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LIFE CARE IS REGISTERED MAGAZINE IN RNI, NO.GUJGUJ/2015/71283
Announcement no. 15
COPENHAGEN, Denmark and BOSTON, Nov. 09, 2022 (GLOBE NEWSWIRE) — BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced interim financial results for the first nine months of 2022 and business progress for the third quarter of 2022.
Tony Pare, BioPorto’s Chief Executive Officer, said: “The third quarter of 2022 reflected our continued focus on disciplined execution towards completion and submission of the De Novo application to the US Food and Drug Administration (FDA) of an NGAL test for pediatric risk assessment of Acute Kidney Injury (AKI). Our data analysis and preparation of the clinical report are proceeding according to plan, and we anticipate submitting the application by fourth quarter 2022 as previously guided.”
Guidance for 2022 adjusted to reflect timing of costs
During the first nine months of 2022, BioPorto exercised appropriate cost control and deferred certain commercialization expenses, thereby reducing its costs below prior expectations. Consequently, BioPorto has revised its 2022 guidance for operating (EBIT) loss from approximately DKK (95) to (100) million down to approximately DKK (83) to (88) million, and adjusted EBITDA loss from approximately DKK (76) to (81) million down to approximately DKK (71) to (75) million. BioPorto maintains its 2022 revenue guidance of approximately DKK 24 to 27 million.
Conference Call and Webcast
The Company’s management team will host an online investor presentation on November 9, 2022, at 14:00 Central European Time / 8:00 Eastern Time, via HC Andersen Capital. Investors interested in attending the webcast may register at: https://hca.videosync.fi/bioporto-presentation-q3-interim-9-nov-2022/register
A separate analyst call will be held on November 9, 2022, at 16:00 Central European Time / 10:00 Eastern Time, with details as follows:
Denmark: +45 8025 0765
International: +1 412 317 5180
US: +1 844 825 9789
Conference ID: 10172482
Investor Relations Contacts
Tim Eriksen, EU Investor Relations, Zenith Advisory, +45 4529 0000, firstname.lastname@example.org
Ashley Robinson, US Investor Relations, LifeSci Advisors, +1 617 430 7577, email@example.com
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 TestTM, which has been designed to aid in the risk assessment of Acute Kidney Injury (AKI), 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 a number of 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 2022; currency exchange rate fluctuations; anticipated events or trends and other matters that are not historical facts, including with respect to the potential FDA marketing authorization, 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 2021, with the Danish Financial Supervisory Authority, particularly under the heading “Risk Factors”.
NOTE – DKK/USD exchange rates used within “Recent Highlights”, above: