Legend Biotech Corporation (Lign): Analyse de Pestle [Jan-2025 Mise à jour]

Dans le paysage dynamique de la biotechnologie, Legend Biotech Corporation (Lign) se dresse au carrefour de l'innovation et des défis mondiaux complexes. Cette analyse complète du pilotage se plonge profondément dans l'environnement multiforme façonnant la trajectoire stratégique de l'entreprise, révélant l'interaction complexe des facteurs politiques, économiques, sociologiques, technologiques, juridiques et environnementaux qui détermineront finalement son potentiel de succès révolutionnaire dans le monde compétitif des thérapeutiques du cancer du cancer. et médecine de précision.

Legend Biotech Corporation (Lign) - Analyse du pilon: facteurs politiques

Environnement réglementaire américain pour les approbations des essais cliniques

La FDA a approuvé 55 nouveaux médicaments en 2023, avec des thérapies en oncologie représentant 37% des nouvelles approbations de médicaments. La thérapie CAR-T du BCMA de la légende BCMA Cilta-Cel a reçu l'approbation de la FDA en février 2022 avec une désignation de thérapie révolutionnaire.

Métrique réglementaire	2023 données
Approbation totale de médicaments sur les romans de la FDA	55
Approbations de médicaments en oncologie	20 (37%)
Désignations de thérapie révolutionnaire	27

Financement de la politique des soins de santé et de la recherche

Les National Institutes of Health (NIH) sont alloués 47,1 milliards de dollars pour la recherche médicale au cours de l'exercice 2023, avec approximativement 6,5 milliards de dollars Dédié aux initiatives de recherche sur le cancer.

• Budget du NIH pour la recherche médicale: 47,1 milliards de dollars
• Financement de la recherche sur le cancer: 6,5 milliards de dollars
• Biotechnology Research Grants: 2,3 milliards de dollars

Règlements sur le commerce international

La chaîne d'approvisionnement pharmaceutique mondiale a été confrontée à des défis importants, les réglementations d'importation / d'exportation ayant un impact sur la recherche et le développement pharmaceutiques transfrontaliers.

Impact de la réglementation commerciale	Pourcentage
Augmentation des coûts de conformité	22%
Perturbation de la chaîne d'approvisionnement	18%
Complexité réglementaire	15%

Soutien du gouvernement à la recherche sur la biotechnologie

Le gouvernement américain a fourni 3,2 milliards de dollars dans le financement direct et les crédits d'impôt pour la recherche et le développement de la biotechnologie en 2023.

• Financement direct de la recherche: 2,7 milliards de dollars
• Crédits d'impôt pour la R&D: 500 millions de dollars
• Biotechnology Innovation subventions: 350 millions de dollars

Legend Biotech Corporation (Lign) - Analyse du pilon: facteurs économiques

Conditions boursières de la biotechnologie volatile affectant l'investissement et la levée de capitaux

Les actions de Legend Biotech Corporation (Lign) ont connu une volatilité significative du marché en 2023-2024. Le cours de l'action variait de 20,45 $ à 47,89 $ par action. La capitalisation boursière totale au quatrième trimestre 2023 était de 4,2 milliards de dollars. Les investissements en capital-risque en biotechnologie ont diminué de 36,7% par rapport à 2022, ce qui concerne les opportunités de collecte de fonds.

Métrique financière	Valeur 2023	Valeur 2022
Gamme de cours des actions	$20.45 - $47.89	$35.12 - $62.33
Capitalisation boursière	4,2 milliards de dollars	5,6 milliards de dollars
Biotech VC Investments	Diminution de 36,7%	13,2 milliards de dollars

Augmentation des dépenses de santé et de la demande de traitements de cancer avancé

Le marché mondial de l'oncologie devrait atteindre 323,1 milliards de dollars d'ici 2026, avec un TCAC de 8,7%. La thérapie CAR-T ciblée par le BCMA de Legend Biotech représente une opportunité de marché importante. Les dépenses de santé aux États-Unis ont atteint 4,5 billions de dollars en 2023, les traitements contre le cancer représentant environ 10% des dépenses totales.

Indicateur de marché des soins de santé	Valeur 2023	Valeur projetée 2026
Marché mondial d'oncologie	250,4 milliards de dollars	323,1 milliards de dollars
Total des dépenses de santé aux États-Unis	4,5 billions de dollars	5,2 billions de dollars
Dépenses de traitement du cancer	450 milliards de dollars	520 milliards de dollars

Impact potentiel des cycles économiques sur les budgets de la recherche et du développement

Legend Biotech a alloué 342,6 millions de dollars à la R&D en 2023, ce qui représente 45,3% des revenus totaux. L'incertitude économique a conduit à des contraintes budgétaires potentielles, les dépenses de R&D biotechnologiques devraient diminuer de 12 à 15% en 2024.

Métrique financière de la R&D	Valeur 2023	2024 projection
Dépenses de R&D	342,6 millions de dollars	291 à 310 millions de dollars
R&D en% des revenus	45.3%	38-42%
Réduction de la R&D projetée	N / A	12-15%

Pressions des prix pharmaceutiques et défis de remboursement

Le prix médian des thérapies CAR-T varie entre 373 000 $ et 475 000 $ par traitement. Medicare et assureurs privés mettant en œuvre des critères de remboursement plus stricts. Le taux de remboursement moyen des thérapies cellulaires avancées est passée de 87% en 2022 à 79% en 2023.

Métrique de tarification et de remboursement	Valeur 2023	Valeur 2022
Gamme de prix de thérapie Car-T	$373,000 - $475,000	$350,000 - $450,000
Taux de remboursement	79%	87%
Complexité de couverture d'assurance	Augmenté	Modéré

Legend Biotech Corporation (Lign) - Analyse du pilon: facteurs sociaux

Conscience croissante et demande de technologies de traitement du cancer personnalisées

Selon l'American Cancer Society, la taille du marché du traitement du cancer personnalisé a atteint 233,3 milliards de dollars en 2022, avec un TCAC projeté de 12,4% à 2030. Le marché mondial de la médecine de précision est estimé à 84,5 milliards de dollars en 2023.

Segment de marché	Valeur 2022	2030 valeur projetée
Traitement du cancer personnalisé	233,3 milliards de dollars	521,6 milliards de dollars
Médecine de précision	84,5 milliards de dollars	216,7 milliards de dollars

Le vieillissement de la population mondiale a augmenté le besoin de solutions avancées en oncologie

Les Nations Unies rapportent que la population mondiale à l'âge de 65 ans devrait atteindre 1,5 milliard d'ici 2050, ce qui représente 16,4% de la population totale. L'incidence du cancer dans 65+ groupes d'âge devrait augmenter de 38% d'ici 2030.

Métrique démographique	Valeur 2023	2050 valeur projetée
Population mondiale 65+	761 millions	1,5 milliard
Pourcentage de la population totale	9.7%	16.4%

Changements de préférences des patients vers des approches d'immunothérapie ciblées

Le marché mondial de l'immunothérapie d'une valeur de 108,3 milliards de dollars en 2022, avec une croissance attendue à 307,8 milliards de dollars d'ici 2030.

Métriques du marché de l'immunothérapie	Valeur 2022	2030 valeur projetée
Taille du marché	108,3 milliards de dollars	307,8 milliards de dollars
Taux de satisfaction des patients	72%	N / A

Attitudes culturelles envers les traitements médicaux innovants et les essais cliniques

Les taux de participation des essais cliniques ont augmenté de 17,3% dans le monde en 2022. La volonté des patients de s'engager dans des traitements innovants contre le cancer est passé à 64% dans les pays développés.

Métriques des essais cliniques	Valeur 2022	S'orienter
Participation de l'essai clinique mondial	Augmentation de 17,3%	Positif
Volonté des patients pour des traitements innovants	64%	Croissance

Legend Biotech Corporation (Lign) - Analyse du pilon: facteurs technologiques

Recherche et développement de thérapie des cellules CRISPR et CAR-T avancées

Legend Biotech a investi 157,4 millions de dollars dans les dépenses de R&D pour l'année 2023. La plate-forme de thérapie cellulaire CAR-T de l'entreprise se concentre sur le ciblage des antigènes de cancer spécifiques avec précision.

Plate-forme technologique	Investissement (2023)	Focus de recherche
Technologie CRISPR	62,3 millions de dollars	Édition de gènes en oncologie
Thérapie par cellules CAR-T	95,1 millions de dollars	Traitements du myélome multiple

Investissement continu dans la médecine de précision et les technologies génomiques

Legend Biotech a alloué 28,6% du total des revenus à la recherche génomique en 2023, représentant 214,5 millions de dollars en investissements en médecine de précision.

Zone de médecine de précision	Budget de recherche	Plates-formes technologiques clés
Séquençage génomique	87,2 millions de dollars	Séquençage de nouvelle génération
Diagnostic moléculaire	65,3 millions de dollars	Identification des biomarqueurs

Intégration de la santé numérique et méthodologies de recherche basées sur les données

Legend Biotech mis en œuvre Plateformes avancées d'analyse de données avec un investissement de 43,7 millions de dollars dans les technologies de santé numérique en 2023.

Technologie de santé numérique	Investissement	Objectif de mise en œuvre
Plateforme de recherche basée sur le cloud	18,5 millions de dollars	Gestion de la recherche collaborative
Analytique d'apprentissage automatique	25,2 millions de dollars	Traitement des données cliniques

Applications d'intelligence artificielle dans la découverte de médicaments et la recherche clinique

Legend Biotech a déployé des technologies d'IA avec un budget dédié de 72,6 millions de dollars en 2023 pour accélérer les processus de découverte de médicaments.

Application d'IA	Investissement	Métriques d'accélération de la recherche
Dépistage prédictif des drogues	34,2 millions de dollars	Identification des candidats 37% plus rapide
Optimisation des essais cliniques	38,4 millions de dollars	22% de délais de développement réduits

Legend Biotech Corporation (Lign) - Analyse du pilon: facteurs juridiques

Compliance réglementaire complexe pour les sociétés biopharmaceutiques à stade clinique

Legend Biotech Corporation fait face à une vaste surveillance réglementaire dans plusieurs juridictions. Depuis 2024, la société doit se conformer:

Corps réglementaire	Exigences de conformité	Coût annuel de conformité
FDA	Application de médicament enquête (IND)	2,3 millions de dollars
EMA (Agence européenne des médicaments)	Autorisation des essais cliniques	1,7 million de dollars
NMPA (Chine)	Approbation des essais cliniques	1,5 million de dollars

Protection de la propriété intellectuelle pour les technologies de traitement du cancer innovantes

Legend Biotech entretient un portefeuille de propriété intellectuelle robuste avec:

• Brevets actifs totaux: 37
• Demandes de brevet en instance: 22
• Régions de protection des brevets: États-Unis, Europe, Chine, Japon

Catégorie de brevet	Nombre de brevets	Valeur estimée
Thérapie par cellules CAR-T	15	120 millions de dollars
Traitement en oncologie	12	95 millions de dollars
Processus de fabrication	10	65 millions de dollars

Distinations potentielles en matière de brevets et de défis de propriété intellectuelle

Procédure judiciaire en cours actuelle:

Type de litige	Nombre de cas	Dépenses juridiques estimées
Défense d'infraction aux brevets	2	4,5 millions de dollars
Différends de la propriété intellectuelle	1	2,8 millions de dollars

FDA et processus d'approbation réglementaire internationale pour les nouvelles thérapies

Statut d'approbation réglementaire pour les thérapies clés:

Thérapie	Statut réglementaire	Calendrier d'approbation
LCAR-B38M (myélome multiple)	Désignation de thérapie révolutionnaire de la FDA	Q3 2024 (projeté)
Thérapie Solid Tumor Car-T	Essais cliniques de phase III	Q4 2024 (prévu)

Legend Biotech Corporation (Lign) - Analyse du pilon: facteurs environnementaux

Pratiques de fabrication durables dans la production pharmaceutique

Legend Biotech a mis en œuvre des stratégies de fabrication vertes avec les mesures suivantes:

Métrique environnementale	Performance actuelle	Année cible
Réduction de l'efficacité énergétique	22,4% de réduction de la consommation d'énergie de fabrication	2024
Consommation d'énergie renouvelable	37,6% de l'énergie de fabrication de sources renouvelables	2024
Conservation de l'eau	Réduction de 18,3% de l'utilisation de l'eau par unité de production	2024

Réduire l'empreinte carbone dans les opérations de recherche et de développement

Les stratégies de réduction de l'empreinte carbone comprennent:

• Émissions directes de gaz à effet de serre: 2 340 tonnes métriques CO2 équivalent
• Émissions indirectes de l'électricité: 4 560 tonnes métriques CO2 équivalent
• Investissements de compensation de carbone: 1,2 million de dollars par an

Gestion des déchets responsables dans les laboratoires de biotechnologie

Catégorie de déchets	Volume annuel	Taux de recyclage / traitement
Déchets biologiques	42,5 tonnes métriques	98,3% correctement traités
Déchets chimiques	16,7 tonnes métriques	95,6% en toute sécurité
Déchets de laboratoire en plastique	8,3 tonnes métriques	92,1% recyclé

Évaluations de l'impact environnemental pour les essais cliniques et les processus de production

Dépenses de conformité environnementale: 3,7 millions de dollars en 2024

• Audits environnementaux externes réalisés: 4 par an
• Investissements d'atténuation des risques environnementaux: 2,1 millions de dollars
• Conformité à l'EPA et aux réglementations environnementales internationales: 100%

Legend Biotech Corporation (LEGN) - PESTLE Analysis: Social factors

Sociological

You're looking at Legend Biotech Corporation (LEGN) and its lead product, Carvykti, and the social factors are overwhelmingly positive on the efficacy side, but there's a real headwind on cost. The core social advantage is that a one-time infusion offers a potential long-term, treatment-free interval, which is a massive quality-of-life improvement over continuous, burdensome chemotherapy regimens. This is a powerful driver of patient and physician acceptance.

The company's Q2 2025 results show this adoption is happening: over 7,500 clinical and commercial patients have been treated with Carvykti globally to date. That number is defintely a testament to the patient appeal of a single-dose therapy that has demonstrated unprecedented durability.

High patient acceptance for one-time infusion therapy over continuous treatment burdens

The biggest social shift Carvykti represents is moving away from continuous treatment to a single, curative-intent dose. Think about the daily, weekly, or monthly burden of standard-of-care (SOC) therapies for a chronic illness like multiple myeloma. The five-year data from the CARTITUDE-1 study, presented in 2025, showed that one-third (32 of 97) of heavily pre-treated patients remained progression-free for five years or more after just one infusion, without needing further myeloma therapy.

This single-infusion model drastically reduces the long-term psychological and physical toll of ongoing treatment, which is a significant social benefit. It's a game-changer for patient quality of life, and that translates directly into high acceptance, despite the short-term intensity of the CAR-T process.

• Single infusion offers long, treatment-free intervals.
• 33% of patients remained progression-free for $\ge$5 years in the CARTITUDE-1 study.
• Reduces the chronic burden of continuous chemotherapy.

Increasing prevalence of chronic diseases like multiple myeloma drives demand

The underlying epidemiology (the study of disease patterns) is a clear tailwind for Legend Biotech Corporation. The simple fact is the patient population for multiple myeloma (MM) is growing, which means the total addressable market for Carvykti is expanding. Here's the quick math on the need for new, effective therapies:

In the United States alone, the American Cancer Society estimates that about 36,110 new cases of multiple myeloma will be diagnosed in 2025. Plus, the projected complete MM prevalence in the USA is expected to increase to 162,339 in 2025. This growth, driven by an aging population, sustains the long-term demand for innovative treatments like Carvykti, especially as it gains approval for earlier lines of therapy.

Multiple Myeloma (MM) US Statistics (2025 Fiscal Year Data)	Amount/Value
Estimated New MM Cases in 2025 (US)	36,110
Projected Total MM Prevalence in 2025 (US)	162,339
Lifetime Risk of Diagnosis (Men)	1 in 108 (<1%)

Public scrutiny over the high cost of specialty cell and gene therapies

This is where the social factor turns into a significant market risk. Cell and gene therapies (CGTs) are incredibly expensive, and public and payor scrutiny over the price tag is intense. The list price for a one-time treatment of Carvykti is reported to be $555,310. While the long-term, curative potential can justify the cost-effectiveness to payors, the sheer size of the number generates significant political and social pressure.

This high cost means access is limited to a network of certified treatment centers, and reimbursement negotiations are complex and lengthy, especially ex-U.S. The social conversation around drug pricing in the US, coupled with the potential for serious side effects like cytokine release syndrome (CRS) and neurological toxicities that require extended monitoring, keeps the pressure on. It's a classic social tension: revolutionary clinical benefit versus massive financial strain on the healthcare system.

Legend Biotech Corporation (LEGN) - PESTLE Analysis: Technological factors

You're looking at Legend Biotech Corporation (LEGN) and trying to figure out if their technology can keep up with the massive demand for cell therapy. The short answer is yes, they are making the critical, capital-intensive investments right now to scale their manufacturing and push their next-generation pipeline, which is defintely the right move.

The core of their technological strength lies in the proven, long-term efficacy of their flagship product, CARVYKTI, coupled with a highly efficient manufacturing process that is currently being aggressively scaled. This combination gives them a significant competitive edge in the autologous chimeric antigen receptor T-cell (CAR-T) market.

Manufacturing capacity target of 10,000 treatment slots per year by late 2025.

Scaling up CAR-T manufacturing is the biggest near-term hurdle for any cell therapy company, but Legend Biotech is on track to hit a major milestone. They are focused on achieving 10,000 annualized doses exiting 2025. This expansion is crucial for meeting the surging global demand, especially after the recent label updates for CARVYKTI.

This capacity boost is being driven by the ramp-up of their existing Raritan facility and the initial commercial production at the Tech Lane facility in Belgium, which began in the first half of 2025 and is set to support the European market. It's a very tangible step toward solving the supply constraint issue that has plagued the industry.

High operational efficiency with a 97% manufacturing success rate.

The technology is only as good as its execution, and Legend Biotech has demonstrated impressive operational efficiency. Their manufacturing process boasts a 97% success rate. This is a key metric for you to track, as it minimizes waste, reduces costs, and ensures more patients actually receive their life-saving, one-time treatment on time.

Plus, their median turn-around time (TAT) for manufacturing is a competitive 30 days. This reliability is a major advantage for physicians and patients dealing with aggressive cancers like multiple myeloma, where time is literally life.

Long-term efficacy data shows one-third of patients progression-free for $\geq$5 years.

The technological proof is in the clinical data, and the five-year survival results for CARVYKTI are a game-changer. The CARTITUDE-1 study, updated in June 2025, showed that an unprecedented 33% (32 of 97) of heavily pretreated patients remained progression-free for five years or more after a single infusion.

This durability is the ultimate technological validation. The median overall survival (OS) in this study reached 60.7 months. This kind of long-term data fundamentally changes the treatment paradigm for relapsed/refractory multiple myeloma (RRMM).

CARVYKTI (cilta-cel) Efficacy Metric	Result (CARTITUDE-1 Study, 2025 Data)	Significance
Patients Progression-Free for $\geq$5 Years	33% (32 of 97 patients)	First CAR-T to show this long-term progression-free outcome
Median Overall Survival (OS)	60.7 months (over 5 years)	Demonstrates a durable survival benefit in RRMM
Manufacturing Success Rate	97%	High operational reliability for a complex cell therapy

R&D investment of $200.2 million in Q1 and Q2 2025 for pipeline expansion.

Legend Biotech isn't resting on CARVYKTI's success; they are pouring cash into the future. For the first half of the 2025 fiscal year, their total Research and Development (R&D) expenses were substantial, totaling $200.2 million.

Here's the quick math:

• Q1 2025 R&D Expense: $101.9 million
• Q2 2025 R&D Expense: $98.3 million
• Total 1H 2025 R&D: $200.2 million

This investment is primarily funding higher pipeline-related activities, including studies for CARVYKTI in earlier lines of therapy (frontline clinical studies) and advancing their next-generation cell therapy modalities.

Advancing next-generation platforms like gamma-delta T cell and universal CAR-T.

The company is strategically moving beyond autologous CAR-T (which uses a patient's own cells) toward allogeneic, or 'off-the-shelf,' therapies. This is the next frontier, as it would eliminate the long wait times and complex logistics of autologous treatment.

Their pipeline includes two key next-generation platforms:

• Gamma-Delta T Cell (CAR-γδ T): These are T-cells that possess both innate and adaptive immunity, making them a promising platform for allogeneic, or universal, CAR-T therapy. They are presenting first-in-human Phase 1 data on Lucar-G39D, an anti-CD20/CD19 dual-CAR allogeneic gamma delta T cell therapy, in late 2025.
• Universal CAR-T: This refers to their allogeneic, non-gene-editing CAR-T platform, which aims to create a ready-to-use product that can be manufactured at scale and stored, drastically improving patient access.

The focus here is on reducing the vein-to-vein time (the time from drawing a patient's blood to administering the final treatment) and lowering the cost of goods, which is what you need to see for long-term growth.

Legend Biotech Corporation (LEGN) - PESTLE Analysis: Legal factors

You're looking at a cell therapy leader, and in this space, regulatory and legal factors don't just shape the market-they are the market. For Legend Biotech Corporation, the near-term legal landscape is defined by streamlined U.S. access for Carvykti (ciltacabtagene autoleucel), a major European label win, and the ever-present, complex product liability and intellectual property (IP) risks inherent to novel biotechnology.

FDA Removed Risk Evaluation and Mitigation Strategies (REMS) for Carvykti, Simplifying Use

The U.S. Food and Drug Administration (FDA) made a significant move on June 26, 2025, by removing the Risk Evaluation and Mitigation Strategies (REMS) requirements for all approved BCMA- and CD19-directed autologous CAR-T cell immunotherapies, including Carvykti. This is a game-changer for logistics and patient access. The FDA determined that the medical community now has enough experience managing the associated risks, like cytokine release syndrome (CRS) and neurological toxicities, making the onerous REMS program unnecessary.

The label updates dramatically simplify patient monitoring requirements. For example, the mandated patient proximity to a certified healthcare facility after infusion was cut from four weeks to just two weeks. Also, the restriction on driving was shortened from a minimum of eight weeks to only two weeks following product administration. This change should defintely help boost patient uptake, especially in community settings, which is crucial for Carvykti to maintain its strong commercial momentum. Net trade sales for Carvykti hit approximately $524 million in Q3 2025, reflecting this growing demand.

Positive CHMP Opinion in Europe to Add Overall Survival Data to the Product Label

In a major regulatory win for the European market, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion in Q1 2025 to add the statistically significant improvement in overall survival (OS) data from the landmark Phase 3 CARTITUDE-4 study to the Carvykti product label. This was subsequently approved by the European Commission (EC) and U.S. FDA in Q3 2025. That's a huge competitive advantage.

This label update allows Legend Biotech and its partner, Johnson & Johnson, to market the therapy with an explicit overall survival benefit over standard-of-care treatments for patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy. The strength of this clinical data provides a robust legal foundation for pricing negotiations and market access across the 14 countries where Carvykti is commercially available as of Q3 2025.

Significant Product Liability Risk Exposure Common in the Novel Cell Therapy Sector

The nature of novel cell therapies means high efficacy comes with high, and sometimes late-onset, risks, creating a substantial product liability exposure. This risk was highlighted in October 2025 when the FDA placed a Boxed Warning on Carvykti to address a distinct late toxicity: immune effector cell-associated enterocolitis (IEC-EC). This is a serious gastrointestinal condition that has led to perforation.

The EMA also published a recommendation in June 2025 to include a warning about immune-mediated enterocolitis, noting that some cases may be refractory to standard treatment and that events of gastrointestinal perforation, including fatal outcomes, have been reported. Here's the quick math on exposure: over 9,000 patients have been treated with Carvykti to date, and manufacturers are legally required to conduct postmarketing observational safety studies to assess long-term safety, following patients for up to 15 years after administration. That is a long tail of liability risk.

Complex IP Landscape Managed Through the Johnson & Johnson Collaboration and Novartis License

Legend Biotech's commercial success is anchored in complex legal agreements that manage its intellectual property (IP) and manufacturing. The core is the exclusive worldwide license and collaboration agreement with Johnson & Johnson (Janssen) for Carvykti. But the IP landscape is complex, with the company's Q1 2025 risk factors explicitly mentioning 'uncertainties arising from challenges to Legend Biotech's patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process.'

The company also manages a crucial legal relationship with a competitor, Novartis, through two distinct agreements:

• Novartis License Agreement: Legend Biotech licensed its autologous CAR-T candidate LB2102 and other potential CAR-T therapies targeting DLL-3 to Novartis. Under this deal, Legend Biotech received a $100 million upfront payment and is eligible for up to $1.01 billion in clinical, regulatory, and commercial milestone payments, plus tiered royalties.
• Novartis Manufacturing Deal: To alleviate supply constraints, Johnson & Johnson and Legend Biotech expanded a manufacturing deal with Novartis in March 2024 for the commercial production of Carvykti. This agreement runs through the end of 2029, with Novartis providing commercial supply from its Morris Plains, New Jersey facility.

The manufacturing deal is a key legal mechanism to support the commercial ramp-up, which is vital for achieving the company's goal of Carvykti profitability by the end of 2025. The financial and legal specifics of these agreements are summarized below:

Legal/Commercial Agreement	Partner	Product/Service	Key Financial/Legal Detail (2025)
Worldwide License & Collaboration	Johnson & Johnson (Janssen)	Carvykti (cilta-cel)	Exclusive global development and commercialization rights; drives collaboration revenue of $261.8 million in Q3 2025.
DLL3 CAR-T License Agreement	Novartis	LB2102 and other DLL3 CAR-T therapies	$100 million upfront payment; eligible for up to $1.01 billion in milestones plus tiered royalties.
Commercial Manufacturing Agreement	Novartis	Carvykti commercial supply	Runs through the end of 2029; provides commercial supply from the Morris Plains, NJ facility to meet growing demand.

The next step is to monitor the post-REMS patient uptake and any legal challenges related to the new Boxed Warning, as both will impact 2026 revenue projections.

Legend Biotech Corporation (LEGN) - PESTLE Analysis: Environmental factors

Published second annual ESG report in April 2025 detailing sustainability commitment.

You need to look at Legend Biotech Corporation's (LEGN) second annual Environmental, Social, and Governance (ESG) report, which was published in April 2025, to understand their environmental footprint and forward-looking strategy. This report covers the 2024 fiscal year performance and clearly signals a formal commitment to sustainability, moving beyond initial disclosures. The company has enhanced its ESG governance by transferring primary oversight to the Controllership function and hiring a dedicated ESG Controller, which shows they are taking external reporting requirements defintely seriously.

This is a critical step for a biotech firm, as investors are increasingly scrutinizing the environmental impact of energy-intensive lab and manufacturing operations. The report is the foundation for measuring their progress and holding management accountable. They are establishing a track record.

Compliance with SASB and GHG Protocol standards for environmental reporting.

The company's approach to environmental reporting is grounded in established global standards, which gives the data credibility. The 2024 ESG report was prepared in accordance with the Sustainability Accounting Standards Board (SASB) Biotechnology & Pharmaceuticals Sustainability Accounting Standard and the Greenhouse Gas (GHG) Protocol Corporate Accounting and Reporting Standard.

Using these standards means the data is comparable to peers, which is what we, as analysts, need for a proper risk assessment. Specifically, their 2024 greenhouse gas inventory provides a clear baseline for their direct and indirect emissions, which is essential for future decarbonization planning. Here's the quick math on their core emissions for the 2024 fiscal year:

Environmental Metric (2024 Fiscal Year Data)	Standard	Amount (Metric Tons CO2 Equivalent)
Scope 1 Emissions (Direct Emissions)	GHG Protocol	768 mtCO2e
Scope 2 Emissions (Market-Based, Indirect)	GHG Protocol	11,897 mtCO2e
Total Scope 1 and 2 Emissions (CO2 only)	GHG Protocol	12,665 mtCO2e

The total Scope 1 and 2 emissions of 12,665 metric tons of CO2 equivalent are primarily driven by Scope 2 (purchased electricity), indicating a clear opportunity to invest in renewable energy procurement or on-site generation to significantly reduce their footprint.

Focus on reducing waste and improving energy efficiency at manufacturing sites.

Legend Biotech Corporation is actively addressing resource management at its global sites, which include manufacturing facilities in the United States, China, and Belgium. In 2024, they strengthened efforts to improve energy efficiency and reduce waste across their operations.

Their strategy for operational efficiency includes several concrete actions:

• Installing LED lighting with timers and sensors at various locations.
• Using variable speed equipment and scheduling systems to manage power demand.
• Maintaining recycling programs across all sites, diverting waste from landfills.

The new, state-of-the-art R&D facility in Philadelphia, Pennsylvania, slated to open in late 2025, is a tangible example of this commitment. This 31,000-square-foot facility is utilizing advanced systems like a heat recovery chiller and is designed to achieve a minimum of 10% energy savings compared to the ASHRAE 90.1-2016 baseline standards.

Enhancing chemical management through specialized training and equipment upgrades.

In the biotech industry, managing hazardous and medical waste streams is a major operational and regulatory risk. Legend Biotech Corporation prioritizes robust Environmental, Health, and Safety (EHS) management, especially concerning chemical handling.

In 2024, they enhanced their chemical management program specifically through specialized training and equipment upgrades. This is a crucial, non-financial investment that directly mitigates regulatory fines and operational disruption risk. All waste, including multiple streams of medical and hazardous waste, is disposed of in accordance with local laws and regulations via a third-party waste vendor. They also utilize waste-to-energy conversion where legally permitted to further divert materials from landfills.