Management review BioPorto 2021
The Company’s flagship product is The NGAL Test, which has
been designed to aid in the risk assessment of Acute Kidney Injury
(AKI), a common clinical syndrome that can have severe
consequences, including significant morbidity and mortality if not
identified and treated early. With the aid of The NGAL Test,
physicians can identify patients potentially at risk of AKI more
rapidly than is possible with current standard of care
measurements, enabling earlier intervention and more tailored
patient management strategies.
The product portfolio of biomarkers, tests and antibodies is
distributed worldwide through the company’s own sales team,
distributors, and strategic OEM partnerships.
Management Review
BioPorto in brief 2
Acute Kidney Injury: A Major Public
Health Concern 4
Key figures 6
Letter to our shareholders 7
Highlights of 2021 – setting the direction
for the future 8
Financial guidance 10
Non-IFRS financial measure 11
BioPorto’s Strategy 12
Corporate information
Risk management 17
Corporate Governance 19
Shareholder matters 23
Company information 26
Board of Directors 27
Executive Management 29
Financial review 2021 30
Financial statements - Group
Income statement and statement of
comprehensive income 33
Balance sheet 34
Statement of changes in equity 35
Cash flow statement 36
Notes - Group 37
Financial statements - Parent
Income statement 63
Balance sheet 64
Statement of changes in equity 65
Notes - Parent 66
Statement by the Management 74
Independent auditor’s report 75
BioPorto in brief
Contents
Management review BioPorto 2021
3
Management review BioPorto 2021
4
Acute Kidney Injury: A Major Public Health Concern
Management review BioPorto 2021
5
Management review BioPorto 2021
6
2021
2020
2019
2018
2017
DKK
million
DKK
million
DKK
million
DKK
million
DKK
million
Revenue
24.3
23.2
26.6
26.0
25.2
Production costs
9.2
9.9
9.3
8.2
6.9
Sales and marketing costs
17.4
20.8
39.3
20.9
18.5
Research and development costs
30.3
28.1
24.6
18.7
21.9
Administrative costs
32.7
28.0
27.8
20.0
14.3
Loss before financial items (EBIT)
(65.3)
(63.6)
(74.3)
(41.8)
(36.5)
Net financials
1.4
(3.2)
0.1
0.2
(0.6)
Loss before tax
(63.8)
(66.8)
(74.2)
(41.6)
(37.1)
Net loss
(57.1)
(61.6)
(69.6)
(38.0)
(32.2)
Total comprehensive income
(58.3)
(59.8)
(70.0)
(38.3)
(32.0)
Non-current assets
17.1
15.5
8.2
3.6
2.6
Current assets
64.2
124.8
34.5
62.6
63.0
Total assets
81.3
140.3
42.7
66.2
65.6
Equity
46.0
100.9
25.3
56.2
56.1
Non-current liabilities
10.5
8.4
2.5
0.8
0.9
Current liabilities
24.8
30.9
14.9
9.2
8.7
Total equity and liabilities
81.3
140.3
42.7
66.2
65.6
2021
2020
2019
2018
2017
DKK
million
DKK
million
DKK
million
DKK
million
DKK
million
Cash flows from operating activities
(64.6)
(35.6)
(60.2)
(38.0)
(29.2)
Cash flows from investing activities, net
(0.4)
(1.5)
(2.1)
(1.5)
(0.1)
Of which investment in property, plant
and equipment
(0.1)
(1.3)
(0.6)
(1.4)
(0.0)
Cash flows from financing activities
1.1
127.0
33.6
39.1
40.7
Total cash flows
(63.9)
89.9
(28.6)
(0.4)
11.4
Revenue growth
5%
(13%)
2%
3%
21%
Gross margin
62%
57%
65%
69%
73%
Equity ratio (solvency)
57%
72%
59%
85%
85%
Average number of employees
29
28
34
28
25
Number of shares by the end of year
(1,000)
267,754
266,582
174,944
165,688
155,510
Earnings per share (EPS), DKK
(0.21)
(0.30)
(0.41)
(0.24)
(0.22)
Net asset value per share, year-end, DKK
0.17
0.38
0.14
0.34
0.36
Share price, year-end, DKK
2.47
4.04
2.93
3.50
3.31
See Note 1 of the consolidated financial statements for definitions of financial highlights.
Comparative figures for the financial years 2018 and 2017 have not been restated following the
adoption of IFRS 16 – Leases.
Key figures
Management review BioPorto 2021
7
Tracking towards a US breakthrough
2021 was clearly another challenging year for the world as the
global COVID-19 pandemic continued to impact global health.
BioPorto was not spared from these challenges as it was
restricted in its ability to execute the pivotal clinical trial required
to support our US Food and Drug Administration (FDA)
submission for our flagship product, The NGAL Test.
But 2021 was also a year of progress for BioPorto that will drive
value creation in 2022 and onwards – particularly in the
progression of our R&D, validation, regulatory, quality and
operational improvement efforts. We also strengthened our
team with key positions in Denmark, appointed a new executive
team experienced in successfully introducing new products to the
US market, and expanded our Board of Directors with highly
respected, diagnostic industry veterans.
Acute Kidney Injury is a massive health
threat, requiring better assessment tools
I joined BioPorto in November 2021 because I was impressed
with the company’s value proposition to address a significant
unmet need for patients in critical care with its technology, and
with its relentless focus on providing physicians and patients
better and faster diagnostic tests.
Since then, my admiration of our potential clinical impact has
only increased my determination to bring our life saving tests to
the market. After significant education on Acute Kidney Injury
(AKI) and its prevalence, and through many meetings with
nephrology and critical care key opinion leaders from leading US
hospitals, it is clear that we face a very serious, underdiagnosed,
and highly lethal disease. The candid, strong desire by clinicians
that BioPorto get The NGAL Test onto the US market has been
overwhelming to experience, because we can save lives by
identifying patients at risk of AKI and adjusting their care
accordingly. Based on clinician feedback, my belief in the need
for BioPorto to succeed has grown even stronger.
Focus, focus, focus
Since taking over as the CEO, in addition to meeting key
stakeholders, I have worked with the leadership team to focus
BioPorto’s strategy on delivering the NGAL biomarker as the new
standard of care in assessment of kidney health, preparing the
company to commercialize and scale, and building a strong team
dedicated to the mission.
We are a small company with a unique technology and very high
ambitions. That calls for clear prioritization and focus on what we
aim to achieve in the next 12-18 months, which is to obtain US
FDA approval of our flagship product, The NGAL Test, for use in
pediatrics (under age 22) and drive its adoption in the US, which
is the largest market for in vitro diagnostic tests in the world.
Currently, we are finalizing the enrollment of pediatric patients
at fifteen top hospitals across the US to complete the third part
of a 3-part clinical study. Enrollment is expected to be completed
in the second quarter of 2022, when the data will be analyzed and
packaged with other technical documentation to support
submission to the US FDA for its approval of the test for use in
identifying children at risk for AKI. Putting this vital test in the
hands of clinicians will help them tailor the care of their critically
ill and vulnerable patients. Following submission, and in parallel
with FDA review, we will undertake steps towards performing
clinical trials and related activities for FDA approval of The NGAL
Test for adult use in the US.
Successful share offering provides
runway for strong execution
The first important step of the strategy was completed in March
2022. Despite times of great difficulty and volatility, we closed a
fully subscribed, pre-emptive rights offering for new shares as
part of a long-term capital plan that includes a potential US
listing. The proceeds of approximately DKK 100 million will,
together with existing funds, provide a strong foundation for the
submission of The NGAL Test application for pediatric use, which
has been assigned Breakthrough Device designation by the FDA
for prioritized approval. The proceeds will also enable us to
prepare for a commercial launch and implement programs to
drive market adoption.
I am very thankful for the support and clear mandate from both
existing shareholders and new investors to focus our efforts and
execute this strategy. It is a strategy that I firmly believe will bring
BioPorto to a very successful and bright future with compelling
value creation for patients, health care providers, and our
shareholders.
Tony Pare
Chief Executive Officer
Letter to our shareholders
Management review BioPorto 2021
8
In spite of facing significant challenges, 2021 ended on a high
note with a new management team and a renewed focus on
driving towards future market adoption of our flagship product,
The NGAL Test. Of course, 2021 continued to be impacted by the
global COVID-19 pandemic, as the spread of the SARS-CoV-2 virus
in multiple variants affected global health, politics and business.
While 2021 started out by showing encouraging trends towards
virus stabilization, the Delta and subsequently the Omicron
variant in the second half of the year meant that BioPorto once
again faced patient access restrictions to conduct clinical studies,
which further delayed patient enrollment for the important trials
to support BioPorto’s FDA application for pediatric use of The
NGAL Test in the US.
However, 2021 was also an important year in progressing
development, validation, regulatory and operational activities for
The NGAL Test. It was also a year of important new additions to
our team of talented employees. Expecting to focus even harder
on commercialization after a possible clearance of The NGAL Test
has been granted, BioPorto in 2021 announced the appointment
of a new executive team with a strong US track record, and a
continued build-up on key positions across the increasingly global
organisation. We highlight key 2021 activities in the timeline
below.
April / May 2021
Search for new CEO and CFO initiated
In Q2 2021, the Board of Directors of BioPorto initiated the
search for a new executive management team following the
resignations of Peter Mørch Eriksen (CEO) and Ole Larsen (CFO),
who both wanted to pursue other career paths. Peter Mørch
Eriksen retained his position as CEO until his successor was
appointed in November and then joined the Board of Directors
of the company.
August 2021
BioPorto Successfully Completes Interim Analysis of Data
from Pivotal Study of NGAL in Pediatrics with Encouraging
Results
In August 2021, BioPorto concluded an interim analysis of data
from the three part pediatric clinical trial to evaluate The NGAL
Test as a tool for risk assessment of moderate to severe AKI in
pediatrics in the US. The interim analysis for the clinical
performance of the assay provided results on key characteristics
such as sensitivity and specificity which were consistent with
expectations. The results are expected to support the case of The
NGAL Test as a biomarker to identify risk of AKI in critically ill
children.
Following this interim data analysis, BioPorto expanded the
ongoing patient enrollment to maximize the pediatric clinical
study’s statistical power for the planned upcoming FDA
submission.
October / November 2021
Appointment of new Executive management team
Following a successful search process for a new executive
management team, in October BioPorto announced the
appointment of Anthony (Tony) Pare as its new Chief Executive
Officer (CEO). Tony Pare joined BioPorto from T2 Biosystems, a
US Nasdaq-listed in vitro diagnostics company, where he served
as the Chief Commercial Officer and presided over several
successful product launches. He brings +25 years’ experience
heading product development, commercialization, marketing,
and operational improvements in leading medtech and
diagnostic companies. He has a track record of delivering strong
results, driving business value, increasing product presence, and
growing sales, both in the US and globally.
Simultaneously, BioPorto announced the appointment of Neil A.
Goldman, CPA, as its new Executive Vice President (EVP) and
Chief Financial Officer (CFO). Prior to BioPorto, Neil Goldman was
EVP and CFO at Chembio Diagnostics, Inc., a US Nasdaq-listed
global developer and manufacturer of point-of-care tests for
infectious disease. He started his career as an auditor and
consultant with Ernst & Young, and since served as an executive
at J.S. Held LLC and Unwired Technology LLC, and brings three
decades of valuable experience establishing strong relations with
investors and global capital markets, raising capital reliably and
successfully, optimizing business operations, and expanding
business through organic growth and strategic partnerships.
Both Tony and Neil assumed their new positions in BioPorto in
November 2021.
November 2021
Enrollment for pediatric trial for The NGAL Test continues,
but is delayed by COVID-19
Despite an increase in number of participating study sites,
enrollment of patients was impacted and delayed by the
continuation of the COVID-19 pandemic which shifted the health
care sectors focus for those patients and combined with fewer
qualified patients admitting to the ICU, and restricted access for
research coordinators to obtain consents and samples
Based on enrollment figures and the COVID-19 outlook, BioPorto
in November 2022 consequently revised the enrollment forecast
and expected to finalize data collection during the first half of
2022.
Election of new member to board of directors and
appointment of new chairmanship
In November 2021, BioPorto convened an extraordinary general
meeting at which Peter Mørch Eriksen, CEO of BioPorto in the
period 2013-2021, was elected to the Board of Directors of
BioPorto A/S. In addition, Thomas Magnussen resigned as
chairman and member of the Board of Directors. Following the
event, Christopher Lindop was appointed as new chairman of the
Board of Directors and John McDonough was elected as vice
chairman.
Highlights of 2021 – setting the direction for the future
Management review BioPorto 2021
9
In an effort to prioritize Emergency Use Authorizations
(EUA), the FDA recommended that BioPorto not pursue
an EUA for its NGAL assay for the prediction of renal
replacement therapy in COVID-19 patients
In July 2021, BioPorto initiated a dialogue with the US Food and
Drug Administration (FDA) on a potential EUA of an NGAL assay
for use in predicting the need for renal replacement therapy in
COVID-19 patients. The dialogue was based on results from a
NGAL ELISA and dipstick study to screen for AKI in COVID-19
patients conducted by clinical researchers at Columbia
University’s Irving Medical Center. The study reported a 97%
negative predictive value for the need of renal replacement
therapy.
In November 2021, the FDA provided guidance to all in-vitro
diagnostics manufacturers that the FDA would focus its reviews
on at-home and point-of-care COVID-19 diagnostic tests, certain
high-volume lab-based molecular COVID-19 tests from home
collected specimens, and requests supported by US government
stakeholders. In spite of the study results, based on a subsequent
dialog with FDA, BioPorto decided to discontinue pursuit of an
EUA for an NGAL assay with this application for COVID-19
patients.
December 2021
Updates on gRAD pipeline
In December 2021, BioPorto provided an update on the support
to Rigshospitalet (RH), Copenhagen (DK) with quantitative
thrombomodulin tests based on its gRAD technology.
Thrombomodulin is a marker of endothelial injury that can occur
as a result of sepsis, COVID, myocardial infarction, and other
disease states and RH is investigating the use of a
thrombomodulin assay in patients with sepsis to indicate who
could benefit from treatment with the drug prostacyclin. RH is
summarizing the results, which is expected to be published after
the assessment is completed.
Furthermore, BioPorto announced that results from the previous
data collection from the feasibility study to detect SARS-CoV-2
based on a gRAD test were not conclusive, and that the company
extended the feasibility study into 2022.
Management review BioPorto 2021
10
Executing strategic activities that together are focused on
launching The NGAL Test as an FDA-cleared product in the
US in 2023
The three strategic activities are:
• Drive Market Adoption of the NGAL Test & have a
Pipeline of Products that Deliver High Medical Value;
• Strengthen the Company to Scale & Execute; and,
• Attract, Develop & Retain the Best and Brightest
Employees aligned with our Values and with Clear Roles
and Responsibilities.
For 2022, BioPorto expects:
• Revenue of approximately DKK 24 to 26 million.
• Operating (EBIT) loss of approximately DKK 95 to 100
million.
• Adjusted EBITDA loss of approximately DKK 76 to 81
million, excluding depreciation and amortization of
approximately DKK 5 million and share-based
compensation expense of approximately DKK 14
million.
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.
Following are the key assumptions relating to the 2022 guidance:
• EBIT from 2021 was favorably impacted on a non-cash basis
by approximately DKK 4 million from the forfeiture of
warrants and related reversal of equity compensation
expenses for members of management and other team
members that resigned. Such forfeitures are not expected in
2022, so EBIT for 2022 is assumed to be negatively impacted
(also on a non-cash basis) by an additional approximately
DKK 11 million for the full year, impact of equity
compensation expenses related to new members of
management and other team members, including certain of
such expenses that will be amortized on an accelerated
basis. The combined non-cash, negative impact of this
accounting treatment is approximately DKK 15 million of
EBIT loss compared to 2021.
• Costs related to clinical studies are assumed to be
comparable to FY2021, which in turn assumes that the
regulatory clinical trial of The NGAL Test in pediatrics can
complete enrollment of patients at the selected clinical sites
in the U.S. and thus not be further delayed by COVID-19.
• EBIT is assumed to be affected negatively by the full year
impact of 2021 hires of management and other team
members. Costs related to sales & marketing are assumed
to increase compared to FY2021 associated with the
preparation for commercializing The NGAL Test in the U.S.
and increasing costs to expand support for distribution in
the rest of the world.
• Cost related to R&D (including quality, regulatory, and non-
clinical trial medical affairs costs) are assumed to increase
compared to 2021, including as a result of the full year
impact of 2021 hirings, investments in quality systems (e.g.,
in preparation of the coming into effect of the new in vitro
diagnostic regulation in the European Union), and other
costs related to preparing and submitting the De Novo
application of The NGAL Test in the U.S. to the FDA. Costs
related to production and depreciation are assumed at
FY2021 levels.
BioPorto’s performance and guidance for 2022 is dependent on
the global development of the 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.
Events after the reporting period
On April 1, 2022, the Group raised gross proceeds of
approximately DKK 100.4 million, with estimated net proceeds of
DKK 93.1 million, from the issuance and sale of 66,938,601 shares
of common stock (the Offering) pursuant to a Prospectus for a
Rights offering with pre-emptive rights for existing shareholders
that was filed on March 7, 2022 (the Prospectus).
Financial guidance
2021 financial guidance
2021 actual result
1
2022 financial guidance
Revenue
Approximately DKK 24 million
DKK 24 million
Approximately DKK 24 to 26 million
EBIT Loss
Approximately DKK 63 million
DKK 65 million
Approximately DKK 95 to 100 million
Adjusted EBITDA Loss
2
N/A
DKK 62 million
Approximately DKK 76 to 81 million
1
2021 actual results were consistent with the Company’s most recent guidance as announced in the third quarter 2021 unaudited financial statements.
2
See “Non-IFRS financial measure”
Management review BioPorto 2021
11
Part of Management’s review – unaudited
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 measures 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).
IFRS refers to an IFRS financial measure.
Adjusted EBITDA
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).
2021
2020
DKK thousand
DKK thousand
Loss before financial items (EBIT)
(65,255)
(63,590)
Depreciation and amortization
4,329
3,994
Share-based compensation (income)/expense
(966)
5,316
Adjusted EBITDA
(61,892)
(54,280)
Non-IFRS financial measure
Management review BioPorto 2021
12
BioPorto is an IVD (in vitro diagnostic) company focused on
developing actionable biomarker tests – tools designed to help
clinicians detect the onset of certain disease states and help
direct appropriate therapy. BioPorto uses 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.
Well Established Key Strengths
BioPorto possesses several key strengths in relation to
developing, sourcing and commercializing tests in the healthcare
market.
• Rapid Analytical and Clinical Development: With the
benefit of an experienced and seasoned leadership
and team of scientists, many of which with 20+ years
of experience in their related fields, BioPorto is nimble
and agile in its product development, decision-making
and execution.
• Team with History of Successful Product
Submissions: Over the past 1-2 years, the Board has
recruited a management team with a track record of
successful clinical trials, product launch, and product
commercialization.
• Deep Clinical Relationships and Reputational
Leadership: BioPorto has longstanding collaborations
with key opinion leaders (KOLs) and the target clinical
audience in nephrology, critical care, cardiology, and
other leading disciplines related to The NGAL Test.
These relationships well-position BioPorto, and its
reputation for the high quality of The NGAL Test, in
advance of the planned commercialization process in
the U.S.
• Rapid Antibody-based Assay Development: With the
proprietary gRAD platform, BioPorto can quickly
evaluate the efficacy of antibodies to accelerate the
launch of research studies.
Clear Strategic priorities
BioPorto helps healthcare providers improve patient
management and outcomes with products that provide early and
specific insights into significant clinical conditions. By 2025,
BioPorto aspires to become one of the world’s leading companies
in diagnostics that improve kidney health. This vision is supported
by three strategic pillars.
Drive Market Adoption of The NGAL Test & have a
Pipeline of Products that Deliver High Medical Value
To achieve this pillar in the US, BioPorto will focus on completing
the clinical pivotal trials required to submit and obtain De Novo
FDA approval for pediatrics (under age 22). Through BioPorto’s
own commercial team and distribution partnerships, it seeks to
drive market adoption of the use of NGAL 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.
Strengthen the Company to Scale & Execute
BioPorto will work towards readying itself for a US product launch
of The NGAL Test by building the required commercial and clinical
organization, scaling production capacity, improving the
robustness of its quality systems, working towards ensuring that
it continues to comply with regulatory requirements applicable
from time to time, expanding its intellectual property portfolio,
and ensuring it has the financing to support operations.
It will also ensure that it prepares for future financing and expand
the sources of capital. BioPorto has historically sought financing
through equity offerings and applied the proceeds towards
implementation of its strategic priorities. To realize its strategic
priorities, BioPorto will need to seek additional financing. Its long
term ambition is to gain access to the U.S. capital markets with
the ultimate goal of a potential U.S listing. As a step towards this,
BioPorto may explore opportunities in relation to a targeted
cross-border offering, including potentially in the U.S.
Attract, Develop & Retain the Best and Brightest
Employees aligned with our Values and with Clear Roles
and Responsibilities
BioPorto will employ proactive efforts to recruit the most
qualified people to drive success and embrace its core values.
BioPorto will motivate employees to stay and contribute by
employing 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 successes.
Products and Pipeline
BioPorto’s technical foundation is based on antibody expertise,
leveraging a robust library of monoclonal antibodies to develop
assays for both research and clinical diagnostics. Product formats
range from enzyme-linked immunosorbent assay (ELISA) kits, IVD
automated assays, to gRAD, a novel platform for the rapid
development of lateral flow tests through the identification of
the analyte(s) of interest.
Within the portfolio of clinically actionable biomarkers, the
biomarker NGAL has been developed across each of these
product formats. NGAL is a protein expressed in a variety of
human tissues, including the lung, liver and kidney. BioPorto
expects that the development of NGAL can create significant
commercial opportunities based on its potential for broad clinical
application.
NGAL – an actionable biomarker for AKI
The NGAL Test is designed to help clinicians identify levels of
NGAL, a biomarker that rises rapidly in response to acute kidney
injury (AKI). AKI is a very rapid loss of kidney function that
typically occurs in a matter of hours as a complication of another
serious illness or intervention, such as sepsis, cardiac surgery,
mechanical ventilation, solid organ or stem cell transplants or
administration of nephrotoxic pharmaceuticals. Identification of
AKI in critically ill patients is growing: from 2000-2014, the U.S.
BioPorto’s Strategy
Management review BioPorto 2021
13
saw a 230% increase among non-diabetics, and a 139% increase
in patients with diabetes.
1
AKI affects both adults and children, with one in five adults
2
affected with AKI during a hospital setting of care and one in four
children
3
affected with AKI during their admissions to the ICU.
The onset of AKI in hospitalized patients, will increase the
chances of mortality by 25%
6
. AKI can be difficult to identify
because acute symptoms, such as pain and other symptoms, do
not usually occur. However, to preserve kidney function, it is
essential that patients at risk for AKI are detected early and
managed promptly. Patients that develop AKI are at an increased
risk of poor outcomes, longer hospital stays
4
, increased risk of
developing chronic kidney disease, and increased mortality
5
.
Based on recent studies, BioPorto estimates AKI to be the third
largest cause of in-hospital death in the U.S after heart diseases
and cancer
6
. It is also important to identify patients that are not
at risk of AKI so inappropriate prophylactic treatment is not
administered.
The NGAL Test is a particle-enhanced immunoassay for the
quantitative determination of NGAL in human specimens. It uses
an analytical method that can be run on most automated clinical
chemistry systems that are used routinely in hospital
laboratories. This facilitates laboratory adoption of the test and
eventual market penetration. The 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.
1
Pavkov ME. (2018) ‘Trends in Hospitalizations for Acute Kidney Injury —
United States, 2000–2014’, MMWR Morb Mortal Wkly Rep. 2018;67.
2
Susantitaphong P. (2014) Correction, Clin J Am Soc Nephrol, CJASN.
2014;9(6)
3
7 Kaddourah A. (2017) ‘Epidemiology of Acute Kidney Injury in Critically
Ill Children and Young Adults’, N Engl J Med. 2017;376(1)
4
Maryland SID 2019
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
7
and
after >50% of total glomerular filtration capacity is already lost
8
.
This difference in both speed and more specific risk of of kidney
injury is important for clinical patient management, as early
5
Lo, LJ. Kidney Int. 2009;76(8):893-899
6
Management estimates based on the following sources: Brown J.R. et
al. (2016) ‘Hospital Mortality in the United States following Akute Kidney
Injury’, https://www.hindawi.com/journals/bmri/2016/4278579/, and
the National Center for Health Statistics for death and mortality in the
U.S., https://www.cdc.gov/nchs/fastats/deaths.htm
detection of kidney damage can allow earlier and more tailored
approaches such as close control of fluid levels, heightened
attention to nephrotoxic drugs, and consideration of renal
replacement therapy. Each of these can be initiated to improve
the chances of kidney recovery. Also importantly, The NGAL Test
identifies if the patient is not at risk of AKI, which can also change
therapy decisions.
7
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
8
) Küllmar M, et al. Crit Care Clin. 2020 Oct;36(4):691-704.
Management review BioPorto 2021
14
The NGAL Test Addresses A significant global market
opportunity
BioPorto’s initial focus with The NGAL Test is in the intensive care
setting, and subsequently towards other long-term expansion
into new indications, such as nephrotoxicity monitoring, testing
in the emergency department, and other out-patient
applications. BioPorto estimates that the total addressable
opportunity in the US for pediatric and adult ICU/medical-surgical
patients of approximately USD 500 million annually. Based on
expanded indications for the emergency department and out-
patient uses, the projection for the addressable market in the
U.S. could increase to over USD 1 billion annually. As the U.S.
constitutes approximately 40% of the Company’s market,
BioPorto estimates the global addressable market for The NGAL
Test could have an annual value of approximately USD 3 billion.
Steady Focus on US Regulatory Pathway for The NGAL
Test
The NGAL Test is currently CE marked for measurement of NGAL
in adults in the ICU and is available for IVD use in Europe and
other geographies. North America represents the largest share of
the IVD market, with the U.S. as the driver behind the market
growth in the region
9
. Accordingly, the U.S. is the focus of
BioPorto’s commercial strategy for The NGAL Test, which
requires a De Novo Approval by the U.S regulatory body, the US
Food and Drug Administration (FDA).
In 2020, as part of FDA’s Breakthrough Device Designation
program, BioPorto engaged with the FDA through the pre-
submission process to align with the FDA on the analytical and
clinical protocols necessary for the company’s planned De Novo
submission.
Following the FDA feedback in early 2020, the clinical protocol
was finalized with FDA alignment, and the clinical study planning
9
Grand View Research (2019) ’In Vitro Diagnostics Market Size, Share &
Trends Analysis Report By Product, By Technology (Molecular
and contracting was conducted. Since the clinical study planning
and contracting was concluded, enrollment of enrollment
patients was initiated, but on several occasions in 2020 and 2021
delayed due to the COVID-19 pandemic. Despite these delays, the
clinical study and analytical work are both currently underway,
with the clinical study being conducted by a consortium of 15
leading U.S. hospitals, including Cincinnati Children’s Hospital,
Boston Children’s Hospital, Children’s Hospital of Colorado,
Children’s Healthcare of Atlanta, Stanford Health, Cohen’s
Children Hospital, and Texas Children’s Hospital. Enrollment and
sample analysis has now been completed for 2 of the 3 studies
comprising the clinical trials. BioPorto expects to finalize data
collection for the third study in the first half of 2022.
After the compilation of the study results and subject to the
results meeting the primary outcomes previously committed to
the FDA and demonstrating that the benefits of the device
outweigh the associated risks, BioPorto expects to submit a De
Novo application to the FDA.
As a next step, BioPorto plans to develop study protocols, sites,
and contracts, engage with the FDA, and begin working on a
submission for use of The NGAL Test in adult populations, with
the intention of filing an appropriate submission using the
pediatric test as its predicate.
US Commercial Strategy under Establishment
BioPorto’s US commercial strategy for The NGAL Test has been
designed to reflect the need 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. In addition to being a narrow
target market, there is a well-established network of pediatric
critical care physicians and nephrologists who are KOLs in AKI,
and whom have favorable opinions of the use of NGAL as a
Diagnostics, Clinical Chemistry), By Application, By End Use, And
Segment Forecast, 2020-2027,
biomarker for diagnosis of AKI, and as such the market potential
for The NGAL Test.
The commercial strategy for the pediatric launch of NGAL rests
on deploying initiatives in 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: Having a dedicated
sales team with clinical experience will allow BioPorto
to engage with doctors at prospective accounts, 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 team will also ensure there is alignment and
buy-in amongst all decision makers in the hospital
system.
• MSLs: Building a dedicated MSL (Medical Science
Liaison) team is critical to furthering deep clinical
discussions with doctors. This team will be comprised
of professionals with pediatric and adult ICU
experience, for example former critical care nurses,
who can engage in scientific discourse about how
NGAL can be used in the medical management of AKI.
This team will be armed with the step-by-step tools to
guide the implementation of new kidney biomarker
program.
Adult hospitals that also care for children are expected to provide
a bridge to the adult ICU market, as the laboratories in these
hospitals will already be exposed to The NGAL Test, and adult
physicians will be able to speak to their pediatric colleagues
https://www.grandviewresearch.com/industry-analysis/in-vitro-
diagnostics-ivd-market
Management review BioPorto 2021
15
about NGAL’s utility. BioPorto estimates that this will give The
NGAL Test a head-start on entering the adult market, speeding
uptake if the expected FDA approval of The NGAL Test for adults
is granted.
With a view to further penetrate the adult market over time,
BioPorto’s strategy will expand to include two additional strategic
initiatives. Firstly, distribution partnerships with instrument
manufacturers, for example, Roche, Siemens and Abbott, to
enable laboratories with any instrument platform to order and
run The NGAL Test. Secondly through collaboration with
advocacy groups such as the National Kidney Foundation, KDIGO,
a global organization to develop and implement evidence-based
clinical practice guidelines in kidney disease, and ADQI, an
international organization of academic researchers and clinicians
focused on setting new standards for the diagnosis and
management of AKI and other kidney-related disorders
The Generic Rapid Assay Device (gRAD)
Platform
BioPorto’s proprietary gRAD platform enables rapid
development of lateral flow assays through the identification of
the analyte(s) of interest. gRAD’s features include optimization
with two printed lines: a test line for a biotinylated antibody (or
biotinylated protein), and a control line designed to capture an
antibody.
gRAD is differentiated from most lateral flow assays because the
biological recognition between the specific capture antibody, the
antigen in the sample, and the detection antibody occurs in a
solution. That means that specific antibodies do not need to be
immobilized on the strip during the manufacturing process. The
assay incubation time is typically short, about 10-15 minutes.
10
Goldstein S. et al. (2019), ‘Point-of-Care Urinary Neutrophil
Gelatinase-Associated Lipocalin Readings Are Highly Predictive of
Formal Laboratory Levels’, https://www.asn-
online.org/education/kidneyweek/2019/program-
abstract.aspx?controlId=3224791
Because a gRAD strip is not analyte dependent, it creates an
open, flexible, and versatile platform that can be applied to a
wide variety of antibodies – requiring only a matched antibody
pair.
Leveraging the gRAD platform, BioPorto is currently performing
feasibility studies, in conjunction with expert academic partners,
on emerging applications, including:
NGALds for point-of-care application: BioPorto has used its gRAD
platform to create a lateral flow test for semi-quantitative
determination of NGAL levels, expanding the potential
applications for this unique biomarker into settings beyond the
hospital laboratory, such as in physician offices, urgent care
clinics, or even on the battlefield for rapid triage of wounded
soldiers.
This product, called The NGALds, has been tested in several
research environments, including a study which compared
NGALds results to results obtained with The NGAL Test and
showed a 100% sensitivity and 89.3% specificity at the 300 ng/mL
cutoff between the two methods.
10
This illustrates the potential
clinical accuracy that a novel, near-patient test option may offer.
Thrombomodulin assay: BioPorto is supporting Rigshospitalet
(“RH”), one of the largest hospitals in Denmark, with quantitative
thrombomodulin tests based on its gRAD technology.
Thrombomodulin is a marker of endothelial injury that can occur
as a result of sepsis, COVID, myocardial infarction, and other
disease states. RH is investigating the use of a thrombomodulin
assay in patients with sepsis to indicate who could benefit from
treatment with the drug prostacyclin. RH is investigating the use
of a thrombomodulin assay in patients with sepsis to indicate
who could benefit from treatment with the drug prostacyclin. RH
11
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’,
is summarizing findings from its feasibility study and plans to
publish the results after completing its assessment.
ELISA Kits and Antibodies
BioPorto’s library of highly specific monoclonal antibodies for
scientific, pharmaceutical, and clinical research includes specific
antibodies for NGAL as well as for important areas such as allergy
and immune system disorders. Off-the-shelf antibodies are
available in small quantities, and BioPorto provides in-house
scaled up production of custom antibodies in bulk volumes to
meet specific program needs, such as for diagnostic kit
manufacturers. The overall research antibodies market is
expected to grow from USD 10.1billion in 2020 to USD 14.10
billion by 2025, at a CAGR of 6.7% from 2020 to 2025, as these
are critical components in life sciences research.
11
BioPorto offers NGAL ELISA kits for human use (CE marked) and
six additional species, ranging from mouse to monkey, for
research applications. 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 during
the development of new pharmaceutical compounds and to
investigate additional potential applications of NGAL. At this
time, BioPorto does not intend to either actively develop new
ELISA kits as a driver of its business strategy or seek FDA approval
for its 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.
https://www.marketsandmarkets.com/MarketReports/research-
antibodies-reagents-market-94212793.html
Management review BioPorto 2021
16
Proprietary rights
Through research and development efforts, 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.
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. It is also registered in and/or has
received regulatory approval for IVD use in several other
countries.
Corporate information BioPorto 2021
17
Risk management is an integral part of BioPorto’s operations. The
Company identifies material risks that could affect revenues,
development, production, future performance, or the interests
of the shareholders in order to run the Company in accordance
with best practices in its industry.
All departments in the Company participate in the identification
and assessment of 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 trial was delayed and the expected
timeline for finalizing enrollment of patients has moved to first
half of 2022.
In 2022, the primary risks are related to completing enrollment
of patients and filing the submission for FDA clearance of The
NGAL Test in pediatrics, as well as in securing continued growth
in NGAL revenues and building up the US organization for launch
of The NGAL Test.
The enrolment rate of patients for the NGAL pediatric trial will
continue to depend on the COVID-19 pandemic, in particular in
the US and Denmark.
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 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 clinical trials depends on many factors
outside of the Company’s control, including the impact
of COVID-19, which may impair the Company’s ability
to complete clinical trials in a timely manner or at all.
• The results from the Company’s ongoing clinical trial
relating to pediatric use of The NGAL Test may not
meet the primary outcomes previously committed to
the FDA, which may prevent the Company from
submitting the clinical trial’s results to the FDA and/or
ultimately obtaining FDA approval of The NGAL Test for
risk assessment of AKI in pediatrics.
• A failure to obtain FDA approval of The 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 The NGAL Test
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.
• 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.
• 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.
Risk management
Corporate information BioPorto 2021
18
• 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 CMOs and CROs.
• Clinical development and results from pipeline projects.
• Cyber attacks.
• Risks relating to trade receivables and inventory.
• Changes in the USD exchange rate and its 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 all of 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.
As long as the DKK is linked to the EUR the Company’s revenue
and costs in EUR will not be hedged.
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 include detailed planning
of individual tasks and planning between finance and the
auditors. It is based on an audit strategy developed by the
auditors and 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.
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 does not necessitate such a function.
Corporate information BioPorto 2021
19
which are available at https://corporategovernance.dk/.
with the Recommendations is available on the Company’s
website.
Corporate Governance
Corporate information BioPorto 2021
20
Review of the gender-based composition
of the Management and Board, cf.
Section 99b of the Danish Financial
Statements Act
Review of corporate social responsibility,
cf. Section 99a of the Danish Financial
Statements Act
website.
Corporate information BioPorto 2021
21
Corporate information BioPorto 2021
22
Corporate information BioPorto 2021
23
Investor relations
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, are made available to the publicon 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 ensure an efficient, expedient dialogue with shareholders,
BioPorto encourages its shareholders to let their shareholding be
registered and to participate in BioPorto’s shareholder meetings.
The Investor Relations (IR) department is also responsible for
ensuring that information from the group’s IR stakeholders is
passed on to 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, 2021 BioPorto’s capital stock had a nominal
value of DKK 267,754,404 divided into 267,754,404 shares with a
nominal value of DKK 1 each, equivalent to 267,754,404 votes.
BioPorto A/S’s shares are listed on NASDAQ Copenhagen under
the symbol “BIOPOR”. The ISIN is DK0011048619. BioPorto had a
market value of DKK 660 million at the end of 2021 (end of 2020:
DKK 1,077 million).
The closing price of BioPorto shares was DKK 2.47 on December
30, 2021, which equals a decrease of 39% in the fiscal year.
The value of traded shares was DKK 1,197 million in 2021 (2020:
DKK 603 million), equivalent to average daily trading of DKK 4.8
million (2020: DKK 2.4 million) and an average daily volume of
970,371 shares (2020: 823,751 shares).
Capital increase
On April 8, 2021, the company’s share capital was increased by
normally DKK 1,172,500, corresponding to 1,172,500 new shares,
as a result of exercise of warrants issued. As a result, the capital
stock of BioPorto A/S was increased in the nominal amount of
DKK 1,172,500, after which it nominally amounted to DKK
267,754,404.
Following the balance sheet date, BioPorto in March 2022
conducted an offering of 66,938,601 new shares with pre-
emptive rights for existing shareholders. As a result, the capital
stock of BioPorto A/S was increased in the nominal amount of
DKK 66,938,601 on April 1, 2022, after which it nominally
amounted to DKK 334,693,005.
Ownership
As of December 31, 2021, BioPorto had 19,536 registered
shareholders (2020: 13,778), that in the aggregate owned 74.57%
of the capital stock. As of December 31, 2021, the following
shareholders stated that they owned 5% or more of the
company’s shares/voting rights:
Ejendomsselskabet Jano ApS, Copenhagen
Above 10 %
Media-Invest Danmark A/S, Copenhagen
Above 10 %
Warrant program
The Board established two warrant programs in 2021 for the
purpose of creating a long-term incentive for retaining and
motivating Management and employees. At the end of the fiscal
year, a total of 21,050,000 warrants remained, which amounted
to 7.9 % of the existing nominal capital stock.
Shareholder matters
0
20
40
60
80
30-12-2020 30-12-2021
BioPorto share, Volume (DKK million)
0
2
4
6
8
10
30-12-2020 30-12-2021
BioPorto share, Closing price (DKK)
Corporate information BioPorto 2021
24
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 new strategic initiatives and ensure the basis for
higher sales, no dividend is expected to be paid in 2021. 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
Yi Chen
Annual Shareholder Meeting
BioPorto A/S will hold its annual shareholder meeting on April 28,
2022, at 1:00 pm at the company’s address Tu borg Havnevej 15 ,
Corporate information BioPorto 2021
25
IR contact
Neil Goldman, Executive Vice President & Chief Financial Officer
Tim Ericksen, Investor Relations
Tel.: +45 4529 0000
E-mail: investo[email protected]
Financial calendar for 2022
Date
Description
April 28, 2022
Annual General Meeting
May 11, 2022
Interim Report – for the three-month period ended March 31, 2022
August 17, 2022
Interim Report – for the six-month period ended June 30, 2022
November 9, 2022
Interim Report – for the nine-month period ended September 30, 2022
Company
Date
No.
Description
March 7, 2022
2
BioPorto A/S publishes prospectus in connection with a rights issue with pre-
emptive subscription rights for its existing shareholders
March 7, 2022
1
BioPorto announces intention to initiate a rights issue with expected gross
proceeds of up to approximately DKK 100.4M, updates on status of The
NGAL Test clinical trials, and announces its financial estimate for 2021 and
guidance for 2022
December 31,
2021
24
Grant of warrants
November 19,
2021
23
In an effort to prioritize Emergency Use Authorizations (EUA), the FDA does
not recommend that BioPorto pursue an EUA for its NGAL assay for the
prediction of renal replacement therapy in COVID-19 patients
November 19,
2021
22
New composition of the management board of BioPorto A/S
November 17,
2021
21
BioPorto Announces Q3 2021 Report
Date
No.
Description
November 15,
2021
20
BioPorto A/S - Extraordinary General Meeting, New Board Member
November 3,
2021
19
Update on Patient Enrollment for Pivotal Study of NGAL in Pediatrics
October 22,
2021
18
Notice Convening the Extraordinary General Meeting
October 20,
2021
17
BioPorto A/S appoints new Chief Financial Officer
October 20,
2021
16
BioPorto A/S appoints new Chief Executive Officer and announces changes to
the Board of Directors
August 31,
2021
15
BioPorto Successfully Completes Interim Analysis of Data from Pivotal Study
of NGAL in Pediatrics with Encouraging Results
August 18,
2021
14
BioPorto Announces Q2 2021 Report
June 29, 2021
13
Pipeline Update Regarding COVID-19 test
May 27, 2021
12
Managers’ transactions
May 12, 2021
11
BioPorto Announces Q1 2021 Report
May 5, 2021
10
Peter Mørch Eriksen resigns as CEO of BioPorto A/S
April 29, 2021
9
BioPorto A/S – Annual General Meeting
April 26, 2021
8
BioPorto initiates search for new CFO as Ole Larsen resigns
April 8, 2021
7
Annual General Meeting. Amended proposal for election to the Board of
Directors.
April 8, 2021
6
Increase in share capital following exercise of warrants – Notice of changes
in share capital and voting rights pursuant to section 32 of the Danish
Capital Markets Act
April 6, 2021
5
Notice Convening the Annual General Meeting
March 17,
2021
4
BioPorto Announces the 2020 Annual Report
March 3, 2021
3
Pipeline Update from BioPorto
February 10,
2021
2
Incentive Warrants
January 21,
2021
1
Manager’s transactions
Corporate information BioPorto 2021
26
Bank
Nordea Bank Danmark A/S
Strandgade 3
DK - 0900 Copenhagen C
Lawyers
Independent accountants
PricewaterhouseCoopers
Statsautoriseret Revisionspartnerselskab
Company information
Locations
Veterinary Diagnostics A/S
BioPorto Inc.
BioPorto Diagnostics Inc.
Tuborg Havnevej 15, ground floor
2900 Hellerup
Denmark
117 Fourth Avenue, Suite 202
Needham, MA 02494
USA
Corporate information BioPorto 2021
27
Board of Directors
Christopher Lindop, Chairman
(M) (1957), Joined board in 2019, Independent
John McDonough, Vice-Chairman
(M) (1959), Joined board in 2021, Independent
Dr. Michael Singer
(M) (1973), Joined board in 2019, Independent
Participation in 15 board meetings in 2021 & participation in
8 committee meetings in 2021
Participation in 11 board meetings in 2021 & participation
in 5 committee meetings in 2021
Participation in 15 board meetings in 2021
& participation in 4 committee meetings in 2021
Qualifications of relevance for BioPorto
Christopher James Lindop became chairman in 2021. Christopher
James Lindop 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.
(HAE). Christopher James Lindop was chief financial officer of Quotient
Limited (QTNT) until his retirement in May 2020. Christopher Lindop
was also a member of the board of directors of Parexel International
(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 U.S. listed health
care 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.
Current directorships in other companies
None
Qualifications of relevance for BioPorto
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 a member of the board of
directors at Solace Therapeutics and Cytrellis Biosystems. He
earned his undergraduate degree in business from Stonehill
College.
Current directorships in other companies
Cytrellis Biosystems, Inc., Chairman of the Board of Directors
Solace Therapeutics, Board member
Qualifications of relevance for BioPorto
Dr. Michael Singer 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.
Current directorships in other companies
Cartesian Therapeutics, Inc., Board member
Pykus Therapeutics, Inc., Board member
Anodyne Nanotech, Inc., Board member
Corporate information BioPorto 2021
28
Jan Leth Christensen
(M) (1963), Joined board in 2021, Independent
Donnie McCoy Hardison Jr.
(M) (1950), Joined board in 2021, Independent
Peter Mørch Eriksen
(M) (1960), Joined board in 2021, Non-independent
Participation in 4 board meetings in 2021 & participation in
0 committee meetings in 2021
Participation in 11 board meetings in 2021 & participation in 3
committee meetings in 2021
Participation in 4 board meetings in 2021 & participation
in 0 committee meetings in 2021
Qualifications of relevance for BioPorto
Jan Leth 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. Jan Leth
Christensen holds a Master’s degree in Law from the University of
Copenhagen.
Current directorships in other companies
Murermester Willy Lynggard Petersens Familiefond, Board member
Rolf Krake Fonden, Board member
Hyldegårdsvej 40 A/S, Chairman of the Board of Directors
WRP-Holding A/S, Board member
K/S Hørsvinget, Board member
Esplanaden Berlin Holding A/S, Board member
Havnen Lersø Parkallé 107 ApS, Chairman of the Board of Directors
Lønberg & Leth Christensen Advokataktieselskab, Board member
Havnens Bygningsudlejning A/S. Chairman of the Board of Directors
W. Lynggard Petersen Holding A/S, Board member
Søborgstræde 2 A/S, Chairman of the Board of Directors
Best Ejendomme A/S, Chairman of the Board of Directors
Advokaternes Ejendomsadministration A/S, Chairman of the Board of
Directors
Qualifications of relevance for BioPorto
Donnie McCoy Hardison Jr. 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 currently serves on the board of
directors of publicly held companies HTG Molecular and MdxHealth
and several privately held companies including Stemina Biomarker
Discovery Inc., YourBio, and Iquity, Inc. He also served on the board of
directors of Exact Sciences Corporation. He received his Bachelor of
Arts in Political Science from the University of North Carolina, Chapel
Hill.
Current directorships in other companies
HTG MOLECULAR, INC., Board member
IQUITY, Board member
MDXHEALTH, Board member
Stemina Biomarker Discovery Inc., Board member
YourBio, Board member
Qualifications of relevance for BioPorto
Peter Mørch Eriksen served as CEO of BioPorto from 2013 – 2021. Peter
Mørch Eriksen 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, 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, member of the Advisory Board at Lund
University Diabetes Centre, member of the Advisory Board at the Medical
Device and Diagnostics Advisory Committee of Cincinnati Children’s
Hospital Center in Cincinnati, Ohio (US) and member of the executive
management in PME Holding ApS.
Current directorships in other companies
Fluo Guide, Chairman of the Board of Directors
Member of the Advisory Board at Lund University Diabetes Centre.
Medical Device and Diagnostics Advisory Committee of Cincinnati
Children’s Hospital Center in Cincinnati, Ohio (US).
MyBlueLabel Compliance Services ApS, Chairman of the Board of Directors
Corporate information BioPorto 2021
29
Executive Management
(M) (1962)
(M) (1967)
Chief Executive Officer
Joined BioPorto as CEO in 2021
Executive Vice President & Chief Financial Officer
Joined BioPorto as EVP & CFO i n 2021
Qualifications of relevance for BioPorto
Anthony Paul Pare has led product development, commercialization,
marketing, operations, and business development in leading medical device
and diagnostic companies for 25 years. Previously, Anthony Paul Pare was the
Chief Commercial Officer (CCO) at T2 Biosystems, a US Nasdaq-listed in vitro
diagnostics company. He held the same role at Hemanext (US), a pre-
commercial company marketing blood transfusion technology. He also held
various leadership roles at Haemonetics (US), specializing in blood processing
and diagnostic technologies. In addition to being CEO of BioPorto, Tony is
actively participating on advisory boards, and mentoring startup medical
technology companies in the Boston (US) area. Anthony Paul Pare holds a
Bachelor of Science in Marine Engineering and a Master’s of Engineering
Administration from George Washington University (US).
Qualifications of relevance for BioPorto
Neil Allan 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. Since 2010, Neil Goldman has been a member of the board of directors
of Ohio Bridge Corp. He is a Certified Public Accountant and received a
Bachelor of Science degree in Business-Accountancy from Miami University
(Ohio).
Current directorships in other companies
None
Current directorships in other companies
Ohio Bridge Corp., Board Member
Corporate information BioPorto 2021
30
Income Statement
The financial review is based on the Group’s consolidated
financial information for the year ended December 31, 2021,
with comparative figures for 2020 in brackets. There is no
significant difference in the development of the Group and
the Parent Company.
In 2021, BioPorto generated revenues of DKK 24.3 million
(DKK 23.2 million). Earnings before interest and taxes (EBIT)
showed a loss of DKK 65.3 million (loss of DKK 63.6 million).
The cash position as of December 31, 2021 amounted to DKK
45.5 million (DKK 107.9 million).
Revenue
Revenue for 2021 was DKK 24.3 million (DKK 23.2 million).
Revenue from The NGAL Test was DKK 12.1 million (DKK 13.4
million) and was composed of DKK 7.6 million (DKK 6.7
million) from RUO sales in the US, DKK 4.5 million (DKK 6.7
million) from sales in the EU and the rest of the world.
Revenue from sale of antibodies amounted to DKK 9.1 million
(DKK 6.8 million).
Revenue from ELISA kits was DKK 2.5 million (DKK 2.5 million).
Revenues from other products, royalties and licenses
amounted to DKK 0.6 million (DKK 0.4 million).
Production costs
Production costs amounted to DKK 9.2 million (DKK 9.9
million) bringing the gross profit for 2021 to DKK 15.0 million
(DKK 13.3 million) and the gross margin to 62% (57%).
The decrease in production costs is primarily related to
reduced spend on consumed goods of DKK 0.8 million.
Sales and marketing costs
Sales and marketing costs totaled DKK 17.4 million (DKK 20.8
million). The decrease in costs is primarily due to reduced
staff related costs of DKK 3.4 million, as warrant- and LTI
programs were reversed subsequent to employee
resignations.
Research and development costs
Research and development costs amounted to DKK 30.3
million (DKK 28.1 million). The increase is mainly due to
increased staff related costs of DKK 1.2 million and an
increase in spend on consumed goods of DKK 1.0 million.
Administrative costs
Administrative expenses were DKK 32.7 million (DKK 28.0
million). In 2021 consultancy costs increased by DKK 5.0
million partly related to the replacement of the CEO and CFO.
The increased costs was partly offset by decreased staff-
related costs of DKK 2.3 million as share-based compensation
expenses were reversed due to employee resignations.
Financial income and expenses
Financial income was DKK 2.5 million and consisted of net
income on exchange rate adjustments of DKK 2.5 million (net
Financial review 2021
Revenue (DKK million)
Revenue by quarter (DKK million)
Revenue by product category (DKK million)
26,6
23,2
24,3
0
5
10
15
20
25
30
2019 2020 2021
5,5
7,8
6,6
6,7
4,2
6,7
4,7
7,6
5,6
6,6
5,3
6,8
0
2
4
6
8
10
Q1 Q2 Q3 Q4
2019 2020 2021
11,6
4,8
9,4
0,8
13,4
2,5
6,8
0,4
12,1
2,5
9,1
0,6
0
2
4
6
8
10
12
14
16
The NGAL test ELISA kits Antibodies Other products
and licenses
2019 2020 2021
Corporate information BioPorto 2021
31
loss of DKK 2.4 million was realized from exchange rate
adjustments).
Financial expenses amounted to DKK 1.0 million (DKK 3.2
million) and consists of interest on leasing liabilities DKK 0.6
million (DKK 0.6 million) and of bank charges and interest.
Tax on income for the year
Tax on income for the year was an income of DKK 6.7 million
(income of DKK 5.3 million) which is primarily related to
refunded tax losses originating from research and
development costs.
Liquidity
As of December 31, 2021, BioPorto had a cash position of DKK
45.5 million (DKK 107.9 million). The Company has primarily
funded cash requirements for 2021 with a combination of
revenue from product sales in 2021 and capital increases
completed in 2020.
Cash flow
Net cash expenditure from operating activities amounted to
DKK 64.6 million (DKK 35.6 million), the increase in
expenditure was primarily driven by changes in working
capital.
Net cash spent on investing activities was DKK 0.4 million
(DKK 1.5 million) mainly following investment in software.
Net cash provided by financing activities totalled DKK 1.1
million (DKK 127.0 million) primarily related to proceeds from
warrant programs exercised partly offset by reduction of
lease obligations.
The net cash flow for 2021 was negative by DKK 63.9 million
(positive by DKK 89.9 million).
Balance Sheet
The balance sheet total was DKK 81.3 million as of December
31, 2021 (DKK 140.3 million).
Assets
Intangible assets in 2021 were DKK 1.0 million (DKK 1.2
million). The decrease is due to the amortization of intangible
assets, partly offset by investments in software.
Fixtures and fittings, tools and equipment totaled DKK 1.9
million (DKK 2.4 million). The increase is primarily due to the
investment in leasehold improvements and lab equipment,
partly off-set by depreciation.
Right-of-use assets have been recognized as of January 1,
2019 as part of implementing IFRS 16. Right-of-use assets
consists of the group leases of office space and vehicles and
total DKK 12.3 million as of December 31, 2021 (DKK 10.3
million). The increase in 2021 consists of an extended office
lease in Hellerup partly offset by depreciations.
Financial assets totaled DKK 1.7 million (DKK 1.6 million) and
consists of deposits in connections to leasing of office space.
The Company has no deferred tax asset on the balance sheet.
As of December 31, 2021, the total writedown of the tax asset
amounted to DKK 76.8 million (DKK 64.7 million). The
Company retains the right to use the tax loss carry forward of
DKK 74.6 million (DKK 63.0 million) and the other tax assets
of net DKK 2.2 million (DKK 1.7 million) that were written
down.
Inventories, net totaled DKK 2.7 million (DKK 3.2 million) of
which finished goods amounted of DKK 2.7 million (DKK 3.3
million), raw materials and consumables amounted of DKK
1.7 million (DKK 1.8 million), offset by reserves of DKK 1.7
million (DKK 1.8 million).
Receivables totaled DKK 16.0 million (DKK 13.7 million), of
which trade receivables, net amounted to DKK 7.2 million
(DKK 6.9 million). The increase is mainly due to higher sales
in December 2021 compared to December 2020 partly offset
EBIT (DKK million)
Cash flows and Cash holdings (DKK million)
-74,3
-63,6
-65,3
-76
-74
-72
-70
-68
-66
-64
-62
-60
-58
2019 2020 2021
-62,2
-37,1
-65,0
18,1
107,9
45,5
-70
-50
-30
-10
10
30
50
70
90
110
2019 2020 2021
Cash flow from operations and investments, net
Cash holdings
Corporate information BioPorto 2021
32
by reductions in the balance of overdue trade receivables.
Income tax receivables totaled DKK 6.3 million (DKK 5.3
million) and other receivables and prepayments DKK 2.5
million (DKK 1.5 million).
As of December 31, 2021, the cash position was DKK 45.5
million (DKK 107.9 million). BioPorto’s cash is primarily
invested in deposit accounts with two Nordic banks and one
U.S bank.
Equity
After the transfer of the loss of the year, equity totaled DKK
46.0 million (DKK 100.9 million).
Liabilities
Non-current liabilities totaled DKK 10.5 million (DKK 8.4
million).
Current liabilities stood at DKK 24.8 million (DKK 30.9 million)
of which trade payables amounted to DKK 4.3 million (DKK
4.6 million) and other payables amounted to DKK 17.5 million
(DKK 23.4 million).
Capital allocation
The capital structure is reviewed continuously with due
consideration for BioPorto’s financial performance and
strategic developments, including in-vestment requirements
and shareholder interests.
The Company continues to anticipate the use of capital to
fund its regulatory activities, commercialization, and product
development activities, as reflected in the company’s outlook
for 2022.
Change of control
The Danish Financial Statements Act, Section 107 a, contains
rules relating to listed companies with respect to certain
disclosures in relation to disclosure of change of control
provisions.
BioPorto has entered into agreements with external parties,
which may be subject to renegotiation in case of a change of
control event in BioPorto. However, detailed information is
not provided here, as it may be restricted from disclosure due
to confidentiality or is not expected to have significant
influence on the Company’s financial position.
Financial statements BioPorto Group 2021
33
Income statement
2021
2020
Note
DKK thousand
DKK thousand
3
Revenue
4,6,14
Production costs
Gross profit
4,6
Sales and marketing costs
4,6
Research and development costs
4,6,7
Administrative costs
Loss before financial items (EBIT)
(65,255 )
(63,590 )
8
Financial income
8
Financial expenses
Loss before tax
(63,840 )
(66,834 )
9
Income taxes
Net loss
(57,113 )
(61,562 )
DKK
DKK
10
Loss per share (EPS & DEPS)
(0.21 )
(0.30 )
Statement of comprehensive income
2021
2020
Note
DKK thousand
DKK thousand
Net loss
(57,113 )
(61,562 )
Other comprehensive income:
Amounts which will be re-classified to the income statement:
Adjustment of foreign currency fluctuations on subsidiaries
(1,219 )
Other comprehensive income
(1,219 )
Comprehensive loss
(58,332 )
(59,790 )
Income statement and statement of comprehensive income
Financial statements BioPorto Group 2021
34
2021
2020
ASSETS
December 31
December 31
Note
DKK thousand
DKK thousand
Non-current assets
Property, plant and equipment and intangible assets
11
Rights and software
12
Fixtures and fittings, tools and equipment
13
Right-of-use assets
Total property, plant and equipment and intangible assets
Financial assets
Deposits
Total financial assets
Total non-current assets
Current assets
14,19
Inventories, net
15,18,19
Trade receivables, net
Income tax receivable
15,18,19
Other receivables
15,19
Prepayments
Total inventories and receivables
18
Cash and cash equivalents
Total current assets
Total assets
2021
2020
LIABILITIES
December 31
December 31
Note
DKK thousand
DKK thousand
Equity
16
Share capital
17
Treasury shares
-
-
Exchange-rate adjustments
(119 )
Retained earnings
(221,671 )
(166,770 )
Total equity
Liabilities
Non-current liabilities
18
Lease obligation
18
Other non-current liabilities
Non-current liabilities
Current liabilities
18
Current portion of non-current liabilities
18,19
Trade payables
Tax payables
18,19
Other payables
Current liabilities
Total liabilities
Total equity and liabilities
Balance sheet
Financial statements BioPorto Group 2021
35
Share capital
Share
premium
Exchange-
rate
adjustments
Retained
earnings
Total
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
Equity January 1, 2021
-
(166,770 )
Loss for the year
-
-
-
(57,113 )
(57,113 )
Other comprehensive income:
Adjustment of foreign currency
fluctuations on subsidiaries
-
-
(1,219 )
-
(1,219 )
Total comprehensive income
(1,219 )
(57,113 )
(58,332 )
Transactions with owners:
Issue
-
-
Issue costs
-
(11 )
-
-
(11 )
Share-based compensation
-
-
-
(966 )
(966 )
Transferred to retained earnings
-
(3,178 )
-
Equity December 31, 2021
(119 )
(221,671 )
Share capital
Share
premium
Exchange-
rate
adjustments
Retained
earnings
Total
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
Equity January 1, 2020
-
(672 )
(148,950 )
Loss for the year
-
-
-
(61,562 )
(61,562 )
Other comprehensive income:
Adjustment of foreign currency
fluctuations on subsidiaries
-
-
-
Total comprehensive income
(61,562 )
(59,790 )
Transactions with owners:
Issue
-
-
Issue costs
-
(16,556 )
-
-
(16,556 )
Share-based compensation
-
-
-
Transferred to retained earnings
-
(38,426 )
-
Equity December 31, 2020
(166,770 )
2021
2020
2019
2018
2017
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
Share capital January 1
266,582
174,944
165,688
155,510
142,494
Issue of new shares
1,172
91,638
9,256
10,178
13,016
Share capital December 31
267,754
266,582
174,944
165,688
155,510
Statement of changes in equity
Financial statements BioPorto Group 2021
36
2021
2020
Note
DKK thousand
DKK thousand
Loss before financial items
(65,255 )
(63,590 )
6
Depreciation and amortization
4
Share-based compensation expenses
(966 )
Other non-cash items
Cash generated from operations before working capital
(61,582 )
(53,365 )
19
Changes in working capital
(7,448 )
Cash generated from operations
(69,030 )
(38,353 )
Financial income, received
Financial expenses, paid
(1,425 )
(2,640 )
Tax refund, net
Cash flows from operating activities
(64,577 )
(35,616 )
12
Purchase of operating equipment
(130 )
(1,315 )
11
Purchase of rights and software
(259 )
(184 )
Purchase of financial assets
(23 )
(22 )
Cash flows from investing activities
(412 )
(1,521 )
Proceeds from warrant programs exercised
20
Issue, gross proceeds
20
Issue costs
(11 )
(16,556 )
Reduction of non-current liabilities
(150 )
(170 )
13
Reduction of lease obligation
(3,099 )
(2,859 )
Cash flows from financing activities
Net cash flow from operating, investing and financing
activities
(63,888 )
Cash and cash equivalents at January 1
Effect of exchange rate changes on cash
(77 )
Cash and cash equivalents at December 31
Cash flow statement
Financial statements BioPorto Group 2021
37
1. Basis of reporting
2. Critical accounting estimates and judgments
3. Business area reporting
4. Staff costs
5. Incentive schemes
6. Amortization and depreciation
7. Fees to auditors appointed by the general meeting
8. Financial income and expenses
9. Deferred tax
10. Earnings per share
11. Rights and software
12. Fixtures and fittings, tools and equipment
13. Right-of-use assets
14. Inventories
15. Receivables
16. Share capital
17. Treasury shares
18. Financial risks and financial instruments
19. Change in working capital
20. Capital increase
21. Commitments and Contingencies
22. Subsequent event
23. Related parties and ownership
Notes - Group
Financial statements BioPorto Group 2021
38
Basis of reporting
Basis of preparation
The financial statements of the BioPorto Group are presented in accordance with the International
Financial Reporting Standards (IFRS) as adopted by the European Union (EU) and additional Danish
disclosure requirements for annual reports of accounting class D (listed) enterprises, cf. the Danish
Statutory Order on Adoption of IFRS issued in pursuance of the Danish Financial Statements Act.
Following December 31, 2021, as discussed in Note 22 – Subsequent event, the Group undertook
to improve its liquidity position:
• On April 1, 2022, the Group raised estimated net proceeds of DKK 93.1 million from the
issuance and sale of 66,938,601 shares of common stock (the Offering) pursuant to a
Prospectus for a Rights offering with pre-emptive rights for existing shareholders (the
Prospectus).
This measure was designed to provide the Group with adequate liquidity to meet its obligations
for at least the twelve-month period following the date of this annual report, and pursuant to the
Prospectus for at least the twelve-month period following the Prospectus date of March 7, 2022.
The assessment as to the adequacy of liquidity relies inter alia on assumptions 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, including the Company’s ongoing clinical trials and planned FDA submission of
The NGAL Test in the U.S all of which under current circumstances remain difficult to predict.
Further, this assessment is subject to the risk factors applicable to the Company. In the event that
any of the risk factors relating to the Company materialize, including if the adverse U.S. clinical
trial environment associated with the outbreak of COVID-19 worsen or persist longer than
expected, the Company's capital resources (including the proceeds from the Offering) may be
significantly and adversely affected to an extent where they are insufficient to meet the
Company's capital requirements considering a twelve-months period after the Prospectus Date.
In such case, the Company will take mitigating actions to seek to protect or further strengthen its
financial position, including reducing costs and potentially by raising further capital, although
there can be no assurance that any such future cost reduction efforts will be successful or that
additional capital will be available to the Company on acceptable terms, or at all.
In the event that the Company’s ongoing R&D, ongoing clinical trials and planned FDA submission
of The NGAL Test in the U.S, and/or commercialization efforts are more positive than expected,
the Company may choose to accelerate projects and/or increase spending, in which case the
Company may be required or may choose to raise additional capital prior to the twelve month
period after the Prospectus Date.
The accompanying consolidated financial statements have been prepared on the basis that the
Group will continue as a going concern, which contemplates continuity of operations, realization
of assets and the satisfaction of liabilities in the normal course of business for the twelve-month
period following the date of the accompanying consolidated financial statements. As such, the
accompanying consolidated financial statements do not include any adjustments relating to the
recoverability and classification of assets and their carrying amounts, or the amount and
classification of liabilities that may result should the Group be unable to continue as a going
concern.
The financial statements are presented in Danish kroner (DKK), which is considered the primary
currency of the Group’s activities and the functional currency of both the parent company and its
most significant subsidiary.
The accounting policies set out below have been used consistently with respect to the financial
year and comparative figures, except as described below regarding changes in accounting policies.
Certain comparative figures have been reclassified to conform to the current year presentation
Applying materiality
Significant items are presented individually in the financial statements as required by IAS 1.
Items that are not individually significant but support the understanding of BioPorto's business
model and performance in the reporting period are also presented in the financial statements.
Currency
The Group's consolidated financial statements are presented in Danish kroner (DKK). Figures are
rounded to the nearest DKK thousand unless otherwise stated.
Basis of consolidation
The consolidated financial statements are prepared as a consolidation of the financial statements
of the Parent Company, BioPor to A/S, and its subsidiaries in accordance with the Group's
accounting policies.
Note 1
Financial statements BioPorto Group 2021
39
All intra-group income, expenses, shareholdings, balances and dividends are eliminated on
consolidation. The accounting items of subsidiaries are included in full in the consolidated financial
statements.
Implementation of new and amended standards and interpretations
All new and amended Standards (IFRS/IAS) and the new Interpretations (IFRIC) issued by IASB and
adopted by EU effective as of January 1, 2021 have been adopted by the BioPorto Group. The
BioPorto Group has adopted the following revised standards and interpretations:
• Amendments to IFRS 9, IAS 39, IFRS 7, and IFRS 16, IBOR-reform phase 2
• Postponement of adoption of IFRS 9
• Amendments to IFRS 16, Covid-19-related rent concessions
The amendments to IFRS standards that became effective on January 1, 2021 did not have a
material impact on the consolidated financial statements of the BioPorto Group.
Standards and interpretations not yet in force
As of the publishing of this Annual Report, several new or modified standards and interpretations
have been issued by the IASB but which are not yet required to be implemented. Therefore, they
have not yet been adopted by the Group and arenot reflected in the consolidated financial
statements. The new or modified standards and interpretations will be implemented when they
become mandatory, and none are presently expected to have a material impact on the
consolidated financial statements of the BioPorto Group.
Translation of foreign currency
A functional currency is determined for each of the Group’s reporting entities. The functional
currency of the Parent Company is Danish kroner (DKK). Transactions denominated in currencies
other than the functional currency are considered transactions denominated in foreign currencies.
On initial recognition, transactions denominated in foreign currencies are translated to the
functional currency at the exchange rates at the transaction date. Differences arising between the
exchange rates at the transaction date and at the date of payment are recognised as financial
income or expenses.
Receivables, payables and other monetary items denominated in foreign currencies are translated
at the exchange rates at the reporting date. The difference between the exchange rates at the
reporting date and at the date at which the receivable or payable arose or the exchange rate in
the latest consolidated finan-cial statements is recognised as financial income or expenses.
Upon recognition in the consolidated financial statements of entities with a functional currency
other than the presentation currency (DKK), the income statement and statement of cash flows
are translated at the exchange rates prevailing at the transaction date, and the statement of
financial position items are translated at the exchange rates prevailing at the reporting date.
Differences arising from the translation of the opening balance of equity of foreign entities at the
exchange rates prevailing at the reporting date, and on translation of the income statement from
the transaction date to the reporting date, are recognised in other comprehensive income and
attributed to a separate transla-tion reserve in equity.
Incentive programs
The company has issued warrants (options) to Management and employees. Share based
incentive programs in which employees only have the option of choosing to subscribe for new
shares in the parent company (equity-settled share-based payment transactions) are measured at
the equity instrument’s fair value on the date of issue and are recognized in the income statement
over the vesting period. The counter entry for this is recognized directly in equity. The fair value
per warrant is specified based on the Black-Scholes equation on the date of issue and is not
adjusted subsequently. Warrants restricted by vesting conditions are forfeited if the vesting
conditions are not met.
Issue costs associated with the exercise of warrants are recognized in equity.
Segment information
The BioPorto Group does not prepare segment reporting internally and therefore only reports one
operating segment externally.
Geographic spilt of revenue and revenue from major customers is disclosed in note 3 to the
consolidated financial statements.
46% of non-current assets are located in Denmark (34% in 2020).
Note 1, continued
Financial statements BioPorto Group 2021
40
Income statement and statement of comprehensive income
Revenue
Revenue from contracts with customers comprises sale of goods, licence fees and royalty income.
Revenue from the sale of goods is recognised at the point in time when control of the goods is
transferred to the customer, which generally takes place on shipment. Contracts generally do not
provide customers with a right of return.
Licence fees and royalty income are recognised when earned according to the terms of the licence
agreements.
Revenue from contracts with customers is measured at an amount that reflects the consideration
to which the Group expects to be entitled in exchange for those goods. Amounts disclosed as net
revenue exclude discounts, VAT and other duties.
The Group considers whether contracts include other promises that constitute separate
performance obligations to which a portion of the transaction price needs to be allocated. In
determining the transaction price, the Group considers the effects of variable consideration. No
element of financing is deemed present.
Discounts generally arise from sales transactions where the customer receives an immediate
reduction in the selling price.
Payment terms are generally net 30 days.
Production costs
Production costs include costs incurred to generate the revenue, including direct and indirect
costs for raw materials and consumables, wages and salaries, freight and packaging material, rent
and leasing and depreciation of production equipment.
Sales and marketing costs
Sales and marketing costs include royalties and costs incurred for the marketing of goods sold
during the year and for sales campaigns, etc. This includes costs related to sales staff, advertising,
exhibitions and depreciation and amortization.
Research and development costs
Research and development costs include wages and salaries, laboratory materials, patent costs,
clinical studies, rent, leasing and other costs relating to the Group's research and development
activities.
Administrative expenses
Administrative expenses include expenses incurred during the year for management and
administration, including expenses for administrative staff, office premises, office expenses and
depreciation.
Financial income and expenses
Financial income and expenses include interest, capital gains and losses and impairment on debt,
securities and transactions in foreign currencies, amortization of financial assets and liabilities,
and additions and remunerations under the Danish tax on account tax scheme, etc.
Income tax
Income tax comprises current tax and changes in deferred tax for the year. The tax expense
associated with current year results is recognized in the income statement, and the tax expense
relating to changes directly recognized in equity or other comprehensive income is recognized in
equity.
To the extent the Group benefits from a deduction in the determination of taxable income due to
share-based compensation, the tax effect of such programs is included in income tax. Any tax
deduction exceeding the accounting cost is recognized directly in equity.
Note 1, continued
Financial statements BioPorto Group 2021
41
Balance sheet
Non-current assets
Development projects
In accordance with IAS 38 Intangible Assets, intangible assets arising from development projects
must be recognized on the balance sheet when the development project is clearly defined and
identifiable, when the technical feasibility has been demonstrated and adequate resources to
complete the development work and market or use the project have been documented, the
project has received FDA clearance and company Management has declared its intention to
manufacture and market or use the product.
Finally, it must be adequately demonstrated that future income from the development project
will exceed the costs of production and development and costs used to sell and administer the
product. Development costs concerning individual projects are only capitalized if there is
adequate documentation that the future income from the individual projects will exceed not only
the production, selling and administrative expenses, but also the actual development costs
relating to the product.
Rights and software
Rights and software are measured at cost less accumulated depreciation and impairment.
The cost comprises the purchase price as well as costs directly related to the purchase until the
date on which the asset is ready for use. In addition, the cost comprises future minimum royalty
payments to which the company is bound, discounted back to present value.
Assets are depreciated on a straight-line basis over their estimated useful lives based on the
following assessment of the expected lives of the assets:
Rights and software; 3 - 10 years
The basis of depreciation is cost less expected residual value at the end of the useful life.
Depreciation methods, useful lives and residual values are reassessed annually.
Depreciation is recognized on the income statement under sales and marketing costs and
administrative expenses.
Fixtures and fittings, tools and equipment
Other plant, operating equipment and fixtures and fittings are measured at cost less accumulated
depreciation and impairment losses. Cost comprises the purchase price and any costs directly
attributable to the acquisition until the date when the asset is ready for use.
Assets are depreciated on a straight-line basis over their estimated useful lives based on the
following assessment of the expected lives of the assets:
Other fixtures and fittings, tools and equipment; 3 - 5 years
The basis of depreciation is cost less expected residual value at the end of the useful life. The cost
of a total asset is split into smaller parts that are depreciated separately if such components have
different useful lives. Depreciation methods, useful lives and residual values are reassessed
annually.
To the extent that depreciation is not reflected in the cost of inventories as production overhead,
depreciation is recognized on the income statement under production costs, sales and marketing
costs, research and development costs and administrative expenses, respectively.
Right-of-use assets
Right-of-use assets are initially measured at the amount equal to the lease liability, adjusted by
the amount of any prepaid or accrued lease payments. Lease liabilities are initially measured as
the net present value of the future lease payments discounted by the incremental borrowing rate.
The right-of-use asset is depreciated over the shorter of the asset's useful life or the lease term
on a straight-line basis.
Depreciation is recognized on the income statement under administrative expenses.
Deferred tax assets
Deferred tax is measured using the balance sheet liability method on temporary differences
between the carrying amount and tax base of assets and liabilities. However, no deferred tax is
recognized on temporary differences regarding non-deductible goodwill or other items for which
temporary differences, with the exception of acquisitions, have arisen at the acquisition date
without affecting either the profit/loss for the year or the taxable income. If the tax base may be
calculated according to several sets of tax regulations, deferred tax is measured in accordance
with the regulations that apply to the use of the asset or settlement of the liability as planned by
Management.
Note 1, continued
Financial statements BioPorto Group 2021
42
Deferred tax assets, including the tax base of tax loss carry-forwards, are recognized under other
non-current assets at the expected value of their utilization, either as an off-set against tax on
future income or as an off-set against deferred tax liabilities within the same legal tax entity or
jurisdiction (joint taxation).
Deferred tax related to elimination of unrealized intra-group profits and losses is adjusted on
consolidation.
Deferred tax is measured based on the tax regulations and rates that, according to the rules in
force at the balance sheet date, will apply at the time the deferred tax is expected to crystallize as
current tax. Changes in deferred tax due to changes in the tax rate are recognized on the income
statement.
Impairment of assets
Deferred tax assets are reviewed annually and recognized to the extent that it is estimated to be
probable that they will be utilized in the foreseeable future.
The carrying amounts of other non-current assets are tested annually to determine whether there
is any indication of impairment. If such an indication exists, the recoverable amount of the asset
is calculated. The recoverable amount is the higher of an asset's fair value less expected costs to
sell and its value in use.
An impairment loss is recognized when the carrying amount of an asset or a cash generating unit
exceeds the recoverable amount of the asset or the cash generating unit. Impairment losses are
recognized in the income statement as production costs, sales and distribution costs or
administrative expenses.
Impairment of assets is reversed to the extent changes have occurred to the assumptions and
estimates leading to the impairment. Impairment is only reversed to the extent the new carrying
amount of an asset does not exceed the carrying amount the asset would have had net of
depreciation, had the asset not been impaired.
Current assets
Inventories
Inventories are measured at the lower of FIFO cost or net realizable value. The cost of raw
materials and consumables comprises the purchase price plus delivery costs. The cost of finished
goods and work in progress comprises the cost of raw materials, consumables, direct labor and
production overheads. Production overhead comprises indirect material and labor costs as well
as costs of maintenance and depreciation of the machinery and equipment used in the
manufacturing process as well as costs of production administration and management.
The net realizable value of inventories is calculated as the selling price less costs of conversion and
costs incurred to execute the sale, and is determined having regard to marketability,
obsolescence, and expected losses.
Receivables
Trade receivables are measured at transaction price less allowance for lifetime expected credit
losses. Trade receivables are grouped based on business area and age to estimate credit losses.
Trade receivables are written off when there is no reasonable expectation of recovery. Allowances
for expected credit losses and write-offs are classified in sales and marketing costs.
Income tax receivables
Current tax receivables are recognized on the balance sheet as calculated tax on the taxable
income for the year, adjusted for tax on prior years’ taxable income and for tax paid under the on-
account tax scheme.
Companies covered by the Danish tax credit scheme (Skattekreditordningen) may obtain payment
of the base of losses originating from research and development expenses subject to a statutory
limit of DKK 25 million.
Prepayments
Prepayments are measured at cost. Prepayments comprise costs incurred relating to subsequent
financial years.
Equity
Treasury shares
Cost and selling prices of treasury shares as well as dividends are recognized directly in equity. A
capital reduction effected by the cancellation of treasury shares will lower the share capital by an
amount equal to the nominal value of the shares.
Issue costs
Issue costs include costs legal fees, placement fees, and other costs associated with the issuing of
new shares.
Note 1, continued
Financial statements BioPorto Group 2021
43
Issue costs incurred during 2021 associated with the rights offering discussed in Note 22 –
Subsequent events are recorded as prepayments
Warrants
Proceeds received from the exercise of warrants are reflected in equity.
Financial liabilities
Lease liabilities
The group leases office space and vehicles. Leases, except for short term assets in which the lease
term is 12 months or less, or low value assets, are recognized as a right-of-use asset and a
corresponding liability at the date at which the leased asset is available for use by the Group.
Short term leases and leases of low value are recognized as an expense on a straight-line basis
over the lease term.
Lease liabilities are initially recognized at the present value of future lease payments. Initial
recognition each lease is assessed individually to determine the probability of exercising any
potential extension options. The option to extend the contract period will be included in the
calculation of the lease liability if it is reasonably certain that the extension option will be
exercised.
Lease costs are accounted for as a single lease component. Variable service components invoiced
separately are expensed as operational costs.
The lease liability is measured using a discount rate equal to the incremental borrowing rate.
If a lease contract is modified, the lease liability is remeasured.
Each lease payment is allocated between the liability and finance cost. The finance cost is
expensed over the lease period to produce a constant periodic rate of interest on the remaining
balance of the liability for each period.
Tax payable
Current tax payables are recognized on the balance sheet as calculated tax on the taxable income
for the year, adjusted for tax on prior years’ taxable income and for tax paid under the on-account
tax scheme.
Other financial liabilities
Debt to banks is recognized at the raising of a loan at fair value less transaction costs. In the
subsequent periods, financial liabilities are measured at amortized cost, applying the “effective
interest rate method”, to the extent that the difference between the proceeds and the nominal
value is recognized on the income statement under financial expenses over the term of the loan.
Other liabilities are measured at amortized cost.
Cash flow statement
The cash flow statement is presented according to the indirect method and cash flows from
operating, investing, and financing activities for the year, the year's changes in cash and cash
equivalents as well as the company's cash and cash equivalents at the beginning and end of the
year.
Cash flows from operating activities are calculated as EBIT adjusted for non-cash operating items,
working capital changes, financial income, financial expenses, establishment cost (subsidiaries),
and income taxes paid.
Cash flows for investing activities comprise acquisitions and disposals of intangible assets,
property, plant and equipment and financial assets.
Cash flows from financing activities comprise changes in the size or composition of the share
capital of BioPorto A /S and related costs as well as the raising of loans, repayment of interest-
bearing debt and payment of dividends to shareholders.
Cash and cash equivalents comprise cash at bank and in hand.
Note 1, continued
Financial statements BioPorto Group 2021
44
Financial ratios
Earnings per share (EPS) and diluted earnings per share (DEPS) are calculated in accordance with
IAS 33.
Financial ratios have been calculated in accordance with the guidelines from the Danish Society
of Financial Analysts. See also “Non-IFRS financial measures”.
The ratios listed in the key figures and ratios section were calculated as follows:
Revenue growth
(Revenue year 1 - Revenue year 0) x 100
Revenue year 0
Gross margin
Gross profit x 100
Net revenue
Equity ratio
Equity, closing x 100
Total liabilities, closing
Earnings
Result for the year
per share (EPS)
Average number of shares
Net asset value per
Capital and reserves, closing
share at year end
No. of shares, closing
Note 1, continued
Financial statements BioPorto Group 2021
45
Critical accounting estimates and judgments
The calculation of the carrying amounts of certain assets and liabilities requires an estimate of
how future events will affect the value of such assets and liabilities at the balance sheet date.
Estimates material to the financial reporting are made in the calculation of, inter alia,
development costs, incentive schemes, inventories, accounts receivable, and deferred taxes.
The estimates made are based on assumptions that Management finds reasonable given the
circumstances, but which are inherently uncertain and unpredictable. The assumptions may be
incomplete or imprecise and unexpected events or circumstances may arise. In addition, the
company is subject to risks and uncertainties that may cause actual results to deviate from the
estimates. Special risks to BioPorto are described in the Management’s review.
Development projects
In the opinion of Management, the development of the Group's products generally involves a high
degree of risk, and therefore there is currently no adequate documentation for the future income.
The future economic benefits from the product development cannot be estimated with sufficient
certainty until the associated development activities have been completed and received
applicable regulatory clearances. Accordingly, development costs are expensed as incurred.
Tax assets
The Group has a significant deferred tax asset (see Note 9). However, Management has concluded
in accordance with IFRS, that it is not sufficiently probable that the tax asset could be utilized in
the foreseeable future. Management has therefore not recognized the calculated tax asset on the
balance sheet.
Business area reporting
GEOGRAPHIC DISTRIBUTION
2021
2020
DKK thousand
DKK thousand
Europe
7,708
10,016
North America
13,451
10,374
Asia
3,065
2,806
Other countries
30
8
Revenue
24,254
23,204
Geographic distribution is based on the customer's registered office.
PRODUCT GROUPS
2021
2020
DKK thousand
DKK thousand
NGAL Revenue:
Product sales
12,092
13,430
Total NGAL revenue
12,092
13,430
Other products and licenses:
ELISA kits
2,495
2,541
Antibodies
9,096
6,791
Royalty
63
19
Other products and licenses
508
423
Total other products and license revenue
12,162
9,774
Revenue
24,254
23,204
Product groups are defined as sale of goods, royalties, and licenses. One customer was responsible for more than
10% of BioPorto’s revenue in 2021: The customer is based in Europe and represented sales of DKK 3,197 thousand in
2021. The customer primarily purchases NGAL kits. One customer was responsible for more than 10% of BioPorto’s
revenue in 2020. The customer is based in Europe and represented sales of DKK 2,391 thousand in 2020. The customer
primarily purchases NGAL kits. Of total net revenue, 55% was invoiced to customers based in North America (2020:
45%) and 32% to customers based in Europe (2020: 43%).
Note 2
Note 3
Financial statements BioPorto Group 2021
46
Staff costs
2021
2020
DKK thousand
DKK thousand
Wages and salaries
40,378
39,266
Defined contribution pension plans
2,455
2,179
Share-based compensation expenses
(966)
5,316
Other social security costs
1,798
1,538
Other staff costs
659
498
Staff costs
44,324
48,797
Average number of employees
SPECIFICATION OF STAFF COSTS
2021
2020
DKK thousand
DKK thousand
Production costs
2,904
3,466
Sales and marketing costs
12,298
15,536
Research and development costs
12,950
12,238
Administrative expenses
16,172
17,557
Staff costs
44,324
48,797
REMUNERATION FOR KEY MANAGEMENT PERSONNEL
2021
2020
DKK
thousand
DKK
thousand
Board of Directors
Remuneration
1,915
1.708
Board of Directors, Total
1,915
1.708
Executive Management
(1)
Salary
4,093
3,268
Bonus
(2)
1,873
1,020
LTI bonus
(1,398)
609
Contribution based pension
591
554
Other employee benefits
297
156
Remuneration, total
5,456
5,607
Share-based compensation expenses
(1,230)
1,430
Executive Management, Total
4,226
7,037
Other Corporate Management
Salary
11,208
10,203
Bonus
3,690
3,583
LTI bonus
(699)
304
Contribution based pension
658
530
Other employee benefits
568
561
Remuneration, total
15,425
15,181
Share-based compensation expenses
(45)
3,424
Other Corporate Management, Total
15,380
18,605
Remuneration for key management personnel
21,521
27,350
(1)
The remuneration for Executive Management is further described in the Remuneration Report for 2021.
(2)
Bonus consists of annual cash bonus, stay-on bonus for the former member of Executive Management, and sign-
on bonus for new member of the Executive Management.
Note 4
Financial statements BioPorto Group 2021
47
Incentive schemes
For the purpose of motivating and retaining Management and key staff and aligning their interests
with those of its shareholders, BioPorto A/S uses warrants as an incentive scheme. The
arrangements, which are exercised by the issuance of new shares (equity-settled share-based
payment transaction), entitle the recipient to subscribe for new shares in the parent company at
a price defined on the date of grant.
Share-based compensation expense totaled income of DKK 1.0 million (2020: expense of DKK 5.3
million) due to forfeited warrants associated with employee resignations during 2021.
The warrant terms are included in the company’s Articles of Association, which can be found at
www.bioporto.com.
In 2021 the Board of Directors in BioPorto used its authorization and issued 12,500,000 warrants.
Upon vesting, each warrant entitles the recipient to subscribe for one share in BioPorto A/S.
Overview of exercise periods
April 2016
April 8, 2018 to April 7, 2021
June 2018
June 15, 2021 to June 14, 2023
August 2018
August 20, 2021 to August 19, 2023
December 2018
December 20, 2021 to December 19, 2023
April 2019
April 16, 2021 to April 15, 2024
August 2019
August 16, 2021 to August 15, 2024
December 2019
December 30, 2021 to December 29, 2024
May 2020
May 11, 2022 to May 10, 2025
February 2021
February 11, 2023 to February 10, 2026
December 2021
December 28, 2022 to September 28, 2026
Note 5
Financial statements BioPorto Group 2021
48
Overview of outstanding warrants on December 31, 2021
Warrants overview 2021
Outstanding at
January 1
Granted
Exercised
Expired
Forfeited
Reclassified
Outstanding at
December 31
Exercisable at
December 31
April 2016
2,432,500
-
(1,172,500)
(1,260,000)
-
-
-
-
June 2018
900,000
-
-
-
(900,000)
-
-
-
August 2018
4,100,000
-
-
-
(2,000,000)
-
2,100,000
-
December 2018
2,500,000
-
-
-
(700,000)
-
1,800,000
-
April 2019
5,100,000
-
-
-
(3,750,000)
-
1,350,000
-
August 2019
1,250,000
-
-
-
-
-
1,250,000
1,250,000
December 2019
250,000
-
-
-
-
-
250,000
250,000
May 2020
2,150,000
-
-
-
(800,000)
-
1,350,000
-
Feb 2021
-
350,000
-
-
-
-
350,000
-
Dec 2021
-
12,150,000
-
-
-
-
12,150,000
-
Total
18,682,500
12,500,000
(1,172,500)
(1,260,000)
(8,150,000)
-
20,600,000
1,500,000
Outstanding at
January 1
Granted
Exercised
Expired
Forfeited
Reclassified
Outstanding at
December 31
Exercisable at
December 31
Executive Management
5,760,000
8,400,000
-
(910,000)
-
(4,850,000)
8,400,000
-
Management
9,850,000
3,450,000
-
-
(7,850,000)
250,000
5,700,000
1,250,000
Other employees
3,072,500
650,000
(1,172,500)
(350,000)
(300,000)
4,600,000
6,500,000
250,000
Total
18,682,500
12,500,000
(1,172,500)
(1,260,000)
(8,150,000)
-
20,600,000
1,500,000
Reclassified represents warrants held by employees for whom their classification changed during the year.
Note 5, continued
Financial statements BioPorto Group 2021
49
Overview of outstanding warrants on December 31, 2020
Warrants overview 2020
Outstanding at
January 1
Granted
Exercised
Expired
Forfeited
Reclassified
Outstanding at
December 31
Exercisable at
December 31
April 2016
2,432,500
-
-
-
-
-
2,432,500
2,432,500
June 2018
900,000
-
-
-
-
-
900,000
-
August 2018
4,100,000
-
-
-
-
-
4,100,000
-
December 2018
2,500,000
-
-
-
-
-
2,500,000
-
April 2019
5,100,000
-
-
-
-
-
5,100,000
-
August 2019
1,250,000
-
-
-
-
-
1,250,000
-
December 2019
250,000
-
-
-
-
-
250,000
-
May 2020
-
2,150,000
-
-
-
-
2,150,000
Total
16,532,500
2,150,000
-
-
-
-
18,682,500
2,432,500
Outstanding at
January 1
Granted
Exercised
Expired
Forfeited
Reclassified
Outstanding at
December 31
Exercisable at
December 31
Executive Management
5,760,000
-
-
-
-
5,760,000
910,000
Management
8,350,000
1,500,000
-
-
-
-
9,850,000
-
Other employees
2,422,500
650,000
-
-
-
-
3,072,500
1,522,500
Total
16,532,500
2,150,000
-
-
-
-
18,682,500
2,432,500
Specification of parameters for Black- Scholes model
Specification of parameters for Black-Scholes
model
Apr 2016
(1)
Jun 2018
Aug 2018
Dec 2018
Apr 2019
Aug 2019
Dec 2019
May 2020
Feb 2021
Dec 2021
Exercise price (DKK)
3.72
2.05
2.28
2.47
2.54
1.70
1.67
1.48
6.11
2.47
Expected volatility rate
59.8%
37.6%
37.3%
50.1%
47.3%
47.2%
50.1%
63.5%
61.8%
72.1%
Expected vesting period (months)
24
36
36
24
24
24
24
24
24
12-48
Expected dividend per share
-
-
-
-
-
-
-
-
-
-
Risk-free interest rate p.a.
-0.429%
-0.556%
-0.578%
-0.514%
-0.604%
-0.87%
-0.69%
-0.60%
-0.58%
-0.58%
Fair value at grant (DKK thousand)
7,509
575
2,868
2,561
5,151
1,102
197
2,005
715
12,231
(1)
Part of the warrant program was exercised on April 8, 2021. The traded share price at the exercise date was DKK 5.42.
Note 5, continued
Financial statements BioPorto Group 2021
50
Amortization and depreciation
RIGHTS AND SOFTWARE
2021
2020
DKK thousand
DKK thousand
Intangible assets
335
294
Total amortization
335
294
Specification of amortization:
Production costs
40
-
Sales and marketing costs
139
201
Research and development costs
40
-
Administrative expenses
116
93
Total amortization
335
294
PROPERTY, PLANT AND EQUIPMENT
2021
2020
DKK thousand
DKK thousand
Property, plant and equipment
719
568
Total depreciation
719
568
Specification of depreciation:
Production costs
114
113
Sales and marketing costs
163
108
Research and development costs
369
305
Administrative expenses
73
42
Total depreciation
719
568
RIGHT-OF-USE ASSETS
2021
2020
DKK thousand
DKK thousand
Right-of-use, assets
3,275
3,132
Total depreciation
3,275
3,132
Specification of depreciation:
Sales and marketing costs
1,447
1,389
Administrative expenses
1,828
1,743
Total depreciation
3,275
3,132
Note 6
Financial statements BioPorto Group 2021
51
Fees to auditors appointed by the general meeting
2021
2020
DKK thousand
DKK thousand
Fees to auditors appointed by the general meeting
831
1,472
Breakdown of fees:
Fees for statutory audit
589
548
Total audit fees
589
548
Other assurance engagements
-
15
Tax advisory services
200
524
Other services
42
385
Total non-audit fee
242
924
Total fees to auditors appointed by the general meeting
831
1,472
Fees for services in addition to the statutory audit of the financial statements which were provided
by the statutory auditor PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab
amounted to DKK 0.2 million (2020: DKK 0.5 million). Non-audit services in addition to the statutory
audit of the financial statements comprise services relating to tax compliance, other assurance
opinions as well as other general accounting consultancy services. In 2020 non-audit services also
included services relating to the rights issue completed.
Financial income and expenses
FINANCIAL INCOME
2021
2020
DKK thousand
DKK thousand
Interest income from bank
-
4
Interest income from financial assets measured at amortized cost
-
4
Exchange rate adjustments, net
2,461
-
Total financial income
2,461
4
FINANCIAL EXPENSES
2021
2020
DKK thousand
DKK thousand
Interest expenses, other debt
284
166
Interest expenses, leasing debt
628
614
Interest expenses on financial liabilities measured at amortized cost
912
780
Exchange rate adjustments, net
-
2,403
Other financial expenses
134
65
Total financial expenses
1,046
3,248
Note 7
Note 8
Financial statements BioPorto Group 2021
52
Deferred tax
The Group has a significant deferred tax asset. However, Management has found that, regarding
IFRS, it is not sufficiently probable that the tax asset can be utilized in the foreseeable future.
Management has therefore decided not to recognize the calculated tax asset on the balance sheet,
cf. Note 2. The tax asset is of indefinite duration.
2021
2020
DKK thousand
DKK thousand
Calculated tax asset
76,769
64,661
Writedown to assessed value
(76,769)
(64,661)
Carrying amount
-
-
DEFERRED TAX ASSETS NOT RECOGNISED IN THE BALANCE SHEET
2021
2020
DKK thousand
DKK thousand
Intangible assets
751
678
Property, plant and equipment
1,026
907
Right-of-use assets
(1,012)
(350)
Current assets
416
92
Leasing liabilities
1,024
371
Tax loss carryforwards
74,564
62,963
Deferred tax at December 31, net
76,769
64,661
INCOME TAX BENEFITS
2021
2020
DKK thousand
DKK thousand
Net result before tax
(63,840)
(66,834)
Computed, 22%
(14,045)
(14,703)
Valuation allowance
12,108
9,618
Income/expenses not taxable/deductible for tax purposes
(2,463)
(435)
Non-recognized deferred tax assets on current year losses in foreign
subsidiaries
-
224
Tax foreign subsidiaries
(365)
-
Adjustment of tax from previous years
(1,962)
24
Total income taxes
(6,727)
(5,272)
In accordance with the Danish tax credit scheme (Skattekreditordningen) BioPorto is eligible to
receive DKK 5,500 thousand (2020: DKK 5,299 thousand) in cash relating to the surrendered tax
loss for 2021 of DKK 25,000 thousand (2020: DKK 24,084 thousand) based on qualifying research
and development expenses.
Note 9
Financial statements BioPorto Group 2021
53
Earnings per share
2021
2020
DKK thousand
DKK thousand
Loss for the period
(57,113)
(61,562)
BioPorto Group's share of loss
(57,113)
(61,562)
Average number of shares
267,436
205,391
Average number of treasury shares
(13)
(13)
Average number of shares in circulation
267,423
205,378
Diluted average number of shares in circulation
267,423
205,378
Earnings per share (EPS)
(0.21)
(0.30)
There is no difference between earnings per share (EPS) and diluted earnings per share (DEPS)
because the company incurred a loss for the year. The warrants are not included in the calculation
of earnings per share (EPS) or diluted earnings per share (DEPS).
Note 10
Financial statements BioPorto Group 2021
54
Rights and software
2021
2020
DKK thousand
DKK thousand
Cost at January 1
2,773
2,589
Additions during the year
259
184
Transfer
(27)
-
Cost at December 31
3,005
2,773
Amortization at January 1
1,621
1,327
Amortization during the year
335
294
Amortization at December 31
1,956
1,621
Carrying amount at December 31
1,049
1,152
Fixtures and fittings, tools and equipment
2021
2020
DKK thousand
DKK thousand
Cost at January 1
5,411
4,110
Transfer
27
-
Additions during the year
130
1,315
Disposals during the year
(14)
-
Currency adjustments
67
(14)
Cost at December 31
5,621
5,411
Depreciation at January 1
2,963
2,400
Depreciation during the year
719
568
Currency adjustments
14
(5)
Depreciation at December 31
3,696
2,963
Carrying amount at December 31
1,925
2,448
Note 11
Note 12
Financial statements BioPorto Group 2021
55
Right-of-use assets
2021
2020
DKK thousand
DKK thousand
Cost at January 1
15,083
5,639
Additions during the year
5,018
9,856
Disposals during the year
(1,602)
(326)
Currency adjustments
856
(86)
Cost at December 31
19,355
15,083
Depreciation at January 1
4,822
2,102
Depreciation during the year
3,275
3,132
Disposals during the year
(1,303)
(283)
Currency adjustments
216
(129)
Depreciation at December 31
7,010
4,822
Carrying amount at December 31
12,345
10,261
LEASE LIABILITIES
2021
2020
DKK thousand
DKK thousand
Current
2,834
2,687
Non-current
10,200
7,992
Lease liabilities at December 31
13,034
10,679
2021
Less than
1 year
Between
1 and 5 years
More than
5 years
Total
DKK thousand
DKK thousand
DKK thousand
DKK thousand
Lease obligations
2,834
9,562
638
13,034
Total
2,834
9,562
638
13,034
2020
Less than
1 year
Between
1 and 5 years
More than
5 years
Total
DKK thousand
DKK thousand
DKK thousand
DKK thousand
Lease obligations
2,687
5,704
2,288
10,679
Total
2,687
5,704
2,288
10,679
AMOUNTS RECOGNIZED IN STATEMENT OF COMPREHENSIVE INCOME
2021
2020
DKK thousand
DKK thousand
Depreciation charge of right-of-use assets
3,275
3,132
Interest expense (included in financial expenses)
628
614
Expense related to short-term leases
7
67
Carrying amount at December 31
3,910
3,813
BioPorto has had no low-value lease contracts in 2021 or 2020.
The total cash outflow for leases in 2021 was DKK 3,032 thousand (2020: DKK 2,859 thousand).
Lease terms are negotiated on an individual basis and contain a wide range of different terms and
conditions. The lease agreements do not impose any covenants other than the security interests in
the leased assets that are held by the lessor. Leased assets may not be used as security for
borrowing purposes.
Note 13
Financial statements BioPorto Group 2021
56
Inventories
2021
2020
DKK thousand
DKK thousand
Finished goods
2,690
3,254
Raw materials and consumables
1,702
1,754
Reserves
(1,674)
(1,843)
Inventories, net
2,718
3,165
Write downs recognized as an expense in the year
548
474
Cost of sales included in production costs
2,650
3,514
All product groups have been individually assessed in terms of historical marketability and future
sales potential. Inventories have been written down to the extent it is estimated that the product
group will not contribute substantially to the company's future revenue. Inventories estimated to
be non-marketable within the next two years are written off and recognized in Production costs.
The cost of inventories are recognized as Research and development costs in the period when they
are identified as being expected to be used in R&D activities.
Receivables
2021
2020
DKK thousand
DKK thousand
Trade receivables
8,076
7,306
Other receivables
738
577
Prepayments
1,769
930
Provision for bad debts
(899)
(420)
Total receivables
9,684
8,393
For receivables that mature within one year after the end of the financial year, the nominal value
is considered to correspond to the fair value.
A provision for bad debts is recognized to reduce the carrying amount of trade receivables by the
value which is impaired due to risk of loss.
An overview of trade receivables is included in Note 18.
Note 14
Note 15
Financial statements BioPorto Group 2021
57
Share capital
2021
2020
NUMBER OF SHARES
Number
Number
January 1
266,581,904
174,944,375
Issue
1,172,500
91,637,529
December 31
267,754,404
266,581,904
Number of
Nominal value
Share price
CAPITAL INCREASES IN 2021
shares
DKK
DKK/share
Warrant exercise
1,172,500
1.00
3.72
Number of
Nominal value
Share price
CAPITAL INCREASES IN 2020
shares
DKK
DKK/share
Rights issue
24,992,053
1.00
1.60
Rights issue
66,645,476
1.00
1.60
The share capital consists of 267,754,404 shares of DKK 1.00 each. The share capital has been paid
up in full. The shares have not been divided into classes and carry no special rights.
Treasury shares
2021
2020
NOMINAL VALUE
DKK thousand
DKK thousand
January 1
13
13
December 31
13
13
NUMBER
No.
No.
January 1
13,000
13,000
December 31
13,000
13,000
% OF SHARE CAPITAL
%
%
January 1
0.00%
0.01%
December 31
0.00%
0.00%
At present, BioPorto A/S is not authorized to acquire treasury shares.
BioPorto A/S did not acquire treasury shares in 2021 or 2020.
Note 16
Note 17
Financial statements BioPorto Group 2021
58
Financial risks and financial instruments
FINANCIAL INSTRUMENT CATEGORIES
2021
2020
DKK thousand
DKK thousand
Trade receivables
7,177
6,886
Other receivables
738
577
Cash and cash equivalents
45,523
107,943
Financial assets at amortized cost
53,438
115,406
2021
2020
DKK thousand
DKK thousand
Lease liabilities
13,034
10,679
Other non-current liabilities
442
593
Trade payables
4,260
4,636
Financial liabilities at amortized cost
17,736
15,908
Financial liabilities
Liabilities under trade payables generally fall due within one year after the end of the financial year.
Their carrying amount is assumed to equal the fair value.
Financial risks
Currency risk
The Group’s presentation currency is DKK, but part of its activities are denominated in other
currencies than DKK, primarily USD and EUR.
The Group is primarily exposed to currency risks through sales and production- or R&D contracts
denominated in currencies other than Danish kroner.
Based on its transaction volume, the company has concluded that it is not feasible 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.
Currency
Exchange rate
as of December
31
2021
2020
DKK thousand
DKK thousand
Trade receivables settled in
EUR
7.44
4,553
5,185
Sensitivity to change in exchange
rates
1.00%
0.07
46
52
Trade receivables settled in
USD
6.56
3,251
1,175
Sensitivity to change in exchange
rates
10.00%
0.66
325
118
Interest rate risk
The Group's exposure to interest rate risk is considered to be limited. The Group’s interest bearing
assets consisted of bank deposits totalling DKK 45.5 million (2020: 107.9 million) at the end of the
financial year.
Currency
Effective rate
2021
2020
of interest
DKK thousand
DKK thousand
Floating-rate deposits
DKK
-0.5% to 0.5%
45,523
107,943
Sensitivity to change in interest rates
0.01
767
630
Note 18
Financial statements BioPorto Group 2021
59
Credit risk
The Group’s credit risk is primarily associated with trade receivables. Cash and cash equivalents are
deposited with major Danish and U.S. banks. The financial situation and ability of customers to pay
trade receivables are regularly evaluated, with payment upon placement of an order required if
ability-to-pay is evaluated to be low. Expected credit losses are estimated by grouping trade
receivables by customer type and days past due. An estimated loss percentage is calculated based
on historical credit losses. Trade receivables are written off when there is no reasonable
expectation of recovery.
2021
Expected credit
loss rate
Trade
receivables
Expected loss
Total
DKK thousand
DKK thousand
DKK thousand
Not due
0.8%
2,941
24
2,917
1-30 days overdue
0.9%
1,626
14
1,612
31-60 days overdue
1.3%
472
6
466
61-90 days overdue
4.1%
291
12
279
More than 90 days overdue
30.7%
2,746
843
1,903
December 31, 2021
8,076
899
7,177
The majority of the ‘More than 90 days overdue’ are receivables from distributors, where the credit
risk is considered lower.
2020
Expected credit
loss rate
Trade
receivables
Expected loss
Total
DKK thousand
DKK thousand
DKK thousand
Not due
0.9%
5,361
48
5,313
1-30 days overdue
3.4%
201
7
194
31-60 days overdue
2.4%
696
17
679
61-90 days overdue
2.0%
327
6
321
More than 90 days overdue
47.5%
720
341
379
December 31, 2020
7,305
419
6,886
BioPorto has recognized a bad debt provision of DKK 0.9 million (DKK 0.4 million in 2020) based on
the simplified expected credit loss model.
Liquidity risk
In connection with BioPorto’s ongoing financing of operations, efforts are made to ensure sufficient
financial resources are available . As of December 31, 2021, BioPorto’s cash and cash equivalents
amounted to DKK 45.5 million (2020: DKK 107.9 million).
Provided that the presented guidance for 2022 is achieved and with the financing completed in
March 2022 the liquid assets and capital resources are deemed sufficient for completing collecting
the additional data and submitting the application for the FDA clearance of The NGAL Test in
pediatrics in 2022 and preparing for commercialization of The NGAL Test in the US market.
Flexibility is guaranteed by placing free funds in deposits.
Maturities for financial liabilities are presented below by the time intervals applied in the Group’s
cash management. The amounts listed represent the amounts falling due including interest, etc.
Capital structure
Management regularly assesses whether the Group’s capital structure properly serves the interests
of the Group and its shareholders.
Note 18, continued
Financial statements BioPorto Group 2021
60
Financial risks and financial instruments
2021
Less than
1 year
Between
1 and 5 years
More than
5 years
Total
DKK thousand
DKK thousand
DKK thousand
DKK thousand
Lease obligations
3,539
10,727
646
14,912
Other non-current liabilities
141
301
-
442
Trade payables and other payables
21,731
-
-
21,731
Financial liabilities
25,411
11,028
646
37,085
2020
Less than
1 year
Between
1 and 5 years
More than
5 years
Total
DKK thousand
DKK thousand
DKK thousand
DKK thousand
Lease obligations
3,243
6,973
2,386
12,602
Other non-current liabilities
141
452
-
593
Trade payables and other payables
28,025
-
-
28,025
Financial liabilities
31,409
7,425
2,386
41,220
Change in working capital
2021
2020
DKK thousand
DKK thousand
Change in inventories
616
565
Change in receivables
(1,770)
(1,104)
Change trade payables
(376)
1,399
Change in other payables
(5,918)
14,152
Total change in working capital
(7,448)
15,012
Note 18, continued
Note 19
Financial statements BioPorto Group 2021
61
Capital increase
2021
2020
DKK thousand
DKK thousand
Issue, gross proceeds
4,361
146,620
Issue costs
(11)
(16,556)
Net proceeds
4,350
130,064
The gross proceeds in 2021 relates to exercised warrants. See Note 22 – Subsequent event.
Commitments and Contingencies
The Company has a 401(k) plan established for its US-based employees whereby it makes a non-
elective safe harbor contribution of 3% of eligible earnings. Contribution expenses totaled DKK 272
thousand for the year ended December 31, 2021 (2020: DKK 207 thousand).
All of the Company’s existing and proposed diagnostic products are regulated by the FDA and
similar regulatory bodies in other countries and/or regions. Most aspects of development,
production and marketing, including product testing, authorizations to market, labeling,
promotion, manufacturing and record keeping, are subject to regulatory review.
After marketing approval has been granted, the Company must continue to comply with
governmental regulations. Failure to comply with applicable requirements can lead to sanctions,
including withdrawal of products from the market, recalls, refusal to authorize government
contracts, product seizures, civil money penalties, injunctions, and criminal prosecution.
From time to time the Company may become involved in legal proceedings or may be subject to
claims arising in the ordinary course of its business. Although the results of litigation and claims
cannot be predicted with certainty, the Company currently believes that the final outcome of these
ordinary course matters will not have a material adverse effect on its business, operating results,
financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impact
on the Company because of defense and settlement costs, diversion of management resources,
and other factors.
Note 20
Note 21
Financial statements BioPorto Group 2021
62
Subsequent event
On April 1, 2022, the Group raised gross proceeds of approximately DKK 100.4 million, with
estimated net proceeds of DKK 93.1 million from the issuance and sale of 66,938,601 shares of
common stock.
Related parties and ownership
BioPorto - The Group's related parties are:
Board of Directors and Executive Management
Christopher Lindop, Chairman (elected August 15, 2019)
John NcDonough (elected April 29, 2021)
Dr. Michael Singer (elected August 15, 2019)
Jan Leth Cristensen (elected April 29, 2021)
Don Hardison (elected April 29, 2021)
Peter Mørch Eriksen (elected November 15, 2021)
Anthony Paul Pare, CEO (appointed November 20, 2021)
Neil Allan Goldman, Executive Vice President & Chief Financial Officer (appointed November 20,
2021)
Group-owned companies
BioPorto Diagnostics A/S, 2900 Hellerup, Denmark. Ownership: 100%
BioPorto Diagnostics Inc, Needham, Massachusetts , USA. Ownership: 100%
BioPorto Inc, Needham, Massachusetts, USA. Ownership: 100%
Veterinary Diagnostics A/S, 2900 Hellerup, Denmark. Ownership: 100%
Related party transactions
Other than Management remuneration, there have been no transactions with related parties
during 2021.
Note 22
Note 23
Financial statements BioPorto A/S 2021
63
2021
2020
Note
DKK thousand
DKK thousand
2
Revenue
9,600
9,600
Gross profit
9,600
9,600
3
Sales and marketing cost
912
4,130
3,4
Administrative expense
29,312
26,943
Loss before financial items (EBIT)
(20,624)
(21,473)
5
Loss from investments in subsidiaries
(51,990)
(43,638)
6
Financial income
15,252
8,363
6
Financial expenses
385
5,873
Loss before tax
(57,747)
(62,621)
7
Income taxes
634
1,059
Net loss
(57,113)
(61,562)
Income statement
Financial statements BioPorto A/S 2021
64
2021
2020
ASSETS
December 31
December 31
Note
DKK thousand
DKK thousand
Non-current assets
Financial assets
Fixtures and fittings, tools and equipment
-
14
Right-of-use assets
4,600
1,590
5
Investments in subsidiaries
973
22
Receivables from subsidiaries
64,814
46,714
Deposits
819
796
Total financial assets
71,206
49,136
Total non-current assets
71,206
49,136
Current assets
Income tax receivables
5,500
5,299
Prepayments
971
137
Total receivables
6,471
5,436
Cash
34,624
98,909
Total current assets
41,095
104,345
Total assets
112,301
153,481
2021
2020
EQUITY AND LIABILITIES
December 31
December 31
Note
DKK thousand
DKK thousand
Equity
Share capital
267,754
266,582
Exchange rate adjustments
(119)
1,100
Retained profit/loss
(221,671)
(166,770)
Total equity
45,964
100,912
Provisions
Investments in subsidiaries with negative equity
52,694
37,789
Total provisions
52,694
37,789
Liabilities
Non-current liabilities
Lease obligation
3,094
255
Non-current liabilities
3,094
255
Current liabilities
Current portion of non-current liabilities
1,560
1,432
Trade payables
2,039
835
Payables to subsidiaries
21
62
Other payables
6,929
12,196
Current liabilities
10,549
14,525
Total liabilities
13,643
14,780
Total equity and liabilities
112,301
153,481
Balance sheet
Financial statements BioPorto A/S 2021
65
Share
capital
Share
premium
Exchange
rate
adjustment
Retained
earnings
Total
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
Equity January 1, 2021
266,582
-
1,100
(166,770)
100,912
Comprehensive income
Loss for the year
-
-
-
(57,113)
(57,113)
Adjustment of foreign currency
fluctuations on subsidiaries
-
-
(1,219)
-
(1,219)
Transactions with owners
Issue
1,172
3,189
-
-
4,361
Issue costs
-
(11)
-
-
(11)
Share-based compensation
-
-
-
(966)
(966)
Transferred to Retained earnings
-
(3,178)
-
3,178
-
Equity December 31, 2021
267,754
-
(119)
(221,671)
45,964
Share
capital
Share
premium
Exchange
rate
adjustment
Retained
earnings
Total
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
DKK
thousand
Equity January 1, 2020
174,944
-
(672)
(148,950)
25,322
Comprehensive income
Loss for the year
-
-
-
(61,562)
(61,562)
Adjustment of foreign currency
fluctuations on subsidiaries
-
-
1,772
-
1,772
Transactions with owners
Issue
91,638
54,982
-
-
146,620
Issue costs
-
(16,556)
-
-
(16,556)
Share-based compensation
-
-
-
5,316
5,316
Transferred to Retained earnings
-
(38,426)
-
38,426
-
Equity December 31, 2020
266,582
-
1,100
(166,770)
100,912
Statement of changes in equity
Financial statements BioPorto A/S 2021
66
1. Accounting policies
2. Revenue
3. Staff costs
4. Fees to auditors appointed by the general meeting
5. Investments in subsidiaries
6. Financial income and expenses
7. Deferred tax
8. Contingent liabilities
9. Distribution of the year’s result
10. Other notes
Notes - Parent
Financial statements BioPorto A/S 2021
67
Accounting policies
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 large reporting class D 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 are consistent with those applied last 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:
Income statement
Income from investments in subsidiaries.
Income from investments in subsidiaries are recognized in the parent company's income
statement.
Share-based compensation
In addition to the requirements of the Danish Financial Statements Act, IFRS has been applied for
equity settled share-based compensation.
Balance sheet
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.
Cash flow statement
As allowed under section 86 (4) of the Danish Financial Statements Act, a cash flow statement is
not presented, as it is included in the consolidated cash flow statement.
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 “Deferred tax assets and Tax payable” in the consolidated financial
statements.
Note 1
Financial statements BioPorto A/S 2021
68
Revenue
2021
2020
GEOGRAPHIC DISTRIBUTION
DKK thousand
DKK thousand
Denmark
9,600
9,600
Revenue
9,600
9,600
The sale of services in BioPorto A/S exclusively represents intra-group selling of services. The
revenue is recognized over time in the accounting period in which the performance obligations
associated with the services are rendered.
Staff costs
2021
2020
DKK thousand
DKK thousand
Wages and salaries
13,749
15,975
Share-based compensation expenses
(966)
5,316
Defined contribution pension plans
1,343
1,280
Other social security costs
1,574
48
Other staff costs
198
80
Staff costs
15,898
22,699
Average number of employees
6
6
SPECIFICATION OF STAFF COSTS
2021
2020
DKK thousand
DKK thousand
Sales and marketing costs
872
4,122
Administrative expenses
15,026
18,577
Staff costs
15,898
22,699
Reference is made to Note 4 in the consolidated financial statements concerning remuneration of
the Executive Management, Board of Directors, and share-based payment.
Note 2
Note 3
Financial statements BioPorto A/S 2021
69
Fees to auditors appointed by the general meeting
2021
2020
DKK thousand
DKK thousand
Audit fee
496
548
Total audit fees
496
548
Other assurance engagements
-
15
Tax advisory services
196
130
Other services
42
385
Total non-audit fee
238
530
Total fees to auditors appointed by the shareholders
734
1,078
Note 4
Financial statements BioPorto A/S 2021
70
Investments in subsidiaries
2021
2020
DKK thousand
DKK thousand
Cost on January 1
51,364
51,364
Additions
-
-
Cost at December 31
51,364
51,364
Revaluation on January 1
(456,001)
(414,135)
Income from investments in subsidiaries
(51,990)
(43,638)
Exchange rate adjustments investments in subsidiaries
(1,219)
1,772
Equity changes in subsidiaries
-
-
Revaluation on December 31
(509,210)
(456,001)
Value on December 31
(457,846)
(404,637)
Negative value of investments set off against receivables from group
406,125
366,870
Negative value of investments recognized as a provision
52,694
37,789
Value on December 31
973
22
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 2021 of 2.14%, 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's review,
including the description of risks. Management believes that some 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 Hellerup, Denmark. Ownership: 100%
BioPorto Inc, Needham, Massachusetts, USA. Ownership: 100%
BioPorto Diagnostics Inc, Needham, Massachusetts , USA. Ownership: 100%
Veterinary Diagnostics A/S, 2900 Hellerup, Denmark. Ownership: 100%
Note 5
Financial statements BioPorto A/S 2021
71
Financial income and expenses
FINANCIAL INCOME
2021
2020
DKK thousand
DKK thousand
Interest income from subsidiaries
9,490
8,359
Interest income from bank
-
4
Exchange rate adjustments, net
5,762
-
Total financial income
15,252
8,363
FINANCIAL EXPENSES
2021
2020
DKK thousand
DKK thousand
Interest expense to subsidiaries
-
1
Interest expenses, leasing debt
110
145
Interest expenses, other debt
275
160
Exchange rate adjustments, net
-
5,567
Total financial expenses
385
5,873
Deferred tax
A deferred tax asset has been calculated. However, Management has concluded that it is not
sufficiently probable that the tax asset can be utilized. Management has therefore decided not to
recognize the calculated tax asset on the balance sheet. Reference is made to Note 2 in BioPorto's
consolidated financial statements.
2021
2020
DKK thousand
DKK thousand
Calculated tax asset
3,219
1,944
Writedown to assessed value
(3,219)
(1,944)
Carrying amount
-
-
DEFERRED TAX ASSETS NOT RECOGNIZED IN THE BALANCE SHEET
2021
2020
DKK thousand
DKK thousand
Right-of-use assets
(1,012)
(350)
Leasing liabilities
1,024
371
Tax loss carryforwards
3,207
1,923
Deferred tax on December 31, net
3,219
1,944
Note 6
Note 7
Financial statements BioPorto A/S 2021
72
TOTAL INCOME TAXES
2021
2020
DKK thousand
DKK thousand
Net result before tax
(57,747)
(62,621)
Computed 22%
(12,704)
(13,777)
Valuation allowance
1,275
1,917
Income from investments in subsidiaries
11,438
9,600
Income/expense not taxable/deductible for tax purposes
(643)
1,177
Adjustment of tax from previous years
-
24
Total income taxes
(634)
(1,059)
Contingent liabilities
BioPorto A/S has acknowledged towards the subsidiaries BioPorto Diagnostics A/S, Veterinary
Diagnostics A/S BioPorto Inc. and BioPorto Diagnostics Inc. that it will finance its operations in
2022. The contingent liability is estimated to be approximately DKK 48-53 million.
Note 7, continued
Note 8
Financial statements BioPorto A/S 2021
73
Distribution of the year’s result
The Board of Directors proposes that BioPorto A/S’s loss for the year 2021 of DKK 57,113 thousand
(2020: loss of DKK 61,562 thousand) be transferred to retained earnings.
Other notes
Reference is made to Notes 16 and 17 in BioPorto's consolidated financial statements with respect
to share capital and treasury shares.
Reference is made to Note 22 in BioPorto's consolidated financial statements with respect to a
subsequent event.
Reference is made to Note 23 in BioPorto's consolidated financial statements with respect to
matters associated with related parties and the section on directorships held by members of the
Board of Directors and Executive Management.
Note 9
Note 10
Statement by Management BioPorto 2021
74
Executive Management:
Anthony Paul Pare
CEO
Neil Allan Goldman
EVP & CFO
Board of Directors:
Statement by Management
Independent auditor’s report BioPorto 2021
75
Report on the audit of the Financial Statements
Our opinion
Basis for opinion
Key audit matters
Statement on Management’s Review
Independent auditor’s report
Independent auditor’s report BioPorto 2021
76
Management’s responsibilities for the Financial Statements
Auditor’s responsibilities for the audit of the Financial Statements
Independent auditor’s report BioPorto 2021
77
Report on compliance with the ESEF Regulation
CVR No 33771231
Henrik Kyhnauv
State Authorised Public Accountant
mne34354
mne40028
BioPorto A/S
Denmark
Tel.: (+45) 4529 0000
Fax: (+45) 4529 0001
E-mail: [email protected]
Website: www.bioporto.com
Company reg. no. 17500317
BioPorto is an in vitro diagnostics company focused on saving lives and improving
the quality of life with actionable biomarkers – tools designed to help clinicians
make changes in patient management. The Company uses its expertise in
antibodies 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 the Company’s tests
can help improve clinical and economic outcomes for patients, providers, and the
healthcare ecosystem.
The Company’s flagship product is The NGAL Test, which has been designed to
aid in the risk assessment of Acute Kidney Injury (AK), a common clinical
syndrome that can have severe consequences, including significant morbidity
and mortality if not identified and treated early. With the aid of The NGAL Test,
physicians can identify patients potentially at risk of AKI more rapidly than is
possible with current standard of care measurements, enabling earlier
intervention and more tailored patient management strategies.
www.bioporto.com