ANNUAL REPORT 2021
LUNDBECK
ANNUAL REPORT 2021
= CONTENTS
KEY RISKS
42/111
RISK AREA
RESEARCH AND
DEVELOPMENT
RISKS
MARKET,
COMMERCIAL AND
STRATEGY RISKS
SUPPLY, QUALITY
AND PRODUCT
SAFETY RISKS
DESCRIPTION
Exposure to delays of regulatory approval
or failure in the development of new and
innovative medicines. Exposure to delays
is higher due to COVID-19.
Increased regulatory requirements for
clinical trials.
Data requirements from production of
non-clinical and clinical studies.
Price pressure, new legislation, regulation
of reimbursement and healthcare reforms
in key markets, etc.
Market dynamic change resulting from
COVID-19.
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.
IT SECURITY RISKS Cyber-attacks and cyber fraud.
LEGAL AND
COMPLIANCE
RISKS
FINANCIAL RISKS
System down-time.
Intellectual property rights.
Non-compliance with laws, industry
standards, regulations and our Code of
Conduct.
Exposure to legal claims or
investigations.
Fluctuations in exchange rates incl.
impact from currency devaluations.
POTENTIAL CONSEQUENCES
Delays or failure of new products could impact patients who
cannot benefit from these products and decrease earnings
for the company and its shareholders.
Delay in regulatory approval may impact the patient's drug
access.
Issues with data integrity can lead to delays in studies and
production - ultimately leading to withdrawals and failure to
gain approval.
Market restrictions could impact patients' access to Lundbeck
products.
Changes in market conditions and health care reforms could
affect the pricing landscape as well as rebates and discounts.
These changes could impact Lundbeck's results.
Product shortage, not giving patients needed access to the
pharmaceuticals they require.
Disruption or compromise of IT security could affect all parts
of Lundbeck's operations and product supply to patients.
Data loss.
Infringement of intellectual property rights could decrease
earnings for shareholders.
Loss, expiration or invalidation of intellectual property rights
could decrease earnings for shareholders.
Non-compliance with laws, industry standards, regulations, or
our Code of Conduct could affect our 'license to operate' and
impact our reputation and earnings for shareholders.
Lundbeck's cash flow and earnings could be impacted in
cases of fluctuations in key currencies.
MITIGATING ACTIONS
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.
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.
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 policies and procedures are in place to safeguard processes and data.
Cyber-attack testing is being performed on a regular basis.
Annual testing of IT disaster recovery plan.
Policies are in place to safeguard intellectual property rights.
The Code of Conduct Compliance Program and global organization are pivotal in
sustaining our compliance culture. Ongoing monitoring is conducted, and annual
training is provided 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.
Treasury policy.
Monitoring the financial exposure and hedging a significant part of Lundbeck's
currency risk up to 18 months in advance.View entire presentation