Interim Report BioPorto, first nine months of 2024
1
November 14, 2024
Announcement no. XX
BioPorto Announces Interim Results and Business Update for the Third Quarter and Nine
Months of Fiscal 2024
Revenue growth and strategic execution
COPENHAGEN, Denmark, November 14, 2024, (GLOBE NEWSWIRE) -- BioPorto A/S CVR-no. 17500317 (BioPorto
or Company) (CPH:BIOPOR), an in vitro diagnostics company focused on empowering the early detection of
Acute Kidney Injury (AKI), today announced interim financial results for the first nine months of 2024 and
business progress for the third quarter of 2024.
Strategic and operational highlights from third quarter ended September 30, 2024
✓ Expansion of commercial organization in both US and Europe and a solid momentum in outgoing NGAL
product activities converting awareness to demand ahead of ProNephro AKI™ (NGAL) launch in US
✓ First standing order with a yearly value of more than USD 200,000 signed
✓ Continued strong cost control preserving cash
Financial Highlights for the period ended September 30, 2024
For the nine months ended September 30, 2024:
• NGAL revenues in the US/Canada increased by 36% over the prior year – global NGAL revenues increased
by 20% over the prior year and comprised 65% of total global revenue
• Total revenue of DKK 28.3 million / USD 4.1 million, an 16% increase over the prior year
• Adjusted EBITDA of DKK (51.1) million / USD (7.4) million, a 16% increase from the prior year
• Cash and cash equivalents of DKK 76.3 million / USD 11.5 million as of September 30, 2024
For the third quarter ended September 30, 2024:
• Total NGAL revenues increased by 16% over the prior year
• Total revenue of DKK 9.7 million / USD 1.4 million, a 12% increase over the prior year
• Adjusted EBITDA of DKK (19.6) million / USD (2.9) million, a 102% increase from the prior year
Events after the reporting period
✓ Partnership negotiations leading to the signing of a new global distribution agreement with Beckman
Coulter, Inc. on distribution of NGAL Tests in October
✓ Strong momentum in process regarding US adult clinical trials for ProNephro AKI (NGAL) - first patient
enrolled in October
Peter Mørch Eriksen, BioPorto’s Group Chief Executive Officer (CEO), commented: “The level of activity was
very high in the third quarter of 2024. Commercially, we expanded our team, secured our first standing order
for NGAL assays and grew NGAL product revenue – in particular in the US. Furthermore, our focus was executing
on two very important elements of our go-to-market strategy: entering a new global partnership with Beckman
Coulter, Inc., a world leader within diagnostics, which was signed in October, and preparing for initiation of our
clinical studies in the US for adult usage of ProNephro AKI (NGAL), where we had the first patient enrolled in
October. I am very encouraged by highly esteemed external parties’ interest in partnering with us and our
continued ability to increase the execution momentum on these elements which are pivotal for converting high
NGAL awareness to high demand for NGAL tests.”
Guidance for 2024 Maintained
Based on the progress and results obtained in the first nine months of 2024, BioPorto maintains its financial
guidance for 2024, as most recently described in its Interim Report for the Second Quarter 2024 of:
• Total Revenue target of DKK 40 million, and
• Adjusted EBITDA loss in the range of DKK 75-90 million.
Interim Report BioPorto, first nine months of 2024
2
Call and Webcast and Investor Meeting
The Company’s management team will host an online investor presentation on November 14, 2024, at 10:30 AM
Central European Time / 4:30 AM Eastern Time, via HC Andersen Capital. Investors interested in attending the
webcast may register at: https://hca.videosync.fi/2024-11-14-bioporto
Investor Relations Contacts
Tim Eriksen, Investor Relations, BioPorto, +45 4529 0000, investor@bioporto.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 products are based on the NGAL biomarker and designed to aid in the risk assessment
and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including
significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, 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 Company
markets NGAL tests under applicable registrations including CE mark in several 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 2024; currency exchange rate fluctuations; anticipated events or trends and other
matters that are not historical facts, including with respect to implementation of manufacturing and quality
systems, commercialization of NGAL tests, and the development of future products and new indications;
concerns that may arise from additional data, analysis or results obtained during clinical trials; and, the
Company’s ability to successfully market both new and existing products. These forward-looking statements,
which may use words such as “aim”, “anticipate”, “believe”, “intend”, “estimate”, “expect” and words of
similar meaning, include all matters that are not historical facts. These forward-looking statements involve
risks, and uncertainties that could cause the actual results of operations, financial condition, liquidity, dividend
policy and the development of the industry in which the Company’s business operates to differ materially from
the impression created by the forward-looking statements. These statements are not guarantees of future
performance and are subject to known and unknown risks, uncertainties and other factors that could cause
actual results to differ materially from those expressed or implied by such forward-looking statements. Given
these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-
looking statements. Forward-looking statements speak only as of the date of such statements and, except as
required by applicable law, the Company undertakes no obligation to update or revise publicly any forward-
looking statements, whether as a result of new information, future events or otherwise. Factors that may impact
BioPorto’s success are more fully disclosed in BioPorto’s periodic financial filings, including its Annual Report
for 2023, with the Danish Financial Supervisory Authority, particularly under the heading “Risk Factors”.
NOTE – DKK/USD exchange rates used within “Recent Highlights”, above:
• Balance sheet measures: September 30, 2023 = 7.039 and September 30, 2024 = 6.6595
Interim Report BioPorto, first nine months of 2024
3
• Income statement measures for nine months ended: September 30, 2023 = 6.8812 and September 30,
2024 = 6.8691. Income statement measures for three months ended: September 30, 2023 = 6.8241 and
September 30, 2024 = 6.8618.
Interim Report BioPorto, first nine months of 2024
4
2024
2023
2024
2023
2023
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
9.7
8.6
28.3
24.4
31.0
Gross profit
6.7
6.1
20.8
16.2
20.2
Sales and marketing costs
10.2
4.6
25.2
15.4
18.9
Research and development costs
9.6
4.6
23.0
21.6
25.4
Administrative costs
8.4
7.2
26.8
27.3
36.0
Lease impairment
-
1.3
-
1.3
1.0
Loss before financial items (EBIT)
(21.6)
(11.7)
(54.2)
(49.5)
(61.2)
Financial items, net
(0.7)
1.1
(0.5)
0.7
(0.0)
Loss before tax
(22.3)
(10.6)
(54.7)
(48.8)
(61.2)
Net loss
(20.9)
(9.6)
(50.3)
(45.3)
(56.3)
Comprehensive loss
(19.7)
(10.3)
(49.4)
(45.9)
(55.9)
Adjusted EBITDA
(19.6)
(9.7)
(51.1)
(44.2)
(56.1)
Non-current assets
8.9
8.7
7.5
Cash and cash equivalents
76.3
69.9
66.4
Current assets
100.0
89.2
82.3
Total assets
108.9
97.9
89.8
Equity
86.5
70.8
60.2
Non-current liabilities
3.0
4.9
4.3
Current liabilities
19.4
22.2
25.4
Total equity and liabilities
108.9
97.9
89.8
Cash flows from operating activities
(66.1)
(52.8)
(55.5)
Cash flows from investing activities
-
(1.0)
(0.3)
Of which investment in property, plant, and
equipment
-
-
(0.0)
Cash flows from financing activities
76.1
41.8
40.8
Net cash flows
10.0
(12.0)
(14.9)
Revenue growth
12%
63%
16%
20%
7%
Gross profit percentage
69%
71%
74%
67%
65%
Equity ratio (solvency)
79%
72%
79%
72%
67%
Average number of employees
42
29
36
33
31
Number of shares at the end of the period (1,000)
429,670
379,670
429,670
379,670
379,670
Loss per share (EPS), DKK
(0.05)
(0.03)
(0.13)
(0.13)
(0.16)
Net asset value per share, period-end, DKK
0.20
0.19
0.20
0.19
0.16
Share price, period-end, DKK
1.87
1.58
1.87
1.58
2.09
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 2023 BioPorto Annual Report.
Reconciliation of Adjusted EBITDA
Loss before financial items (EBIT)
(21.6)
(11.7)
(54.2)
(49.5)
(61.2)
Depreciation and amortization
0.6
0.7
1.8
2.0
2.7
Share-based compensation expenses
1.4
0.1
(2.3)
2.0
1.4
Severance costs
-
-
3.6
-
-
Lease impairment
-
1.3
-
1.3
1.0
Adjusted EBITDA
(19.6)
(9.7)
(51.1)
(44.2)
(56.1)
Consolidated Financial Highlights
Interim Report BioPorto, first nine months of 2024
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.
Interim Report BioPorto, first nine months of 2024
6
Strong growth of 36% in North American sales of The NGAL
Test drives solid revenue increase
Revenue in the first nine months of 2024 totaled DKK 28.3 million, a 16%
increase over the prior year period driven by strong sales performance in
NGAL tests, which saw a 20% increase over the prior year period. Sales
growth was particularly strong in North America, where sales of NGAL tests
for Research Use Only (RUO) increased 36% over the prior year period.
Revenue from sales of antibodies grew 7% over the prior year period and
sales of ELISA kits, representing 5% of total revenues in the first nine
months of 2024, were up 21% compared to the prior year period.
In the third quarter of 2024 total revenue increased 12% over the prior year
period with sales of NGAL test products growing 16% compared to the same
period last year.
Clinical Studies Highlight the Efficacy of NGAL in Predicting
Acute Kidney Injury
BioPorto received marketing clearance by the US Food and Drug
Administration (FDA) for ProNephro AKI (NGAL)™ in December 2023.
In July 2024, the results from the urinary clinical studies supporting the
clearance were published in Kidney International Reports. The results
showed that a sensitivity of 72.3%, a specificity of 86.3% and a negative
predictive value of 96.9% was achieved among the 660 patients in the
validation study, demonstrating an excellent predictive performance for
ProNephro AKI (NGAL).
The data provides further evidence for the utility of urinary NGAL to
distinguish between functional and structural AKI in a manner that the
traditional functional markers of SCr and urine output cannot. This provides
physicians with a tool that allows for earlier clinical intervention, which has
been shown to dramatically improve outcomes in patients susceptible to
AKI.
Strengthening of commercial activities and organization is
expanding sales pipeline
In the third quarter of 2024, BioPorto further intensified its commercial
activities for the NGAL test products. Both in the US to build demand on top
of the increasing awareness of neutrophil gelatinase-associated lipocalin
(NGAL) as a biomarker ahead of the US clinical commercial launch of
ProNephro AKI (NGAL) for pediatric and young adults, and in Rest of the
World (ROW).
Conference attendance is maintained at a high frequency, and during the
third quarter of 2024, BioPorto has participated in and hosted several
presentations in both the US and Europe. The activities and a buildup of the
sales and Medical Scientific Liaisons organization has led to an all-time high
awareness and pipeline, which continues to generate new customers, both
in the US and Europe, including BioPorto’s first US standing order for NGAL
Tests for Research Use Only (RUO) with a yearly value of more than USD
200,000.
BioPorto Enters Global Partnership with Beckman Coulter
on Distribution of NGAL Tests
On 28 October, 2024, BioPorto entered a global distribution partnership
with Beckman Coulter, Inc. – a global clinical diagnostics leader – on
distribution of NGAL tests on their DxC and AU clinical chemistry analyzers.
Beckman Coulter will initially distribute BioPorto’s NGAL test in Europe
followed by distribution in the US pending FDA marketing clearance for
ProNephro AKI (NGAL) for use on Beckman Coulter’s DxC and AU clinical
chemistry analyzer families.
The agreement with Beckman Coulter supplements BioPorto’s existing
partnership portfolio of leading global manufacturers of clinical analyzers
for distribution of the NGAL test products. The expansion of the partnership
portfolio is a testament to the substantial interest in NGAL as a biomarker
and in BioPorto’s technology from market leaders and a significant
milestone in the execution of BioPorto’s strategy.
Expanding the global distribution network with the leading instrument
manufacturers and driving expansion of instruments cleared for ProNephro
AKI (NGAL) and the NGAL Test use will enable more laboratories to
implement the test and increase the serviceable market fast and prepare
for a forceful roll-out of the test for adults once expectedly cleared in the
USA by 2027.
BioPorto is in dialogue with several instrument manufacturers regarding
potential global distribution agreements for the NGAL test product line. The
dialogues are expected to lead to additional partnership agreements in
2025.
Planning for initiation of patient enrollment for US studies
for FDA submission of ProNephro AKI (NGAL) for adult use
On 29 October, 2024, BioPorto announced the enrollment of the first
patient in its US clinical study for ProNephro AKI (NGAL) with the goal of
determining a cut-off point for risk stratification of moderate to severe of
AKI in adult patients.
The enrollment of the first patient follows a successful process path
implemented by BioPorto’s regulatory team leveraging the experience
from the US pediatric clearance process, which was successfully concluded
with a US marketing clearance in December 2023.
The first adult patient was enrolled at Massachusetts General Hospital, MA
(US), which is one of the 12 participating hospital sites the Company seeks
to enroll in the cut-off study.
The cut-off study is the first of two studies which will form a substantial part
of the adult submission for US clearance of ProNephro AKI (NGAL),
scheduled to be submitted to FDA by 2026.
BioPorto expects the FDA submission could lead to a clearance for clinical
use in adult patients by 2027 allowing the test to be commercially
distributed in the US and hence opening up a large part of what is estimated
to be a USD 3 billion yearly market for the test worldwide.
Ongoing funding considerations
As described in BioPorto’s strategy, the company aims to raise a total of
USD 20 million in the period 2024/2025. In June 2024, BioPorto closed a
funding round providing gross proceeds of USD 11.7 million via a direct
share issue. With a cash position of DKK 76.3 million (USD 11.5 million) by
September 2024, BioPorto is well capitalized to progress its strategic plan.
For the remaining part of the funding under the strategy, BioPorto is
currently exploring and considering several options.
Management Review
Interim Report BioPorto, first nine months of 2024
7
This financial review is based on the Group’s consolidated financial
information as of and for the nine months ended September 30, 2024, with
comparative results as of and for the nine months ended September 30,
2023, in brackets.
Revenue
Revenue was DKK 28.3 million (DKK 24.4 million) in the first nine months of
2024.
NGAL test sales totaled DKK 18.3 million (DKK 15.2 million) in the first nine
months of 2024, which comprised 65% of total global revenue. NGAL
revenue in the US/Canada totaled DKK 11.2 million (DKK 8.3 million) in the
first nine months of 2024, which comprised 40% of total revenue. Antibody
sales totaled DKK 8.4 million (DKK 7.9 million) in the first nine months of
2024.
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 2024 was DKK 6.7 million (DKK 6.1
million), which was primarily driven by a DKK 1.1 million increase in revenue
over the prior year period.
Gross profit for the first nine months of 2024 was DKK 20.8 million (DKK
16.2 million), reflecting favorable sales volume and improved gross margin
over the prior year period.
Sales and Marketing Costs
Sales and marketing costs totaled DKK 10.2 million (DKK 4.6 million) in the
third quarter of 2024. For the first nine months of 2024, sales and marketing
costs totaled DKK 25.2 million (DKK 15.4 million). The increase in sales and
marketing costs for the third quarter and the first nine months was
primarily driven by staffing up in areas of business development and sales
force to commercialize ProNephro AKI (NGAL) in the US and grow NGAL
revenue in the rest of the world (ROW) by attending conferences to
increase NGAL awareness.
Research and Development Costs
Research and development costs in the third quarter of 2024 totaled DKK
9.6 million (DKK 4.6 million), the increase mainly due to increased staffing.
For the first nine months of 2024, research and development costs totaled
DKK 23.0 million (DKK 21.6 million), with the increase principally reflecting
higher staffing and lower clinical study costs.
Administrative Costs
Administrative costs in the third quarter of 2024 totaled DKK 8.4 million
(DKK 7.2 million), which reflected increased staffing compared to the prior
year period.
For the first nine months of 2024, administrative costs totaled DKK 26.8
million (DKK 27.3 million), which reflected severance costs for the former
CEO of DKK 3.6 million, increase in consulting costs offset by warrant
expense reversal of DKK 5.4 million primarily related to resignation of the
former CEO, compared to prior year period.
Financials Items, net
Financial income and expenses reflect interest income/expense and
currency transaction gains/losses. Financial items, net for the third quarter
of 2024 was an expense of DKK 0.7 million (DKK 1.1 million net income),
and expense of DKK 0.5 million (DKK 0.7 million net income) for the first
nine months of 2024.
Tax Benefit
In the third quarter of 2024, a DKK 1.4 million tax benefit (income of DKK
1.0 million) was recognized, and DKK 4.4 million (DKK 3.5 million) was
recognized for the first nine months of 2024. The tax benefit is primarily
related to tax credits held by its Danish entities associated with the
Company’s investment in research and development.
EBIT/Adjusted EBITDA
For the third quarter of 2024, Earnings before interest and taxes (EBIT) was
a loss of DKK 21.6 million (DKK 11.7 million), and adjusted EBITDA was a loss
of DKK 19.6 million (DKK 9.7 million), reflecting the mix of variances
described above.
For the first nine months of 2024, Earnings before interest and taxes (EBIT)
was a loss of DKK 54.2 million (DKK 49.5 million), and adjusted EBITDA was
a loss of DKK 51.1 million (DKK 44.2 million), reflecting the mix of variances
described above. BioPorto has in the first nine months of 2024 continuously
exercised strong cost control to preserve cash.
6.5
8.5
5.3
8.7
8.0
7.8
8.6
6.6
9.5
9.2
9.7
0
2
4
6
8
10
12
Q1 Q2 Q3 Q4
2022 2023 2024
3.7
3.3
2.7
5.2
4.8
4.6
5.8
3.4
6.1
5.4
6.8
0
1
2
3
4
5
6
7
8
Q1 Q2 Q3 Q4
2022 2023 2024
Financial Review
Interim Report BioPorto, first nine months of 2024
8
Cash and Cash equivalents
As of September 30, 2024, BioPorto’s cash position was DKK 76.3 million
(DKK 69.9 million) and is 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’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 US clinical commercial launch of ProNephro
AKI (NGAL) for pediatric and young adults, 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.
The Company assessed its liquidity and capital resources based on a
sufficient cash in fallback scenario should no additional financing be added
in the next four quarters and concluded that there are adequate to fund
operations considering a twelve-month period from the balance sheet date
due to the Company’s ability to scale back its strategic initiatives based on
facts and circumstances
Net working capital
Net working capital (i.e., current assets minus current liabilities) as of
September 30, 2024, totaled DKK 80.6 million (DKK 67.0 million).
Cash Flow Statement
Cash used in operating activities during the first nine months of 2024
totaled DKK 66.1 million (DKK 52.8 million), which reflected severance
payments to the former CEO, calendar year 2023 incentive compensation
paid in early 2024, recruiting and hiring of new personnel to support
strategic objectives and working capital improvements over the prior year
period.
Cash used in investing activities was nil (DKK 1.0 million). Cash from
financing activities was 76.1 (DKK 41.8 million), reflecting DKK 78.0 million
net proceeds from the private placement completed in June 2024.
The net cash flow during the first nine months of 2024 was a source of DKK
10.0 million (use of DKK 12.0 million).
Subsequent event
Please see Note 13 for further details.
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.
A variety of factors and events, including the war in Ukraine and Israel-
Palestine, have resulted in delays and other challenges in global supply
chains. To manufacture its products, the Company is dependent on the
supply of raw materials and key components from suppliers, some of which
are single source suppliers. Delays in the manufacture, delivery, or quality
of these components, or delays in the Company’s execution of its
commercialization strategy, including hiring personnel and continuing to
prepare manufacturing and quality systems, could affect the Company’s
ability to deliver products to its customers, which could cause the
Company’s results, prospects, and financial performance to be negatively
impacted.
In addition to the other information set forth in this report, you should
carefully consider the factors discussed in the sections captioned “Risk
management” in BioPorto’s 2023 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 may also have a material adverse effect on the Group’s
business, future opportunities, financial condition, and/or operating
results.
Guidance for 2024 maintained
Based on the progress and results obtained in the first nine months of 2024,
BioPorto maintains its financial guidance for 2024, as most recently
described in its Interim Report for the Second Quarter of 2024 of:
• Total Revenue target of DKK 40 million, and
• Adjusted EBITDA loss in the range DKK 75-90 million.
In 2024, BioPorto expects revenue to grow 29% compared to 2023. Growth
will be driven by increased sales of NGAL products – primarily in the US,
supplemented by growth in the rest of the world. Revenue in the first nine
months of 2024 was in line with expectations.
The expected adjusted EBITDA loss for the fourth quarter of 2024 will be
higher than the third quarter of 2024 due to hiring of more sales staff,
increased marketing costs for ProNephro AKI (NGAL) in the US, and the
accelerated cost of clinical trials to support FDA clearance for ProNephro
AKI (NGAL) for adults.
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, Investor Relations, BioPorto, +45 4529 0000,
investor@bioporto.com
www.bioporto.com
Interim Report BioPorto, first nine months of 2024
9
The Board of Directors and Executive Management today reviewed and approved the Interim Report of the BioPorto Group for the period January 1 to
September 30, 2024.
The Interim Report, which is unaudited and has not been reviewed by the Company’s auditors, is presented in accordance with IAS 34 “Interim Financial
Reporting” as adopted by the EU and additional Danish disclosure requirements for interim reports of listed companies.
In our opinion, the interim report gives a true and fair view of the Group’s financial position as of September 30, 2024, and the results of the Group’s
operations and cash flows for the period January 1 to September 30, 2024.
In our opinion the management’s review includes a fair review of the development and performance of the business, the results for the period and the
Group’s financial position in general and describes changes in principal risks and uncertainties that have occurred relative to what was disclosed in the
consolidated Annual Report for 2023.
Hellerup, November 14, 2024
Executive Management:
___________________________ ___________________________ ___________________________
Peter Mørch Eriksen Gry Louise Husby Larsen Niels Høy Nielsen
CEO CLO CFO
Board of Directors:
___________________________ ___________________________ __________________________
John McDonough Don Hardison Michael Singer
Chair Vice Chair
___________________________ ___________________________ ___________________________
Ninfa Saunders Henrik Juuel Mats Thorén
Statement by the Board of Directors and
Management
Interim Report BioPorto, first nine months of 2024
10
Condensed Consolidated Statements of Profit or Loss
2024
2023
2024
2023
2023
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand
Notes
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Revenue
3
Production costs
Gross profit
Sales and marketing costs
Research and development costs
Administrative costs
Lease impairment
Loss before financial items (EBIT)
(21,602 )
(11,700 )
(54,177 )
(49,505 )
(61,172 )
Financial income
Financial expenses
Loss before tax
(22,320 )
(10,618 )
(54,664 )
(48,785 )
(61,207 )
Income tax benefit, net
5
Net loss
(20,886 )
(9,598 )
(50,282 )
(45,307 )
(56,328 )
DKK
DKK
DKK
Loss per share (EPS & DEPS)
6
(0.05
(0.03
(0.13
(0.13
(0.16
Condensed Consolidated Statements of Comprehensive Loss
2024
2023
2024
2023
2023
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)
Net loss
(20,886 )
(9,598 )
(50,282 )
(45,307 )
(56,328 )
Other comprehensive loss:
Amounts which will be reclassified to the
income statement:
Exchange rate adjustments of investments in
subsidiaries
(712 )
(600 )
Other comprehensive loss
(712 )
(600 )
Comprehensive loss
(19,657 )
(10,310 )
(49,362 )
(45,907 )
(55,869 )
Interim Financial Statements
Interim Report BioPorto, first nine months of 2024
11
Condensed Consolidated Balance Sheets
Assets
2024
2023
2023
Sep 30
Sep 30
Dec 31
DKK thousand
Notes
(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
Lease receivable - Long term
9
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
Lease receivable - short term
9
Total current assets
Total assets
Interim Report BioPorto, first nine months of 2024
12
Equity and Liabilities
2024
2023
2023
Sep 30
Sep 30
Dec 31
DKK thousand
Notes
(Unaudited)
(Unaudited)
Equity
Share capital
8
Treasury shares
8
Exchange-rate adjustments
(834 )
Retained earnings
(344,270 )
(308,071 )
(319,735 )
Total equity
Liabilities
Non-current liabilities
Lease obligations
9
Total non-current liabilities
Current liabilities
Current portion of lease obligations
9
Trade payables
9
Tax payables
Other accrued liabilities
10
Total current liabilities
Total liabilities
Total equity and liabilities
Interim Report BioPorto, first nine months of 2024
13
Condensed Consolidated Statement of Changes in Equity (Unaudited)
Amounts in DKK thousand
Share
Capital
Share
Premium
Treasury
Shares
Accumulated
Deficit
AOCI
Total
Balance at December 31, 2023
(319,735 )
Other comprehensive loss
Transaction with owners:
Issuance of stock
Issuance costs
(3,387 )
(3,387 )
Transferred to Accumulated Deficit
(28,013 )
Share-based compensation
(2,266 )
(2,266 )
Net loss
(50,282 )
(50,282 )
Balance at September 30, 2024
(344,270 )
Amounts in DKK thousand
Share
Capital
Share
Premium
Treasury
Shares
Accumulated
deficit
AOCI
Total
Balance at December 31, 2022
(264,238 )
(234 )
Other comprehensive loss
(600 )
(600 )
Closure of dormant subsidiary
(104 )
(104 )
Transaction with owners:
Exercise of Warrants
Issuance of stock
Issuance costs
(1,629 )
(1,629 )
Transferred to Accumulated Deficit
(449 )
Share-based compensation
Net loss
(45,307 )
(45,307 )
Balance at September 30, 2023
(308,071 )
(834 )
Interim Report BioPorto, first nine months of 2024
14
Condensed Consolidated Statements of Cash Flows
2024
2023
2023
Sep 30
Sep 30
Dec 31
DKK thousand
Notes
(Unaudited)
(Unaudited)
Loss before financial items
(54,177 )
(49,505 )
(61,172 )
Adjustments:
Depreciation and amortization
Share based compensation expenses
4
(2,266 )
Lease impairment
Other non-cash items
(960 )
Changes in operating assets and liabilities:
Inventories
(750 )
(440 )
Trade receivables
(3,836 )
(2,222 )
Trade payables
(4,024 )
(7,977 )
(3,552 )
Other operating assets and liabilities, net
(5,937 )
(3,066 )
(1,399 )
Cash flows from operations
(65,828 )
(53,419 )
(61,799 )
Financial income, received
Financial expenses, paid
(328 )
(65 )
(94 )
Tax refund, net
Cash flows from operating activities
(66,064)
(52,791)
(55,456)
Purchase of property, plant and equipment
(39 )
Purchase of financial assets
(961 )
(238 )
Cash flows from investing activities
(961 )
(277 )
Proceeds from warrant programs exercised
Proceeds from rights issue
Cost related to Issue of new shares
(3,387 )
(1,629 )
(1,629 )
Repayments of lease obligation
(1,951 )
(2,757 )
(3,738 )
Cash flows from financing activities
Net cash flows for the period
(11,980 )
(14,943 )
Cash and cash equivalents at beginning of period
Effect of exchange rate changes on cash
(58 )
(447 )
Cash and cash equivalents end of period
Interim Report BioPorto, first nine months of 2024
15
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 Accounting 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, 2023.
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. We have allocated resources
and significant efforts regarding the US clinical commercial launch of ProNephro AKI (NGAL) for pediatric and young adults, 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 .
The Company assessed its liquidity and capital resources based on a sufficient cash in fallback scenario should no additional financing be added in the next
four quarters and concluded that there are adequate to fund operations considering a twelve-month period from the balance sheet date due to the
Company’s ability to scale back its strategic initiatives based on facts and circumstances. The Company continues to monitor its liquidity needs, manage its
costs, and investigate its financing options.
In the event that the Company’s strategic priorities and tactical decisions, commercialization activities for NGAL tests in the US, under CE Mark and
Antibodies, 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 2023 and in accordance with the recognition and measurement policies of IFRS. Certain comparative figures have been reclassified
to conform to the current period’s presentation.
As of September 30, 2024, the Group has implemented all new or amended accounting standards and interpretations as adopted by the EU and applicable
for the 2024 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.
Notes to Interim Condensed
Consolidated Financial Statements
(Unaudited)
Interim Report BioPorto, first nine months of 2024
16
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 C.f. the Annual Report as of and for the year ended December 31, 2023. The significant judgements made by Management in applying the
Group’s accounting policies and the key sources of estimation uncertainty were not materially different from those that applied to the consolidated
financial statements, C.f. the Annual Report as of and for the year ended December 31, 2023.
3. Business area reporting
GEOGRAPHIC DISTRIBUTION
2024
2023
2024
2023
2023
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)
North America
5,363
4,962
15,077
13,470
17,479
Europe
1,458
2,220
8,194
7,504
9,705
Asia
2,864
1,427
5,075
3,424
3,774
Other regions
-
-
-
-
-
Revenue
9,685
8,609
28,346
24,398
30,958
PRODUCT GROUPS
2024
2023
2024
2023
2023
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
6,803
5,842
18,330
15,236
18,558
Antibodies
2,472
2,215
8,441
7,882
10,681
ELISA kits
402
543
1,521
1,252
1,674
Royalty and other revenue
8
9
54
28
45
Revenue
9,685
8,609
28,346
24,398
30,958
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 2024, share-based compensation totaled an income of DKK 2.3 million primarily due to the reversal of DKK 5.4 million of warrant
expense compared to warrant expense of DKK 2.0 million for the prior year period. 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.
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, 2023, the gross value of the tax asset prior to the valuation allowance was DKK 98.4 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 2024
17
6. Loss per share
2024
2023
2024
2023
2023
Jul 1 - Sep 30
Jul 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Sep 30
Jan 1 - Dec 31
DKK thousand (except where noted)
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Loss for the period
(20,886)
(9,598)
(50,282)
(45,307)
(56,328)
BioPorto Group's share of loss
(20,886)
(9,598)
(50,282)
(45,307)
(56,328)
Weighted average number of shares (in
thousand)
429,670
379,670
397,736
351,381
358,511
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)
429,657
379,657
397,723
351,368
358,498
Loss per share (EPS) basic and diluted, DKK
(0.05)
(0.03)
(0.13)
(0.13)
(0.16)
Warrants outstanding were excluded from the calculation of loss per share because the effect would have been anti-dilutive.
7. Receivables
2024
2023
2023
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables
6,240
5,280
2,404
Other receivables
2,326
1,350
1,164
Prepayments
3,407
1,648
1,741
Provisions for bad debt
(56)
(55)
(58)
Financial assets at amortized costs
11,917
8,223
5,251
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
BioPorto A/S on June 18, 2024, successfully completed an oversubscribed private placement of 50,000,000 new shares at market price – the largest ever
private placement in the company’s history.
The new shares were subscribed for by both existing and new professional investors as well as management and members of the board of directors, and
yielded gross proceeds of DKK 81.4 million. The new shares were issued on June 24, 2024, and payment received in full by the same date.
As of September 30, 2024, the share capital consists of 429,670,461 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, 2024, and 2023, and December 31, 2023, 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, 2024, 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, 2024, or the year
ended December 31, 2023.
Interim Report BioPorto, first nine months of 2024
18
9. Financial risks and financial instruments
Financial instrument categories
2024
2023
2023
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Trade receivables, net
6,184
5,225
2,346
Other receivables
2,326
1,350
1,164
Lease receivable - Short term
1,146
-
960
Lease receivable - Long term
1,541
-
2,728
Cash and cash equivalents
76,342
69,943
66,402
Financial assets at amortized costs
87,539
76,518
73,600
2024
2023
2023
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Lease liabilities
4,625
8,327
7,250
Trade payables
2,881
2,480
6,905
Financial liabilities at amortized costs
7,506
10,807
14,155
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 is denominated in currencies other than DKK, primarily USD and EUR. Consequently,
there is a risk of exchange rate fluctuations having an impact on the Group’s reported results.
The Group is exposed to currency risks through sales, production, R&D contracts, and payroll denominated in currencies other than Danish kroner. The
Group is subjected to transaction risk related to sales and purchases in foreign currencies, and translation risk when translating foreign entities into the
Group’s presentation currency.
Interim Report BioPorto, first nine months of 2024
19
B/S CURRENCIES PERCENTAGES
2024
2023
2023
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Inventory
DKK
100%
100%
100%
Trade receivables
USD
30%
28%
51%
EUR
69%
71%
49%
Other
1%
1%
-
Cash and cash equivalents
DKK
96%
96%
90%
USD
4%
2%
5%
EUR
-
2%
5%
Trade payables
DKK
53%
23%
60%
USD
31%
58%
25%
EUR
16%
13%
6%
Other
-
6%
9%
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 has interest rate exposure because substantially all of its assets consisted of bank deposits. A one percent change in interest rate could result
in a change in interest income of approximately DKK 0.8 million based on the interest-bearing accounts portion of the DKK 76.3 million cash and cash
equivalents as of September 30, 2024.
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 2024
20
AS OF SEPTEMBER 30, 2024 (Unaudited)
DKK thousand
Expected
credit loss rate
Trade
receivables
Expected loss
Total
Not due
0.4%
5,803
22
5,781
1 - 30 days overdue
0.3%
360
1
359
31 - 60 days overdue
0.0%
16
-
16
61 - 90 days overdue
0.0%
-
-
-
More than 90 days overdue
54.1%
61
33
28
September 30, 2024
6,240
56
6,184
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
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 76.3 million and DKK 66.4 million as of September 30, 2024, and December 31, 2023, 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 2024
21
10. Other accrued liabilities
2024
2023
2023
Sep 30
Sep 30
Dec 31
DKK thousand
(Unaudited)
(Unaudited)
Accrued incentive compensation
5,600
5,555
4,158
Accrued board fee
-
2,494
2,756
Accrued vacation
1,861
1,379
1,099
Accrued professional and consulting fees
1,473
2,464
1,726
Accrued clinical trial costs
328
1,531
1,825
Accrued supplier costs
2,445
-
2,483
Accrued staff costs liabilities
436
1,404
-
Accrued severance costs
1,076
-
-
Accrued expenses - Other
1,552
1,421
1,372
Other accrued liabilities
14,771
16,248
15,419
* Effective May 2024, all board fees are paid current on a monthly basis, therefore no accrued board fees.
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
Other than ordinary management and Board of Director remuneration, the company paid Michael Singer, a Board Member, the equivalent of DKK 108K
under a consulting agreement.
Interim Report BioPorto, first nine months of 2024
22
13. Subsequent events
On October 21, the Company announced that by mutual agreement, Jeffrey N. Haas has resigned as President and Chief Executive Officer of BioPorto Inc.
(US), the fully owned subsidiary of BioPorto A/S.
On October 28, the Company announced that the Company enters into a global distribution partnership with Beckman Coulter for acute kidney injury
NGAL Tests.
On October 29, the Company announced initiation of patient enrollment for US study of ProNephro AKI (NGAL)
TM
for adult use at Massachusetts General
Hospital.
Interim Report BioPorto, first nine months of 2024
23
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 products are based on the NGAL biomarker and
designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a
common clinical syndrome that can have severe consequences, including
significant morbidity and mortality, if not identified and treated early. With the
aid of NGAL levels, 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
Company markets NGAL tests under applicable registrations including CE mark
in several 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.
www.bioporto.com
CVR DK-17500317