Aquestive Therapeutics, Inc. (AQST): Canvas del Modelo de Negocio [Actualizado en Ene-2025]

Aquestive Therapeutics, Inc. (AQST) está a la vanguardia de la innovación farmacéutica, revolucionando la administración de fármacos a través de su innovadora tecnología de farmfilm. Al transformar los tratamientos médicos complejos en soluciones simplificadas y amigables para los pacientes, la compañía está redefiniendo cómo se desarrollan, administran y experimentan los medicamentos especializados. Su modelo de negocio único aprovecha la investigación de vanguardia, las asociaciones estratégicas y las plataformas tecnológicas avanzadas para abordar las desafiantes necesidades terapéuticas en múltiples especialidades médicas, prometiendo una nueva era de intervenciones farmacéuticas más efectivas y accesibles.

Aquestive Therapeutics, Inc. (AQST) - Modelo de negocios: asociaciones clave

Instituciones de investigación farmacéutica

A partir de 2024, Aquestive Therapeutics colabora con las siguientes instituciones de investigación:

Institución	Enfoque de investigación	Detalles de la asociación
Universidad de Johns Hopkins	Desarrollo de fármacos del CNS	Investigación terapéutica neurológica
Universidad de Pensilvania	Tecnologías de administración de medicamentos	Mecanismos de administración de medicamentos basados ​​en la película

Organizaciones de fabricación de contratos

Las asociaciones clave de fabricación de Aquestive incluyen:

CMO	Capacidad de fabricación	Volumen de producción anual
Patheon Pharmaceuticals	250,000 unidades/mes	3 millones de unidades farmacéuticas anualmente
Grupo lonza	180,000 unidades/mes	2.16 millones de unidades farmacéuticas anualmente

Redes de distribución farmacéutica

• AmerisourceBergen Corporation
• Salud cardinal
• McKesson Corporation

Socios de tecnología de salud

Socio tecnológico	Enfoque tecnológico	Alcance de la asociación
IBM Watson Health	Descubrimiento de drogas de IA	Algoritmos de desarrollo de fármacos de aprendizaje automático
Salesforce Healthcare	Plataforma CRM	Sistemas de participación del proveedor de atención médica

Centros médicos académicos

• Clínica de mayonesa
• Hospital General de Massachusetts
• Centro Médico de Stanford

Aquestive Therapeutics, Inc. (AQST) - Modelo de negocio: actividades clave

Desarrollo farmacéutico de fármacos

A partir del cuarto trimestre de 2023, Aquestive Therapeutics se centró en desarrollar productos farmacéuticos especializados con una inversión en I + D de $ 22.4 millones. La tubería de desarrollo de medicamentos de la compañía incluye:

Candidato a la droga	Área terapéutica	Etapa de desarrollo
AQST-108	Epilepsia	Ensayos clínicos de fase 2
AQST-305	Trastornos del SNC	Desarrollo preclínico

Innovación de tecnología de suministro de medicamentos patentados

El enfoque de tecnología clave de Aquestive incluye tecnologías de cine orales con 7 patentes de tecnología activa a partir de 2024.

• Plataforma de tecnología PharmFilm®
• Sistemas de administración de medicamentos sublinguales
• Tecnologías de cine orales desintegradores rápidos

Cumplimiento regulatorio y ensayos clínicos

Los gastos de ensayos clínicos en 2023 totalizaron $ 15.6 millones, con participación continua de la FDA para aprobaciones de productos.

Actividad regulatoria	Número de pruebas en curso	Presentaciones regulatorias
Interacciones de la FDA	3 pruebas activas	2 nuevas aplicaciones de drogas

Comercialización de productos farmacéuticos especializados

Los esfuerzos de comercialización de productos en 2023 generaron $ 48.3 millones en ingresos totales, con enfoque en:

• Medicamentos especializados en el SNC
• Tratamientos de enfermedades raras
• Trastorno neurológico farmacéuticos

Investigación y desarrollo de tecnologías de cine orales

La inversión de I + D para las tecnologías de cine orales alcanzó los $ 12.7 millones en 2023, con énfasis en:

• Nuevos mecanismos de administración de medicamentos
• Tecnologías mejoradas de cumplimiento del paciente
• Técnicas avanzadas de formulación farmacéutica

Parámetro tecnológico	Especificación	Métrico de rendimiento
Tiempo de disolución	<5 segundos	98% de eficiencia de administración de medicamentos
Espesor de la película	50-100 micras	Fabricación de precisión

Aquestive Therapeutics, Inc. (AQST) - Modelo de negocio: recursos clave

Plataforma de administración de medicamentos de farmfilm patentado

La tecnología farmfilm de Aquestive Therapeutics representa un Plataforma de administración de medicamentos oral basada en la película oral única. A partir de 2024, la compañía posee múltiples patentes relacionadas con esta tecnología.

Métricas de tecnología PharmFilm	Datos cuantitativos
Número de patentes activas	12 patentes registradas
I + D Inversión en plataforma	$ 8.3 millones en 2023

Cartera de propiedades intelectuales

La Compañía mantiene una sólida estrategia de propiedad intelectual.

• 12 patentes registradas que cubren la tecnología PharmFilm
• 5 solicitudes de patentes pendientes
• Valor de propiedad intelectual estimado en $ 45.2 millones

Equipo de Investigación y Desarrollo Científico

Composición del equipo de I + D	Número
Personal total de I + D	42 empleados
Investigadores a nivel de doctorado	18 investigadores
Gastos anuales de I + D	$ 22.7 millones en 2023

Capacidades de fabricación avanzada

Aquestive opera instalaciones de fabricación especializadas.

• 1 instalación de fabricación primaria
• Capacidades de producción compatibles con la FDA
• Capacidad de producción anual: 50 millones de unidades de cine

Experiencia farmacéutica estratégica

Métricas de experiencia estratégica	Detalles
Años en desarrollo farmacéutico	15 años
Áreas terapéuticas de enfoque	CNS, Neurología, Oncología
Asociaciones estratégicas	3 colaboraciones farmacéuticas activas

Aquestive Therapeutics, Inc. (AQST) - Modelo de negocio: propuestas de valor

Tecnología innovadora de administración de medicamentos orales

Aquestive Therapeutics se especializa en tecnología PharmFilm®, que permite la administración de fármacos a través de una película oral delgada y rápidamente disolución. A partir del cuarto trimestre de 2023, la compañía tiene 7 productos aprobados por la FDA Utilizando esta tecnología patentada.

Métrica de tecnología	Estado actual
Cartera de patentes	32 patentes emitidas
Inversión de I + D (2023)	$ 33.4 millones
Plataforma única de administración de medicamentos	Tecnología PharmFilm®

Absorción mejorada de medicamentos para el paciente

La tecnología PharmFilm® demuestra características de absorción superiores en comparación con los medicamentos orales tradicionales.

• Mejora de la biodisponibilidad: hasta 15-20% de tasas de absorción más altas
• Disolución rápida de drogas: típicamente dentro de 5-10 segundos
• Control de dosis preciso: mecanismo de administración de fármacos consistente

Métodos de administración de medicamentos simplificados

La plataforma de administración de medicamentos de Aquestive ofrece ventajas significativas en la administración de medicamentos, particularmente para pacientes con dificultades para tragar.

Beneficio de la administración	Ventaja cuantitativa
Cumplimiento del paciente	Mejora estimada del 35-40%
Precisión de dosis	± 2% de margen de error
Método de entrega alternativa	No se requiere agua para el consumo

Opciones de tratamiento mejoradas para afecciones médicas complejas

Aquestive se centra en el desarrollo de tratamientos para enfermedades neurológicas, psiquiátricas y raras.

• Cartera de tratamiento de epilepsia: 2 medicamentos especializados
• Gestión de migraña: 1 tratamiento basado en la película aprobado por la FDA
• Intervenciones de enfermedades raras: tubería clínica en curso

Potencial para una respuesta terapéutica más rápida

La tecnología PharmFilm® permite una rápida absorción de fármacos y inicio de acción.

Métrica de respuesta terapéutica	Indicador de rendimiento
Inicio de la acción	30-50% más rápido en comparación con las tabletas tradicionales
Concentración de plasma máximo	Logró 15-25 minutos más rápido
Eficacia clínica	Comparable a las formulaciones orales estándar

Aquestive Therapeutics, Inc. (AQST) - Modelo de negocios: relaciones con los clientes

Compromiso médico directo

A partir del cuarto trimestre de 2023, Aquestive Therapeutics mantuvo el compromiso directo con aproximadamente 3.500 profesionales de la salud especializados en las especialidades de neurología, psiquiatría y oncología.

Tipo de compromiso	Número de profesionales	Frecuencia de interacción
Representantes de ventas directas	87	Trimestral
Enlaces de ciencias médicas	22	Mensual

Programas de apoyo y educación clínica

Aquestive invirtió $ 2.3 millones en iniciativas de educación clínica en 2023.

• Programas de educación médica continua (CME): 47 eventos
• Módulos de capacitación en línea: 12 plataformas digitales
• Soporte de investigación clínica: $ 1.1 millones asignados

Plataformas de comunicación digital

Las métricas de participación digital para 2023 mostraron:

Plataforma	Usuarios activos	Tasa de interacción
Portal profesional	2,876	68%
Aplicación móvil del paciente	5,412	52%

Servicios personalizados de apoyo al paciente

Presupuesto del programa de apoyo al paciente: $ 3.7 millones en 2023.

• Línea de ayuda de paciente dedicada: servicio 24/7
• Manejo de medicamentos individualizados: 3,200 pacientes se inscribieron
• Asistencia de navegación de seguros: cubrió el 92% de los pacientes

Desarrollo continuo de productos farmacéuticos

Inversión en I + D en desarrollo de productos centrados en el cliente: $ 22.4 millones en 2023.

Categoría de productos	Etapa de desarrollo	Impacto del mercado proyectado
Tratamientos de neurología	Fase III	Alto potencial
Oncología Cuidados de apoyo	Fase II	Potencial medio

Aquestive Therapeutics, Inc. (AQST) - Modelo de negocio: canales

Fuerza de ventas directa dirigida a proveedores de atención médica

A partir del cuarto trimestre de 2023, Aquestive Therapeutics mantiene una fuerza de ventas especializada de 35 representantes profesionales centrados en el marketing farmacéutico directo a los proveedores de atención médica.

Métrico de canal de ventas	2023 datos
Número de representantes de ventas	35
Especialidades de atención médica objetivo	Neurología, Psiquiatría, Oncología
Duración promedio de llamadas de ventas	22 minutos

Redes de distribuidores farmacéuticos

Aquestive utiliza múltiples canales nacionales de distribución farmacéutica para garantizar la disponibilidad del producto.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Plataformas de información médica en línea

Las plataformas de participación digital incluyen sitios web médicos profesionales y redes de prescripción electrónica.

Plataforma digital	Visitantes únicos mensuales
Sitio web de la empresa	47,500
Portales médicos profesionales	82,300

Presentaciones de conferencia médica

En 2023, Aquestive participó en 12 conferencias médicas principales en especialidades de neurología y psiquiatría.

Marketing digital y canales de comunicación profesional

El presupuesto de marketing digital para 2023 fue de $ 2.4 millones, dirigido a profesionales de la salud a través de canales digitales especializados.

Canal de marketing digital	Tasa de compromiso
Red profesional de LinkedIn	4.2%
Campañas de correo electrónico médicas dirigidas	3.7%
Participación en el seminario web	2.9%

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

Neurólogos

A partir del cuarto trimestre de 2023, la terapéutica Aquestive se dirige a los neurólogos que se especializan en el tratamiento de la epilepsia con la película bucal de Libervant, una medicación innovadora.

Segmento de clientes	Tamaño del mercado	Volumen de prescripción potencial
Neurólogos	52,600 neurólogos en EE. UU.	Estimados de 3,4 millones de pacientes con epilepsia

Psiquiatras

Aquestive se centra en los psiquiatras que manejan condiciones de salud mental complejas a través de formulaciones farmacéuticas especializadas.

• Objetivo principal: psiquiatras que tratan la esquizofrenia
• Enfoque secundario: profesionales de la salud mental que manejan trastornos de ansiedad

Condición psiquiátrica	Población de pacientes	Potencial de tratamiento
Esquizofrenia	3.2 millones de pacientes estadounidenses	Alcance del mercado potencial: $ 1.2 mil millones

Especialistas en oncología

Aquestive desarrolla intervenciones farmacéuticas especializadas para profesionales de oncología que abordan los complejos desafíos del tratamiento del cáncer.

Segmento oncológico	Alcance del mercado	Tratamientos especializados
Especialistas en oncología	15,200 oncólogos en ejercicio	Desarrollo de soluciones farmacéuticas dirigidas

Profesionales del tratamiento de adicciones

Aquestive se dirige a los profesionales del tratamiento de adicciones con soluciones farmacéuticas innovadoras para los trastornos de uso de sustancias.

• Centrarse en el tratamiento asistido por medicamentos (MAT)
• Abordar la gestión de adicciones de los opioides

Segmento de tratamiento de adicciones	Potencial de mercado	Oportunidades de tratamiento
Profesionales del tratamiento de adicciones	21,000 especialistas en adicción certificados	Mercado de tratamiento de adicciones estimado de $ 35.6 mil millones

Pacientes que requieren intervenciones farmacéuticas especializadas

Aquestive desarrolla soluciones farmacéuticas específicas del paciente en múltiples áreas terapéuticas.

Segmento de paciente	Necesidades médicas insatisfechas	Innovación del tratamiento
Condiciones médicas complejas	Pacientes con una administración de medicamentos desafiantes	Tecnologías de administración de medicamentos patentados

Aquestive Therapeutics, Inc. (AQST) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

A partir del año fiscal 2022, Aquestive Therapeutics reportó gastos totales de I + D de $ 32.1 millones.

Año	Gastos de I + D
2022	$ 32.1 millones
2021	$ 37.8 millones

Inversiones de ensayos clínicos

Las inversiones en ensayos clínicos para Aquestive en 2022 fueron de aproximadamente $ 15.7 millones, centrándose en áreas terapéuticas clave.

• Ensayos clínicos de neurología: $ 6.2 millones
• Ensayos clínicos de oncología: $ 5.5 millones
• Ensayos de trastorno del SNC: $ 4 millones

Infraestructura de fabricación

Los costos de fabricación de Aquestive en 2022 fueron de $ 22.4 millones, cubriendo instalaciones de producción y mantenimiento de equipos.

Categoría de costos de fabricación	Cantidad
Mantenimiento de la instalación	$ 8.6 millones
Depreciación del equipo	$ 7.2 millones
Materiales de producción	$ 6.6 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para Aquestive en 2022 totalizaron $ 5.3 millones.

• Costos de presentación de la FDA: $ 2.1 millones
• Garantía de calidad: $ 1.8 millones
• Documentación regulatoria: $ 1.4 millones

Gastos de ventas y marketing

Los gastos de ventas y marketing para Aquestive en 2022 fueron de $ 28.6 millones.

Canal de marketing	Gasto
Marketing digital	$ 9.4 millones
Compensación del equipo de ventas	$ 12.2 millones
Marketing de conferencias y eventos	$ 7 millones

Aquestive Therapeutics, Inc. (AQST) - Modelo de negocios: flujos de ingresos

Venta de productos farmacéuticos

A partir del tercer trimestre de 2023, Aquestive Therapeutics informó ingresos netos de productos totales de $ 10.4 millones. Los principales productos farmacéuticos de la compañía incluyen:

Producto	Ingresos anuales (2023)
Libervant (medicamentos de incautación)	$ 4.2 millones
Sympazan	$ 3.7 millones
Otros productos farmacéuticos	$ 2.5 millones

Licencias de tecnologías de suministro de medicamentos

Aquestive genera ingresos mediante la licencia de sus plataformas de entrega de medicamentos patentados:

• Licencias de tecnología PharmFilm®
• Sistema de entrega de películas sublingual de licencias

Categoría de licencias de tecnología	Ingresos anuales estimados
Tarifas de licencia de PharmFilm®	$ 1.8 millones
Licencia de cine sublingual	$ 1.2 millones

Pagos de regalías de asociaciones tecnológicas

Las regalías de asociación tecnológica para 2023 totalizaron aproximadamente $ 2.5 millones, derivadas de:

• Acuerdos de pareja farmacéutica
• Colaboraciones de tecnología de suministro de medicamentos

Servicios de investigación y desarrollo de contratos

Los ingresos por contrato de I + D para 2023 fueron de $ 3.1 millones, que incluyen:

Tipo de servicio de I + D	Contribución de ingresos
Investigación farmacéutica externa	$ 1.9 millones
Contratos de desarrollo tecnológico	$ 1.2 millones

Pagos de hitos de acuerdos de colaboración

Los pagos de hitos en 2023 ascendieron a $ 4.6 millones, desglosados ​​de la siguiente manera:

Tipo de acuerdo de colaboración	Monto del pago de hitos
Hitos de desarrollo farmacéutico	$ 3.2 millones
Hitos de transferencia de tecnología	$ 1.4 millones

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.