AYTU BIOPHARMA, INC

Aytu BioPharma, Inc.

Company focus

• Pharmaceutical company advancing medicines for complex central nervous system (CNS) diseases.
• Strategy centers on in-licensing, acquiring, developing and commercializing prescription therapeutics to build a revenue-generating portfolio and use an in-house commercial organization.

Recent corporate and strategic highlights

• Exclusive U.S. commercialization of EXXUA (gepirone)
  • June 2025: Entered into an Exclusive Commercialization Agreement with Fabre-Kramer Holdings, Inc. to commercialize EXXUA in the United States.
  • EXXUA is a first-in-class selective serotonin 5HT1A receptor agonist, approved by the FDA for adults with major depressive disorder (September 2023).
  • Launched for sale in fiscal 2026: sales began mid-December 2025; sales force trained by mid-January 2026; full sales force deployed by late February 2026.
  • EXXUA revenue recognized in fiscal 2026: $6.6 million for the year ended June 30, 2026.
• Core commercial products
  • ADHD Portfolio: Adzenys XR-ODT (amphetamine XR-ODT) and Cotempla XR-ODT (methylphenidate XR-ODT) with authorized generics.
  • Pediatric Portfolio: Karbinal ER (carbinoxamine maleate extended-release suspension).
• Wind-downs, divestitures and operational changes
  • Fiscal 2025: Wind down and divestiture of the Consumer Health business; company operates a single reporting segment from continuing operations.
  • September 2024: Transitioned manufacturing of Adzenys and Cotempla to a U.S.-based contract manufacturer (completed in Q4 fiscal 2024) to improve efficiency and profitability.
• International development
  • September 2024: Exclusive Canada distribution agreement with Lupin Canada to commercialize Adzenys and Cotempla in Canada; Aytu supplies product and Lupin handles regulatory approvals.
• Intellectual property and litigation
  • Ongoing patent litigation to defend Adzenys IP against generic challenges (Granules) filed December 2024; trial scheduled for January 2027.
  • Settlements reached with Actavis (now Teva) and Teva regarding generic versions of Adzenys and Cotempla.
• Corporate finance
  • June 2025: Raised gross proceeds of $16.6 million via a public offering; net proceeds approximately $14.8 million.
  • June 2025: Amended Eclipse loan agreement (Term Loan and Revolving) to support liquidity and commercial activities.

Business operations and structure

• One operating segment: commercial prescription pharmaceutical products sold through third-party wholesalers, distributors and pharmacies, plus direct access programs.
• Primary products and revenue drivers (continuing operations in fiscal 2026)
  • EXXUA (gepirone extended-release) for major depressive disorder — commercial centerpiece.
  • ADHD Portfolio: Adzenys XR-ODT and Cotempla XR-ODT — produced and distributed via a third-party U.S.-based contract manufacturer since 2024.
  • Pediatric Portfolio: Karbinal ER — U.S. market via exclusive distribution with Tris Pharma.
• Commercial reach and access programs
  • Aytu RxConnect patient support program: network of over 1,000 pharmacies offering copay assistance and access to branded medicines.

Key metrics (fiscal year ended June 30, 2026)

• Employees: 76 total (75 full-time), all in the United States.
  • By function: 4 in operations, 45 in commercialization, 27 in general and administrative.
  • Demographics: approximately 43% female, 53% male, 4% declined to disclose.
• Revenue and income
  • Net revenue (continuing operations) for fiscal 2026: $57.6 million.
  • Revenue by product portfolio for fiscal 2026:
    • EXXUA: $6.6 million (year ended June 30, 2026).
    • ADHD Portfolio: $45.8 million (down 20.4% vs. fiscal 2025).
    • Pediatric Portfolio (Karbinal): $5.1 million (down 41.4% vs. fiscal 2025).
• Profitability
  • Net loss for the year ended June 30, 2026: $14.3 million (net loss for 2025: $13.6 million).
  • Accumulated deficit as of June 30, 2026: $347.8 million.
• Cash and debt
  • Cash and cash equivalents as of June 30, 2026: $26.3 million.
  • Eclipse debt facilities (as of June 30, 2026):
    • Term Loan outstanding: $11.1 million.
    • Secured Revolving Loan outstanding: $6.1 million.
    • Incremental advance under the revolving facility: $0.1 million outstanding (paid off in July 2026).
    • Interest terms: Term Loan SOFR + 7.0%; Revolving SOFR + 4.5% (plus a higher rate for the incremental advance during the period).
    • Maturity: principal amortization and terms extend through June 12, 2029; revolving facility availability subject to a borrowing base and reserves.
• Customer concentration
  • Five significant customers accounted for 83% of gross revenue in fiscal 2026.
  • Five customers accounted for approximately 90% of gross accounts receivable in fiscal 2026.
• Facilities and manufacturing
  • Properties: corporate headquarters in Denver, CO (leased) and Berwyn, PA office (leased).
  • ADHD products manufactured by a U.S.-based CMO under contract; the company does not own manufacturing facilities.

Representative product details

• EXXUA (gepirone) extended-release
  • FDA-approved for major depressive disorder in adults; a 5HT1A receptor agonist and not an SSRI.
  • Pivotal support from two Phase 3 trials (FK-GBE-007 and 134001) and multiple supportive studies.
  • Clinical labeling does not include a warning for sexual dysfunction and showed minimal impact on weight, blood pressure, heart rate, or liver function in pivotal studies.
• Adzenys XR-ODT and Cotempla XR-ODT (ADHD)
  • First FDA-approved extended-release amphetamine and methylphenidate XR-ODTs for ADHD, using RDIM (Rapidly Disintegrating Ionic Masking) technology.
  • Adzenys and Cotempla have composition-of-matter patents listed in the Orange Book; protection for Adzenys to 2032; Cotempla to 2032 with a method-of-use patent to 2038.
  • Settlements with Actavis (Teva) set generic entry dates (Adzenys: September 1, 2025; Cotempla: July 1, 2026) and IP enforcement continues for Adzenys.
• Karbinal ER
  • Extended-release carbinoxamine suspension for pediatric allergic conditions; exclusive U.S. distribution via Tris Pharma through August 2033 (subject to termination and extension rights).
  • Patents listed in the Orange Book with the latest expiry in March 2029.

Regulatory and international activities

• Lupin (Canada) exclusive commercialization agreement for Adzenys and Cotempla; Lupin to pursue regulatory approvals in Canada and Aytu to supply the products.
• Company is winding down clinical development programs and focusing on commercial products, organic growth of EXXUA, and marketed CNS medicines.

Key business risks reflected in activities

• Highly concentrated revenue and receivables among a small number of customers.
• Ongoing litigation to protect intellectual property and the risk of generic competition for key products.
• Dependence on third-party manufacturers and supply chain partners for ADHD products.
• Substantial accumulated deficit and reliance on external financing to fund operations and growth.