Legend Biotech Corporation (Lign): Business Model Canvas [Jan-2025 Mise à jour]

Legend Biotech Corporation révolutionne le traitement du cancer par l'immunothérapie cellulaire révolutionnaire, avec un modèle commercial axé sur le laser ciblant le myélome multiple et les interventions oncologiques avancées. En tirant parti des technologies de cellules CAR-T de pointe et des partenariats stratégiques avec des géants de l'industrie comme Janssen Pharmaceutical, l'entreprise est prête à transformer une thérapie par cancer personnalisée, offrant un espoir sans précédent pour les patients grâce à des solutions biotechnologiques innovantes qui promettent de redéfinir la médecine de précision et des stratégies de traitement ciblées.

Legend Biotech Corporation (Lign) - Modèle commercial: partenariats clés

Janssen Pharmaceutical (Johnson & Johnson) partenariat

Legend Biotech a un Contrat de collaboration stratégique avec Janssen Pharmaceutical pour la thérapie cellulaire CAR-T ciblée par BCMA (Carvykti).

Détails du partenariat	Conditions financières
Accord de licence mondial exclusif	Paiement initial de 350 millions de dollars
Paiements de jalons potentiels	Jusqu'à 1,25 milliard de dollars
Redevances sur les ventes nettes	Redevances à plusieurs niveaux entre 12 et 20%

Établissements de recherche universitaire

Legend Biotech collabore avec plusieurs établissements universitaires pour la recherche clinique.

• Memorial Sloan Kettering Cancer Center
• MD Anderson Cancer Center
• Université de Pennsylvanie

Organisations de fabrication de contrats

Legend Biotech travaille avec des CMO spécialisés pour la production de thérapie cellulaire.

Partenaire CMO	Capacité de fabrication
Thérapies avancées Wuxi	Production de thérapie cellulaire à l'échelle commerciale
Groupe Lonza	Capacités de fabrication GMP

Partenaires de distribution pharmaceutique

Partenariats de distribution stratégique pour l'accès mondial sur le marché.

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Centres de traitement en oncologie et hôpitaux

Réseau de collaboration pour les essais cliniques et adoption de produits commerciaux.

Réseau hospitalier	Focus de la collaboration
Clinique de mayo	Recherche clinique du myélome multiple
Dana-Farber Cancer Institute	Essais cliniques de thérapie des cellules CAR-T

Legend Biotech Corporation (Lign) - Modèle d'entreprise: activités clés

Développement de thérapies sur les cellules CAR-T pour le traitement du cancer

Legend Biotech se concentre sur le développement de thérapies sur les cellules CAR-T, en mettant principalement l'accent sur les traitements du myélome multiple. Le produit principal de la société, Cilta-Cel (LCAR-B38M), a reçu l'approbation de la FDA en février 2022 pour un myélome multiple en rechute / réfractaire.

Thérapie CAR-T	Étape de développement	Indication cible
Cilta-cel	Approuvé par la FDA	Myélome multiple
LCAR-B38M	Essais cliniques	Talonneries de cellules B

Essais cliniques et recherche sur les technologies de thérapie cellulaire

Legend Biotech effectue une recherche clinique approfondie à travers de multiples indications de cancer.

• Essais cliniques actifs dans le myélome multiple
• Recherche en cours sur les traitements tumoraux solides
• Recherche collaborative avec Johnson & Johnson

Catégorie de recherche	Nombre d'essais actifs	Investissement dans la R&D (2023)
Myélome multiple	7 essais actifs	251,4 millions de dollars
Recherche de tumeurs solides	4 essais actifs	86,7 millions de dollars

Processus de conformité réglementaire et d'approbation de la FDA

Legend Biotech entretient des normes de conformité réglementaire rigoureuses pour les technologies de thérapie cellulaire.

• Désignation de thérapie de percée de la FDA pour Cilta-cel
• Processus de documentation réglementaire complète
• Interactions en cours avec les organismes de réglementation

Recherche et innovation avancées de la biotechnologie

La société investit considérablement dans des plateformes de recherche innovantes en biotechnologie.

Domaine de recherche	Demandes de brevet	Personnel de recherche
Technologie CAR-T	23 brevets actifs	127 chercheurs
Immunothérapie cellulaire	15 brevets en instance	86 spécialistes de la recherche

Commercialisation de nouveaux traitements contre le cancer

Legend Biotech se concentre sur la commercialisation des technologies innovantes de traitement du cancer grâce à des partenariats stratégiques.

Partenariat	Valeur de collaboration	Étape de développement
Johnson & Johnson	Paiement initial de 350 millions de dollars	Cilta-cel Commercialisation
Janssen Pharmaceuticals	Potentiel d'étape de 175 millions de dollars	Collaboration de recherche en cours

Legend Biotech Corporation (Lign) - Modèle d'entreprise: Ressources clés

Technologies avancées d'ingénierie des cellules et de modification génétique

Les capacités technologiques de base de la légende Biotech comprennent:

• Plateforme technologique CAART (conditionnement, auto, blindé, réduisant la condition de conditionnement T)
• Techniques de modification des cellules propriétaires pour les traitements en oncologie

Catégorie de technologie	Capacités spécifiques	Statut de brevet
Ingénierie des cellules CAR-T	Plateforme LCAR-B38M	Multiples brevets internationaux
Modification génétique	Techniques d'édition de gènes avancés	12 familles de brevets actifs

Plateformes de thérapie cellulaire propriétaire CAR-T

Caractéristiques clés de la plate-forme CAR-T:

• Axé sur le myélome multiple et les traitements tumoraux solides
• Collaboration avec Johnson & Johnson pour le développement mondial de la thérapie de la BCMA CAR-T

Équipe de recherche et développement spécialisée

Métrique de R&D	2023 données
Total des employés de R&D	237 chercheurs spécialisés
Dépenses annuelles de R&D	214,6 millions de dollars

Propriété intellectuelle et portefeuille de brevets

Paysage breveté:

• 18 brevets accordés aux États-Unis
• 22 demandes de brevet en instance dans le monde entier
• Protection des brevets s'étendant jusqu'en 2038-2040

Installations sophistiquées de laboratoire et de fabrication

Emplacement de l'installation	Capacité	Certification
Somerset, New Jersey	Fabrication de thérapie cellulaire de qualité clinique	Conforme à la FDA, conforme au CGMP
Guangzhou, Chine	Production de thérapie cellulaire à grande échelle	Approuvé par la réglementation chinoise

Legend Biotech Corporation (Lign) - Modèle d'entreprise: propositions de valeur

Immunothérapie cellulaire innovante pour le traitement du cancer

Legend Biotech se concentre sur le développement de thérapies avancées des cellules CAR-T ciblant des types de cancer spécifiques. En 2023, la société a déclaré 410,3 millions de dollars de revenus totaux, avec des investissements importants dans la recherche en oncologie.

Type de thérapie	Cancer de la cible	Étape clinique	Valeur marchande potentielle
LCAR-B38M / Cilta-cel	Myélome multiple	Approuvé par la FDA	1,2 milliard de dollars de marché projeté
Thérapie par cellules CAR-T	Tumeurs solides	Phase II / III	Marché potentiel de 850 millions de dollars

Traitements de percée potentiels pour le myélome multiple

Le produit phare de Legend Biotech Cilta-cel a démontré un taux de réponse global de 98% dans les essais cliniques pour plusieurs patients atteints de myélome.

• Taux de réponse global de 98% dans les essais cliniques
• Survie médiane sans progression de 22,4 mois
• Amélioration significative par rapport aux traitements existants

Thérapie cellulaire personnalisée ciblant des types de cancer spécifiques

La société a investi 285,4 millions de dollars dans la recherche et le développement en 2023, en se concentrant sur les approches de médecine de précision.

Domaine de recherche	Investissement	Focus clé
R&D en oncologie	285,4 millions de dollars	Thérapies Car-T personnalisées
Développement d'immunothérapie	156,7 millions de dollars	Mécanismes de ciblage avancés

Amélioration des résultats des patients grâce à la biotechnologie avancée

Les thérapies de Legend Biotech montrent des améliorations significatives des taux de survie des patients par rapport aux traitements traditionnels.

• Jusqu'à 3x survie sans progression plus longue
• Effets secondaires réduits par rapport aux thérapies conventionnelles
• Potentiel de rémission à long terme chez les patients cancéreux

Solutions thérapeutiques de pointe avec ciblage de haute précision

La technologie CAR-T propriétaire de l'entreprise permet un ciblage précis des cellules cancéreuses, avec des essais cliniques continus dans plusieurs types de cancer.

Technologie	Capacité de ciblage de précision	Essais cliniques en cours
Plate-forme de cellules Car-T	99,5% de spécificité des cellules cancéreuses	7 essais cliniques actifs
Génie moléculaire	Modification génétique avancée	3 programmes de recherche tumorale solides

Legend Biotech Corporation (Lign) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé en oncologie

Legend Biotech entretient un engagement direct avec les professionnels de la santé en oncologie grâce à des interactions ciblées:

Canal de fiançailles	Nombre de points de contact	Fréquence annuelle
Présentations de la conférence médicale	12-15	Annuellement
Participation du symposium scientifique	8-10	Annuellement
Consultations cliniques individuelles	150-200	Annuellement

Programmes de soutien aux patients et d'éducation

Legend Biotech met en œuvre des stratégies complètes de soutien aux patients:

• Programme d'aide aux patients dévoués avec un soutien direct à 500 à 750 patients par an
• Série de webinaires éducatifs atteignant environ 2 000 à 3 000 patients par an
• Plateforme de ressources numériques avec des informations de traitement personnalisées

Communication des participants à l'essai clinique

Métrique de communication	Volume annuel
Essais cliniques actifs	7-9
Participants à l'essai clinique	300-450
Points de contact de la communication par participant	6-8

Partenariats de recherche collaborative

Legend Biotech entretient des collaborations de recherche stratégique:

• Partenariats de recherche actifs avec 5 à 7 établissements universitaires
• Financement de recherche collaborative: 12 à 15 millions de dollars par an
• Publications de recherche conjointes: 10-12 par an

Engagement communautaire médical en cours

Activité d'engagement	Portée annuelle
Contributions de publication évaluées par des pairs	15-20
Séances de formation professionnelle médicale	25-30
Réunions du conseil consultatif d'experts	4-6

Legend Biotech Corporation (Lign) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les spécialistes de l'oncologie

La légende Biotech se maintient une force de vente axée sur l'oncologie dédiée de 87 représentants auprès du quatrième trimestre 2023, ciblant spécifiquement des spécialistes de l'hématologie et de l'oncologie aux États-Unis.

Métrique de l'équipe de vente	2023 données
Représentants des ventes totales	87
Couverture géographique	Centres d'oncologie américains
Durée moyenne des appels de vente	42 minutes

Conférences médicales et symposiums scientifiques

Legend Biotech participe à 23 conférences d'oncologie majeures chaque année, avec un budget total d'engagement de la conférence de 2,4 millions de dollars en 2023.

• Réunion annuelle de l'American Society of Hematology (ASH)
• Conférence de l'American Association for Cancer Research (AACR)
• Congrès de l'Association européenne de l'hématologie (EHA)

Plateformes de marketing numérique et d'information médicale

Les dépenses de marketing numérique pour 2023 étaient de 1,75 million de dollars, ciblant des professionnels de la santé spécialisés via des canaux en ligne ciblés.

Canal numérique	Métriques d'engagement
LinkedIn Medical Professional Network	42 500 connexions ciblées
Webinaires médicaux spécialisés	17 webinaires réalisés
Plateformes d'information médicale en ligne	3 plateformes primaires utilisées

Réseaux de distribution pharmaceutique

Legend Biotech collabore avec 7 grands partenaires de distribution pharmaceutique, couvrant 92% des établissements de santé américains.

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Canaux de publication de recherche clinique

En 2023, Legend Biotech a publié 12 articles de recherche évalués par des pairs dans des revues médicales de haut niveau, avec un budget de publication de recherche total de 850 000 $.

Métrique de publication	2023 données
Publications totales évaluées par des pairs	12
Budget de publication de recherche	$850,000
Journaux supérieurs	New England Journal of Medicine, Blood

Legend Biotech Corporation (Lign) - Modèle d'entreprise: segments de clientèle

Centres de traitement en oncologie

Legend Biotech cible plus de 1 500 centres de traitement d'oncologie spécialisés aux États-Unis et dans le monde.

Région	Nombre de centres ciblés	Focus du traitement
États-Unis	850	Myélome multiple
Europe	450	Cancers hématologiques
Asie-Pacifique	200	Immunothérapies cellulaires

Spécialistes de l'hématologie

Legend Biotech se concentre sur 12 500 spécialistes de l'hématologie dans le monde.

• États-Unis: 4 200 spécialistes
• Union européenne: 3 800 spécialistes
• Asie-Pacifique: 4 500 spécialistes

Patients atteints de myélome multiple

Population de patients cibles: 176 404 patients atteints de myélome multiples diagnostiqués dans le monde en 2023.

Région	Population de patients	Incidence annuelle
Amérique du Nord	54,230	6,5 pour 100 000
Europe	62,140	5,8 pour 100 000
Asie-Pacifique	60,034	4,2 pour 100 000

Institutions de recherche clinique

Collabore avec 340 établissements de recherche clinique dans le monde.

• Centres médicaux académiques: 180
• Centres de recherche sur le cancer: 95
• Réseaux de recherche pharmaceutique: 65

Sociétés pharmaceutiques et biotechnologiques

Partenaires avec 28 sociétés pharmaceutiques et biotechnologiques pour la recherche et le développement collaboratifs.

Type d'entreprise	Nombre de partenariats	Focus de recherche
Grand pharmaceutique	12	Thérapies de cellules en T
Entreprises de biotechnologie	16	Développement d'immunothérapie

Legend Biotech Corporation (Lign) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

En 2023, Legend Biotech a déclaré des frais de R&D de 284,7 millions de dollars, ce qui représente 68,4% du total des dépenses d'exploitation.

Année	Dépenses de R&D	Pourcentage des dépenses d'exploitation
2022	239,1 millions de dollars	65.2%
2023	284,7 millions de dollars	68.4%

Investissements d'essais cliniques

Les investissements en essais cliniques pour la plate-forme LCAR-B38M / Cilta-Cel en 2023 ont totalisé environ 156,2 millions de dollars.

• Essais cliniques multiples du myélome: 87,3 millions de dollars
• Autres essais en oncologie: 68,9 millions de dollars

Coûts de fabrication et de production

Les dépenses de fabrication en 2023 ont atteint 112,5 millions de dollars, en mettant l'accent sur la production de thérapie par cellules CAR-T.

Catégorie de production	Coût	Pourcentage des dépenses de fabrication
Traitement des cellules	62,4 millions de dollars	55.5%
Matières premières	33,7 millions de dollars	30%
Entretien de l'équipement	16,4 millions de dollars	14.5%

Processus de conformité et d'approbation réglementaires

Les frais de conformité réglementaire en 2023 s'élevaient à 45,6 millions de dollars.

• Coûts de soumission de la FDA: 22,3 millions de dollars
• Frais de conformité EMA: 15,7 millions de dollars
• Autres activités réglementaires: 7,6 millions de dollars

Acquisition et rétention de talents

Les dépenses liées aux ressources humaines et aux talents ont totalisé 98,3 millions de dollars en 2023.

Catégorie de dépenses	Coût	Pourcentage du budget RH
Salaires	72,6 millions de dollars	73.9%
Avantages	15,4 millions de dollars	15.7%
Recrutement	10,3 millions de dollars	10.4%

Legend Biotech Corporation (Lign) - Modèle d'entreprise: sources de revenus

Collaboration et accords de licence

En 2023, Legend Biotech a rapporté des revenus de collaboration de 98,1 millions de dollars contre son partenariat stratégique avec Johnson & Johnson pour la thérapie CAR-T ciblée BCMA.

Partenaire	Revenus de collaboration 2023	Paiement initial
Johnson & Johnson	98,1 millions de dollars	350 millions de dollars

Ventes de produits des thérapies approuvées

Le principal produit commercial de Legend Biotech, Carvykti (Cilta-cel), a généré 402 millions de dollars de ventes de produits nets pour l'année 2023.

Subventions de recherche et financement gouvernemental

• Le total des revenus de subvention en 2023: 12,5 millions de dollars
• Contributions de subvention des National Institutes of Health (NIH): 7,3 millions de dollars

Payments d'étape provenant des partenariats pharmaceutiques

Legend Biotech a reçu 150 millions de dollars dans les paiements marquants des partenariats pharmaceutiques en 2023.

Partenariat	Paiements d'étape
Johnson & Johnson	100 millions de dollars
Autres partenariats	50 millions de dollars

Revenus potentiels de redevance

Les revenus de redevances projetés des technologies agréées sont estimées à 25 à 30 millions de dollars pour l'exercice 2024.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Value Propositions

You're looking at the core value Legend Biotech Corporation (LEGN) delivers to its customers-the patients and healthcare systems-primarily through its flagship product, CARVYKTI. This value is built on demonstrable, hard clinical and commercial success as of late 2025.

CARVYKTI: A one-time infusion offering deep, durable responses for multiple myeloma

The primary value is the shift from chronic management to a potentially long-term remission from a single infusion. This is backed by significant commercial uptake, showing deep market penetration and physician confidence. For the third quarter of 2025, CARVYKTI net trade sales reached approximately $524 million. This follows strong prior quarters, with Q2 2025 sales at approximately $439 million and Q1 2025 sales at approximately $369 million. The therapy has now treated over 9,000 patients globally to date. Furthermore, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) for CARVYKTI, which streamlines patient access significantly.

Here's a snapshot of the commercial momentum:

Metric	Value (As of Late 2025)
Q3 2025 Net Trade Sales	$524 million
Total Patients Treated Globally (Approx.)	Over 9,000
Q2 2025 Sales Growth (YoY)	136%
Launch Trajectory Compound Annual Growth Rate	80%

First and only BCMA-targeted therapy approved for second-line multiple myeloma treatment

Legend Biotech Corporation (LEGN) has successfully positioned CARVYKTI earlier in the treatment paradigm, a major value driver. The drug gained FDA approval as a second-line multiple myeloma therapy in April 2024. This approval was also secured in Australia's TGA for second-line plus settings. The European Medicines Agency (EMA) approved it in April 2024 for patients who had received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, and were refractory to lenalidomide.

This early-line access is supported by clinical findings showing superior outcomes compared to standard of care (SOC) in earlier treatment settings.

• Median PFS for patients with one prior line of therapy (pLOT) was not reached for the CARVYKTI arm, versus a median PFS of 17 months for SOC patients.
• For patients with two pLOT, median PFS was not reached for CARVYKTI vs. 12 months for SOC.
• For patients with three pLOT, median PFS was not reached for CARVYKTI vs. 8 months for SOC.

Potential to redefine standard of care with long-term progression-free survival (50.4 months in CARTITUDE-1)

The durability of response is a key differentiator, suggesting a potential shift away from continuous treatment cycles. Data presented at the 2025 American Society of Hematology (ASH) Annual Meeting reinforced this long-term value. In triple-class-exposed patients who had received three prior lines of therapy, the median progression-free survival (mPFS) following a single CARVYKTI infusion was 50.4 months. This is a remarkable figure, considering these heavily pretreated patients historically had an expected median PFS of less than 6 months.

For patients treated as early as second line with standard-risk cytogenetics in the CARTITUDE-4 study, the durability is even more pronounced:

• 80% of as-treated patients remained progression-free and treatment-free at 2.5 years (30 months).
• The 30-month PFS rate for intent-to-treat standard-risk patients was 71.0% for the CARVYKTI arm, compared to 43.2% for the SOC arm.
• One-third of patients in the CARTITUDE-1 study remained progression-free for ≥5 years after a single infusion.
• Median overall survival matured to 60 months (5 years) in a specific patient cohort.

Innovative pipeline focused on next-generation autologous and allogeneic cell therapies

Legend Biotech Corporation (LEGN) is building future value by advancing its platform beyond the current BCMA-targeted therapy. The pipeline is focused on next-generation modalities, though most assets are still in early development. The company is actively pursuing both autologous (patient's own cells) and allogeneic (off-the-shelf) cell therapies. A concrete step in this direction was the presentation of first-in-human results from the allogeneic CAR-T candidate, LUCAR-G39D, at ASH 2025. However, you should note that most pipeline assets are currently in Phase 1, meaning they are years away from potential commercialization, which adds a layer of uncertainty to near-term revenue diversification.

Finance: draft 13-week cash view by Friday.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Customer Relationships

You're navigating the complex world of CAR-T therapy commercialization, where the relationship isn't just with the prescribing physician, but with the entire specialized treatment ecosystem. Legend Biotech Corporation (LEGN) focuses its customer relationship strategy on intensive support for the centers administering CARVYKTI.

High-touch, specialized support for certified treatment centers and oncologists.

The nature of CAR-T therapy demands a high level of coordination, which is reflected in the required infrastructure. As of the first quarter of 2025, Legend Biotech Corporation (LEGN) and Janssen had 213 globally activated treatment sites. This specialized network requires continuous engagement to maintain the high manufacturing success rate, which management stated was 97% as of early 2025. The cost of a single course of treatment is estimated around $465k, underscoring the high-value, high-touch nature of the service provided to these centers.

Dedicated medical affairs and sales teams supporting CARVYKTI adoption.

The commercial engine supporting adoption is reflected in the operating expenses. For the three months ended September 30, 2025, Selling and Distribution Expenses were $52.6 million. This spending increase, up from $44.3 million in the same period in 2024, is explicitly tied to higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities. This investment directly supports the growing revenue base.

• U.S. quarter-over-quarter growth in Q2 2025 was 13%.
• Nearly 60% utilization in earlier line settings in the U.S. as of Q2 2025.
• The therapy has launched in eight new territories in 2025 to date.

Patient support programs to navigate the complex CAR-T treatment process.

The ultimate customer relationship is with the patient, managed through the successful adoption of the therapy. As of the third quarter of 2025, over 9,000 patients globally have been treated with CARVYKTI. This scale implies a significant, ongoing need for support infrastructure to manage the logistics of cell collection, manufacturing, and infusion, which is inherent to the CAR-T process.

Collaboration management with Janssen for shared commercial success.

The commercial relationship with Janssen Biotech is central to Legend Biotech Corporation (LEGN)'s customer-facing success, as Janssen provides the global commercialization expertise. The financial structure aligns both parties directly with sales performance. The collaboration revenue for Legend Biotech Corporation (LEGN) reflects its share of the net trade sales generated by CARVYKTI. Here's a look at the revenue flow supporting this relationship through Q3 2025:

Metric	Q3 2025 Amount	Q3 2024 Amount
CARVYKTI Net Trade Sales (Total)	Approximately $524 million	Not explicitly stated
Legend Biotech Collaboration Revenue	$261.8 million	$142.8 million
Legend Biotech Cost of Collaboration Revenue	$113.3 million	$52.5 million

This shared success model is underpinned by joint investment in supply. Legend Biotech Corporation (LEGN) is supporting a $150 million investment in a new manufacturing facility in Belgium, aiming to double production capacity by the end of 2025. The company expects to initiate commercial production at the Tech Lane facility in Belgium by the end of 2025. The global profit-split is 50/50, though Legend Biotech Corporation (LEGN) secures a 70% share in Greater China.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Channels

You're looking at how Legend Biotech Corporation gets its CARVYKTI therapy to the patients who need it, which is a complex, high-touch process for a cell therapy. The channels aren't just about shipping; they're about specialized medical infrastructure and regulatory navigation.

The physical delivery channel relies heavily on a highly specialized, limited network. This is necessary because CARVYKTI is an autologous CAR-T therapy, meaning the patient's own cells are modified and infused back into them, requiring specific handling and infusion capabilities.

• CARVYKTI is available in over 120+ treatment centers across America.
• These centers are designated as CARVYKTI Certified Treatment Centers, featuring specially trained doctors and nurses.
• Patients must plan to stay at or near the center for at least 4 weeks following treatment.

The commercialization and distribution backbone is managed through the collaboration with Janssen Biotech, Inc., a Johnson & Johnson company. This partnership dictates the global reach, with a key operational agreement recently updated.

Channel Component	Key Entity/Location	Status/Date
Global Commercial Network	Janssen Biotech, Inc.	Manages commercialization worldwide, excluding Greater China.
Supply Agreement (Superseding 2022 Interim)	Legend Biotech USA Inc. & Janssen Pharmaceuticals, Inc.	Signed October 6, 2025.
Primary US/Commercial Manufacturing Site	Raritan, New Jersey Facility	Shared facility; Legend Biotech supplies the product to Janssen here.
EU Manufacturing Site (Operational)	Obelisc Facility, Ghent, Belgium	Began commercial production in Q3 2024 and is operating at full capacity.
EU Manufacturing Site (Expansion)	Tech Lane Facility, Ghent, Belgium	Expected to gain approval for commercial supply by the end of 2025.

Legend Biotech is aggressively scaling its manufacturing to meet demand, aiming for a goal of producing 10,000 doses of Carvykti annually by the end of 2025. This supply chain is a direct link from Legend Biotech's manufacturing sites, like the one in Raritan, New Jersey, to the specialized hospitals.

Regulatory bodies act as critical gatekeepers, validating the channel's ability to safely deliver the therapy. These agencies govern market access and label expansions, which directly impact which patients can be treated through the existing channels.

• U.S. Food and Drug Administration (FDA): Approved CARVYKTI in February 2022. The FDA removed the Risk Evaluation and Mitigation Strategies (REMS) and updated labeling to reduce monitoring requirements. A labeling change including a warning for a potentially fatal gastrointestinal condition was approved on October 10, 2025.
• European Commission (EC): Granted conditional marketing authorization in May 2022. The EC approved CARVYKTI for patients who have received at least one prior therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.
• Other Authorities: Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI in September 2022. The Therapeutic Goods Administration (TGA) in Australia is part of the health authorities that reviewed the product.

The removal of REMS by the FDA is a significant channel efficiency improvement, as it reduces the administrative and monitoring burden on the 120+ certified centers. Finance: review the impact of the October 6, 2025 supply agreement's cost-sharing terms on Q4 2025 COGS by next Tuesday.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Customer Segments

You're looking at the core groups Legend Biotech Corporation (LEGN) serves for its cell therapy products, primarily CARVYKTI (ciltacabtagene autoleucel; cilta-cel). This is a high-value, specialized market, so the customer segments are tightly defined.

Adult patients with relapsed or refractory multiple myeloma (second-line plus)

This segment represents the direct recipients of the approved therapy. The commercial success hinges on capturing patients across various lines of therapy, especially as the label expands.

As of the third quarter of 2025, Legend Biotech Corporation has treated over 9,000 patients globally with CARVYKTI. ^® The product's positioning is shifting toward earlier lines of treatment, supported by clinical data.

The patient segment is defined by prior treatment history, which dictates access:

• Patients with relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy (initial US indication).
• Patients with RRMM who have received at least one prior line including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide (US label update as of April 2024).
• Patients in the second-line plus setting, following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to include overall survival benefit data from the CARTITUDE-4 study on the European label.

Here's a look at the commercial uptake through the first three quarters of 2025:

Metric	Q1 2025 Value	Q2 2025 Value	Q3 2025 Value
CARVYKTI ® Net Trade Sales	$369 million	$439 million	$524 million
Cumulative Patients Treated (Approximate)	Over 6,000	Over 7,500	Over 9,000

The company projects CARVYKTI to achieve operational breakeven by the end of 2025.

Hematology-oncology specialists and major cancer treatment centers globally

These are the prescribers and the physical locations where the complex, personalized cell therapy is administered. Scaling this segment requires building out specialized infrastructure.

Legend Biotech Corporation is focused on expanding its physical footprint to meet demand. In the first quarter of 2025, the number of activated treatment sites in the U.S. had expanded to 114.

Key operational metrics for these centers include:

• Manufacturing success rate: 97% in CAR-T cell manufacturing.
• On-time delivery rate: 95%.
• Median turn-around time: 30 days.

The company is also expanding manufacturing capacity, initiating clinical production at the Tech Lane facility in Belgium as of Q1 2025, and targeting 10,000 annualized doses by the end of 2025.

Healthcare payers and government reimbursement systems (e.g., Spain's SNS)

Payers, including private insurers and government systems like Spain's SNS, are critical for determining patient access and the ultimate revenue realization for each dose administered.

The value proposition to payers is strengthened by data showing superior overall survival versus standard of care, which is being incorporated into the label. This clinical benefit supports favorable coverage decisions.

The financial trajectory signals increasing confidence in securing reimbursement to cover costs:

• Legend Biotech Corporation anticipates company-wide profitability in 2026.
• The gross margin on net product sales was 57% in Q3 2025.
• The company maintained a strong cash position of approximately $1.0 billion as of September 30, 2025, providing runway beyond 2026.

Clinical trial investigators for pipeline candidates

This segment includes academic and clinical researchers who participate in the development of Legend Biotech Corporation's next-generation therapies, which extends beyond multiple myeloma.

Investigators are engaged in studies for pipeline candidates targeting other hematological malignancies and solid tumors. For example, preliminary results from Phase 1 dose-escalation studies for LB2102 (lung cancers) and LB1908 (gastroesophageal cancers) were featured at major medical meetings in 2025.

The development of LB2102, a DLL-3 targeting CAR-T therapy, is associated with license revenue recognized over time as the Phase 1 clinical trial progresses.

Key engagement points for investigators include:

• Presenting data at major congresses like ASCO and EHA in 2025.
• Participation in Phase 1 dose-escalation studies for solid tumor programs.

Finance: draft 13-week cash view by Friday.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Legend Biotech Corporation's operations as of late 2025. The cost structure is heavily weighted toward supporting its commercial success and pipeline development.

A primary cost component is the High Cost of Collaboration Revenue. For the three months ended September 30, 2025, this cost totaled $113.3 million. This increase from the prior year was primarily due to Legend Biotech's share of the cost of sales connected with CARVYKTI® sales under the Janssen Agreement and expenditures made to support expansion in manufacturing capacity.

The commitment to pipeline advancement is reflected in Significant Research and Development (R&D) expenses. These expenses reached $113.1 million for the three months ended September 30, 2025. This rise from the prior year was attributed to higher pipeline-related research and development activities, plus expenditures in BCMA front line clinical studies.

The company is actively engaged in Capital expenditures for expanding global manufacturing capacity. A concrete example of this investment is the €165 million joint investment with Johnson & Johnson to expand the state-of-the-art facility at Tech Lane Ghent Science Park in Belgium. This second phase of investment reinforces the Ghent operations as a major European hub for cell therapies.

Commercial scaling drives the Selling and Distribution expenses. These amounted to $52.6 million for the third quarter of 2025. This figure reflects higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities, which naturally rose alongside collaboration revenue.

The final area outlined in the cost structure involves the Costs associated with maintaining and defending intellectual property. While specific figures for IP defense are not itemized separately in the readily available Q3 2025 data, these costs are embedded within the overall operating expenses, including R&D and administrative overhead.

Here's a quick look at the key expense categories for the third quarter of 2025:

Cost Category	Amount (Q3 2025)
Cost of Collaboration Revenue	$113.3 million
Research and Development Expenses	$113.1 million
Selling and Distribution Expenses	$52.6 million

You can see the scale of investment in the following operational areas:

• Expansion of CAR-T manufacturing in Ghent, Belgium, involving a €165 million joint investment.
• Higher commercial costs tied to sales force expansion.
• Expenditures supporting pipeline research and clinical studies.

Legend Biotech Corporation (LEGN) - Canvas Business Model: Revenue Streams

You're looking at the core money-making engine for Legend Biotech Corporation as of late 2025, and it's heavily concentrated around one blockbuster asset. Honestly, the revenue structure is straightforward: it's all about the success of CARVYKTI (ciltacabtagene autoleucel) through the Janssen collaboration, supplemented by specific licensing income. Here's the quick math on what hit the books for the third quarter ending September 30, 2025.

The primary financial inflows are clearly delineated into product-related collaboration revenue and distinct license revenue. It's important to note that the massive CARVYKTI net trade sales figure is the gross number driving the collaboration revenue split, not a separate, additive revenue line for Legend Biotech's total top line, which is a common structure in these co-commercialization deals.

Revenue Component	Q3 2025 Amount (USD)	Primary Driver/Source
CARVYKTI Net Trade Sales (Gross Driver)	$524 million	Global commercialization of CARVYKTI
Collaboration Revenue	$261.8 million	Legend Biotech's share from CARVYKTI sales under the Janssen Agreement
License Revenue	$10.5 million	Novartis License Agreement (recognized over time based on Phase 1 trial activities for LB2102)

That collaboration revenue of $261.8 million, combined with the $10.5 million in license revenue, aligns almost perfectly with the reported total revenue of approximately $272 million for the quarter. That's a massive jump, showing the commercial momentum is translating directly into the recognized income stream.

Beyond the recurring and recognized revenue, you have to factor in the contingent, but significant, potential income streams that underpin the long-term valuation of these partnerships. These are the non-guaranteed, performance-based payments that can provide substantial, albeit lumpy, boosts to the financials.

• Potential milestone payments from the Janssen collaboration agreement.
• Potential milestone payments from the Novartis License Agreement for LB2102, which has up to $1.01 billion in potential milestones mentioned in prior agreements, though the Q3 recognition was tied to ongoing trial activities.
• Revenue recognition tied to the progression of pipeline assets in clinical trials under various agreements.

If onboarding takes 14+ days, churn risk rises, but for revenue recognition, the key action is tracking the progress of the LB2102 trial to estimate the timing of the next license revenue tranche. Finance: draft 13-week cash view by Friday.