Interim Report BioPorto, first nine months of 20
22
1
November 9, 2022
Announcement no. 15
BioPorto Announces Interim Results for the First Nine Months of 2022
COPENHAGEN, Denmark and BOSTON, MA, USA, November 9, 2022, (GLOBE NEWSWIRE) -- BioPorto A/S
(BioPorto) (CPH:BIOPOR) today announced
interim financial results for the first nine months of 2022 and business
progress for the third quarter of 2022.
Recent Highlights
• For the nine months ending September 30, 2022:
o Total revenue of DKK 20.3 million / USD 2.9 million, a 16% increase over the prior year
o Adjusted EBITDA of DKK (49.5) million / USD (7.2) million
o Cash and cash equivalents of DKK 98.9 million / USD 13.0 million as of September 30, 2022 (DKK
59.6 million / USD 9.3 million as of September 30, 2021)
• For the third quarter ending September 30, 2022:
o Total revenue of DKK 5.3 million / USD 0.7 million, a 0.4% decrease over the prior year
o Adjusted EBITDA of DKK (17.1) million / USD (2.3) million
• BioPorto continues preparations for FDA submission of an NGAL test by fourth quarter 2022
Tony Pare, BioPorto’s Chief Executive Officer, said: “The third quarter of 2022 reflected our continued focus
on disciplined execution towards completion and submission of the De Novo application to the US Food and Drug
Administration (FDA) of an NGAL test for pediatric risk assessment of Acute Kidney Injury (AKI). Our data analysis
and preparation of the clinical report are proceeding according to plan, and we anticipate submitting the
application by fourth quarter 2022 as previously guided.”
Guidance for 2022 adjusted to reflect timing of costs
During the first nine months of 2022, BioPorto exercised appropriate cost control and deferred certain
commercialization expenses, thereby reducing its costs below prior expectations. Consequently, BioPorto has
revised its 2022 guidance for operating (EBIT) loss from approximately DKK (95) to (100) million down to
approximately DKK (83) to (88) million, and adjusted EBITDA loss from approximately DKK (76) to (81) million
down to approximately DKK (71) to (75) million. BioPorto maintains its 2022 revenue guidance of approximately
DKK 24 to 27 million.
Conference Call and Webcast
The Company’s management team will host an online investor presentation on November 9, 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://hca.videosync.fi/bioporto-presentation-q3-interim-9-nov-2022/register
A separate analyst call will be held on November 9, 2022, at 16:00 Central European Time / 10:00 Eastern Time,
with details as follows:
Denmark: +45 8025 0765
International: +1 412 317 5180
US: +1 844 825 9789
Conference ID: 10172482
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1577608&tp_key=ea0f8a8f79
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
TM
, 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
t
he Nasdaq Copenhagen stock exchange. For more information visit w
ww.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 marketing authorization,
implementation of manufacturing and quality systems, commercialization of NGAL tests, 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: September 30, 2021 = 6.4220 and September 30, 2022 = 7.6287
• Income statement measures for nine months ended: September 30, 2021 = 6.1842 and September 30,
2022 = 6.9144.
• Income statement measures for third quarter ended: September 30, 2021 = 6.2690 and September 30,
2022 = 7.3067.
Interim Report BioPorto, first nine months of 202
2
3
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK million (except where noted)
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Revenue
5.3
5.3
20.3
17.4
24.3
Gross profit
4.2
3.9
14.2
11.6
15.0
Sales and marketing costs
5.1
5.1
14.3
13.3
17.4
Research and development costs
10.7
7.6
28.5
23.1
30.3
Administrative costs
8.4
5.8
29.8
22.4
32.7
Loss before financial items (EBIT)
(20.0)
(14.5)
(58.3)
(47.2)
(65.3)
Financial items, net
1.2
0.6
1.9
1.1
1.4
Loss before tax
(18.8)
(13.9)
(56.4)
(46.1)
(63.8)
Net loss
(16.9)
(11.4)
(51.0)
(40.4)
(57.1)
Comprehensive loss
(18.5)
(11.9)
(53.3)
(41.1)
(58.3)
Non-current assets
15.7
18.2
17.1
Cash and cash equivalents
98.9
59.6
45.5
Current assets
117.9
82.5
64.2
Total assets
133.6
100.7
81.3
Equity
91.1
62.8
46.0
Non-current liabilities
9.2
11.2
10.5
Current liabilities
33.3
26.7
24.8
Total equity and liabilities
133.6
100.7
81.3
Cash flows from operating activities
(36.1)
(49.9)
(64.6)
Cash flows from investing activities
(0.5)
(0.4)
(0.4)
Of which investment in property, plant, and
equipment
(0.4)
(0.1)
(0.1)
Cash flows from financing activities
89.8
1.8
1.1
Net cash flows
53.2
(48.5)
(63.9)
Adjusted EBITDA
(17.1)
(15.0)
(49.5)
(45.2)
(61.9)
Revenue growth
(0.4%)
12%
16%
11%
5%
Gross profit percentage
80%
73%
70%
67%
62%
Equity ratio (solvency)
68%
62%
68%
62%
57%
Average number of employees
33
26
31
28
29
Number of shares at the end of the period (1,000)
334,693
267,754
334,693
267,754
267,754
Loss per share (EPS), DKK
(0.05)
(0.04)
(0.16)
(0.15)
(0.21)
Net asset value per share, period-end, DKK
0.27
0.23
0.27
0.23
0.17
Share price, period-end, DKK
1.34
3.16
1.34
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)
(20.0)
(14.5)
(58.3)
(47.2)
(65.3)
Depreciation and amortization
1.1
1.2
3.3
3.3
4.3
Share-based compensation expenses
1.8
(1.7)
5.6
(1.3)
(1.0)
Adjusted EBITDA
(17.1)
(15.0)
(49.5)
(45.2)
(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 nine months of 202
2
5
Continued progress on-plan
Revenue totaled DKK 5.3 million in the third quarter of 2022, which
was flat compared to the same period in the prior year. For the first
three quarters of 2022, revenue totaled DKK 20.3 million, a 16%
increase over the prior year period, reflecting sales growth of both
NGAL tests and Antibodies. In the third quarter 2022, revenue from
NGAL tests grew 4% over the prior year, and for the first three
quarters of 2022 revenue from NGAL tests increased by 15%
compared to the same period last year.
BioPorto prepares for FDA submission of NGAL test by
fourth quarter 2022
After achieving targeted subject enrollment in June 2022 for the third
and final part of a 3-part clinical study to support its FDA submission
for use of an NGAL test in identifying patients aged ≥3 months to 22
years at risk for AKI, BioPorto is compiling and analyzing the clinical
data.
Additionally, during the third quarter, BioPorto advanced its
preparations of the clinical report and the other required technical
and analytical documents for the De Novo submission. Consistent
with previous guidance, based on these workstreams and subject to
the quality of the clinical data, 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 the De Novo application for
the test is expected to receive expedited review upon submission.
After De Novo submission to the FDA, BioPorto plans to continue
executing its commercialization strategy, including hiring personnel
and preparing manufacturing and quality systems, while working to
make the test available for the adult populations (age 22 and over).
Considerations on capitalization of BioPorto
BioPorto has historically sought financing and applied the proceeds
towards implementation of its strategic priorities; most recently in a
rights issue in March 2022. As described in the Prospectus published
in connection with the rights issue, BioPorto considers it likely that it
will seek additional funding before or around the date falling twelve
months after the date of the prospectus. In preparation, the Company
may explore opportunities for a targeted cross-border offering,
including potentially in the U.S.
Events after the reporting period
As further described in Note 15, the Group commenced through a
third party the marketing of its leased Needham, MA office space
(“Needham Lease”) to be sub-leased. In due course, Group expects to
lease alternate office space in the Needham, MA area.
Management Review
This financial review is based on the Group’s consolidated financial
information as of and for the three and nine months ended September 30,
2022, with comparative results as of and for the three and nine months
ended September 30, 2021, in brackets.
Revenue
Revenue was DKK 5.3 million (DKK 5.3 million) in the third quarter of 2022
and DKK 20.3 million (DKK 17.4 million) in the first nine months of 2022.
NGAL test sales totaled DKK 2.7 million (DKK 2.6 million) in the third quarter
of 2022 and DKK 9.7 million (DKK 8.5 million) in the first nine months of
2022.
Antibody sales totaled DKK 2.1 million (DKK 1.7 million) in the third quarter
of 2022 and DKK 9.0 million (DKK 7.1 million) in the first nine months of
2022.
Figure 1. Revenue by quarter (DKK
million)
Figure
2. NGAL test product revenue by quarter (DKK
million)
Figure 3. NGAL product revenue, LTM (DKK million)
LTM: last twelve months
Gross Profit
Gross profit for the third quarter of 2022 was DKK 4.2 million (DKK 3.9
million), which was principally driven by a 630bps improvement in gross
profit percentage over the prior year period associated with higher average
selling prices.
Gross profit for the first nine months of 2022 totaled DKK 14.2 million (DKK
11.6 million), was predominantly driven by the DKK 2.0 million favorable
sales volume over the prior year period.
Sales and Marketing Costs
Sales and marketing costs totaled DKK 5.1 million (DKK 5.1 million) in the
third quarter of 2022, was flat compared to the same period in the prior
year.
Year to date, sales and marketing costs totaled DKK 14.3 (DKK 13.3 million).
The increase reflected higher staffing and travel costs, the latter of which
were meaningfully reduced in the prior year period due to COVID-19.
Research and Development Costs
Research and development costs in the third quarter of 2022 totaled DKK
10.7 million (DKK 7.6 million), with the increase principally reflecting an
increased rate of investment in clinical study costs based on the stage of
the Company’s clinical trials for NGAL tests, as well as higher staffing-
related costs.
Year to date, research and development costs totaled DKK 28.5 million (DKK
23.1 million), with the increase principally reflecting an increased rate of
investment in clinical study and related travel costs based on the stage of
the Company’s clinical trials for NGAL tests, as well as higher staffing-
related costs.
Administrative Costs
Administrative costs in the third quarter of 2022 totaled DKK 8.4 million
(DKK 5.8 million). The DKK 2.6 million increase is primarily related to a DKK
2.1 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 1.4 million, and offset by lower recruiting costs
in the current period.
4.2
6.7
4.7
7.6
5.6
6.6
5.3
6.8
6.5
8.5
5.3
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
2.7
0
1
2
3
4
5
6
Q1 Q2 Q3 Q4
2020 2021 2022
6
8
10
12
14
16
Financial Review
Interim Report BioPorto, first nine months of 202
2
7
Year to date, administrative costs totaled DKK 29.8 million (DKK 22.4
million). The DKK 7.4 million increase is primarily related to a DKK 3.6
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 3.3 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 third quarter
of 2022 was income of DKK 1.2 million (income of DKK 0.6 million). For the
first nine months of 2022, financial items, net was an income of DKK 1.9
million (income of DKK 1.1 million).
Tax Benefit
In the third quarter of 2022, a DKK 1.9 million tax benefit (income of DKK
2.5 million) was realized. The tax benefit is primarily related to tax credits
held by its Danish entities associated with the Company’s investment in
research and development.
EBIT/Adjusted EBITDA
For the third quarter of 2022, Earnings before interest and taxes (EBIT) was
a loss of DKK 20.0 million (DKK 14.5 million), and adjusted EBITDA was a loss
of DKK 17.1 million (DKK 15.0 million), reflecting the mix of variances
described above.
For the first nine months of 2022, EBIT was a loss of DKK 58.3 million (DKK
47.2 million), Adjusted EBITDA was a loss of DKK 49.5 million (loss of DKK
45.2 million), also reflecting the mix of variances described above.
Cash and Cash equivalents
As of September 30, 2022, BioPorto’s cash position was DKK 98.9 million
(DKK 59.6 million) and is primarily invested in deposit accounts with two
Nordic banks.
Net working capital
Net working capital (i.e., current assets minus current liabilities) as of
September 30, 2022 totaled DKK 84.6 million (DKK 55.8 million). Net
working capital as of September 30, 2022 reflected the Group’s issuance
and sale of approximately 66.9 million shares of common stock in a rights
offering that closed on April 1, 2022 for gross and net proceeds of DKK 100
million and DKK 93 million, respectively.
Cash Flow Statement
Cash used in operating activities during the first nine months of 2022
totaled DKK 36.2 million (DKK 50.5 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 nine months of 2022 cash from financing activities was DKK 89.8
million (DKK 1.8 million), primarily related to the share capital raise.
The net cash flow during the first nine months of 2022 was a source of DKK
52.9 million (use of DKK 48.5 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 analysis
of clinical trial data for NGAL in pediatrics. The quality or sufficiency of the
clinical or analytical data could be insufficient to support the study’s
endpoints and require the Company to obtain additional data; and, such
activities, if possible, would require additional cost and time.
A variety of factors and events, including the ongoing COVID-19 pandemic
and the war in Ukraine, have resulted in 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, or delays in the
Company’s execution of its commercialization strategy, including hiring
personnel and continuing to prepare manufacturing and quality systems,
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 and “Significant risks and
uncertainties” in BioPorto’s Interim Reports for the first and second
quarters of 2022, each of which sections 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 adjusted to reflect timing of costs
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 fourth quarter of 2022 is expected to reflect
continuing costs of finalizing clinical trials and incremental costs from the
impact of new hires and service contracts, including those that are intended
to support the commercialization of NGAL tests.
During the first nine months of 2022, BioPorto exercised appropriate cost
control and deferred certain commercialization expenses, thereby reducing
its costs below prior expectations. Consequently, BioPorto has revised its
2022 guidance for operating (EBIT) loss from approximately DKK (95) to
(100) million down to approximately DKK (83) to (88) million, and adjusted
EBITDA loss from approximately DKK (76) to (81) million down to
approximately DKK (71) to (75) million. BioPorto maintains its 2022 revenue
guidance of approximately DKK 24 to 27 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
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
Interim Report BioPorto, first nine months of 202
2
9
The Board of Directors and Executive Management today reviewed and approved the Interim Report of the BioPorto Group for the period January 1 to
September 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 September 30, 2022, and
the results of the Group’s operations and cash flows for the three- and nine-month periods ended January 1 to September 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, November 9, 2022
Executive Management:
___________________________ ___________________________
Board of Directors:
___________________________ ___________________________ __________________________
___________________________ ___________________________ ___________________________
Statement by the Board of Directors and
Management
10
Interim report
BioPorto, first nine months of 2022
Condensed Consolidated Statements of Profit or Loss
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Revenue 3 5,271 5,294 20,279 17,447 24,254
Production costs 4, 5, 8
Gross profit 4,207 3,889 14,205 11,613 15,041
Sales and marketing costs 4, 5 5,135 5,055 14,269 13,318 17,381
Research and development costs 4, 5 10,662 7,560 28,509 23,083 30,258
Administrative costs 4, 5 8,379 5,750 29,751 22,382 32,657
Loss before financial items (EBIT) (19,969 ) (14,476 ) (58,324 ) (47,170 ) (65,255 )
Financial income 1,712 843 2,876 1,765 2,461
Financial expenses 520 226 995 692 1,046
Loss before tax (18,777 ) (13,859 ) (56,443 ) (46,097 ) (63,840 )
Income tax benefit, net 6 1,900 2,475 5,445 5,726 6,727
Net loss (16,877 ) (11,384 ) (50,998 ) (40,371 ) (57,113 )
DKK
DKK
DKK
DKK
DKK
Loss per share (EPS & DEPS) 7 (0.05 0.04 0.16 0.15 0.21
Condensed Consolidated Statements of Comprehensive Loss
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Net loss (16,877 ) (11,384 ) (50,998 ) (40,371 ) (57,113 )
Other comprehensive loss:
Amounts which will be reclassified
to the income statement:
Exchange rate adjustments of
investments in subsidiaries
(1,580 ) (534 ) (2,339 ) (737 ) (1,219 )
Other comprehensive loss
(1,580 ) (534 ) (2,339 ) (737 ) (1,219 )
Comprehensive loss (18,457 ) (11,918 ) (53,337 ) (41,108 ) (58,332 )
Interim Financial Statements
Interim Report BioPorto, first nine months of 202
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11
Condensed Consolidated Balance Sheets
Assets
2022
2021
2021
Sep 30
Sep 30
Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Non-current assets
Property, plant and equipment and intangible assets
Rights and software 844 1,179 1,049
Fixtures and fittings, tools, and equipment
Right-of-use assets 8 11,075 13,210 12,345
Total property, plant and equipment and intangible assets 13,747 16,498 15,319
Financial assets
Deposits 1,920 1,720 1,739
Total financial assets
Total non-current assets 15,667 18,218 17,058
Current assets
Inventories, net 9 3,202 3,866 2,718
Trade receivables, net 10, 12
Taxes receivable 6 11,843 10,554 6,272
Other receivables 10, 12 389 604 738
Prepayments 10 1,018 809 1,769
Cash and cash equivalents 12 98,946 59,554 45,523
Total current assets 117,904 82,473 64,197
Total assets 133,571 100,691 81,255
12
Interim report
BioPorto, first nine months of 2022
Equity and Liabilities
2022
2021
2021
Sep 30
Sep 30
Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Equity
Share capital 11 334,693 267,754 267,754
Treasury shares 11
Exchange-rate adjustments (2,299 ) 363 (119 )
Retained earnings 11 (241,314 ) (205,296 ) (221,671 )
Total equity 91,080 62,821 45,964
Liabilities
Non-current liabilities
Lease obligation 8, 12 9,020 10,904 10,200
Other non-current liabilities 12
Non-current liabilities 9,157 11,205 10,501
Current liabilities
Current portion of non-current liabilities 12 3,255 3,015 2,975
Trade payables 12
Tax payables 97 82 84
Other payables 26,004 18,159 17,471
Current liabilities 33,334 26,665 24,790
Total liabilities 42,491 37,870 35,291
Total equity and liabilities 133,571 100,691 81,255
Interim Report BioPorto, first nine months of 202
2
13
Condensed Consolidated Statement of Changes in Equity (Unaudited)
Amounts in DKK thousand
Shares in thousand
Common Stock
Additional
Treasury Stock
Accumulated
Shares
Amount
Paid-in-Capital
Shares
Amount
Deficit
AOCI
Total
Balance at December 31, 2021
(221,671 )
(119 )
Comprehensive loss
(50 )
(50 )
Common Stock:
Issuance of stock, net (Note 11)
Options:
Share-based payment
Transfer of additional paid in
capital
(26,175 )
Net loss
(17,030 )
(17,030 )
Balance at March 31, 2022
(210,617 )
(169 )
Comprehensive loss
(709 )
(709 )
Common Stock:
Issuance of stock, net (Note 11)
(83 )
(83 )
Options:
Share-based payment
Transfer of additional paid in
capital
(83 )
Net loss
(17,091 )
(17,091 )
Balance at June 30, 2022
(225,898 )
(878 )
Comprehensive loss
(1,421 )
(1,421 )
Common Stock:
Issuance of stock, net (Note 11)
(312 )
(312 )
Options:
Share-based payment
Transfer of additional paid in
capital
(312 )
Net loss
(16,877 )
(16,877 )
Balance at September 30, 2022
(241,314 )
(2,299 )
14
Interim report
BioPorto, first nine months of 2022
Amounts in DKK thousand
Shares in thousand
Common Stock
Additional
Treasury Stock
Accumulated
Shares
Amount
Paid-in-Capital
Shares
Amount
Deficit
AOCI
Total
Balance at December 31, 2020
(166,770 )
Comprehensive loss
(229 )
(229 )
Options
Share-based payment
Transfer of additional paid in capital
Net loss
-
(15,364 )
(15,364 )
Balance at March 31, 2021
(180,715 )
Comprehensive loss
Options
Share-based payment
(4,629 )
Transfer of additional paid in capital
(6,790 )
Net loss
(13,623 )
(13,623 )
Balance at June 30, 2021
(192,177 )
Comprehensive loss
(534 )
(534 )
Options
Share-based payment
(3,624 )
(1,735 )
Transfer of additional paid in capital
(3,624 )
Net loss
(11,384 )
(11,384 )
Balance at September 30, 2021
(205,296 )
Interim Report BioPorto, first nine months of 202
2
15
Condensed Consolidated Statements of Cash Flows
2022
2021
2021
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Loss before financial items
(58,324 ) (47,170 ) (65,255 )
Depreciation and amortization
Share-based compensation expenses
Other non-cash items
Changes in inventories
(484 ) (701 ) 616
Changes in receivables
Changes in trade payables
(282 ) 773 (376 )
Changes in other operating assets and liabilities, net
Cash flows from operations
(35,942 ) (50,491 ) (69,030 )
Financial income, received
Financial expenses, paid
(1,034 ) (974 ) (1,425 )
Tax refund, net
Cash flows from operating activities
(36,111 ) (49,850 ) (64,577 )
Purchase of operating equipment
(407 ) (148 ) (130 )
Purchase of rights and software
(65 ) (270 ) (259 )
Purchase of financial assets
(31 ) (23 ) (23 )
Cash flows from investing activities
(503 ) (441 ) (412 )
Proceeds from warrant programs exercised
Proceeds from rights Issue
Cost related to Issue of new shares
(7,688 ) (23 ) (11 )
Reduction of non-current liabilities
(164 ) (151 ) (150 )
Repayments of lease obligation
(2,773 ) (2,368 ) (3,099 )
Cash flows from financing activities
Net cash flows for the period
Cash and cash equivalents at beginning of period
Effect of exchange rate changes on cash
Cash and cash equivalents end of period
16
Interim report
BioPorto, first nine months of 2022
1. Basis of reporting
Basis of preparation
This Interim Report and the accompanying unaudited interim condensed consolidated financial statements include the accounts of BioPorto A/S
subsidiaries (“BioPorto” or “the Group”). All significant intercompany accounts and transactions have been eliminated in consolidation. The accompanying
unaudited interim 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 have 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 interim 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 interim 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 unaudited interim condensed consolidated 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 September 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. The Group has not implemented any new or modified standards and interpretations that are not yet effective. 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 Financial
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 in the Annual Report as of and for the year ended December 31,
2021, to which reference is made.
Notes to Interim Condensed Consolidated
Financial Statements (Unaudited)
Interim Report BioPorto, first nine months of 202
2
17
3. Business area reporting
GEOGRAPHIC DISTRIBUTION
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK Thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Europe 891 672 6,367 5,352 7,708
North America
3,227 4,039 11,387 9,626 13,451
Asia 1,153 568 2,517 2,438 3,065
Other regions - 15 8 31 30
Revenue 5,271 5,294 20,279 17,447 24,254
Product groups
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK Thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
NGAL tests 2,664 2,560 9,722 8,469 12,351
Antibodies
2,119 1,716 9,006 7,068 9,291
ELISA kits 476 996 1,520 1,863 2,548
Royalty and other revenue 12 22 31 47 64
Revenue 5,271 5,294 20,279 17,447 24,254
18
Interim report
BioPorto, first nine months of 2022
4. Share-based payment
For the purpose of motivating and retaining Management and key staff and aligning their interests with those of its shareholders, BioPor to 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.
I
n the first nine months of 2022 and 2021, share-based compensation expense totaled DKK 5.6 million and income of DKK 1.3 million, respectively. The
year-to-date 2021 amount reflects the impact of a DKK 4.0 million non-cash equity compensation recovery related to forfeited warrants.
The warrant terms are included in the Company’s Articles of Association, which can be found at www.bioporto.com
. U
pon vesting, each warrant entitles
the recipient to subscribe for one share in BioPorto A/S.
Warrants overview 2022
Outstanding at
January 1
Granted
Exercised
Expired
Forfeited
Outstanding at
Sep 30
Exercisable at
Sep 30
August 2018 2,100,000 - - (400,000) (1,700,000) - -
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 - - - (350,000) 1,000,000 -
February 2021 350,000 - - - - 350,000 -
December 2021 12,150,000 - - - (550,000) 11,600,000 -
May 2022 - 270,000 - - - 270,000 -
Total 20,600,000 270,000 - (400,000) (6,000,000) 14,470,000 1,250,000
Outstanding at
January 1
Granted
Exercised
Expired
Forfeited
Outstanding at
Sep 30
Exercisable at
Sep 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 - - - (6,000,000) 500,000 -
Total 20,600,000 270,000 - - (6,000,000) 14,870,000 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.
Interim Report BioPorto, first nine months of 202
2
19
5. Amortization and depreciation
The following tables reflect the amortization and depreciation of the respective asset class and the classification of such expenses in the interim
consolidated statements of profit or loss.
RIGHTS AND SOFTWARE
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Intangible assets 77 129 270 245 335
Total amortization
77 129 270 245 335
Classification of amortization:
Production costs 17 28 48 28 40
Sales and marketing costs
35 34 104 104 139
Research and development costs 17 28 48 28 40
Administrative costs 8 39 70 85 116
Total amortization 77 129 270 245 335
PROPERTY, PLANT AND EQUIPMENT
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Property, plant, and equipment 205 272 584 524 719
Total depreciation
205 272 584 524 719
Classification of depreciation:
Production costs 49 33 122 84 114
Sales and marketing costs
29 120 82 120 163
Research and development costs 91 97 275 277 369
Administrative costs 36 22 105 43 73
Total depreciation 205 272 584 524 719
RIGHT-OF-USE ASSETS
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Right-of-use assets 825 770 2,416 2,486 3,275
Total depreciation
825 770 2,416 2,486 3,275
Classification of depreciation:
Sales and marketing costs 408 349 1,162 1,206 1,447
Administrative costs
417 421 1,254 1,280 1,828
Total depreciation 825 770 2,416 2,486 3,275
20
Interim report
BioPorto, first nine months of 2022
6. Taxes
The Group has a deferred tax asset. However, Management has found that it is not sufficiently probable that the tax asset can be utilized in the foreseeable
future. Management has therefore decided not to recognize tax assets 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.
Taxes receivable represent refunds anticipated within the next twelve months for payments in excess of previous US federal tax liabilities and tax credits
held by its Danish entities associated with the Company’s investment in research and development.
7. Loss per share
2022
2021
2022
2021
2021
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand (except where noted)
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Loss for the period (16,877) (11,384) (50,998) (40,371) (57,113)
BioPorto Group's share of loss
(16,877) (11,384) (50,998) (40,371) (57,113)
Weighted average number of shares 334,693 267,754 313,009 267,333 267,436
Weighted average number of treasury shares
(13) (13) (13) (13) (13)
Weighted average number of shares
outstanding – basic
334,680 267,741 312,996 267,320 267,423
Weighted average number of shares in
circulation – diluted
334,680 267,741 312,996 267,320 267,423
Loss per share (EPS), DKK (0.05) (0.04) (0.16) (0.15) (0.21)
Warrants outstanding were not included in the calculation of loss per share because the effect would have been anti-dilutive.
8. Leases
RIGHT-OF-USE ASSETS
2022
2021
2021
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Cost at January 1 19,355 15,083 15,083
Additions during the period
- 5,018 5,018
Disposals during the period - (893) (1,602)
Currency adjustments 1,668 620 856
Cost at end of period 21,023 19,828 19,355
Accumulated depreciation at January 1 7,010 4,822 4,822
Depreciation expense during the period
2,416 2,486 3,275
Disposals during the period - (893) (1,303)
Currency adjustments 522 203 216
Accumulated depreciation at end of period 9,948 6,618 7,010
Carrying amount at end of period 11,075 13,210 12,345
Interim Report BioPorto, first nine months of 202
2
21
LEASE OBLIGATION
2022
2021
2021
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Current 3,114 1,141 2,834
Non-current
9,020 7,619 10,200
Lease obligation end of period 12,134 8,760 13,034
LEASE OBLIGATION
2022
2021
2021
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Less than 1 year 3,114 1,141 2,834
Between 1 and 5 years
9,020 6,534 9,562
More than 5 years - 1,085 638
Total 12,134 8,760 13,034
Amounts recognized in condensed consolidated statements of profit or loss
2022
2021
2021
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Depreciation charge of right-of-use assets 2,416 2,486 3,275
Interest expense (included in financial expenses)
565 435 628
Expense related to short-term leases - 7 7
Total 2,981 2,928 3,910
22
Interim report
BioPorto, first nine months of 2022
9. Inventories
2022
2021
2021
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Raw materials and consumables 1,782 1,841 1,702
Work in Progress
1,232 - -
Finished goods 1,862 2,909 2,690
Reserves (1,674) (884) (1,674)
Inventories, net 3,202 3,866 2,718
Write downs recognized as an expense in the period - 58 548
2022
2021
2021
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
(Unaudited)
(Unaudited)
Cost of sales included in production costs in the period 2,155 860 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
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables 2,862 7,955 8,076
Other receivables
389 604 738
Prepayments 1,018 809 1,769
Provisions for bad debt (356) (869) (899)
Financial assets at amortized costs 3,913 8,499 9,684
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 12.
11. Share capital
As of September 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 September 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 September 30, 2022, BioPorto A/S is
not authorized to acquire treasury shares. BioPorto A/S did not acquire treasury shares during the nine months ended September 30, 2022 or the year
ended December 31, 2021.
Interim Report BioPorto, first nine months of 202
2
23
Following are the increases in share capital for each period presented:
2022
2021
2021
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Issue, gross proceeds 100,408 4,361 4,361
Issue costs
(7,688) (23) (11)
Net proceeds 92,720 4,338 4,350
12. Financial risks and financial instruments
Financial instrument categories
2022
2021
2021
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables, net 2,506 7,086 7,177
Other receivables
389 604 738
Cash and cash equivalents 98,946 59,554 45,523
Financial assets at amortized costs 101,841 67,244 53,438
2022
2021
2021
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Lease liabilities 12,134 9,228 13,034
Other non-current liabilities
278 4,992 442
Trade payables 3,978 5,409 4,260
Financial liabilities at amortized costs 16,390 19,629 17,736
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 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. Substantially all of the Group’s assets consisted of bank deposits.
24
Interim report
BioPorto, first nine months of 2022
Credit risk
The Group’s credit risk is primarily associated with trade receivables. Cash and cash equivalents are deposited with major Nordic 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 and specific customer circumstances. Trade receivables are written off when there is no reasonable
expectation of recovery.
AS OF SEPTEMBER 30, 2022 (UNAUDITED)
DKK thousand
Expected
credit loss
rate
Trade
receivables
Expected loss
Total
Not due 0.7% 1,673 12 1,661
1 - 30 days overdue 0.8% 396 3 393
31 - 60 days overdue 3.1% 64 2 62
61 - 90 days overdue 0.0% 175 - 175
More than 90 days overdue 61.2% 554 339 215
September 30, 2022 2,862 356 2,506
AS OF SEPTEMBER 30, 2021 (UNAUDITED)
DKK thousand
Expected
credit loss
rate
Trade
receivables
Expected loss
Total
Not due 1.8% 2,717 48 2,669
1 - 30 days overdue 2.1% 330 7 323
31 - 60 days overdue 1.9% 885 17 868
61 - 90 days overdue 15.6% 390 61 329
More than 90 days overdue 20.3% 3,633 736 2,897
September 30, 2022 7,955 869 7,086
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 98.9 million and DKK 45.5 million as of September 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 marketing authorization of an NGAL test in pediatrics in 2022, and preparing for its
commercialization 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.
Interim Report BioPorto, first nine months of 202
2
25
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.
15. Subsequent event
After the end of the third quarter, the Group commenced through a third party the marketing of its leased Needham, MA office space (“Needham Lease”)
to be sub-leased. In due course, Group expects to lease alternate office space in the Needham, MA area. The Needham Lease represented DKK 7.7 million
of the Group’s right-of use assets and DKK 8.6 million lease obligation as of September 30, 2022.
26
Interim report
BioPorto, first nine months of 2022
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
BioPorto A/S BioPorto, Inc.
CVR DK-17500137