
31 | Annual Report 2021 Vicore Pharma Holding AB (publ)
authority and / or the ethics committee
will not grant the necessary approvals
for the company's ongoing or future
program approvals or opinions will be
delayed or withdrawn. If the necessary
approvals are not obtained, delayed or
withdrawn, this could delay the relevant
program or mean that it needs to be
could have a material adverse effect
on the company's operations, financial
position and results.
Delays in clinical studies
of, for example, VP01, VP02, VP03
or VP04 will be delayed. Delays can
occur for a variety of reasons, including
difficulties in reaching agreements
with clinics about participation under
acceptable conditions, problems in
identifying patients for studies, patients
not completing a study, or not returning
for follow-up. A pandemic and / or a war
could negatively affect the availability
and recruitment of potential trial
participants as well as their possibility
of carrying out non-essential hospital
visits. Difficulties in adding new clinics
or if a clinic withdraws from a study
there may be delays as a result of
problems in the supplier route, where
a delay in the delivery of an ordered
substance may cause a delay in the
studies. A delay in a program usually
means that the program will be more
expensive, since the research and
development costs will run for a longer
time than planned. This may result in
the company having to raise additional
capital to complete the program.
Development of further candidate
drugs
In addition to the programs, VP01, VP02
identify and develop new selective AT2
receptor molecules for treatment of
diseases within or outside the orphan
disease area in the VP03 program.
collaboration with external researchers.
financial resources will prove insuffi-
cient to conduct such development and
that the company, as a result thereof,
may be forced to discontinue develop-
ment or find other sources of financing.
Continuing the further development of
new molecules could create a need to
expand the company’s organisational
resources, which could incur further
costs for the company. There is thus a
drug candidates will have a negative
impact on its operations, financial
position and results.
Intellectual property issues
The value of Vicore is largely dependent
on its ability to obtain and defend
patents and its ability to protect specific
-
ceutical companies may be uncertain
and involve complicated legal and
a patent sought will not be granted for
an invention, that the patent granted will
not provide sufficient protection, or that
the patent granted will be circumvented
Vicore holds three granted patents
within the VP01 program. There
constitute adequate protection. If
intellectual property protection is not
satisfactory, other parties can exploit
this by circumventing the company's
protection and conduct competing drug
development. Such drug development
could show higher efficacy. This may
force Vicore to terminate a particular
drug program for commercial reasons,
or that the company's future product will
not generate any revenue.
Vicore has several pending patent
applications within the VP01, VP02 and
patent applications or future patent appli-
cations by the company are not granted.
If a patent application is not granted,
it can lead to insufficient commercial
protection which may result in termi-
commercial protection and a decision
to terminate programs would have a
material adverse effect on the company's
Orphan drug status
In addition to the company's patents,
Vicore has received so-called orphan
drug status for C21 for the treatment of
IPF in the USA and EU, which becomes
particularly relevant if Vicore succeeds
in developing and launching a drug.
This means that Vicore will depend on
other protection than patents, such as,
alternative commercial protections
in the form of orphan drug status or
data exclusivity.
are not adequate for Vicore's purposes,
Vicore’s commercial and / or intellectual
property protection is not adequate,
bypassing the company's protection,
and conduct competing drug develop-
ment, or launching competing products
and / or launch competing products that
show higher efficiency or are sold at a
lower price than Vicore's, the company
could lose significant revenue.
Market and competition
The development and commercializa-
tion of new pharmaceutical products
Vicore's competitors are mainly large
pharmaceutical companies, biotech
companies and academic institutions.
It is possible that competitors, such as
large pharmaceutical companies, have
greater opportunities in terms of, for
example, research and development,
contacts with regulatory authorities,
that competitors, who in many cases
have greater resources than Vicore,
may develop competing products more
in parallel with Vicore. This may lead to a
ability to generate revenues and the
company may be forced to terminate
parts of the business for commercial
reasons. Furthermore, this could mean
that the value of the company's program
portfolio is significantly reduced.
Production
Since Vicore has no proprietary produc-
tion facilities, the company is dependent
on sub-suppliers for the production of
pharmaceuticals. The manufacturing
process for Vicore’s drugs are made in
collaboration with contract manufac-
turers in Europe. Vicore is dependent
on the quality of the manufacturing
processes as well as the availability
and maintenance of the production
facilities. Regulatory authorities require
that all manufacturing processes and
methods, as well as all equipment
comply with current requirements of
Good Manufacturing Practice, GMP
requirements and consequences for the
company in the event of deficiencies in
GMP requirements may lead to delays in
None of the company's current
manufacturers are significant in the
sense that they are not replaceable, but
the company is dependent on them,
since changing manufacturers can be
both costly and time-consuming. There
suitable manufacturers that offer the
same quality and quantity on terms
acceptable to the company.
Reliance on key individuals and
employees
Vicore is highly dependent on retaining
and recruiting both qualified employees
and consultants as well as board
members. The company's future perfor-
mance is affected by its ability to attract
leave and the company fails to replace
him or her, this could have a negative
effect on the company's operations,
financial position and earnings.
In order for the company to have
sufficient capacity to further develop
its drug candidates and conduct phase
III studies, several persons must be
recruited. If the recruitment is not
successful, or if Vicore fails to retain
company's drug development programs
cannot be developed according to plan,
which would have significant negative
consequences for the company's