Avecho Biotechnology (AVE) investor relations material

Product development and clinical progress

• Developed a proprietary CBD capsule for insomnia, enhanced with TPM technology to increase absorption and efficacy.

• Currently conducting the world's largest randomized placebo-controlled phase III trial for insomnia, with interim analysis results expected in June.

• Trial design includes placebo run-in to minimize placebo effect and two primary endpoints for increased chance of success.

• Recruitment for interim analysis is complete, and results will inform final patient numbers for statistical significance.

Market opportunity and commercial strategy

• Insomnia affects 10%-30% of the population, with over 9.5 million potential patients in Australia and 200 million globally.

• Unique Australian regulatory pathway allows CBD to be registered as an over-the-counter medicine, providing direct access to consumers.

• Initial forecasts estimate $125 million in first-year sales in Australia, with Sandoz's business case projecting even higher revenues.

• Global insomnia market exceeds $5 billion, and mental health applications could expand the addressable market to $370 billion.

Strategic partnerships and financial outlook

• Secured exclusive licensing deal with Sandoz, the world's largest generics company, for Australia, including $3 million upfront and up to $16 million in milestones.

• Royalties of 14%-19% on net sales and a 7.5% management fee on manufacturing, with year one orders projected at $64 million.

• Sandoz's business case anticipates $20 million-$50 million annual revenue for Avecho from Australia alone.

• Sandoz has first right of refusal for global territories, and discussions are ongoing for further international licensing.