Aytu BioPharma, Inc. — Fiscal 2026 Form 10-K Summary
Business context and reporting period
Aytu BioPharma is a U.S.-focused pharmaceutical company commercializing prescription products for central nervous system and pediatric conditions. The filing covers the fiscal year ended June 30, 2026, and was filed September 22, 2026. Continuing operations consist of one reportable segment and include EXXUA for major depressive disorder, the ADHD Portfolio consisting primarily of Adzenys and Cotempla, and the Pediatric Portfolio consisting primarily of Karbinal. The former Consumer Health business was divested in July 2024 and is presented as discontinued operations.
EXXUA launched in mid-December 2025 and became the centerpiece of the company’s commercial strategy. The company has indefinitely suspended active clinical development programs and is prioritizing commercial growth, positive operating cash flow and potential strategic transactions.
Financial performance and liquidity
| Metric | Fiscal 2026 | Fiscal 2025 | Change |
|---|---|---|---|
| Net revenue | $57.6 million | $66.4 million | Down $8.8 million, or 13.3% |
| Gross profit | $36.8 million | $45.8 million | Down $9.0 million |
| Gross margin | 64% | 69% | Down 5 percentage points |
| Operating loss | $8.3 million | $7.8 million | Loss increased $0.5 million |
| Net loss | $14.3 million | $13.6 million | Loss increased $0.7 million |
| Net loss per share | $1.16 | $2.16 | Improved due principally to higher share count |
| Cash flow from operations | $3.3 million | $(1.9) million | Improved $5.2 million |
| Cash and cash equivalents | $26.3 million | $31.0 million | Down $4.6 million |
Revenue by portfolio was $6.6 million for EXXUA, $45.8 million for the ADHD Portfolio and $5.1 million for the Pediatric Portfolio. ADHD revenue declined 20.4% and Pediatric revenue declined 41.4%, reflecting reduced promotional emphasis, the EXXUA launch and generic competition.
Cost of goods sold was $20.8 million. Gross margin was pressured by lower legacy-product revenue, a $2.2 million inventory write-down, primarily related to the shift from branded Adzenys to generic products, and the absence of a $3.3 million favorable vendor-related variable-consideration adjustment recognized in fiscal 2025. Selling and marketing expense rose 11.8% to $23.4 million, while general and administrative expense increased 10.9% to $19.3 million. Research and development expense declined to zero from $1.3 million.
The company generated $3.3 million of operating cash flow, primarily through accounts receivable collections and inventory turnover, but used $7.9 million in financing activities for debt and liability repayments. Total current assets were $61.8 million against current liabilities of $54.7 million. Accounts receivable were $22.8 million and inventories were $6.9 million.
At June 30, 2026, debt included $11.1 million of term-loan principal and $6.1 million drawn on the revolving facility, with $5.2 million of revolving availability. The term loan bears interest at SOFR plus 7.0%, and the revolving facility generally bears interest at SOFR plus 4.5%. Debt maturity is June 12, 2029, with scheduled principal payments of $1.9 million in each of fiscal 2027 and 2028 and $7.4 million in fiscal 2029. The company was in compliance with its debt covenants at year-end.
Material changes versus the prior comparable period
- EXXUA generated its first fiscal-year revenue of $6.6 million following its commercial launch.
- Total revenue declined because EXXUA growth did not offset lower ADHD and Pediatric Portfolio revenue.
- Operating expenses declined by $8.5 million because fiscal 2025 included $8.3 million of impairment expense and $2.1 million of restructuring costs; however, commercial launch spending increased.
- Interest expense declined $1.8 million to $1.9 million, primarily from debt and fixed-payment reductions.
- The company recorded a $4.7 million derivative warrant-liability loss, compared with a $1.7 million loss in fiscal 2025, primarily due to an increase in the company’s stock price.
- On March 31, 2026, amended warrants were reclassified from liability to equity, reducing derivative warrant liabilities by $26.4 million. The remaining derivative warrant liability was $1.2 million at year-end.
- Common shares outstanding increased to 10.7 million at June 30, 2026, from 9.0 million at June 30, 2025; 10.9 million shares were outstanding as of September 15, 2026. The company also had 12.6 million warrants and prefunded warrants outstanding at June 30, 2026, creating substantial potential dilution.
- The company paid $3.1 million related to a Tris settlement and $0.2 million of other fixed-payment obligations during fiscal 2026.
- On July 1, 2026, Teva’s authorized generic version of Cotempla became eligible for manufacture and marketing. The company stated that it could not estimate the future revenue impact.
Guidance, outlook, risks and unusual items
Management expects fiscal 2027 selling and marketing and general and administrative expenses to increase as it expands EXXUA sales-force activity, promotional programs, patient and physician education, commercial support, personnel, compliance and infrastructure. Research and development spending is expected to remain de minimis. Management expects continued commercial growth to support eventual profitability, but the filing provides no quantitative revenue, earnings or profitability guidance.
- EXXUA execution risk: Future results depend on physician adoption, patient access, reimbursement, pricing, commercial execution and the product’s ability to differentiate itself in a competitive MDD market. EXXUA royalties initially equal 28% of net sales and may increase based on sales levels; additional milestone payments may become material if sales thresholds are achieved.
- Generic competition: Actavis/Teva launched an authorized generic Adzenys in December 2025, Teva’s authorized generic Cotempla right commenced July 1, 2026, and Granules litigation concerning a proposed generic Adzenys remains pending. Trial is scheduled for January 12, 2027.
- Liquidity and financing: The company has incurred losses every year since inception, has an accumulated deficit of $347.8 million and may require additional capital. The filing warns that financing may be unavailable or dilutive and that debt covenant breaches could permit acceleration of secured obligations.
- Customer concentration: Five customers represented 83% of fiscal 2026 gross revenue and 90% of gross accounts receivable, creating material collection and customer-loss exposure.
- Supply and regulatory risk: Products are manufactured by third parties, and Adzenys and Cotempla are Schedule II controlled substances subject to DEA quotas, security, licensing and distribution requirements.
- Accounting and unusual items: Fiscal 2026 included a $2.2 million inventory write-down and a $4.7 million non-cash warrant-liability loss. The company also relies on estimates for rebates, chargebacks, returns and savings offers; these estimates were identified as a critical audit matter.
- Tax attributes: Federal net operating losses totaled $452.2 million, but Section 382 limitations are expected to cause $288.8 million to expire unused by 2037. A $123.7 million valuation allowance covered substantially all deferred tax assets.
- Controls and audit: Grant Thornton issued an unqualified opinion on the financial statements. Management reported effective disclosure controls and internal control over financial reporting; the auditor was not required to provide an internal-control attestation because the company is a smaller reporting company.
- Cybersecurity: The company reported no cybersecurity incident during fiscal 2026 that materially affected, or was reasonably likely to materially affect, its business, results or financial condition.
Most important facts for investors to verify
- Whether EXXUA revenue growth can offset declines in Adzenys, Cotempla and Karbinal and support sustainable positive operating cash flow.
- The commercial impact of Teva’s Cotempla authorized generic and the outcome and timing of the Granules Adzenys patent litigation.
- Cash runway, available revolving capacity, scheduled debt amortization and the likelihood or terms of future equity or debt financing.
- The economic effect of EXXUA royalties, supply costs and potential milestone payments under the Fabre-Kramer agreement.
- Customer concentration, accounts receivable collections and the adequacy of reserves for rebates, chargebacks, returns and savings programs.
- Potential dilution from 12.6 million outstanding warrants and prefunded warrants compared with 10.7 million common shares outstanding at June 30, 2026.
- Whether inventory write-downs, generic competition and reduced legacy-product promotion will continue to pressure gross margin.