AMOEBA (EPA:AMEBA) - Amoeba announces half year results in line with 2018 and continues to develop its biocide and biocontrol applications
Transparency directive : regulatory news
27/09/2019 20:15
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PRESS RELEASE
Amoeba announces half year results in line with 2018 and continues to develop
its biocide and biocontrol applications
Lyon (France), September 27th, 2019 - AMOEBA (FR0011051598 -AMEBA), producer of
biological biocides capable of eliminating bacterial risks in water and human
wounds, and a biocontrol product for plant protection, still in trial phase,
announces today its 2019 half-year results.
The Board of Directors, which met on 27 September 2019, approved the company's
consolidated financial statements for the first half of 2019.
The statutory auditors have carried out their limited review of the half-year
consolidated financial statements as at 30 June 2019 and have not identified
any material misstatements that could affect their conformity.
The half-yearly report is being issued and will be available on the company's
website (www.amoeba-biocide.com) in the coming days.
(In KEUR) 30/06/2019 30/06/2018
Turnover 60 62
Industrialisation costs (589) (916)
R&D costs (1,852) (974)
Subsidies 218 154
Marketing & Sales (156) (298)
General costs (1,162) (1,257)
Operational loss (3,481) (3,229)
Non-Operational loss - (691)
Financial loss (843) (577)
Net loss (4,324) (4,497)
Results in line with 2018
The Group's operating income for the six months ended 30 June 2019 amounted to
EUR3,481k in line with 2018 results despite the recognition of a depreciation
on intangible assets of EUR 933 k.
* Revenues, mainly consisting in the half-yearly portion of the Aquaprox
royalty, amounted to EUR60k at 30 June 2019 compared with EUR62k at 30 June
2018.
* The non-approval of the active substance in Europe and the resulting delay in
the launch of the production activity (see press releases dated 26 April and 29
November 2018) have led to a decrease in industrial deployment costs.
* Research and Development expenses, net of subsidies, increased compared to
the first half of 2018 (EUR1,634k vs. EUR820k). This increase is mainly due to
a EUR933k write-down of development costs due to the withdrawal of the
marketing authorization application in the United States and the resulting
delay in production operations (see press release of 19 august 2019).
* Marketing and sales expenses were down compared to the first half of 2018
(EUR156k vs. EUR298k).
* General and administrative expenses amounted to EUR1,162k at 30 June 2019 and
remained essentially unchanged from the previous year.
* At June 30, 2019, no non-operating charges were recorded, unlike as at June
30, 2018 (restructuring charges amounting to EUR 491K).
* Financial income mainly includes interest expenses related to bank loans
(EUR956k) and foreign exchange losses (EUR113k).
The net result for the first half of the year was EUR4,324k.
At 30 June 2019, the company's shareholders' equity amounted to EUR3.5 million
compared with EUR5.4 million at 31 December 2018.
The company's financial debt amounts to EUR8.9 million and consists mainly of
the EUR5 million EIB loan and capitalized interest of EUR1.6 million, bonds not
yet converted at the closing date amounting to EUR0.8 million and debts related
to rental obligations (EUR0.9 million).
The cash position is EUR4,1 million.
A first semester mainly marked by the continued development of the biocontrol
application for plant protection and the monitoring of regulatory dossiers for
the marketing of the biocidal application:
During the first half of 2019, the company focused on 3 main areas:
1. The development of the biocontrol application.
In this context, the company has announced 2 major scientific advances:
* A new formulation of its active substance in powder form composed of
Willaertia Magna C2c Maky lysed amoebae allowing (i)a longer shelf life,
(ii)ease of transport and storage and (iii)the elimination of any hypothetical
risk of serving as a reservoir for pathogenic bacteria;
* The demonstration of a double eliciting action on the vine and a direct
action by total inhibition of the germination of downy mildew in the vine
(Plasmopara viticola) of Willaertia Magna C2c Maky in lysed form.
Furthermore, in accordance with its business plan, the company carried out 13
field trials against downy mildew in the vine during the second quarter of 2019
(see press release of July 29 2019). These tests will be used to prepare the
regulatory dossier for the active substance at European level, which is due to
be submitted in the first quarter of 2020 and for which Austria has agreed to
be rapporteur Member State.
2. The follow-up of regulatory applications for the marketing of biocidal
applications in Europe and North America.
* In Europe: The Malta Competition and Consumer Affairs Authority (MCCAA) has
agreed to be the competent authority to evaluate the new application for
approval, which is expected to be submitted before the end of 2019.
* In Canada: In January 2019, the Company submitted an application to the
Canadian Pest Management Regulatory Agency (PMRA) for the registration of the
biocidal active substance Willaertia Magna C2c Maky and the biocidal product
BIOMEBA to be marketed in Canada.
* In the United States: The scientific review of the file is still ongoing and
the US EPA decision date initially scheduled for the first quarter of 2019 was
communicated to the company on August 2019 (see press release of 19 August
2019).
3. The implementation and monitoring of a bond financing program with Nice &
Green (OCAPI) through the reserved issue of 312 bonds convertible into shares
representing a total nominal amount of 6,240,000 euros of bonds (refer to press
releases of 3 December 2018 and 16 January 2019). As of June 30, 2019, 156
bonds were issued among which 117 were fully converted representing the
creation of 1,215,988 new shares.
Recent developments and prospects
* With regard to the biocontrol application for the prevention of plant
diseases, the company confirmed the efficacy of its Willaertia Magna C2c Maky
amoeba lysate in the field against downy mildew in the vine and demonstrated an
in plant efficacy of more than 85% against bean rust, thus broadening the
potential spectrum of action of its application (refer to press releases of
1 July and 29 July 2019).
The various communications on the biocontrol application have triggered a wave
of very broad interest in the plant protection field allowing the company to:
o establish many contacts with various stakeholder
o consider its development in new territories such as China or Brazil.
* As to the biocidal application:
o the company submitted a new application for its active substance to the
European Chemical Agency (ECHA) in July 2019 (5 months ahead of the
initial timetable).
o In August 2019, the U.S. Environmental Protection Agency (EPA) determined
that it cannot conclude that the registration requirements are met for the
use of amoeba in cooling towers. After reviewing the file, no danger to
human health or the environment was determined by the EPA. However, on the
basis of the file data, the EPA could not confirm that the biocidal
product containing the amoeba Willaertia Magna C2c Maky, when used in
accordance with commonly accepted practice, will not have unreasonable
effects.
Based on discussions with its US regulatory consultants and the EPA, the
Company has decided to voluntarily withdraw the application.
* In the medium term, the company plans the development stages of its various
applications according to the following schedule:
Tests Tests terrain Dossier
laboratoire Réglementaire
Biotech Blanche
. Biocide
> Traitement TAR USA----------------------------> Re-soumission
prévue S1 2020
EU----------------------------------------->
CANADA-------------------------------------------->
Biotech verte
. Agent de bioontrôle
> Mildiou vigne et USA----------------------------> Soumission
Mildiou Pomme de terre prévue Q1 2020
EU-----------------------------> Soumission
prévue Q1 2020
> Rouille du soja Brésil------> Attendu 2020 Soumission
prévue Q1 2020
> Toutes
applications Chine-------> Attendu 2021 Soumission
prévue 2022
Blotech rouge
. Désinfectant peau
> Plaies chroniques USA-----> Attendu 2020 Soumission
prévue 2021
Commercialisation du produit
Attendu 2022
Autorisation provisoire prévue 2021 et autorisation finale en 2023
Attendu Q1 2021
Attendu 2022
Attendu 2024
Attendu 2023
Attendu 2023
Attendu 2023
(Application procedures for authorization of the biocidal and biocontrol
applications are detailed in the registration document filed with the
"Autorité des Marchés Financiers" on 25 April 2019 under number D19-0383).
* The financial statements for the six-month period ended 30 June 2019 were
approved by the Board of Directors on a going concern basis based on business
and cash flow forecasts.
In this context, the company carried out an analysis of its cash flow forecast.
This analysis shows that the company's further development beyond July 2020 is
conditional on obtaining additional financing. To this end, the company is
currently in discussion with current partners or potential investors. This
analysis takes into account the agreement received from the EIB for
non-compliance with the financial ratio (equity/total assets) for the accounts
closed on 30 June 2019 and to be closed on 31 December 2019.
Failure to obtain these additional financings could jeopardize the application
of certain accounting principles and in particular the valuation of certain
assets and liabilities.
In addition, in order to cover its subsequent needs and to carry out its
various development and research projects, the Board of Directors is continuing
to implement measures to ensure the necessary financing for its development
plan:
o research of new financing in Europe and the United States;
o search for new partnership agreements relating to the distribution of the
biological solution developed by Amoéba;
o development of new applications.
* As part of its governance, Amoéba announces the resignation of its mandate
as director with effect from 1 August 2019 of ELAIA Partners. Amoéba's Board
of Directors is composed of six members, including four independent
directors.
About AMOEBA:
Amoéba's ambition is to become a major player in the treatment of bacterial
risk in the fields of water, healthcare and plant protection. Our biological
solution is an alternative to chemical products widely used today. Amoéba is
currently focusing on the market of industrial cooling towers estimated at
EUR1.7Bn (1) on a global chemical biocide market for water treatment, evaluated
at EUR21Bn (2) and on the biocontrol market for plant protection estimated
globally at EUR1.6Bn (4). In the future, the Company is looking at developing
new applications such as chronic wound care, estimated at EUR 751 million (3)
in the USA. Sales of associated products with healthcare, biocides and crop
protection are subject to the Company being granted local regulatory market
authorizations. The Company is currently in a trial phase for biocidal and
plant protection applications and does not market any products.
Created in 2010, based in Chassieu (Lyon, France) with a subsidiary in Canada
and in the United States, Amoéba is quoted on the compartment C of Euronext
Paris. The Company is a member of the BPIfrance Excellence network and is
eligible for the PEA-PME SME equity savings plan setup. More information on
www.amoeba-biocide.com.
(1) : Amoéba data combined from sources: DRIRE 2013, Eurostat, ARHIA 2013
(2) : Sources combined by Amoéba from water treaters, Freedonia, Eurostat et
MarketsandMarkets
(3): BCC Research, "Markets for Advanced Wound Management Technologies,"
Wellesley, MA, 2017
(4): Biopesticides Worldwide Market 2013, CPL, Wallingford, UK
Contacts:
Amoéba
Valérie FILIATRE
Directeur Général Adjoint
04 26 69 16 00
valerie.filiatre@amoeba-biocide.com
Relations investisseurs
Grégory BOSSON
Agence Calyptus
01 53 65 37 90
gregory.bosson@calyptus.net
Relations médias
Constance LOZET
Agence Ekno
07 78 41 19 70
constance.lozet@ekno.fr
Disclaimer
This press release contains certain forward-looking statements concerning
AMOEBA which are based on its own assumptions and hypothesis and on information
that are available to us. However, AMOEBA gives no assurance that the estimates
contained in such forward-looking statements will be verified, which estimates
are subject to numerous risks including the risks set forth in the reference
document of AMOEBA filed with the French Financial Markets Authority (Autorité
des Marchés Financiers) on April 25, 2019 under number D19-0383 (a copy of
which is available on www.amoeba-biocide.com). The forward-looking statements
contained in this press release are also subject to risks not yet known to
AMOEBA or not currently considered material by AMOEBA. The occurrence of all or
part of such risks could cause actual results, financial conditions,
performance or achievements of AMOEBA to be materially different from such
forward-looking statements.
source : webdisclosure.com