
Financial statements Consolidated financial statements Notes Parent financial statements Reports
Lundbeck Foundation Annual Report 2024 Page 111
Contractual obligations, contingent assets
and liabilities, and collaterals - continued
was held in the second quarter of 2024, and Lundbeck
currently expects that additional procedural steps will
be taken before a first instance court ruling, likely in
2025. The first instance court ruling may be appealed,
and it make take several years before a final conclusion
is reached by the German courts.
In October 2024, Lundbeck received a claim form from
the health authority in one of the regions (comunidades
autónomas) in Spain and in November 2024 Lundbeck
filed its defense. A Case Management Conference is
scheduled in the first quarter of 2025.
Lundbeck has been informed about potential claims in
several other European countries, however, it is still
uncertain whether the potential claims will be actively
pursued.
In Canada, Lundbeck is involved in two product liability
class-action lawsuits relating to Cipralex®/Celexa® (one
case 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 behavior
side effects) and one relating to Rexulti® (also alleging
i.a. failure to warn about compulsive behavior side
effects). Lundbeck strongly disagrees with the claims.
The Celexa birth defect litigation has been discontinued
in Quebec. A settlement agreement has been signed by
the parties in the Abilify Maintena® cases and is pending
approval by the courts.
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’s case
against the last of the four generic companies, Sandoz
Pty Ltd, went up to the High Court of Australia, who has
decided that Sandoz Pty Ltd infringed Lundbeck’s
escitalopram patent between 2009 and 2012. The High
Court has sent the case back to the first instance court
for recalculation of the damages awarded to Lundbeck
in first instance which amounted to AUD 26.3m (DKK
121m). Lundbeck’s appeal of the Australian Patent
Office’s decision to grant Sandoz a license has now been
decided, and the license was substantially limited.
Sandoz can still appeal the license decision to the
Federal Court.
Otsuka and Lundbeck have received paragraph IV
certifications from Sun Pharma and Apotex with respect
to certain patents listed for Abilify Maintena® in the U.S.
and commenced patent infringement proceedings
against both companies. The FDA will stay approval to
Sun and Apotex until 30 months from receipt of the
respective paragraph IV certifications or a court decision
in Sun’s and/or Apotex’ favor.
Lundbeck received a Civil Investigative Demand (“CID”)
from the U.S. Department of Justice (“DOJ”) in March
2020. The CID seeks information regarding the sales,
marketing, and promotion (including the promotional
speaker program) of Trintellix®. Lundbeck is cooperating
with the DOJ.
In June 2022 in the U.S., several entities, created for the
purpose of receiving assignment of claims from payors
providing health insurance coverage pursuant to
Medicare Parts C and D and Medicaid, filed a complaint
against Lundbeck and others. The complaint alleges
that Lundbeck and the other defendants conspired to
in-crease the unit price and quantity dispensed of
Xenazine®. The case was dismissed with prejudice earlier
in 2023 and is currently under appeal.
In June 2023 in the U.S., Humana Inc., an insurer, filed a
complaint against Lundbeck U.S. legal entities. The
complaint alleges that Lundbeck engaged in an illegal
kickback scheme to increase the sales and sale price of
Lundbeck’s Xenazine®. The complaint alleges that
Lundbeck’s activities targeted Humana Inc. and other
private Medicare insurers who were forced to bear the
costs of the alleged illegally subsidized drug sales.
Lundbeck denies the allegations in the complaint and
intends to defend itself.
Product return obligations
The Group has product return obligations that are
normal for the industry. Management does not expect
any major losses from these obligations apart from the
amount already recognised.
Usual representations and warranties are made in
connection with the divestment of enterprises and
operations. There are no significant outstanding claims
that are not sufficiently recognised in the balance sheet.
Research and development milestones and collaborations
The Group has entered into a number of agreements
relating to research and development of new products
and intellectual property rights from acquisitions, as
well as other collaborations. According to these
agreements, the Group is committed to pay certain
milestones. Such amounts entail uncertainties in
relation to the period in which payments are due
because a proportion of the obligations is dependent on
the milestone achievements
At 31 December 2024, potential future milestone
payments amounted to DKK 1,029m (DKK 1,106m at 31
December 2023).
Sales milestones, royalties and other payments
The Group is committed to paying certain commercial
sales milestones, royalties or other payments based on a
percentage of sales generated from the sale of goods
following marketing approval. These amounts are
excluded from the contractual obligations because of
their contingent nature, being dependent on future
sales.
Other purchase obligations
The Group has undertaken purchase obligations relating
to property, plant and equipment in the amount of
DKK 637m (DKK 692m at 31 December 2023).
Contractual obligations with intangible assets, excluding
commitments with R&D milestones and collaborations,
amounted to DKK 24m and other obligations relating to
licensing agreements amounted to DKK 7m at 31
December 2024 (DKK 0 at 31 December 2023).
Environmental obligations
PFAS pollution has been identified at Lundbeck’s site in
Lumsås, pollution to the soil and water has occurred
from the use of PFAS-containing firefighting foam in the
factory’s fire extinguishing system, which was used until
2011 in compliance with applicable law and following
recommendations by the fire authorities at that time.
The case is being managed in accordance with the
requirements set by the authorities and in line with
Lundbeck’s HSE, Compliance and Sustainability Policies.