Aytu BioPharma (NASDAQ:AYTU) held its first investor day in New York City as management marked the company’s formal launch of Exxua (gepirone) for major depressive disorder (MDD). Chief Executive Officer Josh Disbrow said the sales force is “fully deployed” and that the company is “already generating prescriptions,” describing the day as “day one” of a broader commercial push after what he called an earlier “soft launch.”
Management highlights Exxua’s positioning and launch readiness
Disbrow described Exxua as the “first and only selective 5-HT1A agonist approved for MDD in adults,” dosed as a once-daily extended-release tablet. He emphasized the product’s differentiators, particularly its mechanism of action and tolerability profile, and asked investors to review prescribing information, including the boxed warning regarding suicide risk in young patients.
Key opinion leaders discuss mechanism and unmet need in MDD
In a scientific session, psychiatrist and author Dr. Steven Stahl discussed the rationale for targeting the 5-HT1A receptor, contrasting Exxua’s selective agonism with SSRIs and SNRIs that “spill” serotonin across many receptor types. Stahl argued that non-selective serotonin reuptake inhibition can produce “a lot of price of doing business,” including sexual dysfunction and other adverse effects. He also highlighted Exxua’s once-daily extended-release dosing compared with buspirone, another azapirone that requires multiple daily doses and was not approved for MDD.
Dr. Anita Clayton of the University of Virginia presented data on treatment challenges in depression, citing 2021 estimates that about 8.3% of U.S. adults (21 million people) experienced major depression that year. She reviewed STAR*D trial outcomes to underscore declining remission rates with successive treatment steps and said rapid remission is important due to risks such as suicidal ideation and poor functional outcomes. Clayton also discussed the role of adverse effects in non-adherence and switching, citing a study of more than 55,000 outpatients in which 8.6% switched antidepressants within 90 days, with switching exceeding 15% among young adults.
Clayton highlighted that sexual dysfunction and weight gain are among the most distressing antidepressant side effects for patients and can influence switching and discontinuation. She said Exxua did not show sexual dysfunction adverse events above 2% versus placebo in pooled MDD studies and did not show clinically significant weight gain, including in long-term extension data. She also reviewed patient-reported sexual functioning results using the Derogatis Inventory for Sexual Functioning, which she said showed positive effects on sexual functioning with Exxua in both men and women in the trials discussed.
Clinical trial program and safety overview
Dr. Christoph Correll reviewed two eight-week, randomized, double-blind, placebo-controlled Phase 3 studies supporting Exxua’s approval. He said dosing began at 8.2 mg once daily, titrated to 36.3 mg and 54.5 mg, with the option to increase to 72.6 mg if needed. Primary efficacy measures included the HAM-D-17 in one study and MADRS in the other, with additional measures including Clinical Global Impression scales.
Correll said Exxua demonstrated statistically significant improvement versus placebo on the primary endpoint at week eight. He described separation from placebo beginning at week three in one study and week four in the other, while emphasizing that in clinical practice clinicians observe absolute symptom change rather than placebo comparison. He also noted response rates of about half of patients and remission rates of roughly one-third by week eight in the studies reviewed.
On tolerability, Correll said common adverse effects included dizziness, nausea, insomnia, abdominal pain, and dyspepsia, with an overall pattern that he characterized as early and diminishing over time. He highlighted discontinuation rates of 7% for Exxua versus 3% for placebo in the pooled safety data presented. He also discussed QT interval considerations, describing ECG monitoring recommendations in the prescribing information as linked to legacy concerns from immediate-release gepirone, while stating the extended-release formulation was designed to address peak-related effects.
Commercial strategy, RxConnect access, and financial structure
Pizzia outlined a launch strategy centered on an in-house sales force of “roughly 40-plus” sales professionals focused initially on approximately 5,500 high-value psychiatry prescribers. He said the company is emphasizing prescribers with high SSRI/SNRI prescribing and patient switching, branded-prescribing behavior, and familiarity with Aytu’s RxConnect network. Pizzia also described plans for a “rolling CSO model” to scale promotion based on product performance and cash flow, and a virtual sales team expected to deliver roughly 20,000 customer contacts during the initial launch phase.
He described A2Rx Connect as a program intended to provide predictable commercial access and capped out-of-pocket costs; for Exxua, he said commercially insured patients would pay up to $50 when filled through a participating RxConnect pharmacy. During Q&A, management also described a titration pack and a program intended to provide $0 coverage for initial months through the network for commercially insured patients as payer decisions develop.
Chief Financial Officer Ryan Selhorn reviewed the economics of the Exxua partnership, describing a modest upfront structure with performance-based obligations. He said the agreement included $3 million paid at execution in June 2025 and an additional $3 million due within 45 days of the first anniversary of commercial launch, set for January 2027, with the second payment increasing to $5 million if first-year net sales exceed $35 million. Selhorn said the ongoing economics include a 28% base royalty on net sales plus an amount equal to 3% of net sales less actual cost of goods sold, and that royalty rates increase if annual net sales exceed $300 million. He also referenced a $5 million milestone payment beginning at $100 million in annual net sales.
Selhorn said the company held $32.6 million in cash as of September 2025 and, based on current projections, does not expect to require additional capital through profitability. He reported trailing 12-month adjusted EBITDA of $6.7 million and operating cash burn of $1.4 million. He also said the Exxua launch budget had been reduced from $10 million to about $6 million to $8 million due to execution efficiencies, and that Exxua is expected to deliver gross margins of 66% to 68% inclusive of royalty payments.
About Aytu BioPharma (NASDAQ:AYTU)
Aytu BioPharma, Inc is a specialty pharmaceutical company focused on the development, licensing and commercialization of novel therapeutics to address underserved medical needs. Headquartered in Englewood, Colorado, Aytu pursues a strategy of acquiring late-stage or approved products in areas such as urology, endocrinology, women’s health, pediatric care and supportive therapies. The company leverages in-house commercialization capabilities and targeted business development to build a diversified portfolio of prescription medicines and diagnostics.
Aytu’s marketed portfolio includes Natesto, a nasal testosterone gel for treatment of male hypogonadism; ZolpiMist, a zolpidem tartrate lingual spray for the short-term treatment of insomnia; and Tuzistra XR, an extended-release cough syrup formulation indicated for relief of cough and upper respiratory symptoms.
