April 6, 2022
Announcement no. 7

BioPorto Publishes 2021 Annual Report

BioPorto A/S (BioPorto), an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers, today published its Annual Report for 2021. The full report can be found on the company's website, www.bioporto.com.

Highlights from BioPorto’s 2021 Annual Report:

• Achieved 2021 total revenue of DKK 24.3 million, representing growth of 4.5% compared to the prior year period
• Completed an interim analysis of The NGAL Test’s performance that were consistent with expectation
• Enrollment for pediatric trial for The NGAL Test continued, but was delayed by the impact of COVID-19 on access to trial sites and patients
• Appointed new Executive management team, Board Chairman, and Board Vice-Chairman

2021 was another challenging year for the world, as the global COVID-19 pandemic continued to impact global health. For BioPorto, the pandemic also restricted its ability to execute the pivotal clinical trial required to support a US Food and Drug Administration (FDA) submission for the flagship product, The NGAL Test.

But 2021 was also a year of progress for BioPorto that will drive value creation in 2022 and onwards – particularly in the progression of R&D, validation, regulatory, quality and operational improvement efforts. Furthermore, with the appointment of a new experienced executive team with a successful track record from introducing new diagnostic products to the US market, BioPorto developed a clear strategic path for the future.

Focus, focus, focus

Since taking over as the CEO in November 2021, Tony Pare has worked to focus BioPorto’s strategy on delivering the NGAL biomarker as the new standard of care in assessment of kidney health, preparing the company to commercialize and scale, and building a strong team dedicated to the mission.

“We are a small company with a unique technology and very high ambitions. That calls for clear prioritization and focus on what we aim to achieve in the next 12-18 months, which is to obtain US FDA approval of our flagship product, The NGAL Test, for use in pediatrics (under age 22) and drive its adoption in the US, which is the largest market for in vitro diagnostic tests in the world,” said Tony Pare, BioPorto’s Chief Executive Officer.

BioPorto continues to expect to finalize enrollment of pediatric patients at fifteen top hospitals across the US by second quarter of 2022, and subsequently submit for US FDA approval of the test for use in identifying children at risk for AKI. Following submission, and in parallel with FDA review, BioPorto will initiate the application process for FDA approval of The NGAL Test for adult use in the US.

Successful share offering provides runway for strong execution

As a first step of the strategy, BioPorto in March 2022 closed a fully subscribed, pre-emptive rights offering for new shares as part of a long-term capital plan that includes a potential US listing.

“The proceeds from the offering of approximately DKK 100.4 million will, together with existing funds, provide a strong foundation for submission of The NGAL Test application for pediatric use to the FDA, enable us to prepare for a commercial launch, and implement programs to drive market adoption,” said Tony Pare. “I am very thankful for the support and clear mandate from both existing shareholders and new investors to focus our efforts and execute this strategy. It is a strategy that I firmly believe will bring BioPorto to a very successful and bright future with compelling value creation for patients, health care providers, and our shareholders.”

Outlook

The company's outlook for 2022 is as follows (all numbers are approximate):

• Revenue of DKK 24-26 million
• EBIT loss of DKK 95-100 million
• Adjusted EBITDA loss of DKK 76-81million
  
  

The outlook is based on certain assumptions described in the annual report and continues to be subject to uncertainty due to COVID-19.

Investor Meeting

In connection with the release of the 2021 Annual Report, BioPorto will host an online investor presentation on April 6, 2022 at 14:30 CET via HC Andersen Capital. For registration, please visit https://bit.ly/37csHWN. A separate analyst call will be held on April 6, 2022 at 16:00 CET. For further information regarding the analyst call, please visit www.bioporto.com/investor-relations.

For further information, please contact:

Neil Goldman, Executive VP & CFO
Tim Eriksen, Investor Relations

Telephone: +45 4529 0000, email: 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 product is The NGAL Test, which has been designed to aid in the risk assessment 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 The NGAL Test, 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.

BioPorto is headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen stock exchange [CPH:BIOPOR]. More information is available at www.bioporto.com.

Forward-looking statements

Certain statements in this announcement are forward-looking statements, which are based on the Company’s expectations, intentions and projections regarding its future performance, anticipated events or trends and other matters that are not historical facts, including with respect to test performance, potential FDA clearance in pediatrics, development of the Company’s U.S. organization, and commercialization of The NGAL Test. 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.