Benchmark Holdings Regulatory News (BMK)

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+CleanTreatÒ 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® 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® 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® in March 2021 and has the infrastructure and operational capabilities in place to start the delivery of its sea lice solution, Ectosan® Vet and CleanTreat®, 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® Vet and CleanTreat® 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® Vet and CleanTreat® 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® Vet and CleanTreat® 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® Vet will be exclusively administered in a closed contained unit within a wellboat and used together with CleanTreatâ, Benchmark's award winning and validated water purification solution. CleanTreatâ 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 Ectosanâ Vet and CleanTreatâ in the market."

Details of analyst / investor call - Monday 5th July

There will be a call on Monday 5th 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:

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