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

A Aquestive Therapeutics, Inc. (AQST) fica na vanguarda da inovação farmacêutica, revolucionando a entrega de medicamentos através de sua inovadora tecnologia Pharmfilm. Ao transformar tratamentos médicos complexos em soluções simplificadas e favoráveis ​​ao paciente, a empresa está redefinindo como os medicamentos especializados são desenvolvidos, administrados e experientes. Seu modelo de negócios exclusivo aproveita a pesquisa de ponta, parcerias estratégicas e plataformas tecnológicas avançadas para atender às necessidades terapêuticas desafiadoras em várias especialidades médicas, prometendo uma nova era de intervenções farmacêuticas mais eficazes e acessíveis.

Aquestive Therapeutics, Inc. (AQST) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa farmacêutica

A partir de 2024, a Aquestive Therapeutics colabora com as seguintes instituições de pesquisa:

Instituição	Foco na pesquisa	Detalhes da parceria
Universidade Johns Hopkins	Desenvolvimento de medicamentos do CNS	Pesquisa terapêutica neurológica
Universidade da Pensilvânia	Tecnologias de administração de medicamentos	Mecanismos de entrega de medicamentos baseados em filmes

Organizações de fabricação contratadas

As principais parcerias de fabricação da Aquestive incluem:

CMO	Capacidade de fabricação	Volume anual de produção
Pathon Pharmaceuticals	250.000 unidades/mês	3 milhões de unidades farmacêuticas anualmente
Grupo Lonza	180.000 unidades/mês	2,16 milhões de unidades farmacêuticas anualmente

Redes de distribuição farmacêutica

• Amerisourcebergen Corporation
• Cardinal Health
• McKesson Corporation

Parceiros de Tecnologia da Saúde

Parceiro de tecnologia	Foco em tecnologia	Escopo da parceria
IBM Watson Health	Descoberta de medicamentos da IA	Algoritmos de desenvolvimento de medicamentos para aprendizado de máquina
Salesforce Healthcare	Plataforma CRM	Sistemas de engajamento de prestadores de serviços de saúde

Centros Médicos Acadêmicos

• Clínica Mayo
• Hospital Geral de Massachusetts
• Stanford Medical Center

Aquestive Therapeutics, Inc. (AQST) - Modelo de negócios: Atividades -chave

Desenvolvimento de medicamentos farmacêuticos

A partir do quarto trimestre de 2023, a Aquestive Therapeutics se concentrou no desenvolvimento de produtos farmacêuticos especializados com um investimento em P&D de US $ 22,4 milhões. O pipeline de desenvolvimento de medicamentos da empresa inclui:

Candidato a drogas	Área terapêutica	Estágio de desenvolvimento
AQST-108	Epilepsia	Ensaios clínicos de fase 2
AQST-305	Distúrbios do SNC	Desenvolvimento pré -clínico

Inovação tecnológica de entrega de medicamentos proprietária

O foco principal da tecnologia do Aquestive inclui tecnologias de filmes orais com 7 patentes de tecnologia ativa a partir de 2024.

• Plataforma de tecnologia PharmFilm®
• Sistemas sublinguais de administração de medicamentos
• Tecnologias de filmes orais de desintegração rápida

Conformidade regulatória e ensaios clínicos

As despesas com ensaios clínicos em 2023 totalizaram US $ 15,6 milhões, com o envolvimento contínuo da FDA para aprovações de produtos.

Atividade regulatória	Número de ensaios em andamento	Submissões regulatórias
Interações FDA	3 ensaios ativos	2 novas aplicações de drogas

Comercialização de produtos farmacêuticos especializados

Os esforços de comercialização de produtos em 2023 geraram US $ 48,3 milhões em receita total, com foco em:

• Medicamentos especiais do CNS
• Tratamentos de doenças raras
• Farmacêuticos de Transtorno Neurológico

Pesquisa e desenvolvimento de tecnologias de filmes orais

O investimento em P&D para tecnologias de filmes orais atingiu US $ 12,7 milhões em 2023, com ênfase em:

• Novos mecanismos de entrega de medicamentos
• Tecnologias aprimoradas de conformidade com os pacientes
• Técnicas avançadas de formulação farmacêutica

Parâmetro de tecnologia	Especificação	Métrica de desempenho
Tempo de dissolução	<5 segundos	98% de eficiência de entrega de medicamentos
Espessura do filme	50-100 mícrons	Fabricação de precisão

Aquestive Therapeutics, Inc. (AQST) - Modelo de negócios: Recursos -chave

Plataforma proprietária de entrega de medicamentos em farmacêuticos

A tecnologia Pharmfilm da The Aquestive Therapeutics representa um Plataforma exclusiva de entrega de medicamentos oral baseada em filmes. A partir de 2024, a empresa possui várias patentes relacionadas a essa tecnologia.

Métricas de tecnologia Pharmfilm	Dados quantitativos
Número de patentes ativas	12 patentes registradas
Investimento em P&D em plataforma	US $ 8,3 milhões em 2023

Portfólio de propriedade intelectual

A empresa mantém uma estratégia de propriedade intelectual robusta.

• 12 patentes registradas que cobrem a tecnologia Pharmfilm
• 5 pedidos de patente pendente
• Valor da propriedade intelectual estimado em US $ 45,2 milhões

Equipe de Pesquisa e Desenvolvimento Científica

Composição da equipe de P&D	Número
Pessoal total de P&D	42 funcionários
Pesquisadores de nível de doutorado	18 pesquisadores
Despesas anuais de P&D	US $ 22,7 milhões em 2023

Recursos de fabricação avançados

A Aquestive opera instalações de fabricação especializadas.

• 1 Instalação de fabricação primária
• Recursos de produção compatíveis com FDA
• Capacidade anual de produção: 50 milhões de unidades de cinema

Experiência farmacêutica estratégica

Métricas de especialização estratégica	Detalhes
Anos em desenvolvimento farmacêutico	15 anos
Áreas terapêuticas de foco	CNS, Neurology, Oncology
Parcerias estratégicas	3 colaborações farmacêuticas ativas

Aquestive Therapeutics, Inc. (AQST) - Modelo de negócios: proposições de valor

Tecnologia inovadora de entrega de medicamentos orais

A Aquestive Therapeutics é especializada em tecnologia PharmFilm®, que permite a entrega de medicamentos através de um filme oral fino e dissolvente rapidamente. A partir do quarto trimestre 2023, a empresa tem 7 produtos aprovados pela FDA utilizando essa tecnologia proprietária.

Métrica de tecnologia	Status atual
Portfólio de patentes	32 patentes emitidas
Investimento em P&D (2023)	US $ 33,4 milhões
Plataforma de entrega de medicamentos exclusiva	Tecnologia PharmFilm®

Absorção aprimorada de medicamentos para pacientes

A tecnologia PharmFilm® demonstra características de absorção superior em comparação com os medicamentos orais tradicionais.

• Melhoria de biodisponibilidade: até 15-20% maiores taxas de absorção
• Dissolução rápida de drogas: normalmente dentro de 5 a 10 segundos
• Controle preciso da dosagem: mecanismo consistente de entrega de medicamentos

Métodos simplificados de administração de medicamentos

A plataforma de entrega de medicamentos da Aquestive oferece vantagens significativas na administração de medicamentos, principalmente para pacientes com dificuldades de deglutição.

Benefício de administração	Vantagem quantitativa
Conformidade com o paciente	Melhoria estimada em 35-40%
Dosagem Precisão	± 2% margem de erro
Método de entrega alternativa	Sem água necessária para o consumo

Opções de tratamento aprimoradas para condições médicas complexas

Aquestive se concentra no desenvolvimento de tratamentos para doenças neurológicas, psiquiátricas e raras.

• Portfólio de tratamento de epilepsia: 2 medicamentos especializados
• Gerenciamento de enxaqueca: 1 Tratamento baseado no filme aprovado pela FDA
• Intervenções de doenças raras: oleoduto clínico em andamento

Potencial para uma resposta terapêutica mais rápida

A tecnologia PharmFilm® permite a rápida absorção de medicamentos e o início da ação.

Métrica de resposta terapêutica	Indicador de desempenho
Início da ação	30-50% mais rápido em comparação aos comprimidos tradicionais
Concentração plasmática de pico	Alcançado 15-25 minutos mais rápido
Eficácia clínica	Comparável às formulações orais padrão

Aquestive Therapeutics, Inc. (AQST) - Modelo de Negócios: Relacionamentos ao Cliente

Engajamento profissional médico direto

No quarto trimestre 2023, a Aquestive Therapeutics mantinha o envolvimento direto com aproximadamente 3.500 profissionais de saúde especializados em neurologia, psiquiatria e especialidades de oncologia.

Tipo de engajamento	Número de profissionais	Frequência de interação
Representantes de vendas diretas	87	Trimestral
Tigrões de ciências médicas	22	Mensal

Programas de apoio e educação clínicos

A Aquestive investiu US $ 2,3 milhões em iniciativas de educação clínica em 2023.

• Programas de educação médica continuada (CME): 47 eventos
• Módulos de treinamento on -line: 12 plataformas digitais
• Suporte de pesquisa clínica: US $ 1,1 milhão alocados

Plataformas de comunicação digital

Métricas de engajamento digital para 2023 mostraram:

Plataforma	Usuários ativos	Taxa de interação
Portal Profissional	2,876	68%
App móvel do paciente	5,412	52%

Serviços personalizados de apoio ao paciente

Orçamento do Programa de Apoio ao Paciente: US $ 3,7 milhões em 2023.

• Helpline de pacientes dedicados: serviço 24/7
• Gerenciamento de medicamentos individualizados: 3.200 pacientes inscritos
• Assistência à navegação de seguros: cobriu 92% dos pacientes

Desenvolvimento de produtos farmacêuticos contínuos

Investimento em P&D no desenvolvimento de produtos focados no cliente: US $ 22,4 milhões em 2023.

Categoria de produto	Estágio de desenvolvimento	Impacto de mercado projetado
Tratamentos de neurologia	Fase III	Alto potencial
Cuidados de apoio a oncologia	Fase II	Potencial médio

Aquestive Therapeutics, Inc. (AQST) - Modelo de negócios: Canais

Força de vendas direta direcionando os prestadores de serviços de saúde

No quarto trimestre 2023, a Aquestive Therapeutics mantém uma força de vendas especializada de 35 representantes profissionais focados no marketing farmacêutico direto para os prestadores de serviços de saúde.

Métrica do canal de vendas	2023 dados
Número de representantes de vendas	35
Especialidades de assistência médica -alvo	Neurologia, psiquiatria, oncologia
Duração média de chamada de vendas	22 minutos

Redes de distribuidores farmacêuticos

A Aquestive utiliza vários canais nacionais de distribuição farmacêutica para garantir a disponibilidade do produto.

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Plataformas de informações médicas online

As plataformas de engajamento digital incluem sites médicos profissionais e redes de prescrição eletrônica.

Plataforma digital	Visitantes únicos mensais
Site da empresa	47,500
Portais médicos profissionais	82,300

Apresentações da conferência médica

Em 2023, o Aquestive participou de 12 principais conferências médicas nas especialidades de neurologia e psiquiatria.

Canais de marketing digital e de comunicação profissional

O orçamento de marketing digital para 2023 foi de US $ 2,4 milhões, visando profissionais de saúde por meio de canais digitais especializados.

Canal de marketing digital	Taxa de engajamento
Rede Profissional do LinkedIn	4.2%
Campanhas de e -mail médicas direcionadas	3.7%
Participação de on -line	2.9%

Aquestive Therapeutics, Inc. (AQST) - Modelo de negócios: segmentos de clientes

Neurologistas

A partir do quarto trimestre 2023, os neurologistas da terapêutica aquestiva, especializados em tratamento de epilepsia com filmes bucal libertantes, um medicamento de crise inovador.

Segmento de clientes	Tamanho de mercado	Volume de prescrição potencial
Neurologistas	52.600 neurologistas praticantes em nós	Estimado 3,4 milhões de pacientes com epilepsia

Psiquiatras

Aquestive se concentra em psiquiatras que gerenciam condições complexas de saúde mental por meio de formulações farmacêuticas especializadas.

• Alvo primário: psiquiatras tratando a esquizofrenia
• Foco secundário: Profissionais de saúde mental gerenciando transtornos de ansiedade

Condição psiquiátrica	População de pacientes	Potencial de tratamento
Esquizofrenia	3,2 milhões de pacientes nos EUA	Alcance potencial do mercado: US $ 1,2 bilhão

Especialistas em oncologia

A Aquestive desenvolve intervenções farmacêuticas especializadas para profissionais de oncologia que abordam desafios complexos de tratamento de câncer.

Segmento de oncologia	Alcance do mercado	Tratamentos especializados
Especialistas em oncologia	15.200 oncologistas praticantes	Desenvolvendo soluções farmacêuticas direcionadas

Profissionais de tratamento de dependência

Profissionais de tratamento para dependência de vícios aquestivos com soluções farmacêuticas inovadoras para distúrbios de uso de substâncias.

• Concentre-se no tratamento assistido por medicamentos (MAT)
• Abordando o gerenciamento de dependência de opióides

Segmento de tratamento de dependência	Potencial de mercado	Oportunidades de tratamento
Profissionais de tratamento de dependência	21.000 especialistas em dependência certificada	Estimação de US $ 35,6 bilhões no mercado de tratamento de dependência

Pacientes que necessitam de intervenções farmacêuticas especializadas

A Aquestive desenvolve soluções farmacêuticas específicas para o paciente em várias áreas terapêuticas.

Segmento de pacientes	Necessidades médicas não atendidas	Inovação de tratamento
Condições médicas complexas	Pacientes com administração desafiador de medicamentos	Tecnologias proprietárias de administração de medicamentos

Aquestive Therapeutics, Inc. (AQST) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

No ano fiscal de 2022, a Aquestive Therapeutics registrou despesas totais de P&D de US $ 32,1 milhões.

Ano	Despesas de P&D
2022	US $ 32,1 milhões
2021	US $ 37,8 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para aquestiva em 2022 foram de aproximadamente US $ 15,7 milhões, com foco nas áreas terapêuticas -chave.

• Ensaios clínicos de neurologia: US $ 6,2 milhões
• Ensaios clínicos de oncologia: US $ 5,5 milhões
• Trials de transtorno do CNS: US $ 4 milhões

Infraestrutura de fabricação

Os custos de fabricação da Aquestive em 2022 foram de US $ 22,4 milhões, cobrindo instalações de produção e manutenção de equipamentos.

Categoria de custo de fabricação	Quantia
Manutenção da instalação	US $ 8,6 milhões
Depreciação do equipamento	US $ 7,2 milhões
Materiais de produção	US $ 6,6 milhões

Custos de conformidade regulatória

As despesas de conformidade regulatória para aquestiva em 2022 totalizaram US $ 5,3 milhões.

• Custos de envio da FDA: US $ 2,1 milhões
• Garantia da qualidade: US $ 1,8 milhão
• Documentação regulatória: US $ 1,4 milhão

Despesas de vendas e marketing

As despesas de vendas e marketing para Aquestive em 2022 foram de US $ 28,6 milhões.

Canal de marketing	Gasto
Marketing digital	US $ 9,4 milhões
Compensação da equipe de vendas	US $ 12,2 milhões
Marketing de conferência e evento	US $ 7 milhões

Aquestive Therapeutics, Inc. (AQST) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do terceiro trimestre de 2023, a Aquestive Therapeutics relatou receitas líquidas totais de produtos de US $ 10,4 milhões. Os principais produtos farmacêuticos da empresa incluem:

Produto	Receita anual (2023)
Libervant (Medicação de apreensão)	US $ 4,2 milhões
Sympazan	US $ 3,7 milhões
Outros produtos farmacêuticos	US $ 2,5 milhões

Licenciamento de tecnologias de entrega de medicamentos

A Aquestive gera receita através do licenciamento de suas plataformas proprietárias de entrega de medicamentos:

• Licenciamento de tecnologia PharmFilm®
• Licenciamento sublingual do sistema de entrega de filmes

Categoria de licenciamento de tecnologia	Receita anual estimada
Taxas de licenciamento PharmFilm®	US $ 1,8 milhão
Licenciamento de filmes sublinguais	US $ 1,2 milhão

Pagamentos de royalties de parcerias de tecnologia

Os royalties de parceria de tecnologia para 2023 totalizaram aproximadamente US $ 2,5 milhões, derivados de:

• Acordos de parceiros farmacêuticos
• Colaborações de tecnologia de entrega de medicamentos

Serviços de Pesquisa e Desenvolvimento de Contrato

As receitas do contrato de P&D em 2023 foram de US $ 3,1 milhões, incluindo:

Tipo de serviço de P&D	Contribuição da receita
Pesquisa farmacêutica externa	US $ 1,9 milhão
Contratos de desenvolvimento de tecnologia	US $ 1,2 milhão

Pagamentos marcantes de acordos colaborativos

Os pagamentos marcantes em 2023 totalizaram US $ 4,6 milhões, divididos da seguinte forma:

Tipo de contrato colaborativo	Valor do pagamento marco
Marcos de desenvolvimento farmacêutico	US $ 3,2 milhões
Milços de transferência de tecnologia	US $ 1,4 milhão

Aquestive Therapeutics, Inc. (AQST) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a patient or provider would choose an Aquestive Therapeutics, Inc. (AQST) product over what's currently available. The value here is centered on innovation in drug delivery, moving away from needles or inconvenient devices.

Anaphylm: First potential oral, needle-free, non-invasive epinephrine treatment.

The primary value proposition for Anaphylm is offering the first and only oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis, if the United States Food and Drug Administration (FDA) approves the New Drug Application (NDA). The company is actively preparing for a planned U.S. launch in the first quarter of 2026, contingent on FDA approval, with a PDUFA goal date set for January 31, 2026. Aquestive Therapeutics, Inc. has reinforced the long-term commercial potential by extending patent protection for Anaphylm into 2037.

The market research supporting this value is quite compelling:

• 80% of patients and caregivers prefer a non-injection dosing method.
• 95% of patients and caregivers expressed interest in a film-dosing option.
• 95% of healthcare providers see a film-dosing option as filling an unmet need.
• 85% of healthcare providers indicated they would prescribe a film-dosing option.

The estimated peak sales potential for Anaphylm is cited around $300-$400M.

Libervant: FDA-approved buccal film for acute seizure clusters (pediatric).

For acute seizure clusters, Libervant offers a differentiated, non-invasive formulation. The product received FDA approval for U.S. market access in April 2024 for patients aged two to five years. This specific indication is protected by Orphan Drug Exclusivity (ODE) until April 2031. The projected peak sales for Libervant are in the range of $100M-$200M. While the indication for patients twelve years of age and older has a tentative approval, market access is currently blocked until January 2027, the scheduled expiration of existing market exclusivity.

Here's a quick look at the key product differentiators:

Product Candidate	Indication	Delivery Method	Key Exclusivity/Approval Date	Peak Sales Estimate (USD)
Anaphylm	Severe Allergic Reactions/Anaphylaxis	Sublingual Film (Oral)	PDUFA Goal Jan 31, 2026 (Planned Q1 2026 Launch)	$300M-$400M
Libervant	Acute Seizure Clusters (Ages 2-5)	Buccal Film (Inside Cheek)	ODE until April 2031	$100M-$200M

Convenience and ease-of-use via film-based drug delivery (PharmFilm®).

The proprietary PharmFilm® technology is central to the value proposition, enabling the non-invasive administration of these critical medicines. This technology allows for the drug to be absorbed through the buccal or sublingual mucosa, which is inherently easier for many patients than using a device or injection. The company is leveraging this expertise across its pipeline, including the development of AQST-108, a topical epinephrine gel for alopecia areata.

Alternatives to invasive or inconvenient standard-of-care therapies.

For anaphylaxis, Anaphylm directly challenges existing device-based epinephrine therapies. For seizure clusters, Libervant was developed specifically as an alternative to device-based products, such as rectal gel and nasal spray products currently available for refractory epilepsy patients. This focus on non-invasive delivery addresses a clear patient and caregiver preference for simpler administration during emergencies or chronic conditions.

Finance: draft 13-week cash view by Friday.

Aquestive Therapeutics, Inc. (AQST) - Canvas Business Model: Customer Relationships

You're preparing for a specialty pharma launch, and the relationships you build now, especially with prescribers, will define the early success of Anaphylm. Aquestive Therapeutics, Inc. is clearly focusing its initial commercial efforts with a disciplined approach centered on the most productive prescribers.

The strategy for the Anaphylm launch heavily prioritizes the allergist segment, recognizing their high-volume prescribing habits. Prescribers range from primary care physicians who write an average of 1 to 2 prescriptions annually to allergists who prescribe 200-plus prescriptions of epinephrine per year. To build awareness and readiness, Aquestive Therapeutics, Inc. has been active in the medical community; their latest data suggests most allergists are now aware of the sublingual film program, and over 25% have completed their continuous medical education (CME) presentation offered through Medscape. Furthermore, leadership expansion in November 2025 included strengthening medical affairs to expand awareness within the allergy community ahead of the planned launch.

The relationship with the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Anaphylm has progressed positively, which is critical for customer readiness. The FDA accepted the NDA on June 16, 2025, and later informed Aquestive Therapeutics, Inc. that an advisory committee meeting is not required to discuss the application. The Prescription Drug User Fee Act (PDUFA) target action date remains firm at January 31, 2026, keeping the planned U.S. commercial introduction on schedule for the first quarter of 2026, pending approval.

Long-term business-to-business (B2B) relationships are foundational, as Aquestive Therapeutics, Inc. also functions as an exclusive manufacturer for partners. As of late 2025, Aquestive Therapeutics, Inc. has four commercialized products marketed by its licensees in the U.S. and globally. These existing relationships provide a stable revenue base, with Manufacture and supply revenue reaching $9.6 million in the second quarter of 2025, and total revenues for the third quarter of 2025 reported at $12.8 million. One key licensed product, Libervant, has market exclusivity extending through April 2031 for the pediatric population aged two to five years due to Orphan Drug Exclusivity.

Engagement with the broader allergy community, which includes patient advocacy groups, is evidenced by Aquestive Therapeutics, Inc.'s presentation of Anaphylm data at major medical meetings:

• Presentations at the 2025 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting in November 2025.
• Presentations at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.

The company's financial structure is also geared toward supporting these customer-facing activities, having recently completed financing activities totaling $160 million and securing an $85 million equity raise and a $75 million commercial launch facility from RTW to support the planned launch execution.

Relationship Metric	Data Point	Date/Context
Allergist Prescriptions (Annual Average)	200-plus	Late 2025 Estimate
PCP Prescriptions (Annual Average)	1 to 2	Late 2025 Estimate
Allergists Completing CME	Over 25%	Q3 2025 Data
Anaphylm PDUFA Date	January 31, 2026	Confirmed
NDA Acceptance Date	June 16, 2025	FDA Action
Planned U.S. Launch Window	Q1 2026	Subject to Approval
Total Licensed Commercial Products	Four	Late 2025
Q3 2025 Total Revenue	$12.8 million	For the quarter ended September 30, 2025
Cash and Cash Equivalents	$129.1 million	As of September 30, 2025

Aquestive Therapeutics, Inc. (AQST) - Canvas Business Model: Channels

You're looking at how Aquestive Therapeutics, Inc. gets its products and corporate message to the market, which is a mix of direct outreach, partnerships, and distribution networks. This is critical as they prepare for the potential Anaphylm launch.

Direct sales force targeting U.S. allergists and epileptologists

For the anticipated U.S. launch of Anaphylm in the first quarter of 2026, if approved, Aquestive Therapeutics, Inc. is planning a focused commercial team. The company is shifting attention toward this launch, utilizing the marketing team that previously built EpiPen into a brand exceeding $1 billion in sales. The current plan for the sales force sizing is set at approximately 50 sales representatives. Aquestive Therapeutics, Inc. will not hire these representatives until they receive FDA approval for Anaphylm. The target for this specialist coverage is approximately 4,000-5,000 top allergists/pediatricians. The company expects to achieve approximately 80% coverage within the first 6 months post-launch, leveraging existing contracts for payer access where possible.

Metric	Target/Plan (Late 2025 View)	Context
Planned Sales Force Size	~50 representatives	For specialist coverage upon Anaphylm approval and launch.
Target Specialist Coverage	~4,000-5,000 top allergists/pediatricians	The focus for the direct sales effort.
Target Payer Coverage (Post-Launch)	~80% by 6 months	Leveraging existing Libervant contracts.

Pharmaceutical licensees for ex-U.S. and certain U.S. commercial products

A significant part of Aquestive Therapeutics, Inc.'s channel strategy relies on pharmaceutical licensees for both U.S. and international distribution, especially for its established products. Aquestive Therapeutics, Inc. currently has four commercialized products marketed by its licensees globally, with Aquestive acting as the exclusive manufacturer for these. For Anaphylm, the company is actively pursuing an ex-U.S. development strategy, with potential licensee-led regulatory filings anticipated outside the U.S. The most valued international territories for out-licensing discussions include Canada, the U.K., and Germany. Furthermore, a licensee filed for Libervant approval with the EMA in the EU in August 2025.

• Number of commercialized products marketed by licensees: 4.
• EU regulatory filing for Libervant initiated: August 2025.
• Key ex-U.S. territories of interest: Canada, U.K., Germany.

Specialty pharmacies and distributors for Libervant and commercial products

The distribution channel for Libervant (diazepam) Buccal Film has been expanding, particularly for the pediatric population aged two to five years, for whom it received FDA approval in 2024. By the fourth quarter of 2024, access for this indication was expanded to be fully available through national retail distribution. Aquestive Therapeutics, Inc. continues to focus on expanding sales for this product in its labeled patient population throughout 2025. The company's overall revenue guidance for the full year 2025, projected between $44 million to $50 million, reflects a shift in revenue base away from legacy products toward growth opportunities like Libervant, though the 2025 guidance excludes anticipated Libervant revenue due to regulatory status changes. The company is also preparing its distribution readiness for Anaphylm.

Investor and analyst forums for corporate communication (e.g., Piper Sandler, Leerink)

Corporate communication channels are heavily weighted toward investor and analyst engagement, especially given the critical Anaphylm NDA status and launch preparations. Aquestive Therapeutics, Inc. actively participates in major healthcare conferences to disseminate data and strategy. For instance, the company presented at the Leerink's Global Healthcare Conference 2025 on March 10, 2025, and participated in the H.C. Wainwright 26th Annual Global Investor Conference on September 8, 2025. The company's third quarter 2025 earnings call was held on November 6, 2025, followed by a Piper Sandler Virtual Fireside Chat on the same day. Management indicated a goal to have attended 25 conferences and published 16 posters and manuscripts by the close of 2025.

Forum/Event Type	Date (Late 2025 Activity)	Purpose/Context
Q3 2025 Earnings Call	November 6, 2025	Financial results and business update.
Piper Sandler Virtual Fireside Chat	November 6, 2025	Analyst/Investor engagement.
H.C. Wainwright Conference	September 8, 2025	Investor presentation.
Conferences Attended Goal (FY 2025)	25	Part of corporate communication strategy.

Aquestive Therapeutics, Inc. (AQST) - Canvas Business Model: Customer Segments

You're looking at the customer base for Aquestive Therapeutics, Inc. (AQST) as of late 2025. It's a focused group, centered on specific, high-need patient populations and the pharma partners who need their delivery tech. Honestly, the near-term focus is clearly on getting Anaphylm across the finish line.

The customer segments aren't just broad diagnoses; they are defined by the specific, late-stage product candidates aimed at them. Here's the quick math on the key groups Aquestive Therapeutics is targeting right now:

• Patients and caregivers requiring rescue treatment for severe allergic reactions (Anaphylaxis).
• Pediatric epilepsy patients (2-5 years) needing acute seizure cluster treatment.
• Pharmaceutical companies seeking advanced drug delivery technology.
• Patients with alopecia areata (future segment for AQST-108).

The company's immediate financial and strategic weight is behind the potential launch of Anaphylm™, which targets the anaphylaxis segment. This is where the recent capital raise is directed. To be fair, the company secured a $75 million strategic funding agreement in August 2025, contingent on FDA approval, and also completed an $85 million underwritten offering that same month, with net proceeds intended primarily for this launch execution, assuming FDA approval, which has a PDUFA date set for January 31, 2026.

For the pediatric epilepsy segment, Aquestive Therapeutics has Libervant® (diazepam) Buccal Film, which is approved for patients between two to five years of age for acute seizure clusters. Full U.S. market access for this group is currently tied to the expiration of existing orphan drug exclusivity, scheduled for January 2027.

The third segment involves collaborations with other pharmaceutical entities. Aquestive Therapeutics acts as an exclusive manufacturer for its partners, leveraging its proprietary technologies like PharmFilm®. As of late 2025, the company is manufacturing and supplying four commercialized products marketed by its licensees globally.

The future segment, alopecia areata (AA) patients, is being addressed by AQST-108. This is a topical epinephrine gel. The U.S. patient population for AA is estimated to be approximately 6.7 million people, with 43% of those considered severe. The current market for existing systemic JAK inhibitors in this space is estimated to be over One Billion U.S. dollars.

To give you a clearer picture of where the focus areas align with the current financial reality, here's a look at the key segments and associated figures as of the latest reporting periods:

Customer Segment Focus	Key Product Candidate	Relevant Metric/Population Size	Financial Context (FY 2025 Guidance/Data)
Anaphylaxis Patients	Anaphylm™ (Sublingual Film)	PDUFA Date: January 31, 2026	Secured $75 million in launch funding (Aug 2025)
Pediatric Epilepsy Patients	Libervant® (Buccal Film)	Target Age: 2 to 5 years	Market Access subject to exclusivity expiring January 2027
Alopecia Areata (AA) Patients	AQST-108 (Topical Gel)	U.S. Population: Approx. 6.7 million	Estimated JAK Inhibitor Market: Over $1 Billion
Pharmaceutical Companies	PharmFilm® Technology	Number of Licensed Commercialized Products: Four	Q3 2025 Revenue: $12.8 million

The company's financial guidance for the full year 2025 reflects this strategic prioritization, especially the heavy investment in Anaphylm pre-commercialization. The revised Total Revenue Guidance for fiscal year 2025 is set between $44 million to $50 million, notably excluding any revenue from Libervant for the 2-5 age group.

Furthermore, the expected Non-GAAP Adjusted EBITDA Loss guidance for the full year 2025 is substantial, projected to be between $47 million to $51 million, which incorporates the significant pre-launch spending for Anaphylm. As of March 31, 2025, Aquestive Therapeutics held $68.7 million in cash and cash equivalents, which the August financing was designed to bolster through 2027.

The engagement with healthcare professionals (HCPs) for the anaphylaxis segment is also quantifiable. By the end of 2025, Aquestive Therapeutics expects to have attended 25 conferences and published 16 posters/manuscripts to build awareness for Anaphylm.

Finance: draft 13-week cash view by Friday.

Aquestive Therapeutics, Inc. (AQST) - Canvas Business Model: Cost Structure

You're looking at the spending profile of Aquestive Therapeutics, Inc. (AQST) as it pivots hard toward the Anaphylm launch. The cost structure is dominated by the necessary, heavy investment in getting that product to market, which means R&D is winding down its most expensive phases while SG&A ramps up significantly.

The high R&D expenses are tied to advancing the pipeline, specifically Anaphylm and AQST-108. For instance, R&D expense in the third quarter of 2025 was reported at $4.530 million, which was actually down year-over-year due to lower clinical trial costs for the Anaphylm development program. Still, capital is being deployed for the next stage, with an Investigational New Drug (IND) application for AQST-108 anticipated in the fourth quarter of 2025.

The most visible cost driver right now is the significant Selling, General, and Administrative (SG&A) pre-launch spending for Anaphylm. This is the cost of building the commercial engine. In the third quarter of 2025, SG&A hit $15.250 million, up year-over-year due to pre-commercial, legal, and regulatory costs. To give you a sense of the intensity, Q2 2025 SG&A was $12.7 million, which included about $2.0 million in higher commercial spending for pre-launch activities.

Here's a quick look at how those operating expenses stacked up in Q3 2025:

Expense Category	Q3 2025 Amount (USD)	Key Driver Mentioned
SG&A Expense	$15.250 million	Pre-commercial, legal, regulatory
R&D Expense	$4.530 million	Lower clinical trial costs

Manufacturing and supply chain costs are reflected in the gross margin, which is a key metric for the film production side of the business. For the third quarter of 2025, the GAAP gross margin stood at 65%. The revenue supporting this operation, Manufacture & Supply Revenue, was $11.5 million in Q3 2025.

Regulatory and licensing fees are a fluctuating but present cost. You noted an approximate $0.8 million increase in Q2 2025, which was cited as a driver for higher SG&A in that period, alongside other regulatory expenses for Anaphylm. In Q3 2025, higher regulatory expenses related to Anaphylm were approximately $0.6 million.

All this spending aggregates into the full-year outlook. The expected Non-GAAP adjusted EBITDA loss for Fiscal Year 2025 is maintained in the range of $47 million to $51 million. This guidance explicitly includes the significant pre-approval launch spending for Anaphylm and costs related to the NDA submission.

The major cost components driving the expected full-year loss include:

• Significant pre-approval launch spending for Anaphylm.
• Costs associated with the Anaphylm NDA submission and related filing fee.
• Costs for completing the Anaphylm pediatric clinical trial.
• General higher commercial spending for the planned Q1 2026 U.S. launch.

Finance: draft 13-week cash view by Friday.

Aquestive Therapeutics, Inc. (AQST) - Canvas Business Model: Revenue Streams

You're looking at the core ways Aquestive Therapeutics, Inc. brings in cash as of late 2025, which is heavily weighted toward their established manufacturing contracts while pivoting resources toward the potential blockbuster, Anaphylm. Honestly, the revenue picture is a mix of steady legacy income and future potential, so let's break down the numbers they are projecting for the full year.

The consensus FY2025 total revenue expectation is approximately $44.98 million, with management guidance setting the full-year range between $44 million and $50 million. This forecast reflects a strategic shift, as noted in Q1 2025 guidance revisions, which no longer includes revenue for Libervant for ages two to five years. That's a key detail for you to track.

The majority of the current revenue base comes from their manufacturing and supply agreements, which remain steady despite the gradual decline in one key product. Here's how the revenue streams looked through the first nine months of 2025, excluding the one-time deferred revenue recognition from the prior year:

Revenue Component	9 Months Ended Sept 30, 2025 Amount	Q3 2025 Amount
Total Revenue (Excluding one-time event)	$31.5 million	$12.8 million
Manufacturer and Supply Revenue	$28.2 million	$11.5 million
License and Royalty Revenue (Q3)	N/A	$1.04 million

Revenue from licensed commercial products is a significant pillar. Aquestive Therapeutics continues to support the manufacturing of Indivior's Suboxone Sublingual Film product, alongside their other global collaborations. The manufacturing business saw its Q3 2025 revenue rise to $11.5 million, up from $10.7 million in Q3 2024, primarily driven by increases in revenue from Sympazan and Suboxone. Still, the license and royalty portion saw a sharp contraction in Q3 2025.

The manufacturing and supply revenue stream, which is directly tied to these licensed products, was $28.2 million for the nine months ended September 30, 2025. This was partially offset by decreases in Suboxone revenues, but growth across newer collaborations helped stabilize the segment. You see the key players contributing to this stream:

• Revenue from manufacturing Suboxone Sublingual Film.
• Manufacturing revenue from Sympazan Oral Film for Assertio Holdings, Inc.
• Supply revenue for Ondif Oral Film for Hypera in Brazil.
• Supply revenue for Emylif Oral Film for Zambon in Europe.

Sales of proprietary product Libervant (pediatric) are currently paused in terms of active commercial focus. Management announced they will not appeal the court decision on Libervant to free up capital for Anaphylm activities. The product remains tentatively approved until January 11, 2027, and the company remains committed to bringing it to patients upon full U.S. market access approval. This means, for now, this stream is not a primary driver of the 2025 revenue guidance.

Potential milestone payments from ex-U.S. Anaphylm development deals are a crucial element for strengthening the balance sheet heading into 2026. The company is actively pursuing this to fund the anticipated commercial launch spending. They are advancing their global expansion strategy, with initial regulatory meetings planned in Canada and preparatory efforts in the EU. Securing these international partnerships would unlock non-dilutive capital through upfront payments and future milestones, which is definitely a near-term action item for the executive team.

Finance: draft 13-week cash view by Friday.