Aytu BioPharma Highlights EXXUA Launch as Fiscal 2026 Revenue Reaches $57.6M

Aytu BioPharma (NASDAQ:AYTU) outlined its fiscal 2026 financial results and commercial strategy at the Lytham Partners Fall 2026 Investor Conference, emphasizing the continued launch of its antidepressant EXXUA alongside its established ADHD and pediatric product portfolios.

Chief Executive Officer Josh Disbrow said the company is focused on commercializing differentiated treatments for central nervous system conditions. Its portfolio generated approximately $57 million to $58 million in revenue over the 12 months ended June 30, led by ADHD brands ADZENYS and COTEMPLA, as well as pediatric products and the initial contribution from EXXUA.

Disbrow said the ADHD portfolio has received less promotional emphasis as the company prioritizes EXXUA. ADZENYS also faces generic competition, though he said the generic competitor has captured about 20% market share and that Aytu’s legacy products have remained relatively resilient.

Patient Access Program Supports Legacy Brands

Aytu attributes some of the portfolio’s durability to its in-house Aytu RxConnect patient-access platform. The program routes prescriptions to preferred pharmacy partners, which assist patients with reimbursement processes and prior authorizations. According to Disbrow, the program provides predictable co-pays, with EXXUA and the company’s ADHD medications carrying co-pays that do not exceed $50.

The company uses the platform’s analytics to monitor prescription-level reimbursement and pricing information, as well as de-identified patient refill patterns. Disbrow said patients using the program and its pharmacy partners have shown greater persistence than those using traditional retail pharmacies.

Aytu has approximately 40 sales territories and recently added coverage in Colorado, Arizona and California. Its commercial model uses a contract sales organization, allowing the company to assess representatives before deciding whether to hire them as full-time employees. Disbrow said some representatives from the initial group have become among Aytu’s higher-performing in-house sales personnel.

EXXUA Launch Takes Center Stage

EXXUA is approved for major depressive disorder in adults and is positioned by Aytu as a first-in-class treatment. Disbrow said the drug is a 5-HT1A agonist rather than a selective serotonin reuptake inhibitor, or SSRI. He said EXXUA selectively targets the 5-HT1A serotonin receptor and was designed to avoid certain side effects commonly associated with antidepressants.

According to Disbrow, the treatment demonstrated efficacy in two randomized, placebo-controlled Phase III studies. He said results showed separation from placebo in depression symptoms within two weeks of treatment initiation, while anxiety-related symptom measures showed separation at about one week.

Disbrow highlighted EXXUA’s labeling and tolerability profile, stating that it does not carry a warning related to sexual dysfunction and did not demonstrate statistically significant weight gain. He said 7% of patients discontinued treatment in clinical studies, while nausea and dizziness led to withdrawals in only a small percentage of patients.

The company sees a substantial commercial opportunity in the U.S. depression market, which Disbrow described as a $22 billion market serving 21 million patients annually and involving nearly 350 million antidepressant prescriptions each year. He also pointed to coverage available through government payer programs, saying that Medicare, Medicaid and TRICARE represent an estimated 30% to 40% of the depression market.

EXXUA launched in mid- to late December, and Disbrow said prescription demand has followed a positive trajectory. He cited nearly 400 prescriptions for the week ended Sept. 4 and said subsequent data showed continued growth. Aytu evaluates both prescriptions and factory shipments, with revenue based on shipments, he said.

Fiscal 2026 Results and Balance Sheet

Chief Financial Officer Ryan Selhorn reported fiscal 2026 net revenue of approximately $57.6 million. Revenue reflected sales from the company’s ADHD and pediatric products as well as the initial EXXUA launch. Selhorn said revenue was lower than in prior years as the company managed generic competition in ADHD and invested in the EXXUA launch.

Adjusted EBITDA was a loss of $3.7 million for fiscal 2026. Selhorn said the result reflected deliberate commercialization spending for EXXUA, including sales-force expansion, market-access initiatives and promotional activities.

The company ended fiscal 2026 with $26.3 million in cash and cash equivalents and $61.8 million in total current assets. Total liabilities were approximately $69.7 million, including $17 million of borrowings consisting of term debt amortized monthly and a revolving credit facility with up to $14 million of availability.

Selhorn said Aytu intends to use its commercial infrastructure to support EXXUA prescription growth while maintaining expense discipline. The company’s priorities are to maximize the value of its existing portfolio, expand EXXUA and improve operating leverage over time.

About Aytu BioPharma (NASDAQ:AYTU)

Aytu BioPharma, Inc is a specialty pharmaceutical company focused on commercializing prescription medicines, primarily for pediatric and primary-care markets. The company’s activities include acquiring, developing and commercializing products intended to address unmet needs in areas such as attention deficit hyperactivity disorder (ADHD), allergies and other common medical conditions.

Aytu’s ADHD portfolio has included Adzenys XR-ODT, an orally disintegrating extended-release amphetamine tablet; Cotempla XR-ODT, an orally disintegrating extended-release methylphenidate tablet; and Dyanavel XR, an extended-release liquid amphetamine formulation.