- A cash position of more than €20 million at the end of 2022,
which provides the Company financial visibility until the end of
the first half of 2024;
- A decisive year on the clinical front with the results of the
Phase II/III REVERSE-IT study on TOTUM•63, expected before the end
of the first half of 2023;
- Continued structuring of the Company towards the first
commercial launches in early 2024, both in France and through
international partnerships.
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible)
(Paris:ALVAL), a commercially oriented Research and Development
company committed to scientific innovation for preventing and
combating metabolic and cardiovascular diseases, announces its
results for fiscal year 2022 and reviews its clinical and
scientific news and recent strategic advances.
Sébastien PELTIER, Chairman of the Board of Directors at
Valbiotis, comments: "During the year 2022, Valbiotis continued to
pursue its R&D roadmap while providing itself with the means to
accelerate its commercial strategy. On the clinical and scientific
front, the year was marked by the positive results of the Phase II
HEART study on the efficacy of TOTUM•070 against "bad cholesterol",
the end of recruitment for the Phase II/III REVERSE-IT study on
TOTUM•63, the launch of two Phase II/III studies (INSIGHT and
INSIGHT 2) on TOTUM•854, as well as the first significant
preclinical results for TOTUM•448 against metabolic liver diseases.
On the strategic front, we announced a decisive new step with the
marketing of our products through our own distribution network in
France (excluding TOTUM•63), in parallel with their international
launch through global or regional agreements. This dual lever will
be the driving force behind Valbiotis' transition from an R&D
model to a commercially oriented company, in order to optimize the
value of our active substances and rapidly generate sales. At the
same time, we have strengthened our commitment to CSR by joining
the United Nations Global Compact and implementing the ISO 26000
standard. With a solid financial situation and a cash position of
more than €20 million at the end of 2022, Valbiotis' teams are both
confident and focused as we enter the pivotal year 2023."
Key clinical advances for the year 2022
TOTUM•63, prediabetes
- Final phase of clinical development before decisive
results
- New step for the mode of action study conducted by INAF at
Laval University in Quebec City
Valbiotis completed enrollment last summer for the Phase II/III
REVERSE-IT clinical study (press release of July 28, 2022) designed
with Nestlé Health Science teams as part of the global strategic
partnership signed in February 2020. This randomized,
placebo-controlled study is being conducted in more than 50
clinical centers worldwide in a population with prediabetes or
early, untreated Type 2 Diabetes (600 patients). It has the same
primary endpoint (reduction in fasting blood glucose compared to
placebo) as the previous Phase II clinical study, which reported
positive results in summer 2019.
The results of this Phase II/III REVERSE-IT will be a decisive
milestone in finalization of the preparation for commercialization
and, in parallel, of a health claim submission. Given the duration
of the study (24 weeks) and the time required to analyze the data,
Valbiotis will be in a position to communicate the main results at
the latest before the end of the first half of 2023. This timetable
is supported by the last visit of the last patient scheduled in the
protocol (press release of March 13, 2023).
Regarding the clinical mode of action study on TOTUM•63 in 20
volunteers at risk of developing Type 2 Diabetes, which is being
conducted by the Institute on Nutrition and Functional Foods (INAF)
at Laval University in Quebec City in partnership with Nestlé
Health Science, the First Patient First Visit was conducted in
April 2022 (press release of April 28, 2022). This new milestone
resulted in a payment from Nestlé Health Science of CHF 500,000,
received in early July 2022. The results of the study are expected
to be reported in 2023.
TOTUM•070, reduction of the blood
concentration of LDL cholesterol ("bad cholesterol")
- Major success of the Phase II HEART clinical study
- Positive results from the bioavailability and mode of action
study
The year 2022 was marked by the positive results of the Phase II
HEART study, announced in June (press release of June 13, 2022).
The study achieved its objective of significantly reducing LDL
cholesterol, which is a cardiovascular risk factor, compared to
placebo. It showed a significant lipid-lowering effect after 3
months of supplementation with TOTUM•070: blood LDL cholesterol
levels were reduced by 13% compared to placebo, and triglyceride
levels by 14%. The additional results of the study were also
positive (press release of October 3, 2022), showing in particular
a very high response rate (up to 100% saw results when LDL
cholesterol levels at baseline exceeded 160 mg/dL).
In addition, results from the clinical bioavailability and mode
of action study demonstrated that TOTUM•070 and its metabolites
exerted a dual effect on human liver cells: inhibition of the de
novo cholesterol synthesis pathway, a key mechanism against
hypercholesterolemia, as well as inhibition of cholesterol storage
in the liver (press release of March 29, 2022).
TOTUM•854, lowering blood
pressure
- Simultaneous launch of the INSIGHT and INSIGHT 2 Phase II/III
studies and a bioavailability and mode of action study
Regarding TOTUM•854, Valbiotis launched the Phase II/III INSIGHT
and INSIGHT 2 clinical studies in early 2022 (press release of
February 17, 2022). These randomized, placebo-controlled studies
test the effect of a daily dose of 3.7 g and 2.6 g of TOTUM•854 for
3 months, respectively, with the primary endpoint being a reduction
in systolic blood pressure compared to placebo. Enrollment is
expected to end in the first half of 2023.
In parallel, the results of the clinical bioavailability and
mode of action study have just confirmed the potential of TOTUM•854
for the reduction of early-stage elevated blood pressure (press
release of January 30, 2023).
TOTUM•448, reduction of non-alcoholic
fatty liver disease (NAFL)
- First significant preclinical results
At the beginning of 2022, Valbiotis updated the development
strategy for TOTUM•448 (press release of January 6, 2022). In order
to ensure that TOTUM•448 has the best possible place in the
management of NAFL and NASH, the strategy is now based on a
clinical efficacy study in healthcare centers and a clinical
bioavailability and mode of action study currently being initiated.
Last fall, Valbiotis presented the first significant preclinical
results for TOTUM•448 against metabolic liver diseases (NAFL and
NASH) at the annual meeting of the American Association for the
Study of Liver Diseases (AASLD) (press release of October 27,
2022).
The latest step forward in the R&D field, Valbiotis signed a
research partnership in intestinal microbiota at the end of the
year with the MEDIS Unit at the University of Clermont Auvergne on
its active substances TOTUM•070 and TOTUM•448 against dyslipidemia
and metabolic liver disorders (press release of December 14, 2022).
This project is partly funded by the French National Research
Agency (ANR).
Strategic acceleration and securing of financial structure
In 2022, the Company's structural transformation continued on
several fronts. First of all, Valbiotis strengthened its commitment
to Corporate Social Responsibility (CSR), by joining the United
Nations Global Compact and applying the ISO 26000 standard (press
release of March 22, 2022). In terms of governance, the Board of
Directors was bolstered by the arrival of Frédéric PELONG (press
release of September 6, 2022), who joined Valbiotis on June 1 as
the Company's Chief Financial Officer.
From a strategic point of view, the year was marked by the
announcement of a new phase in commercial development designed to
make the most of the TOTUM products and to rapidly generate
turnover (press release of October 7, 2022). Valbiotis has thus
opted for a two-tier commercial strategy with, in France, the
internalization of commercial operations for direct distribution
and, internationally, the signing of licensing and/or distribution
partnerships with major nutrition and health players.
In order to finance this strategic acceleration, the Company
raised €9.7 million last November through the issuing of 2,681,059
new shares, of which 200,674 were purchased by individuals, at a
unit price of €3.60 (press release of November 9, 2022). Valbiotis
has thus secured its cash flow while initiating the ramp-up of
industrial and commercial operations (press release of January 10,
2023).
In this way, Valbiotis is putting itself in a strong position to
prepare, by the first half of 2024, the direct launch of TOTUM•070
on the French market, as well as the delivery of the first
commercial batches of TOTUM•63 to partner Nestlé Health Science.
The Company's structuring also aims to support future international
licensing agreements, with the first signature expected for
TOTUM•070, by the second half of 2023.
Annual accounts: a financial situation tailored to the new
roadmap
The 2022 financial statements of the Company, prepared in
accordance with IFRS, were approved by the Board of Directors on
March 13, 2023. They have been audited by the Statutory Auditor and
are available on the Valbiotis website: www.valbiotis.com
(investors section).
IFRS in €K, as of December 31
2022
2021
Operating income
2,814
2,693
Including:
- Turnover
785
298
- Grants
137
645
- Other
200
- Research Tax Credit
1,692
1,750
R&D expenditure
-9,102
-7,028
Sales & Marketing expenditure
-1,703
-1,509
Overhead expenditure
-1,651
-1,115
Share-based payment expenses
-2,344
-1,447
Other operating income and expenses
-40
-70
Operating profit for the period
-12,026
-8,475
Operating profit
-12,026
-8,475
Earnings before tax
-12,314
-8,681
Net income
-12,312
-8,681
IFRS in €K
2022
2021
Cash flow from operating activities
-9,192
-7,156
Cash flow from investing activities
-197
-7
Cash flow from financing activities
8,401
14,398
Net cash flow
-988
7,235
Closing cash position
20,828
21,819
In 2022, Valbiotis' turnover more than doubled to €785,000. This
amount includes €298,000 for the upfront payment under the
partnership with Nestlé Health Science (€4,679,000 in total over
the duration of the contract) and €487,000 for the milestone
payment following the First Patient First Visit in the TOTUM•63
mode of action clinical study.
Other operating income includes €1,692,000 in research tax
credit, virtually unchanged from the previous year, and €137,000 in
grants.
As expected, Research and Development expenditure increased
(+29.5%) due to the continuation of both the Phase II/III
REVERSE-IT clinical study on TOTUM•63 and the TOTUM•854 studies,
with the launch of the TOTUM•63 mode of action clinical study (in
the first quarter of 2022), and with the completion of the
TOTUM•070 Phase II clinical study. In total, R&D expenditure
amounted to €9,102,000 in 2022, compared to €7,028,000 in 2021.
Sales and marketing expenditure is up 12.8% to €1,703,000,
reflecting the efforts required to accelerate the marketing
strategy, including expenses related to market research. Overheads
amounted to €1,651,000 in 2022 compared to €1,115,000 in 2021,
mainly due to the increase in personnel costs.
Cash flow from operating activities amounted to €(9,192,000) for
the year, compared to €(7,156,000) in 2021, reflecting the
intensification of R&D activities and the increase in sales and
marketing expenses. Cash flow from financing activities was
positive at €8,401,000, fueled by the November 2022 fundraising (an
amount of €9,004,000 net of fees); a new Bpifrance innovation loan
was also obtained, for €700,000.
As of December 31, 2022, Valbiotis had a cash position of
€20,828,000, close to its level at the end of 2021 (€21,819,000).
This enables the Company to finance its operating expenses and to
meet its financial debt repayment schedule, with an estimated
end-of-cash horizon at the end of the first half of 2024. This
horizon does not take into account in particular the milestone
payments expected during 2023 in the context of the global
partnership with Nestlé Health Science for TOTUM•63, as well as
potential revenues from a licensing and/or international
distribution partnership for TOTUM•070, which is still expected to
be signed in the second half of 2023.
The annual financial report as of December 31, 2022, has been
made available to the public and filed with the AMF. This document
is available online: www.valbiotis.com/en/investors.
Valbiotis confirms that it complies with the PEA-SME eligibility
criteria specified in Article D.221-113-5 of the implementing
decree n°2014-283 of March 4, 2014, namely:
- a total workforce of less than 5,000 employees;
- a turnover of less than 1.5 billion euros or a balance sheet
total of less than 2 billion euros.
As a result, Valbiotis shares continue to be included in PEA-SME
accounts, which benefit from the same tax advantages as the
traditional stock savings plan (PEA).
The Company's corporate profile is available at:
www.valbiotis.com.
About Valbiotis
Valbiotis is a commercially oriented Research & Development
company, committed to scientific innovation for preventing and
combating metabolic and cardiovascular diseases in response to
unmet medical needs.
Valbiotis has adopted an innovative approach, aiming to
revolutionize healthcare by developing a new class of health
nutrition products designed to reduce the risk of major metabolic
diseases, relying on a multi-target strategy enabled by the use of
plant-based terrestrial and marine resources.
Internationally, its products are intended to be the subject of
licensing or distribution agreements with global and regional
health and nutrition players. In France, Valbiotis will be
responsible for marketing its own products.
Created at the beginning of 2014 in La Rochelle, the Company has
forged numerous partnerships with leading academic centers. The
Company has established three sites in France – Périgny, La
Rochelle (17) and Riom (63) – and a subsidiary in Quebec City
(Canada).
Valbiotis is a member of the "BPI Excellence" network and has
been recognized as an "Innovative Company" by the BPI label.
Valbiotis has received major financial support from the European
Union for its research programs via the European Regional
Development Fund (ERDF). Valbiotis is a PEA-SME eligible
company.
For more information about Valbiotis, please visit:
www.valbiotis.com
Name: Valbiotis ISIN code: FR0013254851 Ticker symbol: ALVAL
EnterNext© PEA-SME 150
This press release contains forward-looking statements about
Valbiotis’ objectives. Valbiotis considers that these projections
are based on rational hypotheses and the information available to
Valbiotis at the present time. However, in no way does this
constitute a guarantee of future performance, and these projections
may be affected by changes in economic conditions and financial
markets, as well as certain risks and uncertainties, including
those described in the Valbiotis Universal Registration Document
filed to the French Financial Markets Regulator (AMF) on May 19,
2022 and completed by an amendment on November 8, 2022. This
document is available on the Company’s website
(www.valbiotis.com).
This press release and the information it contains do not
constitute an offer to sell or subscribe, or a solicitation to
purchase or subscribe to Valbiotis’ shares or financial securities
in any country.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230315005519/en/
Corporate communication / Valbiotis Carole ROCHER Communication
and Public Affairs Director + 33 6 77 82 56 88
Marc DELAUNAY Communication Manager media@valbiotis.com
Financial communication / Seitosei Actifin Stéphane RUIZ
Associate Director +33 1 56 88 11 14 sruiz@actifin.fr
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