The following is not investment advice.
With an FDA decision looming in the very near term ( under 3 months ) , and one which IMO the most likely FDA approval on the ASX right now , lets have a think about what a post approval might look like, based on what post approval in Japan looked like ( all be it in the middle of Covid - 19 ).
Kraken is the seller for the equivalent of SOFDRA in Japan, although they use a less potent version ( 5% vs Botanix 15% active ingredient). Ecclock gained approval in Japan right when Covid was taking off in 2020, and although it has only endured 3 years of growth since, with the last year having approximately 70% YoY sales growth, we can expect the final adopted market to be significantly larger in Japan that what it was in 2023.
The Japan vs USA statistics:
In 2023 Japan sales of Ecclock were equivalent to 14 million USD ( roughly 3 years after launch for a new product ).
Axillary hyperhidrosis in Japan is reported at a rate of 5.75% or around 1 in 20 people.
In 2018 a study found that 90% of the yearly patient treatement costs were from recieving a botulinum injection, priced around 450 USD per patient in that year. https://onlinelibrary.wiley.com/doi/full/10.1111/1346-8138.16050
In 2004 a study on 150,000 households in the USA revealed that 1 / 3rd of those with primary axillary hyperhidrosis reported that their sweating is barely tolerable and frequently interferes, or is intolerable and always interferes, with daily activities, and that only 38% of the sufferers had discussed their sweating with a healthcare professional. That equates to 15 million US patients.
Of the 15 million, only around 50% in 2016 would have visited a GP, and only around 27% of the total would be diagnosed.
That would leave around 4 million diagnosed sufferers in the USA, who had visited a doctor and been given treatment advice.ferers.
https://pubmed.ncbi.nlm.nih.gov/15280843/
In Japan, Ecclock was reportedly charged ( in 2022 ), at around 37USD for a 20 gram bottle ( 2 weeks supply ).... which has been suspected to be significantly lower than the expected US pricing, but even if we assume the pricing remains the same, that equates to $888 USD per patient per year.
If we only took 10% of the 4 million that are diagnosed as a potential market penetration starting point ( 400,000 ), then potential sales are in the 300 - 400 million USD range use Japan pricing.
This will all come down to market adoption, manufacturing, distribution etc and how fast they can spool up.
Current market cap.... 307 million.
Thoughts ?
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