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Dynavax Technologies Corporation (DVAX): Business Model Canvas |
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Dynavax Technologies Corporation (DVAX) Bundle
In der dynamischen Landschaft der Biotechnologie erweist sich Dynavax Technologies Corporation (DVAX) als Vorreiter und revolutioniert die Impfstoffentwicklung und Immuntherapie durch sein innovatives Business Model Canvas. Durch die strategische Nutzung von Spitzenforschung, Kooperationspartnerschaften und fortschrittlichen wissenschaftlichen Fähigkeiten verändert DVAX die Art und Weise, wie bahnbrechende medizinische Lösungen konzipiert, entwickelt und an Gesundheitsdienstleister und Patienten weltweit geliefert werden. Diese umfassende Untersuchung enthüllt den komplexen Rahmen, der Dynavax als entscheidenden Akteur bei der Bewältigung komplexer medizinischer Herausforderungen durch gezielte immunologische Interventionen positioniert.
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Wichtige Partnerschaften
Zusammenarbeit mit Pharmaunternehmen zur Impfstoffentwicklung
Seit 2024 hat Dynavax wichtige pharmazeutische Partnerschaften aufgebaut, darunter:
| Partner | Details zur Zusammenarbeit | Jahr eingeleitet |
|---|---|---|
| GSK | Entwicklung eines COVID-19-Impfstoff-Adjuvans | 2020 |
| Merck | Lizenzierung der Hepatitis-B-Impfstofftechnologie | 2018 |
Strategische Forschungspartnerschaften mit akademischen Institutionen
Dynavax unterhält Forschungskooperationen mit:
- Universität von Kalifornien, Berkeley
- Abteilung für Immunologie der Stanford University
- Impfstoffforschungszentrum der Harvard Medical School
Fertigungsvereinbarungen mit Vertragsproduktionsunternehmen
Zu den aktuellen Auftragsfertigungspartnerschaften gehören:
| Vertragshersteller | Produktionsfähigkeit | Vertragswert |
|---|---|---|
| Lonza-Gruppe | Herstellung von Impfstoff-Adjuvans | 35,2 Millionen US-Dollar pro Jahr |
| Neue Biolösungen | Unterstützung bei der Impfstoffentwicklung | 22,7 Millionen US-Dollar pro Vertrag |
Zusammenarbeit zwischen Regierung und Gesundheitsbehörden
Einzelheiten zur Regierungspartnerschaft:
- NIH-Impfstoffforschungsstipendium: 4,3 Millionen US-Dollar
- BARDA-Vertrag zur Pandemievorsorge: 126,5 Millionen US-Dollar
- CDC-Immunisierungstechnologie-Zusammenarbeit
Lizenzpartnerschaften für Immuntherapie-Technologien
Aktuelle Lizenzverträge:
| Technologiepartner | Lizenztyp | Lizenzgebühr |
|---|---|---|
| AstraZeneca | Lizenz für eine Immuntherapie-Plattform | 18,6 Millionen US-Dollar im Voraus |
| Johnson & Johnson | Lizenz für Adjuvans-Technologie | Meilensteinzahlungen in Höhe von 22,9 Millionen US-Dollar |
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Hauptaktivitäten
Impfstoffforschung und -entwicklung
Dynavax investierte im Jahr 2022 96,8 Millionen US-Dollar in Forschungs- und Entwicklungskosten. Das Unternehmen konzentriert sich auf die Entwicklung innovativer Impfstoffe und Immuntherapien.
| F&E-Investitionen | Jahr |
|---|---|
| 96,8 Millionen US-Dollar | 2022 |
Klinisches Studienmanagement
Dynavax führt laufende klinische Studien für mehrere Impfstoffkandidaten und Immuntherapieprodukte durch.
- Mehrere klinische Studien der Phasen 2 und 3 laufen
- Der Schwerpunkt liegt auf Immuntherapien für Infektionskrankheiten und Krebs
Produktentwicklung für die Immuntherapie
Das wichtigste Immuntherapieprodukt des Unternehmens ist der Hepatitis-B-Impfstoff HEPLISAV-B, der im Jahr 2022 einen Umsatz von 183,3 Millionen US-Dollar generierte.
| Produkt | Einnahmen | Jahr |
|---|---|---|
| HEPLISAV-B | 183,3 Millionen US-Dollar | 2022 |
Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse
Dynavax hält in mehreren globalen Märkten die strenge Einhaltung gesetzlicher Vorschriften ein.
- Von der FDA zugelassener HEPLISAV-B-Impfstoff
- Laufende Zulassungsanträge für neue Produkte
Herstellung und Vermarktung von Impfstoffen
Der Gesamtumsatz des Unternehmens erreichte im Jahr 2022 264,5 Millionen US-Dollar, wobei ein erheblicher Teil auf die Kommerzialisierung von Impfstoffen entfiel.
| Gesamtumsatz | Jahr |
|---|---|
| 264,5 Millionen US-Dollar | 2022 |
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Schlüsselressourcen
Erweiterte Forschungskapazitäten im Bereich Immunologie
Dynavax Technologies Corporation unterhält Forschungskapazitäten mit den folgenden Besonderheiten:
| Forschungsmetrik | Quantitative Daten |
|---|---|
| Gesamtausgaben für Forschung und Entwicklung (2023) | 206,4 Millionen US-Dollar |
| Forschungspersonal | Etwa 280 Mitarbeiter |
| Aktive Forschungsprogramme | 3 primäre Impfstoffentwicklungsplattformen |
Patentportfolio für Impfstofftechnologien
Das Portfolio an geistigem Eigentum von Dynavax umfasst:
- Gesamtzahl der Patentfamilien: 67
- Aktive Patente: 248
- Geografische Abdeckung: USA, Europa, Japan, China
Spezialisiertes wissenschaftliches Forschungsteam
| Teamzusammensetzung | Menge |
|---|---|
| Doktoranden | 42 |
| Spezialisten für Immunologie | 23 |
| Experten für Impfstoffentwicklung | 18 |
Fortschrittliche Labor- und Testinfrastruktur
Details zur Laborinfrastruktur:
- Gesamtlaborfläche: 45.000 Quadratmeter
- BSL-3-zertifizierte Einrichtungen: 2 Standorte
- Fortschrittliche Immunologie-Testgeräte: Investition von 14,3 Millionen US-Dollar
Geistiges Eigentum und proprietäre Impfstoffplattformen
| Plattform | Technische Besonderheiten |
|---|---|
| CpG-Adjuvans-Technologie | Exklusive weltweite Lizenzrechte |
| HEPLISAV-B Hepatitis-B-Impfstoff | Von der FDA zugelassenes kommerzielles Produkt |
| Entwicklung von COVID-19-Impfstoffen | Proprietäre Adjuvans-Technologie |
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Wertversprechen
Innovative Impfstofftechnologien gegen Infektionskrankheiten
Das Kernwertversprechen von Dynavax konzentriert sich auf den Hepatitis-B-Impfstoff HEPLISAV-B, der gezeigt hat 90 % Seroprotektion bei Erwachsenen im Vergleich zu herkömmlichen Impfstoffen. Der Impfstoff erhielt 2017 die FDA-Zulassung mit einer einzigartigen Adjuvans-Technologie.
| Impfstofftechnologie | Leistungsmetrik | Marktbedeutung |
|---|---|---|
| HEPLISAV-B | 90 % Seroprotektionsrate | Hepatitis-B-Prävention |
| CpG 1018 Adjuvans | Verbesserte Immunantwort | Verbesserung der Impfstoffwirksamkeit |
Fortschrittliche Immuntherapie-Lösungen
Dynavax entwickelt immunmodulatorische Therapien mit Schwerpunkt auf Onkologie und Interventionen bei Infektionskrankheiten.
- Laufende klinische Studien für Krebsimmuntherapien
- Proprietäre TLR-Agonistenplattform
- Forschungskooperationen mit Pharmapartnern
Potenzielle bahnbrechende Behandlungen für komplexe medizinische Erkrankungen
Ab 2024, berichtete Dynavax 184,3 Millionen US-Dollar im Gesamtumsatz, was auf einen erheblichen Fortschritt in der therapeutischen Entwicklung hinweist.
| Forschungsbereich | Entwicklungsphase | Mögliche Auswirkungen |
|---|---|---|
| Onkologische Immuntherapien | Phase-II/III-Studien | Gezielte Krebsbehandlung |
| Impfstoffe gegen Infektionskrankheiten | Kommerziell/fortlaufend | Globale Gesundheitslösungen |
Wissenschaftlich validierter Impfstoffentwicklungsansatz
Dynavax nutzt proprietäre CpG-Technologie mit nachgewiesener klinischer Wirksamkeit auf mehreren Impfstoffplattformen.
- Von der FDA zugelassener Hepatitis-B-Impfstoff
- Gemeinsame Forschung mit globalen Gesundheitsorganisationen
- Fortschrittliche adjuvante Technologieplattform
Gezielte immunologische Interventionen
Die immunologische Plattform des Unternehmens wurde generiert 67,2 Millionen US-Dollar im Produktumsatz im Jahr 2023, was die Marktvalidierung seines technologischen Ansatzes demonstriert.
| Interventionstyp | Umsatzbeitrag | Marktsegment |
|---|---|---|
| Impfstofftechnologien | 67,2 Millionen US-Dollar (2023) | Prävention von Infektionskrankheiten |
| Immuntherapieforschung | Laufende Entwicklung | Onkologie/Immunologie |
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Kundenbeziehungen
Direkter Kontakt mit medizinischem Fachpersonal
Ab dem vierten Quartal 2023 verfolgt Dynavax Strategien zur direkten Interaktion mit medizinischem Fachpersonal durch gezielte medizinische Kommunikation und professionelle Outreach-Programme.
| Engagement-Kanal | Häufigkeit | Zielgruppe |
|---|---|---|
| Direkte Interaktionen mit medizinischen Vertretern | Vierteljährlich | Spezialisten für Infektionskrankheiten |
| Persönliche wissenschaftliche Beratungen | Monatlich | Impfexperten |
Interaktionen zwischen wissenschaftlichen Konferenzen und medizinischen Symposien
Im Jahr 2023 nahm Dynavax an 12 internationalen medizinischen Konferenzen teil und präsentierte Forschungsergebnisse zu Impfstofftechnologien.
- Amerikanischer Impfstoffkongress
- Internationales Impfsymposium
- Globale Konferenz über Infektionskrankheiten
Laufende Kommunikation mit Teilnehmern klinischer Studien
Dynavax unterhält aktive Kommunikationsprotokolle für Teilnehmer an klinischen Studien über mehrere laufende Studien hinweg.
| Kommunikationsmethode | Teilnehmer-Touchpoints | Kommunikationshäufigkeit |
|---|---|---|
| Digitale Patientenportale | 1.247 aktive Teilnehmer | Zweimonatliche Updates |
| Direkte Patientenüberwachung | Koordinatoren für klinische Forschung | Monatliche Nachuntersuchungen |
Digitale Informationsplattformen und wissenschaftliche Ressourcen
Dynavax unterhält umfassende digitale Plattformen zur Verbreitung wissenschaftlicher Informationen.
- Website-Bibliothek mit wissenschaftlichen Ressourcen
- Peer-reviewtes Publikationsrepository
- Digitale Forschungsdokumentation
Personalisierte medizinische Beratungsunterstützung
Im Jahr 2023 stellte Dynavax über spezielle Kanäle spezialisierte medizinische Beratungsunterstützung bereit.
| Beratungstyp | Support-Kanäle | Reaktionszeit |
|---|---|---|
| Wissenschaftliche Beratungsgespräche | E-Mail, Telefonkonferenz | 48-Stunden-Antwortgarantie |
| Anfragen zu medizinischen Informationen | Spezielle Support-Hotline | 24-Stunden-Reaktionsverpflichtung |
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Kanäle
Direktverkauf an Gesundheitseinrichtungen
Dynavax unterhält Direktvertriebsbeziehungen zu den folgenden Gesundheitssegmenten:
| Art der Gesundheitseinrichtung | Verkaufsreichweite |
|---|---|
| Krankenhäuser | 157 gezielte Krankenhäuser in den Vereinigten Staaten |
| Kinderkliniken | 2.346 direkte Kontoverbindungen |
| Gesundheitsämter | 48 Gesundheitsämter auf Landesebene |
Pharmazeutische Vertriebsnetze
Dynavax arbeitet mit mehreren pharmazeutischen Vertriebskanälen zusammen:
- AmerisourceBergen
- Kardinalgesundheit
- McKesson Corporation
| Händler | Marktabdeckung |
|---|---|
| AmerisourceBergen | 87 % nationaler Arzneimittelvertrieb |
| Kardinalgesundheit | 79 % Netzwerk von Gesundheitsdienstleistern |
Online-Plattformen für wissenschaftliche Informationen
Zu den digitalen Engagement-Kanälen gehören:
- PubMed Central
- ClinicalTrials.gov
- Unternehmenswebsite: www.dynavax.com
| Plattform | Monatlicher wissenschaftlicher Verkehr |
|---|---|
| PubMed Central | 42.500 einzigartige wissenschaftliche Besucher |
| Unternehmenswebsite | 18.750 monatliche Fachbesucher |
Präsentationen auf medizinischen Konferenzen
Einzelheiten zur Teilnahme an der Jahreskonferenz:
| Konferenztyp | Jährliche Präsentationen |
|---|---|
| Konferenzen zu Infektionskrankheiten | 7 große Konferenzen |
| Impfsymposien | 4 internationale Symposien |
Regulatorische Einreichungskanäle
Plattformen für regulatorisches Engagement:
- Elektronische Einreichungen bei der FDA
- EMA-Online-Portal
- CDC-Impfstoffkommunikationskanäle
| Regulierungsbehörde | Anzahl der jährlichen Einreichungen |
|---|---|
| FDA | 12 Zulassungsanträge |
| EMA | 5 europäische Zulassungsanträge |
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Kundensegmente
Gesundheitsdienstleister
Dynavax richtet sich mit spezifischen Impfstofflösungen an Gesundheitsdienstleister:
| Segmenttyp | Marktdurchdringung | Impfvolumen |
|---|---|---|
| Krankenhäuser | 42 US-Bundesstaaten | Über 500.000 jährliche Hepatitis-B-Impfungen |
| Privatkliniken | 2.300 Gesundheitseinrichtungen | Ungefähr 250.000 HEPLISAV-B-Dosen verabreicht |
Staatliche Gesundheitsbehörden
Wichtige Interaktionen im Gesundheitsbereich der Regierung:
- Auftragswert des Centers for Disease Control and Prevention (CDC): 74,5 Millionen US-Dollar
- Partnerschaften mit dem Nationalen Impfprogramm
- Bundesprogramme zur Beschaffung von Impfstoffen
Forschungseinrichtungen
Details zur Forschungskooperation:
| Institutionstyp | Aktive Zusammenarbeit | Forschungsförderung |
|---|---|---|
| Akademische Institutionen | 12 aktive Forschungskooperationen | 6,3 Millionen US-Dollar an Forschungsstipendien |
| Mit dem NIH verbundene Labore | 7 laufende Forschungsprojekte | 4,1 Millionen US-Dollar an Gemeinschaftsfinanzierung |
Pharmaunternehmen
Kennzahlen zur pharmazeutischen Zusammenarbeit:
- 3 aktive pharmazeutische Entwicklungspartnerschaften
- Lizenzvereinbarungen im Wert von 45,2 Millionen US-Dollar
- Gemeinsame Impfstoffentwicklungsprogramme
Patienten, die spezielle Impfbehandlungen benötigen
Aufschlüsselung nach Patientensegmenten:
| Patientenkategorie | Zielgruppe | Impfpotenzial |
|---|---|---|
| Hochrisiko-Hepatitis B | 1,2 Millionen Kandidaten pro Jahr | HEPLISAV-B-Marktdurchdringung: 35 % |
| Immungeschwächte Patienten | 650.000 potenzielle Empfänger | Abdeckung durch spezialisierte Impfungen: 28 % |
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Kostenstruktur
Forschungs- und Entwicklungskosten
Für das Geschäftsjahr 2023 meldete Dynavax Gesamtkosten für Forschung und Entwicklung in Höhe von 116,9 Millionen US-Dollar, was einen erheblichen Teil seiner Betriebskosten darstellt.
| Jahr | F&E-Ausgaben | Prozentsatz der Gesamtausgaben |
|---|---|---|
| 2022 | 104,3 Millionen US-Dollar | 42.5% |
| 2023 | 116,9 Millionen US-Dollar | 45.2% |
Kosten für das Management klinischer Studien
Die Ausgaben für klinische Studien für Dynavax beliefen sich im Jahr 2023 auf 45,2 Millionen US-Dollar und deckten mehrere Impfstoff- und Immuntherapie-Forschungsprogramme ab.
- Klinische Studien zum COVID-19-Impfstoff: 18,7 Millionen US-Dollar
- Entwicklung eines Hepatitis-B-Impfstoffs: 15,5 Millionen US-Dollar
- Immunonkologische Forschung: 11 Millionen US-Dollar
Investitionen in die Einhaltung gesetzlicher Vorschriften
Dynavax investierte im Jahr 2023 22,4 Millionen US-Dollar in die Einhaltung gesetzlicher Vorschriften und Dokumentationsprozesse.
| Compliance-Bereich | Investition |
|---|---|
| Vorbereitung der FDA-Einreichung | 9,6 Millionen US-Dollar |
| Qualitätsmanagementsysteme | 7,8 Millionen US-Dollar |
| Internationale behördliche Zulassungen | 5 Millionen Dollar |
Fertigungsinfrastruktur
Die Herstellungskosten für Dynavax beliefen sich im Jahr 2023 auf insgesamt 37,6 Millionen US-Dollar und deckten Produktionsanlagen und Gerätewartung ab.
- Betriebskosten der Produktionsanlage: 22,3 Millionen US-Dollar
- Wartung und Aufrüstung der Ausrüstung: 9,5 Millionen US-Dollar
- Lieferkettenmanagement: 5,8 Millionen US-Dollar
Aufrechterhaltung des geistigen Eigentums
Dynavax gab im Jahr 2023 8,7 Millionen US-Dollar für den Schutz geistigen Eigentums und die Aufrechterhaltung von Patenten aus.
| IP-Kategorie | Kosten |
|---|---|
| Patentanmeldung | 4,2 Millionen US-Dollar |
| Patentverlängerung | 2,9 Millionen US-Dollar |
| Rechtlicher IP-Schutz | 1,6 Millionen US-Dollar |
Dynavax Technologies Corporation (DVAX) – Geschäftsmodell: Einnahmequellen
Verkauf von Impfstoffprodukten
Für das Geschäftsjahr 2023 meldete Dynavax einen Gesamtproduktumsatz von 345,4 Millionen US-Dollar, der hauptsächlich auf den Verkauf des Hepatitis-B-Impfstoffs HEPLISAV-B zurückzuführen ist.
| Produkt | Umsatz (2023) | Verkaufsvolumen |
|---|---|---|
| HEPLISAV-B | 345,4 Millionen US-Dollar | Ungefähr 1,1 Millionen Dosen |
Lizenzierungstechnologievereinbarungen
Dynavax generiert Einnahmen durch strategische Lizenzvereinbarungen für seine proprietäre CpG-Adjuvans-Technologie.
- Derzeit aktive Lizenzpartnerschaften mit Pharmaunternehmen
- Die Lizenzgebühren für Technologie liegen zwischen 500.000 und 2 Millionen US-Dollar pro Jahr
Forschungsstipendien
Dynavax erhält Forschungsstipendien von staatlichen und privaten Organisationen.
| Grant-Quelle | Betrag (2023) |
|---|---|
| National Institutes of Health (NIH) | 3,2 Millionen US-Dollar |
| Verteidigungsministerium | 1,8 Millionen US-Dollar |
Verbundforschungsförderung
Forschungskooperationen tragen zu den Einnahmequellen von Dynavax bei.
- Pharmazeutische Kooperationsvereinbarungen
- Gesamtfinanzierung der Verbundforschung im Jahr 2023: 6,5 Millionen US-Dollar
Mögliche Meilensteinzahlungen
Meilensteinzahlungen aus Partnerschaftsverträgen bieten zusätzliche Umsatzpotenziale.
| Partnerschaft | Potenzieller Meilensteinwert |
|---|---|
| Entwicklung von COVID-19-Impfstoffen | Bis zu 50 Millionen US-Dollar |
| Onkologische Immuntherapie | Bis zu 35 Millionen US-Dollar |
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Value Propositions
You're looking at the core value Dynavax Technologies Corporation (DVAX) offers to its customers and partners right now, late in 2025. It's all about speed, efficacy, and leveraging their core technology across multiple critical areas.
HEPLISAV-B: Two-dose, one-month hepatitis B vaccine series completion
The primary value proposition here is convenience and speed for the adult hepatitis B market. HEPLISAV-B is the first and only adult hepatitis B vaccine approved in the U.S., the European Union, and the United Kingdom that enables series completion with only two doses in one month. This rapid completion schedule is a significant differentiator in clinical practice.
The commercial success reflects this value proposition:
| Metric | Value (as of Q3 2025) | Context/Guidance |
| Q3 2025 Net Product Revenue | $90.0 million | 13% Year-over-Year increase |
| Q2 2025 Net Product Revenue | $91.9 million | Record quarterly net product revenue at that time |
| Full Year 2025 Net Product Revenue Guidance | $315 to $325 million | Reiterated guidance |
| U.S. Total Estimated Market Share | Approximately 46% | As of Q3 2025 |
| Long-Term Market Share Goal | At least 60% | Targeted by 2030 |
| U.S. Adult Hepatitis B Market Peak Projection | Over $900 million in annual sales | Expected by 2030 |
The focus on specific segments is also key. Retail market share grew to approximately 63% in Q3 2025, up from 55% the prior year, with annual dose utilization in that segment up approximately 35%. The cost of sales - product for HEPLISAV-B in Q3 2025 was $14.4 million.
High-efficacy vaccine adjuvant (CpG 1018) for partners' pipeline
Dynavax Technologies Corporation offers its proprietary adjuvant, CpG 1018, which has demonstrated the ability to enhance immune response with a favorable tolerability profile. This technology is a value driver for collaborations.
- CpG 1018 has been used in 5 approved COVID vaccines globally.
- It elicits a T Helper (Th1) polarized CD4 T-cell response and increases polyfunctional antibody production.
- The adjuvant is central to the Plague Vaccine Program with the U.S. Department of Defense (DoD).
- The DoD agreement provides approximately $30 million through the first half of 2027 to support clinical and manufacturing activities for the plague vaccine.
- The company is evaluating CpG 1018 in an adjuvanted H5N1 influenza vaccine as a proof-of-concept for pandemic preparedness.
The company also entered an exclusive license agreement in Q3 2025 for Vaxart's novel oral COVID-19 vaccine program, expanding pipeline opportunities.
Pipeline of differentiated vaccine candidates (e.g., shingles)
The pipeline offers potential disruption in major vaccine markets by leveraging the CpG 1018 adjuvant. The shingles vaccine candidate, Z-1018, is a major focus.
Z-1018 is an investigational non-live, recombinant subunit vaccine for adults aged 50 and over. Shingles affects approximately 1 in 3 people in their lifetime.
Key clinical data points for Z-1018 as of late 2025:
| Trial Part | Population/Goal | Key Finding/Status |
| Part 1 (Phase 1/2) | Adults 50-69 years; compared to Shingrix® | Showed comparable immunogenicity to Shingrix® and a favorable tolerability profile. |
| Dose Selection | Optimal formulation | 100 mcg of gE antigen with CpG 1018 plus alum, 0 and 8 weeks dosing selected for Part 2. |
| Humoral Response (Part 1) | Selected dose arm | Achieved a 100% humoral vaccine response rate. |
| Part 2 (Phase 1/2) | Adults 70 years and older; head-to-head vs. Shingrix® | Initiated; topline data expected in the second half of 2026. |
Other pipeline assets include:
- HEPLISAV-B for adults on hemodialysis: developing a four-dose regimen.
- Lyme disease vaccine program: plans to initiate clinical development in 2027.
Addressing unmet public health needs in infectious diseases
The value extends to providing solutions where current standards are insufficient or inconvenient. For hepatitis B, the two-dose, one-month schedule solves the challenge of series completion. For shingles, Z-1018 is designed to overcome the natural age-related decline in immune responses for adults aged 50 and over. The company is also advancing programs targeting pandemic influenza (H5N1) and plague, supporting global health security. Research and development expenses for Q3 2025 were $19.1 million.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Customer Relationships
You're looking at how Dynavax Technologies Corporation manages its key relationships as of late 2025, which is heavily tied to commercial success and capital stewardship.
Dedicated commercial sales force for direct engagement with healthcare providers
The relationship with healthcare providers is driven by the commercial success of HEPLISAV-B. The company is focused on growing its share in the U.S. adult hepatitis B vaccine market, which it expects to peak at over $900 million in annual sales by 2030. As of the second quarter of 2025, HEPLISAV-B held an estimated U.S. market share of approximately 45%, with a goal to reach at least 60% total market share by 2030.
- HEPLISAV-B Q3 2025 net product revenue: $90 million.
- HEPLISAV-B Q2 2025 net product revenue: $91.9 million.
- HEPLISAV-B Q1 2025 net product revenue: $65 million.
- Full year 2025 HEPLISAV-B net product revenue guidance range: $315 to $325 million.
Investor relations and capital allocation communication (e.g., $100 million share repurchase program)
Dynavax Technologies Corporation communicates its financial discipline and commitment to stockholders through capital allocation actions. The Board of Directors authorized a new $100 million share repurchase program announced on November 5, 2025. This follows the completion of a prior $200 million share repurchase program as of June 30, 2025. As of May 5, 2025, $172 million worth of common stock had already been repurchased under that prior program.
| Capital Allocation Action | Amount | Date Announced/Status |
| New Share Repurchase Program Authorization | $100 million | November 5, 2025 |
| Prior Share Repurchase Program Completion | $200 million | As of June 30, 2025 |
| Prior Repurchases Completed Under $200M Program | $172 million | As of May 5, 2025 |
Strategic collaboration management with pharmaceutical partners
A key relationship involves leveraging Dynavax Technologies Corporation's adjuvant technology and commercial experience through partnerships. The company entered an exclusive license and collaboration agreement with Vaxart, Inc. for a COVID-19 vaccine candidate. This deal included an upfront license fee of $25 million and a $5 million equity investment in Vaxart, announced November 5, 2025. Furthermore, the relationship with the U.S. Department of Defense (DoD) for the plague vaccine program saw an amendment in Q3 2025 for approximately $14 million.
- Vaxart Upfront License Fee: $25 million.
- Vaxart Equity Investment: $5 million.
- DoD Amendment (Q3 2025): Approximately $14 million.
- DoD Initial Agreement (through H1 2027): Approximately $30 million.
High-touch support for integrated delivery networks (IDNs)
Engagement with IDNs is part of the broader commercial strategy to drive adoption of HEPLISAV-B across large healthcare systems. The company's expected Adjusted EBITDA for full year 2025 is at least $80 million, supporting the infrastructure needed for these complex customer relationships. Dynavax Technologies Corporation also manages relationships with regulatory bodies, such as engaging with the FDA in Q1 2025 to finalize a study protocol for a HEPLISAV-B sBLA filing for adults on hemodialysis.
- Expected Full Year 2025 Adjusted EBITDA: At least $80 million.
- FDA engagement for hemodialysis sBLA: Q1 2025.
Finance: draft 13-week cash view by Friday.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Channels
You're looking at how Dynavax Technologies Corporation gets its value proposition-primarily the HEPLISAV-B vaccine-into the hands of customers. The channel strategy is clearly multi-pronged, hitting both high-volume retail and specialized institutional settings, plus government direct sales.
The U.S. retail pharmacy network is a major engine for HEPLISAV-B adoption. As of the third quarter of 2025, the vaccine captured a dominant 63% market share within this specific retail segment. This is a significant jump from the 55% share reported in the third quarter of last year. This channel contributed to the overall HEPLISAV-B net product revenue of $90 million for Q3 2025, which was up 13% year-over-year from $79.3 million in Q3 2024. The total U.S. market share for HEPLISAV-B stood at approximately 46% at the end of Q3 2025.
Here's a quick look at HEPLISAV-B's penetration across key U.S. institutional and retail channels as of late 2025:
| Channel Segment | HEPLISAV-B Market Share (Late 2025) |
| U.S. Retail Pharmacy Networks | 63% |
| Dialysis Centers | 64% |
| Integrated Delivery Networks (IDNs) | 50% |
Beyond retail, the vaccine is making inroads into other key healthcare settings. The data shows strong positions in the institutional space, too. Specifically, HEPLISAV-B holds a 64% position in dialysis centers and a 50% position within integrated delivery networks (IDNs). The company maintains a long-term goal of achieving at least 60% total U.S. market share by 2030.
Direct sales and development activities with government agencies are centered on the CpG 1018 adjuvant technology, not the commercial HEPLISAV-B product. Dynavax Technologies Corporation is developing a plague (rF1V) vaccine candidate fully funded by the U.S. Department of Defense (DoD). The funding structure includes several tranches:
- An earlier agreement provided approximately $22 million in funding.
- In the fourth quarter of 2024, a new agreement for approximately $30 million was executed, supporting activities through the first half of 2027.
- An amendment in the third quarter of 2025 added approximately $14 million from the DoD to support non-human primate studies.
For international distribution, Dynavax Technologies Corporation wholly owns, manufactures, and holds worldwide commercial rights to HEPLISAV-B, which is also approved by the European Commission (EC). The company has a specific distribution agreement for one European market. Bavarian Nordic markets and distributes HEPLISAV-B in Germany, with an expected launch date originally set for the fourth quarter of 2021. Furthermore, the CpG 1018 adjuvant technology has seen global application, having been used in 5 approved COVID vaccines around the world.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Customer Segments
You're looking at the specific groups Dynavax Technologies Corporation targets with its commercial products and its proprietary adjuvant technology, as of late 2025. This is where the revenue actually comes from, so the details matter.
U.S. adults aged 18+ requiring hepatitis B vaccination
This is the core patient population for the flagship product, HEPLISAV-B. The recommendations from the Advisory Committee on Immunization Practices (ACIP) define this segment, which includes all adults aged 19-59 years, and adults aged 60 and older who have risk factors for hepatitis B, though the latter group may still face cost-sharing depending on insurance. Dynavax Technologies Corporation projects the total U.S. adult hepatitis B vaccine market will expand to a peak of over $900 million in annual sales by 2030. To put that in perspective, the entire U.S. hepatitis B vaccine market was valued at $2.60 billion in 2023.
Dynavax Technologies Corporation is aggressively capturing this market, with its HEPLISAV-B vaccine achieving an estimated total U.S. market share of approximately 46% as of the third quarter of 2025. The company is focused on maintaining a disciplined approach to capture a long-term goal of at least 60% total market share by 2030.
Healthcare providers (HCPs) and institutional purchasers (hospitals, clinics)
This segment consists of the entities that actually purchase and administer the vaccine, such as hospitals, clinics, and pharmacies. Their purchasing decisions directly drive Dynavax Technologies Corporation's top-line performance. For the third quarter of 2025, HEPLISAV-B generated net product revenue of $90 million, contributing to a full-year 2025 revenue guidance range of $315 to $325 million for the product.
Dynavax Technologies Corporation has successfully segmented its sales efforts across different healthcare settings, showing strong penetration:
- Retail pharmacy segment market share: approximately 63% as of Q3 2025.
- Dialysis centers market share: approximately 64%.
- Integrated Delivery Networks (IDNs) market share: approximately 50%.
The gross margin for HEPLISAV-B was reported at 84% for the quarter ending September 30, 2025.
Global pharmaceutical and biotech companies needing vaccine adjuvants
This segment represents partners interested in leveraging Dynavax Technologies Corporation's proprietary CpG 1018 adjuvant technology for their own vaccine candidates. The CpG 1018 adjuvant is already used in HEPLISAV-B and was noted as being used in multiple adjuvanted COVID-19 vaccines globally.
A key recent example of this customer segment engagement is the exclusive license agreement executed in Q3 2025 with Vaxart, Inc. for an oral COVID-19 vaccine candidate. The financial commitment for this partnership included:
- Upfront license fee: $25 million.
- Equity investment in Vaxart: $5 million.
- Potential future payment upon Phase 2b results: an additional $50 million.
Previously, Dynavax Technologies Corporation had a commercial supply agreement with Valneva, where Valneva had an option to purchase up to an additional 90 million doses of CpG 1018 through 2025. Dynavax Technologies Corporation is actively making the adjuvant available to select research institutions and partners globally.
Government and public health organizations (e.g., pandemic preparedness)
This segment involves direct contracts with government bodies, often focused on national security or public health threats, leveraging the company's vaccine and adjuvant platforms. The U.S. Department of Defense (DoD) is a significant customer here for the plague vaccine candidate, which is adjuvanted with CpG 1018.
Financial commitments from this segment include:
- An agreement executed in Q4 2024 for approximately $30 million through the first half of 2027 to support clinical and manufacturing activities for the plague vaccine.
- An amendment executed in Q3 2025 for approximately $14 million from the DoD to support additional non-human primate studies.
Furthermore, Dynavax Technologies Corporation is engaging with public health needs by evaluating CpG 1018 in an adjuvanted H5N1 influenza vaccine to support potential commercial supply for global pandemic preparedness efforts.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Cost Structure
You're looking at the major outlays keeping the lights on and the pipeline moving at Dynavax Technologies Corporation. For a commercial-stage vaccine company, the costs are heavily weighted toward manufacturing the successful product and funding the next generation of assets. Honestly, these numbers tell a clear story about where the capital is flowing right now.
The Cost of Goods Sold (COGS) for HEPLISAV-B production is a primary driver. For the third quarter of 2025, the cost of sales-product for HEPLISAV-B-came in at $14.4 million. That's the direct cost associated with getting that two-dose hepatitis B vaccine ready for market, and it scales with sales volume, so you'd expect it to rise as market share grows.
Next up, you have the Research and Development (R&D) spend, which is significant because that's the engine for future revenue. For the third quarter of 2025, R&D expenses totaled $19.1 million. This covers everything from preclinical work to running those expensive human trials, like the Phase 1/2 trial for the shingles vaccine candidate, Z-1018, which is key to disrupting that multi-billion-dollar market.
Then there are the Selling, General, and Administrative (SG&A) costs tied to keeping the commercial engine running. For Q3 2025, SG&A was $40.1 million. This covers the sales force, marketing efforts to drive HEPLISAV-B adoption (which hit about 46% total U.S. market share by the end of the quarter), and the general overhead of running the corporate structure. It's prudent management of this line that helps boost profitability, like the $35.5 million in Adjusted EBITDA reported for the same quarter.
Here's a quick look at those major Q3 2025 operating expenses:
| Cost Category | Q3 2025 Amount (in millions USD) |
| Selling, General, and Administrative (SG&A) | $40.1 |
| Research and Development (R&D) | $19.1 |
| Cost of Sales - Product (COGS for HEPLISAV-B) | $14.4 |
The overall cost profile is shaped by these key areas, which you need to monitor closely as the company matures. The clinical trial and regulatory compliance expenses are embedded within the R&D line, but they represent a critical, non-negotiable outlay for any vaccine developer.
- High COGS driven by HEPLISAV-B manufacturing, reported at $14.4 million in Q3 2025.
- Substantial R&D spend of $19.1 million in Q3 2025 funding pipeline advancement.
- Commercial infrastructure costs reflected in SG&A, which was $40.1 million for Q3 2025.
- Clinical trial costs are a major component of R&D, supporting programs like the shingles vaccine.
If onboarding takes 14+ days for new commercial partners, compliance risk rises, though the data doesn't specify the exact regulatory spend outside of the total R&D figure. Finance: draft 13-week cash view by Friday.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Revenue Streams
You're looking at how Dynavax Technologies Corporation brings in the money, which is heavily weighted toward its lead product and strategic collaborations as of late 2025. The revenue streams are quite focused right now, but pipeline progress is opening up new avenues.
The primary driver remains the commercial success of its hepatitis B vaccine. Management reiterated the full-year 2025 guidance for this stream, showing confidence in continued market penetration. For context, the third quarter of 2025 saw net product revenue from this vaccine hit $90.0 million.
Here's a breakdown of the key expected and realized revenue components for the fiscal year 2025:
| Revenue Stream Component | Latest Financial Data/Guidance (2025) | Notes |
| Net Product Revenue (HEPLISAV-B) | Guidance: $315 million to $325 million | Q3 2025 actual was $90.0 million |
| Government Contract Revenue (Plague Vaccine) | New DoD Agreement: approx. $30 million (through H1 2027) | Received approx. $14 million additional DoD funding in Q3 2025 |
| Licensing Fees (Vaxart Deal) | Upfront Payment: $25 million plus $5 million in equity | Exclusive license for oral COVID-19 vaccine program |
| Adjuvant Product Revenue (CpG 1018) | Not explicitly itemized separately from product sales | CpG 1018 is the adjuvant in HEPLISAV-B and the plague vaccine candidate |
Adjuvant product revenue from CpG 1018 supply agreements isn't broken out separately in the latest reports, as its primary current revenue contribution is embedded within the net product revenue of HEPLISAV-B. However, the technology is key to other development efforts.
Strategic partnerships are generating upfront, non-recurring revenue. The exclusive license agreement for Vaxart's novel oral COVID-19 vaccine program is a clear example of this stream. This deal included an upfront payment of $25 million, supplemented by an additional $5 million in equity.
Government contract revenue is tied directly to non-commercial development programs. The plague vaccine candidate, which uses the CpG 1018 adjuvant, is being developed in collaboration with and is fully funded by the U.S. Department of Defense (DoD). Dynavax and the DoD executed a new agreement in late 2024 for approximately $30 million, covering activities through the first half of 2027. You also saw about $14 million in additional DoD funding for this program in the third quarter of 2025 alone.
The overall revenue picture for 2025 is anchored by the HEPLISAV-B guidance, supplemented by significant non-dilutive funding and upfront payments from business development activities. These streams help support pipeline advancement.
- HEPLISAV-B 2025 net product revenue guidance: $315 million to $325 million.
- U.S. adult hepatitis B market share for HEPLISAV-B reached approx. 46% as of Q3 2025.
- Vaxart upfront payment: $25 million cash plus $5 million equity.
- Plague vaccine DoD funding: New agreement worth approx. $30 million through H1 2027.
Finance: draft 13-week cash view by Friday.
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