Aytu Biopharma (AYTU) Investor Day 2026 summary

Strategic overview and product launch

• Exxua (EXXUA) is the first and only selective 5-HT1A agonist approved for major depressive disorder (MDD) in adults, offering a novel mechanism distinct from SSRIs/SNRIs, with once-daily dosing and a favorable side effect profile.

• The launch features a fully deployed, lean, and experienced sales force, initial coverage of 40-44 territories, and nationwide pharmacy distribution, with rapid expansion possible via a contract sales organization model.

• Launch strategy emphasizes capital efficiency, targeted prescriber activation, virtual promotion, and scalable sales force expansion based on real-time performance and cash flow.

• Patient access is supported by the proprietary RxConnect network, ensuring broad coverage, low out-of-pocket costs, and a free titration pack for new patients.

• The launch plan includes efficient, multi-faceted promotion, metrics-based performance management, and broad retail distribution.

Clinical efficacy, safety, and differentiation

• Exxua offers a novel mechanism of action, targeting both pre- and postsynaptic 5-HT1A receptors, differentiating it from SSRIs/SNRIs and addressing key unmet needs in MDD treatment.

• Phase 3 studies demonstrated statistically significant improvements in depression scores (HAM-D17, MADRS) versus placebo, with separation as early as week 3 and sustained efficacy through week 8.

• Clinical data show Exxua provides antidepressant efficacy without significant sexual dysfunction or weight gain, two major side effects driving treatment switching in MDD.

• Most common adverse events were mild to moderate and transient, with dizziness, nausea, and insomnia being the most frequent; discontinuation due to adverse events was 7%.

• Exxua prolongs the QTc interval, requiring ECG monitoring during titration and treatment, but no cases of QT prolongation were reported in Phase 3 trials.

Financial guidance and business model

• Exxua partnership structured for performance-based economics: $3M upfront, an additional $3M (or $5M if first-year net sales exceed $35M) within 45 days of the first anniversary, 28% base royalty on net sales, and milestone payments starting at $100M in annual net sales.

• Gross margins for Exxua expected at 66%-68%, with launch budget reduced from $10M to $6-8M due to cost efficiencies, supporting sustainable profitability.

• Company maintains a strong cash position ($32.6M as of September 2025), with no additional cash requirement expected through profitability; TTM adjusted EBITDA was $6.7M and operating cash burn was $1.4M.

• Term loan outstanding was $12.5M, with high-interest liabilities reduced by $7.4M in the trailing twelve months.

• Sales force currently covers 44 territories, with plans to expand to 100+ as demand and cash flow allow, using a rolling CSO model for flexible scaling.