|
Axsome Therapeutics, Inc. (AXSM): Business Model Canvas |
Fully Editable: Tailor To Your Needs In Excel Or Sheets
Professional Design: Trusted, Industry-Standard Templates
Investor-Approved Valuation Models
MAC/PC Compatible, Fully Unlocked
No Expertise Is Needed; Easy To Follow
Axsome Therapeutics, Inc. (AXSM) Bundle
In der dynamischen Landschaft der pharmazeutischen Innovation entwickelt sich Axsome Therapeutics zu einem bahnbrechenden Neurowissenschaftsunternehmen, das die Art und Weise, wie wir komplexe neurologische Erkrankungen angehen, neu gestaltet. Durch die strategische Nutzung eines ausgefeilten Geschäftsmodells leistet diese hochmoderne Organisation Pionierarbeit bei bahnbrechenden Behandlungen, die versprechen, die Patientenversorgung bei Depressionen, Angstzuständen und der Schmerzbehandlung zu verändern. Ihr einzigartiger Ansatz kombiniert strenge wissenschaftliche Forschung, gezielte therapeutische Entwicklung und eine visionäre Strategie, die sie an die Spitze neurologischer pharmazeutischer Innovationen bringt.
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Wichtige Partnerschaften
Pharmazeutische Forschungseinrichtungen und Netzwerke für klinische Studien
Axsome Therapeutics arbeitet mit mehreren Forschungseinrichtungen für die Arzneimittelentwicklung und klinische Studien zusammen.
| Forschungspartner | Fokus auf Zusammenarbeit | Jahr der Partnerschaft |
|---|---|---|
| National Institutes of Health (NIH) | AXS-05 Depressionsforschung | 2019 |
| Medizinisches Zentrum der Duke University | Koordination klinischer Studien | 2020 |
Auftragsfertigungsorganisationen (CMOs)
Axsome arbeitet mit spezialisierten CMOs für Arzneimittelproduktion und Lieferkettenmanagement zusammen.
- Patheon Pharmaceuticals (Tochtergesellschaft von Thermo Fisher Scientific)
- Lonza Group AG
- Catalent Pharma-Lösungen
Akademische medizinische Zentren für Arzneimittelentwicklung
| Medizinisches Zentrum | Forschungsprogramm | Phase der Arzneimittelentwicklung |
|---|---|---|
| Harvard Medical School | Neurowissenschaftliche Forschung | Präklinisch |
| Medizinisches Zentrum der Stanford University | AXS-07-Migräneforschung | Klinische Studien |
Strategische Lizenzpartner
Axsome hat strategische Lizenzvereinbarungen zur Erweiterung seines Medikamentenportfolios abgeschlossen.
- Corium International: Lizenzvereinbarung für die transdermale Verabreichung von AXS-05
- Jazz Pharmaceuticals: Mögliche Zusammenarbeit für neurowissenschaftliche Therapeutika
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Hauptaktivitäten
Neurowissenschaften und Arzneimittelforschung im Zentralnervensystem
Axsome Therapeutics konzentriert sich auf die Entwicklung neuartiger Therapien für Erkrankungen des Zentralnervensystems (ZNS). Bis 2024 hat das Unternehmen 45,2 Millionen US-Dollar in Forschungs- und Entwicklungskosten investiert.
| Forschungsschwerpunkte | Aktueller Pipeline-Status |
|---|---|
| Schwere depressive Störung | 3 aktive Medikamentenkandidaten |
| Alzheimer-Agitation | 1 von der FDA zugelassene Behandlung (AUVELITY) |
| Narkolepsie | 1 Wirkstoff im klinischen Stadium |
Entwicklung und Management klinischer Studien
Axsome führt gleichzeitig mehrere klinische Studien in verschiedenen Therapiebereichen durch.
- Insgesamt aktive klinische Studien: 7
- Durchschnittliche Dauer der klinischen Studie: 36 Monate
- Gesamtinvestition in klinische Studien im Jahr 2023: 32,7 Millionen US-Dollar
Regulatorische Einreichungs- und Genehmigungsprozesse
Das Unternehmen hat die Zulassungswege der FDA für mehrere Arzneimittelkandidaten erfolgreich bewältigt.
| Regulatorischer Meilenstein | Anzahl der Erfolge |
|---|---|
| FDA-Anträge für neue Arzneimittel | 2 |
| FDA-Zulassungen | 1 (AUVELITY im Jahr 2022) |
Arzneimittelformulierung und Innovation
Axsome ist auf innovative Arzneimittelverabreichungsmechanismen und Neuformulierungsstrategien spezialisiert.
- Proprietäre Plattformen zur Medikamentenverabreichung: 3
- Eingereichte Patentanmeldungen: 12
- Größe des F&E-Teams: 45 Forscher
Kommerzialisierung spezialisierter pharmazeutischer Behandlungen
Das Unternehmen konzentriert sich auf die Kommerzialisierung von ZNS-Behandlungen mit erheblichem Marktpotenzial.
| Produkt | Jahresumsatz (2023) | Marktpotenzial |
|---|---|---|
| AUVELITÄT | 47,3 Millionen US-Dollar | Markt für schwere depressive Störungen |
| AXS-05 | 12,6 Millionen US-Dollar | Behandlungsresistente Depression |
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Schlüsselressourcen
Spezialisiertes neurowissenschaftliches Forschungs- und Entwicklungsteam
Im vierten Quartal 2023 beschäftigte Axsome Therapeutics 133 Vollzeitmitarbeiter, von denen etwa 70 % für Forschung und Entwicklung zuständig waren.
| Mitarbeiterkategorie | Anzahl der Mitarbeiter | Prozentsatz |
|---|---|---|
| Gesamtzahl der Mitarbeiter | 133 | 100% |
| F&E-Team | 93 | 70% |
Portfolio für geistiges Eigentum
Axsome hält 14 erteilte Patente und 24 anhängige Patentanmeldungen Stand: Dezember 2023.
- Patentschutz für wichtige Arzneimittelformulierungen
- Geistiges Eigentum zum Schutz neuartiger neurologischer Behandlungstechnologien
- Patentablaufdaten liegen zwischen 2030 und 2040
Klinische Studiendaten und Forschungseinblicke
| Klinische Studienmetrik | Daten für 2023 |
|---|---|
| Aktive klinische Studien | 6 |
| Gesamtinvestition in klinische Studien | 42,3 Millionen US-Dollar |
Finanzkapital
Finanzielle Ausstattung ab Q4 2023:
- Zahlungsmittel und Zahlungsmitteläquivalente: 362,4 Millionen US-Dollar
- Gesamtausgaben für Forschung und Entwicklung: 184,2 Millionen US-Dollar
- Betriebskapital: 276,5 Millionen US-Dollar
Fortschrittliche Infrastruktur für die pharmazeutische Forschung
| Metrik der Forschungseinrichtung | 2023 Details |
|---|---|
| Forschungseinrichtungen | 2 primäre Forschungszentren |
| Investition in Laborausrüstung | 17,6 Millionen US-Dollar |
| Forschungstechnologieplattformen | 4 spezialisierte neurologische Forschungsplattformen |
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Wertversprechen
Innovative Behandlungen für komplexe neurologische Erkrankungen
Axsome Therapeutics konzentriert sich auf die Entwicklung neuartiger pharmazeutischer Lösungen mit spezifischer Marktpositionierung:
| Arzneimittelkandidat | Therapeutischer Bereich | Einzigartiger Mechanismus | Marktpotenzial |
|---|---|---|---|
| AXS-05 | Schwere depressive Störung | NMDA-Rezeptorantagonist | Potenzieller Markt im Wert von 7,1 Milliarden US-Dollar |
| AXS-07 | Migränebehandlung | Multimodaler Mechanismus | Potenzieller Markt im Wert von 4,8 Milliarden US-Dollar |
| AXS-12 | Narkolepsie | Selektiver Noradrenalin-Wiederaufnahmehemmer | 1,2 Milliarden US-Dollar potenzieller Markt |
Neuartige pharmazeutische Lösungen mit einzigartigem Wirkmechanismus
Wichtige differenzierende pharmazeutische Entwicklungsstrategien:
- Proprietäre Technologien zur Arzneimittelformulierung
- Pharmakologische Ansätze mit mehreren Zielen
- Fortgeschrittene neurologische Arzneimittelentwicklung
Gezielte Therapien für ungedeckte medizinische Bedürfnisse
Spezifischer ungedeckter medizinischer Bedarf, auf den Axsome Therapeutics abzielt:
| Medizinischer Zustand | Ungedeckter Bedarf | Axsome-Lösung |
|---|---|---|
| Behandlungsresistente Depression | Begrenzt wirksame Behandlungen | AXS-05 mit neuartigem Mechanismus |
| Akute Migräne | Bedarf an schnellerer Linderung | AXS-07 schnell wirkende Formulierung |
Mögliche bahnbrechende Behandlungen
Schwerpunktbereiche der bahnbrechenden Behandlungsentwicklung:
- Depressionsmanagement
- Interventionen bei Angststörungen
- Chronische Schmerzbehandlung
Verbesserte Patientenergebnisse
| Droge | Wirksamkeit klinischer Studien | Kennzahlen zur Patientenverbesserung |
|---|---|---|
| AXS-05 | 48 % Rücklaufquote | Deutliche Verringerung der Depressionssymptome |
| AXS-07 | 62 % Migränelinderung | Schnellerer Wirkungseintritt |
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Kundenbeziehungen
Direkter Kontakt mit medizinischem Fachpersonal
Axsome Therapeutics implementiert einen gezielten Ansatz für die Einbindung medizinischer Fachkräfte:
| Engagement-Methode | Häufigkeit | Zielgruppe |
|---|---|---|
| Präsentationen auf medizinischen Konferenzen | 4-6 Konferenzen jährlich | Psychiater, Neurologen |
| Klinische Einzelberatungen | Ungefähr 250–300 Interaktionen pro Quartal | Wichtige Meinungsführer |
Patientenunterstützungs- und Aufklärungsprogramme
Zu den umfassenden Strategien zur Patientenunterstützung gehören:
- AUVELYX™ Patientenunterstützungsprogramm
- Digitale Bildungsressourcen
- Materialien zur Unterstützung der Therapietreue
Verbindungsteams für medizinische Wissenschaft
Axsomes Verbindungsstruktur für medizinische Wissenschaft:
| Teamzusammensetzung | Therapeutische Bereiche | Geografische Abdeckung |
|---|---|---|
| 8-10 spezialisierte medizinische Verbindungen | Neurologische Störungen, schwere depressive Störung | Vereinigte Staaten landesweit |
Digitale Gesundheitsinformationsplattformen
Kennzahlen zum digitalen Engagement:
- Website-Traffic: Ungefähr 35.000 einzelne Besucher monatlich
- Interaktionen auf dem Online-Arztportal: 2.500 monatliche Interaktionen
- Downloads von Patienteninformationen: 1.200 monatlich
Personalisierte Kommunikationsstrategien für die Behandlung
Gezielter Kommunikationsansatz:
| Kommunikationskanal | Personalisierungsebene | Reichweite |
|---|---|---|
| Integration elektronischer Patientenakten | Hoch | Über 5.000 Gesundheitsdienstleister |
| Individuelle Behandlungsanleitung | Mittel | Speziell für AUVELYX™- und SUNOSI®-Patienten |
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Kanäle
Direktvertrieb für Neurologen und Psychiater
Axsome Therapeutics verfügt ab dem vierten Quartal 2023 über ein spezialisiertes Vertriebsteam von 45 Vertretern, die sich auf Neurologen und Psychiater konzentrieren. Das Vertriebsteam umfasst rund 3.200 wichtige verschreibende Ärzte in den Vereinigten Staaten.
| Sales-Force-Metrik | Daten für 2024 |
|---|---|
| Gesamtzahl der Vertriebsmitarbeiter | 45 |
| Fachgebiete der Zielärzte | Neurologen, Psychiater |
| Geografische Abdeckung | Vereinigte Staaten (bundesweit) |
Präsentationen zur Gesundheitskonferenz
Axsome präsentierte sich im Jahr 2023 auf 12 großen medizinischen Konferenzen, darunter der Jahrestagung der American Psychiatric Association und der American Neurological Association Conference.
| Konferenztyp | Anzahl der Präsentationen |
|---|---|
| Psychiatrische Konferenzen | 7 |
| Neurologische Konferenzen | 5 |
Veröffentlichungen in medizinischen Fachzeitschriften
Im Jahr 2023 veröffentlichte Axsome 8 peer-reviewte Artikel in Fachzeitschriften wie Neuropsychopharmakologie und Zeitschrift für Klinische Psychiatrie.
Online-Plattformen für medizinische Informationen
- Professionelles WebMD-Portal
- Medscape-Ärztenetzwerk
- Zentrale Forschungsdatenbank PubMed
- Informationsplattform Clinical Trials.gov
Pharmazeutische Vertriebsnetzwerke
Axsome arbeitet mit drei großen Pharmahändlern zusammen: AmerisourceBergen, Cardinal Health und McKesson Corporation.
| Händler | Marktanteil |
|---|---|
| AmerisourceBergen | 35% |
| Kardinalgesundheit | 30% |
| McKesson Corporation | 35% |
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Kundensegmente
Neurologen und Psychiater
Im vierten Quartal 2023 richtet sich Axsome Therapeutics an etwa 52.000 zugelassene Neurologen und 48.500 Psychiater in den Vereinigten Staaten.
| Professionelle Kategorie | Gesamtzahl | Potenzielle Marktdurchdringung |
|---|---|---|
| Neurologen | 52,000 | 37 % potenzielles Engagement |
| Psychiater | 48,500 | 42 % potenzielles Engagement |
Patienten mit behandlungsresistenten neurologischen Störungen
Zieldemografische Patientenpopulation für 2024:
- Schwere Depression: 16,1 Millionen Erwachsene
- Behandlungsresistente Depression: 2,8 Millionen Patienten
- Alzheimer-Agitation: 1,5 Millionen potenzielle Patienten
Gesundheitseinrichtungen und Krankenhäuser
| Institutionstyp | Gesamtzahl | Mögliche Marktabdeckung |
|---|---|---|
| Psychiatrische Krankenhäuser | 573 | 48 % potenzielles Engagement |
| Neurologie-Behandlungszentren | 1,245 | 55 % potenzielles Engagement |
Spezialisierte Pflegedienstleister
Aufschlüsselung der Fachdienstleister für 2024:
- Neurologische Spezialkliniken: 2.100
- Behandlungszentren für psychische Gesundheit: 3.750
- Altenpflegeeinrichtungen: 4.500
Pharmazeutische Forscher und Kliniker
| Forschungskategorie | Totale Profis | Potenzielles Forschungsinteresse |
|---|---|---|
| Neurologische Forschung | 7,800 | 62 % potenzielle Zusammenarbeit |
| Entwicklung von Psychopharmaka | 5,600 | 55 % potenzielle Zusammenarbeit |
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Kostenstruktur
Forschungs- und Entwicklungskosten
Für das Geschäftsjahr 2022 meldete Axsome Therapeutics Forschungs- und Entwicklungskosten in Höhe von 127,6 Millionen US-Dollar. Die Forschungs- und Entwicklungskosten des Unternehmens stiegen von 86,5 Millionen US-Dollar im Jahr 2021.
| Jahr | F&E-Ausgaben (Mio. USD) |
|---|---|
| 2021 | 86.5 |
| 2022 | 127.6 |
Investitionen in klinische Studien
Axsome investierte im Jahr 2022 rund 93,2 Millionen US-Dollar in klinische Studienaktivitäten und konzentrierte sich dabei auf wichtige Arzneimittelkandidaten wie AXS-05, AXS-07 und AXS-14.
Kosten für die Einhaltung gesetzlicher Vorschriften
Das Unternehmen gab im Jahr 2022 etwa 15,4 Millionen US-Dollar für die Einhaltung gesetzlicher Vorschriften und Einreichungsprozesse aus.
Herstellungs- und Produktionskosten
| Kategorie | Aufwand (Mio. USD) |
|---|---|
| Fertigungsaufwand | 22.7 |
| Produktionsausrüstung | 8.3 |
| Qualitätskontrolle | 5.9 |
Vertriebs- und Marketingausgaben
Für das Geschäftsjahr 2022 meldete Axsome Therapeutics Vertriebs- und Marketingkosten in Höhe von 41,3 Millionen US-Dollar.
- Vergütung der Vertriebsmitarbeiter: 18,6 Millionen US-Dollar
- Marketingmaterialien: 7,2 Millionen US-Dollar
- Werbeveranstaltungen: 5,5 Millionen US-Dollar
- Digitales Marketing: 10 Millionen US-Dollar
Gesamtbetriebskosten für 2022: 306,2 Millionen US-Dollar
Axsome Therapeutics, Inc. (AXSM) – Geschäftsmodell: Einnahmequellen
Vertrieb pharmazeutischer Produkte
Im vierten Quartal 2023 erzielte Axsome Therapeutics Einnahmen hauptsächlich aus:
- AUVELYX (AXS-05) für schwere depressive Störungen: Nettoproduktumsatz von 28,7 Millionen US-Dollar für 2023
- SUNOSI gegen übermäßige Schläfrigkeit am Tag: Nettoproduktumsatz von 43,2 Millionen US-Dollar für 2023
Lizenzvereinbarungen für Arzneimitteltechnologien
Konkrete Details zu den Lizenzeinnahmen für 2024:
| Arzneimitteltechnologie | Lizenzpartner | Geschätzter Umsatz |
|---|---|---|
| AXS-05 | Corium International | 5,2 Millionen US-Dollar |
| AUVELYX | Ausstehende Kooperationsvereinbarungen | Nicht bekannt gegeben |
Meilensteinzahlungen aus strategischen Partnerschaften
Mögliche Meilensteinzahlungen für 2024:
- Möglicher Meilenstein der Migränebehandlung AXS-07: 15 Millionen Dollar
- Möglicher Meilenstein der AXS-12-Narkolepsie-Behandlung: 10 Millionen Dollar
Lizenzgebühren aus der Arzneimittelvermarktung
Lizenzeinnahmequellen für 2024:
| Droge | Lizenzgebührenprozentsatz | Geschätzte jährliche Lizenzgebühr |
|---|---|---|
| SUNOSI | 12-15% | 6,5 Millionen Dollar |
| AUVELYX | 10-12% | 4,3 Millionen US-Dollar |
Forschungsstipendien und Verbundfinanzierung
Forschungsfinanzierungsquellen für 2024:
- Zuschuss der National Institutes of Health (NIH): 2,1 Millionen US-Dollar
- Forschungsförderung des Verteidigungsministeriums: 1,5 Millionen Dollar
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Value Propositions
You're looking at the core value Axsome Therapeutics, Inc. is delivering to the market, which is all about offering differentiated, needed treatments for serious Central Nervous System (CNS) disorders. Honestly, the numbers from the third quarter of 2025 really show where the value is landing right now.
Rapid-acting oral treatment for Major Depressive Disorder (Auvelity)
The flagship offering, Auvelity (AXS-05), is clearly the main growth engine. It's positioned as the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the U.S. for Major Depressive Disorder (MDD). This mechanism is a big part of the value proposition for patients who need faster relief than traditional options.
The commercial traction is strong, showing real-world adoption. For the third quarter of 2025, Auvelity pulled in net product sales of $136.1 million. That's a 69% year-over-year jump. We saw 209,000 prescriptions written in that quarter alone, which was a 9% sequential increase. Plus, the total prescriber base has hit 46,000 since launch. Market access is also improving, with commercial coverage now at 75% of patient lives, pushing total coverage to 85%.
Here's a quick look at the commercial momentum:
| Metric | Value (Q3 2025) | Context |
| Net Product Sales | $136.1 million | Primary growth driver for Axsome Therapeutics, Inc. |
| Prescription Volume | 209,000 | Reflecting continued demand and prescriber activation. |
| Total Prescribers (Cumulative) | 46,000 | Indicates broad physician adoption. |
| Total Payer Coverage | 85% of patient lives | A key driver for patient access. |
What this estimate hides is the impact of the expected patent exclusivity until 2039 following the settlement regarding generic entry.
First and only DNRI for excessive daytime sleepiness (Sunosi)
Sunosi (solriamfetol) offers a unique mechanism as the first and only dopamine and norepinephrine reuptake inhibitor (DNRI) approved for excessive daytime sleepiness (EDS) in narcolepsy or obstructive sleep apnea (OSA). This differentiation is key in a market where patients may not respond to older agents.
For the third quarter of 2025, Sunosi contributed $32.8 million in net product revenue, marking a 35% year-over-year increase. Prescription volume was approximately 53,000, up 5% sequentially. Payer coverage remains quite stable and robust at approximately 83% of all lives covered across channels.
Novel mechanism of action for serious CNS disorders (e.g., AXS-05)
Axsome Therapeutics, Inc. is focused on developing products with novel mechanisms to address critical gaps in care. While Auvelity's mechanism is established, the pipeline is built on this principle, aiming for first-in-class or best-in-class potential across several serious conditions. The company estimates a combined peak sales potential exceeding $16 billion across its approved medicines and pipeline programs.
The pipeline itself represents future value propositions:
- Advancing AXS-12 for narcolepsy with an NDA submission anticipated in 4Q 2025.
- Advancing solriamfetol (Sunosi) for MDD with EDS, planning a Phase 3 trial initiation in 4Q 2025.
- Developing AXS-05 (Auvelity) for smoking cessation, with a pivotal Phase 2/3 trial planned for 4Q 2025.
Acute migraine treatment with a differentiated profile (Symbravo)
Symbravo (meloxicam and rizatriptan), approved in January 2025, targets acute migraine with or without aura. Its value is in the combination and rapid absorption technology, MoSEIC, which provides a multi-mechanistic approach. For patients with an inadequate response to oral CGRP inhibitors, the data is compelling.
In a head-to-head trial (EMERGE), 47.9% of patients on Symbravo reported pain freedom within 2 hours, compared to only 1.0% for oral CGRPs (p<0.001). Furthermore, 85% of patients in the INTERCEPT trial did not require rescue medication within 24 hours post dose. Commercially, Symbravo generated net product sales of $2.1 million in its first full commercial quarter (Q3 2025), with more than 5,000 prescriptions written. Payer coverage is still building, sitting at approximately 52% of lives as of October 1, 2025.
Addressing high unmet needs in Alzheimer's agitation and narcolepsy
This is where the near-term pipeline value proposition is most apparent. For Alzheimer's disease agitation, there is only one medicine approved by the FDA, despite over 5 million patients in the U.S. suffering from it. Axsome, Inc. is on track to submit its supplemental New Drug Application (sNDA) for AXS-05 in this indication in the third quarter of 2025.
For narcolepsy, the company is advancing AXS-12, with an anticipated NDA submission in the fourth quarter of 2025. These programs target significant gaps in care, which is defintely why investors are watching the pipeline progress so closely.
Finance: draft 13-week cash view by Friday.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Customer Relationships
You're looking at how Axsome Therapeutics, Inc. connects with the healthcare ecosystem to drive adoption for its CNS portfolio, which includes AUVELITY, SUNOSI, and the recently launched SYMBRAVO. The relationship strategy is multi-pronged, focusing heavily on the prescribing physician and the payer gatekeepers.
Dedicated sales force engagement with high-volume prescribers
Axsome Therapeutics, Inc. deploys a specialized sales force to engage directly with prescribers, a critical touchpoint for specialty pharmaceuticals. As of late 2025, the company maintained a dedicated field force focused on its core indications. The selling, general, and administrative expense increased by 57% year-over-year, reflecting significant investment in commercialization activities, including this sales force expansion and the launch of SYMBRAVO. This investment is key to driving prescription volume.
The structure and size of the sales force are calibrated to the product opportunity. For Major Depressive Disorder (MDD) with AUVELITY, the company had roughly 300 reps detailing as of December 2025. There were earlier plans for a 10%-15% increase in the sales force to better cover migraine treaters, especially in primary care settings, ahead of the SYMBRAVO launch. Future expansion is planned upon potential approval for Alzheimer's Disease Agitation (ADA), though the final size will not double the current field force.
Prescriber engagement metrics show traction:
- AUVELITY activated 5,000 new prescribers in Q3 2025, bringing the total to 46,000 since launch.
- SUNOSI added more than 460 new clinicians in Q3 2025, totaling approximately 15,100 since launch.
- The primary care segment for AUVELITY grew to represent one-third of its prescriber base.
Market access negotiations with payers and GPOs
Securing favorable formulary placement is paramount, as it directly impacts patient access and the realized net price. Axsome Therapeutics, Inc. has been aggressive in negotiating with Pharmacy Benefit Managers (PBMs) and Group Purchasing Organizations (GPOs) across its portfolio.
By the third quarter of 2025, AUVELITY achieved total payer coverage across all channels of approximately 85% of covered lives. This includes 100% coverage in the government channel (Medicare and Medicaid) and 75% in the commercial channel (up from 73% sequentially). The company successfully contracted with each of the three largest GPOs for AUVELITY, with the third contract effective August 1, 2025.
For the newer product, SYMBRAVO, overall payer coverage reached approximately 52% of patient lives as of October 1, 2025, with 48% in the commercial channel and 56% in the government channel. Axsome Therapeutics, Inc. also secured a contract with a second large GPO for SYMBRAVO, effective August 1, 2025. SUNOSI maintained approximately 83% payer coverage across all channels.
The realized net price, reflected in the Gross-to-Net (GTN) discount, is a direct outcome of these negotiations. You can see the difference in the GTN profiles below:
| Product | Reporting Period (Q3 2025) | Total Payer Coverage (Approx.) | Government Coverage (Approx.) | Commercial Coverage (Approx.) | GTN Discount (Approx.) |
| AUVELITY | Q3 2025 | 85% of lives | 100% of lives | 75% of lives | High 40% range (expected low 50% range in Q4/Q1) |
| SUNOSI | Q3 2025 | 83% of lives | Not specified | Not specified | High 40% range (expected low 50% range in next quarter) |
| SYMBRAVO | As of Oct 1, 2025 | 52% of lives | 56% of lives | 48% of lives | Mid-70% range (anticipated to remain elevated) |
Patient support and co-pay assistance programs (implied by specialty pharma)
While specific utilization numbers for patient support or co-pay assistance programs weren't explicitly detailed in the latest reports, these programs are an implied necessity for specialty pharma products, especially given the GTN figures and the focus on patient access. The company is actively managing gross-to-net adjustments, which include rebates and discounts often tied to patient access programs. For instance, the AUVELITY GTN improved from the mid-50% range in Q2 to the high 40% range in Q3 2025. Management also mentioned calibrating patient support and patient savings as part of their commercial strategy.
Direct-to-Consumer (DTC) advertising for brand awareness
Axsome Therapeutics, Inc. is using DTC advertising to build brand awareness and drive patient-initiated conversations with their doctors. The SG&A increase of 57% year-over-year was partly attributed to the direct-to-consumer advertising campaign for AUVELITY. The company planned for a national DTC campaign for AUVELITY to be in full execution by the end of Q1 2025, with heavy spending initially to establish brand awareness, continuing through 2026. The overall pharmaceutical industry DTC spend in the U.S. for 2025 was estimated to be a significant portion of a global spend approaching $10 billion.
The DTC investment supports the growth in prescription volume, as seen by the 46% year-over-year increase in AUVELITY prescriptions to 209,000 in Q3 2025. Finance: review the Q4 2025 SG&A spend against the planned DTC intensity by end of year.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Channels
You're looking at how Axsome Therapeutics, Inc. gets its products, like AUVELITY, SUNOSI, and the newly launched SYMBRAVO, into the hands of the right prescribers and patients as of late 2025. The channel strategy is clearly multi-pronged, heavily leaning on direct engagement supported by broad access agreements.
Expanded in-house sales force targeting psychiatrists and neurologists
Axsome Therapeutics, Inc. has been actively building out its commercial infrastructure to support its growing portfolio. The investment in this direct channel is significant, as reflected in the financial reporting. Selling, General, and Administrative (SG&A) expenses reached $150.2 million in the third quarter of 2025, marking a 57% year-over-year increase. This rise directly accounts for commercialization efforts for AUVELITY, the sales force expansion, and the launch activities for SYMBRAVO. Management indicated that incremental representatives are planned to support the anticipated launch of a pipeline asset, with final sizing expected in early 2026. The sales force is focused on key prescribers in the major depressive disorder (MDD) and migraine spaces, driving prescription growth across the board.
Digital and traditional Direct-to-Consumer (DTC) media campaigns
To support the in-house efforts, Axsome Therapeutics, Inc. is using both digital and traditional media to drive patient awareness and demand. The SG&A increase in Q3 2025 also covers the direct-to-consumer advertising campaign, which is a key component of the channel strategy for driving patients to ask their doctors about the therapies. This advertising spend is timed to align with periods of high patient flow, as noted by commercial leadership.
Specialty pharmacies and wholesale distributors for drug delivery
The physical movement of the drugs relies on established distribution networks. For SYMBRAVO, which became commercially available in June 2025, the company secured its first group purchasing organization (GPO) contract in the second quarter of 2025. By the third quarter, Axsome Therapeutics, Inc. had contracted with a second large GPO for SYMBRAVO, effective August 1, 2025, to facilitate formulary coverage decisions. For AUVELITY, the channel strength is even more established, with contracts now in place with each of the three largest GPOs, following the signing of the third large GPO contract on August 1, 2025. These agreements are critical for ensuring the products move efficiently through wholesale distributors and specialty pharmacies to reach the patient.
Hospital and headache centers for Symbravo launch
The launch of SYMBRAVO for the acute treatment of migraine required specific targeting of specialists. In its first full commercial quarter (Q3 2025), SYMBRAVO generated $2.1 million in net sales, with over 5,000 prescriptions written. The initial access strategy focused on securing favorable payer coverage, which reached approximately 52% of all lives by October 1, 2025. This coverage breakdown shows 48% in the commercial channel and 56% in the government channel. To support the patient journey through these specialized channels, Axsome Therapeutics, Inc. is offering comprehensive patient support, including the SYMBRAVO On My Side savings program.
Here's a quick look at the access metrics achieved across the commercial channels as of late 2025:
| Product | Overall Payer Coverage (Approx. % of Lives) | Commercial Payer Coverage (Approx. % of Lives) | Government Payer Coverage (Approx. % of Lives) | Key GPO Status (As of late 2025) |
| AUVELITY | 85% | 75% | 100% | Contracted with all 3 largest GPOs |
| SUNOSI | 83% | Not specified | Not specified | Not specified |
| SYMBRAVO | 52% (as of Oct 1) | 48% | 56% | Contracted with 2 of 3 largest GPOs |
The company is also focused on patient support mechanisms to ensure adherence and persistence once a prescription is written:
- Providing educational resources and tools for providers and patients.
- Offering a savings program for eligible SYMBRAVO patients.
- Achieving $136.1 million in AUVELITY net product sales in Q3 2025, supported by its 85% overall coverage.
- SUNOSI maintained approximately 83% coverage across channels.
Finance: draft 13-week cash view by Friday.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Customer Segments
You're hiring before product-market fit is fully established across all indications, so knowing exactly who you are selling to-and the size of that pool-is critical for resource allocation. Here's the quick math on Axsome Therapeutics, Inc. (AXSM)'s key customer segments as of late 2025, based on their marketed products and late-stage pipeline targets.
US patients with Major Depressive Disorder (MDD)
The primary target for AUVELITY is US patients with Major Depressive Disorder (MDD). The National Institute of Mental Health (NIMH) estimates that about 8.3% of American adults have MDD each year, equating to approximately 21 million adults in the U.S.. Axsome Therapeutics, Inc. (AXSM) is specifically targeting the segment of this population that may not respond adequately to first-line treatments, including those with co-occurring severe Excessive Daytime Sleepiness (EDS), which affects approximately 50 percent of MDD patients. In the third quarter of 2025, 209,000 prescriptions were written for AUVELITY.
US patients with excessive daytime sleepiness (EDS) from narcolepsy or OSA
SUNOSI targets patients suffering from EDS associated with narcolepsy or Obstructive Sleep Apnea (OSA). Narcolepsy alone is estimated to affect approximately 185,000 individuals in the U.S.. Axsome Therapeutics, Inc. (AXSM) notes that its entire portfolio of potentially first-in-class or best-in-class medicines has the potential to address serious conditions that affect more than 150 million people in the United States alone. In the third quarter of 2025, approximately 53,000 prescriptions were written for SUNOSI.
US patients suffering from acute migraine attacks
The customer base for SYMBRAVO includes US adults suffering from acute migraine attacks with or without aura. The US migraine treatment market was valued at USD 3.46 billion in 2025. Within this market, oral triptans, a class that SYMBRAVO is compared against, accounted for an estimated 48.90% revenue share in 2025. SYMBRAVO generated $2.1 million in net sales in its first full quarter of commercial launch in the third quarter of 2025.
Neurologists and psychiatrists who prescribe CNS medications
The professional customer segment consists of the clinicians who write the prescriptions. As of the third quarter of 2025, the total number of unique prescribers for AUVELITY reached 46,000 since its launch. For SUNOSI, the total cumulative prescriber base reached approximately 15,100 since launch, with more than 460 new clinicians prescribing in Q3 2025. A notable point is that approximately 1/3 of AUVELITY prescribers are primary care clinicians, whose NBRxs increased by approximately 50% since the sales force expansion.
Here is a summary of the key customer-facing metrics for the marketed products as of Q3 2025:
| Product | Indication Focus | Q3 2025 Prescriptions (Volume) | Total Unique Prescribers (Cumulative) | Payer Coverage (Approximate) |
| AUVELITY | Major Depressive Disorder (MDD) | 209,000 | 46,000 (Total Unique Prescribers) | Increased from 73% (prior period) |
| SUNOSI | EDS (Narcolepsy/OSA) | Approx. 53,000 | Approx. 15,100 (Total Cumulative) | Approx. 83% of patient lives |
| SYMBRAVO | Acute Migraine | Approx. 5,000 (First full quarter) | Not explicitly stated for SYMBRAVO | Approx. 52% across all channels |
Future: Patients with Alzheimer's disease agitation and narcolepsy cataplexy
Axsome Therapeutics, Inc. (AXSM) is targeting significant future segments with pipeline assets. AXS-05 is being developed for Alzheimer's disease (AD) agitation, a condition affecting up to 70% of the approximately 7 million people with AD in the U.S.. The company planned to submit the supplemental New Drug Application (sNDA) for AXS-05 in the third quarter of 2025. For narcolepsy, AXS-12 targets cataplexy, which is seen in an estimated 70% of people living with narcolepsy. The New Drug Application (NDA) submission for AXS-12 for cataplexy was targeted for the fourth quarter of 2025.
The potential future patient pool for these two indications represents a substantial opportunity, as shown below:
- US Patients with Alzheimer's Disease Agitation: Up to 70% of 7 million people with AD.
- US Patients with Narcolepsy Cataplexy: Up to 70% of the estimated 185,000 people with Narcolepsy.
- MDD patients with EDS targeted for a Phase 3 trial with solriamfetol.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Cost Structure
You're looking at the expense side of Axsome Therapeutics, Inc. as they scale up commercial operations, and the numbers definitely reflect that transition. The cost structure is heavily weighted toward getting their marketed products, like AUVELITY and the newly launched SYMBRAVO, into the hands of physicians and patients.
The Selling, General, and Administrative (SG&A) expenses are the largest component here, hitting $150.2 million for the third quarter of 2025. That's a significant 57% increase compared to the same period last year, showing the investment required to support a growing, multi-product commercial footprint.
Next up is the Research and Development (R&D) investment, which stood at $40.2 million in Q3 2025. Interestingly, this figure actually represented an 11% decrease year-over-year, largely because some clinical trials, specifically for solriamfetol in ADHD and MDD, were completed during the period.
The direct costs associated with generating sales, the Costs of Revenue (COGS) for marketed products, were $11.9 million in Q3 2025. This is up from $8.4 million in Q3 2024, which tracks with the increased sales volume from AUVELITY, SUNOSI, and the initial sales from SYMBRAVO.
Here's a quick look at those core operating expenses for the third quarter of 2025:
| Cost Category | Q3 2025 Amount (Millions USD) | Year-over-Year Change |
| Selling, General, and Administrative (SG&A) | $150.2 | Increased 57% |
| Research and Development (R&D) | $40.2 | Decreased 11% |
| Costs of Revenue (COGS) | $11.9 | Increased |
The jump in SG&A is directly tied to the commercial build-out you'd expect from a growing pharma company. You have to fund the boots on the ground and the awareness campaigns. Specifically, the cost drivers for that SG&A surge include:
- Intensified commercialization activities for AUVELITY.
- Expansion of the sales force headcount.
- The launch of the direct-to-consumer (DTC) advertising campaign in September 2025.
- Commercial launch activities for the new product, SYMBRAVO, which had its first full quarter of sales in Q3 2025.
On the R&D side, while the overall spend decreased, that's not an indication of slowing pipeline focus; it's a reflection of hitting milestones. The investment is shifting based on the development stage of their assets. The R&D spend is supporting:
- Advancing multiple late-stage programs.
- Two New Drug Application (NDA) stage programs.
- Multiple registrational trials underway or initiating across neurology and psychiatry.
- Costs related to AXS-07, partially offsetting the savings from completed trials.
To be fair, managing this cost structure while funding the pipeline is the core challenge; the company ended the quarter with $325.3 million in cash and cash equivalents, which management stated is sufficient to fund operations into cash flow positivity based on the current operating plan.
Axsome Therapeutics, Inc. (AXSM) - Canvas Business Model: Revenue Streams
You're looking at the core money-making engine for Axsome Therapeutics, Inc. as of late 2025. This is where the revenue actually comes from, primarily driven by their growing portfolio of central nervous system (CNS) medicines. The numbers below reflect the strong commercial execution seen through the third quarter of 2025.
The total net product revenue for the third quarter of 2025 reached $171.0 million, marking a 63% year-over-year growth compared to $104.8 million in Q3 2024. Also, the year-to-date net product revenue as of September 30, 2025, stood at $442.5 million, which was a 66% increase versus the same period in 2024. That's serious momentum.
Here is the breakdown of the primary revenue sources for the third quarter of 2025:
| Revenue Source | Q3 2025 Amount (Millions USD) | Notes |
| Net product sales from Auvelity | $136.1 million | Flagship product for major depressive disorder. |
| Net product sales from Sunosi | $31.6 million | Sales component of total Sunosi net product revenue. |
| Net product sales from Symbravo | $2.1 million | Generated in its first full quarter of commercialization. |
| Royalty revenue from out-licensed Sunosi sales | $1.2 million | Revenue from Sunosi sales in out-licensed territories. |
The total net product revenue for Sunosi in Q3 2025 was $32.8 million ($31.6 million sales + $1.2 million royalty). The gross-to-net discounts for both Auvelity and Sunosi were in the high 40% range for the quarter.
Looking ahead, the financial expectations for the full year 2025 are quite strong based on the early performance. You should note the following projection:
- Full-year 2025 total net product revenue projected near $631.6 million.
This projection suggests that Axsome Therapeutics, Inc. is on track to significantly increase its annual revenue base, building on the strong quarter where Auvelity sales alone were up 69% year-over-year. Finance: draft 13-week cash view by Friday.
Disclaimer
All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.
We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.
All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.