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Research and clinical pipeline risks1 |
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Findings in clinical activities, regulatory processes or misjudging of commercial potential, leading to delays or failure of products in the pipeline. |
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- Patients would not be provided with innovative treatment options.
- Could have an adverse impact on sales, profits and market position.
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- 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.
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Product supply, quality and safety risks |
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Higher-than-expected demand or disruption of product supply due to, e.g. geopolitical instability or quality issues, may compromise product availability, ultimately impacting patients and representing a lost commercial opportunity. In addition, there could be risks related to safety and product liability. |
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- Product shortages could have potential implications for patients.
- Could jeopardise reputation and license to operate if regulatory compliance is not ensured.
- Compromised patient safety and exposure to product liability legal proceedings.
- Could diminish trust in Novo Nordisk, impacting our reputation.
- Could have an adverse impact on sales, profits and market position.
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- Significantly expanding global production with multiple facilities and safety stock to reduce supply risk.
- Planning and management of supply chain.
- Regular quality audits of internal units and suppliers to document Good Manufacturing Practice (GMP) compliance.
- Identification and correction of root causes when issues are identified. If necessary, products are recalled.
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Commercialisation risks1 |
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Competitive pressures, as well as market dynamics and geopolitical, macroeconomic or healthcare crises (e.g. pandemics) leading to reduced payer ability and willingness to pay. |
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- Market dynamics could impact price levels and patient access.
- Could have an adverse impact on sales, profits and market position.
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- Innovation of novel products, clinical trial data and real-world evidence demonstrate added value of new products.
- Payer negotiations to ensure improved patient access.
- Increased and new access and affordability initiatives.
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IT security risks |
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Disruption to IT systems, such as cyber-attacks or infrastructure failure, resulting in business disruption or breach of data confidentiality. |
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- 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.
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- Proactive company-wide information security awareness initiatives.
- 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.
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Financial risks |
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Exchange rate fluctuations (mainly in USD, CNY, JPY, CAD and BRL), geopolitical risks (e.g. tariffs), disputes with tax authorities and changes to tax legislation and interpretation. |
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- Could lead to tax adjustments, fines and higher-than-expected tax level.
- Could have an adverse impact on sales and profits.
- Geopolitical actions could lead to an increase in corporate taxes and duties.
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- Hedging for selected currencies.
- Integrated treasury management.
- Applicable taxes paid in jurisdictions where business activity generates profits and multi-year Advance Pricing Agreements with tax authorities.
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Legal, patents and compliance risks1 |
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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. |
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- Potential exposure to investigations, criminal and civil sanctions and other penalties.
- Could compromise our reputation and the rights and integrity of individuals involved.
- Could lead to unexpected loss of exclusivity for, or injunctions against, existing and pipeline products.
- Could have an adverse impact on sales, profits and market position.
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- Code of Conduct integrated in our business.
- Compliance Hotline in place.
- Legal review of key activities and internal audit of compliance with business ethics standards.
- Internal controls to minimise vulnerability to patent infringement and invalidity actions.
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