Responsible Business Conduct
Responsible business conduct is crucial to Lundbeck
as a global pharmaceutical company. It translates
into how Lundbeck upholds stakeholder integrity and
minimizes the risk of financial repercussions.
The number of Due Diligence screenings
conducted in the first quarter of 2024 increased by
44%, compared to the first quarter of 2023. This
increase is due to continued growing awareness
across the organization on the importance of ethical
business conduct in the value chain.
2.10 GENERAL CORPORATE MATTERS
Pending legal proceedings
Lundbeck is involved in a number of legal
proceedings, including patent disputes and
environmental matters, the most significant of which
are described below. Some of these involve
significant amounts and are subject to considerable
uncertainty. Management continuously assesses the
risks associated with the legal proceedings, and their
likely outcome. It is the opinion of the management
that, apart from items recognized in the financial
statements, the outcome of these legal proceedings
and disputes are not probable or cannot be reliably
estimated in terms of amount or timing. Such
proceedings may, however, develop over time, and
new proceedings may occur, in a way which could
have a material impact on the Group’s financial
position and/or cash flows.
In June 2013, Lundbeck received the European
Commission’s decision that agreements concluded
with four generic competitors concerning citalopram
violated competition law. The decision included fining
Lundbeck EUR 93.8 million (approximately DKK 700
million). Lundbeck paid and expensed the fine in the
third quarter of 2013. In March 2021, the European
Court of Justice rejected Lundbeck’s final appeal of
the European Commission’s decision. So-called
“follow-on claims” for reimbursement of alleged
losses, resulting from violation of competition law,
often arise when decisions and fines issued by the
European Commission are upheld by the European
Court of Justice. The below mentioned “follow-on
claims” are ongoing or threatened. Lundbeck
disagrees with all claims and intends to defend itself
against them.
At the end of first quarter 2023, the UK health
authorities served their claim form on Lundbeck and
several generic companies, and Lundbeck filed its
defence in the third quarter of 2023. In September
2023, a Case Management Conference was held, at
which the Competition Appeal Tribunal approved an
application for a preliminary issue hearing on whether
the claim is time-barred. The preliminary issue
hearing was held in April 2024 and a ruling on time-
barring is expected in the second or third quarter of
2024.
In late October 2021, Lundbeck received a writ of
summons from a German health care company
claiming compensation for an alleged loss of profit
plus interest payments, allegedly resulting from
Lundbeck’s conclusion of agreements with two of the
four generic competitors, which were comprised by
the EU Court of Justice ruling. Lundbeck filed its first
defence in May 2022 and the parties have
subsequently exchanged additional pleadings. The
first instance court hearing has been postponed to the
second quarter of 2024. It may take several years
before a final conclusion is reached by the German
courts.
Lundbeck has been informed about potential claims
in other European countries, however, it is still
uncertain whether the potential claims will be actively
pursued.
In Canada, Lundbeck is involved in three product
liability class-action lawsuits relating to
Cipralex
®
/Celexa
®
(two cases alleging various
Celexa-induced birth defects and one case against
several SSRI manufacturers (incl. Lundbeck) alleging
that SSRI (Celexa
®
/Lexapro
®
) induces autism birth
defect), three relating to Abilify Maintena
®
(alleging
i.a. failure to warn about compulsive behaviour side
effects) and one relating to Rexulti
®
(also alleging i.a.
failure to warn about compulsive behaviour side
effects). The cases are in the preliminary stages and
as such there is significant uncertainty as to how
these lawsuits will be resolved. Lundbeck strongly
disagrees with the claims.
In 2018, Lundbeck entered into settlements with three
of four generic companies involved in an Australian
federal court case, in which Lundbeck was pursuing
patent infringement and damages claims over the
sale of escitalopram products in Australia. Lundbeck
received AUD 51.7 million (DKK 242 million) in 2018.
Lundbeck’s case against the last of the four generic
companies, Sandoz Pty Ltd, went up to the High