Response to ASX Price Query Letter

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Stock Botanix Pharmaceuticals Ltd (BOT.ASX)
Release Time 12 May 2025, 12:26 p.m.
Price Sensitive Yes
 Botanix Responds to ASX Price Query
Key Points
  • Botanix is aware of a proposed US executive order on drug pricing, but this is not expected to impact the company
  • Botanix's products are only approved in the US and Japan, with no overlap in markets
  • Botanix confirms compliance with ASX Listing Rules
Full Summary

Botanix Pharmaceuticals Ltd (ASX: BOT) has responded to an ASX price query letter, providing details on the recent trading in its securities. The company states that it is aware of an announcement apparently made by President Trump on Telegram regarding a proposed executive order on 'Prescription Drug and Pharmaceutical Prices'. However, Botanix notes that its product Sofdra (sofpironium) topical gel, 12.45% is only approved in the USA and is not marketed in any other jurisdiction worldwide. Similarly, Ecclock gel 5%, which contains sofpironium bromide, is marketed in Japan by Botanix's partner Kaken Pharmaceutical Company, but is a different concentration and formulation than Sofdra and was tested in different clinical studies. Neither Ecclock nor any other 5% concentration of sofpironium bromide gel are approved for sale in the USA, and Sofdra is also not approved for sale in Japan. Based on this, Botanix does not consider it likely to be subject to price reductions based on sales of Sofdra outside the USA, as there are none. The company confirms it is in compliance with the ASX Listing Rules, including Listing Rule 3.1.