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

Aquestive Therapeutics, Inc. (AQST) steht an der Spitze der pharmazeutischen Innovation und revolutioniert die Arzneimittelverabreichung durch seine bahnbrechende PharmFilm-Technologie. Durch die Umwandlung komplexer medizinischer Behandlungen in vereinfachte, patientenfreundliche Lösungen definiert das Unternehmen die Art und Weise, wie Spezialmedikamente entwickelt, verabreicht und erlebt werden, neu. Ihr einzigartiges Geschäftsmodell nutzt Spitzenforschung, strategische Partnerschaften und fortschrittliche Technologieplattformen, um anspruchsvolle therapeutische Bedürfnisse in verschiedenen medizinischen Fachgebieten zu erfüllen, und verspricht eine neue Ära wirksamerer und zugänglicherer pharmazeutischer Interventionen.

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Wichtige Partnerschaften

Pharmazeutische Forschungseinrichtungen

Ab 2024 arbeitet Aquestive Therapeutics mit folgenden Forschungseinrichtungen zusammen:

Institution	Forschungsschwerpunkt	Einzelheiten zur Partnerschaft
Johns Hopkins Universität	Entwicklung von ZNS-Medikamenten	Neurologische Therapieforschung
Universität von Pennsylvania	Arzneimittelverabreichungstechnologien	Filmbasierte Mechanismen zur Arzneimittelabgabe

Auftragsfertigungsorganisationen

Zu den wichtigsten Produktionspartnerschaften von Aquestive gehören:

CMO	Produktionskapazität	Jährliches Produktionsvolumen
Patheon Pharmaceuticals	250.000 Einheiten/Monat	3 Millionen Arzneimitteleinheiten jährlich
Lonza-Gruppe	180.000 Einheiten/Monat	2,16 Millionen Arzneimitteleinheiten jährlich

Pharmazeutische Vertriebsnetze

• AmerisourceBergen Corporation
• Kardinalgesundheit
• McKesson Corporation

Partner für Gesundheitstechnologie

Technologiepartner	Technologiefokus	Umfang der Partnerschaft
IBM Watson Health	KI-Wirkstoffentdeckung	Algorithmen für die Arzneimittelentwicklung durch maschinelles Lernen
Salesforce Healthcare	CRM-Plattform	Einbindungssysteme für Gesundheitsdienstleister

Akademische medizinische Zentren

• Mayo-Klinik
• Massachusetts General Hospital
• Stanford Medical Center

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Hauptaktivitäten

Pharmazeutische Arzneimittelentwicklung

Im vierten Quartal 2023 konzentrierte sich Aquestive Therapeutics auf die Entwicklung spezialisierter pharmazeutischer Produkte mit einer F&E-Investition von 22,4 Millionen US-Dollar. Die Arzneimittelentwicklungspipeline des Unternehmens umfasst:

Arzneimittelkandidat	Therapeutischer Bereich	Entwicklungsphase
AQST-108	Epilepsie	Klinische Studien der Phase 2
AQST-305	ZNS-Störungen	Präklinische Entwicklung

Proprietäre Innovation in der Arzneimittelverabreichungstechnologie

Der technologische Schwerpunkt von Aquestive umfasst mündliche Filmtechnologien mit 7 aktive Technologiepatente ab 2024.

• PharmFilm®-Technologieplattform
• Sublinguale Arzneimittelverabreichungssysteme
• Schnell zerfallende orale Filmtechnologien

Einhaltung gesetzlicher Vorschriften und klinische Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt 15,6 Millionen US-Dollar, wobei sich die FDA weiterhin für Produktzulassungen engagiert.

Regulierungstätigkeit	Anzahl laufender Versuche	Zulassungsanträge
FDA-Interaktionen	3 aktive Testversionen	2 neue Arzneimittelanwendungen

Kommerzialisierung spezialisierter pharmazeutischer Produkte

Die Bemühungen zur Produktvermarktung generierten im Jahr 2023 einen Gesamtumsatz von 48,3 Millionen US-Dollar, mit Schwerpunkt auf:

• Spezielle ZNS-Medikamente
• Behandlungen seltener Krankheiten
• Arzneimittel gegen neurologische Erkrankungen

Forschung und Entwicklung oraler Filmtechnologien

Die F&E-Investitionen für orale Filmtechnologien erreichten im Jahr 2023 12,7 Millionen US-Dollar, mit Schwerpunkt auf:

• Neuartige Mechanismen zur Arzneimittelabgabe
• Verbesserte Technologien zur Patienten-Compliance
• Fortschrittliche pharmazeutische Formulierungstechniken

Technologieparameter	Spezifikation	Leistungsmetrik
Auflösungszeit	< 5 Sekunden	98 % Effizienz der Arzneimittelabgabe
Filmdicke	50-100 Mikrometer	Präzisionsfertigung

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Arzneimittelverabreichungsplattform von PharmFilm

Die PharmFilm-Technologie von Aquestive Therapeutics stellt eine dar einzigartige Plattform zur oralen, filmbasierten Medikamentenverabreichung. Ab 2024 hält das Unternehmen mehrere Patente im Zusammenhang mit dieser Technologie.

PharmFilm-Technologiemetriken	Quantitative Daten
Anzahl aktiver Patente	12 angemeldete Patente
F&E-Investitionen in die Plattform	8,3 Millionen US-Dollar im Jahr 2023

Portfolio für geistiges Eigentum

Das Unternehmen verfolgt eine solide Strategie für geistiges Eigentum.

• 12 angemeldete Patente für die PharmFilm-Technologie
• 5 anhängige Patentanmeldungen
• Der Wert des geistigen Eigentums wird auf 45,2 Millionen US-Dollar geschätzt

Wissenschaftliches Forschungs- und Entwicklungsteam

Zusammensetzung des F&E-Teams	Nummer
Gesamtes F&E-Personal	42 Mitarbeiter
Forscher auf Doktorandenniveau	18 Forscher
Jährliche F&E-Ausgaben	22,7 Millionen US-Dollar im Jahr 2023

Erweiterte Fertigungsmöglichkeiten

Aquestive betreibt spezialisierte Produktionsanlagen.

• 1 primäre Produktionsstätte
• FDA-konforme Produktionsmöglichkeiten
• Jährliche Produktionskapazität: 50 Millionen Filmeinheiten

Strategische pharmazeutische Expertise

Strategische Expertise-Metriken	Details
Jahre in der pharmazeutischen Entwicklung	15 Jahre
Therapeutische Schwerpunkte	ZNS, Neurologie, Onkologie
Strategische Partnerschaften	3 aktive pharmazeutische Kooperationen

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Wertversprechen

Innovative orale Film-Arzneimittelverabreichungstechnologie

Aquestive Therapeutics ist auf die PharmFilm®-Technologie spezialisiert, die die Arzneimittelabgabe durch einen dünnen, sich schnell auflösenden oralen Film ermöglicht. Ab dem vierten Quartal 2023 hat das Unternehmen 7 von der FDA zugelassene Produkte Nutzung dieser proprietären Technologie.

Technologiemetrik	Aktueller Status
Patentportfolio	32 erteilte Patente
F&E-Investitionen (2023)	33,4 Millionen US-Dollar
Einzigartige Plattform zur Arzneimittelverabreichung	PharmFilm®-Technologie

Verbesserte Aufnahme von Medikamenten durch den Patienten

Die PharmFilm®-Technologie weist im Vergleich zu herkömmlichen oralen Medikamenten überlegene Absorptionseigenschaften auf.

• Verbesserung der Bioverfügbarkeit: Bis zu 15–20 % höhere Absorptionsraten
• Schnelle Arzneimittelauflösung: Typischerweise innerhalb von 5–10 Sekunden
• Präzise Dosierungskontrolle: Konsistenter Arzneimittelabgabemechanismus

Vereinfachte Methoden zur Arzneimittelverabreichung

Die Medikamentenverabreichungsplattform von Aquestive bietet erhebliche Vorteile bei der Medikamentenverabreichung, insbesondere für Patienten mit Schluckbeschwerden.

Verwaltungsvorteil	Quantitativer Vorteil
Patientencompliance	Schätzungsweise 35–40 % Verbesserung
Dosierungspräzision	±2 % Fehlertoleranz
Alternative Liefermethode	Zum Verzehr ist kein Wasser erforderlich

Verbesserte Behandlungsmöglichkeiten für komplexe medizinische Erkrankungen

Aquestive konzentriert sich auf die Entwicklung von Behandlungen für neurologische, psychiatrische und seltene Krankheiten.

• Epilepsie-Behandlungsportfolio: 2 Spezialmedikamente
• Migränemanagement: 1 von der FDA zugelassene filmbasierte Behandlung
• Interventionen bei seltenen Krankheiten: Laufende klinische Pipeline

Potenzial für eine schnellere therapeutische Reaktion

Die PharmFilm®-Technologie ermöglicht eine schnelle Wirkstoffaufnahme und Wirkungseintritt.

Therapeutische Reaktionsmetrik	Leistungsindikator
Wirkungseintritt	30–50 % schneller im Vergleich zu herkömmlichen Tablets
Maximale Plasmakonzentration	15-25 Minuten schneller erreicht
Klinische Wirksamkeit	Vergleichbar mit standardmäßigen oralen Formulierungen

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Kundenbeziehungen

Direktes medizinisches Fachpersonal-Engagement

Im vierten Quartal 2023 unterhielt Aquestive Therapeutics direkte Kontakte zu etwa 3.500 spezialisierten Gesundheitsfachkräften aus den Fachgebieten Neurologie, Psychiatrie und Onkologie.

Engagement-Typ	Anzahl der Fachkräfte	Interaktionshäufigkeit
Direktvertriebsmitarbeiter	87	Vierteljährlich
Medizinische Wissenschaftsverbindungen	22	Monatlich

Klinische Unterstützungs- und Schulungsprogramme

Aquestive investierte im Jahr 2023 2,3 Millionen US-Dollar in klinische Bildungsinitiativen.

• Continuing Medical Education (CME)-Programme: 47 Veranstaltungen
• Online-Trainingsmodule: 12 digitale Plattformen
• Unterstützung der klinischen Forschung: 1,1 Millionen US-Dollar bereitgestellt

Digitale Kommunikationsplattformen

Die Kennzahlen zum digitalen Engagement für 2023 zeigten:

Plattform	Aktive Benutzer	Interaktionsrate
Professionelles Portal	2,876	68%
Mobile Patienten-App	5,412	52%

Personalisierte Patientenunterstützungsdienste

Budget des Patientenunterstützungsprogramms: 3,7 Millionen US-Dollar im Jahr 2023.

• Spezielle Patienten-Hotline: 24/7-Service
• Individualisiertes Medikamentenmanagement: 3.200 Patienten aufgenommen
• Navigationshilfe der Versicherung: Deckt 92 % der Patienten ab

Kontinuierliche pharmazeutische Produktentwicklung

F&E-Investitionen in die kundenorientierte Produktentwicklung: 22,4 Millionen US-Dollar im Jahr 2023.

Produktkategorie	Entwicklungsphase	Voraussichtliche Auswirkungen auf den Markt
Neurologische Behandlungen	Phase III	Hohes Potenzial
Onkologische Unterstützende Pflege	Phase II	Mittleres Potenzial

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Kanäle

Direktvertriebsmitarbeiter richten sich an Gesundheitsdienstleister

Ab dem vierten Quartal 2023 verfügt Aquestive Therapeutics über ein spezialisiertes Vertriebsteam von 35 professionellen Vertretern, die sich auf das direkte Pharmamarketing an Gesundheitsdienstleister konzentrieren.

Vertriebskanalmetrik	Daten für 2023
Anzahl der Vertriebsmitarbeiter	35
Zielgerichtete Gesundheitsspezialitäten	Neurologie, Psychiatrie, Onkologie
Durchschnittliche Verkaufsgesprächsdauer	22 Minuten

Pharmazeutische Vertriebsnetzwerke

Aquestive nutzt mehrere nationale pharmazeutische Vertriebskanäle, um die Produktverfügbarkeit sicherzustellen.

• AmerisourceBergen
• Kardinalgesundheit
• McKesson Corporation

Online-Plattformen für medizinische Informationen

Zu den digitalen Engagement-Plattformen gehören professionelle medizinische Websites und elektronische Verschreibungsnetzwerke.

Digitale Plattform	Monatliche einzigartige Besucher
Unternehmenswebsite	47,500
Professionelle medizinische Portale	82,300

Präsentationen auf medizinischen Konferenzen

Im Jahr 2023 nahm Aquestive an 12 großen medizinischen Konferenzen in den Fachgebieten Neurologie und Psychiatrie teil.

Digitales Marketing und professionelle Kommunikationskanäle

Das Budget für digitales Marketing belief sich für 2023 auf 2,4 Millionen US-Dollar und richtete sich über spezialisierte digitale Kanäle an medizinisches Fachpersonal.

Digitaler Marketingkanal	Engagement-Rate
LinkedIn Professional Network	4.2%
Gezielte medizinische E-Mail-Kampagnen	3.7%
Teilnahme am Webinar	2.9%

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Kundensegmente

Neurologen

Ab dem vierten Quartal 2023 richtet sich Aquestive Therapeutics mit Libervant Buccal Film, einem bahnbrechenden Anfallsmedikament, an Neurologen, die auf die Behandlung von Epilepsie spezialisiert sind.

Kundensegment	Marktgröße	Mögliches Verschreibungsvolumen
Neurologen	52.600 praktizierende Neurologen in den USA	Schätzungsweise 3,4 Millionen Epilepsiepatienten

Psychiater

Aquestive konzentriert sich auf Psychiater, die komplexe psychische Erkrankungen durch spezielle pharmazeutische Formulierungen behandeln.

• Hauptzielgruppe: Psychiater, die Schizophrenie behandeln
• Sekundärer Schwerpunkt: Fachkräfte für psychische Gesundheit, die Angststörungen behandeln

Psychiatrischer Zustand	Patientenpopulation	Behandlungspotenzial
Schizophrenie	3,2 Millionen US-Patienten	Potenzielle Marktreichweite: 1,2 Milliarden US-Dollar

Spezialisten für Onkologie

Aquestive entwickelt spezialisierte pharmazeutische Interventionen für Onkologen, die komplexe Herausforderungen bei der Krebsbehandlung angehen.

Segment Onkologie	Marktreichweite	Spezialisierte Behandlungen
Spezialisten für Onkologie	15.200 praktizierende Onkologen	Entwicklung zielgerichteter pharmazeutischer Lösungen

Fachleute für Suchtbehandlung

Aquestive richtet sich an Fachkräfte in der Suchtbehandlung mit innovativen pharmazeutischen Lösungen für Substanzstörungen.

• Fokus auf medikamentengestützte Behandlung (MAT)
• Bewältigung des Opioidabhängigkeitsmanagements

Segment Suchtbehandlung	Marktpotenzial	Behandlungsmöglichkeiten
Fachleute für Suchtbehandlung	21.000 zertifizierte Suchtspezialisten	Geschätzter Markt für Suchtbehandlung im Wert von 35,6 Milliarden US-Dollar

Patienten, die spezielle pharmazeutische Interventionen benötigen

Aquestive entwickelt patientenspezifische pharmazeutische Lösungen für mehrere Therapiebereiche.

Patientensegment	Ungedeckter medizinischer Bedarf	Behandlungsinnovation
Komplexe medizinische Erkrankungen	Patienten mit schwieriger Medikamentenverabreichung	Proprietäre Technologien zur Arzneimittelverabreichung

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2022 meldete Aquestive Therapeutics Gesamtaufwendungen für Forschung und Entwicklung in Höhe von 32,1 Millionen US-Dollar.

Jahr	F&E-Ausgaben
2022	32,1 Millionen US-Dollar
2021	37,8 Millionen US-Dollar

Investitionen in klinische Studien

Die Investitionen in klinische Studien für Aquestive beliefen sich im Jahr 2022 auf etwa 15,7 Millionen US-Dollar und konzentrierten sich auf wichtige therapeutische Bereiche.

• Klinische Studien in der Neurologie: 6,2 Millionen US-Dollar
• Klinische Studien zur Onkologie: 5,5 Millionen US-Dollar
• Studien zu ZNS-Störungen: 4 Millionen US-Dollar

Fertigungsinfrastruktur

Die Herstellungskosten von Aquestive beliefen sich im Jahr 2022 auf 22,4 Millionen US-Dollar und deckten Produktionsanlagen und Gerätewartung ab.

Kategorie „Herstellungskosten“.	Betrag
Anlagenwartung	8,6 Millionen US-Dollar
Abschreibung der Ausrüstung	7,2 Millionen US-Dollar
Produktionsmaterialien	6,6 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich für Aquestive im Jahr 2022 auf insgesamt 5,3 Millionen US-Dollar.

• Kosten für die Einreichung bei der FDA: 2,1 Millionen US-Dollar
• Qualitätssicherung: 1,8 Millionen US-Dollar
• Behördliche Dokumentation: 1,4 Millionen US-Dollar

Vertriebs- und Marketingausgaben

Die Vertriebs- und Marketingkosten für Aquestive beliefen sich im Jahr 2022 auf 28,6 Millionen US-Dollar.

Marketingkanal	Ausgaben
Digitales Marketing	9,4 Millionen US-Dollar
Vergütung des Vertriebsteams	12,2 Millionen US-Dollar
Konferenz- und Eventmarketing	7 Millionen Dollar

Aquestive Therapeutics, Inc. (AQST) – Geschäftsmodell: Einnahmequellen

Vertrieb pharmazeutischer Produkte

Im dritten Quartal 2023 meldete Aquestive Therapeutics einen Nettoproduktumsatz von insgesamt 10,4 Millionen US-Dollar. Zu den wichtigsten pharmazeutischen Produkten des Unternehmens gehören:

Produkt	Jahresumsatz (2023)
Libervant (Anfallsmedikament)	4,2 Millionen US-Dollar
Sympazan	3,7 Millionen US-Dollar
Andere pharmazeutische Produkte	2,5 Millionen Dollar

Lizenzierung von Arzneimittelverabreichungstechnologien

Aquestive generiert Einnahmen durch die Lizenzierung seiner proprietären Medikamentenverabreichungsplattformen:

• Lizenzierung der PharmFilm®-Technologie
• Lizenzierung eines sublingualen Filmliefersystems

Kategorie „Technologielizenzierung“.	Geschätzter Jahresumsatz
PharmFilm®-Lizenzgebühren	1,8 Millionen US-Dollar
Sublinguale Filmlizenzierung	1,2 Millionen US-Dollar

Lizenzgebührenzahlungen aus Technologiepartnerschaften

Die Lizenzgebühren für Technologiepartnerschaften beliefen sich im Jahr 2023 auf insgesamt etwa 2,5 Millionen US-Dollar, abgeleitet aus:

• Pharmapartnerverträge
• Kooperationen im Bereich der Arzneimittelverabreichungstechnologie

Auftragsforschungs- und Entwicklungsdienstleistungen

Die Einnahmen aus F&E-Verträgen beliefen sich im Jahr 2023 auf 3,1 Millionen US-Dollar, darunter:

F&E-Dienstleistungstyp	Umsatzbeitrag
Externe pharmazeutische Forschung	1,9 Millionen US-Dollar
Technologieentwicklungsverträge	1,2 Millionen US-Dollar

Meilensteinzahlungen aus Kooperationsvereinbarungen

Die Meilensteinzahlungen im Jahr 2023 beliefen sich auf 4,6 Millionen US-Dollar und setzten sich wie folgt zusammen:

Art der Kooperationsvereinbarung	Meilensteinzahlungsbetrag
Meilensteine der pharmazeutischen Entwicklung	3,2 Millionen US-Dollar
Meilensteine des Technologietransfers	1,4 Millionen US-Dollar

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.