GenFit S.A. (GNFT): Analyse du pilon [Jan-2025 MISE À JOUR]

Dans le monde dynamique de la biotechnologie, Genfit S.A. se dresse au carrefour de l'innovation et des défis mondiaux complexes, naviguant dans un paysage multiforme qui exige une perspicacité stratégique et une adaptabilité. Cette analyse complète du pilon dévoile le réseau complexe de facteurs politiques, économiques, sociologiques, technologiques, juridiques et environnementaux qui façonnent la trajectoire de l'entreprise dans l'écosystème de recherche pharmaceutique. Des obstacles réglementaires aux percées technologiques, le parcours de GenFit reflète l'interaction nuancée des forces externes à l'origine des entreprises biotechnologiques modernes, offrant un récit convaincant de résilience, de potentiel et de recherche médicale transformatrice.

Genfit S.A. (GNFT) - Analyse du pilon: facteurs politiques

Environnement réglementaire de la biotechnologie française

L'Agence Nationale de Sécurit du Médicament et des produits de Santé (ANSM) supervise le développement de médicaments avec les paramètres de régulation suivants:

Aspect réglementaire	Détails spécifiques
Calendrier moyen d'approbation des médicaments	18-24 mois
Coût d'approbation des essais cliniques	€75,000 - €150,000
Budget annuel de conformité réglementaire	€500,000 - €750,000

Financement de la recherche sur les soins de santé de l'Union européenne

Attribution du programme Horizon Europe pour la recherche sur la biotechnologie:

• Budget total de recherche en biotechnologie: 10,1 milliards d'euros (2021-2027)
• Financement spécifique de la recherche en santé: 3,4 milliards d'euros
• Bourse potentielle pour la recherche sur les maladies rares: jusqu'à 2,5 millions d'euros par projet

Impact de la stabilité politique

L'indice de l'innovation pharmaceutique française démontre un soutien cohérent:

Métrique d'innovation	Valeur 2023
Pourcentage d'investissement en R&D	2,3% du PIB
Inscriptions aux brevets pharmaceutiques	1 247 brevets
Soutien de la recherche gouvernementale	6,8 milliards d'euros par an

Considérations de politique de santé

Cadre actuel de remboursement des soins de santé:

• Taux de remboursement maximal: 65%
• Couverture de médicaments par maladie rare: jusqu'à 100%
• Budget de revue de politique de santé annuelle: 120 millions d'euros

Genfit S.A. (GNFT) - Analyse du pilon: facteurs économiques

Déterprès du paysage de financement biotechnologique dans le climat économique post-pandemique

Genfit S.A. a fait face à des défis de financement importants dans le secteur biotechnologique. En 2023, l'investissement mondial en capital-risque en biotechnologie a diminué de 42% par rapport à 2022, le financement total atteignant 11,4 milliards de dollars.

Année	Financement du capital-risque biotechnologique	Changement d'une année à l'autre
2022	19,7 milliards de dollars	+12%
2023	11,4 milliards de dollars	-42%

Les taux de change fluctuants ont un impact sur les coûts internationaux de recherche et de développement

La volatilité du taux de change EUR / USD a eu un impact directement sur les dépenses de R&D de GenFit. En 2023, le taux de change a fluctué entre 1,05 et 1,12, créant une incertitude financière.

Paire de devises	2023 bas	2023 haut	Taux moyen
EUR / USD	1.05	1.12	1.08

La volatilité mondiale du marché pharmaceutique affecte les investissements et les opportunités de partenariat

Le marché pharmaceutique mondial a connu une volatilité importante. En 2023, la taille du marché était estimée à 1,48 billion de dollars, avec un taux de croissance annuel composé (TCAC) de 5,8%.

Métrique du marché	Valeur 2023	Valeur 2030 projetée	TCAC
Marché pharmaceutique mondial	1,48 billion de dollars	2,25 billions de dollars	5.8%

Les ressources financières limitées nécessitent une allocation stratégique des ressources et un financement potentiel sur les actions

Genfit S.A. a déclaré un chiffre d'affaires total de 12,3 millions d'euros en 2023, avec des dépenses de R&D représentant 25,6 millions d'euros. La position de trésorerie de la société était de 47,5 millions d'euros au 31 décembre 2023.

Métrique financière	Valeur 2023	Valeur 2022
Revenus totaux	12,3 millions d'euros	15,7 millions d'euros
Dépenses de R&D	25,6 millions d'euros	32,4 millions d'euros
Poste de trésorerie	47,5 millions d'euros	62,1 millions d'euros

GenFit S.A. (GNFT) - Analyse du pilon: facteurs sociaux

La sensibilisation croissante aux maladies du foie métaboliques augmente le potentiel du marché

Selon l'Organisation mondiale de la santé, la maladie hépatique non alcoolique (NAFLD) affecte environ 25% de la population mondiale. La prévalence mondiale de la NAFLD par région se décompose comme suit:

Région	NAFLD Prévalence
Amérique du Nord	30.1%
Europe	23.7%
Asie-Pacifique	27.4%

La population vieillissante stimule la demande de solutions thérapeutiques innovantes

La population mondiale âgée de 65 ans et plus devrait atteindre 1,5 milliard d'ici 2050, la prévalence des maladies métaboliques augmentant proportionnellement.

Groupe d'âge	Risque de maladie métabolique
45-54 ans	22.3%
55 à 64 ans	36.7%
65 ans et plus	48.5%

L'approche des soins de santé centrée sur le patient influence la stratégie de développement des médicaments

L'engagement des patients dans les essais cliniques a augmenté 47% Au cours des cinq dernières années, avec des mesures spécifiques pour les essais cliniques de GenFit:

• Taux de recrutement des patients: 68%
• Taux de rétention des patients: 82%
• Intégration des commentaires des patients: 55%

L'augmentation des dépenses de santé soutient la recherche médicale avancée

Projections de dépenses de santé mondiales:

Année	Dépenses de santé totales	Recherche & Allocation de développement
2022	9,4 billions de dollars	240 milliards de dollars
2024	10,2 billions de dollars	276 milliards de dollars
2026 (projeté)	11,5 billions de dollars	315 milliards de dollars

Genfit S.A. (GNFT) - Analyse du pilon: facteurs technologiques

Technologies de médecine génomique et de précision avancée

GenFit S.A. La plate-forme de développement de médicaments Elafibranor de l'entreprise utilise des techniques de dépistage génomique avancées.

Catégorie de technologie	Montant d'investissement (€)	Focus de recherche
Dépistage génomique	4,3 millions	Marqueurs de maladies métaboliques
Médecine de précision	3,9 millions	Thérapeutique des maladies du foie

Intelligence artificielle et apprentissage automatique

GenFit utilise des plateformes de découverte de médicaments dirigés par l'IA, allouant environ 22% du budget de la R&D aux technologies d'apprentissage automatique. La société a intégré des algorithmes de biologie informatique pour accélérer les processus de recherche.

Technologie d'IA	Investissement annuel	Amélioration de l'efficacité
Algorithmes d'apprentissage automatique	2,8 millions d'euros	37% d'accélération de la recherche
Biologie informatique	2,1 millions d'euros	29% d'identification cible

Plateformes de santé numérique

GenFit a développé des systèmes de gestion des essais cliniques numériques, investissant 1,5 million d'euros dans les technologies de surveillance à distance. Les plateformes permettent la collecte et l'analyse des données des patients en temps réel.

Plate-forme numérique	Investissement	Efficacité du recrutement des patients
Surveillance des essais à distance	1,5 million d'euros	Recrutement 42% plus rapide
Analyse des données des patients	1,2 million d'euros	35% Amélioration de la qualité des données

Outils de biotechnologie émergents

GenFit exploite des outils de biotechnologie avancés, avec un accent spécifique sur les interventions thérapeutiques ciblées. La société a alloué 3,6 millions d'euros pour développer des technologies de dépistage moléculaire spécialisées en 2022.

Outil de biotechnologie	Investissement	Cible thérapeutique
Dépistage moléculaire	3,6 millions d'euros	Intervention des maladies métaboliques
Développement de la thérapie ciblée	2,9 millions d'euros	Stratégies de traitement de précision

Genfit S.A. (GNFT) - Analyse du pilon: facteurs juridiques

Exigences strictes de conformité réglementaire pour la recherche pharmaceutique

GenFit S.A. fonctionne dans des cadres réglementaires rigoureux, notamment:

Corps réglementaire	Exigences de conformité	Coût annuel de conformité
Agence européenne des médicaments (EMA)	Règlement sur les essais cliniques (UE) No 536/2014	1,2 million d'euros
Administration américaine de l'alimentation et du médicament (FDA)	21 CFR Part 11 Records électroniques	1,5 million de dollars
Conseil international de l'harmonisation (ICH)	Bonnes directives de pratique clinique	€850,000

Protection de la propriété intellectuelle

Répartition du portefeuille de brevets:

Catégorie de brevet	Nombre de brevets	Durée de protection estimée
Technologie Elafibranor	7 brevets	Jusqu'en 2035
Recherche de maladies métaboliques	5 brevets	Jusqu'en 2032
Mécanismes d'administration de médicament	3 brevets	Jusqu'en 2030

Règlement sur les essais cliniques internationaux

Métriques de la conformité réglementaire pour les essais cliniques internationaux:

• Temps de soumission réglementaire moyen: 42 jours
• Fréquence d'audit de la conformité: trimestriel
• Taux de modification du protocole d'essai clinique: 18% par an

Stratégies d'expiration des brevets et de protection

Drogue	Expiration des brevets	Stratégie de protection	Investissement estimé en R&D
Elafibranor	2035	Amélioration continue, nouvelle formulation	12,5 millions d'euros
Technologie RMN	2032	Méthode supplémentaire d'utilisation des brevets	8,3 millions d'euros

Budget de conformité juridique: 4,7 millions d'euros par an

Dépenses totales de protection de la propriété intellectuelle: 21,6 millions d'euros par an

Genfit S.A. (GNFT) - Analyse du pilon: facteurs environnementaux

Pratiques de recherche durable dans le secteur pharmaceutique

GenFit S.A. La stratégie d'investissement environnemental de l'entreprise alloue environ 7,5% du budget de recherche annuel aux technologies de laboratoire vert.

Métrique environnementale	2022 données	2023 projection
Investissement durable R&D	1,5 million d'euros	2,3 millions d'euros
Cible de réduction du carbone	Réduction de 12%	Réduction de 18%
Équipement de laboratoire vert	€750,000	1,1 million d'euros

Réduction de l'empreinte carbone

GenFit S.A.

Approvisionnement éthique des matériaux de recherche

Le budget du matériel de recherche pour 2023 est de 3,2 millions d'euros, avec 65% alloués aux fournisseurs certifiés durables. Le taux de conformité de l'approvisionnement éthique a atteint 92% lors d'audits externes récents.

Focus sur les critères ESG des investisseurs

Métriques d'investissement environnementales, sociales et de gouvernance (ESG) pour GenFit S.A. Show:

• Évaluation ESG: BB (cote MSCI)
• Pourcentage d'investissement vert: 22% du total des investissements institutionnels
• Score de conformité environnementale: 8,4 / 10

Métrique d'investissement ESG	Valeur 2022	2023 Valeur projetée
Pourcentage d'investissement vert	18%	22%
Classement de l'indice de durabilité	Niveau 2	Niveau 1
Budget de conformité environnementale	1,7 million d'euros	2,5 millions d'euros

Genfit S.A. (GNFT) - PESTLE Analysis: Social factors

You're looking at Genfit S.A. (GNFT) and its market, and the social dynamics are a huge, often underestimated, driver of success in specialized pharma. The core takeaway here is that rising patient awareness and the global obesity crisis are creating a massive, growing market, but this tailwind is met by the hard reality of political pressure on high drug costs.

The social environment isn't just about demographics; it's about patient power and the public's willingness to pay for innovation. For Genfit, this translates to a clear opportunity in Non-Alcoholic Steatohepatitis (NASH) and a complex pricing risk for their approved orphan drug, Iqirvo® (elafibranor).

Growing patient advocacy and awareness for rare liver diseases like PBC pressures faster drug development.

Patient advocacy groups are defintely not passive anymore; they're demanding faster access to novel treatments for rare conditions like Primary Biliary Cholangitis (PBC). This pressure is a direct accelerant for Genfit's commercial success with Iqirvo®, which is licensed to Ipsen.

The market is responding quickly. Ipsen reported accelerated sales growth for Iqirvo® of €59 million in the first half of 2025 across the U.S. and Europe. Plus, the voluntary withdrawal of a key competitor, OCALIVA® (obeticholic acid), from the U.S. market in September 2025 dramatically simplifies the competitive landscape for Genfit's partner. This strong uptake and reduced competition are a direct result of patient and physician demand for better second-line options.

• Iqirvo® Sales Growth (1H 2025): €59 million accelerated sales reported by Ipsen.
• PBC Milestone Payment (May 2025): €26.5 million milestone paid to Genfit following pricing and reimbursement approval in Italy (the third major European country).
• Competitive Advantage: Key competitor OCALIVA® withdrew from the U.S. market in September 2025.

Lifestyle changes and obesity trends continue to increase the prevalence of Non-Alcoholic Steatohepatitis (NASH), Genfit's long-term focus.

This is the big macro-trend. The global obesity epidemic is the engine driving the Non-Alcoholic Steatohepatitis (NASH) market, which is Genfit's long-term, high-potential focus area. The World Health Organization (WHO) reported that in 2022, approximately 2.5 billion adults were classified as overweight, with 890 million living with obesity. This massive public health crisis is creating a huge, underserved patient population.

The market size reflects this trend. The global NASH market grew from $4.5 billion in 2024 to an estimated $6.06 billion in 2025, representing a Compound Annual Growth Rate (CAGR) of 34.7%. Here's the quick math: North America alone accounted for a market size of $3,640.8 million in 2025, which is over 60% of the global revenue. That's a massive target for any successful NASH therapy Genfit develops.

Metric	Value (2025 Fiscal Year Data)	Implication for Genfit
Global NASH Market Size	$6.06 billion	Represents a 34.7% CAGR from 2024, showing explosive demand.
North America NASH Market Size	$3,640.8 million	Largest regional market, critical for future NASH drug pricing and volume.
Global Overweight/Obese Adults (2022 WHO)	2.5 billion / 890 million	Indicates the vast, underlying patient pool for NASH.

Public scrutiny on high drug costs for orphan drugs (like Elafibranor) could affect payer reimbursement decisions.

While the demand is high, the cost of orphan drugs is a growing political flashpoint, especially in the US. Genfit's PBC drug, Iqirvo®, is an orphan drug, and its pricing is under the microscope. The US Congress is actively debating changes to the Inflation Reduction Act (IRA) that could eliminate the blanket exemption for orphan-only drugs from Medicare price negotiations.

Specifically, a proposal introduced in late 2025 suggests a drug would lose its exemption if its annual Medicare spending exceeds $400 million. This is a critical risk; if Iqirvo® becomes a blockbuster, its success could ironically trigger price negotiation, capping its long-term revenue potential in the largest market. The Congressional Budget Office (CBO) estimated that recent changes to the orphan drug exclusion will increase Medicare spending by $8.8 billion between 2025 and 2034, which fuels the political pushback.

Increased demand for personalized medicine and patient-centric treatment options.

The broader social trend in healthcare is a shift away from a one-size-fits-all approach toward personalized medicine (precision medicine). This is particularly true in complex areas like hepatology (liver disease treatment), which is a key growth driver.

The global liver disease treatment market is projected to grow from $46 billion in 2024 to $69.1 billion by 2030, a 7.1% CAGR, with personalized therapies being a significant factor. Genfit is already moving in this direction by developing new, targeted assets. They are pursuing next-generation therapies for Acute-on-Chronic Liver failure (ACLF), such as VS-01 and CLM-022, which target specific disease mechanisms like inflammation and fibrosis. This focus aligns perfectly with the evolving social demand for treatments that address the individual patient's pathology, rather than just managing symptoms.

Genfit S.A. (GNFT) - PESTLE Analysis: Technological factors

Advancements in non-invasive diagnostics (e.g., biomarkers) for liver fibrosis could expand the PBC and NASH patient pool.

The biggest technological shift for Genfit S.A. is the move away from the invasive liver biopsy, which is the current gold standard but carries risks and poor patient acceptance. Non-invasive diagnostics (NIDs) are now accurate enough to change the game, especially for Primary Biliary Cholangitis (PBC) and Metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH).

Genfit S.A. is defintely positioned to capitalize on this with its proprietary diagnostic franchise. Its flagship test, NIS2+®, is designed to detect MASH, which is crucial for identifying the right patients for treatment. This technology is vital because, for advanced fibrosis, composite non-invasive scores are demonstrating diagnostic accuracy comparable to a biopsy, with some achieving an Area Under the Curve (AUC) of up to 0.90. Better diagnostics mean a much larger, more easily identifiable patient pool for its partner Ipsen's drug, Iqirvo® (elafibranor), and future pipeline assets.

Development of next-generation drug candidates targeting multiple pathways for complex liver diseases.

The complexity of liver diseases like Acute-on-Chronic Liver Failure (ACLF) demands a multi-pronged attack, and Genfit S.A.'s pipeline reflects this next-generation approach. We are seeing a clear pivot toward drug candidates that hit multiple biological pathways, moving beyond single-target therapies.

The company's ACLF pipeline is a perfect example, with multiple programs in development, each targeting a different mechanism. This diversification mitigates the high risk inherent in single-asset biotech development. For instance, the company expects data readouts by the end of 2025 for two key programs, providing near-term catalysts:

• G1090N (a novel formulation of nitazoxanide): Safety data from a Phase 1 First-in-Human study and early signals of efficacy from ex-vivo functional assays are expected.
• GNS561 in Cholangiocarcinoma (CCA): Phase 1b data is expected.

This is smart science; you can't fix a systemic, multi-organ failure like ACLF with just one key.

Use of Artificial Intelligence (AI) in clinical trial design and patient recruitment to accelerate R&D timelines.

The use of Artificial Intelligence (AI) in drug development is no longer theoretical; it's a core operational technology that directly impacts the bottom line. The global AI in clinical trials market is projected to reach $9.17 billion in 2025, reflecting its real-world adoption.

AI is being deployed to streamline the most expensive and time-consuming part of R&D: clinical trials. Studies show AI can cut overall development timelines by 6-12 months and boost patient enrollment efficiency by 10-20%. Genfit S.A. is already leveraging this, noting in its February 2025 corporate update that its strategic development in the ACLF pipeline is informed by AI-driven analysis to enhance patient recruitment and streamline trial execution. This technological adoption helps reduce the cash burn from R&D, which is critical for a company focused on rare diseases.

Patent protection for Elafibranor and other pipeline assets is critical for long-term revenue security.

For a biotech firm, intellectual property (IP) is the entire business model, and the patent estate around Iqirvo® (elafibranor) is the foundation of Genfit S.A.'s current revenue stream. The drug's commercial success, with Ipsen reporting accelerated sales growth of €59 million in the first half of 2025, is directly tied to its exclusivity.

The long-term security comes from its regulatory and patent protections. For the Primary Biliary Cholangitis (PBC) indication in the U.S., the Orphan Drug Exclusivity is set to expire on June 10, 2031. Furthermore, the latest estimated generic launch date, based on the last expiring patents and exclusivities combined, is March 30, 2037. This extended protection period is what backs the company's financial stability, including the royalty financing agreement of up to €185 million signed in March 2025. The company's revenues for the first nine months of 2025 amounted to €39.2 million, including €12.6 million in royalties and a €26.5 million milestone payment, all underpinned by this IP.

Asset/Technology	Mechanism/Application	2025 Status/Milestone	Impact on Genfit S.A.
NIS2+®	Non-invasive diagnostic (NID) for MASH	Validated as a key component of the diagnostic franchise.	Expands identifiable patient population for MASH/NASH treatments.
Iqirvo® (elafibranor) Patent Estate	PPAR alpha/delta agonist for PBC	US Orphan Drug Exclusivity until June 10, 2031; Latest patent expiry estimated at March 30, 2037.	Secures royalty revenue stream, which contributed €12.6 million in royalties in 9M 2025.
AI in Clinical Trials	Patient recruitment, trial design optimization	Genfit S.A. using AI-driven analysis in ACLF trials.	Potential to cut R&D timelines by 6-12 months and boost enrollment by 10-20%.
ACLF Pipeline (G1090N, SRT-015, CLM-022)	Next-generation, multi-pathway targeting	G1090N safety/efficacy data expected by end of 2025.	Diversifies pipeline risk and addresses complex liver diseases with novel mechanisms.

Genfit S.A. (GNFT) - PESTLE Analysis: Legal factors

You're looking at Genfit S.A.'s (GNFT) legal landscape in 2025, and the key takeaway is that their primary asset, Iqirvo (elafibranor), is now a commercial product, which shifts the legal focus from regulatory approval to market exclusivity, post-marketing compliance, and competitive patent defense. The company's legal foundation is solid, but the post-approval obligations are extensive, and the competitive patent risk is a constant reality in the rare liver disease space.

Intellectual Property (IP) Protection for Elafibranor's Composition of Matter

The core value of Iqirvo, which is licensed to Ipsen, rests on its intellectual property (IP) protection. The composition of matter patent for Elafibranor, supported by later patents covering the Primary Biliary Cholangitis (PBC) indication, provides a clear market exclusivity window that is critical for long-term revenue projections. This primary exclusivity is generally anticipated to run until 2032, which is a significant runway for a rare disease drug.

Here's the quick math: that seven-year window from 2025 gives Ipsen, and by extension Genfit S.A. through royalties, a strong period of protection before generic competition can enter. This exclusivity is what underpins the milestone payments, such as the €26.5 million milestone Genfit S.A. received in May 2025 following the third major European pricing and reimbursement approval for Iqirvo. The legal team's job is to defintely defend this window.

• Primary Exclusivity: Expected to last until 2032 based on the latest patents and extensions.
• Financial Impact: Secures the royalty stream, which is tiered double-digit and up to 20% of net sales.
• Key Transaction: The €26.5 million milestone payment in May 2025 was triggered by the third major European market approval, validating the commercial IP value.

Strict FDA and EMA Requirements for Post-Marketing Surveillance and Real-World Data Collection

Because Iqirvo received accelerated approval from the U.S. Food and Drug Administration (FDA) in June 2024 and conditional marketing authorization from the European Medicines Agency (EMA) in September 2024, the legal and regulatory burden for post-marketing surveillance is exceptionally high. This isn't a typical approval; it's a conditional one, so the company must verify the drug's clinical benefit after launch.

The FDA mandates specific Postmarketing Requirements (PMRs) that Genfit S.A. and its partner Ipsen must fulfill. This includes conducting a long-term, randomized, double-blind, placebo-controlled study, Trial CLIN-60190-454, to confirm the clinical benefit on outcomes like all-cause mortality and liver transplant. Plus, there is a requirement for a ten-year worldwide descriptive study to collect data on women exposed to Elafibranor during pregnancy. The EMA also requires a long-term study to investigate the clinical benefits and continuous submission of Periodic Safety Update Reports (PSURs) and an updated Risk Management Plan (RMP). This is a massive, long-term data collection effort.

Regulatory Body	Post-Marketing Requirement (PMR)	Scope/Duration
U.S. FDA (Accelerated Approval)	Complete Confirmatory Trial (CLIN-60190-454)	Long-term efficacy/safety on clinical endpoints (mortality, transplant, etc.)
U.S. FDA (Safety)	Worldwide Descriptive Pregnancy Study	Ten-year collection of prospective and retrospective data on maternal/fetal risk
EMA (Conditional Approval)	Long-term Clinical Benefit Study	Confirm safety and effectiveness in PBC patients over the long term
EMA (Pharmacovigilance)	Periodic Safety Update Reports (PSURs)	Ongoing, regular submission of safety data post-authorization

Ongoing Litigation Risk Related to Competitor Patents or Off-Label Use

The liver disease market is highly competitive, and where there's competition, there's always the risk of patent litigation, even if no major cases are currently active against Genfit S.A. or Ipsen. The competitive landscape is a legal risk factor in itself. For example, the presence of Gilead's Livdelzi (seladelpar) in the PBC market, following the $4.3 billion acquisition of CymaBay Therapeutics, creates a duopoly (along with Ocaliva's withdrawal) that could lead to future patent challenges or defensive filings as market share battles intensify. You need to keep an eye on this. Any successful challenge to a key patent could immediately erase the 2032 exclusivity, opening the door for a generic version and gutting the royalty stream.

The risk also extends to off-label use. While Iqirvo is approved for PBC, the company's focus on Acute-on-Chronic Liver Failure (ACLF) and other liver diseases with its pipeline (G1090N, GNS561) means they must strictly manage communications and marketing to prevent any perception of promoting unapproved uses, which can lead to massive regulatory fines and legal action from the Department of Justice.

Compliance with Evolving Global Data Privacy Regulations (e.g., GDPR) for Clinical Trial Data

Given Genfit S.A.'s headquarters in France and operations in the U.S. and Switzerland, compliance with global data privacy laws like the European Union's General Data Protection Regulation (GDPR) is non-negotiable for their extensive clinical trial data. The company is actively managing this, stating compliance with the European Regulation 2016/679 and the ICH-GCP E6 (R2) guidelines for their clinical trial data.

The major legal hurdle here is the transfer of personal data outside the EU/EEA, especially to the U.S. for their clinical programs. They must ensure a sufficient level of protection is provided for this data, often through specific contractual agreements or explicit patient consent, which adds complexity and cost to every multi-national trial. Also, the company is monitoring developments in new European reporting standards, such as the Corporate Sustainability Reporting Directive (CSRD) framework, which will increase the scope of their non-financial legal and compliance reporting in the coming years.

Genfit S.A. (GNFT) - PESTLE Analysis: Environmental factors

Increased focus on pharmaceutical waste disposal and the environmental impact of manufacturing operations.

You're seeing regulators and the public push hard on pharmaceutical waste, and for good reason. Drug residues in water bodies are a serious issue, but Genfit S.A.'s business model-focused on research and development (R&D) rather than large-scale manufacturing-significantly limits its direct exposure here. The risk is less about mass production and more about laboratory and clinical trial waste, which still requires strict protocols.

Honesty, Genfit S.A. is proactive in this area for a biotech of its size. The company ensures it does not discharge liquid effluents, like solvents or biological media, into the urban wastewater network. Instead, it uses a reprocessing method, typically incineration, to avoid environmental contamination. This is a critical risk mitigation step, especially for hazardous materials.

Here is a quick look at their 2025 waste management practices, based on 2024 activity data:

Waste Type / Indicator	Management Practice	Environmental Impact Mitigation
Solvents & Biological Media (Effluents)	Reprocessed by incineration	Prevents discharge into urban wastewater network.
Infectious Risks Waste (DASRI)	Sorted and collected separately	Ensures elimination in compliance with current legislation.
Drug Residues in Rivers (Iqirvo®)	Monitored in collaboration with partner Ipsen	Leverages partner's sustainable development commitment for marketed drug.

ESG (Environmental, Social, and Governance) reporting requirements for publicly traded companies are tightening globally.

The regulatory landscape for non-financial reporting is defintely getting tighter, and this is a major transition risk. As a publicly traded company, Genfit S.A. is directly impacted by the push for greater transparency, especially with the European Union's Corporate Sustainability Reporting Directive (CSRD) and its associated European Sustainability Reporting Standards (ESRS).

Genfit S.A. has a dedicated ESG Committee, established in 2021, and published its 2025 Extra-Financial Performance Report (covering 2024 activity) to address this investor demand. They were monitoring the CSRD framework closely, but the transition plan to the ESRS standards was suspended following the Omnibus Directive published in early 2025. Still, their commitment remains, and they are moving closer to European standards voluntarily. That's a smart move to maintain investor confidence.

• ESG Committee: Established in 2021, meets at least bi-annually.
• 2025 Report: Published in May 2025, detailing social, societal, and environmental performance.
• Regulatory Stance: Voluntarily moving toward European standards despite the suspension of the ESRS transition plan in early 2025.

Need for ethical sourcing of raw materials used in drug synthesis and clinical trials.

For a biotech, ethical sourcing is less about vast supply chains and more about precision and minimizing waste in the lab. Genfit S.A.'s core business is R&D, meaning its consumption of raw materials is inherently low and its supply chain is minimal. This is a significant structural advantage that reduces their exposure to complex ethical sourcing audits that plague large manufacturers.

The raw materials used for their synthetic chemistry are organic compounds, typically used in quantities up to 1,000. They calculate orders precisely so the materials can be fully transformed during the synthesis process, which means less waste generation. That's just good business and good environmental practice rolled into one.

Climate change impacts on supply chain logistics and manufacturing site resilience.

While Genfit S.A. has a low environmental footprint and a minimal supply chain, the global risks from climate change still affect the broader logistics environment they rely on for clinical trials and essential lab supplies. You can't ignore the macro-trend.

Global economic losses from natural catastrophes are rising; they reached $162 billion in the first half of 2025 alone, up from $156 billion the previous year. These events disrupt key transportation infrastructure-roads, ports, and railways-leading to delays and higher freight costs, even for small-volume, high-value shipments of clinical trial materials. The key risk for Genfit S.A. is not site resilience (as they are not a major manufacturer) but the resilience of their third-party logistics partners and the global freight market. Diversifying clinical trial sites and logistics partners is the clear action here.