OBSERVE MEDICAL ASA | ANNUAL REPORT 2025
10
UnoMeter™ portfolio and other products, the cost of
goods sold is mainly denominated in USD and EUR,
while the majority of sales revenues are currently
generated in the same currencies. This provides a
natural hedge that mitigates the net impact of
currency fluctuations on operating margins.
Expected sales growth in the coming periods will
increase the absolute exposure to foreign currencies.
The Group currently does not use derivative financial
instruments to hedge this risk but monitors its
exposure closely. As the Group transitions towards
becoming self-financing through its operations, the
strengthened cash flow and reduced reliance on
external financing are expected to further improve its
capacity to manage currency volatility.
Regarding credit risk, the Group’s exposure has
historically been low, as the customer base primarily
consists of large public enterprises and established
distributors. While global expansion may lead to a
moderate increase in credit exposure, the Group has
implemented several measures to mitigate this risk.
The Group maintains a factoring agreement with
Avida for the purchase of receivables. This
agreement is without recourse, effectively
transferring the credit risk to the factor while
simultaneously improving the Group's working
capital position. For customers or transactions not
covered by the factoring agreement, prepayment is
maintained as the standard commercial term.
Consequently, the Group considers its net credit risk
to be well-managed.
O P E R A T I O N A L A N D M A R K E T
R I S K
Observe Medical operates in the medical technology
market and faces common industry risks, including
competition from new products with better features
or stronger market penetration. Increased
competition may also impact pricing potential.
The Group’s operations are characterized by third-
party dependencies across two key areas: the
commercial effectiveness of international distributors
and the production integrity of our manufacturing
partners. Commercially, growth is contingent upon
the capacity of the distribution network to penetrate
local markets and successfully secure competitive
tenders. Operationally, the Group maintains a high
degree of reliance on its manufacturers to uphold
stringent quality standards and meet delivery
timelines, as any disruption could delay
commercialization and impact market position.
The Group is further subject to risks stemming from
geopolitical volatility, as ongoing global conflicts
continue to disrupt raw material supplies, financial
markets, and international logistics. These
instabilities directly affect access to critical
components and lead to fluctuating freight costs, to
which the Group is particularly exposed regarding
shipments from China. Such fluctuations and
logistical disruptions may lead to increased
transportation costs and delayed deliveries, which
could in turn negatively affect the Group's margins
and market position. To mitigate these risks, the
Group focuses on supply chain resilience and cost-
management routines. Furthermore, the Group
recognizes that climate-related factors and extreme
weather events can disrupt international logistics and
manufacturing, while evolving environmental
regulations may impact product requirements.
Regulatory Environment and the International
Procurement Instrument (IPI): The Group
manufactures a significant portion of its medical
device portfolio in China and serves the European
market primarily through independent distributors
participating in public procurement processes. On
June 30th the EU adopted new rules related to the
EU procurement directives (Directive 2014/23/EU,
Directive 2014/24/EU and Directive 2014/25/EU).
The rules apply to the procurement of medical
devices through tender procedures in the EU, where
the estimated value of the tender is EUR 5 million
exclusive of VAT or more. The rules aim at regulating
the access of economic operators and the use of
medical devices originating in the People’s Republic
of China to the EU public procurement market.
As the rules are still new and legally untested and the
reaction from the tenderers remains to be seen, the
actual effect on Observe Medical remains uncertain
but the effect of the rules will be monitored closely in
cooperation with its distributors across the EU.
Protecting intellectual property is crucial to the
Group’s long-term success. Failure to do so, or
infringement by third parties, could harm brand value
and business operations.
Ensuring compliance with applicable laws and
regulations is a key priority for Observe Medical. This
includes adherence to data protection standards
(GDPR) and maintaining robust IT security to protect
against potential cyber threats. Non-compliance or
security breaches can result in financial penalties,
operational disruptions, and reputational damage.
Observe Medical is mindful of the risk profile
associated with limited internal resources and “key
person” dependency. Such conditions may impact
operational flexibility and the capacity to navigate
unforeseen challenges. Consequently, risk
management remains a top priority for both
Management and the Board. To strengthen the
organization and enhance operational capacity,
recruitment of new resources has been initiated
Research and development expenditures are
managed across the product portfolio in accordance
with our strategic priorities. Investment decisions