Ann: Response to ASX Price Query Letter, page-71

Despite the recent sell-off in Botanix Pharmaceuticals (ASX: BOT) shares following President Trump's executive order on prescription drug pricing, current information suggests that Sofdra (sofpironium) is unlikely to be directly impacted by the policy.

The executive order, signed on May 11, 2025, introduces a "Most Favored Nation" (MFN) pricing model, aiming to align U.S. Medicare payments for certain physician-administered drugs with the lowest prices paid by other developed countries. This policy primarily targets medications covered under Medicare Part B, such as injectable treatments administered in clinical settings.

Sofdra, a topical gel approved by the FDA for treating primary axillary hyperhidrosis (excessive underarm sweating), is self-administered and typically covered under Medicare Part D or private insurance plans, rather than Medicare Part B. Therefore, it does not fall under the scope of the MFN pricing model outlined in the executive order.

Concerns may stem from Sofdra's availability in Japan under the name Ecclock, where drug pricing is subject to government regulation. However, the MFN policy focuses on aligning U.S. prices with those in other countries for specific Medicare-covered drugs, and there is no indication that it would directly affect the pricing of self-administered topical treatments like Sofdra.Dermatology Times

Botanix has also implemented patient access programs to mitigate out-of-pocket costs, further insulating Sofdra from potential pricing pressures resulting from the executive order. biotechdispatch.com.au+1Skadden+1

In summary, while market reactions have been influenced by the executive order, the specific provisions of the policy suggest that Sofdra's pricing and market position remain unaffected.