1 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Vicore Pharma Holding AB (publ)
vicorepharma.com
Annual Report 2022
Table of
Contents
Vicore in brief .................................................3
Year in brief ....................................................4
CEO comments .............................................6
Vicore ambition and strategic priorities .......8
Market overview ............................................. 9
ATRAG - Unlocking the potential
of a new class of drugs .................................11
R&D program overview ..................................13
Pulmonary fibrosis and anxiety
– the patient experience ................................ 16
QA - an important pillar
in clinical development ..................................17
The Vicore team ............................................. 18
Intellectual property ....................................... 19
Vicore equity story .........................................20
Shareholder information ................................21
Annual report 2022
Administration report .....................................23
Multi-year overview ........................................30
Financial reports, group................................. 31
Financial reports, parent company................ 33
Notes, group....................................................36
Notes, parent company.................................. 53
Signatures....................................................... 57
Auditor's report........................................ .......58
Board and management.......................... ......61
Corporate governance report.........................65
Glossary..................................................... .....72
Contact information..................................... ..74
3 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Vicore
in Brief
Vicore is a clinical-stage pharmaceutical company focused on severe lung
diseases and related indications.
V
icore is an innovative Swedish
clinical-stage pharmaceutical
company dedicated to creating
life-changing treatments in diseases
where the angiotensin II type 2 receptor
(AT2 receptor) has a central role in
stopping and reversing disease pathol-
ogy. The company is establishing a
portfolio in rare lung diseases including
idiopathic pulmonary fibrosis (IPF) and
pulmonary arterial hypertension (PAH).
C21 is a first-in-class orally available
small molecule angiotensin II type 2
receptor agonist (ATRAG). Almee™ (an
investigational medical device in clinical
development) is a digital therapeutic
(DTx) based on cognitive behavioral
therapy (CBT) created to address the
psychological impact of living with
pulmonary fibrosis. Inhaled IMID is a
new formulation and delivery route of
thalidomide targeting the severe cough
associated with IPF. With our unique
expertise in the ATRAG biology we fuel
our pipeline with several new assets for
a variety of diseases, some of which
could be partnered while others could
be taken to the market by Vicore.
The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see
www.vicorepharma.com.
Vicore pipeline
Indication Program Preclinical Phase 1 Phase 2 Phase 3 Comments
IPF C21 Final data phase 2a, Q4 2023. Phase 2b trial preparations during 2023
PAH C21 Proof-of-principle study on endothelial function planned during 2023
PF anxiety Almee™ DTx Read-out pivotal study in Q4 2023
IPF cough Inhaled IMID Preclinical formulation
Cardiorenal C106 Phase 1 data, H1 2023
Multiple
indications
C103, C111,
C112
Preclinical studies
Additional
market potential
(untreated patients)
$2.8 Bn
(1)
Current
market
$4.2 Bn
(2)
There is a high unmet need for effective
treatments in IPF today and a large share of the
patients remain untreated or undertreated due
to the side effects of current treatments.
IPF market
1. Estimated based on ~40% of IPF patients currently not on treatment
2. Combined sales of Ofev and Esbriet where Ofev sales since 2019 includes the indication SSc-ILD. Source: Evaluate Pharma
4 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Stabilized disease and gain-
ing of lung function in the
phase 2a trial with C21(AIR)
in idiopathic pulmonary
fibrosis (IPF)
The AIR trial continued to recruit
patients during 2022 despite difficulties
due to the pandemic and the war
between Russia and Ukraine, where
Vicore had recruiting sites. Vicore
performed two interim analyses of
the trial during the year, the first in
February and the second in November.
The results were encouraging with an
initial stabilization of disease and a
demonstrated increase in FVC (Forced
Vital Capacity - a measurement of lung
function) up to the end of the study at 36
weeks. The second analysis, including
41 patients, further confirmed the pre-
vious results with a stabilization of lung
capacity already at week 6 and, as also
seen in the previous interim analysis, a
subsequent demonstrated increase of
lung capacity from weeks 18 to 36. The
increase was more pronounced in IPF
patients without end-stage destruction
of lung parenchyma as documented by
high resolution computer tomography
(HRCT). No new side effects occurred
which combined gives extra strength
to the benefit-risk profile of C21. The
AIR trial continues to recruit patients
and final data is estimated to the end
of 2023 with possibilities to do an
additional interim analysis mid-year.
Preparatory activities and discussions
with regulators for the next trial,
ANDAS (breathe in Swedish)- a global,
placebo-controlled phase 2b trial, are
ongoing.
Almee
TM
, pilot study com-
pleted with positive results
and pivotal study ongoing
During 2022, Vicore performed a first
phase pilot study with COMPANION.
The study is a a randomized, controlled
and parallel-group clinical investigation
evaluating the impact of digital cognitive
behavioral therapy on psychological
symptom burden in adults diagnosed
with pulmonary fibrosis (PF). This pilot
was a four week, open-label, decentral-
ized clinical investigation in ten patients
with self-reported symptoms of anxiety
related to idiopathic pulmonary fibrosis
(IPF). The primary objective of the pilot
was to test the functionality, user experi-
ence and safety of Almee
TM
. The pilot trial
objectives were met and preliminary effi-
cacy results were encouraging; after four
weeks of using the DTx GAD-7 scores
reduced by 4.2 points. A reduction in the
GAD score of ≥2 points is regarded as
clinically meaningful. The second phase,
a pivotal study, started in December
2022 and will include approximately 250
patients in the US diagnosed with any
kind of PF including IPF. The pivotal study
is estimated to read-out during Q4 2023.
C21 promotes vascular
function
In September, Vicore announced the
results from a forearm blood flow study
with intra-arterial administration of
clinically relevant doses of C21. The
results showed a significant dose-de-
pendent increase in local blood flow
(63% increase (p=0.026) in the injected
arm) and in addition, the systemic
blood pressure was unaffected and no
side effects occurred. Vasodilation by
angiotensin II type 2 receptor agonists
(AT2 receptor agonists) is mediated
by nitric oxide (NO) released from the
endothelium, and the observed effects
show that this can be achieved in man
with clinically relevant doses of C21.The
forearm blood flow study was measured
by plethysmography (an instrument to
measure changes in volume within and
organ or whole body) and is a robust
technique for early clinical concept
testing and dose-finding.
Year
in Brief
Continued progress in Vicores clinical programs, potential game-changing results
in patients with IPF and a new asset entering clinical phase during 2022.
Financial calendar
May 4, 2023 Interim report Q1 2023
May 11, 2023 Annual General Meeting
August 24, 2023 Interim report Q2 2023
November 2, 2023 Interim report Q3 2023
February 28, 2024 Year-end report 2023
Financial reports are available on the company’s website
www.vicorepharma.com from the day of publication.
Financial overview for 2022
Net sales amounted to 0.0 MSEK (0.0)
The operating loss was -290.7 MSEK (-294.8)
Loss for the period amounted to -288.4 MSEK (-296.5)
Loss per share before and after dilution -3.99 SEK (-4.25)
Cash, cash equivalents and short-term investments as of
December 31, 2022, amounted to 261.7 MSEK (371.5)
5 | Annual Report 2022 Vicore Pharma Holding AB (publ)
C106, a novel angiotensin
II type 2 receptor agonist
(ATRAG) in clinical develop-
ment
In June, the first subject was dosed
with C106, an orally administered drug
with demonstrated effects in human
fibrotic lung and kidney tissue at clinically
relevant concentrations, the next ATRAG
after C21 in clinical development. The
trial is a double-blind, placebo-controlled,
randomized, single-center trial to
evaluate the safety, tolerability and
pharmacokinetics of single and multiple
ascending oral doses of C106. It is
planned to include 72 healthy volunteers
and is being performed in Uppsala,
Sweden. The results from the trial are
expected in H1 2023.
Results from the phase 3
trial in COVID-19
In September, Vicore announced the
top-line results from the phase 3 trial
with C21 in hospitalized patients with
COVID-19 (ATTRACT-3). Vicore failed to
repeat the positive restorative results
on lung function as were seen with C21
in the phase 2 trial. In the phase 3 trial,
C21 did not meet the primary endpoint,
reduction of all-cause mortality at
60 days nor the secondary efficacy
endpoints related to disease progres-
sion and discharge. No safety signals
were detected.
The results can be explained by the
different variants of the SARS-COV-2
virus. The early wild-type virus, was
unique in that it infected alveolar epithe-
lial cells deep into the lung parenchyma,
resulting in a distinct clinical pattern and
a pathogenesis very similar to idiopathic
pulmonary fibrosis (IPF)
1
. In contrast,
the later virus mutations and especially
the Omicron variant, that became
predominant during the ATTRACT-3 trial
period, reproduces more superficially
in the bronchial mucosa in the upper
airways giving rise to a much milder
disease. The findings strengthen the
view that C21 acts by stimulating
alveolar epithelial cells which is critical
in the treatment of IPF, and explain why
it was efficacious in COVID-19 caused
by the wild type virus. Vicore decided to
discontinue further clinical development
with C21 in COVID-19.
C103, selected as next
ATRAG drug candidate
In October, Vicore announced that the
third ATRAG candidate, C103, was
selected as drug candidate. In preclin-
ical testing, C103 has shown a more
than 40,000 times higher affinity for
the angiotensin II type 2 receptor (AT2
receptor) compared to the angiotensin II
type 1 receptor (AT1 receptor). The AT2
receptor is a resolution and repair recep-
tor whereas AT1 receptor stimulation
increases blood pressure and promotes
inflammation and fibrosis. This profile
makes C103 particularly suitable for
indications such as preeclampsia.
C103, with expected patent protection
until at least 2040, will next be tested
in both general toxicology and safety
pharmacology studies as well as
reproduction toxicology studies.
Multiple abstracts and
scientific presentations
during 2022
During 2022, Vicore presented several
scientific abstracts and presentations
at medical conferences in the US
and Europe. An oral “late-breaker” at
ERS (European Respiratory Society
congress) in September covering the
IPF interim data and presented by
Professor Toby Maher was one of the
highlights gaining high interest from the
conference attendees.
Strengthened financial
situation through a directed
share issue
Vicore completed a directed share issue
in December, raising gross proceeds of
200 MSEK before transaction costs. The
share issue was subscribed by Swedish
and international institutional investors.
1.E Sinha et. al. The Lancet eBiomedicine vol 82, 2022. DOI: https://doi.org/10.1016/j.ebi-
om.2022.104185(December 2022, accessed February 2023)
6 | Annual Report 2022 Vicore Pharma Holding AB (publ)
CEO
Comments
2022 has been a productive and
successful year. The demonstration
of disease stabilization with C21 over
time in the ongoing phase 2a trial (AIR)
in idiopathic pulmonary fibrosis (IPF)
were surprisingly strong from the early
analysis in February. Prompted by
reports of success by investigators,
they have turned even more solid in the
new follow-up analysis performed in
November. By mid-2023 we expect to
have a robust data set including more
than 25 patients followed through 24
weeks and 20 patients followed through
to 36 weeks and we anticipate a further
strengthening of the previous data. So
far, C21 have shown a very mild side
effect profile without nausea or diarrhea,
which is a serious problem with the
licensed medicines.
As a consequence of the strong data
set in the AIR trial, we have started to
prepare for the next step in the develop-
ment, the ANDAS trial, a placebo-con-
trolled, randomized double-blind phase
2b study with two doses. Should data
continue to be as strong as we have
seen in the AIR trial, C21 has potential
to become a game-changer for patients
with IPF. With early diagnosis and early
treatment, we see an opportunity to
stop the disease progression and some
patients can perhaps even regain some
of the lost lung function. We aim to
design the trial to apply for a conditional
approval, should the results warrant.
Almee
TM
the digital cognitive
behavioral therapy (dCBT) for anxiety
associated with pulmonary fibrosis, has
already shown great promise. In a pilot
study performed during 2022, we saw a
50% reduction of anxiety after only four
weeks of treatment. We anticipate that
the pivotal study will be finalized during
Q4 2023, and if successful we will apply
for regulatory approval in the US.
The action of C21 in lung disease at
the alveolus, where IPF is initiated, was
further strengthened in the COVID-19
trial, where we demonstrated significant
effects of C21 in SARS-COV-2 infection
when the wild-type virus was predom-
inant. This initial SARS-COV-2 variant
infected the alveolar epithelial cells, as
opposed to the more recent variants
like Omicron which replicate only in the
airway mucosa were the AT2 receptor is
not expressed, explaining why C21 was
2022 was the year Vicore completed trials in COVID-19, which confirmed the mechanism
of action with C21 in restoring alveolar function, demonstrated stabilization of disease
with C21 in IPF in two interim analyses, showed promising effects of Almee
TM
on anxiety
in relation to pulmonary fibrosis, expanded the scope of ATRAGs to diseases associated
with endothelial dysfunction and finally advanced the first of the new ATRAG molecules
(C106) into clinical trials.
7 | Annual Report 2022 Vicore Pharma Holding AB (publ)
ineffective in the more recent COVID-19
trial. We have discontinued further
development in COVID-19, but should
there be a new surge of a deadly virus
infecting alveolar epithelium, we know
we have a promising drug candidate.
In addition to the effects demon-
strated in lung disease and on alveolar
epithelial cells, we have also demon-
strated effects on the cell lining of the
inner surface of the blood vessels, the
endothelial cells. Endothelial dysfunc-
tion is a common denominator in a wide
range of diseases with a cardiovascular
component. In two mechanistic studies
we have results demonstrating the
effects of C21 on vascular function.
Firstly in healthy volunteers, where C21
increased the forearm blood-flow in a
dose dependent manner. Secondly, and
even more impressive, were the effects
seen in patients with systemic sclerosis
(SSc) that have severe vasculopathy
and Raynaud’s phenomenon.
Pulmonary arterial hypertension (PAH)
is a microvascular disease character-
ized by endothelial dysfunction. Given
the results in healthy volunteers and SSc
patients, we are planning a proof-of-prin-
ciple study assessing effects on
endothelial dysfunction, which could
then serve as an indicator of effects also
in PAH.
Besides the therapy area rare lung
disease, we are developing a clinical
pipeline with novel and improved
molecules that, in addition to serving as
backup molecules for the development
in IPF and PAH, also could broaden the
scope for ATRAGs in medicine. Based
on the wealth of preclinical data that
has been generated with C21 and the
human data we have seen so far, it is
possible that ATRAGs will become a
new class of drugs that have potential to
merit its own chapter in pharmacology
textbooks. C21 has paved the way
and Vicore has capitalized on this
frontrunner compound to further
develop the ATRAG chemistry. This
has resulted in eight patent families
covering new molecules with different
properties, the first of which, C106, is
about to complete a phase 1 trial in
healthy volunteers assessing safety and
pharmacokinetics.
2022 was the year Vicore completed
trials in COVID-19, which confirmed
the mechanism-of-action with C21 in
restoring alveolar function, demon-
strated stabilization of disease with
C21 in IPF in two interim analyses,
showed promising effects of Almee
TM
on anxiety in relation to pulmonary
fibrosis, expanded the scope of ATRAGs
to diseases associated with endothelial
dysfunction and finally advanced the
first of the new ATRAG molecules
(C106) into clinical trials.
We are grateful for the continued
support by the investors, the hard-work-
ing Vicore team, the investigators and
the patients who are part of our clinical
trials. We look forward to keeping you
updated on our progress during 2023.
Carl-Johan Dalsgaard, CEO
8 | Annual Report 2022 Vicore Pharma Holding AB (publ)
V
icore has a strong history of
collaboration with the scientific
community, leading to a wealth
of preclinical data and ongoing clinical
research in multiple indications to
prove the AT2 receptor biology. Patients
motivate us to explore this protective
resolution and repair system to address
unmet medical needs and create value
Vicore ambition and
strategic priorities
across multiple disease areas.
With our deep expertise in the ATRAG
area, and the extensive chemistry
program generating novel ATRAGs with
improved properties, we are in a unique
position to exploit opportunities to bring
novel therapies to patient populations
with large unmet medical need.
Our near-term priorities include
advancing C21 to late-stage develop-
ment in IPF (Idiopathic Pulmonary Fibro-
sis) and realizing the DTx opportunity by
completing the ongoing clinical study
and commercializing Almee
TM
in anxiety
related to pulmonary fibrosis.
Vicore is unlocking the potential of a new class of drugs – Angiotensin II
Type 2 Receptor Agonists (ATRAGs) – with a vision to stop disease
progression and restore function.
Build and expand
Expand our presence and build a strong position
within the IPF and interstitial lung disease (ILD)
communities
Expand visibility and capabilities in the US
Optimize the Vicore operating model
Partner
Work with the scientific community, patients, and
other companies to maximize current and explore
new indications
Maximize portfolio value by combining in-house
expertise with partners in select programs to co-
develop and commercialize innovative treatments
Advance pipeline
Advance C21 to late-stage development in IPF
Realize the DTx opportunity, firstly by completing
the COMPANION trial and commercializing Almee™
in PF anxiety
Complete the phase 1 trial with C106 and continue
to fuel our clinical pipeline with new ATRAGs
Establish programs in new therapy areas, priori-
tized by strategic fit, scientific rationale and unmet
patient need
9 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Market
Overview
The global pharmaceutical markets
continue to grow, and in 2022 the overall
market is estimated to reach
$1,139 Bn with expected steady growth
rate of around 6% in the years to come,
driven by increasing access to healthcare
globally in combination with more
innovative treatments
1
. Products for rare
diseases with Orphan Drug Designation
are becoming a more and more signifi-
cant part of the pharmaceutical market,
making up about 13% of the total market
in 2022 and expected to grow at almost
double the rate compared to the overall
market, about 11% annually until 2028
2
.
IPF – still a large unmet
medical need
Idiopathic pulmonary fibrosis (IPF) is a
progressive, lethal fibrotic lung disease
that occurs primarily in middle-aged and
elderly adults. An increased prevalence
of fibrotic diseases in combination with a
rising geriatric population is driving future
growth of the IPF patient population. IPF
is considered an orphan disease and the
worldwide estimated prevalence ranges
from 0.3-4.5 per 10,000
3
.
In 2014, FDA approved two anti-fibrotic
medications: Ofev (nintedanib) and
Esbriet (pirfenidone). These drugs can
reduce the decline in lung function by
about 50 percent, but they are also
associated with side effects, causing a
large share of patients to opt out of or
not comply with their treatment. It is esti-
mated that as much as 43% of patients
in the US discontinue treatment
4
. Even
though many patients are untreated
today, the combined sales of these drugs
is estimated to be $4.2 Bn in 2022
5
.
With a growing patient population
and limited treatment options, there
is room for innovative and disease
modifying treatments. IPF is seen as an
attractive indication for drug developers
and has significant interest from the
large pharmaceutical companies.
Many acquisitions and licensing deals
have been made in the past years, with
Roche’s acquisition of Promedior in 2019
as a prominent example (see Table on
next page).
The rise of digital
therapeutics
Digital Health encompasses a broad
scope of technologies, where digital
therapeutics (DTx) are expected to show
strong growth in the coming years driven
by regulatory approvals of new products,
reimbursement routes becoming more
established and an increased demand for
digital care solutions in the wake of the
Covid-pandemic
6
. While the use of DTx is
still in its early stages, it has the potential
to disrupt the way healthcare is delivered
as it offers a cost-effective alternative to
traditional in-person behavioral health
therapies as well as pharmaceutical
treatments. With these strong funda-
mental growth drivers, the market for
digital therapeutics is estimated to grow
Patients not on
treatment in the US
43%
Prevalence (US and EU)
250,000
patients
Market size
$4.2 Bn
Orphan drug market
Forecasted annual
growth 11%
Idiopathic Pulmonary Fibrosis (IPF)
*Note: combined sales of Ofev and Esbriet where Ofev sales
since 2019 includes the indication SSc-ILD.
10 | Annual Report 2022 Vicore Pharma Holding AB (publ)
1. Evaluate Pharma – World preview 2022 (October 2022)
2. Evaluate Pharma
3. Maher et al. Global incidence and prevalence of idiopathic
pulmonary fibrosis. Respiratory research 22, 197 (2021)
4. Dempsey et al. Adoption of the Antifibrotic Medications
Pirfenidone and Nintedanib for Patients with Idiopathic
Pulmonary Fibrosis. Ann Am Thorac Soc. 18, 7 (2021)
5. Evaluate Pharma; Company reports, Roche and Boehringer
Ingelheim
6. Global Data - Digital therapeutics will empower remote
patient care in 2023 (December 2022)
7. Markets and Markets - Digital Therapeutics Market
(October 2022)
8. IQVIA – Digital Health Trends 2021 (July 2022)
9. Mobihealthnews.com – “Bill could pave the way for
prescription digital therapeutics reimbursement” (December
2022, accessed February 2023)
10. Dealroom.co - Digital Therapeutics – medical intervention
beyond the pill. (December 2022, accessed February 2023)
with 32% p.a. in the next years
7,8
. In the
US reimbursement has been the main
obstacle for broader adoption of DTx,
but an important step towards broader
reimbursement coverage was taken
during 2022 with the introduction of the
“Access to Prescription Digital Therapeu-
tics Act” to the US senate
9
. Investors see
these opportunities and venture capital
funding in DTx has increased four times
since 2017 and is estimated to reach
$1.3 Bn in 2022
10
.
Many major pharma companies have
established in-house digital health teams
or partnered with digital health develop-
ers to create and integrate DTx as they
see the opportunities in this market and
how DTx can strengthen their portfolios
by supporting drug assets. Pharma
interest in the area is taking the form of
partnerships as well as investments.
Some of the notable alliances in 2022
were the strategic deal between Sanofi
and Dario Health and the Biogen-Med-
Rhythms licensing deal for a multiple
sclerosis DTx (see Table below).
Year Target/Licensor Acquiror/Licensee Type of deal
Development stage
at transaction Area Total deal value (MUSD)*
2022 DJS Antibodies Abbvie Acquisition Preclinical Fibrosis/IPF 255
2022 Dario Health Roche Co-promotion Marketed DTx 30
2022 MedRhythms Biogen License Feasability DTx 121
2021 Aptar Voluntis Acquisition Marketed DTx 79
2020 Redx Pharma AstraZeneca License Preclinical Fibrosis/IPF 377
2020 Forbius BMS Acquisition Phase 1 Fibrosis/IPF Undisclosed
2020 Curzion Pharmaceuticals Horizon Therapeutics Acquisition Phase 2 Fibrosis/IPF 45 + milestones
2020 Enleofen Boehringer Ingelheim License Preclinical Fibrosis/IPF >1,000 per product, subject to milestones
2019 Propeller ResMed Acquisition Marketed DTx 225
2019 Promedior Roche Acquisition Phase 2 Fibrosis/IPF 1,390
2019 Galapagos Gilead Sciences License Phase 3 IPF (part of larger portfolio) 5,000
2019 Bridge Biotherapeutics Boehringer Ingelheim License Phase 1 Fibrosis/IPF 1,300
2016 Nitto Denko BMS License Phase 1b Fibrosis/IPF Undisclosed
2016 Afferent Pharmaceuticals Merck Acquisition Phase 2b IPF cough 1,250
2015 Promedior BMS Option** Phase 2 Fibrosis/IPF 1,250
2014 InterMune Roche Acquisition Marketed Fibrosis/IPF 8,300
2014 Galecto Biotech BMS Option Phase 1/2a Fibrosis/IPF 444
2012 Stromedix Biogen Acquisition Phase 2 Fibrosis/IPF 563
2011 Amira Pharmaceuticals BMS Acquisition Phase 1 Fibrosis/IPF 475
2011 Arresto BioSciences Gilead Sciences Acquisition Phase 1 Fibrosis/IPF 225 + milestones
* Total deal values including potential milestone payments
** BMS decided not to exercise its option
Source: Corporate webpages
Deals in IPF, fibrosis and DTx
11 | Annual Report 2022 Vicore Pharma Holding AB (publ)
T
he renin-angiotensin system
(RAS) is a hormone system that
regulates several important phys-
iological processes. In this system the
AT1 receptor is a well-established drug
target with ARB’s (Angiotensin receptor
blockers) as a block-buster drug class,
while the AT2 receptor has been more
elusive and difficult to study. With C21
as the first-in-class highly selective small
molecule AT2 receptor agonist (ATRAG)
taken into clinical trials, the therapeutic
benefit of targeting the AT2 receptor is
becoming increasingly apparent.
The renin-angiotensin
system (RAS) and the AT2
receptor
The RAS is regulated by the hormone
Angiotensin II and the peptide fragments
Ang 1-9 and Ang 1-7 which act on the AT1
and AT2 receptors.
The AT1 receptor is mainly involved
in blood pressure regulation through
several different mechanisms related to
constriction of blood vessels and fluid
retention, but also contributes to innate
immunity through proinflammatory
actions. When this system “over-
shoots”, it can also contribute to the
pathogenesis of diseases such as hyper-
tension, myocardial infarction and different
fibrotic conditions including pulmonary
fibrosis and chronic kidney disease.
The expression of the AT2 receptor, on
the other hand, is normally low in adult
tissues but can be upregulated during
repair and regeneration situations,
following immune and vascular reac-
tions to injury. There is strong scientific
evidence for an important protective
role of AT2 receptor activation in several
serious diseases related to cellular
senescence, fibrosis and microvascular
dysfunction. In addition to IPF, these
include e.g. pulmonary hypertension,
chronic kidney disease, atherosclerosis,
heart failure and several cognitive
disorders such as Alzheimer’s disease.
The benefit of AT2 receptor stim-
ulation has been demonstrated in
more than 100 preclinical studies, and
clinical evidence is now accumulating,
validating the preclinical results. In lung
disease, C21 can restore lung function
both in IPF and wildtype COVID-19
infection. In COVID-infection involving
the lower airways (alveoli) C21 treated
patients had a significantly lower risk
of needing oxygen supplementation
and at the 3-month follow-up, treated
patients had fewer pathological signs
on chest computer tomography.
ATRAGs - Unlocking
the potential of a
new class of drugs
ACE inhibitors
AT2R
Angiotensin 1-9
Angiotensin 1-7
AT1R
Cytoplasm
Renin
ACE
ACE2
ATRAGs
Angiotensin ll
Angiotensin l
Angiotensinogen
ARBs
• Hypertension
• Fibrosis
• Inflammation
• Small vessel dilation
• Resolution
• Repair
ACE: Angiotensin Converting Enzyme. ARB: Angiotensin Receptor Blocker. ATRAG: Angiotensin II Type 2 Receptor Agonist. AT1R: Angiotensin II Type 1 Receptor. AT2R: Angiotensin II Type 2 Receptor
Interim data from the ongoing AIR trial
in IPF indicates that patients on C21
can regain lung function, seen as an
increase in forced vital capacity.
Vascular effects of C21, seen as
increase in blood flow, was demon-
strated in systemic sclerosis patients
with severe vasculopathy and fibrosis.
The effects on endothelial cells have
now also been demonstrated in
healthy volunteers, where a robust
dilation of peripheral vessels was seen.
Since endothelial dysfunction is a key
component in many severe diseases
this finding is clinically relevant.
Vicore’s candidate drug C21 and the
new compounds C106, C103, C112
and C111 are AT2 receptor agonists
(ATRAGs). With a strong position in
ATRAG chemistry and an evolving
platform of promising new ATRAGs
with patent protection to at least
2040, Vicore holds a unique and large
potential in this area.
The renin-angiotensin system
12 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Normal alveolus Lung fibrosis development Alveolar repair
AEC1
AEC - Alveolar Epithelial Cell
Fibroblasts
AEC2
Extracellular
matrix
Myofibroblasts
CO
2
O
2
AEC1 – gas exchange. AEC2 – repair function Dysfunctional AEC2 – trigger for fibrosis
C21 stimulates AEC2 and alveolar repair
Gas exchange
TGFβ-1
ATRAG
Normal alveolus
AEC1 cells – gas exchange. AEC2 cells – repair function
Normal alveolus Lung fibrosis development Alveolar repair
AEC1
AEC - Alveolar Epithelial Cell
Fibroblasts
AEC2
Extracellular
matrix
Myofibroblasts
CO
2
O
2
AEC1 – gas exchange. AEC2 – repair function Dysfunctional AEC2 – trigger for fibrosis
C21 stimulates AEC2 and alveolar repair
Gas exchange
TGFβ-1
ATRAG
Lung fibrosis development
Dysfunctional AEC2 cells – trigger for fibrosis
Normal alveolus Lung fibrosis development Alveolar repair
AEC1
AEC - Alveolar Epithelial Cell
Fibroblasts
AEC2
Extracellular
matrix
Myofibroblasts
CO
2
O
2
AEC1 – gas exchange. AEC2 – repair function
Dysfunctional AEC2 – trigger for fibrosis
C21 stimulates AEC2 and alveolar repair
Gas exchange
TGFβ-1
ATRAG
Alveolar repair
ATRAG stimulates AEC2 cells and alveolar repair
Mechanism of action in IPF
IPF develops in lung alveoli – tiny air-filled sacks where the
exchange of oxygen and carbon dioxide takes place. Type 2
alveolar epithelial cells (AEC2) maintain alveolar integrity to keep
the lungs healthy and functioning properly. In IPF, the AEC2 cells
become dysfunctional and lose their ability to repair and maintain
alveolar integrity which is a starting point for fibrosis.
AT2 receptors are highly expressed on the AEC2 in the alveoli.
ATRAGs bind to and activate the AT2 receptor, triggering
protective signaling pathways, promoting alveolar repair and
maintenance of alveolar integrity.
13 | Annual Report 2022 Vicore Pharma Holding AB (publ)
C21 in idiopathic
pulmonary fibrosis (IPF)
AIR interim analysis data early in 2022
generated external interest in Vicore,
and gained an oral “late breaker”
presentation at ERS
1
.
In November 2022 Vicore announced
new data from the AIR, further strength-
ening the benefit-risk profile of C21.
The new results showed stabilization of
disease from week 6 and reconfirmed
the unprecedented increase in lung
function over time
2
.
The focus for 2023 is on the comple-
tion of the AIR study, and planning for
the next phase of clinical development,
ANDAS, a phase 2b trial.
R&D Program
Overview
To prepare, the Vicore team has met
with the FDA to discuss the planning of
the ANDAS trial. The trial is designed
with the input of an advisory committee
comprised of six key opinion leaders
from different countries and co-chaired
by Professor Toby Maher.
C21 in pulmonary
arterial hypertension (PAH)
In September 2022, Vicore shared data
demonstrating that intra-arterial admin-
istration of C21 results in a significant
dose-dependent increase in local blood
flow
3
. The effect of ATRAGs on blood
vessels is important for both PAH and
IPF. Vicore is now planning a proof-of-
principle study on endothelial function.
Impaired endothelial function is the
basis for the onset of PAH and such a
study can guide whether angiotensin II
type 2 receptor agonists (ATRAGs) can
affect the central mechanism of the
disease.
Immunomodulatory drug
(IMiD) in IPF cough
A new formulation of an existing
pharmaceutically active medicine,
thalidomide (an IMiD), is currently in
formulation development and is in
preclinical phase.
Vicore pipeline
Indication Program Preclinical Phase 1 Phase 2 Phase 3 Comments
IPF C21 Final data phase 2a, Q4 2023. Phase 2b trial preparations during 2023
PAH C21 Proof-of-principle study on endothelial function planned during 2023
PF anxiety Almee™ DTx Read-out pivotal study in Q4 2023
IPF cough Inhaled IMID Preclinical formulation
Cardiorenal C106 Phase 1 data, H1 2023
Multiple
indications
C103, C111,
C112
Preclinical studies
14 | Annual Report 2022 Vicore Pharma Holding AB (publ)
IPF and PF – road ahead
As a potential future leader in the treat-
ment of fibrotic lung diseases, Vicore is
committed to bringing transformational
medicines to patients. For Vicore this
means not only treating the underlying
disease but also considering the patient
in a holistic way and therefore managing
both the physical and mental impact
that comes with lung diseases.
Vicore team works collaboratively
with the scientific community and with
patients, to ensure their insights are built
into our development programmes. This
collaboration expedites the progress
of our medicines towards regulators,
payers, and ultimately brings innovative
treatments to patients.
IPF is a progressive lung disease,
characterized by an impaired ability
of the lungs to expand, due to fibrosis.
The disease develops in lung alveoli. In
IPF, type 2 epithelial cells in the alveoli
become dysfunctional and lose their
ability to repair and maintain alveolar
integrity. The loss of alveolar integrity
leads to release of profibrotic mediators
stimulating fibroblasts to produce
excessive collagen fibers causing
fibrosis.
Despite two marketed treatments for
IPF available for almost a decade, life
expectancy following diagnosis is still
only 3-5 years. In addition, the currently
available antifibrotics have limited
efficacy and significant tolerability
issues.
Vicore has an opportunity to address
the significant unmet need in IPF, based
on the mechanism of action of our novel
lead compound C21. Activating the
AT2 receptor, C21 triggers protective
signaling pathways, promoting alveolar
repair and maintenance of alveolar
integrity. It has been shown preclinically
to work through multi-modal pathways,
which may benefit complex diseases
such as IPF.
C21 has been granted orphan drug
designation in IPF by the FDA and the
EMA. The safety and pharmacokinetics
of C21 have been studied in 88 healthy
or obese subjects. Overall, C21 was
well tolerated at doses up to 100 mg
BID, administered for up to 8 days. To
date, more than 300 subjects have been
exposed.
Based on a strong scientific rationale
and the established safety and tolera-
bility of C21 in human subjects, a phase
2a study in IPF patients (AIR) is currently
underway. In February and November
2022, unprecedented interim data from
AIR was reported. The objective of this
program is to deliver supporting data for
the development of C21 in IPF.
We have a strategic commitment to
advance C21 to late-stage development
in IPF, and to bring new hope to patients
to ease their disease burden.
Vicore also aims to treat pulmonary
fibrosis (PF) anxiety – one of the most
pronounced symptoms in patients with
PF, and other interstitial lung diseases,
which propagates negative impact on
patients’ and caregivers' quality of life.
Approximately 250,000 people in the
US are living with pulmonary fibrosis,
whilst 40,000 people die from pulmo-
nary fibrosis each year. 63% of people
with pulmonary fibrosis report treatable
levels of anxiety. The cause of anxiety in
these patients is not well documented,
however it has been reported that
dyspnea (difficulty breathing) is an
independent predictor of anxiety in ILD
patients
6
.
In IPF patient studies in particular,
participants report a poor quality of life
due to their dyspnea, fatigue and poor
quality of sleep, along with depression
and anxiety
7
. Patients are often psy-
chologically affected by their diagnosis,
since the illness and the worry can
severely limit their ability to engage in
normal daily living, their independence
is often compromised, and family
relationships can become strained
8
.
Interestingly, several studies in ILD
patients have reported that there
appears to be no relationship between
anxiety and disease severity, and
that increased anxiety is more likely a
reflection of a patients’ symptomatic
burden and psychological state, than
their respiratory physiology. ILD patients
tend also to have comorbidities such
as gastro-oesophageal reflux disease,
hypertension, diabetes and COPD,
and the burden of treatment of such
comorbidities can add to the overall
psychological burden of disease. These
studies together suggest that anxiety
should be assessed in all ILD patients
regardless of the disease duration,
severity or prognosis
9
.
Current treatment options leave
significant room for improvement, with
the lack of palliative care options for IPF
patients in particular leaving much to be
desired. Variable knowledge and con-
fidence among health professionals in
managing symptoms, and psychosocial
indicators often lead to an underestima-
tion of the need
10
. Although anti-fibrotics
have been shown to reduce disease
Almee
TM
DTx in pulmonary fibrosis (PF) anxiety
Vicore’s digital Cognitive Behavioral Therapy (dCBT), Almee
TM
(an investigational medical in clinical development); for patients
with pulmonary fibrosis was demonstrated to be safe, functional,
user-friendly and to reduce anxiety symptoms by 49% in patients
with idiopathic pulmonary fibrosis in a pilot study of ten patients
4
completed in 2022.
Based on the successful pilot study, and very encouraging
feedback from patients and health care providers, a pivotal trial was
initiated in all pulmonary fibrosis patients with anxiety, scheduled to
conclude in Q4 2023
5
.
Throughout 2023 the Vicore team will closely collaborate with US
trial sites to ensure the successful completion of the pivotal study.
15 | Annual Report 2022 Vicore Pharma Holding AB (publ)
progression, no significant effect has
been observed regarding the quality
of life or mental health status of IPF
patients.
Vicore is aiming to make a real
difference in managing the psycho-
logical burden of pulmonary fibrosis
by developing an innovative digital
therapeutic, Almee
TM
, that offers digital
Cognitive Behavioural Therapy (dCBT)
to these patients.
Almee™ has been developed through
collaboration with Alex Therapeutics,
leading psychologists, ILD experts,
pulmonary rehabilitation experts, KOLs,
patient groups, and market research to
develop a series of dCBT tools to impact
clinically relevant endpoints (reducing
anxiety with ≥ 2 points in the GAD-7
scale).
New ATRAGs
Vicore is developing new patent-pro-
tected angiotensin II type 2 receptor
agonists (ATRAGs) to address a variety
of diseases where the angiotensin II
type 2 receptor (AT2 receptor) has a
central role.
In the drug discovery engine, the
collaboration with Emeriti Bio and
HaLaCore Pharma for the design and
synthesis of new potential ATRAG
compounds continues. Initial screening
of the compounds is followed by more
comprehensive tests including efficacy,
toxicology, and safety pharmacology
studies. Vicore aims is to have several
candidate drugs in different develop-
ment stages and to be a pioneer in the
development of ATRAGs as a new class
of drugs, for the treatment of different
diseases.
C106
C106 is the first follow-on ATRAG after
C21. In addition to use in IPF, there is
strong scientific rationale with preclin-
ical data supporting the stimulation of
AT2 receptor in the treatment of many
diabetes complications, such as for
example chronic kidney disease.
C106 has undergone toxicology and
safety pharmacology evaluations to
enable clinical trials for up to 4-weeks of
treatment. Toxicology studies enabling
longer-term treatment in humans are
planned. During 2022, a phase 1 study
was initiated. The aim of this study is
to evaluate the safety, tolerability, and
pharmacokinetics of single and multiple
ascending oral doses of C106 in healthy
male and female volunteers. The trial
is being conducted in Uppsala, Sweden
and results are expected H1 2023.
C103
C103 is currently in the preclinical stage.
There are intriguing preclinical data
supporting the rationale of stimulation
of the AT2 receptor in the treatment
of preeclampsia. C103 has a very high
affinity for the AT2R compared to
the AT1 receptor which makes C103
suitable for indications where any AT1
receptor stimulation is undesirable,
such as in preeclampsia. The oral
bioavailability of C103 is expected to
be low and therefore C103 is developed
using an I.V. route of administration.
Preclinical phase 1 enabling studies are
ongoing.
Scientific Advisors
Vicores scientific advisors are key opinion leaders from around the globe:
Toby Maher, Professor of Medicine and Director of Interstitial Lung Dis-
ease at Keck School of Medicine, University of Southern California, Los
Angeles (USC);
Maureen Horton, Professor of Medicine in the Division of Pulmonary
and Critical Care Medicine at the Johns Hopkins University School of
Medicine and Co-Director of the Johns Hopkins Interstitial Lung Disease
Clinic;
Dr. Fernando Martinez, Chief of the Division of Pulmonary and Critical
Care Medicine at Weill Cornell Medical College;
Kevin R. Flaherty, Professor of Medicine in the Division of Pulmonary and
Critical Care Medicine, Department of Internal Medicine at the University
of Michigan in Ann Arbor, Michigan;
Chris Denton, Professor in experimental rheumatology at UCL Medical
School and Joint Director of the Centre for Rheumatology, Royal Free
Hospital, London, and
Yoshikazu Inoue, M.D., Ph.D., Executive Director, Clinical Research
Center, National Hospital Organization Kinki-Chuo Chest Medical Center,
Osaka, Japan, and an Invited Professor, Infection, Immunology and
Oncology Cooperating Course, Graduate School of Medicine, Osaka
University;
Tamera Corte, BSc (Med), MBBS, FRACP, PhD, is Director of Interstitial
Lung Disease at Royal Prince Alfred Hospital, and Clinical Professor at
the University of Sydney.
1. Maher et al. Interim Results from AIR, An Open-label,
Single Arm, 36-week Phase 2 Trial of C21 in Subjects with
Idiopathic Pulmonary Fibrosis. Presented at ERS 2022,
Barcelona.
2.. Vicore announces new data from the IPF AIR trial
further strengthening the benefit-risk profile of C21 -
Vicore Pharma
3. Vicore announces that C21 promotes vascular function
in humans - Vicore Pharma
4. Vicore’s digital therapeutic for IPF patients shows near-
ly 50% anxiety reduction in pilot study - Vicore Pharma
5. Vicore announces first patient enrolled in COMPANION;
a digital therapeutic pivotal study for patients with pulmo-
nary fibrosis - Vicore Pharma
6. Holland et al. Respirology (2014) 19, 1215–1221.
7. Jaarsveld et al. AJTCCM Vol.25 No.1 2019
8. Bajwah et al. Palliative Medicine. 2013;27(9):869-876.
9. Holland et al. Respirology (2014) 19, 1215–1221
10. Bajwah et al. Palliative Medicine. 2013;27(9):869-876.
16 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Patients describing anxiety
When I received the diagnosis, it was
like a ton of bricks hitting you in the face.
Then, when reading that I have a three
to five years’ life expectancy following
diagnosis, was really scary and challeng-
ing. I have more than three to five years of
things that I want to do in my life.
Understanding that you have an
incurable disease and one that is likely
terminal in the not-so-distant future,
this, of course, affects your emotional
status and your positive outlook on a lot
of things. I had all kinds of images and
visions of what the future would hold, but
now I have no idea what I’m going to be
able to do or to be in the future.
When you can’t breathe or do simple
stuff like make the bed or bend over to
pick stuff up, it creates this negative
anxiety in yourself. The disease affects
Pulmonary fibrosis and
anxiety –
the patient experience
When developing Almee™ (an investigational medical device in clinical development)
we interviewed patients to create a digital therapeutic addressing the psychologi-
cal impact of living with pulmonary fibrosis. Below is an excerpt of some of these
patient interviews as well as an interview with Dr. Andrea Wierzchowski, licensed
psychologist specialized in neuropsychology in Dallas, US.
Dr. Wierzchowski - What is anxiety and how do you
recognize symptoms of anxiety?
Anxiety is an emotion characterized by feelings of persistent and excessive worries
and could include physical changes.
Some of the physiological and psychological symptoms associated with anxiety
can be feeling restless, wound up or on edge, being easily fatigued, having difficulty
concentrating, feeling irritable, having headaches, muscle aches, stomach aches, or
even unexplained pain.
You can have difficulty controlling the feelings of worry. Having sleep problems
such as difficulty falling or staying asleep, or even when you're asleep, you might
feel restless, and it might feel unsatisfying. You might experience a racing heart or
chest discomfort. You might experience trembling, nausea, dizziness, hot or cold
flashes, sweating, lump in your throat, choking, feeling confused or disoriented. Some
experience a numbness or tingling sensation, shallow or rapid breathing.
How common is anxiety in pulmonary fibrosis and how can it
be addressed?
About 60% or more of patients who have been diagnosed with pulmonary fibrosis also
experience anxiety symptoms. There is a difference between being diagnosed with an
anxiety disorder and experiencing anxiety symptoms. It can become debilitating to the
point where the worry impacts our thought process, or we have difficulty controlling
our worry or engaging in activities - so we start avoiding certain things.
Read more about the way Almee
TM
addresses this and the COMPANION trial
at almeetherapy.com
Andrea Wierzchowski, Ph.D.,
LP is a licensed Psychologist
in the Dallas-Fort Worth,
Texas area who specializes
in neuropsychology and has
worked with advanced heart
and lung patients, including
transplant recipients, over
the years. She currently
has her own practice and
is an adjunct professor at
the University of Dallas and
Texas Woman’s University.
every part of your daily life, but nobody
can see on the outside that you’re sick.
You get embarrassed of your physical
limitations, that you can’t do as much
as you used to. You’re disappointed
and scared: if I can’t do this now, what’s
going to happen next month?
The thoughts that tend to hook me
are thoughts of desperation, because
there is no cure for pulmonary fibrosis. I
feel fear because I don’t know how fast
the disease is progressing. And I feel
guilt because I worry about becoming
a burden on my family and people that
I love.
From interviews with pulmonary
fibrosis patients.
17 | Annual Report 2022 Vicore Pharma Holding AB (publ)
B
eing able to demonstrate how results were obtained requires a substantial amount of
documentation. Quality Assurance ensures processes are in place to meet the regulatory
requirements and to produce the documentation needed to demonstrate compliance with
these requirements. If a drug development company has good results from the studies but is not
able to demonstrate how these were obtained, the authorities will most likely not approve the new
drug.
Lene, what is your role and responsibilities?
I am Head of Quality Assurance, meaning that I am overall responsible for our Quality Management
System (QMS). In very close collaboration with the different stakeholders in Vicore, I ensure we have
adequate processes in place. Our QMS includes processes related to staff training, maintenance
of quality documents and systems, qualification of suppliers, handling of changes etc. as well as
processes specific to the pre-clinical, clinical, and product manufacturing areas. Part of my role is
to maintain a close collaboration with my colleagues to prevent and/or to quickly and effectively
handle the challenges that inevitably occur.
Quality Assurance
- an important pillar in
clinical development
As a drug development company, Vicore has to comply with strict regulatory
requirements related to the quality of products produced and studies conducted.
In order to ensure that studies are safe for the participants and deliver reliable
results, Vicore and our collaborators are vigilant to comply with the regulations
and at the same time demonstrate to authorities how the results are obtained.
What is Quality
Assurance?
Quality Assurance is about
having systematic and planned
processes in place to ensure
quality. These processes are
designed to ensure that studies
and products meet the quality
standards and regulatory
requirements set by the indus-
try and authorities. The work in
Quality Assurance is constantly
seeking to improve the quality
of studies and products to meet
the highest standards.
Meet Lene Eskildsen, Head of Quality Assurance
What is the most challeng-
ing part of your role?
As an employee in a small company, you
cover a wide range of tasks and have to
be a good “generalist”. Since the regula-
tory landscape and technology develops
very fast, it can be quite challenging to
be on top of everything at all times. On
the other hand, I really enjoy the large
variety and broad perspective in my role.
India is a high recruiting
site for the IPF trial. How is
Vicore securing the quality
of the clinical sites?
Vicore has a robust audit program in
place. This means that we ensure that
both our suppliers and the investiga-
tional sites which are recruiting the clin-
ical trial participants are appropriately
qualified. We ensure the quality of the
sites by having thorough site selection
and qualification procedures in place
Lene has been leading the Quality Assurance work in Vicore since
2021. She has more than 24 years of experience in a variety of
pharmaceutical industry roles, having worked in contract research
organisations, medtech companies and biotech companies.
and via audits of sites once the trial gets
going. Especially high-recruiting sites
generating a substantial amount of
data in our trials are often selected for
audits. This has also been the case for
the high-recruiting sites in India which
we have audited on-site to ensure the
quality is as expected.
What gives you the most
satisfaction/motivates you
in your work?
One real advantage of being in a small
company is the agile way of working.
I thrive with the fast decision making
and uncomplicated communication
pathways we have at Vicore. The
company culture is built on trust, which
is also a very important factor for my
motivation.
I really like driving the quality agenda
and the fact that I can contribute to
ensuring Vicore delivers safe and
efficacious new drugs to patients.
18 | Annual Report 2022 Vicore Pharma Holding AB (publ)
The Vicore
team
Employee engagement vital
to our success
In Vicore, we share the ambition to
create life-changing treatments in areas
where the AT2 receptor has a central
role in stopping and reversing disease.
Vicore has a lean and agile organization
comprised of highly experienced team
members with functional expertise
ranging from early asset development to
commercialisation and patient access.
Our success as a company depends
on our ability to attract and retain qual-
ified people who are highly engaged,
embrace change and enjoy working in
a creative and fast-paced environment.
All employees are important to turn the
Vicore ambition into reality.
We value a growth mindset
In order to accomplish our ambition,
we are building an organisation based
on trust, collaboration and challenge.
We encourage and ensure that all
employees can grow in their roles in
order to find solutions for patients and
their families.
Gender distribution, management
Education, all employees
58%
42%
Female
Male
48%
44%
8%
Ph.D.
University
High-school
Gender equality
Vicore is proud to have a gender equalized
management team and board and as a
result, Vicore have been nominated for the
Allbright award* two years in a row.
The number of employees in the group
at year-end amounted to 23, whereof 18
women and 5 men. Of the employees 17
are active within R&D.
* The Allbright award is awarded to a
Swedish company working for and showing
results for increased diversity and inclusion.
40%
Female
60%
Male
Gender distribution, board of directors
19 | Annual Report 2022 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. Moreover, Vicore relies
on orphan drug status obtained in the
EU and the US for C21 regarding treat-
ment of IPF. 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
market approval, the sale of C21 for the
treatment of IPF will also be protected
by regulatory data/ market exclusivity
(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 AT2 receptor agonists
(ATRAGs). Eight patent applications
with new ATRAGs have been filed (see
Table A).
Intellectual
Property
Table A – Substance patents related to C21 and new ATRAGs
Project Country Application date (priority) Status Expiry year (planned)
C21 US 31.05.2001 Granted 2024
ATRAG National 20.09.2019 Pending 2040
ATRAG National 19.03.2020 Pending 2041
ATRAG National 20.03.2020 Pending 2041
ATRAG National, International 01.09.2020 Pending 2041
ATRAG International 23.03.2021 Pending 2042
ATRAG International 23.03.2021 Pending 2042
ATRAG International 23.03.2021 Pending 2042
ATRAG International 09.07.2021 Pending 2042
Table B – Other patents related to product C21
Project Country Application date (priority) Status Expiry year (planned)
C21 National 23.03.2020
Granted in US/
Pending
2040/41
C21 National 24.04.2020 Pending 2041
C21 National 24.04.2020 Pending 2041
C21 National 24.04.2020 Pending 2041
C21 National 14.05.2020 Pending 2041
C21 Priority/US 10.02.2022 Pending 2042/43
20 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Vicore
equity story
Unlocking the potential of a new
class of drugs – Angiotensin II type 2 receptor
agonists (ATRAGs)
The AT2 receptor– an attractive drug target
+100 publications supporting efficacy in various
preclinical models
Unique MoA mediating tissue repair addressing
fibrosis and vasculopathy
C21 – first-in-class ATRAG
Highly selective for AT2 vs AT1 receptor
Oral bioavailability
Goodsafety and tolerability profile
Clinical efficacy data emerging in IPF andendothelial
dysfunction, confirming preclinical data
Leading position in AT2 receptor biology and
chemistry sets foundation for future growth
First follow-on ATRAG in phase 1, and one more
candidate drug has been selected
7 families of NCEs with high AT2 receptor selectivity
and patent protection to 2040+
Several significant milestones
in the coming years
Key value inflection points 2023-2025
Additional interim data in IPF phase 2a trial during 2023,
final data later in the year
Advancing C21 to late-stage development in IPF
Completion of COMPANION study in PF-related anxiety
in 2023 and prepare for launch ofAlmee™
Completion of phase 1 with C106 in H1 2023
Prove clinical concept of Thalidomide in IPF cough
Enter the clinic with novel ATRAGs (C103, C112, C111)
and continue development in new indications
Unique opportunity for
market leadership in IPF
IPF – large unmet need
Efficacy and tolerability
of current treatments are
unsatisfactory – low overall
treatment rate
With a better tolerated
therapy and improved
efficacy, significant
commercial opportunity
exists beyond the current
$4.2 Bn market
Unprecedented interim data from the IPF
phase 2a trial with C21(AIR)
Stabilized disease and increased lung unction
from week 18
Well tolerated with no identified adverse safety signals
Vicore takes a holistic patient approach to address
psychological impact of living with pulmonary
fibrosis
Almee
TM
- A digital therapy (DTx) to relieve and reduce
anxiety in pulmonary fibrosis, pivotal trial during 2023
Mean change (±SEM*) from baseline in FVC* over time
* SEM= Standard Error of the Mean, a meausure of variability. FVC= Forced Vital Capacity, a
measure of lung function
Source: Internal data from interim analysis of AIR trial, November 2022
Additional
market potential
(untreated patients)
$2.8 Bn
(1)
Current
market
$4.2 Bn
(2)
1. Estimated based on ~40% of IPF patients currently not on treatment
2. Combined sales of Ofev and Esbriet where Ofev sales since 2019 includes the indication SSc-ILD. Source: Evaluate Pharma
21 | Annual Report 2022 Vicore Pharma Holding AB (publ)
The share
Vicore’s shares are listed on Nasdaq
Stockholm with the ticker VICO and
ISIN SE0007577895. As of December
31, 2022, the total number of shares
amounted to 81,847,979 and the market
capitalization was 1,465 MSEK. The
number of shareholders amounted to
7,636. The company’s shares are issued in
one class and each share carries one vote.
Capital supply
In June 2022, Vicore carried out a
directed share issue of 87,686 shares,
corresponding to approximately 3 MSEK,
as part of milestone compensation to
the company's partners Emeriti Bio and
HaLaCore Pharma in connection with the
first subject being dosed with C106.
On December 8, 2022, Vicore success-
fully completed a directed share issue of
10,000,000 shares at a subscription price
of SEK 20,0 per share, raising 200 MSEK
before transaction costs.
Analyst coverage
The following analysts cover Vicore and
continuously analyze the company's
development:
ABG Sundal Collier, Gonzalo Artiach
Bryan Garnier, Alex Cogut
Carnegie, Arvid Necander and
Erik Hultgård
Largest shareholders
Shareholder No. of shares %
HealthCap VII L.P. 17,234,834 21.1%
Fourth Swedish National Pension Fund 8,032,041 9.8%
HBM Healthcare Investments (Cayman) Ltd. 5,425,432 6.6%
Protem 4,010,340 4.9%
Third Swedish National Pension Fund 3,066,425 3.7%
Unionen 2,771,681 3.4%
Avanza Pension 2,709,152 3.3%
Swedbank Robur Funds 2,696,549 3.3%
Handelsbanken Funds 2,672,882 3.3%
The Invus Group* 1,770,000 2.2%
Kjell Stenberg 1,551,303 1.9%
Jesper Lyckeus 1,470,000 1.8%
Karl Perlhagen 1,358,177 1.7%
Second Swedish National Pension Fund 1,012,894 1.2%
SEB Funds 726,983 0.9%
Nordnet Pension 542,451 0.7%
Carl-Johan Dalsgaard 477,981 0.6%
Mats K Andersson 440,000 0.5%
Apo Asset Management 350,734 0.4%
Nordea Life & Pension 296,322 0.4%
Jonas Wikström 292,372 0.4%
Other 22,939,426 28.0%
Total number of shares 81,847,979 100.0%
* As of May 3, 2022
Source: Monitor by Modular Finance as of December 31, 2022
Largest shareholders in Vicore as of December 31, 2022:
Shareholder
information
DNB, Patrik Ling
Nordea, Viktor Sundberg
Pareto, Dan Akschuti
Share price development
At the end of 2022, the share price was
17.90 SEK. The highest price paid for the
share during the year was 36.95 SEK on
June 9 and the lowest price paid was
12.36 SEK on February 9. The share
price increased by a total of 18 percent
during 2022.
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,
taking into account present and future
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.
Development of the share
22 | Annual Report 2022 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
2022 Share issue 0.5 10,000,000 5,000,000 81,847,979 40,923,989
2022 Share issue 0.5 87,686 43,843 71,847,979 35,923,990
2021 Share issue 0.5 11,200,000 5,600,000 71,760,293 35,880,147
2021 Issue in kind 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 Issue in kind 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 5,244 1,227,256 1.5%
10,001 - 50,000 44 1,005,018 1.2%
50,001 - 100,000 21 1,766,169 2.2%
100,001 - 500,000 28 5,768,806 7.1%
500,001 - 1,000,000 2 1,269,434 1.6%
1,000,001 - 5,000,000 11 25,089,403 31.0%
5,000,001 - 3 30,692,307 37.5%
Anonymous holdings 2,283 15,029,586 17.9%
Totalt 7,636 81,847,979 100.0%
Ownership distribution by holding
Ownership distribution in Vicore as of December 31, 2022:
Shareholder category
Number
of shares % of capital
Swedish shareholders 65,342,211 79.9%
International shareholders 16,505,768 20.1%
Shareholder types
Number
of shares % of capital
Swedish institutional shareholders 36,993,295 45.2%
International institutional shareholders 7,859,769 10.0%
Swedish retail investors 8,773,744 10.7%
Other 12,605,889 15.4%
Anonymous holdings 5,658,726 6.5%
Shareholder categories
Shareholder categories in Vicore as of December 31, 2022:
23 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Annual Report 2022
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 financial statements for the 2022 fiscal year.
The Vicore shares (VICO) are listed on
Nasdaq Stockholm’s main market. For
more information, see www.vicore-
pharma.com.
Important events during
2022
In February, an interim analysis of
the AIR phase 2 trial in idiopathic
pulmonary fibrosis (IPF) suggested
that C21 stabilizes disease and
shows an unanticipated increase in
lung function in IPF patients.
In February, Vicore announced the
advancement of C106, a novel an-
giotensin II type 2-receptor agonist
(ATRAG), to a first in human phase 1
trial.
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
flow study with C21, planned to
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.
In April, Vicore announced that the
first IPF patient to the pilot phase in
the clinical investigation (COM-
PANION) of the digital therapeutic
Almee
TM
was enrolled.
In April, Vicore submitted a clinical
trial application (CTA) to start a
phase 1 trial with the new drug
candidate C106.
In June, Vicore announced an
amendment of the primary endpoint
to all-cause mortality and a reduced
sample size in the phase 3 trial in
COVID-19.
In June, Vicore announced that the
first subject was dosed in the phase
1 trial with C106.
In June, Vicore resolved on a set-off
issue of 87,686 shares and a total
of 3 MSEK in cash as part of a mile-
stone compensation to Emeriti Bio
and HaLaCore for the start of the
phase 1 trial with C106.
In August, Vicore announced
late-breaker presentation of interim
data with C21 in the IPF trial (AIR) at
the 2022 ERS congress.
In September, Vicore announced
continued stabilization and increase
in lung capacity with C21 in the
IPF trial (AIR) and a second interim
analysis is planned for Q4 2022.
In September, Vicore announced
that the phase 3 trial with C21 in
COVID-19 (ATTRACT-3) did not
reach the primary and secondary
endpoints. Further clinical develop-
ment in this indication is discontin-
ued.
In September, Vicore announced
that clinically relevant doses of
C21 increase bloodflow in humans
without affecting systemic blood
pressure and with no side effects
observed.
In October, Vicore announced re-
sults in a pilot study with the investi-
gational digital therapeutic Almee
TM
,
addressing pulmonary fibrosis-re-
lated anxiety, which demonstrated
a nearly 50% reduction in anxiety
measured by theGAD-7 scale.
In October, Vicore announced that
C103, a novel angiotensin II type
2-receptor agonist (ATRAG), was
selected as a drug candidate.
In November, a second interim
analysis of the AIR phase 2a trial in
idiopathic pulmonary fibrosis (IPF)
with C21 showed stabilization of
disease, reinforcing previously pre-
sented data and further strengthen-
ing the benefit-risk profile.
In December, Vicore announced
that the first patient with pulmonary
fibrosis (PF) had been enrolled in
pivotal phase of COMPANION; a
pivotal study with Almee
TM
.
In December, Vicore successfully
completed a directed share issue
raising gross proceeds of 200 MSEK
before transaction costs.
Important events after the
year-end
In January, Vicore divested its entire
holding of 91,829 shares in I-Tech
AB (publ). As of December 31, 2022,
the value of the financial asset was
approximately 4.9 MSEK.
In March, Vicore was awarded
Innovation Passport designation
by the UK regulatory agency MHRA
(Medicines and Healthcare prod-
ucts Regulatory Agency) for C21 in
IPF.
24 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Result
The operating loss amounted to -290.7
MSEK (-294.8) for the full year 2022. The
result after tax for the full year 2022 was
-288.8 MSEK (-296.7). Tax amounted
to 0.4 MSEK (0.3) for the full year 2022.
Tax is mainly related to a change in
deferred tax liability attributable to
acquired intangible assets. The group’s
accumulated tax loss carryforwards
as of December 31, 2022, amounted
to 1,023.7 MSEK. 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 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 2022 amounted to -288.4
MSEK (-296.5). The loss per share before
and after dilution amounted to SEK -3.99
(-4.25) for the full year 2021.
Cash flow, investments and
financial position
Cash flow from operating activities
amounted to -299.9 MSEK (-265.2) for
the full year 2022.
Cash flow from investing activities
for the full year 2022 was 74.0 MSEK
(-7.0). 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 187.0 MSEK (318.2) for
the full year 2022. On December 8, 2022,
the company successfully completed
a directed share issue of 200 MSEK
before transaction costs amounting to
approximately 12.7 MSEK. The issue
was subscribed for by both new and
Personnel
As of December 31, 2022, the group
had 23 employees, of whom 18 were
women and five men. Of the employees,
17 are active within R&D. The group also
engages consultants for specialist tasks
and assignments on a frequent basis.
Shareholders and the share
At the end of 2022, Vicore had 7,636
shareholders and the number of shares
was 81,847,979 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, 2022, HealthCap VII
L.P. was the single largest shareholder in
Vicore, with a total of 17,234,834 shares,
corresponding to 21.1 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
21-22 in the 2022 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
management and other co-workers in
line with the interests of the sharehold-
ers. 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
existing Swedish and international
institutional investors.
As of December 31, 2022, cash
and cash equivalents amounted to
256.8 MSEK (294.2) and short-term
investments were 4.9 MSEK (77.3).
Accordingly, cash, cash equivalents and
short-term investments amounted in
total to 261.7 MSEK (371.5). The equity
ratio as of December 31, 2022, was
85.5 percent (85.0 percent) and equity
amounted to 289.1 MSEK (383.3). Total
equity and liabilities amounted to 338.0
MSEK (451.2).
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 30.4 MSEK (38.7) for
the full year 2022. Net sales mainly
consisted of management fees to group
companies. Administrative expenses
amounted to -27.8 MSEK (-19.9) for
the full year 2022. The operating profit
for the full year 2022 amounted to 0.7
MSEK (17.1). The profit amounted to
0.7 MSEK (17.6) for the full year 2022.
During the full year 2022, shareholder
contributions amounting to 250 MSEK
were provided to the subsidiaries.
Revenue
Net sales amounted to 0.0 MSEK (0.0)
for the full year 2022.
Operating expenses
Operating expenses amounted to -292.3
MSEK (-295.9) for the full year 2022.
Research and development expenses
comprise a large fraction of the
operating expenses.
Administrative expenses amounted to
-28.4 MSEK (-20.2) for the full year 2022.
The costs for share-based incentive
programs related to administrative staff
amounted to -1.1 MSEK (+2.3) for the
full year 2022.
Marketing and distribution expenses
were -9.1 MSEK (-1.4) for the full year
2022. The costs for share-based incen-
tive programs related to staff within
marketing and distribution amounted to
-0.3 MSEK (-0.1) for the full year 2022.
Research and development expenses
amounted to -250.0 MSEK (-271.8) for
the full year 2022. Research and devel-
opment expenses are mainly related to
clinical trial costs with C21. The costs
for share-based incentive programs
related to research and development
staff amounted to -3.4 MSEK (-0.7) for
the full year 2022.
Other operating income and expenses
amounted to -3.2 MSEK (-1.4) for the full
year 2022.
The total costs for the share-based
incentive programs for the full year
2022 amounted to -4.9 MSEK (+1.5),
of which -1.0 MSEK (+5.4) consisted of
provisions for social security contribu-
tions and -3.9 MSEK (-3.9) were IFRS
2 classified salary costs. These costs
have had no cash flow impact.
implement a new incentive program:
a maximum of 2,000,000 employee
stock options to senior leaders and key
persons (”Co-worker 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 3,000,000 employee stock options
to senior leaders and key persons
(”Co-worker LTIP 2021”), and 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" and the company’s website,
www.vicorepharma.com.
Assuming full utilization and
maximum goal achievement of all
granted employee stock options and
share awards as of December 31, 2022,
corresponding to 2,988,489 shares,
would entail a dilution of 3.5 percent.
Taking into account also non-granted
employee stock options and warrants
that may be used as hedge for social
security contributions, the maximum
dilution as of December 31, 2022,
amounts to 5.6 percent.
25 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Guidelines for executive
remuneration 2022
The board of directors, the CEO and
other members of the executive
management fall within the provisions
of these guidelines. The guidelines are
forward-looking, i.e. they are applicable
to remuneration agreed, and amend-
ments to remuneration already agreed,
after adoption of the guidelines by the
annual general meeting 2022. 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
Vicore is a clinical-stage pharmaceu-
tical company focused on developing
innovative medicines in severe lung
diseases and other indications where
the Angiotensin II type 2 receptor (AT2R)
plays an important role.
For more information about the
company, please see Vicore Pharma’s
company presentation at; https://vicore-
pharma.com/investors/events-pres-
entations/.
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
and key employees with those of the
shareholders.
Types of remuneration, etc.
The remuneration shall be on market
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
beyond the individual’s ordinary tasks.
Such remuneration may not exceed an
amount corresponding to 50 percent 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,
including health insurance (Sw: sjuk-
försäkring), shall be premium defined.
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 exam-
ple, life insurance and medical insurance
(Sw: sjukvårdsförsäkring). 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
and other benefits may be duly adjusted
for compliance with mandatory rules
or established local practice, taking
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 termi-
nation 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
26 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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 for non-compete undertakings.
Such 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
the non-compete undertaking applies,
however not for more than 12 months
following termination of employment.
Criteria for awarding variable cash
remuneration, etc.
The variable cash remuneration shall be
linked to predetermined and measurable
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
qualitative objectives. The criteria shall
be designed so as to contribute to the
company’s business strategy and long-
term interests, including its sustainabil-
ity, by for example being clearly linked to
the business strategy or the executive’s
long-term development. The board of
directors shall have the possibility, under
applicable law or contractual provisions,
subject to the restrictions that may
apply under law or contract, to in whole
or in part reclaim variable remuneration
paid on incorrect grounds (claw-back).
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-
tion, subject to approval by the board
of directors for those executives who
report directly to the CEO. For financial
objectives, the evaluation shall be based
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-
pany have been taken into account by
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-
tee’s tasks include preparing the board of
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
committee’s tasks include preparing
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 and how the share-
holders' views have been taken into
account
The Board has reviewed the description
of the company's business in the remu-
neration guidelines and made a minor
editorial change. No significant changes
have been made to these proposed
guidelines compared to previously
adopted guidelines. No shareholders
have provided any comments.
Description of significant
changes to the guidelines
for 2023 and how the
shareholders' views have
been taken into account
No changes have been made to the
proposed guidelines for 2023 compared
to previously adopted guidelines.
No shareholders have provided any
comments.
Nomination committee for
the 2023 Annual General
Meeting
Vicore’s nomination committee for the
2021 Annual General Meeting consists
of Staffan Lindstrand, appointed
by HealthCap VII L.P., Jan Särlvik,
appointed by Fourth Swedish National
Fund AB, Ivo Staijen, appointed by HBM
Healthcare Investments (Cayman) and
Jacob Gunterberg, Chairman of the
Board of Directors of Vicore.
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
also consider these risks.
Set forth below is a description,
without any internal order of priority, of
the risks which are considered to have
greatest significance for the company’s
future development. Risk factors related
to Vicore’s operations, industry and
markets, and further include operational
risks, regulatory risks and financial risks.
COVID-19-pandemic
The pandemic is currently not con-
sidered to have a significant negative
impact on the company's operations.
Research and development and the
dependency of four programs
Vicore's business consists mainly
of four programs (C21, IMiD, new
ATRAGs and Almee
TM
). The company's
main value may be attributable to the
potential of the company's respective
programs. The programs are in
preclinical or clinical phase. There is a
risk that Vicore's 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
27 | Annual Report 2022 Vicore Pharma Holding AB (publ)
the more advanced program C21, which
is currently of the greatest value to the
company. For example, there is a risk
that Vicore, any collaborating partners,
institutional review bodies and / or regu-
latory 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 sig-
nificant 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
ethics committee. The main markets
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").
There is a risk that the regulatory
authority and / or the ethics committee
will not grant the necessary approvals
for the company's ongoing or future
programs. There is also a risk that
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
cancelled. The aforementioned risks
could have a material adverse effect
on the company's operations, financial
position and results.
Delays in clinical studies
There is a risk that the company's
clinical studies, for example C21 in IPF,
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
also entail a risk of delays. Furthermore,
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, C21, IMiD,
and Almee
TM
, work is being performed
to identify and develop new selective
AT2 receptor molecules (ATRAGs) for
treatment of diseases within or outside
the orphan disease area. This develop-
ment work is performed in collaboration
with external researchers.
There is a risk that Vicore’s available
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
risk that the company’s work on further
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
knowhow. Patent protection for pharma-
ceutical companies may be uncertain
and involve complicated legal and
technical questions. There is a risk that
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
or revoked.
Vicore holds three granted patents for
C21. There is a risk that these patents
do not 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 programs C21,
IMiD, Almee
TM
and new ATRAGs. There is
a risk that these patent applications
28 | Annual Report 2022 Vicore Pharma Holding AB (publ)
or future patent applications by the
company are not granted. If a patent
application is not granted, it can lead to
insufficient commercial protection which
may result in termination of relevant pro-
grams due to lack of market prospects.
Both insufficient commercial protection
and a decision to terminate programs
would have a material adverse effect on
the company's program portfolio and
outlook.
Orphan drug status
In addition to the company's patents,
Vicore has received 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.
There is a risk that these protections
are not adequate for Vicore's purposes,
or that the market exclusivity or the
orphan drug status is revoked. If
Vicore’s commercial and / or intellectual
property protection is not adequate,
other actors can take advantage of this,
bypassing the company's protection,
and conduct competing drug develop-
ment, or launching competing products
on the market. If other players develop
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
constitute a competitive market.
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,
payers, patient recruitment and market-
ing than Vicore. Therefore, there is a risk
that competitors, who in many cases
have greater resources than Vicore,
may develop competing products more
quickly and / or more efficiently, achieve
broader market acceptance or succeed
in obtaining market exclusivity earlier or
in parallel with Vicore. This may lead to a
significant weakening of the company's
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 is 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
clinical trials or to market products.
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
is a risk that the company will not find
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
and retain qualified key personnel. In
the event that one or more key persons
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
key personnel, there is a risk that the
company's drug development programs
cannot be developed according to plan,
which would have significant negative
consequences for the company's
operations and program portfolio. Such
a lack of competence or resources may,
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
revenue from drug sales. It may take a
several years 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
results, market conditions, general
access to capital and Vicore's credit
rating and credit capacity. Disruptions
and uncertainty in the credit and
capital markets can also limit access to
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
financial risks, see Note 19.
The Board of Directors and the CEO
continuously assess the group’s liquidity
and financial resources in both the
short- and long-term. The annual report
has been prepared with the assumption
that the company has the ability to
continue operations for the next 12
months, in line with the going concern
principle.
Currency risk
Assets, liabilities, income and expenses
in foreign currency give rise to currency
exposures. A weakening of the Swedish
krona (SEK) against other currencies
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 compa-
ny’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 company’s financial
statements, which in turn could have
negative effects on Vicore’s financial
position and results. For further
description of the company's currency
risks, see Note 19.
29 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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, 2022, Vicore's tax
loss carryforwards amounted to 1,023.7
MSEK. Changes in ownership resulting
in a change of controlling influence
over Vicore, may impose restrictions,
in whole or in part, on the possibility
of utilizing such losses in the future.
There is also a risk that Vicore 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 2022
financial year
The following profit/loss stated in SEK
is at the disposal of the Annual General
Meeting:
Share premium reserve 1,189,010,066
Loss brought forward -38,903,595
Profit/loss of the year 1,324,806
1,151,431,277
The Board of Directors proposes that
SEK 1,151,431,277 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,
taking into account present and future
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.
30 | Annual Report 2022 Vicore Pharma Holding AB (publ)
2022 2021 2020 2019 2020
Net sales (KSEK) 0 0 0 0 508
Loss after financial items (KSEK) -288,806 -296,735 -147,315 -93,329 -21,681
Total assets (KSEK) 338,007 451,168 406,515 341,108 -301,600
Equity ratio (%) 85.5 85.0 87.2 94.3 94.6
Number of employees (average) 21 16 13 8 6
2022 2021 2020 2019 2020
Net sales (KSEK) 30,402 38,730 3,672 3,092 2,653
Profit/loss after financial items
(KSEK)
1,325 17,709 -21,826 -24,803 -11,100
Total assets (KSEK) 1,203,141 1,075,894 669,514 503,959 488,965
Equity ratio (%) 99.1 92.6 97.7 98.4 82.1
Number of employees (average) 5 4 4 3 3
Multi-year
Overview
Multi-year overview, group
Multi-year overview, parent company
31 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Consolidated statement of financial position
KSEK Note
2022
Dec 31
2021
Dec 31
ASSETS
Fixed assets
Patents, licenses and similar rights 15 68,100 67,427
Equipment 16 54 84
Contract asset 6 63 317
Long-term investments 17, 18 0 5,409
Total fixed assets 68,217 73,237
Current Assets
Other receivables 2,180 1,417
Prepaid expenses and accrued income 20 5,867 5,034
Short-term investments 21 4,940 77,281
Cash and cash equivalents 22 256,803 294,199
Total current assets 269,790 377,931
TOTAL ASSETS
EQUITY AND LIABILITIES
EQUITY 24
Share capital 40,924 35,880
Other contributed capital 1,210,811 1,021,666
Retained earnings (including profit (loss) for the period) -962,652 -674,230
Total equity attributable to the parent company's shareholders 289,083 383,316
LIABILITIES
Non-current liabilities
Contract liability 6 0 320
Other provisions 25 1,600 600
Deferred tax liability 13 905 1,210
Total non-current liabilities 2,505 2,130
Current liabilities
Contract liability 6 65 0
Trade payables 18, 19 23,495 23,984
Current tax liability 760 335
Other liabilities 3,751 1,112
Other provisions 25 127 152
Accrued expenses and deferred income 26 18,221 40,139
Total current liabilities 46,419 65,722
TOTAL LIABILITIES 48,924 67,852
TOTAL EQUITY AND LIABILITIES
Financial reports
Group
Consolidated statement of comprehensive income
KSEK Note
2022
Jan-Dec
2021
Jan-Dec
Net sales 0 0
Gross profit 0 0
Administrative expenses 4, 5 -28,380 -20,204
Marketing and distribution expenses 4 -9,149 -1,404
Research and development expenses 4 -249,965 -271,812
Other operating income and expenses 4, 9, 10 -3,231 -1,398
Profit/loss from operations -290,725 -294,818
Financial income 11 2,395 646
Financial expenses 12 -476 -2,563
Net financial income/expense 1,919 -1,917
Loss after financial items -288,806 -296,735
Tax 13 384 254
Loss for the year attributable to the parent company´s
shareholders
-288,422 -296,481
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
-288,422 -296,481
Earnings per share, before and after dilution 14 -3.99 4.25
32 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Consolidated statement of cash flow
KSEK Note
2022
Jan-Dec
2021
Jan-Dec
Operating activities
Operating profit -290,725 -294,818
Adjustment for items not included in the cash flow 27 10,560 2,099
Interest received 1,194 483
Interest paid -8 -8
Cash flow from operating activities before changes in working capital -278,979 -292,244
Cash flow from changes in working capital
Change in operating receivables -1,598 -340
Change in operating payables -19,342 27,413
Cash flow from operating activities
-299,919 -265,171
Investing activities
Acquisition of intangible assets 29 -3,000 0
Acquisition of financial assets 21 0 -77,000
Sale of financial assets 21 77,000 70,000
Cash flow from investing activities
Financing activities
Amortization contract liability -252 -239
Issue of new shares 200,000 336,000
Issue costs -12,708 -17,578
Cash flow from financing activities
Cash flow for the year
-38,879 46,012
Cash and cash equivalents at the beginning of the year
Foreign exchange difference in cash and cash
equivalents
11, 12 1,483 -431
Cash and cash equivalents at year-end
22 256,803 294,199
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, 2021
Profit/loss for the year 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
kind
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
Equity Jan 1, 2022
Profit/loss for the year 0 0 -288,422 -288,422
Other comprehensive income for
the year
Total comprehensive income for
the year
Transactions with owners:
Issue of new shares 5,044 197,956 0 203,000
Issue costs 0 -12,708 0 -12,708
Long-term incentive program 0 3,897 0 3,897
Total transactions with owners 5,044 189,145 0 194,189
Equity Dec 31, 2022
33 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Parent company’s income statement
KSEK Note
2022
Jan-Dec
2021
Jan-Dec
Net sales 2 30,402 38,730
Gross profit 30,402 38,730
Administrative expenses 3, 4, 5, 6 -27,759 -19,911
Research and development expenses 3 -1,936 -1,686
Other operating income and expenses 3 -53 -67
Profit/loss from operations 654 17,066
Interest income and similar profit items 7 676 645
Interest expenses and similar loss items 8 -5 -2
Net financial income/expense 671 643
Profit/loss after financial items 1,325 17,709
Tax 9 0 -131
Profit/loss for the year 1,325 17,578
Financial reports
Parent company
KSEK Note
2022
Jan-Dec
2021
Jan-Dec
Profit/loss for the year 1,325 17,578
Other comprehensive income
Other comprehensive income 0 0
Other comprehensive income for the year 0 0
Comprehensive income for the year
1,325 17,578
Parent company’s statement of comprehensive income
34 | Annual Report 2022 Vicore Pharma Holding AB (publ)
KSEK
Note
2022
Dec 31
2021
Dec 31
ASSETS
Fixed assets
Financial assets
Participations in group companies 10 1,049,433 796,389
Long-term investments 11 0 565
Total financial assets 1,049,433 796,954
Total fixed assets 1,049,433 796,954
Current assets 12
Receivables
Receivables from group companies 13,000 32,386
Other receivables 918 65
Prepaid expenses and accrued income 13 633 812
14,551 33,263
Short-term investments 14 565 77,281
Cash and cash equivalents 15 138,592 168,396
Total current assets 153,708 278,940
TOTAL ASSETS
1,203,141 1,075,894
Parent company’s balance sheet Parent company’s balance sheet
KSEK
Note
2022
Dec 31
2021
Dec 31
EQUITY AND LIABILITIES
EQUITY 16
Restricted equity
Share capital 40,924 35,880
Total restricted equity 40,924 35,880
Non-restricted equity
Share premium reserve 1,189,010 1,003,762
Accumulated profit or loss -38,904 -60,379
Profit for the year 1,325 17,578
Total non-restricted equity 1,151,431 960,961
TOTAL EQUITY 1,192,355 996,841
LIABILITIES
Provisions
Other provisions 17 744 507
Deferred tax liability 264 184
Total provisions 1,008 691
Current liabilities
Trade payables 5,352 622
Liabilities to group companies 18 0 75,000
Current tax liability 0 61
Other liabilities 1,935 595
Accrued expenses and deferred income 19 2,491 2,084
Total current liabilities 9,778 78,362
TOTAL LIABILITIES 10,786 79,053
TOTAL EQUITY AND LIABILITIES
1,203,141 1,075,894
35 | Annual Report 2022 Vicore Pharma Holding AB (publ)
KSEK
Share
capital
Share
premium
reserve
Loss
brought
forward
Loss
for the
year Total
Equity Jan 1, 2021
30,209 688,011 -42,483 -21,758 653,979
Transfer of previous year’s profit/loss 0 0 -21,758 21,758 0
Profit/loss for the year 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:
Issue of new shares and issue in kind 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
Equity Jan 1, 2022
35,880 1,003,762 -60,379 17,578 996,841
Transfer of previous year’s profit/loss 0 0 17,578 -17,578 0
Profit/loss for the year 0 0 0 1,325 1,325
Other comprehensive income for the year 0 0 0 0 0
Total comprehensive income for the year 0 0 17,578 -16,253 1,325
Transactions with owners:
Issue of new shares 5,044 197,956 0 0 203,000
Issue costs 0 -12,708 0 0 -12,708
Incentive programs 0 0 3,897 0 3,897
Total transaction with owners 5,044 185,248 3,897 0 194,189
Equity Dec 31, 2022
40,924 1,189,010 -38,904 1,325 1,192,355
The parent company’s report of changes in equity The parent company’s cash flow statement
KSEK Note
2022
Jan-Dec
2021
Jan-Dec
Operating activities
Operating profit 654 17,066
Adjustments for items not included in the cash flow 20 1,170 -2,215
Interest received 957 482
Interest paid -5 -2
Cash flow from operating activities before changes in working capital 2,776 15,331
Cash flow from changes in working capital
Change in operating receivables 18,712 -36,438
Change in operating payables -65,584 2,259
Cash flow from operating activities
-44,096 -18,848
Investing activities
Shareholder contributions to group companies -250,000 -320,000
Acquisition of financial assets 14 0 -77,000
Sale of financial assets 14 77,000 70,000
Cash flow from investing activities
-173,000 -327,000
Financing activities
Issue of new shares 200,000 336,000
Issue costs -12,708 -17,578
Cash flow from financing activities
187,292 318,422
The cash flow for the year
-29,804 -27,426
Cash and cash equivalents at the beginning of the year
168,396 195,822
Cash and cash equivalents at the end of the year
15 138,592 168,396
36 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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 Kornhamnstorg
53, 111 27 Stockholm
of the group is research and development of
pharmaceutical products.
On April 4, 2023, 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, 2023.
Applied regulations
Basis for the consolidated accounts
Notes
Group
New and amended standards and interpretations
not yet adopted by 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
Operating segments
expected to be recovered or settled more
37 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Financial income and expenses
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 amount.
Temporary differences are not taken into account
in consolidated goodwill or differences attributable
to participations in subsidiaries, which
38 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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
it is no longer deemed likely that they can be uti-
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.
Intangible assets
of the instruments.
39 | Annual Report 2022 Vicore Pharma Holding AB (publ)
• Amortized cost
• Fair value through profit or loss, or
• Fair value through other comprehensive
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Share capital
At December 31, 2022, the registered share capital encompassed 81,847,979 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, 2022, 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 2023, no dividend will be proposed by the board of directors for the
financial year 2022.
53 | Annual Report 2022 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
instruments. For other financial assets, impairments are based on market values.
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 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:
2022 2021
Other external expenses 10,025 10,947
Personnel expenses 19,670 10,648
Other operating expenses 60 69
Total 29,755 21,664
Note 4 Audit fees
Ernst & Young AB 2022 2021
Audit fees 310 300
Other audit related services 170 92
Tax consultancy services 0 0
Other services 0 10
Total 480 402
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 1,184 KSEK (1,066 KSEK).
Future payment commitments as of December 31 for operating leases are divided up as follows:
Future minimum lease payments 2022 2021
No later than 1 year 358 279
Between 1 and 5 years 0 0
Later than 5 years 0 0
Total 358 279
54 | Annual Report 2022 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
stock options, see Note 8 "Share-based payments" for the group.
Note 7 Interest income and similar profit items
2022 2021
Financial assets measured at amortized cost
Interest income from other financial assets 676 645
Total interest income according to the effective interest method 676 645
Total 676 645
Total in profit or loss from financial items 676 645
Note 8 Interest expenses and similar loss items
2022 2021
Financial assets measured at amortized cost
Interest expenses other financial liabilities -5 -2
Total interest expenses calculated using the effective interest method -5 -2
Total -5 -2
Total in profit or loss from financial items -5 -2
Note 9 Tax on profit for the year
2022 2021
Current tax 0 0
Change in deferred tax assets 0 -131
Recognized tax 0 -131
Reconciliation of effective tax rates 2022 2021
Loss before tax 1,325 17,709
Tax according to applicable tax rate for parent company 20.6% (20.6%) -273 -3,648
Tax effect non-deductible expenses -347 -81
Tax effect non-deductible income 0 990
Tax effect unrecognized deferred tax assets 620 2,608
Recognized tax 0 -131
Effective tax rate 0% 1%
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:
2022
Dec 31
2021
Dec 31
Provision for pension premium 0 0
Carrying amount 0 0
Specification of change in deferred tax assets:
2022
Dec 31
2021
Dec 31
Opening carrying amount 0 131
Change of temporary differences 0 -131
Carrying amount deferred tax asset 0 0
Tax loss carryforwards for which deferred tax assets have not been recognized in the balance sheet
amounted to 117,530 KSEK (107,833 KSEK). These carryforwards have no time limit. Deferred tax assets
have not been recognized for these items, as it is unlikely that the group in a foreseeable future will utilize
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
2022
Dec 31
2021
Dec 31
Vicore Pharma AB 10,000 100% 100% 918,621 665,577
INIM Pharma AB 50,000 100% 100% 130,812 130,812
1,049,433 796,389
Corp. Reg. No. Domicile of the entity Equity
Loss for the
year
Vicore Pharma AB 556607-0743 Stockholm 72,261 -276,145
INIM Pharma AB 559156-8471 Stockholm 16,615 -11,722
2022
Dec 31
2021
Dec 31
Opening cost 796,389 396,303
Acquisitions for the year 253,044 400,086
Closing accumulated cost 1,049,433 796,389
Closing carrying amount 1,049,433 796,389
55 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Note 11 Long-term investments
2022
Dec 31
2021
Dec 31
Opening cost 565 565
Reclassifications -565 0
Closing carrying amount 0 565
Note 12 Financial assets and liabilities
Financial assets and liabilities at December 31, 2022
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 13,000 13,000
Other current receivables 0 15 15
Short-term investments 0 0 0
Cash and cash equivalents 0 138,592 138,592
Total 0 151,607 151,607
Financial liablilities
Trade payables 0 5,352 5,352
Accrued expenses 0 980 980
Total 0 6,332 6,332
The maximum credit risk of the financial assets consists of the net amounts of the reported values in
the table above. The parent company has not received any pledged assets for the financial net assets.
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 maximum credit risk of the financial assets consists of the net amounts of the reported values in
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.
Based on the parent company’s assessment, taking into account other known information and
forward-looking factors, expected credit losses for any of the parent company’s financial assets are
deemed to be non-significant and no provision has therefore been recognized. The counterparties do not
have credit ratings, except for cash and cash equivalents where counterparties have credit risk ratings of
AA-, A+ and A. For a description of the expected credit loss for the cash and cash equivalents according to
the general method, see Note 19 "Financial risks" for the group.
Note 13 Prepaid expenses and accrued income
2022
Dec 31
2021
Dec 31
Prepaid rental charges 109 181
Prepaid insurances 188 120
Other prepaid expenses 336 511
Total 633 812
56 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Note 14 Short-term investments
2022
Dec 31
2021
Dec 31
Fixed-rate account, SBAB 0 77,000
Accrued interest income 0 281
Reclassification long-term investments (I-Tech AB) 565 0
Total 565 77,281
Not 15 Cash and cash equivalents
2022
Dec 31
2021
Dec 31
Available balances 138,592 168,396
Total 138,592 168,396
Note 16 Shareholders’ equity
At December 31, 2022, the registered share capital comprised 81,847,979 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
2022
Dec 31
2021
Dec 31
Opening amount 507 5,312
Provisions for the year 237 -4,805
Total 744 507
For more information about incentive programs, see Note 8 "Share-based payments" for the group.
Note 18 Liabilities to group companies
Current liabilities
2022
Dec 31
2021
Dec 31
Opening cost 75,000 0
Reclassifications -75,000 0
Additions 0 75,000
Closing carrying amount 0 75,000
Note 19 Accrued expenses and deferred income
2022
Dec 31
2021
Dec 31
Accrued personnel-related expenses 1,867 1,799
Accrued consulting fees 425 150
Other 199 135
Total 2,491 2,084
Note 20 Supplementary information to the cash flow statement
Adjustment for items not included in the cash flow
2022
Dec 31
2021
Dec 31
Incentive programs, salary costs 853 2,526
Incentive programs, social security contributions* 237 -4,805
Provision payroll tax, pension premium 80 64
Total 1,170 -2,215
Note 21 Pledged assets and contingent liabilities
For information about pledged assets and contingent liabilities in the parent company, see Note 29
"Pledged assets and contingent liabilities" for the group.
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
2022 30,402 0 0 13,000 0
2021 37,866 0 859 32 386 75,000
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.
57 | Annual Report 2022 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
describes material risks and uncertainties faced by the parent company and the companies included in the group.
Gothenburg April 4, 2023
Our audit report was submitted on April 4, 2023
Ernst & Young AB
Linda Sallander
Authorized Public Accountant
Heidi Hunter
Board member
58 | Annual Report 2022 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 2022. The annual accounts
and consolidated accounts of the company are
included on pages 23-57 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
2022 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 2022 and
their financial performance and cash flow for the year
then ended in accordance with International Financial
Reporting Standards (IFRS), as adopted by the EU,
and the Annual Accounts Act. The statutory adminis-
tration report is consistent with the other parts of the
annual accounts and consolidated accounts.
We therefore recommend that the general meeting
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 consistent 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 Inter-
national Standards on Auditing (ISA) and generally
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
the best of our knowledge and belief, no prohibited
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
that, in our professional judgment, were of most
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
risks of material misstatement of the financial
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.
Key Audit Matter 1
Description How our audit addressed this key audit matter
As of December 31, 2022, a substantial part (20.1% or SEK
68.1 million) of the Group's total assets consists of patents,
licenses and similar rights (hereinafter referred to as the
assets). The Company tests the assets for impairment
annually and when events or changes in conditions indi-
cate that the carrying value of the assets may be below the
recoverable amount. Impairment testing involves a number
of material estimates and judgments, including estimating
value in use by assessing the likelihood of future product
launch, estimating expected future discounted cash flows,
and calculating weighted average cost of capital ("WACC").
The carrying amount of the assets amounts to a
significant amount. Furthermore, impairment tests are
sensitive to changes in assumptions and are therefore a
particularly important area of our audit.
For further information, please refer to the Group's
accounting policies in Note 1, assessments and estimates
in Note 2 and information on patents, licenses and similar
rights in Note 15
Our review, conducted together with our valuation
specialists, has included, but is not limited to, the
following actions:
• Obtained an understanding of the company's
process for identifying indications of impairment
• Evaluated the methods and models used by
management when assessing impairment
including sensitivity analyses
• Reviewed the assumptions made by the
Company when examining impairment with a
focus on the assumptions for which the results of
the impairment test are most sensitive. This has
been performed, along with other procedures,
by comparing the assumptions that formed
the basis for previous years' impairment tests,
reviewing relevant market data, evaluating the
company's sensitivity analyzes and conducting
its own sensitivity analyzes.
• We have also assessed the company's
disclosures in the annual report
Other Information than the annual accounts and
consolidated account
This document also contains other information
than the annual accounts and consolidated
accounts and is found on pages 1-22 and 61-74.
The other information also includes the remuner-
ation report and were obtained before the date of
this auditor’s report. The Board of Directors and the
Managing Director 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
also take into account our knowledge otherwise
obtained in the audit and assess whether the
information otherwise appears to be materially
misstated.
If we, based on the work performed concerning
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.
59 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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.
The Audit Committee shall, without prejudice to
the Board of Director’s responsibilities and tasks in
general, among other things oversee the compa-
ny’s financial reporting process.
Auditor’s responsibility
Our objectives are to obtain reasonable assur-
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
influence the economic decisions of users taken on
the basis of these annual accounts and consoli-
dated accounts.
As part of an audit in accordance with ISAs, we
exercise professional judgment and maintain
professional skepticism throughout the audit. We
also:
• Identify and assess the risks of material
misstatement of the annual accounts and
consolidated accounts, whether due to
fraud or error, design and perform audit
procedures responsive to those risks, and
obtain audit evidence that is sufficient
and appropriate to provide a basis for our
opinions. The risk 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 disclo-
sures 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 consolidated accounts. We
also draw a conclusion, based on the audit
evidence obtained, as to whether any mate-
rial 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 inadequate,
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 dis-
closures, 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
consolidated accounts. We are responsible
for the direction, supervision and perfor-
mance 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,
actions taken to eliminate threats or related
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,
including the most important assessed risks for
material misstatement, and are therefore the key
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
In 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 2022 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.
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
justifiable considering the requirements which the
company's and the group’s type of operations, size
and risks place on the size of the parent company's
and the group’s equity, consolidation requirements,
liquidity and position in general.
60 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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
and instructions and among other matters take
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
Our objective concerning the audit of the
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:
• has undertaken any action or been guilty of
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.
Our objective concerning the audit of the 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
exercise professional judgment and maintain
professional skepticism throughout the audit.
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
on our professional judgment with starting point
in risk and materiality. This means that we focus
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.
We examine and test decisions undertaken,
support for decisions, actions taken and other
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
the Swedish Securities Market Act (2007:528) for
Vicore Phamra Holding AB (publ) for the financial
year 2022.
Our examination and our opinion relate only to the
statutory requirements.
In our opinion, the Esef report 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 (publ) 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)
of the Swedish Securities Market Act (2007:528),
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
Swedish Securities Market Act (2007:528), based
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
influence the economic decisions of users taken on
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
auditor’s judgment, including the assessment of
the risks of material misstatement in the report,
whether due to fraud or error. In carrying out this
risk assessment, and in order to design audit
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 validation that
the Esef report has been prepared in a valid XHTML
format 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 consolidated state-
ment of financial performance, financial position,
changes in equity, cash flow and disclosures in
the Esef report have been marked with iXBRL
in accordance with what follows from the Esef
regulation.
Ernst & Young AB with Linda Sallander as auditor
in charge Box 7850, 103 99 Stockholm, was
appointed auditor of Vicore Pharma Holding AB
(publ) by the general meeting of the shareholders
on the 11 May 2022 and has been the company’s
auditor since the 10 October 2018.
Gothenburg the 4th of April 2023
Ernst & Young AB
Linda Sallander
Authorized Public Accountant
61 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Board of Directors and
Management
Board of Directors
Hans Schikan
Board member since 2018
Hans Schikan is the former CEO of Prosensa (acquired by BioM-
arin). 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 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: Chairman of
InteRNA Technologies BV. Board member of Asceneuron, Hansa
Medical, Sobi, Therachon and Wilson Therapeutics.
Holdings in the company: 20,591 share awards in the framework
of the company's incentive program and 4,000 shares.
Hans is chairman of Vicore's Remuneration Committee and member
of the Audit Committee.
Independent of the company and its senior management and
independent of major shareholders of the company.
Jacob Gunterberg
Chairman since 2022. Board member since 2018
Jacob Gunterberg is a former partner at HealthCap and has a
background in venture capital investment operations and corporate
finance advisory services focusing on the life sciences sector. 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: Board member in AO Pharma AB, Aurelia
Invest AB, Disruptive Pharma Holding AB, EllAug AB, Tova Skrenen
Stockholm AB and Twiceme Technlogy Sweden AB.
Previous assignments for the past five years: Partner at Health-
Cap. Board member in 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 and Synox Therapeutics Ltd.
Holdings in the company: 6,400 shares.
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.
Heidi Hunter
Board member since 2020
Heidi Hunter has more than 25 years of experience from leading
positions in different roles within pharmaceutical development and
commercialization. She has worked strategically and operationally
from clinical and commercial development to launch execution.
Her leadership experience spans alliance management, investment
risk mitigation, global clinical and commercial management, new
business strategy development, product launch, and business
sustainability.
Born: 1958
Education: M.B.A., Marketing and International Business, The
University of Chicago. B.A., Economics and German, Magna cum
laude, The University of Michigan
Other assignments: Board member Sutro Biopharma and Bavarian
Nordic. Advisory board member MiGenTra.
Previous assignments for the past five years: President, Cardinal
Health Specialty Solutions. SVP, Global immunology business unit at
UCB, Belgium.
Holdings in the company: 116,667 share awards in the framework
of the company's incentive program and 5,000 shares.
Heidi is a member of Vicore's Audit Committee and Scientific
Committee.
Independent of the company and its senior management and
independent of major shareholders of the company.
62 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Sara Malcus
Board member since 2018
Sara Malcus has more than ten years of experience from
operational management and board work through her work
with developing early drug projects at GU Ventures, Astra
Zeneca AB and in smaller start-up 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: 20,591 share awards in the frame-
work of the company's incentive program and 2,902 shares.
Sara is a member of Vicore's Remuneration 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 positions at Schering Plough,
Bristol Myers Squibb, Roche/Genentech and AstraZeneca AB
where he was responsible for the research and development
of medicines for respiratory, inflammatory and autoimmune
symptoms.
Born: 1961
Education: Medical degree, PhD in translational science, board
certification in rheumatology, all at the University of Leiden.
Other assignments: CMO at AM-Pharma. Maarten Kraan is
a board member of Toleranzia AB and CDS Gmbh. Scientific
advisor for AER therapeutics and Cyxone AB.
Previous assignments for the past five years: R&D Director of
Pierre-Fabre SA, CMO at AM-Pharma BV.
Holdings in the company: 20,591 share awards in the frame-
work of the company's incentive program and 4,025 shares.
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.
63 | Annual Report 2022 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: MD from the Karolinska
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
framework of the company's incentive
program.
Hans Jeppsson
Chief Financial Officer since 2017
Hans Jeppsson has a cross-disciplinary
background in finance and medicine.
He has previously worked as a
biotechnology analyst at Danske Bank
as well as within preclinical research at
AstraZeneca R&D.
Education: Ph.D. in Business
Administration from the University
of Gothenburg. After he obtained his
Ph.D.-degree he conducted postdoctoral
studies at the Haas School of Business
at the UC Berkeley in the US. He also has
a background in chemical engineering
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 265,000 options within the
framework of the company's incentive
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
market, effective management of global,
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: 150,000
options within the framework of the
company's incentive program.
Johanna Gräns
Program Director, early development
since 2015
Johanna has a Ph.D and expertise in
pharmaceutical metabolism. She has
extensive experience in preclinical
interpretation and is responsible for
drug development projects.
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 168,750 options within the
framework of the company's incentive
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
securing market access and launching
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: BBA and B2B marketing
from Lund University.
Other assignments: Board member of
Think Brand Direction.
Holdings in the company: 100,000
options within the framework of the
company's incentive program.
64 | Annual Report 2022 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
industrial drug discovery projects.
Education: MD Ph.D. from the Karolinska
Institute and Vanderbilt university, USA.
Other assignments: None.
Holdings in the company: 238,991
shares and 130,000 options within the
framework of the company's incentive
program.
Mikael Nygård
VP Business Development since 2021
Mikael has extensive experience from
Business Development in the healthcare
industry. He has led M&A and Corporate
Development at the care provider
Humana AB and has also worked in the
global healthcare team at the strategy
consulting firm Boston Consulting
Group.
Education: M.Sc. Pharmacy, Uppsala
University. Ph.D. Neurobiology,
Karolinska Institutet.
Other assignments: None.
Holdings in the company: 4,031
shares and 91,000 options within the
framework of the company's incentive
program.
Rohit Batta
Chief Medical Officer since 2018
Rohit Batta has over 20 years of
experience as a medical doctor with an
extensive background leading medical
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: 215,000
options within the framework of the
company's incentive program.
Nina Carlén
Chief Administrative Officer since 2009
Nina has more than 20 years of
experience working with marketing and
communication in the pharmaceutical
industry.
Education: Completed training in project
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 200,000 options within the
framework of the company's incentive
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
roles she worked on digital health
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. in
Biomedicine.
Other assignments: None.
Holdings in the company: 100,000
options within the framework of the
company's incentive program.
65 | Annual Report 2022 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 2022 corporate
governance report.This report on
corporate governance has been prepared
in accordance with the provisions of the
Swedish Code of Corporate Governance
("the Code") and ch. 6. Sections 6–9
of the Annual Accounts Act and ch. 9
Section 31 of the Companies Act and
refers to the financial year 2022.
The company's shares have been listed
on Nasdaq Stockholm since September
27, 2019. The company's shares were
previously, since December 2015, listed
on the Nasdaq First North Growth
Market. 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. aktiebolagslagen) and
other Swedish legislation, the Nasdaq
Stockholm Rulebook for issuers and the
Code.
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 2022. No infringements of Nasdaq
Stockholm’s rules and no breach of good
practice on the securities market was
reported by the stock exchange’s discipli-
nary 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
and financial reporting (IFRS)
Nasdaq Stockholm Rulebook for
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
the financial reporting instruction
Finance policy
Financial handbook
Internal control policy
Risk management policy
Information policy
Insider policy
IT policy
Authorization framework
Shareholders and the share
At the end of 2022, Vicore had 7,638
shareholders and the number of shares
was 81,847,979 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, 2022, HealthCap VII
L.P. was the single largest shareholder in
Vicore, with a total of 17,234,834 shares,
corresponding to 21.1 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
21-22 in the 2022 annual report.
General meetings of shareholders
According to the Companies Act
(2005: 551), the General Meetings of
shareholders is the company's highest
decision-making body. At the General
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
be held in Stockholm or Gothenburg.
Shareholders who wish to attend
General Meetings, in person or through
a representative, must be included in the
share book kept by Euroclear Sweden AB
six (6) banking days before the General
Meeting and make a notification to the
company in accordance with the notice.
Notice of General Meetings is made
through advertising and via the company
website (www.vicorepharma.com).
Nomination
Committee
Remuneration
Committee
Board of
Directors
Audit
Committee
Scientific
Committee
CEO and
Management
team
Shareholders
Annual General
Meeting
External
Auditors
66 | Annual Report 2022 Vicore Pharma Holding AB (publ)
2022 AGM
The Annual General Meeting 2022
was held through advance voting
(postal voting), pursuant to temporary
legislation, on May 11, 2022. At the
AGM, approximately 62.2 percent of
the total votes were represented. Jacob
Gunterberg was elected chairman of the
meeting.
At the AGM the following principal
resolutions were passed:
Jacob Gunterberg, Maarten Kraan,
Sara Malcus, Hans Schikan and
Heidi Hunter were re-elected as
board members. Jacob Gunterberg
was elected Chairman of the Board.
Ernts & Young AB with principal au-
ditor Linda Sallander was re-elected
as auditor.
Remuneration, including an
additional fee subject to the board
members’ acquisition of shares in
Vicore Pharma, to the Chairman of
the Board and the Board's mem-
bers, elected by the Annual General
Meeting and the auditor were estab-
lished.
Proposed guidelines for remuner-
ation to senior executives were
approved.
Authorization to issue new shares
corresponding to not more than 20
per cent of the number of outstand-
ing shares and votes at the time of
the AGM.
Resolution on adoption of remuner-
ation report 2021.
Resolution on adoption of balance
sheet and income statement.
No dividend will be paid for 2021
and the company's earnings shall be
carried forward.
Discharge from liability of the Board
of Directors and CEO for the finan-
cial year 2021.
Full minutes and information from the
AGM are available on Vicore's website
(www.vicorepharma.com).
AGM 2023
The 2023 Annual General Meeting will
be held on May 11, 2023, in Stockholm.
Information on the decisions made
at the Annual General Meeting will be
published on May 11, 2023, 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
2023 consists of Staffan Lindstrand
(Chairman) appointed by HealthCap VII
L.P., Jan Särlmark appointed by Fjärde
AP-fonden and Ivo Staijen appointed by
HBM Healthcare Investments (Cayman)
Ltd. Staffan Lindstrand is chairman
of the Nomination Committee. The
Committee also includes the Chairman
of the Board, Jacob Gunterberg, as
convenor.
The task of the Nomination Commit-
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
any, remuneration for committee work,
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
latest in conjunction with the notice of
the AGM 2023.
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. In
addition, the auditor has participated in
all Audit Committee meetings without
the presence of the CEO or other senior
executive.
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 Ernst
& Young AB has been auditor of the
company. As of the 2022 AGM, certified
public accountant Linda Sallander is
the auditor in charge. Linda Sallander
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
2022 Annual Report.
67 | Annual Report 2022 Vicore Pharma Holding AB (publ)
The Board of Directors
The Board of Directors is the company's
highest decision-making body after the
Annual General Meeting. According to
the Companies Act, the Board of Direc-
tors is responsible for the company's
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
of the Board of Directors' work and
for the Board of Directors' work being
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
and tasks of the Board of Directors,
decision-making within the company,
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
meeting in conjunction with the Annual
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. The CEO, CFO and CAO have
attended the board meetings 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 five
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
Board, education, work experience,
assignments in the company, other
significant assignments and their
respective direct and indirect holdings in
the company as of December 31, 2022.
Ownership in the company includes
personal and / or related parties'
holdings.
Board of Directors’ work 2022
During 2022, the Board of Directors
held 12 board meetings, including the
inaugural meeting, of which 5 through
digital channels. In addition, the Board
of Directors has made decisions per
capsulam on 6 occasions during 2022.
The issues that the Board of Directors
dealt with in 2022 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 2022, the members have
been present as shown below.
Evaluation of the Board of Directors’
work
Pursuant to the Code, the Board of
Directors is to evaluate its work annually,
using a systematic and structured
process, with the aim of developing the
Board of Directors' working methods
and efficiency. The work of the Board of
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.
Reporting period January 1 – December 31, 2022
1) Fee set by the AGM, excluding social security contributions, for the May 2022 to May 2023 financial year
2) Figures in table show the total number of meetings attended/total number of meetings
3) Additional fee subject to the board members’ acquisition of shares in Vicore Pharma
4) Excluding per capsulam meetings
Independent in relation to Remuneration, KSEK
1
Attendance
2)
Board member Function Elected
The company and
its management
Major
shareholders
Board
fees
Additional
board fee
3
Remuneration
Committee
Audit
Committee
Scientific
Committee Total
Board of
Directors
4
Remuneration
Committee
Audit
Committee
Scientific
Committee
Jacob Gunterberg Chairman 2018 Yes Yes 437.5 437.5 - 100 25 1,000 11/12 - 6/6 5/5
Heidi Hunter Board member 2020 Yes Yes 175 175 - 50 25 425 12/12 - 5/6 5/5
Hans Schikan Board member 2018 Yes Yes 175 175 50 50 - 450 11/12 5/5 3/3
5
2/2
6
Maarten Kraan Board member 2018 Yes Yes 175 175 25 - 50 425 10/12 5/5 - 5/5
Sara Malcus Board member 2018 Yes Yes 175 175 25 - - 375 12/12 2/2
7
3/3
8
-
Michael Wolff Jensen
9
Chairman 2020 Yes Yes - - - - - - 3/3 2/2 - -
5) Elected to the Audit Committee in May 2022
6) Exited the Scientific Committee in May 2022
7) Elected to the Remuneration Committee in May 2022
8) Exited from the Audit Committee in May 2022
9) Resigned from the board in March 2022
68 | Annual Report 2022 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: Hans Schikan (Chairman),
Sara Malcus and Maarten Kraan. The
Remuneration Committee shall fulfill the
tasks specified in the Code. The Remu-
neration Committee shall keep minutes
at its meetings and make the minutes
available to the Board of Directors.
The Remuneration Committee's main
tasks are as follows:
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 2022, the Remuneration Committee
held five meetings.
Audit Committee
The Audit Committee is appointed by
the Board of Directors and consists of
Jacob Gunterberg (Chairman), Heidi
Hunter and Hans Schikan.
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,
monitor the company’s financial
reporting, monitor the effectiveness
of the company’s internal control,
internal audit and risk management,
keep informed of the audit of the
annual accounts and the consolidat-
ed 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 2022, 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),
Jacob Gunterberg and Heidi Hunter.
The main tasks and responsibilities of
the Committee are:
Reviewing and discussing the
company's preclinical and clinical
product portfolio, including its com-
mercial attractiveness and ranking.
Reviewing and discussing the com-
pany's R&D strategy and reviewing
scientific and technological trends
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 2022, the Scientific Committee held
five meetings.
Remuneration
Remuneration to the Board of Directors
At the Annual General Meeting on
May 11, 2022, it was resolved that the
remuneration to the members of the
Board of Directors for the period up to the
end of the 2023 Annual General Meeting
shall be paid with 437,500 SEK to the
Chairman of the Board and 175,000 SEK
to each of the other board members.
As remuneration for committee work,
it was decided that the Chairman of the
Audit Committee should receive 100,000
SEK and the other members of the Audit
Committee 50,000 SEK each. Further-
more, it was decided that the Chairman
of the Remuneration Committee should
receive 50,000 SEK and the other mem-
bers of the Remuneration Committee
25,000 SEK each. The Chairman of
the Scientific Committee shall receive
50,000 SEK and the other members of
the Scientific Committee 25,000 SEK
each. In addition, it was resolved to pay
an additional fee to the board members
of 437,500 SEK to the Chairman of the
Board and 175,000 SEK to each of the
other board members. The additional fee
was conditional of the board member
purchasing shares in Vicore Pharma
Holding for the full amount (net tax).The
table on page 67, shows the fees paid to
members elected by the AGM in 2022.
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
are based on market conditions and
consist of a balanced mix of fixed salary,
variable remuneration, pension benefits
and terms of notice. Salaries and other
remuneration for the 2022 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
2022.
Guidelines on remuneration to senior
executives and Board of Directors
2022
This is a summary of the guidelines for
executive remuneration. The complete
guidelines are available in the annual
report 2022 and on the company
website.
At the 2022 AGM, guidelines were
adopted that are valid up to the 2026
AGM as follows. Vicore shall offer
remuneration in accordance with
market practice which enables the
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
The fixed remuneration shall take into
account the individual's responsibilities,
experience and performance. The fixed
salary should be reviewed annually.
Variable salary
Variable remuneration paid in cash may
amount to a maximum of 40 percent
of the annual fixed remuneration of the
CEO and a maximum of 30 percent of
the annual fixed remuneration to other
senior executives. Further variable
cash remuneration may be awarded
in extraordinary circumstances. Such
remuneration may not exceed an
amount corresponding to 50 percent of
the fixed annual cash salary and may
not be paid more than once per year for
each individual. Variable remuneration
must be linked to predetermined
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 8-9.
69 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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
Directors has the right, without prejudice
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 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 up 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
if there are special reasons that justify it
in an individual case.
Incentive programs
At the end of 2022, Vicore has four
active programs that include the compa-
ny's management and staff, and certain
board members. In 2018, a long-term
incentive program , “Co-worker LTIP
2018”, was set up. 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 up:
“Co-worker LTIP 2021” and “Board LTIP
2021”.
Assuming full utilization and
maximum goal achievement of all
granted employee stock options and
share awards as of December 31, 2022,
corresponding to 2,988,489 shares,
would entail a dilution of approximately
3.5 percent. Taking into account also
non-granted employee stock options
and warrants that may be used as
hedge for social security contributions,
the maximum dilution as of December
31 amounts to approximately 5.6
percent.
Below is a description of the various
programs. For other information about
the incentive programs, see Note 8 in
the Annual Report 2022.
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
executives and key employees
("Co-worker LTIP 2018"). A maximum
of 2,000,000 options may be granted
to participants in the program. The
increase in the company's share capital
upon full utilization of both incentive
programs amounts to a maximum of
around SEK 1,000,000, which corre-
sponds to a dilution of approximately
2.4 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 are made with equity
instruments.
Co-worker LTIP 2018
Co-worker LTIP 2018 is an incentive
program intended for members of
senior management and key persons
in the company. According to the
program, participants will be granted,
free of charge, options subject to a
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
package in order to attract, retain and
motivate competent members of senior
management and key persons in the
company, and to focus the participants
on delivering exceptional performance
which contributes to value creation for
all shareholders.
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 0.6 percent of
the total number of shares.
Board LTIP 2020
Board LTIP 2020 is a program under
which the participants will be granted,
free of charge, share awards subject
to performance vesting that entitle to
shares in the company to be calculated in
accordance with the principles stipulated
below, however a maximum of 525,000
shares. The share awards shall vest
gradually over approximately three years
and are subject to performance vesting
based on the development of the compa-
ny’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 Committee
believes that an equity-based incentive
program is a central part of a competitive
remuneration package 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.
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
senior management and key persons
in the company (“Co-worker LTIP
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
(Co-worker LTIP 2021) and 61,773
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 3.6 percent of the total
number of shares.
Board LTIP 2021
Board LTIP 2021 is a program under
which the participants will be granted,
free of charge, share awards subject
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
subject to performance 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.
70 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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
a competitive remuneration package
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.
Co-worker LTIP 2018
Co-worker LTIP 2021 is an incentive
program intended for members of
senior management and key persons
in the company. According to the
program, participants will be granted,
free of charge, options subject to
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
package in order to attract, retain and
motivate competent members of senior
management and key persons in the
company, and to focus the participants
on delivering exceptional performance
which contributes to value creation for
all shareholders.
Internal control and risk
management regarding the
financial reporting
Introduction
According to the Companies Act and
the Annual Accounts Act, the Board
of Directors is 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 guide-
lines.
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 compo-
nents:
1. Control environment
2. Risk assessment
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 is ultimately
responsible for internal control and
continuously evaluates, via the Audit
Committee, Vicore's risk management
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
analysis is to identify risks linked to
significant and transaction-intensive
items. The qualitative analysis aims to
identify risks linked to complexity and
irregularities. Based on the results of the
analysis, significant financial processes
and risks have been identified.
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 concluded that it is not justified
in Vicore in view of the scope of the
business and that the Board's follow-up
of internal control 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 is
part of the framework for the orientation
and culture that the Company's Board
and management communicate to
the organization. In order to ensure
appropriate risk management and
good internal control, the Company has
adopted a series of internal guidelines,
work processes and routines, in addition
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 Audit
Committee whose main task is to moni-
tor the Company's financial position, the
effectiveness of the Company's internal
control, internal audit and risk manage-
ment to be informed of the audit of the
annual accounts and the consolidated
accounts, and to review and monitor
the auditor's impartiality and independ-
ence. Responsibility for ongoing work
regarding the internal 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
annually conduct a risk assessment
of strategic, operational, legal and
financial risks with the aim of identifying
potential problem areas and assessing
the risk exposure in the company. The
risk assessment includes identifying
risks that may arise that may prevent
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
scope of each risk area, the responsible
person identifies risks and their potential
consequences and probabilities, and pro-
poses measures. The Audit Committee is
responsible for continuously evaluating
the company's risk situation and shall
assist the Board of Directors with
proposals regarding the management
of the company's financial risk exposure
and risk management.
Control activities
To identify and manage the risks asso-
ciated with the company's operations,
the Board of Directors has adopted a risk
management policy. Risk management is
a high priority within Vicore. Ultimately, it is
the Board of Directors that is responsible
for risk management. The company's
risk situation must be evaluated annually,
after which an action plan will be drawn
up. Vicore bases its control environment
on the risks identified during the risk
assessment process. The company has
also appointed process owners who are
responsible for individual processes. The
CEO and other senior executives are all
involved in the ongoing work to manage
the risks associated with the business.
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 bank transactions and
cooperation agreements, proxy and
authorization instructions, and accounting
and valuation principles. The company's
CFO has a key role in analyzing and
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
other stakeholders.
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.
71 | Annual Report 2022 Vicore Pharma Holding AB (publ)
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
subject to annual evaluation. The results
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
support in its work to fulfill its responsi-
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 ten people:
CEO
Chief Financial Officer
Chief Medical Officer
Chief Scientific Officer
VP Clinical Development
Program Director, early develop-
ment
Chief Administrative Officer
Chief Commercial Officer
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
research and development projects,
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,
including Nasdaq Stockholm’s Rule Book
for Issuers.
The CEO shall keep the Board of
Directors continuously informed of
the development of the company's
operations, the company's earnings and
financial position, liquidity and credit
situation, important business events
and any other event, circumstances
or conditions that may be of material
importance to the company's share-
holders.
The CEO is also responsible for
producing reports and necessary
documentation 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, Program Director, early
development Johanna Gräns, Chief
Administrative Officer Nina Carlén, Chief
Commercial Officer Åsa Magnusson, VP
Business Development Mikael Nygård
and Director of Digital Therapeutics
Jessica Shull.
For further information about
Vicore's management team, including
name, position, year of employment,
education, work experience, significant
assignments outside the company and
holdings (own and / or related parties)
in Vicore on December 31, 2022, see
pages 63-64.
72 | Annual Report 2022 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.
The most potent form known as
Angiotensin II, which may bind to two
different receptors; the AT1 receptor and
the AT2 receptor.
AT1 receptor
Stimulation of the AT1 receptor via Angi-
otensin II provides, among other things,
a contraction of the blood vessels and
raised blood pressure
AT2 receptor
The Angiotensin II type 2 receptor or AT2
receptor is regarded as the “protective”
receptor of the Renin-Angiotensin
system. In contrast to the ubiquitous AT1
receptor, the AT2 receptor is predom-
inantly expressed during embryonic
development. In adults, however, it is
mainly expressed after injury and in
different disease states.
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
investigated, how it is broken down in the
body and its effects. In the phase I study
the subject is only given a small fraction
of the amount that is given to experimen-
tal animals, because the effect on people
is completely unknown.
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
out in the market yet and during phase
IIIb the drug is on the market, but new
areas of use for it are tested.
Phase 4 comes after the drug has
started to be sold in the market, when
new unusual side effects can be
discovered. Phase IV can be seen as
a monitoring of what is happening.
Interstitiell lungsjukdom.
73 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Digital Therapeutics (DTx)
Digital therapeutics (DTx) deliver
medical interventions directly to
patients using evidence-based, clinically
evaluated software to treat, manage,
and prevent a broad spectrum of
diseases and disorders.
Interstitial lung disease
(ILD)
Term used for a group of lung diseases.
Idiopathic pulmonary
fibrosis (IPF) and pulmo-
nary fibrosis (PF)
IPF is a chronic and ultimately fatal
disease characterized 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. When the cause
of the disease is not known, the fibrosis
may be termed "idiopathic" . 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 hyper-
tension (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 water
(fluid) balance. Drugs that block the
ras, e.g. ACE inhibitors and Angiotensin
receptor blockers, 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 are blocked,
which occurs when AT1r stimulated.
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 molecules
that bind with hormone or neurotrans-
mitter molecules and react with other
molecules that respond in a specific
way.
Regulatory
Summary term for the work done to
meet the authorities’ formal require-
ments regarding, for example, pharma-
ceutical registration.
Orphan drugs
The regulatory authorities can grant a
drug candidate Orphan Drug Desig-
nation (ODD). Orphan drug status is
a way of encouraging research and
development of drugs for the treatment
of rare diseases. The market for orphan
drugs is growing faster than other
pharmaceuticals market.
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)
74 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Adress
Kornhamnstorg 53
SE-111 27 Stockholm, Sweden
Tel: + 46 31 788 05 60
Org.no.: 556680-3804
www.vicorepharma.com
Contact
Information
Contact
Carl-Johan Dalsgaard, CEO
Tel: +46 70 975 98 63
Hans Jeppsson, CFO
Tel: +46 70 553 14 65
75 | Annual Report 2022 Vicore Pharma Holding AB (publ)
Vicore Pharma Holding AB Kornhamnstorg 53, 111 27 Stockholm, Sweden | +46 (0)31-788 05 60 | vicorepharma.com