BioPorto Announces Interim Results and Business Update for the Second Quarter and Six Months of Fiscal Year 2024 | 15.08.24

August 15, 2024
Announcement No. 18

BioPorto Announces Interim Results and Business Update for the Second Quarter and Six Months of Fiscal Year 2024

Continued strong growth in US NGAL test sales and focused execution of all elements of BioPorto’s strategic plan

COPENHAGEN, Denmark and BOSTON, MA, USA, Aug. 15, 2024, (GLOBE NEWSWIRE) — BioPorto A/S CVR No. 17500317 (BioPorto or Company) (CPH:BIOPOR), an in vitro diagnostics company focused on improving the early detection of acute kidney injury (AKI), today announced interim financial results for the first six months of 2024 and business progress for the second quarter of 2024.

Strategic and operational highlights for the second quarter ended June 30, 2024

• Double-digit growth across all product lines, driven by increased US NGAL product sales to new and existing customers, including the first US firm order
• Focused execution in building the sales organization and preparing marketing activities in the US prior to the launch of ProNephro AKI™ (NGAL)
• Dialogues with several new potential global partners for the distribution of NGAL products
• Draft protocol finalized and site selection initiated for clinical studies for FDA submission of ProNephro AKI™ (NGAL) for adults in the US – enrollment to start in 2024 (previously 2025)
• Establishment of a new management team with the appointment of a CLO, CFO and US President
• Completion of the oversubscribed direct share offering at market price with gross proceeds of DKK 81 million

Financial highlights for the period ending June 30, 2024
For the six months ended June 30, 2024:

• US NGAL revenues increased 43% year-over-year. Global NGAL revenues increased 22% year-over-year, accounting for 62% of total global revenues.
• Total turnover of DKK 18.7 million / USD 2.7 million, an increase of 18% compared to the previous year
• Adjusted EBITDA of DKK (31.5) million / USD (4.6) million, down 8% year-on-year
• Cash and cash equivalents of DKK 103.9 million / USD 14.9 million as of June 30, 2024

For the second quarter ending June 30, 2024:

• NGAL revenues grew 18% in the US and 14% in the rest of the world year-on-year
• Total turnover of DKK 9.2 million / USD 1.3 million, an increase of 19% compared to the previous year
• Adjusted EBITDA of DKK (16.2) million / USD (2.4) million, a decrease of 16% compared to the previous year

Peter Mørch Eriksen, Group Chief Executive Officer (CEO) of BioPorto, commented: “BioPorto continued its strong momentum in the second quarter of 2024 and with a strict focus on executing our strategy, we achieved all the key milestones we set out to achieve. Operationally, we increased sales across all product lines, particularly in U.S. sales of NGAL products, and maintained tight cost control. We invested significant effort in the upcoming U.S. clinical commercialization of ProNephro AKI™ (NGAL) by attending conferences and hiring, resulting in increased learning and new significant orders. Financially, we successfully completed the largest private placement of new shares in the company’s history to fund our strategic initiatives, and organizationally, we established a new management team with the appointment of highly experienced industry leaders.”

Mr. Eriksen continued: “As we enter a very busy second half of 2024, with a focus on the US launch, new partnerships and enrolling the first patients in the studies supporting an FDA filing for ProNephro AKI (NGAL) for adults slightly faster than expected, I am very pleased with our performance, progress and the Company’s outlook, which I believe is stronger than ever.”

Guidelines for 2024 maintained
Based on the progress and results achieved in the first six months of 2024, BioPorto maintains its financial guidance for 2024, as recently described in its interim report for the first quarter of 2024:

• Target total turnover of DKK 40 million, and
• Adjusted EBITDA loss in the order of DKK 75-90 million.

Call and webcast and investors meeting
The Company’s management team will host an online presentation for investors via HC Andersen Capital on August 15, 2024 at 10:30 a.m. Central European Time / 4:30 a.m. Eastern Time. Investors wishing to attend the webcast can register at: https://www.inderes.dk/videos/bioporto-opdatering-pa-q2-2024.

In addition, the Company’s management team will hold a physical investor meeting on August 15, 2024 at 15:00 CEST at Tuborg Havnevej 15, ground floor, 2900 Hellerup, Denmark. Investors should register by writing to [email protected].

Investor Relations Contacts
Tim Eriksen, EU Investor Relations, Zenith Advisory, +45 4529 0000, [email protected]
Ashley Robinson, US Investor Relations, LifeSci Advisors, +1 617 430 7577, [email protected]

About BioPorto
BioPorto is an in vitro diagnostics company focused on saving lives and improving quality of life with actionable biomarkers – tools designed to help clinicians drive transformational change in patient management. The company is leveraging its expertise in antibody and assay development, as well as its assay development platform, to create a pipeline of novel and compelling products targeting conditions where there is significant unmet medical need, and where the company’s tests can help improve clinical and economic outcomes for patients, caregivers and the healthcare ecosystem.

The company’s flagship products are based on the NGAL biomarker and are designed to aid in the risk assessment and diagnosis of acute kidney injury, a common clinical syndrome that can have serious consequences, including significant morbidity and mortality, if not identified and treated early. NGAL levels can help physicians identify patients who may be at risk for AKI earlier than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The company is commercializing NGAL tests under applicable regulatory approvals, including CE Mark in several countries worldwide.

BioPorto has offices in Copenhagen, Denmark and Boston, MA, USA. BioPorto A/S shares are listed on the Nasdaq Copenhagen Stock Exchange. For more information, visit www.bioporto.com.

Disclaimer for forward-looking statements

Certain statements in this press release are not historical facts and may be forward-looking statements. Forward-looking statements include statements regarding the intent, belief or current expectations regarding the Company’s expectations, intentions and projections regarding its future performance, including the Company’s 2024 guidance; fluctuations in exchange rates; anticipated events or trends and other matters that are not historical facts, including with respect to the implementation of manufacturing and quality systems, commercialization of NGAL assays and development of future products and new indications; concerns that may arise from additional data, analyses or results obtained during clinical trials; and the Company’s ability to successfully commercialize both new and existing products. These forward-looking statements, which may use words such as “aim,” “expect,” “believe,” “intend,” “estimate,” “anticipate” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks and uncertainties that could cause actual operating results, financial condition, liquidity, dividend policy and the development of the industry in which the Company operates to differ materially from the impression given 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, potential 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 assumes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that could affect BioPorto’s success are disclosed in more detail in BioPorto’s periodic financial filings, including the 2023 Annual Report, with the Danish Financial Supervisory Authority, in particular under the heading “Risk Factors”.

NOTE – DKK/USD exchange rates used in “Recent Highlights”, above:

• Balance sheet measures: June 30, 2023 = 6.8539 and June 30, 2024 = 6.9664
• Profit and loss account figures for the six months ending: June 30, 2023 = 6.9097 and June 30, 2024 = 6.8728.

Profit and loss account figures for the three months ending: June 30, 2023 = 6.8696 and June 30, 2024 = 6.9091.

• 2024 08 15 – Interim report Q2 – BioPorto