Aytu BioPharma signs EXXUA commercialization deal with Fabre-Kramer, pays $3,000,000 upfront

Aytu BioPharma, Inc. (Nasdaq: AYTU) entered into an exclusive agreement on June 5, 2025 to commercialize EXXUA (gepirone) extended release tablets in the United States. EXXUA is an FDA-approved treatment for major depressive disorder in adults. Aytu paid an upfront cash payment of $3,000,000 to Fabre-Kramer Holdings, Inc. and agreed to further payments, sales milestones and royalties. It disclosed the deal in a Form 8-K filed June 6, 2025.

The payments

The upfront payment was made on the effective date. A second payment of $3,000,000 falls due within 45 days of the one-year anniversary of the first physical sale of the product in the territory. That payment rises to $5,000,000 if first-year net sales reach $35 million or more.

Aytu also owes Fabre-Kramer sales milestones ranging from $5,000,000 to more than $100,000,000 a year, once net sales pass set levels, with a threshold of $100,000,000 in net sales. It will pay 10% of net sales above $1 billion. The royalty starts at 28% of net sales and rises to 39% if net sales exceed $300 million in any year, until a reduced royalty trigger is reached. After that trigger, the rate is 24.5%, rising to 35.5% above $300 million. A supply price of 3% of net sales, less cost of goods sold, rises to 4% if annual net sales exceed $300 million.

Those are the company's obligations if the product sells. The 8-K does not give any sales forecast, and the company has not yet launched the product.

What Aytu gets, and when

The filing says Aytu acquired certain rights and obligations to commercialize EXXUA in any formulation and dosage strength, for all current and future indications, in the United States and its territories. It expects to launch EXXUA in the fourth quarter of 2025 through its own commercial team. The company calls EXXUA a first-in-class treatment with a novel mechanism of action, and says it has been studied in more than 5,000 patients. Those descriptions are the company's own.

The 8-K puts the U.S. antidepressant market above $22 billion and cites more than 340 million antidepressant prescriptions written in 2024. It also cites unacceptable side effects of current therapies.

Exit terms

Either party may end the agreement by mutual consent. Either may also terminate for a material breach that is not cured within 90 days, with a possible extension to a reasonable period of up to 120 days. The agreement may end if the product is withdrawn for safety reasons, if the FDA materially restricts its indications, or if pricing controls would cause substantial loss of sales. Aytu says it will file the full agreement with its annual report on Form 10-K for the year ending June 30, 2025, with confidential terms redacted.

The finances behind the deal

The most recent annual report before this deal covers the year ended June 30, 2024, and was filed September 26, 2024. It shows a net loss of $15,844 thousand for fiscal 2024, against $17,051 thousand for fiscal 2023. The accumulated deficit was $320.0 million at June 30, 2024.

The report says the company had not established an ongoing source of revenue sufficient to cover operating costs. It also says Aytu had resolved a going-concern doubt during fiscal 2024, mainly by retiring a $15.0 million term loan due in January 2025 and taking a new $13.0 million term loan. The report warns the company may keep losing money, and that its ability to generate positive operating cash flow is uncertain.

The report also describes the indefinite suspension of certain research and development activities.

Chief Financial Officer Ryan J. Selhorn signed the 8-K on June 6, 2025.

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