Strong Performance of The NGAL Test Drives Revenue Growth
May 11,
2022Announcement no.
11
Strong Performance of
The NGAL Test Drives
Revenue
Growth
Revenues totaled DKK 6.5 million in the first
quarter of 2022, a 17% increase over the prior year. This growth
was driven by a 70% increase in The NGAL Test sales, primarily from
research use only (RUO) sales in the US and the timing of customer
orders, which were up 116% over the prior year and a 10% increase
in rest-of-the-world (ROW) sales of the test. ELISA kit revenue
increased 138% in the first quarter of 2022 over the prior year
period, offset by a 38% reduction in antibodies sales that were
consistent with expectations in the absence of an individual bulk
order during the quarter.
Tony Pare, BioPorto’s Chief Executive Officer,
commented, “The first quarter of 2022 was an encouraging start for
BioPorto and this new team on several fronts. We have developed and
are executing detailed plans to support US FDA submission,
approval, and launch of The NGAL test. We also achieved favorable
revenue growth, including The NGAL Test sales, reflecting a
combination of growing clinician interest in this impactful
biomarker for critical care patients and the timing of customer
orders.”
Strategic focus on preparing BioPorto
for US breakthroughThe NGAL Test has been granted
Breakthrough Device designation by the FDA for expedited review.
Breakthrough Device designation is granted for devices that provide
for more effective treatment or diagnosis of life-threatening or
irreversibly debilitating human disease or conditions, and where
neither approved nor cleared alternatives exist.
In the first quarter of 2022, BioPorto’s new
leadership team developed an 18 month strategy focused on
delivering the NGAL biomarker as the new standard of care in
assessing Acute Kidney Injury (AKI), preparing the Company to
commercialize and scale, and building a strong team dedicated to
the mission.
Consequently, BioPorto’s clear priority and
focus is on obtaining US FDA approval of its flagship product, The
NGAL Test, for use in pediatrics (under age 22) and drive its
adoption in the US.
Targeted Enrollment of Pediatric
Patients Remains On-track by end-June 2022As planned,
BioPorto is enrolling pediatric patients at fifteen top hospitals
across the US for the third part of a 3-part clinical study to
support an US Food and Drug Administration (FDA) submission of The
NGAL Test for use in identifying children under age 22 at risk of
AKI. The Company continues to expect that it will complete the
targeted enrollment for the study's objectives in the second
quarter of 2022, and then finalize analysis of the data to support
the FDA filing.
Successful and Fully Subscribed Share
Offering Provides Runway for Strong Strategic ExecutionOn
April 1, 2022, BioPorto raised net proceeds of approximately DKK
93.1 million, from a fully subscribed pre-emptive rights offering
of new shares as part of a long-term capital plan that includes a
potential US listing.
The proceeds will, together with existing funds,
provide a foundation for the submission of The NGAL Test
application for pediatric use in the US, prepare for a commercial
launch, and implement programs to drive market adoption.
Guidance for 2022
maintainedBased on the progress and results obtained in
first three months of 2022, BioPorto maintains its financial
guidance for 2022, as most recently described in its Annual Report
2021 of:
- Revenue of approximately DKK 24 to
26 million;
- Operating (EBIT) loss of
approximately DKK 95 to 100 million; and,
- Adjusted EBITDA loss of
approximately DKK 76 to 81 million.
In March and April BioPorto raised net proceeds
of DKK 93.1 million in a fully-subscribed pre-emptive rights issue
that provides funding to complete the targeted enrollment in the US
for our pediatric trial of The NGAL Test, and subsequently prepare
and submit the application to the FDA.
Investor and Analyst MeetingsIn
connection with the release of the Interim Report for the first
quarter of 2022, the Company’s management team will host an online
investor presentation on May 11, 2022 at 14:00 CET via HC Andersen
Capital. For registration, please visit:
https://hcandersencapital643.clickmeeting.com/bioporto-presentation-of-q1-quarterly-results-2022/register.
A separate analyst call will be held on May 11,
2022 at 16:00 CET. For further information regarding the analyst
call, please visit: www.bioporto.com/investor-relations.
For further information, please
contact: Neil Goldman, Executive VP & CFOTim Eriksen,
Investor Relations, Zenith AdvisoryTel: +45 45 29 00 00Email:
investor@bioporto.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, 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.
BioPorto is headquartered in Hellerup, Denmark and is listed on
the NASDAQ Copenhagen stock exchange [CPH:BIOPOR]. More information
is available at www.bioporto.com.
Forward-looking statement disclaimer:
Certain statements in this announcement are
forward-looking statements, which are based on 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 the timing,
terms and consummation of the rights issue described herein and
potential FDA clearance in pediatrics, development of the Company’s
U.S. organization and commercialization of The NGAL Test. 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.
- 2022 05 11 - Q1 2022 Report
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