Aytu Biopharma (AYTU) Corporate presentation summary

Strategic realignment and business focus

• Shifted to a profitable prescription pharmaceutical business, exiting consumer health and R&D pipeline activities, with a $34.7M adjusted EBITDA improvement over four years.

• Key events include suspension of clinical programs, outsourcing manufacturing, divesting consumer health, and launching EXXUA for MDD.

• Exclusive agreement to commercialize EXXUA in the US, with commercial launch in late 2025/early 2026.

Product portfolio and innovation

• Focused on novel, patent-protected CNS therapeutics, especially for MDD and ADHD.

• EXXUA is the first and only selective 5-HT1A agonist approved for MDD in adults, offering a unique mechanism distinct from SSRIs and SNRIs.

• ADHD and pediatric brands include Adzenys XR-ODT, Cotempla XR-ODT, Karbinal ER, Poly-Vi-Flor, and Tri-Vi-Flor.

EXXUA launch and market opportunity

• EXXUA demonstrated efficacy in MDD with a favorable adverse event profile, showing no significant sexual dysfunction or weight gain.

• Positioned for premium pricing and government reimbursement, with Orange Book patent protection through 2030.

• Large US MDD market ($22B+), with significant unmet needs and high patient turnover from existing therapies.

• Commercial strategy targets psychiatrists and leverages the Aytu RxConnect platform for broad access and adherence.