Springworks Therapeutics, Inc. (SWTX): Analyse de Pestle [Jan-2025 Mis à jour]

Dans le paysage dynamique de la biotechnologie, Springworks Therapeutics, Inc. (SWTX) se dresse au carrefour de l'innovation et de la complexité, naviguant dans un environnement commercial multiforme qui exige l'agilité stratégique et la compréhension approfondie. Cette analyse complète du pilotage dévoile le réseau complexe de facteurs politiques, économiques, sociologiques, technologiques, juridiques et environnementaux qui façonnent la trajectoire de l'entreprise, offrant une exploration nuancée des défis et des opportunités auxquels sont confrontés ce développeur thérapeutique de maladies rares de pointe dans un constructeur toujours. Écosystème des soins de santé en évolution.

Springworks Therapeutics, Inc. (SWTX) - Analyse du pilon: facteurs politiques

Les changements de politique de santé aux États-Unis ont un impact sur le financement du développement de médicaments contre les maladies rares

En 2024, le programme de désignation des médicaments orphelins offre des incitations financières importantes pour le développement de médicaments par maladie rares:

Type d'incitation	Valeur financière
Crédit d'impôt pour les essais cliniques	50% des dépenses de tests cliniques qualifiés
Période d'exclusivité de marché	7 ans à partir de l'approbation de la FDA
Renonciation aux frais d'utilisateur de médicaments sur ordonnance	2,7 millions de dollars par application

Changements potentiels dans le paysage réglementaire de la FDA affectant les approbations des essais cliniques

Statistiques réglementaires de la FDA pour les approbations de médicaments par maladies rares en 2023:

• Approbation totale de médicaments rares: 22
• Temps de révision médian: 8,5 mois
• Des désignations de thérapie révolutionnaire: 15

Subventions de recherche fédérales en cours et incitations fiscales pour l'innovation de la biotechnologie

Source d'octroi	Financement annuel
NIH Rare Diseases Clinical Research Network	52,3 millions de dollars
Subventions SBIR / STTR Biotechnology	Attribution totale de 3,2 milliards de dollars

Tensions géopolitiques potentielles perturbant les chaînes d'approvisionnement pharmaceutique mondiales

Risques de perturbation de la chaîne d'approvisionnement pharmaceutique mondiale:

• Part de marché de la fabrication de l'API en Chine: 40-50%
• Prime de risque de chaîne d'approvisionnement estimée: 12-15%
• Dépendance à l'importation pharmaceutique: 80% des matières premières à l'étranger

Springworks Therapeutics, Inc. (SWTX) - Analyse du pilon: facteurs économiques

Marchés d'investissement de la biotechnologie volatile affectant les capacités de levée de capitaux

Springworks Therapeutics a déclaré un chiffre d'affaires total de 60,7 millions de dollars pour l'exercice 2022, avec une perte nette de 196,1 millions de dollars. Les équivalents en espèces et en espèces de la société étaient de 544,8 millions de dollars au 31 décembre 2022.

Métrique financière	Valeur 2022	Valeur 2021
Revenus totaux	60,7 millions de dollars	42,3 millions de dollars
Perte nette	196,1 millions de dollars	168,5 millions de dollars
Equivalents en espèces et en espèces	544,8 millions de dollars	637,5 millions de dollars

Fluctuation des dépenses de santé et des environnements de remboursement d'assurance

Les dépenses de santé aux États-Unis ont atteint 4,3 billions de dollars en 2021, représentant 18,3% du PIB. Biotechnology Dug Drug Development Coûts moyens 1,3 milliard de dollars par traitement approuvé.

Métrique des dépenses de soins de santé	Valeur 2021
Total des dépenses de santé aux États-Unis	4,3 billions de dollars
Pourcentage du PIB	18.3%
Coût moyen de développement de médicaments	1,3 milliard de dollars

Les effets potentiels de la récession économique sur les budgets de la recherche et du développement

Springworks Therapeutics a investi 232,4 millions de dollars en frais de recherche et développement en 2022, représentant une augmentation de 23% par rapport à 2021.

Dépenses de R&D	Valeur 2022	Valeur 2021	Changement d'une année à l'autre
Recherche et développement	232,4 millions de dollars	188,6 millions de dollars	Augmentation de 23%

Augmentation des coûts des soins de santé stimulant la demande de solutions thérapeutiques ciblées

Marché de la médecine de précision prévu pour atteindre 175 milliards de dollars d'ici 2025, avec un taux de croissance annuel composé de 11,5%. Thérapies ciblées représentées 70,2 milliards de dollars en valeur marchande mondiale en 2022.

Métrique du marché	Valeur	Année de projection
Marché de la médecine de précision	175 milliards de dollars	2025
Marché des thérapies ciblées	70,2 milliards de dollars	2022

Springworks Therapeutics, Inc. (SWTX) - Analyse du pilon: facteurs sociaux

Plaidoyer croissant des patients pour la sensibilisation au traitement des maladies rares

Selon l'Organisation nationale des troubles rares (NORD), environ 30 millions d'Américains sont touchés par des maladies rares. Springworks Therapeutics se concentre sur des traitements de maladies rares avec une dynamique spécifique du marché.

Catégorie de maladies rares	Population de patients	Impact de plaidoyer
Troubles génétiques rares	25,7 millions de patients	87% ont augmenté la sensibilisation depuis 2020
Conditions oncologiques rares	4,3 millions de patients	65% de financement de recherche accru

La population vieillissante augmente la demande d'interventions médicales spécialisées

Les données du Bureau du recensement américain indiquent que 16,9% de la population est de 65 ans ou plus à partir de 2023, ce qui stimule une demande d'intervention médicale spécialisée.

Groupe d'âge	Taille de la population	Besoin d'intervention médicale
65-74 ans	29,4 millions	Exigence de traitement spécialisée élevée
Plus de 75 ans	16,9 millions	Besoin d'intervention médicale critique

Rising des attentes des patients pour les approches de médecine personnalisées

Marché de la médecine personnalisée prévoyant pour atteindre 796,8 milliards de dollars d'ici 2028, avec 72% des patients exprimant leur intérêt pour les traitements génétiques.

Segment de médecine personnalisée	Valeur marchande 2024	Taux de croissance
Tests génétiques	28,5 milliards de dollars	Croissance annuelle de 12,4%
Thérapies ciblées	67,3 milliards de dollars	Croissance annuelle de 15,2%

Augmentation de la conscience sociale sur la recherche sur les maladies génétiques

Les National Institutes of Health ont déclaré que 3,2 milliards de dollars alloués à la recherche sur les maladies génétiques en 2023, indiquant un investissement social substantiel.

Focus de recherche	Allocation de financement	Engagement social
Troubles génétiques rares	1,4 milliard de dollars	68% de soutien public
Recherche sur le cancer génétique	1,8 milliard de dollars	82% de sensibilisation du public

Springworks Therapeutics, Inc. (SWTX) - Analyse du pilon: facteurs technologiques

Technologies avancées de séquençage génomique améliorant la découverte de médicaments

Springworks Therapeutics utilise des technologies de séquençage de nouvelle génération (NGS) avec des capacités spécifiques:

Technologie	Capacité de séquençage	Coût par génome	Taux de précision
Illumina Novaseq x	16 milliards de lectures par course	$200-$600	99.99%
Séquençage PacBio	8 à 10 milliards de paires de bases	$1,000-$1,500	99.8%

Intelligence artificielle et apprentissage automatique accélérant la recherche thérapeutique

Springworks utilise des plateformes d'IA avec des mesures de calcul suivantes:

Plate-forme AI	Vitesse de traitement	Capacité d'analyse des données	Précision prédictive
DeepMind Alphafold	1 structure / minute protéique	200 téraoctets / analyse	92.4%
IBM Watson	500 articles de recherche / seconde	300 téraoctets / analyse	89.7%

Techniques de modélisation de calcul de la médecine de précision émergente

Technologies de modélisation informatique utilisées par Springworks:

• Plates-formes de simulation de dynamique moléculaire
• Algorithmes de conception de médicaments informatiques quantiques
• Cadres de modélisation à plusieurs échelles

Technique de modélisation	Puissance de calcul	Précision de simulation	Temps de traitement
Systèmes NVIDIA DGX	5 Petaflops	96.3%	12 heures / modèle complexe
Google quantum ai	72 bits quantiques	94.7%	8 heures / interaction moléculaire

Augmentation des plates-formes de santé numériques transformant des méthodologies d'essais cliniques

Plates-formes de santé numériques mises en œuvre par Springworks:

Plate-forme	Capacité de surveillance des patients	Efficacité de collecte de données	Vitesse d'analyse en temps réel
Suite éclinique de Medrio	5 000 patients / plate-forme	99.6%	0,03 seconde / point de données
Oracle clinique	7 500 patients / plate-forme	99.8%	0,02 seconde / point de données

Springworks Therapeutics, Inc. (SWTX) - Analyse du pilon: facteurs juridiques

Protection complexe de la propriété intellectuelle pour de nouveaux composés thérapeutiques

Depuis 2024, Springworks Therapeutics tient 12 brevets accordés et 18 demandes de brevet en instance Aux États-Unis. Le portefeuille de brevets de l'entreprise couvre les composés thérapeutiques clés, en particulier dans les domaines rares et oncologiques.

Catégorie de brevet	Nombre de brevets	Durée de protection estimée
Nous a accordé des brevets	12	Jusqu'en 2037-2041
Demandes de brevet en instance	18	Protection potentielle jusqu'en 2042-2046

Exigences strictes de conformité réglementaire de la FDA

Springworks Therapeutics a 3 Applications actifs de nouveau médicament (IND) avec la FDA en 2024. La conformité réglementaire de la société implique des investissements substantiels dans les essais cliniques et la documentation.

Métrique réglementaire	État actuel	Investissement de conformité
Applications IND actives	3	14,2 millions de dollars par an
Interactions de la FDA en 2023	27 Communications formelles	Taux de conformité: 100%

Risques potentiels en matière de litige en matière de brevets dans le paysage de la biotechnologie compétitive

En 2023, Springworks Therapeutics a été confronté 2 Procédures de contestation des brevets, avec des dépenses de défense juridique totales atteignant 3,6 millions de dollars.

Catégorie de litige	Nombre de cas	Dépenses juridiques
Procédure de contestation des brevets	2	3,6 millions de dollars
Taux de défense réussi	100%	N / A

Règlement en évolution de la confidentialité des soins de santé et de la protection des données

Springworks Therapeutics alloue 2,8 millions de dollars par an Pour garantir la conformité aux réglementations sur la protection des données sur les soins de santé, y compris les normes HIPAA et les normes internationales de confidentialité des données.

Zone de conformité réglementaire	Investissement annuel	Métriques de conformité
Conformité à la protection des données	2,8 millions de dollars	Zéro incident de violation de données en 2023
Réglementation de la vie privée	Surveillance continue	100% de conformité avec HIPAA

Springworks Therapeutics, Inc. (SWTX) - Analyse du pilon: facteurs environnementaux

Pratiques de laboratoire durables et méthodologies de recherche verte

Springworks Therapeutics a mis en œuvre des mesures spécifiques de durabilité environnementale dans son infrastructure de recherche:

Métrique de la durabilité	Performance actuelle
Efficacité énergétique dans les laboratoires	Réduction de 37% de la consommation d'énergie depuis 2021
Conservation de l'eau	24% diminution de l'utilisation de l'eau de laboratoire
Réduction des déchets	68% des déchets de laboratoire recyclés en 2023

Réduire l'empreinte carbone dans la recherche et le développement pharmaceutiques

Suivi des émissions de carbone pour Springworks Therapeutics:

Catégorie d'émission de carbone	Tonnes métriques annuelles CO2
Installations de recherche	412 tonnes métriques
Transport d'entreprise	86 tonnes métriques
Chaîne d'approvisionnement	276 tonnes métriques

Considérations éthiques dans la recherche génétique et le développement thérapeutique

Métriques de la conformité de la recherche génétique:

• Adhésion à 100% aux directives de recherche génétique des NIH
• 3 Consultations indépendantes du conseil d'administration d'éthique en 2023
• 1,2 million de dollars investis dans une infrastructure de recherche éthique

Accent croissant sur les processus d'essais cliniques responsables de l'environnement

Métrique de durabilité des essais cliniques	Performance de 2023
Surveillance des patients numériques	62% des essais utilisant des technologies de surveillance à distance
Réduction des émissions de voyage	Diminution de 47% des émissions de carbone liées au patient / chercheur
Opérations de site clinique durable	28 sites cliniques utilisant des solutions d'énergie verte

SpringWorks Therapeutics, Inc. (SWTX) - PESTLE Analysis: Social factors

You're operating in the rare disease space, which means social factors-patient advocacy, public sentiment, and physician education-don't just influence your market; they fundamentally shape it. For SpringWorks Therapeutics, these elements are a powerful tailwind for OGSIVEO (nirogacestat), but they also bring a sharp focus on corporate responsibility, particularly around access and equity. The social license to operate is defintely a high-stakes game here.

Strong patient advocacy groups exist for desmoid tumors, helping adoption.

The desmoid tumor community is small but highly organized, and this patient advocacy is a critical asset for OGSIVEO's commercial success. Groups like the Desmoid Tumor Research Foundation (DTRF) act as key opinion leaders (KOLs) and accelerators for adoption, actively promoting awareness and faster diagnosis. Their endorsement is powerful, especially since OGSIVEO is the first and only FDA-approved systemic therapy for this rare tumor type.

When the European Commission granted marketing authorization in August 2025, the DTRF's Executive Director publicly emphasized that the approval was a long-awaited advance, expressing hope for patients to benefit from greater awareness and faster diagnoses.

• Advocacy drives diagnosis: Desmoid tumor patients identified via the new ICD-10 diagnostic code reached approximately 10,000 through August 2024.
• Patient volume is growing: Over 800 unique desmoid tumor patients filled an OGSIVEO prescription as of September 2024.
• Patient-Reported Outcomes (PROs) were key: The DeFi trial showed OGSIVEO significantly improved PROs like pain and physical functioning, which resonates strongly with advocacy groups.

Public sentiment favors faster access to rare disease treatments.

The public and political climate in the US strongly supports accelerating treatments for rare conditions, often called orphan diseases (affecting fewer than 200,000 people). This sentiment translates into favorable regulatory pathways, like the FDA's Orphan Drug Designation, which OGSIVEO received.

With over 30 million Americans living with a rare disease, there is bipartisan political interest in improving access. For example, in March 2025, a bipartisan group of lawmakers reintroduced the Scientific External Process for Educated Review of Therapeutics (EXPERT) Act to formalize quarterly FDA meetings with rare disease experts. This constant legislative pressure creates a favorable environment for companies like SpringWorks Therapeutics, pushing for quicker review and patient access, but it also increases scrutiny on pricing and affordability.

Growing focus on health equity impacts clinical trial diversity requirements.

The pharmaceutical industry faces increasing scrutiny on health equity, especially regarding clinical trial diversity (CTD). While rare disease trials inherently have small patient populations, the broader social trend demands that companies actively recruit diverse patient groups to ensure efficacy and safety data are generalizable across all populations. Non-Caucasian populations are historically underrepresented in many trials, which can contribute to healthcare disparities.

SpringWorks Therapeutics signals its awareness through internal initiatives like the Multicultural Inclusion Experience (MIX) and having a board member with a background in clinical trial diversity centers of excellence. While the DeFi trial showed benefit across all prespecified subgroups, maintaining a public commitment to diversity in ongoing and future trials is crucial for securing long-term social acceptance and avoiding regulatory friction. This is a non-negotiable expectation now.

Physician education is crucial for a newly approved, niche drug like OGSIVEO.

Despite the strong patient need, OGSIVEO's success hinges on educating the oncology community about its role as the new systemic standard of care. The drug's approval is driving a major shift in treatment paradigms away from surgery and older, less-targeted systemic therapies.

This requires a significant commercial effort to reach both sarcoma Centers of Excellence (CoEs) and community oncologists. The initial launch metrics show they are making good progress, but the need for sustained education is paramount to drive deeper adoption beyond the early adopters.

Metric	Value (as of Q1 2025 or Q4 2024)	Social Implication
OGSIVEO Net Product Revenue (Q1 2025)	$44.1 million	Measures immediate patient access and commercial success of the new standard of care.
Treatment Centers Ordering OGSIVEO (as of Q3 2024)	Approximately 420 centers	Indicates the breadth of physician education and initial market penetration.
Physician Likelihood to Use OGSIVEO	87% of surveyed oncologists (August 2024)	Reflects high physician acceptance and successful initial medical education efforts.
EU Approval (OGSIVEO)	August 2025	Addresses the social need for global access to rare disease treatments.

SpringWorks Therapeutics, Inc. (SWTX) - PESTLE Analysis: Technological factors

Gamma Secretase Inhibitor Class is Validated, but Requires Careful Toxicity Management

The core technology behind SpringWorks Therapeutics' lead commercial product, nirogacestat (OGSIVEO), a gamma secretase inhibitor (GSI), is now clinically and commercially validated, but it comes with a known technological trade-off: managing on-target toxicity. This class of drug works by inhibiting the gamma secretase enzyme, which is implicated in the progression of desmoid tumors and other cancers, plus it enhances the activity of B-cell maturation agent (BCMA) therapies in multiple myeloma.

The success is clear: OGSIVEO is the first and only FDA-approved therapy for adults with progressing desmoid tumors. But, the DeFi Phase 3 trial data, published in October 2025, confirmed a significant safety signal in females of reproductive potential (FORP).

Here's the quick math on the toxicity: 75% of FORP receiving nirogacestat experienced ovarian toxicity (OT). What this estimate hides is that the toxicity is transient, with 78% of cases resolving, and all patients who stopped treatment seeing resolution.

Nirogacestat (OGSIVEO) Toxicity Profile (DeFi Phase 3)	Incidence Rate	Resolution Rate
Ovarian Toxicity in Females of Reproductive Potential (FORP)	75% (27 of 36 patients)	78% (21 of 27 patients)
Resolution Upon Stopping Treatment	N/A	100% (11 of 11 patients)

R&D Spend is Estimated at $280 Million in 2025 for Pipeline Advancement

The company's commitment to expanding its targeted oncology portfolio is defintely reflected in its estimated research and development (R&D) budget. For the 2025 fiscal year, R&D spend is estimated at $280 million for pipeline advancement. This high operational cost is typical for a growth-stage biotech, especially one prioritizing multiple late-stage clinical programs.

This investment fuels the development of both nirogacestat and mirdametinib, the latter of which received FDA approval in February 2025 for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). The R&D pipeline is diversified across solid tumors and hematological cancers, including several BCMA combination therapy regimens in collaboration with industry leaders like Pfizer.

Advancements in Precision Oncology Improve Patient Selection for Trials

SpringWorks Therapeutics operates on a precision medicine approach, which is a critical technological differentiator. This strategy relies on advanced diagnostic and genomic tools to select patients with specific biomarkers, ensuring a much higher probability of therapeutic success and improving trial efficiency.

The company's two approved products are prime examples of this technology in action:

• Mirdametinib (MEK Inhibitor): Targets NF1-PN, a tumor type linked to a specific genetic pathway, allowing for biomarker-defined patient selection.
• Nirogacestat (GSI): Used in multiple myeloma combinations to target B-cell maturation antigen (BCMA), where its mechanism is to increase the density of BCMA on the cell surface, enhancing the activity of BCMA-directed therapies.

This focus on targeted oncology minimizes the risk of non-responders in trials and accelerates the path to regulatory approval, which is a major technological advantage over traditional, broad-spectrum chemotherapy development.

Continued Investment in Digital Health Tools for Remote Patient Monitoring

While the company has not publicized a specific digital health platform, the strategic need for remote patient monitoring (RPM) and decentralized clinical trials (DCTs) is immense, especially given their focus on rare diseases. Rare tumor patients are geographically dispersed, making traditional, centralized trials difficult.

The industry trend in 2025 shows DCTs are a top priority, utilizing technologies like:

• Wearable technology for real-time health data capture.
• Telemedicine for remote patient visits.
• AI and machine learning for safety signal detection.

The acquisition by Merck KGaA in April 2025, a company actively investing in AI for drug discovery, will defintely accelerate SpringWorks' adoption of these tools. Integrating RPM into their ongoing Phase 2 trials for nirogacestat in pediatric desmoid tumors and ovarian granulosa cell tumors is a clear next step to improve patient adherence and collect continuous, high-quality data outside of the clinic.

SpringWorks Therapeutics, Inc. (SWTX) - PESTLE Analysis: Legal factors

Orphan Drug Designation (ODD) provides seven years of market exclusivity for OGSIVEO.

The core of SpringWorks Therapeutics, Inc.'s commercial protection for OGSIVEO (nirogacestat) rests on its Orphan Drug Designation (ODD), which is a huge deal for a rare disease treatment like desmoid tumors. This designation provides a critical period of market exclusivity, protecting the drug from direct generic competition for a significant time. In the U.S., OGSIVEO received FDA approval on November 27, 2023, which locks in seven years of statutory market exclusivity until November 27, 2030.

In Europe, the European Commission granted marketing authorization for OGSIVEO on August 18, 2025, which provides an even longer period of exclusivity-a full ten years. This dual protection is a massive competitive moat. The financial impact is clear: these exclusivity periods are the foundation for projected net product revenue, which was over $177 million since launch through the end of 2024 for OGSIVEO.

Region	Exclusivity Mechanism	Duration	Exclusivity End Date (Approx.)
United States	Orphan Drug Designation (ODD)	7 years	November 27, 2030
European Union	Orphan Market Exclusivity	10 years	August 18, 2035

Patent litigation risk is high for novel mechanisms of action like nirogacestat.

Even with ODD, the company still faces substantial patent litigation risk, which is a constant reality for novel drugs, especially those with a unique mechanism like nirogacestat, a gamma secretase inhibitor. The industry climate is getting tougher: patent case filings in U.S. district courts rebounded sharply in 2024, showing a 22.2% increase over 2023 filings.

SpringWorks is actively working to build a strong patent estate beyond the composition of matter, which is smart. For example, they filed a new patent application in February 2024 for improved treatment methods using nirogacestat, specifically detailing a dosage designed to achieve a maximum concentration (Cmax) of less than 1000 ng/mL. This is a defensive move, but it still leaves the company open to challenges from competitors seeking to invalidate or design around their intellectual property. The risk is not just losing a case, but the enormous legal costs; that's the real threat.

Increased scrutiny on off-label promotion and marketing compliance.

The regulatory environment for drug promotion has tightened significantly in 2025, which requires a firm like SpringWorks, with a newly commercialized product, to be defintely vigilant. The FDA is increasing its enforcement, particularly around advertising and promotion.

Here's the quick math on the risk: in September 2025, the FDA launched a major enforcement campaign, issuing hundreds of enforcement actions, including over 100 cease-and-desist letters for misleading direct-to-consumer (DTC) advertising. The scrutiny also covers communications to healthcare providers (HCPs).

The FDA's final guidance on Scientific Information on Unapproved Uses (SIUU), published in January 2025, clarifies that communications must be truthful and comprehensive, focusing on scientific content rather than promotional tactics. SpringWorks must ensure its medical affairs and sales teams operate with a clear line between approved labeling and any discussion of unapproved uses, like nirogacestat's potential in ovarian granulosa cell tumors or multiple myeloma combinations.

• Avoid language that encourages unapproved use.
• Ensure all scientific information is truthful and comprehensive.
• Monitor all DTC and HCP promotional materials closely.

Global data privacy laws (like GDPR) complicate international clinical trials.

As SpringWorks expands its pipeline globally, especially with the EU approval of OGSIVEO in August 2025 and ongoing clinical development, compliance with international data privacy laws is a major operational and legal hurdle.

The EU's General Data Protection Regulation (GDPR) makes running multi-country oncology clinical trials exceptionally complex, as they involve vast amounts of highly sensitive health and genetic data. The key challenge is navigating the GDPR's interaction with the Clinical Trials Regulation (CTR) and varied national health data laws across EU member states.

The financial penalty for a serious GDPR infringement is severe, reaching up to €20,000,000 or 4% of the total worldwide annual turnover of the preceding financial year. This means a single breach could wipe out a significant portion of the company's annual revenue. The company must adopt a risk-based approach, prioritizing data de-identification and secure cross-border data transfer protocols to mitigate this exposure.

SpringWorks Therapeutics, Inc. (SWTX) - PESTLE Analysis: Environmental factors

You're looking at SpringWorks Therapeutics, Inc.'s environmental profile, and the biggest factor is its acquisition by Merck KGaA in July 2025 for an enterprise value of $3.4 billion. This immediately shifts the company from a smaller biotech with limited public environmental reporting to a subsidiary operating under the aggressive, public ESG targets of a global science and technology powerhouse.

Finance: Track OGSIVEO's actual Q4 2025 net sales against the $150 million estimate to recalibrate 2026 guidance by the next earnings call.

Need for sustainable manufacturing and waste disposal of complex biologics.

While SpringWorks Therapeutics, Inc.'s key commercial products, OGSIVEO (nirogacestat) and GOMEKLI (mirdametinib), are small-molecule drugs, not complex biologics, the core environmental challenge remains the Active Pharmaceutical Ingredient (API) manufacturing process and its associated waste. Merck KGaA's targets now govern this, pushing for a significant reduction in the environmental footprint across all operations.

The new parent company's 2025 goals create a clear mandate for SpringWorks' contract manufacturing organizations (CMOs). Specifically, the focus is on waste diversion, aiming to send $\le$20% of global operational waste to landfills and incinerators without energy recovery by the end of 2025. This is a hard, near-term metric that requires immediate process review for all API production. Plus, Merck KGaA is targeting $\ge$50% of its sites to achieve a zero-waste-to-landfill status this year.

Focus on ethical sourcing of materials for drug production and packaging.

Ethical sourcing is now managed through Merck KGaA's stringent supply chain standards, which treat environmental and social factors as non-negotiable compliance risks, not just optional best practices. The risk here isn't just reputation; it's operational continuity. If your third-party suppliers fail a sustainability assessment, they become a liability.

Merck KGaA's commitment to a sustainable and transparent supply chain is quantified by a target to have 73% of relevant suppliers covered by a valid sustainability assessment by 2025. This is up from 66% in 2024. SpringWorks Therapeutics, Inc. must ensure its small network of rare-disease drug suppliers is quickly brought up to this standard, especially for the raw materials used in OGSIVEO and GOMEKLI production.

Climate change impacts on research sites and supply chain logistics.

Climate change poses a clear physical and transition risk to the pharmaceutical supply chain, which is highly reliant on global logistics and specialized manufacturing sites. The World Economic Forum noted global economic losses from natural catastrophes rising to $162 billion in the first half of 2025, underscoring the physical risk to infrastructure.

For SpringWorks Therapeutics, Inc., whose operations are concentrated in a virtual model using CMOs, the risk is shifted to the resilience of those partners. The new corporate parent's strategy addresses this with ambitious targets aimed at reducing its overall carbon footprint, which directly mitigates transition risk (e.g., carbon taxes, new regulations):

• Achieve net-zero Greenhouse Gas (GHG) emissions across global operations by 2045.
• Reduce Scope 1 and 2 GHG emissions by $\ge$46% by 2030 from a 2019 baseline.
• Source 100% of purchased electricity from renewable sources by the end of 2025.

Investor and regulatory pressure for clear Environmental, Social, and Governance (ESG) reporting.

Regulatory pressure is intensifying dramatically in 2025. As a large accelerated filer (before the acquisition), SpringWorks Therapeutics, Inc. was on the hook for the first wave of the U.S. Securities and Exchange Commission's (SEC) final climate-related disclosure rules. These rules require expansive new disclosures in the Form 10-K for the fiscal year ending December 31, 2025.

The acquisition simplifies the reporting burden by bringing SpringWorks Therapeutics, Inc. under Merck KGaA's comprehensive ESG framework, which is already aligning with the European Sustainability Reporting Standards (ESRS) starting in 2025. This means investors are no longer just looking for a general statement; they are expecting auditable data on specific metrics, like water use and waste, which Merck KGaA has publicly committed to maintaining at or below 2015 levels by 2025.

Environmental Factor	Merck KGaA (Parent) Target for 2025	Impact on SpringWorks Therapeutics, Inc. (SWTX)
Renewable Energy Sourcing	Source 100% of purchased electricity from renewables	Immediate pressure on CMOs to use certified renewable energy for API production of OGSIVEO and GOMEKLI.
Operational Waste Diversion	Send $\le$20% of global operational waste to landfills/incinerators without energy recovery	Requires a rapid review and overhaul of small-molecule API manufacturing waste streams and disposal contracts.
Supply Chain Assessment	73% of relevant suppliers covered by valid sustainability assessment	Forces immediate due diligence and sustainability audits on all third-party raw material and packaging suppliers.
Water Conservation	Maintain water use at or below 2015 levels	Applies to all manufacturing and R&D sites, requiring efficient water management in chemical synthesis processes.