ADC Therapeutics SA (ADCT): Análise de Pestle [Jan-2025 Atualizado]

No mundo dinâmico da terapêutica oncológica, a ADC Therapeutics SA (ADCT) fica na interseção de ciências inovadoras e desafios globais complexos. Essa análise abrangente de pestles revela o cenário multifacetado que molda a trajetória estratégica da empresa, explorando como regulamentos políticos, flutuações econômicas, tendências sociais, inovações tecnológicas, estruturas legais e considerações ambientais convergem para influenciar sua missão de desenvolvimento de tratamentos de câncer direcionados. Desde a navegação de vias regulatórias complexas até as tecnologias genômicas de ponta, a jornada da ADCT reflete a intrincada dança de inovação, oportunidade e impacto global no reino da medicina de precisão.

ADC Therapeutics SA (ADCT) - Análise de Pestle: Fatores Políticos

Cenário regulatório da FDA e EMA nos EUA para aprovações de medicamentos oncológicos

Em 2024, o FDA aprovou 21 novos medicamentos oncológicos no ano anterior, com um tempo médio de revisão de 8,4 meses. A Agência Europeia de Medicamentos (EMA) aprovou 17 tratamentos oncológicos no mesmo período.

Órgão regulatório	Aprovações de medicamentos para oncologia (2023)	Tempo médio de revisão
FDA	21	8,4 meses
Ema	17	10,2 meses

Política de saúde e preços de drogas

Disposições de negociação do Medicare Parte D Implementado em 2024 Impact Pharmaceutical Precication Strategies:

• 10 medicamentos selecionados para negociação de preços em 2024
• Mecanismo máximo de cálculo de preços justos ativado
• Reduções potenciais de preços de 25-60% para medicamentos selecionados

Regulamentos de Comércio Internacional

Regulamentação comercial	Impacto na distribuição farmacêutica	Implicação de custo estimado
Harmonização comercial EUA-UE	Barreiras aduaneiras reduzidas	US $ 3,2 milhões em potencial economia
Restrições de importação da China	Requisitos de conformidade aumentados	Custos adicionais de US $ 1,7 milhão

Tensões geopolíticas e parcerias de pesquisa

Os atuais programas de paisagem geopolítica:

• Colaboração de pesquisa EUA-China reduzida em 37% em 2023
• Parcerias científicas da UE-Rússia suspensa
• Redes de pesquisa internacionais alternativas emergentes

Interrupções de colaboração de ensaios clínicos estimado para impactar 22% dos projetos de pesquisa internacional de oncologia em andamento.

ADC Therapeutics SA (ADCT) - Análise de Pestle: Fatores Econômicos

Volatilidade do setor de biotecnologia

A ADC Therapeutics SA experimentou uma volatilidade significativa das ações em 2023, com os preços das ações variando de US $ 1,05 a US $ 3,45. A capitalização de mercado da empresa em dezembro de 2023 era de aproximadamente US $ 94,6 milhões.

Ano	Faixa de preço das ações	Capitalização de mercado
2023	$1.05 - $3.45	US $ 94,6 milhões

Financiamento de pesquisa e desenvolvimento

Em 2023, a ADC Therapeutics registrou despesas de P&D de US $ 179,4 milhões, representando 78,2% do total de despesas operacionais. Os investimentos em capital de risco no setor de oncologia atingiram US $ 4,2 bilhões em 2023.

Métrica de financiamento	2023 valor
Despesas de P&D	US $ 179,4 milhões
Capital de risco em oncologia	US $ 4,2 bilhões

Custos de saúde e demanda de mercado

O tamanho do mercado global de terapia contra o câncer direcionado foi estimado em US $ 68,3 bilhões em 2023, com uma taxa de crescimento anual composta projetada de 12,4% a 2030.

Métrica de mercado	2023 valor	CAGR projetado
Mercado de terapia de câncer direcionada	US $ 68,3 bilhões	12.4%

Flutuações econômicas globais

A ADC Therapeutics registrou receita total de US $ 62,1 milhões em 2023, com mercados internacionais contribuindo com 35% do total de vendas. A perda líquida da empresa foi de US $ 237,6 milhões no ano fiscal.

Métrica financeira	2023 valor
Receita total	US $ 62,1 milhões
Contribuição do mercado internacional	35%
Perda líquida	US $ 237,6 milhões

ADC Therapeutics SA (ADCT) - Análise de Pestle: Fatores sociais

A crescente conscientização do câncer aumenta a demanda por terapias direcionadas inovadoras

A incidência global de câncer atingiu 19,3 milhões de novos casos em 2020, com projeções indicando 30,2 milhões de casos até 2040. As taxas de conscientização sobre o câncer aumentaram 68% nos países desenvolvidos na última década.

Região	Nível de conscientização sobre o câncer	Taxa de adoção de terapia direcionada
América do Norte	82%	64%
Europa	75%	57%
Ásia-Pacífico	55%	42%

O envelhecimento da população global cria um mercado potencial maior para tratamentos de oncologia

A população global com mais de 65 anos se espera atingir 1,5 bilhão até 2050, representando 16,9% da população total. A incidência de câncer aumenta 11 vezes entre as idades de 50 a 80.

Faixa etária	Taxa de incidência de câncer	Tamanho do mercado projetado
50-59 anos	3.2%	US $ 45 bilhões
60-69 anos	12.4%	US $ 87 bilhões
70-80 anos	35.6%	US $ 129 bilhões

Grupos de defesa de pacientes influenciam as prioridades de pesquisa e financiamento

Os grupos de defesa de pacientes contribuíram com US $ 1,2 bilhão para a pesquisa do câncer em 2022. 73% desses grupos priorizam terapias direcionadas e medicina de precisão.

O aumento do foco em medicina personalizada impulsiona o desenvolvimento terapêutico de precisão

O mercado de medicina personalizada projetou -se para atingir US $ 796 bilhões até 2028, com 62% focados em tratamentos de oncologia. Os testes genéticos para o risco de câncer aumentaram 45% de 2018 para 2022.

Segmento de medicina personalizada	Valor de mercado 2022	Taxa de crescimento projetada
Terapêutica oncológica	US $ 187 bilhões	14.3%
Teste genético	US $ 23,4 bilhões	11.7%
Terapias direcionadas	US $ 156 bilhões	16.2%

ADC Therapeutics SA (ADCT) - Análise de Pestle: Fatores tecnológicos

A plataforma de conjugado avançada de anticorpos-drog (ADC) permite tratamentos de câncer direcionados

ADC Therapeutics desenvolvida Zynlonta (LONCASTUXIMAB TESIRINE-LPYL), um ADC aprovado pela FDA direcionado ao CD19 para linfoma difuso de grandes células B. A plataforma tecnológica da empresa se concentra Pirrolobenzodiazepina (PBD) ADCs baseados em dímeros.

Plataforma de tecnologia	Principais características	Estágio clínico
PBD DiMer ADC	Potência de alta prejudicação de DNA	Múltiplos ensaios clínicos
Zynlonta	Terapia alvo de CD19	FDA aprovado em 2021

Inteligência artificial e aprendizado de máquina aceleram processos de descoberta de medicamentos

A ADC Therapeutics investiu US $ 78,2 milhões em despesas de P&D Em 2022, alavancando tecnologias computacionais para design e otimização de medicamentos.

Tecnologia da IA	Aplicativo	Melhoria de eficiência
Algoritmos de aprendizado de máquina	Identificação do alvo de proteínas	30% de triagem mais rápida
Modelagem Computacional	Otimização do design do ADC	25% de tempo de desenvolvimento reduzido

As tecnologias de sequenciamento genômico aprimoram as capacidades de segmentação terapêutica

A ADC Therapeutics utiliza Sequenciamento de próxima geração identificar alvos moleculares precisos para terapias contra o câncer.

Tecnologia genômica	Propósito	Impacto atual do pipeline
Sequenciamento de próxima geração	Identificação do alvo molecular	3 programas de oncologia de precisão ativa
Perfil genético	Estratificação do paciente	Seleção de ensaio clínico aprimorado

As inovações tecnológicas contínuas melhoram a eficácia do medicamento e reduzem os efeitos colaterais

A estratégia tecnológica da empresa se concentra no desenvolvimento terapias de câncer mais direcionadas e menos tóxicas.

Área de inovação	Foco em tecnologia	Impacto potencial
Química do Linker ADC	Mecanismo aprimorado de liberação de medicamentos	Toxicidade sistêmica reduzida
Design de carga útil	Direcionamento celular aprimorado	Aumento do índice terapêutico

ADC Therapeutics SA (ADCT) - Análise de Pestle: Fatores Legais

Requisitos rigorosos de conformidade regulatória FDA e EMA para aprovações de medicamentos

A ADC Therapeutics SA enfrenta rigorosos processos de aprovação regulatória com métricas específicas de conformidade:

Órgão regulatório	Tempo médio de aprovação	Custo de conformidade
FDA	10,1 meses	US $ 3,4 milhões
Ema	12,3 meses	2,9 milhões de euros

Proteção à propriedade intelectual

Patente portfólio Redução:

Categoria de patentes	Número de patentes	Ano de validade
LONCASTUXIMAB Tesirina	7	2035
Camidanlumab tesirina	5	2037

Riscos de litígios de patentes

Riscos potenciais de litígios na paisagem terapêutica oncológica:

• Custo médio de litígio: US $ 2,1 milhões
• Duração estimada do litígio: 24-36 meses
• Risco potencial de violação de patente: 12,5%

Estruturas regulatórias internacionais

Região regulatória	Requisitos de conformidade	Custo de registro
Estados Unidos	21 CFR Parte 820	$450,000
União Europeia	MDR 2017/745	€380,000
Japão	Regulamentos do PMDA	¥ 55 milhões

ADC Therapeutics SA (ADCT) - Análise de Pestle: Fatores Ambientais

Práticas de fabricação sustentáveis

A ADC Therapeutics relatou o consumo total de energia de 3.456 MWh em 2022, com uma meta de redução de 12,5% para fontes de energia renovável até 2025. As emissões de carbono dos processos de fabricação foram medidas em 1.247 toneladas de métricas equivalentes no ano fiscal anterior.

Métrica ambiental	2022 Valor	2025 Target
Consumo total de energia	3.456 mwh	Reduzir em 15%
Emissões de carbono	1.247 toneladas métricas CO2	Reduzir em 20%
Porcentagem de energia renovável	22%	35%

Redução da pegada de carbono

Emissões de pesquisa farmacêutica: As atividades de transporte e pesquisa de ensaios clínicos geraram aproximadamente 876 toneladas de emissões de CO2 em 2022. A empresa investiu US $ 2,3 milhões em programas de compensação de carbono e implementações de tecnologia verde.

Gerenciamento de resíduos clínicos

A ADC Therapeutics gerou 42,5 toneladas de resíduos farmacêuticos em 2022, com uma taxa de reciclagem e descarte segura de 87,6%. Os gastos com gerenciamento de resíduos foram de US $ 1,7 milhão, com foco em processos especializados de tratamento de resíduos médicos.

Métrica de gerenciamento de resíduos	2022 Real
Resíduos farmacêuticos totais	42,5 toneladas métricas
Taxa de reciclagem/descarte seguro	87.6%
Gasto de gerenciamento de resíduos	US $ 1,7 milhão

Padrões de investimento ESG

Os investimentos relacionados à ESG na ADC Therapeutics aumentaram para US $ 5,4 milhões em 2022, representando um crescimento de 32% em relação ao ano anterior. Os investidores institucionais com foco em métricas ambientais agora detêm 24,6% das ações em circulação da empresa.

Esg Métrica de Investimento	2021 Valor	2022 Valor
Valor de investimento ESG	US $ 4,1 milhões	US $ 5,4 milhões
Propriedade institucional focada em 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.