Aytu Biopharma (AYTU) Corporate presentation summary

Strategic realignment and operational improvements

• Refocused on profitable prescription pharmaceuticals, exiting consumer health and pipeline R&D to streamline operations and improve financial performance.

• Achieved $34.7 million adjusted EBITDA improvement over four years, with key events including outsourcing manufacturing and divesting non-core businesses.

• Reduced annualized operating expenses by nearly $40 million over three years, driving improved gross margins and operational efficiency.

• Completed refinancing and paydown of term loan, strengthening the balance sheet.

• Lean commercial infrastructure with 40 sales reps and over 1,000 pharmacy partners enables scalable product launches.

Product portfolio and commercial focus

• Portfolio centers on novel, patent-protected CNS therapeutics, including EXXUA for MDD and branded ADHD and pediatric products.

• EXXUA, a first-in-class 5HT1A partial agonist for MDD, is set for U.S. launch in Q4 2025, with exclusive commercialization rights secured.

• ADHD brands (Adzenys XR-ODT, Cotempla XR-ODT) and pediatric products generate established revenue streams.

• Aytu RxConnect program supports patient access, adherence, and affordability, covering all commercially insured patients.

• Commercial launch strategy for EXXUA emphasizes psychiatry-focused sales, KOL development, and broad retail distribution.

EXXUA market opportunity and clinical profile

• EXXUA addresses significant unmet needs in MDD, offering efficacy without sexual dysfunction or weight gain, unlike many current antidepressants.

• Demonstrated efficacy in two pivotal trials, with statistically significant symptom improvement versus placebo.

• Favorable adverse event profile: no warning for sexual dysfunction, minimal weight change, and low discontinuation rates.

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

• Potential for over 1 million annual prescriptions with modest market penetration, supported by large and growing $22B+ MDD market.