August 15, 2024
Announcement no. 18
BioPorto Announces Interim Results and Business Update for the Second Quarter and Six Months of Fiscal 2024
Continued strong growth in US sales of NGAL tests and focused execution of all elements of BioPorto's strategy plan
COPENHAGEN, Denmark and BOSTON, MA, USA, August 15, 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 six months of 2024 and business progress for the second quarter of 2024.
Strategic and operational highlights from 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 standing order
- Focused execution in building sales organization and preparing US marketing activities ahead of ProNephro AKI (NGAL) launch
- Dialogues with several new potential global partners for 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 new management team with hirings of CLO, CFO and US President
- Completion of oversubscribed direct share issue at market price with gross proceeds of DKK 81 million
Financial Highlights for the period ended June 30, 2024
For the six months ended June 30, 2024:
- NGAL revenues in the US increased by 43% over the prior year - global NGAL revenues increased by 22% over the prior year and comprised 62% of total global revenue.
- Total revenue of DKK 18.7 million / USD 2.7 million, an 18% increase over the prior year
- Adjusted EBITDA of DKK (31.5) million / USD (4.6) million, an 8% decrease from the prior year
- Cash and cash equivalents of DKK 103.9 million / USD 14.9 million as of June 30, 2024
For the second quarter ended June 30, 2024:
- NGAL revenues increased by 18% in the US and 14% in ROW over the prior year
- Total revenue of DKK 9.2 million / USD 1.3 million, a 19% increase over the prior year
- Adjusted EBITDA of DKK (16.2) million / USD (2.4) million, a 16% decrease from the prior year
Peter Mørch Eriksen, BioPorto's Group Chief Executive Officer (CEO), commented: "BioPorto continued its strong momentum in the second quarter of 2024 and with a strict focus on execution of our strategy, we secured all important milestones we set out to reach. Operationally, we increased revenue in all product lines, most importantly in US sales of NGAL products, and maintained tight cost control. We have allocated a lot of efforts to the pending clinical commercialization in the US of ProNephro AKI (NGAL) by attending conferences and staffing up, which is resulting in increased knowledge and new important orders. Financially, we successfully closed 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 very experienced industry leaders."
Mr. Eriksen continued: "Going into what will be a very busy second half of 2024 with focus on US launch, new partnerships and enrolment of the first patients for the studies supporting an FDA submission of ProNephro AKI (NGAL) for adults a bit faster than expected, I am very pleased with our performance, progress, and the company's perspectives, which I believe are stronger than ever."
Guidance for 2024 Maintained
Based on the progress and results obtained in the first six months of 2024, BioPorto maintains its financial guidance for 2024, as most recently described in its Interim Report for the First 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 August 15, 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://www.inderes.dk/videos/bioporto-opdatering-pa-q2-2024.
Additionally, the Company's management team will host 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 investor@bioporto.com.
Investor Relations Contacts
Tim Eriksen, EU Investor Relations, Zenith Advisory, +45 4529 0000, investor@bioporto.com
Ashley Robinson, US Investor Relations, LifeSci Advisors, +1 617 430 7577, arr@lifesciadvisors.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: June 30, 2023 = 6.8539 and June 30, 2024 = 6.9664
- Income statement measures for six months ended: June 30, 2023 = 6.9097 and June 30, 2024 = 6.8728.
Income statement measures for three months ended: June 30, 2023 = 6.8696 and June 30, 2024 = 6.9091.
