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Beskrivning

LandDanmark
ListaSmall Cap Copenhagen
SektorHälsovård
IndustriLäkemedel & Handel
BioPorto är verksamt 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.
2022-08-17 08:23:38

August 17, 2022
Announcement no. 13

BioPorto Announces Interim Results for the First Six Months of 2022

COPENHAGEN, DENMARK and BOSTON, MA, USA, August 17, 2022, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced interim financial results for the first six months of 2022 and business progress for the second quarter of 2022.

Recent Highlights

  • For the six months ending June 30, 2022:
    • Total revenue of DKK 15.0 million / USD 2.2 million, a 23% increase over the prior year
    • Adjusted EBITDA of DKK (32.4) million / USD (4.8) million
    • Cash and cash equivalents of DKK 107.9 million / USD 15.1 million as of June 30, 2022 (DKK 75.0 million / USD 12.0 million as of June 30, 2021)
  • For the second quarter ending June 30, 2022:
    • Total revenue of DKK 8.5 million / USD 1.2 million, a 29% increase over the prior year
    • Adjusted EBITDA of DKK (17.1) million / USD (2.5) million
  • Achieved targeted enrollment in clinical study supporting FDA De Novo submission for The NGAL Test in the US
  • Appointed world-leading nephrologist and NGAL biomarker pioneer, Dr. Prasad Devarajan, as new Senior Medical Director
  • Successful implementation of NGAL testing programs was highlighted at the 40th Vincenza Course on AKI & CRRT meeting in Vincenza, Italy – “Meet the Expert” video

Tony Pare, BioPorto’s Chief Executive Officer, said: “I am pleased with our strong second quarter of 2022, a result of disciplined execution on our strategic agenda. We look forward to completing The NGAL Test clinical trial data analysis and related work, and then submitting the De Novo application to the US Food and Drug Administration (FDA). We remain excited about The NGAL Test’s potential impact to assist clinicians in improving outcomes for critical care patients.”

Guidance for 2022 Updated
During the first half of 2022, BioPorto experienced solid sales performance driven by both The NGAL Test and a notable bulk order of antibodies. Based on this, BioPorto increases the upper end of its revenue guidance for the 2022 fiscal year, with a new range of DKK 24 to 27 million. The previous range was DKK 24 to 26 million. BioPorto maintains its 2022 financial guidance for:

  • Operating (EBIT) loss of approximately DKK 95 to 100 million
  • Adjusted EBITDA loss of approximately DKK 76 to 81 million

Conference Call and Webcast
The Company’s management team will host an online investor presentation on August 17, 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://bit.ly/3PkwjX9

A separate analyst call will be held on August 17, 2022, at 16:00 Central European Time / 10:00 Eastern Time, with details as follows:

Denmark: +45 8025 1917
International: +1 201-689-8562
US: +1 877 407 0789
Conference ID: 13732188
Webcast: https://bit.ly/3C342S0

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 is The NGAL Test, 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 clearance, commercialization of The NGAL Test, 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:

  • Balance sheet measures: June 30, 2021 = 6.2573 and June 30, 2022 = 7.1620
  • Income statement measures for six months ended: June 30, 2021 = 6.1479 and June 30, 2022 = 6.7864.
  • Income statement measures for second quarter ended: June 30, 2021 = 6.1797 and June 30, 2022 = 6.9061.