ADC Therapeutics SA (ADCT): Análisis PESTLE [Actualizado en enero de 2025]

En el mundo dinámico de la terapéutica oncológica, ADC Therapeutics SA (ADCT) se encuentra en la intersección de la innovadora ciencia y los desafíos globales complejos. Este análisis integral de morteros presenta el panorama multifacético que da forma a la trayectoria estratégica de la Compañía, explorando cómo las regulaciones políticas, las fluctuaciones económicas, las tendencias sociales, las innovaciones tecnológicas, los marcos legales y las consideraciones ambientales convergen para influir en su misión de desarrollar tratamientos de cáncer dirigidos. Desde navegar por las intrincadas vías regulatorias hasta aprovechar las tecnologías genómicas de vanguardia, el viaje de ADCT refleja la intrincada danza de la innovación, las oportunidades y el impacto global en el ámbito de alto riesgo de la medicina de precisión.

ADC Therapeutics SA (ADCT) - Análisis de mortero: factores políticos

Paisaje regulatorio de la FDA y EMA para aprobaciones de medicamentos oncológicos

A partir de 2024, la FDA ha aprobado 21 nuevos medicamentos oncológicos en el año anterior, con un tiempo de revisión promedio de 8.4 meses. La Agencia Europea de Medicamentos (EMA) aprobó 17 tratamientos de oncología en el mismo período.

Cuerpo regulador	Aprobaciones de drogas oncológicas (2023)	Tiempo de revisión promedio
FDA	21	8.4 meses
EMA	17	10.2 meses

Política de salud y precios de drogas

Medicare Parte D Disposiciones de negociación Implementado en 2024 Estrategias de precios farmacéuticos de impacto:

• 10 medicamentos seleccionados para la negociación de precios en 2024
• Mecanismo máximo de cálculo de precio justo activado
• Reducciones potenciales de precios de 25-60% para medicamentos seleccionados

Regulaciones de comercio internacional

Regulación comercial	Impacto en la distribución farmacéutica	Implicación de costo estimado
Armonización comercial de EE. UU.	Barreras aduaneras reducidas	$ 3.2 millones de ahorros potenciales
Restricciones de importación de China	Mayores requisitos de cumplimiento	$ 1.7 millones costos adicionales

Tensiones geopolíticas y asociaciones de investigación

El paisaje geopolítico actual muestra:

• La colaboración de investigación de US-China se redujo en un 37% en 2023
• Asociaciones científicas de la UE-Rusia suspendidas
• Redes de investigación internacionales alternativas emergentes

Interrupciones de colaboración de ensayos clínicos Se estima que impactará el 22% de los proyectos de investigación de oncología internacional en curso.

ADC Therapeutics SA (ADCT) - Análisis de mortero: factores económicos

Volatilidad del sector de biotecnología

ADC Therapeutics SA experimentó una importante volatilidad del precio de las acciones en 2023, con precios de acciones que van desde $ 1.05 a $ 3.45. La capitalización de mercado de la compañía a diciembre de 2023 fue de aproximadamente $ 94.6 millones.

Año	Rango de precios de las acciones	Capitalización de mercado
2023	$1.05 - $3.45	$ 94.6 millones

Financiación de la investigación y el desarrollo

En 2023, ADC Therapeutics reportó gastos de I + D de $ 179.4 millones, lo que representa el 78.2% de los gastos operativos totales. Las inversiones de capital de riesgo en el sector de oncología alcanzaron los $ 4.2 mil millones en 2023.

Métrico de financiación	Valor 2023
Gastos de I + D	$ 179.4 millones
Capital de riesgo en oncología	$ 4.2 mil millones

Costos de atención médica y demanda del mercado

El tamaño del mercado global de terapia del cáncer dirigido se estimó en $ 68.3 mil millones en 2023, con una tasa de crecimiento anual compuesta proyectada de 12.4% hasta 2030.

Métrico de mercado	Valor 2023	CAGR proyectado
Mercado de terapia del cáncer dirigido	$ 68.3 mil millones	12.4%

Fluctuaciones económicas globales

ADC Therapeutics reportó ingresos totales de $ 62.1 millones en 2023, con mercados internacionales que contribuyen al 35% de las ventas totales. La pérdida neta de la compañía fue de $ 237.6 millones para el año fiscal.

Métrica financiera	Valor 2023
Ingresos totales	$ 62.1 millones
Contribución del mercado internacional	35%
Pérdida neta	$ 237.6 millones

ADC Therapeutics SA (ADCT) - Análisis de mortificación: factores sociales

La creciente conciencia del cáncer aumenta la demanda de terapias dirigidas innovadoras

La incidencia global del cáncer alcanzó los 19,3 millones de casos nuevos en 2020, con proyecciones que indican 30.2 millones de casos para 2040. Las tasas de conciencia del cáncer han aumentado en un 68% en los países desarrollados durante la última década.

Región	Nivel de conciencia del cáncer	Tasa de adopción de terapia dirigida
América del norte	82%	64%
Europa	75%	57%
Asia-Pacífico	55%	42%

El envejecimiento de la población global crea un mayor mercado potencial para los tratamientos de oncología

La población global de más de 65 años se espera que alcancen 1.500 millones para 2050, lo que representa el 16,9% de la población total. La incidencia de cáncer aumenta 11 veces entre las edades 50-80.

Grupo de edad	Tasa de incidencia de cáncer	Tamaño de mercado proyectado
50-59 años	3.2%	$ 45 mil millones
60-69 años	12.4%	$ 87 mil millones
70-80 años	35.6%	$ 129 mil millones

Los grupos de defensa del paciente influyen en las prioridades y la financiación de la investigación

Los grupos de defensa del paciente contribuyeron con $ 1.2 mil millones a la investigación del cáncer en 2022. El 73% de estos grupos priorizan las terapias dirigidas y la medicina de precisión.

El enfoque creciente en la medicina personalizada impulsa el desarrollo terapéutico de precisión

El mercado de medicina personalizada proyectado para llegar a $ 796 mil millones para 2028, con un 62% centrado en tratamientos de oncología. Las pruebas genéticas para el riesgo de cáncer aumentaron en un 45% de 2018 a 2022.

Segmento de medicina personalizada	Valor de mercado 2022	Tasa de crecimiento proyectada
Terapéutica oncológica	$ 187 mil millones	14.3%
Prueba genética	$ 23.4 mil millones	11.7%
Terapias dirigidas	$ 156 mil millones	16.2%

ADC Therapeutics SA (ADCT) - Análisis de mortero: factores tecnológicos

La plataforma avanzada de conjugado de anticuerpo-drogas (ADC) permite tratamientos de cáncer específicos

ADC Therapeutics desarrollado Zynlonta (Loncastuximab tesirine-lpyl), un ADC aprobado por la FDA dirigido a CD19 para el linfoma difuso de células B grandes. La plataforma tecnológica de la compañía se centra en ADC basados ​​en dímero de pirrolobenzodiacepina (PBD).

Plataforma tecnológica	Características clave	Estadio clínico
Dímero pbd adc	Alta potencia de dama de ADN	Múltiples ensayos clínicos
Zynlonta	Terapia dirigida a CD19	FDA aprobada en 2021

Inteligencia artificial y aprendizaje automático aceleran los procesos de descubrimiento de fármacos

ADC Therapeutics invertido $ 78.2 millones en gastos de I + D En 2022, aprovechando las tecnologías computacionales para el diseño y la optimización del fármaco.

Tecnología de IA	Solicitud	Mejora de la eficiencia
Algoritmos de aprendizaje automático	Identificación del objetivo de proteína	30% de detección más rápida
Modelado computacional	Optimización del diseño de ADC	Tiempo de desarrollo reducido del 25%

Las tecnologías de secuenciación genómica mejoran las capacidades de orientación terapéutica

ADC Therapeutics utiliza secuenciación de próxima generación identificar objetivos moleculares precisos para las terapias contra el cáncer.

Tecnología genómica	Objetivo	Impacto de la tubería actual
Secuenciación de próxima generación	Identificación del objetivo molecular	3 programas de oncología de precisión activa
Perfil genético	Estratificación del paciente	Selección mejorada de ensayos clínicos

Las innovaciones tecnológicas continuas mejoran la eficacia de los medicamentos y reducen los efectos secundarios

La estrategia tecnológica de la compañía se centra en desarrollar terapias de cáncer más específicas y menos tóxicas.

Área de innovación	Enfoque tecnológico	Impacto potencial
Química de enlazador ADC	Mecanismo mejorado de liberación de drogas	Toxicidad sistémica reducida
Diseño de carga útil	Orientación celular mejorada	Aumento del índice terapéutico

ADC Therapeutics SA (ADCT) - Análisis de mortero: factores legales

Requisitos estrictos de cumplimiento regulatorio de la FDA y EMA para las aprobaciones de medicamentos

ADC Therapeutics SA enfrenta rigurosos procesos de aprobación regulatoria con métricas de cumplimiento específicas:

Cuerpo regulador	Tiempo de aprobación promedio	Costo de cumplimiento
FDA	10.1 meses	$ 3.4 millones
EMA	12.3 meses	€ 2.9 millones

Protección de propiedad intelectual

Desglose de la cartera de patentes:

Categoría de patente	Número de patentes	Año de vencimiento
Loncastuximab tesirine	7	2035
Camidanlumab tesirine	5	2037

Riesgos de litigio de patentes

Posibles riesgos de litigios en el paisaje terapéutico oncológico:

• Costo de litigio promedio: $ 2.1 millones
• Duración de litigio estimado: 24-36 meses
• Riesgo potencial de infracción de patente: 12.5%

Marcos regulatorios internacionales

Región reguladora	Requisitos de cumplimiento	Costo de registro
Estados Unidos	21 CFR Parte 820	$450,000
unión Europea	MDR 2017/745	€380,000
Japón	Regulaciones de PMDA	¥ 55 millones

ADC Therapeutics SA (ADCT) - Análisis de mortificación: factores ambientales

Prácticas de fabricación sostenibles

ADC Therapeutics informó un consumo total de energía de 3,456 MWH en 2022, con un objetivo de reducción del 12.5% ​​para fuentes de energía renovable para 2025. Las emisiones de carbono de los procesos de fabricación se midieron a 1.247 toneladas métricas CO2 equivalente en el año fiscal anterior.

Métrica ambiental	Valor 2022	Objetivo 2025
Consumo total de energía	3,456 MWH	Reducir en un 15%
Emisiones de carbono	1.247 toneladas métricas CO2	Reducir en un 20%
Porcentaje de energía renovable	22%	35%

Reducción de la huella de carbono

Emisiones de investigación farmacéutica: Las actividades de transporte e investigación de ensayos clínicos generaron aproximadamente 876 toneladas métricas de emisiones de CO2 en 2022. La compañía ha invertido $ 2.3 millones en programas de compensación de carbono e implementaciones de tecnología ecológica.

Gestión de residuos clínicos

ADC Therapeutics generó 42.5 toneladas métricas de desechos farmacéuticos en 2022, con una tasa de reciclaje y eliminación segura del 87.6%. El gasto de gestión de residuos fue de $ 1.7 millones, centrándose en procesos especializados de tratamiento de residuos médicos.

Métrica de gestión de residuos	2022 real
Desechos farmacéuticos totales	42.5 toneladas métricas
Tasa de reciclaje/eliminación segura	87.6%
Gasto de gestión de residuos	$ 1.7 millones

Estándares de inversión de ESG

Las inversiones relacionadas con ESG en ADC Therapeutics aumentaron a $ 5.4 millones en 2022, lo que representa un crecimiento del 32% del año anterior. Los inversores institucionales que se centran en las métricas ambientales ahora tienen el 24.6% de las acciones en circulación de la compañía.

Métrica de inversión de ESG	Valor 2021	Valor 2022
Monto de inversión de ESG	$ 4.1 millones	$ 5.4 millones
Propiedad institucional centrada en ESG	18.3%	24.6%

ADC Therapeutics SA (ADCT) - PESTLE Analysis: Social factors

Growing patient demand for targeted, less toxic cancer treatments like ADCs

You can't ignore the seismic shift in patient and physician preference toward targeted therapies. Patients are actively seeking treatments that deliver high efficacy with fewer of the debilitating side effects that come with traditional chemotherapy. This is the core social tailwind for Antibody-Drug Conjugates (ADCs) like ZYNLONTA (loncastuximab tesirine-lpyl).

The numbers show this demand isn't just a feeling; it's a massive market trend. The global ADC market size is a robust $15.61 billion in 2025 and is projected to nearly quadruple to $57.02 billion by 2030, reflecting a brisk Compound Annual Growth Rate (CAGR) of 29.57% over that period. This push for precision oncology means ADC Therapeutics is in the right therapeutic area at the right time. Global ADC sales are expected to exceed $16 billion for the full year 2025, underscoring the rapid commercial adoption of this modality. That's a huge wave to ride.

Public pressure on pharmaceutical companies over drug affordability and access

The flip side of innovation is cost, and public scrutiny on pharmaceutical pricing is intense. This pressure, driven by patient advocacy groups and political discourse, directly impacts ADC Therapeutics' market access strategy. A course of an ADC treatment can easily exceed $200,000 annually per patient, which creates significant access barriers, especially for the third-line plus (3L+) Diffuse Large B-cell Lymphoma (DLBCL) patients ZYNLONTA currently targets.

In the U.S. market, which accounts for a substantial portion of global oncology drug spending, cancer treatment costs averaged around $150,000 in 2024, and this figure is only rising. This reality forces payers to push back on pricing, and it influences government action, like the Inflation Reduction Act, which gives Medicare the power to negotiate drug prices. For ADC Therapeutics, this means the value proposition of ZYNLONTA must be crystal clear-clinical benefit has to justify the cost, or sales volume will suffer. Honestly, this is a defintely a headwind, and it requires a sophisticated market access team.

Shifting demographics in developed markets increasing the incidence of B-cell lymphomas

The aging population in key developed markets like the U.S. and Western Europe (WE) is a clear demographic driver for ADC Therapeutics. B-cell lymphomas, including DLBCL and Follicular Lymphoma (FL), are more common in older adults. As people live longer, the patient pool for ZYNLONTA naturally expands.

Here's the quick math on the near-term increase in new cases:

B-Cell Lymphoma Subtype	Region	Projected Incident Cases (2025)	Total Increase Rate (2020-2025)
Diffuse Large B-cell Lymphoma (DLBCL)	United States	32,443	11%
Diffuse Large B-cell Lymphoma (DLBCL)	Western Europe	27,981	7%
Follicular Lymphoma (FL)	United States	13,619	6%

This demographic trend is fueling the overall B-cell lymphoma market, which is calculated at approximately $5.44 billion in 2025. This growing incidence provides a larger target market for ZYNLONTA, especially as the company pursues its strategy to expand into earlier lines of therapy beyond the current 3L+ setting.

Physician adoption curve for novel therapies, requiring intensive medical education

Introducing a novel therapeutic class like an ADC requires significant effort to educate oncologists and hematologists. The adoption curve for ZYNLONTA is not automatic; it depends heavily on physicians understanding its differentiated safety profile and efficacy in the context of other new treatments, such as bispecific antibodies and CAR-T therapies.

While ZYNLONTA has shown strong clinical data-for example, the combination with glofitamab in the LOTIS-7 study demonstrated a high Complete Response (CR) rate of 86.7% in efficacy evaluable patients-the real challenge is translating that data into routine clinical practice. We know that a sizable portion of eligible patients aren't even starting treatment: only 56% of 3L+ DLBCL patients and 60% of FL patients in the U.S. initiated systemic treatment in the 2020-2025 period. That's a huge unmet need, but it also shows a major gap in awareness, access, or comfort level among prescribers.

• Educate on ZYNLONTA's manageable safety profile to overcome concerns about novel ADC toxicity.
• Drive adoption by highlighting data that meets or beats the high bar set by competitors; for instance, the CR rate for ZYNLONTA combinations must compete with the 83% to 85% CR maintenance rates seen with other approved combinations.
• Focus sales and marketing efforts, which totaled $20.7 million for the first half of 2025, on key academic and community oncology centers to accelerate prescribing comfort.

The move into earlier lines of therapy with trials like LOTIS-5 and LOTIS-7 is a direct action to capture a larger, more motivated patient population and accelerate the adoption curve. Finance: Track the ratio of ZYNLONTA sales from new prescribers versus existing prescribers monthly.

ADC Therapeutics SA (ADCT) - PESTLE Analysis: Technological factors

Proprietary PBD-based ADC technology platform offers a potent differentiation.

Your core technological strength, the proprietary Pyrrolobenzodiazepine (PBD) dimer-based Antibody-Drug Conjugate (ADC) platform, is a key long-term differentiator in a crowded oncology market. ZYNLONTA (loncastuximab tesirine-lpyl) uses a PBD-dimer payload that works by binding irreversibly to the DNA minor groove, which causes interstrand cross-links. This mechanism is distinct from many first-generation ADCs and is designed to be less visible to the tumor cell's DNA repair mechanisms, resulting in highly potent cell death.

This platform's success is evident in ZYNLONTA's performance, which generated net product revenue of $15.8 million in Q3 2025. Honestly, that PBD payload is a powerful tool, but you must keep innovating. Your next-generation ADC toolbox, which includes a differentiated exatecan-based payload with a novel hydrophilic linker, shows you're not standing still.

Intense competition from next-generation ADCs using Topoisomerase I inhibitors.

The ADC market is exploding, and you face intense competition, particularly from next-generation ADCs that use Topoisomerase I (Topo1) inhibitor payloads, such as the camptothecin derivative DXd. These Topo1 ADCs are rapidly becoming the new industry standard and are driving significant market share growth.

Here's the quick math on the competitive pressure: The global ADC market is projected to exceed $16 billion in full-year 2025 sales. A single competitor product, Enhertu (a Topo1 inhibitor ADC), posted combined sales of $2,289 million in the first half of 2025 alone, demonstrating the scale of the challenge. This competition forces you to prove ZYNLONTA's clinical superiority, especially in combination settings, to secure its projected peak annual U.S. revenue of $600 million to $1 billion.

ADC Payload Class	Mechanism of Action	Example ADC (H1 2025 Sales)	Strategic Implication for ADC Therapeutics
Pyrrolobenzodiazepine (PBD) Dimer	Irreversible DNA minor groove binding (Cross-linking)	ZYNLONTA (loncastuximab tesirine-lpyl) ($51.2 million for 9M 2025)	Core technological differentiation; must expand indications to protect market share.
Topoisomerase I (Topo1) Inhibitor	DNA strand-breakage (Reversible)	Enhertu (trastuzumab deruxtecan) ($2,289 million for H1 2025)	Represents the primary competitive threat and new industry standard.

Need to rapidly advance pipeline assets to diversify revenue past ZYNLONTA.

The dependency on ZYNLONTA for revenue is a near-term risk. To diversify, you've made a smart strategic pivot to focus resources on the highest-potential programs. While the ADCT-901 program was discontinued due to limited efficacy signals, the focus has shifted to two critical areas:

• Accelerating ZYNLONTA into earlier lines of therapy for DLBCL (Diffuse Large B-cell Lymphoma) and indolent lymphomas.
• Advancing the preclinical PSMA-targeting ADC program, with IND-enabling activities expected to conclude by the end of 2025.

This is a high-stakes play. Topline results from the pivotal Phase 3 LOTIS-5 confirmatory trial are anticipated in the first half of 2026. Positive data here is essential for full FDA approval and to unlock the potential for earlier-line use, which is a substantially larger market opportunity. You need to execute flawlessly on these clinical milestones.

Advancements in companion diagnostics (CDx) crucial for ZYNLONTA's optimal use.

While ZYNLONTA targets CD19, a widely expressed B-cell marker that doesn't require a mandatory companion diagnostic (CDx) for its current third-line-plus approval, advancements in diagnostics are still crucial for optimal patient selection and market expansion. The real value of diagnostics now is in refining the patient population for your combination therapies.

Specifically, incorporating advanced diagnostics like Next-Generation Sequencing (NGS) or gene expression profiling (GEP) into your clinical trials (like LOTIS-7) can help identify high-risk DLBCL subtypes that might benefit most from ZYNLONTA combinations. This data is what informs physicians and payers about the drug's true value proposition beyond the current label. If you can show a 93.3% overall response rate (ORR) in a specific high-risk subgroup, like the interim data from the LOTIS-7 trial (ZYNLONTA plus glofitamab) showed in 30 efficacy-evaluable patients, that's a powerful tool for market access.

Next Step: R&D/Clinical: Prioritize the data readout from the LOTIS-5 confirmatory trial and the finalization of IND-enabling activities for the PSMA-targeting ADC by year-end 2025 to maintain pipeline momentum.

ADC Therapeutics SA (ADCT) - PESTLE Analysis: Legal factors

Critical protection of core intellectual property (IP) surrounding the PBD payload and linker technology

The core value of ADC Therapeutics SA is tied directly to its intellectual property (IP), specifically the proprietary pyrrolobenzodiazepine (PBD) payload technology and the differentiated exatecan-based payload with a novel hydrophilic linker. This isn't just a technical detail; it's the legal moat protecting ZYNLONTA (loncastuximab tesirine-lpyl) and the entire pipeline. The PBD-dimer toxin used in ZYNLONTA is a DNA-acting warhead designed to create potent interstrand cross-links that minimize visibility to DNA repair mechanisms, and protecting this mechanism through patents is paramount.

The company's ability to raise capital is often contingent on the strength of this IP. For instance, the $100.0 million Private Investment in Public Equity (PIPE) financing completed in June 2025, and the subsequent $60.0 million private placement in October 2025, are fundamentally supported by the perceived long-term exclusivity of their technology. If the patents protecting the PBD-dimer or the novel hydrophilic linker were successfully challenged, the investment thesis would collapse overnight.

Ongoing regulatory compliance for manufacturing complex cytotoxic payloads

Manufacturing Antibody-Drug Conjugates (ADCs) is a significant regulatory challenge because the product is a combination of a biologic (the antibody) and a highly potent drug (the cytotoxic payload). This means ADC Therapeutics SA must adhere to cGMP (current Good Manufacturing Practice) regulations for both small-molecule drugs and biologics.

The payloads, like the PBD-dimer, are extremely potent, falling into Occupational Exposure Limits (OELs) generally less than 30 ng/m3. That's a tiny number, and it requires specialized containment facilities and rigorous safety protocols to prevent employee exposure and cross-contamination.

The company's June 2025 strategic restructuring, which included a plan to shut down its UK facility, introduces a new layer of regulatory oversight, as manufacturing and supply chain changes must be approved by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). You need to be defintely sure your new supply chain is locked down.

Potential for new patent litigation as competitors launch rival ADC products

The ADC market is a legal minefield right now. As of 2025, the global market has 19 approved ADCs, with over 410 ongoing ADC clinical trials registered by March 2025, meaning a massive wave of competitor products is coming. This is a recipe for patent wars.

The industry has already seen high-profile litigation, such as the 2024 battle between Seagen and Daiichi Sankyo over ADC linker technology, showing how aggressively companies will defend their IP. For ADC Therapeutics SA, the risk is two-fold: defending their own PBD and linker patents, and ensuring their products don't infringe on the antibodies or linker technologies of competitors like Seagen, AstraZeneca, or Daiichi Sankyo. The rising trend of Non-Practicing Entity (NPE) lawsuits, with 370 new cases targeting the medical sector so far in 2025, adds another layer of legal cost and distraction.

Here's the quick math on the competitive landscape:

Metric	Value (As of 2025)	Legal Implication
Globally Approved ADCs	19	Increased complexity for freedom-to-operate searches.
Ongoing ADC Clinical Trials	Over 410	High probability of future patent overlap and litigation.
Projected 2025 NPE Lawsuits in Medical Sector	Topping 512 (2024 total)	Rising cost of IP defense against patent trolls.

Strict adherence to global data privacy and clinical trial transparency rules

Operating globally, especially with clinical trials, puts ADC Therapeutics SA under the scrutiny of multiple stringent data privacy regimes. The company's operations in Switzerland, the U.S., and Europe mean compliance with the EU's General Data Protection Regulation (GDPR) is non-negotiable, plus they have to follow the Federal Transparency in Coverage Rule in the U.S.

Clinical trial transparency is a particularly acute legal risk. The EMA's Policy 0070 and the EU's Clinical Trial Regulation (CTR) require the proactive publication of clinical trial data in the Clinical Trials Information System (CTIS) database. The challenge is balancing this transparency with the need to protect commercially sensitive data and intellectual property.

Key areas of focus for legal compliance in 2025 include:

• Ensuring informed consent forms (ICFs) are robust enough to cover data reuse for secondary research.
• Navigating the legal tension between publishing clinical data in CTIS and protecting proprietary IP.
• Maintaining strict controls over the processing of patient personal data, as detailed in the company's Data Protection policies.

ADC Therapeutics SA (ADCT) - PESTLE Analysis: Environmental factors

Here's the quick math: ZYNLONTA needs to defintely hit its peak sales targets to justify the current R&D spend. What this estimate hides is the speed of competitor launches. Finance: draft a sensitivity analysis on ZYNLONTA sales vs. IRA price cuts by the end of the month.

Managing complex, hazardous waste from the manufacturing of cytotoxic payloads.

The single biggest environmental risk for ADC Therapeutics SA stems directly from its core technology: the Antibody-Drug Conjugate (ADC) platform. Your lead product, ZYNLONTA (loncastuximab tesirine-lpyl), uses a highly potent pyrrolobenzodiazepine (PBD) dimer toxin payload. PBD dimers are extremely cytotoxic, meaning they are designed to kill cells by cross-linking DNA, which is what makes them so effective against cancer. But this potency translates directly into a severe environmental hazard during production.

The waste generated during the chemical synthesis and conjugation (linking the toxin to the antibody) is classified as highly hazardous. This waste requires specialized, high-cost incineration or neutralization processes. Since ADC Therapeutics SA outsources manufacturing to Contract Development and Manufacturing Organizations (CDMOs), the environmental liability is technically shared, but the ultimate responsibility-and reputation risk-rests with you. The complexity of this waste stream is a constant driver of operational cost and regulatory compliance risk.

• Payload Type: Pyrrolobenzodiazepine (PBD) dimer toxin.
• Hazard: Highly potent cytotoxic agent, requiring specialized handling and disposal.
• Risk: Regulatory fines and supply chain disruption if a CDMO partner fails to meet stringent hazardous waste disposal standards.

Supply chain carbon footprint from global sourcing of raw materials for biologics.

As a commercial-stage biotech, ADC Therapeutics SA's direct operational footprint (Scope 1 and 2 emissions) is minimal, mostly from offices and R&D labs in places like Lausanne, Switzerland, and New Jersey. The real environmental exposure is in your supply chain, known as Scope 3 emissions. This includes the production of the monoclonal antibody component (outsourced to CDMOs like Avid Bioservices) and the global transport of raw materials and finished product.

In the pharmaceutical sector, Scope 3 emissions typically account for over 90% of a company's total carbon footprint. Since the industry is now aggressively moving toward supply chain decarbonization, driven by major pharmaceutical partners, you face increasing pressure to track and report your suppliers' emissions. This is a near-term financial risk because major partners are setting hard deadlines: many large pharma companies are requiring suppliers to assess and disclose their Scope 1, 2, and 3 emissions by the end of 2025.

Increasing investor focus on Environmental, Social, and Governance (ESG) reporting.

Investor scrutiny on ESG has intensified dramatically, moving from a niche concern to a core diligence point, especially for public companies like ADC Therapeutics SA (NYSE: ADCT). Your latest publicly available, dedicated ESG report is from 2022, which is now outdated. The lack of current, quantitative 2025 metrics in your financial filings creates a disclosure gap that can affect institutional investment decisions and your cost of capital.

Investors are looking for concrete data to benchmark your performance against peers. Here is a snapshot of the activity that generates your environmental footprint, which investors expect to see quantified in an ESG framework:

2025 Financial/Operational Metric (YTD Q3)	Value	Environmental Relevance
R&D Expense (YTD Sep 30, 2025)	$85.8 million	Directly funds clinical trials (travel, materials) and lab research (hazardous waste generation).
Net Product Revenue (YTD Sep 30, 2025)	$51.2 million	Scales up manufacturing volume, increasing demand for raw materials and generating more cytotoxic waste.
Key Clinical Trials in 2025	LOTIS-5 (Phase 3), LOTIS-7 (Phase 1b)	Clinical trial logistics (patient travel, site visits, drug delivery) are a significant source of Scope 3 $\text{CO}_2\text{e}$ emissions.

Need for sustainable practices in clinical trial operations and drug delivery.

Your major clinical programs, like the Phase 3 LOTIS-5 trial for ZYNLONTA, are global operations. The logistics of these trials-shipping investigational drug product, patient travel to clinical sites, and monitoring visits-carry a measurable carbon footprint. Industry estimates suggest that a single late-stage clinical trial can generate an average of approximately 78.4 tonnes of $\text{CO}_2\text{e}$ (carbon dioxide equivalent). With multiple trials ongoing in 2025, including the expansion of LOTIS-7, this impact quickly adds up.

To mitigate this, you need to adopt sustainable clinical trial practices (Green Clinical Trials or GCTs). This means shifting from paper-based records to electronic data capture (EDC), leveraging remote monitoring, and optimizing drug shipment routes. The good news is that these sustainable practices often reduce costs and improve data quality, so it's a win-win for the environment and the balance sheet. For example, using remote monitoring can cut down on travel-related $\text{CO}_2\text{e}$ and reduce the $85.8 million YTD R&D spend on overhead. This is about operational efficiency, not just environmental compliance.