BioPorto Announces Interim Results and Business Update For the Third Quarter and Nine Months of Fiscal 2023

2023-11-01

财报上市批准

November 1, 2023

Announcement no. 18

BioPorto Announces Interim Results and Business Update For the Third Quarter and Nine Months of Fiscal 2023

COPENHAGEN, Denmark and BOSTON, MA, USA, November 1, 2023, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced interim financial results and business updates for the third quarter and nine months of fiscal 2023.

Recent Highlights

For the first nine months ending September 30, 2023: Total revenue of DKK 24.4 million / USD 3.5 million, a 20% increase over the prior year

Total NGAL revenue of 15.2 million / USD 2.2 million, a 57% increase over the prior year

Adjusted EBITDA of DKK (41.2) million / USD (6.0) million

Cash and cash equivalents of DKK 69.9 million / USD 9.9 million as of September 30, 2023 (DKK 98.9 million / USD 13.0 million as of September 30, 2022)

For the third quarter ending September 30, 2023: Total revenue of DKK 8.6 million / USD 1.3 million, a 63% increase over the prior year

Total NGAL revenue of 5.8 million / USD 0.9 million, a 119% increase over the prior year

Adjusted EBITDA of DKK (9.7) million / USD (1.4) million

In response to FDA recommendations regulatory approval pathway for NGAL was efficiently moved from De Novo application to submission of 510(k) pre-market notification

Two abstracts were accepted for presentation at this week’s upcoming American Society of Nephrology (ASN) Kidney Week conference in Philadelphia

Tony Pare, BioPorto’s Chief Executive Officer, said: “We continue our focus on top line growth, and are pleased to report nine months total revenue increased 20% over the prior year and 63% over prior year quarter. Our NGAL revenue increased 57% over prior year and 119% over prior year quarter. We are also pleased with the progress of our 510(k) submission and continue to have dialog with the FDA concerning the marketing authorization of NGAL in the U.S. We also continue to execute our strategic priorities to grow revenues in Europe and other markets that accept CE Mark, while expanding the total addressable market for our NGAL tests. With our latest financial results, we will maintain our guidance for revenue, while improving our guidance for EBITDA reflecting aggressive expense control during the FDA review period.”

Guidance for 2023 Revised

Based on the progress and results obtained in the first nine months of 2023, BioPorto has revised its financial guidance for 2023, as most recently described in its Annual Report 2022 to:

Revenue of approximately DKK 30 to 33 million, and

Adjusted EBITDA loss of approximately DKK (56) to (59) million, from previous guidance of DKK (60) to (65) million.

Conference Call and Webcast

The Company’s management team will host an online investor presentation on November 1, 2023, at 14:00 Central European Time / 9:00 Eastern Time, via HC Andersen Capital. Investors interested in attending the webcast may register at:

https://hca.videosync.fi/2023-10-11-bioporto-q3/register.

A separate analyst call will be held on November 1, 2023, at 16:00 Central European Time / 11:00 Eastern Time, with details as follows:

Denmark landline: +45 8025 2164

Denmark mobile: +45 8025 1917

International: +1 201 689 8562

US: +1 877 407 0789

Conference ID: 13742263

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1640499&tp_key=67270c5bab

Operator assisted dial-out:

https://callme.viavid.com/viavid/?callme=true&passcode=13732188&h=true&info=company-email&r=true&B=6

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 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 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 with the Danish Financial Supervisory Authority, including its Annual Report for 2022 and Interim Reports, particularly under the heading “Risk Factors”.

NOTE – DKK/USD exchange rates used within “Recent Highlights”, above:

Balance sheet measures: September 30, 2022 = 7.6287 and September 30, 2023 = 7.039.

Income statement measures for nine months ended: September 30, 2022 = 6.9421 and September 30, 2023 = 6.8812.

Income statement measures for the third quarter ended: September 30, 2022 = 7.2995 and September 30, 2023 = 6.8241.

Attachment

2023 11 01 - Q3 2023 Interim Report - BioPorto AS