Risikomanagement

Risiken kennen und bewerten

Wir identifizieren, überwachen, bewerten und reagieren auf Geschäftsrisiken und -chancen in einem sich ständig verändernden Geschäftsumfeld.

Führungsstruktur des Risikomanagements

In der gesamten Wertschöpfungskette ist Lundbeck Risiken ausgesetzt: von den ersten Phasen der Entwicklung innovativer Arzneimittel in unseren eigenen Laboren bis hin zu den geprüften Arzneimitteln, die die Patienten erreichen. Deshalb werden unsere Prozesse zum Risikomanagement kontinuierlich aktualisiert und an neue Gegebenheiten angepasst. Risiken, die übergreifende Trends, globale Wirtschaftsentwicklungen oder Geopolitik betreffen werden von Lundbecks strategischem Planungsteam bewertet, das auch langfristige Prognosen erstellt.

Dieser Makrokontext verbunden mit dem Überblick über Lundbecks aktuelle Geschäftsaktivitäten und Ressourcen stellt für die Geschäftsführung eine hervorragende Ausgangsbasis dar, um Entscheidungen zu treffen. Dabei geht es nicht nur darum, welche Risikoexposition akzeptabel ist, sondern auch, welche Chancen wir wahrnehmen wollen.

Die endgültige Verantwortung für das Risikomanagement liegt beim Verwaltungsrat. Die Einhaltung der Vorschriften innerhalb des etablierten Risikomanagement-Rahmens überwacht der Prüfungsausschuss.

Rahmen für das Risikomanagement

Das Lundbeck-Rahmenwerk für das Risikomanagement leitet unsere Prozesse zur Bewertung und Reaktion auf Risiken.

Der Prozess beginnt in den dezentralen Teams innerhalb der Geschäftseinheiten und Unternehmensfunktionen, die über detaillierte und umfassende Kenntnisse der Risiken in ihrem Verantwortungsbereich verfügen.

Die Teams sind strategisch aufgestellt, um unsere Risikoexposition von vorneherein zu verringern. Die Geschäftseinheiten und Unternehmensfunktionen berichten halbjährlich an das zentrale Risikobüro.

Das setzt das gemeldete Risiko in den Kontext, führt Interviews und macht Workshops mit den Risikoverantwortlichen in den jeweiligen Geschäftseinheiten oder Unternehmensfunktionen.

Dies ist ein integraler Bestandteil bei der Einordnung der dem Risikobüro gemeldeten Risiken. Dabei wird gemeinsam die Wahrscheinlichkeit, dass das unerwünschte Ereignis eintritt, beurteilt und die potenziellen finanziellen Verluste abgeschätzt.

Das Ergebnis wird der Geschäftsleitung zur Beurteilung und Genehmigung vorgelegt, bevor es dem Prüfungsausschuss gemeldet und vom Verwaltungsrat freigegeben wird.

Das vom Risikobüro geführte Unternehmensrisikoregister bietet einen umfassenden Überblick über unsere Risikoexposition. Jedes Risiko, jede Risikokategorie und jeden Risikotyp ist dort detailliert aufführt.

Das Ereignis selbst ist dort genau beschrieben, der aktuelle Status festgehalten und die Wahrscheinlichkeit des Eintretens zusammen mit den möglichen Auswirkungen notiert.

Potenzielle Ereignisse werden in sechs Risikokategorien eingeteilt:

Forschung und Entwicklung
Markt, Handel und Strategie
Lieferung, Qualität und Produktsicherheit
IT-Sicherheit
Recht und Compliance
Finanzen

Lundbeck hat einen straffen Prozess zur regelmäßigen Erkennung, Überwachung, Minderung und Berichterstattung von Risiken innerhalb der Geschäftseinheiten und Unternehmensfunktionen entwickelt.

Ein abschließender Bericht wird an die Geschäftsleitung weitergeleitet, die somit in der Lage ist, die Risikobereitschaft des Unternehmens bei strategischen und praktischen Entscheidungen genauso wie im Tagesgeschäft zu zügeln.

Key Risks

Risk Area	Description	Potential Consequences	Mitigating Actions
Research and Development	Exposure to delays of regulatory approval or failure in the development of new and innovative medicines. Increased regulatory requirements for clinical trials. Data requirements from production of nonclinical and clinical studies.	Delays or failure of new products could impact patients who cannot benefit from these products and decrease earnings expectations for Lundbeck and its shareholders. Delay in regulatory approval may impact the patient’s drug access. Issues with data integrity could lead to delays in studies and production – ultimately leading to withdrawals and failure to gain approval.	Clinical trials are run and evaluated throughout the research and development phase. Ongoing evaluation of the product pipeline, regulatory requirements, and product benefit. Robust quality management system is in place to ensure consistent quality, data integrity, and the compliance of clinical trials and clinical safety activities
Market , Commercial and Strategy	Price pressure, new legislation, regulation of reimbursement and healthcare reforms in key markets, etc. Market dynamic change derived from COVID-19 or ongoing war between Russia and Ukraine.	Market restrictions could impact patients’ access to Lundbeck products. Changes in market conditions and healthcare reforms could affect the pricing landscape as well as rebates and discounts. These changes could decrease earnings for Lundbeck and its shareholders.	Understanding the price development in main markets. Working with healthcare authorities around the world to document the value of our pharmaceuticals. Monitor political developments and requirements.
Supply, Quality and Product Safety	Disruption of production or supply or unpredictable demand and stock-out. Loss of licenses to manufacture or sell pharmaceuticals. Defects in product quality or safety.	Product shortage, not giving patients needed access to the pharmaceuticals they require.	Systems, policies, and procedures are in place to ensure product supply, quality, and safety. Dual sourcing strategy and high level of safety stock of key products. Robust pharmacovigilance system.
IT Security	Cyber attacks and cyber fraud. System down-time.	Disruption or compromise of IT security could affect all parts of Lundbeck’s operations and product supply to patients. Data loss.	IT policies and procedures are in place to safeguard systems and data. Cyber defenses are tested on a regular basis. Annual testing of IT disaster recovery plan.
Legal and Compliance	Loss, expiration or infringement of intellectual property rights. Non-compliance with laws, industry standards, regulations, and our Code of Conduct. Exposure to legal claims or investigations.	Loss, expiration, infringement, or invalidation of intellectual property rights could decrease earnings for Lundbeck and its shareholders. Non-compliance with laws, industry standards, regulations, or our Code of Conduct could affect our ‘license to operate’, result in litigations or investigations, expose Lundbeck to significant fines, and impact our reputation and earnings for Lundbeck and its shareholders.	Policies and processes are in place to safeguard intellectual property rights. The Code of Conduct Compliance Program and global organization are pivotal in sustaining our compliance culture. The Code of Conduct Compliance Program includes global activities and ensures continuous monitoring of compliance with laws and industry standards and annual training to all employees. Third parties are committed to observe our legal and ethical standards in mutually binding agreements and are subject to monitoring. Global Compliance Hotline and investigation procedure.
Financial	Fluctuations in exchange rates incl. impact from currency devaluations.	Lundbeck’s cash flow and earnings could be impacted in cases of fluctuations in key currencies.	Treasury policy. Monitoring the financial exposure and hedging a significant part of Lundbeck’s currency risk up to 18 months in advance.

Risk Area

Description

Potential Consequences

Mitigating Actions

Research and Development

Exposure to delays of regulatory approval or failure in the development of new and innovative medicines.

Increased regulatory requirements for clinical trials.

Data requirements from production of nonclinical and clinical studies.

Delays or failure of new products could impact patients who cannot benefit from these products and decrease earnings expectations for Lundbeck and its shareholders.

Delay in regulatory approval may impact the patient’s drug access.

Issues with data integrity could lead to delays in studies and production – ultimately leading to withdrawals and failure to gain approval.

Clinical trials are run and evaluated throughout the research and development phase.

Ongoing evaluation of the product pipeline, regulatory requirements, and product benefit.

Robust quality management system is in place to ensure consistent quality, data integrity, and the compliance of clinical trials and clinical safety activities

Market , Commercial and Strategy

Price pressure, new legislation, regulation of reimbursement and healthcare reforms in key markets, etc.

Market dynamic change derived from COVID-19 or ongoing war between Russia and Ukraine.

Market restrictions could impact patients’ access to Lundbeck products.

Changes in market conditions and healthcare reforms could affect the pricing landscape as well as rebates and discounts.

These changes could decrease earnings for Lundbeck and its shareholders.

Understanding the price development in main markets.

Working with healthcare authorities around the world to document the value of our pharmaceuticals.

Monitor political developments and requirements.

Supply, Quality and Product Safety

Disruption of production or supply or unpredictable demand and stock-out.

Loss of licenses to manufacture or sell pharmaceuticals.

Defects in product quality or safety.

Product shortage, not giving patients needed access to the
pharmaceuticals they require.

Systems, policies, and procedures are in place to ensure product supply, quality, and safety.

Dual sourcing strategy and high level of safety stock of key products.

Robust pharmacovigilance system.

IT Security

Cyber attacks and cyber fraud.

System down-time.

Disruption or compromise of IT security could affect all parts of Lundbeck’s operations and product supply to patients.

Data loss.

IT policies and procedures are in place to safeguard systems and data.

Cyber defenses are tested on a regular basis.

Annual testing of IT disaster recovery plan.

Legal and Compliance

Loss, expiration or infringement of intellectual property rights.

Non-compliance with laws, industry standards, regulations, and our Code of Conduct.

Exposure to legal claims or investigations.

Loss, expiration, infringement, or invalidation of intellectual property rights could decrease earnings for Lundbeck and its shareholders.

Non-compliance with laws, industry standards, regulations, or our Code of Conduct could affect our ‘license to operate’, result in litigations or investigations, expose Lundbeck to significant fines, and impact our reputation and earnings for Lundbeck and its shareholders.

Policies and processes are in place to safeguard intellectual property rights.

The Code of Conduct Compliance Program and global organization are pivotal in sustaining our compliance culture. The Code of Conduct Compliance Program includes global activities and ensures continuous monitoring of compliance with laws and industry standards and annual training to all employees.

Third parties are committed to observe our legal and ethical standards in mutually binding agreements and are subject to monitoring.

Global Compliance Hotline and investigation procedure.

Financial

Fluctuations in exchange rates incl. impact from currency devaluations.

Lundbeck’s cash flow and earnings could be impacted in cases of
fluctuations in key currencies.

Treasury policy.

Monitoring the financial exposure and hedging a significant part of Lundbeck’s currency risk up to 18 months in advance.

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