AQUESTIVE Therapeutics, Inc. (AQST): Business Model Canvas [Jan-2025 Mis à jour]

Aquestive Therapeutics, Inc. (AQST) est à l'avant-garde de l'innovation pharmaceutique, révolutionnant la livraison de médicaments grâce à sa technologie révolutionnaire de pharmfilm. En transformant des traitements médicaux complexes en solutions simplifiées et conviviales, l'entreprise redéfinit la façon dont les médicaments spécialisés sont développés, administrés et expérimentés. Leur modèle commercial unique exploite des recherches de pointe, des partenariats stratégiques et des plateformes technologiques avancées pour répondre aux besoins thérapeutiques difficiles à travers de multiples spécialités médicales, promettant une nouvelle ère d'interventions pharmaceutiques plus efficaces et plus accessibles.

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle commercial: partenariats clés

Institutions de recherche pharmaceutique

Depuis 2024, la thérapeutique aquatique collabore avec les institutions de recherche suivantes:

Institution	Focus de recherche	Détails du partenariat
Université Johns Hopkins	Développement de médicaments du SNC	Recherche thérapeutique neurologique
Université de Pennsylvanie	Technologies d'administration de médicaments	Mécanismes d'administration de médicaments à base de film

Organisations de fabrication de contrats

Les principaux partenariats de fabrication d'Adestif comprennent:

CMO	Capacité de fabrication	Volume de production annuel
Patheon Pharmaceuticals	250 000 unités / mois	3 millions d'unités pharmaceutiques par an
Groupe Lonza	180 000 unités / mois	2,16 millions d'unités pharmaceutiques par an

Réseaux de distribution pharmaceutique

• Amerisourcebergen Corporation
• Santé cardinale
• McKesson Corporation

Partners de la technologie des soins de santé

Partenaire technologique	Focus technologique	Portée du partenariat
IBM Watson Health	Découverte de médicaments IA	Algorithmes de développement de médicaments d'apprentissage automatique
Salesforce Healthcare	Plate-forme CRM	Systèmes d'engagement des fournisseurs de soins de santé

Centres médicaux académiques

• Clinique de mayo
• Hôpital général du Massachusetts
• Centre médical de Stanford

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle d'entreprise: Activités clés

Développement de médicaments pharmaceutiques

Depuis le quatrième trimestre 2023, la thérapeutique aquatique s'est concentrée sur le développement de produits pharmaceutiques spécialisés avec un investissement en R&D de 22,4 millions de dollars. Le pipeline de développement de médicaments de l'entreprise comprend:

Drogue	Zone thérapeutique	Étape de développement
AQST-108	Épilepsie	Essais cliniques de phase 2
AQST-305	Troubles du SNC	Développement préclinique

Innovation de la technologie de livraison de médicaments propriétaires

L'objectif de la technologie clé de l'Adestif comprend les technologies de cinéma orale avec 7 brevets technologiques actifs En 2024.

• Plate-forme technologique Pharmfilm®
• Systèmes de livraison de médicaments sublinguaux
• Technologies cinématographiques orales à désintégration rapide

Conformité réglementaire et essais cliniques

Les dépenses d'essais cliniques en 2023 ont totalisé 15,6 millions de dollars, avec l'engagement en cours de la FDA pour les approbations de produits.

Activité réglementaire	Nombre d'essais en cours	Soumissions réglementaires
Interactions de la FDA	3 essais actifs	2 nouvelles applications de médicament

Commercialisation de produits pharmaceutiques spécialisés

Les efforts de commercialisation des produits en 2023 ont généré 48,3 millions de dollars de revenus totaux, en mettant l'accent sur:

• Médicaments spécialisés du SNC
• Traitements de maladies rares
• Troubles neurologiques pharmaceutiques

Recherche et développement des technologies cinématographiques orales

L'investissement en R&D pour les technologies cinématographiques a atteint 12,7 millions de dollars en 2023, en mettant l'accent sur:

• Nouveaux mécanismes d'administration de médicaments
• Amélioration des technologies de conformité des patients
• Techniques de formulation pharmaceutique avancées

Paramètre technologique	Spécification	Métrique de performance
Temps de dissolution	<5 secondes	98% d'efficacité de l'administration de médicaments
Épaisseur de film	50-100 microns	Fabrication de précision

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle commercial: Ressources clés

Plateforme de livraison de médicaments pharmaliques propriétaires

La technologie de pharmfilm de la thérapeutique aquatique représente un Plateforme de livraison de médicaments à base de films orales uniques. En 2024, la société détient plusieurs brevets liés à cette technologie.

Métriques de la technologie pharmfilm	Données quantitatives
Nombre de brevets actifs	12 brevets enregistrés
Investissement en R&D dans la plate-forme	8,3 millions de dollars en 2023

Portefeuille de propriété intellectuelle

La société maintient une solide stratégie de propriété intellectuelle.

• 12 brevets enregistrés couvrant la technologie pharmfilm
• 5 demandes de brevet en instance
• Valeur de la propriété intellectuelle estimée à 45,2 millions de dollars

Équipe de recherche et développement scientifique

Composition de l'équipe R&D	Nombre
Personnel total de R&D	42 employés
Chercheurs de doctorat	18 chercheurs
Dépenses annuelles de R&D	22,7 millions de dollars en 2023

Capacités de fabrication avancées

Aquostive exploite des installations de fabrication spécialisées.

• 1 installation de fabrication primaire
• Capacités de production conformes à la FDA
• Capacité de production annuelle: 50 millions d'unités cinématographiques

Expertise pharmaceutique stratégique

Métriques d'expertise stratégique	Détails
Années dans le développement pharmaceutique	15 ans
Domaines thérapeutiques	SNC, neurologie, oncologie
Partenariats stratégiques	3 collaborations pharmaceutiques actives

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle d'entreprise: propositions de valeur

Technologie innovante de livraison de médicaments par film oral

La thérapie aquatique est spécialisée dans la technologie Pharmfilm®, qui permet l'administration de médicaments grâce à un film oral mince et rapidement dissolvant. Depuis le quatrième trimestre 2023, la société a 7 produits approuvés par la FDA en utilisant cette technologie propriétaire.

Métrique technologique	État actuel
Portefeuille de brevets	32 brevets délivrés
Investissement en R&D (2023)	33,4 millions de dollars
Plateforme de livraison de médicaments uniques	Technologie Pharmfilm®

Absorption améliorée des médicaments pour les patients

La technologie Pharmfilm® démontre des caractéristiques d'absorption supérieures par rapport aux médicaments oraux traditionnels.

• Amélioration de la biodisponibilité: jusqu'à 15 à 20% de taux d'absorption plus élevés
• Dissolution rapide du médicament: généralement en 5 à 10 secondes
• Contrôle de posologie précise: mécanisme cohérent d'administration de médicaments

Méthodes d'administration de médicament simplifiées

La plate-forme d'administration de médicaments d'Adestive offre des avantages importants dans l'administration de médicaments, en particulier pour les patients ayant des difficultés de déglutition.

Prestation d'administration	Avantage quantitatif
Conformité des patients	Amélioration estimée de 35 à 40%
Précision posologique	± 2% de marge d'erreur
Méthode de livraison alternative	Aucune eau requise pour la consommation

Amélioration des options de traitement pour des conditions médicales complexes

L'aquestif se concentre sur le développement de traitements pour les maladies neurologiques, psychiatriques et rares.

• Portfolio de traitement de l'épilepsie: 2 médicaments spécialisés
• Gestion de la migraine: 1 traitement au cinéma approuvé par la FDA
• Interventions de maladies rares: pipeline clinique en cours

Potentiel de réponse thérapeutique plus rapide

La technologie Pharmfilm® permet une absorption rapide des médicaments et un début d'action.

Métrique de réponse thérapeutique	Indicateur de performance
Début de l'action	30 à 50% plus rapidement par rapport aux tablettes traditionnelles
Concentration plasmatique maximale	Réalisé 15-25 minutes plus rapidement
Efficacité clinique	Comparable aux formulations orales standard

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle d'entreprise: relations avec les clients

Engagement professionnel médical direct

Depuis le quatrième trimestre 2023, les thérapies aquatiques ont maintenu un engagement direct avec environ 3 500 professionnels de la santé spécialisés à travers les spécialités de neurologie, de psychiatrie et d'oncologie.

Type d'engagement	Nombre de professionnels	Fréquence d'interaction
Représentants des ventes directes	87	Trimestriel
Liaisons de science médicale	22	Mensuel

Programmes de soutien clinique et d'éducation

Aquostive a investi 2,3 millions de dollars dans les initiatives d'éducation clinique en 2023.

• Programmes de formation médicale continue (CME): 47 événements
• Modules de formation en ligne: 12 plateformes numériques
• Support de recherche clinique: 1,1 million de dollars alloués

Plateformes de communication numérique

Les mesures d'engagement numérique pour 2023 ont montré:

Plate-forme	Utilisateurs actifs	Taux d'interaction
Portail professionnel	2,876	68%
Application mobile patient	5,412	52%

Services de soutien aux patients personnalisés

Budget du programme de soutien aux patients: 3,7 millions de dollars en 2023.

• Aide à patient dédiée: service 24/7
• Gestion des médicaments individualisés: 3 200 patients inscrits
• Assistance à la navigation en assurance: couvert 92% des patients

Développement continu de produits pharmaceutiques

Investissement en R&D dans le développement de produits axé sur le client: 22,4 millions de dollars en 2023.

Catégorie de produits	Étape de développement	Impact du marché projeté
Traitements de neurologie	Phase III	Potentiel élevé
Soins de soutien en oncologie	Phase II	Potentiel moyen

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle d'entreprise: canaux

Force de vente directe ciblant les prestataires de soins de santé

Depuis le quatrième trimestre 2023, la thérapeutique aquatique maintient une force de vente spécialisée de 35 représentants professionnels axés sur le marketing pharmaceutique direct auprès des prestataires de soins de santé.

Métrique du canal de vente	2023 données
Nombre de représentants commerciaux	35
Cibler les spécialités des soins de santé	Neurologie, psychiatrie, oncologie
Durée moyenne des appels de vente	22 minutes

Réseaux de distributeurs pharmaceutiques

L'aquestif utilise plusieurs canaux nationaux de distribution pharmaceutique pour assurer la disponibilité des produits.

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Plateformes d'information médicale en ligne

Les plateformes d'engagement numérique comprennent des sites Web médicaux professionnels et des réseaux de prescription électroniques.

Plate-forme numérique	Visiteurs uniques mensuels
Site Web de l'entreprise	47,500
Portails médicaux professionnels	82,300

Présentations de la conférence médicale

En 2023, Adestive a participé à 12 grandes conférences médicales à travers les spécialités de neurologie et de psychiatrie.

Marketing numérique et canaux de communication professionnels

Le budget du marketing numérique pour 2023 était de 2,4 millions de dollars, ciblant les professionnels de la santé par le biais de canaux numériques spécialisés.

Canal de marketing numérique	Taux d'engagement
LinkedIn Professional Network	4.2%
Campagnes par e-mail médicales ciblées	3.7%
Participation au webinaire	2.9%

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle d'entreprise: segments de clientèle

Neurologues

Depuis le quatrième trimestre 2023, la thérapeutique aquatique cible les neurologues spécialisés dans le traitement de l'épilepsie avec un film buccal libérateur, un médicament contre la crise.

Segment de clientèle	Taille du marché	Volume de prescription potentiel
Neurologues	52 600 neurologues pratiquants aux États-Unis	3,4 millions de patients d'épilepsie

Psychiatres

L'aquestif se concentre sur les psychiatres gérant des problèmes de santé mentale complexes grâce à des formulations pharmaceutiques spécialisées.

• Cible principale: les psychiatres traitant la schizophrénie
• Focus secondaire: les professionnels de la santé mentale gérant les troubles anxieux

Condition psychiatrique	Population de patients	Potentiel de traitement
Schizophrénie	3,2 millions de patients américains	Reach du marché potentiel: 1,2 milliard de dollars

Spécialistes en oncologie

L'aquestif développe des interventions pharmaceutiques spécialisées pour les professionnels de l'oncologie qui relèvent des défis complexes de traitement du cancer.

Segment d'oncologie	Portée du marché	Traitements spécialisés
Spécialistes en oncologie	15200 oncologues pratiquants	Développer des solutions pharmaceutiques ciblées

Professionnels du traitement de la toxicomanie

L'aquestif cible les professionnels du traitement de la toxicomanie avec des solutions pharmaceutiques innovantes pour les troubles liés à la consommation de substances.

• Concentrez-vous sur le traitement assisté par les médicaments (MAT)
• Aborder la gestion de la dépendance aux opioïdes

Segment de traitement de la toxicomanie	Potentiel de marché	Possibilités de traitement
Professionnels du traitement de la toxicomanie	21 000 spécialistes de la toxicomanie certifiés	Marché estimé à 35,6 milliards de dollars de traitement de la toxicomanie

Patients nécessitant des interventions pharmaceutiques spécialisées

L'aquestif développe des solutions pharmaceutiques spécifiques au patient dans plusieurs zones thérapeutiques.

Segment des patients	Besoins médicaux non satisfaits	Innovation du traitement
Conditions médicales complexes	Patients avec une administration de médicaments stimulante	Technologies de livraison de médicaments propriétaires

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Depuis l'exercice 2022, les thérapies aquatiques ont déclaré des dépenses totales de R&D de 32,1 millions de dollars.

Année	Dépenses de R&D
2022	32,1 millions de dollars
2021	37,8 millions de dollars

Investissements d'essais cliniques

Les investissements en essais cliniques pour les ajustés en 2022 étaient d'environ 15,7 millions de dollars, axés sur les principaux domaines thérapeutiques.

• Essais cliniques de neurologie: 6,2 millions de dollars
• Essais cliniques en oncologie: 5,5 millions de dollars
• Essais sur les troubles du SNC: 4 millions de dollars

Infrastructure de fabrication

Les coûts de fabrication d'Adestif en 2022 étaient de 22,4 millions de dollars, couvrant les installations de production et l'entretien de l'équipement.

Catégorie de coûts de fabrication	Montant
Entretien d'installation	8,6 millions de dollars
Dépréciation de l'équipement	7,2 millions de dollars
Matériaux de production	6,6 millions de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour les aquastes en 2022 ont totalisé 5,3 millions de dollars.

• Coûts de soumission de la FDA: 2,1 millions de dollars
• Assurance qualité: 1,8 million de dollars
• Documentation réglementaire: 1,4 million de dollars

Dépenses de vente et de marketing

Les dépenses de vente et de marketing pour aquotes en 2022 étaient de 28,6 millions de dollars.

Canal de marketing	Dépense
Marketing numérique	9,4 millions de dollars
Compensation de l'équipe de vente	12,2 millions de dollars
Marketing de conférence et d'événements	7 millions de dollars

AQUESTIVE Therapeutics, Inc. (AQST) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Au troisième trimestre 2023, Aquostive Therapeutics a rapporté des revenus nets du produit total de 10,4 millions de dollars. Les principaux produits pharmaceutiques de l'entreprise comprennent:

Produit	Revenus annuels (2023)
Libervant (médicaments contre la crise)	4,2 millions de dollars
Sympathique	3,7 millions de dollars
Autres produits pharmaceutiques	2,5 millions de dollars

Licence des technologies d'administration de médicaments

L'aquestif génère des revenus grâce à la licence de ses plateformes de livraison de médicaments propriétaires:

• Licence de technologie pharmfilm®
• Licence de système de livraison de films sublinguaux

Catégorie de licence technologique	Revenus annuels estimés
Frais de licence Pharmfilm®	1,8 million de dollars
Licence de film sublingual	1,2 million de dollars

Paiements de redevances à partir de partenariats technologiques

Les redevances de partenariat technologique pour 2023 ont totalisé environ 2,5 millions de dollars, dérivé de:

• Accords de partenaires pharmaceutiques
• Collaborations de technologie de livraison de médicaments

Services de recherche et développement contractuels

Les revenus du contrat de R&D pour 2023 étaient de 3,1 millions de dollars, notamment:

Type de service R&D	Contribution des revenus
Recherche pharmaceutique externe	1,9 million de dollars
Contrats de développement technologique	1,2 million de dollars

Payments d'étape des accords collaboratifs

Les paiements d'étape en 2023 s'élevaient à 4,6 millions de dollars, ventilés comme suit:

Type d'accord de collaboration	Montant de paiement d'étape
Jalons de développement pharmaceutique	3,2 millions de dollars
Jalons de transfert de technologie	1,4 million de dollars

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.