CVR no. 39296438
DK - 2200 Copenhagen N
ANNUAL REPORT 2023
2
IN THIS REPORT
COMPANY INFORMATION & MANAGEMENT REVIEW ............................................................. 3
CEO LETTER TO SHAREHOLDERS .............................................................................................. 4
FINANCIAL HIGHLIGHTS ............................................................................................................ 5
FLUOGUIDE ............................................................................................................................... 7
OUTLOOK FOR FLUOGUIDE .................................................................................................... 13
MANAGEMENT ....................................................................................................................... 14
SHAREHOLDER INFORMATION ............................................................................................... 16
FINANCIAL DEVELOPMENT ..................................................................................................... 18
MANAGEMENT STATEMENT ON THE ANNUAL REPORT ........................................................ 20
INDEPENDENT AUDITOR’S REPORT ........................................................................................ 21
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME ............................... 24
BALANCE SHEET ...................................................................................................................... 25
STATEMENT OF CHANGES IN EQUITY ..................................................................................... 26
CASH FLOW STATEMENTS ...................................................................................................... 27
NOTES ..................................................................................................................................... 29
“FluoGuide delivered positive results in
all three phase II trials during 2023,
and we are now preparing registration
trials, optimizing commercialization,
and partnering to improve outcomes of
surgical treatment for cancer patients.
This will enhance shareholder value by
improving the probability of success
and increase the potential of our
products.”
- Morten Albrechtsen, CEO
ANNUAL REPORT 2023
3
COMPANY INFORMATION
& MANAGEMENT REVIEW
In this document, the following definitions shall apply unless otherwise specified: “the
Company” or “FluoGuide” refers to FluoGuide A/S, with CVR number 39 29 64 38.
Figures in ‘()’ refer to the same period last year.
The Company
FluoGuide A/S
Ole Maaløes Vej 3
DK-2200 Copenhagen N
CVR no.: 39 29 64 38
Board of Directors
Peter Mørch Eriksen (Chairman)
Mats Thorén (Vice Chairman)
Lisa Micaela Sjökvist
Shomit Adhip Ghose
Andreas Kjær
Michael Engsig
Executive Management
Morten Albrechtsen, CEO
Auditors
CVR-no. DK 33 77 12 3 1
NASDAQ
FluoGuide is listed on Nasdaq First North Growth Market, Sweden (FLUO)
ANNUAL REPORT 2023
4
CEO LETTER TO SHAREHOLDERS
Dear shareholder,
FluoGuide is dedicated to elevating precision
surgery for cancer patients. With our lead product
FG001 progressing successfully through clinical
development, we are helping surgeons to perform
more precise surgeries by illuminating cancer.
In 2023, all three of our phase II trials had positive
results: for the use of FG001 to guide surgery in
brain, head & neck, and lung cancers. On the back
of these strong data, we initiated discussions with
regulatory authorities to plan and optimize design
of registration trials.
The successful progress in 2023 has also shown
that we can do even more for cancer patients. By
integrating our products with specialized
equipment, we can provide surgeons with an
option to treat cancer that could not otherwise be
surgically removed. The potential to help a greater
number of patients is hugely appealing to
surgeons, while surgical equipment
manufacturers can expand the application of their
devices into previously untapped markets.
We also decided to evaluate FG001’s
photothermal effect in aggressive brain cancer, as
it in our view constitutes an important new
treatment alternative with attractive market
opportunities.
We were very pleased to receive Orphan Drug
Designation for FG001 in guiding aggressive brain
cancer surgery in the US. Additionally, we received
feedback on the regulatory documentation
needed to obtain approval for FG001 for use to
guide aggressive brain cancer surgery, which
provides a clear route forward towards
commercialization.
FluoGuide has benefited from having a lean
organization and focused strategy, as rising
interest rates have made financing more costly for
development companies. Our strategy and
priorities are: (1) brain cancer; registration trials
are being prepared for surgical guidance and
assess the effect of FG001’s photothermal therapy
effect, and (2) head & neck cancer; progressing
the development of FG001 for guiding surgery.
Our company has developed rapidly since our
Initial Public Offering (IPO) in 2019, and we are
pleased that this is being widely recognized. This
includes a recent award from the Association of
Listed Danish Growth Companies for the
performance of our stock, which we were very
proud to receive.
Our long-term vision remains unchanged. We
continually secure to position for sustainable
development of the company, even during the
challenging market conditions in the biotech
sector over the last years. With FG001’s further
advancement, we are looking towards
investments that align with our growth strategy
and long-term objectives, targeting a shareholder
friendly funding approach.
This exciting progress has provided us with the
basis for commercial preparation of FG001. We
have had, and are continuing, positive and
constructive interactions with key opinion leaders
and equipment manufacturers, based on the very
strong data from the clinical trials.
It is truly a privilege to serve as the CEO for
FluoGuide, which is making such strong advances
in our mission to help cancer patients. Once again,
I would like, to acknowledge the outstanding
support from our shareholders, investigators,
partners, and the fantastic team here at
FluoGuide. This is also an opportunity to extend
my gratitude for your contributions, making all
this possible.
Morten Albrechtsen
CEO, FluoGuide A/S
ANNUAL REPORT 2023
5
FINANCIAL HIGHLIGHTS
KEY FIGURES
2023
2022
2021
2020
2019
DKK thousand
Income Statement
Income before interest and tax (EBIT)
-43,924
-32,461
-28,809
-22,161
-10,644
Net financial items
47
-379
-461
-25
-1,062
Net result for the year
-38,377
-27,340
-23,770
-17,460
-9,653
Balance sheet
Total assets
29,609
35,620
53,309
16,742
5,238
Equity
12,720
31,969
38,701
4,411
4,542
Cash flow
Cash flow from:
Operating activities
-31,809
-37,645
-15,062
-8,847
-10,553
Investing activities
-37
-117
0
-42
-390
Financing activities
27,500
17,018
51,183
17,182
13,228
The period’s cash flow
-4,345
-20,745
36,121
8,293
2,285
Dividend
0
0
0
0
0
Ratios
Solvency ratio
43%
90%
73%
26%
87%
Earnings per share (DKK)
-3.22
-2.33
-2.15
-1.78
-1.49
FluoGuide had no revenue for the period and posted a
net loss of DKK 38,377 thousand (DKK 27,340 thousand)
for the period 1 January to 31 December 2023. The
financial result for the period is in line with the Company's
development plans.
For definitions of ratios, see under accounting policies.
The total number of shares as of December 31, 2023,
amounted to 12,208,384 shares. The total number of
shares as of December 31, 2022, amounted to
11,814,500 shares. The average number of shares in
2023 amounted to 11,930,746 shares.
ANNUAL REPORT 2023
6
2023
HIGHLIGHTS
Q1
Q3
Q4
Q2
Release of positive interim result of
FG001 in the phase ll trial with head &
neck cancer
Ole Larsen appointed as CFO
Update of clinical timelines for the
ongoing phase ll trial in aggressive brain
cancer
Awarded a prestigious grant from
Innovation Fund Denmark, together with
four academic groups
Provides update on strong
clinical trial progress
Positive topline
results from phase II trial of FG001 in lung cancer
Positive interim results from phase II trial of FG001 in
head & neck cancer
Positive interim data from phase ll trial of
FG001 in head & neck cancer presented
at WMIC
Further positive interim data from phase ll trial
of FG001 in head & neck cancer
Completes patient enrollment and treatment in FG001
phase ll trial in aggressive brain cancer
Completes a Directed Share Issue raising SEK 15 million
Issue of warrants to Board members, management, and
employees, as well as the investors participating in the
Directed Share Issue
Receives FDA Orphan Drug Designation
for FG001 in high-grade glioma
Confirms positive topline results from
phase ll trial of FG001 in head & neck cancer at IAOO
Announces FG001 meets primary endpoint in phase ll trial in
aggressive brain cancer
FluoGuide raises SEK 12 million through exercise of warrants
ANNUAL REPORT 2023
7
FLUOGUIDE
Precision surgery improving outcome for cancer patients
About FluoGuide
FluoGuide enhances precision surgery by using the urokinase-type plasminogen activator receptor (uPAR)
targeted luminescent technology. This compound illuminates tumors during surgical procedures, aiming to
improve outcomes for cancer patients. This helps ensure the removal of cancerous tissue, while preserving
healthy tissue. FluoGuide is listed on Nasdaq First North Growth Market, Stockholm under the ticker “FLUO”.
FG001
The Company’s lead product, FG001, is a uPAR
targeting fluorescent drug that lights up the cancer
and works with many commonly available imaging
devices. The goal is to improve surgical precision by
illuminating cancer cells in real-time
intraoperatively. This allows a complete removal of
tumor tissue while leaving healthy tissue
unharmed.
The improved precision is expected to have a dual
benefit of reducing both the frequency of local
recurrence post-surgery and surgical sequelae.
Ultimately, this could improve patients’ chances of
being cured and lower system-wide healthcare
costs.
FG001 was first shown to be effective and well
tolerated by patients undergoing surgery in phase
I/II clinical trials testing for removal of aggressive
brain cancer (high grade glioma). Later, this efficacy
and safety was further documented in the phase ll
trial in aggressive brain cancer with regulatory
endpoint (completion of surgery). The Company has
also reported positive topline results in two further
phase ll trials, respectively in head & neck and lung
cancer.
FG001
1. Effectiveness demonstrated in
all three indications; brain, head
& neck, and lung cancer
2. Safe and well tolerated in all
indications
2024 milestones
• Advancing FG001 towards market. FG001
met the primary endpoint in a phase II trial
for guiding surgery in aggressive brain cancer
(High Grade Glioma). A registration trials are
being prepared, based on interactions with
regulators.
• Expanding the number of patients. Brain
cancers constitute a total number of cases
which is 14 times larger than aggressive brain
cancers alone. The target market for head &
neck is similar to the entire market for brain
cancer, having approx. 300,000 cases/year.
• Enhancing the benefit. Adding a novel
treatment modality (photothermal therapy)
could help surgeons to treat cancers which
are currently hard-to-reach.
Focus for 2024
1. Continue regulatory evaluation to confirm
the design of registration trials for FG001
as an imaging agent in guiding aggressive
brain cancer surgery
2. Initiate a head & neck phase II trial with
benefit endpoint(s)
3. Enter into partnership agreement(s) for
FG001, in accordance with our partnership
strategy
4. Evaluate and implement photothermal
therapy into brain cancer development
ANNUAL REPORT 2023
8
uPAR – Cancer specific and broadly
expressed in over 80% of all solid
cancers
uPAR is a protein present on the cells in the
surface of the cancer. The expression directly
correlates to the aggressiveness of the cancer and
its ability to metastasize.
uPAR is part of a cell-bound enzyme system
present on the invasive forefront of cancer where
it degrades normal tissue to allow the cancer to
spread. The protein is extensively expressed in
most solid tumors, including prevalent cancer
types like breast, colorectal, lung, and head & neck
cancers, as well as in less common yet highly
aggressive forms such as high-grade glioma and
pancreatic cancer. The pervasive expression of
uPAR is a notable characteristic, with scientific
support for its extensive presence in more than 80
percent of all solid cancers. This prevalence
positions FG001 as an attractive target, holding
the potential to improve surgical outcomes for
cancer patients.
Market Potential
Surgery is the cornerstone of cancer therapy. Of
the 18 million new cancer patients each year
worldwide, 80 percent will need surgery
sometimes during their disease. For localized
cancers, surgery is a preferred treatment with
curative intent.
Half the patients experience local recure of the
cancer post-surgery, with wide variation,
depending on the type of cancer.
Significant potential for FG001
FluoGuide has chosen aggressive brain cancer
(high-grade glioma) as the primary indication for
development of FG001, due to the significant
unmet need of these patients. Nearly all high-
grade gliomas express uPAR and is an aggressive
form of brain cancer that has a close to 100
percent local recurrence rate post-surgery,
translating into a very poor prognosis for most
patients. Half of all high-grade glioma patients die
within 14 months, with only 5 percent surviving
after five years. The improved precision that
FG001 can offer in this setting has the potential to
dramatically improve patient outcomes.
Meningioma accounts for approx. 35 percent of
primary brain tumors worldwide. Approx. 7 per
100,000 are diagnosed with meningioma annually.
Of meningioma patients, an estimated 20-30
percent of patients will have cancer recur locally
within 10 years after their first surgery. FluoGuide
estimates that approx. 60,000 meningioma
patients annually will undergo surgery. This is
more patients compared to high grade gliomas.
Surgery is particularly relevant when a cancer is
localized. The shift towards identifying cancer
earlier will increase the
Ovarian
Glioblastoma
Bladder
Percentage of local recurrence
rates following surgical
intervention for cancer types
Pancreas
Breast
Head & neck
Lung
Colorectal
‘100%’
85%
50%
35%
30%
25%
25%
17%
Source: Primeau, A. (2018) Cancer Recurrence
Statistics. Cancer Therapy Advisor
https://www.cancertherapyadvisor.com/home/tools/f
act-sheets/cancer-recurrence-statistics/
ANNUAL REPORT 2023
9
number of patients qualifying for surgery and will
drive an increased demand for a product that can
guide the surgeon.
There is a high number of malignant non-brain
cancers metastasizing to the brain, also known as
secondary brain cancers. Patients with secondary
brain cancers frequently undergo surgery
although these constitute a diverse type of
cancers.
Brain cancers (malignant and non-malignant,
primary, and secondary) constitute a total number
of cases which is 14 times larger than aggressive
brain cancers alone. Photothermal therapy has a
target price 30 times higher than the expected
target price for guiding surgery alone.
FG001 has also demonstrated efficacy in head &
neck cancer. Head & neck cancer includes cancers
in the lining of the lips, tongue, mouth, or upper
throat. Head & neck cancers often occur in close
anatomical proximity to small vital structures such
as blood vessels supplying the brain and many
important nerves. Further, cosmetic
considerations are important for most locations of
head & neck cancers and surgical precision is
therefore essential. Most head & neck cancers
arise from squamous cells and are termed oral
oropharyngeal squamous cell carcinomas cancer
(OPSCC). Worldwide, head & neck cancer accounts
for approximately 525,000 cases and over 400,000
deaths annually. There are approximately 317,000
cases of head & neck cancer per year in the US and
Europe altogether, and 208,000 cases per year in
the rest of the world.
FG001 has also demonstrated efficacy in lung
cancer. Globally, there are 2.2 million individuals
diagnosed with lung cancer annually, and 1.8
million patients die each year. Lung cancer is the
second most diagnosed cancer and was the
leading cause of cancer deaths in 2020.
Colorectal and breast cancer are two other cancer
types that has a high frequency and where FG001
could significantly improve surgery outcomes.
Additionally, FG001 is relevant in several other
less frequent cancer types.
Clinical Data
After good safety and efficacy data as well as
proof-of-concept in the lead indication (aggressive
brain cancer), FG001 has been advanced into a
phase II clinical trial testing regulatory endpoints
in this indication. The compound has also been
investigated in two clinical phase II trials in
respectively head & neck and lung cancer.
Phase l/II clinical data in aggressive
brain cancer – positive result
The results in 40 patients were reported in April
2022. FG001 was well tolerated. The specificity
was 100% and the sensitivity was 79%, validated
by two independent blinded histopathologists.
They evaluated 31 biopsies from the dose cohort
7a (36 mg, evening before surgery) and dose
cohort 8a (48 mg, evening before surgery).
The picture shows the illumination of the brain
tumor compared to surrounding healthy tissue
after administration of FG001 36 mg the evening
before surgery. The picture is a part of a video
shown at the SNS Congress (Source: Data from
phase I/II trial testing FG001 in patients with
aggressive brain cancer).
Phase II clinical trial in aggressive
brain cancer – positive result
The controlled, randomized, multi-center phase ll
trial (FG001-CT-001) investigated the effect of
FG001 in guiding surgery of patients with
aggressive brain cancer and compared FG001’s
effect to 5-ALA. 5-ALA is the only imaging agent
approved worldwide, including in Europe and US,
for guiding surgery of aggressive brain cancer
(grade III and IV glioma) The patients were
randomized 1:1 to FG001 or 5-ALA. Fluorescence-
guided surgery using FG001 or 5-ALA were
compared to white light surgery with each patient
serving as its own control. The trial was not
designed to show statistical difference
ANNUAL REPORT 2023
10
(superiority, non-inferiority). The results are used
to plan further clinical development.
• All patients receiving FG001 (12/12) had
additional cancer detected showing
FG001 was superior to white light. The
result for 5-ALA was 12/12
• FG001 was safe and well tolerated in all
patients with 2 related adverse events
(grade 1). The result for 5-ALA was 10
related adverse events (8 grade I and 2
grade II)
• FG001 visualize tumor on dura prior to
incision in 4/12 patients (deeper
visualization). The result for 5-ALA was
0/12.
FG001
5-ALA
White light means that no product is used to guide
the surgeon in removing the aggressive brain
cancer. Hospitals around the world use either
white light – i.e. nothing – 5-ALA, or an off-label
product, which has not been approved for guiding
brain cancer surgery. FG001 has several
technological advantages over 5-ALA. One as such
is being more specific to cancer and being based on
near infrared light which gives deeper visibility (1-
2 cm versus 1-2 mm). This thereby gives a higher
chance of detecting cancer located deeper in
tissue.
Phase II trial in head & neck cancer –
positive result
The phase II trial was designed to obtain proof-of
concept. The primary endpoint was sensitivity
defined as the relative number of patients where
FG001 lights up the cancer confirmed by
histopathology. The positive top-line result
demonstrated that FG001 lit up the cancer in all 16
patients enrolled. The effect of FG001 has been
very robust across a broad dose range. The trial is
conducted at the department of Otolaryngology,
Head & Neck Surgery and Audiology,
Rigshospitalet, University of Copenhagen,
Denmark.
Phase II trial in lung cancer –
positive result
The efficacy of FG001 (as a tumor imaging agent)
was examined by sensitivity verified by the
contrast expressed as tumor-to-background ratio
(TBR). Here it was showed that 11/15 (73%)
patients had a clinically relevant TBR value. The
TBR values were measured under conditions with
varying amounts of lung tissue covering the
tumors, thus attenuating the signal from FG001. If
the tumors had been uncovered, the proportion
lightening up would likely have been even higher.
The first lung cancer cohort (7 patients) received
36 mg administered the evening before surgery.
The second cohort (8 patients) received 36 mg
administered 2 days prior to surgery. The ability of
FG001 to illuminate the tumors was similar in the
two cohorts, indicating a broad time window for
administration of FG001. FG001 was shown to be
safe and well tolerated in all patients.
Photothermal therapy with FG001
Research has shown that when exposed to light,
FG001 undergoes a process that releases energy in
the form of heat. Preclinical in vivo data indicates
that this generated heat has the potential to
selectively eliminate cancer cells bound to FG001,
with a notable sparing effect on surrounding
normal tissue. Photothermal therapy with FG001
has already demonstrated effect in preclinical
models. These data were published in August
2021. Photothermal therapy has the potential to
take treatment to the next level of cellular
precision. In March 2023 Innovation Fund
Denmark (Innovationsfonden) awarded its largest
and most prestigious grant for research and
ANNUAL REPORT 2023
11
development of photothermal therapy to a
consortium of four highly reputed academic
groups and FluoGuide. The grant valued at DKK
49.2 million was structured through a combination
of a cash contribution from Innovation Fund
Denmark and a co-financing from the consortium.
The grant is a significant milestone for FluoGuide,
in its aim to support the research and development
of the optimal molecule for photothermal therapy
while using FG001 as a model molecule to feed
information from the surgical room back into
research.
Photothermal therapy is a new pillar in the
treatment of cancer and has the potential to
significantly contribute to the long-term growth of
FluoGuide.
FG002
FG002 is a uPAR targeted IRDye800 product with
particular use in abdominal cancers (e.g.,
colorectal) being excreted from the body
differently than FG001. FG002 manufacturing is
currently being prepared for pre-clinical and
clinical development.
Intellectual property protection
FluoGuide has established strong IP protection
related to FG001, FG002 and, more broadly, uPAR
targeted cancer imaging agents in general. Several
patent families contribute to the protection of
FG001. The first filed patent family, issued in US
and EU, last until 2035. The earliest patent family
filed is being processed around the world and is
expected to prolong the protection until 2039. The
following patent families are in the public domain:
• WO2016041558
• WO2021009219
• WO2021009237
• WO2021144450
• WO2021130237
FluoGuide owns or is granted an exclusive license
to the patent families.
Sources and references
Skjøth-Rasmussen, J., Azam, A., Larsen, C. C., Scheie, D., Juhl, K., & Kjaer, A. (2021). A new uPAR-targeting fluorescent probe for optical guided intracranial surgery in resection of a meningioma—a
case report. Acta Neurochirurgica. https://doi.org/10.1007/s00701-021-05051-3. • Christensen, A., Juhl, K., Persson, M., Charabi, B. W., Mortensen, J., Kiss, K., … Kjær, A. (2017). uPAR-targeted
optical near-infrared (NIR) fluorescence imaging and PET for image-guided surgery in head & neck cancer: proof-of-concept in orthotopic xenograft model. Oncotarget, 8(9), 15407–15419.
https://doi.org/10.18632/oncotarget.14282. • Juhl, K., Christensen, A., Persson, M., Ploug, M., & Kjaer, A. (2016). Peptide-Based Optical uPAR Imaging for Surgery: In Vivo Testing of ICG-Glu-Glu-
AE105. PLoS ONE, 11(2), 1–15. https://doi.org/10.1371/journal.pone.0147428. • Juhl, K., Christensen, A., Rubek, N., Schmidt, K. K., Buchwald, C. Von, & Kjaer, A. (2019). Improved surgical resection
of metastatic pancreatic cancer using uPAR targeted in vivo fluorescent guidance: comparison with traditional white light surgery. Oncotarget, 10(59), 6308–6316. • Simón, M., Jørgensen, J. T., Juhl,
K., & Kjaer, A. (2021). The use of a uPAR-targeted probe for photothermal cancer therapy prolongs survival in a xenograft mouse model of glioblastoma. Oncotarget, 12(14), 1366–1376.
https://doi.org/10.18632/oncotarget.28013. • Kurbegovic, S., Juhl, K., Sørensen, K. K., Leth, J., Willemoe, G. L., Christensen, A., … Kjaer, A. (2021). IRDye800CW labeled uPAR-targeting peptide for
fluorescence-guided glioblastoma surgery: Preclinical studies in orthotopic xenografts. Theranostics, 11(15), 7159–7174. https://doi.org/10.7150/thno.49787. • Metrangolo, V., Ploug, M., &
Engelholm, L. H. (2021). The Urokinase Receptor (uPAR) as a “Trojan Horse” in Targeted Cancer Therapy: Challenges and Opportunities. Cancers, 13(21), 5376.
https://doi.org/10.3390/cancers13215376. • Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M., Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global Cancer Statistics 2020: GLOBOCAN Estimates of
Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians, 71(3), 209–249. https://doi.org/10.3322/caac.21660. • Yousaf-Khan, U., Van Der Aalst, C., De
Jong, P. A., Heuvelmans, M., Scholten, E., Lammers, J. W., … De Koning, H. (2017). Final screening round of the NELSON lung cancer screening trial: The effect of a 2.5-year screening interval. Thorax,
72(1), 48–56. https://doi.org/10.1136/thoraxjnl-2016-208655. • The National Lung Screening Trial Research Team. (2011). Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic
Screening. N Engl J Med, 365(5), 395–409. Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. N Engl J Med, 365(5), 395–40. • Abstract, 68th Scandinavian Neurosurgical Society
(SNS) Congress held 14-16 May 2022 in Bergen, Norway. Presentation by Chief Surgeon Jane Skjøth Rasmussen, The Norwegian Neurosurgical Society
ANNUAL REPORT 2023
12
FG001 is a uPAR target imaging agent designed to work with any
standard imaging device
FG001 PIPELINE
ANNUAL REPORT 2023
13
OUTLOOK FOR
FLUOGUIDE
In 2024 FluoGuide’s main objectives are:
• Position registration trials design for FG001
in guiding aggressive brain cancer surgery
• Initiating a phase II trial of FG001 in head &
neck cancer, with benefit endpoint(s)
• Enter into partnership agreement(s) on
FG001, under our partnership strategy
• Evaluate and implement photothermal
therapy into brain cancer development
• Secure funding for plans and operations
through 2024 and beyond
ANNUAL REPORT 2023
14
MANAGEMENT
Board of Directors
Peter Mørch Eriksen – Chairman of the Board since 2021
Peter Mørch Eriksen has more than 20 years of experience in the
medtech/life science sectors, both in Denmark and internationally. He is
CEO at BioPorto A/S. His extensive background includes key positions such
as Vice President of Medtronic in the US and Denmark. These roles have
endowed Peter with a wealth of knowledge in driving growth, executing
restructuring, and securing funding in technologically advanced and complex
organizations. Peter's professional foundation is in accounting,
complemented by various management courses. He chairs the board of
Monsenso A/S, is a board member at BioPorto A/S, chairman in AptaShape
Aps and Director of PMEconsult ApS. Additionally, he contributes his
expertise to the Medical Device and Diagnostics Advisory Committee of
Cincinnati Children’s Hospital Medical Center in Ohio, US.
Mats Thorén – Vice-Chairman of the Board since 2022
Mats Thorén brings 25 years of financial market experience, specializing in
healthcare through roles in equity analysis and corporate finance. He has
spent 19 years as a Healthcare investment expert, working with firms like
Nalka Life Science AB and MedCap AB, and now leads Vixco Capital. Mats
holds board positions at Xbrane BioPharma AB, Arcoma AB, and Herantis
Pharma Oy, with past board roles at C-Rad AB, Cellartis AB, and others. His
educational background includes Economics, focusing on Accounting and
Financial Economics, and medical studies at the Karolinska Institute in
Stockholm.
Micaela Sjökvist – Board member since 2019
Micaela Sjökvist, with over 20 years of experience in corporate and financial
communications and investor relations, is the Head of Investor Relations at
Securitas AB. Her background includes roles at the international PR firm
Grayling and Telia Sonera AB. She holds a B.Sc. in Economics and Business
Administration from Uppsala University.
Andreas Kjær – Board member since 2018
Andreas is an MD, PhD, DMS, and professor at the University of Copenhagen
as well as chief physician at Rigshospitalet, the National University Hospital
of Denmark. His research is focused on molecular imaging with PET and
PET/MRI in cancer and cardiovascular disease and his achievements include
development of several new tracers that have reached first-in-humans
clinical use. He is the holder of an ERC Advanced Grant, has published 400+
peer-review articles, and has received multiple prestigious scientific awards
throughout the years. Andreas also holds an MBA from Copenhagen
Business School.
Shomit Ghose – Board member since 2019
Shomit is an adjunct professor in entrepreneurship at the University of San
Francisco and a lecturer in engineering at UC Berkeley. He was a Managing
Director at Silicon Valley venture fund ONSET Ventures since 2001, leading
investments in data-driven startups for over two decades. With 19 years of
executive experience in Silicon Valley's high-tech companies, Shomit is a
seasoned technology executive and venture capitalist specializing in IT,
particularly in software, networking, and infrastructure. He has played a key
role in several IPOs and holds a Computer Science degree from UC Berkeley.
Michael Engsig – Board member since 2023
Michael has extensive experience within the pharmaceutical industry with
20+ years of experience in both foreign capital markets and publicly listed
companies. This includes a successful track record in general management,
R&D, and commercial functions. Since 2019 Michael has been CEO at
Nykode Therapeutics, Norway. Michael holds a M.Sc. in chemistry with a
specialization in biotechnology from the Technical University of Denmark
(DTU) and a graduate diploma in Business Administration (HD) from
Copenhagen Business School (CBS).
ANNUAL REPORT 2023
15
Executive Management
Morten Albrechtsen – CEO since 2018
Morten Albrechtsen is an MD and BBA (‘HD’ in marketing, CBS). Morten is a
seasoned entrepreneur with a strong medical, commercial, and financial
background. The expertise is gained within a broad range of therapeutic
areas and with both drugs and devices. Morten has developed and launched
new health care products and concepts internationally, e.g. in Nycomed
Pharma, now Takeda Pharmaceuticals Ltd., Nanovi A/S and Boehringer
Ingelheim GmbH.
Corporate Management
Andreas Kjær – CSO and CMO since 2018
Andreas Kjær is an MD, PhD, DMSc and professor at the University of
Copenhagen and chief physician at Rigshospitalet, the National University
Hospital of Denmark. His research is focused on molecular imaging with PET,
PET/MRI and OPTICAL IMAGING in cancer and cardiovascular disease and his
achievements include development of several new tracers that have reached
first-in-humans clinical use. He is the holder of an ERC Advanced Grant, has
published more than 400 peer-review articles and has received numerous
prestigious scientific awards over the years. Andreas also has an MBA from
Copenhagen Business School.
Grethe Nørskov Rasmussen – CDO since 2019
Grethe Nørskov Rasmussen holds a M.Sc. and PhD. Grethe Rasmussen is
an experienced product developer with a profound understanding of CMC
and former Senior Vice President Product Development at Ascendis
Pharma A/S, where she worked for over 10 years. Previously, Grethe
served as Vice President for Protein Science at Maxygen, Inc. and later as
Managing Director for the Danish subsidiary of Maxygen. Prior to joining
Maxygen, Grethe held various positions at Novo Nordisk A/S, a global
healthcare company, where she contributed to research and development.
Grethe holds a PhD in Biochemistry from the Danish Technical University.
Dorthe Grønnegaard Mejer - VP Clinical Development since
2020
Dorthe Grønnegaard Mejer has a M.Sc. in Pharmaceutical Sciences from
Copenhagen University. She has previously held several positions across
different clinical development disciplines as well as positions within clinical
oncology development in other biotech companies such as Genmab, Larix,
Orphazyme, and Oncology Venture.
Ole Larsen – CFO since 2023
Ole Larsen holds a M.Sc. and is an experienced CFO with a strong history of
working in various industries in both listed and unlisted companies, including
Bavarian Nordic, BioPorto, Nordisk Film, and Berlingske Tidende. Ole is
skilled in growth/start-ups, M&A and Corporate Finance, and has a finance
professional background with a M.Sc. focused on Economics from
Copenhagen Business School. Ole currently serves as member of the board
at Linkfire.
ANNUAL REPORT 2023
16
SHAREHOLDER INFORMATION
The share
The shares in FluoGuide were listed in 2019 on
Spotlight Stock Market and moved from Spotlight
to Nasdaq First North Growth Market, Stockholm
in February 2021. The ticker is FLUO, and the ISIN
code is DK0061123312.
The total number of outstanding shares as of
December 31, 2023, amounted to 12,208,384
(11,814,500) shares, each with a nominal value of
DKK 0.10. Each individual share entitles to one
vote in the company and has an equal right to the
company’s assets and results.
In July 2023, FluoGuide completed a directed
share issue and raised SEK 15 million by issuing
211,389 units. Each unit contained one share and
one warrant. In December 2023, FluoGuide raised
SEK 12 million as 182,495 warrants were exercised
from the July 2023 unit financing. Accordingly,
182,495 new shares were issued.
Share price performance in 2023
At year-end, the closing price for FluoGuide shares
on Nasdaq First North Growth Market, Sweden
was SEK 61.20 – up 63.2% since year-end 2022.
During
the same period, the First North Health Care GI
decreased by 5.0%.
The total trading volume of FluoGuide shares on
Nasdaq First North Growth Market, Sweden was
2,739,140 in 2023 (22.4% of shares issued).
At year-end, FluoGuide’s market capitalization
was SEK 747 million against SEK 443 million at the
end of 2022.
0
50
100
150
200
250
300
350
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Index
FluoGuide stock development in 2023
FluoGuide First North Healthcare GI
ANNUAL REPORT 2023
17
Ownership
The number of shares is always defined, however
there is no complete record at any given time of
all shareholders and their ownership. Based on
the available information as of December 31,
2023, FluoGuide had 8,822 registered
shareholders. The 20 largest shareholders owned
70.0% of the share capital.
FluoGuide has no majority shareholders.
Shareholders owning more than 15% in FluoGuide
according to latest shareholding notifications are:
• Life Science ApS, a fully owned company
by Board Member, CSO and CMO Andreas
Kjær (17.42%)
Shareholders owning more than 10% in FluoGuide
according to latest shareholding notifications are:
• Wexotec ApS, a fully owned company by
CEO Morten Albrechtsen (12.19%)
Shareholders owning more than 5% in FluoGuide
according to latest shareholding notifications are:
• Linc AB
• Arbejdernes Landsbank, including
withholds repositories from holding for
clients
Management and Board of Directors owns 34.07%
of the total amount of outstanding shares.
Warrants
FluoGuide has established incentive programs for
its employees, management, and Board. On July
31, 2023, the Board of Directors of FluoGuide has
exercised its authorization to issue new warrants
by issuing 83,175 warrants to employees and
management and 45,000 warrants to the Board of
Directors. On March 29, 2022, the Company
decided to issue 40,000 warrants to employees
and management. On May 28, 2021, the Company
decided to issue 272,700 warrants to employees
and management and 50,000 warrants to the
Board of Directors.
The three warrant programs are issued to ensure
alignment of interests between the Company’s
employees, management, Board of Directors, and
shareholders. The Company believes that the
issue of warrants will provide motivation for the
achievement of FluoGuide’s short-term and long-
term goals to support the Company’s business
strategy, sustainability, and value creation for the
benefit of shareholders. Warrants represent a
total dilution of 3.9 percent of the current share
capital, if vested and exercised. Please see note 5.
Proposed appropriation of retained
earnings
The Board of Directors have proposed that no
dividend is paid out for the fiscal year, January 1,
2023 – December 31, 2023.
ANNUAL REPORT 2023
18
FINANCIAL DEVELOPMENT
Financial Development
Operating income & Other operating
income
Net revenue amounted to DKK 0 (DKK 0). Other
operating income amounted to DKK 423
thousand (DKK 6,511 thousand) and comprised of
grant from Innovation Fund Denmark
(Innovationsfonden) regarding a business post
doc and participation in a project with Danish Life
Science Cluster. In 2022 FluoGuide had Other
operating income of DKK 6,247 thousand from an
EU grant.
Other external expenses
Other external expenses amounted to DKK
29,234 thousand (DKK 24,099 thousand) and
comprised of Sales & marketing costs of DKK 450
thousand (DKK 499 thousand) and General &
admin costs of DKK 5,756 thousand (DKK 3,533
thousand). The increase in General & admin is
primarily related to Finance and IT-licenses and -
validation.
In 2023 Research & development costs including
IP, but excluding salaries amounted to DKK
23,027 thousand (DKK 20,067 thousand).
During 2022 FluoGuide initiated three clinical
trials with FG001 in aggressive brain cancer
(HGG), lung cancer and head & neck cancer. In
second half of 2023 the trials were all finalized
with last patient being enrolled and data
published.
Staff expenses
Staff expenses amounted to DKK 14,848
thousand (DKK 14,623 thousand) and comprised:
• Wages and salaries including bonus and
Board fee’s DKK 11,594 thousand (DKK
11,116 thousand)
• Employee share schemes DKK 3,115
thousand (DKK 3,363 thousand)
• Other social security costs DKK 139
thousand (DKK 143 thousand)
In 2023 the average number of full-time
employees was 7.8 (7.9).
Financial items
Financial income and expenses reflect interest
income/expense and currency transaction
gains/losses, bank charges and interest. In 2023
the financial income amounted to DKK 1,824
thousand (DKK 12 thousand) primarily due to
change in the fair value of the subscription rights
to shares in FluoGuide in connection with the
warrants issued to investors in July 2023. The
income has no cash impact.
In 2023 the financial expenses amounted to DKK
1,777 thousand (DKK 391 thousand) primarily due
to costs and interest in connection with the credit
facility of DKK 20 million of which DKK 10 million
were drawn on December 31, 2023.
Tax benefit
In 2023, a tax benefit of DKK 5,500 thousand (DKK
5,500 thousand) was realized. The tax benefit is
related to tax credits derived from investments in
research & development in 2022.
Net result for the year
In 2023 the net result of the year showed a loss
of DKK 38,377 thousand (loss of DKK 27,340
thousand) each reflecting the mix of variances
described above. The result was in accordance
with the Company’s expectations for the year.
Balance sheet
As of December 31, 2023, the Company’s balance
was DKK 29,609 thousand (DKK 35,620
thousand).
ANNUAL REPORT 2023
19
The assets primarily consist of cash and a tax
benefit related to tax credits derived from
investments in research & development in 2023.
The liabilities primarily consist of equity, the
credit facility and working capital.
Cash and cash equivalents
As of December 31, 2023, FluoGuide’s balance of
cash totaled DKK 21,668 thousand (DKK 26,013
thousand) and is deposited at a national Danish
bank.
As a development stage start-up life-science
company, and like other similar development
stage companies, the Company expects negative
cash flow in 2024 from operating activities. In
2023 the company raised SEK 27 million to fund
the ongoing and planned activities. The company
is dependent on being recapitalized or selling
rights to its products against cash until reaching
the point where the size of the revenue surpasses
the costs resulting in a positive cash flow. The
activities of the company in the future will
depend on proceeds obtained from capital
increases, sales of rights, loans and so forth.
Please refer to note 2 in the Financial Statements.
Equity
The total equity on December 31, 2023,
amounted to DKK 12,720 thousand (DKK 31,969
thousand). The change in equity is primarily due
to the realized net loss of DKK 38,377 thousand
partly off-set by capital raises of DKK 17,809
thousand. As per December 31, 2023, the solidity
was 43 percent (90 percent).
Current liabilities
As of December 31, 2023, the current liabilities
amounted to DKK 16,266 thousand (DKK 3,652
thousand). The current liabilities primarily consist
of a credit facility DKK 10,000 thousand (DKK 0)
and payables of DKK 6,060 thousand (DKK 3,269
thousand).
Subsequent events
On January 8, 2024, the Company announced a
strategic update and outlined development plans
towards commercialization of FG001.
On February 23, 2024, the Company announced
the issuing of warrants to the CFO in relation to
the CFO becoming a part of the executive
management.
Operational risks and uncertainties
The risks to and uncertainties of FluoGuide’s
operations are related to several factors such as
development, clinical trials, regulatory, patents
and other intellectual property rights, key
individuals and employees, registration and
licensing with agencies / governmental
authorities, competitors, customers, suppliers /
manufacturers, international operations, and
exchange rate changes, interest rates, tax,
financing needs and capital. During the current
period, no significant changes in risk factors or
uncertainties have occurred. For a more detailed
description of risks and uncertainties, please refer
to the company description published in February
2021.
The company description is available on our
website: www.fluoguide.com/investor/filings-
archive/
Financial calendar 2024
Annual General Meeting 20 March
Q1 report 2024 30 May
Q2 report 2024 29 August
Q3 report 2024 28 November
All financial reports are available on FluoGuide’s
company page:
www.fluoguide.com/investor/financial-reports
More information
A comprehensive description of the company’s
strategy, development plans and programs can
be found on our website: www.fluoguide.com
ANNUAL REPORT 2023
20
Executive Management:
Board of Directors:
ANNUAL REPORT 2023
21
ANNUAL REPORT 2023
22
ANNUAL REPORT 2023
23
CVR No 33 77 12 31
Mne18651
Mne29465
ANNUAL REPORT 2023
24
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
2023
2022
DKK thousand
Note
1 Jan – 31 Dec
1 Jan – 31 Dec
3
Other operating income
Other external expenses
-29,234
-24,099
4
Staff expenses
-14,848
-14,623
Depreciation and amortization
-265
-251
Income before interest and tax (EBIT)
-43,924
-32,461
6
Financial income
6
Financial expenses
-1,777
-391
Income before tax
-43,877
-32,840
7
Tax on income for the year
Net result for the year
-38,377
-27,340
Other comprehensive income for the year, net of tax
Total comprehensive income
-38,377
-27,340
11
Basis and diluted earnings per share (DKK)
-3.22
-2.33
ANNUAL REPORT 2023
25
BALANCE SHEET
ASSETS
2023
2022
DKK thousand
31 Dec
31 Dec
Note
Non-current assets
8
Intangible assets
9
Right of use assets
10
Tangible Fixed assets
Deposit
Total non-current assets
Total current assets
Other receivables
7
Receivable corporate tax
Prepayments
Cash
Total current assets
Total assets
EQUITY AND LIABILITIES
2023
2022
DKK thousand
31 Dec
31 Dec
Note
Equity
Share capital
Share premium
Retained earnings
11
Total equity
Liabilities
12
Lease liabilities
Non-current liabilities
Debt to credit institutions
12
Lease liabilities
Trade payables
Other payables
Deferred income
Current liabilities
Total liabilities
Total equity and liabilities
ANNUAL REPORT 2023
26
STATEMENT OF CHANGES IN EQUITY
EQUITY
Share capital
Share premium
Retained earnings
Total equity
DKK thousand
Equity as of December 31, 2021
Total comprehensive income 2022
-27,340
-27,340
Contribution – cash
Expenses in connection with capital increase
-626
-626
Employee share schemes – value of employee services
Transfer
-17,821
Equity as of December 31, 2022
Total comprehensive income 2023
-38,377
-38,377
Contribution – cash
Expenses in connection with capital increase
-84
-84
Employee share schemes – value of employee services
Fair value of warrants issued subsequently to right of issue
-1,712
-1,712
Transfer
-17,770
Equity as of December 31, 2023
ANNUAL REPORT 2023
27
CASH FLOW STATEMENTS
CASH FLOW
2023
2022
DKK thousand
Note
1 Jan – 31 Dec
1 Jan – 31 Dec
Income before tax
-43,877
-32,840
Net financial items reversed
-47
14
Change in working capital
-13,919
Depreciation and amortisation
5
Adjustment for non-cash employee benefits expense – share-based payments
Cash flows from operating activities before net financials
-35,644
-42,766
Net financial items paid
-1,665
-379
Tax credit paid out
Cash flows from operating activities
-31,809
-37,645
Purchase of tangible assets
-64
Paid deposit
-37
-53
Cash flows from investing activities
-37
-117
Proceeds from capital increase
Proceeds from credit facility
Principal elements of lease payments
-225
-227
Costs related to capital increase
-84
-626
Cash flows from financing activities
Total cash flows for the year
-4,345
-20,745
Cash as of January 1
Cash as of December 31
ANNUAL REPORT 2023
28
CASH FLOW STATEMENTS CONTINUED
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES
2023
2022
DKK thousand
As per January 1
205
57
Proceeds from credit facility
10,000
0
New leases
936
375
Interest
43
12
Repayment
-356
-239
As per December 31
10,828
205
ANNUAL REPORT 2023
29
NOTES
1. Accounting policies
2. Capital resources and liquidity
3. Other operating income
4. Staff expenses
5. Warrants
6. Financial Income and Expenses
7. Tax
8. Intangible assets
9. Right of use of assets
10. Tangible fixed assets
11. Share capital
12. Lease Liabilities
13. Distribution of profit/loss for the year
14. Change in working capital
15. Financial risks and financial instruments
16. Related parties
17. Fees to statutory auditors
18. Operating lease commitments and other commitments
19. Events occurring after the balance sheet date
ANNUAL REPORT 2023
30
Financial statements
The financial statements of FluoGuide A/S for 2023
are the Company’s fifth financial year and are
prepared in accordance with IFRS Accounting
Standards as adopted by the EU and further
requirements in the Danish Financial Statements
Act for annual reports of class B companies.
New standards not yet effective
There are no IFRSs or IFRIC interpretations that are
not yet effective that is expected to have a
material impact on the Company.
Foreign currency translation
On initial recognition, transactions in currencies
other than the functional currency of the Company
are recognized at the exchange rate applicable at
the transaction date. Receivables, payables, and
other monetary items denominated in foreign
currency not settled at the balance sheet date are
translated using the exchange rate applicable at
the balance sheet date. Exchange rate differences
between the exchange rate applicable at the
transaction date and the exchange rate at the date
of payment and the balance sheet date,
respectively, are recognized in the income
statement as net financials.
Leases
Leases in terms of which the Company assumes
substantially all the risks and rewards of ownership
are recognized in the balance sheet at the lower of
the fair value of the leased asset and the net
present value of the lease payments computed by
applying the interest rate implicit in the lease or an
approximated value as the discount rate, if leases
exceed DKK 33,000 in value and are longer than
twelve months.
Leased assets acquired under finance leases are
depreciated and written down for impairment
under the same policy as determined for the other
fixed assets of the Group.
The remaining lease liability is capitalized and
recognized in the balance sheet under debt, and
the interest element on the lease payments is
charged over the lease term to the income
statement.
Tax
Tax for the year, consisting of current tax and
changes in deferred tax, is recognized in the
income statement with the portion attributable to
tax on the profit or loss for the year, and directly in
equity or in other comprehensive income with the
portion attributable to amounts recognized
directly in equity or in other comprehensive
income, respectively.
Current tax payables and receivables are
recognized in the balance sheet as tax computed
based on the taxable income for the year results in
taxes to be paid or refunded.
FluoGuide A/S is a limited liability
company domiciled in Denmark. The
Financial Statements have been
prepared in accordance with IFRS
Accounting Standards as adopted by
the EU and further requirements in the
Danish Financial Statements Act.
Danish kroner (DKK) is the Company's
presentation currency and functional
currency. The financial statements are
presented in Danish kroner thousand.
1.
ACCOUNTING
POLICIES
ANNUAL REPORT 2023
31
Current tax for the year is computed based on the
tax rules and tax rates applicable at the balance
sheet date.
Deferred tax is recognized using the balance sheet
liability method on the basis of all temporary
differences between the carrying amounts and tax
bases of assets and liabilities, except for deferred
tax on temporary differences due to either initial
recognition of goodwill or initial recognition of a
transaction that is not a business combination, and
where the temporary difference ascertained at the
time of initial recognition does not affect either
the tax results or the taxable income. The deferred
tax is calculated based on the planned use of the
individual asset or settlement of the individual
liability.
Deferred tax is measured applying the tax rules
and tax rates expected to be applicable when the
deferred tax is expected to crystallize as current
tax. Any change in deferred tax because of changes
in tax rules or rates is recognized in the income
statement unless the deferred tax is attributable
to transactions that have previously been
recognized directly in equity or in other
comprehensive income. In the latter case, the
change is recognized directly in equity or in other
comprehensive income, respectively.
Deferred tax assets, including the tax value of tax
losses allowed for carryforward, are recognized in
the balance sheet at the expected realizable value,
either through offsetting against deferred tax
liabilities or as a net tax asset for offsetting against
future positive taxable incomes. An assessment is
made on each balance sheet date of whether it is
probable that sufficient taxable income will be
generated in future to enable utilization of the
deferred tax asset.
Statement of comprehensive income
Other operating income
Other income comprises income of a secondary
nature in relation to the group’s activities,
including grants and license income. Income from
licenses that do not transfer the right of ownership
to an intangible asset are recognized over time in
accordance with the substance of the agreements.
Government grants relating to costs are deferred
and recognized in profit or loss over the period
necessary to match them with the costs that they
are intended to cover.
Other external expenses
Other external expenses comprise expenses
relating to administrative expenses, costs of
premises, etc. as well as research & development
costs.
Research & development costs comprise external
expenses relating to research & development
work, clinical trials, clinical consultants, IP,
patents, and external costs related to patent
processing etc. excluding salaries.
Staff expenses
Staff expenses comprise wages, salaries, and
bonuses as well as social security expenses,
pensions for group staff, other staff-related
expenses, and share-based payment
compensation.
Employee options Plan
The fair value of warrants granted under the
FluoGuide A/S’s Employee Option Plan is
recognized as an employee benefits expense, with
a corresponding increase in equity. The total
amount to be expensed is determined by
reference to the fair value of the options granted:
- including any market performance conditions
(e.g. the entity’s share price) - excluding the impact
of any service and non-market performance
vesting conditions (e.g. profitability, sales growth
targets and remaining an employee of the entity
over a specified time period), and - including the
impact of any non-vesting conditions (e.g. the
requirement for employees to save or hold shares
for a specific period of time).
The total expense is recognized over the vesting
period, which is the period over which all the
specified vesting conditions are to be satisfied. At
the end of each period, the entity revises its
estimates of the number of options that are
expected to vest based on the non-market vesting
and service conditions. It recognizes the impact of
ANNUAL REPORT 2023
32
the revision to original estimates, if any, in profit
or loss, with a corresponding adjustment to equity.
Net financials
Net financials comprise interest income and
expenses, realized and unrealized gains and losses
on transactions in foreign currency and realized
and unrealized gains and losses on other financial
assets.
Amortization of capital losses and borrowing costs
relating to financial liabilities is recognized on an
ongoing basis as part of the interest expenses.
Earnings per share
Basic net result per share is calculated as the net
result for the year divided by the weighted average
number of outstanding ordinary shares, excluding
treasury shares.
Diluted net result per share is calculated as the net
result for the year divided by the weighted average
number of outstanding ordinary shares, excluding
treasury shares adjusted for the dilutive effect of
share equivalents. As the income statement shows
a net loss, no adjustments have been made for the
dilutive effect.
Balance sheet
Acquired patents
Acquired patents are measured in the balance
sheet at the lower of cost less accumulated
amortization and recoverable amount.
Cost comprises the acquisition price, costs directly
related to the acquisition and costs for preparation
of the asset until such time as the asset is ready for
use. The amortization is performed on a straight-
line basis with no residual value over the period of
validity starts when patent is taken into
commercial use. Amortization methods, useful
lives and residual values are reviewed every year.
Receivables
Receivables comprise trade receivables and other
receivables. Receivables are included in the
category loans and receivables, which are financial
assets with fixed or determinable payments that
are not listed in an active market and are not
derivative financial instruments.
On initial recognition, receivables are measured at
the amount of consideration that is unconditional
unless they contain significant financing
components, when they are recognized at fair
value and subsequently at amortized cost, which
usually corresponds to the nominal value, less
write-downs for bad debts.
The Company applies the IFRS 9 simplified
approach to measuring expected credit losses
which uses a lifetime expected loss allowance for
all receivables.
Cash
Cash includes deposits in bank accounts as well as
operating cash.
Equity
Direct and incremental costs associated with
capital increases are accounted for as a reduction
in the proceeds from the capital increase and
recognized in shareholders’ equity.
Liabilities
Other financial liabilities comprise debt to credit
institutions, trade payables, other payables to
public authorities and other liabilities. On initial
recognition, other financial liabilities are measured
at fair value less any transaction costs.
Subsequently, the liabilities are measured at
amortized cost according to the effective interest
method, so that the difference between the
proceeds and the nominal value is recognized in
the income statement as a financial expense over
the period of the loan.
Cash flow statement
The cash flow statement shows cash flows from
operating, investing, and financing activities as
well as cash at the beginning and end of the year.
Cash flows from operating activities are presented
in accordance with the indirect method and are
determined as the operating profit or loss adjusted
for non-cash operating items, changes in working
capital and paid financial income, financial
expenses, and income tax.
Cash flows from investing activities comprise
payments in connection with the acquisition and
ANNUAL REPORT 2023
33
sale of companies and financial assets as well as
the purchase, development, improvement and
sale of property, plant and equipment and
intangible assets.
Cash flows from financing activities comprise
changes in the Company's share capital and
associated costs as well as the raising and
repayment of loans, the repayment of interest-
bearing debt, the purchase and sale of treasury
shares and the payment of dividends.
Cash flows in currencies other than the functional
currency are recognized in the cash flow
statement using average exchange rates unless
they deviate significantly from the actual exchange
rates at the transaction dates.
Cash and cash equivalents comprise cash less
overdraft facilities that are an integrated part of
the cash management.
Financial highlights
Explanation of financial ratios:
Solvency ratio:
Equity at year end x 100
Total assets at year end
Earnings per
share:
Net result for the year
Average numbers of
outstanding shares
Significant accounting estimates and
assessments
In connection with the preparation of the financial
statements, the management performs
accounting estimates and assessments that affect
the recognized values of assets, liabilities, income,
expenses, and cash flows as well as their
presentation.
Accounting estimates reflect the management's
best estimates in terms of amounts where the
measurement is subject to uncertainty, typically
because the estimate is based on assumptions
concerning future events. The accounting
estimates are based on historical experience and
other assumptions deemed relevant, but the
actual results may, naturally, deviate from the
estimates made. The estimates are regularly
reassessed, and the effect of changes is recognized
in the consolidated financial statements.
Accounting judgements reflect decisions made by
the management as to how the accounting policies
are applied in specific situations where the
accounting treatment depends on qualitative
assessments. Examples could be when the risk
passes or how a certain transaction or item is best
presented to provide reliable and relevant
information.
Costs incurred in relation to individual
development projects are capitalized only when
the future economic benefit of the project is
probable and the following main conditions are
met: (i) the development costs can be measured
reliably, (ii) the technical feasibility of the product
has been ascertained and approved by an
authority like the European Medicines Agency
(EMA), the U.S. Food & Drug Administration or the
like and (iii) Management has the intention and
ability to complete the intangible asset and use or
sell it.
Currently no other significant accounting
estimates and judgements have been applied in
the preparation of the financial statements for
2023.
ANNUAL REPORT 2023
34
As a development stage start-up life-science
company, and like other similar development
stage companies, the Company has had a
negative cash flow in 2023 why the company is
dependent on being recapitalized or selling rights
to its products against cash until reaching the
point where the size of the revenue exceeds the
costs resulting in a positive cash flow.
The activities of the company in the future will
depend on proceeds obtained from capital
increases or sales of rights. The company, if
necessary, will in the future carry out external
capital increases to finance the future activities.
In 2023 the company raised SEK 27 million to fund
the ongoing and planned activities.
The Company continually evaluates its liquidity
requirements, capital needs and availability of
capital resources based on its operating needs
and planned initiatives. Such assessment has also
been carried out in relation to preparing the 2023
Annual report.
The Budget for 2024 and the expected cash
position on December 31, 2024, are based on
assumptions of financing or re-financing with net
proceeds of DKK 20 million. This amount though
is excluding initiation of clinical trials in 2024.
The Company will seek funding that is equity
friendly being issuance of new shares or a
convertible loan.
If against expectations, FluoGuide do not
complete the financing or raises a lower cash
amount than expected in the financing, the Board
of Directors and Management will take mitigating
actions to secure sufficient cash until December
31, 2024.
On this background the Board of Directors and
Management has decided to prepare the
financial statements for 2023 on a going concern
basis.
Although the Board of Directors and
Management based on this assessment considers
that FluoGuide A/S will have adequate and
enough liquidity resources available to finance
the operations of the Company for the coming
year, the above indicate that a material
uncertainty exists that may cast significant doubt
on the Company’s ability to continue as a going
concern.
2.
CAPITAL
RESOURCES AND
LIQUIDITY
ANNUAL REPORT 2023
35
Other operating income amounted to DKK 423
thousand (DKK 6,511 thousand) and comprised of
a grant from Danish Innovation Fund
(Innovationsfonden) regarding a business post
doc and participation in a project with Danish Life
Science Cluster. In 2022 FluoGuide had Other
operating income of DKK 6,247 thousand from an
EU grant.
The EU grant was awarded in June 2020 with a
total payout of EUR 2.5 million.
Two instalments were paid out in 2020 and 2021
of EUR 2.1 million. The last instalment was paid in
2023. The income was recognized over the
duration of the project. The Project was finalized
by December 31, 2022, and the final approval
from the EU was received in 2023.
OTHER OPERATING INCOME
2023
2022
DKK thousand
1 Jan – 31 Dec
1 Jan – 31 Dec
EU-grant
0
6,247
Other, including subsidy/grant for business PhD
423
264
Total
423
6,511
3.
OTHER
OPERATING
INCOME
ANNUAL REPORT 2023
36
COMPENSATION FOR KEY MANAGEMENT PERSONNEL
2023
2022
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Short term employee benefits
4,100
2,675
Share based payments
2,215
2,432
Total
6,315
5,107
Compensation for key management personnel
includes Morten Albrechtsen, Andreas Kjær, and
the Board of Directors.
The average number of full-time employees
during 2023 was 7.8 (7.9).
STAFF EXPENSES
2023
2022
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Wages and salaries
11,594
11,116
Employee share schemes – value of employee services
3,115
3,363
Other social security costs etc.
139
143
Total
14,848
14,623
4.
STAFF EXPENSES
ANNUAL REPORT 2023
37
FluoGuide has established incentive programs for
its employees, management, and Board of
Directors. In July 2023, the Company issued
83,175 warrants to employees and management
and 45,000 warrants to certain members of the
Board of Directors. Each warrant grants the
holder the right to subscribe for one (1) new
share in FluoGuide. The warrants are issued to
ensure alignment of interests between the
Company’s employees, management, Board of
Directors, and shareholders. The Company
believes that the issue of warrants will provide
motivation for the achievement of FluoGuide’s
short-term and long-term goals to support the
Company’s business strategy, sustainability, and
value creation for the benefit of shareholders.
Warrants represent a total dilution of 3.9 percent
of the current share capital, if vested and
exercised.
The number of warrants that will vest depends
mainly on the receiver not leaving the Company
in the vesting period and the warrants vest with
1/36 per month. For 200,000 warrants granted to
management in 2021 vesting furthermore
depends on achievement of certain activities-
based milestones KPI's and vest with 1/60 per
month. Warrants are granted under the plan for
no consideration and carry no dividend or voting
rights. The vested warrants remain exercisable
for a period of 10 years after the grant date. The
exercise price of warrants is based on the
Company's prevailing share price at the day of
grant.
5.
WARRANTS
ANNUAL REPORT 2023
38
Set out below are summaries of warrants granted under the plan:
WARRANT OVERVIEW - 2023
Outstanding as
of January 1
Additions
Exercised
Annulled
Terminated
Outstanding as
of December 31
Can be exercised
as of December 31
Average exercise
price (SEK)
May 2021
322,700
-
-
-
-
322,700
242,700
95
Mar 2022
40,000
-
-
-
-
40,000
23,331
65
July 2023
-
128,175
-
-
-
128,175
-
79
TOTAL
362,700
128,175
-
-
-
490,875
266,031
WARRANT OVERVIEW - 2023
Outstanding
as of January 1
Additions
Exercised
Annulled
Terminated
Transferred
Outstanding as of
December 31
Board of Directors
50,000
45,000
-
-
-
-
95,000
Executive Management
110,000
18,750
-
-
-
-
128,750
Corporate Management
156,800
43,525
-
-
-
-
200,325
Other employees
7,100
20,900
-
-
-
-
28,000
Former employees
38,800
-
-
-
-
-
38,800
TOTAL
362,700
128,175
-
-
-
-
490,875
Weighted average exercise price SEK)
92
79
-
-
-
-
88
Number of warrants which can be exercised as of December 31, 2023
266,031
at a weighted average exercise price of SEK
92
ANNUAL REPORT 2023
39
SPECIFICATION OF PARAMETERS FOR BLACK-SCHOLES MODEL
May 2021
Mar 2022
Jul 2023
Exercise price at grant (SEK)
95.00
95.00
65.00
79.00
Applied volatility
1)
53.5%
53.5%
48.3%
56.3%
Expected life (years)
6.3
7.3
6.3
6.3
Expected dividend per share
-
-
-
-
Risk-free interest rate p.a.
-0.07%
-0.07%
0.63%
2.65%
Fair value per share at grant (SEK)
2)
47.29
50.32
30.74
44.33
Fair value per share at grant (DKK)
2)
34.73
36.96
21.83
28.51
1) The applied volatility is based on the historical volatility of the FluoGuide share, except for programs issued since July 2023 where the volatility is based on the volatility for a
peer group.
2) Fair value of each warrant at grant date applying the Black-
Scholes model.
WARRANT OVERVIEW - 2022
Outstanding as
of January 1
Additions
Exercised
Annulled
Terminated
Transferred
Outstanding as
of December 31
Board of Directors
50,000
-
-
-
-
-
50,000
Executive Management
100,000
10,000
-
-
-
-
110,000
Corporate Management
140,300
16,500
-
-
-
-
156,800
Other employees
1,100
6,000
-
-
-
-
7,100
Former employees
31,300
7,500
-
-
-
-
38,800
TOTAL
322,700
40,000
-
-
-
-
362,700
Weighted average exercise price (SEK)
95
65
-
-
-
-
92
Number of warrants which can be exercised as of December 31, 2022
80,900
at a weighted average exercise price of SEK
95
ANNUAL REPORT 2023
40
RECOGNIZED COSTS FROM SHARE-BASED PAYMENT TRANSACTIONS
2023
2022
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Warrants issued under employee share scheme
3,115
3,363
Total for the year
3,115
3,363
Fair value of options granted:
The fair value at grant date is independently
determined using the Black-Scholes model which
includes, the share price at grant date and
expected price volatility of the underlying share,
the expected dividend yield, the risk-free interest
rate for the term of the warrants, and the
correlations and volatilities of the peer group
companies.
Warrants are granted for no consideration and
vests based on receiver not leaving the Company
and certain activity-based milestones. Vested
warrants are exercisable for a period of 10 years
after grant date. Vesting period are from 36
months to 60 months (the ladder only applies to
warrants granted to management in 2021).
The expected price volatility is based on the
historic volatility (based on the remaining life of
the warrants), adjusted for any expected changes
to future volatility due to publicly available
information.
ANNUAL REPORT 2023
41
FINANCIAL INCOME
2023
2022
DKK thousand
1 Jan – 31 Dec
1 Jan – 31 Dec
Interest income from financial assets measured at amortized costs
112
12
Net foreign exchange gains
0
0
Change in fair value of subscription rights to shares in the company
1,712
0
Other
0
0
Total
1,824
12
FINANCIAL EXPENSES
2023
2022
DKK thousand
1 Jan – 31 Dec
1 Jan – 31 Dec
Interest expense on liabilities measured at amortized costs
0
163
Interest related to right-of-use assets
43
12
Credit facility costs
1,646
0
Net foreign exchange losses
88
215
Other
0
1
Total
1,777
391
6.
FINANCIAL INCOME
AND EXPENSES
ANNUAL REPORT 2023
42
Under the Danish tax credit scheme, the 22
percent tax value of negative taxable income
related to costs from development activities up to
DKK 25 million can be received in cash. Tax value
of costs to the related to development activities
amounts to DKK 5,500 thousand (DKK 5,500
thousand), is anticipated to be paid out from the
tax authority in Q4 2024 to the Company. The tax
credit is not considered as a subsidy as the paid-
out tax credit reduces the Company´s tax loss
carries forward.
The unrecognized deferred tax assets amounted
to DKK 11,847 thousand (DKK 5,973 thousand)
can be carried forward indefinitely. Tax has been
computed at 22 percent corresponding to the
current tax rate.
TAX
2023
2022
DKK thousand
1 Jan – 31 Dec
1 Jan – 31 Dec
Tax on profit/loss for the year:
Current tax (tax under the tax credit scheme)
5,500
5,500
Total
5,500
5,500
Reconciliation of effective tax:
Tax computed on loss
-9,653
-7,225
Non-deductible expenses
689
741
Other permanent differences
-2,411
-2,056
Non-recognized deferred tax asset
5,875
3,040
Effective tax (13% / 17%)
-5,500
-5,500
Deferred tax:
Tax loss carried forward
11,817
5,956
Right of use assets
15
6
Intangible and tangible fixed asset
15
10
Total
11,847
5,973
Write down to accessed value
-11,847
-5,973
Total
0
0
7.
TAX
ANNUAL REPORT 2023
43
8. Intangible Asset
INTANGIBLE ASSETS
Acquired patents
Intangible assets
DKK thousand
Costs on January 1, 2023
378
378
Addition for the year
0
0
Costs on December 31, 2023
378
378
Amortization and impairment losses January 1, 2023
0
0
Amortization and impairment losses for the year
0
0
Amortization and impairment losses December 31, 2023
0
0
Net book value on December 31, 2023
378
378
8.
INTANGIBLE
ASSETS
ANNUAL REPORT 2023
44
RIGHT OF USE ASSETS
Buildings
Right of use assets
DKK thousand
Costs on January 1, 2023
705
705
Addition for the year
936
936
Disposals for the year
-705
-705
Costs on December 31, 2023
936
936
Depreciation January 1, 2023
506
506
Depreciation for the year
244
244
Depreciation disposals for the year
-617
-617
Depreciation December 31, 2023
134
134
Net book value on December 31, 2023
803
803
9.
RIGHT OF USE
ASSETS
ANNUAL REPORT 2023
45
TANGIBLE FIXED ASSETS
Equipment
Tangible assets
DKK thousand
Costs on January 1, 2023
64
64
Addition for the year
0
0
Costs on December 31, 2023
64
64
Amortization and impairment losses January 1, 2023
21
21
Amortization and impairment losses for the year
21
21
Amortization and impairment losses December 31, 2023
43
43
Net book value on December 31, 2023
21
21
10.
TANGIBLE FIXED
ASSETS
ANNUAL REPORT 2023
46
Share capital
The share capital consists of 12,208,384 shares
with a nominal value of DKK 0.1 each. The shares
are not divided into classes, and no shares have
special rights.
SHARE CAPITAL
2023
2022
Shares issued as per January 1
11,814,500
11,319,500
Increase in shares in directed issue and exercise of warrants
393,884
495,000
Shares issued as per December 31
12,208,384
11,814,500
Weighted average number of shares used as the denominator, when calculating
earnings per share
11,930,746
11,720,925
11.
SHARE CAPITAL
Capital management
The Company aims to ensure structural and
financial flexibility as well as competitive
strength. For that purpose, the Company
regularly assesses what the appropriate capital
structure for the Company.
On July 5, 2023, FluoGuide completed a SEK 15
million capital increase by issuing 211,389 shares
to several exciting and new investors. In
connection with the subscription the investors
received one warrant per share.
On December 8, 2023, FluoGuide completed a
SEK 12 million capital increase by issuing 182,495
shares as investors exercised 182,495 warrants
from the capital increase in July 2023.
ANNUAL REPORT 2023
47
LEASE LIABILITIES
2023
2022
DKK thousand
31 Dec
31 Dec
Non-current
623
0
Current
205
205
Total
828
205
12.
LEASE LIABILITIES
ANNUAL REPORT 2023
48
DISTRIBUTION OF PROFIT/LOSS FOR THE YEAR
2023
2022
DKK thousand
31 Dec
31 Dec
Proposed dividend for the year
0
0
Retained earnings
-38,377
-27,340
Total
-38,377
-27,340
13.
DISTRIBUTION OF
PROFIT/LOSS FOR
THE YEAR
ANNUAL REPORT 2023
49
CHANGE IN WORKING CAPITAL
2023
2022
DKK thousand
31 Dec
31 Dec
Other receivables and prepayments
2,286
-2,815
Change in trade payables
2,490
-5,231
Change in other payables
302
-2,155
Change in deferred income
-178
-3,718
Total
4,900
-13,919
14.
CHANGE IN WORKING
CAPITAL
ANNUAL REPORT 2023
50
15. Financial risks and financial
instruments
Risk management policy
The Company's financial risks are managed by the
Executive Management. The Company has an
insurance plan. Otherwise, the company has not
prepared policies for the identification and
handling of risks. The management of the
Company's risks is included in the Executive
Management's day-to-day monitoring of the
Company.
Interest rate risk
The Company is not subject to material interest
rate risks.
Currency risk
The Company is not subject to material currency
risks.
Credit risk
The Company’s cash is placed on deposit
accounts without restrictions at a national Danish
bank, with a Moody’s rating A2.
Liquidity risk
The Company's liquidity risk covers the risk that
the Company is not able to meet its liabilities as
they fall due.
As a development stage life-science company, the
Company has had a negative cash flow in 2023.
Thus, the company is dependent on being able to
finance the operations until reaching the point
where the size of the revenue increases the costs
resulting in a positive cash flow.
The Board of Directors and Executive
Management are constantly monitoring the
Company’s financial position to be prepared to
take adequate measures to secure the company.
Several options are possible such as partnering
deals, service agreements, reduce investments in
fixed assets, loans and increase the capital in the
company.
The Board of Directors and Management have
confidence in the company as a going concern.
See Note 2 for further explanation.
The maturities of financial liabilities appear from
the tables below. All amounts are contractual
cash flows, i.e. inclusive of interest.
15.
FINANCIAL RISKS AND
FINANCIAL
INSTRUMENTS
ANNUAL REPORT 2023
51
2023 - MATURITIES OF FINANCIAL LIABILITIES
< 1 year
1-2 year(s)
2-5 years
> 5 years
Total
DKK thousand
As per December 31, 2023
Debt to credit institutions
10,000
0
0
0
10,000
Lease Liabilities
205
623
0
0
828
Trade payables
4,094
0
0
0
4,094
Other payables
1,966
0
0
0
1,966
Total
16,266
623
0
0
16,889
2022 - MATURITIES OF FINANCIAL LIABILITIES
< 1 year
1-2 year(s)
2-5 years
> 5 years
Total
DKK thousand
As per December 31, 2022
Lease Liabilities
205
0
0
0
205
Trade payables
1,604
0
0
0
1,604
Other payables
1,665
0
0
0
1,665
Total
3,474
0
0
0
3,474
There were no assets nor liabilities measured at
fair value as of 31 December 2023 and 2022.
ANNUAL REPORT 2023
52
Transactions with related parties
TRANSACTIONS RELATED PARTIES
2023
2022
DKK thousand
31 Dec
31 Dec
Other related parties:
Financial Advisory Services - Vixco Capital AB
*)
95
0
*) Vixco Capital AB is a wholly owned company by board member Mats Thorén
There have been no other transactions with related parties - excempt from wages etc cf Note 4
16.
RELATED PARTIES
The Board of Directors and the Executive
Management of FluoGuide A/S are considered
related parties.
Besides the remuneration of the Board of
Directors and the Executive Management and
the share-based payments, there are one
transaction with related parties.
ANNUAL REPORT 2023
53
FEES TO STATUTORY AUDITORS
2023
2022
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Statutory audit
142
135
Audit related services
35
0
Tax advisory services
13
13
Other services
103
36
Total
292
183
17.
FEES TO STATUTORY
AUDITORS
The fee for non-audit services provided by
PricewaterhouseCoopers Statsautoriseret
Revisionspartnerselskab of DKK 151 thousand
(DKK 49 thousand) relates to HR consulting, tax
advisory, and other general financial
accounting matters.
ANNUAL REPORT 2023
54
18.
OPERATING LEASE
COMMITMENTS AND
OTHER COMMITMENTS
The company has entered purchase obligations
with suppliers in the amount of DKK 4.7 million
(DKK 15 million) as of 31 December 31, 2023.
ANNUAL REPORT 2023
55
On January 8, 2024, the Company provided a
strategic update and outlined development plans
towards commercialization of FG001.
On February 23, 2024, the Company announced
the issuing of warrants to the CFO in relation to
the CFO becoming a part of the executive
management.
Except as noted above, there have been no
significant events between December 31, 2023,
and the date of approval of these financial
statements that would require a change to or
additional disclosure in the financial
statements.
19.
EVENTS OCCURING
AFTER THE BALANCE
SHEET DATE
ANNUAL REPORT 2023
56