BioPorto Annual Report 2022
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Note: 2023 Annual Report
(pending cover page with picture;
to be updated by Feb 23rd)
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BioPorto Annual Report 2023
Table of Contents
Letter to our Stakeholders 3
BioPorto’s Strategy 4
Consolidated Financial Highlights 10
Risk Management 12
Governance 15
Corporate Social Responsibility, cf. Section 99a and 99b of the
Danish Financial Statements Act 17
Shareholder Matters 21
Board of Directors 24
Executive Management 26
Financial Management 27
Financial Review 28
Financial Statements 31
Notes to Consolidated Financial Statements 36
Parent Company 64
Notes to Financial Statements of Parent Company 68
Statement by the Board of Directors and Management 74
Independent Auditor’s Report 75
BioPorto Annual Report 2023
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Letter to our Stakeholders
Reflecting on 2023, the most important milestone for BioPorto was undoubtedly the FDA clearance
received in December for NGAL (ProNephro AKI
TM
NGAL) for pediatric and young adult use. The NGAL test
is designed to help doctors identify intensive care unit (ICU) patients at risk of developing acute kidney
injury (AKI) earlier than current standard care, which allows for prompt intervention and saving lives. The
FDA clearance is a major proof of concept and defining for the future of BioPorto.
The process leading up to FDA clearance has admittedly been very long, extending over many years, but
nonetheless a valuable and educational journey. We have gained significant process know-how and clinical
experience which will help us in our pursuit of FDA clearance for adult use and not least with respect to
the design of clinical trials and documentation requirements.
Our goal is to submit a clearance application to the FDA in 2026, which will enable us to commence US
commercialization of NGAL for adults in 2027. The process to seek FDA clearance for adult use including
extensive clinical trials, is estimated to require an investment of USD 15-20m in the period 2024-2026. We
intend to raise USD 20m by mid-2025 on Nasdaq Copenhagen through the issuance of new shares to fund this investment and to unlock the total
potential of a USD 3bn addressable global market for ProNephro AKI.
In February 2024, we launched our updated strategy plan laying the foundation for our strategic objectives and a detailed action plan for the next 3-5
years. The central elements of our strategy are to secure commercial traction in the US for clinical NGAL testing of pediatric and young adult patients,
increase the sales of NGAL for adult use in CE marked countries, continued focus on growing revenue for all products in Europe and initiating and
submitting US FDA application for clearance of NGAL for adult use. We will focus on expanding the use of NGAL for testing pediatric and young adults both
in the US and in CE-marked countries. Our commercial sales efforts include boosting awareness via Key Opinion Leaders and Medical Science Liaisons as
well as leveraging existing partnerships and build new partnerships with Top5 instrument distributors, combined with our own dedicated and well-
connected sales team. At the same time, we have initiated dialogue with KDIGO, which is the leading global organization developing and implementing
evidence-based clinical practice guidelines for kidney diseases. The purpose is to have NGAL included in KDIGO’s guideline for AKI and to make NGAL part
of the new standard care for AKI, which will ensure a much broader exposure and volume. The guidelines were last updated in 2012 and typically, clinical
practice will have changed well before the guidelines are updated. In general, biomarkers are expected to play a central role in standard care guidelines
in future.
An important element in our commercialization plan is to expand the portfolio of instruments that are FDA cleared for NGAL use in order to enable more
laboratories to implement the test and hence increase the serviceable market. The first step was to expand our global cooperation agreement with Roche
in February 2024 to include additional analyzers. We plan to engage in more strategic distribution partnerships with more leading instrument
manufacturers in the coming years.
Our 2023 results showed a total revenue of DKK 31m (USD 4.5m) deriving from our antibodies product line as well as from NGAL for research use only in
the US, and for general use in Europe, Canada, Israel, South Korea and other markets where the test is CE marked. In 2023, we maintained tight control
over costs and adjusted the organization to the leanest possible structure whilst awaiting the outcome of the FDA application.
In 2024, our target is to achieve a 30% revenue growth with total revenue of DKK 40m (USD 6m). Growth will be driven by increased sales of NGAL
through our distribution agreement with Roche and is expected to be back-end loaded, as US clinical commercialization will commence in the second half
of 2024. We expect an adjusted EBITDA loss in the range DKK 75-90m (USD 11-13m loss) in 2024 due to higher marketing costs for NGAL in the US and
increased costs related to clinical trials for adult use.
Looking towards 2026, revenue from sales of NGAL for pediatric and young adult use is expected to be our strongest revenue growth driver. Our target is
to reach total revenue of USD 15-25m and become cash flow positive and EBITDA neutral by 2026 if we meet the high end of our revenue target.
Following a potential FDA clearance of NGAL for adult use in the US, our ambition is to reach USD +100m in revenue with increased profitability by 2029.
Since BioPorto is now effectively changing status from a pure research-based company to a growth company, we need different competences in the
management team. I have been tasked with the position as CEO and in close co-operation with the Board of directors, we will seek to build an organization
and establish a strong management team with a profound understanding of in vitro diagnostic that can lead the business in the early phases of
commercialization and towards FDA clearance of NGAL for adult use in 2026.
Peter Mørch Eriksen
Chief Executive Officer
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BioPorto Annual Report 2023
Vision
BioPorto is an IVD (in vitro diagnostic) company focused on developing actionable biomarker tests designed to help clinicians detect the onset of disease
states and help direct appropriate therapies.
BioPorto applies its expertise in test development and antibody to create a pipeline of novel and compelling products that focus on conditions where
there is significant unmet medical need, and where its tests may help to improve clinical and economic outcomes for patients, providers, and the
healthcare ecosystem.
BioPorto helps healthcare providers improve patient management and outcomes with tests that provide early and specific insights into significant clinical
conditions.
BioPorto aspires to be a world leader in diagnostics that improve kidney health.
Strategy: Unlocking a USD 3bn addressable market potential for NGAL Tests
The vision is supported by a 5-year strategy plan adopted by the Board of Directors and launched on 22 February 2024 with the target to unlock a total
estimated global addressable market potential for NGAL Test of USD 3bn.
Based on the achievement of FDA clearance for ProNephro AKI
TM
NGAL in US for pediatric and young adults (3 months – 21 Years of age) in December
2023, BioPorto is effectively changing status from a diagnostic innovator and a research-based company to a growth company, as reflected in the new
strategy plan for 2024-2029.
From diagnostic innovator to profitable growth company
The three core elements of the strategy are to:
1) Expand the use of ProNephro AKI
TM
NGAL Tests in US for pediatric and young adults (Growth driver 2024-2026)
2) Increase sales of NGAL Tests for adults in CE mark countries (Growth 2024-2026)
3) Initiate and submit US FDA application for ProNephro AKI
TM
NGAL Test for adults (Growth 2027-2029)
1. Expand the use of ProNephro AKITM NGAL Tests in US for pediatric and young adults (Growth driver 2024-2026)
Commercial strategy
With the FDA clearance for US marketing of the test for pediatric and young adults successfully received in December 2023, the primary focus in 2024 is to
prepare and execute the US commercial launch of ProNephro AKI™ NGAL for pediatric and young adults, leveraging the distribution agreement with
Roche Diagnostics GmbH (Roche) on the Roche Cobas® c 501 analyzer.
BioPorto’s initial focus with The NGAL Test is in the pediatric intensive care (ICU) setting, followed by expansion into new settings such as nephrotoxicity
(toxicity in the kidneys) monitoring and testing in emergency departments (ECU).
The primary target accounts and customers for BioPorto’ s commercial activities are nephrologists, cardiologists, intensivists and laboratory directors at
large hospitals and centers.
The commercial strategy for the pediatric launch of the NGAL Test has three focus areas:
• Peer-to-peer education: Leveraging KOLs and other experts to describe the value of using NGAL in daily practice to other doctors through grand round
presentations, events, webinars, testimonials, and presentations at scientific meetings.
• Medical Science Liaisons (MSLs): Having a dedicated MSL team is critical to furthering deep clinical discussions with doctors. This team will consist of
professionals with pediatric and adult ICU experience, who can engage in scientific discourse on the use of NGAL in the medical management of Acute
Kidney Injury (AKI). This team will provide step-by-step tools to guide hospitals’ implementation of new NGAL test-based kidney biomarker programs.
• Clinical sales representatives: A dedicated sales team with clinical experience allowing BioPorto to engage with doctors at prospective accounts and have
detailed clinical discussions about the product and its use and connect prospective customers with reference customers who are champions of The NGAL
Test. This sales team will also help to ensure alignment and buy-in among all decision makers in the hospital system.
BioPorto’s Strategy
BioPorto Annual Report 2023
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In addition to the increased marketing and sales activities, BioPorto has initiated a dialogue with KDIGO (Kidney Disease: Improving Global Outcomes), the
leading global organization developing and implementing evidence-based clinical practice guidelines in kidney disease, to pursue including ProNephro AKI
(NGAL), which is the first AKI biomarker test cleared for pediatric and young adult use in the US, in KDIGO’s highly important guidelines for AKI.
Instrument expansion
An important element in BioPorto’s commercialization plan is to secure expansion of instruments that are FDA cleared for ProNephro AKI (NGAL) use to
enable more laboratories to implement the test and hence increase the serviceable market. In February 2024, BioPorto expanded the global cooperation
agreement with Roche to include the Cobas c 503 analyzer in addition to the Cobas c 501 and c 502 analyzers.
In 2025 and 2026, BioPorto plans to engage in more strategic distribution partnerships with additional leading instrument manufacturers e.g. Siemens,
QuidelOrtho, Bekcman, and Abbott to enable the use of ProNephro AKI (NGAL) on their platforms, following completion of the necessary technical and
clinical requirements.
Following the first FDA approval, the Company can conduct validation work and file to expand the marketing authorization to include additional
instruments. These subsequent submissions will be filed as 510(k) applications and can use existing pediatric samples for instrument expansions and adult
clinical trials for specified adult populations. With the first approval of the NGAL Test serving as a predicate device referable for future submissions, it is
anticipated that the regulatory review cycle should be less time intensive.
In CE mark countries, the focus up until now has been on adult use, and now the focus will be expanded to include the pediatric and young adult testing
market by leveraging existing partnerships and the data upon which the FDA clearance in the US was given.
2. Increase sales of NGAL Test for adults in CE mark countries (Growth driver 2024-2026)
The NGAL Test is currently available for In Vitro Diagnostic (IVD) (testing of samples taken from the human body) use in Europe and other geographies
under its CE mark for all patient populations, disease states, and instruments.
The FDA clearance for using the test in Pediatric and young Adults and leveraging already existing clinical experience from US and South Korean hospitals,
will help the company facilitate initiation of clinical use in European hospitals. Combined with the Company’s global marketing organization, BioPorto’s
executive team will focus on activities to drive market adoption in targeted European markets, including extensive market education on AKI and the value
of testing for NGAL, while also strengthening the distribution sales channels.
BioPorto will work towards driving market adoption by expanding its commercial and medical affairs organization, investing in distributor education in
Europe, and by expanding distribution partnerships.
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BioPorto Annual Report 2023
BioPorto currently generates revenue from The NGAL Test for research use only (RUO) in the US and EU, and for general use in (EEA) The European
Economic Area, Canada, Israel, South Korea and other markets under the CE mark.
In Europe, new EU regulation related to in vitro medical devices (IVDR) has been adopted and entered into force in May 2022. The regulation will replace
the current CE mark for in vitro medical devices. The deadline for applying with IVDR has been postponed several times and is now expected in 2026.
BioPorto will take the necessary steps to apply in due time and expect that the experience gained through the application for FDA clearance for ProNephro
TM
AKI NGAL for pediatric and young adult use, and the FDA clearance itself, will facilitate the process. The new regulation focuses on a new classification of
IVDs into four risk classes, a more precise description of their analytical and clinical performance, more stringent requirements for the conduct of clinical
trials, more precise execution and planning of post market surveillance, as well as better traceability of IVDs and more transparency for patients.
Commercially, IVDR approvals may help to drive demand as the lower requirements for clinical evidence of the former IVDD regulation, may have caused
physicians to wait for better data for approval of specific tests and indications before considering clinical use.
3. Initiate and submit US FDA application for ProNephro AKITM NGAL for adults (Growth driver 2027-2029)
Following the successful pursuit of FDA clearance for ProNephro AKI (NGAL) in pediatric and young adult patients for ICU risk assessment, BioPorto believes
it has the experience and skills to obtain similar clearance for adults. BioPorto is designing clinical trials for this purpose. The literature review has been
completed, KOLs have been engaged and biostatisticians are being onboarded to move into protocol draft completion. Patient enrolment will be initiated
in 2025. The goal is to submit a clearance application to the FDA in 2026. This could enable US commercialization of ProNephro AKI for adult use in 2027.
The pediatric and young adult indication includes patients from 3 months up to the age of 21. Therefore, adult hospitals that also care for patients aged 18
to 21 are expected to provide a bridge to the adult ICU market, as the laboratories in these hospitals will already be able to run NGAL Tests, and adult-
focused physicians will be able to refer to their pediatric colleagues as to their experience with the NGAL Tests clinically. BioPorto anticipates this will
accelerate NGAL Test adoption in the adult market with prospective FDA approval of NGAL following the design and completion of one or more
corresponding, necessary clinical trials.
Products and Pipeline
NGAL – an actionable biomarker for AKI
Acute Kidney Injury is the abrupt loss of kidney function that develops rapidly over a few hours or days. It typically occurs as a complication of another
serious illness or intervention, such as cardiac surgery, mechanical ventilation, solid organ or stem cell transplants, or sepsis, or the administration of
nephrotoxic pharmaceuticals. The incidence of AKI in critically ill patients is growing from 2000-2014, the US saw a 230% increase among non-diabetics,
and a 139% increase in patients with diabetes.
While AKI symptoms may include decreased urinary output, swelling due to fluid retention, nausea, fatigue, and shortness of breath, AKI is often painless
and starts without symptoms. As such, it is very difficult to diagnose. AKI affects 13.3 million people per year worldwide with a 52% community acquired
rate and with 48% of cases acquired during hospital stays. Among patients that are hospitalized, 1 in 5 adults, and 1 in 4 children will acquire AKI.
The onset of AKI in hospitalized patients increases the likelihood of mortality by 25%.
However, to preserve kidney function, it is essential that patients at risk for AKI are detected early and managed promptly. If not diagnosed early, AKI can
progress to Acute Kidney Disease (AKD) and eventually to Chronic Kidney Disease (CKD). Patients who develop AKI also have increased risk of other
comorbidities and longer hospital stays. When AKI is diagnosed early enough, preventive, or therapeutic procedures can be taken to maintain or restore
full functionality.
It is similarly important to identify patients that are not at risk of AKI so inappropriate prophylactic treatment such as dialysis or aggressive fluid
management therapies can be employed where more conservative treatment paths might have otherwise been undertaken.
BioPorto's NGAL Tests are designed to help clinicians identify the level of NGAL, a biomarker that rapidly rises within the first 2 hours of the onset of AKI.
The NGAL Test
The NGAL Test is a particle-enhanced immunoassay (biochemical test) that measures the concentration of NGAL in humans. It uses an analytical method
that can run on automated clinical chemistry systems such as the Roche Cobas®, Siemens Atellica®, and Abbott Alinity® families of instruments that are
used routinely in hospital core laboratories and fits seamlessly into established test workflow in laboratories. This facilitates laboratory adoption of the
test and potential market penetration. The NGAL Test does not require any proprietary instrumentation or capital purchase arrangements by the customer
that could otherwise add months to the sales cycle.
BioPorto Annual Report 2023
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As illustrated below, The NGAL Test identifies the risk of damage to the kidney as quickly as two hours after insult to the kidney, whereas the current
standard of care, serum creatinine (sCr), identifies potential kidney dysfunction after 48 to 72 hours and after >50% of total glomerular filtration capacity
(the first step in creating urine where excess fluid and waste products are filtered out of the blood via the kidney) is already lost.
This difference in both speed and more specific risk of kidney injury is important for clinical patient management, as early detection of kidney damage can
permit earlier and more tailored approaches such as close control of fluid levels, heightened attention to nephrotoxic drfinanugs, and consideration of
renal replacement therapy. Used in conjunction with measurement of serum creatinine (sCr) levels, even more tailored therapy decisions can be
considered.
Each of these can be initiated to improve the chances of kidney recovery. Also important, the NGAL Test identify patients that are not at risk of AKI which,
together with clinician judgement, can also influence decisions as to appropriate therapy.
ELISA Kits and Antibodies
BioPorto’s existing revenue-generating product line includes a library of highly specific monoclonal antibodies for scientific, pharmaceutical, and clinical
research. This library includes specific antibodies for NGAL and other analytes in areas such as allergy and immune system disorders. BioPorto also provides
in-house scaled-up production of custom antibodies in bulk volumes to meet specific customer needs, such as for diagnostic kit manufacturers.
BioPorto offers NGAL ELISA kits (Enzyme-Linked ImmonuSorbent Assay) for research applications in humans (CE marked) and six additional animal species,
ranging from mouse to monkey. These NGAL ELISA kits target different forms of NGAL and help scientists bridge their development work from preclinical
study through clinical development.
These research tools are often used to investigate nephrotoxicity (rapid deterioration in the kidney function due to toxic effect) and/or effectiveness during
the development of new pharmaceutical compounds.
BioPorto does not intend to actively develop new ELISA kits or seek FDA approval for ELISA kits. However, it will continue to include ELISA kits as part of its
product offering, as these kits may serve as research tools that could evolve into future products in the form of FDA cleared or approved actionable
biomarkers.
Proprietary rights
Through its research and development activities, BioPorto has developed expertise in the development of research and diagnostic assays to detect analytes
present in various disease states. The Company’s antibodies and other aspects of its diagnostic products are proprietary and fundamental to the Company’s
business. While BioPorto considers its intellectual property rights to be valuable, the Company does not believe that its competitive position in the industry
depends solely on obtaining legal protection for its diagnostic products and technology. Instead, BioPorto believes that the success of its business also
depends on the Company’s ability to commercialize its current and future products, as well as maintaining a reputational leadership position in relation to
NGAL by continuing to develop innovative antibodies and diagnostic products utilizing the NGAL biomarker and other health related biomarkers, including
for kidney health.
Registration
For a diagnostic product to be marketed for clinical use, it must undergo a registration process with the Health Authorities in each country and/or region.
The NGAL Test is CE marked in the EU as an IVD biomarker for AKI; certain countries outside of the EU recognize the CE mark. The NGAL Test is also
registered in and/or has received regulatory approval for IVD use in several other countries.
The NGAL Test has received FDA clearance in the US for the ProNephro AKI
TM
NGAL Test for pediatric and young adult use (ages 3 months through 21 years)
on the Roche Cobas® c 501 analyser.
A total global addressable market of USD 3bn
BioPorto believes that the global addressable market for The NGAL Test is approximately $3 billion.
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BioPorto Annual Report 2023
The total addressable market opportunity in the US is estimated at USD 1.2bn annually for all potential applications including outpatient monitoring
equivalent to around 40% of the global market, while the total addressable market opportunity in Europe is estimated at USD 1bn.
The global addressable market for adult use of the NGAL Test is estimated at USD 2.8bn annually, while the global market for NGAL Test for pediatric and
young adult use is estimated at USD 150-200m annually. The global addressable market for NGAL is estimated to grow at a CAGR of 3.5%-5.5% over the
next 5-6 years
1
.
The overall research antibodies market is expected to grow at a CAGR of approximately 6-7% from USD 10bn billion in 2020 to approximately USD 14bn by
2025, as these are critical components in life sciences research. BioPorto is tapping into this market via its antibodies business and ELISA kits.
Financial aspirations 2024-2029
BioPorto expects that the US market for testing pediatric and young adult patients with the FDA-cleared ProNephro AKI (NGAL) will be the strongest
contributor to growth for BioPorto through 2026.
BioPorto also believes that success in the US market will drive use of NGAL for testing pediatric, young adult and adult patients throughout the rest of the
world. As a result, BioPorto’s target is to reach total revenue of USD 15-25m by 2026. Revenue at the top of this range could enable BioPorto to become
cash flow positive and EBITDA neutral by 2026.
Following a potential FDA clearance of ProNephro AKI (NGAL) for adult use in the US, BioPorto’s ambition is to reach and exceed USD 100m in revenue
with increased profitability by 2029.
While commercialization of the NGAL Test will be the primary contributor for growth, BioPorto expects a stable revenue from its existing antibodies
business.
Financial aspirations 2024-2029
Capital requirements 2024-2026
To maximize BioPorto’s growth and value creation potential, the company is investigating opportunities to bolster its financial position.
The FDA clearance of ProNephro AKI for pediatrics / young adults was a major milestone, allowing marketing in the world’s largest IVD market. To unlock
the USD 2.8bn adult market, BioPorto will be seeking FDA clearance for adult use which is estimated to require an investment of USD 15-20m in the period
2024-2026.
During this period through 2026, BioPorto plans to increase its operating costs associated with sales and marketing and in particular associated with R&D
with the FDA application process for ProNephro AKI for adult usage in the US. The accumulated adjusted EBITDA loss for the period is estimated to be
approximately USD 20-25m, which BioPorto will seek to finance from existing cash and by issuing new shares of approx. USD 20m on Nasdaq Copenhagen
in 2024 and 2025 to current, strategic, and institutional investors to enable the company to exploit the full growth and value creation potential provided
by its technology. The board of directors is currently evaluating available strategies with the aim of initiating the first issue in Q2 2024.
1
Clinical Diagnostics Market – Size, Overview & Industry Trends, Clinical Laboratory Services Market Size, Share Report, 2030
BioPorto Annual Report 2023
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Outlook for 2024
Expected revenue growth of 30% in 2024
In 2024, BioPorto is targeting a total revenue of DKK 40m (USD 6m) which corresponds to a growth rate of 30% compared to 2023. Growth will be driven
by increased sales of NGAL products – primarily in the US following the FDA clearance, supplemented by growth in the rest of the world. Revenue is
expected to be back-end loaded, as US clinical commercialization of NGAL will commence in the second half of 2024.
For 2024, an adjusted EBITDA loss in the range DKK 75-90m (USD 11m to 13m loss) is expected. The higher expected loss results from higher marketing
costs for ProNephro AKI (NGAL) in the US, and the cost of new clinical trials to support FDA clearance for ProNephro AKI (NGAL) for adults.
Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA) is an alternative measure of performance utilized by
management, investors and investment analysts to evaluate and analyze the Company’s results. Adjusted EBITDA excludes non-cash share-based
compensation and non-recurring costs (e.g., merger and acquisition integration costs).
Adjusted EBITDA is a non-IFRS financial measure that does not have a standard meaning prescribed by IFRS and may not be defined and calculated by other
companies in the same manner and thus may not be comparable with such measure.
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BioPorto Annual Report 2023
2023
2022
2021
2020
2019
Jan 1 – Dec 31
Jan 1 – Dec 31
Jan 1 – Dec 31
Jan 1 – Dec 31
Jan 1 – Dec 31
DKK million (except where noted)
Revenue
31.0
29.0
24.3
23.2
26.6
Gross profit
20.2
19.0
15.0
13.3
17.3
Sales and marketing costs
18.9
21.2
17.4
20.8
39.3
Research and development costs
25.4
34.9
30.3
28.1
24.6
Administrative costs
36.0
41.8
32.7
28.0
27.8
Lease impairment
1.0
2.6
-
-
-
Loss before financial items (EBIT)
(61.2)
(81.5)
(65.3)
(63.6)
(74.3)
Financial items, net
(0.0)
(0.0)
1.4
(3.2)
0.1
Loss before tax
(61.2)
(81.5)
(63.8)
(66.8)
(74.2)
Net loss
(56.3)
(75.9)
(57.1)
(61.6)
(69.6)
Comprehensive loss
(55.9)
(76.0)
(58.3)
(59.8)
(70.0)
Adjusted EBITDA
(56.1)
(67.3)
(62.0)
(54.3)
(68.3)
Non-current assets
7.5
7.2
17.1
15.5
8.2
Cash and cash equivalents
66.4
81.8
45.5
107.9
18.1
Current assets
82.3
101.4
64.2
124.8
34.5
Total assets
89.8
108.6
81.3
140.3
42.7
Equity
60.2
70.2
46.0
100.9
25.3
Non-current liabilities
4.3
7.4
10.5
8.4
2.5
Current liabilities
25.4
31.0
24.8
30.9
14.9
Total equity and liabilities
89.8
108.6
81.3
140.3
42.7
Cash flows from operating activities
(55.5)
(52.5)
(64.6)
(35.6)
(60.2)
Cash flows from investing activities
(0.3)
(0.5)
(0.4)
(1.5)
(2.1)
Of which investment in property, plant, and
equipment
(0.0)
(0.4)
(0.1)
(1.3)
(0.6)
Cash flows from financing activities
40.8
88.7
1.1
127.0
33.6
Net cash flows
(14.9)
35.7
(63.9)
89.9
(28.6)
Revenue growth
7%
19%
5%
(13%)
2%
Gross profit percentage
65%
66%
62%
57%
65%
Equity ratio (solvency)
67%
65%
57%
72%
59%
Average number of employees
31
32
29
28
34
Number of shares at the end of the period (1,000)
379,670
334,693
267,754
266,582
174,944
Loss per share (EPS), DKK
(0.16)
(0.24)
(0.21)
(0.30)
(0.41)
Net asset value per share, period-end, DKK
0.16
0.21
0.17
0.38
0.14
Share price, period-end, DKK
2.09
2.32
2.47
4.04
2.93
: Loss per share (EPS) is calculated in accordance with IAS 33 “Earning per share”. Other financial ratios have been calculated as shown in the Financial
Ratio section below.
Reconciliation of Adjusted EBITDA
Loss before financial items (EBIT)
(61.2)
(81.5)
(65.3)
(63.6)
(74.3)
Depreciation and amortization
2.7
4.0
4.3
4.0
2.9
Share-based compensation expenses
1.4
7.6
(1.0)
5.3
3.1
Lease impairment
1.0
2.6
-
-
-
Adjusted EBITDA
(56.1)
(67.3)
(62.0)
(54.3)
(68.3)
Consolidated Financial Highlights
BioPorto Annual Report 2023
11
Non-IFRS Financial Measure
In the Annual Report, BioPorto discloses a financial measure of the Group’s financial performance that reflects adjustments to the most directly comparable
measures calculated and presented in accordance with IFRS. This non-IFRS financial measure may not be defined and calculated by other companies in the
same manner and may thus not be comparable.
The non-IFRS financial measure presented in the Annual Report is Adjusted earnings before interest, taxes, depreciation, and amortization (Adjusted
EBITDA).
Adjusted EBITDA is an alternative measure of performance utilized by management, investors, and investment analysts to evaluate and analyze the
Company’s results. Adjusted EBITDA excludes non-cash share-based compensation and non-recurring costs (e.g., merger and acquisition integration costs
and Right-of-use lease asset impairment charges), if any. We believe that earnings exclusive of non-cash and non-recurring costs is a key indication of how
a company is progressing from period to period and that the non-IFRS financial measure Adjusted EBITDA is useful to investors, lenders, and other creditors
because such information enables them to better understand earnings exclusive of non-cash and non-recurring costs from period to period. However, we
also believe that Adjusted EBITDA data has limitations, particularly as non-cash and non-recurring costs could significantly impact our performance. We
caution the readers of this report to follow a similar approach by considering data on Adjusted EBITDA only in addition to, and not as a substitute for or
superior to, EBIT or net income or loss in accordance with IFRS.
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BioPorto Annual Report 2023
Risk management is an integral part of BioPorto’s operations. The Company identifies material risks that could affect revenues, development, production,
future performance, regulatory affairs, or the interests of the shareholders in order to run the Company effectively.
All departments in the Company participate in the identification and assessment of financial and operational risk factors in order to address them properly.
Risk Management is part of the Rules of Procedures for the Audit Committee. The Board of Directors receives updates and recommendations on initiatives,
which then form part of the Board’s overall assessment and decisions on the Company’s activities and future plans.
In 2024, primary risks include commercialization of ProNephro AKI in the USA, instrument expansion, initiation of adult indication study, working towards
future IVDR compliance, securing market adoption and continued growth in NGAL revenues including in regions where CE Mark is accepted, and attracting
new talent and retaining qualified personnel in a competitive environment.
Risk Factors
Expectations and assumptions in the annual report concerning BioPorto’s business – the market for diagnostics in AKI, antibodies, and ELISA kits – and the
Company’s revenue, accounting results, and market share are subject to substantial uncertainty. There is no guarantee that the Company as a whole or in
part will achieve its expectations for revenue, Adjusted EBITDA, or the profit/loss for the year. Key risks that are specific for the Company that, among
others, could cause the Company’s results, prospects, and financial performance to differ materially from those expressed forward-looking statements are:
• The Company’s products and future products may fail to achieve the degree of market acceptance by physicians, laboratory management,
healthcare payors and others in the medical community necessary for commercial success and market penetration may be lengthy and difficult.
The mitigating actions are having trained Commercial and Medical Liaison personnel, HEOR and reimbursement dossiers to payers and
institution administration, IIS programs for publication on NGAL protocols and KDIGO Guideline public responses.
• Timing of future clinical trials depends on many factors outside of the Company’s control, including regulatory pathways and their conditions
associated with submissions presently under review that will serve as predicates to other submissions, the impact of future potential pandemics,
wars and other events, each of which may impair the Company’s ability to complete clinical trials in a timely manner or at all. The mitigating
actions are alignment with competent CRO, having internal R&D talent that can effectively and efficiently manage future clinical trials and bring
to regulatory bodies for required clearance and approvals. See public health epidemics, pandemics or outbreaks below.
• A failure to successfully commercialize NGAL tests for pediatric and later adult uses would have a material adverse effect on the Company’s
prospective future revenues, future growth prospects, future cash-flows and future results of operations. The mitigating actions are key partner
negotiations and commercial enablement, current lab customer case stories and peer-to-peer support and new product considerations.
• The product benefits of NGAL tests may not demonstrably provide a clinical and economic case to drive market adoption, including until the
Company completes a direct health economics and outcomes study of such factors. The mitigating actions are recent FDA clearance of
ProNephro AKI (NGAL) which creates a new market in the US and synergies for rest of world revenue growth opportunities.
• Public health epidemics, pandemics or outbreaks, such as COVID-19 could adversely impact the Company’s business, future financial position,
timeline, results of operations and future growth prospects. The mitigating actions are constantly monitoring news, medical outlets and other
media to be informed of new epidemics, pandemics or outbreaks to take the necessary steps to protect our entire community and stakeholders.
• The Company’s future success depends in part on its ability to attract and retain its management team and key employees. The mitigating
actions are to challenge existing employees with meaningful work growth opportunities and use of tools such as LinkedIn and other forums to
market new job opportunities and exciting endeavors at BioPorto.
• The Company’s products and future products are complex to manufacture, and the Company may encounter difficulties in manufacturing that
could have a material adverse effect on the Company’s revenues, cash flow, results of operations and future growth prospects. The mitigating
actions are having in-house qualified production leadership and personnel connected to R&D, regulatory, quality assurance and external insights
regarding manufacturing of complex products.
• The manufacture of the Company’s products is dependent on the supply of raw materials and key components from suppliers, some of which
are sole source suppliers for the Company. The mitigating actions are developing, at a minimum, dual source supply for critical raw materials
and components.
• Several patents used by the Company will expire in the near term, which may lead to increased competition and materially adversely affect the
Company’s business, financial condition, results of operations and prospects. The mitigating actions are creating new intellectual property and
new product introductions.
• The Company operates in a highly regulated industry, and changes in regulations or the implementation or enforcement of existing regulations
could have a material adverse effect on the Company. The mitigating actions are having regulatory intelligence and compliance execution.
Risk Management
BioPorto Annual Report 2023
13
• To realize its strategic objectives, the Company will require additional capital to fund its operations, which may not be available to the Company
on acceptable terms or at all. The mitigating actions are financing strategy and plan exist to generate investor interest and potential
participation.
• The Company has incurred net losses and may continue to do so. The mitigating actions are a multiyear financial strategy and plans created to
achieve positive cash flows in mid-2026.
Other short-to-medium-term uncertainties include, but are not limited to the following:
• The ability to obtain the Freedom to Operate in commercially relevant markets. The mitigating actions are Freedom to Operate analysis created
for The NGAL Test and ProNephro AKI.
• The ability to prevent competing companies from having Freedom to Operate in commercially relevant markets and general competition. The
mitigating actions are to create new intellectual property and new product introduction. Performance and dependence of the
Company’s subcontractors; most significantly Contract Manufacturing Organizations and Contract Research Organizations. The mitigating
actions are to ensure that alternative suppliers are identified for critical subcontractors.
• Clinical development and results from pipeline projects. The mitigating actions are to invest in development pipelines, communication with
customers and create new intellectual property.
• Cyber-attacks. The mitigating actions are MFA, device recognition, data recovery processes, phishing awareness, training programs, IT security
through Company’s IT suppliers and cyber security insurance.
• Risks relating to trade receivables and inventory. The mitigation actions are low expected credit losses and plans to expand key inventory
suppliers.
• Changes in the USD exchange rate, capital markets, and the costs of financing, and their impact on the free liquidity, future revenue and net
finances. The mitigating actions are a natural hedge for portions of the USD denominated expenses by invoicing part of the customer portfolio
in USD and FDA cleared product has potential for meaningful revenue growth and achievement of future positive free cash flows. See Note 17
for further specification.
• Tax risks. The mitigating actions are the use of tax experts as deemed appropriate for compliance with local laws and regulations.
• Risks related to IT in general. See Cyber-attacks above.
The Company’s risks further include the ability to enter into collaborations with partners for development, manufacturing, marketing and financial
resources. There are additional risks related to sales contracts and the related production and logistics.
Currency risks include the risk arising from sales and production contracts being denominated in currencies other than Danish kroner. Contracts are
primarily in USD and EUR.
Revenues and contracts are still relatively modest and thus the Company is not hedging its USD exposure. However, the Company is monitoring its USD
exposure and will be ready to use financial instruments to hedge this exposure if the need arises. Based on its transaction volume, the Group has
determined not to hedge its USD exposure. As the Danish kroner is pegged to the EUR, hedging of the Company’s transactions in EUR is not necessary.
To the extent these risk factors are within the Company’s control, the Company seeks to address them in the ordinary course of business.
Internal controls
The Board of Directors and the Management of BioPorto are responsible for the Company’s control and risk management in connection with the financial
reporting process, including compliance with rules and regulations that are relevant in reporting.
The Board of Directors has established an Audit Committee that reviews and discusses the accounting and audit practices with the Company’s auditors and
Management in accordance with the Rules of Procedures of the Audit Committee.
The annual audit and reporting process includes detailed planning of individual tasks and planning by finance based on an audit strategy approved by the
Audit Committee.
At least annually, the Audit Committee evaluates the risks connected with the financial reporting process, including the presence of internal controls and
guidelines. The Audit Committee assesses the Company’s organizational structure, including the risk of fraud and the measures to be taken to reduce
14
BioPorto Annual Report 2023
and/or eliminate such risk. In that regard, any incentive or motivation of Management to manipulate earnings or perform any other fraudulent action is
discussed.
The Company’s internal controls and guidelines provide a reasonable but not an absolute certainty that unlawful use of assets, loss and/or significant errors
or deficiencies in relation to the financial reporting process can be avoided. The Board of Directors has not instituted an internal audit function at BioPorto,
based on its assessment that the Company’s size and complexity do not necessitate such a function.
BioPorto Annual Report 2023
15
16
BioPorto Annual Report 2023
BioPorto Annual Report 2023
17
18
BioPorto Annual Report 2023
BioPorto Annual Report 2023
19
20
BioPorto Annual Report 2023
Notwithstanding the foregoing, BioPorto has defined a target, that no later than in 2027 at least 40% members of the Board of Directors consists of the
underrepresented gender, which will constitute equal representation according to applicable law. This target is not intended to detract from other
competency requirements in the nomination of members to the Management team of the Company.
BioPorto Annual Report 2023
21
Investor Relations
BioPorto maintains an active dialogue with shareholders, analysts, prospective investors, and other stakeholders by providing communication about
relevant strategic, economic, financial, operational, and scientific affairs of the Company. Management and Investor Relations are routinely available to
existing and potential shareholders via participation in investor conferences, roadshows, investor meetings, and conference calls.
BioPorto aims to provide the market with transparent and adequate information about the Group’s strategy, operations, and results with a view to ensuring
fair pricing of its shares. BioPorto operates in a highly complex sector in terms of both products and market conditions. The Group endeavors to strike a
reasonable balance so that the information it communicates is both technically correct and understandable to laypeople. All stakeholders should have
rapid, equal access to material information about BioPorto’s development and growth. This means, among other things, that relevant information is
published in Company Announcements via NASDAQ Copenhagen A/S and is made available on the group’s website: www.bioporto.com.
Other published information, including general Company and investor presentations, is made available to the public on the Company’s website. The
investor section of the website also includes an email service where shareholders and others can subscribe to receive news by email immediately after the
publication of Company announcements, press releases, and other news.
Registered shareholders are offered a range of electronic information services through the shareholder portal, which can be accessed from the Company’s
website. The portal also offers the opportunity to request admission cards and/or vote by proxy for the General Meetings. Shareholders are encouraged
to sign-up to receive Company announcements via e-mail from the Company, which can be done here. Investor Relations (IR) is responsible for ensuring
that information from the group’s IR stakeholders is shared with the Management and the Board of Directors. For more relevant details relating to BioPorto,
investors are referred to the Company’s website: www.bioporto.com.
Shares
ISIN, capital stock and price trends
On December 31, 2023, BioPorto’s capital stock had a nominal value of DKK 379,670,461 divided into 379,670,461 shares with a nominal value of DKK 1
each. Each share carries one vote. BioPorto A/S ’s shares are listed on NASDAQ Copenhagen.
In May 2023, the Company increased its share capital following exercise of warrants. A total of 2,000,000 new shares. The exercise prices were DKK 1.70
per share for 1,000,000 of the new shares and DKK 1.48 for the remaining 1,000,000 of the new shares. The total proceeds from the capital increase
amounted to DKK 3,180,000
In June 2023, BioPorto completed a rights offering of 42,977,456 new shares raising net proceeds of DKK 41.3 million.
Other published information, including general Company and investor presentations, is made available to the public on the Company’s website. The
investor section of the website also includes an email service where shareholders and others can subscribe to receive news by email immediately after the
publication of Company announcements, press releases and other news.
To support efficient, expedient dialogue with shareholders, BioPorto encourages its shareholders to let their shareholding be registered and to participate
in BioPorto’s shareholder meetings.
Ownership
As of December 31, 2023, BioPorto had 20.486 registered shareholders (2022: 19,638), that in the aggregate owned 87,61 % of the capital stock. As of
December 31, 2023, the following shareholders stated that they owned 5% or more of the Company’s shares/voting rights:
Ejendomsselskabet Jano ApS, Toldbodgade 36A, Copenhagen K Above 10 %
Media-Invest Danmark A/S, Gammel Kongevej 174, 4., Frederiksberg C Above 10 %
A/S Arbejdernes Landsbank Vesterbrogade 5, Copenhagen V Above 5%
Warrant Program
The Board established warrant programs in 2023 for the purpose of creating a long-term incentive for retaining and motivating Management and
employees in accordance with the Company’s remuneration policy and the authorization in section 18a of the Articles of Association. Each warrant granted
in 2023 (as listed below) includes conditions on claw-back in case of e.g., erroneous financial information and provisions on accelerated vesting in case of
e.g., a takeover bid and/or business combinations, and provides the holder the right to subscribe for one share in BioPorto:
Shareholder Matters
22
BioPorto Annual Report 2023
• On February 16, 2023, the Board of Directors of BioPorto A/S issued 500,000 warrants for the subscription of an equal number of shares. The
exercise price was DKK 2.405 per share corresponding the closing price on Nasdaq Copenhagen on 16 February 2023. The theoretical market
value of the issued warrants was DKK 472,127 based on the Black-Scholes formula using an interest rate of 2.81% and the historical volatility of
anniversary of the Grant Date and the remaining three-quarters of the Stock Option shall vest and become exercisable in twelve equal tranches,
each tranche vesting per calendar quarter thereafter (i.e., 1 January, 1 April, 1 July and 1 October, provided that first such tranche shall vest on
1 April 2024), subject to the U.S. Grantee’s continued service to the Company or a subsidiary of the Company through the applicable vesting
date. The warrants vest over a four-year period.
• On April 25, 2023, the Board of Directors of BioPorto A/S issued 4,987,721 warrants for the subscription of an equal number of shares to
Executive Management. The exercise price was DKK 1.532 per share, corresponding to the closing price on Nasdaq Copenhagen on April 25,
2023. The theoretical market value of the newly issued warrants is DKK 3,479,000 based on the Black-Scholes formula using an interest rate of
2.92% and the historical volatility of BioPorto A/S’ shares over 33 months calculated to 68.95%. The warrants will vest upon the achievement
of certain performance criteria. With respect to each holder, 50% of the warrants will vest in twenty-four (24) equal tranches on the first day of
each month following the Company achieving marketing rights from the FDA for The NGAL Test for pediatric use, and the remaining 50% will
vest in twelve (12) equal tranches on the first day of each month following the Company achieving regulatory approval that expands clinical
indication to include expanded pediatric indication outside the Intensive Care Unit, or any adult indications, in the United States. Neil Goldman
former CFO resigned effective October 15, 2023 and all of his warrant expense was fully reversed in 2023 in the Consolidated Statement of
Profit or Loss. Tony Pare resigned as CEO effective January 9, 2024, and forfeited 3,528,973 of his shares related to this grant. The company
recognized warrant expense of DKKt 515 in 2023 for this grant.
• On September 22, 2023, the Board of Directors of BioPorto A/S issued a total of 700,000 warrants to members of the Board of Directors of the
Company, and further to issue a total of 2,750,000 warrants to employees of the BioPorto group for the subscription of an equal number of
shares. The exercise price was DKK 1.686 per share, corresponding to the closing price on Nasdaq Copenhagen on September 22, 2023. The
theoretical market value of the newly issued warrants is DKK 1,689,141. The calculation is based on the Black-Scholes formula using an interest
rate of 3.39% and the historical volatility of BioPorto A/S’ shares over 15 months calculated to 62.90%. The warrants to the employees’ vest
twelve (12) months after the Company achieves marketing rights from the FDA for its NGAL test for pediatric use. Regarding the warrants to
the Board of Directors, fifty percent (50%) of the Warrants shall vest and become immediately exercisable on the first anniversary of the date
of the 2023 Annual General Meeting, which is April 27, 2024, and fifty percent (50%) of the Warrants shall vest and become immediately
exercisable six months after shares of the Company (or an entity succeeding the Company) have been admitted to trading on a recognized stock
exchange, regulated market, multilateral trading facility or similar in the United States (whether as a separate or dual listing and/or in the form
depositary receipts or similar), provided such admission to trading takes place prior to December 31, 2028, in each case, subject to the
Beneficiary’s continued service as a board member in the Company through the date of the Company’s 2024 Annual General Meeting expected
to be held in the first half of 2025.The warrants include conditions on claw-back in case of e.g., erroneous financial information and provisions
on accelerated vesting in case of e.g., a takeover bid and/or business combinations. The warrants to the members of the board are subject to
the terms set out in the notice for the annual general meeting included in company Announcement no. 5 of April 5, 2023.
Detailed terms of the new and existing warrants, including applicable vesting schedules, can be found in the Articles of Association on www.bioporto.com
under Investor Relations> Governance> Company Articles. At the end of 2023, a total of 16,024,058 warrants were outstanding, corresponding to 4.2%of
the issued and outstanding nominal capital stock, Cf. Note 5.
Dividend policy
BioPorto’s policy is that shareholders should receive a return on their investment in the form of a share price increase based on the Group’s growth.
Because of the Group’s need for capital to implement its strategic initiatives and achieve higher sales, no dividend is expected to be paid in 2024. In the
long term, and as the Company generates profits, the Company wishes to be able to give shareholders direct returns in the form of dividends and/or share
buybacks in addition to a return on the share price.
BioPorto Annual Report 2023
23
Equity analysts and investor meetings
BioPorto has ongoing contacts with investors and equity analysts and, in this context, holds regular presentations and meetings where strategy, pipeline
development and risks are discussed. BioPorto usually holds investor meetings after the publication of the annual report and interim reports and quarterly
announcements.
The following analyst covers BioPorto:
H.C. Wainwright, US
Mr. Yi Chen
Annual Shareholder Meeting
Additional information will become available on the Company’s website no later than three weeks before the Annual General Meeting.
Financial Calendar 2024
March 18, 2024
Deadline for shareholder proposals – Annual General Meeting
April 4, 2024
Annual Report 2023
April 30, 2024
Annual General Meeting
May 8, 2024
Interim Report – for the three-month period ended March 31, 2024
August 1, 2024
Interim Report – for the six-month period ended June 30, 2024
October 30, 2024
Interim Report – for the nine-month period ended September 30, 2024
24
BioPorto Annual Report 2023
(born 1959, American nationality) has been a member of BioPorto’ s Board of Directors since 2021 and
currently serves as the chairman of the Board of Directors. John McDonough previously served as President
and chief executive officer, of T2 BioSystems, Inc., a diagnostics company focused on the rapid detection of
sepsis-causing pathogens. John held several positions at Cytyc Corporation, a company focused on women’s
health, and ultimately served as president of Cytyc Development Corporation. He also led the efforts that
resulted in Cytyc’s acquisition by Hologic Inc. for over $6 billion. John McDonough is currently Executive
Chairman of the Board of Directors at Sunbird Bio and chairman of the board at Cytrellis Biosystems. He earned
his undergraduate degree in business from Stonehill College.
Other directorships: · Cytrellis Biosystems, Inc., Chairman of the Board of Directors, Solace Therapeutics, Board
member.
Don Hardison, Jr., Vice Chairperson
(born 1950, American nationality) has been a member of BioPorto’s Board of Directors since 2021. Don
Hardison most recently served as President, Chief Executive Officer, and as a member of the board of Board of
Directors of Biotheranostics, Inc., an oncology-focused molecular diagnostics company which was acquired by
Hologic Inc. Prior to Biotheranostics, he was the President and Chief Executive Officer and Director of Good
Start Genetics, a molecular diagnostics company focused on reproductive health. Earlier in his career, he held
many executive and senior management positions at a number of public companies including Laboratory
Corporation of America and Quest Diagnostics, the two largest US clinical laboratories; Exact Sciences
Corporation, a molecular diagnostics company; and SmithKline Beecham Corporation, a pharmaceutical
company. He currently serves on the Board of Directors of publicly held companies Cytek Biosciences and
mdxhealth and several privately held companies including Stemina Biomarker Discovery., YourBio, Decode
Health, Breathe BioMedical, Arima Genomics and GeneCentric. He also served as President and CEO and a
director of Exact Sciences Corporation, through its initial public offering and the initial years of being a public company. He received his Bachelor of Arts in
Political Science from the University of North Carolina, Chapel Hill.
Other directorships: DeCode Health. Board Member, mdxhealth. Board member, Stemina Biomarker Discovery Inc., Board member, YourBio, Board
member, Cytek Biosciences. Board member, Breathe BioMedica, Arima Genomics, GeneCentric. Board member.
Michael Singer, MD, PhD
(born 1973, American nationality) has been a member of BioPorto’s Board of Directors since 2019. He is
currently Chief Scientific Officer (CSO) and co-founder of Cartesian Therapeutics, Inc, a US biotech company
that develops RNA-modified cell therapies. Prior to founding Cartesian, he was co-founder and CSO of two
startups: Topokine and HealthHonors. Dr. Singer previously served as Director of Translational Medicine at the
Novartis Institutes for Biomedical Research. He is a licensed physician and has been admitted to practice patent
law. He serves as an adjunct professor at the Yale University School of Medicine. Dr. Singer completed
residency at Harvard and holds a BS, MD, and PhD from Yale University.
Other directorships: Cartesian Therapeutics, Inc., Board member, Cartesian Therapeutics, Inc., Chief Scientific Officer,
Vice President, Pykus Therapeutics, Inc., Board member, Anodyne Nanotech, Inc., Board member.
Board of Directors
BioPorto Annual Report 2023
25
Ninfa Saunders
(born 1959, American nationality) has been a member of BioPorto’s Board of Directors since 2023. Ninfa has
over 50 years of healthcare experience from the bedside as a Clinical Nurse Specialist, to C-Suite roles, topping
of her career as President and CEO of multi-hospital systems. She maintained a laser focus on strategy,
operations and people while optimizing patient care and enhancing the bottom line. She created innovative
strategies that accelerated growth, strengthened operations and saved lives. As CEO of Navicent Health, Ninfa
expanded the hospital’s reach in Georgia through mergers and acquisitions, partnerships, new service lines
and a strategic alliance with 30+ hospitals region-wide. In 2019, she orchestrated a merger with Charlotte
based Atrium Health to position Navicent for future growth and sustainability. Since her retirement in 2020,
she has served on the Board of Directors for Horizon Blue Cross Blue Shield,NJ, Quorum Health, Pipeline Health
and T2 Biosystems. She serves on the Compensation Committee, Audit. Committee, Finance Committee and
Governance Committee. Ninfa is a seasoned healthcare executive sought after for her competencies in all areas of leadership, management and
governance.
Other directorships: BioPorto Inc., Member of the Board of Directors, Horizon Blue Cross and Shield NJ Member, Board of Directors, Quorum Health, Member of
the Board of Directors, Pipeline Health, Member of the Board of Directors, T2 Biosystems, Member of the Board of Directors, Avia Health, Executive in Residence.
Peter Mørch Eriksen
(born 1960, Danish nationality) has been a member of BioPorto’s Board of Directors since 2021 and served as
CEO of BioPorto from 2013 – 2021 and now as CEO as from 9 January 2024. Peter Mørch Eriksen has spent
more than 25 years in the MedTech/life science industries, including as CEO of Sense A/S and VP of Medtronic.
From these positions, Peter Mørch Eriksen has extensive experience in creating growth, restructuring and
funding in technology-intensive and complex companies. Peter Mørch Eriksen is an experienced leader with a
record of business within the medical device industry and has broad experience selling and developing medical
devices for both small and large MedTech companies. Peter Mørch Eriksen has an accounting background,
supplemented with management experience. He is chairman of the Board of Directors in FluoGuide A/S and
MONSENSO A/S and member of the executive management in AptaShape ApS and PME Holding ApS.
Other directorships: FluoGuide A/S, Chairman of the Board of Directors, MONSENSO A/S, Chairman of the Board of
Directors, PME Holding ApS, Member of the executive management, AptaShape ApS, Member of the executive management, BioPorto Diagnostics A/S, Member of
the Board of Directors, The Medical Device and Diagnostics Advisory Committee of Cincinnati Children’s Hospital Center, Board member.
Other Board Information
First
elected
Term Expires
Independent
Nationality
Year of Birth
Gender
Shares held
in BioPorto
Dec. 31, 2021
Shares held in
BioPorto
Dec. 31, 2022
Shares held in
BioPorto
Dec. 31, 2023
John McDonough
2021
2024
Yes
USA
1959
M
-
-
407,750
Don Hardison
2021
2024
Yes
USA
1950
M
-
-
20,000
Michael Singer
2019
2024
Yes
USA
1973
M
167,433
209,291
-
Peter Mørch Eriksen
2021
2024
No
*
1960
M
105,506
131,882
155,155
Ninfa Saunders
2023
2024
Yes
USA
1959
F
-
-
-
Resigned Board Members
Christopher Lindop
2019
27 April 2023
Yes
USA
1957
M
446,487
558,108
-
Jan Leth Christensen
2021
4 December
2023
Yes
1963
M
32,169,732
40,212,165
47,308,429
*
As Mr. Eriksen currently is appointed as CEO, he is considered non-independent under the criteria defined by the Danish Committee on Corporate Governance.
26
BioPorto Annual Report 2023
Peter Mørch Eriksen
(born 1960, Danish nationality) currently serves as the CEO of BioPorto since 9 January 2024. He has been a
member of BioPorto’s Board of Directors since 2021 and served as CEO of BioPorto from 2013 – 2021. Peter
Mørch Eriksen has spent more than 25 years in the MedTech/life science industries, including as CEO of Sense
A/S and VP of Medtronic. From these positions, Peter Mørch Eriksen has extensive experience in creating
growth, restructuring and funding in technology-intensive and complex companies. Peter Mørch Eriksen is an
experienced leader with a record of business within the medical device industry and has broad experience
selling and developing medical devices for both small and large MedTech companies. Peter Mørch Eriksen has
an accounting background, supplemented with management experience. He is chairman of the Board of
Directors in FluoGuide A/S and MONSENSO A/S and member of the executive management in AptaShape ApS
and PME Holding ApS.
Other directorships: FluoGuide A/S, Chairman of the Board of Directors, MONSENSO A/S, Chairman of the Board of Directors, PME Holding ApS, Member of the
executive management, AptaShape ApS, Member of the executive management, BioPorto Diagnostics A/S, Member of the Board of Directors, The Medical Device
and Diagnostics Advisory Committee of Cincinnati Children’s Hospital Center, Board member.
Executive Management
BioPorto Annual Report 2023
27
George Rosa
(born 1967, American nationality) currently serves as the Vice President of Global Reporting and Controls since
2 May 2022. He is a member of BioPorto’s Leadership Team and has more than 30 years of experience
successfully working at Fortune 500 companies, private and multinationals enterprises. George has over 10
years in the MedTech/life science industries, including as Senior Director of Finance at Smith and Nephew and
Finance Director at Bruker Corporation. From these positions, George has extensive experience in creating
growth, integration of acquisitions, restructuring and operating model redesign to improve business outcomes
and profitability. George is an experienced global leader with a record of timely and accurate reporting,
improving business process controls, building strategic alliances, and developing internal talent. George has an
accounting and finance background and obtained his Bachelor of Science in Business Administration from
Northeastern University in Boston, Massachusetts, USA.
Financial Management
28
BioPorto Annual Report 2023
This financial review is based on the Group’s consolidated financial information for the year ended December 31, 2023, with comparative results for the
year ended December 31, 2022, in brackets.
Revenue
Revenue for 2023 was DKK 31.0 million (DKK 29.0 million), an increase of 6.9%, and comprised:
• NGAL tests: DKK 18.6 million (DKK 14.9 million);
• Antibodies: DKK 10.7 million (DKK 12.0 million);
• ELISA kits: DKK 1.7 million (DKK 1.8 million); and,
• Royalty and other: DKK 0.1 million (DKK 0.2 million).
Revenue for 2023 was within Guidance of 30 to 33 million DKK, which reflected a favorable performance with NGAL test revenue. NGAL test revenue
increased by DKK 3.7 million, or 24.9%, over the prior year period. Antibody revenue decreased by DKK 1.3 million, or 11.2%, over the prior year period.
ELISA kits revenue decreased of DKK 0.1 million, or 8.8%, compared to the prior year period.
Figure 1. Revenue by quarter (DKKM) Figure 2. NGAL test product revenue by quarter (DKKM)
Gross profit
Gross profit for 2023 totaled DKK 20.2 million (DKK 19.0 million). The DKK 1.2 million increase in gross profit was mainly comprised of DKK 1.3 million from
favorable sales volume.
Sales and marketing costs
Sales and marketing costs totaled DKK 18.9 million (DKK 21.2 million). The decrease is primarily due to lower staffing costs, due to the restructuring in Q2
2023.
Research and development costs
Research and development costs totaled DKK 25.4 million (DKK 34.9 million), with the decrease reflecting lower clinical study costs and a reduction in staff
costs due to the restructuring in Q2 2023.
Administrative costs
Administrative costs totaled DKK 36.0 million (DKK 41.8 million), with the decrease related to lower share-based expenses and lower staff costs compared
to previous year.
Lease impairment
The Company recorded a non-cash lease impairment charge of DKK 1.0 million during 2023. The sublease agreement was executed in November 2023 of
its office space in Needham, MA, USA. The company established a lease receivable as described in Note 18.
5.6
6.6
5.3
6.8
6.5
8.5
5.3
8.7
8
7.8
8.6
6.6
0
2
4
6
8
10
Q1 Q2 Q3 Q4
2021 2022 2023
2.2
3.7
2.6
3.9
3.7
3.3
2.7
5.2
4.8
4.6
5.8
3.4
0
1
2
3
4
5
6
7
Q1 Q2 Q3 Q4
2021 2022 2023
Financial Review
BioPorto Annual Report 2023
29
Financials items, net
Financial income and expenses reflect interest income/expense and currency transaction gains/losses, bank charges and interest. In 2023 there was an
income for a net amount of approximately DKK 0.0 million (DKK 0.0 million), with the net amount related to currency rate changes and interest income.
Tax benefit
A DKK 4.9 million tax benefit (DKK 5.6 million tax benefit) was realized during 2023. The tax benefit is primarily related to tax credits derived by BioPorto’s
Danish entities associated with investments in research and development.
EBIT/Adjusted EBITDA
For 2023, EBIT was a loss of DKK 61.2 million (DKK 81.5 million), Adjusted EBITDA was a loss of DKK 56.1 million (loss of DKK 67.3 million), each reflecting
the mix of variances described above.
Adjusted EBITDA loss for 2023 was favorable compared to the Company’s original outlook of a loss of DKK 60 to 65 million and was within the updated
guidance of a loss of DKK 56 to 59 million. The improved adjusted EBITDA guidance was mainly driven by the reduction in force executed as part of a
restructuring event during Q2 2023.
Cash and cash equivalents
As of December 31, 2023, BioPorto’s balance of cash and cash equivalents totaled DKK 66.4 million (DKK 81.8 million) and is deposited at major, national
Danish, Nordic, and US banks. The Company continually evaluates its liquidity requirements, capital needs and availability of capital resources based on its
operating needs and planned initiatives. The Company assessed its liquidity and capital resources and concluded that they are adequate to fund operations
considering a twelve-month period from the date of this Annual Report. The Company’s assessment as to the adequacy of liquidity relies inter alia on
assumptions and significant judgements (in addition to those matters discussed cf. Note 2) applied in the Company's budgets and forecasts as well as
customary sensitivities, existing capital resources and assumptions concerning the timing, costs and resources required to undertake the Company’s
strategic priorities and tactical decisions, including the timing of marketing ProNephro AKI (NGAL) in the US, commercialization activities for NGAL tests
under CE Mark and Antibodies in Europe, supply chain management, and ongoing R&D, all of which under current circumstances remain difficult to predict.
Equity
As noted above, on June 23, 2023, BioPorto raised net proceeds of DKK 41.3 million, from a rights offering of new shares. In total, 42,977,456 new shares
of common stock were offered and sold for a rights offering with pre-emptive rights for existing shareholders that was filed on May 30, 2023.
See the Consolidated Statement of Changes in Equity below for further details in the movements in equity.
Net working capital
Net working capital (i.e., current assets minus current liabilities) as of December 31, 2023 totaled DKK 56.9 million (DKK 70.5 million). The decrease is
related to the cash burn in 2023.
Cash Flow Statement
Cash used in operating activities for the year ended December 31, 2023 totaled DKK 55.5 million (DKK 52.5 million), with the increase over the prior year
primarily associated with the timing of account payables, offset by lower share-based expenses.
Cash used in investing activities was DKK 0.3 million (DKK 0.5 million) which primarily consisted of investments in financial assets.
Cash from financing activities was DKK 40.8 million (DKK 88.7 million), reflecting the proceeds of the net rights offering, offset by facility lease costs.
The net cash flow for the year ended December 31, 2023 reflected a use of DKK 14.9 million (source of DKK 35.7 million).
Events after the reporting period
On January 9, 2024, the Company announced that BioPorto’s CEO, Anothony Pare, is stepping down and leaving BioPorto effective on that date, and
appointed Board Member Peter Mørch Eriksen as CEO of the Company.
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BioPorto Annual Report 2023
Change of control
The Danish Financial Statements Act, Section 107 a, contains rules relating to listed companies with respect to certain disclosures associated with change
of control provisions in contracts. BioPorto has entered into agreements with external parties that may be subject to renegotiation in the event of a change
of control in BioPorto. However, detailed information is not provided here, as it may be restricted from disclosure due to confidentiality provisions or is
not otherwise expected to have a material effect on the Company’s financial position.
BioPorto Annual Report 2023
31
Consolidated Statements of Profit or Loss
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Notes
Revenue
3
Production costs
4, 5, 6
Gross profit
Sales and marketing costs
4, 5, 6
Research and development costs
4, 5, 6
Administrative costs
4, 5, 6
Lease impairment
Loss before financial items (EBIT)
(61,172 )
(81,527 )
Financial income
8
Financial expenses
8
Loss before tax
(61,207 )
(81,547 )
Income tax benefit, net
9
Net loss
(56,328 )
(75,923 )
DKK
DKK
Loss per share (EPS & DEPS)
10
(0.16
(0.24
Consolidated Statements of Comprehensive Loss
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Notes
Net loss
(56,328 )
(75,923 )
Other comprehensive loss:
Amounts which will be reclassified to the income statement:
Exchange rate adjustments of investments in subsidiaries
(115 )
Other comprehensive loss
(115 )
Comprehensive loss
(55,869 )
(76,038 )
Financial Statements
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BioPorto Annual Report 2023
Consolidated Balance Sheets
Assets
2023
2022
Dec 31
Dec 31
DKK thousand
Notes
Non-current assets
Property, plant and equipment and intangible assets
Rights and software
11
Property, plant and equipment
12
Right-of-use assets
13
Total property, plant and equipment and intangible assets
Financial assets
Lease receivable - Long term
Deposits
Total financial assets
Total non-current assets
Current assets
Inventories, net
14
Trade receivables, net
15, 18
Tax receivable
9
Other receivables
15, 18
Prepayments
15
Cash and cash equivalents
18
Assets held-for-sale
13
Lease receivable - short term
Total current assets
Total assets
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Equity and Liabilities
2023
2022
Dec 31
Dec 31
DKK thousand
Notes
Equity
Share capital
17
Treasury shares
17
Exchange-rate adjustments
(234 )
Retained earnings
(319,735 )
(264,238 )
Total equity
Liabilities
Non-current liabilities
Lease obligations
13
Total non-current liabilities
Current liabilities
Current portion of lease obligations
13
Trade payables
18
Tax payables
Other accrued liabilities
16
Total current liabilities
Total liabilities
Total equity and liabilities
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BioPorto Annual Report 2023
Consolidated Statements of Changes in Equity
Amounts in DKK thousand
Shares in thousands
Share
Capital
Share
Premium
Treasury
Shares
Accumulated
Deficit
AOCI
Total
Balance at December 31, 2022
(264,238 )
(234 )
Other comprehensive loss
Closure of dormant subsidiary
(104 )
(104 )
Transaction with owners:
Exercise of warrants
Issuance of stock
Issuance costs
(1,629 )
(1,629 )
Tranferred to Accumulated Deficit
(449 )
Share-based compensation
Net loss
(56,328 )
(56,328 )
Balance at December 31, 2023
(319,735 )
Amounts in DKK thousand
Shares in thousands
Share
Capital
Share
Premium
Treasury
Shares
Accumulated
deficit
AOCI
Total
Balance at December 31, 2021
(221,671 )
(119 )
Other comprehensive loss
(115 )
(115 )
Transaction with owners:
Issuance of stock
Issuance costs
(7,672 )
(7,672 )
Tranferred to Accumulated Deficit
(25,797 )
Share-based compensation
Net loss
(75,923 )
(75,923 )
Balance at December 31, 2022
(264,238 )
(234 )
BioPorto Annual Report 2023
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Consolidated Statements of Cash Flows
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Notes
Loss before financial items
(61,172 )
(81,527 )
Adjustments:
Depreciation and amortization
6
Share based compensation expenses
Lease impairment
13
Other non-cash items
(960 )
(945 )
Changes in assets and liabilities:
Inventories
(440 )
Trade receivables
Trade payables
(3,552 )
Other operating assets and liabilities, net
(1,399 )
(1,051 )
Cash flows from operations
(61,799 )
(57,768 )
Financial income, received
Financial expenses, paid
(94 )
(1,618 )
Tax refund, net
Cash flows from operating activities
(55,456 )
(52,485 )
Purchase of property, plant and equipment
12
(39 )
(407 )
Purchase of rights and software
11
(64 )
Purchase of financial assets
(238 )
(32 )
Cash flows from investing activities
(277 )
(503 )
Proceeds from warrant programs exercised
Proceeds from rights issue
Cost related to Issue of new shares
17
(1,629 )
(7,671 )
Repayments of non-current liabilities
(301 )
Repayments of lease obligation
13
(3,738 )
(3,737 )
Cash flows from financing activities
Net cash flows for the period
(14,943 )
Cash and cash equivalents at beginning of period
Effect of exchange rate changes on cash
(447 )
Cash and cash equivalents end of period
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Statements of Profit or Loss
2023
2022
DKK thousand
Notes
Jan 1 - Dec 31
Jan 1 - Dec 31
Revenue
2
9,600
9,600
Gross profit
9,600
9,600
Sales and marketing costs
-
83
Administrative costs
3
14,153
25,319
Loss before financial items (EBIT)
(4,553)
(15,802)
Loss from investments in subsidiaries
4
(58,215) (65,896)
Financial income
5
8,643 6,354
Financial expenses
5
2,933
579
Loss before tax
(57,058)
(75,923)
Income tax benefit, net
6
730
-
Net loss
(56,328)
(75,923)
Proposed distribution of loss
Accumulated Deficit
(56,328)
(75,923)
(56,328)
(75,923)
Parent Company
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Balance Sheets
Assets
2023
2022
DKK thousand
Notes
Dec 31
Dec 31
Non-current assets
Property, plant and equipment and intangible assets
Property, plant and equipment
-
-
Right-of-use assets
1,254
2,927
Total property, plant and equipment and intangible assets
1,254
2,927
Financial assets
Investments in subsidiaries
4
2,163
2,208
Receivables from subsidiaries
91,248
76,345
Deposits
923
851
Total financial assets
94,334
79,404
Total non-current assets
95,588
82,331
Current assets
Taxes receivable
4,956
5,500
Other receivables
556
379
Total receivables
5,512
5,879
Cash and cash equivalents
57,662
74,941
Total current assets
63,174
80,820
Total assets
158,762
163,151
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BioPorto Annual Report 2023
Equity and liabilities
2023
2022
DKK thousand
Notes
Dec 31
Dec 31
Equity
Share capital
379,670
334,693
Exchange rate adjustments
225
(234)
Retained loss
(319,735)
(264,238)
Total equity
60,160
70,221
Provisions
Provisions in subsidiaries with negative equity
90,968
85,141
Total provisions
90,968
85,141
Liabilities
Non-current liabilities
Lease obligation
-
1,387
Non-current liabilities
-
1,387
Current liabilities
Current portion of lease obligations
1,387
1,707
Trade payables
3,526
2,838
Other payables
2,721
1,857
Current liabilities
7,634
6,402
Total liabilities
7,634
7,789
Total equity and liabilities
158,762
163,151
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Statements of changes in equity
Amounts in DKK thousand
Shares in thousands
Share
Capital
Share
Premium
Treasury
Shares
Accumulated
Deficit
AOCI
Total
Balance at December 31, 2022
334,693
-
13
(264,238)
(234)
70,221
Other comprehensive loss
-
-
-
-
459
459
Closure of dormant subsidiary
-
-
-
(104)
-
(104)
Transactions with owners:
Exercise of warrants
2,000
1,180
-
-
-
3,180
Issuance of Stock
42,977
-
-
-
-
42,977
Issuance costs
-
(1,629)
-
-
-
(1,629)
Transferred to Accumulated Deficit
-
449
-
(449)
-
-
Share-based compensation
-
-
-
1,384
-
1,384
Net loss
-
-
-
(56,328)
-
(56,328)
Balance at December 31, 2023
379,670
-
13
(319,735)
225
60,160
Amounts in DKK thousand Shares in
thousands
Share
Capital
Share
Premium
Treasury
Shares
Accumulated
Deficit
AOCI
Total
Balance at December 31, 2021
267,754
-
13
(221,671)
(119)
45,964
Other comprehensive loss
-
-
-
-
(115)
(115)
Transaction with owners:
Issuance of Stock
66,939
33,469
-
-
-
100,408
Issuance costs
-
(7,672)
-
-
-
(7,672)
Transferred to Accumulated Deficit
-
(25,797)
-
25,797
-
-
Share-based compensation
-
-
-
7,559
-
7,559
Net loss
-
-
-
(75,923)
-
(75,923)
Balance at December 31, 2022
334,693
-
13
(264,238)
(234)
70,221
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BioPorto Annual Report 2023
1. Basis of reporting
The financial statements of the parent company, BioPorto A/S, have been prepared in accordance with the provisions of the Danish Financial Statements Act
for Reporting class D (listed) enterprises.
The annual report is presented in Danish kroner (DKK), which also is the functional currency of the company.
Changes in accounting policies
The accounting policies of the Parent Company are unchanged from the prior year.
Differences relative to the Group’s accounting policies
The Parent Company’s accounting policies for recognition and measurement are in accordance with the Group’s policies with the exceptions set out below.
Statements of Profit or Loss
Income from investments in subsidiaries.
Income from investments in subsidiaries are recognized in the parent company’s income statement as the proportional share of the subsidiaries results for year
corresponding to the Parent Company’s ownership.
Balance Sheets
Investments in subsidiaries.
Investments in subsidiaries are recognized and measured under the equity method. Subsidiaries with a negative net asset value are recognized at DKK nil, and
any receivable amount from these companies is written down by the negative net asset value to the extent it is deemed to be irrecoverable.
Statements of Cash Flows
As permitted under section 86 (4) of the Danish Financial Statements Act, a statement of cash flows for the parent company is not presented, as it is included
in the Consolidated Statement of Cash Flows.
Taxation
The parent company is taxed jointly with its domestic subsidiary. The jointly taxed Danish enterprises are taxed under the Danish on-account tax scheme. Current
tax for jointly-taxed companies is recognized in each individual company. All jointly-taxed companies are covered by the joint-taxation liability. See disclosures
related to “Deferred tax assets” and “Tax payables” in the Consolidated Financial Statements and related notes thereto.
Notes to Financial Statements of Parent
Company
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69
2. Business area reporting
GEOGRAPHIC DISTRIBUTION
2023
2022
Jan 1 – Dec 31
Jan 1 – Dec 31
DKK thousand
Denmark
9,600
9,600
Revenue
9,600
9,600
The sale of services in BioPorto A/S exclusively represents intra-group services. Revenue is recognized over time in the accounting period in which the
performance obligations associated with the services are rendered.
3. Staff costs
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Wages and salaries
3,865
7,670
Defined contribution pension plans
-
299
Share-based compensation expenses
71
7,556
Other social security costs
17
3
Other staff costs
26
108
Staff costs
3,979
15,636
Average number of employees
0
3
Reclassification of share-based compensation expenses have been made in 2023. Reference is made to note 4 in the Consolidated financial statements.
SPECIFICATION OF STAFF COSTS
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Sales and marketing costs
-
-
Administrative costs
3,979
15,636
Staff costs
3,979
15,636
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REMUNERATION FOR KEY MANAGEMENT PERSONNEL
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Board of Directors
Remuneration
3,956
4,161
Board of Directors, Total
3,956
4,161
Executive Management
Salary
-
-
Bonus
-
-
LTI bonus
-
-
Contribution based pension
-
-
Other employee benefits
-
-
Remuneration, total
-
-
Share-based compensation expenses
-
4,842
Executive Management, Total
-
4,842
Other Corporate Management
Salary
-
720
Bonus
-
97
LTI bonus
-
-
Contribution based pension
-
64
Other employee benefits
-
-
Remuneration, total
-
881
Share-based compensation expenses
-
2,702
Other Corporate Management, Total
-
3,583
Remuneration for key management personnel
3,956
12,586
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4. Investments in subsidiaries
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Cost on January 1
51,364
51,364
Additions (Disposals)
(2,000)
-
Cost at December 31
49,364
51,364
Revaluation on January 1
(509,209) (443,197)
Loss from investments in subsidiaries
(58,215) (65,897)
Exchange rate adjustments investments in subsidiaries
459
(115)
Equity changes in subsidiaries
2,102
-
Revaluation on December 31
(564,863) (509,209)
Value on December 31
(515,499) (457,845)
Negative value of investments set off against receivables from group
426,797 374,909
Negative value of investments recognized as a provision
90,865
85,144
Value on December 31
2,163
2,208
BioPorto A/S regularly contributes capital to the subsidiary BioPorto Diagnostics A/S to support the subsidiary’s operating activities. The receivable amount
carries interest at an average annual rate for 2023 of 9.4%, which accrues at the end of each quarter. The Management members of BioPorto A/S and BioPorto
Diagnostics A/S are identical. As BioPorto Diagnostics A/S activities account for the bulk of the Group’s activities, and reference is made to the Management
Review, including the description of risks. Management believes that uncertainty attached to BioPorto Diagnostics A/S possibility of repaying the part of the
Parent Company’s receivable from the subsidiary which corresponds to the subsidiary’s negative equity. Accordingly, a write-down has been made to reflect
this.
List of subsidiaries
BioPorto Diagnostics A/S, 2900 Hellerup, Denmark . Ownership: 100%
BioPorto Inc., Needham, Massachusetts, USA. Ownership: 100%
BioPorto Diagnostics Inc., Needham, Massachusetts, USA. Ownership: 100%
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5. Financial income and expenses
FINANCIAL INCOME
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Interest income from subsidiaries
7,755 2,495
Interest income from bank
888
21
Exchange rate adjustments, net
-
3,838
Total financial income
8,643 6,354
FINANCIAL EXPENSES
2023
2022
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Interest expenses, leasing debt
139
237
Interest expenses, other debt
19
342
Exchange rate adjustments, net
2,776
-
Total financial expenses
2,934
579
6. Taxes
A deferred tax asset has been calculated. However, Management has concluded that it is not sufficiently probable that the tax asset can be utilized in the
foreseeable future. Therefore, tax assets have not been recognized on the balance sheet. Reference is made to Note 9 in the Consolidated Financial Statements.
DEFERRED TAX ASSETS NOT RECOGNIZED IN THE BALANCE SHEET
2023
2022
Jan 1 – Dec 31
Jan 1 – Dec 31
DKK thousand
Right-of-use assets
(276)
(644)
Leasing liabilities
305
681
Tax loss carryforwards
-
361
Deferred tax on December 31, net
29
398
Through the consolidated tax return, the Parent receives a refundable tax credit for research and development activities associated with one of its subsidiaries
that is recognized in that subsidiary.
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7. Commitments and contingencies
BioPorto A/S has acknowledged that it will finance the operations of its subsidiaries BioPorto Diagnostics A/S, BioPorto Inc., and BioPorto Diagnostics Inc.
through 2024. The Parent is jointly taxed with its Danish subsidiary, and they are jointly liable for any such tax liabilities.
8. Distribution of this year’s result
The Board of Directors proposes that BioPorto A/S’s loss of DKK 57.0 million for the year ended December 31, 2023 be transferred to retained deficit.
9. Other notes
Reference is made to Note 7 in BioPorto’s consolidated financial statements with respect to auditor fees.
Reference is made to Note 17 in BioPorto’s consolidated financial statements with respect to share capital and treasury shares.
Reference is made to Note 21 in BioPorto’s consolidated financial statements with respect to subsequent events.
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BioPorto Annual Report 2023
Executive Management:
___________________________
Board of Directors:
___________________________ ___________________________ __________________________
___________________________ ___________________________
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Report on the audit of the Financial Statements
To the shareholders of BioPorto A/S
Independent Auditor’s Report
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78
BioPorto Annual Report 2023
CVR No. 33963556
Identification No (MNE) mne34532
Identification No (MNE) mne24828
BioPorto Annual Report 2023
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Forward-looking safe harbor statements
This Annual Report contains forward-looking statements that involve risks, uncertainties, and other factors, many of which are outside of BioPorto’s control,
that could cause actual results to differ materially from the results or expectations discussed in the forward-looking statements. Forward-looking statements
include statements concerning the Group’s plans, objectives, goals, future events, performance and/or other information that is not historical information. The
words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may
differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to regulatory approval,
uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack
of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability
to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated
entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please
refer to the section “Risk Management” in this Annual Report. All such forward-looking statements are expressly qualified by these cautionary statements and
any other cautionary statements which may accompany the forward-looking statements. BioPorto does not undertake any obligation to update or revise forward
looking statements in this Annual Report nor to confirm such statements in relation to actual results, subsequent events, or circumstances after the date made.
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www.bioporto.com
CVR DK-17500317