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Beskrivning

LandDanmark
ListaSmall Cap Copenhagen
SektorHälsovård
IndustriLäkemedel & Handel
BioPorto är verksamma inom bioteknik. Bolaget tillverkar och marknadsför tester för diagnostisering av diverse allvarliga sjukdomar. Produktportföljen består av egenutvecklade antikroppsläkemedel som används för farmaceutisk bruk samt inom diverse forskningssammanhang. Produkterna återfinns på global nivå och används exempelvis vid behandling och analys av fetma, diabetes och diverse allergier.
2023-05-10 08:20:25

May 10, 2023
Announcement no. 8

BioPorto Announces Interim Results for the First Three Months of 2023

COPENHAGEN, Denmark and BOSTON, MA, USA, May 10, 2023, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced interim financial results for the first three months of 2023 and business progress for the first quarter of 2023.

Recent Highlights

  • For the three months ended March 31, 2023:
    • Total revenue of DKK 8.0 million / USD 1.2 million, a 24% increase over the prior year
    • Adjusted EBITDA of DKK (15.2) million / USD (2.2) million
    • Cash and cash equivalents of DKK 57.7 million / USD 8.4 million as of March 31, 2023 (DKK 27.0 million / USD 4.0 million as of March 31, 2022)
  • Sponsored “AKI and Biomarkers: Interesting Cases from the Bedside,” at the 28th International Conference on Advances in Critical Care Nephrology, presented by Dr. Stuart Goldstein, MD, FAAP, FNKF, FASN on March 31, 2022

Tony Pare, BioPorto’s Chief Executive Officer, said: “During the first quarter of 2023, we focused on executing our strategic priorities to grow revenues in European and other markets that accept CE Mark, prepare responses to the US Food and Drug Administration’s (FDA) request for additional information, and expand the total addressable market for NGAL tests. I am also very pleased with this quarter’s financial results.”

Mr. Pare continued, “We remain on track to respond to the recent request for Additional Information from the FDA by the end of this quarter, which is in advance of the July 23, 2023 deadline. The team has made meaningful progress in preparing the materials, which will be submitted together when complete.”

Guidance for 2023 Maintained
Based on the progress and results obtained in the first three months of 2023, BioPorto maintains its financial guidance for 2023, as most recently described in its Annual Report 2022 of:

  • Revenue of approximately DKK 30 to 33 million, and
  • Adjusted EBITDA loss of approximately DKK (60) to (65) million.

Conference Call and Webcast
The Company’s management team will host an online investor presentation on May 10, 2023, 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/2023-05-10-bioporto/register

A separate analyst call will be held on May 10, 2023, at 16:00 Central European Time / 10:00 Eastern Time, with details as follows:

Denmark: +45 8025 0765
International: +1 412 317 5195
US: +1 844 826 3035
Conference ID: 10178628
Webcast:  https://viavid.webcasts.com/starthere.jsp?ei=1613202&tp_key=6eeb78a398

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 product, The NGAL TestTM, 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 2023; 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 2022, 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: March 31, 2022 = 6.7007 and March 31, 2023 = 6.8492
  • Income statement measures for three months ended: March 31, 2022 = 6.636 and March 31, 2023 = 6.9498.