BioPorto Annual Report 2022
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BioPorto 2022 Annual Report Draft
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BioPorto Annual Report 2022
Table of Contents
Letter to our Stakeholders 3
BioPorto’s Strategy 4
Outlook for 2023 10
Consolidated Financial Highlights 11
Risk Management 13
Corporate Governance 16
Shareholder Matters 21
Board of Directors 23
Executive Management 25
Financial Review 26
Financial Statements 29
Notes to Consolidated Financial Statements 35
Parent Company 61
Notes to Financial Statements of Parent Company 65
Statement by the Board of Directors and Management 71
Independent Auditor’s Report 72
BioPorto Annual Report 2022
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Letter to our Stakeholders
Wind in Our Sails
One year ago, as the world tenuously emerged from the worst of the COVID-19 pandemic, BioPorto’s
new management team set out an ambitious series of 2022 objectives for the clinical development and
regulatory submission of our flagship NGAL biomarker test, designed and demonstrated to assess the
risk of Acute Kidney Injury (AKI) for pediatric patients in the Intensive Care Unit (ICU). Over the last
twelve months, our team has met or surpassed all of those objectives through focused operational
execution and prudent financial management.
Foremost, we are encouraged in having met our guidance by having completed:
• June enrollment in our three-part clinical study investigating the use of an NGAL test in identifying
pediatric ICU patients under the age of 22 at risk for AKI; and
• November submission of a marketing authorization application for NGAL test to the US Food and
Drug Administration (FDA).
We are also pleased with the steps we have taken to strengthen our executive team, including the additions of Mr. Nis Kruse, EVP of
Strategic Partnerships and GM of EMEA/APAC, Dr. Tabari Baker, VP of Global Medical Affairs, and Dr. Prasad Devarajan, MD FAAP FASN
as Senior Medical Director, and to underscore our commitment to timely execution for the benefit of patients and shareholders alike.
Commercially, over the last twelve months, we have raised and exceeded our revenue and Adjusted EBITDA guidance through antibody
and NGAL test sales into accessible markets and disciplined cost control. Extrapolating from this performance, we continue to have
confidence in our ability to grow and expand the market opportunity for the NGAL test with increasing recognition, approval, and
availability for clinical use. Taken together, our clinical and commercial operations are delivering as planned and as communicated, and
we remain determined to maintain this record of performance.
Charting the Course
With our NGAL submission to the FDA complete, BioPorto is presently engaged in correspondence with the FDA, including an Additional
Information (AI) request in support of their ongoing review. We expect to deliver our response in advance of the July 23
rd
deadline.
We are also taking deliberate steps to navigate turbulent financial markets. Like other prudent companies, we have taken proactive
measures to run lean, conserve capital, and plan expenditures carefully and critically. While our 2022 financial outperformance has helped
us in this exercise, BioPorto’s team will limit discretionary spending to persuasive, value-added uses. In particular, we are ramping up our
commercial and marketing efforts in Europe, where The NGAL Test
TM
is already available for both pediatric and adult use under CE mark.
Mr. Kruse focused on this opportunity.
Bright Horizon
With sails up and a course set, we are now well underway in our plan for 2023. While we invest in and expand the European market and
engage in productive dialogue with the FDA, we are also taking steps to expand market potential beyond the anticipated first approval of
the NGAL Test for pediatric ICU use in the US.
Because, consistent with the FDA’s Instrument Family Policy guidance, our first FDA approval will be for use on one Roche instrument,
through 2023 and beyond we will seek to expand market access to an increasing number of hospitals, where a variety of compatible
instruments are already installed. This will be pursued through two strategies to establish the NGAL test as compatible and approved for
use on the broader Roche family of instruments and other brands of instruments. We are performing the validation work on our CE Mark
version of the assay, which is not tied to specific instruments, for a 510(k) submission to the FDA.
Neither of these strategies is expected to require a clinical trial.
Also, to broaden our US total addressable market, we are investigating additional indications and points of care, including for pediatric
patients outside the ICU and adult patients at high risk of AKI. This includes planning for corresponding clinical trials.
I appreciate the support of our shareholders and am dedicated to building on the opportunity inherent in the NGAL biomarker test. I am
firm in my conviction that BioPorto’s work will bring value to our shareholders and a new, lifesaving test to patients and healthcare
providers.
Tony Pare
Chief Executive Officer
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BioPorto Annual Report 2022
BioPorto is an IVD (in vitro diagnostic) company focused on developing actionable biomarker tests – tools designed to help clinicians detect the onset of
disease states and help direct appropriate therapies. BioPorto applies its expertise in antibody and assay development, as well as its platform for assay
development, 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 improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem.
Clear Strategic Priorities
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. This vision is supported by three strategic pillars.
Drive Market Adoption of NGAL Biomarker Tests & Have a Pipeline of Products that Deliver High Medical Value
In the US, BioPorto will first focus on obtaining De Novo FDA approval for pediatrics (under age 22) in the ICU. The De Novo application is currently under
review by the FDA, following its submission in November 2022.
BioPorto’s NGAL biomarker test is already CE Marked for use in the European market in both adult and pediatric populations on any brand of clinical
chemistry analyzer. Historically, the Company has made minimal investments in its own and its distributors’ commercial and medical education capabilities
to drive adoption in Europe. With the addition of a new EVP of Strategic Partnerships and GM of EMEA & APAC, a new VP of Global Medical Affairs, and
additional commercial staff, the Company is making investments to drive customer adoption in this up to $1 billion market.
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Through the Company’s own commercial team and its distribution partnerships, BioPorto seeks to drive market adoption of NGAL tests to assess kidney
health in early stages of AKI. It intends to accomplish this by communicating and marketing the clinical and economic value of current and future NGAL
products in a clear, efficient, and compelling manner. Further, BioPorto will continue to evaluate opportunities to develop and commercialize other high
value, actionable biomarkers focused on kidney health.
Strengthen the Company to Scale & Execute
BioPorto will work towards driving market adoption by building the necessary commercial and medical affairs organization, investing in distributor
education in Europe initially, expanding education into the US following prospective FDA approval, scaling production capacity, improving the robustness
of its quality systems, ensuring compliance with regulatory requirements, expanding its intellectual property portfolio, and ensuring sufficient capital to
support operations.
To realize its strategic priorities, BioPorto will need to seek additional operating capital, with longer-term aspirations to access US capital markets, including
through a potential U.S stock market listing. Towards this goal, BioPorto may explore opportunities in relation to a targeted international share offering,
potentially including the US.
As the Company routinely assesses and addresses outstanding risks in its business, such as prospective FDA approval, we will continue to manage these
risks during a period of conservatism in the capital markets through proactive management of cash reserves. For example, the Company is judiciously
managing its infrastructure cost by pursuing a sublease for unused office space in Boston, insourcing clinical research activities, rationalizing product
portfolios, outsourcing low-volume work activities, and selectively reducing its workforce. BioPorto is also decreasing the pace of spending related to
preparing for the US market commercialization, while awaiting prospective FDA approval, and has also taken actions to improve product pricing and overall
product margins.
Attract, Develop & Retain the Best and Brightest Employees Aligned with our Values and with Clear Roles and
Responsibilities
BioPorto undertakes proactive efforts to recruit the most qualified people to drive success and embrace its core values. BioPorto motivates employees to
stay and contribute through consistent, long term incentive programs and flexible work arrangements that are aligned with personal and company needs,
providing frequent feedback and clarity in their contribution to BioPorto’s success, and celebrating success.
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
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Management estimate.
BioPorto’s Strategy
BioPorto Annual Report 2022
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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.
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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
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with a 52% community acquired
rate and with 48% of cases acquired during hospital stays. Among patients that are hospitalized, 1 in 5 adults
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, and 1 in 4 children
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will acquire AKI.
The onset of AKI in hospitalized patients increases the likelihood of mortality by 25%.
3
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 for the quantitative determination of NGAL in humans. It uses an analytical method that can be run on
most 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. This facilitates laboratory adoption of the test and eventual market penetration. The NGAL test does not require any
proprietary instrumentation, thereby avoiding any requirement for capital purchase arrangements by the customer that could otherwise add months to
the sales cycle.
2
Pavkov ME. (2018) ‘Trends in Hospitalizations for Acute Kidney Injury — United States, 2000–2014’, MMWR Morb Mortal Wkly Rep. 2018;67.
3
Mehta RL. Lancet. 2015,
4
Susantitaphong P. CJASN. 2014;9(6)
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Kaddourah A. N Engl J Med. 2017
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BioPorto Annual Report 2022
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
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and after >50% of total glomerular filtration capacity
is already lost
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.
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 drugs, 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.
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Haase-Fielitz A, et al. (2014) ’Neutrophil gelatinase-associated lipocalin as a biomarker of acute kidney injury: a critical evaluation of current status’, Ann
Clin Biochem, 2014 51(0 3): 335–351. doi:10.1177/0004563214521795
7
) Küllmar M, et al. Crit Care Clin. 2020 Oct;36(4):691-704.
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The NGAL Test Addresses a significant global market opportunity
In the US, BioPorto’s initial focus with The NGAL Test is in the pediatric intensive care setting, followed by future expansion into new indications such as
nephrotoxicity monitoring, testing in the emergency department, and the adult population. BioPorto estimates that the total addressable opportunity in
the US is approximately $1.2 billion annually for all potential applications including outpatient monitoring. BioPorto believes that the global addressable
market for The NGAL Test is approximately $3 billion.
Focus on $1B European and Other Markets that accept CE Mark while FDA approval is Pending
The NGAL Test is currently available for IVD use in Europe and other geographies under its CE Mark for measurement of NGAL for all patient populations,
disease states, and instruments. While awaiting the FDA’s decision on the NGAL test submission for pediatric use in the ICU in the US, BioPorto is expanding
its presence to drive adoption in Europe. The Company recently announced the additions of Mr. Nis Kruse as EVP of Strategic Partnerships and GM of
EMEA/APAC and Dr. Tabari Baker as VP of Global Medical Affairs. 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 our distribution sales channels.
Steady Focus on US Regulatory Pathway for The NGAL Test
In 2022, the Company achieved a major milestone. After three years of dedicated effort during the COVID-19 pandemic, BioPorto completed a three-phase
clinical study that included 16 hospital sites in the US. Extensive data analysis was completed to determine if the Company’s targeted endpoints were met.
The De Novo application for the NGAL test for risk assessment of pediatric patients admitted to the ICU, ages 3 months to 21 years old, on the Roche Cobas
c501 clinical chemistry analyzer was submitted to the FDA on November 10, 2022. BioPorto previously obtained a Breakthrough Device Designation from
the FDA for the NGAL test, and therefore engagement with the FDA began immediately following submission. The review is ongoing, with formal FDA
requests for Additional Information (AI) issued as required. Although a single instrument represents a limited market opportunity, it does follow the
guidelines dictated by the FDA’s Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices. Following FDA approval, the Company
can conduct brief validation work and file to expand the marketing authorization to include additional, common Roche instruments. Roche is generally
recognized to have the largest share of the clinical chemistry market.
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 prospective approval of the NGAL test serving as a predicate device referable for future submissions, it is
anticipated that the regulatory review cycle will be brief and less complex.
Approach to Expand the US Total Addressable Market
Pediatric Market Expansion
BioPorto’s US commercial strategy for NGAL tests is designed to build a market for urinary biomarkers in AKI. Starting in the smaller, focused pediatric
market will help to build awareness and momentum ahead of launch in the larger adult market. The pediatric market includes a well-established network
of nephrologists and critical care physicians that present as Key Opinion Leaders (KOLs) in AKI, and that have objective, independent experience with, and
favorable opinions of, NGAL as a biomarker for risk assessment of AKI and, in turn, the market potential for NGAL tests.
Upon prospective FDA approval, the Company will invest in a commercial strategy for the pediatric launch of the NGAL test with 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.
• 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 ensure there is alignment and buy-in among all decision makers in the hospital system.
• Medical Science Liaisons (MSLs): Building 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, for example former critical care nurses, who can engage in scientific discourse
on the use of NGAL in the medical management of AKI. This team will provide step-by-step tools to guide hospitals’ implementation of new
NGAL test-based kidney biomarker programs.
Adult Market Entry and Expansion
The pediatric indication includes patients up to the age of 22. 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.
To expand access to the adult market, the Company will select and perform appropriate clinical trials to support older adults and other clinical indications.
BioPorto’s strategy includes initiatives that will follow the initial adult FDA approval and any associated clinical trials:
• Distribution partnerships with additional instrument manufacturers, e.g., Roche, Siemens, and Abbott, to enable laboratories with any
instrument platform to order and run NGAL tests.
• Collaboration with advocacy groups, such as the National Kidney Foundation, KDIGO—Kidney Disease Improving Global Outcomes (a global
organization that develops and implements evidence-based clinical practice guidelines in kidney disease), and ADQI—Adult Disease Quality
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BioPorto Annual Report 2022
Initiative (a global organization of academic researchers and clinicians focused on setting new standards for the diagnosis and management of
AKI and other kidney-related disorders).
The following chart projects the growth of BioPorto’s US addressable market, first for pediatric ICU patients on the Roche Cobas c501 instrument, followed
by the broader Roche family, instruments from additional manufacturers, and then adult indications.
ELISA Kits and Antibodies
BioPorto’s revenue-generating product line also 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. The overall
research antibodies market is expected to grow at a CAGR of 6.7% from $10.1 billion in 2020 to $14.10 billion by 2025, as these are critical components in
life sciences research.
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BioPorto offers NGAL ELISA kits 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 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, the Company 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 the Company 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, the Company 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.
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Markets and Markets ‘Research Antibodies Market by Product (Antibodies (Primary, Secondary)(Mouse, Rabbit)), Reagents), Technology (Western Blot,
Flow Cytometry, Elisa, Immunofluorescence, Immunohistochemistry), Application, & End User - Global Forecast to 2025’,
https://www.marketsandmarkets.com/MarketReports/research-antibodies-reagents-market-94212793.html
BioPorto Annual Report 2022
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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.
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BioPorto Annual Report 2022
BioPorto’s three strategic activities in 2023 are to:
• Grow revenues in European and other markets that accept CE Mark
• Focus on the US NGAL test’s regulatory pathway
• Expand the total addressable market for NGAL tests
Key assumptions relating to the 2023 outlook are as follows:
• Assumes minimal growth in NGAL test revenues in the US during the FDA’s review process, and since the timing for an approval is unknown,
BioPorto is not including any post-approval revenue in its outlook.
• While FDA approval is pending, costs related to future clinical studies are assumed to be lower than in 2022.
• Sales & marketing costs are assumed to increase compared to 2022 associated with European-focused business development and global product
marketing (including travel and related expenses), reimbursement studies, and expanded distributor material and content support.
• R&D costs (excluding those related to clinical trial activities) are assumed to increase compared to 2022, including as a result of the full year
impact of 2022 hirings, investments in studies to prepare regulatory filings to increase the addressable US market through expanded clinical
chemistry analyzer claims, and investments in manufacturing and quality systems.
• Administrative costs are expected to be comparable to 2022.
• The Company will take judicious mitigating actions throughout the year to protect or strengthen its financial position, including reducing
operating expenses in targeted areas.
Actual 2022
Revenue
DKK 29 million
Outlook 2023
Approximately DKK 30 to 33 million
Adjusted EBITDA Loss
1
DKK (67) million
Approximately DKK (60) to (65) million
BioPorto’s performance and guidance for 2023 are dependent on the continued resolution of the COVID-19 pandemic. The guidance above is predicated
on an assumption of the continued opening of societies and the normalization of access to hospitals, research laboratories, and regulatory bodies.
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.
Outlook for 2023
1
See “Non-IFRS financial measure”
BioPorto Annual Report 2022
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2022
2021
2020
2019
2018
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
29.0
24.3
23.2
26.6
26.0
Gross profit
19.0
15.0
13.3
17.3
17.8
Sales and marketing costs
21.2
17.4
20.8
39.3
20.9
Research and development costs
34.9
30.3
28.1
24.6
18.7
Administrative costs
41.8
32.7
28.0
27.8
20.0
Lease impairment
2.6
-
-
-
-
Loss before financial items (EBIT)
(81.5)
(65.3)
(63.6)
(74.3)
(41.8)
Financial items, net
(0.0)
1.4
(3.2)
0.1
0.2
Loss before tax
(81.5)
(63.8)
(66.8)
(74.2)
(41.6)
Net loss
(75.9)
(57.1)
(61.6)
(69.6)
(38.0)
Comprehensive loss
(76.0)
(58.3)
(59.8)
(70.0)
(38.3)
Adjusted EBITDA
(67.3)
(62.0)
(54.3)
(68.3)
(42.2)
Non-current assets
7.2
17.1
15.5
8.2
3.6
Cash and cash equivalents
81.8
45.5
107.9
18.1
46.7
Current assets
101.4
64.2
124.8
34.5
62.6
Total assets
108.6
81.3
140.3
42.7
66.2
Equity
70.2
46.0
100.9
25.3
56.2
Non-current liabilities
7.4
10.5
8.4
2.5
0.8
Current liabilities
31.0
24.8
30.9
14.9
9.2
Total equity and liabilities
108.6
81.3
140.3
42.7
66.2
Cash flows from operating activities
(52.5)
(64.6)
(35.6)
(60.2)
(38.0)
Cash flows from investing activities
(0.5)
(0.4)
(1.5)
(2.1)
(1.5)
Of which investment in property, plant, and
equipment
(0.4)
(0.1)
(1.3)
(0.6)
(1.4)
Cash flows from financing activities
88.7
1.1
127.0
33.6
39.1
Net cash flows
35.7
(63.9)
89.9
(28.6)
(0.4)
Revenue growth
19%
5%
(13%)
2%
3%
Gross profit percentage
66%
62%
57%
65%
69%
Equity ratio (solvency)
65%
57%
72%
59%
85%
Average number of employees
32
29
28
34
28
Number of shares at the end of the period (1,000)
334,693
267,754
266,582
174,944
165,688
Loss per share (EPS), DKK
(0.24)
(0.21)
(0.30)
(0.41)
(0.24)
Net asset value per share, period-end, DKK
0.21
0.17
0.38
0.14
0.34
Share price, period-end, DKK
2.32
2.47
4.04
2.93
3.50
Note: Loss per share (EPS) is calculated in accordance with IAS 33 “Earning per share”. Other financial ratios have been calculated in accordance with the
guidelines from the Danish Society of Financial Analysts.
Reconciliation of Adjusted EBITDA
Loss before financial items (EBIT)
(81.5)
(65.3)
(63.6)
(74.3)
(41.8)
Depreciation and amortization
4.0
4.3
4.0
2.9
0.5
Share-based compensation expenses
7.6
(1.0)
5.3
3.1
(0.9)
Lease impairment
2.6
-
-
-
-
Adjusted EBITDA
(67.3)
(62.0)
(54.3)
(68.3)
(42.2)
Consolidated Financial Highlights
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BioPorto Annual Report 2022
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
therefore limit our use of Adjusted EBITDA and do not evaluate our results and performance without considering both non-IFRS Adjusted EBITDA on the
one hand and EBIT or net income or loss on the other. 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.
BioPorto Annual Report 2022
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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.
Since 2020, the Company was – as was most of the world – affected by the COVID-19 pandemic whereby the Company took measures to safeguard its
employees and modify facilities to enable the Company to continue operations.
While it is hard to measure the impact of the pandemic on revenues, our clinical studies have been broadly affected. Multiple waves of SARS-CoV-2
infections restricted BioPorto’s access to hospitals and limited the healthcare system’s ability to process and conduct studies according to the schedule the
Company originally anticipated.
As a result, the NGAL pediatric De Novo application to the FDA was delayed until November 2022.
In 2023, primary risks include obtaining FDA market authorization for NGAL tests in pediatrics in the US, securing market adoption and continued growth
in NGAL revenues including in regions where CE Mark is accepted, 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 in 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.
• 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 Company’s pending pediatric NGAL test submission may not be approved by the FDA, or its approval may be delayed by or conditioned by
the FDA.
• A failure to obtain FDA approval of a NGAL test for risk assessment of AKI would have a material adverse effect on the Company’s prospective
future revenues, future growth prospects, future cash-flows and future results of operations.
• 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 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.
• 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 Company’s future success depends in part on its ability to attract and retain its management team and key employees.
• 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 manufacture of the Company’s products is dependent on the supply of raw materials and key components from suppliers, some of which
are single source suppliers for the Company.
• 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.
Risk Management
14
BioPorto Annual Report 2022
• 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.
• 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 Company has incurred net losses and may continue to do so.
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 ability to prevent competing companies from having Freedom to Operate in commercially relevant markets.
• Performance and dependence of the Company’s subcontractors; most significantly Contract Manufacturing Organizations and Contract
Research Organizations.
• Clinical development and results from pipeline projects.
• Cyber-attacks.
• Risks relating to trade receivables and inventory.
• 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.
• Tax risks.
• Risks related to IT in general.
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
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.
BioPorto Annual Report 2022
15
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.
16
BioPorto Annual Report 2022
https://bioporto.com/about-bioporto/.
BioPorto Annual Report 2022
17
18
BioPorto Annual Report 2022
BioPorto Annual Report 2022
19
20
BioPorto Annual Report 2022
BioPorto Annual Report 2022
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 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 have their shares registered with the Company; registration must be through the holder’s custodian bank. Shareholders are also encouraged to sign-up
to receive Company announcements via e-mail from the Company. Investor Relations (IR) is responsible for ensuring that information from the group’s IR
stakeholders is shared with 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, 2022 BioPorto’s capital stock had a nominal value of DKK 334,693,005 divided into 334,693,005 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 April 2022, BioPorto completed a rights offering of 66,938,601 new shares raising gross proceeds of DKK 100.4 million. No warrants were exercised
during the year.
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, 2022, BioPorto had 19,638 registered shareholders (2021: 19,356), that in the aggregate owned 88.21% of the capital stock. As of
December 31, 2022, 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 2022 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 18 a of the Articles of Association. Each warrant granted
in 2022 (as listed below) vests over a four-year period, 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:
• On May 5, 2022, the Board of Directors of BioPorto A/S issued 270,000 warrants for the subscription of an equal number of shares. The exercise
price was DKK 1.28 per share corresponding the closing price on Nasdaq Copenhagen on May 5, 2022. The theoretical market value of the issued
Shareholder Matters
22
BioPorto Annual Report 2022
warrants was DKK 149,000 based on the Black-Scholes formula using an interest rate of 0.50% and the historical volatility of BioPorto A/S' shares
of 27 months calculated to 75.37%.
• On December 8, 2022, the Board of Directors of BioPorto A/S issued 1,200,000 warrants for the subscription of an equal number of shares. The
exercise price was DKK 2.55 per share, corresponding to the closing price on Nasdaq Copenhagen on December 8, 2022. The theoretical market
value of the newly issued warrants is DKK 1,316,500 based on the Black-Scholes formula using an interest rate of 2.11% and the historical
volatility of BioPorto A/S’ shares over 27 months calculated to 73.07%.
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 2022 , a total of 14,982,500 warrants were outstanding, corresponding to 4.5% of
the issued and outstanding nominal capital stock.
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 2023. 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.
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 2023
March 15, 2023
Deadline for shareholder proposals – Annual General Meeting
March 30, 2023
Annual Report 2022
Annual General Meeting
May 10, 2023
Interim Report – for the three-month period ended March 31, 2023
August 1, 2023
Interim Report – for the six-month period ended June 30, 2023
October 31, 2023
Interim Report – for the nine-month period ended September 30, 2023
BioPorto Annual Report 2022
23
Mr. Lindop became chairman in 2021. He is qualified as a Chartered Accountant and Certified Public
Accountant and was previously a partner with Arthur Andersen LLP and Ernst & Young LLP. He took the
position as Chief Financial Officer of Inverness Medical Ltd., before being appointed Chief Financial Officer and
VP of Business Development at Haemonetics Corporation Ltd. (NYSE: HAE). Mr. Lindop was Chief Financial
Officer of Quotient Limited (Nasdaq:QTNT) until his retirement in May 2020. He was also a member of the
board of directors of Parexel International (Nasdaq:PRXL), where he served as Chairman of the audit
committee and as a member of the nominating and governance committee. As a result, he has considerable
experience in the management of US listed healthcare and diagnostic companies and within the functional
areas of finance and reporting, corporate governance, mergers & acquisitions, public and private market
financing and strategy development and execution.
Other directorships: None.
John McDonough, Vice Chairman
Mr. 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. He
earned his undergraduate degree in business from Stonehill College.
Other directorships: Cytrellis Biosystems, Inc. (Chair), Sunbird Biosystems (Executive Chair).
Don Hardison, Jr.
Mr. Hardison most recently served as President, Chief Executive Officer, and as a member of the 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 received his Bachelor of Arts in Political Science from the University of North Carolina, Chapel
Hill.
Other directorships: HTG MOLECULAR, MDXHEALTH, Cytek Biosciences, Arima Genomics, YourBio,
Genoescopy, Breath BioMedical.
Michael Singer, MD, PhD
Dr. Singer is Chairman and Chief Strategy Officer at Cartesian Therapeutics, Inc, a US biotech company that
develops RNA-modified cell therapies. Prior to founding Cartesian, he was co-founder and Chief Scientific
Officer of Topokine Therapeutics 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, Pykus Therapeutics, Anodyne Nanotech.
Board of Directors
24
BioPorto Annual Report 2022
Jan Leth Christensen
Mr. Christensen is an attorney-at-law and is currently a board member and partner at Lønberg & Leth
Christensen Advokataktieselskab. He serves as Chairman of Havnens Bygningsudlejnings A/S, Best Ejendomme
A/S, and Advokaternes Ejendomsadministration A/S, and is also a member of the executive management
and/or the board of directors of several other companies and foundations. Mr. Christensen holds a Master’s
degree in Law from the University of Copenhagen.
Other directorships: Murermester Willy Lynggard Petersens Familiefond, Rolf Krake Fonden, Hyldegårdsvej 40
A/S (Chair), WRP-Holding A/S, K/S Hørsvinget, Esplanaden Berlin Holding A/S, Havnen Lersø Parkallé 107 ApS
(Chair), Lønberg & Leth Christensen Advokataktieselskab, Havnens Bygningsudlejning A/S (Chair), W. Lynggard
Petersen Holding A/S, Søborgstræde 2 A/S (Chair), Best Ejendomme A/S (Chair), Advokaternes
Ejendomsadministration A/S (Chair).
Peter Mørch Eriksen
Mr. Eriksen served as CEO of BioPorto from 2013 – 2021. He has spent more than 20 years in the MedTech/life
science industries, including as CEO of Sense A/S and VP of Medtronic. From these positions, Mr. Eriksen has
extensive experience in creating growth, restructuring and funding in technology-intensive and complex
companies. He 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. He has
an accounting background, supplemented with management experience.
Other directorships: FluoGuide A/S (Chair), Monsenso A/S (Chair), Pharma Equity Group A/S (Chair),
MyBlueLabel Compliance Services ApS (Chair), PME Holding ApS.
Other Board Information
Number of meetings attended by each Board member out of the total number of meetings within the member’s term:
Board of Directors
Remuneration
Committee
Nomination
Committee
Audit Committee
Strategy
Committee
Business, Research and
Development
Committee
Christopher Lindop
20/20
1/3
1/1
4/4
5/5
1/1
John McDonough
19/20
2/3
1/1
4/4
5/5
1/1
Don Hardison
20/20
1/3
0/1
5/5
1/1
Michael Singer
19/20
4/4
5/5
1/1
Jan Leth Christensen
19/20
5/5
1/1
Peter Mørch Eriksen
20/20
5/5
1/1
First
elected
Term Expires
Independent
Nationality
Year of Birth
Gender
Shares held in
BioPorto
Dec. 31, 2021
Shares held in
BioPorto
Dec. 31, 2022
Christopher Lindop
2019
2023
Yes
USA
1957
M
446,487
558,108
John McDonough
2021
2023
Yes
USA
1959
M
-
-
Don Hardison
2021
2023
Yes
USA
1950
M
-
-
Michael Singer
2019
2023
Yes
USA
1973
M
167,433
209,291
Jan Leth Christensen
2021
2023
Yes
1963
M
32,169,732
40,212,165
Peter Mørch Eriksen
2021
2023
No
*
1960
M
105,506
131,882
*
As BioPorto’s former CEO, Mr. Ericksen is considered non-independent under the criteria defined by the Danish Committee on Corporate Governance.
BioPorto Annual Report 2022
25
Anthony Pare, Chief Executive Officer
Joined the Company in 2021. Mr. Pare has led product development, commercialization, marketing,
operations, and business development in leading medical device and diagnostic companies for 25 years.
Previously, he was the Chief Commercial Officer (CCO) at T2 Biosystems, a US Nasdaq-listed in vitro diagnostics
company. He held the same role at Hemanext, a pre-commercial company marketing blood transfusion
technology. Mr. Pare also held various leadership roles at Haemonetics, specializing in blood processing and
diagnostic technologies. He actively participates on advisory boards and mentors startup medical technology
companies in the Boston (US) area. Mr. Pare holds a Bachelor of Science in Marine Engineering and a Master’s
of Engineering Administration from George Washington University (US).
Other directorships: None.
Neil Goldman, Executive Vice President & Chief Financial Officer.
Joined the Company in 2021. Mr. Goldman previously served as the Executive Vice President and Chief
Financial Officer of Chembio Diagnostics, Inc. (Nasdaq:CEMI). He has been the Executive Vice President-
Corporate Development and Chief Financial Officer at J.S. Held LLC, a construction consulting firm. He was the
Global Finance Director for the Delphi Data Connectivity division of Delphi Corp. (now Aptiv plc, NYSE:APTV),
an automotive supplier, following Delphi’s acquisition of Unwired Technology LLC (Unwired), a tier-1 global
automotive electronics manufacturer and distributor, from a private equity firm. At Unwired, he was the
Executive Vice President-Corporate Development and Chief Financial Officer, the Senior Vice President-Chief
Operating and Financial Officer, and previously Chief Financial Officer. He also served as the Chief Financial
Officer at EPPCO Enterprises, Inc., an importer and manufacturer of consumer and aftermarket products, and
as a Senior Manager at Ernst & Young LLP and its successor Cap Gemini Ernst & Young LLC. He is a Certified
Public Accountant and received a Bachelor of Science degree in Business-Accountancy from Miami University
(Ohio, US).
Other directorships: Ohio Bridge Corp.
Executive Management
26
BioPorto Annual Report 2022
This financial review is based on the Group’s consolidated financial information for the year ended December 31, 2022, with comparative results for the
year ended December 31, 2021, in brackets.
Revenue
Revenue for 2022 was DKK 29.0 million (DKK 24.3 million), an increase of 19.4%, and comprised:
• NGAL tests: DKK 14.9 million (DKK 12.4 million);
• Antibodies: DKK 12.0 million (DKK 9.3 million);
• ELISA kits: DKK 1.8 million (DKK 2.5 million); and,
• Royalty and other: DKK 0.2 million (DKK 0.1 million).
Revenue for 2022 exceeded both the Company’s original outlook of DKK 24 to 26 million and its updated range of DKK 24 to 27 million, principally reflecting
favorable performance with the two largest product lines. NGAL test revenue increased by DKK 2.5 million, or 20.3%, over the prior year period. Antibody
revenue increased by DKK 2.7 million, or 29.5%, over the prior year period. This growth was somewhat offset by a reduction in revenue from ELISA kits of
DKK 0.7 million, or 27.9%, 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 2022 totaled DKK 19.0 million (DKK 15.0 million). The DKK 4.0 million increase in gross profit was comprised of DKK 3.1 million from
favorable sales volume and DKK 0.9 million from the 370bps improvement in gross profit percentage over the prior year period.
Sales and marketing costs
Sales and marketing costs totaled DKK 21.2 million (DKK 17.4 million). The increase reflected higher staffing and travel costs, the latter of which was
meaningfully reduced in the prior year period due to COVID-19.
Research and development costs
Research and development costs totaled DKK 34.9 million (DKK 30.3 million), with the increase principally reflecting progress in and the related rate of
investment in the US clinical trial for an NGAL test, related travel, and consulting costs as the Company completed and submitted its application to the FDA
in November 2022, as well as higher staffing-related costs.
Administrative costs
Administrative costs totaled DKK 41.8 million (DKK 32.7 million), with the increase related to net higher non-cash equity compensation costs of DKK 6.7
million due to the benefit realized from recovering such costs related to executive turnover in 2021. Excluding these non-cash amounts, the remaining DKK
2.5 million increase similarly reflects incentive compensation earned in 2022 vs. the related forfeiture in 2021, and Danish tax equalization costs.
Lease impairment
The Company executed a letter of intent to sublease its office space in Needham, MA, USA to reduce its cash infrastructure costs by an estimated DKK 2.8
million over the next three years. Accordingly, the non-cash lease impairment charge of DKK 2.6 million represents the excess of the fair value of the cash
flows from the sublease less broker commissions compared to the net book value of the right-of-use asset associated with the underlying lease.
4.2
6.7
4.7
7.6
5.6
6.6
5.3
6.8
6.5
8.5
5.3
8.7
0
2
4
6
8
10
Q1 Q2 Q3 Q4
2020 2021 2022
2.1
5.0
2.7
3.6
2.2
3.7
2.6
3.9
3.7
3.3
2.7
5.2
0
1
2
3
4
5
6
Q1 Q2 Q3 Q4
2020 2021 2022
Financial Review
BioPorto Annual Report 2022
27
Financials items, net
Financial income and expenses reflect interest income/expense and currency transaction gains/losses, bank charges and interest. In 2022, those amounts
effectively offset each other for a net amount of approximately DKK 0 (income of DKK 1.4 million), with the variance substantially related to currency rate
changes.
Tax benefit
A DKK 5.6 million tax benefit (DKK 6.7 million tax benefit) was realized during 2022. 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 2022, EBIT was a loss of DKK 81.5 million (DKK 65.3 million), Adjusted EBITDA was a loss of DKK 67.3 million (loss of DKK 62.0 million), each reflecting
the mix of variances described above, and EBIT loss was unfavorably impacted by the non-cash Lease impairment charge, also described above.
EBIT loss for 2022 was favorable compared to both the Company’s original outlook of a loss of DKK 95 to 100 million and the updated range of DKK 83 to
88 million. Adjusted EBITDA loss was favorable compared to both the Company’s original outlook of a loss of DKK 76 to 81 million and the updated range
of DKK 71 to 75 million.
Cash and cash equivalents
As of December 31, 2022, BioPorto’s balance of cash and cash equivalents totaled DKK 81.8 million (DKK 45.5 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, independent of the timing and potential marketing authorization of NGAL tests by
the FDA in the US. 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
and potential marketing authorization of NGAL tests by the FDA 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 April 1, 2022, BioPorto raised net proceeds of approximately DKK 92.7 million, from a fully subscribed pre-emptive rights offering of
new shares as part of a long-term capital plan that includes a potential US listing. In total, 66,938,601 new shares of common stock were offered and sold
pursuant to a Prospectus for a rights offering with pre-emptive rights for existing shareholders that was filed on March 7, 2022.
The Parent Company has lost half of its share capital. Management plans to reestablish the share capital through the measures described under Cash and
cash equivalents, above.
Net working capital
Net working capital (i.e., current assets minus current liabilities) as of December 31, 2022 totaled DKK 70.5 million (DKK 39.4 million). Net working capital
as of December 31, 2022 reflected the Group’s issuance and sale of approximately 66.9 million shares of common stock in a rights offering that closed on
April 1, 2022 for net proceeds of DKK 92.7 million. Net working capital was also favorably impacted by a DKK 10.6 million improvement through an overall
focus on managing working capital.
Cash Flow Statement
Cash used in operating activities for the year ended December 31, 2022 totaled DKK 52.5 million (DKK 64.6 million), with the improvement over the prior
year primarily associated with favorable management of working capital, in particular accounts receivable, together with the timing benefit of accounts
payable related to clinical trials and other items.
Cash used in investing activities was DKK 0.5 million (DKK 0.4 million) which primarily consisted of investments in lab equipment.
Cash from financing activities was DKK 88.7 million (DKK 1.1 million), reflecting the proceeds of the net rights offering, offset by facility lease costs.
The net cash flow for the year ended December 31, 2022 reflected a source of DKK 35.7 million (use of DKK 63.9 million).
28
BioPorto Annual Report 2022
Events after the reporting period
Several years ago, BioPorto established Veterinary Diagnostics A/S (“Veterinary”) as a wholly owned subsidiary associated with potential opportunities in
that market that ultimately were not pursued. As part of the Company’s present strategy and focus, and to save the costs of maintaining this separate legal
entity, after December 31, 2022, BioPorto has closed Veterinary. Such closure does not impact any amounts recognized in either the Consolidated or the
Parent’s financial statements, cf. Note 21.
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 affect on the Company’s financial position.
BioPorto Annual Report 2022
29
Consolidated Statements of Profit or Loss
2022
2021
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
13
Loss before financial items (EBIT)
(81,527 )
(65,255 )
Financial income
8
Financial expenses
8
Loss before tax
(81,547 )
(63,840 )
Income tax benefit, net
9
Net loss
(75,923 )
(57,113 )
DKK
DKK
Loss per share (EPS & DEPS)
10
(0.24
(0.21
Consolidated Statements of Comprehensive Loss
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Notes
Net loss
(75,923 )
(57,113 )
Other comprehensive loss:
Amounts which will be reclassified to the income statement:
Exchange rate adjustments of investments in subsidiaries
(115 )
(1,219 )
Other comprehensive loss
(115 )
(1,219 )
Comprehensive loss
(76,038 )
(58,332 )
Financial Statements
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Consolidated Balance Sheets
Assets
2022
2021
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
Deposits
Total financial assets
Total non-current assets
Current assets
Inventories, net
14
Trade receivables, net
15, 18
Taxes receivable
9
Other receivables
15, 18
Prepayments
15
Cash and cash equivalents
18
Assets held-for-sale
13
Total current assets
Total assets
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31
Equity and Liabilities
2022
2021
Dec 31
Dec 31
DKK thousand
Notes
Equity
Share capital
17
Treasury shares
17
Exchange-rate adjustments
(234 )
(119 )
Retained deficit
(264,238 )
(221,671 )
Total equity
Liabilities
Non-current liabilities
Lease obligations
13
Other non-current liabilities
Total non-current liabilities
Current liabilities
Current portion of non-current liabilities
13
Trade payables
18
Tax payables
Other accrued liabilities
16
Total current liabilities
Total liabilities
Total equity and liabilities
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Consolidated Statements of Changes in Equity
Amounts in DKK thousand
Shares in thousand
Common Stock
Treasury Stock
Retained
Shares
Amount
Shares
Amount
Deficit
AOCI
Total
Balance at December 31, 2021
(221,671 )
(119 )
Comprehensive loss
-
-
(50 )
(50 )
Transactions with owners:
Issuance of stock, net (Note 17)
-
Share-based compensation
-
-
Net loss
-
-
(17,030 )
(17,030 )
Balance at March 31, 2022
(210,617 )
(169 )
Comprehensive loss
-
-
(709 )
(709 )
Transactions with owners:
Equity issuance costs (Note 17)
-
-
(83 )
(83 )
Share-based compensation
-
-
Net loss
-
-
(17,091 )
(17,091 )
Balance at June 30, 2022
(225,898 )
(878 )
Comprehensive loss
-
-
(1,421 )
(1,421 )
Transactions with owners:
Equity issuance costs (Note 17)
-
-
(312 )
(312 )
Share-based compensation
-
-
Net loss
-
-
(16,877 )
(16,877 )
Balance at September 30, 2022
(241,314 )
(2,299 )
Comprehensive loss
-
-
Transactions with owners:
Equity issuance costs (Note 17)
-
-
Share-based compensation
-
-
Net loss
-
-
(24,925 )
(24,925 )
Balance at December 31, 2022
(264,238 )
(234 )
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Amounts in DKK thousand
Shares in thousand
Common Stock
Treasury Stock
Retained
Shares
Amount
Shares
Amount
Deficit
AOCI
Total
Balance at December 31, 2020
(166,770 )
Comprehensive loss
-
-
(229 )
(229 )
Transactions with owners:
Share-based compensation
-
-
Net loss
-
-
(15,364 )
(15,364 )
Balance at March 31, 2021
(180,715 )
Comprehensive loss
-
-
Transactions with owners:
Exercise of warrants
-
Share-based compensation
(1,005 )
(1,005 )
Net loss
-
-
(13,623 )
(13,623 )
Balance at June 30, 2021
(192,177 )
Comprehensive loss
-
-
(534 )
(534 )
Transactions with owners:
Share-based compensation
-
-
(1,735 )
(1,735 )
Net loss
-
-
(11,384 )
(11,384 )
Balance at September 30, 2021
(205,296 )
Comprehensive loss
-
-
(482 )
(482 )
Transactions with owners:
Exercise of warrants issuance costs
Share-based compensation
-
-
Net loss
-
-
(16,742 )
(16,742 )
Balance at December 31, 2021
(221,671 )
(119 )
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BioPorto Annual Report 2022
Consolidated Statements of Cash Flows
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Notes
Loss before financial items
(81,527 )
(65,255 )
Adjustments:
Depreciation and amortization
6
Share-based compensation expenses
(966 )
Lease impairment
13
Other non-cash items
(945 )
Changes in assets and liabilities:
Inventories
Trade receivables
(771 )
Trade payables
(376 )
Other operating assets and liabilities, net
(1,051 )
(6,918 )
Cash flows from operations
(57,768 )
(69,030 )
Financial income, received
Financial expenses, paid
(1,618 )
(1,425 )
Tax refund, net
Cash flows from operating activities
(52,485 )
(64,577 )
Purchase of property, plant and equipment
12
(407 )
(130 )
Purchase of rights and software
11
(64 )
(259 )
Purchase of financial assets
(32 )
(23 )
Cash flows from investing activities
(503 )
(412 )
Proceeds from warrant programs exercised
Proceeds from rights issue
Cost related to issue of new shares
17
(7,671 )
(11 )
Repayments of non-current liabilities
(301 )
(150 )
Repayments of lease obligations
(3,737 )
(3,099 )
Cash flows from financing activities
Net cash flows for the period
(63,888 )
Cash and cash equivalents at beginning of period
Effect of exchange rate changes on cash
Cash and cash equivalents end of period
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Notes to Consolidated Financial
Statements
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46
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50
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52
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Statements of Profit or Loss
2022
2021
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
3
83
912
Administrative costs
3
25,319
29,312
Loss before financial items (EBIT)
(15,802)
(20,624)
Loss from investments in subsidiaries
4
(81,184)
(51,990)
Financial income
5
21,642
15,252
Financial expenses
5
579
385
Loss before tax
(75,923)
(57,747)
Income tax benefit, net
6
-
634
Net loss
(75,923)
(57,113)
Parent Company
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Balance Sheets
Assets
2022
2021
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
2,927
4,600
Total property, plant and equipment and intangible assets
2,927
4,600
Financial assets
Investments in subsidiaries
4
2,208
973
Receivables from subsidiaries
-
12,120
Deposits
851
819
Total financial assets
3,059
13,912
Total non-current assets
5,986
18,512
Current assets
Taxes receivable
5,500
5,500
Other receivables
379
971
Total receivables
5,879
6,471
Cash and cash equivalents
74,941
34,624
Total current assets
80,820
41,095
Total assets
86,806
59,607
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Equity and liabilities
2022
2021
DKK thousand
Notes
Dec 31
Dec 31
Equity
Share capital
334,693
267,754
Exchange rate adjustments
(234)
(119)
Retained deficit
(264,238)
(221,671)
Total equity
70,221
45,964
Provisions
Provisions in subsidiaries with negative equity
4
8,796
-
Total provisions
8,796
-
Liabilities
Non-current liabilities
Lease obligation
1,387
3,094
Other non-current liabilities
-
-
Non-current liabilities
1,387
3,094
Current liabilities
Current portion of non-current liabilities
1,707
1,560
Trade payables
2,838
2,039
Payables to subsidiaries
-
21
Other payables
1,857
6,929
Current liabilities
6,402
10,549
Total liabilities
7,789
13,643
Total equity and liabilities
86,806
59,607
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BioPorto Annual Report 2022
Statements of changes in equity
Amounts in DKK thousand
Shares in thousand
Common Stock
Treasury Stock
Retained
Shares
Amount
Shares
Amount
Deficit
AOCI
Total
Balance at December 31 2020
266,582
266,582
13
-
(166,770)
1,100
100,912
Comprehensive loss
-
-
-
-
-
(1,219)
(1,219)
Transactions with owners
Issuance of Stock, net
1,172
1,172
-
-
-
-
4,350
Share-based compensation
recovery
-
-
-
-
(966)
-
(966)
Transfer of additional paid in
capital
-
-
-
-
3,178
-
-
Net loss
-
-
-
-
(57,113)
-
(57,113)
Balance at December 31, 2021
267,754
267,754
13
-
(221,671)
(119)
45,964
Amounts in DKK thousand
Shares in thousand
Common Stock
Treasury Stock
Retained
Shares
Amount
Shares
Amount
Deficit
AOCI
Total
Balance at December 31
2021
267,754
267,754
13
-
(221,671)
(119)
45,964
Comprehensive loss
-
-
-
-
-
(115)
(115)
Transactions with owners
Issuance of Stock, net
66,939
66,939
-
-
-
-
92,736
Share-based compensation
-
-
-
-
7,559
-
7,559
Transfer of additional paid in
capital
-
-
-
-
25,797
-
-
Net loss
-
-
-
-
(75,923)
-
(73,340)
Balance at December 31,
2022
334,693
334,693
13
-
(264,238)
(234)
70,221
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65
Notes to Financial Statements of Parent
Company
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.
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 subsidiaries. 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.
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2. Business area reporting
GEOGRAPHIC DISTRIBUTION
2022
2021
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
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Wages and salaries
7,670
15,248
Defined contribution pension plans
299
1,343
Share-based compensation expenses
7,556
(966)
Other social security costs
3
75
Other staff costs
108
198
Staff costs
15,636
15,898
Average number of employees
3
6
SPECIFICATION OF STAFF COSTS
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Sales and marketing costs
-
872
Administrative costs
15,636
15,026
Staff costs
15,636
15,898
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67
REMUNERATION FOR KEY MANAGEMENT PERSONNEL
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Board of Directors
Remuneration
4,161
1,915
Board of Directors, Total
4,161
1,915
Executive Management
Salary
-
3,420
Bonus
-
1,369
LTI bonus
-
(1,398)
Contribution based pension
-
591
Other employee benefits
-
211
Remuneration, total
-
4,193
Share-based compensation expenses
-
(1,281)
Executive Management, Total
-
2,912
Other Corporate Management
Salary
720
4,673
Bonus
97
1,713
LTI bonus
-
(699)
Contribution based pension
64
503
Other employee benefits
-
130
Remuneration, total
881
6,320
Share-based compensation expenses
-
(1,194)
Other Corporate Management, Total
881
5,126
Remuneration for key management personnel
5,042
9,953
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BioPorto Annual Report 2022
4. Investments in subsidiaries
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Cost on January 1
51,364
51,364
Additions
-
-
Cost at December 31
51,364
51,364
Revaluation on January 1
(509,210)
(456,001)
Income from investments in subsidiaries
(81,185)
(51,990)
Exchange rate adjustments investments in subsidiaries
(115)
(1,219)
Equity changes in subsidiaries
-
-
(590,510)
(509,210)
Subtotal
(539,146)
(457,846)
Negative value of investments set off against receivables from group
456,210
406,123
Negative value of investments recognized as a provision
85,144
52,696
Value on December 31
2,208
973
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 2022 of 3.6%, 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 attaches 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 Denmark . Ownership: 100%
Veterinary Diagnostics A/S, 2900 Hellerup, Denmark. Ownership: 100%
BioPorto Inc., Needham, Massachusetts, USA. Ownership: 100%
BioPorto Diagnostics Inc., Needham, Massachusetts , USA. Ownership: 100%
BioPorto Annual Report 2022
69
5. Financial income and expenses
FINANCIAL INCOME
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Interest income from subsidiaries
17,783
9,490
Interest income from bank
21
-
Exchange rate adjustments, net
3,838
5,762
Total financial income
21,642
15,252
FINANCIAL EXPENSES
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Interest expenses, leasing debt
237
110
Interest expenses, other debt
342
275
Total financial expenses
579
385
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 ON THE BALANCE SHEET
2022
2021
Jan 1 - Dec 31
Jan 1 - Dec 31
DKK thousand
Right-of-use assets
(644)
(1,012)
Leasing liabilities
681
1,024
Tax loss carryforwards
361
3,207
Deferred tax on December 31
398
3,219
As a result of the Parent’s net loss, it does not incur income taxes in Denmark and has an effective Danish tax rate of 0%. 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.
7. Commitments and contingencies
BioPorto A/S has acknowledged that it will finance the operations of its subsidiaries BioPorto Diagnostics A/S, Veterinary Diagnostics A/S, BioPorto Inc., and
BioPorto Diagnostics Inc. through 2023. The Parent is jointly taxed with its Danish subsidiaries, and they are jointly liable for any such tax liabilities.
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BioPorto Annual Report 2022
8. Distribution of this year’s result
The Board of Directors proposes that BioPorto A/S’s loss of DKK 75.9 million for the year ended December 31, 2022 be transferred to retained earnings.
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 20 in BioPorto's consolidated financial statements with respect to matters associated with related parties (excluding intercompany
balances and transactions between any Group-owned companies with the Parent) and the section on directorships held by members of the Board of Directors
and Executive Management.
Reference is made to Note 21 in BioPorto's consolidated financial statements with respect to subsequent events.
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71
Executive Management:
___________________________ ___________________________
Board of Directors:
___________________________ ___________________________ __________________________
___________________________ ___________________________ ___________________________
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BioPorto Annual Report 2022
Report on the audit of the Financial Statements
To the shareholders of BioPorto A/S
Independent Auditor’s Report
BioPorto Annual Report 2022
73
74
BioPorto Annual Report 2022
CVR No. 33963556
Accountant Identification No
(MNE) mne34532
Accountant Identification No
(MNE) mne2 4828
BioPorto Annual Report 2022
75
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
DK-2900 Hellerup Needham, MA 02494
CVR DK -17500317