TIDMBMK
RNS Number : 0640E
Benchmark Holdings PLC
02 July 2021
2 July 2021
Information within this announcement is deemed by the Company to
constitute inside information under the Market Abuse Regulations
(EU) No. 596/2014.
Benchmark Holdings plc
("Benchmark", the "Company" or the "Group")
BMK08+CleanTreat Ò and Trading Update
Marketing Authorisation from the Norwegian Medicines Agency
A major milestone for the Group
Benchmark (LSE: BMK), the aquaculture biotechnology company, is
pleased to announce that it has received Marketing Authorisation
from the Norwegian Medicines Agency ("NoMA") for Ectosan(R) Vet
(product code name BMK08) in Norway (the "MA").
The granting of the MA is a major milestone for Benchmark and a
transformational solution for the salmon industry, supporting
sustainable growth by reducing the economic and operational impact
of sea lice whilst improving fish welfare and protecting the
environment. Sea lice are one of the biggest biological challenges
in salmon farming, estimated to cost producers more than US$1bn
annually, and c.US$600m in Norway alone. Ectosan(R) Vet will be the
first sea lice veterinary medicinal treatment to be introduced to
the Norwegian salmon market in over a decade.
The final steps for commercialisation are the ratification of
the MRL (Maximum Residue Limit) into Norwegian regulation and the
approval of product labels by the NoMA. The MRL ratification into
Norwegian regulation is a procedural step following EU legislation
and is anticipated to complete in the next few weeks.
The Company announced its first customer agreements for
CleanTreat(R) in March 2021 and has the infrastructure and
operational capabilities in place to start the delivery of its sea
lice solution, Ectosan(R) Vet and CleanTreat(R), once the final
steps are completed in the coming weeks.
At this stage the MA does not fully include all anticipated
label claims on usage. Benchmark will work closely with its
customers as they develop their knowledge on the most effective
usage of the product in the field. Benchmark will also continue to
develop the optimal product usage in conjunction with NoMA through
applications for field trials and variations to the MA.
Based on the Market Authorisation granted, Ectosan(R) Vet and
CleanTreat(R) are expected to be profitable from the outset, with
expectations for the Group's performance in FY 2021 and potential
market for the new sea lice solution unchanged, but with a slower
ramp up. As previously communicated the initial launch will be with
two vessels. Based on the current label claims, we expect to
achieve an Adjusted EBITDA margin of 25%-30% (excluding IFRS 16)
for Ectosan(R) Vet and CleanTreat(R) which we anticipate will
increase as new claims are granted.
Trading update & Notice of Q3 Results
The Company's expectations for FY 2021 remain unchanged. The
Company has continued to perform well in Q3 FY2021 and is trading
in line with market expectations for the full year. The Company
will announce its Q3 results on 24 August 2021.
Environmental Stewardship
Benchmark's mission is to drive sustainability in aquaculture.
Its sea lice solution Ectosan(R) Vet and CleanTreat(R) addresses
one of the biggest challenges in aquaculture while improving animal
welfare and protecting the environment.
The process to obtain Marketing Authorisation includes rigorous
environmental risk assessments to ensure the medicine meets the
highest environmental standards of the European Medicines Agency
guidelines and of the NoMA in Norway.
Ectosan(R) Vet will be exclusively administered in a closed
contained unit within a wellboat and used together with CleanTreat
â , Benchmark's award winning and validated water purification
solution. CleanTreat â removes the active ingredient from the
treatment water safely before returning purified water back to the
Ocean.
Update on MRL Resolution in the European Parliament
The Company notes the adoption of the Resolution (B9-0313/2021)
by the EU Parliament objecting to the Maximum Residue Limit (MRL)
for imidacloprid on fin fish. As previously announced, the MRL was
ratified as European law through a European Commission Implementing
Regulation on 15th April 2021.
The European Commission's decision was taken following a
rigorous programme of studies confirming the safety of BMK08
(imidacloprid), and a thorough assessment of robust scientific
evidence by the European Medicines Agency Committee for Veterinary
Medicinal Products, on 9 September 2020. Subsequently the
Commission recommended on 26 February 2021 that a maximum residue
limit in fin fish is established. This recommendation was confirmed
on 20 March 2021 by the Commission's Standing Committee on
Veterinary Medicinal Products and adopted by the European
Commission on 15 April 2021.
The Company has full confidence in the European Medicines Agency
and European Commission's scientific and regulatory process and is
committed to working closely with professional scientists, marine
experts and regulators to continue developing innovative products
to help the aquaculture industry grow sustainably, in line with the
UN's Sustainable Development Goals.
The Company is monitoring any further decisions the Commission
may or may not take following the adoption of the Resolution, and
will update the market at such time.
Trond Williksen, CEO, commented:
"We are pleased to have received Marketing Authorisation from
the Norwegian Medicines Agency, which represents a major milestone
for the Company. It is testament to the team of scientists at
Benchmark that we are able to bring the first new sea lice
veterinary medicinal treatment to the Norwegian salmon market in
over a decade.
"We are excited to bring this much needed solution to the salmon
industry, driving sustainability through improved animal welfare
and yield while protecting the environment.
"We look forward to working with our customers as we roll-out
Ectosan (â) Vet and CleanTreat (â) in the market."
Details of analyst / investor call - Monday 5(th) July
There will be a call on Monday 5(th) July at 9:30am UK time for
analysts and investors. To register for the call please contact MHP
Communications on +44 (0)20 3128 8990 or 8742, or by email on
benchmark @mhpc.com
Enquiries:
Benchmark Holdings plc Tel: 020 3696 0630
Trond Williksen, CEO
Septima Maguire, CFO
Ivonne Cantu, Investor Relations Director
Numis (Broker and NOMAD) Tel: 020 7260 1000
James Black / Freddie Barnfield / Duncan
Monteith
MHP
Katie Hunt /Alistair de Kare-Silver / Tel: 020 3128 8742
Charlie Protheroe benchmark@mhpc.com
About Benchmark
Benchmark is a leading aquaculture biotechnology company.
Benchmark's mission is to enable aquaculture producers to improve
their sustainability and profitability.
We bring together biology and technology, to develop innovative
products which improve yield, quality and animal health and welfare
for our customers. We do this by improving the genetic make-up,
health and nutrition of their stock - from broodstock and hatchery
through to nursery and grow out.
Benchmark has a broad portfolio of products and solutions,
including salmon eggs, live feed (Artemia), diets and probiotics
and sea lice treatments. Find out more at www.benchmarkplc.com
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