Novo Nordisk Annual Report 2021

Contents Introducing Novo Nordisk Strategic Aspirations Key risks Management Consolidated statements Additional information Novo Nordisk Annual Report 2021 42 Risk area 1 Clinical Pipeline Risks 2 Product Supply, Quality and Safety Risks 3 Commercialisation Risks 4 IT Security Risks 5 Financial Risks Description Findings in clinical activities, regulatory processes or misunderstanding of commercial potential leading to delays or failure of products in the pipeline Disruption of product supply or quality failures may compromise the availability of products, ultimately impacting the health of patients and a lost commercial opportunity Market dynamics and geopolitical, macroeconomic or healthcare crises (e.g., pandemics) leading to reduced payer ability and willingness to pay Disruption to IT systems, such as cyber-attacks or infrastructure failure resulting in business disruption or breach of data confidentiality Exchange rate fluctuations (mainly in USD, CNY and JPY), disputes with tax authorities and changes to tax legislation and interpretation Impact - Patients would not benefit from innovative treatments - Could have an adverse impact on sales, profits and market position - Product shortages could have potential implications for patients - Could put patients' health and lives at risk and jeopardise reputation and license to operate if regulatory compliance is not ensured Mitigating actions - Pre-clinical and clinical activities to demonstrate safety and efficacy - Consultations with regulators to review pre-clinical and clinical findings and obtain guidance on development path - Establishing global production with multiple facilities and safety stock to reduce supply risk - Regular quality audits of internal units and suppliers and annual inspections by authorities document GMP compliance - Could have an adverse impact on sales, profits and market position - Identification and correction of root causes when issues are - Market dynamics could impact price levels and patient access - Could have an adverse impact on sales, profits and market position - Could limit our ability to produce and safeguard product quality - Could compromise patients' or other individuals' privacy - Could limit our ability to maintain operations or limit future business opportunities if proprietary information is lost - Could have an adverse impact on sales, profits and market position - Could lead to significant tax adjustments, fines and higher-than- expected tax level identified. If necessary, products are recalled - Innovation of novel products, clinical trial data and real-world evidence demonstrate added value of new products - Payer negotiations to ensure improved patients' access - Increased and new access and affordability initiatives -Company-wide information security awareness activities - Continuity plans for non-availability of IT systems -Company-wide internal audit of IT security controls - Detection and protection mechanisms in IT systems and business processes - Hedging for selected currencies Integrated treasury management - Could have an adverse impact on sales, profits and market position - Applicable taxes paid in jurisdictions where business activity generates profits and multi-year Advance Pricing Agreements with tax authorities 6 Legal, Patents and Compliance Risks Breach of legislation, industry codes or company policies. Competitors asserting patents against Novo Nordisk or challenging patents critical for protection of commercial product and pipeline candidates - Potential exposure to investigations, criminal and civil sanctions and other penalties - Could compromise our reputation and the rights and integrity of individuals involved - Unexpected loss of exclusivity for or injunctions against existing and pipeline products could have an adverse impact on future sales - Could have an adverse impact on sales, profits and market position - Legal review of key activities Business Ethics Code of Conduct integrated in our business, Compliance hotline in place and Internal Audit of compliance with business ethics standards - Internal controls to minimise vulnerability to patent infringement and invalidity actions

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