AYTU BIOPHARMA, INC Q4 FY2025 earnings call

• Fiscal 2025 saw stability in existing ADHD and pediatric portfolios, with ninth consecutive quarter and third consecutive year of positive adjusted EBITDA. Net revenue was $66.4 million, adjusted EBITDA was $9.2 million. • In June 2025, signed exclusive agreement to commercialize ExuA in US, a novel first-in-class treatment for MDD. ExuA is a 5-HT1A receptor agonist, long-acting, targets mood-related receptors without sexual dysfunction or weight change risks. • Work underway for ExuA launch: finalizing manufacturing, bringing on Dr. Gerwin Westfield for medical affairs, refining sales territory alignment, optimizing branding/promotional materials, integrating into RxConnect access platform. • ADHD portfolio: Teva activated ANDA but not yet launched; company launched authorized generic Adzenys AG, with strategies in place to mitigate potential impact, including high percentage of scripts through RxConnect, prescribers' preference for brands, and lower potential for price erosion.

For fiscal 2025 full year, net revenue was $66.4 million. The ADHD portfolio net revenue was $57.6 million, which was a slight decrease from the prior year period, offset by improvements in gross to net through Aytu RxConnect platform. The pediatric portfolio net revenue was $8.8 million, an increase from the prior year. Gross margin was 69% in fiscal 2025, down from 75% last year. Contribution margin was 77.9%. ADHD portfolio contributed approximately 86.7% of total net revenue ($57.6 million / $66.4 million), and pediatric portfolio contributed approximately 13.3% ($8.8 million / $66.4 million).

• ExuA is expected to launch by end of 2025 calendar year, with revenue expected to ramp up starting in June 2026 quarter and beyond. • Fiscal 2026 is expected to invest approximately $10 million in ExuA launch. • Base business of ADHD and pediatric portfolios, with new cost structure, is expected to breakeven at about $52.6 million annually or $13.2 million quarterly.

• Potential impact of FDA warning letters on promotional materials handling, though management plans to use traditional 2253 submission process. • Risk of unfavorable payer contracts and rebates if not selective, as it could affect margin. • Uncertainty regarding Teva's entry into ADHD market and its impact on pricing and market share.

Q: Thomas Flaten asked about preclearing promotional materials for ExuA and payer engagement approach.

A: Josh Disbrow said they do not plan to preclear, have a compliant promotional platform and will use traditional 2253 submission. On payer engagement, it's case-by-case based on plan pull-through and to preserve margin and patient access.

Q: Naz Rahman asked about potential annual sales and contributions of ADHD and pediatric businesses.

A: Josh Disbrow said they are shifting promotional resources to ExuA, base business will be margin positive with shifted expenses, and Ryan Selhorn added base business needs to hit about $13 million a quarter to breakeven.

Q: Ed Woo asked about distribution pattern of ExuA launch expenses.

A: Ryan Selhorn said a good chunk of about 50% in Q2 of December period, and the other 50% in Q3 and Q4.