Aytu Biopharma (AYTU) Investor Day 2026 summary

Scientific and clinical highlights

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

• Clinical trials showed statistically significant improvements in depression scores (HAM-D17, MADRS) versus placebo, with separation as early as week three and remission rates of about one-third by week eight.

• Exxua demonstrated no clinically significant weight gain or sexual dysfunction, with most adverse events being mild to moderate and transient; discontinuation due to adverse events was 7%.

• The extended-release formulation addresses prior QTc prolongation concerns, minimizing the need for ECG monitoring, and no cases of QT prolongation were reported in Phase 3 trials.

• Safety and tolerability were established in over 1,900 patients, with no treatment-related serious adverse events leading to discontinuation.

Commercial strategy and launch execution

• The formal launch marks a transition from a soft launch, with full national distribution, a fully trained sales force, and a focus on psychiatric practices.

• The commercial approach emphasizes capital efficiency, targeted prescriber activation, and a scalable sales model, starting with 40+ territories and plans to expand to over 100 as performance dictates.

• The proprietary RxConnect program ensures broad patient access, predictable coverage, and capped out-of-pocket costs, with free titration packs and initial therapy to accelerate uptake.

• Early prescriptions are predominantly for patients switching from SSRIs or SNRIs, with a payer mix of roughly 60% commercial and 40% government insurance.

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

Financial outlook and deal structure

• The Exxua partnership is structured with modest upfront payments ($3M), additional milestone payments, and a 28% base royalty on net sales, aligning costs with commercial success and limiting downside risk.

• Gross margins for Exxua are projected at 66%-68%, consistent with company-wide margins, and launch investment has been reduced from $10 million to $6–8 million through cost efficiencies.

• As of September 30, 2025, cash on hand was $32.6 million, with no additional cash requirement expected through profitability; TTM adjusted EBITDA was $6.7 million and operating cash burn was $1.4 million.

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

• The financial structure is designed to preserve liquidity, scale costs with revenue, and support sustainable profitability and shareholder value.