
KEY
RIS KS
Macro-economic Cyber security New product launches Market access and pricing pressure
Supply disruption and
financial commitments Third-party compliance
RISK AREA
While still recovering from the
Covid-19 pandemic, the global
economy is facing pressures from
increasing inflation and interest
rates, an energy crisis brought
about by the war in Ukraine and
stagnating global trade growth.
As a result, healthcare budgets
in countries are tight and payers
remain focused on reducing drug
spend by exercising increasing
pressure on the pharmaceutical
industry. Similarly, patients have
become more price sensitive in
view of inflation outpacing salary
increases.
Remote/flexible work prac-
tices and adoption of cloud
services are among many
factors contributing to a
record high number of cyber
attacks in 2022. Numerous
high-profile organizations
have fallen victim to some
form of cyber attack,
severely affecting their IT
infrastructure, production
and distribution. Any form of
cyber security breach may
happen anywhere along the
global LEO Pharma
value chain and across all
locations.
The success of a new product
launch depends on many
factors, some of which
are beyond our control.
Events such as authorities
requesting additional clinical
trial data or delays at the
manufacturing sites can have
serious consequences for
regulatory approval process-
es and subsequent product
launches. Moreover, results of
reimbursement negotiations
are crucial to successful
product commercialization.
Achieving an acceptable pricing
and reimbursement level for
our products is essential to our
ability to launch new innovative
treatments and commercialize our
existing portfolio. This depends
on various factors, such as com-
petition, discount demands from
private and public payers as well as
negotiations with national health
authorities. Meanwhile, due the
unfolding energy crisis and growing
inflation, healthcare budgets in
many countries are under tremen-
dous pressure, which has translated
into health authorities and payers
seeking more aggressive price con-
cessions from drug manufacturers.
LEO Pharma’s manufacturing
lines are unique. This leads to
limited flexibility to move prod-
ucts between manufacturing
lines, and in turn an increased
vulnerability to disruptions in
supply caused by natural di-
sasters or other adverse events.
Meanwhile, the unfolding global
energy crisis and ongoing
global supply chain challenges
are putting further pressure on
our manufacturing opera-
tions. Additionally, for certain
products, LEO Pharma relies on
contract manufacturer organi-
zations (CMO), which increases
the risk of exposure to product
supply shortages, quality issues
and financial commitments on
minimum ordering of products
for a certain period.
As part of its global
business activities, LEO
Pharma engages with a
broad range of third-par-
ty intermediaries, with
a significant number of
interactions taking place
in countries that have
high perceived levels of
corruption and weak law
enforcement. Under local
and global anti-corrup-
tion laws, LEO Pharma can
be held liable for corrupt
acts committed by our
intermediaries.
IMPACT
Increased cost-consciousness
of payers and patients could
increase pricing pressures on LEO
Pharma’s existing products, lead
to more challenging negotiations
for reimbursement of future
products as well as affect the vol-
ume of products used. Currently,
growing inflation also affects
prices of raw materials used in
LEO Pharma’s products, thereby
increasing the overall production
costs. As result, expected product
sales and profitability could be
impacted negatively.
Being targeted by a
cyber-attack can result in
significant business disrup-
tion, financial losses and fines
imposed by authorities. This
can have a negative impact
on expected sales and profits
and limit patients’ access to
LEO Pharma’s products.
Delay in marketing authori-
zation or non-approval of a
new product can have a
negative impact on expect-
ed sales and profits and
also limit or delay patients’
access to new innovative
treatments.
Not achieving acceptable
reimbursement and pricing levels
would limit LEO Pharma’s ability
to launch and commercialize our
products. This could have a neg-
ative impact on expected sales
and the possibility for patients
to benefit from new innovative
treatments.
Supply disruptions could lead
to LEO Pharma’s products
being out of stock in certain
markets. This would in turn
affect LEO Pharma’s ability to
serve our patients as well as
lead to lost sales and profit.
Financial commitments of
minimum ordering can im-
pact LEO Pharma’s operating
financial result.
Wrongdoings of the
third-party intermediaries
acting on LEO Pharma’s
behalf can expose us to
financial loss and reputa-
tional damage.
MITIGATING ACTIONS
LEO Pharma monitors the macro-
economic situation and is working
closely with payers and other
stakeholders to demonstrate the
value of our products. Various
strategies are being deployed to
contain increases in production
costs and other costs.
LEO Pharma has imple-
mented several mitigating
measures to manage
exposure from cyber security
threats – including, but not
limited to, conducting infor-
mation security awareness
training as well as improving
our technical capabilities to
prevent, detect and respond
to attempted attacks.
LEO Pharma works closely
with regulatory authorities to
be able to promptly respond
to their requests.
LEO Pharma closely monitors
market access and pricing
developments and requirements in
key markets, while working actively
with payers, advocacy groups and
authorities to sufficiently docu-
ment the value of our products
(e.g. through clinical trial data).
Strategies for increased
internal capability or external
sourcing are continuously eval-
uated and include monitoring
as well as upgrading manufac-
turing lines. Furthermore, safety
stock is kept compensating
for a potential breakdown.
Contracts are reviewed con-
tinuously to monitor potential
breach of minimum ordering
clauses with CMOs.
LEO Pharma conducts
anti-corruption due
diligence for selected
types of third-party
intermediaries.
Risk management
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