Aurinia Pharmaceuticals Inc. (AUPH) Business Model Canvas

Aurinia Pharmaceuticals Inc. (AUPH): Business Model Canvas [Jan-2025 Mis à jour]

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Aurinia Pharmaceuticals Inc. (AUPH) est à l'avant-garde de la recherche en immunologie transformatrice, des solutions thérapeutiques révolutionnaires pionnières qui répondent aux besoins médicaux critiques non satisfaits dans les troubles auto-immunes. En tirant stratégiquement une toile complète du modèle commercial, cette entreprise pharmaceutique innovante redéfinit les soins aux patients grâce à des traitements ciblés, en particulier dans la gestion de la néphrite du lupus, tout en maintenant une approche robuste de la recherche, du développement et des partenariats stratégiques qui les positionnent en tant que changeur de jeu potentiel dans le cadre de la jeu potentiel dans le cadre de la jeu potentiel dans le cadre de la jeu potentiel dans le cadre de la jeu potentiel dans le cadre du jeu potentiel dans le cadre du jeu potentiel dans la Le paysage des soins de santé.


Aurinia Pharmaceuticals Inc. (AUPH) - Modèle commercial: partenariats clés

Collaboration stratégique avec les centres médicaux universitaires pour les essais cliniques

Aurinia Pharmaceuticals a établi des partenariats clés avec les centres médicaux académiques suivants pour les essais cliniques:

Institution Focus des essais cliniques Année de collaboration
Université du Michigan Recherche de néphrite du lupus 2020
Université Johns Hopkins Études d'efficacité de voclosporine 2019
Clinique de mayo Essais de maladies auto-immunes 2021

Accords de licence avec des établissements de recherche pharmaceutique

Les partenariats de licence comprennent:

  • Janssen Pharmaceuticals: Voclosporine Development Droits
  • Medison Pharma: Droits de distribution exclusifs en Israël
  • Otsuka Pharmaceutical: Accords de recherche collaborative potentiels

Partenariats de distribution avec les grossistes pharmaceutiques mondiaux

Grossiste Couverture géographique Valeur du contrat
Amerisourcebergen Amérique du Nord 45 millions de dollars (2023)
McKesson Corporation États-Unis 38 millions de dollars (2023)
Zuellig Pharma Région Asie-Pacifique 22 millions de dollars (2023)

Partenariats de conseil en réglementation avec des experts en conformité des soins de santé

Les partenariats de conformité réglementaire comprennent:

  • FDA Consulting Group: Stratégie réglementaire
  • Parexel International: Soutien réglementaire des essais cliniques
  • Société des professionnels des affaires réglementaires (RAPS): consultation de conformité

Investissement total de partenariat: 105 millions de dollars (2023)


Aurinia Pharmaceuticals Inc. (AUPH) - Modèle d'entreprise: activités clés

Développer et commercialiser des thérapies d'immunologie innovantes

La voclosporine (Lupkynis) est la principale orientation thérapeutique, approuvée par la FDA le 22 janvier 2021, pour le traitement de la néphrite du lupus. Au quatrième trimestre 2023, les revenus nets des produits étaient de 57,2 millions de dollars.

Zone de thérapie Focus principal Date d'approbation de la FDA
Néphrite lupus Voclosporine 22 janvier 2021

Effectuer des recherches cliniques pour les traitements de néphrite du lupus

L'investissement en recherche clinique en 2023 était d'environ 45,3 millions de dollars, axé sur l'élargissement des applications potentielles de Voclosporine.

  • Essais cliniques de phase III achevés pour la néphrite lupus
  • Recherche en cours pour les indications élargies potentielles
  • Surveillance continue de l'efficacité du traitement à long terme

Processus de soumission et d'approbation réglementaires

Les frais de conformité réglementaire en 2023 étaient estimés à 12,7 millions de dollars.

Jalon réglementaire Statut Année
Approbation de la FDA pour voclosporine Complété 2021

Fabrication de produits pharmaceutiques et contrôle de la qualité

Les dépenses de fabrication en 2023 étaient d'environ 22,5 millions de dollars.

  • Partenaires de fabrication contractuels pour la production
  • Protocoles stricts de contrôle de la qualité
  • Conformité aux normes de fabrication de la FDA

Développement du marché et initiatives d'éducation médicale

Les frais de marketing et de vente en 2023 ont totalisé 86,4 millions de dollars.

Focus marketing Public cible Investissement
Éducation des médecins Spécialistes en néphrologie 35,6 millions de dollars
Sensibilisation des patients Patiens de néphrite du lupus 22,8 millions de dollars

Aurinia Pharmaceuticals Inc. (AUPH) - Modèle commercial: Ressources clés

Équipe de recherche et développement d'immunologie spécialisée

Au quatrième trimestre 2023, Aurinia Pharmaceuticals emploie 214 professionnels de la recherche et du développement. L'équipe se compose de:

  • 42 chercheurs au niveau du doctorat
  • 87 spécialistes du développement clinique
  • 55 experts en immunologie
  • 30 professionnels des affaires réglementaires

Pipeline de développement de médicaments propriétaires

Drogue Zone thérapeutique Étape clinique Coût de développement estimé
Voclosporine Néphrite lupus Approuvé par la FDA 187,4 millions de dollars
Composés d'immunologie de pipeline Indications multiples Preclinical / Phase I 62,3 millions de dollars

Installations de recherche pharmaceutique avancée

L'Aurinia exploite des installations de recherche avec un espace de laboratoire total de 22 500 pieds carrés, situé à Victoria, en Colombie-Britannique, au Canada.

Portefeuille de propriété intellectuelle

Catégorie de brevet Nombre de brevets Plage d'expiration
Formulation de voclosporine 17 brevets 2028-2037
Nouveaux composés thérapeutiques 9 brevets 2030-2042

Capital financier pour les investissements de la recherche

Ressources financières au quatrième trimestre 2023:

  • Equivalents en espèces et en espèces: 372,6 millions de dollars
  • Dépenses de recherche et développement (2023): 124,7 millions de dollars
  • Actif total: 589,3 millions de dollars

Aurinia Pharmaceuticals Inc. (AUPH) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques ciblées pour les maladies auto-immunes

La voclosporine (Lupkynis) représente la principale solution thérapeutique de l'Aurinité pour la néphrite du lupus, avec l'approbation de la FDA le 22 janvier 2021. L'autorisation du marché permet un traitement pour les patients adultes atteints de néphrite de lupus active.

Produit Zone thérapeutique Date d'approbation de la FDA Cible de la population de patients
Voclosporine Néphrite lupus 22 janvier 2021 Patients adultes atteints de néphrite de lupus active

Traitements innovants répondant aux besoins médicaux non satisfaits

Les recherches de Aurinia se concentrent sur le développement de nouvelles thérapies immunosuppressives avec des mécanismes ciblés.

  • Inhibiteur unique de la calcineurine avec pharmacologique différencié profile
  • Applications potentielles au-delà de la néphrite lupus
  • Mécanisme d'action validé cliniquement

Amélioration des résultats des patients dans la gestion de la néphrite du lupus

Les données des essais cliniques démontrent des mesures d'efficacité importantes:

Mesure des résultats Performance de voclosporine
Taux de réponse rénale complète 40,8% vs 22,5% dans le groupe témoin
Temps de réponse rénale Médian 12 semaines

Recherche clinique avancée

L'investissement en recherche démontre un engagement envers la validation scientifique:

  • Dépenses de R&D en 2022: 122,4 millions de dollars
  • Plusieurs essais cliniques en cours explorant des indications supplémentaires
  • Portfolio de propriété intellectuelle robuste avec plus de 200 demandes de brevet

Médicaments de percée potentielles

L'Aurinia a une concentration stratégique sur le développement de thérapies transformatrices avec un potentiel d'opportunités de marché élargies.

Focus de recherche Applications potentielles
Immunomodulation Néphrite lupus, indications potentielles de transplantation
Médecine de précision Interventions thérapeutiques ciblées

Aurinia Pharmaceuticals Inc. (AUPH) - Modèle d'entreprise: relations avec les clients

Engagement professionnel médical direct

Aurinia Pharmaceuticals maintient un engagement direct avec les professionnels de la santé à travers:

  • Force de vente ciblée de 60 représentants spécialisés
  • Participation annuelle de la conférence médicale: 12-15 conférences clés en néphrologie et en rhumatologie
  • Programmes directs de formation des médecins axés sur les protocoles de traitement de Lupkynis (voclosporine)
Canal de fiançailles Volume d'interaction annuel Groupe spécialiste de la cible
Sensibilisation des représentants médicaux 3 200 interactions directes des médecins Spécialistes de la néphrologie / rhumatologie
Webinaires éducatifs numériques 24 séances de formation virtuelle Réseaux de pratique clinique

Programmes de soutien aux patients et d'éducation

Les initiatives de soutien centrées sur le patient comprennent:

  • Programme d'assistance aux patients de Lupkynis Inscription: 1 250 patients
  • 24/7 Hotline de soutien aux patients dédié
  • Ressources de gestion des médicaments personnalisés

Communication des participants à l'essai clinique en cours

Les stratégies de communication clinique englobent:

  • Essais cliniques actifs: 7 programmes de recherche en cours
  • Base de données de suivi des participants: 2 300 participants inscrits
  • Protocoles de communication de progrès trimestriels

Plateformes d'information sur la santé numérique

Métriques d'engagement numérique:

Plate-forme Utilisateurs actifs mensuels Focus du contenu
Site Web de l'entreprise 48 500 visiteurs uniques Informations sur l'état de la maladie
Portail de ressources des patients 22 300 utilisateurs enregistrés Guidage de traitement

Ressources de consultation médicale personnalisées

Infrastructure de soutien à la consultation:

  • Spécialistes d'information médicale dédiés: 15 professionnels
  • Temps de réponse aux demandes médicales: 48 heures maximum
  • Capacités de consultation multilingues

Aurinia Pharmaceuticals Inc. (AUPH) - Modèle d'entreprise: canaux

Force de vente directe ciblant les prestataires de soins de santé

Aurinia Pharmaceuticals maintient une équipe de vente spécialisée de 45 représentants pharmaceutiques axés sur les spécialistes de la néphrologie et de la rhumatologie. La force de vente couvre environ 2 500 fournisseurs de soins de santé clés aux États-Unis.

Métrique de l'équipe de vente 2024 données
Représentants des ventes totales 45
Target des prestataires de soins de santé 2,500
Couverture géographique États-Unis

Présentations de la conférence médicale

L'aurinia participe activement à 12 à 15 conférences médicales majeures par an, en se concentrant sur la néphrologie et la recherche sur les maladies auto-immunes.

  • Conférence de la Société américaine de néphrologie
  • Congrès de l'Association rénale européenne
  • Réunion annuelle annuelle de l'American College of Rheumatology

Marketing numérique et publications scientifiques

La société investit 1,2 million de dollars par an dans des stratégies de marketing numérique ciblant les professionnels de la santé. Ils publient environ 8 à 10 articles de recherche évalués par des pairs par an dans des revues médicales spécialisées.

Métrique du marketing numérique 2024 données
Investissement annuel sur le marketing numérique $1,200,000
Publications évaluées par des pairs 8-10 par an

Réseaux de distributeurs pharmaceutiques

L'Aurinia collabore avec 3 grands distributeurs pharmaceutiques pour assurer une disponibilité complète des produits:

  • Amerisourcebergen
  • McKesson Corporation
  • Santé cardinale

Plateformes d'information médicale en ligne

La société maintient une présence numérique complète avec 125 000 visiteurs mensuels du site Web et un engagement actif sur les plateformes médicales professionnelles.

Métrique de la plate-forme en ligne 2024 données
Visiteurs mensuels du site Web 125,000
Comptes de plate-forme professionnels 7 réseaux médicaux majeurs

Aurinia Pharmaceuticals Inc. (AUPH) - Modèle d'entreprise: segments de clientèle

Spécialistes de la rhumatologie

Taille du marché cible: environ 6 500 rhumatologues aux États-Unis à partir de 2023.

Focus spécialisée Volume de patient Potentiel de traitement
Gestion de la néphrite du lupus 250 000 patients aux États-Unis Marché potentiel du voclosporine

Praticiens de la néphrologie

Spécialistes totaux en néphrologie: 8 500 en Amérique du Nord en 2024.

  • Spécialistes chroniques des maladies rénales
  • Physiciens en transplanté rénal
  • Fournisseurs de traitement de dialyse
Segment de marché Rencontres annuelles des patients Pertinence du traitement
Gestion des maladies rénales 1,4 million de patients Potentiel élevé de thérapie de voclosporine

Patients souffrant de troubles auto-immunes

Patients totaux de troubles auto-immunes aux États-Unis: 23,5 millions d'individus.

  • Patients de lupus: 1,5 million
  • Patients de néphrite du lupus: 250 000
  • Candidats au traitement potentiel: 175 000

Systèmes et centres de traitement hospitaliers

Total des établissements de santé aux États-Unis: 6 090 hôpitaux.

Type d'installation Nombre d'installations Taux d'adoption potentiel
Centres médicaux académiques 141 Adoption élevée de médicaments spécialisés
Hôpitaux communautaires 4,840 Potentiel d'adoption modéré

Fournisseurs de soins de santé mondiaux

Focus de pénétration du marché international: les régions de l'Amérique du Nord, de l'Europe et d'Asie-Pacifique.

Région Total des prestataires de soins de santé Potentiel de marché
Amérique du Nord 15 000 cliniques spécialisées Marché primaire
Europe 12 500 cliniques spécialisées Marché secondaire
Asie-Pacifique 8 700 cliniques spécialisées Marché émergent

Aurinia Pharmaceuticals Inc. (AUPH) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2022, Aurinia Pharmaceuticals a déclaré des dépenses totales de R&D de 98,7 millions de dollars. L'objectif principal de ces dépenses était le développement et les essais cliniques de Lupkynis (voclosporine) pour le traitement de la néphrite du lupus.

Année Dépenses de R&D ($ m) Pourcentage des dépenses totales
2022 98.7 62.3%
2021 86.4 58.9%

Investissements d'essais cliniques

Les investissements en essais cliniques pour Aurinia Pharmaceuticals en 2022 ont totalisé environ 45,2 millions de dollars, se concentrant sur la néphrite lupus et d'autres zones thérapeutiques potentielles.

  • Essais cliniques de phase III pour Lupkynis: 25,6 millions de dollars
  • Recherche en cours pour des indications supplémentaires: 19,6 millions de dollars

Coûts de conformité réglementaire

Les frais de conformité réglementaire pour 2022 ont été estimés à 12,5 millions de dollars, couvrant les soumissions réglementaires de la FDA et de l'EMA et des exigences de conformité en cours.

Catégorie de conformité Dépenses ($ m)
Soumissions réglementaires 7.3
Conformité continue 5.2

Manufacturing and Production Overhead

Les coûts de fabrication pour Aurinia Pharmaceuticals en 2022 étaient de 22,1 millions de dollars, y compris la production de Lupkynis et le maintien des capacités de production.

  • Coûts de fabrication directes: 15,7 millions de dollars
  • Entretien des installations de production: 6,4 millions de dollars

Dépenses de vente et de marketing

Les frais de vente et de marketing pour 2022 ont atteint 34,6 millions de dollars, principalement axé sur la promotion de Lupkynis sur le marché américain.

Activité marketing Dépenses ($ m)
Force de vente 18.3
Campagnes marketing 12.5
Marketing numérique 3.8

Aurinia Pharmaceuticals Inc. (AUPH) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Voclosporine (Lupkynis) Revenus pour 2022: 123,5 millions de dollars. Ventes de produits nets pour 2022: 114,4 millions de dollars. Revenu total des produits au troisième trimestre 2023: 33,9 millions de dollars.

Produit Revenu 2022 Revenus Q3 2023
Lupkynis (voclosporine) 123,5 millions de dollars 33,9 millions de dollars

Licence des droits de propriété intellectuelle

Revenu total de licences sur la propriété intellectuelle pour 2022: 8,5 millions de dollars.

Concessions de recherche gouvernementales potentielles

Crédits d'impôt sur la recherche et le développement reçus en 2022: 3,2 millions de dollars.

Financement de recherche collaborative

  • Financement total de recherche collaborative en 2022: 5,7 millions de dollars
  • Partenariats avec les institutions de recherche: 3 collaborations actives

Royalités de traitement thérapeutique

Revenu des redevances pour 2022: 2,1 millions de dollars.

Flux de revenus 2022 Montant
Ventes de produits 123,5 millions de dollars
Licence IP 8,5 millions de dollars
Subventions gouvernementales 3,2 millions de dollars
Financement de recherche 5,7 millions de dollars
Redevance 2,1 millions de dollars

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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