RE: Interim results27 Sep 2025 14:56
My observations on the half-year results presentation and the Q&A session. Any other points / thoughts that anyone would like to share?
Schedule:
• 2025 Q4 – results of ICU study
• 2025 Q4 (end) – FDA phase 3 trial recruitment complete
• 2026 Spring – FDA phase 3 trial top-line results expected
• 2026 Q2 (end) – end of cash runway
• 2026 Mid-summer – new drug application submission to FDA and initiate distribution discussions
• 2026 Q4 (end) – FDA approval granted
Utilisation:
• Pre-operation treatment
• ICU
• Burns, ventilator tubes, sinus issues, wound odour control, dialysis, cancer patient protection, catheters and other indications
Market:
• Potential: c£5bn pa in N America and Europe
• No plans to explore the Chinese market
Performance:
• H1 year on year revenue – increase CAD $150,000. At a cost of CAD $70 per treatment which equates to an increase of approximately 2,100 treatments
• Gross margin up to 65% from 62%
• Rapid growth in Canada (no metrics on this point)
• Expanding sales into UK and other countries
• Interest from US healthcare providers other than HCA
• 100% retention of current hospitals with an increasing range of uses
• R&D costs will reduce at the end of the FDA trial
No material comment to a question about strategic investment v placing to raise further capital.
I would like to see greater transparency about the actual number of applications. Whilst there is no doubting the potential, I think that any significant move in the share price before FDA approval will require major announcements in terms of new customers or large sales volumes. In the UK, there are 6 hospitals listed as using Steriwave; with c90 surgical hubs, there is potential for significant growth, especially taking into account the potential £194m saving to the NHS per the recent study.
LTH for me.
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