Set-back for Newmarket-based Tristel’s drive to break into the United States market
- Credit: Gregg Brown
East Anglian infection control products manufacturer Tristel has suffered a delay in its bid to break into the lucrative North American market.
Tristel, which is based at Snailwell, near Newmarket, is seeking approval from the United States Environmental Protection Agency (EPA) for its foam-based chlorine dioxide product Duo.
A submission filed in June was expected to result in approval by the end of this year but a change of approach on the part of the EPA, requiring additional data from Tristel, means clearance is now not expected until May 2018.
Tristel said in a statement: “A meeting with the EPA in October 2016 and subsequent communications with the agency guided the scope and content of the company’s Duo submission which was made on June 30, 2017.
“The EPA has now informed the company that it has changed its approach and additional information has been requested. This additional data has largely been compiled and submitted.
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“As a result, the EPA approval is now expected in May 2018, rather than late 2017 as originally anticipated. Approval will be followed by the state-by-state registration process and the company’s revenue expectations are not affected by this slight delay.”
Paul Swinney, chief executive of Tristel, added: “Whilst we are disappointed that the EPA’s change of approach will require us to restart the submission timetable and incur a five-month delay to the timetable that we originally anticipated, our expectation for first revenues from North America in financial year 2018-19 remains unchanged.”
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EPA clearance will enable Duo to claim intermediate disinfection of all non-porous surfaces. This includes medical instruments which represents Tristel’s core activity worldwide and accounts for around 80% of the company’s revenues.
In all other markets worldwide Duo is classified as a high-level disinfectant and Tristel is continuing to work on submissions to the US Food and Drug Administration (FDA) to permit Duo to claim high-level disinfection of medical instruments in the US too.
Corporate adviser and broker finnCap said its forecasts for Tristel for 2017-18 remained unchanged, adding it had held back from issuing forecasts for 2018-19 until the launch timetable for Duo in the US became clearer.
It noted that, despite the delay, the first revenues from the US were still expected during 2018-19 and confirmed that it would issue 2018-19 forecasts when Tristel publishes its annual results for the year to June 30 2017 on October 19.
In the six months to December 31, 2016, Tristel saw revenues grow by 22% compared with the previous year’s first half to £9.75m and earnings before interest, tax and depreciation by 21% to £2.3m, with pre-tax profits 15% higher at £1.7m.
In July, in a final trading update ahead of its results for the year to June 30, Tristel said annual turnover would reach a new record of more than £20m, compared with £17.1m for the previous 12 months, with a pre-tax profit of at least £4m, against £3.3m a year ago.