1 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Vicore Pharma Holding AB (publ)
vicorepharma.com
Annual Report 2021
Table of
Contents
Summary of the period ..................................3
Vicore in brief .................................................4
Year in brief ....................................................5
CEO comments ..............................................7
Moving towards a platform company ...........9
Market overview ............................................. 11
ATRAGs ...........................................................13
AT2R expression and mechanisms ..............14
Interview:
Vicore's clinical trial in PAH ........................... 15
Digital therapeutics for patients with IPF .....16
Interview:
Vicore's digital therapeutic ............................17
Program overview ..........................................18
Our programs .................................................19
Interview:
Vicore's commercial activities ......................22
Intellectual property ....................................... 23
Shareholder information ................................24
Annual Report 2021
Administration report .....................................26
Multi-year overview ........................................33
Financial reports, group ................................. 34
Financial reports, parent company ...............36
Notes, group ...................................................39
Notes, parent company .................................57
Board and management ................................61
Signatures.......................................................65
Auditor's report ...............................................66
Corporate governance report ........................69
Glossary ..........................................................76
Contact information .......................................78
3 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Summary of
the Period
Important events
during 2021
In February, Vicore completed a
directed share issue raising 336
MSEK. The share issue was ap-
proved at an Extraordinary General
Meeting in March.
In March, Vicore reported top-line
data from the mechanistic phase II
study in systemic sclerosis and Ray-
naud's phenomenon (SSc) showing
In May, Vicore announced that the
company had entered into a collab-
oration agreement with Alex Ther-
apeutics for the development of a
digital therapeutic (DTx) for patients
living with idiopathic pulmonary
In June, Vicore announced that the
company had received approval
from the U.S. Food and Drug Admin-
istration (FDA) to start the pivotal
phase 3 trial with C21 in COVID-19.
In August, Vicore announced a
strengthened management team
with three senior recruitments;
Jessica Shull, Head of Digital Ther-
apeutics, Åsa Magnusson, Chief
Nygård, VP Business Development.
Important events after
the year-end
In February, an interim analysis of
the AIR phase 2 trial in idiopathic
that C21 stabilizes disease and
shows an unanticipated increase in
lung function in IPF patients.
In February, Vicore announced the
-
ical entity from the VP03 program
clinical trial application (CTA) is
expected to be submitted during the
second quarter 2022.
In March, Vicore announced the
plan to initiate a proof-of-concept
trial with C21 in pulmonary arterial
hypertension (PAH).
In March, Vicore announced the
initiation of a human forearm blood
start in Q2 2022.
In March, Vicore announced that
Michael Wolff Jensen resigned
from the board and was replaced
by Jacob Gunterberg as chairman
until the annual general meeting in
May 2022.
Financial calendar
May 5, 2022 Interim report, Q1
May 11, 2022 Annual General Meeting 2022
August 25, 2022 Interim report, Q2
November 3, 2022 Interim report, Q3
February 28, 2023 Year-end report 2022
Financial reports are available on the company’s website
www.vicorepharma.com from the day of publication.
Financial overview for 2021
Net sales amounted to 0.0 MSEK (0.0)
The operating loss was -294.8 MSEK (-149.5)
Loss for the period amounted to -296.5 MSEK (-146.9)
Loss per share before and after dilution was -4.25 SEK (-2.71)
Cash, cash equivalents and short-term investments as of
December 31, 2021, amounted to 371.5 MSEK (318.7)
In September, Vicore announced
phase 3 trial with C21 in COVID-19
(ATTRACT-3) were dosed.
In September, Vicore announced
that the company was granted a
patent in the US covering the use of
C21 to treat infections caused by
Severe Acute Respiratory Syndrome
(SARS) coronavirus (CoV), including
SARS CoV-2.
In October, Vicore announced
that the results from the phase 2
trial in COVID-19 (ATTRACT) were
published in EClinicalMedicine,
the Lancet.
In November, Vicore announced
results from the ATTRACT phase
2 extension trial showing that C21
COVID-19.
4 | Annual Report 2021 Vicore Pharma Holding AB (publ)
V
icore is a clinical-stage pharmaceutical
company focused on developing
innovative medicines in severe diseases
where the Angiotensin II type 2 receptor
(AT2R) plays an important role . The company
currently has four development programs:
VP01, VP02, VP03 and VP04. VP01 aims to
develop the substance C21 for the treatment
of idiopathic pulmonary fibrosis (IPF), COVID-
19 and pulmonary arterial hypertension (PAH).
VP02 is a new formulation and delivery route
of thalidomide and focuses on the underlying
disease and the severe cough associated
with IPF. VP03 includes the development of
new AT2 receptor agonists (ATRAGs). VP04
develops a clinically validated digital therapeu-
tic for IPF patients.
The company's shares (VICO) are listed on
Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis ("IPF") is characterized by progressive fibrosis (scarring) in
the lungs. The disease gradually causes impaired lung function leading to shortness of
breath and cough. In later stages of IPF, signs of pulmonary hypertension are often seen.
Vicore
in Brief
Healthy alveolus
Alveolus in brosis
Bronchioles
(small lung airways)
“Honeycombing”
(clustered cystic
spaces)
Fibrosis between alveoli
decreases gas exchange so
that less oxygen is transferred
to the bloodstream
Healthy lung
Lung with IPF
Alternating areas of
fibrotic and normal lung
Vicore pipeline
Indication Program Preclinical Phase 1 Phase 2 Phase 3 Next event
COVID-19 C21 Phase 3 read-out H2 2022
IPF C21 Phase 2 read-out H2 2022
PAH C21 Phase 2 start Q4/Q1 2023
IPF anxiety DTx Clinical trial 2022
IPF cough Inhaled IMID Formulation development
Multiple
indications
C106 Phase 1 start estimated 2022
"Patients with IPF have a high
incidence of anxiety. The impact of
untreated anxiety may synergize
with the physiological burden of IPF
and further decrease quality of life
for these patients."
– Prof. Maureen Horton,
Worldwide prevalence of PAH:
0.5
of 100 000
Worldwide prevalence of IPF:
13-20
of 100 000
"All I know is decline, acceptance for
my new reality, which is hard to do. "
– Patient with IPF
5 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Progress in preclinical and
clinical development
Topline data from the mechanistic trial
in Raynaud's phenomenon in systemic
sclerosis
During the first quarter, the results from
the mechanistic phase 2 trial in twelve
patients with systemic sclerosis (SSc)
and Raynaud's phenomenon were
presented. The patients received a
single-dose of C21 and the aim of the
trial was to shed light on the angiotensin
II type 2 receptor's (AT2R) role in acute
improvement of blood flow in affected
tissues.
The result from the trial showed a
statistically significant temperature
recovery as a result of dilation of periph-
eral vessels suggesting that C21 can
increase blood flow in fibrotic tissue.
The temperature recovery continued
after the study measurement period.
This vasodilatory effect is believed to
be a benefit in the treatment of IPF.
C21 reduced long-term lung injury
after COVID-19 in the ATTRACT phase
2 extension trial
The results from the extension trial,
3-6 months after treatment, including
a subset of 33 patients (ATTRACT-2)
showed that patients receiving C21
(n=17) displayed reduced pathological
abnormalities compared to the placebo
group (n=16). In the C21 group, on
average 10.3 percent of the lung was
affected compared to 19.2 percent in
the placebo group meaning a nearly
in the C21 group compared with the
placebo group. Radiological change
was measured as ground glass opacity,
a pathological characteristic following
viral respiratory infection. These positive
findings together with the other clinical
trial results from ATTRACT suggest that
C21 could accelerate recovery from
COVID-19.
Start of FDA-approved, phase 3
trial (ATTRACT-3) in patients with
COVID-19
Previously reported positive phase
2 trial results strongly supported
further evaluation of C21 in COVID-19
and in June 2021, Vicore received
approval from the U.S. Food and Drug
Administration (FDA) to start a pivotal
phase 3 trial with C21 in COVID-19
(ATTRACT-3) and in September the first
patients in the trial were dosed. The
study is as a randomized, double-blind,
placebo-controlled, multinational,
phase 3 trial that will include 600 adult
patients hospitalized with COVID-19
and requiring oxygen support but not
invasive mechanical ventilation. The
effect of C21 on recovery from COVID-
19. The trial has been activated in more
than 50 study centers in the US, Czech
Republic,
Philippines, Argentina, Brazil, Columbia
and Russia. In February 2022, the
stopped due to the conflict. Topline data
from ATTRACT-3 is expected during the
second half of 2022.
The ongoing phase 2 AIR trial in
patients with IPF presents positive
interim results
The open-label, 60 patients trial in
patients with IPF progressed during the
for COVID-19, as they are particularly
susceptible to respiratory diseases due
to an already impaired lung function.
Recruiting patients for the study, has
been challenging, as regular hospital
visits are required and the company
patient safety. After year-end, an interim
analysis suggested that C21 stabilized
disease and increased lung function in
iPF patients, results that gave Vicore
confidence to prepare for the next trial.
Year
in Brief
2021 was a year of progress in building Vicore for the next development milestones
and exploring new areas, despite the many challenges faced due to COVID-19. With a
clear purpose and a highly dedicated team, Vicore is well positioned.
Reported encouraging results showing an increase in lung func-
tion and stabilized disease, in patients with IPF from an interim
analysis of the phase 2 AIR trial in IPF
Results from COVID-19 extension trial showed a nearly 50%
reduction in lung injury with C21 compared to placebo
Expanded pipeline with a digital therapeutic in IPF
Secured the companys financing through a directed share issue
of 336 MSEK
First drug candidate in the preclinical VP03 program ready to
enter clinic
PAH, decided as a new indication for clinical development
Start of phase 3 trial in COVID-19
Highlights during 2021 and the period
thereafter:
6 | Annual Report 2021 Vicore Pharma Holding AB (publ)
New AT2R agonists (ATRAGS)
developed further
Throughout 2021, Vicore efforts
to develop proprietary molecules
that modulate AT2R in a controlled
manner was intensified. The company
is in the process of establishing strong
intellectual property protection around
the class of AT2R stimulating drugs
(ATRAGs) through patent filings.
After year-end, Vicore announced
that the first compound was ready for a
phase 1 trial.
New addition to
development pipeline
During the second quarter, Vicore
expanded the pipeline with a digital
therapeutic to treat anxiety in patients
with IPF by the signing of an agreement
with Alex Therapeutics for development
and clinical validation.
The agreement with Alex Thera-
peutics, a medtech company with
expertise in artificial intelligence and
initiation of a new development program
and commercialization of a clinically
validated digital therapeutic (Vicore DTx)
to provide cognitive behavioural therapy
(CBT) to treat anxiety for people living
with IPF. Under the agreement, Vicore
will own all rights to VP04 in exchange
for an upfront payment to Alex
Therapeutics of 8.1 MSEK (1 MUSD),
plus potential milestone payments and
royalties on sales.
During 2021, the main focus was on
technical and software development.
The first pilot phase investigation of the
Vicore DTx received approval to start
and a following pivotal investigation is
estimated to start during H2 2022.
Secured patent protection
covering COVID-19
Patent protection for the use of C21 in
SARS CoV viruses
Vicore was granted a patent in the
US covering the use of C21 to treat
infections caused by Severe Acute
Respiratory Syndrome (SARS)
coronavirus (CoV), including SARS
CoV-2(COVID-19).
Several important
recruitments during
the year
During 2021, Vicore strengthened
the organization on several fronts,
spanning from R&D, Quality Assurance
to commercial functions. In August,
Vicore announced a strenghtened
management team with three senior
recruitments; Jessica Shull, Head of
Digital Therapeutics, Åsa Magnusson,
Nygård, VP Business Development. At
the end of 2021, a total of 21 employees
were employed in Vicore.
Strengthened financial
position
Vicore completed a successful directed
share issue raising 336 MSEK during the
first quarter 2021. The share issue was
subscribed by Swedish and interna-
tional institutional investors.
7 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Vital Capacity (FVC), a measure of
treatment with C21, FVC in the first
nine patients increased on average by
+250 ml: over the same period, FVC in
untreated patients would be expected
to decline by 120 ml. Seven of those
C21 treatment and that led to further
improvements in FVC.
For patients, a treatment that
halted the decline in IPF would be a
medicines. These interim results
suggest that C21 does more
than that, and actually increases
lung function. We at Vicore have
begin planning the next trial with C21
in IPF. Over the next few months, we
will be discussing the details of the trial
design with our clinical collaborators
and with regulators. We believe that it
is our obligation to do our utmost to
accelerate the development of C21 for
IPF patients.
The past year has been an intensive
year of preparation for another part
of Vicore’s offering in IPF, our digital ther-
CEO
Comments
Read more
has been about growth
and renewal. The
progress we made during the year has
put the company in a very optimistic
position as we begin 2022. With a firm
foundation in the treatment of rare lung
diseases Vicore is ready to enter new
therapeutic areas through the advanced
development of new angiotensin II type
2 receptor agonists (ATRAGs). The first
compound - C106 - from the
next generation of ATRAGs,
is ready to enter clinical devel-
opment during 2022 and an
additional three compounds
are in the late stages of
preclinical development.
In addition, our
multi-product effort in IPF was
boosted by positive interim data from
the AIR trial with our lead molecule,
C21, and the company will be striving
to advance that program into the next
phase. We also plan to launch a new
clinical program for C21 in the related
area of Pulmonary Arterial Hypertension
during Q4/Q1 2023.
We began our Phase 3 trial
(ATTRACT-3) with C21 in COVID-19
in the summer of 2021 following FDA
approval in Q2 2021. With more than
50 centers in 10 countries now active,
around half of the patients are enrolled
in the study. A formal safety review
implemented when 150 patients had
been enrolled raised no safety concerns.
As previously communicated, we expect
to provide topline read-out of the results
from the trial in the second half of 2022.
In February 2022, when approaching
half of the patients enrolled in the
IPF-trial (AIR), Vicore reported data from
an interim analysis of the trial. The data
showed the potential of C21 to restore
lung function, widely exceeding our
expectations. The AIR trial measured
lung function using a standard and
8 | Annual Report 2021 Vicore Pharma Holding AB (publ)
apeutic (Vicore DTx) designed to help
patients with anxiety and depression
due to their disease through cognitive
behavioral therapy. A pilot study
involving around 20 patients is about
to start at a number of leading centers
for respiratory disease. The pilot study
will help shape a much larger pivotal
study in approximately 250 patients
which is due to begin in H2 2022. The
pivotal study is designed to provide the
information needed for FDA clearance
of the product which is estimated to
2024.
Based on a variety of preclinical
and clinical data that the company
gathered during the years, Vicore will
expand its clinical program both within
rare lung disease and beyond. In one
initiative, the company will build a new
clinical program for C21 in pulmonary
arterial hypertension (PAH). PAH is a rare
disease characterized by dysfunction
of the arteries of the lung. In preclinical
models, C21 reverses vascular damage
and significantly improves blood flow;
in patients, C21 can help restore blood
flow in systemic sclerosis and Raynauds
phenomenon. Based on this and other
evidence, we plan to begin a proof-of-
concept trial with C21 in PAH in Q4 2022/
Q1 2023.
Our second new clinical initiative
within the VP03 program represents
a greater advancement for Vicore
and recognizes the broad potential of
ATRAGs. C21 is the original ATRAG and,
until now, the only one tested in clinical
on C21 in clinical trials, the company
also conducted an exhaustive discovery
and preclinical development program
on a series of new, proprietary ATRAGs.
The first ATRAG, C106 is now ready
for a phase 1 trial and Vicore expects
to submit a clinical trial application in
Q2 2022. An additional three ATRAGs
are expected to finalize preclinical
evaluation during H1 2023.
ATRAGs are about repairing. The
antifibrotic, repair and regenerative
effects seen in many preclinical models
of diseases are reflected in human
disease. The recent interim data in IPF
illustrate how deep that impact could
be. The emergence of a pipeline of new,
proprietary small molecule agonists of
AT2R and the submission of the clinical
trial application represents a first step
in transforming Vicore from a rare lung
disease company to a clinical platform
company exploring a new class of drugs,
the ATRAGs, in multiple indications.
Vicore is on the threshold of change.
in COVID-19 and reinforcement of our
interim data in IPF. We are also at the
start of a new era of exploration of
the potential of ATRAGs with our next
generation of AT2R modulators. As
closely with the academic community
on C21, we are planning to establish a
broad platform – the ATRAG Academy
- for promoting research into the use of
ATRAGs to treat human disease. The
idea is to provide drug plus placebo plus
documentation to groups who share
our ambition to accelerate ATRAGs
from model studies into humans. And
to the investors who support us and the
to the investigators and patients who
are part of our ongoing clinical trials, we
once again extend our gratitude for their
continued support.
Carl-Johan Dalsgaard, CEO
"The recent interim data in
IPF illustrate how deep the
impact of ATRAG's
antifibrotic, repair and
regenerative effects can be."
9 | Annual Report 2021 Vicore Pharma Holding AB (publ)
A
t Vicore, we are devoted to
exploiting the full potential of the
angiotensin II type 2 receptor
(AT2R). We are in a unique position
to leverage our deep expertise in the
area to bring novel therapies to patient
populations with a large unmet
medical need.
Clinically relevant data in COVID-19,
IPF and systemic sclerosis with C21
confirm the vascular and antifibrotic
effects of C21 and suggest that AT2R
agonists (ATRAGs) represent an
important new class of drugs and bodes
well for the translation also in other
diseases with similar strong preclinical
support.
Moving towards a
platform company
AT2R agonists, and a plethora of
preclinical studies pointing to the
disease modifying effects in several
indications, there is a multitude of
opportunities to explore. To prioritize
among these opportunities, Vicore
conducted a strategic review during
2021. Parameters including scientific
rationale, medical need and commercial
potential were guiding in the process
that resulted in the selection of three
potential new indications for AT2R
agonists, pulmonary artery hyperten-
sion (PAH), diabetic nephropathy (DN)
and preeclampsia (PE).
Of these, PAH is first in line. Vicore has
generated preclinical data in pulmonary
hypertension that support the decision
for a proof-of-concept trial, which is
planned for 2022.
In parallel with the ongoing clinical
development, Vicore is running an
extensive chemistry program to gener-
ate novel selective AT2R agonists with
long patent life and improved properties.
The aim is to generate a robust pipeline
of clinical candidates, and the first new
compound is planned to enter the clinic
in 2022.
We strongly believe that Vicore is
better positioned than anyone to pursue
these opportunities and feel that it is our
responsibility to do so.
Read more
Vicore strategic priorities
– moving towards a platform company
10 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Strategic priorities
Partnerships
Increase visibility and attention
for Vicore’s assets and clinical
programs.
Leadership position in rare lung diseases
Accelerate development of C21, a best-in-class IPF treatment.
clinical experts.
Drive innovation with digital therapeutic (DTx) addressing IPF-related
anxiety.
Initiate a proof-of-concept trial in PAH .
New proprietary ATRAGs
Continued accelerated drug dis-
covery and chemistry approach to
generate novel ATRAGs with strong
IP protection.
Capabilities and skills
Strengthening team capabilities to advance the clinical programs
Strengthen technical capabilities to ensure product supply.
-
ment of new ATRAGs.
New indications
Leverage our deep expertise in AT2R to expand the clinical pipeline to new
indications supported by strong preclinical data and unmet medical need.
Attract academic partners.
11 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Market
Overview
T
he most advanced clinical
programs in Vicore are targeting
IPF and COVID-19, two therapeutic
opportunities. As the biology around
AT2R agonists (ATRAGs) is being eluci-
dated, it is becoming evident that several
additional indications beyond IPF and
COVID-19 may be of relevance for this
new class of drugs. With a broadened
spectrum of indications, the commercial
will also be expanded.
IPF – a rare disease with
large unmet need
It is estimated that between 80,000 and
111,000 people in the EU are currently
living with idiopathic pulmonary fibrosis
("IPF"), with up to 35,000 new cases
being diagnosed each year
1
. In the
US, approximately 100,000 people are
currently living with IPF according to the
National Institute of Health (NIH), with
30,000-40,000 new cases per year. Both
the incidence and prevalence of IPF are
increasing worldwide
2
. Despite targeted
treatments being available for more
than ten years, mortality is still high
with a median survival of approximately
three years from the time of diagnosis.
From the moment of diagnosis, patients
will experience symptoms throughout
most of their disease, with disabling
dyspnea and cough that reduce quality
of life. A large proportion of people
with IPF also suffer from anxiety and
depression.
IPF is classified as a rare disease, and
the development of drugs to treat IPF
can therefore be granted orphan status.
Developing an orphan drug provides
exclusivity for up to seven years from
approval in the US and up to ten years
in the EU and Japan
3
. Other benefits
of orphan drug status can include tax
credits for parts of the development
costs or a discounted fee to the FDA in
the US. In the EU, assistance with the
development of the drug is possible and
a discount on the fee to the European
Medicines Agency (EMA) is also
possible. For orphan drugs, which are
aimed at a relatively fewer number of
patients, the studies are often smaller,
and the development phases are
often combined, which can lead to
a faster development timeline
3
. The
growth in recent years and is estimated
to continue to outgrow the overall
3
.
There are currently two approved
drugs for IPF, Esbriet (pirfenidone;
Roche/Shionogi) approved since
2011/2014 and Ofev (nintedanib;
Boehringer Ingelheim) approved
2014/2015 in Europe and the US.
Although both drugs can slow down the
progression of the deterioration of lung
function, they are associated with side
effects such as vomiting and diarrhea
and have not yet conclusively shown
that they can improve the survival or
quality of life of the affected patients.
The combined global sales of these
drugs are estimated to approximately
$4.0 billion in 2021 of which approxi-
mately 70% in US
4
in recent years attracted a great deal of
interest from the pharmaceutical indus-
try due to the significant unmet medical
need and a number of licensing deals
and acquisitions have been completed
such as the acquisition of Promedior by
Roche in 2019 at a value of $1.4 billion
(see table on next page).
COVID-19 – long-term need
for better treatments
The COVID-19 pandemic has impacted
many aspects of society and people’s
lives, and in February 2022, over 354
million cases had been confirmed
world-wide
5
. With increasing vaccine
coverage in developed countries many
nations are now preparing for an
endemic phase of the virus, accepting
that the virus is here to stay, although
at a more stable level. Many factors are
pointing in this direction such as viral
immune escape, waning immunity,
uneven global vaccine distribution
6
. The
global effort to develop vaccines has
been a scientific success, and novel
treatments and approaches towards
the reduction of disease mortality
have also emerged. However, although
Read more
There are two drugs for IPF available on
sales in 2021 amounted to approximately
$4.0billion
Source: Company reports from Roche
and Boehringer Ingelheim
$4.5billion
in 2019 and forecasted to continue
to grow
Idiopathic Pulmonary Fibrosis (IPF)
Prevalence (US and EU) : 250,000
Global market size: $4.0 Bn
Patients not on treatment in the US: 40%
12 | Annual Report 2021 Vicore Pharma Holding AB (publ)
long-term consequences of infection,
new data hint at a “hidden pandemic” of
long-term sequelae of severe Covid-19.
Observational studies indicate that a
significant proportion of patients expe-
rience long-term respiratory problems,
decreased exercise tolerance, and lung
tissue damage
7, 8
.
Thus, there is still a need for more
effective treatment to reduce long-term
health consequences. In an endemic
situation with new viral strains, there
treatment strategies also long term.
Covid therapeutics sales are forecasted
to reach $17 billion in 2021 and are
expected to increase in 2022 and
thereafter gradually go down and
reach a more stable level of $4 billion
annual sales from 2025 and onwards
9
.
However due to the changing nature of
the disease and pandemic, it is difficult
Pulmonary arterial
hypertension (PAH) – a rare
disease with large unmet
medical need
PAH is a progressive disease in which
a pulmonary vascular dysfunction
leads to high blood pressure in the lung
arteries which ultimately leads to heart
failure. The currently available treat-
ments reduce blood pressure by dilating
blood vessels but do not modify the
underlying disease or improve survival.
PAH is considered a rare disease and
treatment is estimated to $4.5 billion
10
.
Digital therapeutics
taking off
Digital therapeutics (DTx) is a new class
of medical products that has been
gaining traction in the last years, to date
about 35-40 DTx products have been
approved by the FDA
11
. As the value
of DTx products are becoming more
evident in e.g. managing and treating
Year Target/Licensor Acquiror/Licensee Type of deal
Development stage
at transaction Area Total deal value (MUSD)*
2021 Aptar Voluntis Acquisition DTx 79
2020 Redx Pharma AstraZeneca License Preclinical Fibrosis/IPF 377
2020 Forbius BMS Acquisition Phase I Fibrosis/IPF Undisclosed
2020 Curzion Pharmaceuticals Horizon Therapeutics Acquisition Phase II Fibrosis/IPF 45 + milestones
2020 Enleofen Boehringer Ingelheim License Preclinical Fibrosis/IPF
2019 Propeller ResMed Acquisition DTx 225
2019 Promedior Roche Acquisition Phase II Fibrosis/IPF 1,390
2019 Galapagos Gilead Sciences License Phase III IPF (part of larger portfolio) 5,000
2019 Bridge Biotherapeutics Boehringer Ingelheim License Phase I Fibrosis/IPF 1,300
2018 Morphic Therapeutic AbbVie License Preclinical Fibrosis/IPF 100 + milestones
2016 BMS License Phase Ib Fibrosis/IPF Undisclosed
2016 Afferent Pharmaceuticals Acquisition Phase IIb IPF cough 1,250
2015 Promedior BMS Option** Phase II Fibrosis/IPF 1,250
2014 InterMune Roche Acquisition Fibrosis/IPF 8,300
2014 Galecto Biotech BMS Option** Phase I/IIa Fibrosis/IPF 444
2012 Stromedix Biogen Acquisition Phase II Fibrosis/IPF 563
2011 Amira Pharmaceuticals BMS Acquisition Phase I Fibrosis/IPF 475
2011 Arresto BioSciences Gilead Sciences Acquisition Phase I Fibrosis/IPF 225 + milestones
* Total deal values including potential milestone payments
** BMS decided not to exercise its option
Source: Corporate webpages
chronic conditions and acceptance
with regulatory bodies and payers has
increased, DTx is receiving increasing
attention also from investors and the
pharmaceutical industry. In the last
couple of years several partnerships
have been formed e.g. Sanofi partnering
with Happify Health and Boehringer
develop new DTx products, and several
large acquisitions have also been made
e.g. ResMed’s acquisition of Propeller
in 2019 (see table). This activity is
expected to accelerate in the coming
is estimated to grow from $3.4 billion in
2021 to $13 billion in 2026
12
.
1. European Idiopathic Pulmonary Fibrosis and Related
Disorders Foundation
history; Diagnosis; Outcome. Am J
3. EvaluatePharma, Orphan Drug Report 2019 and 2020
4. Company reports; Roche, sales in 2021 (Esbriet) and
Boehringer Ingelheim, estimated sales in 2021 (Ofev)
5. Coronavirus (COVID-19) - Cross-Sector Impact - Glob-
al data, February 2022
6. “COVID is here to stay: countries must decide how to
adapt”. Nature 601, 165 (2022)
7. Bazdyrev, E et al. Lung Fibrosis after COVID-19: Treat-
ment Prospects. Pharmaceuticals 2021, 14, 807
8. Wu X et al. 3-month, 6-month, 9-month, and 12-month
respiratory outcomes in patients following COVID-19-re-
lated hospitalisation: a prospective study. Lancet Respir
Med. 2021, 9, 747-54
9. Pharmaceutical executive brief. Global data Jan 2022
2029, Global Data 2020
11. Morning consult, June 2021
Deals in IPF, fibrosis and DTx
13 | Annual Report 2021 Vicore Pharma Holding AB (publ)
The renin-angiotensin
system (RAS)
The AT1R (see illustration) is mainly
involved in blood pressure regulation
through several diffe rent mechanisms
related to constriction of blood vessels
and fluid retention, but also contributes
to innate immunity through pro-inflam-
matory actions. When this system
“over-shoots”, it can also contribute to
the pathogenesis of diseases such as
hypertension, myocardial infarction and
different fibrotic conditions including
disease.
The AT2R is on the other hand an
inducible system that can be seen as a
mechanism responsible for resolution
and regeneration following immune
ligands/agonists of AT2R such as Ang
1-9 and Ang 1-7 are fragments cleaved
from Angiotensin I and II.
Vicore’s candidate drug C21 and
the new compounds within the VP03
program are AT2R agonists, i.e. they
bind to and activate AT2R.
AT2R agonists (ATRAGs)
There is strong scientific evidence for
an important protective role of AT2R
activation in several serious diseases
related to cellular senescence, fibrosis
and microvascular dysfunction. In
addition to IPF, these include pulmonary
atherosclerosis, heart failure and cogniti-
ve disorders. This is based on more than
100 preclinical studies from different
research laboratories around the world.
Clinical evidence is now accumulating,
validating the preclinical results.
In COVID-19, patients treated with
the AT2R agonist C21 had a signifi-
supplementation by the end of study,
suggesting a restoration of respiratory
function by the drug. In addition, at the
3-month follow-up, treated patients
had fewer pathological signs on chest
computer tomographies.
Vascular effects of C21 were demon-
strated in systemic sclerosis patients
with severe vascu lopathy and fibrosis.
The total body of evidence suggests
that the AT2R is a relevant target far
beyond COVID-19, systemic sclerosis
and IPF.
Vicore has during the last years built
a strong position in AT2R agonist
chemistry and has a platform of very
promising new molecules with patent
protection to at least 2040 and beyond
under development.
The first new AT2R agonist to follow
C21 has finalized the preclinical devel-
opment and is ready to enter a phase
1 trial. A clinical trial application (CTA)
is expected to be submitted during the
second quarter of 2022.
The renin-angiotensin system (RAS) is a hormone system that regulates several
important physiological proces ses. The key hormone in the RAS is angiotensin II
which acts via two specic receptors, the angiotensin II type 1 receptor (AT1R) and
the angiotensin II type 2 receptor (AT2R).
"The AT2R is a
repair receptor"
2
The AT2R is an inducible regeneration and repair receptor
• A novel target with
untapped potential
• C21 is a first-in-
class selective
AT2R agonist
• Well established pathway
targetd by ACE inhibitors
(e.g. enalapril) and
angiotensin receptor
blockers (e.g. losartan)
AT2RAT1R
AT1R
Well established pathway
targeted by ACE inhibitors (e.g.
enalapril) and angiotensin
AT2R
A novel target with untapped
potential
AT2R agonist
Angiotensinogen
Angiotensin II Type 2
Receptor Agonists
- ATRAGs
The renin-angiotensin system (RAS)
14 | Annual Report 2021 Vicore Pharma Holding AB (publ)
1. [
3
H] C21 1nM
Shows binding of isotope-labeled
(tritium) C21 (1 nM) to thin sections
of human lung.
3. [
125
I] Ang II 0.15 1 nM
Shows binding of isotope-labeled
angiotensin II (Ang II, 0.15 nM) to
human lung sections.
2. [
3
H] C21 1nM C21 0.75 μM
binding is specific.
4. [
125
I] Ang II 0.15 1 nM C21 0.75 μM
Ang II, which illustrates that the AT2 receptor is the dominant Ang II
receptor in the human lung (the binding of Ang II is not affected by
AT2R expression and
possible mechanisms
Multiple mechanisms mediating AT2R agonist effects
1
C21
ECM
TIMP1 MMP1
C21
ECM
degradation
Fibroblast
Myofibroblast
Myofibroblast
transformation
C21
ECM, Fibrosis
Matrix
secretion
TGFβ1
Proliferation
1
C21
Endothelial cells
NO
2
3 4
C21
NO release
MMP activation
TGFβ1 inhibition
Epithelial function
Vascular remodeling and vasodilation
Fibrolysis
Alveolar integrity
Antifibrosis
Differentiation
Proliferation
AEC1
AEC2
Myofibroblast
Fibroblast
Surfactant
Multiple mechanisms mediating AT2R agonist effects
1
C21
ECM
TIMP1 MMP1
C21
ECM
degradation
Fibroblast
Myofibroblast
Myofibroblast
transformation
C21
ECM, Fibrosis
Matrix
secretion
TGFβ1
Proliferation
1
C21
Endothelial cells
NO
2
3
4
C21
NO release
MMP activation
TGFβ1 inhibition
Epithelial function
Vascular remodeling and vasodilation
Fibrolysis
Alveolar integrity
Antifibrosis
Differentiation
Proliferation
AEC1
AEC2
Myofibroblast
Fibroblast
Surfactant
Multiple mechanisms mediating AT2R agonist effects
1
C21
ECM
TIMP1 MMP1
C21
ECM
degradation
Fibroblast
Myofibroblast
Myofibroblast
transformation
C21
ECM, Fibrosis
Matrix
secretion
TGFβ1
Proliferation
1
C21
Endothelial cells
NO
2
3
4
C21
NO release
MMP activation
TGFβ1 inhibition
Epithelial function
Vascular remodeling and vasodilation
Fibrolysis
Alveolar integrity
Antifibrosis
Differentiation
Proliferation
AEC1
AEC2
Myofibroblast
Fibroblast
Surfactant
Vicore has recently conrmed, using so-called receptor autoradiog-
raphy, that human lung tissue expresses the AT2 receptor and that
C21 at very low concentrations binds specically to AT2R in the lung
tissue. (see gure below).
The multimodal effects of AT2R
activation are mediated by a num-
ber of possible mechanisms, includ-
ing one or more of those shown
in the figure to the right. (1) In the
lung, the AT2R is highly expressed
on alveolar epithelial cells type 2
(AEC2). These progenitor cells are
involved in the repair of damaged
alveoli, and they also fill a critical
function in secreting surfactant
which reduces alveolar surface
easier to expand the lungs. (2) AT2R
vascular endothelial cells to release
nitric oxide which is a vasodilator
and is an important molecule for
The antifibrotic effects of AT2R
activation with C21 is at least in
part mediated through inhibition of
(4) C21 also has fibrolytic activities
in that it can increase matrix
metalloproteinase (MMP) enzymes
that degrade fibrotic changes that
has already been formed.
extracellular matrix, MMP1 – matrix metalloproteinase 1, TIMP1 – tissue inhibitor of metalloproteinase-1
Key sources: Sumners et al. Acta Physiologica. 2019;227(1):e13280, Peluso et al. Clin Sci. 2018;132(7):777-90, Bruce et al. Br J Pharmacology
2015;172(9);2219–2231, Rathinasabapathy et al. Front Physiol. 2018;9:180. Vicore data on file.
Multiple mechanisms mediating AT2R agonist effects
1
C21
ECM
TIMP1 MMP1
C21
ECM
degradation
Fibroblast
Myofibroblast
Myofibroblast
transformation
C21
ECM, Fibrosis
Matrix
secretion
TGFβ1
Proliferation
1
C21
Endothelial cells
NO
2
3 4
C21
NO release
MMP activation
TGFβ1 inhibition
Epithelial function
Vascular remodeling and vasodilation
Fibrolysis
Alveolar integrity
Antifibrosis
Differentiation
Proliferation
AEC1
AEC2
Myofibroblast
Fibroblast
Surfactant
15 | Annual Report 2021 Vicore Pharma Holding AB (publ)
What is the difference
between Pulmonary Hyper-
tension and Pulmonary
Arterial Hypertension, and
are both of interest to
Vicore?
Pulmonary Hypertension (PH) is the
general term for a set of conditions in
which elevated pressure in the lung
blood supply can lead to progressive
heart failure. Pulmonary Arterial Hyper-
tension (PAH), is a particular severe rare
require intensive care unit level care at
some point in their life, and over 30%
of patients with PAH die within 3 years
of diagnosis. Vicore’s initial focus is on
PAH because we believe our drugs will
disease modifying treatment options
are currently available. The way our
blood vessels - means that they could
also be effective more broadly in PH.
PAH is a severe lung
disease, but is there a
connection to your current
work in IPF?
There is a connection. As mentioned,
the general category of Pulmonary
Hypertension encompasses several
groups of diseases leading to heart
failure. PH can also occur as a com-
plication to many lung diseases such
as IPF, where it is a strong predictor of
mortality. In a World Health Organization
classification, PAH is in group 1 of PH.
WHO group 3 includes PH associated
with already-diagnosed lung disease,
which is where IPF fits.
What drove Vicore to
consider PAH as a new
indication?
In short, we have evidence that our drug
is a clear pathway to approval. Vicore’s
lead compound, C21, is a highly specific
stimulator or agonist of the Angiotensin
Type 2 Receptor (AT2R). A lot of animal
data shows that C21 reverses vascular
remodelling and improves hemod-
ynamic pressure in the lungs. Quite
recently, using a ‘gold standard’ animal
model of Pulmonary Hypertension, we
showed that C21 prevented remodelling
of the blood vessels. The prevalence of
orphan drug status protection in the
US and Europe.
How will the trial in PAH be
designed?
All clinical trial designs have to be
agreed with drug regulators, but we
have an outline view of the study. This is
based, among other factors, on Vicore’s
experience in developing medicines in
PAH, and extensive inputs from Vicore’s
expert clinical advisors. The plan is to
conduct a ‘smart’ proof-of-concept
in a relatively short period of time from
will be intensive remote monitoring
of patients using a smart implantable
and providing a highly efficient,
decentralized design.
Interview with
Rohit Batta, CMO, on
Vicore’s new trial in PAH
In 2022, Vicore will begin a new clinical program in Pulmonary Arterial
Hypertension (PAH).
"With our AT2R agonists
we are addressing the
vascular component of
rare lung diseases."
16 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Vicore is developing a digital therapeutic
to treat anxiety and depression in people
living with Idiopathic Pulmonary Fibrosis
(IPF). Digital therapeutics (DTx) are
clinically evaluated software, designed,
built, and tested to treat a disease or
condition. DTx are classified as medical
There are more than 100 companies
developing DTx products, and there are
Belgium, and France.
Some of these products treat type I
or type II diabetes, there are products
for Alzheimer’s, others provide a
pain management, and others are in
the mental health space, such as the
product Vicore is developing.
IPF causes scarring of the lung and dif-
ficulty in breathing which is debilitating.
Activities that were once possible may
around a grocery store or going up stairs.
The diagnosis is usually unexpected, so
it can negatively impact a person’s state
of mind. The he Vicore DTx Almee™, an
investigational medical device pending
FDA clearance, offers a therapy for the
symptoms of anxiety and depression
that patients with IPF may experience
and helps patients cope.
The basic idea with Almee™ is to have
your own personal psychologist in
of sessions of Cognitive Behavioural
Therapy (CBT) built specifically for
people with IPF. The sessions are
made up of complex interactions and
psychological tools that people can
a smartphone or tablet in the comfort
of home rather than at a psychologist’s
office, whenever the patient prefers. The
sessions are built by software devel-
opers, psychologists and lung disease
experts and delivered through a device
the patient already has.
Almee™ will be validated through a
Randomised Control Trial (RCT), so
that potential payors and prescribers as
well as patients will have evidence of its
effectiveness. Throughout the design
process Vicore ensured patient and
physician insight was incorporated to
build something that they could identify
with and find useful.The ambition
is that Almee™ will offer support to
patients who have a rare disease and an
additional resource for hospital systems
that can’t provide daily counselling; the
goal of the Almee™ , as with every Vicore
pipeline, is to create better patient
outcomes.
Digital Therapeutic for
patients with IPF
17 | Annual Report 2021 Vicore Pharma Holding AB (publ)
What background do you
bring to Vicore?
In 2002 I finished a master’s degree in
Medical Illustration at the medical Col-
lege of Georgia, which included training
in Gross Anatomy, Neuropathology, and
Histology as well as detailed drawing.
was digital, done on computers with
high-end 3D modeling software and
coordination with a haptics team to
create virtual surgery devices. Since
health; for many years I collaborated
national health systems through
digital advances, and I produced digital
image-based protocols during the Ebola
epidemic for local populations.
Now digital health has entered the
personalized treatment space with
digital therapeutics, and for the last
four years I’ve been deeply involved
in advocacy, national policy and now
development of products under this new
approach to healtcare.
How do you see digital
therapeutics (DTx) fitting
into existing healthcare
practices?
I would say that a DTx needs to be con-
ceptualized, designed, and continually
evaluated for alignment with the patient
and physician experience. We have been
collaborating from day one with patient
groups and specialists to ensure that
this was a needed therapy, and that
it wouldn’t create an extra burden
on anyone.
As for the patients, we need to ensure
our design will have the desired effect,
reducing symptoms of anxiety and
depression in people with IPF.
How is a decentralized
investigation for DTx
different from a traditional
drug trial, and what are the
benefits?
With a decentralized trial for a digital
therapy, we can study individual param-
eters which are relevant and meaningful
from a patient perspective, directly from
the patients.
Our decentralized trial is a randomized
controlled trial (RCT) for a digital prod-
uct, which is easy to deliver across a
large geography. We designed the study
with one central Coordinating Inves-
tigator, and we will be able to accept
referrals from any eligible participant,
regardless of location. Being a digital
product means that collecting adverse
events, documenting adherence, and
even participant onboarding of how
to use Almee™ can be done entirely
virtually.
to those national regulations and
standards. So while a DTx can be
easily distributed and Patient Reported
Outcomes (PROs) collected, there are
strict requirement on the cybersecurity
and privacy systems in place to protect
patient data.
Where do you see the DTx
industry in 10 years?
In the last five years the DTx industry
industry saw deals worth $3.4 billion.
It’s an impressive statement about the
France are now structuring national
reimbursement pathways for these
Germany did in 2019. I’m an optimist,
but I see DTx continuing that global
trend, especially as millennials age and
personalized care becomes the norm.
Interview with Jessica
Shull, Director of Digital
Therapeutics
"I expect to see digital therapeutics
as a part of clinical guidelines in the
coming years."
18 | Annual Report 2021 Vicore Pharma Holding AB (publ)
VP01 (C21) – Idiopathic
pulmonary fibrosis ("IPF")
Completed phase 1 dose optimization trial in
2019, including 54 individuals. It established
a safe and tolerable daily dose of 200 mg for
further studies in IPF.
The phase 2 trial is an open 6 month study
in approximately 60 patients. In addition, pa-
tients will be given the opportunity to contin-
ue treatment for another three months. The
study is currently active in the UK and India.
in November 2020.
An interim analysis of the trial suggests that
C21 stabilizes disease and increases lung
function in patients with IPF.
Estimated read-out of the phase 2 trial is
during the second half of 2022. In parallel,
preparations for the next trial is ongoing.
VP04 (DTx) – A digital
therapeutic to treat anxiety
in IPF
Technical development of software
during 2021.
COMPANION, a randomized, con-
trolled, parallel-group clinical inves-
tigation, in two phases, evaluating
the impact of our digital cognitive
behavioural therapy on psychological
symptom burden, in adults diagnosed
with IPF, has been initiated.
patients will be followed by a pivotal
study (second phase), on approximate-
ly 250 patients in H2 2022. The pivotal
2023.
VP01 (C21) – COVID-19
Finalized phase 2 trial in 2020. The trial was a
randomized, double-blind, placebo controlled study
in 106 COVID-19 patients with a moderately severe
disease, requiring oxygen support, but not mechan-
ical ventilation. Summarized, the study shows that
-
tion in the C21 group was decreased.
The results from an extension trial, 3-6 months after
treatment, including a subset of 33 patients (AT-
TRACT-2) showed that patients receiving C21 had a
to placebo.
The phase 3 trial is a randomized, double-blind,
placebo-controlled, multinational, phase 3 trial
that will include 600 adult patients hospitalized
with COVID-19 and requiring oxygen support but
not invasive mechanical ventilation. The trial has
currently been activated in more than 50 study
in September 2020 and the estimated read-out is
during the second half of 2022.
Program
Overview
VP01 (C21) – Pulmonary arterial
hypertension (“PAH”)
A phase 2 proof-of-concept trial on patients with
PAH is expected to start during 2022.
VP02 (IMiD) – IPF cough
Preclinical development. Evaluation of alternative
formulations to deliver thalidomide locally to the
lung ongoing.
VP03 (multiple indications)
Preclinical research is underway to develop new
AT2R-agonists for multiple indications.
Clinical trial application (CTA) for a phase 1 trial for
-
ted during Q2 2022.
development during H1 2023.
Vicore pipeline
Indication Program Preclinical Phase 1 Phase 2 Phase 3 Next event
COVID-19 C21 Phase 3 read-out in H2 2022
IPF C21 Phase 2 read-out in H2 2022
PAH C21 Phase 2 start Q4/Q1 2023
IPF anxiety DTx Clinical trial 2022
IPF cough Inhaled IMID Formulation development
Multiple indications C106 Phase 1 start estimated 2022
19 | Annual Report 2021 Vicore Pharma Holding AB (publ)
VP01 – AT2 receptor
agonist - first in class
Vicore’s drug candidate C21 (VP01
program) originates from extensive
research on the Renin-Angiotensin
System (RAS) and binds specifically to
and activates AT2R.
Vicore has shown pronounced effects
with C21 in a gold-standard preclinical
model considered predictive of human
pulmonary hypertension (PH), the so
called Sugen-Hypoxia-induced PH
model. PH is a common and serious
complication of interstitial lung disease,
including IPF, and treatment options are
extremely limited.
Vicore has also shown robust effects
with C21 in lung tissue from patients with
idiopathic pulmonary fibrosis (IPF). Treat-
ment with clinically relevant concentra-
tions of C21 caused a dose-dependent
in fibrosis development.
Recently, Vicore has also shown that
human lung tissue expresses the AT2
receptor and that very low concentra-
tions of C21 bind specifically to AT2R in
the lung tissue which has been shown
by so-called receptor autoradiography.
C21 has previously shown very good
effects in animal models with pulmo-
nary fibrosis and is now being evaluated
in a phase 2 trial in patients with IPF and
a phase 3 trial in COVID-19.
Vicore has received Orphan Drug
Designation for C21 in IPF from the
FDA and EMA. Among other benefits,
eventually receiving orphan drug status
exclusivity (from the date of registration
of an approved drug) in Europe and
seven years in the United States.
Program status VP01
Idiopathic pulmonary fibrosis (IPF)
The phase 2 trial in IPF (AIR
1
) has
been designed in collaboration with
international clinical experts in IPF
and will investigate both safety and
lung function. The trial aims to support
the decision to initiate a confirmatory
trial and is performed in the UK, India,
was stopped due to the current war
situation.
The study is designed as an open-label
six month trial in approximately 60
patients and also offers patients the
opportunity to continue treatment for an
additional three months. The goal is to
perform the best possible trial to answer
the question if C21 can significantly
slow the decline in lung function in
patients with IPF.
The first patient was dosed in India in
November 2020.
In February 2022, Vicore performed an
interim analysis showing an initial stabi-
lization of disease and then an increase
in FVC up to the end of the study at 36
-
sis, there were 21 evaluable patients of
which 13, 9 and 7 patients reached 12,
-
mean FVC was +251 ml, a considerable
difference of 371 ml compared to the
in an untreated population
2
. Five of the
seven patients who completed both 24
continued improvement in FVC and
two remained stable. Analysis of FVC
are statistically significant (p=0.016 at
mean for untreated patients. The study
drug was well tolerated with no related
serious adverse events related to C21 or
gastrointestinal signals.
The trial is estimated to read-out in
H2 2022 at current recruiting plan and
Our
Programs
Read more
20 | Annual Report 2021 Vicore Pharma Holding AB (publ)
for the next trial in IPF.
COVID-19
During 2020, Vicore conducted a phase
2 trial with C21 in 106 patients with
COVID-19 (ATTRACT
3
). In October 2020,
the company reported that the trial
was fully recruited. Top-line data was
published in December 2020.
The study was designed as a
randomized, double-blind, place-
bo-controlled trial in patients with
moderately severe disease and signs
of acute respiratory infection but not
requiring mechanical ventilation. It
investigated the safety and efficacy
of C21 on respiratory failure and other
of the patients received corticosteriod
treatment as part of standard of care.
The clinical results from the trial
were positive demonstrating that C21
can restore lung function in COVID-19,
suggesting that C21 can prevent
disease progression.
Summarized, the trial showed that
supplementation in the C21 group was
decreased by 58 percent (p=0.026) at
day 8 after start of treatment. At day 14
there was only one patient in the C21
group in need of oxygen supplementa-
tion compared to eleven patients in the
placebo group (p=0.003), a reduction of
more than 90 percent.
There was also a clear trend for
C21 reducing the number of patients
needing mechanical ventilation and a
trend for C21 reducing mortality. The
treatment was reported safe and well
tolerated. There were no treatment-re-
lated side effects.
The results from an extension trial,
3-6 months after treatment, including
a subset of 33 patients (ATTRACT-2
4
)
showed that patients receiving C21
(n=17) displayed reduced pathological
abnormalities compared to the placebo
group (n=16). In the C21 group, on
average 10.3 percent of the lung was
affected compared to 19.2 percent in
the placebo group. The dominating
radiological change was ground glass
opacity, a pathological characteristic
following viral respiratory infection.
In June 2021, Vicore received approval
from the U.S. Food and Drug Adminis-
tration (FDA) to start a pivotal phase 3
trial with C21 in COVID-19 (ATTRACT-3
5
)
and in September the first patients in the
trial were dosed.
The study is designed as a
randomized, double-blind, placebo-con-
trolled, multinational, phase 3 trial that
will include 600 adult patients hospi-
talized with COVID-19 and requiring
oxygen support but not invasive
mechanical ventilation. The primary
C21 on recovery from COVID-19. The
patients are randomized to receive 100
mg C21 or placebo twice daily on top of
standard of care (SoC) for 14 days and
patients will be followed for 60 days.
The trial has currently been activated in
more than 50 study centers in the US,
India, Philippines, Argentina, Brazil,
Columbia and Russia. In February 2022,
was stopped due to the current war
situation.
According to the current recruitment
plan, top-line results from ATTRACT-3
are expected during the second half of
2022.
Pulmonary arterial hypertension (PAH)
In March 2022, Vicore communicated
plans to commence a phase 2 trial in
PAH. The tentative design is an open
label trial investigating the safety and
efficacy of C21 in patients with PAH,
with the aim of first patient screened in
Q4 2022/Q1 2023. Haemodynamics will
be assessed using the Abbott remote
monitoring CardioMEMS device.
VP02 – Targeting IPF and
IPF-related cough
In the VP02 program, Vicore is develop-
ing a novel formulation of thalidomide,
which is an existing immunomodulatory
drug (IMiD), to be administered locally
to the lung. It is thought that the actions
of thalidomide suppress pathways
involved in the cough reflex together with
antifibrotic effects.
Many IPF patients suffer from a
chronic intractable cough which
considerably affects the patients’
quality of life due to sleep disturbances,
-
nence
6
. Currently, there is no established
therapy for IPF-related cough and
standard cough medications have
little or no effect on the disease. The
anti-cough mechanism of VP02 in IPF is
due to structural changes in the lungs,
increased sensitivity of the cough reflex,
airway inflammation and/or changes in
mucus production and clearance
7
.
Using IMiDs to treat IPF-related cough
been shown to have clinical validity.
IMiDs have documented antifibrotic and
anti-inflammatory attributes and may
therefore be well suited for treatment of
Read more
21 | Annual Report 2021 Vicore Pharma Holding AB (publ)
a number of interstitial lung diseases.
In a clinical trial, an IMiD given orally
demonstrated a significant positive
effect on patients with IPF, reducing
the cough and dramatically improving
quality of life which is not seen in other
interventional clinical trials
8
.
effects such as peripheral neuropathy,
constipation and sedation due to
systemic IMiD exposure has limited
their use. Vicore’s novel VP02 program
aims to eliminate the negative aspects
of systemic exposure by developing
thalidomide for local administration to
the lungs.
Program status VP02
The inhaled formulation for local deliv-
ery of thalidomide to treat IPF-related
cough is in preclinical development.
Vicore continues to evaluate alternative
formulations to deliver thalidomide
locally to the lung. Further details on the
progress in the VP02 program will be
announced in coming reports.
VP03 – New AT2R agonists
Within this program, Vicore aims to
develop new patentable AT2R agonists
competitive pharmaceutical products
also for broader indications.
Program status VP03
The first drug candidate, C106, has
completed preclinical development and
a CTA for a phase 1 trial is expected
during the second quarter of 2022.
Three additional ATRAGs are expected
to finalize preclinical development
during H1 2023.
additional ATRAGs continues
in parallell.
VP04 – Digital Therapeutics
– a broader perspective
The VP04-program consists of a digital
therapeutic (DTx) based on cognitive
behavioral therapy (CBT) to address the
psychological impact of living with IPF.
DTx products are clinically evaluated
software, designed, built, and tested
to treat a disease or condition. DTx are
device regulations in the country of
use. DTx products can be a stand-alone
software, or used with a wearable
sensor, or be part of a medicinal therapy
protocol, depending on the intended
use and target condition. Vicore is
collaborating with Alex Therapeutics for
the development. Alex Therapeutics is a
Swedish medtech company specializing
in design and development of medical
device software, with expertise in
technology and clinical psychology.
The Vicore DTx will be evaluated
through real-world pilots and clinical
trials as well as secure regulatory
approvals, according to national and
international medical device develop-
ment standards.
Program status VP04
Technical development of the software
is nearing completion. In March 2022,
COMPANION was approved; a rand-
omized, controlled, parallel-group clinical
investigation evaluating the impact of
digital cognitive behavioural therapy on
psychological symptom burden in adults
diagnosed with IPF. The study will be
conducted in two phases. The first phase
is a pilot study with 20 patients. This
will be followed by the second phase, a
pivotal trial, with 250 patients in Q3 2022.
The pivotal study is estimated to read-out
during H1, 2023 and thereafter Vicore will
to be made available to patients in 2024.
1. NCT04533022
2. Richeldi et al 2014; King et al 2014
3. NCT04452435
4. NCT04878913
5. NCT04880642
6. Saini et al 2011
7. Vigeland et al 2017
8. Horton et al 2012
22 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Interview on our
commercial activities
Åsa Magnusson joined Vicore in the fall of 2021 as Chief Commercial Ofcer.
With an ongoing phase 3 trial in COVID-19 and an advanced patient focused pro-
gram in IPF, it was time to complement the R&D focused team with a strategic
commercial person.
What experiences do you
bring to Vicore?
With 30 years in different commercial
roles in the pharmaceutical industry,
I challenge myself to stay curious,
continuously learning new things and
that’s why Vicore is a perfect match for
me. I bring my experience of launching
rare disease medicines in areas with
high unmet medical need, mainly by
ensuring that patients get access
to these orphan medicines. Beyond
the scientific evidence proving that a
medicine is efficacious and safe, we
closely with the highly innovative team
at Vicore and focus our cross-functional
collaborative forces to create value for
What is your key priority?
My first priority this year is to prepare
for the commercialization of C21
in COVID-19.
expert, Jessica Shull, to ensure that our
innovative digital therapy specifically
designed to treat anxiety and depres-
sion with cognitive behavioral therapy
(CBT) in people with IPF gets to the
learned that there is a huge need both
from the patient perspective as well as
from the health care providers.
Last, but not least, the commercial
perspective is needed also during the
planning of next steps of our of our
development programs to ensure that
C21 and our next generation of ATRAGs
beyond efficacy and safety.
How could C21 add value
to patients suffering from
COVID-19?
Despite recent advances in preventing
and treating COVID-19, there will be a
group of patients who are hospitalized
and need oxygen supplementation, and
this is the patient group that we target.
C21 has a unique position in therapy
by addressing the alveolar damage of
COVID-19. With C21 we have a first in
class selective AT2R agonist (ATRAG),
targeting the angiotensin II type 2
receptor. This alternate mode of action
(vs. current treatments) promotes
alveolar healing and reduces the need of
oxygen support.
In the treatment regimen C21 is clearly
positioned between antivirals/anti-
bodies and acute respiratory distress
syndrome. Our ATTRACT program aims
at confirming how C21 (on top of ster-
oids and antivirals) restores respiratory
function and reduces long-term lung
alternate mode of action not targeting
the virus per se, expected to be effective
independently of variant.
How is the value of a new
product established?
Countries have different ways of
evaluating the value that a new
treatment brings. In general, I would
parameters, ranging from the severity of
the disease, how many other treatments
are available and how efficacious and
safe they are, as well as their price.
In addition, payers in many countries
would also want to see that there is a
patient relevant benefit when evaluating
if they are willing to reimburse a new
treatment. Here patient reported
outcomes and quality of life evaluations
play an important role.
"My focus is to ensure that payers
see the value of a product for
patients, beyond its efficacy
and safety"
23 | Annual Report 2021 Vicore Pharma Holding AB (publ)
T
he granted original C21 patent
is in force until 2024 (see Table
A). In addition to this patent,
C21 is expected to be protected by
different types of patents, including
those directed to new formulations
and methods of use. In the US a patent
covering the use of C21 in the treatment
of COVID-19 has been granted (Product
patents, See Table B). Moreover, Vicore
so-called orphan drug status Vicore
obtained in the EU and the US for C21
regarding treatment of IPF in the VP01
program. Orphan drug designation
provides for up to ten-year protection
in Europe and an up to seven-year
protection in the United States from
the time of registration of an approved
drug. If Vicore subsequently receives a
treatment of IPF will also be protected
(ten years in Europe and five years in
the US). The company also sees good
opportunities to obtain orphan drug
status for C21 for certain diseases other
than IPF. Overall, Vicore believes that the
company has strong product protection
for C21 based on the development plan
being followed.
Vicore also develops new improved
patentable AT2R agonists in the VP03
programme. The goal is to develop
competitive pharmaceutical products
for broader indications where it is not
possible to obtain orphan drug status.
Eight patent applications with new AT2R
agonists have been filed (see Table A).
Intellectual
Property
Table A – Substance patents VP01 (C21) and VP03
Project Country Application date (priority) Status Expiry year (planned)
VP01 US 31.05.2001 Granted 2024
VP03 National 20.09.2019 Pending 2040
VP03 International 19.03.2020 Pending 2041
VP03 International 20.03.2020 Pending 2041
VP03 International 01.09.2020 Pending 2041
VP03 International 23.03.2021 Pending 2042
VP03 International 23.03.2021 Pending 2042
VP03 International 23.03.2021 Pending 2042
VP03 International 09.07.2021 Pending 2022
Table B – Other pantents related to product VP01 (C21)
Project Country Application date (priority) Status Expiry year (planned)
VP01 International/US 23.03.2020
Granted in US/
Pending
2040/41
VP01 International 24.04.2020 Pending 2041
VP01 International/US 24.04.2020 Pending 2041
VP01 International/US 24.04.2020 Pending 2041
VP01 International 14.05.2020 Pending 2041
VP01 Priority 25.10.2021 Pending 2042
VP01 Priority/US 10.02.2022 Pending 2042/43
24 | Annual Report 2021 Vicore Pharma Holding AB (publ)
The share
As of December 31, 2021, the total number of
capitalization was 999 MSEK. The number of
shareholders amounted to 5,141. The compa-
ny’s shares are issued in one class and each
share carries one vote.
Capital supply
In November 2020, Vicore acquired novel AT2R
agonists from HaLaCore Pharma and decided
of the payment, which was registered at the
Swedish Companies Registration Office during
the first quarter of 2021.
On February 10, 2021, Vicore completed a
directed share issue of 11,200,000 shares at
a subscription price of SEK 30,0 per share,
raising a total amount of approximately 336
MSEK before transaction costs. The directed
share issue was approved at an Extraordinary
General Meeting in March 2021.
Analyst coverage
The following analysts cover Vicore and contin-
uously analyze the company's development:
Largest shareholders
Shareholder No. of shares %
HealthCap VII L.P. 15,834,834 22,1%
Fourth Swedish National Pension Fund 6,632,041 9,2%
HBM Healthcare Investments (Cayman) Ltd. 4,620,302 6,4%
Protem 4,030,340 5,6%
3,120,425 4,3%
Unionen 2,663,990 3,7%
2,644,165 3,7%
Third Swedish National Pension Fund 2,641,425 3,7%
Avanza Pension 2,527,370 3,5%
1,531,303 2,1%
Second Swedish National Pension Fund 1,050,000 1,5%
Alexander Shaps 685,108 1,0%
Nordnet Pension 502,001 0,7%
Lancelot Asset Management 500,000 0,7%
Alfred Berg Funds 484,537 0,7%
Carl-Johan Dalsgaard 477,981 0,7%
410,000 0,6%
Mats K Andersson 390,000 0,5%
SEB Funds 376,641 0,5%
Other 20,637,830 28,8%
Total number of shares 70,760,293 100.0%
Source: Monitor by Modular Finance as of February 28, 2022
Largest shareholders in Vicore as of February 28, 2022:
Shareholder
information
Share price development
At the end of 2021, the share price was
13.9 SEK. The highest price paid for the
share during the year was 34.6 SEK on
February 16 and the lowest price paid was
12.8 SEK on December 21. The share price
decreased by a total of 56 percent during
999 MSEK as of December 31, 2021.
Share data
The number of registered shares on
December 31, 2021 amounted to
71,760,293 ordinary shares.
Financial targets and
dividend policy
The target is to distribute approximately 50
percent of the company’s annual net profit
as dividends when Vicore has achieved
account present and future profit levels,
investment needs, liquidity and develop-
ment opportunities as well as general
economic and business conditions.
In accordance with the Board of
Directors' dividend policy, no dividend is
to be paid before the company generates
significant revenue.
Development of the share during 2021
25 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Year Event
Quota
value
Increase in
number of
shares
Increase in
share capital
Total no.
of shares
Total share
capital
2021 Share issue 0.5 11,200,000 5,600,000 71,760,293 35,880,147
2021 0.5 142,054 71,027 60,560,293 30,280,146
2020 Share issue 0.5 10,000,000 5,000,000 60,418,239 30,209,119
2020 Share issue 0.5 243,525 121,763 50,418,239 25,209,119
2019 Share issue 0.5 7,800,000 3,900,000 50,174,714 25,087,357
2019 Share issue 0.5 9,414,706 4,707,353 42,374,714 21,187,357
2018 Share issue 0.5 8,240,002 4,120,001 32,960,008 16,480,004
2018 0.5 8,851,502 4,425,751 24,720,006 12,360,003
2017 Share issue 0.5 1,500,000 750,000 15,868,504 7,934,252
2017 Share issue 0.5 2,000,000 1,000,000 14,368,504 7,184,252
2015 Share issue/Listing 0.5 3,248,144 1,624,072 12,368,504 5,684,252
2015 Reverse split,1:10 0.5 -73,083,239 - 8,120,360 4,060,180
2015 Share issue 0.05 12,639,073 631,954 81,203,599 4,060,180
2013 Share issue 0.05 34,282,263 1,714,113 68,564,526 3,428,226
2012 Offset issue 0.05 474,498 23,725 34,282,263 1,714,113
2011 Share issue 0.05 10,402,389 520,120 33,807,765 1,690,388
2010 Offset issue 0.05 1,000,000 50,000 23,405,376 1,170,269
2010 Share issue 0.05 5,601,344 280,067 22,405,376 1,120,269
2010 Share issue 0.05 5,601,344 280,067 16,804,032 840,202
2008 Share issue 0.05 688 34 11,202,688 560,134
2008 Split 1:2000 0.05 11,196,399 - 11,202,000 560,100
2008 Bonus issue 100 4,601 460,100 5,601 560,100
2005 Formation 100 1,000 100,000 1,000 100,000
Share capital development
Size categories
Number of known
shareholders Number of shares % of capital
1 - 10,000 5,773 5,086,679 7.1%
10,001 - 50,000 188 4,237,692 5.9%
50,001 - 100,000 30 2,249,991 3.1%
100,001 - 500,000 26 6,379,482 8.9%
500,001 - 1,000,000 2 1,187,109 1.7%
1,000,001 - 5,000,000 9 24,829,320 34.6%
5,000,001 - 2 22,466,875 31.3%
Anonymous holdings - 5,323,145 7.4%
Totalt 6,030 71,760,293 100.0%
Ownership distribution by holding
Ownership distribution in Vicore as of February 28, 2022:
Shareholder category
Number
of shares % of capital
Swedish shareholders 60,575,144 84.4%
International shareholders 11,185,149 15.6%
Shareholder types
Number
of shares % of capital
Swedish institutional shareholders 34,523,574 48.1%
International institutional shareholders 4,650,951 6.5%
Swedish retail investors 17,406,644 24.3%
Other 9,804,694 13.7%
Anonymous holdings 5,374,430 7.5%
Shareholder categories
Shareholder categories in Vicore as of February 28, 2022:
26 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Annual Report 2021
Administration Report
The Board of Directors and the CEO of Vicore Pharma Holding AB (publ.), Corp. Reg. No. 556680-3804,
hereby submit the annual report and consolidated nancial statements for the 2021 scal year.
Vicore’s operations
company currently has four development
programs, VP01, VP02, VP03 and VP04.
VP01 aims to develop the substance
C21 for the treatment of idiopathic
pulmonary fibrosis (IPF), COVID-19 and
pulmonary arterial hypertension (PAH).
VP02 is a new formulation and delivery
route of thalidomide and focuses on the
underlying disease and the severe cough
associated with IPF. VP03 includes the
development of new AT2R-agonists.
VP04 develops a clinically validated
digital therapeutic for IPF patients
(Vicore DTx).
The company's shares (VICO) are listed
In the beginning of the year, Vicore
completed a directed share issue raising
336 MSEK. The issue was subscribed by
Swedish and international institutional
investors and the intended use of the
proceeds was among others, to finance
the phase 3 trial in COVID-19. The share
issue was approved at an Extraordinary
General Meeting in March.
The results from the trial with C21 in
patients with systemic sclerosis and
Raynaud's phenomenon was presented
in March and showed vasodilating
effects with C21 on peripheral resist-
ance vessels.
In May, Vicore entered into a collabora-
tion agreement with Alex Therapeutics
for the development of a digital
therapeutic (DTx) to treat anxiety in
patients living with idiopathic pulmonary
fibrosis (IPF). A pilot phase study on
20 patients will be followed by a pivotal
study on approximately 250 patients in
H2 2022.
In September, the first patients in
the global phase 3 trial in COVID-19
(ATTRACT-3) on 600 patients, were
dosed.
In September, Vicore was granted a
patent in the US covering the use of
C21 to treat infections caused by
Severe Acute Respiratory Syndrome
(SARS) coronavirus (CoV), including
SARS CoV-2.
In November, Vicore announced
results from the phase 2 extension
trial in COVID-19 (ATTRACT-2) showing
after COVID-19.
The open-label phase 2 trial in 60
patients with IPF is progressing. After
year-end an interim analysis suggests
that C21 stabilizes disease and increases
lung function in patients with IPF.
Estimated read-out of the phase 2
trial is during the second half of 2022. In
parallel, preparations for the next trial is
ongoing.
The evaluation of alternative formula-
tions to o deliver thalidomide locally to
the lung in the VP02 program continued
during 2021.
The VP03 program progressed well
during 2021 and after year-end, Vicore
announced that the first drug candidate,
C106, is ready for clinical development
and a phase 1 trial is expected to start
during 2022.
After year-end, Vicore announced
the plan to initiate a proof-of-concept
trial with C21 in pulmonary arterial
hypertension (PAH).
During 2021, Vicore strengthened the
organization, spanning from R&D, Quality
Assurance to commercial functions.
In August, Vicore announced a streng-
htened management team with three
senior recruitments; Jessica Shull, Head
of Digital Therapeutics, Åsa Magnusson,
Nygård, VP Business Development. At
the end of 2021, a total of 21 employees
were employed by Vicore.
Important events during
2021
In February, Vicore completed a
directed share issue raising 336
MSEK. The share issue was ap-
proved at an Extraordinary General
Meeting in March.
In March, Vicore reported top-line
data from the mechanistic phase II
study in systemic sclerosis and Ray-
naud's phenomenon (SSc) showing
In May, Vicore announced that the
company had entered into a collab-
oration agreement with Alex Ther-
apeutics for the development of a
digital therapeutic (DTx) for patients
living with idiopathic pulmonary
In June, Vicore announced that the
company had received approval
from the U.S. Food and Drug Admin-
istration (FDA) to start the pivotal
phase 3 trial with C21 in COVID-19.
In August, Vicore announced a
strengthened management team
with three senior recruitments;
Jessica Shull, Head of Digital Ther-
apeutics, Åsa Magnusson, Chief
Nygård, VP Business Development.
In September, Vicore announced
phase 3 trial with C21 in COVID-19
(ATTRACT-3) were dosed.
In September, Vicore announced
that the company was granted a
patent in the US covering the use of
C21 to treat infections caused by
Severe Acute Respiratory Syndrome
(SARS) coronavirus (CoV), including
SARS CoV-2.
In October, Vicore announced
that the results from the phase 2
trial in COVID-19 (ATTRACT) were
published in EClinicalMedicine,
the Lancet.
In November, Vicore announced
results from the ATTRACT phase
2 extension trial showing that C21
COVID-19.
Important events after the
year-end
In February, an interim analysis of
the AIR phase 2 trial in IPF suggests
that C21 stabilizes disease and
27 | Annual Report 2021 Vicore Pharma Holding AB (publ)
amounted to +2.3 MSEK (-6.9) for the
full year 2021.
were -1.4 MSEK (0.0) for the full year
2021. The costs for share-based incen-
tive programs related to staff within
-0.1 MSEK (0.0) for the full year 2021.
Research and development expenses
amounted to -271.8 MSEK (-142.0) for
the full year 2021. Research and devel-
opment expenses are mainly related to
clinical trial costs for VP01. The costs
for share-based incentive programs
related to research and development
staff amounted to -0.7 MSEK (-1.3) for
the full year 2021.
Other operating income and expenses
amounted to -1.4 MSEK (17.5) for the
full year 2021. During the second quar-
ter of 2020, Vicore received a grant of
1.5 GBP million from the British research
charity LifeArc for the ATTRACT study in
patients with COVID-19.
The total costs for the share-based
incentive programs for the full year
2021 amounted to +1.5 MSEK (-8.2),
of which +5.4 MSEK (-5.6) consisted of
provisions for social security contribu-
tions and -3.9 MSEK (-2.6) were IFRS
2 classified salary costs. These costs
have had no cash flow impact.
Result
The operating loss amounted to -294.8
MSEK (-149.5) for the full year 2021. The
result after tax for the full year 2021 was
-296.7 MSEK (-147.3). Tax amounted to
0.3 MSEK (0.5) for the full year 2021. Tax
is mainly related to a change in deferred
tax liability attributable to acquired intan-
gible assets. The group’s accumulated
tax loss carryforwards as of December
31, 2021, amounted to 729.8 MSEK. The
As of December 31, 2021, cash
and cash equivalents amounted to
294.2 MSEK (248.6) and short-term
investments were 77.3 MSEK (70.1).
Accordingly, cash, cash equivalents and
short-term investments amounted in
total to 371.5 MSEK (318.7). The equity
ratio as of December 31, 2021, was
85.0 percent (87.2 percent) and equity
amounted to 383.3 MSEK (354.5). Total
equity and liabilities amounted to 451.2
MSEK (406.5).
Parent company
The group ("Vicore") consists of the
parent company, Vicore Pharma Holding
AB (publ) and the subsidiaries Vicore
Pharma AB and INIM Pharma AB. The
parent company’s operations mainly
consist of providing management and
administrative services for the group’s
operative companies. The research and
development operations are conducted
in the wholly owned subsidiaries Vicore
Pharma AB and INIM Pharma AB.
Net sales for the parent company
amounted to 38.8 MSEK (3.7) for the full
year 2020. Net sales mainly consisted of
re-invoiced costs and management fees
to group companies. Administrative
expenses amounted to -19.9 MSEK
(-24.7) for the full year 2021. The oper-
ating profit (loss) for the full year 2021
amounted to 17.1 MSEK (-22.6). The
profit (loss) amounted to 17.6 MSEK
(-21.8) for the full year 2021. During the
full year 2021, shareholder contributions
amounting to 400 MSEK were provided
to the subsidiaries.
Personnel
As of December 31, 2021, the group had
21 employees, of whom 14 were women
group’s tax loss carryforwards have not
been measured and are not recognized
as a deferred tax asset. These tax loss
carryforwards will be accounted for only
when the group has established a level
of earnings which management with
confidence estimates will lead to taxable
profits. The loss for the full year 2021
amounted to -296.5 MSEK (-146.9). The
loss per share before and after dilution
amounted to SEK -4.25 (-2.71) for the full
year 2021.
Cash flow, investments and
financial position
Cash flow from operating activities
amounted to -265.2 MSEK (-119.9) for
the full year 2021.
Cash flow from investing activities
for the full year 2021 was -7.0 MSEK
(4.0). The difference compared with the
previous year is mainly attributable to
the acquisition and sale of short-term
interest-bearing investments.
Cash flow from financing activities
amounted to 318.2 MSEK (177.0) for the
full year 2021. On February 10, 2021, the
company completed a directed share
issue of 336 MSEK before transaction
costs amounting to approximately 17.6
MSEK. The directed share issue was
approved at an Extraordinary General
Meeting in March 2021. The directed
share issue was subscribed for by
Swedish and international institutional
investors. The subscription price of 30.0
SEK per share was determined through
and corresponds to approximately 0.6
percent premium to the 10-day volume
weighted average share price. The issue
proceeds are mainly intended to finance
the company's development programs.
shows an unanticipated increase in
lung function in IPF patients.
In February, Vicore announced the
-
ical entity from the VP03 program
clinical trial application (CTA) is
expected to be submitted during the
second quarter 2022.
In March, Vicore announced the
plan to initiate a proof-of-concept
trial with C21 in pulmonary arterial
hypertension (PAH).
In March, Vicore announced the
initiation of a human forearm blood
start in Q2 2022.
In March, Vicore announced that
Michael Wolff Jensen resigned
from the board and was replaced
by Jacob Gunterberg as chairman
until the annual general meeting in
May 2022.
Revenue
Net sales amounted to 0.0 MSEK (0.0)
for the full year 2021.
Operating expenses
Operating expenses amounted to
-295.9 MSEK (-167.7) for the full year
2021. Research and development
expenses comprise a large fraction of
the operating expenses. The increase in
operating expenses is according to plan
and is mainly attributable to increasing
research and development expenses.
Administrative expenses amounted to
-20.2 MSEK (-25.0) for the full year 2021.
The costs for share-based incentive
programs related to administrative staff
and seven men. Of the employees, 15
are active within R&D. The group also
and assignments on a frequent basis.
Shareholders and the share
At the end of 2021, Vicore had 5,141
shareholders and the number of shares
was 71,760,293 with a quotient value of
SEK 0.5 each. There is only one class of
shares. The company's shares are issued
in one class and each share carries one
vote at the Annual General Meeting.
On December 31, 2021, HealthCap VII
L.P. was the single largest shareholder in
Vicore, with a total of 15,834,834 shares,
corresponding to 22.1 percent of the
votes and capital. No shareholder other
than HealthCap VII L.P. has a direct or
indirect shareholding that represents
one tenth, or more, of the voting rights
for all shares in the company. Further
information on shareholders and
Vicore's share is presented on pages
24-25 in the 2021 annual report.
Share-based incentive
programs
The purpose of share-based incentive
programs is to promote the company’s
long-term interests by motivating
and rewarding the company’s senior
line with the interests of the sharehold-
ers. As of December 31, 2021, Vicore
has four active programs that include
the management team, employees and
certain board members.
At the Extraordinary General Meeting
on August 13, 2018, it was resolved to
implement two new incentive programs:
a maximum of 2,000,000 options to sen-
28 | Annual Report 2021 Vicore Pharma Holding AB (publ)
LTIP 2018”); and a maximum of 475,000
share awards to board members
(”Board LTIP 2018”).
At the Annual General Meeting on May
20, 2020, it was resolved to implement
a new incentive program for the new
board members ("Board LTIP 2020")
amounting to a maximum of 525,000
share awards.
At the Annual General Meeting on May
11, 2021, it was resolved to implement
two new incentive programs: a maximum
of 73,000 share awards to certain board
members (”Board LTIP 2021”).
All these programs are perfor-
mance-based programs entitling the
holder to a maximum of one common
share in Vicore per option or share
award after three years.
For further information about these
programs, see Note 8 "Share-based
payments", the minutes of the Extraordi-
nary General Meeting 2018, the minutes
of the Annual General Meeting 2020
and the minutes of the Annual General
Meeting 2021, which are published on
the company’s website, www.vicore-
pharma.com.
During the third quarter of 2021, Board
LTIP 2018 expired. As the share price
increased by less than 50 percent during
the measurement period no share
awards were earned. The program is
now closed.
The increase in the company’s share
capital, assuming full utilization and
maximum goal achievement of all actíve
incentive programs (i.e. including non-
warrants that may be used as hedge for
social security contributions), amounts
to a maximum of SEK 2,793,387, 2022
corresponding to a dilution of 7.2
percent of the total number of shares.
As of December 31, 2021, a total
of 525,000 share awards have been
granted in the Board LTIP 2020 program,
61,773 share awards have been granted
in the Board LTIP 2021 program,
to 1,325,800 shares have been granted
to 807,600 shares have been granted in
Guidelines for executive
remuneration 2021
The board of directors, the CEO and
other members of the executive
management fall within the provisions
of these guidelines. The guidelines are
to remuneration agreed, and amend-
ments to remuneration already agreed,
after adoption of the guidelines by the
annual general meeting 2021. These
guidelines do not apply to any remuner-
ation already decided or approved by the
general meeting.
The guidelines’ promotion of the
company’s business strategy, long-
term interests and sustainability
In short, the company’s business
strategy is the following.
Vicore Pharma is a rare disease
pharmaceutical company with a focus
on fibrotic lung diseases and related
indications. The company currently
has three drug development programs,
VP01, VP02 and VP03. The VP01
program aims to develop the substance
C21 for the treatment of IPF and COVID-
19. The VP02 program is based on a
new formulation and delivery route of an
existing immunomodulatory compound
(an “IMiD”). The VP02 program focuses
on the underlying disease and the
severe cough associated with IPF. Both
-
ated for other indications within the field
of fibrotic lung diseases which have a
significant unmet need. The VP03 pro-
gram includes follow-up molecules for
C21. Vicore’s long-term goal is to obtain
regulatory approvals and establish the
company as a pharmaceutical company
specializing in fibrotic lung disease.
For more information regarding
the company’s business strategy,
please see Vicore Pharma’s company
presentation at https://vicorepharma.
com/investors/events-presentations/.
A prerequisite for the successful
implementation of the company’s
business strategy and safeguarding
of its long-term interests, including
its sustainability, is that the company
is able to recruit and retain qualified
personnel. To this end, it is necessary
that the company offers a competitive
European level remuneration.
These guidelines enable the company
to offer the executive management a
competitive total remuneration.
Variable cash remuneration covered
by these guidelines shall aim at promot-
ing the company’s business strategy
and long-term interests, including its
sustainability.
The company also has long-term
share-related incentive plans in place.
The plans have been resolved by the
general meeting and aim to align
the interests of the board members
shareholders.
29 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Types of remuneration, etc.
terms and may consist of the following
components: fixed cash salary, variable
cash remuneration, pension benefits
and other benefits. Furthermore,
additional variable cash remuneration
may be awarded in extraordinary
circumstances. Additionally, the general
meeting may – irrespectively of these
guidelines – resolve on, among other
things, share-related or share price-re-
lated incentive programs. The satis-
faction of criteria for awarding variable
cash remuneration shall be measured
over a period of one to several years.
The variable remuneration payable in
cash may amount to a maximum of 40
percent of the annual fixed cash salary
for the CEO and a maximum of 30
percent of the annual fixed cash salary
to other senior executives under the
measurement period for such criteria.
Further variable cash remuneration
may be awarded in extraordinary
circumstances, provided that such
extraordinary arrangements are limited
in time and only made on an individual
basis, either for the purpose of recruiting
or retaining executives, or as remuner-
ation for extraordinary performance
Such remuneration may not exceed an
amount corresponding to 50 per cent
of the fixed annual cash salary and may
not be paid more than once per year
for each individual. Any resolution on
such remuneration shall be made by the
board of directors based on a proposal
from the remuneration committee.
For the CEO, pension benefits,
-
Variable cash remuneration shall
not qualify for pension benefits. The
pension premiums for premium defined
pension shall amount to not more than
30 per cent of the fixed annual cash
salary. For other executives, pension
benefits, including health insurance,
shall be premium defined unless other-
wise required by for example collective
agreements. The pension premiums for
premium defined pension shall amount
to not more than 30 per cent of the fixed
annual cash salary.
Other benefits may include, for
example, life insurance and medical
Such benefits may not amount to more
than 10 per cent of the fixed annual
cash salary.
For employments governed by rules
other than Swedish, pension benefits
for compliance with mandatory rules
into account, to the extent possible, the
overall purpose of these guidelines.
Termination of employment
For all executives the notice period
may be up to six months if notice of
termination of employment is made by
the company. For the CEO, fixed cash
salary during the notice period and
severance pay may, in total, not exceed
twelve months’ fixed salary, and for
other executives, such remuneration
may not correspond to an amount which
exceeds six months’ fixed salary. The
period of notice may be up to six months
without any right to severance pay when
termination is made by the executive.
Additionally, remuneration may be paid
remuneration shall compensate for loss
of income and shall only be paid in so far
as the previously employed executive
is not entitled to severance pay. The
remuneration shall amount to not
more than 60 per cent of the monthly
income at the time of termination of
employment and be paid during the time
however not for more than 12 months
following termination of employment.
Criteria for awarding variable cash
remuneration, etc.
The variable cash remuneration shall be
criteria. These criteria can be measur-
able advancements in the company’s
preclinical and clinical trials and other
associated activities. The criteria can
be financial or non-financial. They may
also be individualized, quantitative or
be designed so as to contribute to the
company’s business strategy and long-
term interests, including its sustainabil-
the business strategy or the executive’s
long-term development. The board of
directors shall have the possibility, under
applicable law or contractual provisions,
apply under law or contract, to in whole
or in part reclaim variable remuneration
To which extent the criteria for
awarding variable cash remuneration
have been satisfied shall be evaluated/
determined when the measurement
period has ended. The remuneration
committee is responsible for the
evaluation so far as it concerns variable
remuneration to the CEO. For variable
cash remuneration to other executives,
the CEO is responsible for the evalua-
of directors for those executives who
report directly to the CEO. For financial
on the latest financial information made
public by the company.
Salary and employment conditions for
employees
In the preparation of the board of
directors’ proposal for these remunera-
tion guidelines, salary and employment
conditions for employees of the com-
including information on the employees’
total income, the components of the
remuneration and increase and growth
rate over time, in the remuneration com-
mittee’s and the board of directors’ basis
of decision when evaluating whether the
guidelines and the limitations set out
herein are reasonable
The decision-making process to
determine, review and implement the
guidelines
The board of directors has established a
remuneration committee. The commit-
directors’ decision to propose guidelines
for executive remuneration. The board
of directors shall prepare a proposal for
new guidelines at least every fourth year
and submit it to the general meeting.
The guidelines shall be in force until new
guidelines are adopted by the general
meeting. The remuneration committee
shall also monitor and evaluate pro-
grams for variable remuneration for the
executive management, the application
of the guidelines for executive remunera-
tion as well as the current remuneration
structures and compensation levels in
the company. The members of the remu-
neration committee are independent of
the company and its executive man-
agement. The CEO and other members
of the executive management do not
participate in the board of directors’
processing of and resolutions regarding
remuneration-related matters in so far as
they are affected by such matters.
Derogation from the guidelines
The board of directors may temporarily
resolve to derogate from the guidelines,
in whole or in part, if in a specific case
there is special cause for the derogation
and a derogation is necessary to serve
the company’s long-term interests,
including its sustainability, or to ensure
the company’s financial viability.
As set out above, the remuneration
the board of directors’ resolutions in
remuneration-related matters. This
includes any resolutions to derogate
from the guidelines.
Description of significant
changes to the guidelines
for 2022 and how the
shareholders' views have
been taken into account
No significant changes have been
made to the proposed guidelines for
2022 compared to previously adopted
guidelines. No shareholders have
provided any comments.
Nomination committee for
the 2022 Annual General
Meeting
Vicore’s nomination committee for the
2021 Annual General Meeting consists
of Staffan Lindstrand, appointed
National Fund AB and Michael Wolff
Jensen, Chairman of the Board of
Directors of Vicore.
30 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Risk factors
Vicore’s business is influenced by a
number of factors, the effects of which
on the company’s earnings and financial
position, in certain respects, cannot be
controlled by the company at all or in
part. In an assessment of the compa-
ny’s future development, it is important,
alongside the possibilities for growth, to
Set forth below is a description,
without any internal order of priority, of
greatest significance for the company’s
to Vicore’s operations, industry and
Clinical trials in Russia and Ukraine
negatively affected the availability
and recruitment of potential trial
participants as well as their ability to
carry out non-essential hospital visits.
This can lead to patients not completing
a study or not returning for follow-up.
studies with VP01 in IPF and COVID-19,
respectively, will be delayed or need
to be withdrawn, which could have
a material negative impact on the
company's operations, financial position
and results.
COVID-19-pandemic
disruptions in the economies of many
countries, including the group’s ability to
carry out clinical studies. The duration
and expected development of the
no predictions can be made in relation
to the length of present and further
measures that different countries and
crisis. However, any prolongation or
lead to e.g. the following:
the availability and recruitment of
potential trial participants in clinical
studies as well as their possibility of
carrying out non-essential hospital
visits is negatively affected. This
could lead to delays of the studies,
greater study costs and capital need
than anticipated,
disruptions in the operations of
third-party manufacturers, clinical
research organizations, and other
parties on whom Vicore relies, the
availability or cost of materials,
which could damage Vicore’s supply
chain or otherwise limit its ability to
-
facture Vicore’s drug candidates to
be used in clinical trials,
regulatory approvals or opinions for
programs are delayed,
commercialization of new products
is hampered, and
which can impact the company’s
Given the evolving nature of the
pandemic, the above list is by no means
exhaustive, but each of these events, or
any combination of them, could amplify
the negative impact of the crisis on the
group’s financial performance and have
material adverse effect on the group’s
business, financial development and
shareholder value.
Research and development and the
dependency of four programs
Vicore's business consists mainly of
four programs (VP01, VP02, VP03 and
VP04). The company's main value may
be attributable to the potential of the
company's respective programs. The
programs are in preclinical or clinical
various programs will not develop as
planned, which could have a material
adverse effect on the company's value
and future potential. This is especially
true if any of the above would occur
in the more advanced program VP01,
which is currently of the greatest value
to the company. For example, there
partners, institutional review bodies
and / or regulatory authorities will
discontinue clinical studies if the results
of such studies do not demonstrate the
intended treatment effect, fail to achieve
an acceptable safety profile, or due to
results from unwanted side effects.
If a program or study is interrupted,
in addition to a significant decline in
the company's share price as a result
of a reduced value of the company's
program portfolio and a significantly
impaired revenue potential for the
specific program, it may cause an
impairment of fixed assets.
Clinical trials and regulatory approvals
Before conducting certain clinical trials,
approval must be obtained from the
relevant regulatory authority and an
for the company's future products are
the United States and the EU, and the
relevant regulators are the US Food and
Drug Administration ("FDA") and / or the
European Medicines Agency ("EMA").
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
32 | Annual Report 2021 Vicore Pharma Holding AB (publ)
operations and program portfolio. Such
in the long run, lead to delays in the
company's programs, which would be
associated with significant research and
development costs.
Financing and capital requirements
The company currently has no approved
drugs and does not generate any
long time before the company's drug
candidates will be sold commercially
and generate recurring cash flows.
The company's ongoing and planned
clinical trials entail significant costs. The
company is therefore still dependent on
raising capital or borrowing money to
finance clinical studies. Both the extent
and timing of Vicore's future capital
needs will depend on a number of
factors, including results from and costs
for future studies. The access to, and
the conditions for, additional financing,
for example through new share issues,
licenses or partnership agreements
or loans are affected by a number of
factors such as Vicore's clinical study
access to capital and Vicore's credit
rating and credit capacity. Disruptions
and uncertainty in the credit and
additional capital. If Vicore fails to raise
sufficient capital on favorable terms, or
at all, it would mean that the company
may have to accept a more expensive
financing solution, share issues with
significant discount and large dilution,
or cause the company to limit its
development or cease operations. For
further description of the company's
Currency risk
Assets, liabilities, income and expenses
in foreign currency give rise to currency
increases the reported amounts of
Vicore’s assets, liabilities, income
and earnings while a strengthening
of the SEK against other currencies
decreases these items. The company
is exposed to such changes, as parts
of the company’s costs are paid in
EUR and other international currencies
and because a part of the company’s
future sales revenue may be received
in international currencies. A material
change in such exchange rates could
have a negative impact on the compa-
ny’s financial statements, which in turn
could have negative effects on Vicore’s
financial position and results. To reduce
currency exposure in EUR, the company
exchanges SEK to EUR in the range of
60-100% of expected future cash flows.
See also Note 19.
Tax loss carryforwards
As a result of the business having gen-
erated significant loss, Vicore has large
accumulated tax loss carryforwards.
As of December 31, 2021, Vicore's
tax loss carryforwards amounted to
729.8 MSEK. Changes in ownership
resulting in a change of controlling
influence over Vicore, or certain internal
transfers described above, may impose
restrictions, in whole or in part, on the
possibility of utilizing such losses in the
will not be able to generate enough
profits to exploit such tax losses. The
possibility of utilizing the losses in the
future may also be adversely affected
by future changes in the applicable
legislation.
Proposed appropriation of the
company’s profits or loss for the 2021
financial year
The following profit/loss stated in SEK
is at the disposal of the Annual General
Meeting:
Share premium reserve 1,003,761,527
Loss brought forward -60,378,841
Loss of the year 17,578,105
960,960,791
The Board of Directors proposes that
SEK 960,960,791 are to be carried
forward.
Financial targets and
dividend policy
The target is to distribute approximately
50 percent of the company’s annual
net profit as dividends when Vicore has
achieved the desired financial stability,
profit levels, investment needs, liquidity
and development opportunities as
well as general economic and
business conditions.
In accordance with the Board of Direc-
tors' dividend policy, no dividend is to
be paid before the company generates
significant revenue.
33 | Annual Report 2021 Vicore Pharma Holding AB (publ)
2021 2020 2019 2018
Net sales (KSEK) 0 0 0 508
-296,735 -147,315 -93,329 -21,681
Total assets (KSEK) 451,168 406,515 341,108 301,600
Equity ratio (%) 85.0 87.2 94.3 94.6
Number of employees (average) 16 13 8 6
2021 2020 2019 2018
Net sales (KSEK) 38,730 3,672 3,092 2,653
17,709 -21,826 -24,803 -11,100
Total assets (KSEK) 1,075,894 669,514 503,959 488,965
Equity ratio (%) 92.6 97.7 98.4 82.1
Number of employees (average) 4 4 3 3
Multi-year
Overview
Multi-year overview, group
Multi-year overview, parent company
34 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Consolidated statement of financial position
KSEK Note
2020
Dec 31
2019
Dec 31
ASSETS
Fixed assets
Patents, licenses and similar rights 15 67,427 70,755
Equipment 16 84 113
Contract asset 6 317 139
Long-term investments 17, 18 5,409 7,530
Deferred tax asset 13 0 131
Total xed assets 73,237 78,668
Current Assets
Other receivables 1,417 5,354
Prepaid expenses and accrued income 20 5,034 3,757
Short-term investments 21 77,281 70,118
Cash and cash equivalents 22 294,199 248,618
Total current assets 377,931 327,847
TOTAL ASSETS
EQUITY AND LIABILITIES
EQUITY 24
Share capital 35,880 30,209
Other contributed capital 1,021,666 702,053
-674,230 -377,749
Total equity attributable to the parent company's shareholders 383,316 354,513
LIABILITIES
Non-current liabilities
Contract liability 6 320 0
Other provisions 25 600 2,385
Deferred tax liability 13 1,210 1,531
Total non-current liabilities 2,130 3,916
Current liabilities
Contract liability 6 0 140
Trade payables 18, 19 23,984 10,943
Current tax liability 335 553
Other liabilities 1,112 3,132
Other provisions 25 152 3,792
Accrued expenses and deferred income 26 40,139 29,526
Total current liabilities 65,722 48,086
TOTAL LIABILITIES 67,852 52,002
TOTAL EQUITY AND LIABILITIES
Financial reports
Group
Consolidated statement of comprehensive income
KSEK Note
2021
Jan-Dec
2020
Jan-Dec
Net sales 0 0
Gross prot 0 0
Administrative expenses 4, 5 -20,204 -24,986
4 -1,404 0
Research and development expenses 4 -271,812 -142,021
Other operating income and expenses 4, 9, 10 -1,398 17,469
Prot/loss from operations -294,818 -149,538
Financial income 11 646 2,229
Financial expenses 12 -2,563 -6
Net nancial income/expense -1,917 2,223
Loss after nancial items -296,735 -147,315
Tax 13 254 453
Loss for the year attributable to the parent company´s
shareholders
-296,481 -146,862
Other comprehensive income
Other comprehensive income 0 0
Other comprehensive income for the year, net of tax 0 0
Total comprehensive income attributable to the parent
company´s shareholders
-296,481 -146,862
Earnings per share, before and after dilution 14 -4.25 -2.71
35 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Consolidated statement of cash flow
KSEK Note
2021
Jan-Dec*
2020
Jan-Dec
Operating activities
-294,818 -149,538
27 2,099 6,202
Interest received 483 726
Interest paid -8 -6
Cash ow from operating activities before changes in working capital -292,244 -142,616
Cash ow from changes in working capital
Change in operating receivables -340 -3,867
Change in operating payables 27,413 26,548
Cash ow from operating activities
-265,171 -119,935
Investing activities
Acquisition of intangible assets 29 0 -3,000
21 -77,000 -70,000
21 70,000 77,000
Cash ow from investing activities
-7,000 4,000
Financing activities
Amortization contract liability -239 -179
Issue of new shares 336,000 187,550
Issue costs -17,578 -10,404
Cash ow from nancing activities
Cash ow for the year
Cash and cash equivalents at the beginning of the year
Foreign exchange difference in cash and cash
equivalents
11, 12 -431 0
Cash and cash equivalents at year-end
22 294,199 248,618
Consolidated statement of changes in shareholders´ equity
Shareholders' equity attributable to the parent company
KSEK Share capital
Other
contributed
capital
Retained earnings
including profit
(loss) for the
period Total
Equity Jan 1, 2020
0 0 -146,862 -146,862
Other comprehensive income for
the year
Total comprehensive income for
the year
Transactions with owners:
Issue of new shares 5,122 182,428 0 187,550
Issue costs 0 -10,404 0 -10,404
Long-term incentive program 0 2,632 0 2,632
Total transactions with owners 5,122 174,656 0 179,778
Equity Dec 31, 2020
Equity Jan 1, 2021
0 0 -296,481 -296,481
Other comprehensive income for
the year
Total comprehensive income for
the year
Transactions with owners:
Issue of new shares and issue in
Issue costs 0 -17,578 0 -17,578
Long-term incentive program 0 3,862 0 3,862
Total transactions with owners 5,671 319,613 0 325,284
Equity Dec 31, 2021
* Correction of the cash flow statement
In the year-end report for the fiscal year 2021, social security contributions for share-based incentive programs were reported in the cash flow
36 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Parent company’s income statement
KSEK Note
2021
Jan-Dec
2020
Jan-Dec
Net sales 2 38,730 3,672
Gross prot 38,730 3,672
Administrative expenses 3, 4, 5, 6 -19,911 -24,663
Research and development expenses 3 -1,686 -1,658
Other operating income and expenses 3 -67 44
Prot/loss from operations 17,066 -22,605
7 645 815
Interest expenses and similar loss items 8 -2 -36
Net nancial income/expense 643 779
Prot/loss after nancial items 17,709 -21,826
Tax 9 -131 68
Prot/loss for the year 17,578 -21,758
Financial reports
Parent company
KSEK Note
2021
Jan-Dec
2020
Jan-Dec
Prot/loss for the year 17,578 -21,758
Other comprehensive income
Other comprehensive income 0 0
Other comprehensive income for the year 0 0
Comprehensive income for the year
17,578 -21,758
Parent company’s statement of comprehensive income
37 | Annual Report 2021 Vicore Pharma Holding AB (publ)
KSEK
Note
2021
Dec 31
2020
Dec 31
ASSETS
Fixed assets
Intangible xed assets
Patents, licenses and similar rights 0 6,000
Total intangible assets 0 6,000
Tangible assets
Equipment 0 0
Total tangible assets 0 0
Financial assets
Participations in group companies 10 796,389 396,303
Long-term investments 11 565 565
Deferred tax asset 9 0 131
Total nancial assets 796,954 396,999
Total xed assets 796,954 402,999
Current assets 12
Receivables
Receivables from group companies 32,386 0
Other receivables 65 305
Prepaid expenses and accrued income 13 812 270
33,263 575
Short-term investments 14 77,281 70,118
Cash and cash equivalents 15 168,396 195,822
Total current assets 278,940 266,515
TOTAL ASSETS
1,075,894 669,514
Parent company’s balance sheet Parent company’s balance sheet
KSEK
Note
2021
Dec 31
2020
Dec 31
EQUITY AND LIABILITIES
EQUITY 16
Restricted equity
Share capital 35,880 30,209
Total restricted equity 35,880 30,209
Non-restricted equity
Share premium reserve 1,003,762 688,011
-60,379 -42,483
17,578 -21,758
Total non-restricted equity 960,961 623,770
TOTAL EQUITY 996,841 653,979
LIABILITIES
Provisions
Other provisions 17 507 5,312
Deferred tax liability 184 120
Total provisions 691 5,432
Non-current liabilities
Liabilities to group companies 18 0 0
Total non-current liabilities 0 0
Current liabilities
Trade payables 622 765
Liabilities to group companies 18 75,000 0
Current tax liability 61 385
Other liabilities 595 1,725
Accrued expenses and deferred income 19 2,084 7,228
Total current liabilities 78,362 10,103
TOTAL LIABILITIES 79,053 15,535
TOTAL EQUITY AND LIABILITIES
1,075,894 669,514
38 | Annual Report 2021 Vicore Pharma Holding AB (publ)
KSEK
Share
capital
Share
premium
reserve
Loss
brought
forward
Loss
for the
year Total
Equity Jan 1, 2020
25,087 515,988 -20,376 -24,740 495,959
Transfer of previous year’s loss 0 0 -24,740 24,740 0
0 0 0 -21,758 -21,758
Other comprehensive income for the year 0 0 0 0 0
Total comprehensive income for the year 0 0 -24,740 2,982 -21,758
Transactions with owners:
Issue of new shares 5,122 182,428 0 0 187,550
Issue costs 0 -10,405 0 0 -10,405
Incentive programs 0 0 2,633 0 2,633
Total transaction with owners 5,122 172,023 2,633 0 179,778
Equity Dec 31, 2020
30,209 688,011 -42,483 -21,758 653,979
Equity Jan 1, 2021
30,209 688,011 -42,483 -21,758 653,979
Transfer of previous year’s loss 0 0 -21,758 21,758 0
0 0 0 17,578 17,578
Other comprehensive income for the year 0 0 0 0 0
Total comprehensive income for the year 0 0 -21,758 39,336 17,578
Transactions with owners:
5,671 333,329 0 0 339,000
Issue costs 0 -17,578 0 0 -17,578
Incentive programs 0 0 3,862 0 3,862
Total transaction with owners 5,671 315,751 3,862 0 325,284
Equity Dec 31, 2021
35,880 1,003,762 -60,379 17,578 996,841
The parent company’s report of changes in equity The parent company’s cash flow statement
KSEK Note
2021
Jan-Dec
2020
Jan-Dec
Operating activities
17,066 -22,605
20 -2,215 2,104
Interest received 482 726
Interest paid -2 -2
Cash ow from operating activities before changes in working capital 15,331 -19,777
Cash ow from changes in working capital
Change in operating receivables -36,438 550
Change in operating payables 2,259 1,925
Cash ow from operating activities
-18,848 -17,302
Investing activities
Sale/liquidation of group company 0 75
Shareholder contributions to group companies -320,000 -120,000
14 -77,000 -70,000
14 70,000 77,000
Cash ow from investing activities
-327,000 -112,925
Financing activities
Issue of new shares 336,000 187,550
Issue costs -17,578 -10,404
Cash ow from nancing activities
318,422 177,146
The cash ow for the year
-27,426 46,919
Cash and cash equivalents at the beginning of the year
195,822 148,903
Foreign exchange difference in cash and cash
equivalents
0 0
Cash and cash equivalents at the end of the year
15 168,396 195,822
39 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 1 Accounting principles
This Annual Report and the consolidated financial
statements comprise the Swedish parent company
tration number 556680-3804, and its subsidiaries.
The parent company is a limited liability company
with its registered office in Gothenburg , Sweden .
The address of the main office is Kronhusgatan 11,
411 05 Gothenburg . The main operation of the
group is research and development of pharmaceu-
tical products.
On April 6, 2022, the Board of Directors approved
this Annual Report and the consolidated financial
statements, which will be presented for approval at
the Annual General Meeting on May 11, 2022.
Applied regulations
Vicore’s consolidated accounts have been prepared
in accordance with the International Financial
Reporting Standards (IFRS) issued by the Interna-
tional Accounting Standards Board (IASB) as well
as the interpretations from the IFRS Interpretation
Committee (IFRS IC) as adopted by the European
Union (EU). Furthermore, the group also applies the
Annual Accounts Act (1995: 1554) and the Swedish
Financial Reporting Board’s recommendation RFR
1 ”Supplementary Accounting Rules for Groups”.
Basis for the consolidated accounts
Preparing financial statements in accordance
with IFRS requires the company management
These assessments and estimates are based on
historical experiences, as well as other factors that
are considered to be reasonable during the current
circumstances. The actual result can deviate from
these estimates and assessments.
the issue of equity instruments or debt instruments,
which arise are reported directly in the profit/loss
for the year. For business combinations where the
transferred remuneration exceeds the fair value of
acquired assets and assumed liabilities that are
reported separately, the difference is reported as
goodwill. When the difference is negative, a so-called
bargain purchase, this is reported directly in the
profit/loss for the year.
When acquiring an asset, the acquisition value is
allocated to the individual identifiable assets and
the debts, based on their relative fair values. Such a
transaction does not give rise to goodwill.
Eliminated transactions during consolidation
Intra-group receivables and liabilities, income or
expenses and unrealised gains or losses which
arise from intra-group transactions between group
companies are eliminated in the preparation of the
consolidated accounts. Unrealised gains arising
from transactions with associated companies
are eliminated to the extent which corresponds to
the group’s ownership in the company. Unrealised
losses are eliminated in the same way, but only to
the extent that there is no impairment of the asset.
Currency
Functional currency and reporting currency
Functional currency is the currency in the primary
economic environments in which the companies
operate. The parent company’s functional currency
currency for the parent company and the group.
Unless otherwise stated, all amounts are rounded
to the nearest thousand (KSEK).
Notes
Group
New and amended standards and interpretations
not yet adopted by the group
Updated standards and interpretations from IASB
and IFRIC interpretations that came into force
during the 2021 calendar year have had no material
impact on the group.
Valuation principles
Assets and liabilities have been recognised at
their historical cost, except for certain financial
assets that are stated at fair value. Financial assets
valued at fair value consist of holdings in listed and
non-listed shares.
Consolidation
Subsidiaries
Subsidiaries are all the companies over which Vicore
has a controlling influence. The group controls
a company when it is exposed to, or has rights
to, variable returns from its involvement with the
investee and has the ability to affect those returns
through its power over the investee. Subsidiaries are
included in the consolidated accounts as of the date
on which the controlling influence is transferred to
the group. They are excluded from the consolidated
accounts as of the date on which the controlling
influence ceases.
Subsidiaries are reported according to the acqui-
sition method. The method implies that acquiring a
subsidiary is considered a transaction, whereby the
group indirectly acquires the subsidiary’s assets and
liabilities. In the acquisition analysis, the fair value of
acquired identifiable assets and assumed liabilities,
as well as any holdings without controlling influence,
is determined on the acquisition date. Transaction
costs, excluding transaction costs attributable to
Foreign currency transactions
Transactions in foreign currency are translated
to the functional currency at the exchange rate
as on the transaction date. Monetary assets
and liabilities denominated in foreign currencies
are translated to the functional currency at the
exchange rate on the balance sheet date. Exchange
rate differences that arise are recognized in the
profit/loss for the year. Exchange gains and
exchange losses on operating receivables and
operating liabilities are reported in operating
results, while exchange gains and exchange losses
on financial receivables and liabilities are reported
as financial items.
Operating segments
Operating segments are reported in a way that
corresponds with internal reporting structures. The
profit/loss generated by a business segment is
then followed up by the company’s chief operating
the profit/loss figures and allocating resources to
the business segment. In the group, this function is
identified as the company’s CEO.
An operating segment is a component of the group
that engages in business activities from which it
may earn revenues and incur expenses, and for
which discrete financial information is available.
Vicore does not divide its business into different
segments, instead it sees the entire business of the
group as one segment. This follows the company’s
internal organization and reporting structures.
Classification
Non-current assets and non-current liabilities
consist in all essentials solely of amounts that
are expected to be recovered or settled more
40 | Annual Report 2021 Vicore Pharma Holding AB (publ)
than twelve months after the reporting period.
Current assets and current liabilities consist in all
essential solely of amounts that are expected to be
recovered or settled within twelve months of the
reporting period.
Revenue from contracts with customers
The group reports revenue when the group fulfils a
performance obligation, i.e. when a promised prod-
uct is delivered to the customer and the customer
-
mance obligation can be transferred over time or at
a point in time. Revenue consists of the amount the
company expects to receive as compensation for
the transferred products or services. For the group
to report revenue from contracts with customers,
each customer contract is analyzed according to
the five-step model included in the standard:
Step 1: Identify a contract between at least two
parties that consists of enforceable rights and
obligations.
Step 2: Identify the performance obligations in the
contract.
Step 3: Determine the transaction price, i.e. the
amount of consideration that the company is
expected to receive in exchange for the promised
goods or services.
Step 4: Allocate the transaction price over the
identified performance obligations.
Step 5: Recognize revenue when the performance
obligations are satisfied, i.e. when control is
transferred to the customer.
The group’s net sales are currently not a
significant part of the business.
Government grants
Government grants are reported in the statement
of financial position and the statement of
comprehensive income when there is reasonable
assurance that the entity will comply with the
conditions attached to them and the grants will
be received. The grant is recognised as income
over the period necessary to match them with
and bonus, is expensed when the employees
perform the services.
Pension obligations
The group only has defined contribution pension
plans. In defined contribution plans, the group pays
fixed contributions to a separate entity and has
no legal or constructive obligation to pay further
contributions if this entity does not have sufficient
assets to pay all the remuneration to employees
connected with the employees’ service during
the current or prior periods. Therefore, the group
regarding contributions for defined contribution
plans, these are reported as an expense in the
consolidated profit/loss as the benefits are earned.
Incentive programs
There are four types of share-based incentive
programs in the group: two option programs for
employees, and two share awards programs for
certain board members. The option and share
awards have been granted free of charge and are
settled with equity instruments.
The fair value of share-based payments is
accounted for as personnel costs. The fair value
of options. For the share awards, the fair value is
determined at the time of allocation using a Monte
The cost is reported, along with a corresponding
increase in equity, during the period in which the
vesting conditions are fulfilled, up to and including
the date when the persons concerned are fully
entitled to the compensation.
The accumulated cost included in each reporting
period shows to what extent the vesting period has
been recognised with an estimate of the number of
share-related instruments that eventually will
be vested.
Social security contributions attributable to
share-related instruments to employees as
compensation for purchased services must
the related costs, for which they are intended to
compensate, on a systematic basis.
Leasing agreement
The group’s leasing portfolio consists of a few
operating leases for premises, which are the two
classes of leased assets presented by the group.
The leasing agreements are reported as contract
assets with a corresponding lease liability on the
day that the leased asset is available for use by the
group. Short-term leases and low value leases
are excluded.
Each leasing payment is divided between amor-
tization of the lease debt and financial cost. The
financial cost shall be distributed over the lease
period so that each accounting period is charged
with an amount corresponding to a fixed interest
rate for the liability reported during each period.
The leasing period is determined as the non-can-
cellable period together with both periods covered
by an option to extend the lease if the lessee is
and periods covered by an opportunity to terminate
the lease if the lessee is reasonably sure not to
exercise that option.
The group's leasing liabilities are recognized at
the present value of the group's future leasing fees.
Leasing payments have been discounted with the
group's marginal loan interest rate.
The group's contract assets are recognized at
cost and initially include the present value of the
or before the commencement date and initial direct
expenses. Recovery costs are included in the asset if
a corresponding provision regarding recovery costs
has been identified. The contract asset is amortized
on a straight-line basis over the shorter of the asset's
useful life and the duration of the lease.
Employee benefits
Short-term remuneration
Short-term remuneration to employees, such as
salary, social security contributions, holiday pay
be expensed over the periods during which the
services are performed. This cost must then be
calculated using the same valuation model that
was used when the options were issued. The pro-
vision made shall be reassessed at each reporting
date based on a calculation of the amount social
charges that may be payable when the instruments
are settled.
Financial income and expenses
Financial income
Financial income consists of capital gains on and
dividend incomes from financial fixed assets.
Dividend income is recognized when the right to
receive a dividend has been established.
Exchange rate gains and losses are reported net.
Financial costs
Financial costs consist mainly of interest expenses
on loans. Exchange rate gains and losses are
reported net.
Income taxes
Income taxes consist of current tax and deferred
tax. Income taxes are recognized in profit or loss
for the year, except when the underlying transac-
tion is recognized in other comprehensive income
or equity, in which case the tax effect is recognized
in other comprehensive income or equity.
Current tax
Current tax is the tax that must be paid or received
for the current year, with the application of the tax
rates that have been decided, or in practice decided,
on the balance sheet date. Current tax also includes
previous periods.
Deferred tax asset/tax liability
Deferred tax is reported in its entirety, according
to the balance sheet method and is based on
the temporary differences between the tax base
value of assets and liabilities and their carrying
41 | Annual Report 2021 Vicore Pharma Holding AB (publ)
account in consolidated goodwill or differences
attributable to participations in subsidiaries, which
are not expected to be taxed in the foreseeable
future. The valuation of deferred tax is based on
how underlying assets or liabilities are expected
to be realized or regulated. Deferred tax amounts
are calculated by applying the tax rates and tax
rules that have been decided or announced as of
the balance sheet date and which are expected to
apply when the deferred tax asset is realized or the
deferred tax liability is settled.
Deferred tax assets related to deductible
temporary differences and loss carry forwards are
only recognized to the extent it is probable that
these will be utilized.
The value of deferred tax assets is reduced when
-
lized. Deferred tax assets and deferred tax liabilities
are offset if there is a legal right to offset short-term
tax assets against short-term tax liabilities and the
deferred tax is attributable to the same entity in the
group and the same tax authority.
Earnings per share
Earnings per share before dilution are calculated
as profit or loss attributable to the parent company
shareholders divided by the weighted average
number of ordinary shares outstanding during
the period.
Earnings per share after dilution are calculated
as profit or loss attributable to the parent company
by the sum of the weighted average number of
ordinary shares and potential ordinary shares that
may give rise to dilution effects. A dilution effect
of potential ordinary shares is recognized only if
a translation into ordinary shares would lead to a
reduction of earnings per share after dilution.
Intangible assets
Acquired intangible assets
Intangible assets in the group consist of patents,
licenses and similar rights. They are valued at cost
that is decreased by accumulated depreciation and
any accumulated impairment losses.
An intangible asset is recognized if it is probable
that the asset will generate future economic
benefits for the group, the criteria for capitalization
are met and the costs can be measured reliably. An
intangible asset is valued at cost when it is included
for the first time in the financial report. Intangible
assets with finite useful lives are reported at cost
less depreciation and any impairment losses.
Intangible fixed assets with finite useful lives are
depreciated linearly over the asset’s estimated
useful life. Intangible assets with indefinite useful
lives are instead tested annually for impairment.
Intangible assets with finite and indefinite useful
lives are reviewed for impairment requirements in
cases where there are indications that a write-
down may be needed. The useful life of intangible
assets is reviewed at each balance sheet date and
Capitalization of development expenditure
The expenses that arise during the development
phase are capitalized as intangible assets when,
according to management’s assessment, they are
group, the criteria for capitalization are met and the
costs can be measured in a reliable way. Otherwise,
development expenses are expensed as normal
operating expenses.
The group only has acquired intangible assets.
Depreciation principles
Depreciation begins when the asset can be used, i.e.
when it is in the place and in the condition required to
be able to use it in the way management intends.
The estimated useful life for intangible fixed
assets with a finite useful life is 5 years. Depre-
ciation is made on a straight-line basis over the
estimated useful life of the asset, which coincides
with the remaining patent period for the product.
Tangible fixed assets
Tangible fixed assets are reported in the group at
cost after deductions for accumulated deprecia-
tion and any accumulated impairment losses. The
cost includes the purchase price and any costs
directly attributable to the asset to bring it in place
and in condition to be utilized in accordance with
the purpose of the acquisition.
The carrying amount of an asset is derecognized
from the balance sheet when disposing or
divesting, or when no future economic benefits
are expected from use or disposing/divesting of
the asset. Gains or losses arising from the sale
or disposal of an asset consist of the difference
between the selling price and the asset’s carrying
amount with the deduction of direct sales costs.
Gains and losses are reported as other operating
income/expenses.
Additional expenses
Additional expenses are added to the asset’s
carrying amount only if it is probable that the future
economic benefits associated with the asset will
be leveraged by the group and that the cost of the
asset can be measured reliably. All other additional
expenses are reported as an expense during the
period they arise. Repairs are expensed on an
ongoing basis.
Depreciation principles
The depreciable amount shall be allocated on a
systematic basis over the asset’s estimated useful
life. Used depreciation methods, residual values and
useful lives are reviewed at the end of each year.
The estimated useful lives are:
Equipment ...............................5 years
Impairment of non-financial assets
The group’s reported assets are assessed in cases
where there are indications of a decline in value of
tangible or intangible assets, i.e. whenever events
or changes in circumstances indicate that the fair
value is not recoverable. Furthermore, the group’s
impairment requirements until they are available
for use. This is done regardless of whether there
are indications of a decline in value or not.
An impairment is recognized when an asset’s
carrying amount exceeds its recoverable amount.
The recoverable amount is the higher of the asset’s
fair value less the cost of sale on the one hand
and the value in use on the other. When assessing
impairment, assets are grouped at the lowest
level where there are separate identifiable cash
flows (cash-generating units). When the need for
impairment has been identified for a cash-gener-
ating unit (group of units), the impairment amount
is distributed proportionally among the assets
included in the cash-generating unit (group of units).
A previously recognized impairment is reversed
if the recovery amount is deemed to exceed the
fair value. Reversal does not occur with an amount
that is greater than what the fair value would have
been recorded to if the impairment had not been
recognized in previous periods. Any reversals are
reported in the income statement.
Financial assets and liabilities
A financial asset or financial liability is recognized
in the balance sheet when the group becomes a
party according to the instrument’s contractual
terms. A financial asset is removed from the
balance sheet when the rights in the agreement
are realized, expire or when the group loses
control over them. The same applies to a part of
a financial asset. A financial liability is removed
from the balance sheet when the obligation in the
agreement is fulfilled or otherwise extinguished.
The same applies to a part of a financial debt.
Acquisitions and divestments of financial assets
are reported on the trade date. The trade date
to acquire or divest the asset.
Financial instruments are classified on initial
recognition, including on the basis of what
purpose the instrument was acquired and man-
aged. This classification determines the valuation
of the instruments.
42 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Classification and valuation of financial assets
The classification of financial assets that are debt
instruments, is based on the group’s business
model for managing the asset and the nature of the
asset’s contractual cash flows.
Assets are classified according to:
Amortized cost
Fair value through other comprehensive
income
The group’s financial assets that are classified
at amortized cost include accounts receivable,
certain other receivables, short-term investments,
and cash and cash equivalents. Financial assets
classified at amortised cost are initially measured
at fair value with the addition of transaction costs.
After initial recognition, the assets are valued at
amortized cost after a deduction of a loss reserve
for expected credit losses. Assets classified at
amortized cost are held according to the business
model to collect contractual cash flows, which are
solely payments of principal and interest on the
outstanding principal amount.
The group’s financial assets that are classified at
fair value through profit or loss relate to holdings in
listed and non-listed shares.
Impairment of financial assets
The group’s impairment model is based on
prospective information. A loss reserve is made
initial recognition for an asset or receivable.
Classification and valuation of financial liabilities
The group’s financial liabilities consist of accounts
payable and other current liabilities, which are all
classified at amortized cost. Financial liabilities
recognized at amortized cost are initially measured
at fair value including transaction costs. After the
initial recognition, they are valued according to the
effective interest method.
Cash and cash equivalents
Cash and cash equivalents consist of cash and
balances as well as immediately available credit
financial institutions.
Equity
All shares in the company are ordinary shares, which
are reported as equity. The share capital is reported
up to its quota value and any excess part is reported
as Other contributed capital. Transaction costs,
directly attributable to the issue of new ordinary
shares or options, are reported, net after tax, in
equity as a deduction from the issue proceeds.
Contingent liabilities
A contingent liability is recognised when there is a
possible commitment that arises from past events
and whose existence is confirmed only by one or
more uncertain future events, or when there is a
commitment that is not reported as a liability or
resources will be required.
Cash flow
Cash and cash equivalents consist of available
investments with an original maturity of less than
three months, which are exposed to insignificant
value fluctuation. Incoming and outgoing
payments are reported in the cash flow statement.
The cash flow statement has been prepared in
accordance with the indirect method.
Note 2 Judgements and
accounting estimates
The preparation of the financial statements in
accordance with IFRS requires company man-
estimates that affect the application of the
accounting policies and the carrying amounts of
assets, liabilities, revenue and expenses. The actual
outcome could deviate from these estimates.
The accounting estimates and assumptions are
evaluated continuously. Changes to the accounting
estimates are recognized in the period in which
the change is made if the change only has affected
the period, or in the period in which the change is
made and future periods if the change affects both
the current period and future periods.
Sources of uncertainty in the accounting
estimates
The sources of uncertainty in the accounting
a material extent during the forthcoming fiscal year,
include impairment testing of intangible assets
with indefinite useful lives.
Impairment testing of intangible assets
When impairment testing intangible assets, a num-
a recoverable amount. These assumptions
expected selling price for the company’s products
-
will pass the remaining stages of development.
The assumptions are based on industry- and
-
agement and reviewed by the Board of Directors.
For more information about impairment testing,
see Note 15 "Patent, licenses and similar rights".
Other judgments and accounting estimates
Capitalization of intangible assets
Development expenditures are capitalized when
they fulfill the criteria set out in IAS 38 and are
expected to represent material amounts for the
development initiative as a whole. Development
expenditures are otherwise expensed as normal
operating costs. The most important criteria
for capitalization are that the end product of the
earning capacity or cost savings and cash flow, and
that there are technical and financial preconditions
group only has acquired intangible assets. Since
regulatory approval has not yet been obtained, no
costs have been capitalized.
Research and development expenses
The company conducts research and development
with external collaboration partners, such as
clinical research organizations (CROs). The
company estimate the timing of the costs when
basis for settlement with the external collaboration
partner. An evaluation and update of the calculation
is performed monthly and forms the basis for
and development.
Incentive programs
The group has four active share-based long-term
incentive programs. The applicable accounting poli-
cies are described in Note 1 "Accounting principles".
The cost for the remuneration that is recognized in
a period is dependent on the original valuation that
was made on the contract date of with the holder
of the option/share award, the number of months
of service required by the participant for becoming
entitled to options (accruals are made over this
period), the number of options that are expected
to be vested by the participant under the terms of
the programs and a continuous reassessment of
the value of the tax benefits for the participants in
the incentive programs (for determining provisions
for social security contributions). Those estimates
which affect the cost in a period and the corre-
sponding increase in equity mainly refer to inputs
for the valuation of the options. The models used
a Monte Carlo simulation. Significant assumptions
in these valuations are described in Note 8 "Share-
based payments".
43 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Tax loss carryforwards
The group’s tax loss carryforwards have not been measured and are not recognized as a deferred tax
asset. These tax loss carryforwards will be measured valued only when the group has established a level
of earnings which management with confidence estimate will lead to taxable profits.
Not 3 Operating segments
Vicore does not divide its business into different operating segments. Instead the group’s entire business
is treated as one operating segment. This reflects the company’s internal organisation and reporting sys-
where the group’s tangible and intangible fixed assets are attributed.
Note 4 Operating expenses by
nature of expense
The total expenses classified by function are distributed in the following cost categories:
2021 2020
Other external expenses 256,517 129,249
Personnel expenses 33,304 34,221
Depreciation and amortization 3,598 3,537
Other operating expenses 2,492 721
Total 295,911 167,728
Note 5 Audit fees
Ernst & Young AB 2021 2020
Audit fees* 450 538
Other audit related services 92 47
Tax consultancy services 0 0
Other services 10 88
Total 552 673
advisory services provided in connection with the audit engagement.
Note 6 Leases
2021
Dec 31
2020
Dec 31
Contract assets
Premises 317 139
Total 317 139
Contract liabilities
Long-term 320 0
Short-term 0 140
Total 320 140
The following amounts related to leasing contracts are reported
in the consolidated statement of comprehensive income:
2021 2020
Leasing fees, short-term 1,066 817
Depreciation
Premises 239 175
Equipment 0 4
Interest 6 3
Total 1,311 999
The total cash flow related to leasing agreements was 245 KSEK (182 KSEK) for 2021. For information on
Note 7 Employees and personnel costs
Average number of
employees
2021 2020
No. of
employees
of which men/
women
No. of
employees
of which men/
women
Parent company 4 50%/50% 4 50%/50%
Subsidiaries 12 30%/70% 9 67%/33%
Group total 16 36%/64% 13 62%/38%
44 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Personnel costs for the Board of Directors, senior executives and
other employees 2021 2020
Group
The Board and other senior executives
Salaries and other remuneration 17,898 12,273
Social security contributions -120 7,364
Pension costs 3,046 1,690
20,824 21,327
Group
Other employees
Salaries and other remuneration 9,048 9,496
Social security contributions 744 1,879
Pension costs 2,239 1,154
12,031 12,529
Group
Other personnel costs 449 365
449 365
Total personnel costs 33,304 34,221
Parent company
The Board and other senior executives
Salaries and other remuneration 9,813 10,245
Social security contributions -2,154 6,730
Pension costs 1,508 1,407
9,167 18,382
Parent company
Other employees
Salaries and other remuneration 906 592
Social security contributions 277 203
Pension costs 72 90
1,255 885
Parent company
Other personnel costs 226 90
226 90
Total personnel costs 10,648 19,357
Senior executives include members of the Board of Directors, the CEO and other senior executives.
Salaries and other remuneration
Costs related to the long-term incentive programs amounts to 3,862 KSEK (2,632 KSEK) of the payroll
expenses and -5,425 KSEK (5,602 KSEK) of the social security contributions.
Pensions
All pension plans in the group are defined contribution plans. The group’s total cost for defined
contribution plans amounted to 5,285 KSEK (2,844 KSEK).
Gender breakdown among senior executives
2021
Dec 31
2020
Dec 31
Group
Proportion of women on the Board 33% 29%
Proportion of men on the Board 67% 71%
Proportion of women among other senior executives 50% 43%
Proportion of men among other senior executives 50% 57%
Parent company
Proportion of women among other senior executives 25% 33%
Proportion of men among other senior executives 75% 67%
Information regarding remuneration to the Board and other senior executives
2021
Basic
salary,
board fee*
Pension
costs
Variable
remuneration
Share-
based
payments
Other
remuneration Total
Chairman of the Board
Michael Wolff Jensen 450 0 0 730 50 1 230
Members of the Board
Jacob Gunterberg 150 0 0 0 125 275
150 0 0 142 50 342
Maarten Kraan 150 0 0 142 75 367
Sara Malcus 150 0 0 108 50 308
Heidi Hunter 150 0 0 365 50 565
Senior executives
CEO 2,753 745 261 431 0 4,190
Other senior executives** 9,484 2,301 753 1,287 0 13,825
Total 13,437 3,046 1,014 3,205 400 21,102
** For more information, see "Remuneration for senior executives" below.
45 | Annual Report 2021 Vicore Pharma Holding AB (publ)
2020
Basic
salary,
board fee*
Pension
costs
Variable
remuneration
Share-
based
payments
Other
remuneration Total
Chairman of the Board
Michael Wolff Jensen 300 0 0 692 25 1,017
Members of the Board
Jacob Gunterberg 100 0 0 0 100 200
100 0 0 126 75 301
Maarten Kraan 100 0 0 126 75 301
100 0 0 51 0 151
Sara Malcus 100 0 0 51 50 201
Heidi Hunter 100 0 0 346 50 496
Senior executives
CEO 2,540 697 787 343 0 4,367
Other senior executives** 4,582 993 938 536 0 7,049
Total 8,022 1,690 1,725 2,272 375 14,084
** For more information, see "Remuneration for senior executives" below.
Share-based payments
Share-based payments refer to share awards and options granted to independent directors, the CEO,
other senior executives, and other employees. Each vested share award entitles the holder to receive one
share in the company, provided that the holder is still a member of the Board of Directors of the company
at the relevant time of vesting. Each option entitles the holder to acquire one share in the company for
options shall be vested on the third anniversary of the granting date, provided that the holder, with some
customary exceptions is still employed by the company. The participants in the programs have received
the share awards / options free of charge. For further information about the incentive programs, see Note
8 "Share-based payments".
Other remuneration
Remuneration for senior executives
Remuneration of the CEO and other senior executives consists of, in accordance with the guidelines for
remuneration decided by the shareholder's meeting in 2021, basic salary, pension benefits, bonus and
executives refer to the individuals who, together with the CEO, constitute the group management. During
the period January 1, 2020, to November 2, 2020, other senior executives refer to the Chief Financial
November 3, 2020, other senior executives refer to the Chief Financial Officer, Chief Medical Officer, Chief
Scientific Officer, VP Clinical Development, Head of Preclinical Development, and Chief Administrative
Officer. During 2021, the group of other senior executives was expanded as follows: Head of Digital
Therapeutics (July 1, 2021), Chief Commercial Officer (October 2, 2021) and Head of Business Develop-
ment (November 8, 2021).
The CEO has a period of notice of six months in the event the termination is made by the group or if
the CEO resigns. Other senior executives have a period of notice of three to six months, in the event the
termination is made by the group or if the senior executive resigns.
In addition to salary during the termination period, the CEO is entitled to a termination benefit
corresponding of six months’ salary in the event of termination by the company on a basis other than
a breach of contract.
Note 8 Share-based payments
The purpose of share-based incentive programs is to promote the company’s long-term interests by
interests of the shareholders. As of December 31, 2021, Vicore has four active incentive programs that
include the management team, other employees and certain board members. For more information,
see below.
Long-term incentive programs 2018
The Extra General Meeting in Vicore held on August 13, 2018, resolved, in accordance with the Board of
Directors’ proposal, to adopt a long-term incentive program for certain of the company’s senior manage-
(Board LTIP 2018) may be allotted to participants under the program. Of these, a total of 1,325,800 options
and 475,000 share awards have been allocated. The increase in the company’s share capital in full utiliza-
tion of both incentive programs amounts to a maximum of approximately SEK 1,237,500, corresponding
to a dilution of approximately 3,3 percent of the total number of shares. The options and share awards
have been granted to the participants of the incentive programs free of charge and the settlement is made
with equity instruments.
Board LTIP 2018
Board LTIP 2018 is a program under which the participants will be granted, free of charge, share awards
accordance with the principles stipulated below, however a maximum of 475,000 shares.
Board LTIP 2018 is intended for members of the Board of Directors of the company independent from
the main owners. The main owners believe that an equity-based incentive program is a central part of an
competent members of the Board of Directors of the company, and to focus the participants on delivering
exceptional performance which contributes to value creation for all shareholders.
to three terms until the day of publication of the interim report for the second quarter of 2021. The share
awards shall be vested by 1/3 at the end of each term, provided that the participant is still a member of the
46 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Board of Directors of the company on said date. In
based on the development of the company’s share
price, in accordance with the vesting conditions
below.
vesting based on the development of the compa-
ny’s share price over the period from the date of 13
August, 2018, up to and including the date of the
annual general meeting 2021. The development
of the share price will be measured based on the
volume weighted average price of the share price
will be measured based on the volume weighted
average price of the company’s share price for the
30 trading days immediately following after 17
August, 2018, and the 30 trading days immediately
preceding the date of the publication of the interim
report for the second quarter 2021. In the event the
price of the company’s share has thereby increased
by more than 150 percent, 100 percent of the share
awards shall vest, and should the share price have
increased by 50 percent, 25 percent of such share
awards shall vest. In the event of an increase of the
share price between 50 and 150 percent, vesting
of the share awards will occur linearly. Should the
increase of the share price be less than 50 percent,
no vesting will occur. The earliest date at which
accrued share awards may be exercised is the date
of publication of the interim report for the second
quarter of 2021.
The valuation of the share awards is based on
a Monte Carlo simulation in accordance with
accepted valuation theory. Volatility has been
based on the expected volatility of the Vicore share
and other listed companies with similar operations.
an interpolation between a 2-year and 5-year
government bond, respectively. The fair value of the
share awards at the time of allocation amounts to
SEK 4.70 per share award. In order to calculate the
value of the share awards in relation to the current
performance conditions, a starting value is used
that corresponds to the volume-weighted average
price paid for the Vicore share over a fixed period,
which in this case corresponds to the value of the
underlying share at the time of valuation.
During the third quarter of 2021, Board LTIP 2018
expired. As the share price increased by less than 50
percent during the measurement period no share
awards were earned. The program is now closed.
Co-worker LTIP 2018
intended for members of senior management
the program participants will be granted, free of
entitle to acquire a maximum of 2,000,000 shares
in the company in total, in accordance with the
terms stipulated below.
The Board of Directors of the company believes
that an equity-based incentive program is a central
part of an attractive and competitive remuneration
competent members of senior management and
-
ipants on delivering exceptional performance which
contributes to value creation for all shareholders.
under which the participants will be granted
options free of charge. The Board of Directors shall
resolve upon the allocation of options annually
or at such time as the Board of Directors can be
considered as relevant to such decision (with each
respective date of granting being a “granting date”).
Each option entitles the holder to acquire one share
in the company for a predetermined exercise price.
The exercise price per share shall correspond
to 150 percent of the volume weighted average
price of the company’s share for the five trading
days preceding the granting date. The options are
all options shall be vested on the third anniversary
of the granting date, provided that the holder, with
some customary exceptions is still employed by
the company. The latest point in time at which
vested options may be exercised shall be the fourth
anniversary of the granting date.
The options are valued according to the so-called
of the options depends, among other things, on the
value of the underlying share, the options’s issue
The volatility has been based on the expected vola-
tility of the Vicore share and other listed companies
was equated with the interest rate for Swedish
government bonds. The fair value of the options at
the time of allocation during 2020 amounts to SEK
inputs have been used in the model:
2020
Underlying share price 18.85 SEK
Excercise price 29.25 SEK
Expected volatility 45.00 %
Option life 4 years
Expected dividends 0 SEK
-0.35 %
Long-term incentive program 2020
The Annual General Meeting in Vicore Pharma
Holding AB held on May 20, 2020, resolved, in
accordance with the proposal from the Nomination
Committee, to adopt a long-term incentive program
for the new members of the Board of Directors
(“Board LTIP 2020”) in Vicore Pharma Holding
AB. A maximum of 525,000 share awards may be
allotted to participants in the program Board LTIP
2020. The increase in the company’s share capital,
assuming full utilization, amounts to a maximum
of approximately SEK 262,500, corresponding to
a dilution of 0.7% of the total number of shares.
be issued pursuant to previously implemented
incentive programs in the company, the maximum
dilution amounts to 3.4% on a fully diluted basis.
Board LTIP 2020
Board LTIP 2020 is a program under which the
participants will be granted, free of charge, share
awards”) that entitle to shares in the company to
be calculated in accordance with the principles
stipulated below, however a maximum of
525,000 shares.
Board LTIP 2020 is intended for the newly
elected, main owner independent, members of the
Board of Directors in the company. The Nomi-
nation Committee believes that an equity-based
incentive program is a central part of a competitive
motivate internationally competent members of
the Board of Directors, and to focus the partici-
pants on delivering exceptional performance which
contributes to value creation for all shareholders.
The share awards shall vest gradually over
approximately three years, corresponding to three
terms up to the date of, whichever is earliest, (i)
the Annual General Meeting 2023 or (ii) June 1,
2023 (”vesting date”), where each term equals the
period from one Annual General Meeting up until
the day falling immediately prior to the next Annual
General Meeting or the vesting date, as applicable
(each such period a “term”). The share awards shall
vest by 1/3 at the end of each term, provided that
the participant is still a member of the Board of
Directors of the company on said date. In addition
on the development of the company’s share price,
in accordance with the vesting conditions below.
vesting based on the development of the compa-
ny’s share price over the period from the date the
share awards are allocated (”grant date”) up to
and including the vesting date. The development
of the share price will be measured based on the
volume weighted average price of the company’s
immediately following the grant date and the 30
trading days immediately preceding the vesting
date, respectively. In the event the price of the com-
pany’s share has thereby increased by more than
150 percent, 100 percent of the share awards shall
vest, and should the share price have increased by
50 percent, 25 percent of the share awards shall
vest. In the event of an increase of the share price
47 | Annual Report 2021 Vicore Pharma Holding AB (publ)
between 50 and 150 percent, vesting of the share
awards will occur linearly. Should the increase of
the share price be less than 50 percent, no vesting
will occur. The earliest point in time at which vested
share awards may be exercised shall be the day
falling immediately after the vesting date.
The valuation of the share awards is based on
a Monte Carlo simulation in accordance with
accepted valuation theory. Volatility has been
based on the expected volatility of the Vicore share
and other listed companies with similar operations.
an interpolation between a 2-year and 5-year
government bond, respectively. The fair value of the
share awards at the time of allocation amounts to
SEK 5.18 per share award. In order to calculate the
value of the share awards in relation to the current
performance conditions, a starting value is used
that corresponds to the volume-weighted average
price paid for the Vicore share over a fixed period,
which in this case corresponds to the value of the
underlying share at the time of valuation.
Long-term incentive programs 2021
The Annual General Meeting in Vicore Pharma
Holding AB held on May 11, 2021, resolved to
implement a long-term incentive program for sen-
term performance-based incentive program for
independent board members in the company who
are not participants in Board LTIP 2020 (“Board
LTIP 2021”). A maximum of 3,000,000 options
(Board LTIP 2021) may be allotted to participants in
the programs. The increase in the company’s share
capital, assuming full utilization of both incentive
programs, amounts to a maximum of approxi-
mately SEK 1,530,887, corresponding to a dilution
of approximately 4.1 percent of the total number of
may be issued pursuant to previously implemented
of the share price will be measured based on the
volume weighted average price of the company’s
immediately following the grant date and the 30
trading days immediately preceding the vesting
date, respectively. In the event the price of the com-
pany’s share has thereby increased by more than
80 percent, 100 percent of the share awards shall
vest, and should the share price have increased by
40 percent, 25 percent of the share awards shall
vest. In the event of an increase of the share price
between 40 and 80 percent, vesting of the share
awards will occur linearly. Should the increase of
the share price be less than 40 percent, no vesting
will occur. The earliest point in time at which vested
share awards may be exercised shall be the day
falling immediately after the vesting date.
The valuation of the share awards is based on
a Monte Carlo simulation in accordance with
accepted valuation theory. Volatility has been
based on the expected volatility of the Vicore share
and other listed companies with similar operations.
an interpolation between a 2-year and 5-year
government bond, respectively. The fair value of
the share awards at the time of allocation amounts
to SEK 10.99 per share award. In order to calculate
the value of the share awards in relation to the
current performance conditions, a starting value
is used that corresponds to the volume-weighted
average price paid for the Vicore share over a fixed
period, which in this case corresponds to the value
of the underlying share at the time of valuation.
Co-worker LTIP 2021
intended for members of senior management
the program participants will be granted, free of
entitle to acquire a maximum of 3,000,000 shares
in the company in total.
incentive programs in the company, the maximum
dilution amounts to approximately 7.2 percent on a
fully diluted basis.
Board LTIP 2021
Board LTIP 2021 is a program under which the
participants will be granted, free of charge, share
to shares in the company to be calculated in
accordance with the principles stipulated below,
however a maximum of 61,773 shares.
Board LTIP 2021 is intended for independent
board members in the company who are not
participants in Board LTIP 2020. The Nomination
Committee believes that an equity-based
incentive program is a central part of a competitive
motivate internationally competent members of
the Board of Directors, and to focus the partici-
pants on delivering exceptional performance which
contributes to value creation for all shareholders.
The share awards shall vest gradually over
approximately three years, corresponding to three
terms up to the date of, whichever is earliest, (i)
the Annual General Meeting 2024 or (ii) June 1,
2024 (”vesting date”), where each term equals the
period from one Annual General Meeting up until
the day falling immediately prior to the next Annual
General Meeting or the vesting date, as applicable
(each such period a “term”). The share awards shall
vest by 1/3 at the end of each term, provided that
the participant is still a member of the Board of
Directors of the company on said date. In addition
on the development of the company’s share price,
in accordance with the vesting conditions below.
vesting based on the development of the compa-
ny’s share price over the period from the date the
share awards are allocated (”grant date”) up to
and including the vesting date. The development
The Board of Directors of the company believes
alignment of the interests of the participants and
2021 is adapted to the current position and needs
of the company. The Board of Directors is of the
and strengthen the participants’ dedication to the
company’s operations, improve company loyalty
both the shareholders and the company.
participants will be granted, free of charge, options.
The Board of Directors shall annually resolve upon
the allocation of options no later than the day falling
three years after the Annual General Meeting 2021
(with each respective date of granting being a “grant
date”). Each Option entitles the holder to acquire
one share in the company for a pre-determined
exercise price. The exercise price shall correspond
to 125 percent of the volume weighted average price
the five trading days preceding the grantdate. The
options shall vest over a three-year period with one
third each year on the anniversary of the grant day,
whereby all options shall vest on the third anni-
versary of the grant date, provided that the holder,
with some customary exceptions, still is employed
by the company. The latest point in time at which
vested options may be exercised shall be the fifth
anniversary of the grant date.
The options are valued according to the so-called
of the options depends, among other things, on the
value of the underlying share, the options’s issue
The volatility has been based on the expected
volatility of the Vicore share and other listed
interest rate was equated with the interest rate for
48 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Swedish government bonds. The fair value of the options at the time of allocation during 2021 amounts to
SEK 8.45 per option. The following inputs have been used in the model:
2021
Underlying share price 20.00 SEK
Excercise price 26.48 SEK
Expected volatility 50.00 %
Option life 5 år
Expected dividends 0 SEK
0.10 %
Summary of issued share awards and options
2021 2020
Issued share awards (Board LTIP
2018)
Average
exercise price
per share award
Number
of share
awards
Average
exercise price
per share award
Number
of share
awards
At January 1 0 433,333 0 475,000
Forfeited/expired during the year 0 -433,333 0 -41,667
At December 31 0 0 0 433,333
A total of 433,333 share awards have expired during the year.
2021 2020
Issued share awards (Board LTIP
2020)
Average
exercise price
per share award
Number
of share
awards
Average
exercise price
per share award
Number
of share
awards
At January 1 0 525,000 0 0
Granted during the year 0 0 0 525,000
At December 31 0 525,000 0 525,000
No share awards have been exercised, forfeited or expired during the year.
2021
Issued share awards (Board LTIP 2021)
Average exercise price
per share award Number of share awards
At January 1 0 0
Granted during the year 0 61,773
At December 31 0 61,773
No share awards have been exercised, forfeited or expired during the year.
2021 2020
Issued options (Co-worker LTIP
2018)
Average
exercise price
per option
Number of
options
Average
exercise price
per option
Number of
options
At January 1 27.48 1,239,600 25.81 765,800
Granted during the year 0 0 29.25 560,000
Forfeited during the year 0 0 25.99 -86,200
At December 31 27.48 1,239,600 27.48 1,239,600
No options have been exercised, forfeited or expired during the year.
2021
Issued options (Co-worker LTIP 2021)
Average exercise price
per option Number of options
At January 1 0 0
Granted during the year 26.26 807,600
At December 31 26.26 807,600
No options have been exercised, forfeited or expired during the year.
Outstanding share awards and options at year-end
Dec 31, 2021 Dec 31, 2020
Program per year
Date of
expiration
Exercise
price
Share awards/
options
Vested
(%)
Share awards/
options
Vested
(%)
Program share awards
(Board LTIP 2018)
September,
2021
0 - - 433,333 92%
Program share awards
(Board LTIP 2020)
Annual Gen-
eral Meeting
2023
0 525,000 78% 525,000 38%
Program share awards
(Board LTIP 2021)
Annual Gen-
eral Meeting
2024
0 61,773 38% - -
Program 2018 options
September 27,
2022
25.26 283,333 100% 283,333 93%
Program 2019 options
September 27,
2023
26.17 396,267 92% 396,267 71%
Program 2020 options
September 24,
2024
29.25 560,000 68% 560,000 15%
Program 2021 options
September 16,
2026
26.26 807,600 15% - -
The costs for social security contributions related to share-based incentive programs varies from quarter
to quarter due to the change in the underlying share price. Related provisions are reported as non-current
liabilities. Total IFRS 2-classified payroll expenses for the incentive programs for the entire duration of the
programs amount to 9,779 KSEK. The total costs for the share-based incentive programs for each year is
presented below. These costs have had no cash impact.
49 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Summary of the total cost of the incentive programs
2021 2020
3,862 2,632
Provisions for social security contributions -5,425 5,602
Total -1,563 8,234
Summary of allotted options and share awards
Program 2018
share awards
(Board LTIP
2018)
2021 2020
Number
outstanding
at Jan 1,
2021
Granted/
forfeited
Number
outstanding
at Dec 31,
2021
Number
outstanding
at Jan 1,
2020
Granted/
forfeited
Number
outstanding
at Dec 31,
2020
Former chairman
of the Board Leif
Darner
83,333 -83,333 0 125,000 -41,667 83,333
Member of the
125,000 -125,000 0 125,000 0 125,000
Member of the
Board Maarten
Kraan
125,000 -125,000 0 125,000 0 125,000
Member of the
50,000 -50,000 0 50,000 0 50,000
Member of the
Board Sara Malcus
50,000 -50,000 0 50,000 0 50,000
Total 433,333 -433,333 0 475,000 -41,667 433,333
Program 2020
share awards
(Board LTIP
2020)
2021 2020
Number
outstanding
at Jan 1,
2021
Granted/
forfeited
Number
outstanding
at Dec 31,
2021
Number
outstanding
at Jan 1,
2020
Granted/
forfeited
Number
outstanding
at Dec 31,
2020
Chairman of the
Board Michael Wolff
Jensen
350,000 0 350,000 0 350,000 350,000
Member of the
Board Heidi Hunter
175,000 0 175,000 0 175,000 175,000
Total 525,000 0 525,000 0 525,000 525,000
Program 2021
share awards
(Board LTIP
2021)
2021
Number
outstanding
at Jan 1,
2021
Granted/
forfeited
Number
outstanding
at Dec 31,
2021
Member of the
0 20,591 20,591
Member of the
Board Maarten
Kraan
0 20,591 20,591
Member of the
Board Sara Malcus
0 20,591 20,591
Total 0 61,773 61,773
Program 2018,
2019 and 2020
options (Co-wor-
ker LTIP 2018)
2021 2020
Number
outstanding
at Jan 1,
2021
Granted/
forfeited
Number
outstanding
at Dec 31,
2021
Number
outstanding
at Jan 1,
2020
Granted/
forfeited
Number
outstanding
at Dec 31,
2020
CEO Carl-Johan
Dalsgaard
300,000 0 300,000 200,000 100,000 300,000
Other senior
executives
703,750 0 703,750 337,500 366,250 703,750
Other employees 235,850 0 235,850 228,300 7,550 235,850
Total 1,239,600 0 1,239,600 765,800 473,800 1,239,600
Program 2021
options (Co-wor-
ker LTIP 2021)
2021
Number
outstanding
at Jan 1,
2021
Granted/
forfeited
Number
outstanding
at Dec 31,
2021
CEO Carl-Johan
Dalsgaard
0 100,000 100,000
Other senior
executives
0 436,000 436,000
Other employees 0 271,600 271,600
Total 0 807,600 807,600
For information about other senior executives, see Note 7 "Employees and personnel costs".
50 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 9 Other operating income
2021 2020
Exchange rate gains 1,094 654
Grants received 0 17,536
Total other operating income 1,094 18,190
Note 10 Other operating expenses
2021 2020
Exchange rate losses 2,492 721
Total other operating expenses 2,492 721
Note 11 Financial income
2021 2020
Financial assets measured at fair value through prot and loss
Change in value for long-term investments 0 1,414
Total 0 1,414
Financial assets measured at amortized cost
Interest income short-term investments 646 815
Total interest income calculated using the effective interest method 646 815
Total disclosed in net nancial income/expenses 646 2,229
Note 12 Financial expenses
2021 2020
Financial assets measured at fair value through prot and loss
Change in value for long-term investments -2,121 0
Exchange rate losses currency accounts -431 0
Total -2,552 0
Financial liabilities measured at amortized cost
-11 -6
Total interest expenses calculated using the effective interest method -11 -6
Total disclosed in net nancial income/expenses -2,563 -6
Not 13 Tax
2021 2020
Current tax 0 0
Change in deferred tax regarding temporary differences 254 453
Recognized tax 254 453
Reconciliation of effective tax rates 2021 2020
Loss before tax -296,735 -147,315
Tax according to applicable tax rate 20.6% (21.4%) 61,127 31,525
Non-deductable expenses -95 -1,309
Tax effect non-taxable income 1,118 0
Tax effect unrecognized tax assets -61,896 -30,216
Change in deferred tax 254 453
Recognized tax 254 453
Effective tax rate 0% 0%
The group has no tax items that are recognized in other comprehensive income, but there are issue costs
Information about deferred tax assets and tax liabilities
In the table below, the tax effect of the temporary differences is specified:
Deferred tax liability
2021
Dec 31
2020
Dec 31
Intangible assets 1,026 1,411
Tax provision for pension premium 184 120
Carrying amount 1,210 1,531
Deferred tax asset
Provision for pension premium 0 131
Carrying amount 0 131
Tax loss carryforwards
Tax loss carryforwards for which deferred tax assets have not been recognized in the balance sheet
amounted to 729,828 KSEK (414,472 KSEK). These carryforwards have no time limit. Deferred tax assets
them to offset future taxable profits. For further information about tax loss carryforwards, see Note 2
"Judgements and accounting estimates".
51 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 14 Earnings per share
Earnings per share before and after dilution 2021 2020
-296,480,577 -146,861,265
Average number of ordinary shares 69,678,461 54,249,185
Earnings per share before and after dilution -4.25 -2.71
average number of ordinary shares outstanding for the dilution effect from all potential ordinary shares.
These potential ordinary shares are attributable to the options and share awards allocated to senior execu-
tives, other employees and certain board members during the years 2018-2021. For further information,
see Note 8 "Share-based payments". If there is a loss for the year, the options are not treated as dilutive.
Neither are the options considered dilutive if the exercise rate, including the addition of the value of
remaining future services to be recognized during the vesting period, exceeds the average trading price
for the period. There is no dilution effect for potential ordinary shares as there was a loss for the year, as
demonstrated above.
For more information about the changes of the number of outstanding shares, see Note 24 "Sharehold-
ers’ equity".
Note 15 Patents, licenses and similar rights
2021
Dec 31
2020
Dec 31
Opening cost 75,192 69,192
Additions for the year 0 6,000
Closing accumulated cost 75,192 75,192
Opening amortizations -4,437 -1,110
Amortizations for the year -3,328 -3,327
Closing accumulated amortizations -7,765 -4,437
Closing carrying amount 67,427 70,755
Amortizations
Amortization refers to previously acquired intangible assets. This consists of a patent portfolio related to
C21, whose main patent expires in the United States in September 2024. Amortization began in Septem-
ber 2019 and is amortized over its estimated useful life, which is the remaining patent period. Amortization
has not yet begun for the group's other intangible assets.
Impairment testing
model based on fair value. The value in use for VP01, VP02 and VP02 is determined by calculating the
does not involve calculation of any residual value thereafter. The methodology used is an accepted one for
impairment testing within the biopharmaceutical industry. The measurement is attributed to Level 3 in the
fair value hierarchy and comprises the material assumptions specified below:
Revenue- and cost forecasts for VP01 stretches over 7 years for the US and 10 years for the EU and
Revenue- and cost forecasts for VP02 and VP03 stretches over 20 years.
Revenue is calculated using estimations based on available data of different types considered indica-
and assessed price level is derived from secondary sources, accepted industry assumptions and
assumptions made by Vicore.
Vicore’s business plan. Operating margins are derived from secondary sources, accepted industry
assumptions and assumptions made by Vicore.
-
VP01 is estimated at 25.6%, VP02 at 7.2% (8.9%), and VP03 at 15.3% (10.0%).
The weighted average pre-tax cost of capital has been estimated at 14% (15%).
altogether. Where appropriate, the valuation has been calibrated against completed share issues with
external investors.
The impairment assessment for December 31, 2021, has not demonstrated a need for any impairments.
No reasonable changes in the assumptions and estimates made would lead to an impairment.
Note 16 Equipment
2021
Dec 31
2020
Dec 31
Opening cost 147 147
Additions for the year 0 0
Sales/disposals 0 0
Closing accumulated cost 147 147
Opening depreciations -34 -4
Depreciations for the year -29 -30
Sales/disposals 0 0
Closing accumulated depreciations -63 -34
Closing carrying amount 84 113
52 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 17 Long-term investments
2021
Dec 31
2020
Dec 31
Opening carrying amount 7,530 6,116
-2,121 1,414
Closing carrying amount 5,409 7,530
Vicore holds 91,829 shares in I-Tech AB (publ), which are classified as long-term investments.
Note 18 Financial assets and liabilities
Financial assets and liabilities at December 31, 2021
Financial assets/ liabilities
measured at fair value
through profit and loss
Financial assets/
liabilities measured
at amortized cost
Total
carrying
amount
Financial assets
Long-term investments 5,409 0 5,409
Other current receivables 0 60 60
Accrued income 0 281 281
Short-term investments 0 77,000 77,000
Cash and cash equivalents 0 294,199 294,199
Total 5,409 371,540 376,949
Financial liablilities
Contract liability 0 320 320
Trade payables 0 23,984 23,984
Accrued expenses 0 35,311 35,311
Total 0 59,615 59,615
the table above The group has not received any pledged assets for the financial net assets.
Financial assets and liabilities at December 31, 2020
Financial assets/ liabilities
measured at fair value
through profit and loss
Financial assets/
liabilities measured at
amortized cost
Total
carrying
amount
Financial assets
Long-term investments 7,530 0 7,530
Other current receivables 0 3,783 3,783
Accrued income 0 3,151 3,151
Short-term investments 0 70,118 70,118
Cash and cash equivalents 0 248,618 248,618
Total 7,530 325,670 333,200
Financial liablilities
Contract liability 0 140 140
Trade payables 0 10,943 10,943
Accrued expenses 0 21,843 21,843
Total 0 32,926 32,926
the table above The group has not received any pledged assets for the financial net assets.
Fair value measurement
IFRS 13, Fair Value Measurement contains a valuation hierarchy regarding inputs to the measurements.
This measurement hierarchy is divided into three levels, which comprise:
Level 1 -
Level 2 - Inputs other than quoted prices included within level 1 that are observable for the asset or liability,
either directly (that is, as price quotations) or indirectly (that is, derived from price quotations)
Level 3 - -
able inputs)
Long-term investments
Investments in financial fixed assets are measured at fair value with changes in value in profit and loss.
Investments in listed shares are measured at fair value according to Level 1 in the valuation hierarchy.
Listed investments are measured on the basis of their share price on the closing day.
Other financial assets and liabilities
For other current receivables and liabilities, short-term investments, cash and cash equivalents, trade
payables, and accrued income and expenses with a short maturity, the carrying amount is considered a
reasonable estimate of the fair value.
53 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 19 Financial risks
Through its operations, Vicore is exposed to
-
potentially unfavorable consequences for the
group’s financial position and performance.
The Board of Directors has overall responsibility
and transactions are managed centrally by the
parent company through the group’s CFO and
cash management, to ensure that all payment
commitments are processed at the right time, to
ensure that all financial transactions are organized
in a way that supports the group in achieving the
are reduced to an acceptable level.
The Board of Directors establishes written
and the handling of excess liquidity. The group
does not currently use derivatives, but allows
hedging of currency in certain situations.
Credit risk
of a financial instrument cannot fulfill its obligation
and thereby causes a financial loss for the group.
Given the nature of the group’s business, with no
issue at this stage of the company’s development.
management, which is managed through Vicore’s
treasury policy.
Foreign exchange risk
of or future cash flow from a financial instrument
may vary due to changes in foreign exchange rates.
-
ations in exchange rates will have a negative impact
on the group’s P&L, balance sheet or cash flow.
Transaction currency risk
The main exposure derives from the group’s
expenses in foreign currencies. This exposure is
referred to as transaction exposure. The company's
development costs for VP01 are mainly paid
within Sweden and the eurozone, such as fluctua-
tions where the exchange rate changes from the
time an agreement is entered into until its payment
is to be made in accordance with the agreement.
Foreign exchange hedging is decided by the Board
of Directors based on cash flow forecasts. In
accordance with the company's policy for financial
60-100% of expected flows. See the table below for
the level of exposure in each currency.
Operating
income
Operating
expenses
Foreign exchange
exposure 2021 (%)
GBP 100% 7%
EUR - 52%
DKK - 2%
USD - 2%
SEK - 37%
Foreign exchange
exposure 2020 (%)
GBP 100% 21%
EUR - 27%
DKK - 6%
USD - 1%
SEK - 45%
Operating expenses in the table above are
excluded from payroll expenses.
Financial credit risk
The financial assets that are covered by provi-
sions for expected credit losses according to
the general method consist of cash and cash
equivalents. Vicore applies a rating-based method
credit losses. The group has defined default as
when payment of the claim is 90 days overdue or
more, or if other factors indicate a suspension of
not been considered to exist for any receivable or
asset on the reporting date. Such assessment is
based on whether payment is 30 days overdue or
more, or if significant deterioration of the rating
occurs, entailing a rating below investment grade.
In cases where the amounts are not deemed to be
insignificant, a provision for expected credit losses
is also recognized for these financial instruments.
The assessment has been made that there has
the group’s financial assets. There counterparties
do not have credit ratings, except for cash and cash
equivalents where the counterparties have credit
Market risks
cash flows of a financial instrument will fluctuate
according to IFRS divided into three types: foreign
the greatest impact on the group as the financing
received shall cover for research and development
costs mainly in foreign currencies.
The group does not currently have any loans
may occur in short term cash management, and is
regulated by maximum maturities.
from investments in listed shares. However, the
been considered to be significant.
As indicated in the table above, the group’s main
transaction exposure consists of EUR (EUR and
GBP in 2020). A 10% stronger EUR and GBP against
SEK would have a negative impact on the profit
after tax and shareholders’ equity by approximately
14,191 KSEK (4,112 KSEK).
Refinancing risk
cash equivalents are unavailable and that financing
can only be obtained partially, not at all or at an
elevated cost. Currently, the group is financed by
shareholders’ equity and is therefore not exposed
equity investments from Vicore’s shareholders.
Liquidity risk
-
ter difficulties in fulfilling its obligations related to
financial liabilities. The Board of Directors manage
of the group.
Vicore uses rolling forecasts to ensure that
the company has sufficient cash assets to meet
its operational requirements. This monitoring
outcomes and forecasts are compared with the
budget that is produced and approved by the Board
each year.
Surplus liquidity in Vicore, in excess of what is
is invested in interest-bearing current accounts.
At the balance sheet date, Vicore had short-term
investments in twelve-month fixed-rate accounts
of 77,000 KSEK (70,000 KSEK). In addition to
(248,618 KSEK) at the balance sheet date.
54 | Annual Report 2021 Vicore Pharma Holding AB (publ)
The group’s contractual and undiscounted interest payments and financial liability repayments are
shown in the table below. Amounts in foreign currencies have been translated into SEK at the closing
rate on the reporting date. Financial instruments with a variable interest rate have been calculated using
the interest rate at the reporting date. Liabilities have been included in the earliest period during which
repayment may be required.
Dec 31, 2021
<1 month 1-3 months >3 months
Maturity analysis
Contract liability 21 42 257
Trade payables 23,785 198 0
Accrued expenses 0 13,934 21,377
Total 23,806 14,174 21,634
Dec 31, 2020
<1 month 1-3 months >3 months
Maturity analysis
Contract liability 24 72 44
Trade payables 10,919 24 0
Accrued expenses 28 21,815 0
Total 10,971 21,911 44
Capital management
The group’s goals regarding the capital structure are to ensure financing of the company’s development
and business plan. Equity or financing related to equity is expected to be the most realistic and possible
alternative in the near future.
No change occurred in the group’s capital management during the year. None of the group companies
Note 20 Prepaid expenses and accrued income
2021
Dec 31
2020
Dec 31
Prepaid rental charges 214 135
Prepaid insurances 591 0
Prepaid research and development expenses 3,123 0
Accrued income 0 3,151
Other prepaid expenses 1,106 471
Total 5,034 3,757
Note 21 Short-term investments
2021
Dec 31
2020
Dec 31
Fixed-rate account, SBAB 77,000 70,000
Accrued interest income 281 118
Total 77,281 70,118
Vicore has as of December 31, 2021, a total of eleven fixed-rate accounts (investment accounts) at SBAB.
Each account amounts to 7 MSEK and were opened during March 2021 (fixed for 12 months). The annual
interest rate per account is between 0.45% and 0.47%.
Note 22 Cash and cash equivalents
Available balances
2021
Dec 31
2020
Dec 31
SEK 232,568 248,618
EUR 61,631 0
Total 294,199 248,618
Note 23 Group companies
Share of equity and voting rights
Company Principal activity
2021
Dec 31
2020
Dec 31
Vicore Pharma Holding AB Own and manage shares in subsidiaries Parent company
Vicore Pharma AB
Research and development of
pharmaceutical products
100% 100%
INIM Pharma AB
Research and development of
pharmaceutical products
100% 100%
Note 24 Shareholders’ equity
Share capital and other contributed capital
SEK
Number of
ordinary shares Share capital
Other contributed
capital
At January 1, 2020 50,174,714 25,087,357 527,397,207
New share issue of warrants, January 8, 2020 243,525 121,762 2,427,944
New share issue, August 13, 2020 10,000,000 5,000,000 169,595,120
Share-based payments 0 0 2,632,679
At December 31, 2020 60,418,239 30,209,119 702,052,950
At January 1, 2021 60,418,239 30,209,119 702,052,950
22, 2021
142,054 71,027 2,928,973
New share issue, February 22, 2021, registered March
9, 2021
11,200,000 5,600,000 312,821,895
Share-based payments 0 0 3,861,698
At December 31, 2021 71,760,293 35,880,146 1,021,665,516
55 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Share capital
At December 31, 2021, the registered share capital encompassed 71,760,293 ordinary shares. All shares
have been fully paid and no shares are reserved for transfer. Each share carries one vote. The quotient
value is SEK 0.50 (0.50). No shares are held by the company itself or its subsidiaries.
Other contributed capital
Other contributed capital comprises capital contributed by the owners of the company, for example share
premiums when subscribing for shares.
Share-based payments
As of December 31, 2021, Vicore has four active incentive programs that include the management team,
other employees and certain board members. For more information, see Note 8 "Share-based payments".
Dividend
At the Annual General Meeting in May 2022, no dividend will be proposed for the financial year 2021.
Note 25 Other provisions
Social security contributions related to share-based incentive programs
2021
Dec 31
2020
Dec 31
Opening amount 6,177 575
Provisions for the year -5,425 5,602
Total 752 6,177
For more information about incentive programs, see Note 8 "Share-based payments".
Note 26 Accrued expenses and deferred income
2021
Dec 31
2020
Dec 31
Accrued personnel-related expenses 4,644 1,655
Accrued expenses, research and development 35,036 21,843
Accrued expenses, other 459 6,028
Total 40,139 29,526
Note 27 Supplementary information to the cash flow statement
Adjustment for items not included in the cash flow
2021
Dec 31
2020
Dec 31
Depreciations 3,598 3,537
Loss on disposal of equipment 0 0
Incentive programs, payroll expenses 3,862 2,632
Incentive programs, social security contributions* -5,425 0
Provision for payroll tax, pension premium 64 0
Other 0 33
Total 2,099 6,202
* Social security contributions for share-based incentive programs were reported in the Annual Report for the fiscal year 2020 in the cash flow
Note 28 Related-party transactions
Related parties are defined as individuals with holdings of more than ten percent, members of the group’s
senior management, meaning the Board of Directors and senior executives, as well as their immediate
family members.
For information about remuneration to senior executives and the Board of Directors, see Note 7
"Employees and personnel costs".
Note 29 Contingent liabilities
Below a summary of material agreements which the company has entered into during the most recent years:
Agreement with Emeriti Bio AB
Vicore Pharma AB ("Vicore Pharma") entered into a cooperation and development agreement with
Emeriti Bio AB on August 24, 2016, which was expanded on November 1, 2017. The main purpose of the
agreement is to develop new follow-on molecules based on C21 and other drug substances targeting
the AT2 receptor (AT2R). On November 2, 2020, the parties expanded their cooperation and development
agreement in connection with the acquisition of a number of new intellectual proporty rights as part of the
development of new AT2R agonists from HaLaCore Pharma AB, where HaLaCore Pharma AB became a
new party to the agreement. The agreement is valid until there is no longer any obligation to pay Emeriti
56 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Vicore Pharma pays consultancy fees, possible
of predefined development goals. Vicore Pharma
owns all results. The total maximum payments
in the form of milestone compensation under
the agreement is limited to 49.5 MSEK. In 2020,
a milestone payment of 1,000 KSEK (250 KSEK)
was paid to Emeriti Bio AB in connection with the
filing of a patent application by Vicore Pharma. As
compensation for the acquisition of intellectual
propoarty rights, HaLaCore received a one-time
payment of 6 MSEK in 2020, divided between 3
MSEK in cash and 142,054 newly issued shares in
Vicore, corresponding to approximately 3 MSEK.
Agreement with Nanologica AB
On May 9, 2018, INIM Pharma AB ("INIM Pharma")
entered into a license agreement with Nanologica
AB (publ) regarding the use of Nanologica AB’s
drug delivery technology, NLAB Silica® for a
unique product that INIM Pharma is developing.
The agreement is valid until further notice, where
INIM Pharma has a unilateral right to terminate the
agreement at any time without any period of notice.
All results are owned by INIM Pharma. In order to
fully obtain the license, INIM Pharma is required to
pay a one-time payment equivalent to 2 MSEK. This
payment was completed in the fourth quarter of
2018. Furthermore, INIM Pharma is obliged to pay
milestone compensations equivalent to 1 MSEK
per product at a defined stage of development.
INIM Pharma has an obligation to develop products
within a certain period of time in order not to loose
the license. However, INIM Pharma is entitled to
maintain its license by issuing a new one-time
payment equivalent to 2 MSEK. INIM Pharma is
responsible for all development.
Note 30 Events after the balance
sheet date
In February, an interim analysis of the AIR
(IPF) suggests that C21 stabilizes disease
and shows an unanticipated increase in lung
function in IPF patients.
In February, Vicore announced the advance-
clinical trial application (CTA) is expected to be
submitted during the second quarter 2022.
In March, Vicore announced the plan to initiate
a proof-of-concept trial with C21 in pulmonary
arterial hypertension (PAH).
In March, Vicore announced the initiation of
planned to start in Q2 2022.
In March, Vicore announced that Michael Wolff
Jensen resigned from the board and was re-
placed by Jacob Gunterberg as chairman until
the annual general meeting in May 2022.
57 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Notes
Parent company
Note 1 Accounting principles
The parent company's accounting principles
The parent company has prepared its financial reports in accordance with the Annual Accounts Act
and the Swedish Financial Reporting Board recommendation RFR 2 “Accounting for Legal Entities”. The
differences between the group’s and the parent company’s accounting principles are described below. The
accounting policies set out below for the parent company have been consistently applied for all periods as
presented in the parent company’s financial statements, unless otherwise stated.
Classification and format
The parent company’s income statement and balance sheets are prepared in accordance with the Annual
Accounts Act’s scheme, while the statement of comprehensive income, statement of changes in equity
and the statement of cash flow are based on IAS 1 Presentation of Financial Statements and IAS 7,
Statement of Cash Flow. The differences concerning the group’s statements, which are relevant to the
parent company’s income statement and balance sheet consist mostly of the presentation of equity.
Subsidiary and associated companies
Participations in subsidiaries and associated companies are recognized in the parent company according
to the cost method less any write-downs. This means that transaction costs are included in the carrying
amount of the subsidiaries.
Financial assets and liabilities
Due to the relation between accounting and tax, the rules pertaining to the financial instruments in IFRS
9 are not applied in the parent company as a legal entity. Instead the parent company applies accounting
at cost in accordance with the Annual Accounting Act. In the parent company, therefore, financial
non-current assets are valued at cost and financial current assets according to the lowest value principle,
with the application of impairments for expected credit losses according to IFRS 9 for assets that are debt
Leasing
The parent company does not apply IFRS 16 Leases. The parent company as lessee recognizes leasing
fees as a linear cost over the lease period, unless another systematic way better reflects the user's
economic benefit over time. The parent company only recognizes leasing fees from leasing contracts
as a linear cost over the leasing period under administrative expenses. Thus, the contract asset and the
contract liability are not recognized in the balance sheet.
Group contributions and shareholder contributions
Both received and paid group contributions are recognized as appropriations in accordance with the alter-
native method. Shareholder contributions are recognized directly in the receiver’s equity and capitalised in
shares and participations of the parent company, to the extent that impairment is not required.
Note 2 Net sales
Net sales mainly consists of reinvoiced costs and management fees to group companies.
Note 3 Operating expenses by nature of expense
The total expenses classified by function are distributed in the following cost categories:
2021 2020
Other external expenses 10,947 6,970
Personnel expenses 10,648 19,357
Depreciation and amortization 0 0
Other operating expenses 69 10
Total 21,664 26,337
Note 4 Audit fees
Ernst & Young AB 2021 2020
Audit fees 300 388
Other audit related services 92 47
Tax consultancy services 0 0
Other services 10 88
Total 402 523
For further information on audit fees, see Note 5 "Audit fees" for the group.
Note 5 Leases
Operating leasing costs for the year concerning operating leases mainly comprise rent for premises and
office equipment and amounts to 1,066 KSEK (817 KSEK).
Future payment commitments as of December 31 for operating leases are divided up as follows:
Future minimum lease payments 2021 2020
No later than 1 year 279 130
Between 1 and 5 years 0 0
Later than 5 years 0 0
Total 279 130
58 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 6 Employees and personnel costs
For salaries and remuneration to employees and senior executives as well as information on the number
of employees, see Note 7 "Employees and personnel costs" for the group. For information on employee
Note 7 Interest income and similar profit items
2021 2020
Financial assets measured at amortized cost
645 815
Total interest income according to the effective interest method 645 815
Total 645 815
Total in prot or loss from nancial items 645 815
Note 8 Interest expenses and similar loss items
2021 2020
Financial assets measured at amortized cost
-2 -36
Total interest expenses calculated using the effective interest method -2 -36
Total -2 -36
Total in prot or loss from nancial items -2 -36
Note 9 Tax on profit for the year
2021 2020
Current tax 0 0
Change in deferred tax assets -131 68
Recognized tax -131 68
Reconciliation of effective tax rates 2021 2020
Loss before tax 17 709 -21 826
Tax according to applicable tax rate for parent company 20.6% (21.4%) -3 648 4 671
Tax effect non-deductible expenses -81 -1 133
Tax effect non-deductible income 990 0
Tax effect unrecognized deferred tax assets 2 608 -3 470
Recognized tax -131 68
Effective tax rate 1% 0%
The parent company has no tax items that are recognized in other comprehensive income or directly in
equity.
Information about deferred tax assets and tax liabilities
The following table specifies the tax effect of the temporary differences:
Deferred tax asset:
2021
Dec 31
2020
Dec 31
Provision for pension premium 0 131
Carrying amount 0 131
Specification of change in deferred tax assets:
2021
Dec 31
2020
Dec 31
Opening carrying amount 131 63
Change of temporary differences -131 68
Carrying amount deferred tax asset 0 131
Tax loss carryforwards for which deferred tax assets have not been recognized in the balance sheet
amounted to 109,689 KSEK (105,521 KSEK). These carryforwards have no time limit. Deferred tax assets
them to offset future taxable profits.
Note 10 Participations in group companies
Carrying amount
Company No. of shares
Proportion of
equity
Share of
voting power
2021
Dec 31
2020
Dec 31
Vicore Pharma AB 10,000 100% 100% 665,577 295,491
INIM Pharma AB 50,000 100% 100% 130,812 100,812
796,389 396,303
Corp. Reg. No. Domicile of the entity Equity
Loss for the
year
Vicore Pharma AB 556607-0743 95,362 -291,864
INIM Pharma AB 559156-8471 28,337 -18,658
2021
Dec 31
2020
Dec 31
Opening cost 396,303 276,274
Acquisitions for the year 400,086 120,529
This year's sales / liquidations 0 -500
Closing accumulated cost 796,389 396,303
Closing carrying amount 796,389 396,303
59 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 11 Long-term investments
2021
Dec 31
2020
Dec 31
Opening cost 565 565
Closing carrying amount 565 565
Note 12 Financial assets and liabilities
Financial assets and liabilities at December 31, 2021
Financial assets/liabilities
measured at fair value
through profit and loss
Financial assets/
liabilities measured
at amortized cost
Total
carrying
amount
Financial assets
Receivables from group companies 0 32,386 32,386
Other current receivables 0 65 65
Short-term investments 0 77,281 77,281
Cash and cash equivalents 0 168,396 168,396
Total 0 278,128 278,128
Financial liablilities
Liabilities to group companies 0 75,000 75,000
Trade payables 0 622 622
Accrued expenses 0 1,145 1,145
Total 0 76,767 76,767
the table above. The parent company has not received any pledged assets for the financial net assets.
Financial assets and liabilities at December 31, 2020
Financial assets/liabilities
measured at fair value
through profit and loss
Financial assets/
liabilities measured at
amortized cost
Total
carrying
amount
Financial assets
Other current receivables 0 15 15
Short-term investments 0 70,118 70,118
Cash and cash equivalents 0 195,822 195,822
Total 0 265,955 265,955
Financial liablilities
Trade payables 0 765 765
Accrued expenses 0 241 241
Total 0 1,006 1,006
the table above. The parent company has not received any pledged assets for the financial net assets.
For fair value measurement of long-term investments see Note 18 "Financial assets and liabilities" for
the group.
For other current receivables and liabilities, short-term investments, cash and cash equivalents, trade
payables, and accrued expenses and income with a short maturity, the carrying amount is considered a
reasonable estimate of the fair value.
deemed to be non-significant and no provision has therefore been recognized. The counterparties do not
AA-, A+ and A. For a description of the expected credit loss for the cash and cash equivalents according to
Note 13 Prepaid expenses and accrued income
2021
Dec 31
2020
Dec 31
Prepaid rental charges 181 126
Prepaid insurances 120 0
Other prepaid expenses 511 144
Total 812 270
60 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 14 Short-term investments
2021
Dec 31
2020
Dec 31
Fixed-rate account, SBAB 77,000 70,000
Accrued interest income 281 118
Total 77,281 70,118
Vicore has as of December 31, 2021, a total of eleven fixed-rate accounts (investment accounts) at SBAB.
Each account amounts to 7 MSEK and were opened during March 2021 (fixed for 12 months). The annual
interest rate per account is between 0.45% and 0.47%.
Not 15 Cash and cash equivalents
2021
Dec 31
2020
Dec 31
Available balances 168,396 195,822
Total 168,396 195,822
Note 16 Shareholders’ equity
At December 31, 2021, the registered share capital comprised 71,760,293 ordinary shares. All shares are
fully paid and no shares are reserved for transfer. Each share carries one vote. The quota value amounts to
0.5 SEK (0.5 SEK). No shares are held by the company itself or its subsidiaries.
The share premium reserve refers to capital from new share issues that have been issued at a price that
exceeds the quotient value and includes deductions of expenditures for new share issues.
Note 17 Other provisions
Social security contributions related to share-based incentive
programs
2021
Dec 31
2020
Dec 31
Opening amount 5,312 500
Provisions for the year -4,805 4,812
Total 507 5,312
For more information about incentive programs, see Note 8 "Share-based payments" for the group.
Note 18 Non-current liabilities to group companies
Non-current liabilities
2021
Dec 31
2020
Dec 31
Opening cost 0 400
0 -400
Additions 75,000 0
Closing carrying amount 75,000 0
Note 19 Accrued expenses and deferred income
2021
Dec 31
2020
Dec 31
Accrued personnel-related expenses 1,799 962
Accrued consulting fees 150 241
Accrued expense for patents 0 6,000
Other 135 25
Total 2,084 7,228
Note 20 Supplementary information to the cash flow statement
Adjustment for items not included in the cash flow
2021
Dec 31
2020
Dec 31
Incentive programs, salary costs 2,526 2,104
Incentive programs, social security contributions* -4,805 0
Provision payroll tax, pension premium 64 0
Total -2,215 2,104
* In the year-end report for the fiscal year 2021, social security contributions for share-based incentive programs were reported in the cash
flow statement as "Change in operating payables" and amounted to 4,805 KSEK, but has for the fiscal year 2021 been reclassified to the item
Note 21 Pledged assets and contingent liabilities
For information about pledged assets and contingent liabilities in the parent company, see to the group’s
Note 29 "Pledged assets and contingent liabilities".
Note 22 Related-party transactions
Sales of
goods or
services
Purchase
of goods or
services Other
Receivables
on closing
day
Payables
on closing
day
Transactions with subsidiaries
2021 37,866 0 859 32,386 75,000
2020 3,672 0 56 0 0
Sales of goods or services relate to reinvoiced costs and management fee.
For information about salaries and remuneration to employees and senior executives, see Note 7
"Employees and personnel costs" for the group.
For further information on related-party transactions, see Note 28 "Related-party transactions"
for the group.
61 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Board of Directors and
Management
Michael Wolff Jensen
Chairman of the Board since 2020
(Resigned from the board on March 23, 2022)
Michael Wolff Jensen has 20 years of experience from strategic
leadership from Pharma/Biotech – as CFO, Chairman of the Board,
responsible partner and as Chief Legal Officer. Michael has been
responsible for four IPOs and has been responsible for several funding
rounds. Michael has more than 15 years of experience as board mem-
ber and as chairman, both in private and publicly traded companies.
Born: 1971
Education: Law degree from the University of Copenhagen.
Other assignments: SVP / Chief Legal Officer of Ascendis Pharma
AB (publ). Chairman of Visen Pharmaceuticals and MIWO Invest ApS.
Previous assignments for the past five years: Chairman of Ascen-
dis Pharma A/S, XSPRAY PHARMA (publ), VANX ApS and Eurocine
Vaccines AB (PUBL).
Holdings in the company:
the company's incentive program.
Michael is chairman of Vicore's remuneration committee.
Independent of the company and its senior management and
independent of major shareholders of the company.
Board of Directors
Hans Schikan
Board member since 2018
His previous assignments include leading roles at Genzyme
(acquired by Sanofi) and Organon (acquired by Schering Plough).
He has served on the Board of Directors of Wilson Therapeutics
(acquired by Alexion) and Therachon (acquired by Pfizer). He is a
co-founder of Pharvaris NV.
Born: 1958
Education: PharmD from the University of Utrecht.
Other assignments: Chairman of Microbiotica Ltd, InteRNA Technol-
ogies BV and Complix NV. Board member of VectivBio AG, Pharvaris
NV and the Dutch Top Sector Life Sciences & Health. Advisor to
various organisations in Life Sciences & Health.
Previous assignments for the past five years: Board member of
Asceneuron, Hansa Medical, Sobi, Therachon and Wilson Therapeu-
tics.
Holdings in the company:
the company's incentive program.
Hans is member of Vicore's remuneration committee and scientific
committee.
Independent of the company and its senior management and
independent of major shareholders of the company.
Jacob Gunterberg
Board member since 2018
(New chairman of the board since March 23, 2022)
Jacob Gunterberg is a former partner at HealthCap and has extensive
experience in venture capital investment operations and corporate
finance in life science. Jacob Gunterberg has long experience as board
member in both private and publicly traded companies.
Born: 1967
Education: M.Sc. in Business Administration and Economics from
Lund University.
Other assignments:
Previous assignments for the past five years: Board member in
MIPS Helmet AB, MIPS AB, Trimb Holding AB, Trimb Healthcare AB,
HealthCap Holdings GP AB, HealthCap Annex Fund I-II Bis GP AB
and HealthCap Aero Holdings GP AB (which were merged in 2016),
Carisma Therapeutics Inc, SynOx Therapeutics Ltd and Cenova
AB. Deputy board member in BONESUPPORT AB, BONESUPPORT
HOLDING AB and Wilson Therapeutics AB.
Holdings in the company: None.
Jacob is chairman of Vicore's audit committee and a member of the
scientific committee.
Independent of the company and its senior management and
independent of major shareholders of the company.
62 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Sara Malcus
Board member since 2018
Sara Malcus has more than ten years of experience from operational
companies.
Born: 1975
Education: Doctor’s degree in immunology and inflammatory
medicine at the University of Gothenburg.
Other assignments: Sara Malcus is the Managing Director of
MetaboGen AB.
Previous assignments for the past five years: Board member
of Oncorena AB, Oncorena Holding AB, Cereno Scientific AB and
MetaboGen AB.
Holdings in the company:
the company's incentive program.
Sara is a member of Vicore's audit committee.
Independent of the company and its senior management and
independent of major shareholders of the company.
Maarten Kraan
Board member since 2018
Maarten Kraan has extensive experience in biomedicine and has,
among others, held a senior position at AstraZeneca AB where he
was responsible for the research and development of medicines for
respiratory, inflammatory and autoimmune symptoms.
Born: 1961
Education: Doctor’s degree in rheumatology at the University of
Leiden.
Other assignments: CMO at AM-Pharma. Maarten Kraan is a board
member of Toleranzia AB and CDS Gmbh.
Previous assignments for the past five years: None.
Holdings in the company:
the company's incentive program.
Maarten is chairman of Vicore’s scientific committee and a member of
the remuneration committee
Independent of the company and its senior management and
independent of major shareholders of the company. .
Heidi Hunter
Board member since 2020
Heidi Hunter (born 1958) has more than 25 years of experience from
leading positions in different roles within pharmaceutical devel-
operationally from clinical and commercial development to launch
execution. Her leadership experience spans alliance management,
-
agement, new business strategy development, product launch, and
business sustainability.
Born: 1958
Education:
University of Chicago. B.A., Economics and German, Magna cum
laude, The University of Michigan
Other assignments: President, Cardinal Health Specialty Solutions.
Previous assignments for the past five years:
SVP, Global immunology business unit i UCB, Belgien
Holdings in the company:
company's incentive program.
Heidi is a member of Vicore's audit committee.
Independent of the company and its senior management and
independent of major shareholders of the company.
63 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Carl-Johan Dalsgaard
Chief Executive Officer since 2018
Carl-Johan Dalsgaard has been a
Venture Partner at HealthCap since
2000, thereby he has served as CEO of
several companies in which HealthCap
has invested. Prior to that, he has
ten years of experience from senior
positions within the AstraZeneca Group,
such as pre-clinical research director,
therapeutic area manager of pain and
anesthesia, CEO of Astra Pain Control
AB and part of the Group’s research
management team.
Born: 1956
Education:
Institute. Ph.D. in neurobiology and post-
doc experience from Harvard Medical
School. Carl-Johan has also completed
a specialist training in plastic surgery.
Other assignments: Board member
and CEO of INIM Pharma AB and Vicore
Pharma AB.
Holdings in the company: 477,981
shares and 400,000 options within the
program.
Hans Jeppsson
Chief Financial Officer since 2017
Hans Jeppsson has a cross-disciplinary
as well as within preclinical research at
AstraZeneca R&D.
Education: Ph.D. in Strategic Financial
Management from the University of
Gothenburg. After he obtained his
Ph.D.-degree he conducted postdoctoral
studies at the Haas School of Business
with a focus on biotechnology from
Chalmers University of Technology.
Other assignments: Deputy board
member of Vicore Pharma AB and INIM
Pharma AB.
Holdings in the company: 5,000
shares and 250,000 options within the
program.
Management
Elin Rosendahl
VP Clinical Development since 2020
Elin Rosendahl has more than 20 years’
experience of managing global biophar-
maceutical development programs and
leading cross-functional teams. Solid
experience of all phases of clinical drug
development with focus on design of
innovative and patient-focused paths to
cross-functional teams and optimized
collaborations with contract research
organizations (CROs)
Education: M.Sc., Pharmacy from
Uppsala University.
Other assignments: None.
Holdings in the company: 100,000
company's incentive program.
Johanna Gräns
Head of Preclinical Development since
2015
Johanna has a Ph.D and expertise in
pharmaceutical metabolism. She has
extensive experience in preclinical
interpretation and is responsible for
Education: Ph.D. in biology with a focus
on toxicology from the University of
Gothenburg.
Other assignments: None.
Holdings in the company: 7,004
shares and 143,750 options within the
program.
Åsa Magnusson
Chief Commercial Officer since 2021
Åsa has more than 20 years of experi-
ence as a commercial executive in the
pharmaceutical industry with focus on
rare disease medicines. Her previous
roles include leading cross-functional
teams as General Manager at Arvelle
and in different senior commercial
roles at Alexion, expanding innovative
antibody products and heading the
commercial launch of Actelion’s
pulmonary arterial hypertension (PAH)
pharmaceuticals.
Education:
from Lund University.
Other assignments: Board member of
Holdings in the company: 50,000
company's incentive program.
64 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Johan Raud
Chief Scientific Officer since 2018
Johan Raud has many years of experi-
ence from drug research and managing
Education:
Institute and Vanderbilt university, USA.
Other assignments: None.
Holdings in the company: 238,991
shares and 130,000 options within the
program.
Mikael Nygård
VP Business Development since 2021
Business Development in the healthcare
industry. He has led M&A and Corporate
Development at the care provider
global healthcare team at the strategy
consulting firm Boston Consulting
Group.
Education: MSc Pharmacy, Uppsala
University. PhD Neurobiology,
Other assignments: None.
Holdings in the company: 4,031
shares and 41,000 options within the
program.
Rohit Batta
Chief Medical Officer since 2018
Rohit Batta has over 20 years of
experience as a medical doctor with an
and clinical development teams whilst
developing drugs for rare diseases.
His previous roles include senior level
positions within Cell and Gene Therapy
at GlaxoSmithKline leading the clinical
development and defining the clinical
strategy for haemoglobinopathy gene
therapy medicines. He also led the
global medical and late stage clinical
development teams to launch the
world’s first gene therapy for patients
with a paediatric rare disease.
Education: MBBS from Kings College
London, a fellow of the Faculty of
Pharmaceutical Medicine and a
member of the Royal College of General
Practitioners.
Other assignments: Visiting Senior
Lecturer at Kings College London.
Holdings in the company: 200,000
company's incentive program.
Nina Carlén
Chief Administrative Officer since 2009
Nina has more than 20 years of
communication in the pharmaceutical
industry.
Education:
management, PR, communication and
graphic design at, among others, Bergh's
School of Communication.
Other assignments: Deputy board
member of North River AB and North
River Maintenance AB.
Holdings in the company: 24,480
shares and 125,000 options within the
program.
Jessica Shull
Head of Digital Therapeutics since
2021
Jessica has more than 20 years’
experience in the field of digital
technologies for healthcare including
development of virtual surgical devices.
She is considered an authority in
HTA requirements for patient-facing
software and innovation adoption in
Europe and internationally. In previous
best practices for the WHO and with
the Digital Therapeutics Alliance she
focused on digital therapeutic product
integration, regulation, and policy.
Education: MA, M.Sc., Ph.D. candidate in
Biomedicine.
Other assignments: None.
Holdings in the company: 50,000
company's incentive program.
65 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Signatures
Sara Malcus
Board member
Carl-Johan Dalsgaard
CEO
Hans Schikan
Board member
Jacob Gunterberg
Chairman
Maarten Kraan
Board member
The undersigned give their assurance that the annual accounts have been prepared in accordance with generally accepted accounting standards in Sweden and that
the consolidated financial statements have been prepared in accordance with international accounting standards, IFRS, as adopted by the EU. The annual accounts
and the consolidated financial statements each provide a fair and accurate impression of the parent company’s and the group’s position and earnings. The Administra-
tion Report for the parent company and the group provides a fair and accurate overview of the parent company’s and the group’s operations, position and earnings, and
Gothenburg April 6, 2022
Our audit report was submitted on April 6, 2022
Ernst & Young AB
Andreas Mast
Authorized Public Accountant
Heidi Hunter
Board member
66 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Auditors-
Report
To the general meeting of the shareholders of
Vicore Pharma Holding AB (publ), corporate
identity number 556680-3804.
Report on the annual accounts and
consolidated accounts
Opinions
We have audited the annual accounts and
consolidated accounts of Vicore Pharma Holding
AB (publ) for the year 2021. The annual accounts
and consolidated accounts of the company are
included on pages 26-65 in this document.
In our opinion, the annual accounts have been
prepared in accordance with the Annual Accounts
Act and present fairly, in all material respects, the
financial position of the parent company as of 31
December 2021 and its financial performance and
cash flow for the year then ended in accordance
with the Annual Accounts Act. The consolidated
accounts have been prepared in accordance with
the Annual Accounts Act and present fairly, in all
material respects, the financial position of the
group as of 31 December 2021 and their financial
performance and cash flow for the year then ended
in accordance with International Financial Report-
ing Standards (IFRS), as adopted by the EU, and the
Annual Accounts Act. The statutory administration
report is consistent with the other parts of the
annual accounts and consolidated accounts.
We therefore recommend that the general meet-
ing of shareholders adopts the income statement
and balance sheet for the parent company and the
group.
Our opinions in this report on the annual
accounts and consolidated accounts are consist-
ent with the content of the additional report that
has been submitted to the parent company's audit
committee in accordance with the Audit Regulation
(537/2014) Article 11.
Basis for Opinions
We conducted our audit in accordance with
International Standards on Auditing (ISA) and gen-
erally accepted auditing standards in Sweden. Our
responsibilities under those standards are further
described in the Auditor’s Responsibilities section.
We are independent of the parent company and the
group in accordance with professional ethics for
accountants in Sweden and have otherwise fulfilled
our ethical responsibilities in accordance with
these requirements. This includes that, based on
services referred to in the Audit Regulation
(537/2014) Article 5.1 have been provided to the
audited company or, where applicable, its parent
company or its controlled companies within the EU.
We believe that the audit evidence we have
obtained is sufficient and appropriate to provide a
basis for our opinions.
Key Audit Matters
Key audit matters of the audit are those matters
significance in our audit of the annual accounts
and consolidated accounts of the current period.
These matters were addressed in the context of
our audit of, and in forming our opinion thereon, the
annual accounts and consolidated accounts as a
whole, but we do not provide a separate opinion
on these matters. For each matter below, our
description of how our audit addressed the matter
is provided in that context.
We have fulfilled the responsibilities described
in the Auditor’s responsibilities for the audit of
the financial statements section of our report,
including in relation to these matters. Accordingly,
our audit included the performance of procedures
designed to respond to our assessment of the
statements. The results of our audit procedures,
including the procedures performed to address
the matters below, provide the basis for our audit
opinion on the accompanying financial statements.
Other information than the annual accounts and
consolidated accounts
This document also contains other information
than the annual accounts and consolidated
accounts and is found on pages 1-25 and 69-78.
The Board of Directors and the Managing Director
Key Audit Matter 1
Reporting of development costs How our audit addressed this key audit matter
The costs of the Group's development activities amounted
2021, corresponding to 92% of Vicore Pharma's total
operating expenses.
Most of these costs relate to the development of the prod-
uct candidates VP01, VP02 and VP03 and mainly consists
of costs for the clinical studies conducted.
For further information, please refer to the Group's
accounting policies in Note 1 and operating expenses per
cost type in Note 4.
In our audit, we have focused on this area as the expenses
elements of assessments involved to be able to decide
whether the expense should be expensed or reported as
expenses from other expenses in the income statement
Our review of the development costs has included, but is
not limited to the following measures:
• Evaluation of the company's procedures and internal
• Testing of internal controls for approval and payment
of invoices.
• Reconciled and performed detailed testing to invoice
documentation.
• -
• We have also assessed the company's information in
the annual report.
Key Audit Matter 2
Valuation of intangible assets
How our audit addressed
this key audit matter
As of 31st December 2021, a substantial portion (15% or SEK 67,4 m) of the Group's
total assets consists of patents and goodwill (hereinafter referred to as the assets). The
company examines the assets for impairment annually and when events or changes
in circumstances indicate that the carrying amount of the assets may be less than the
recoverable amount. Impairment assessment involves a number of material estimates
-
ing weighted average cost of capital ("WACC").
For further information, please refer to the Group's accounting policies in Note 1,
assessments and estimates in Note 2, as well as information on patents, licenses and
similar rights in Note 15.
We focused on this area as the carrying value of the assets is material and impairment
testing is sensitive to changes in assumptions and is therefore a particularly important
area in our audit.
• Evaluation of the compa-
impairment testing.
• Examination of the
assumptions made
by the company when
assessing impairment
requirements with a fo-
cus on the assumptions
for which the result of the
impairment test is most
sensitive.
• We have also assessed
the company's informa-
tion in the annual report
67 | Annual Report 2021 Vicore Pharma Holding AB (publ)
are responsible for this other information.
Our opinion on the annual accounts and consoli-
dated accounts does not cover this other informa-
tion and we do not express any form of assurance
conclusion regarding this other information.
In connection with our audit of the annual
accounts and consolidated accounts, our
responsibility is to read the information identified
above and consider whether the information is
materially inconsistent with the annual accounts
and consolidated accounts. In this procedure we
obtained in the audit and assess whether the
information otherwise appears to be materially
misstated.
this information, conclude that there is a material
misstatement of this other information, we are
required to report that fact. We have nothing to
report in this regard.
Responsibilities of the Board of Directors and the
Managing Director
The Board of Directors and the Managing Director
are responsible for the preparation of the annual
accounts and consolidated accounts and that
they give a fair presentation in accordance with
the Annual Accounts Act and, concerning the
consolidated accounts, in accordance with IFRS as
adopted by the EU. The Board of Directors and the
Managing Director are also responsible for such
internal control as they determine is necessary
to enable the preparation of annual accounts and
consolidated accounts that are free from material
misstatement, whether due to fraud or error.
In preparing the annual accounts and consoli-
dated accounts, The Board of Directors and the
Managing Director are responsible for the assess-
ment of the company’s and the group’s ability to
continue as a going concern. They disclose, as
applicable, matters related to going concern and
using the going concern basis of accounting. The
going concern basis of accounting is however not
applied if the Board of Directors and the Managing
Director intends to liquidate the company, to cease
operations, or has no realistic alternative but to do
so.
general, among other things oversee the compa-
ny’s financial reporting process.
Auditor’s responsibility
-
ance about whether the annual accounts and
consolidated accounts as a whole are free from
material misstatement, whether due to fraud or
error, and to issue an auditor’s report that includes
our opinions. Reasonable assurance is a high level
of assurance, but is not a guarantee that an audit
conducted in accordance with ISAs and generally
accepted auditing standards in Sweden will always
detect a material misstatement when it exists.
Misstatements can arise from fraud or error and
are considered material if, individually or in the
aggregate, they could reasonably be expected to
the basis of these annual accounts and consoli-
dated accounts.
As part of an audit in accordance with ISAs, we
also:
•
misstatement of the annual accounts and
consolidated accounts, whether due to fraud
or error, design and perform audit procedures
evidence that is sufficient and appropriate
of not detecting a material misstatement
resulting from fraud is higher than for one
resulting from error, as fraud may involve
collusion, forgery, intentional omissions,
misrepresentations, or the override of internal
control.
• Obtain an understanding of the company’s
internal control relevant to our audit in order to
design audit procedures that are appropriate
in the circumstances, but not for the purpose
of expressing an opinion on the effectiveness
of the company’s internal control.
• Evaluate the appropriateness of accounting
policies used and the reasonableness of
accounting estimates and related disclosures
made by the Board of Directors and the
Managing Director.
• Conclude on the appropriateness of the Board
of Directors’ and the Managing Director’s use
of the going concern basis of accounting in
preparing the annual accounts and consoli-
dated accounts. We also draw a conclusion,
based on the audit evidence obtained, as
to whether any material uncertainty exists
related to events or conditions that may cast
significant doubt on the company’s and the
group’s ability to continue as a going concern.
If we conclude that a material uncertainty
exists, we are required to draw attention in
our auditor’s report to the related disclosures
in the annual accounts and consolidated
accounts or, if such disclosures are inade-
quate, to modify our opinion about the annual
accounts and consolidated accounts. Our
conclusions are based on the audit evidence
obtained up to the date of our auditor’s report.
However, future events or conditions may
cause a company and a group to cease to
continue as a going concern.
• Evaluate the overall presentation, structure
and content of the annual accounts and
consolidated accounts, including the
disclosures, and whether the annual accounts
and consolidated accounts represent the
underlying transactions and events in a
manner that achieves fair presentation.
• Obtain sufficient and appropriate audit
evidence regarding the financial information
of the entities or business activities within the
group to express an opinion on the consoli-
dated accounts. We are responsible for the
direction, supervision and performance of the
group audit. We remain solely responsible for
our opinions.
We must inform the Board of Directors of, among
other matters, the planned scope and timing of
the audit. We must also inform of significant audit
findings during our audit, including any significant
deficiencies in internal control that we identified.
We must also provide the Board of Directors with
a statement that we have complied with relevant
ethical requirements regarding independence, and
to communicate with them all relationships and
other matters that may reasonably be thought to
bear on our independence, and where applicable,
safeguards applied.
From the matters communicated with the
Board of Directors, we determine those matters
that were of most significance in the audit of the
annual accounts and consolidated accounts,
audit matters. We describe these matters in the
auditor’s report unless law or regulation precludes
disclosure about the matter
Report on other legal and
regulatory requirements
Report on the audit of the administration and the
proposed appropriations of the company’s profit
or loss
Opinions
IIn addition to our audit of the annual accounts
and consolidated accounts, we have also audited
the administration of the Board of Directors and
the Managing Director of Vicore Pharma Holding
AB (publ) for the year 2021 and the proposed
appropriations of the company’s profit or loss.
We recommend to the general meeting of
shareholders that the profit be appropriated in
accordance with the proposal in the statutory
administration report and that the members of the
Board of Directors and the Managing Director be
discharged from liability for the financial year.
Basis for opinions
We conducted the audit in accordance with gen-
erally accepted auditing standards in Sweden. Our
responsibilities under those standards are further
described in the Auditor’s Responsibilities section.
We are independent of the parent company and the
group in accordance with professional ethics for
accountants in Sweden and have otherwise fulfilled
our ethical responsibilities in accordance with
these requirements.
We believe that the audit evidence we have
obtained is sufficient and appropriate to provide a
basis for our opinions.
68 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Responsibilities of the Board of Directors and the
Managing Director
The Board of Directors is responsible for the
proposal for appropriations of the company’s
profit or loss. At the proposal of a dividend, this
includes an assessment of whether the dividend is
company's and the group’s type of operations, size
and the group’s equity, consolidation requirements,
liquidity and position in general.
The Board of Directors is responsible for the
company’s organization and the administration of
the company’s affairs. This includes among other
things continuous assessment of the company’s
and the group’s financial situation and ensuring
that the company's organization is designed so
that the accounting, management of assets and
the company’s financial affairs otherwise are
controlled in a reassuring manner. The Managing
Director shall manage the ongoing administration
according to the Board of Directors’ guidelines
measures that are necessary to fulfill the compa-
ny’s accounting in accordance with law and handle
the management of assets in a reassuring manner.
Auditor’s responsibility
administration, and thereby our opinion about
discharge from liability, is to obtain audit evidence
to assess with a reasonable degree of assurance
whether any member of the Board of Directors or
the Managing Director in any material respect:
•
any omission which can give rise to liability
to the company, or
• in any other way has acted in contravention
of the Companies Act, the Annual Accounts
Act or the Articles of Association.
proposed appropriations of the company’s profit
or loss, and thereby our opinion about this, is to
assess with reasonable degree of assurance
whether the proposal is in accordance with the
Companies Act.
Reasonable assurance is a high level of
assurance, but is not a guarantee that an audit
conducted in accordance with generally accepted
auditing standards in Sweden will always detect
actions or omissions that can give rise to liability to
the company, or that the proposed appropriations
of the company’s profit or loss are not in accord-
ance with the Companies Act.
As part of an audit in accordance with generally
accepted auditing standards in Sweden, we
The examination of the administration and the
proposed appropriations of the company’s profit or
loss is based primarily on the audit of the accounts.
Additional audit procedures performed are based
the examination on such actions, areas and
relationships that are material for the operations
and where deviations and violations would have
particular importance for the company’s situation.
circumstances that are relevant to our opinion
concerning discharge from liability. As a basis for
our opinion on the Board of Directors’ proposed
appropriations of the company’s profit or loss we
examined whether the proposal is in accordance
with the Companies Act.
The auditor’s examination of the ESEF report
Opinion
In addition to our audit of the annual accounts
and consolidated accounts, we have also
examined that the Board of Directors and the
Managing Director have prepared the annual
accounts and consolidated accounts in a format
that enables uniform electronic reporting (the Esef
report) pursuant to Chapter 16, Section 4(a) of
Vicore Pharma Holding AB for the financial year
2021.
Our examination and our opinion relate only to the
statutory requirements.
has been prepared in a format that, in all material
respects, enables uniform electronic reporting.
Basis for opinion
We have performed the examination in
accordance with FAR’s recommendation RevR 18
Examination of the ESEF report. Our responsibility
under this recommendation is described in more
detail in the Auditors’ responsibility section. We
are independent of Vicore Pharma Holding AB in
accordance with professional ethics for account-
ants in Sweden and have otherwise fulfilled our
ethical responsibilities in accordance with these
requirements.
We believe that the evidence we have obtained is
sufficient and appropriate to provide a basis for our
opinion.
Responsibilities of the Board of Directors and the
Managing Director
The Board of Directors and the Managing Director
are responsible for the preparation of the Esef
report in accordance with Chapter 16, Section 4(a)
and for such internal control that the Board of
Directors and the Managing Director determine
is necessary to prepare the Esef report without
material misstatements, whether due to fraud or
error.
Auditor’s responsibility
Our responsibility is to obtain reasonable
assurance whether the Esef report is in all material
respects prepared in a format that meets the
requirements of Chapter 16, Section 4(a) of the
on the procedures performed.
RevR 18 requires us to plan and execute
procedures to achieve reasonable assurance that
the Esef report is prepared in a format that meets
these requirements.
Reasonable assurance is a high level of assur-
ance, but it is not a guarantee that an engagement
carried out according to RevR 18 and generally
accepted auditing standards in Sweden will always
detect a material misstatement when it exists.
Misstatements can arise from fraud or error
and are considered material if, individually or in
aggregate, they could reasonably be expected to
the basis of the Esef report.
The audit firm applies ISQC 1 Quality Control for
Firms that Perform Audits and Reviews of Financial
Statements, and other Assurance and Related Ser-
vices Engagements and accordingly maintains a
comprehensive system of quality control, including
documented policies and procedures regarding
compliance with professional ethical requirements,
professional standards and legal and regulatory
requirements.
The examination involves obtaining evidence,
through various procedures, that the Esef report
has been prepared in a format that enables uniform
electronic reporting of the annual and consolidated
accounts. The procedures selected depend on the
whether due to fraud or error. In carrying out this
procedures that are appropriate in the circum-
stances, the auditor considers those elements of
internal control that are relevant to the preparation
of the Esef report by the Board of Directors and
the Managing Director, but not for the purpose of
expressing an opinion on the effectiveness of those
internal controls. The examination also includes an
evaluation of the appropriateness and reason-
ableness of assumptions made by the Board of
Directors and the Managing Director.
The procedures mainly include a technical valida-
tion of the Esef report, i.e. if the file containing the
Esef report meets the technical specification set
out in the Commission’s Delegated Regulation (EU)
2019/815 and a reconciliation of the Esef report
with the audited annual accounts and consolidated
accounts.
Furthermore, the procedures also include an
assessment of whether the Esef report has been
-
plete machine-readable version of the consolidated
statement of financial performance, financial
position, changes in equity and cash flow.
Ernst & Young AB, with Andreas Mast au auditor
appointed auditor of Vicore Pharma Holding by the
general meeting of the shareholders on the 11th
of May, 2021 and has been the company’s auditor
since the 10th of October 2018.
Gothenburg the 6th of April
Ernst & Young AB
Andreas Mast
Authorized Public Accountant
69 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Corporate Governance
Report
Introduction
The Board of Directors of Vicore Pharma
Holding AB (publ), company reg. no.
556680-3804 (“Vicore” or the “company”)
hereby submits the 2021 corporate
governance report in accordance with
the requirements of the Swedish Annual
Accounts Act) (Sw. årsredovisningsla-
gen) and the Swedish Code of Corporate
Governance (the “Code”; see the Swedish
Corporate Governance Board website at
www.bolagsstyrning.se). The company's
shares have been listed on Nasdaq
The company's shares were previously,
since December 2015, listed on the
company’s corporate governance is
mainly regulated by the provisions of the
company’s articles of association, the
Swedish Companies Act (2005:551) (Sw.
The corporate governance report
has been reviewed by the company’s
auditors in accordance with the Swedish
Annual Accounts Act. It does not
constitute a part of the formal annual
report documents.
The group comprises the parent
company Vicore Pharma Holding AB
("Vicore") and the subsidiaries Vicore
Pharma AB ("Vicore Pharma") and
INIM Pharma AB ("INIM Pharma"). The
company's research and development
operations are conducted in Vicore
Pharma and INIM Pharma.
There are no deviations from the
Swedish Corporate Governance Code
(the “Code”) to report for the financial
year of 2021. No infringements of Nas-
of good practice on the securities
exchange’s disciplinary committee or
the Swedish Securities Council during
the financial year.
Corporate governance within Vicore
The purpose of Vicore’s corporate gov-
ernance is to create a clear allocation
of roles and responsibilities among the
shareholders, the Board of Directors and
management. Corporate governance,
management and control of Vicore are
allotted among the general meeting, the
Board of Directors, its elected commit-
tees and the CEO.
Important external and internal
regulations and policies that affect
corporate governance:
Signficant external regulations:
Swedish Companies Act
Swedish Accounting Act
Swedish Annual Accounts Act
International standards for audits
issuers
Swedish Code of Corporate Gover-
nance
Other applicable rules and recom-
mendations
Significant internal regulations and
policies:
Articles of association
Rules of procedure for the Board of
Directors
Instruction for the CEO, including
Finance policy
Internal control policy
Information policy
Insider policy
IT policy
Shareholders and the share
At the end of 2021, Vicore had 5,140
shareholders and the number of shares
was 71,760,293 with a quotient value
of SEK 0.5 each. There is only one class
of shares. The company's shares are
issued in one class and each share
carries one vote at the AGM.
On December 31, 2021, HealthCap VII
L.P. was the single largest shareholder in
Vicore, with a total of 15,834,834 shares,
corresponding to 22.1 percent of the
votes and capital. No shareholder other
than HealthCap VII L.P. has a direct or
indirect shareholding that represents
one tenth, or more, of the voting rights
for all shares in the company. Further
information on shareholders and
Vicore's share is presented on pages
24-25 in the 2021 annual report.
General meetings of shareholders
According to the Companies Act
(2005: 551), the General Meetings of
shareholders is the company's highest
Meetings, the shareholders exercise
their voting rights in the company. The
Annual General Meeting shall be held
within six (6) months from the end of
the financial year. At the Annual General
Meeting, the shareholders decide,
among other things, on the Board
of Directors and, where applicable,
auditors, how the Nomination Commit-
tee is to be appointed and on discharge
from liability for the Board of Directors
and the CEO for the past year. Decisions
are also made on the adoption of Annual
Report, the appropriation of profit or
loss, fees for the Board of Directors and
auditors, guidelines for remuneration to
the CEO and other senior executives as
well as the remuneration report.
The Articles of Association stipulate
that the Annual General Meeting shall
Shareholders who wish to attend
General Meetings, in person or through
a representative, must be included in the
to the company in accordance with
the notice. Notice of General Meetings
is made through advertising and via
the company's website (www.vicore-
pharma.com).
2021 AGM
The Annual General Meeting 2021
was held through advance voting
(postal voting), pursuant to temporary
legislation, on May 11, 2021. At the
AGM, approximately 52.1 percent of the
total votes were represented. Michael
Wolff Jensen was elected chairman of
the meeting.
Nomination
Committee
Remuneration
Committee
Board of
Directors
Audit
Committee
Scientific
Committee
CEO and
Management
team
Shareholders
Annual General
Meeting
External
Auditors
70 | Annual Report 2021 Vicore Pharma Holding AB (publ)
At the AGM the following principal
resolutions were passed:
Jacob Gunterberg, Maarten Kraan,
Wolff Jensen and Heidi Hunter
were re-elected as board members.
Michael Wolff Jensen was elected
Chairman of the Board.
EY AB with principal auditor Andreas
Mast was re-elected as auditor.
Remuneration to the Chairman of
the Board and the Board's members
elected by the Annual General Meet-
ing and the auditor were established.
Resolution on adoption of a long-
term performance-based incentive
program (Board LTIP 2021) of a
maximum 73,000 options to three
board members.
Resolution on adoption of a long-
term performance-based incentive
maximum 3.000.000 options to se-
Proposed guidelines for remuner-
ation to senior executives were
approved.
Resolution on adoption of remuner-
ation report 2020.
Resolution on adoption of articles
of association with increased
margins in number of shares and
share capital.
Resolution on adoption of balance
sheet and income statement.
No dividend will be paid for 2020
and the company's earnings shall be
carried forward.
Discharge from liability of the Board
-
cial year 2020.
Full minutes and information from the
AGM are available on Vicore's website
(www.vicorepharma.com).
AGM 2022
The 2022 Annual General Meeting will
be held on Wednesday, May 11, 2022.
The meeting will held through postal
voting and with no opportunity to attend
in person or by proxy. Information
on the decisions made at the Annual
General Meeting will be published on
11 May 2022 as soon as the outcome
of the voting is finally compiled. For
the right to participate and more
information, see Vicore's website (www.
vicorepharma.com). The minutes of
the Annual General Meeting will be
available on Vicore's website (www.
vicorepharma.com).
Nomination Committee
The Nomination Committee for
the AGM 2022 consists of Staffan
Lindstrand (Chairman) appointed by
Staffan Lindstrand is chairman of the
Nomination Committee. The Committee
also includes the Chairman of the Board,
Michael Wolff Jensen, as convenor.
-
tee is to prepare and present proposals
for the number of board members to
be elected by the AGM, the election of
a Chairman and other members of the
Board of Directors, board fees and, if
election of a Chairman to the Annual
General Meeting, election of auditors (if
applicable) and auditors fees (if appli-
cable) and proposals for rules for the
appointment of a Nomination Commit-
tee for the next annual general meeting.
The proposals will be published at the
the AGM 2022.
External auditors
The external audit of the accounts of
the parent company and the group, as
well as of the management by the Board
of Directors and the CEO, is carried out
in accordance with generally accepted
accounting standards in Sweden. The
auditor participates in at least one
board meeting per year, going through
the accounts for the year and leading a
discussion with the Board of Directors
without the CEO or any other senior
executive present.
Pursuant to the articles of association,
Vicore must have an authorized public
accountant or a registered accounting
firm as its external auditor. Since the
AGM 2010, the accounting firm EY AB
has been auditor of the company. As of
the 2019 AGM, certified public account-
ant Andreas Mast is the auditor in
charge. Andreas Mast is member of the
Swedish Institute of Authorized Public
Accountants. For information regarding
fees paid to the auditors, please refer to
Note 5 of the 2021 Annual Report.
The Board of Directors
The Board of Directors is the company's
Annual General Meeting. According to
the Companies Act, the Board of Direc-
tors is responsible for the company's
71 | Annual Report 2021 Vicore Pharma Holding AB (publ)
management and organization, which
means that the Board of Directors is
responsible for, among other things,
setting goals and strategies, ensuring
routines and systems for evaluating
established goals, continuously evaluat-
ing the company's results and financial
position and evaluating the operational
management. The Board of Directors is
also responsible for ensuring that the
annual accounts and interim reports are
prepared in a timely manner. In addition,
the Board of Directors appoints the
company's CEO. Board members are
normally elected by the AGM for the
period until the end of the next AGM.
According to the Code, the Chairman of
the Board must be elected by the Annual
General Meeting and have a special
responsibility for the management
well organized and implemented in an
efficient manner. The Board of Directors
adheres to written rules of procedure that
are reviewed annually and are deter-
mined at the statutory board meeting
each year. The rules of procedure govern,
among other things, the practices
the Board of Directors' meeting agenda,
the Chairman’s duties and the allocation
of responsibilities between the Board of
Directors and the CEO. Instructions for
financial reporting and instructions for
the CEO are also determined in connec-
tion with the statutory board meeting.
The Board of Directors meets in
accordance with a yearly schedule and
essentially follows an annual cycle
determined by the Board of Directors,
which is decided at the statutory board
General Meeting. If necessary, special
decisions are made such as acquisi-
tions or divestments, other investment
decisions, financing decisions and
decisions on structural or organizational
issues. In 2021, the Board of Directors
held 13 board meetings, of which 6
were ordinary meetings. At the board
meetings, the company's CEO and CFO
were also present when needed.
Board of Directors
According to the Articles of Association,
Vicore's Board of Directors shall consist
of a minimum of three and a maximum
of nine members. The Company's Board
of directors currently consists of seven
people without deputies. The assign-
ment for all members runs until the end
of the upcoming AGM.
On page 61-62 is a presentation of
the Board of Directors with information
on year of birth, year of inclusion in the
assignments in the company, other
significant assignments and their
respective direct and indirect holdings
in the company as of March 31, 2021.
Ownership in the company includes
personal and / or related parties' holding.
Board of Directors’ work 2021
During 2021, the Board of Directors
held 13 board meetings, including the
inaugural meeting, of which 13 through
digital channels. In addition, the Board
of Directors has made decisions per
capsulam on 2 occasions during 2021.
The issues that the Board of Directors
dealt with in 2021 are mainly: decision to
carry out a new share issue, preclinical,
clinical studies and organizational issues.
At the board meetings held during the
financial year 2021, the members have
been present as shown below.
Evaluation of the Board of Directors’
work
Pursuant to the Code, the Board of
using a systematic and structured
process, with the aim of developing the
Directors has been evaluated by having
the board members anonymously
answer a number of questions about the
Board of Directors' activities. The results
of the evaluation have been compiled
and reported orally to the members of
the Board of Directors and the Nomina-
tion Committee.
Independent in relation to Remuneration, KSEK
1)
Attendance
2)
Board member Function Elected
The company and
its management
Major
shareholders
Board
fees
Remuneration
Committee
Audit
Committee
Scientific
committee Total
Board of
Directors
3)
Remuneration
Committee
Audit
Committee
Scientific
committee
Michael Wolff Jensen Chairman 2020 Yes Yes 450 50 - - 500 12/13 4/4 - -
Heidi Hunter Board member 2020 Yes Yes 150 50 200 10/13 - 6/6 -
Board member 2018 Yes Yes 150 25 - 25 200 13/13 4/4 - 3/3
Jacob Gunterberg Board member 2018 Yes No 150 - 100 25 275 12
4)
/13 - 6/6 3/3
Maarten Kraan Board member 2018 Yes Yes 150 25 - 50 225 12/13 4/4 - 3/3
Sara Malcus Board member 2018 Yes Yes 150 - 50 - 200 12/13 - 5/6 -
5)
Board member 2015 Yes Yes - - - - - 7/13 - - -
Reporting period January 1 – December 31, 2021
1) Fee set by the AGM, excluding social security contributions, for the May 2021 to May 2022 financial year
2) Figures in table show the total number of meetings attended/total number of meetings
3) Excluding per capsulam meetings
4) Absence due to conflict of interest on one occasion
Directors
72 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Board committees
Remuneration Committee
The Remuneration Committee is
appointed by the company's Board
of Directors and consists of three
members: Michael Wolff Jensen
Kraan. The Remuneration Committee
Code. The Remuneration Committee
of Directors.
The Remuneration Committee's main
Prepare decisions for the Board of
Directors regarding remuneration
principles, remuneration and other
employment terms and conditions
for senior management.
Monitor and evaluate any programs
pending or adopted during the year
for variable compensation for senior
management.
monitor and evaluate the applica-
tion of the guidelines for remunera-
tion adopted by the annual general
meeting, as well as applicable remu-
neration structures and levels for
the company.
In 2021, the Remuneration Committee
held four meetings.
Audit Committee
The Audit Committee is appointed by
the Board of Directors and consists of
Jacob Gunterberg (Chairman), Heidi
Hunter and Sara Malcus.
Primary duties of the Audit Committee:
The Audit Committee shall, without
impact on the responsibilities and
duties of the Board of Directors in
other respects, among other things,
reporting, monitor the effectiveness
of the company’s internal control,
-
nual accounts and the consolidated
accounts, review and monitor the
auditor’s impartiality and indepen-
dence and in this case pay special
attention to whether the auditor
provides the company with services
other than audit services, and assist
in the preparation of proposals
for the general meeting’s election
of auditor.
In 2021, the Audit Committee held six
meetings.
Scientific Committee
The Scientific Committee shall consist
of at least three non-employed board
members with a broad scientific and
medical understanding and experience
in the field concerned. The Board of
Directors shall appoint the members of
the Scientific Committee, including the
Chairman. Vicore's Scientific Committee
consists of Maarten Kraan (chairman),
the Committee are:
Reviewing and discussing the
company's preclinical and clinical
product portfolio, including its com-
Reviewing and discussing the com-
pany's R&D strategy and reviewing
that the company considers are of
great importance.
Providing strategic advice and rec-
ommendations for the company's
ongoing R&D program.
To review the (quality of) R&D
capacity of the company and its
organization, including the product
development process.
To review and discuss the compa-
ny's intellectual property strategies.
In 2021, the Scientific Committee held
three meetings.
Remuneration
Remuneration to the Board of Directors
At the Annual General Meeting on May
11, 2021, it was resolved that the remu-
neration to the members of the Board
of Directors for the period up to the end
of the 2022 Annual General Meeting
shall be paid with SEK 450,000 to the
Chairman of the Board and SEK 150,000
to each of the other board members.
it was decided that the Chairman of
the Audit Committee should receive
SEK 100,000 and the other members
of the Audit Committee SEK 50,000
each. Furthermore, it was decided that
the Chairman of the Remuneration
Committee should receive SEK 50,000
and the other members of the Remuner-
ation Committee SEK 25,000 each. The
Chairman of the Scientific Committee
shall receive SEK 50,000 and the other
members of the Scientific Committee
SEK 25,000 each. The table on page
4, shows the fees paid to members
elected by the AGM in 2021.
Remuneration to management
Remuneration issues for senior
executives are dealt with by the Board
of Directors Remuneration Committee.
The Board of Directors decides on the
CEO's remuneration on a proposal from
the Remuneration Committee. Remu-
neration and terms for senior executives
and consist of a balanced mix of fixed
salary, variable remuneration, pension
benefits and terms of notice. Salaries
and other remuneration for the 2021
financial year were paid to the CEO and
other senior executives in accordance
with what is stated in note 7 "Employees
and Personnel costs" in the Annual
Report 2021.
Guidelines on remuneration to senior
executives and Board of Directors
2021
This is a summary of the guidelines
for executive remuneration. The
complete guidelines are available in
the annual report 2021 and on the
company's website.
At the 2021 AGM, guidelines were
adopted that are valid up to the 2025
AGM as follows. Vicore shall offer
remuneration in accordance with
recruitment and retention of interna-
tionally qualified senior executives.
Remunerations within Vicore shall be
based on principles of performance,
competitiveness and fairness.
Senior executives refer to the CEO
and the other members of the executive
management. The guidelines shall apply
to employment agreements concluded
after the annual general meeting’s
resolution to adopt these guidelines,
as well as when changes are made to
existing agreements thereafter. The
remuneration to senior executives
consists of fixed remuneration, variable
remuneration, share and share-price
related incentive programs, pension and
other benefits.
The Board of Directors is entitled to
deviate from the guidelines if the Board
of Directors, in a certain case, deems that
there are good reasons for the deviation.
Fixed salary
account the individual's responsibilities
and experience. The fixed salary should
be reviewed annually.
Variable salary
Variable remuneration paid in cash may
amount to a maximum of 40 per cent
of the annual fixed remuneration of the
CEO and a maximum of 30 per cent of
the annual fixed remuneration to other
senior executives. Variable remunera-
and measurable criteria, designed to
promote the company's long-term
value creation.
Share- and share price-based
remuneration
Share- and share price-based incentive
programs shall, if applicable, be decided
by the AGM. Already decided incentive
programs are described on page 74-75.
Pension
Pension should, where possible, be
premium-based. For the CEO and other
senior executives, the premium, in
cases where a premium-based pension
is applicable, can amount to up to 30
percent of the fixed salary. The Board of
to the above, to offer other solutions
that are equivalent in cost to the above.
Severance pay etc.
A notice period of up to six months
between the company and the CEO shall
apply if notice is given by the company.
If notice is given by the company, the
Board of Directors may decide that the
CEO shall be entitled to severance pay
73 | Annual Report 2021 Vicore Pharma Holding AB (publ)
of up to twelve months' salary. In the
event of termination by the CEO, a notice
period of up to six months shall apply.
Other senior executives shall have a
notice period of three to six months.
During the notice period, normal salary
shall be paid.
Other benefits
Senior executives may be awarded
customary other benefits such as
occupational health care, etc. Such
other benefits shall not constitute a sig-
nificant part of the total remuneration.
Vetting and decision processes
The CEO's remuneration shall be vetted
by the Remuneration Committee and
decided by the Board of Directors. The
remuneration of other senior executives
shall be vetted by the CEO and the Remu-
neration Committee, which shall submit
a proposal for approval to the Board of
Directors. The Board of Directors has the
right to deviate from the above guidelines
in an individual case.
At the end of 2021, Vicore has four
active programs that include the
company's management and staff, and
certain board members. In 2018, two
long-term incentive programs were set
LTIP 2018” (expired in 2021). In 2020,
a long-term incentive program, "Board
LTIP 2020", for the two new board
members was introduced. In 2021, two
long-term incentive programs were set
LTIP 2021”.
The increase in the company’s share
capital, assuming full utilization and
maximum goal achievement of all
actíve incentive programs (i.e. including
warrants that may be used as hedge for
social security contributions), amounts
to a maximum of SEK 2,793,387,
corresponding to a dilution of 7.2 percent
of the total number of shares.
Below is a description of the various
programs. For other information about
the incentive programs, see Note 8 in
the Annual Report 2021.
Long-term incentive program 2018
The Extraordinary General Meeting of
Vicore Pharma Holding AB on August
13, 2018 resolved, in accordance with
the Board of Directors proposal to adopt
a long-term incentive program for senior
a performance-based long-term
incentive plan for certain directors
("Board LTIP 2018”) in Vicore Pharma
Holding AB. A maximum of 2,000,000
475,000 share rights (Board LTIP 2018)
may be granted to participants in the
programs. The increase in the compa-
ny's share capital upon full utilization
of both incentive programs amounts to
a maximum of around SEK 1,237,500,
which corresponds to a dilution of
approximately 3.3 percent with respect
to the total number of shares. The
participants in the programs have
received the share rights / options free
of charge and settlements is made with
equity instruments.
Board LTIP 2018
Board LTIP 2018 is a program under
which the participants will be granted,
to performance vesting that entitle to
shares in the company to be calculated
in accordance with the principles
stipulated below, however a maximum
of 475,000 shares.
Board LTIP 2018 is intended for
members of the Board of Directors of
the company independent from the
main owners. The main owners believe
that an equity-based incentive program
is a central part of an attractive and
order to attract, retain and motivate
internationally competent members of
the Board of Directors of the company,
and to focus the participants on
delivering exceptional performance
which contributes to value creation for
all shareholders.
The share awards shall vest gradually
over approximately three years and are
on the development of the company’s
share price over the period from the
date the share awards are allocated up
to and including the vesting date.
The development of the share
price will be measured based on the
volume weighted average price of the
company's share price for the 30 trading
days immediately following after 17
August, 2018, and the 30 trading days
immediately preceding the date of the
publication of the Q2 report 2021. In the
event the price of the company’s share
has thereby increased by more than
150 percent, 100 percent of the share
awards shall vest, and should the share
price have increased by 50 percent, 25
percent of such share awards shall vest.
In the event of an increase of the share
price between 50 and 150 percent,
vesting of the share awards will occur
linearly. Should the increase of the share
price be less than 50 percent, no vesting
will occur. The earliest date at which
accrued share rights may be exercised
is the date of publication of the Q2
report 2021.
During the third quarter of 2021, Board
LTIP 2018 expired. As the share price
increased by less than 50 percent during
the measurement period no share
awards were earned. The program is
now closed.
Co-worker LTIP 2018
program intended for members of
in the company. According to the
program, participants will be granted,
three-year vesting that entitle to acquire
a maximum of 2,000,000 shares in the
company in total. The exercise price per
share shall correspond to 150 percent
of the volume weighted average price of
the company’s share for the five trading
days preceding the granting date. The
latest point in time at which vested
options may be exercised shall be the
fourth anniversary of the granting date.
The Board of Directors of the
company believes that an equity-based
incentive program is a central part of an
attractive and competitive remuneration
motivate competent members of senior
company, and to focus the participants
on delivering exceptional performance
which contributes to value creation for
all shareholders.
As of December 31, 2021, options
corresponding to 1,325,800 shares have
Long-term incentive program 2020
The Annual General Meeting in Vicore
Pharma Holding AB held on May 20,
2020, resolved, in accordance with the
proposal from the Nomination Com-
mittee, to adopt a long-term incentive
program for the new members of the
Board of Directors (“Board LTIP 2020”) in
Vicore Pharma Holding AB. A maximum
of 525,000 share awards may be
allotted to participants in the program
Board LTIP 2020. The increase in the
company’s share capital, assuming full
utilization, amounts to a maximum of
approximately SEK 262,500, corre-
sponding to a dilution of 0.7 percent of
the total number of shares.
Board LTIP 2020
Board LTIP 2020 is a program under
which the participants will be granted,
to performance vesting that entitle to
shares in the company to be calculated
in accordance with the principles stip-
ulated below, however a maximum of
525,000 shares. The share awards shall
vest gradually over approximately three
vesting based on the development of
the company’s share price over the
period from the date the share awards
are allocated up to and including the
vesting date.
Board LTIP 2020 is intended for the
newly elected, main owner independent,
members of the Board of Directors in
the company. The Nomination Com-
mittee believes that an equity-based
incentive program is a central part of
in order to attract, retain and motivate
internationally competent members of
the Board of Directors, and to focus the
participants on delivering exceptional
performance which contributes to value
creation for all shareholders.
As of December 31, 2021, a total
of 525,000 share awards have been
granted in Board LTIP 2020.
74 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Long-term incentive program 2021
The Annual General Meeting in Vicore
Pharma Holding AB held on May
11, 2021, resolved to implement
a long-term incentive program for
2021”) and to implement a long-term
performance-based incentive program
for independent board members in the
company who are not participants in
Board LTIP 2020 (“Board LTIP 2021”).
A maximum of 3,000,000 options
share awards (Board LTIP 2021) may be
allotted to participants in the programs.
The increase in the company’s share
capital, assuming full utilization of
both incentive programs, amounts
to a maximum of approximately SEK
1,530,887, corresponding to a dilution
of approximately 4.1 percent of the total
also the shares which may be issued
pursuant to previously implemented
incentive programs in the company,
the maximum dilution amounts to
approximately 7.2 percent on a fully
diluted basis.
Board LTIP 2021
Board LTIP 2021 is a program under
which the participants will be granted,
to performance vesting that entitle to
shares in the company to be calculated
in accordance with the principles
stipulated below, however a maximum
of 61,773 shares. The share awards are
on the development of the company’s
share price over the period from the
date the share awards are allocated up
to and including the vesting date.
Board LTIP 2021 is intended for
independent board members in the
company who are not participants in
Board LTIP 2020. The Nomination Com-
mittee believes that an equity-based
incentive program is a central part of
in order to attract, retain and motivate
internationally competent members of
the Board of Directors, and to focus the
participants on delivering exceptional
performance which contributes to value
creation for all shareholders.
As of December 31, 2021, a total of
61,773 share awards have been granted
in Board LTIP 2021.
Co-worker LTIP 2018
program intended for members of
in the company. According to the
program, participants will be granted,
three-year vesting that entitle to acquire
a maximum of 3,000,000 shares in the
company in total. The exercise price per
share shall correspond to 125 percent
of the volume weighted average price of
the company’s share for the five trading
days preceding the granting date. The
latest point in time at which vested
options may be exercised shall be the
fifth anniversary of the granting date.
The Board of Directors of the
company believes that an equity-based
incentive program is a central part of an
attractive and competitive remuneration
motivate competent members of senior
company, and to focus the participants
on delivering exceptional performance
which contributes to value creation for
all shareholders.
As of December 31, 2021, options
corresponding to 807,600 shares have
Internal control and risk
management regarding the
financial reporting
Introduction
According to the Companies Act and
the Annual Accounts Act, the Board of
Directors are responsible for internal
control. The purpose of internal control
is to achieve efficient and effective
operations, to ensure reliable financial
reporting and information about the
business, and to comply with applicable
laws, regulations, policies and guidelines.
Vicore's internal control is based on
principles developed by the Committee
of Sponsoring Organizations of the
Treadway Commission (COSO)
which consists of five consecutive
components:
1. Control environment
2.
3. Control activities
4. Information and communication
5. Monitoring including monitoring and
evaluation
Internal control of financial reporting
Internal control over financial reporting
aims to provide reasonable reliability
and security in financial reporting and to
ensure that financial external reporting
is conducted in accordance with appli-
cable laws and accounting standards.
The Board of Directors are ultimately
responsible for internal control and
continuously evaluates, via the Audit
and internal control.
Vicore ensures internal control of
financial reporting through a qualitative
and quantitative analysis of the balance
sheet and income statement for the
Group. The purpose of the quantitative
significant and transaction-intensive
items. The qualitative analysis aims to
irregularities. Based on the results of the
analysis, significant financial processes
Vicore has designed procedures
and activities to follow up on financial
reporting and to ensure that any errors
are detected and corrected. Key controls
have been designed and followed up
as part of the effort to maintain good
internal control.
Internal audit
The Board of Directors has evaluated the
need for an internal audit function and
in view of the scope of the business and
that the Board's follow-up of internal con-
trol is deemed sufficient to ensure that
internal control is effective. The Board
reexamines the need, when changes
occur that can lead to re-examination
and at least once a year.
Control environment and risk
assessment
The control environment within Vicore
and culture that the Company's Board
and management communicate to
the organization. In order to ensure
good internal control, the Company has
adopted a series of internal guidelines,
to governing documents such as the
Board's rules of procedure, instructions
for the CEO with associated instructions
for delegation and attestation.
The Board has also established an
monitor the Company's financial posi-
tion, the effectiveness of the Company's
management to be informed of the
audit of the annual accounts and the
consolidated accounts, and to review
and monitor the auditor's impartiality
and independence. Responsibility for
control of the financial reporting has
been delegated to the Company's CEO
and CFO.
In addition to the abovementioned
controls, the company has standardized
procedures that govern the control and
quality of drug development.
Vicore's group management shall
of strategic, operational, legal and
potential problem areas and assessing
the company from achieving its vision
and goals, for example if the basic
requirements for financial reporting in
the company are not met. Within the
consequences and probabilities, and pro-
poses measures. The Audit Committee is
responsible for continuously evaluating
assist the Board of Directors with
proposals regarding the management
75 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Control activities
associated with the company's
operations, the Board of Directors has
within Vicore. Ultimately, it is the Board
situation must be evaluated annually,
after which an action plan will be drawn
up. Vicore base its control environment
assessment process. The company has
also appointed process owners who are
responsible for individual processes. The
CEO and other senior executives are all
Vicore has designed procedures
and activities to follow up on financial
reporting and to ensure that any
errors are detected and corrected.
These activities include, among other
things, follow-up and comparison of
earnings performance or items, account
reconciliations and balance sheet
specifications, as well as approval of
agreements, proxy and authorization
instructions, and accounting and
valuation principles. The company's
following up the company's financial
reporting and results. Authorizations
to IT systems are limited according to
powers, responsibilities and roles.
Information and communication
The company also has internal control
functions for information and commu-
nication that aim to ensure that correct
financial and other company informa-
tion is communicated to employees and
The company's internal instructions
and policies are available to all
employees and provide detailed
information on current routines in all
parts of the company and describe
the control functions and how they are
implemented.
Monitoring including follow-up and
evaluation
Compliance and effectiveness regarding
internal controls are regularly monitored.
The CEO ensures that the Board of
Directors receives regular reports on
the development of the company's
operations, including the development
of the company's earnings and financial
position and information on important
events, such as research results and
important agreements and contracts.
The CEO reports on these issues at
each board meeting. The company's
compliance with applicable policies
and governance documents and the
effectiveness of internal control are
of these evaluations are compiled by
the company's CEO and reported to the
Board of Directors annually. The Board of
Directors handles all interim reports and
annual reports before they are published
and follows up the audit of the internal
control via the Audit Committee. The
Audit Committee supports the Board
of Directors by preparing questions and
provides the Board of Directors with
-
bilities in the areas of internal control and
accounting and to assure the quality of
Vicore's financial reporting.
Management
The Board of Directors appoints the CEO
to lead the company. The management
team consists of 10 people:
CEO
VP Clinical Development
Head of Preclinical Development
VP Business Development
Director of Digital Therapeutics
The management team holds monthly
meetings to discuss the group's results
and financial position, follow-up of
budgets and forecasts, status in
administration, HR and organization, IR
and strategy.
The CEO's responsibility
The CEO is subordinate to the Board
of Directors and is responsible for the
company's day-to-day management and
operations of the company. The division
of duties between the Board of Directors
and CEO is specified in the rules of pro-
cedure for the Board of Directors and the
CEO's instructions. The CEO shall ensure
that the company's accounting is in order
and that the business is conducted in
accordance with relevant regulations,
for Issuers.
Directors continuously informed of
the development of the company's
operations, the company's earnings and
financial position, liquidity and credit situ-
ation, important business events and any
other event, circumstances or conditions
that may be of material importance to
the company's shareholders.
The CEO is also responsible for pro-
ducing reports and necessary documen-
tation to facilitate decisions for board
meetings and is the main presenter of
the material at board meetings.
Management team
Vicore's management team currently
consist of ten individuals; CEO Carl-Jo-
han Dalsgaard; Chief Financial Officer
Hans Jeppsson; CMO Rohit Batta, CSO
Johan Raud, VP Clinical Development
Elin Rosendahl, Head of Preclinical
Administrative Officer Nina Carlén, Chief
Commercial Officer Åsa Magnusson, VP
and Director of Digital Therapeutics
Jessica Shull.
For further information about
Vicore's management team, including
name, position, year of employment,
assignments outside the company and
holdings (own and / or related parties)
in Vicore on March 31, 2022, see page
63-64.
76 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Glossary
Agonist
A drug that has affinity for, and stimu-
lates physiological activity, via cellular
receptors that are normally stimulated
by naturally occurring substances.
Antagonist
A substance that tends to nullify the
action of another; in pharmaceutical
terms, a drug that binds to a receptor
without eliciting a biological response.
Angiotensin
Peptides and hormonal substances
within the renin-angiotensin system.
Angiotensin II, which may bind to two
different receptors; the AT1 receptor and
the AT2 receptor. Stimulation of the AT1
receptor via Angiotensin II provides inter
alia a contraction of the blood vessels
and increases the blood pressure.
AT1 receptor
Stimulation of the AT1 receptor (AT1R)
via Angiotensin II provides, among
other things, a contraction of the blood
vessels and raised blood pressure
AT2 receptor (AT2R)
The Angiotensin II type 2 receptor or AT2
receptor is regarded as the “protective”
receptor of the Renin-Angiotensin sys-
tem. Many effects seen after stimulation
of the AT2 receptor counteracts effects
mediated via the AT1 receptor thus coun-
The AT2 receptor belongs to a family of
G protein-coupled receptors. In contrast
to the ubiquitous AT1 receptor, the AT2
receptor is predominantly expressed
during embryonic development. In adults,
however, it is mainly expressed after
Clinical studies
Phase 1 is the first time that the drug is
tested on humans. This is usually done
on a small group (10-30) of healthy volun-
teers with normal weight who are men.
This is because women’s reproductive
capacity is more sensitive if it should
prove that the substance is toxic. In the
phase I study the safety of the drug is
body and its effects. In the phase I study
of the amount that is given to experimen-
tal animals, because the effect on people
Phase 2 is carried out on a larger group
of patients suffering from a disease (20-
3,000) to study how effective the drug
is to treat the disease. During phase II,
dose studies are also usually conducted
to arrive at the right dose to be given to
patients in the future. This dose is used
later in the phase III studies. Phase II
studies can be divided into early phase
(IIa) and late phase (IIb).
Phase 3 is carried out in a large
population (300-30,000) to conclusively
define how suitable the drug is to treat
the disease. This patient group should
as far as possible mimic the population
of which the finished product is to be
used on, e.g. weight, age, gender, etc.
Comparisons are made to the current
standard treatment or placebo (sugar
pill) if there is no standard treatment for
the disease. Phase III may also be divided
into two subgroups phase IIIa and phase
IIIb. In phase IIIa, the drug has not come
areas of use for it are tested.
Phase 4 comes after the drug has
new unusual side effects can be
discovered. Phase IV can be seen as
a monitoring of what is happening.
77 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Interstitial lung disease (ILD)
Term used for a group of lung diseases.
Idiopathic pulmonary fibrosis (IPF)
IPF is a chronic and ultimately fatal disease char-
acterized by a progressive decline in lung function.
The term pulmonary fibrosis means scarring
of lung tissue and is the cause of worsening
dyspnoea (shortness of breath). Fibrosis is usually
associated with a poor prognosis. IPF usually
occurs in adult individuals of between 50 and 70
years of age, and affects more men than women.
IMiD (Immunomodulatory drugs)
Is a class of drugs that affect the immune response
and contains an imide group. The IMiD class
includes thalidomide.
Preclinical research
Preclinical research is a stage of research that
begins before clinical trials (testing in humans)
can begin, and during which important feasibility,
iterative testing and drug safety data are collected.
The main goals of pre-clinical studies are to
determine the safe dose for first-in-man study and
assess a product’s safety profile.
Pulmonary arterial hypertension
(PAH)
Pulmonary arterial hypertension (PAH) is a
progressive disease characterized by high blood
pressure in the lung arteries caused by narrowing
and obstruction in the arteries of the lung.
RAS or Renin-Angiotensin System
The Renin-Angiotensin System (RAS) or the
Renin-Angiotensin-Aldosterone System (RAAS) is a
hormone system that regulates blood pressure and
have been widely used clinically to treat high blood
pressure, and for reducing mortality of patients with
myocardial infarction and heart failure patients. With
these drugs, the negative effects of Angiotensin II
Receptor
A specific molecule on the surface or within the
cytoplasm of a cell that recognizes and binds with
other specific molecules, such as the cell mole-
cules that bind with hormone or neurotransmitter
molecules and react with other molecules that
respond in a specific way.
Regulatory
authorities’ formal requirements regarding, for
example, pharmaceutical registration.
Raynaud's phenomenom
Expresses itself in that fingers or toes whitens. This
is due to decreased blood flow due to temporary
cramps in the blood vessels of the fingers.
You distinguish between primary form, which
The secondary form is often caused by damage
in connection with arteriosclerosis, SLE, previous
connection with cold. It is a side effect that occurs
there are some hereditary relationships.
Systemic sclerosis (SSc)
Systemic sclerosis (SSc) is a rheumatic disease
the fingers and toes (Raynaud's phenomenon).
(systemic sclerosis) are also affected.
Systemic sclerosis is a so-called chronic
autoimmune disease, which means that the body
responds to its own tissues in a similar way that
disease usually debuts in the ages between 30
and 50 years. There are two types of the disease.
One is called diffuse cutaneous systemic sclerosis
(dcSSc) and the other type is limited cutaneous
systemic sclerosis (lcSSc).
Orphan drugs
The regulatory authorities can grant a drug
candidate Orphan Drug Designation (ODD). Orphan
drug status is a way of encouraging research and
development of drugs for the treatment of rare
In the US and Europe, about 60 million people are
estimated to suffer from one of the 7,000 identified
rare diseases. In total, some 350 million people
around the world are estimated to suffer from one
of the rare diseases identified.
The definition of rare disease for different
markets:
USA: <200,000 patients per indication
Japan: <50,000 patients per indication
Europe: <5 per 10,000 inhabitants (approximately
250,000 patients per indication)
78 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Adress
Contact
Information
Contact
Carl-Johan Dalsgaard, CEO
Tel: +46 70 975 98 63
Hans Jeppsson, CFO
Tel: +46 70 553 14 65
Kornhamnstorg 53
Tel: + 46 31 788 05 60
Org.no.: 556680-3804
www.vicorepharma.com
79 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Vicore Pharma Holding AB Kronhusgatan 11, 411 05 Gothenburg, Sweden | +46 (0)31-788 05 60 | vicorepharma.com