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BioPorto

Earnings Release Aug 15, 2025

3424_ir_2025-08-15_6b526b26-5807-4a69-91e3-705a5374133f.pdf

Earnings Release

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August 15, 2025 Announcement no. 19

BioPorto Interim Result for the Second Quarter of 2025 - Continued progress with full execution of strategic objectives and strong NGAL sales growth.

Copenhagen, Denmark, August 15, 2025, (GLOBE NEWSWIRE) – BioPorto A/S ("BioPorto" or the "Company") (CPH:BIOPOR), today announced interim financial results for the second quarter of 2025 and a business update.

Continued progress on key strategic milestones for the second quarter of 2025

  • Full execution of the objectives outlined in our February 2024 Strategic Plan.
  • A major milestone in the second quarter of 2025 was the receipt of the first purchase order for ProNephroTM AKI (NGAL) for the US market, marking the first step in the commercial launch.
  • The enrollment of patients in the US clinical cut-off study for ProNephro AKI (NGAL) for adult use is progressing as planned and is reaching the final phase. We maintain our goal to submit to the FDA by the end of 2026.
  • Strong NGAL sales growth of 39% compared to the second quarter of 2024.
  • The Board was restructured with Jens Due Olsen stepping in as Chairman and Carsten Buhl appointed as new CEO as of September 1, to drive the next growth phase.
  • On April 15, 2025, the Company successfully completed a funding round of 25,000,000 new shares in a direct issue at market price providing gross proceeds of DKK 33.5 million. The funding round was met with strong support from existing shareholders.

Peter Mørch Eriksen, BioPorto's Group Chief Executive Officer (CEO), comments:

"The second quarter of 2025 marked a pivotal chapter for BioPorto, with the first US order of ProNephro AKI (NGAL) initiating our commercial journey and laying the foundation for a commercial platform to drive broad adoption of ProNephro AKI through strategic partnerships.

We are pleased with the strong market momentum in the US and the progress in clinical studies toward the FDA submission by the end of 2026. With a clearly defined strategy and new leadership, we are well positioned to move into the next phase of our growth journey."

Financial highlights for the second quarter of 2025

  • Total revenue in the second quarter of 2025 totaled DKK 10.6 million, representing a 15% increase compared to the same period last year. This growth was driven by rising NGAL sales in both the US and the rest of the world (ROW).
  • NGAL sales increased by 39% compared to the second quarter of 2024, driven by a 23% increase in the US and a substantial growth of 71% in the ROW, primarily due to a bulk order.
  • EBITDA loss in the second quarter of 2025 amounted to DKK 18.4 million compared to DKK 16.2 million in the second quarter last year. The increase is primarily driven by higher costs associated with the adult clinical study.
  • As of June 30, 2025, the Company's cash position was DKK 47.8 million compared to DKK 103.9 million in the same period last year.

For the first half of 2025 total revenue amounted to DKK 18.3 million, representing a 2% decrease compared to the same period last year, primarily driven by lower Antibody sales due to timing in orders. NGAL sales rose by 5% compared to the first half of 2024, driven by a 22% increase in US NGAL sales. Adjusted EBITDA loss for the first half of 2025 amounted to DKK 46.5 million, compared to DKK 31.5 million in the same period last year.

Guidance

Based on the results for the first half of 2025 and better visibility for the remainder of 2025, we narrow the full-year guidance for 2025.

  • Total revenue is expected to be in the range of DKK 45-50 million (previously DKK 45-60 million). Sales for the rest of 2025 are still expected to be back-end loaded.
  • Adjusted EBITDA loss is expected to be in the range of DKK 75-80 million (previously DKK 75-85 million).
DKK million Q2 2025 Q2 2024 Change H1 2025 H1 2024 Change Guidance
2025
Previous
Guidance
Revenue 10.6 9.2 15% 18.3 18.7 -2% 45-50 45-60
Adjusted EBITDA loss 18.4 16.2 14% 46.5 31.5 48% 75-80 75-85

To receive BioPorto's Company Announcements, Press Releases, Newsletters and other business relevant information, please sign up on https://bioporto.com/investor-contact/.

Investor Relations Contacts

Hanne S. Foss, Head of Investor Relations, BioPorto A/S, [email protected], C: +45 26368918

About BioPorto

BioPorto is an in vitro diagnostics company focused on saving patients' lives and improving their quality of life with actionable kidney biomarkers – tools designed to help clinicians make changes in patient management. The Company leverages its expertise in 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 risk assessment and diagnosis 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 NGAL levels, physicians can identify patients 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 and FDA cleared ProNephro AKITM (NGAL) in the US.

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 2025; 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 2024, particularly under the heading "Risk Factors".

Consolidated Financial Highlights

2025 2024 2025 2024 2024
DKK million (except where noted) Apr 1 – Jun 30
(Unaudited)
Apr 1 – Jun 30
(Unaudited)
Jan 1 – Jun 30
(Unaudited)
Jan 1 – Jun 30
(Unaudited)
Jan 1 - Dec 31
Revenue 10.6 9.2 18.3 18.7 36.2
Gross profit 7.1 7.0 12.0 14.2 24.5
Sales and marketing costs 5.0 8.9 13.1 14.9 30.2
Research and development costs 12.0 7.1 29.6 13.4 33.5
Administrative costs 8.4 8.8 18.3 18.4 36.2
Loss before financial items (EBIT) (18.3) (17.9) (49.1) (32.6) (75.5)
Financial items, net (1.4) 0.4 (1.8) 0.2 1.7
Loss before tax (19.7) (17.5) (50.9) (32.3) (73.7)
Net loss (18.1) (15.8) (45.5) (29.4) (68.2)
Comprehensive loss (16.1) (16.0) (42.9) (29.7) (69.5)
Adjusted EBITDA (18.4) (16.2) (46.5) (31.5) (70.6)
Non-current assets 16.3 7.7 12.1
Cash and cash equivalents 47.8 103.9 59.7
Current assets 71.8 123.9 83.9
Total assets 88.0 131.5 96.0
Equity 57.2 104.8 67.8
Non-current liabilities 5.8 3.5 7.8
Current liabilities 25.0 23.2 20.4
Total equity and liabilities 88.0 131.5 96.0
Cash flows from operating activities (41.2) (39.8) (83.6)
Cash flows from investing activities (1.4) - 1.2
Of which investment in property, plant, and
equipment (1.4) - (0.4)
Cash flows from financing activities 30.9 76.8 75.5
Net cash flows (11.7) 37.0 (6.9)
Revenue growth 15% 19% -2% 18% 17%
Gross profit percentage 67% 76% 66% 76% 68%
Equity ratio (solvency) 65% 80% 65% 80% 71%
Average number of employees 44 37 48 33 38
Number of shares at the end of the period (1,000) 454,670 429,670 454,670 429,670 429,670
Loss per share (EPS), DKK (0.04) (0.04) (0.10) (0.08) (0.17)
Net asset value per share, period-end, DKK 0.13 0.24 0.13 0.24 0.16
Share price, period-end, DKK 1.40 2.14 1.40 2.14 1.55

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 2024 BioPorto Annual Report.

Reconciliation of Adjusted EBITDA
Loss before financial items (EBIT) (18.3) (17.9) (49.1) (32.6) (75.5)
Depreciation and amortization 0.6 0.6 1.3 1.2 2.4
Share-based compensation expenses (0.9) 1.1 (0.5) (3.7) (0.9)
Severance costs 0.1 0.0 1.7 3.6 3.4
Adjusted EBITDA (18.4) (16.2) (46.5) (31.5) (70.6)

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.

Management Review

Strong revenue growth in the second quarter of 2025 driven by NGAL sales growth

Total Revenue for the second quarter of 2025 totaled DKK 10.6 million, a 15% increase compared to Q2 2024. Total NGAL sales rose by 39% compared to the second quarter of 2024, driven by a 23% increase in US NGAL research use only (RUO) sales and a 71% growth in sales for the rest of the world, primarily due to a bulk order.

Revenue in the second quarter of 2025 from antibodies sales declined by 16% and sales of ELISA kits decreased by 37% compared to the second quarter of 2024. These declines are due to timing differences between quarters and are expected to recover in the coming quarters of 2025.

The growth in NGAL sales for the second quarter of 2025 was encouraging and demonstrated strong momentum in our core business. We remain pleased with the sustained growth in US NGAL RUO sales, our primary market, and are optimistic about the rest of the year, especially given the first step in the commercialization of ProNephro AKITM (NGAL) in the US market.

DKK million Q2 2025 Q2 2024 Change H1 2025 H1 2024 Change
- US NGAL 4.4 3.6 23% 8.9 7.3 22%
- ROW NGAL 3.1 1.8 71% 3.3 4.2 -23%
NGAL Total 7.5 5.4 39% 12.1 11.5 5%
Antibodies 2.8 3.3 -16% 5.3 6.0 -12%
ELISA & other 0.3 0.5 -38% 0.9 1.2 -26%
Total Revenue 10.6 9.2 15% 18.3 18.7 -2%

Total Revenue for the first half of 2025 totaled DKK 18.3 million, a 2% decrease compared to the first half of 2024. NGAL sales rose by 5% compared to the first half of 2024, driven by a 22% increase in US NGAL sales. Revenue in the first half of 2025 from antibodies sales declined by 12% and sales of ELISA kits declined by 27% compared to the first half of 2024.

BioPorto receives first order for ProNephro AKI for the US market

The key highlight for the second quarter of 2025 was the receipt of the first purchase order for ProNephro AKI (NGAL) for the US market in June 2025, marking the initial step in the commercial launch of the test on the Roche Cobas® c501 analyzer. This represents a significant milestone and the first commercial step in BioPorto's ambition to establish a commercial platform for kidney diagnostics and to drive broader adoption of ProNephro AKI.

The next phase involves submitting ProNephro AKI (NGAL) for integration on Roche Cobas c502 and c503 analyzers, while also expanding the global distribution network through partnerships with the remaining three of the "Big 5" leading instrument manufacturers. These efforts aim to accelerate the adoption of NGAL-cleared instruments, broaden test availability across laboratories, and significantly increase the addressable market — laying the foundation for a strong commercial launch of the adult test indication, once expectedly cleared in the US in 2027.

Preparation of FDA application for ProNephro AKI (NGAL) for adults

The enrollment of patients in the US clinical cut-offstudy for ProNephro AKI (NGAL) is progressing as planned. The goal of the cut-off study is to determine a cut-off point for risk stratification of moderate to severe AKI in adult patients. 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). The enrollment of patients follows the 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.

As the patient enrollment for cut-off study has progressed as planned in the second quarter of 2025, the study is reaching the final phase. Accordingly, enrollment pauses have now been initiated at several sites. The interim analysis and preliminary results of the cut-off study are expected in October 2025 at the latest followed by patient enrollment for the validation study. The timeline for the adult submission for US FDA clearance remains unchanged, with submission planned by the end of 2026.

BioPorto expects the FDA submission could lead to a clearance for clinical use in adult patients in 2027, allowing the test to be commercially distributed to this segment in the US.

New Board composition and CEO to drive next phase of growth

As commercial opportunities in the US begin to materialize, BioPorto has transitioned from a research-based organization to a growth-oriented company. To support the next phase of development and reinforce our strategic positioning in the Nordic region, Jens Due Olsen has been appointed Chairman of the Board. He brings extensive leadership experience from Danish and international companies across industrial, financial, and technology sectors.

In addition, Donna Haire has joined the Board as a new member. With her deep expertise in US regulatory affairs, she will play a key role in the preparation of the planned FDA submission for adult use of ProNephro AKI.

The newly appointed Board of Directors thereafter consists of Jens Due Olsen as Chair, Henrik Juuel as Vice Chair, Donna Haire and Mats Thorén. This new composition provides a strong foundation for executing our strategic priorities and enhancing BioPorto's visibility and positioning in the Nordic market.

To lead the business in the next phases of commercialization and towards FDA clearance of ProNephro AKI (NGAL) for adult use in 2027, the Board of Directors has in June 2025 appointed Carsten Buhl as new Chief Executive Officer (CEO), effective September 1, 2025. With more than 25 years of experience in the MedTech and life science industry – most recently as President of the Americas at WSAudiology and part of the Executive Management of the Company's global top management team – Carsten brings strong commercial insight and international perspective.

Ongoing funding considerations

On April 15, 2025, BioPorto completed a fully subscribed funding round of 25,000,000 new shares at market price providing gross proceeds of DKK 33.5 million. The proceeds are to be applied to finance clinical trials to seek FDA clearance for ProNephro AKI (NGAL) for adult use in the US, increase sales and marketing activities as well as general corporate purposes until the beginning of 2026. The Company will continue to evaluate financing opportunities, including share issuance and alternative financing solutions.

Financial Review

This financial review is based on the Group's consolidated financial information as of and for the second quarter and the first half of 2025 ended June 30, 2025, with comparative results as of and for the second quarter and the first half of 2024 ended June 30, 2024, in brackets.

Revenue

Revenue totaled DKK 10.6 million (DKK 9.2 million) in the second quarter of 2025, increasing 15% over prior the year period, mainly due to increased NGAL test sales. In the first half of 2025 revenue totaled DKK 18.3 million (DKK 18.7 million), declining 2%. Assuming constant exchange rates, total revenue declined by 2%.

In the second quarter NGAL test sales totaled DKK 7.5 million (DKK 5.4 million), growing 39% due to an increase of 23% in NGAL US/Canada sales and an increase of 71% in NGAL ROW sales compared to the prior year period. Antibody sales totaled DKK 2.8 million (DKK 3.3 million), declining by 16%.

Figure 1. Revenue by quarter (DKK million)

Figure 2. NGAL test product revenue by quarter (DKK million)

For the first half of 2025 NGAL test sales totaled DKK 12.1 million (DKK 11.5 million), growing 5%, which comprised 66% of total revenue. NGAL revenue in the US/Canada totaled DKK 8.9 million (DKK 7.3 million), growing 22%, while NGAL revenue in ROW declined by 23% to DKK 3.3 million (DKK 4.2 million). Further, the Antibody sales declined by 12% to DKK 5.3 million (DKK 6.0 million).

Gross Profit

Gross profit for the second quarter of 2025 was DKK 7.1 million (DKK 7.0 million), the increase was driven by higher sales volume; offset by lower margin due to higher staff costs in Production compared to prior year period.

Gross profit for the first half of 2025 was DKK 12.0 million (DKK 14.2 million), the decrease was mainly driven by lower margin due to higher consultancy costs and staff costs in Production compared to prior year period.

Sales and Marketing Costs

Sales and marketing costs totaled DKK 5.0 million (DKK 8.9 million) in the second quarter of 2025. The decrease in sales and marketing costs was primarily driven by reversal of share-based compensation expenses and lower recruiting and consultancy costs.

Sales and marketing costs totaled DKK 13.1 million (DKK 14.9 million) in the first half of 2025. The decrease is due to the above-mentioned items; offset by the carry-over from end of 2024 of 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).

Research and Development Costs

Research and development costs, consisting of research and development, regulatory affairs, quality assurance, clinical, and medical affairs, totaled in the second quarter of 2025 DKK 12.0 million (DKK 7.1 million), with the increase mainly due to our adult clinical study.

For the first half of 2025, these costs amounted to DKK 29.6 million (DKK 13.4 million), also primarily driven by our adult clinical study.

Administrative Costs

Administrative costs in the second quarter of 2025 totaled DKK 8.4 million (DKK 8.8 million). The decrease in costs is due to lower consultancy costs; offset by carry-over of additional staff being hired in the second half of 2024.

Administrative costs in the first half of 2025 totaled DKK 18.3 million (DKK 18.4 million). The decrease in costs is due to severance costs that incurred in the first quarter of 2024 and lower consultancy costs; offset by the carryover of additional staff being hired in the second half of 2024.

Financials Items, net

Financial income and expenses reflect interest income/expense and currency transaction gains/losses. Financial items, net for the second quarter of 2025 were an expense of DKK 1.4 million (income of DKK 0.4 million), and expense of DKK 1.8 million (income of DKK 0.2 million) in the first half of 2025.

Tax Benefit

In the second quarter of 2025, a DKK 1.7 million tax benefit (DKK 1.6 million) was recognized, and DKK 5.4 million (DKK 2.9 million) was recognized for the first half of 2025. 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 second quarter of 2025, Earnings before interest and taxes (EBIT) was a loss of DKK 18.3 million (DKK 17.9 million), and adjusted EBITDA was a loss of DKK 18.4 million (DKK 16.2 million), reflecting the mix of variances described above.

For the first half of 2025, Earnings before interest and taxes (EBIT) was a loss of DKK 49.1 million (DKK 32.6 million), and adjusted EBITDA was a loss of DKK 46.5 million (DKK 31.5 million), reflecting the mix of variances described above.

Cash and Cash equivalents

As of June 30, 2025, BioPorto's cash position was DKK 47.8 million (DKK 103.9 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 on inter alia on assumptions and significant judgements (in addition to those matters discussed cf. Note 2). These assumptions are 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. This includes 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 sufficient cash in a fallback scenario should no additional financing be added in the next four quarters and concluded that these 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. BioPorto has continuously exercised strong cost control to preserve cash in the first half of 2025.

Net working capital

Net working capital (i.e., current assets minus current liabilities) as of June 30, 2025, totaled DKK 46.8 million (DKK 100.7 million).

Cash Flow Statement

Cash used in operating activities during the first half of 2025 totaled DKK 41.2 million (DKK 39.8 million), which reflected costs for the adult clinical study and the reasons described above.

Cash used in investing activities was DKK 1.4 million (inflow of DKK 0.6 million). Cash from financing activities was DKK 30.9 (DKK 76.2 million), reflecting DKK 32.8 million net proceeds from the directed offering completed in April 2025.

The net cash flow during the first half of 2025 was a use of DKK 11.7 million (source of DKK 37.0 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 and could potentially impact the Company across the value chain including clinical and regulatory, research and development, manufacturing, commercial, and financial activities. Furthermore, the uncertainty in the US could impact the Company adversely by implementation of tariffs or delaying any submissions with the FDA.

A variety of factors and events, including geopolitical uncertainty, 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 manufacturing, 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, a full description of risks can be found in BioPorto's 2024 Annual Report in the section captioned "Risk Management", describing 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 2025

Based on the results for the first half of 2025 and the outlook for the remaining part of 2025, we narrow our financial guidance for 2025 due to better visibility for the remainder of 2025:

Total Revenue is expected to end in the range DKK 45-50 million, previously in the range DKK 45-60 million. Sales for the remaining part of 2025 are still expected to be back-end loaded.

Adjusted EBITDA loss is expected to end in the range DKK 75-80 million, previously in the range DKK 75-85 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. Forwardlooking 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. BioPorto does not undertake any obligation to update or revise forward-looking statements to reflect subsequent events or circumstances after the date made.

For Further Information

Hanne Søgaard Foss, Head of Investor Relations, BioPorto, +45 4529 0000, [email protected] www.bioporto.com

Statement by the Board of Directors and Management

The Board of Directors and Executive Management today reviewed and approved the Interim Report of the BioPorto Group for the period January 1 to June 30, 2025.

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 June 30, 2025, and the results of the Group's operations and cash flows for the period January 1 to June 30, 2025.

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 2024.

Hellerup, August 15, 2025

Executive Management:

Peter Mørch Eriksen Gry Louise Husby Larsen Niels Høy Nielsen CEO CLO CFO

___________________________ ___________________________ ___________________________

___________________________ ___________________________ __________________________

Board of Directors:

Jens Due Olsen Henrik Juuel Mats Thorén Chair Vice Chair

Donna Haire

___________________________

Interim Financial Statements

Condensed Consolidated Statements of Loss

2025 2024 2025 2024 2024
DKK thousand Notes Apr 1 - Jun 30
(Unaudited)
Apr 1 - Jun 30
(Unaudited)
Jan 1 - Jun 30
(Unaudited)
Jan 1 - Jun 30
(Unaudited)
Jan 1 - Dec 31
Revenue 3 10,591 9,200 18,258 18,661 36,243
Production costs 3,530 2,217 6,289 4,508 11,713
Gross profit 7,061 6,983 11,969 14,153 24,530
Sales and marketing costs 5,042 8,930 13,148 14,923 30,202
Research and development costs 11,966 7,086 29,625 13,405 33,533
Administrative costs 8,369 8,840 18,302 18,400 36,247
Loss before financial items (EBIT) (18,316) (17,873) (49,106) (32,575) (75,452)
Financial income 141 434 349 720 2,543
Financial expenses 1,542 45 2,187 489 834
Loss before tax (19,717) (17,484) (50,944) (32,344) (73,743)
Income tax benefit, net 5 1,653 1,641 5,422 2,948 5,500
Net loss (18,064) (15,843) (45,522) (29,396) (68,243)
DKK DKK
Loss per share (EPS & DEPS) 6 (0.04) (0.04) (0.10) (0.08) (0.17)

Condensed Consolidated Statements of Comprehensive Loss

2025 2024 2025 2024 2024
DKK thousand Apr 1 - Jun 30
(Unaudited)
Apr 1 - Jun 30
(Unaudited)
Jan 1 - Jun 30
(Unaudited)
Jan 1 - Jun 30
(Unaudited)
Jan 1 - Dec 31
Net loss (18,064) (15,843) (45,522) (29,396) (68,243)
Other comprehensive loss:
Amounts which will be reclassified to the
income statement:
Exchange rate adjustments of investments in
subsidiaries
1,945 (164) 2,648 (309) (1,277)
Other comprehensive loss 1,945 (164) 2,648 (309) (1,277)
Comprehensive loss (16,119) (16,007) (42,874) (29,705) (69,520)

Condensed Consolidated Balance Sheets

Assets

2025 2024 2024
Jun 30 Jun 30 Dec 31
DKK thousand Notes (Unaudited) (Unaudited)
Non-current assets
Property, plant and equipment and intangible assets
Rights and software 207 346 276
Property, plant and equipment 1,785 679 2,136
Right-of-use assets 5,702 418 6,579
Total property, plant and equipment and intangible assets 7,694 1,443 8,991
Financial assets
Lease receivable - Long term 9 967 1,912 1,707
Deposits 2,101 1,348 1,415
Non-current tax receivable 5 5,500 2,948 -
Total financial assets 8,568 6,208 3,122
Total non-current assets 16,262 7,651 12,113
Current assets
Inventories 4,830 4,294 4,640
Trade receivables 7, 9 7,029 4,479 8,187
Current tax receivable 5 6,288 5,931 6,392
Other receivables 7, 9 1,874 1,746 1,368
Prepayments 7 2,896 2,327 2,448
Lease receivable - short term 9 1,090 1,198 1,200
Cash and cash equivalents 9 47,766 103,909 59,664
Total current assets 71,773 123,884 83,899
Total assets 88,035 131,535 96,012

Equity and Liabilities

2025 2024 2024
DKK thousand Notes Jun 30
(Unaudited)
Jun 30
(Unaudited)
Dec 31
Equity
Share capital 8 454,670 429,670 429,670
Treasury shares 8 - - -
Exchange-rate adjustments 1,596 (84) (1,052)
Retained earnings (399,046) (324,766) (360,840)
Total equity 57,220 104,820 67,778
Liabilities
Non-current liabilities
Lease obligations 9 5,821 3,539 7,846
Total non-current liabilities 5,821 3,539 7,846
Current liabilities
Current portion of lease obligations 9 3,321 2,180 3,344
Trade payables 9 4,770 5,545 5,706
Tax payables - 80 -
Other accrued liabilities 10 16,903 15,371 11,338
Total current liabilities 24,994 23,176 20,388
Total liabilities 30,815 26,715 28,234
Total equity and liabilities 88,035 131,535 96,012

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, 2024 429,670 - 13 (360,840) (1,052) 67,778
Other comprehensive loss - - - - 2,648 2,648
Transaction with owners:
Issuance of stock 25,000 8,505 - - - 33,505
Issuance costs - (735) - - - (735)
Transferred to Accumulated Deficit - (7,770) - 7,770 - -
Share-based compensation - - - (454) - (454)
Net loss - - - (45,522) - (45,522)
Balance at June 30, 2025 454,670 - 13 (399,046) 1,596 57,220
Amounts in DKK thousand Share
Capital
Share
Premium
Treasury
Shares
Accumulated
deficit
AOCI Total
Balance at December 31, 2023 379,670 - 13 (319,735) 225 60,160
Other comprehensive loss - - - - (309) (309)
Transaction with owners:
Issuance of stock 50,000 31,400 - - - 81,400
Issuance costs - (3,336) - - - (3,336)
Transferred to Accumulated Deficit - (28,064) - 28,064 - -
Share-based compensation - - - (3,699) - (3,699)
Net loss - - - (29,396) - (29,396)
Balance at June 30, 2024 429,670 - 13 (324,766) (84) 104,820

Condensed Consolidated Statement of Cash Flows

2025 2024 2024
DKK thousand Notes Jun 30
(Unaudited)
Jun 30
(Unaudited)
Dec 31
Loss before financial items (49,106) (32,575) (75,452)
Adjustments:
Depreciation and amortization 1,296 1,195 2,382
Share based compensation expenses 4 (454) (3,699) (875)
Other non-cash items 1,231 3,508 (1,400)
Remeasurement of lease - - (984)
Changes in operating assets and liabilities:
Inventories (202) (449) (864)
Trade receivables 1,178 (2,124) (5,847)
Trade payables (936) (1,360) (1,199)
Other operating assets and liabilities, net 5,758 (4,062) (5,542)
Cash flows from operations (41,235) (39,566) (89,781)
Financial income, received 143 67 1,641
Financial expenses, paid (69) (290) (381)
Tax refund, net - - 4,938
Cash flows from operating activities (41,161) (39,789) (83,583)
Purchase of property, plant and equipment (1,368) - (350)
Purchase of financial assets (700) - (165)
Proceeds from financial assets - - 921
Proceeds from sublease 674 596 781
Cash flows from investing activities (1,394) 596 1,187
Proceeds from rights issue 33,505 81,400 81,400
Cost related to Issue of new shares (735) (3,336) (3,387)
Repayments of lease obligation (1,919) (1,894) (2,547)
Cash flows from financing activities 30,851 76,170 75,466
Net cash flows for the period (11,704) 36,977 (6,930)
Cash and cash equivalents at beginning of period 59,664 66,402 66,402
Effect of exchange rate changes on cash (194) 530 192
Cash and cash equivalents end of period 47,766 103,909 59,664

Notes to Interim Condensed Consolidated Financial Statements (Unaudited)

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 prepared in accordance with IFRS 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, 2024.

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 these 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 2024 and in accordance with the recognition and measurement policies of IFRS. Certain comparative figures have been reclassified to conform to the current period's presentation.

As of June 30, 2025, the Group has implemented all new or amended IFRS accounting standards and interpretations as adopted by the EU and applicable for the 2025 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.

The new IFRS 18 is expected to change the presentation of the Income statement and to differentiate between earnings from operating activities, investment activities and financing activities. IFRS 18 will also add additional disclosures but will not change any accounting policies on recognition and measurement, hence it will not change reported net results. IFRS 18 will come into effect in 2027 or later.

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 Annual Report as of and for the year ended December 31, 2024. 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, 2024.

3. Business area reporting

GEOGRAPHIC DISTRIBUTION
DKK Thousand
2025
Apr 1 - Jun 30
(Unaudited)
2024
Apr 1 - Jun 30
(Unaudited)
2025
Jan 1 - Jun 30
(Unaudited)
2024
Jan 1 - Jun 30
(Unaudited)
2024
Jan 1 - Dec 31
North America 5,888 4,980 11,693 9,714 20,634
Europe 2,850 3,822 4,281 6,736 10,237
Asia 1,853 398 2,284 2,211 5,372
Other regions - - - - -
Revenue 10,591 9,200 18,258 18,661 36,243
PRODUCT GROUPS
DKK Thousand
2025
Apr 1 - Jun 30
(Unaudited)
2024
Apr 1 - Jun 30
(Unaudited)
2025
Jan 1 - Jun 30
(Unaudited)
2024
Jan 1 - Jun 30
(Unaudited)
2024
Jan 1 - Dec 31
NGAL tests 7,523 5,419 12,127 11,527 23,054
Antibodies 2,768 3,296 5,273 5,969 10,783
ELISA kits 289 457 815 1,119 2,269
Royalty and other revenue 11 28 43 46 137
Revenue 10,591 9,200 18,258 18,661 36,243

4. Share-based payment

For the purpose of motivating and retaining Management and key staff and aligning their interests with those of its shareholders, BioPorto A/S uses warrants as an incentive scheme. The arrangements, which are exercised by the issuance of new shares (equity-settled share-based payment transaction), entitle the recipient to subscribe for new shares in the parent company at a price defined on the date of grant.

In the first half of 2025, share-based compensation totaled an income of DKK 0.5 million compared to an income of DKK 3.7 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 the deferred tax assets on the balance sheet, cf. Note 2. The deferred tax asset is of indefinite duration. As of the most recent year-end, December 31, 2024, the gross value of the deferred tax asset prior to the valuation allowance was DKK 105.4 million.

Taxes receivable represent refunds of previous US federal tax liabilities and tax credits held by its Danish entities associated with the Company's investment in research and development.

6. Loss per share

2025 2024 2025 2024 2024
DKK thousand (except where noted) Apr 1 - Jun 30
(Unaudited)
Apr 1 - Jun 30
(Unaudited)
Jan 1 - Jun 30
(Unaudited)
Jan 1 - Jun 30
(Unaudited)
Jan 1 - Dec 31
Loss for the period (18,064) (15,843) (45,522) (29,396) (68,243)
BioPorto Group's share of loss (18,064) (15,843) (45,522) (29,396) (68,243)
Weighted average number of shares (in
thousand)
448,077 383,517 438,925 381,594 405,763
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)
448,064 381,504 438,912 381,581 405,750
Loss per share (EPS) basic and diluted, DKK (0.04) (0.04) (0.10) (0.08) (0.17)

Warrants outstanding were excluded from the calculation of loss per share because the effect would have been anti-dilutive.

7. Receivables

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.

2025 2024 2024
DKK thousand Jun 30
(Unaudited)
Jun 30
(Unaudited)
Dec 31
Trade receivables 7,073 4,528 8,251
Other receivables 1,874 1,746 1,368
Prepayments 2,896 2,327 2,448
Write-down for bad debt (44) (49) (64)
Receivables at amortized costs 11,799 8,552 12,003

A write-down for bad debts is recognized to reduce the carrying amount of trade receivables by the value which is impaired due to risk of loss.

AS OF JUNE 30, 2025

DKK thousand Expected
credit loss rate
Trade
receivables
Expected loss Total
Not due 0.1% 5,357 7 5,350
1 - 30 days overdue 0.2% 634 1 633
31 - 60 days overdue 0.0% 345 - 345
61 - 90 days overdue 0.0% 158 - 158
More than 90 days overdue 6.2% 579 36 543
As of June 30, 2025 7,073 44 7,029

AS OF JUNE 30, 2024

DKK thousand Expected
credit loss rate
Trade
receivables
Expected loss Total
Not due 0.2% 3,898 9 3,889
1 - 30 days overdue 0.2% 541 1 540
31 - 60 days overdue 0.0% - - -
61 - 90 days overdue 0.0% 17 - 17
More than 90 days overdue 54.2% 72 39 33
As of June 30, 2024 4,528 49 4,479

8. Share capital

As of June 30, 2025, the share capital consists of 454,670,461 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 June 30, 2025, and 2024, and December 31, 2024, the Company held 13,000 treasury shares representing less than 0.01% of outstanding shares as of each date with nominal value of DKK 13,000. As of June 30, 2025, BioPorto A/S is not authorized to acquire treasury shares. BioPorto A/S did not acquire treasury shares during the six months ended June 30, 2025, or the year ended December 31, 2024.

9. Financial risks and financial instruments

Financial instrument categories

2025 2024 2024
DKK thousand Jun 30
(Unaudited)
Jun 30
(Unaudited)
Dec 31
Trade receivables 7,029 4,479 8,187
Other receivables 1,874 1,746 1,368
Lease receivable - Short term 1,090 1,198 1,200
Lease receivable - Long term 967 1,912 1,707
Cash and cash equivalents 47,766 103,909 59,664
Financial assets at amortized costs 58,726 113,244 72,126

2025 2024 2024 Jun 30 Jun 30 Dec 31 DKK thousand (Unaudited) (Unaudited) Lease liabilities 9,142 5,719 11,190 Trade payables 4,770 5,545 5,706

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.

Financial liabilities at amortized costs 13,912 11,264 16,896

The Group is exposed to currency risks through sales, production, R&D contracts, and payroll denominated in currencies other than DKK. 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.

B/S CURRENCIES PERCENTAGES 2025 2024 2024
DKK thousand Jun 30
(Unaudited)
Jun 30
(Unaudited)
Dec 31
Inventory
DKK 100% 100% 100%
Trade receivables
USD 81% 30% 30%
EUR 18% 68% 68%
Other 1% 2% 2%
Cash and cash equivalents
DKK 88% 97% 93%
USD 10% 3% 6%
EUR 2% - 1%
Trade payables
DKK 18% 79% 53%
USD 79% 8% 29%
EUR 2% 11% 17%
Other 1% 2% 1%

Based on its transaction volume, the Group has determined not to hedge its USD exposure. As the DKK 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 consist of bank deposits. A one percent change in interest rate could result in a change in interest income of approximately DKK 0.5 million based on the interest-bearing accounts portion of the DKK 47.8 million cash and cash equivalents as of June 30, 2025.

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.

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 47.8 million and DKK 59.7 million as of June 30, 2025, and December 31, 2024, 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.

10. Other accrued liabilities

2025 2024 2024
DKK thousand Jun 30
(Unaudited)
Jun 30
(Unaudited)
Dec 31
Accrued incentive compensation 2,366 3,416 3,290
Accrued vacation 1,901 1,864 1,599
Accrued professional and consulting fees 1,563 3,957 1,014
Accrued clinical trial costs 6,528 - 892
Accrued supplier costs 2,926 2,384 2,926
Accrued severance costs - 2,009 -
Accrued expenses - Other 1,619 1,741 1,617
Other accrued liabilities 16,903 15,371 11,338

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

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 executive management and Board of Director remuneration, the company did not have any transactions with related parties in the first half of 2025.

13. Subsequent events

There have been no significant subsequent events.

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

BioPorto A/S BioPorto, Inc. Tuborg Havnevej 15, ground floor 117 Kendrick Street, Suite 300 DK-2900 Hellerup Needham, MA 02494 Denmark USA CVR DK-17500317

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