US $ 25,1 milhões	Sistema nervoso central

Acordos de licenciamento e royalties

A Avadel gera receita por meio de parcerias estratégicas de licenciamento e acordos de royalties.

• Acordos de licenciamento ativos em terapêutica neurológica
• Potenciais pagamentos marcantes de colaborações farmacêuticas

Subsídios de pesquisa e colaborações

A empresa recebe financiamento de parcerias de pesquisa e subsídios do governo focados no desenvolvimento farmacêutico inovador.

Comercialização de portfólio de medicamentos especializada

A Avadel se concentra na comercialização de produtos farmacêuticos especializados em áreas terapêuticas de nicho.

Área terapêutica	Foco do produto	Receita potencial
Distúrbios do sono	Lumryz	Fluxo de receita primária

Monetização da propriedade intelectual

O portfólio de propriedade intelectual da Avadel representa uma fonte de receita potencial significativa por meio de licenciamento de patentes e transferência de tecnologia.

• Portfólio de patentes cobrindo tecnologias inovadoras de entrega de medicamentos
• Receita potencial do licenciamento de IP

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Value Propositions

The core value proposition for Avadel Pharmaceuticals plc centers on its differentiated product profile for narcolepsy treatment, specifically the extended-release sodium oxybate, LUMRYZ.

Once-at-bedtime dosing for narcolepsy, a key differentiator from twice-nightly oxybates.

LUMRYZ is positioned as the first and only once-at-bedtime oxybate for narcolepsy patients aged 7 years and older. This single nightly dose avoids the need for nocturnal arousal to take a second dose, which the FDA found makes a major contribution to patient care over currently available, twice-nightly oxybate products. Data from the RESTORE study showed that 94% of participants favored the once-nightly medication over traditional twice-nightly oxybate treatments.

Treatment for excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients.

LUMRYZ is a prescription medicine used to treat cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The product generated $77.5 million in net product revenue for the third quarter ended September 30, 2025.

FDA-approved option for pediatric narcolepsy patients aged 7 years and older.

The U.S. Food and Drug Administration (FDA) approved LUMRYZ for pediatric patients aged 7 years and older with narcolepsy on October 16, 2024. This pediatric approval granted Orphan Drug Exclusivity through October 16, 2031.

Dedicated patient support and reimbursement assistance programs.

Avadel Pharmaceuticals plc has actively built out support infrastructure to help patients access and stay on therapy. This includes doubling its field reimbursement team to accelerate the pace of patient fulfillment. The company also expanded its nurse team and added patient ambassadors to help educate people with narcolepsy. As of December 31, 2024, approximately 74% of patients on therapy were reimbursed.

Here's a quick look at the commercial progress supporting these value drivers as of late 2025:

Metric	Value/Period	Date/Period End
Net Product Revenue (Q3 2025)	$77.5 million	September 30, 2025
Patients on Therapy (Q3 2025)	Approximately 3,400	September 30, 2025
Reimbursed Patients (End of 2024)	Approximately 74%	December 31, 2024
Year-End 2025 Revenue Guidance (Raised)	$265 - $275 million	Full Year 2025
Year-End 2025 Patient Expectation (Raised)	3,400 - 3,600	By Year End 2025

The company generated positive cash flow in the third quarter, with cash, cash equivalents and marketable securities at $91.6 million at September 30, 2025.

You can see the growth in patient numbers:

• Patients on LUMRYZ: 2,500 as of December 31, 2024.
• Patients on LUMRYZ: Approximately 3,400 as of September 30, 2025.
• Expected Patients on LUMRYZ: 3,300 - 3,500 by end of 2025 (based on March guidance).

The company also made a strategic move to license valiloxybate from XWPharma, paying an upfront payment of $15 million during the quarter ended September 30, 2025, with an additional $5 million due in the fourth quarter of 2025.

Finance: review the Q4 2025 cash flow projection by next Tuesday.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Customer Relationships

You're looking at how Avadel Pharmaceuticals plc builds and maintains connections with the healthcare professionals and patients who use LUMRYZ. For a specialty pharmaceutical company like Avadel Pharmaceuticals plc, these relationships are the engine of adoption and persistence, especially given the complexity of specialty pharmacy access.

High-touch, direct support via a dedicated field reimbursement team

Avadel Pharmaceuticals plc has made significant investments in the infrastructure needed to get patients on and keep them on therapy. This support is critical because navigating insurance and cost barriers can stop a prescription before it even starts. To address this, Avadel Pharmaceuticals plc invested in doubling its field reimbursement team early in 2025, following the close of 2024, specifically to accelerate the pace of patient fulfillment. This team works directly with providers and payers.

The focus on access is reflected in the reimbursement metrics achieved. As of December 31, 2024, approximately 74% of patients on LUMRYZ therapy were reimbursed. The company is clearly prioritizing this touchpoint to ensure that the prescription written by the physician translates into a patient receiving the medication.

Patient ambassador programs for education and community building

To support patients directly, Avadel Pharmaceuticals plc has been actively building out its patient-facing support structure. This includes the addition of patient ambassadors to help educate people with narcolepsy. This initiative was a stated priority for 2025 commercial efforts, building on expanded direct-to-patient programs. While specific enrollment numbers for Avadel Pharmaceuticals plc's ambassador program aren't public, the industry context shows the value: patients receiving such support can adhere to medications 29.3% more often and stay on treatment an average of 133.5 days longer. This type of personal intervention helps bridge the trust gap, which is important when only about 5% of patients consider pharma companies the most trusted players in healthcare.

Direct engagement with prescribing physicians through a specialized sales force

Direct engagement with prescribing physicians is managed through a specialized sales force focused on communicating the differentiated profile of LUMRYZ. Avadel Pharmaceuticals plc has been scaling this team throughout 2025. Management detailed plans to expand the sales force to 60 representatives in the second half of 2025, alongside increased investments in HCP marketing programs. This expansion supports the growing patient base; as of June 30, 2025, there were 3,100 active patients on LUMRYZ, a 63% year-over-year increase. Furthermore, new patient starts were outpacing the twice-nightly mixed-salts competitor by more than 2:1 since July 2023, indicating successful physician engagement and adoption.

Here's a look at the growth metrics tied to these commercial relationship efforts:

Metric	Value/Period	Date/Context
Active Patients on LUMRYZ	3,100	As of June 30, 2025
Projected Year-End 2025 Patients	3,300 - 3,500	End of 2025 Guidance
Sales Force Size	Expansion to 60 representatives	H2 2025 Investment
Q1 2025 New Patient Adds	300 patients	Quarter Ended March 31, 2025
Q4 2024 New Patient Adds	200 patients	Q4 2024 Figure

Managed access programs to help patients navigate insurance and cost barriers

The managed access strategy is intrinsically linked to the field reimbursement team's work and the overall patient support services, which also include an expansion of the nurse team for more personal intervention. The goal is to ensure that the high rate of patient adoption translates into sustained therapy. The company is focused on improving key patient metrics, including the percent of reimbursed patients on therapy. The initial reimbursement rate reported at the end of 2024 was 74%. The overall market opportunity is substantial, with an estimated population of over 50,000 oxybate-eligible narcolepsy patients in the United States, meaning the managed access programs are crucial for capturing this segment.

Avadel Pharmaceuticals plc is also supporting its commercial efforts by expanding its direct support beyond traditional telephonic and digital tools to a more personal intervention at the patient and physician office level. This high-touch approach is designed to manage the risk of patient attrition, which has been a noted factor in outlook adjustments.

• Invested in doubling the field reimbursement team in 2025.
• Expanded the nurse team for direct patient/physician support.
• Focused on improving patient persistency trends.
• Sales force expansion to 60 reps planned for H2 2025.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Channels

You're looking at how Avadel Pharmaceuticals plc gets LUMRYZ to the people who need it, which is a complex job for a specialty drug with a mandatory safety program. The channel strategy is built around a highly controlled distribution system supported by an expanding, specialized commercial team.

Here's a quick look at the scale of the business these channels are supporting as of late 2025:

Metric	Value/Range (2025)	Date/Period
Net Product Revenue (Q3)	$77.5 million	Quarter ended September 30, 2025
Patients on Therapy	Approx. 3,400	As of September 30, 2025
Raised Full-Year Revenue Guidance	$265 - $275 million	As of August 7, 2025
Projected Patients on Therapy (Year-End)	3,400 - 3,600	Year-end 2025 projection

The channel strategy is definitely focused on control and high-touch support, which makes sense given the product type.

Exclusive specialty pharmacy network for dispensing LUMRYZ

Avadel Pharmaceuticals plc relies on a targeted distribution model, using an exclusive specialty pharmacy network to dispense LUMRYZ. This channel is critical because it manages the complex logistics and patient support required for a Schedule III controlled substance. While the exact number of contracted pharmacies isn't public, the network must scale to support the growing patient base, which reached approximately 3,400 patients as of September 30, 2025. This network handles fulfillment after the patient is cleared through the REMS program.

Dedicated field sales and medical science liaison (MSL) teams

The company has actively invested in its customer-facing teams to drive adoption among prescribers. This investment is a key channel for education and relationship building. As of early 2025, Avadel Pharmaceuticals plc initiated significant expansion:

• Expanded and upgraded field sales team by nearly 15% to reach more physicians.
• Doubled the field reimbursement team to speed up patient fulfillment processes.

This structure suggests a direct sales force channel targeting prescribers, supported by a dedicated reimbursement team acting as a crucial intermediary channel to ensure patients can access the drug post-prescription. The MSL team, while not quantified in size, supports this channel by providing high-level medical education to key opinion leaders and specialists.

Digital and direct-to-physician marketing materials and educational resources

Beyond the field teams, Avadel Pharmaceuticals plc uses direct engagement channels to activate patients and support physicians. This includes expanding patient ambassador direct-to-patient initiatives to educate and activate people with narcolepsy to seek out LUMRYZ. Furthermore, the company is progressing field-based patient support services that go beyond traditional telephonic and digital tools, offering a more personal intervention at the physician's office level. This blend of digital outreach and personal, field-based support acts as a layered channel to drive prescription volume and improve persistency.

The LUMRYZ Risk Evaluation and Mitigation Strategy (REMS) program

Enrollment in the LUMRYZ REMS program is a mandatory prerequisite channel for any patient to receive the medication. This safety channel controls distribution by requiring prescribers, pharmacies, and patients to be certified and enrolled. For any necessary patient or provider interaction with the REMS program, the contact point is:

• Phone Number: 1-877-453-1029.
• Website: www.LUMRYZREMS.com.

This regulatory channel is the gatekeeper for all other commercial channels.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so knowing exactly who you are selling to is step one. Avadel Pharmaceuticals plc targets specific patient populations and the healthcare professionals who manage their care for its commercial product, LUMRYZ.

The primary customer segment is narcolepsy patients, specifically those experiencing cataplexy or Excessive Daytime Sleepiness (EDS). LUMRYZ is approved for this indication in patients 7 years of age and older in the United States. As of September 30, 2025, Avadel Pharmaceuticals plc reported approximately 3,400 patients were being treated with LUMRYZ. This represented a 48% year-over-year increase from the approximately 2,300 patients on therapy as of September 30, 2024.

The existing narcolepsy patient base on LUMRYZ can be further segmented by their prior treatment history with oxybates, based on data from the end of 2024:

Patient Sub-Segment	Percentage of New Patient Starts (as of Dec 31, 2024)
Switching from first-generation oxybates	38%
New to oxybate therapy	34%
Previously tried and discontinued oxybates	28%

The second key segment involves the healthcare providers who drive prescription volume. Avadel Pharmaceuticals plc focuses its commercial efforts on sleep specialists and neurologists identified as high-volume oxybate prescribers. The company has been investing in expanding its customer-facing teams to strengthen engagement with these providers.

A significant future segment is the potential market for adults with Idiopathic Hypersomnia (IH). Avadel Pharmaceuticals plc received Orphan Drug Designation for LUMRYZ for IH on June 5, 2025. Patient enrollment for the pivotal Phase 3 REVITALYZ study evaluating LUMRYZ in IH remains on track to be completed by the end of 2025. The potential market size is substantial; as of early 2025, there were approximately 42,000 diagnosed IH patients under the care of physicians, yet less than 8% were on the only FDA-approved treatment for IH at that time.

The potential for the IH indication is tied to a contingent value right (CVR) in the proposed acquisition by Alkermes, which entitles holders to an additional cash payment of $1.50 per share contingent upon LUMRYZ being commercially sold for IH in the United States by the end of 2028.

• LUMRYZ net product revenue for the third quarter ended September 30, 2025, was $77.5 million.
• Full year 2025 net product revenue guidance was raised to $265 - $275 million.
• LUMRYZ has Orphan Drug Exclusivity for narcolepsy treatment until May 2030 (adults) and October 2031 (pediatric).

Finance: draft 13-week cash view by Friday.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Cost Structure

You're looking at the costs Avadel Pharmaceuticals plc is bearing to support the commercialization of LUMRYZ and manage its corporate structure, especially with the Alkermes acquisition pending. Honestly, the cost profile shifted significantly as they scaled up the launch and dealt with one-time items in the third quarter of 2025.

The major operating expenses for the quarter ended September 30, 2025, totaled $79.6 million under GAAP. This is a substantial increase from the $44.2 million reported for the same period in 2024. This jump reflects the ongoing investment in commercial activities and other non-recurring charges.

Here's a breakdown of the key cost components based on the latest reported figures:

Cost Category	Period Reported	Amount (in millions USD)	Context/Driver
Selling, General, and Administrative (SG&A) Expenses	Q2 2025	$48.6	High costs for the ongoing commercial launch of LUMRYZ.
Selling, General, and Administrative (SG&A) Expenses	Q3 2025	$52.6	Primarily driven by higher commercial costs related to the LUMRYZ launch.
Research and Development (R&D) Expenses	Q2 2025	$4.3	Standard R&D spend.
Research and Development (R&D) Expenses	Q3 2025	$27.0	Includes a $20.0 million upfront license fee paid to XWPharma.
Total GAAP Operating Expenses	Q3 2025 (Quarter ended Sept 30)	$79.6	Reflects commercial investment plus the XWPharma license fee.

Cost of Goods Sold (COGS) for LUMRYZ manufacturing and supply chain showed an unusual positive impact in the third quarter. Gross profit for the quarter ended September 30, 2025, was $81.6 million, which represented 105% of net product revenue of $77.5 million. This high gross profit percentage was due to a specific event:

• A reversal of $9.5 million within cost of products sold for royalties that had accrued through June 30, 2025, which were waived by Jazz in conjunction with the Settlement Agreement.

Regarding the Alkermes acquisition, while the deal itself values Avadel at up to approximately $2.1 billion (initially) or up to $2.37 billion (increased offer), the search results don't detail the specific, realized legal and transaction costs Avadel recognized on its income statement for that event in Q3 2025. However, the Q3 operating expenses did include a significant non-acquisition related charge:

• The $20.0 million upfront license fee paid to XWPharma, of which $15.0 million was paid in the quarter ended September 30, 2025.

The Transaction Agreement with Alkermes does stipulate reimbursement for documented, specific, quantifiable Third Party costs incurred in connection with the Acquisition, but the exact amount booked by Avadel is not explicitly stated in the provided Q3 2025 summaries. The transaction is expected to close in the first quarter of 2026.

Finance: draft the pro-forma operating expense impact for Q4 2025, excluding the one-time XWPharma fee, by Monday.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Revenue Streams

You're looking at the financial engine driving Avadel Pharmaceuticals plc as of late 2025, focusing strictly on where the cash comes from. It's all about product sales and the potential from pipeline and partnership deals.

Net Product Revenue from LUMRYZ Sales

The primary revenue driver is the net product revenue from the sale of LUMRYZ in the United States. This stream is showing strong momentum.

For the quarter ended September 30, 2025, Avadel Pharmaceuticals plc recognized $77.5 million in net product revenue from LUMRYZ sales. That figure represents a 55% year-over-year increase compared to the $50.0 million recognized for the same period in 2024. By September 30, 2025, approximately 3,400 patients were being treated with LUMRYZ. Honestly, the company has since raised its full-year 2025 net product revenue guidance to a range of $265 - $275 million.

Milestone Payments and Royalties from Partnerships

Avadel Pharmaceuticals plc is also building in revenue potential from strategic alliances, specifically the exclusive global license agreement for valiloxybate with XWPharma Ltd., announced in September 2025. This deal structure includes several contingent payments that become revenue streams upon hitting specific targets. Here's the quick math on what XWPharma is eligible to receive from Avadel Pharmaceuticals plc:

Payment Type	Amount/Rate	Condition/Threshold
Upfront Payment (Total)	$20 million	Paid in installments; $15 million paid in Q3 2025, with $5 million due in Q4 2025.
Development Milestones (Aggregate)	Up to $30 million	Tied to certain development milestones.
Sales Milestones (Aggregate)	Up to an aggregate of $155 million	For first achievement of annual net sales up to $750 million.
Sales Milestones (Incremental)	10% of each sales milestone payment	For first achievement of annual net sales exceeding $750 million and up to $3.5 billion.
Royalties on Net Sales	Tiered, ranging from high-single digit to mid-teens percentages	As a percentage of annual net sales of the licensed products.
Indication Milestone Payment	$10 million	After first commercial sale in the U.S. for each indication beyond narcolepsy and idiopathic hypersomnia following FDA approval.

These figures represent potential future revenue streams contingent on the successful development and commercialization of valiloxybate.

Contingent Value Right (CVR) Potential Payment

A significant, though conditional, revenue event is tied to the definitive agreement with Alkermes plc, announced October 22, 2025, which values Avadel Pharmaceuticals plc at approximately $2.1 billion in total consideration. The CVR component is a direct potential cash inflow to shareholders, which impacts the company's overall financial picture.

• The CVR entitles holders to a potential additional cash payment of $1.50 per share.
• This payment is contingent upon final FDA approval of LUMRYZ for the treatment of idiopathic hypersomnia (IH) in adults by the end of 2028.
• The total acquisition consideration is up to $20.00 per share, comprised of $18.50 per share in cash at closing plus the $1.50 CVR.

What this estimate hides is that if the IH Milestone is not achieved by the Milestone Expiration, the CVRs will have zero value. Still, the structure clearly defines the maximum potential payout tied to this regulatory success.