BioPorto Publishes 2021 Annual Report
April
6,
2022Announcement no.
7
BioPorto
Publishes 2021 Annual
Report
BioPorto A/S (BioPorto), an in vitro diagnostics
company focused on saving lives and improving the quality of life
with actionable biomarkers, today published its Annual Report for
2021. The full report can be found on the company's website,
www.bioporto.com.
Highlights from BioPorto’s 2021 Annual
Report:
- Achieved 2021 total revenue of DKK
24.3 million, representing growth of 4.5% compared to the prior
year period
- Completed an interim analysis of
The NGAL Test’s performance that were consistent with
expectation
- Enrollment for pediatric trial for
The NGAL Test continued, but was delayed by the impact of COVID-19
on access to trial sites and patients
- Appointed new Executive management
team, Board Chairman, and Board Vice-Chairman
2021 was another challenging year for the world,
as the global COVID-19 pandemic continued to impact global health.
For BioPorto, the pandemic also restricted its ability to execute
the pivotal clinical trial required to support a US Food and Drug
Administration (FDA) submission for the flagship product, The NGAL
Test.
But 2021 was also a year of progress for
BioPorto that will drive value creation in 2022 and onwards –
particularly in the progression of R&D, validation, regulatory,
quality and operational improvement efforts. Furthermore, with the
appointment of a new experienced executive team with a successful
track record from introducing new diagnostic products to the US
market, BioPorto developed a clear strategic path for the
future.
Focus, focus,
focus
Since taking over as the CEO in November 2021,
Tony Pare has worked to focus BioPorto’s strategy on delivering the
NGAL biomarker as the new standard of care in assessment of kidney
health, preparing the company to commercialize and scale, and
building a strong team dedicated to the mission.
“We are a small company with a unique technology
and very high ambitions. That calls for clear prioritization and
focus on what we aim to achieve in the next 12-18 months, which is
to obtain US FDA approval of our flagship product, The NGAL Test,
for use in pediatrics (under age 22) and drive its adoption in the
US, which is the largest market for in vitro diagnostic tests in
the world,” said Tony Pare, BioPorto’s Chief Executive Officer.
BioPorto continues to expect to finalize
enrollment of pediatric patients at fifteen top hospitals across
the US by second quarter of 2022, and subsequently submit for US
FDA approval of the test for use in identifying children at risk
for AKI. Following submission, and in parallel with FDA review,
BioPorto will initiate the application process for FDA approval of
The NGAL Test for adult use in the US.
Successful share offering provides
runway for strong
execution
As a first step of the strategy, BioPorto in
March 2022 closed a fully subscribed, pre-emptive rights offering
for new shares as part of a long-term capital plan that includes a
potential US listing.
“The proceeds from the offering of approximately
DKK 100.4 million will, together with existing funds, provide a
strong foundation for submission of The NGAL Test application for
pediatric use to the FDA, enable us to prepare for a commercial
launch, and implement programs to drive market adoption,” said Tony
Pare. “I am very thankful for the support and clear mandate from
both existing shareholders and new investors to focus our efforts
and execute this strategy. It is a strategy that I firmly believe
will bring BioPorto to a very successful and bright future with
compelling value creation for patients, health care providers, and
our shareholders.”
Outlook
The company's outlook for 2022 is as follows
(all numbers are approximate):
- Revenue of DKK 24-26 million
- EBIT loss of DKK 95-100
million
- Adjusted EBITDA loss of DKK
76-81million
The outlook is based on certain assumptions
described in the annual report and continues to be subject to
uncertainty due to COVID-19.
Investor Meeting
In connection with the release of the 2021
Annual Report, BioPorto will host an online investor presentation
on April 6, 2022 at 14:30 CET via HC Andersen Capital. For
registration, please visit https://bit.ly/37csHWN. A separate
analyst call will be held on April 6, 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 & CFO Tim
Eriksen, Investor Relations
Telephone: +45 4529 0000, email:
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
statements
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 test
performance, 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.
- 5299004SWFL5JAN4W830-2021-12-31-en
- Annual Report 2021
- Remuneration Report 2021
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