May 11, 2022
Announcement no. 11

Strong Performance of The NGAL Test Drives Revenue Growth

Revenues totaled DKK 6.5 million in the first quarter of 2022, a 17% increase over the prior year. This growth was driven by a 70% increase in The NGAL Test sales, primarily from research use only (RUO) sales in the US and the timing of customer orders, which were up 116% over the prior year and a 10% increase in rest-of-the-world (ROW) sales of the test. ELISA kit revenue increased 138% in the first quarter of 2022 over the prior year period, offset by a 38% reduction in antibodies sales that were consistent with expectations in the absence of an individual bulk order during the quarter.

Tony Pare, BioPorto’s Chief Executive Officer, commented, “The first quarter of 2022 was an encouraging start for BioPorto and this new team on several fronts. We have developed and are executing detailed plans to support US FDA submission, approval, and launch of The NGAL test. We also achieved favorable revenue growth, including The NGAL Test sales, reflecting a combination of growing clinician interest in this impactful biomarker for critical care patients and the timing of customer orders.”

Strategic focus on preparing BioPorto for US breakthrough
The NGAL Test has been granted Breakthrough Device designation by the FDA for expedited review. Breakthrough Device designation is granted for devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions, and where neither approved nor cleared alternatives exist.

In the first quarter of 2022, BioPorto’s new leadership team developed an 18 month strategy focused on delivering the NGAL biomarker as the new standard of care in assessing Acute Kidney Injury (AKI), preparing the Company to commercialize and scale, and building a strong team dedicated to the mission.

Consequently, BioPorto’s clear priority and focus is on obtaining US FDA approval of its flagship product, The NGAL Test, for use in pediatrics (under age 22) and drive its adoption in the US.

Targeted Enrollment of Pediatric Patients Remains On-track by end-June 2022
As planned, BioPorto is enrolling pediatric patients at fifteen top hospitals across the US for the third part of a 3-part clinical study to support an US Food and Drug Administration (FDA) submission of The NGAL Test for use in identifying children under age 22 at risk of AKI. The Company continues to expect that it will complete the targeted enrollment for the study's objectives in the second quarter of 2022, and then finalize analysis of the data to support the FDA filing.

Successful and Fully Subscribed Share Offering Provides Runway for Strong Strategic Execution
On April 1, 2022, BioPorto raised net proceeds of approximately DKK 93.1 million, from a fully subscribed pre-emptive rights offering of new shares as part of a long-term capital plan that includes a potential US listing.

The proceeds will, together with existing funds, provide a foundation for the submission of The NGAL Test application for pediatric use in the US, prepare for a commercial launch, and implement programs to drive market adoption.

Guidance for 2022 maintained
Based on the progress and results obtained in first three months of 2022, BioPorto maintains its financial guidance for 2022, as most recently described in its Annual Report 2021 of:

• Revenue of approximately DKK 24 to 26 million;
• Operating (EBIT) loss of approximately DKK 95 to 100 million; and,
• Adjusted EBITDA loss of approximately DKK 76 to 81 million.
  
  

In March and April BioPorto raised net proceeds of DKK 93.1 million in a fully-subscribed pre-emptive rights issue that provides funding to complete the targeted enrollment in the US for our pediatric trial of The NGAL Test, and subsequently prepare and submit the application to the FDA.

Investor and Analyst Meetings
In connection with the release of the Interim Report for the first quarter of 2022, the Company’s management team will host an online investor presentation on May 11, 2022 at 14:00 CET via HC Andersen Capital. For registration, please visit: https://hcandersencapital643.clickmeeting.com/bioporto-presentation-of-q1-quarterly-results-2022/register.

A separate analyst call will be held on May 11, 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, Zenith Advisory
Tel: +45 45 29 00 00
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 statement disclaimer:

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 the timing, terms and consummation of the rights issue described herein and 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.