November 14, 2024
Announcement no. 22

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
• Continued sales growth of NGAL products, with first standing order with a yearly value of more than USD 200,000 signed
• Continued collaboration with distribution partner in preparation for US launch of ProNephro AKI NGAL, now expected in first half of 2025
• 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 2024
• Strong momentum in process regarding US adult clinical trials for ProNephro AKI (NGAL) - first patient enrolled in October 2024

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 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.

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/register.

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”.