Aytu BioPharma(AYTU) - 2025 Q4 - Annual Results

Executive Summary & Business Outlook Aytu BioPharma reported fiscal 2025 results, detailed EXXUA launch plans, and discussed strategic direction Full Year Fiscal 2025 Highlights FY2025 net revenue increased 2% to $66.4 million, with a net loss of $13.6 million and $9.2 million adjusted EBITDA Full Year Fiscal 2025 Key Financial Highlights | Metric | FY2025 | FY2024 | Change | | :----- | :----- | :----- | :----- | | Net Revenue | $66.4 million | $65.2 million | +2% | | ADHD Portfolio Net Revenue | $57.6 million | $57.8 million | -0.3% | | Pediatric Portfolio Net Revenue | $8.8 million | $7.3 million | +20.5% | | Net Loss | $(13.6) million | $(15.8) million | Improved | | Adjusted EBITDA | $9.2 million | $10.8 million | -14.8% | | Cash & Cash Equivalents (June 30, 2025) | $31.0 million | N/A | N/A | Q4 Fiscal 2025 Highlights Q4 FY2025 net revenue grew 4% to $15.1 million, with a net loss of $19.8 million and $2.0 million adjusted EBITDA Q4 Fiscal 2025 Key Financial Highlights | Metric | Q4 FY2025 | Q4 FY2024 | Change | | :----- | :----- | :----- | :----- | | Net Revenue | $15.1 million | $14.6 million | +4% | | ADHD Portfolio Net Revenue | $13.1 million | $13.8 million | -5.1% | | Pediatric Portfolio Net Revenue | $2.0 million | $0.8 million | +150% | | Net Loss | $(19.8) million | $(4.6) million | Worsened | | Adjusted EBITDA | $2.0 million | $2.0 million | 0% | EXXUA Commercial Launch Update EXXUA launch is on track for Q4 calendar 2025, targeting the significant U.S. MDD market - EXXUA launch is on track for Q4 calendar 2025, expected to be a major growth catalyst in the over $22 billion U.S. MDD market[1][5] - Key launch activities include finalizing product manufacturing, labeling, serialization, engaging key opinion leaders, refining sales territories and physician targeting, preparing promotional materials, and assessing commercial and government payors[6][9] Management Discussion CEO highlighted EXXUA's strategic fit, portfolio stability, and 9th consecutive quarter of positive adjusted EBITDA - EXXUA is a "perfect strategic fit" and will be a "centerpiece of Aytu's commercial efforts" due to its significant potential, uniqueness, sales force's CNS focus, and alignment with the Aytu RxConnect platform[7] - The company achieved its 9th consecutive quarter of positive adjusted EBITDA, demonstrating stability in existing ADHD and Pediatric portfolios and focus on operational efficiencies[7] Financial Performance Analysis Detailed analysis of net revenue by product portfolio and comprehensive financial results for FY2025 and Q4 Net Revenue by Product Portfolio Detailed breakdown of net revenue contributions from ADHD and Pediatric portfolios for Q4 and full fiscal year 2025 Net Revenue by Product Portfolio (in thousands) | Portfolio | Q4 FY2025 (in thousands) | Q4 FY2024 (in thousands) | FY2025 (in thousands) | FY2024 (in thousands) | | :---------------- | :----------------------- | :----------------------- | :-------------------- | :-------------------- | | ADHD Portfolio | $13,107 | $13,758 | $57,576 | $57,784 | | Pediatric Portfolio | $2,017 | $841 | $8,769 | $7,280 | | Other | $11 | $(6) | $37 | $119 | | Total Net Revenue | $15,135 | $14,593 | $66,382 | $65,183 | Full Year Fiscal 2025 Financial Results FY2025 net revenue increased 2% to $66.4 million, with gross profit decline and improved net loss despite impairments - Net revenue increased 2% to $66.4 million, driven by Pediatric Portfolio growth (49% increase in units sold) offsetting a slight decrease in ADHD prescriptions[10][11][12] - Gross profit percentage decreased from 75% to 69% due to increased cost of sales in ADHD inventory, attributed to overhead allocation from a closed manufacturing facility to reduced production, which is expected to normalize[13] - Operating expenses (excluding amortization, restructuring, impairment) decreased by $5.2 million to $39.6 million, reflecting continued cost reduction and operational efficiencies[14] Full Year Fiscal 2025 Key Financial Results | Metric | FY2025 | FY2024 | Change | | :----- | :----- | :----- | :----- | | Net Loss | $(13.6) million | $(15.8) million | Improved | | Net Loss per Share (Basic & Diluted) | $(2.16) | $(2.86) | Improved | | Adjusted EBITDA | $9.2 million | $10.8 million | -14.8% | | Cash and Cash Equivalents (June 30) | $31.0 million | $20.0 million | +55% | - Net loss was impacted by $8.3 million impairment expense on the Pediatric Portfolio due to shifted focus to psychiatric products and EXXUA launch, $1.7 million derivative warrant liabilities loss, and $2.1 million restructuring costs related to the Grand Prairie facility closure[16] Q4 Fiscal 2025 Financial Results Q4 net revenue grew 4% to $15.1 million, with gross profit decline and widened net loss due to impairment and liabilities - Q4 net revenue increased 4% to $15.1 million, driven by the Pediatric Portfolio's return-to-growth plan, while ADHD portfolio revenue decreased due to fewer prescriptions[18][19] - Gross profit percentage decreased from 76% to 68% in Q4[19] - Operating expenses (excluding amortization, restructuring, impairment) decreased by $1.8 million to $8.7 million, reflecting ongoing cost reduction and operational efficiencies[20] Q4 Fiscal 2025 Key Financial Results | Metric | Q4 FY2025 | Q4 FY2024 | Change | | :----- | :----- | :----- | :----- | | Net Loss | $(19.8) million | $(4.6) million | Worsened | | Net Loss per Share (Basic & Diluted) | $(2.92) | $(0.82) | Worsened | | Adjusted EBITDA | $2.0 million | $2.0 million | 0% | - Q4 net loss was significantly impacted by $8.3 million impairment expense on the Pediatric Portfolio and $9.9 million derivative warrant liabilities loss, primarily due to an increase in the fair value of prefunded warrants and the company's stock price[22] Corporate Information & Product Details Overview of Aytu BioPharma, EXXUA product details, and investor communication information Conference Call Details Details for the fiscal 2025 results conference call and webcast, including replay information - Conference call and webcast held on September 23, 2025, at 4:30 p.m. Eastern time, with replay available until October 7, 2025[24][25] About Aytu BioPharma Aytu BioPharma focuses on innovative CNS medicines, including EXXUA, ADHD, and pediatric products - Aytu BioPharma focuses on advancing innovative medicines for complex central nervous system diseases[1][26] - Key prescription products include EXXUA (MDD), Adzenys XR-ODT and Cotempla XR-ODT (ADHD), and legacy pediatric products[26] About EXXUA EXXUA is a novel oral selective serotonin 5HT1a receptor agonist for major depressive disorder (MDD) in adults - EXXUA is a novel oral selective serotonin 5HT1a receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults[27][28] Indications and Important Safety Information for EXXUA EXXUA is indicated for MDD in adults, with warnings for suicidal thoughts and contraindications - EXXUA is indicated for MDD in adults, but not approved for pediatric patients[28][29] - Boxed WARNING: Antidepressants, including EXXUA, increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies, requiring close monitoring[29] - Contraindications include prolonged QTc interval, use with strong CYP3A4 inhibitors, severe liver problems, and concurrent use with MAOIs[29][31] - Serious side effects may include QT prolongation (irregular heartbeats) and serotonin syndrome when taken with certain other medicines[29][30] Supplementary Information Details on non-GAAP reconciliation, forward-looking statements, and investor contact information Adjusted EBITDA Non-GAAP Reconciliation Adjusted EBITDA is a non-GAAP measure used for performance analysis, reconciled to GAAP net loss - Adjusted EBITDA is a non-GAAP financial indicator used to analyze and compare companies based on operating performance, with net loss being the most directly comparable GAAP measure[32] Forward-Looking Statements Press release contains forward-looking statements subject to risks and uncertainties detailed in SEC filings - The press release contains forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially[33] - Risks include overall financial and operational performance, changes in financial position, market acceptance of products, financing ability, regulatory challenges, and future collaborations[33] Contacts for Investors Investor contacts provided for Aytu BioPharma's CFO and Lytham Partners for inquiries - Investor contacts are Ryan Selhorn (CFO, Aytu BioPharma) and Robert Blum (Lytham Partners)[34] Consolidated Financial Statements Presentation of Aytu BioPharma's consolidated statements of operations, balance sheets, and EBITDA reconciliation Consolidated Statements of Operations Presents revenues, costs, expenses, and net loss for Q4 and full fiscal year 2025 and 2024 Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Q4 FY2025 | Q4 FY2024 | FY2025 | FY2024 | | :------------------------------------ | :-------- | :-------- | :------- | :------- | | Net revenue | $15,135 | $14,593 | $66,382 | $65,183 | | Cost of goods sold | $4,881 | $3,541 | $20,551 | $16,129 | | Gross profit | $10,254 | $11,052 | $45,831 | $49,054 | | Total operating expenses | $17,877 | $13,325 | $53,658 | $50,645 | | Net loss | $(19,818) | $(4,617) | $(13,562) | $(15,844) | | Basic and diluted - net loss per share | $(2.92) | $(0.82) | $(2.16) | $(2.86) | Consolidated Balance Sheets Snapshot of assets, liabilities, and equity as of June 30, 2025 and 2024, showing increases in assets and liabilities Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | | :------------------------------------ | :------------ | :------------ | | ASSETS | | | | Cash and cash equivalents | $30,952 | $20,006 | | Accounts receivable, net | $31,155 | $23,526 | | Inventories | $11,434 | $12,141 | | Total current assets | $79,179 | $61,891 | | Intangible assets, net | $42,201 | $52,453 | | Total assets | $124,177 | $118,095 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Total current liabilities | $63,064 | $62,228 | | Derivative warrant liabilities | $26,334 | $12,745 | | Total liabilities | $105,211 | $90,379 | | Total stockholders' equity | $18,966 | $27,716 | | Total liabilities and stockholders' equity | $124,177 | $118,095 | Reconciliation of Net Loss to Adjusted EBITDA Reconciliation of GAAP net loss to non-GAAP Adjusted EBITDA for Q4 and full fiscal year 2025 and 2024 Reconciliation of Net Loss to Adjusted EBITDA (in thousands) | Metric (in thousands) | Q4 FY2025 | Q4 FY2024 | FY2025 | FY2024 | | :------------------------------------ | :-------- | :-------- | :------- | :------- | | Net loss - GAAP | $(19,818) | $(4,617) | $(13,562) | $(15,844) | | Interest expense | $730 | $1,253 | $3,703 | $5,059 | | Income tax expense | $437 | $841 | $437 | $2,142 | | Depreciation and amortization | $1,278 | $1,398 | $5,191 | $5,910 | | Stock-based compensation expense | $113 | $243 | $576 | $2,374 | | Derivative warrant liabilities loss (gain) | $9,860 | $(1,463) | $1,703 | $4,004 | | Impairment expense | $8,263 | $0 | $8,263 | $0 | | Net (income) loss from discontinued operations, net of tax | $(62) | $1,239 | $(620) | $3,324 | | Adjusted EBITDA - non-GAAP | $2,039 | $2,029 | $9,186 | $10,833 |