Novo Nordisk Annual Report 2021
Contents
Introducing Novo Nordisk
Strategic Aspirations
Key risks Management
Consolidated statements
Additional information
Novo Nordisk Annual Report 2021
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restrictions on the sale or distribution of 340B drugs. Novo Nordisk has
appealed the decision to the US Court of Appeals for the Third Circuit. A
decision on this appeal is not expected before the end of 2022. Depending
on the outcome of these matters, there may be a significant impact on Novo
Nordisk's financial position, net sales and cash flow.
Mosaic Health Inc. and Central Virginia Health Services, Inc. (both 340B
covered entities) filed a putative class action lawsuit in NY Federal Court
against Novo Nordisk US, Eli Lilly, Sanofi and AstraZeneca alleging a
conspiracy among the manufacturers to artificially fix prices of diabetes
medications through changes to their policies relating to the distribution of
340B drugs through contract pharmacy arrangements. A motion to dismiss
the lawsuit has been filed and is currently pending before the Court.
Novo Nordisk does not expect the lawsuits to have a material impact on
Novo Nordisk's financial position, operating profit, or cash flow.
Pending claims against Novo Nordisk and Investigations involving
Novo Nordisk
Several authorities in the US have served Novo Nordisk with Civil Investigative
Demands (CIDS) or subpoenas calling for the production
of documents and information. Below is a list of ongoing matters:
- Washington Attorney General's Office CID (March 2017), relating to, among
other things, pricing, and trade practices for insulin products, including
Levemir®, NovoLog®, and NovolinⓇ, from 1 January 2005 through the
present date.
New Mexico Attorney General's Office CID (April 2017), relating to, among
other things, trade practice and pricing of insulin products, namely
NovoLogⓇ and NovolinⓇ from 1 January 2012 through the present date.
- New York State Attorney General's Office Subpoena (July 2019), relating to,
among other things, pricing, and trade practices for insulin products, from
1 July 2013 through the present.
- Colorado Attorney General's Office CID (December 2019), relating to, among
other things, pricing, and trade practices for insulin products, for the period
from 1 January 2010 to present.
Vermont Attorney General's Office Subpoena (December 2020), related to,
among other things, pricing and trade practices for insulin products sold by
Novo Nordisk during the period 1 January 2011 through the present date.
US Department of Justice (December 2021), relating to the financial
relationships with healthcare professional and prescriptions for OzempicⓇ
and Rybelsus during the period of 1 January 2016 to present.
In all matters Novo Nordisk is cooperating with the authorities in question.
Novo Nordisk does not expect the above investigations to have a material
impact on Novo Nordisk's financial position, operating profit, or cash flow.
Novo Nordisk is one of several pharmaceutical companies that received
requests for information involving pricing practices for its diabetes products
from several committees of the Unites States House of Representatives
and/or United States Senate. Novo Nordisk has responded to the various
committees in response to their requests. Novo Nordisk does not expect
the inquiries to have a material impact on Novo Nordisk's financial position,
operating profit, or cash flow.
Other contingent liabilities
In addition to the above, the Novo Nordisk Group is engaged in certain
litigation proceedings and various ongoing audits and investigations. In
the opinion of Management, neither settlement or continuation of such
proceedings, nor such pending audits and investigations, are expected to
have a material effect on Novo Nordisk's financial position, operating profit,
or cash flow.
Accounting policies
Provisions for sales rebates and discounts granted to government agencies,
wholesalers, retail pharmacies, Managed Care and other customers
are recorded at the time the related revenues are recorded or when
the incentives are offered. Provisions are calculated based on historical
experience and the specific terms in the individual agreements. Unsettled
rebates are recognised as provisions when the timing or amount is
uncertain. Where absolute amounts are known, the rebates are recognised
as other liabilities. Please refer to note 2.1 for further information on sales
rebates and provisions.
Provisions for legal disputes are recognised where a legal or constructive
obligation has been incurred as a result of past events and it is probable
that there will be an outflow of resources that can be reliably estimated. In
this case, Novo Nordisk arrives at an estimate based on an evaluation of the
most likely outcome. Disputes for which no reliable estimate can be made
are disclosed as contingent liabilities.
Provisions are measured at the present value of the anticipated expenditure
for settlement. This is calculated using a pre-tax discount rate that reflects
current market assessments of the time value of money and the risks
specific to the obligation. The increase in the provision for interest is
recognised as a financial expense.
Novo Nordisk issues credit notes for expired goods as a part of normal
business. Where there is historical experience or a reasonably accurate
estimate of expected future returns can otherwise be made, a provision for
estimated product returns is recorded. The provision is measured at gross
sales value.
Key accounting estimates regarding ongoing legal disputes, litigation
and investigations
Provisions for legal disputes consist of various types of provisions linked to
Provisions for legal disputes consist of various types of provisions linked to
ongoing legal disputes. Management makes estimates regarding provisions
and contingencies, including the probability of pending and potential
future litigation outcomes. These are by nature dependent on inherently
uncertain future events. When determining likely outcomes of litigation, etc.,
Management considers the input of external counsels on each case, as well
as known outcomes in case law.
Although Management believes that the total provisions for legal
proceedings are adequate based on currently available information, there
can be no assurance that there will not be any changes in facts or matters,
or that any future lawsuits, claims, proceedings or investigations will not
be material.
3.5 Other liabilities
Other liabilities primarily comprises employee cost payables, payables
related to non-current assets, sales rebates as well as deferred revenue.View entire presentation