Interim Report BioPorto, first nine months of 2023
1
November 1, 2023
Announcement no. 18
BioPorto Announces Interim Results and Business Update For the Third Quarter and Nine
Months of Fiscal 2023
COPENHAGEN, Denmark and BOSTON, MA, USA, November 1, 2023, (GLOBE NEWSWIRE) -- BioPorto A/S
(BioPorto) (CPH:BIOPOR) today announced interim financial results and business updates for the third quarter
and nine months of fiscal 2023.
Recent Highlights
• For the first nine months ending September 30, 2023:
o Total revenue of DKK 24.4 million / USD 3.5 million, a 20% increase over the prior year
o Total NGAL revenue of 15.2 million / USD 2.2 million, a 57% increase over the prior year
o Adjusted EBITDA of DKK (41.2) million / USD (6.0) million
o Cash and cash equivalents of DKK 69.9 million / USD 9.9 million as of September 30, 2023 (DKK
98.9 million / USD 13.0 million as of September 30, 2022)
• For the third quarter ending September 30, 2023:
o Total revenue of DKK 8.6 million / USD 1.3 million, a 63% increase over the prior year
o Total NGAL revenue of 5.8 million / USD 0.9 million, a 119% increase over the prior year
o Adjusted EBITDA of DKK (9.7) million / USD (1.4) million
• In response to FDA recommendations regulatory approval pathway for NGAL was efficiently moved
from De Novo application to submission of 510(k) pre-market notification
• Two abstracts were accepted for presentation at this week’s upcoming American Society of
Nephrology (ASN) Kidney Week conference in Philadelphia
Tony Pare, BioPorto’s Chief Executive Officer, said: “We continue our focus on top line growth, and are
pleased to report nine months total revenue increased 20% over the prior year and 63% over prior year quarter.
Our NGAL revenue increased 57% over prior year and 119% over prior year quarter. We are also pleased with the
progress of our 510(k) submission and continue to have dialog with the FDA concerning the marketing
authorizationof NGAL in the U.S. We also continue to execute our strategic priorities to grow revenues in Europe
and other markets that accept CE Mark, while expanding the total addressable market for our NGAL tests. With
our latest financial results, we will maintain our guidance for revenue, while improving our guidance for EBITDA
reflecting aggressive expense control during the FDA review period.”
Guidance for 2023 Revised
Based on the progress and results obtained in the first nine months of 2023, BioPorto has revised its financial
guidance for 2023, as most recently described in its Annual Report 2022 to:
• Revenue of approximately DKK 30 to 33 million, and
• Adjusted EBITDA loss of approximately DKK (56) to (59) million, from previous guidance of DKK (60) to
(65) million.
Conference Call and Webcast
The Company’s management team will host an online investor presentation on November 1, 2023, at 14:00
Central European Time / 9:00 Eastern Time, via HC Andersen Capital. Investors interested in attending the
webcast may register at:
https://hca.videosync.fi/2023-10-11-bioporto-q3/register.
A separate analyst call will be held on November 1, 2023, at 16:00 Central European Time / 11:00 Eastern Time,
with details as follows:
Denmark landline: +45 8025 2164
Denmark mobile: +45 8025 1917
International: +1 201 689 8562
US: +1 877 407 0789
Conference ID: 13742263
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1640499&tp_key=67270c5bab
Operator assisted dial-out:
https://callme.viavid.com/viavid/?callme=true&passcode=13732188&h=true&info=company-email&r=true&B=6
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
the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com.
Forward-looking statement disclaimer
Certain statements in this news release are not historical facts and may be forward-looking statements.
Forward-looking statements include statements regarding the intent, belief or current expectations with respect
to the Company’s expectations, intentions and projections regarding its future performance including the
Company’s Guidance for 2023; 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 with the Danish Financial Supervisory Authority, including its Annual Report for 2022 and Interim Reports,
particularly under the heading “Risk Factors”.
Interim Report BioPorto, first nine months of 2023
3
NOTE – DKK/USD exchange rates used within “Recent Highlights”, above:
• Balance sheet measures: September 30, 2022 = 7.6287 and September 30, 2023 = 7.039.
• Income statement measures for nine months ended: September 30, 2022 = 6.9421 and September 30,
2023 = 6.8812.
• Income statement measures for the third quarter ended: September 30, 2022 = 7.2995 and September
30, 2023 = 6.8241.
2023
2022
2023
2022
2022
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
8.6
5.3
24.4
20.3
29.0
Gross profit
6.1
4.2
16.4
14.2
19.0
Sales and marketing costs
4.7
5.1
15.1
14.3
21.2
Research and development costs
4.7
10.7
19.5
28.5
34.9
Administrative costs
7.2
8.4
27.0
29.8
41.8
Lease impairment
1.3
-
1.3
-
2.6
Restructuring costs
(0.0)
-
2.9
-
-
Loss before financial items (EBIT)
(11.7)
(20.0)
(49.5)
(58.3)
(81.5)
Financial items, net
1.1
1.2
0.7
1.9
(0.0)
Loss before tax
(10.6)
(18.8)
(48.8)
(56.4)
(81.5)
Net loss
(9.6)
(16.9)
(45.3)
(51.0)
(75.9)
Comprehensive loss
(10.3)
(18.5)
(45.9)
(53.3)
(76.0)
Adjusted EBITDA
(9.7)
(17.1)
(41.2)
(49.5)
(67.3)
Non-current assets
10.7
21.2
7.2
Cash and cash equivalents
69.9
98.9
81.8
Current assets
87.2
112.4
101.4
Total assets
97.9
133.6
108.6
Equity
70.8
91.1
70.2
Non-current liabilities
4.9
9.2
7.4
Current liabilities
22.2
33.3
31.0
Total equity and liabilities
97.9
133.6
108.6
Cash flows from operating activities
(52.8)
(36.1)
(52.5)
Cash flows from investing activities
(1.0)
(0.5)
(0.5)
Of which investment in property, plant, and
equipment
0.0
(0.4)
(0.4)
Cash flows from financing activities
41.8
89.8
88.7
Net cash flows
(12.0)
53.2
35.7
Revenue growth
63%
(0.4%)
20%
16%
19%
Gross profit percentage
71%
80%
67%
70%
66%
Equity ratio (solvency)
72%
68%
72%
68%
65%
Average number of employees
29
33
33
31
32
Number of shares at the end of the period (1,000)
379,670
334,693
379,670
334,693
334,693
Loss per share (EPS), DKK
(0.03)
(0.05)
(0.13)
(0.16)
(0.24)
Net asset value per share, period-end, DKK
0.19
0.27
0.19
0.27
0.21
Share price, period-end, DKK
1.58
1.34
1.58
1.34
2.32
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 and 2022 BioPorto Annual Report.
Reconciliation of Adjusted EBITDA
Loss before financial items (EBIT)
(11.7)
(20.0)
(49.5)
(58.3)
(81.5)
Depreciation and amortization
0.7
1.1
2.0
3.3
4.0
Share-based compensation expenses
0.1
1.8
2.0
5.6
7.6
Lease Impairment
1.3
-
1.3
-
2.6
Restructuring costs
(0.0)
-
2.9
-
-
Adjusted EBITDA
(9.7)
(17.1)
(41.2)
(49.5)
(67.3)
Consolidated Financial Highlights
Interim Report BioPorto, first nine months of 2022
5
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., restructuring charges,
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.
Strong revenue growth from NGAL test sales drives
total revenue increase
Revenue totaled DKK 24.4 million in the nine months of 2023, a 20%
increase over the prior year period, reflecting 57% sales growth of
NGAL tests, offset by an 12% sales decline of Antibodies. In the third
quarter of 2023, revenue from NGAL tests grew 119% and Antibodies
grew 5%, respectively over the prior year. Results for the third quarter
of 2023 were somewhat bolstered by a 14% increase in sales of ELISA
kits, which represent 5% of total revenues.
FDA 510(k) pre-market submission accepted
The Company’s regulatory pathway for NGAL has moved from a De
Novo application to submission of a 510(k) pre-market notification
which the FDA accepted immediately. 510(k) pre-market notification
is required by the FDA, for registered device manufacturers who must
notify the FDA of their intent to market a medical device at least 90
days in advance of a planned launch.
We are now awaiting clearance from the FDA approving launch of
NGAL in the U.S. We are pleased with the progress to date which
continues to move forward. To date, there has been no interruption
in dialogue with the FDA through this transition and no impact in the
continuity of the NGAL review process.
We also want to clarify the approval pathway change, we are pleased
knowing that the FDA is permitting BioPorto to transition to the
510(k) approval pathway by applying principles from the FDA’s Least
Burdensome Provisions guidance, which require ‘the most efficient
manner’ to expeditiously get this important test with breakthrough
device status to the US market.
Focusing on sales of The NGAL Test in Europe and
other markets
The NGAL test is already available for both pediatric and adult use in
Europe and elsewhere with a CE mark registration, and during the
third quarter the Company continue executing on its plan to grow
revenues as evidenced by a 57% growth in NGAL global revenue
during the third quarter 2023 compared to prior year.
Managing Capital
While waiting for FDA clearance, BioPorto has taken proactive
measures to run lean by reducing staff to those essential to our
immediate 2023 objectives, conserve capital, and plan expenditures
carefully and critically. Investments are focused on the Company’s
strategic priorities, together with preparing materials to expand to the
total addressable market for NGAL tests.
As part of implementing its strategic priorities, BioPorto has
historically sought financing, most recently in a rights offering (the
“Offering”) with pre-emptive rights for existing shareholders that was
executed last quarter, whereby the Company raised gross proceeds
of DKK 43.0 million. The Company’s articles of association were
updated to reflect the capital increase. The Company assessed its
liquidity and capital resources and concluded that they are adequate
to fund operations considering a twelve-month period from the date
of this Interim Report, cf. Note 1.
In addition, we continue to see the positive results in EBITDA from the
Company’s reduction in work force implemented in second quarter
2023 to better align the Company’s resources with its strategic
priorities.
Management Review
Interim Report BioPorto, first nine months of 2022
7
This financial review is based on the Group’s consolidated financial
information as of and for the three and nine months ended September 30,
2023, with comparative results as of and for the three and nine months
ended September 30, 2022 in brackets.
Revenue
Revenue was DKK 8.6 million (DKK 5.3 million) in the third quarter of 2023
and DKK 24.4 million (DKK 20.3 million) for the nine months of 2023.
NGAL test sales totaled DKK 5.8 million (DKK 2.7 million) in the third quarter
of 2023 and DKK 15.2 million (DKK 9.7 million) for the nine months of 2023.
Antibody sales totaled DKK 2.2 million (DKK 2.1 million) in the third quarter
of 2023 and DKK 7.9 (DKK 9.0 million) for the nine months of 2023.
Figure 1. Revenue by quarter (DKK million)
Figure 2. NGAL test product revenue by quarter (DKK
million)
Gross Profit
Gross profit for the third quarter of 2023 was DKK 6.1 million (DKK 4.2
million), primarily driven by higher revenue over the prior year period.
Gross profit for the nine months of 2023 totaled DKK 16.4 million (DKK 14.2
million), reflecting DKK 4.1 million favorable sales volume, offset by 290 bps
reduction in gross profit percentage over the prior year period.
Sales and Marketing Costs
Sales and marketing costs totaled DKK 4.7 million (DKK 5.1 million) in the
third quarter of 2023, reflecting the full effects of the reduction in work
force that was implemented during the previous quarter.
For the nine months of 2023, sales and marketing costs totaled DKK 15.1
million (DKK 14.3 million), reflecting all around higher costs of marketing,
congresses and professional fees in the beginning of the year.
Research and Development Costs
Research and development costs in the third quarter of 2023 totaled DKK
4.7 million (DKK 10.7 million), with the decrease principally reflecting lower
clinical study costs and reduction in work force.
For the nine months of 2023, research and development costs totaled DKK
19.5 million (DKK 28.5 million), with the decrease principally reflecting
lower clinical study and reduction in work force.
Administrative Costs
Administrative costs in the third quarter of 2023 totaled DKK 7.2 million
(DKK 8.4 million), with the decrease principally reflecting lower non-cash
equity compensation costs compared to the prior period.
For the nine months of 2023, administrative costs totaled DKK 27.0 million
(DKK 29.8 million), with the decrease principally reflecting lower non-cash
equity compensation costs compared to the prior period.
Restructuring Costs
During the last quarter, the Company implemented a reduction in work
force to better align the Company’s resources with its strategic priorities.
This action corresponded to a total restructuring charge of DKK 2.9 million.
Financials Items, net
Financial income and expenses reflect interest income/expense and
currency transaction gains/losses. Financial items, net for the third quarter
of 2023 was an income of DKK 1.1 million (income of DKK 1.2 million), and
an income of DKK 0.7 million for the first nine months of 2023 (income of
DKK 1.9 million).
Tax Benefit
The tax benefit is primarily related to tax credits held by its Danish entities
associated with the Company’s investment in research and development.
In the third quarter of 2023, a DKK 1.0 million tax benefit (DKK 1.9 benefit)
was recognized. For the nine months of 2023, a DKK 3.5 million tax benefit
(DKK 5.4 million) was recognized.
EBIT/Adjusted EBITDA
For the third quarter of 2023, Earnings before interest and taxes (EBIT) was
a loss of DKK 11.7 million (DKK 20.0 million), and adjusted EBITDA was a loss
of DKK 9.7 million (DKK 17.1 million), reflecting the mix of variances
described above.
5.6
6.6
5.3
6.8
6.5
8.5
5.3
8.7
8.0
7.8
8.6
0
2
4
6
8
10
Q1 Q2 Q3 Q4
2021 2022 2023
2.1
3.7
2.6
3.73.7
3.3
2.7
5.2
4.8
4.6
5.8
0
1
2
3
4
5
6
7
Q1 Q2 Q3 Q4
2021 2022 2023
Financial Review
For the nine months of 2023, EBIT was a loss of DKK 49.5 million (DKK 58.3
million) reflecting favorable revenue and cost reduction and offset by
restructuring charge related to a reduction in force of DKK 2.9 million.
Adjusted EBITDA was a loss of DKK 41.2 million (loss of DKK 49.5 million).
Cash and Cash equivalents
As of September 30, 2023, BioPorto’s cash position was DKK 69.9 million
(DKK 98.9 million) and deposited at major national Danish, Nordic, and US
banks.
The Company continually evaluates its liquidity requirements, capital needs
and availability of capital resources based on its operating needs and
planned initiatives. The Company assessed its liquidity and capital
resources and concluded that they are adequate to fund operations
considering a twelve-month period from the date of this Interim Report,
independent of the timing and potential marketing authorization of NGAL
tests by the FDA in the US. The Company’s assessment as to the adequacy
of liquidity relies inter alia on assumptions and significant judgements (in
addition to those matters discussed cf. Note 2) applied in the Company's
budgets and forecasts as well as customary sensitivities, existing capital
resources and assumptions concerning the timing, costs and resources
required to undertake the Company’s strategic priorities and tactical
decisions, including the timing and potential marketing authorization of
NGAL tests by the FDA in the US, commercialization activities for NGAL tests
under CE Mark and Antibodies in Europe, supply chain management, and
ongoing R&D, all of which under current circumstances remain difficult to
predict.
Net working capital
Net working capital (i.e., current assets minus current liabilities) as of
September 30, 2023 totaled DKK 64.9 million (DKK 79.1 million).
Cash Flow Statement
Cash used in operating activities during the first nine months of 2023
totaled DKK 52.8 million (DKK 36.1 million), which reflected the payment of
clinical trial invoices that were received in late December 2022 and DKK 2.7
million of the restructuring costs as described above.
Cash used in investing activities for the first nine months of 2023 was DKK
1.0 million (DKK 0.5 million). Cash from financing activities was DKK 41.8
million (DKK 89.8 million), reflecting DKK 41.3 million of net proceeds from
the rights offering completed during the second quarter of 2023 and DKK
3.2 million proceeds from the exercise of warrants, net of DKK 2.8 million
of routine lease payments.
Net cash flow for the first nine months of 2023 was a use of DKK 12.0 million
(source of DKK 53.2 million). Net cash flows for the first nine months of
2022 reflected DKK 92.7 million net proceeds from a rights offering
completed during the second quarter of 2022.
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’s De Novo submission,
now 510(k) submission, required clinical and analytical data to support the
use of NGAL in pediatrics remains under review by the FDA. 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.
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 2022 Annual Report and its Interim Reports,
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 2023 revised
Based on the progress and results obtained in the first nine months of 2023,
BioPorto has revised its financial guidance for 2023, as most recently
described in its Annual Report 2022 to:
• Revenue of approximately DKK 30 to 33 million, and
• Adjusted EBITDA loss of approximately DKK (56) to (59) million,
from previous guidance of DKK (60) to (65) million.
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 2023
9
Executive Management:
___________________________
Board of Directors:
___________________________ ___________________________ __________________________
___________________________ ___________________________ ___________________________
Statement by the Board of Directors and
Management
Interim report BioPorto, first nine months of 2023
Condensed Consolidated Statements of Profit or Loss
2023
2022
2023
2022
2022
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
Production costs
Gross profit
Sales and marketing costs
Research and development costs
Administrative costs
Lease impairment
Restructuring costs
10
(45 )
Loss before financial items (EBIT)
(11,700 )
(19,969 )
(49,505 )
(58,324 )
(81,527 )
Financial income
Financial expenses
Loss before tax
(10,618 )
(18,777 )
(48,785 )
(56,443 )
(81,547 )
Income tax benefit, net
5
Net loss
(9,598 )
(16,877 )
(45,307 )
(50,998 )
(75,923 )
DKK
DKK
DKK
DKK
DKK
Loss per share (EPS & DEPS)
6
(0.03
(0.05
(0.13
(0.16
(0.24
Condensed Consolidated Statements of Comprehensive Loss
2023
2022
2023
2022
2022
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
(9,598 )
(16,877 )
(45,307 )
(50,998 )
(75,923 )
Other comprehensive loss:
Amounts which will be reclassified
to the income statement:
Exchange rate adjustments of
investments in subsidiaries
(712 )
(1,580 )
(600 )
(2,339 )
(115 )
Other comprehensive loss
(712 )
(1,580 )
(600 )
(2,339 )
(115 )
Comprehensive loss
(10,310 )
(18,457 )
(45,907 )
(53,337 )
(76,038 )
Interim Financial Statements
Interim Report BioPorto, first nine months of 2023
11
Condensed Consolidated Balance Sheets
Assets
2023
2022
2022
Sep 30
Sep 30
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
Total property, plant and equipment and intangible assets
Financial assets
Deposits
Non-current tax receivable
5
Total financial assets
Total non-current assets
Current assets
Inventories, net
Trade receivables, net
7, 9
Current tax receivable
5
Other receivables
7, 9
Prepayments
7
Cash and cash equivalents
9
Assets held-for-sale
Total current assets
Total assets
Interim report BioPorto, first nine months of 2023
Equity and Liabilities
2023
2022
2022
Sep 30
Sep 30
Dec 31
DKK thousand
Note
(Unaudited)
(Unaudited)
Equity
Share capital
8
Treasury shares
8
Exchange-rate adjustments
(834 )
(2,299 )
(234 )
Retained earnings
(308,071 )
(241,314 )
(264,238 )
Total equity
Liabilities
Non-current liabilities
Lease liabilities
9
Other non-current liabilities
9
Total non-current liabilities
Current liabilities
Current portion of non-current liabilities
9
Trade payables
9
Taxes payable
Other accrued liabilities
10
Total current liabilities
Total liabilities
Total equity and liabilities
Interim Report BioPorto, first nine months of 2023
13
Condensed Consolidated Statement of Changes in Equity (Unaudited)
Amounts in DKK thousand
Shares in thousand
Common Stock
Treasury Stock
Shares
Amount
Shares
Amount
Accumulated
Deficit
AOCI
Total
Balance at December 31, 2022
(264,238 )
(234 )
Comprehensive loss
(13 )
(13 )
Transactions with owners:
Share-based compensation
Net loss
(16,060 )
(16,060 )
Balance at March 31, 2023
(279,233 )
(247 )
Comprehensive loss
Closure of dormant subsidiary
(104 )
(104 )
Transactions with owners:
Exercise of warrants
Issuance of stock, net
(1,587 )
Share-based compensation
Net loss
(19,649 )
(19,649 )
Balance at June 30, 2023
(298,492 )
(122 )
Comprehensive loss
(712 )
(712 )
Transactions with owners:
Issuance of stock, net
(42 )
(42 )
Share-based compensation
Net loss
(9,598 )
(9,598 )
Balance at September 30, 2023
(308,071 )
(834 )
Interim report BioPorto, first nine months of 2023
Amounts in DKK thousand
Shares in thousand
Common Stock
Treasury Stock
Shares
Amount
Shares
Amount
Accumulated
Deficit
AOCI
Total
Balance at December 31, 2021
-
(221,671 )
(119 )
Comprehensive loss
(50 )
(50 )
Transactions with owners:
Issuance of stock, net
Share-based compensation
Net loss
(17,030 )
(17,030 )
Balance at March 31, 2022
(210,617 )
(169 )
Comprehensive loss
(709 )
(709 )
Transaction with owners
Equity issuance costs
(83 )
(83 )
Share-based compensation
Net loss
(17,091 )
(17,091 )
Balance at June 30, 2022
(225,898 )
(878 )
Comprehensive loss
(1,421 )
(1,421 )
Transaction with owners
Issuance of stock, net
(312 )
(312 )
Share-based compensation
Net loss
(16,877 )
(16,877 )
Balance at September 30, 2022
(241,314 )
(2,299 )
Interim Report BioPorto, first nine months of 2023
15
Condensed Consolidated Statements of Cash Flows
2023
2022
2022
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Loss before financial items
(49,505 )
(58,324 )
(81,527 )
Adjustments:
Depreciation and amortization
Share-based compensation expenses
Lease impairment
Restructuring non-cash
Other non-cash items
(271 )
(945 )
Changes in assets and liabilities:
Inventories
(484 )
Trade receivables
(2,222 )
Trade payables
(7,977 )
(282 )
Other operating assets and liabilities, net
(319 )
(1,051 )
Restructuring cash items
(2,747 )
Cash flows from operations
(53,419 )
(35,942 )
(57,768 )
Financial income, received
Financial expenses, paid
(65 )
(1,034 )
(1,618 )
Tax refund, net
Cash flows from operating activities
(52,791 )
(36,111 )
(52,485 )
Purchase of property, plant and equipment
(407 )
(407 )
Purchase of rights and software
(65 )
(64 )
Purchase of financial assets
(961 )
(31 )
(32 )
Cash flows from investing activities
(961 )
(503 )
(503 )
Proceeds from rights issue
Cost related to issue of new shares
(1,629 )
(7,688 )
(7,671 )
Proceeds from warrant programs exercised
Repayments of non-current liabilities
(164 )
(301 )
Repayments of lease obligation
(2,757 )
(2,773 )
(3,737 )
Cash flows from financing activities
Net cash flows for the period
(11,980 )
Cash and cash equivalents at beginning of period
Effect of exchange rate changes on cash
Cash and cash equivalents end of period
Interim report BioPorto, first nine months of 2023
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 and its
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, 2022.
The Company assessed its liquidity and capital resources and concluded that they are adequate to fund operations considering a twelve-month period
from the date of this Interim Report, independent of the revenue potential associated with the timing and potential marketing authorization of NGAL tests
by the FDA in the US. The Company’s assessment as to the adequacy of liquidity relies inter alia on assumptions and significant judgements (in addition to
those matters discussed cf. Note 2) applied in the Company's budgets and forecasts as well as customary sensitivities, existing capital resources and
assumptions concerning the timing, costs and resources required to undertake the Company’s strategic priorities and tactical decisions, including the timing
and potential marketing authorization of NGAL tests by the FDA in the US, commercialization activities for NGAL tests under CE Mark and Antibodies in
Europe, supply chain management, and ongoing R&D, all of which under current circumstances remain difficult to predict.
In the event that the Company’s strategic priorities and tactical decisions, including the timing and potential marketing authorization of NGAL tests by the
FDA in the US, commercialization activities for NGAL tests under CE Mark and Antibodies in Europe, and ongoing R&D are more positive than expected,
the Company may choose to accelerate projects and/or increase spending, in which case the Company may be required or may choose to raise additional
capital prior to the twelve month period after the date of this Interim Report.
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 2022 and in accordance with the recognition and measurement policies of IFRS.
As of June 30, 2023, the Group has implemented all new or amended accounting standards and interpretations as adopted by the EU and applicable for
the 2023 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 and cf. the Annual Report as of and for the year ended December 31, 2022. The significant judgements made by Management in applying the
Notes to Interim Condensed
Consolidated Financial Statements
(Unaudited)
Interim Report BioPorto, first nine months of 2023
17
Group’s accounting policies and the key sources of estimation uncertainty were not materially different from those that applied to the consolidated
financial statements, cf. the Annual Report as of and for the year ended December 31, 2022.
3. Business area reporting
GEOGRAPHIC DISTRIBUTION
2023
2022
2023
2022
2022
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
2,220
891
7,504
6,367
10,090
North America
4,962
3,227
13,470
11,387
14,953
Asia
1,427
1,153
3,424
2,517
3,919
Other regions
-
-
-
8
7
Revenue
8,609
5,271
24,398
20,279
28,969
PRODUCT GROUPS
2023
2022
2023
2022
2022
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
5,842
2,664
15,236
9,722
14,857
Antibodies
2,215
2,119
7,882
9,006
12,033
ELISA kits
543
476
1,252
1,520
1,836
Royalty and other revenue
9
12
28
31
243
Revenue
8,609
5,271
24,398
20,279
28,969
4. Share-based payment
For the purpose of motivating and retaining Management and key staff and aligning their interests with those of its shareholders, BioPorto A/S uses
warrants as an incentive scheme. The arrangements, which are exercised by the issuance of new shares (equity-settled share-based payment transaction),
entitle the recipient to subscribe for new shares in the parent company at a price defined on the date of grant.
In the first nine months of 2023 and 2022, share-based compensation expense totaled DKK 2.0 million and DKK 5.6 million, respectively. The warrant terms
are included in the Company’s Articles of Association, which can be found at www.bioporto.com. Upon vesting, each warrant entitles the recipient to
subscribe for one share in BioPorto A/S. In accordance their provisions, no adjustments were made to the warrants as a result of the rights offering
completed by the Company during the second quarter of 2023.
5. 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, 2022, the gross value of the tax asset prior to the valuation allowance was DKK 88.8 million.
Taxes receivable represent refunds that are 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.
Interim report BioPorto, first nine months of 2023
6. Loss per share
2023
2022
2023
2022
2022
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Jun 30
Jan 1 - Jun 30
Jan 1 - Dec 31
DKK thousand (except where noted)
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Loss for the period
(9,598)
(16,877)
(45,307)
(50,998)
(75,923)
BioPorto Group's share of loss
(9,598)
(16,877)
(45,307)
(50,998)
(75,923)
Weighted average number of shares (in
thousand)
379,670
334,693
351,381
313,009
318,554
Weighted average number of treasury shares
(in thousand)
(13)
(13)
(13)
(13)
(13)
Weighted average number of shares in
circulation – basic and diluted (in thousand)
379,657
334,680
351,368
312,996
318,541
Loss per share (EPS), DKK
(0.03)
(0.05)
(0.13)
(0.16)
(0.24)
Warrants outstanding were excluded from the calculation of loss per share because the effect would have been anti-dilutive.
7. Receivables
2023
2022
2022
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables
5,280
2,862
3,058
Other receivables
1,350
389
1,769
Prepayments
1,648
1,018
1,555
Provisions for bad debt
(55)
(356)
(229)
Financial assets at amortized costs
8,223
3,913
6,153
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 9.
8. Share capital
As of September 30, 2023, the share capital consisted of 379,670,461 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, 2023 and 2022, and December 31, 2022, 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, 2023, 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, 2023 or the year
ended December 31, 2022. During the nine months ended September 30, 2023, the Company received net proceeds of DKK 41.4 million from a rights
issuance completed June 20, 2023, and DKK 3.2 million cash proceeds from the exercise of warrants where the corresponding common shares were issued
May 25, 2023.
Interim Report BioPorto, first nine months of 2023
19
9. Financial risks and financial instruments
Financial instrument categories
2023
2022
2022
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables, net
5,225
2,506
2,829
Other receivables
1,350
389
1,769
Cash and cash equivalents
69,943
98,946
81,792
Financial assets at amortized costs
76,518
101,841
86,390
2023
2022
2022
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Lease liabilities
8,327
12,134
10,645
Other non-current liabilities
-
278
-
Trade payables
2,480
3,978
10,457
Financial liabilities at amortized costs
10,807
16,390
21,102
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 the 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.
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 analyzing 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.
Interim report BioPorto, first nine months of 2023
AS OF SEPTEMBER 30, 2023 (UNAUDITED)
DKK thousand
Expected
credit loss
rate
Trade
receivables
Expected loss
Total
Not due
0.4%
3,887
14
3,873
1 - 30 days overdue
0.2%
1,169
2
1,167
31 - 60 days overdue
3.4%
87
3
84
61 - 90 days overdue
25.0%
12
3
9
More than 90 days overdue
26.4%
125
33
92
September 30, 2023
5,280
55
5,225
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
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 totaled DKK 69.9 million and DKK 81.8 million as of September 30, 2023 and December 31, 2022, respectively.
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 2023
21
10. Other accrued liabilities
2023
2022
2022
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Accrued incentive compensation
5,555
8,900
8,574
Accrued board fee
2,494
1,801
2,179
Accrued vacation
1,379
1,347
1,906
Accrued professional and consulting fees
2,464
5,695
648
Accrued clinical trial costs
1,531
6,919
1,059
Accrued restructuring costs
175
-
-
Accrued staff costs liabilities
1,404
4
-
Accrued expenses - Other
1,246
1,338
2,871
Other accrued liabilities
16,248
26,004
17,237
Accrued restructuring costs represent the remaining liability from the reduction in work force implemented during last quarter that affected 28% of the
Company’s global employees. The restructuring was implemented to better align the Company’s resources with its strategic priorities to grow revenues in
European and other markets that accept CE Mark, prepare responses to the FDA’s request for Additional Information and support ongoing submission
review, and expand the total addressable market for NGAL tests.
Accrued staff costs liabilities are representing the extended deadline of payment of A-tax and labour market contributions for July and August. The Danish
government has extended the deadline due to increased costs of energy and therefore, the payments are due on 10 November, 2023 and 29 February
2024, respectively.
11. 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.
12. 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 150,000 for consulting services (via his wholly
owned legal entity, PME Holding ApS) last quarter.
Interim report BioPorto, first nine months of 2023
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, The NGAL Test
TM
, is 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
CVR DK-17500317