Interim Report BioPorto, first half of 2022
1
August 17, 2022
Announcement no. 13
BioPorto Announces Interim Results for the First Six Months of 2022
COPENHAGEN, DENMARK and BOSTON, MA, USA, August 17, 2022, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto)
(CPH:BIOPOR) today announced interim financial results for the first six months of 2022 and business progress
for the second quarter of 2022.
Recent Highlights
• For the six months ending June 30, 2022:
o Total revenue of DKK 15.0 million / USD 2.2 million, a 23% increase over the prior year
o Adjusted EBITDA of DKK (32.4) million / USD (4.8) million
o Cash and cash equivalents of DKK 107.9 million / USD 15.1 million as of June 30, 2022 (DKK 75.0
million / USD 12.0 million as of June 30, 2021)
• For the second quarter ending June 30, 2022:
o Total revenue of DKK 8.5 million / USD 1.2 million, a 29% increase over the prior year
o Adjusted EBITDA of DKK (17.1) million / USD (2.5) million
• Achieved targeted enrollment in clinical study supporting FDA De Novo submission for The NGAL Test in
the US
• Appointed world-leading nephrologist and NGAL biomarker pioneer, Dr. Prasad Devarajan, as new Senior
Medical Director
• Successful implementation of NGAL testing programs was highlighted at the 40th Vincenza Course on
AKI & CRRT meeting in Vincenza, Italy – “Meet the Expert” video
Tony Pare, BioPorto’s Chief Executive Officer, said: “I am pleased with our strong second quarter of 2022, a
result of disciplined execution on our strategic agenda. We look forward to completing The NGAL Test clinical
trial data analysis and related work, and then submitting the De Novo application to the US Food and Drug
Administration (FDA). We remain excited about The NGAL Test’s potential impact to assist clinicians in
improving outcomes for critical care patients.”
Guidance for 2022 Updated
During the first half of 2022, BioPorto experienced solid sales performance driven by both The NGAL Test and a
notable bulk order of antibodies. Based on this, BioPorto increases the upper end of its revenue guidance for
the 2022 fiscal year, with a new range of DKK 24 to 27 million. BioPorto maintains its 2022 financial guidance
of:
• Operating (EBIT) loss of approximately DKK 95 to 100 million
• Adjusted EBITDA loss of approximately DKK 76 to 81 million
Conference Call and Webcast
The Company’s management team will host an online investor presentation on August 17, 2022 at 14:00 Central
European Time / 8:00 Eastern Time via HC Andersen Capital. Investors interested in attending the webcast may
register at: https://bit.ly/3PkwjX9
A separate analyst call will be held on August 17, 2022 at 16:00 Central European Time / 10:00 Eastern Time,
with details as follows:
Denmark: +45 8025 1917
International: +1 201-689-8562
US: +1 877 407 0789
Conference ID: 13732188
Webcast: https://bit.ly/3C342S0
Investor Relations Contacts
Tim Eriksen, EU Investor Relations, Zenith Advisory, +45 4529 0000, investor@bioporto.com
Ashley Robinson, US Investor Relations, LifeSci Advisors, +1 617 430 7577, arr@lifesciadvisors.com
About BioPorto
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 (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 NGAL Test
is CE marked and registered in a number of countries worldwide.
BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on
the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com.
Forward-looking statement disclaimer
Certain statements in this news release are not historical facts and may be forward-looking statements.
Forward-looking statements include statements regarding the intent, belief or current expectations with respect
to the Company’s expectations, intentions and projections regarding its future performance including the
Company’s Guidance for 2022; currency exchange rate fluctuations; anticipated events or trends and other
matters that are not historical facts, including with respect to the potential FDA clearance, commercialization
of The NGAL Test, and the development of future products and new indications; concerns that may arise from
additional data, analysis or results obtained during clinical trials; and, the Company’s ability to successfully
market both new and existing products. These forward-looking statements, which may use words such as “aim”,
“anticipate”, “believe”, “intend”, “estimate”, “expect” and words of similar meaning, include all matters that
are not historical facts. These forward-looking statements involve risks, and uncertainties that could cause the
actual results of operations, financial condition, liquidity, dividend policy and the development of the industry
in which the Company’s business operates to differ materially from the impression created by the forward-
looking statements. These statements are not guarantees of future performance and are subject to known and
unknown risks, uncertainties and other factors that could cause actual results to differ materially from those
expressed or implied by such forward-looking statements. Given these risks and uncertainties, prospective
investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements
speak only as of the date of such statements and, except as required by applicable law, the Company undertakes
no obligation to update or revise publicly any forward-looking statements, whether as a result of new
information, future events or otherwise. Factors that may impact BioPorto’s success are more fully disclosed in
BioPorto’s periodic financial filings, including its Annual Report for 2021, with the Danish Financial Supervisory
Authority, particularly under the heading “Risk Factors”.
NOTE – DKK/USD exchange rates used within “Recent Highlights”, above:
• Balance sheet measures: June 30, 2021 = 6.2573 and June 30, 2022 = 7.1620
• Income statement measures for six months ended: June 30, 2021 = 6.1479 and June 30, 2022 = 6.7864.
• Income statement measures for second quarter ended: June 30, 2021 = 6.1797 and June 30, 2022 =
6.9061.
Interim Report BioPorto, first half of 2022
3
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK million (except where noted)
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Revenue
8.5
6.6
12.2
24.3
Gross profit
6.1
4.5
7.7
15.0
Sales and marketing costs
5.1
2.9
8.3
17.4
Research and development costs
9.8
7.3
15.5
30.3
Administrative costs
11.3
8.9
16.6
32.7
Loss before financial items (EBIT)
(20.1)
(14.5)
(32.7)
(65.3)
Financial items, net
0.8
(0.6)
0.5
1.4
Loss before tax
(19.4)
(15.2)
(32.2)
(63.8)
Net loss
(17.1)
(13.6)
(29.0)
(57.1)
Comprehensive loss
(17.8)
(13.6)
(29.2)
(58.3)
Non-current assets
14.2
17.1
Cash and cash equivalents
75.0
45.5
Current assets
95.3
64.2
Total assets
109.5
81.3
Equity
76.5
46.0
Non-current liabilities
8.0
10.5
Current liabilities
25.0
24.8
Total equity and liabilities
109.5
81.3
Cash flows from operating activities
(35.1)
(64.6)
Cash flows from investing activities
(0.4)
(0.4)
Of which investment in property, plant and
equipment
(0.1)
(0.1)
Cash flows from financing activities
2.6
1.1
Net cash flows
(33.0)
(63.9)
Adjusted EBITDA
(17.1)
(14.5)
(30.2)
(61.9)
Revenue growth
29%
(2%)
11%
5%
Gross profit percentage
71%
69%
64%
62%
Equity ratio (solvency)
73%
70%
70%
57%
Average number of employees
34
29
29
29
Number of shares at the end of the period (1,000)
334,693
267,754
267,754
267,754
Loss per share (EPS), DKK
(0.05)
(0.05)
(0.11)
(0.21)
Net asset value per share, period-end, DKK
0.32
0.29
0.29
0.17
Share price, period-end, DKK
1.22
3.16
3.16
2.47
Note: Loss per share (EPS) is calculated in accordance with IAS 33 “Earning per share”. Other financial ratios have been calculated in accordance with the
guidelines from the Danish Society of Financial Analysts.
Reconciliation of Adjusted EBITDA
Loss before financial items (EBIT)
(20.1)
(14.5)
(32.7)
(65.3)
Depreciation and amortization
1.1
1.0
2.1
4.3
Share-based compensation expenses
1.9
(1.0)
0.4
(0.9)
Adjusted EBITDA
(17.1)
(14.5)
(30.2)
(61.9)
Consolidated Financial Highlights
Non-IFRS Financial Measure
In the Interim Report, BioPorto discloses a financial measure of the Group’s financial performance that reflects adjustments to the most
directly comparable measures calculated and presented in accordance with IFRS. This non-IFRS financial measure may not be defined and
calculated by other companies in the same manner and may thus not be comparable.
The non-IFRS financial measure presented in the Interim Report is Adjusted earnings before interest, taxes, depreciation, and amortization
(Adjusted EBITDA).
Adjusted EBITDA is an alternative measure of performance utilized by management, investors, and investment analysts to evaluate and
analyze the Company’s results. Adjusted EBITDA excludes non-cash share-based compensation and non-recurring costs (e.g., merger and
acquisition integration costs), if any. We believe that earnings exclusive of non-cash and non-recurring costs is a key indication of how a
company is progressing from period to period and that the non-IFRS financial measure Adjusted EBITDA is useful to investors, lenders,
and other creditors because such information enables them to better understand earnings exclusive of non-cash and non-recurring costs
from period to period. However, we also believe that Adjusted EBITDA data has limitations, particularly as non-cash and non-recurring
costs could significantly impact our performance. We therefore limit our use of Adjusted EBITDA and do not evaluate our results and
performance without considering both non-IFRS Adjusted EBITDA on the one hand and net income or loss on the other. We caution the
readers of this report to follow a similar approach by considering data on Adjusted EBITDA only in addition to, and not as a substitute for
or superior to, net income or loss in accordance with IFRS.
Interim Report BioPorto, first half of 2022
5
Robust revenue growth in the second quarter and first
half of 2022
Revenue totaled DKK 8.5 million in the second quarter of 2022, a 29%
increase over the prior year period. Revenue in the second quarter
was favorably impacted by a bulk order of antibodies. In the first half
of 2022, revenue totaled DKK 15.0 million, a 23% increase over the
prior year period, reflecting growth in all product groups. Revenue
from The NGAL Test in the second quarter was 10% lower than the
prior year period, reflecting the timing of ordering patterns, as The
NGAL Test revenue for the first half of 2022 increased by 19% over
the prior year period.
Year-to-date revenue from US-based sales of The NGAL Test on a
research use only (RUO) basis totaled DKK 4.8 million, a 31% increase
over the prior year period. These sales reflect an increase in the
average volume purchased by hospitals acquiring RUO versions of
The NGAL Test.
Achieves targeted enrollment and prepares for FDA
submission of The NGAL Test
Consistent with previous guidance, in June 2022 BioPorto announced
a major strategic milestone when the targeted subject enrollment for
the third part of a 3-part clinical study to support its FDA De Novo
submission for use of The NGAL Test in identifying patients under the
age of 22 at risk for AKI was achieved.
The Company is collecting, compiling, and analyzing the clinical data
to confirm that no additional data is required, after which it will
prepare the clinical report and combine with the other required
technical and analytical documents, and submit the application to the
FDA for De Novo approval.
Based on the quality of the clinical data and other material to support
the desired claims, BioPorto anticipates submitting its De Novo
application to the FDA by the fourth quarter of 2022. The NGAL Test
was previously granted Breakthrough Device designation by the FDA,
and therefore it will be prioritized for review upon submission.
Following the submission and in parallel with the FDA’s review,
BioPorto plans to invest in market access activities, including clinical
education, medical and scientific liaisons, commercial preparations,
which include adding resources responsible for taking The NGAL Test
to the US market. The Company will advance its strategy to expand
The NGAL Tests’ patient population and related indications.
Strengthened Clinical and Scientific Team with
appointment of world-leading nephrologist and NGAL
biomarker pioneer
In the second quarter of 2022, BioPorto announced the appointment
of Dr. Prasad Devarajan, MD FAAP FASN, as its new Senior Medical
Director effective July 1, 2022.
Considered a world leading Pediatric Nephrologist and physician-
scientist and a pioneer in understanding the relationship between
Neutrophil gelatinase-associated lipocalin (NGAL) and AKI, Dr.
Devarajan brings unique and unparalleled clinical and scientific
reputation, knowledge, and expertise to BioPorto. Management
anticipates that Dr. Devarajan will deliver meaningful value to the
Company’s global markets’ understanding of the benefits of The
NGAL Test, and also assist in preparing its submission for FDA review
and approval.
While supporting BioPorto, Dr. Devarajan will maintain his role as a
Professor of Pediatrics & Developmental Biology, Director of
Nephrology and Hypertension, and CEO of the Dialysis Unit at
Cincinnati Children’s Hospital Medical Center (Ohio, US).
Closing of fully subscribed share offering
On April 1, 2022, BioPorto received net proceeds of DKK 93 million
from a fully subscribed offering of new shares as part of a long-term
capital plan that includes a potential US listing.
In total, 66,938,601 new shares of common stock were offered and
sold pursuant to a Prospectus for a rights offering with pre-emptive
rights for existing shareholders that was filed on March 7, 2022. Post-
closing, the nominal value of the Company’s total share capital
amounted to DKK 334,693,005 divided into 334,693,005 shares each
carrying 1 voting right, corresponding to a total of 334,693,005 voting
rights.
Together with existing funds, the proceeds from the offering will be
applied towards the submission of The NGAL Test application for
pediatric use in the US, prepare for a commercial launch, and
implement programs to drive market adoption.
Other matters
The Company’s feasibility study confirmed that its gRAD platform
detected the omicron SARS-CoV-2 variant using commercially
available antibodies. Management has assessed that a future COVID-
19 test on this platform would likely not be sufficiently differentiated
from widely available commercial products. In addition, further
development followed by clinical studies and regulatory activities
would require substantial investment. Therefore, the project has been
cancelled to keep the Company’s financial and human resources
focused on its core strategy.
Events after the reporting period
No material events occurred after the reporting period.
Management Review
The financial review is based on the Group’s consolidated financial
information as of and for the three and six months ended June 30, 2022,
with comparative results as of and for the three and six months ended June
30, 2021, in brackets.
Revenue
Revenue in the second quarter of 2022 was DKK 8.5 million (DKK 6.6 million)
and in the first half of 2022 totaled DKK 15.0 million (DKK 12.2 million).
Sales of The NGAL Test in the second quarter of 2022 included DKK 2.1
million (DKK 2.4 million) from RUO sales in the US and DKK 1.2 million (DKK
1.3 million) from sales in the EU and rest of the world.
NGAL product revenue in the first half of 2022 included DKK 4.8 million (DKK
3.7 million) from RUO sales in the US and DKK 2.3 million (DKK 2.2 million)
from sales in the EU and rest of the world.
Revenue from the sale of antibodies was DKK 5.0 million (DKK 2.4 million)
in the second quarter of 2022. Revenue from the sale of antibodies was DKK
6.9 million (DKK 5.3 million) in the first half of 2022.
Figure 1. Revenue by quarter (DKK million)
Figure 2. NGAL product revenue by quarter (DKK million)
Figure 3. NGAL product revenue, LTM (DKK million)
LTM: last twelve months
Gross Profit
Gross profit for the second quarter of 2022 was DKK 6.1 million (DKK 4.5
million), which was principally driven by favorable sales volume together
with a 210 bps improvement in gross profit percentage.
Gross profit for the first half of 2022 totaled DKK 10.0 million (DKK7.7
million), which was also principally driven by favorable sales volume
together with a 300 bps improvement in gross profit percentage.
Sales and Marketing Costs
Sales and marketing costs totaled DKK 5.1 million (DKK 2.9 million) in the
second quarter of 2022. The increase reflected higher staffing and travel
costs, which due to COVID-19 were meaningfully reduced in the prior year
period.
Research and Development Costs
Research and development costs in the second quarter of 2022 totaled DKK
9.8 million (DKK 7.3 million), reflecting an increased rate of investment in
clinical study costs based on the stage of the Company’s clinical trials for
The NGAL Test and other R&D activities.
Administrative Costs
Administrative costs in the second quarter of 2022 totaled DKK 11.3 million
(DKK 8.9 million). The DKK 2.4 million increase is primarily related to a DKK
1.7 million non-cash equity compensation recovery in the prior year period
related to forfeited warrants, combined with higher non-cash equity
compensation cost of DKK 1.2 million in the current period.
Financials Items, net
Financial income and expenses reflect interest income/expense and
currency transaction gains/losses. Financial items, net for the second
quarter of 2022 was income of DKK 0.8 million (expense of DKK 0.6 million).
For the first half of 2022, financial items, net was an income of DKK 0.7
million (income of DKK 0.5 million).
Tax Benefit
In the second quarter of 2022, a DKK 2.3 million tax benefit (income of DKK
1.5 million) was realized. The tax benefit is primarily related to tax credits
associated with the Company’s investment in research and development.
4,2
6,7
4,7
7,6
5,6
6,6
5,3
6,8
6,5
8,5
0
2
4
6
8
10
Q1 Q2 Q3 Q4
2020 2021 2022
2,1
5,0
2,7
3,6
2,1
3,7
2,6
3,73,7
3,3
0
2
4
6
Q1 Q2 Q3 Q4
2020 2021 2022
4
6
8
10
12
14
16
Q2 2019
Q3 2019
Q4 2019
Q1 2020
Q2 2020
Q3 2020
Q4 2020
Q1 2021
Q2 2021
Q3 2021
Q4 2021
Q1 2022
Q2 2022
Financial Review
Interim Report BioPorto, first half of 2022
7
EBIT/Adjusted EBITDA
For the second quarter of 2022, Earnings before interest and taxes (EBIT)
was a loss of DKK 20.1 million (DKK 14.5 million). Adjusted EBITDA was a
loss of DKK 17.1 million (DKK 14.5 million).
For the first half of 2022, EBIT was a loss of DKK 38.4 million (DKK 32.7
million) reflecting favorable revenue and margin, and an increase in sales
and marketing costs and administrative costs, including a DKK 3.4 million
increase in non-cash equity compensation costs as described further under
Administrative Costs, above. Adjusted EBITDA was a loss of DKK 32.4 million
(loss of DKK 30.2 million).
Cash and Cash equivalents
As of June 30, 2022, BioPorto’s cash position was DKK 107.9 million (DKK
75.0 million) and is primarily invested in deposit accounts with two Nordic
banks.
Net working capital
Net working capital as of June 30, 2022 totaled DKK 101.1 million (DKK 70.3
million). Net working capital as of June 30, 2022 reflected the Group’s
issuance and sale of approximately 66.9 million shares of common stock for
gross proceeds of DKK 100.4 million and net proceeds of DKK 93.0 million.
Cash Flow Statement
Cash used in operating activities during the first half of 2022 totaled DKK
28.7 million (DKK 35.1 million), with the improvement over the prior year
primarily associated with favorable management of working capital.
Cash used in investing activities was DKK 0.5 million (DKK 0.4 million) which
primarily consisted of investments in lab equipment.
In the first half of 2022 cash from financing activities was DKK 91.4 million
(DKK 2.6 million), primarily related to the share capital raise.
The net cash flow during the first half of 2022 was a source of DKK 62.1
million (use of DKK 33.0 million).
Significant risks and uncertainties
BioPorto faces a number of risks and uncertainties, including those
common for the biotech/medical device industry. These relate to clinical
and regulatory, operations, research and development, manufacturing,
commercial, and financial activities. The Company is finalizing the collection
and analysis of clinical trial for NGAL in pediatrics. The quality or sufficiency
of the clinical data could be insufficient to support the study’s endpoints
and require the Company to obtain additional data prior to submitting it to
the FDA; and, such activities, if possible, would require additional cost and
time.
The ongoing COVID-19 pandemic and war in Ukraine have created delays
and other challenges in global supply chains. To manufacture its products,
the Company is dependent on the supply of raw materials and key
components from suppliers, some of which are single source suppliers.
Delays in the manufacture, delivery, or quality of these components could
affect the Company’s ability to deliver products to its customers, which
could cause the Company’s results, prospects, and financial performance
to be negatively impacted.
In addition to the other information set forth in this report, you should
carefully consider the factors discussed in the sections captioned “Risk
management” in BioPorto’s 2021 Annual Report that are incorporated
herein by reference, which factors could materially affect the Group’s
business, financial condition, and/or future results. The risks described in
those sections and in this report are not the only risks BioPorto faces.
Additional risks and uncertainties not currently known to management or
the Group or that the Group currently deems to be immaterial also may
have a material adverse effect on the Group’s business, future
opportunities, financial condition, and/or operating results.
Guidance for 2022 Updated
The Company has a small base of customers that provide dependable
repeat business. Large one-time orders, such as those in the first and
second quarter of 2022, could be forecasted but are not yet of a reasonable
level of probability. Also, the second half of 2022 is expected to reflect
continuing costs of clinical trials and incremental costs from the impact of
new hires and service contracts, including those that are intended to
support the commercialization of The NGAL Test.
During the first half of 2022, BioPorto experienced solid sales performance
driven by both The NGAL Test and a notable bulk order of antibodies. Based
on this, BioPorto increases the upper end of its revenue guidance for the
2022 fiscal year, with a new range of DKK 24 to 27 million. BioPorto
maintains its 2022 financial guidance of:
• Operating (EBIT) loss of approximately DKK 95 to 100 million, and
• Adjusted EBITDA loss of approximately DKK 76 to 81 million.
BioPorto’s guidance continues to reflect the key assumptions most recently
described in its Annual Report for 2021.
Forward-looking safe harbor statements
This interim report contains forward-looking statements that involve risks,
uncertainties, and other factors, many of which are outside of BioPorto’s
control, that could cause actual results to differ materially from the results
or expectations discussed in the forward-looking statements. Forward-
looking statements include statements concerning the Group’s plans,
objectives, goals, future events, performance and/or other information
that is not historical information. All such forward-looking statements are
expressly qualified by these cautionary statements and any other
cautionary statements which may accompany the forward-looking
statements. The Company undertakes no obligation to publicly update or
revise forward-looking statements to reflect subsequent events or
circumstances after the date made.
For Further Information
Neil Goldman, Executive VP & CFO
Tim Eriksen, EU Investor Relations, Zenith Advisory, +45 4529 0000,
investor@bioporto.com
Ashley Robinson, US Investor Relations, LifeSci Advisors, +1 617 430 7577,
arr@lifesciadvisors.com
www.bioporto.com
8
Interim report BioPorto, first half of 2022
The Board of Directors and Executive Management today reviewed and approved the Interim Report of the BioPorto Group for the period January 1 to
June 30, 2022.
The Interim Report, which is unaudited and has not been reviewed by the company's auditors, is presented in accordance with IAS 34 “Interim Financial
Reporting” as adopted by the EU and additional Danish disclosure requirements for interim reports of listed companies.
In our opinion, the interim report gives a true and fair view of the Group’s assets, equity and liabilities and financial position as of June 30, 2022, and the
results of the Group’s operations and cash flows for the period January 1 to June 30, 2022.
In our opinion the management's report includes a fair review of the development and performance of the business, the results for the period and the
Group’s financial position in general and describes changes in principal risks and uncertainties that have occurred relative to what was disclosed in the
consolidated Annual Report for 2021.
Hellerup, August 17, 2022
Executive Management:
___________________________ ___________________________
Anthony Paul Pare Neil Allan Goldman
CEO EVP & CFO
Board of Directors:
___________________________ ___________________________ __________________________
Christopher Lindop John McDonough Michael Singer
Chairman Vice Chairman
___________________________ ___________________________ ___________________________
Jan Leth Christensen Don Hardison Peter Mørch Eriksen
Statement by the Board of Directors and
Management
Interim Report BioPorto, first half of 2022
9
Condensed Consolidated Statements of Profit or Loss
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Revenue
3
8,506
6,576
15,008
12,153
Production costs
4,5,8
2,454
2,041
5,010
4,429
Gross profit
6,052
4,535
9,998
7,724
Sales and marketing costs
4,5
5,090
2,857
9,134
8,263
Research and development costs
4,5
9,826
7,282
17,847
15,523
Administrative costs
4,5
11,273
8,912
21,372
16,632
Loss before financial items (EBIT)
(20,137)
(14,516)
(38,355)
(32,694)
Financial income
979
(412)
1,164
922
Financial expenses
226
222
475
466
Loss before tax
(19,384)
(15,150)
(37,666)
(32,238)
Income tax benefit, net
6
2,293
1,527
3,545
3,251
Net loss
(17,091)
(13,623)
(34,121)
(28,987)
DKK
DKK
DKK
DKK
Loss per share (EPS & DEPS), DKK
7
(0.05)
(0.05)
(0.11)
(0.11)
Condensed Consolidated Statements of Comprehensive Loss
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Net loss
(17,091)
(13,623)
(34,121)
(28,987)
(57,113)
Other comprehensive loss:
Amounts which will be reclassified
to the income statement:
Exchange rate adjustments of
investments in subsidiaries
(709)
26
(759)
(203)
(1,219)
Other comprehensive loss
(709)
26
(759)
(203)
(1,219)
Comprehensive loss
(17,800)
(13,597)
(34,880)
(29,190)
(58,332)
Financial Statements
10
Interim report BioPorto, first half of 2022
Condensed Consolidated Balance Sheets
Assets
2022
2021
2021
Jun 30
Jun 30
Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Non-current assets
Property, plant and equipment and intangible assets
Rights and software
921
1,307
Fixtures and fittings, tools and equipment
1,999
2,366
Right-of-use assets
8
11,419
8,816
Total property, plant and equipment and intangible assets
14,339
12,489
Financial assets
Deposits
1,855
1,696
Total financial assets
1,855
1,696
Total non-current assets
16,194
14,185
Current assets
Inventories, net
9
2,225
3,029
Trade receivables, net
10,12
8,122
7,346
Income tax receivable
9,797
8,060
Other receivables
10,12
1,106
684
Prepayments
10
1,572
1,196
Total inventories and receivables
22,822
20,315
Cash and cash equivalents
12
107,862
74,979
Total current assets
130,684
95,294
Total assets
146,878
109,479
Interim Report BioPorto, first half of 2022
11
Equity and Liabilities
2022
2021
2021
Jun 30
Jun 30
Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Equity
Share capital
11
334,693
267,754
Treasury shares
11
-
-
Exchange-rate adjustments
(878)
897
Retained earnings
11
(225,898)
(192,177)
Total equity
107,917
76,474
Liabilities
Non-current liabilities
Lease obligations
9,256
7,743
Other non-current liabilities
12
137
301
Non-current liabilities
9,393
8,044
Current liabilities
Current portion of non-current liabilities
12
3,233
1,726
Trade payables
12
6,008
3,584
Tax payables
-
80
Other payables
20,327
19,571
Current liabilities
29,568
24,961
Total liabilities
38,961
33,005
Total equity and liabilities
146,878
109,479
12
Interim report BioPorto, first half of 2022
Condensed Consolidated Statement of Changes in Equity (Unaudited)
DKK thousand
Common Stock
Additional
Treasury Stock
Accumulated
Shares
Amount
Paid-in-Capital
Shares
Amount
Deficit
AOCI
Total
Balance at December 31, 2021
267,754
267,754
-
13
-
(221,671)
(119)
45,964
Comprehensive loss
-
-
-
-
-
-
(50)
(50)
Common Stock:
Issuance of stock, net (Note 11)
66,939
66,939
26,175
-
-
-
-
93,114
Options:
Share-based payment
-
-
-
-
-
1,909
-
1,909
Transfer of additional paid in
capital
-
-
(26,175)
-
-
26,175
-
-
Net loss
-
-
-
-
-
(17,030)
-
(17,030)
Balance at March 31, 2022
334,693
334,693
-
13
-
(210,617)
(169)
123,907
Comprehensive loss
-
-
-
-
-
-
(709)
(709)
Common Stock:
Issuance of stock, net (Note 11)
-
-
(83)
-
-
-
-
(83)
Options:
Share-based payment
-
-
-
-
-
1,893
-
1,893
Transfer of additional paid in
capital
-
-
83
-
-
(83)
-
-
Net loss
-
-
-
-
-
(17,091)
-
(17,091)
Balance at June 30, 2022
334,693
334,693
-
13
-
(225,898)
(878)
107,917
Interim Report BioPorto, first half of 2022
13
DKK thousand
Common Stock
Additional
Treasury Stock
Accumulated
Shares
Amount
Paid-in-Capital
Shares
Amount
Deficit
AOCI
Total
Balance at December 31, 2020
266,582
266,582
-
13
-
(166,770)
1,100
100,912
Comprehensive loss
-
-
-
-
-
-
(229)
(229)
Options
Share-based payment
-
-
-
-
-
1,419
-
1,419
Transfer of additional paid in capital
-
-
-
-
-
-
-
-
Net loss
-
-
-
-
-
(15,364)
-
(15,364)
Balance at March 31, 2021
266,582
266,582
-
13
-
(180,715)
871
86,738
Comprehensive loss
-
-
-
-
-
-
26
26
Options
Share-based payment
1,172
1,172
6,790
-
-
(4,629)
-
3,333
Transfer of additional paid in capital
-
-
(6,790)
-
-
6,790
-
-
Net loss
-
-
-
-
-
(13,623)
-
(13,623)
Balance at June 30, 2021
267,754
267,754
-
13
-
(192,177)
897
76,474
14
Interim report BioPorto, first half of 2022
Condensed Consolidated Statements of Cash Flows
2022
2021
2021
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Loss before financial items
(38,355)
(32,694)
Depreciation and amortization
2,163
2,084
Share-based compensation expenses
3,802
414
Other non-cash items
-
284
Change in inventories
493
136
Change in receivables
(1,116)
(833)
Change in trade payables
1,748
(1,052)
Change in other payables
2,856
(3,818)
Cash flows from operations
(28,409)
(35,479)
Financial income, received
392
252
Financial expenses, paid
(725)
(366)
Tax refund, net
-
473
Cash flows from operating activities
(28,742)
(35,120)
Purchase of operating equipment
(407)
(270)
Purchase of rights and software
(65)
(148)
Purchase of financial assets
(31)
(23)
Cash flows from investing activities
(503)
(441)
Proceeds from warrant programs exercised
-
4,361
Proceeds from rights issue
100,408
-
Cost related to issue of new shares
(7,377)
(23)
Reduction of non-current liabilities
(164)
(151)
Repayments of lease obligation
(1,513)
(1,635)
Cash flows from financing activities
91,354
2,552
Net cash flows for the period
62,109
(33,009)
Cash and cash equivalents at beginning of period
45,523
107,943
Effect of exchange rate changes on cash
230
45
Cash and cash equivalents end of period
107,862
74,979
Interim Report BioPorto, first half of 2022
15
1. Basis of reporting
Basis of preparation
This Interim Report and the accompanying unaudited condensed consolidated financial statements include the accounts of BioPorto A/S and its subsidiaries
(“BioPorto” or “the Group”). All significant intercompany accounts and transactions have been eliminated in consolidation. The accompanying unaudited
condensed consolidated financial statements have been prepared in accordance with IAS 34 “Interim Financial Reporting” as issued by the International
Accounting Standards Board (IASB) and adopted by the EU, and the additional Danish regulations for the presentation of quarterly interim reports by listed
companies. Certain information and footnote disclosures normally included in the consolidated financial statements been prepared in accordance with
International Financial Reporting Standards (“IFRS”) as adopted by the EU have been condensed or omitted pursuant to such rules and regulations. The
accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements
and notes thereto contained in BioPorto’s Annual Report for the fiscal year ended December 31, 2021.
The unaudited condensed consolidated financial statements are presented in Danish Kroner (DKK), which is considered the primary currency of the Group’s
activities and the functional currency of the parent company.
Accounting policies
The accounting policies used in the interim financial statements are consistent with those used in the consolidated financial statements for 2021 and in
accordance with the recognition and measurement policies of IFRS. Certain comparative figures have been reclassified to conform to the current period’s
presentation.
As of June 30, 2022, the Group has implemented all new or amended accounting standards and interpretations as adopted by the EU and applicable for
the 2022 financial year. None of the new or amended standards or interpretations are assessed to have a material impact on the unaudited condensed
consolidated financial statements. At the time of publishing this Interim Report, there are several new or modified standards and interpretations which
are not yet effective and therefore not implemented by the Group. The new or modified standards and interpretations will be implemented when they
become mandatory. They are not presently expected to have a material impact on the Group’s consolidated financial statements.
2. 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. Such estimates comprise judgments made on the basis of the most
recent information available at the reporting date. It may be necessary to change previous estimates as a result of changes to the assumptions on which
the estimates were based or due to supplementary information, additional experience or subsequent events.
Similarly, the value of assets and liabilities often depends on future events that are somewhat uncertain. In that connection, it is necessary to set out e.g.,
a course of events that reflects Management’s assessment of the most probable course of events. Special risks to BioPorto are described in the
Management’s review. The significant judgements made by Management in applying the Group’s accounting policies and the key sources of estimation
uncertainty were not materially different from those that applied to the consolidated financial statements as of and for the year ended December 31,
2021.
Notes to Condensed Consolidated
Financial Statements (Unaudited)
16
Interim report BioPorto, first half of 2022
3. Business area reporting
GEOGRAPHIC DISTRIBUTION
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK Thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Europe
4,306
2,142
5,476
4,680
North America
3,900
3,401
8,160
5,587
Asia
292
1,023
1,364
1,870
Other regions
8
10
8
16
Revenue
8,506
6,576
15,008
12,153
PRODUCT GROUPS
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - June 30
Jan 1 - June 30
Jan 1 - Dec 31
DKK Thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
NGAL tests
3,329
3,715
7,058
5,909
Antibodies
5,019
2,359
6,887
5,352
ELISA kits
148
490
1,044
867
Royalty and other revenue
10
12
19
25
Revenue
8,506
6,576
15,008
12,153
Interim Report BioPorto, first half of 2022
17
4. Share-based payment
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.
In the first half of 2022 share-based compensation expense totaled DKK 3.8 million (2021: expense of DKK 0.4 million).
The warrant terms are included in the Company’s Articles of Association, which can be found at www.bioporto.com. Upon vesting, each warrant entitles
the recipient to subscribe for one share in BioPorto A/S.
Warrants overview 2022
Outstanding at
January 1
Granted
Forfeited
Outstanding at
June 30
Exercisable at
June 30
August 2018
2,100,000
-
(1,700,000)
400,000
-
December 2018
1,800,000
-
(1,800,000)
-
-
April 2019
1,350,000
-
(1,350,000)
-
-
August 2019
1,250,000
-
-
1,250,000
1,250,000
December 2019
250,000
-
(250,000)
-
-
May 2020
1,350,000
-
(200,000)
1,150,000
-
February 2021
350,000
-
-
350,000
-
December 2021
12,150,000
-
(350,000)
11,800,000
-
May 2022
-
270,000
-
270,000
-
Total
20,600,000
270,000
(5,650,000)
15,220,000
1,250,000
Outstanding at
January 1
Granted
Forfeited
Outstanding at
June 30
Exercisable at
June 30
Executive Management
8,400,000
-
-
8,400,000
-
Management
5,700,000
270,000
-
5,970,000
1,250,000
Other employees
6,500,000
-
(5,650,000)
850,000
-
Total
20,600,000
270,000
(5,650,000)
15,220,000
1,250,000
For a specification of the parameters for the Black-Scholes model for pre-2021 grants, see Note 5 in Annual Report 2021 of the BioPorto Group.
18
Interim report BioPorto, first half of 2022
5. Amortization and depreciation
RIGHTS AND SOFTWARE
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Intangible assets
101
58
193
116
Total amortization
101
58
193
116
Classification of amortization:
Production costs
18
-
31
-
Sales and marketing costs
34
35
69
70
Research and development costs
18
-
31
-
Administrative expenses
31
23
62
46
Total amortization
101
58
193
116
PROPERTY, PLANT AND EQUIPMENT
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Property, plant and equipment
197
124
379
252
Total depreciation
197
124
379
252
Classification of depreciation:
Production costs
43
25
73
51
Sales and marketing costs
27
-
53
-
Research and development costs
93
89
184
180
Administrative costs
34
10
69
21
Total depreciation
197
124
379
252
RIGHT-OF-USE ASSETS
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Right-of-use assets
803
861
1,591
1,716
Total depreciation
803
861
1,591
1,716
Specification of depreciation:
Sales and marketing costs
384
431
754
857
Administrative expenses
419
430
837
859
Total depreciation
803
861
1,591
1,716
Interim Report BioPorto, first half of 2022
19
6. Deferred tax
The Group has a 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. As of the most recent year-end, December 31, 2021, the gross value of the tax asset prior to the valuation allowance was DKK 76.8
million.
7. Loss per share
2022
2021
2022
2021
2021
Apr 1 - Jun 30
Apr 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand (except where noted)
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Loss for the period
(17,091)
(13,623)
(34,121)
(28,987)
BioPorto Group's share of loss
(17,091)
(13,623)
(34,121)
(28,987)
Weighted average number of shares
334,693
267,119
301,987
267,754
Weighted average number of treasury shares
(13)
(13)
(13)
(13)
Weighted average number of shares
outstanding – basic
334,680
267,106
301,974
267,741
Weighted average number of shares in
circulation – diluted
334,680
267,106
301,974
267,741
Loss per share (EPS), DKK
(0.05)
(0.05)
(0.11)
(0.11)
8. Right-of-use assets
2022
2021
2021
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Cost at January 1
19,355
15,083
Additions during the period
-
-
Disposals during the period
-
(870)
Currency adjustments
938
340
Cost at end of period
20,293
14,553
Accumulated depreciation at January 1
7,010
4,822
Depreciation expense during the period
1,591
1,716
Disposals during the period
-
(870)
Currency adjustments
273
69
Accumulated Depreciation at end of period
8,874
5,737
Carrying amount at end of period
11,419
8,816
20
Interim report BioPorto, first half of 2022
LEASE LIABILITY
2022
2021
2021
Jun 30
Jun 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Current
3,092
1,585
Non-current
9,256
7,743
Lease liability end of period
12,348
9,328
LEASE OBLIGATIONS
2022
2021
2021
Jun 30
Jun 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Less than 1 year
3,092
1,585
Between 1 and 5 years
9,256
6,244
More than 5 years
-
1,499
Total
12,348
9,328
AMOUNTS RECOGNIZED IN CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR
LOSS
2022
2021
2021
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Depreciation charge of right-of-use assets
1,591
1,716
3,275
Interest expense (included in financial expenses)
381
304
628
Expense related to short-term leases
0
7
7
Total
1,972
2,027
3,910
9. Inventories
2022
2021
2021
Jun 30
Jun 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Finished goods
2,573
2,413
Raw materials and consumables
1,326
999
Reserves
(1,674)
(783)
Inventories, net
2,225
2,629
Write downs recognized as an expense in the period
-
58
Interim Report BioPorto, first half of 2022
21
2022
2021
2021
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
(Unaudited)
(Unaudited)
Cost of sales included in production costs in the period
1,564
860
2,650
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 is recognized as Research and development
costs in the period when they are identified as being expected to be used in R&D activities.
10. Receivables
2022
2021
2021
Jun 30
Jun 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables
9,010
8,215
Other receivables
1,106
684
Prepayments
1,572
1,196
Provisions for bad debt
(888)
(869)
Financial assets at amortized costs
10,800
9,226
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 13.
11. Share capital
As of June 30, 2022, the share capital consists of 334,693,005 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. As of June 30, 2022 and 2021, and December 31, 2021, the Company held 13,000 treasury shares
representing less than 0.01% of outstanding shares as of each date with nominal value of DKK 13,000. As of June 30, 2022, BioPorto A/S is not authorized
to acquire treasury shares. BioPorto A/S did not acquire treasury shares during the six months ended June 30, 2022 or the year ended December 31, 2021.
Following are the increases in share capital for each period presented:
2022
2021
2021
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Issue, gross proceeds
100,408
4,361
Issue costs
(7,377)
(23)
Net proceeds
93,031
4,338
22
Interim report BioPorto, first half of 2022
12. Financial risks and financial instruments
Financial instrument categories
2022
2021
2021
Jun 30
Jun 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables
8,122
7,346
Other receivables
1,106
684
Cash and cash equivalents
107,862
74,979
Financial assets at amortized costs
117,090
83,009
2022
2021
2021
Jun 30
Jun 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Lease obligations
12,348
9,328
Other non-current liabilities
278
442
Trade payables
6,008
3,584
Financial liabilities at amortized costs
18,634
13,354
Financial liabilities
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.
Currency risk
The Group’s presentation currency is DKK, but part of its activities are denominated in currencies other than DKK, primarily USD and EUR.
The Group is primarily exposed to currency risks through sales, production, R&D contracts, and payroll denominated in currencies other than Danish kroner.
Based on its transaction volume, the Group has determined not to hedge its USD exposure. As the Danish kroner is pegged to the EUR, hedging of the
Company’s transactions in EUR is not necessary.
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 totaling DKK 107.9
million and DKK 45.5 million as of June 30, 2022 and December 31, 2021, respectively.
Interim Report BioPorto, first half of 2022
23
Credit risk
The Group’s credit risk is primarily associated with trade receivables. Cash and cash equivalents are deposited with major Danish and US 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.
AS OF JUNE 30, 2022 (UNAUDITED)
DKK thousand
Expected
credit loss
rate
Trade
receivables
Expected loss
Total
Not due
0.6%
2,465
14
2,451
1 - 30 days overdue
1.5%
538
8
530
31 - 60 days overdue
2.2%
763
17
746
61 - 90 days overdue
0.7%
1,492
10
1,482
More than 90 days overdue
22.4%
3,752
839
2,913
June 30, 2022
9,010
888
8,122
AS OF JUNE 30, 2021 (UNAUDITED)
DKK thousand
Expected
credit loss rate
Trade
receivables
Expected loss
Total
Not due
1.5%
3,280
48
3,232
1 - 30 days overdue
0.5%
1,423
7
1,416
31 - 60 days overdue
5.9%
288
17
271
61 - 90 days overdue
16.9%
361
61
300
More than 90 days overdue
25.7%
2,863
736
2,127
June 30, 2021
8,215
869
7,346
Liquidity risk
In connection with BioPorto’s ongoing financing of operations, efforts are made to ensure sufficient financial resources are available. BioPorto’s cash and
cash equivalents amounted to DKK 107.9 million and DKK 45.5 million as of June 30, 2022 and December 31, 2021, respectively.
Provided that the presented guidance for 2022 is achieved, the liquid assets and capital resources are deemed sufficient for completing collecting the
additional data, 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.
Free funds are placed in deposits to maintain flexibility.
Capital structure
Management regularly assesses whether the Group’s capital structure properly serves the interests of the Group and its shareholders.
24
Interim report BioPorto, first half of 2022
13. Commitments and Contingencies
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.
14. Related parties
Related parties with significant interests
Other related parties of BioPorto with significant interests include the Board of Directors, the Executive Management, and their close family members.
Related parties also include companies in which these persons have control or significant interests.
Transactions with related parties
In addition to remuneration as board member, Peter Mørch Eriksen earned an aggregate amount of DKK 300,000 for consulting services (via his wholly-
owned legal entity, PME Holding ApS) during the three months ended March 31, 2022.
Interim Report BioPorto, first half of 2022
25
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 (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.
www.bioporto.com
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