First Quarter 2024: Strong growth in US sales of The NGAL Test

May 8, 2024

Announcement no. 11

First Quarter 2024: Strong growth in US sales of The NGAL Test

COPENHAGEN, Denmark and BOSTON, MA, USA, May 8, 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 three months of 2024 and business progress for the first quarter of 2024.

Financial Highlights

• For the three months ended March 31, 2024:
  • NGAL revenues in the US increased by 80% over the prior year
  • Total revenue of DKK 9.5 million / USD 1.4 million
  • Adjusted EBITDA of DKK (15.3) million / USD (2.2) million
  • Cash and cash equivalents of DKK 45.3 million / USD 6.6 million as of March 31, 2024 (DKK 57.7 million / USD 8.4 million as of March 31, 2023)

Peter Mørch Eriksen, BioPorto’s Chief Executive Officer (CEO), commented: “BioPorto had a successful first quarter of 2024 in setting a new direction for the Company. In February, we announced the updated strategy to transition BioPorto from a research-based company to a growth company. As part of this, we have set and communicated a strong commercial roadmap with clear growth and profitability targets. Success will be achieved by launching ProNephro AKI™ (NGAL) in the US in second half of 2024, increase sales of The NGAL Test in all existing markets and prepare a submission with the FDA for adult use of the test in the US.”

Mr. Eriksen continued, “As promised, we have in the first quarter delivered on the near-term milestones that were laid out. We have extended our agreement with Roche Diagnostics (Roche) to cover more analyzers, grown NGAL test revenue in the US by 80% over prior year and built strong momentum in our adult submission process. In addition, we have strengthened our management team in April with the addition of a Chief Legal Officer and in May with a CEO of the US-subsidiary. A group CFO is expected to be appointed later in the second quarter. Operationally, our full operational attention in the second quarter of 2024 is on preparing for the launch of ProNephro AKI in the US, grow sales and continue preparations for the adult study process.”

Guidance for 2024 Maintained

Based on the progress and results obtained in the first three months of 2024, BioPorto maintains its financial guidance for 2024, as most recently described in its Annual Report 2023 of:

• Total Revenue target of DKK 40 million, and
• Adjusted EBITDA loss in the range of DKK 75-90 million.

Call and Webcast and Investor Meeting

The Company’s management team will host an online investor presentation on May 8, 2024, at 11:00 AM Central European Time / 5:00 AM Eastern Time, via HC Andersen Capital. Investors interested in attending the webcast may register at: .

Additionally, the Company’s management team will host a physical investor meeting on May 8, 2024, at 15:00 CEST at Tuborg Havnevej 15, ground floor, 2900 Hellerup, Denmark. Investors should register by writing to .

Investor Relations Contacts

Claus Thestrup, HC Andersen Capital, ,

Ashley Robinson, US Investor Relations, LifeSci Advisors, ,

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 .

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: March 31, 2023 = 6.8492 and March 31, 2024 = 6.8955
• Income statement measures for three months ended: March 31, 2023 = 6.9498 and March 31, 2024 = 6.8364.

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