AYTU BIOPHARMA, INC Q2 FY2026 earnings call

• ExuA is the first and only 5-HT1A agonist approved by the FDA for MDD, with a differentiated mechanism acting on 5-HT1A receptors. Its launch strategy includes a motivated sales organization, scalable initiatives like a virtual sales team, patient access via RxConnect platform with no-cost titration packs, and medical education through KOL networks.
• ADHD portfolio net revenue was $13.2 million, slightly decreased due to marketing deemphasis and generic competition, but the authorized generic helped limit impact.
• Pediatric portfolio net revenue increased in Q2 but remains non-core as resources are focused on ExuA, given FDA commentary on fluoride.

The ADHD portfolio had net revenue of $13.2 million, a slight decrease from the prior year and flat compared to Q1. The pediatric portfolio saw net revenue of $1.7 million in Q2, up from $715,000 in the most recent sequential Q1 but down from $2.7 million last year. ExuA was commercially launched, with scripts written from 27 states, over 100 doctors having prescribed it, and early patient feedback being positive. The ADHD portfolio's revenue decrease was due to deemphasis in marketing and generic competition, while the pediatric portfolio's increase was related to reduced returns and stabilized prescriptions, though it remains non-core as resources focus on ExuA.

• ExuA net revenue expected to have a small initial ramp in the March 2026 quarter due to deliberate early access removal. Gross margins are expected to be in the mid- to high 60% range. Breakeven is projected at ~$17.3 million net revenue per quarter, cash breakeven at ~$16.6 million per quarter. Initial ExuA launch investment budget reduced to under $8 million, with ~$3 million being one-time items.

• Weather-related issues initially affected script filling and inventory distribution, causing delays in getting products to pharmacies, but these supply issues have been corrected.

Q: Feedback from doctors who prescribed ExuA?

A: Mix of motivations including treating challenging patients, interest in the mechanism of action, and ease of prescribing via RxConnect.

Q: Expectation of Salesforce expansion in 2026?

A: Unlikely to expand quickly; waiting for profitability and cash flow to support expansion, with no plan to raise capital for this specifically.

Q: Details of direct-to-consumer campaign?

A: Largely web-based, including search engine optimization, cautious social media engagement due to FDA compliance, and forum engagement like Reddit.

Q: Weather impact on scripts and supply?

A: Weather caused delays in script filling and inventory, but supply issues have been corrected and there is adequate supply to ramp if demand increases