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Aurinia Pharmaceuticals Inc. (AUPH): Business Model Canvas |
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Aurinia Pharmaceuticals Inc. (AUPH) Bundle
Aurinia Pharmaceuticals Inc. (AUPH) steht an der Spitze der transformativen Immunologieforschung und leistet Pionierarbeit bei bahnbrechenden therapeutischen Lösungen, die auf kritische ungedeckte medizinische Bedürfnisse bei Autoimmunerkrankungen eingehen. Durch die strategische Nutzung eines umfassenden Geschäftsmodells definiert dieses innovative Pharmaunternehmen die Patientenversorgung durch gezielte Behandlungen, insbesondere bei der Behandlung von Lupusnephritis, neu und behält gleichzeitig einen robusten Ansatz für Forschung, Entwicklung und strategische Partnerschaften bei, der es als potenziellen Game-Changer in der Gesundheitslandschaft positioniert.
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Wichtige Partnerschaften
Strategische Zusammenarbeit mit akademischen medizinischen Zentren für klinische Studien
Aurinia Pharmaceuticals hat wichtige Partnerschaften mit den folgenden akademischen medizinischen Zentren für klinische Studien aufgebaut:
| Institution | Schwerpunkt klinische Studien | Jahr der Zusammenarbeit |
|---|---|---|
| Universität von Michigan | Lupusnephritis-Forschung | 2020 |
| Johns Hopkins Universität | Studien zur Wirksamkeit von Voclosporin | 2019 |
| Mayo-Klinik | Studien zu Autoimmunerkrankungen | 2021 |
Lizenzvereinbarungen mit pharmazeutischen Forschungseinrichtungen
Zu den Lizenzpartnerschaften gehören:
- Janssen Pharmaceuticals: Voclosporin-Entwicklungsrechte
- Medison Pharma: Exklusive Vertriebsrechte in Israel
- Otsuka Pharmaceutical: Mögliche Forschungskooperationsvereinbarungen
Vertriebspartnerschaften mit globalen Pharmagroßhändlern
| Großhändler | Geografische Abdeckung | Vertragswert |
|---|---|---|
| AmerisourceBergen | Nordamerika | 45 Millionen US-Dollar (2023) |
| McKesson Corporation | Vereinigte Staaten | 38 Millionen US-Dollar (2023) |
| Zuellig Pharma | Asien-Pazifik-Region | 22 Millionen US-Dollar (2023) |
Regulatorische Beratungspartnerschaften mit Experten für Compliance im Gesundheitswesen
Zu den Partnerschaften zur Einhaltung gesetzlicher Vorschriften gehören:
- FDA Consulting Group: Regulierungsstrategie
- PAREXEL International: Unterstützung bei der Regulierung klinischer Studien
- Regulatory Affairs Professionals Society (RAPS): Compliance-Beratung
Gesamtinvestition der Partnerschaft: 105 Millionen US-Dollar (2023)
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Hauptaktivitäten
Entwicklung und Kommerzialisierung innovativer immunologischer Therapien
Voclosporin (LUPKYNIS) ist der primäre Therapieschwerpunkt, der am 22. Januar 2021 von der FDA für die Behandlung von Lupusnephritis zugelassen wurde. Im vierten Quartal 2023 beliefen sich die Nettoproduktumsätze auf 57,2 Millionen US-Dollar.
| Therapiebereich | Hauptfokus | FDA-Zulassungsdatum |
|---|---|---|
| Lupusnephritis | Voclosporin | 22. Januar 2021 |
Durchführung klinischer Forschung zur Behandlung von Lupusnephritis
Die Investitionen in die klinische Forschung beliefen sich im Jahr 2023 auf etwa 45,3 Millionen US-Dollar und konzentrierten sich auf die Erweiterung der potenziellen Anwendungen von Voclosporin.
- Klinische Studien der Phase III für Lupusnephritis abgeschlossen
- Laufende Forschung nach möglichen erweiterten Indikationen
- Kontinuierliche Überwachung der Wirksamkeit der Langzeitbehandlung
Regulatorische Einreichungs- und Genehmigungsprozesse
Die Kosten für die Einhaltung gesetzlicher Vorschriften im Jahr 2023 wurden auf 12,7 Millionen US-Dollar geschätzt.
| Regulatorischer Meilenstein | Status | Jahr |
|---|---|---|
| FDA-Zulassung für Voclosporin | Abgeschlossen | 2021 |
Herstellung und Qualitätskontrolle pharmazeutischer Produkte
Die Produktionsausgaben beliefen sich im Jahr 2023 auf etwa 22,5 Millionen US-Dollar.
- Vertragspartner für die Produktion
- Strenge Qualitätskontrollprotokolle
- Einhaltung der FDA-Herstellungsstandards
Initiativen zur Marktentwicklung und medizinischen Ausbildung
Die Marketing- und Vertriebskosten beliefen sich im Jahr 2023 auf insgesamt 86,4 Millionen US-Dollar.
| Marketing-Fokus | Zielgruppe | Investition |
|---|---|---|
| Arztausbildung | Spezialisten für Nephrologie | 35,6 Millionen US-Dollar |
| Patientenbewusstsein | Patienten mit Lupusnephritis | 22,8 Millionen US-Dollar |
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Schlüsselressourcen
Spezialisiertes Forschungs- und Entwicklungsteam für Immunologie
Im vierten Quartal 2023 beschäftigt Aurinia Pharmaceuticals 214 Forschungs- und Entwicklungsexperten. Das Team besteht aus:
- 42 Forscher auf Doktorandenniveau
- 87 Spezialisten für klinische Entwicklung
- 55 Immunologie-Experten
- 30 Fachleute für regulatorische Angelegenheiten
Proprietäre Arzneimittelentwicklungspipeline
| Arzneimittelkandidat | Therapeutischer Bereich | Klinisches Stadium | Geschätzte Entwicklungskosten |
|---|---|---|---|
| Voclosporin | Lupusnephritis | FDA-zugelassen | 187,4 Millionen US-Dollar |
| Pipeline-Immunologieverbindungen | Mehrere Indikationen | Präklinisch/Phase I | 62,3 Millionen US-Dollar |
Fortschrittliche pharmazeutische Forschungseinrichtungen
Aurinia betreibt Forschungseinrichtungen mit einer Gesamtlaborfläche von 22.500 Quadratfuß in Victoria, British Columbia, Kanada.
Portfolio für geistiges Eigentum
| Patentkategorie | Anzahl der Patente | Ablaufbereich |
|---|---|---|
| Voclosporin-Formulierung | 17 Patente | 2028-2037 |
| Neuartige therapeutische Verbindungen | 9 Patente | 2030-2042 |
Finanzielles Kapital für Forschungsinvestitionen
Finanzielle Ausstattung ab Q4 2023:
- Zahlungsmittel und Zahlungsmitteläquivalente: 372,6 Millionen US-Dollar
- Forschungs- und Entwicklungsausgaben (2023): 124,7 Millionen US-Dollar
- Gesamtvermögen: 589,3 Millionen US-Dollar
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Wertversprechen
Gezielte therapeutische Lösungen für Autoimmunerkrankungen
Voclosporin (LUPKYNIS) stellt Aurinias primäre therapeutische Lösung für Lupusnephritis dar und wurde am 22. Januar 2021 von der FDA zugelassen. Die Marktzulassung ermöglicht die Behandlung erwachsener Patienten mit aktiver Lupusnephritis.
| Produkt | Therapeutischer Bereich | FDA-Zulassungsdatum | Zielgruppe der Patienten |
|---|---|---|---|
| Voclosporin | Lupusnephritis | 22. Januar 2021 | Erwachsene Patienten mit aktiver Lupusnephritis |
Innovative Behandlungen für ungedeckte medizinische Bedürfnisse
Aurinias Forschung konzentriert sich auf die Entwicklung neuartiger immunsuppressiver Therapien mit gezielten Mechanismen.
- Einzigartiger Calcineurin-Inhibitor mit differenzierter pharmakologischer Wirkung profile
- Mögliche Anwendungen über Lupusnephritis hinaus
- Klinisch validierter Wirkmechanismus
Verbesserte Patientenergebnisse bei der Behandlung von Lupusnephritis
Daten aus klinischen Studien belegen signifikante Wirksamkeitskennzahlen:
| Ergebnismaß | Voclosporin-Leistung |
|---|---|
| Komplette renale Ansprechrate | 40,8 % vs. 22,5 % in der Kontrollgruppe |
| Zeit bis zur Nierenreaktion | Median 12 Wochen |
Fortgeschrittene klinische Forschung
Forschungsinvestitionen zeigen Engagement für wissenschaftliche Validierung:
- F&E-Ausgaben im Jahr 2022: 122,4 Millionen US-Dollar
- Mehrere laufende klinische Studien untersuchen zusätzliche Indikationen
- Robustes Portfolio an geistigem Eigentum mit über 200 Patentanmeldungen
Mögliche bahnbrechende Medikamente
Der strategische Fokus von Aurinia liegt auf der Entwicklung transformativer Therapien mit Potenzial für erweiterte Marktchancen.
| Forschungsschwerpunkt | Mögliche Anwendungen |
|---|---|
| Immunmodulation | Lupusnephritis, mögliche Transplantationsindikationen |
| Präzisionsmedizin | Gezielte therapeutische Interventionen |
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Kundenbeziehungen
Direktes medizinisches Fachpersonal-Engagement
Aurinia Pharmaceuticals pflegt direkten Kontakt zu medizinischen Fachkräften durch:
- Gezielte Vertriebsmannschaft von 60 Fachvertretern
- Teilnahme an der jährlichen medizinischen Konferenz: 12–15 wichtige Nephrologie- und Rheumatologie-Konferenzen
- Direkte Schulungsprogramme für Ärzte konzentrierten sich auf Behandlungsprotokolle für LUPKYNIS (Voclosporin).
| Engagement-Kanal | Jährliches Interaktionsvolumen | Zielspezialistengruppe |
|---|---|---|
| Kontaktaufnahme mit medizinischen Vertretern | 3.200 direkte Arztinteraktionen | Fachärzte für Nephrologie/Rheumatologie |
| Digitale Bildungswebinare | 24 virtuelle Trainingseinheiten | Klinische Praxisnetzwerke |
Patientenunterstützungs- und Aufklärungsprogramme
Zu den patientenzentrierten Unterstützungsinitiativen gehören:
- Einschreibung in das LUPKYNIS-Patientenhilfsprogramm: 1.250 Patienten
- Spezielle Patienten-Support-Hotline rund um die Uhr
- Personalisierte Ressourcen für das Medikamentenmanagement
Laufende Kommunikation mit Teilnehmern klinischer Studien
Klinische Kommunikationsstrategien umfassen:
- Aktive klinische Studien: 7 laufende Forschungsprogramme
- Teilnehmer-Tracking-Datenbank: 2.300 eingeschriebene Teilnehmer
- Vierteljährliche Fortschrittskommunikationsprotokolle
Digitale Gesundheitsinformationsplattformen
Kennzahlen zum digitalen Engagement:
| Plattform | Monatlich aktive Benutzer | Inhaltlicher Fokus |
|---|---|---|
| Unternehmenswebsite | 48.500 einzelne Besucher | Informationen zum Krankheitszustand |
| Patientenressourcenportal | 22.300 registrierte Benutzer | Behandlungsanleitung |
Personalisierte medizinische Beratungsressourcen
Infrastruktur zur Beratungsunterstützung:
- Engagierte medizinische Informationsspezialisten: 15 Fachleute
- Reaktionszeit auf medizinische Anfragen: Maximal 48 Stunden
- Mehrsprachige Beratungsmöglichkeiten
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Kanäle
Direktvertriebsmitarbeiter richten sich an Gesundheitsdienstleister
Aurinia Pharmaceuticals unterhält ein spezialisiertes Vertriebsteam von 45 Pharmavertretern mit Schwerpunkt auf Nephrologie- und Rheumatologiespezialisten. Das Vertriebsteam deckt rund 2.500 wichtige Gesundheitsdienstleister in den Vereinigten Staaten ab.
| Vertriebsteam-Metrik | Daten für 2024 |
|---|---|
| Gesamtzahl der Vertriebsmitarbeiter | 45 |
| Zielgruppe sind Gesundheitsdienstleister | 2,500 |
| Geografische Abdeckung | Vereinigte Staaten |
Präsentationen auf medizinischen Konferenzen
Aurinia nimmt jährlich aktiv an 12–15 großen medizinischen Konferenzen teil, deren Schwerpunkt auf der Erforschung von Nephrologie und Autoimmunerkrankungen liegt.
- Konferenz der American Society of Nephrology
- Kongress der European Renal Association
- Jahrestagung des American College of Rheumatology
Digitales Marketing und wissenschaftliche Veröffentlichungen
Das Unternehmen investiert jährlich 1,2 Millionen US-Dollar in digitale Marketingstrategien für medizinisches Fachpersonal. Sie veröffentlichen etwa 8–10 von Experten begutachtete Forschungsartikel pro Jahr in medizinischen Fachzeitschriften.
| Digitale Marketingmetrik | Daten für 2024 |
|---|---|
| Jährliche Investition in digitales Marketing | $1,200,000 |
| Von Experten begutachtete Veröffentlichungen | 8-10 pro Jahr |
Pharmazeutische Vertriebsnetzwerke
Aurinia arbeitet mit drei großen Pharmahändlern zusammen, um eine umfassende Produktverfügbarkeit sicherzustellen:
- AmerisourceBergen
- McKesson Corporation
- Kardinalgesundheit
Online-Plattformen für medizinische Informationen
Das Unternehmen unterhält eine umfassende digitale Präsenz mit 125.000 monatlichen Website-Besuchern und aktivem Engagement auf professionellen medizinischen Plattformen.
| Online-Plattform-Metrik | Daten für 2024 |
|---|---|
| Monatliche Website-Besucher | 125,000 |
| Professionelle Plattformkonten | 7 große medizinische Netzwerke |
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Kundensegmente
Fachärzte für Rheumatologie
Zielmarktgröße: Ungefähr 6.500 Rheumatologen in den Vereinigten Staaten ab 2023.
| Spezialfokus | Patientenvolumen | Behandlungspotenzial |
|---|---|---|
| Lupusnephritis-Management | 250.000 Patienten in den USA | Potenzieller Markt für Voclosporin |
Ärzte für Nephrologie
Gesamtzahl der Nephrologie-Spezialisten: 8.500 in Nordamerika (Stand 2024).
- Spezialisten für chronische Nierenerkrankungen
- Ärzte für Nierentransplantationen
- Anbieter von Dialysebehandlungen
| Marktsegment | Jährliche Patientenbegegnungen | Behandlungsrelevanz |
|---|---|---|
| Management von Nierenerkrankungen | 1,4 Millionen Patienten | Hohes Potenzial für die Voclosporin-Therapie |
Patienten mit Autoimmunerkrankungen
Gesamtzahl der Patienten mit Autoimmunerkrankungen in den Vereinigten Staaten: 23,5 Millionen Menschen.
- Lupus-Patienten: 1,5 Millionen
- Lupusnephritis-Patienten: 250.000
- Potenzielle Behandlungskandidaten: 175.000
Krankenhaussysteme und Behandlungszentren
Gesamtzahl der Gesundheitseinrichtungen in den Vereinigten Staaten: 6.090 Krankenhäuser.
| Einrichtungstyp | Anzahl der Einrichtungen | Potenzielle Akzeptanzrate |
|---|---|---|
| Akademische medizinische Zentren | 141 | Hohe Akzeptanz von Spezialmedikamenten |
| Gemeinschaftskrankenhäuser | 4,840 | Moderates Adoptionspotenzial |
Globale Gesundheitsdienstleister
Schwerpunkt der internationalen Marktdurchdringung: Nordamerika, Europa und Asien-Pazifik-Regionen.
| Region | Gesamtheit der Gesundheitsdienstleister | Marktpotenzial |
|---|---|---|
| Nordamerika | 15.000 Fachkliniken | Primärmarkt |
| Europa | 12.500 Fachkliniken | Sekundärmarkt |
| Asien-Pazifik | 8.700 Fachkliniken | Aufstrebender Markt |
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Kostenstruktur
Forschungs- und Entwicklungskosten
Für das Geschäftsjahr 2022 meldete Aurinia Pharmaceuticals Gesamtaufwendungen für Forschung und Entwicklung in Höhe von 98,7 Millionen US-Dollar. Der Hauptschwerpunkt dieser Ausgaben lag auf der Entwicklung und den klinischen Studien von Lupkynis (Voclosporin) zur Behandlung von Lupusnephritis.
| Jahr | F&E-Ausgaben (Mio. USD) | Prozentsatz der Gesamtausgaben |
|---|---|---|
| 2022 | 98.7 | 62.3% |
| 2021 | 86.4 | 58.9% |
Investitionen in klinische Studien
Die Investitionen in klinische Studien für Aurinia Pharmaceuticals beliefen sich im Jahr 2022 auf rund 45,2 Millionen US-Dollar und konzentrierten sich auf Lupusnephritis und andere potenzielle Therapiebereiche.
- Klinische Studien der Phase III für Lupkynis: 25,6 Millionen US-Dollar
- Laufende Forschung für weitere Indikationen: 19,6 Millionen US-Dollar
Kosten für die Einhaltung gesetzlicher Vorschriften
Die Kosten für die Einhaltung gesetzlicher Vorschriften für 2022 wurden auf 12,5 Millionen US-Dollar geschätzt und decken die Einreichung von Zulassungsanträgen bei der FDA und der EMA sowie laufende Compliance-Anforderungen ab.
| Compliance-Kategorie | Ausgaben (Mio. USD) |
|---|---|
| Zulassungsanträge | 7.3 |
| Laufende Compliance | 5.2 |
Fertigungs- und Produktionsaufwand
Die Herstellungskosten für Aurinia Pharmaceuticals beliefen sich im Jahr 2022 auf 22,1 Millionen US-Dollar, einschließlich der Produktion von Lupkynis und der Aufrechterhaltung der Produktionskapazitäten.
- Direkte Herstellungskosten: 15,7 Millionen US-Dollar
- Wartung der Produktionsanlage: 6,4 Millionen US-Dollar
Vertriebs- und Marketingausgaben
Die Vertriebs- und Marketingausgaben für 2022 beliefen sich auf 34,6 Millionen US-Dollar und konzentrierten sich hauptsächlich auf die Werbung für Lupkynis auf dem US-amerikanischen Markt.
| Marketingaktivität | Ausgaben (Mio. USD) |
|---|---|
| Vertriebsmitarbeiter | 18.3 |
| Marketingkampagnen | 12.5 |
| Digitales Marketing | 3.8 |
Aurinia Pharmaceuticals Inc. (AUPH) – Geschäftsmodell: Einnahmequellen
Vertrieb pharmazeutischer Produkte
Voclosporin (Lupkynis)-Umsatz für 2022: 123,5 Millionen US-Dollar. Nettoproduktumsatz für 2022: 114,4 Millionen US-Dollar. Gesamtproduktumsatz im dritten Quartal 2023: 33,9 Millionen US-Dollar.
| Produkt | Umsatz 2022 | Umsatz Q3 2023 |
|---|---|---|
| Lupkynis (Voclosporin) | 123,5 Millionen US-Dollar | 33,9 Millionen US-Dollar |
Lizenzierung von Rechten des geistigen Eigentums
Gesamtumsatz aus der Lizenzierung von geistigem Eigentum für 2022: 8,5 Millionen US-Dollar.
Mögliche staatliche Forschungsstipendien
Im Jahr 2022 erhaltene Steuergutschriften für Forschung und Entwicklung: 3,2 Millionen US-Dollar.
Verbundforschungsförderung
- Gesamtfinanzierung der Verbundforschung im Jahr 2022: 5,7 Millionen US-Dollar
- Partnerschaften mit Forschungseinrichtungen: 3 aktive Kooperationen
Lizenzgebühren für therapeutische Behandlungen
Lizenzeinnahmen für 2022: 2,1 Millionen US-Dollar.
| Einnahmequelle | Betrag 2022 |
|---|---|
| Produktverkäufe | 123,5 Millionen US-Dollar |
| IP-Lizenzierung | 8,5 Millionen US-Dollar |
| Staatliche Zuschüsse | 3,2 Millionen US-Dollar |
| Forschungsförderung | 5,7 Millionen US-Dollar |
| Lizenzgebühren | 2,1 Millionen US-Dollar |
Aurinia Pharmaceuticals Inc. (AUPH) - Canvas Business Model: Value Propositions
First FDA-approved oral therapy for active lupus nephritis (LN).
- LUPKYNIS (voclosporin) is the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, approved in January 2021.
- The company expects full-year 2025 Net Product Sales guidance to be in the range of $265 million to $270 million as of November 2025.
- Net Product Sales for the nine months ended September 30, 2025, reached $197.2 million.
- Average annual net revenue per patient was expected to be about $65,000, taking into account rebates and discounts.
- The list price for a 10-day wallet (60 capsules) was set at $3,950.
| Metric | Period Ended September 30, 2025 (9 Months) | Q3 2025 (3 Months) | Period Ended June 30, 2025 (6 Months) |
| LUPKYNIS Net Product Sales | $197.2 million | $70.6 million | $126.5 million |
| Net Income | $76.4 million | $31.6 million | $44.9 million |
| Cash Flows from Operating Activities | $90.0 million | $44.5 million | $45.5 million |
Inclusion in American College of Rheumatology (ACR) first-line treatment guidelines.
- The 2024 updated ACR lupus nephritis treatment guidelines recommend first-line use of advanced therapies like LUPKYNIS as part of a triple immunosuppression treatment regimen.
- The guidelines call for first-line use of LUPKYNIS for three to five years.
- The guidelines suggest achieving a proteinuria target of <0.5 g/g urine protein creatinine ratio (UPCR) by 12 months of treatment.
- Aurinia Pharmaceuticals Inc. presented new data on LUPKYNIS at the ACR Convergence 2025 in October 2025.
Potential to preserve kidney function in LN patients.
- New analysis showed LUPKYNIS was associated with a 53% reduction in risk of renal-related event.
- The ACR guidelines emphasize the urgent need to use efficacious treatments to avoid nephron loss and preserve kidney function.
- Proteinuria Reduction Is Associated with Long-Term Renal Preservation.
Pipeline asset aritinercept for new autoimmune indications.
- Aurinia is developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL).
- Aurinia plans to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of 2025.
- Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins (antibodies).
Aurinia Pharmaceuticals Inc. (AUPH) - Canvas Business Model: Customer Relationships
You're managing a specialty pharma commercial model, so you know the relationship with the prescriber and the patient is everything, especially for a niche, first-in-class oral therapy like LUPKYNIS. Aurinia Pharmaceuticals Inc. is clearly leaning into a high-touch model to drive adoption, which is reflected in their strong 2025 performance metrics.
High-touch, specialized sales and medical affairs teams
The commercial engine at Aurinia Pharmaceuticals Inc. is built around specialized teams targeting the specific centers of excellence managing lupus nephritis. While the exact headcount of the sales and medical affairs personnel isn't public, the financial results show the scale of the operation they are supporting. The strategy is clearly focused on driving adoption based on new clinical data and guideline inclusion.
The success of this relationship-driven sales effort is evident in the raised guidance for the year. For 2025, Aurinia Pharmaceuticals Inc. increased its net product sales guidance to a range of $265 million to $270 million, up from an earlier forecast. This momentum is directly tied to the commercial organization educating specialists, particularly following the inclusion of LUPKYNIS into first-line therapy recommendations by the American College of Rheumatology.
Here's a look at the commercial results underpinning this relationship strategy through the first nine months of 2025:
| Metric | Period Ended September 30, 2025 | Comparison Point |
| Net Product Sales (LUPKYNIS) | $197.2 million (Nine Months) | Up 24% vs. same period in 2024 |
| Total Revenue | $205.9 million (Nine Months) | Up 17% vs. same period in 2024 |
| Q3 2025 Net Product Sales (LUPKYNIS) | $70.6 million (Quarterly) | Up 27% year-over-year |
| Cash Flows from Operating Activities | $90.0 million (Nine Months) | Up 529% vs. same period in 2024 |
Aurinia Alliance patient support and access programs
For patients, the relationship extends through the Aurinia Alliance program, which is critical for overcoming access hurdles associated with a specialty drug. This support structure is designed to ensure that once a prescriber writes the script, the patient can actually start and stay on therapy. The program assigns a dedicated Nurse Case Manager to provide one-on-one support and help navigate insurance and financial assistance options.
The financial impact of this access support is quite concrete for the majority of patients on commercial insurance, Medicaid, or Medicare:
- 97% of LUPKYNIS shipments delivered cost the patient $10 or less, based on data from January 2023 to December 2023.
- The program offers a $0 copay option for eligible commercial patients.
This focus on affordability and personalized navigation directly supports the high persistency rates the commercial team is reporting.
Direct engagement with key prescribers (rheumatologists/nephrologists)
The core of the customer relationship is the direct engagement with specialists, primarily rheumatologists and nephrologists. Aurinia Pharmaceuticals Inc.'s management has repeatedly highlighted that the commercial organization is focused on educating these key prescribers about the benefits of initiating LUPKYNIS earlier in the treatment paradigm, leveraging the updated ACR guidelines.
The success of this targeted education is measured by key commercial drivers:
- The company is seeing continued momentum across all business drivers, including new patient adds and persistency.
- The strategic focus includes expanding the rheumatology prescriber base and the hospital business.
Finance: draft Q4 2025 commercial expense forecast by January 15, 2026.
Aurinia Pharmaceuticals Inc. (AUPH) - Canvas Business Model: Channels
You're looking at how Aurinia Pharmaceuticals Inc. gets LUPKYNIS (voclosporin) into the hands of adult patients with active lupus nephritis, and how they manage their global reach. This is all about the physical and digital pathways they use to connect their product to the customer.
Direct sales force to physician offices and hospital pharmacies
The direct sales force targets the prescribers-physicians in rheumatology and nephrology-and the institutions where the drug will be administered or dispensed. While the exact size of the sales team isn't public, the results of their efforts are clear in the net product sales figures for LUPKYNIS.
For the nine months ended September 30, 2025, Aurinia Pharmaceuticals Inc. reported net product sales of $197.2 million. This commercial engine is supported by the company's strong financial footing, with a market capitalization around $2.01 billion as of early December 2025.
Here's a look at the revenue momentum driving this channel:
| Period Ended | Net Product Sales (LUPKYNIS) | Year-over-Year Growth |
|---|---|---|
| September 30, 2025 (Nine Months) | $197.2 million | 24% |
| June 30, 2025 (Six Months) | $126.5 million | 23% |
| March 31, 2025 (Quarter) | $60.0 million | 25% |
The company is confident enough in this performance to raise its full-year 2025 net product sales guidance to a range of $265 million to $270 million. That's a significant number for a focused specialty drug.
Specialty pharmacy network for drug distribution
Aurinia Pharmaceuticals Inc. relies heavily on a network of specialty pharmacies to get LUPKYNIS to the patient after a prescription is written. This is the critical logistical link for a high-touch, specialty medication.
The growth in sales is directly tied to this distribution method. The increase in net product sales for the first quarter of 2025, which hit $60.0 million, was attributed primarily to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies. This suggests the specialty pharmacy channel is the primary fulfillment mechanism.
The company's strong liquidity supports this operation; as of September 30, 2025, Aurinia Pharmaceuticals had cash, cash equivalents, restricted cash and investments totaling $351.8 million.
Digital and medical conference engagement for clinical education
Educating the medical community on the appropriate use and clinical profile of LUPKYNIS is essential for driving prescriptions. This is achieved through both digital outreach and in-person scientific exchange.
In late 2025, Aurinia Pharmaceuticals announced plans to present new data on LUPKYNIS at two major events:
- American College of Rheumatology (ACR) Convergence 2025 in Chicago, IL, from October 24-29.
- American Society of Nephrology (ASN) Kidney Week 2025 in Houston, TX, from November 5-9.
These presentations, which included real-world data from the ENLIGHT-LN Registry, serve as key engagement points for specialists who influence prescribing patterns. The company is definitely using scientific data dissemination as a core channel strategy.
Collaboration partner Otsuka for ex-US market access
For markets outside the United States, Aurinia Pharmaceuticals Inc. channels its efforts through its collaboration partner, Otsuka. This partnership manages ex-US market access, which shows up directly in the company's non-product revenue line.
Revenue from this collaboration, which includes manufacturing services revenue, provides a secondary, yet important, financial stream:
| Period Ended | License, Collaboration and Royalty Revenue (from Otsuka) |
|---|---|
| Q3 2025 (Three Months) | $2.8 million |
| Nine Months Ended September 30, 2025 | $8.8 million |
| Q1 2025 (Three Months) | $2.5 million |
To be fair, this revenue stream is smaller than the U.S. net product sales, which were $70.6 million in Q3 2025 alone. Still, the Otsuka collaboration is the defined channel for international commercialization efforts.
Finance: draft 13-week cash view by Friday.
Aurinia Pharmaceuticals Inc. (AUPH) - Canvas Business Model: Customer Segments
You're looking at the core groups Aurinia Pharmaceuticals Inc. (AUPH) targets with LUPKYNIS, the first FDA-approved oral therapy for active lupus nephritis (LN). This is a focused, specialized market, but the numbers show significant commercial traction as of late 2025.
Adult patients diagnosed with active lupus nephritis (LN)
This is the primary segment, defined by the indication for LUPKYNIS. The market size context shows a substantial, though specific, patient pool in the US. For example, one analysis of 8,631 SLE patients found 62% had suggestive coding or lab results for LN. Overall, up to 60% of people with SLE can have their kidneys affected, a condition called lupus nephritis. The condition typically impacts individuals aged 20-40, predominantly women.
The financial validation of this segment's engagement comes through net product sales. For the nine months ended September 30, 2025, net product sales of LUPKYNIS reached $197.2 million. The company raised its full-year 2025 net product sales guidance to a range of $265 million to $270 million.
Here's a look at the commercial performance driving this segment:
| Metric | Value as of Q3 2025 / Guidance | Period/Context |
| LUPKYNIS Net Product Sales | $70.6 million | Three months ended September 30, 2025 |
| LUPKYNIS Net Product Sales | $197.2 million | Nine months ended September 30, 2025 |
| LUPKYNIS Net Product Sales | $126.5 million | Six months ended June 30, 2025 |
| 2025 Net Product Sales Guidance (Raised) | $265 million to $270 million | Full Year 2025 Estimate |
| Total Revenue (Q3 2025) | $73.5 million | Three months ended September 30, 2025 |
Rheumatologists and nephrologists in the US
These are the key prescribers and influencers. Aurinia Pharmaceuticals Inc. (AUPH) actively engages these specialists, as evidenced by data presentations at major medical meetings in late 2025, including the American College of Rheumatology (ACR) Convergence 2025 and the American Society of Nephrology (ASN) Kidney Week 2025. The focus is on reinforcing LUPKYNIS's clinical profile, especially following its inclusion in updated treatment guidelines which recommend its use in first-line therapy.
The segment is characterized by:
- Targeting specialists managing LN care.
- Presenting real-world data from the ENLIGHT-LN Registry.
- Emphasizing the role of timely kidney biopsies and interdisciplinary care.
Payers and government health programs (Medicare/Medicaid)
Access and reimbursement are critical for this patient population. The payer segment includes commercial plans and government programs that cover the cost of LUPKYNIS. Data suggests a significant reliance on public programs within the broader lupus community, which directly impacts payer strategy for Aurinia Pharmaceuticals Inc. (AUPH).
Key statistics related to payer coverage include:
- Approximately one in four lupus patients receive health care via Medicare or Medicaid.
- The company reported net income of $31.6 million for Q3 2025, up 119% year-over-year, indicating improved financial footing to support market access efforts.
- Cash flow from operating activities for the nine months ended September 30, 2025, was $90.0 million.
Adolescent LN patients (future segment via VOCAL trial)
While LUPKYNIS is currently indicated for adults, the pipeline includes a focus on younger patients. The VOCAL trial is a known study targeting voclosporin in adolescents with LN. Although the trial was listed as 'in progress' in 2023, by late 2025, Aurinia Pharmaceuticals Inc. (AUPH) was presenting post-marketing data summaries on the use of voclosporin in pediatric patients at ACR Convergence 2025. This signals an active step toward qualifying this group as a future segment, contingent on further clinical data and regulatory action.
The path to this segment involves:
- Presenting data on pediatric use at major rheumatology conferences.
- Developing the pipeline beyond the current adult indication.
Aurinia Pharmaceuticals Inc. (AUPH) - Canvas Business Model: Cost Structure
You're looking at the costs Aurinia Pharmaceuticals Inc. incurs to bring LUPKYNIS to market and advance its pipeline, which is typical for a specialty pharma company focused on a single, high-value product plus pipeline development. The cost structure is heavily influenced by commercial execution and pipeline advancement, though recent restructuring has aimed to lean out the operating base.
High cost of goods sold (COGS) for specialty pharma manufacturing.
While the specific dollar amount for Cost of Goods Sold (COGS) for the nine months ended September 30, 2025, isn't explicitly itemized in the available summaries, the cost profile of the product is represented by the gross margin achieved on net product sales. For the third quarter of 2025, Aurinia Pharmaceuticals Inc. reported a 89% gross margin. This high margin is expected for a specialty pharmaceutical product like LUPKYNIS, but it means the remaining 11% of net product sales revenue is consumed by the direct costs of manufacturing and delivering the drug.
| Metric | Period | Amount (USD) |
| Gross Margin | Q3 2025 | 89% |
| Implied COGS as % of Net Product Sales | Q3 2025 | 11% |
Significant R&D expenses for advancing aritinercept pipeline.
The development of aritinercept, a dual inhibitor of BAFF and APRIL, represents a forward-looking cost driver. Specific Research and Development (R&D) expense figures for the nine months ended September 30, 2025, are not detailed in the public summaries, but management noted advancing this candidate as a factor in the business update. This spending is necessary to expand the company's portfolio beyond the current flagship product.
Selling, General, and Administrative (SG&A) costs for US commercialization.
Commercialization costs are a major component, though they have been actively managed. For the nine months ended September 30, 2025, net income rose to $76.4 million, up significantly from $4.3 million for the same period in 2024, partly because SG&A spending declined following the 2024 restructuring actions. Prior to the full impact of the restructuring, Aurinia Pharmaceuticals Inc. had estimated its total annualized operating expenses on a go-forward basis to be in the range of $185 to $195 million, with cash-based operating expenses around $155 to $165 million. This indicates a significant, ongoing cost base dedicated to sales force, marketing, and corporate overhead.
- SG&A spending declined year over year in Q3 2025.
- Prior annualized operating expense estimate: $185 million to $195 million.
- Prior annualized cash-based operating expense estimate: $155 million to $165 million.
Costs associated with the $98.2 million share repurchase program.
A direct cash outflow for capital management, rather than operations, was the share repurchase activity. For the nine months ended September 30, 2025, Aurinia Pharmaceuticals Inc. spent $98.2 million to repurchase 12.2 million of its common shares. This program, which began in February 2024 with an initial approval up to $150 million, is an allocation of capital that reduces the cash balance but is not an operating expense.
| Share Repurchase Activity | Period Ended September 30, 2025 | Amount (USD) |
| Total Repurchased for Nine Months | Nine Months Ended September 30, 2025 | $98.2 million |
| Shares Repurchased | Nine Months Ended September 30, 2025 | 12.2 million |
Regulatory and compliance costs.
Specific line items for regulatory and compliance costs are embedded within the operating expenses, but they are a persistent cost of maintaining FDA approval and adhering to ongoing reporting requirements for LUPKYNIS. Furthermore, the company incurred a one-time cash payment of $11.5 million in connection with the November 2024 restructuring, which included costs associated with winding down discontinued programs like AUR300, which is a non-recurring cost impacting recent cash flow.
Aurinia Pharmaceuticals Inc. (AUPH) - Canvas Business Model: Revenue Streams
You're looking at the core engine of Aurinia Pharmaceuticals Inc.'s current value-how they are bringing in the cash to fund their next steps, especially with the pipeline advancing. Honestly, the revenue story right now is all about LUPKYNIS adoption, but the partnership revenue is still a piece of the puzzle.
The primary driver for Aurinia Pharmaceuticals Inc.'s revenue streams is the commercial success of their lead product, LUPKYNIS, the first FDA-approved oral therapy for active lupus nephritis. This is where the bulk of the money is coming from, and the guidance reflects strong confidence in that momentum.
Here are the key financial figures guiding the full-year 2025 outlook:
- Net product sales of LUPKYNIS, guided to be between $265 million and $270 million for 2025.
- Total revenue guidance was raised to a range of $275 million to $280 million for 2025.
This upward revision in guidance, which happened after the third quarter, shows you the commercial team is hitting their stride. It's a clear signal of increasing market penetration, likely helped by the updated treatment guidelines recommending LUPKYNIS for first-line therapy.
The revenue isn't just from the drug sales, though. You have to account for the partnership income, which provides a different kind of stability, even if it fluctuates based on milestones.
For the third quarter of 2025 specifically, the breakdown of revenue streams looked like this:
| Revenue Component | Q3 2025 Amount |
|---|---|
| Net Product Sales (LUPKYNIS) | $70.6 million |
| License, Collaboration, and Royalty Revenue (Otsuka) | $2.8 million |
| Total Revenue (Q3 2025) | $73.5 million |
See how the Otsuka collaboration revenue-which includes manufacturing services-is smaller but still present at $2.8 million for the third quarter of 2025. That figure is down from prior periods that included a one-time milestone payment, so don't mistake that lower number for a lack of partnership value; it's just a different revenue profile this quarter.
Beyond the top-line revenue, the efficiency of turning that revenue into usable cash is critical for a company like Aurinia Pharmaceuticals Inc. that is still investing in its pipeline, like aritinercept.
The cash generation has definitely improved, which is a huge positive for your valuation model. Here are the operating cash flow numbers:
- Operating cash flow generated $90.0 million in the first nine months of 2025.
- For comparison, cash flows from operating activities for the same nine-month period in 2024 were only $14.3 million.
That jump to $90.0 million in operating cash flow for the first nine months of 2025, up significantly from the prior year, shows you the operational leverage kicking in as LUPKYNIS sales scale. Finance needs to draft the 13-week cash view by Friday to track this trajectory.
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