March 15, 2023
News release
BioPorto Provides a Business Update
COPENHAGEN, DENMARK and BOSTON, MA, March 15, 2023, (GLOBE NEWSWIRE) - BioPorto A/S (BioPorto or Company) (CPH:BIOPOR) today provided a business update.
Preliminary key 2022 Financial Results
Revenue for the full year 2022 is expected to be approximately DKK 29.0 million, which represents a 19% increase over the prior year and exceeds the upper end of the Company's most recent guidance by 7%. Cash and cash equivalents are estimated to be approximately DKK 81.1 million as of December 31, 2022. These amounts are unaudited and preliminary. They also are subject to the Company's management completing its customary procedures for finalizing the Annual Report and the Company's independent auditor completing the year-end audit for 2022, among other factors.
The Annual Report for 2022 will be published on March 30, 2023.
"We are very pleased with our preliminary 2022 financial results, having delivered on the expectations we set last year. I commend the great work by our entire team," said Tony Pare, BioPorto's CEO.
Considerations on BioPorto's Capitalization
As part of implementing its strategic priorities, BioPorto has historically sought financing, most recently in a rights issue in March 2022. As described in the Prospectus published in connection with the rights issue and in subsequent Interim Reports, BioPorto considers it likely that it will seek additional funding around the date falling twelve months after the date of the Prospectus. In preparation, the Company is currently exploring opportunities for a capital raise of up to DKK 75 million.
Status of US Food and Drug Administration (FDA) Review
In November 2022, BioPorto achieved a major milestone and submitted its De Novo application for Marketing Authorization of an NGAL test to the FDA to aid in identifying pediatric patients at risk of moderate to severe Acute Kidney Injury (AKI).
Currently, the FDA is undergoing a review process of the De Novo application. Accordingly, BioPorto has been in an ongoing dialog with the FDA regarding BioPorto's NGAL assay and is currently in the process of answering questions communicated in an Additional Information (AI) Letter from the FDA, with responses required by July 23, 2023.
Mr. Pare continued, "We have analyzed their questions and plan to respond with the information requested prior to the deadline. Our team anticipated this as AI requests are a standard part of the regulatory review process."
If the application is granted by the FDA, the NGAL test would be the first authorized pediatric AKI biomarker test commercially available in the US.
Expanding focus on Europe
The Company is taking new measures to ramp up its commercial and marketing efforts in Europe, where NGAL tests are already available for both pediatric and adult use under a CE mark. BioPorto recently announced the additions of Mr. Nis Kruse as EVP of Strategic Partnerships and GM of EMEA/APAC and Dr. Tabari Baker as VP of Global Medical Affairs. In these roles, Mr. Kruse and Dr. Baker are focused on activities to drive market adoption in targeted European markets.
For investor inquiries, please contact:
Tim Eriksen, EU Investor Relations, Zenith Advisory, +45 4529 0000, investor@bioporto.com
Ashley R. 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 product, The NGAL TestTM, is 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. The NGAL Test is CE marked and registered 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, anticipated events or trends and other matters that are not historical facts, including with respect to potential FDA marketing authorizations; concerns that may arise from additional data, analysis or results obtained during clinical trials or requested by the FDA, or possible additional requests for data or information; 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 with the Danish Financial Supervisory Authority, particularly under the heading "Risk Factors".
