DK-2900 Hellerup
CVR DK-17500317
Interim Report
First Quarter of 2022, BioPorto Group
May 11, 2022
Announcement no. 11
2
Interim Report BioPorto, first quarter of 2022
Strong performance of The NGAL
Test drives revenue growth
Revenues totaled DKK 6.5 million in the first quarter of 2022, a 17% increase
over the prior year. This growth was driven by a 70% increase in The NGAL
Test sales, primarily from research use only (RUO) sales in the US and the
timing of customer orders, which were up 116% over the prior year and a
10% increase in rest-of-the-world (ROW) sales of the test. ELISA kit revenue
increased 138% in the first quarter of 2022 over the prior year period, offset
by a 38% reduction in antibodies sales that were consistent with
expectations in the absence of an individual bulk order during the quarter.
Tony Pare, CEO, commented “The first quarter of 2022 was an encouraging
start for BioPorto and this new team on several fronts. We have developed
and are executing detailed plans to support US FDA submission, approval,
and launch of The NGAL test. We also achieved favorable revenue growth,
including The NGAL Test sales, reflecting a combination of growing clinician
interest in this impactful biomarker for critical care patients and the timing
of customer orders.”
Strategic focus on preparing
BioPorto for US breakthrough
The NGAL Test has been granted Breakthrough Device designation by the
FDA for expedited review. Breakthrough Device designation is granted for
devices that provide for more effective treatment or diagnosis of life-
threatening or irreversibly debilitating human disease or conditions, and
where neither approved nor cleared alternatives exist.
In the first quarter of 2022, BioPorto’s new leadership team developed an
18 month strategy focused on delivering the NGAL biomarker as the new
standard of care in assessing Acute Kidney Injury (AKI), preparing the
Company to commercialize and scale, and building a strong team dedicated
to the mission.
Consequently, BioPorto’s clear priority and focus is on obtaining US FDA
approval of its flagship product, The NGAL Test, for use in pediatrics (under
age 22) and drive its adoption in the US.
Targeted Enrollment of Pediatric
Patients Remains On-track by end-
June 2022
As planned, BioPorto is enrolling pediatric patients at fifteen top hospitals
across the US for the third part of a 3-part clinical study to support an US
Food and Drug Administration (FDA) submission of The NGAL Test for use
in identifying children under age 22 at risk of AKI. The Company continues
to expect that it will complete the targeted enrollment for the study's
objectives in the second quarter of 2022, and then finalize analysis of the
data to support the FDA filing.
Successful and Fully Subscribed
Share Offering Provides Runway for
Strong Strategic Execution
On April 1, 2022, BioPorto raised net proceeds of approximately
DKK 93.1 million, from a fully subscribed pre-emptive rights offering of new
shares as part of a long-term capital plan that includes a potential US listing.
The proceeds will, together with existing funds, provide a foundation for
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.
Guidance for 2022 maintained
Based on the progress and results obtained in first three months of 2022,
BioPorto maintains its financial guidance for 2022, as most recently
described in its Annual Report 2021 of:
• Revenue of approximately DKK 24 to 26 million;
• Operating (EBIT) loss of approximately DKK 95 to 100 million; and,
• Adjusted EBITDA loss of approximately DKK 76 to 81 million.
In March and April BioPorto raised net proceeds of DKK 93.1 million in a
fully-subscribed pre-emptive rights issue that provides funding to complete
the targeted enrollment in the US for our pediatric trial of The NGAL Test,
and subsequently prepare and submit the application to the FDA.
Investor and Analyst Meetings
In connection with the release of the Interim Report for the first quarter of
2022, the Company’s management team will host an online investor
presentation on May 11, 2022 at 14:00 CET via HC Andersen Capital. For
registration, please visit:
https://hcandersencapital643.clickmeeting.com/bioporto-presentation-
of-q1-quarterly-results-2022/register.
A separate analyst call will be held on May 11, 2022 at 16:00 CET. For
further information regarding the analyst call, please visit:
www.bioporto.com/investor-relations.
Highlights
Interim Report BioPorto, first quarter of 2022
3
2022
2021
2021
DKK million
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
(Unaudited)
(Unaudited)
(Unaudited)
Revenue
6.5
5.6
24.3
Production costs
2.6
2.4
9.2
Sales and marketing costs
4.0
5.4
17.4
Research and development costs
8.0
8.2
30.3
Administrative costs
10.1
7.7
32.7
Loss before financial items (EBIT)
(18.2)
(18.2)
(65.3)
Financial items, net
(0.1)
1.1
1.4
Loss before tax
(18.3)
(17.1)
(63.8)
Net loss
(17.0)
(15.4)
(57.1)
Total comprehensive income
(17.1)
(15.6)
(58.3)
Non-current assets
16.7
15.2
17.1
Current assets
146.6
106.2
64.2
Total assets
163.3
121.4
81.3
Equity
123.9
86.7
46.0
Non-current liabilities
9.7
8.3
10.5
Current liabilities
29.6
26.3
24.8
Total equity and liabilities
163.3
121.4
81.3
Cash flows from operating activities
(16.6)
(21.1)
(64.6)
Cash flows from investing activities, net
(0.5)
(0.2)
(0.4)
Of which investment in property, plant and equipment
(0.1)
(0.1)
(0.1)
Cash flows from financing activities
(1.4)
(1.0)
1.1
Total cash flows
(18.5)
(22.3)
(63.9)
Adjusted EBITDA
(15.2)
(15.7)
(61.9)
Revenue growth
17%
33%
5%
Gross margin
61%
57%
62%
Equity ratio (solvency)
76%
71%
57%
Average number of employees
32
29
29
Number of shares by the end of the period (1,000)
334,693
266,582
267,754
Earnings per share (EPS), DKK
(0.06)
(0.06)
(0.21)
Net asset value per share, period-end, DKK
0.37
0.33
0.17
Share price, period-end, DKK
1.91
5.52
2.47
Consolidated Financial Highlights
4
Interim Report BioPorto, first quarter of 2022
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK million
(Unaudited)
(Unaudited)
(Unaudited)
Reconciliation of Adjusted EBITDA
Loss before financial items (EBIT)
(18,218)
(18,178)
(65,255)
Depreciation and amortization
1,062
1,041
4,329
Share-based compensation expenses
1,909
1,419
(966)
Adjusted EBITDA
(15,247)
(15,718)
(61,892)
Interim Report BioPorto, first quarter of 2022
5
Strong growth in revenue from sales of The NGAL Test
drives increase in total revenue
In the first quarter of 2022, revenue was DKK 6.5 million, corresponding to
a growth of 17% year-over-year.
The increase in revenue in the first quarter was driven by an increase in
sales of The NGAL Test by 70% in the first quarter of 2022 compared to the
same period last year. Revenue from Research Use Only sales of The NGAL
Test in the US increased 116% year-on-year to DKK 2.7 million in first
quarter 2022 reflecting in part the timing of customer orders, while sales of
The NGAL Test in EU and the rest of the world increased 10% in the same
period to DKK 1.0 million.
Revenue from sales of antibodies in the first quarter of 2022 was DKK 1.9
million compared to DKK 3.0 million in the prior year period, reflecting
results in line with expectations
Revenue from sales of ELISA kits saw an increase of 138% to DKK 0.9 million
in first quarter of 2022 compared to last year.
Strategic Focus on Preparing BioPorto for US Breakthrough
In the first quarter of 2022, BioPorto’s new leadership team developed a
12-18 month strategy focused on delivering the NGAL biomarker as the new
standard of care in assessing AKI, preparing the Company to commercialize
and scale, and building a strong team dedicated to the mission.
With a unique technology and high ambitions, BioPorto will have a clear
prioritization and focus on obtaining US FDA approval of its flagship
product, The NGAL Test, for use in pediatrics (under age 22) and drive its
adoption in the US. Following a submission of the pediatric test to the FDA,
and in parallel with FDA review, BioPorto will take steps towards FDA
approval of an adult indication in the US. BioPorto will also continue
activities to discover, develop and commercialize other high medical value
biomarker tests.
Enrollment of Pediatric Patients Expected to be Finalized
end-June 2022
As planned, BioPorto is working towards completing enrollment of
pediatric patients at fifteen top hospitals across the US for the third part of
a 3-part clinical study to support an FDA submission of The NGAL Test for
use in identifying children at risk for AKI. The NGAL Test has been granted
Breakthrough Device designation by the FDA for expedited review.
Breakthrough Device designation is granted for devices that provide for
more effective treatment or diagnosis of life-threatening or irreversibly
debilitating human disease or conditions, and where neither approved nor
cleared alternatives exist.
Enrollment remains on-track to complete the targeted level for the study’s
objectives in the second quarter of 2022, after which the data will be
analyzed and packaged with other technical documentation to support
submission to the US FDA for its review.
Successful and Fully Subscribed Share Offering Provides
Runway for Strong Strategic Execution
On April 1, 2022, BioPorto raised net proceeds of approximately
DKK 93.1 million, from a fully subscribed pre-emptive rights offering of new
shares as part of a long-term capital plan that includes a potential US listing.
In total, 66,938,601 new shares of common stock were offered and sold
pursuant to a Prospectus for a rights offering with pre-emptive rights for
existing shareholders that was filed on March 7, 2022.
The proceeds will, together with existing funds, provide a foundation for
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.
Events after the reporting period
On April 28, 2022, BioPorto A/S convened its annual general meeting for
presentation of the Annual Report for 2021 and reelection of the Board of
Directors. Furthermore, the Board of Directors’ proposals were approved.
Management Review
6
Interim Report BioPorto, first quarter of 2022
The financial review is based on the Group’s consolidated financial
information as of and for the three months ended March 31, 2022, with
comparative results as of and for the three months ended March 31, 2021
in brackets.
In the first quarter of 2022, revenues totaled DKK 6.5 million (DKK 5.6
million). Earnings before interest and taxes (EBIT) showed a loss of DKK 18.2
million (DKK 18.2 million). Adjusted EBITDA reflected a loss of DKK 15.3
million (DKK 15.7 million)
Revenue
Revenue in the first quarter of 2022 was DKK 6.5 million (DKK 5.6 million).
Total revenue in the first quarter included DKK 2.7 million (DKK 1.2 million)
from RUO sales in the US and DKK 1.0 million (DKK 0.9 million) from sales
in the EU and rest of the world. In the first quarter of 2022 NGAL revenue
totaled DKK 3.7 million (DKK 2.2 million).
Revenue from the sale of antibodies amounted to DKK 1.9 million (DKK 3.0
million) in the first quarter of 2022.
Revenues from the sale of ELISA kits totaled DKK 0.9 million (DKK 0.4
million) during the first quarter 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
Production Costs
Production costs in the first quarter of 2022 were DKK 2.6 million (DKK 2.4
million) bringing the gross profit for the quarter to DKK 3.9 million (DKK 3.2
million), corresponding to gross profit percentage of 61% (57%).
Sales and Marketing Costs
Sales and marketing costs totaled DKK 4.0 million (DKK 5.4 million) in the
first quarter of 2022. The reduction is driven primarily by lower staffing
costs of DKK 1.3 million.
Research and Development Costs
Research and development costs in the first quarter of 2022 totaled DKK
8.0 million (DKK 8.2 million), reflecting consistent investment in clinical
study costs and R&D activities.
Administrative Costs
Administrative costs in the first quarter of 2022 totaled DKK 10.1 million
(DKK 7.7 million). The increase is primarily related to increased staffing
costs and the timing of certain changes in personnel.
Financials Items, Net
Financial items, net for the first quarter of 2022 was an expense of DKK 0.1
million (income of DKK 1.1 million).
Tax on Income for the Period
In the first quarter of 2022 tax on income for the year was an income of
DKK 1.3 million (income of DKK 1.7 million). Tax on income for the year is
primarily related to refunded tax losses originating from research and
development costs.
EBIT/Adjusted EBITDA
Earnings before interest, taxes, and financial items (EBIT) was a loss of DKK
18.2 million (DKK 18.2 million) reflecting favorable revenue and margin, and
a reduction in sales and marketing costs, somewhat offset by an increase in
administrative costs.
Adjusted EBITDA was a loss of DKK 15.2 million (loss of DKK 15.7 million),
reflecting a DKK 0.5 million increase in non-cash equity compensation costs.
4,2
6,7
4,7
7,6
5,6
6,6
5,3
6,8
6,5
0
2
4
6
8
Q1 Q2 Q3 Q4
2020 2021 2022
2,1
5,0
2,7
3,6
2,1
3,7
2,6
3,73,7
0
2
4
6
Q1 Q2 Q3 Q4
2020 2021 2022
4
6
8
10
12
14
16
Q1 2018
Q2 2018
Q3 2018
Q4 2018
Q1 2019
Q2 2019
Q3 2019
Q4 2019
Q1 2020
Q2 2020
Q3 2020
Q4 2020
Q1 2021
Q2 2021
Q3 2021
Q4 2021
Q1 2022
Financial Review
Interim Report BioPorto, first quarter of 2022
7
Cash and cash equivalents
As of March 31, 2022, BioPorto’s cash position was DKK 27.0 million (DKK
86.7 million) and is primarily invested in deposit accounts with two Nordic
banks.
Net working capital
Net working capital as of March 31, 2022 totals DKK 117.6 million (DKK 79.9
million). Net working capital as of March 31, 2022 reflected the Group’s
issuance and sale of approximately 66.9 million shares of common stock for
gross proceeds of approximately DKK 100.4 million and net proceeds of DKK
93.1 million. The gross proceeds were classified within Other receivables as
of March 31, 2022, as they were legally bound for the benefit of the Group
as of that date. Correspondingly, unpaid costs of the offering as of March
31, 2022 totaling approximately DKK 6.7 million were accrued within Trade
payables and Other payables.
Equity
The DKK 93.1 million net increase in Share capital was recognized as of
March 31, 2022.
Cash Flow Statement
Cash used in operating activities during the first quarter of 2022 totaled
DKK 16.6 million (DKK 21.1 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 0.2 million) which
primarily consisted of investments in lab equipment.
In the first quarter of 2022 cash used in financing activities was DKK 1.4
million (DKK 1.0 million), primarily related to the repayment of lease
obligations.
The net cash flow during the first quarter of 2022 was a use of DKK 18.5
million (use of DKK 22.3 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. 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, 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, financial condition, and/or operating
results.
Guidance for 2022 maintained
Based on the progress and results obtained in first three months of 2022,
BioPorto maintains its financial guidance for 2022, as most recently
described in its Annual Report 2021 of:
• Revenue of approximately DKK 24 to 26 million;
• Operating (EBIT) loss of approximately DKK 95 to 100 million; and,
• Adjusted EBITDA loss of approximately DKK 76 to 81 million.
Forward-looking 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
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, Zenith Advisory
Tel: +45 4529 0000
E-mail: investor@bioporto.com
www.bioporto.com
8
Interim report BioPorto, first quarter of 2022
Executive Management:
___________________________ ___________________________
Board of Directors:
___________________________ ___________________________ __________________________
___________________________ ___________________________ ___________________________
Interim Report BioPorto, first quarter of 2022
9
Condensed Consolidated Statements of Operations
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Revenue
3
Production costs
4,5,8
Gross profit
Sales and marketing costs
4,5
Research and development costs
4,5
Administrative costs
4,5
Loss before financial items (EBIT)
(18,218 )
(18,178 )
(65,255 )
Financial income
Financial expenses
Loss before tax
(18,282 )
(17,088 )
(63,840 )
Income taxes
6
(1,252 )
(1,724 )
Net loss
(17,030 )
(15,364 )
(57,113 )
DKK
DKK
DKK
Loss per share (EPS & DEPS)
7
(0.06 )
(0.06 )
(0.21 )
Condensed Consolidated Statements of Comprehensive Loss
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Net loss
(17,030 )
(15,364 )
(57,113 )
Other comprehensive loss:
Amounts which will be reclassified to the income statement:
Adjustment of foreign currency fluctuations on subsidiaries
(50 )
(229 )
(1,219 )
Other comprehensive loss
(50 )
(229 )
(1,219 )
Comprehensive loss
(17,080 )
(15,593 )
(58,332 )
Financial Statements
10
Interim report BioPorto, first quarter of 2022
Condensed Consolidated Balance Sheets
Assets
2022
2021
2021
Mar 31
Mar 31
Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Non-current assets
Property, plant and equipment and intangible assets
Rights and software
Property, plant and equipment
Right-of-use assets
8
Total property, plant and equipment and intangible assets
Financial assets
Deposits
Total financial assets
Total non-current assets
Current assets
Inventories, net
9,14
Trade receivables, net
10,13,14
Income tax receivable
Other receivables
10,13,14
Prepayments
10,14
Total inventories and receivables
Cash and cash equivalents
13
Total current assets
Total assets
Interim Report BioPorto, first quarter of 2022
11
Equity and Liabilities
2022
2021
2021
Mar 31
Mar 31
Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Equity
Share capital
11,15
Treasury shares
12
Exchange-rate adjustments
(169 )
(119 )
Retained earnings
(210,617 )
(180,715 )
(221,671 )
Total equity
Liabilities
Non-current liabilities
Lease obligation
13
Other non-current liabilities
13
Non-current liabilities
Current liabilities
Current portion of non-current liabilities
13
Trade payables
13,14
Tax payables
Other payables
14
Current liabilities
Total liabilities
Total equity and liabilities
12
Interim report BioPorto, first quarter of 2022
Condensed Consolidated Statements of Changes in Equity (Unaudited)
DKK thousand
Share capital
Share premium
Exchange rate
adjustments
Retained
earnings
Total
Equity January 1, 2022
(119 )
(221,671 )
Loss for the year
(17,030 )
(17,030 )
Other comprehensive income:
Adjustment of foreign currency fluctuations on subsidiaries
(50 )
(50 )
Total comprehensive income
(50 )
(17,030 )
(17,080 )
Transactions with owners:
Issue
Issue costs
(7,294 )
(7,294 )
Share-based compensation
Transferred to retained earnings
(26,175 )
Equity March 31, 2022
(169 )
(210,617 )
DKK thousand
Share capital
Share premium
Exchange rate
adjustments
Retained
earnings
Total
Equity January 1, 2021
(166,770 )
Loss for the year
(15,364 )
(15,364 )
Other comprehensive income:
Adjustment of foreign currency fluctuations on subsidiaries
(229 )
(229 )
Total comprehensive income
(229 )
(15,364 )
(15,593 )
Transactions with owners:
Share-based compensation
Transferred to retained earnings
Equity March 31, 2021
(180,715 )
Interim Report BioPorto, first quarter of 2022
13
Condensed Consolidated Statements of Cash Flows
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Loss before financial items
(18,218 )
(18,178 )
(65,255 )
Depreciation and amortization
Share-based compensation expenses
(966 )
Other non-cash items
Cash generated from operations before working capital
(15,247 )
(15,718 )
(61,582 )
Changes in working capital
14
(1,180 )
(5,109 )
(7,448 )
Cash generated from operations
(16,427 )
(20,827 )
(69,030 )
Financial income, received
Financial income, paid
(301 )
(324 )
(1,425 )
Tax refund, net
Cash flows from operating activities
(16,625 )
(21,069 )
(64,577 )
Purchase of property, plant and equipment
(407 )
(53 )
(130 )
Purchase of rights and software
(65 )
(196 )
(259 )
Purchase of financial assets
(23 )
Cash flows from investing activities
(472 )
(249 )
(412 )
Proceeds from warrant programs exercised
Issue costs
(603 )
(11 )
Payments of non-current liabilities
(161 )
(151 )
(150 )
Payments of lease obligation
(669 )
(808 )
(3,099 )
Cash flows from financing activities
(1,433 )
(959 )
Net cash flow from operating, investing and financing activities
(18,530 )
(22,277 )
(63,888 )
Cash and cash equivalents at beginning of period
Effect of exchange rate changes on cash
Cash and cash equivalents end of period
14
Interim report BioPorto, first quarter of 2022
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 year
presentation.
As of March 31, 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
onsolidated 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.
Development projects
In the opinion of Management, the development of the Group's products generally involves a high degree of risk, and therefore there is currently no
adequate documentation for the future income. The future economic benefits from the product development cannot be estimated with sufficient certainty
until the associated development activities have been completed and received applicable regulatory clearances. Accordingly, development costs are ex-
pensed as incurred.
Tax assets
The Group has a significant deferred tax asset (see Note 9). However, Management has concluded in accordance with IFRS, that it is not sufficiently probable
that the tax asset could be utilized in the foreseeable future. Management has therefore not recognized the calculated tax asset on the balance sheet.
Notes to Condensed Consolidated
Financial Statements (Unaudited)
Interim Report BioPorto, first quarter of 2022
15
3. Business area reporting
GEOGRAPHIC DISTRIBUTION
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK Thousand
(Unaudited)
(Unaudited)
Europe
1,170
2,538
7,708
North America
4,260
2,186
13,451
Asia
1,072
847
3,065
Other regions
-
6
30
Revenue
6,502
5,577
24,254
PRODUCT GROUPS
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK Thousand
(Unaudited)
(Unaudited)
NGAL tests
3,729
2,194
12,351
ELISA kits
896
377
2,548
Antibodies
1,868
2,993
9,291
Royalty and other revenue
9
13
64
Revenue
6,502
5,577
24,254
16
Interim report BioPorto, first quarter of 2022
4. Incentive schemes
For the purpose of motivating and retaining Management and key staff and aligning their interests with those of its shareholders, BioPorto A/S uses
warrants as an incentive scheme. The arrangements, which are exercised by the issuance of new shares (equity-settled share-based payment transaction),
entitle the recipient to subscribe for new shares in the parent company at a price defined on the date of grant.
In the first quarter of 2022 share-based compensation expense totaled DKK 1.9 million (2021: expense of DKK 1.4 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 B ioPorto A/S . No new warrants were issued during the first quarter of 2022.
WARRANTS OVERVIEW 2022
Outstanding at
January 1
Forfeited
Outstanding at
March 31
Exercisable at
March 31
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
-
12,150,000
-
Total
20,600,000
(5,300,000)
15,300,000
1,250,000
Outstanding at
January 1
Forfeited
Outstanding at
March 31
Exercisable at
March 31
Executive Management
8,400,000
-
8,400,000
-
Management
5,700,000
-
5,700,000
1,250,000
Other employees
6,500,000
(5,300,000)
1,200,000
-
Total
20,600,000
(5,300,000)
15,300,000
1,250,000
For a specification of the parameters for the Black-Scholes model see Note 5 in Annual Report 2021 of the BioPorto Group.
Interim Report BioPorto, first quarter of 2022
17
5. Amortization and depreciation
RIGHTS AND SOFTWARE
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Intangible assets
92
58
335
Total amortization
92
58
335
Specification of amortization:
Production costs
13
-
40
Sales and marketing costs
35
35
139
Research and development costs
13
-
40
Administrative expenses
31
23
116
Total amortization
92
58
335
PROPERTY, PLANT AND EQUIPMENT
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Property, plant and equipment
182
128
719
Total depreciation
182
128
719
Specification of depreciation:
Production costs
30
26
114
Sales and marketing costs
26
-
163
Research and development costs
91
91
369
Administrative expenses
35
11
73
Total depreciation
182
128
719
RIGHT-OF-USE ASSETS
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Right-of-use assets
788
855
3,275
Total depreciation
788
855
3,275
Specification of depreciation:
Sales and marketing costs
370
426
1,447
Administrative expenses
418
429
1,828
Total depreciation
788
855
3,275
18
Interim report BioPorto, first quarter of 2022
6. Deferred tax
The Group has a significant deferred tax asset. However, Management has found that, regarding IFRS, it is not sufficiently probable that the tax asset can
be utilized in the foreseeable future. Management has therefore decided not to recognize the calculated tax asset on the balance sheet, cf. Note 2. The
tax asset is of indefinite duration.
7. Earnings per share
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand except per share amounts
(Unaudited)
(Unaudited)
Loss for the period
(17,030)
(15,364)
(57,113)
BioPorto Group's share of loss
(17,030)
(15,364)
(57,113)
Weighted average number of shares
268,918
266,582
267,436
Weighted average number of treasury shares
(13)
(13)
(13)
Weighted average number of shares outstanding – basic
268,905
266,569
267,423
Weighted average number of shares in circulation – diluted
268,905
266,569
267,423
Loss per share (EPS)
(0.06)
(0.06)
(0.21)
8. Right-of-use assets
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Cost at January 1
19,355
15,083
15,083
Additions during the period
-
-
5,018
Disposals during the period
-
-
(1,602)
Currency adjustments
218
486
856
Cost at end of period
19,573
15,569
19,355
Accumulated depreciation at January 1
7,010
4,822
4,822
Depreciation expense during the period
788
855
3,275
Disposals during the period
-
-
(1,303)
Currency adjustments
57
93
216
Depreciation at end of period
7,855
5,770
7,010
Carrying amount at end of period
11,718
9,799
12,345
Interim Report BioPorto, first quarter of 2022
19
LEASE LIABILITY
2022
2021
2021
Mar 31
Mar 31
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Current
2,929
2,285
2,834
Non-current
9,583
7,996
10,200
Lease liability end of period
12,512
10,281
13,034
LEASE OBLIGATIONS
2022
2021
2021
Mar 31
Mar 31
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Less than 1 year
2,929
2,285
2,834
Between 1 and 5 years
9,419
6,035
9,562
More than 5 years
164
1,961
638
Total
12,512
10,281
13,034
AMOUNTS RECOGNIZED IN CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Depreciation charge of right-of-use assets
788
855
3,275
Interest expense (included in financial expenses)
193
157
628
Expense related to short-term leases
-
7
7
Total
981
1,019
3,910
9. Inventories
2022
2021
2021
Mar 31
Mar 31
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Finished goods
2,354
2,413
2,690
Raw materials and consumables
1,542
999
1,702
Reserves
(1,674)
(783)
(1,674)
Inventories, net
2,222
2,629
2,718
Write downs recognized as an expense in the period
-
58
548
20
Interim report BioPorto, first quarter of 2022
2022
2021
2021
Jan 1 – Mar 31
Jan 1 – Mar 31
Jan 1 – Dec 31
(Unaudited)
(Unaudited)
Cost of sales included in production costs in the period
860
671
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
Mar 31
Mar 31
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables
8,204
7,521
8,076
Other receivables
101,440
1,215
738
Prepayments
1,075
1,982
1,769
Provision for bad debts
(899)
(869)
(899)
Total receivables
109,820
9,849
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 13.
11. Share capital
2022
2021
2021
NUMBER OF SHARES
Mar 31
Mar 31
Dec 31
(Unaudited)
(Unaudited)
January 1
267,754,404
266,581,904
266,581,904
Issue
66,938,601
-
1,172,500
Total number of shares end of period
334,693,005
266,581,904
267,754,404
CAPITAL INCREASE IN 2022
Number of
shares
Nominal value
DKK
Share price
DKK/share
Rights issue
66,938,601
1.00
1.50
As of March 31, 2022, the share capital consists of 334,693,005 shares of DKK 1.00 each. Taking into consideration the binding obligation as of March 31,
2022 for the gross proceeds associated with the rights issue, the share capital has been paid up in full. The shares have not been divided into classes and
carry no special rights.
Interim Report BioPorto, first quarter of 2022
21
12. Treasury shares
As of March 31, 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 March 31, 2022, BioPorto A/S is not authorized to acquire treasury shares. BioPorto A/S did not
acquire treasury shares during the three months ended March 31, 2022 or the year ended December 31, 2021.
13. Financial risks and financial instruments
Financial instrument categories
2022
2021
2021
Mar 31
Mar 31
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables
7,305
6,652
7,177
Other receivables
101,440
1,215
738
Cash and cash equivalents
27,016
86,715
45,523
Financial assets at amortized costs
135,761
94,582
53,438
2022
2021
2021
Mar 31
Mar 31
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Lease liabilities
12,512
10,281
13,034
Other non-current liabilities
278
442
442
Trade payables
7,233
2,490
4,260
Financial liabilities at amortized costs
20,023
13,213
17,736
Financial liabilities
Liabilities under trade payables generally fall due within one year after the end of the financial year. Their carrying amount is assumed to equal the fair
value.
Currency risk
The Group’s presentation currency is DKK, but part of its activities are denominated in other currencies than DKK, primarily USD and EUR.
The Group is primarily exposed to currency risks through sales, production, R&D contracts, and payroll denominated in currencies other than Danish kroner.
Based on its transaction volume, the Group has concluded that it is not feasible to hedge its USD exposure. As the Danish kroner is pegged to the EUR,
hedging of the Company’s transactions in EUR is not necessary.
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 27.0
million and DKK 45.5 million as of March 31, 2022 and December 31, 2021, respectively.
22
Interim report BioPorto, first quarter of 2022
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 MARCH 31, 2022 (UNAUDITED)
DKK thousand
Expected credit
loss rate
Trade
receivables
Expected loss
Total
Not due
0.6%
2,678
15
2,663
1 - 30 days overdue
1.1%
2,133
24
2,109
31 - 60 days overdue
2.1%
745
16
729
61 - 90 days overdue
4.4%
752
33
719
More than 90 days overdue
42.8%
1,896
811
1,085
March 31, 2022
8,204
899
7,305
AS OF MARCH 31, 2021 (UNAUDITED)
DKK thousand
Expected credit
loss rate
Trade
receivables
Expected loss
Total
Not due
1.7%
2,903
48
2,855
1 - 30 days overdue
0.9%
774
7
767
31 - 60 days overdue
2.8%
604
17
587
61 - 90 days overdue
3.7%
1,660
61
1,599
More than 90 days overdue
46.6%
1,580
736
844
March 31, 2021
7,521
869
6,652
Liquidity risk
In connection with BioPorto’s ongoing financing of operations, efforts are made to ensure sufficient financial resources are available. As of March 31, 2022,
BioPorto’s cash and cash equivalents amounted to DKK 27.0 million and DKK 45.5 million as of March 31, 2022 and December 31, 2021, respectively.
Including DKK 93.1 million net proceeds from the rights issue (c.f., note 17), pro forma cash and cash equivalents amounted to DKK 120.1 million as of
March 31, 2022.
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.
To maintain flexibility free funds are placed in deposits.
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 quarter of 2022
23
14. Change in working capital
2022
2021
2021
Jan 1 - Mar 31
Jan 1 - Mar 31
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Change in inventories
496
536
616
Change in receivables
272
(1,456)
(1,770)
Change in trade payables
1,737
(2,146)
(376)
Change in other payables
(3,685)
(2,043)
(5,918)
Total change in working capital
(1,180)
(5,109)
(7,448)
The above changes in working capital during the three months ended March 31, 2022 exclude amounts accrued for the issuance of common stock, c.f.
Note 15.
15. Capital increase
2022
2021
2021
Jan 1 – Mar 31
Jan 1 – Mar 31
Jan 1 – Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Issue, gross proceeds
100,408
-
4,361
Issue costs
(7,294)
-
(11)
Net proceeds
93,114
-
4,350
As described in Note 17, on April 1, 2022, the Group raised gross proceeds of approximately DKK 100.4 million, with net proceeds of DKK 93.1 million from
the issuance and sale of 66,938,601 shares of common stock. The gross proceeds were classified within Other receivables as of March 31, 2022, as they
were legally bound for the benefit of the Group as of that date. Correspondingly, costs of approximately DKK 1.2 million and DKK 5.5 million related to the
offering were accrued within Trade payables and Other payables, respectively, and the DKK 93.1 million net increase in Share capital was recognized as of
March 31, 2022.
16. 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.
24
Interim report BioPorto, first quarter of 2022
17. Subsequent event
On April 1, 2022, the Group received gross proceeds of approximately DKK 100.4 million, with net proceeds of DKK 93.1 million from the issuance and sale
of 66,938,601 shares of common stock. See note 15 for further information.
18. 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 quarter 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.