SEC Form 10-Q filed by Aytu BioPharma Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly period ended
or
For the transition period from __________ to ___________
Commission File Number:
AYTU BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
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| (Address of principal executive offices and zip code) | (Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b‑2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| | ☒ | Smaller reporting company | |
| Emerging growth company | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b‑2 of the Exchange Act). Yes
As of November 1, 2025, the registrant had
FORM 10-Q
TABLE OF CONTENTS
CAUTIONARY INFORMATION REGARDING FORWARD-LOOKING STATEMENTS
This Report on Form 10‑Q (“Form 10-Q” or “this report”) includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this report, including statements regarding our regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as “may,” “will,” “should,” “forecast,” “could,” “expect,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “potential,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, without limitation: our anticipated future cash position; the planned expanded commercialization of our products and the potential future commercialization of our product candidates; our anticipated future growth rates; anticipated sales increases; anticipated net revenue increases; amounts of certain future expenses and cost of goods sold; our plans to acquire additional assets or dispose of assets, anticipated increases or decreases to operating expenses, and selling, general, and administrative expenses; and future events under our current and potential future collaborations.
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including without limitation the risks described in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10‑K for the year ended June 30, 2025 (“2025 Form 10-K”), and in the reports we file with the United States Securities and Exchange Commission (“SEC”). These risks are not exhaustive. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. We can provide no assurance that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. We assume no obligation to update or supplement forward-looking statements, except as may be required under applicable law.
This Form 10-Q may refer to registered trademarks that we currently own or license, such as Aytu, Aytu BioPharma, Aytu RxConnect, Neos Therapeutics, EXXUA, which are protected under applicable intellectual property laws and are our property or the property of our subsidiaries. This Form 10-Q also contains trademarks, service marks, copyrights and trade names of other companies, which are the property of their respective owners. Solely for convenience, our trademarks and tradenames referred to in this Form 10-Q may appear without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights to these trademarks and tradenames. We obtained statistical data, market and product data, and forecasts used throughout this Form 10-Q from market research, publicly available information and industry publications.
PART 1 - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
AYTU BIOPHARMA, INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
| September 30, | June 30, | |||||||
| 2025 | 2025 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Inventories | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Non-current assets: | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use assets | ||||||||
| Intangible assets, net | ||||||||
| Other non-current assets | ||||||||
| Total non-current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued liabilities | ||||||||
| Revolving credit facility | ||||||||
| Current portion of debt | ||||||||
| Other current liabilities | ||||||||
| Total current liabilities | ||||||||
| Non-current liabilities: | ||||||||
| Debt, net of current portion | ||||||||
| Derivative warrant liabilities | ||||||||
| Other non-current liabilities | ||||||||
| Total non-current liabilities | ||||||||
| Commitments and contingencies (note 13) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value $; shares authorized; shares issued or outstanding | ||||||||
| Common stock, par value $; shares authorized; and shares issued and outstanding, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
The accompanying notes to the unaudited consolidated financial statements are an integral part of this statement.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Net revenue | $ | $ | ||||||
| Cost of goods sold | ||||||||
| Gross profit | ||||||||
| Operating expenses: | ||||||||
| Selling and marketing | ||||||||
| General and administrative | ||||||||
| Research and development | ||||||||
| Amortization of intangible assets | ||||||||
| Restructuring costs | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income, net | ||||||||
| Interest expense | ( | ) | ( | ) | ||||
| Derivative warrant liabilities gain | ||||||||
| Income from continuing operations before income tax expense | ||||||||
| Income tax expense | ( | ) | ||||||
| Net income from continuing operations | ||||||||
| Net income from discontinued operations, net of tax | ||||||||
| Net income | $ | $ | ||||||
| Basic weighted-average common shares outstanding (note 17) | ||||||||
| Diluted weighted-average common shares outstanding (note 17) | ||||||||
| Net income (loss) per share (note 17): | ||||||||
| Basic - continuing operations | $ | $ | ||||||
| Diluted - continuing operations | $ | ( | ) | $ | ( | ) | ||
| Basic - discontinued operations, net of tax | $ | $ | ||||||
| Diluted - discontinued operations, net of tax | $ | $ | ||||||
| Basic - net income | $ | $ | ||||||
| Diluted - net loss | $ | ( | ) | $ | ( | ) | ||
The accompanying notes to the unaudited consolidated financial statements are an integral part of this statement.
UNAUDITED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balances, June 30, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation expense | — | — | ||||||||||||||||||
| Issuance of common stock from exercise of warrants | — | — | ||||||||||||||||||
| Net income | — | |||||||||||||||||||
| Balances, September 30, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balances, June 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation expense | — | — | ||||||||||||||||||
| Issuance of common stock from exercise of warrants | — | — | ||||||||||||||||||
| Net income | — | |||||||||||||||||||
| Balances, September 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
The accompanying notes to the unaudited consolidated financial statements are an integral part of this statement.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net income | $ | $ | ||||||
| Adjustments to reconcile net income to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation expense | ||||||||
| Derivative warrant liabilities gain | ( | ) | ( | ) | ||||
| Amortization of debt discount and issuance costs | ||||||||
| Inventory write-down | ||||||||
| Other non-cash adjustments | ( | ) | ||||||
| Non-cash adjustments from discontinued operations | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable, net | ( | ) | ||||||
| Inventories | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Accounts payable | ||||||||
| Accrued liabilities | ( | ) | ( | ) | ||||
| Other operating assets and liabilities, net | ||||||||
| Changes in operating assets and liabilities from discontinued operations | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Cash received from sales of fixed assets | ||||||||
| Cash payments for fixed asset purchases | ( | ) | ||||||
| Net cash provided by investing activities | ||||||||
| Cash flows from financing activities: | ||||||||
| Net proceeds received from revolving credit facility | ||||||||
| Payment made to fixed payment arrangements | ( | ) | ( | ) | ||||
| Payments made to borrowings | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Net change in cash and cash equivalents | ||||||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for income taxes | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Other non-cash investing and financing activities | $ | $ | ||||||
The accompanying notes to the unaudited consolidated financial statements are an integral part of this statement.
NOTES TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
Note 1 - Nature of Business and Financial Condition
Aytu BioPharma, Inc. (“Aytu,” the “Company,” “we,” “us,” or “our”), is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system (“CNS”) diseases to improve the quality of life for patients. The Company was originally incorporated as Rosewind Corporation on August 9, 2002, in the state of Colorado and was re-incorporated as Aytu BioScience, Inc. in the state of Delaware on June 8, 2015. In March 2021, the Company changed its name to Aytu BioPharma, Inc.
The Company’s strategy is to become a leading pharmaceutical company that improves the lives of patients. The Company uses a focused approach of in-licensing, acquiring, developing and commercializing novel prescription therapeutics in order to continue building its portfolio of revenue-generating products and leveraging its commercial team’s expertise to build leading brands within large therapeutic markets. In June 2025, the Company entered into an Exclusive Commercialization Agreement (the “Commercialization Agreement”) with Fabre-Kramer Holdings, Inc. (“Fabre-Kramer”) to commercialize EXXUA (gepirone) extended-release tablets (“EXXUA”) in the United States. Gepirone is a new chemical entity, and the Company believes EXXUA to be a novel first-in-class selective serotonin 5HT1a receptor agonist approved by the United States Food and Drug Administration (“FDA”) for the treatment of major depressive disorder (“MDD”) in adults. It is the Company’s expectation that EXXUA has the potential to serve as a major growth catalyst for the Company and anticipates launching EXXUA in the second quarter of fiscal 2026 as a centerpiece of its commercial efforts.
In addition, the Company will continue to focus on commercializing innovative prescription products that primarily address CNS conditions, including attention deficit hyperactivity disorder (“ADHD”). The Company is focusing its efforts on accelerating the growth of its commercial business and achieving positive operating cash flows. To achieve these goals, the Company indefinitely suspended active development of its clinical development programs and has wound down and divested unprofitable operations.
In the first quarter of fiscal 2025 the Company completed the previously announced wind down of its Consumer Health business and on July 31, 2024, the Company entered into a definitive agreement to divest its Consumer Health business. The accounting requirements for reporting the Consumer Health business as a discontinued operation were met when the wind down and divestiture was completed on July 31, 2024. Accordingly, the Company’s unaudited consolidated financial statements for all periods presented reflect the Consumer Health business as a discontinued operation and the Company determined that its continuing operations now operate in a operating and reportable segment (see Note 20 - Discontinued Operations and the Segment Information section within Note 2 - Summary of Significant Accounting Policies for further detail).
The Company’s business from continuing operations is focused on the upcoming launch of EXXUA and on its current prescription pharmaceutical products sold primarily through third party wholesalers, distributors and pharmacies and which primarily consists of two product portfolios. The first consists of products for the treatment of ADHD (the “ADHD Portfolio”) and the second consists of a line of legacy products (the “Pediatric Portfolio”). The Company contracts with contract manufacturing organizations (“CMOs”) for the manufacture and testing of all of its products.
The Company has entered into two international exclusive collaboration, distribution and supply agreements to commercialize certain of the Company’s ADHD products. The first agreement is with Medomie Pharma Ltd (“Medomie”), a privately owned pharmaceutical company, which will commercialize the ADHD products in Israel and the Palestinian Authority. The second agreement is with Lupin Pharma Canada Ltd (“Lupin”), a subsidiary of global pharmaceutical company Lupin Limited, which will commercialize the ADHD products in Canada. The Company will supply the ADHD products to Medomie and Lupin based on forecasts and provide various product commercialization, regulatory and quality assurance resources. Medomie and Lupin are responsible for seeking local regulatory approvals and marketing authorizations for the ADHD products, which is expected to occur over the next 24 months.
Note 2 - Summary of Significant Accounting Policies
Principals of Consolidation
The Company’s unaudited consolidated financial statements and notes thereto include the accounts of its wholly owned subsidiaries Aytu Therapeutics, LLC and Neos Therapeutics, Inc. (“Neos”) and their respective wholly owned subsidiaries, as well as Innovus Pharmaceuticals, Inc. (“Innovus”) and its wholly owned subsidiaries prior to the divestiture of Innovus on July 31, 2024. All significant inter-company balances and transactions have been eliminated in consolidation.
Basis of Presentation
The unaudited consolidated financial statements and notes thereto contained in this Form 10-Q represent the financial statements of the Company and its wholly owned subsidiaries and have been prepared pursuant to the rules and regulations of the SEC regarding interim financial reporting. Accordingly, certain information and disclosures normally included in the complete financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been omitted pursuant to such rules and regulations. The unaudited consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s 2025 Form 10-K, which included all disclosures required by U.S. GAAP. In the opinion of management, these unaudited consolidated financial statements and notes thereto contain all adjustments necessary for the fair statement of the financial position of the Company and the results of operations and cash flows for the interim periods presented. The consolidated balance sheet as of June 30, 2025, was derived from the audited annual financial statements but does not contain all of the footnote disclosures from the annual financial statements. The results of operations for the period ended September 30, 2025, are not necessarily indicative of expected operating results for the full year or any future period.
Use of Estimates
The preparation of financial statements and footnotes requires the use of management estimates, judgments and assumptions. Actual results may differ from estimates. In the accompanying unaudited consolidated financial statements and notes thereto, estimates are used for, but not limited to, stock-based compensation; revenue recognition, determination of variable consideration for accruals of chargebacks, administrative fees and rebates, government rebates, returns and other allowances; allowance for credit losses; inventory impairment; determination of right-of-use (“ROU”) assets and lease liabilities; valuation of financial instruments, warrants and derivative warrant liabilities, intangible assets, and long-lived assets; purchase price allocations and the depreciable lives of long-lived assets; accruals for contingent liabilities; and determination of the income tax provision, deferred taxes and valuation allowance. Because of the uncertainties inherent in such estimates, actual results may differ from those estimates. The Company periodically evaluates estimates used in the preparation of the financial statements for reasonableness.
Prior Period Reclassification
Certain prior year amounts in the Company’s unaudited consolidated financial statements and the notes thereto have been reclassified to conform to the current year presentation. These reclassifications did not impact operating results or cash flows for the three months ended September 30, 2025, and 2024, or the Company’s financial position as of September 30, 2025, or June 30, 2025.
Segment Information
Operating segments are identified as components that engage in business activities from which it may earn revenues and incur expenses and for which discrete information is available and regularly reviewed by the Company’s chief operating decision maker (“CODM”) to make decisions about resources to be allocated to the segment and to assess performance. Operating segments are aggregated for reporting purposes when the operating segments are identified as similar in accordance with the basic principles and aggregation criteria in the accounting standards. After the previously announced successful wind down and divestiture of the Consumer Health business in the first quarter of fiscal 2025, the Company determined that its continuing operations operate in a single operating and reportable segment. The Company’s CODM is its Chief Executive Officer, who manages operations and regularly reviews the financial information of the Company’s continuing operations as a single operating segment for the purposes of allocating resources and evaluating its financial performance. The results of the Consumer Health business have been reported as discontinued operations (see Note 20 - Discontinued Operations for further detail).
The CODM reviews net income or loss as a measure of segment profit or loss in assessing performance and allocating resources. Segment revenues, expenses and profit or loss is reported on the unaudited consolidated statements of operations, with particular emphasis on net revenue by product portfolio (see Note 3 - Revenue for net revenue disaggregated by product portfolio). Additionally, the measure of segment assets is reported on the Company’s unaudited balance sheet as total assets, with particular emphasis on the Company’s available liquidity and working capital, including its cash and cash equivalents, accounts receivables, net, inventories and current liabilities. As of September 30, 2025, and June 30, 2025, all long-lived assets were domiciled within the United States.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC Topic 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common shares and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. Liability and equity classified warrants are valued using a Black-Scholes option pricing model or Monte Carlo simulation model at issuance and for each reporting period when applicable.
Income Taxes
The Company calculates its quarterly income tax provision based on estimated annual effective tax rates applied to ordinary income (or loss) and other known items computed and recognized when they occur. In July 2025, the One Big Beautiful Bill Act (the “OBBBA”) was enacted in the United States. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act (the “TCJA”), allowing for accelerated tax deductions for qualified property and research expenditures, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in calendar year 2025 and others implemented through calendar year 2027. None of the provisions are expected to impact the realizability of the Company’s deferred tax assets and liabilities on the unaudited consolidated balance sheets as of September 30, 2025, and June 30, 2025. However, because the OBBBA is a wide-reaching law, the Company is currently assessing its potential impact on its business, financial condition, results of operations and future plans and the Company plans to provide an update in future SEC filings once this assessment is complete. Other than the OBBBA, there have been no changes in tax law affecting the tax provision during the three months ended September 30, 2025.
For the three months ended September 30, 2025, and 2024, there was
An ownership change has limited the Company’s ability to offset, post-change, United States federal taxable income. Section 382 of the IRC imposes an annual limitation on the amount of post-ownership change taxable income a corporation may offset with pre-ownership change net operating loss carryforwards and certain recognized built-in losses. Previous acquisitions, financing transactions, and equity ownership changes in the past five years have caused a significant limitation on the Company’s ability to use the change in control net operating loss carryovers. The ownership changes result in increased future tax liability and are a driver of the change from a zero percent effective tax rate.
The provision for income taxes is determined using the asset and liability approach of accounting for income taxes. Under this approach, deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and net operating loss and tax credit carryforwards. The amount of deferred taxes on these temporary differences is determined using the tax rates that are expected to apply to the period when the asset is realized or the liability is settled, as applicable, based on tax rates and laws in the respective tax jurisdiction enacted as of the balance sheet date. A valuation allowance is recorded to reduce the net deferred tax asset when it is more likely than not that some portion or all of its deferred tax asset will not be utilized.
The Company recognizes the effect of income tax positions only if those positions are more likely than not to be sustained upon an examination. The Company recognizes interest and penalties related to uncertain tax positions in income tax expense in the unaudited consolidated statements of operations.
Recently Issued Accounting Guidance
As of September 30, 2025, and through the filing of this report, no accounting guidance applicable to the Company has been issued and not yet adopted in fiscal 2026 that would have a material effect on the Company’s unaudited consolidated financial statements and related disclosures. For information about accounting guidance issued in previous years but not yet adopted by the Company and a complete set of the Company’s significant accounting policies, refer to the audited consolidated financial statements and notes thereto included in the Company’s 2025 Form 10-K.
Note 3 - Revenue
Net revenue from continuing operations primarily consists of sales of prescription pharmaceutical products from the Company’s ADHD Portfolio and Pediatric Portfolio, principally to a limited number of wholesalers, distributors and pharmacies in the United States. Net revenue is recognized at the point in time that control of the product transfers to the customer, which typically aligns with shipping terms (i.e., upon delivery), generally “free-on-board” destination when shipped domestically within the United States, consistent with contractual terms.
Savings offers, rebates, and wholesaler chargebacks reflect the terms of underlying agreements, which may vary. Accordingly, actual amounts will depend on the mix of sales by product and contracting entity. Future returns may not follow historical trends. The Company’s periodic adjustments of its estimates are subject to time delays between the initial product sale, and the ultimate reporting and settlement of deductions. In fiscal 2025, the Company entered into negotiations with a vendor related to certain variable interest accruals that reduce revenue for the Company’s ADHD Portfolio. As a result of these negotiations, the Company and the vendor agreed to a reduction to the liability purportedly owed by the Company of $
Net Revenue by Product Portfolio
Net revenue disaggregated by product portfolio for the three months ended September 30, 2025, and 2024, were as follows:
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| (in thousands) | ||||||||
| ADHD Portfolio | $ | $ | ||||||
| Pediatric Portfolio | ||||||||
| Other | ||||||||
| Total net revenue | $ | $ | ||||||
Other includes net revenue from various discontinued or deprioritized products. The Consumer Health business was divested in the first quarter of fiscal 2025 and is reported within discontinued operations (see Note 20 - Discontinued Operations).
Net Revenue by Geographic Location
The Company’s net revenue is predominately within the United States, with insignificant international sales.
Note 4 - Inventories
Inventories consist of raw materials, work in process and finished goods, and are recorded at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company periodically reviews the composition of its inventories to identify obsolete, slow-moving or otherwise unsaleable items. In the event that such items are identified and there are no alternate uses for the inventory, the Company will record a charge to reduce the value of the inventory to net realizable value in the period first recognized. The Company incurred inventory write-downs primarily as a result of unsalable and slow-moving products of $
Inventories consist of the following:
| September 30, | June 30, | |||||||
| 2025 | 2025 | |||||||
| (in thousands) | ||||||||
| Raw materials | $ | $ | ||||||
| Work in process | ||||||||
| Finished goods | ||||||||
| Inventories | $ | $ | ||||||
Note 5 - Property and Equipment
Property and equipment are recorded at cost and depreciated on a straight-line basis over the assets’ estimated economic life. Leasehold improvements are amortized over the shorter of the estimated economic life or remaining lease term. Depreciation and amortization expense from property and equipment was less than $
Property and equipment, net, consist of the following:
| September 30, | June 30, | |||||||
| 2025 | 2025 | |||||||
| (in thousands) | ||||||||
| Manufacturing and lab equipment | $ | $ | ||||||
| Office equipment, furniture and other | ||||||||
| Leasehold improvements | ||||||||
| Property and equipment, gross | ||||||||
| Less: accumulated depreciation and amortization | ( | ) | ( | ) | ||||
| Property and equipment, net | $ | $ | ||||||
Note 6 - Leases
The Company’s operating leases are for its offices, and these leases have original lease periods expiring between 2029 and 2030. Most leases include option provisions under which the parties may extend the lease term. The Company’s lease agreements generally do not contain any material residual value guarantees or material restrictive covenants. The Company has
In June 2024, the Company entered into a forward-starting operating lease agreement to lease office space in Berwyn, Pennsylvania from the owner of the office space that the Company was renting that same space under a sublease arrangement. The Company determined that it was an operating lease, and that lease commencement occurred in July 2024. The initial lease termination date is July 31, 2030, and under the lease agreement the Company has one -year renewal option to extend the lease through July 2035. The Company has elected to utilize the practical expedient to not separate lease and non-lease components upon recognition and variable lease payments will be expensed as incurred. The Company recorded an operating lease ROU asset of $
In May 2023, the Company entered into an operating lease agreement to relocate its principal office to Denver, Colorado. The initial lease termination date is March 31, 2029, and under the lease agreement the Company has one five-year renewal option to extend the lease through March 2034. Undiscounted minimum monthly rent payments average approximately $
The components of lease costs from continuing operations are as follows:
| Three Months Ended | |||||||||
| September 30, | |||||||||
| 2025 | 2024 | Statement of Operations Classification | |||||||
| (in thousands) | |||||||||
| Lease cost: | |||||||||
| Operating lease cost | $ | $ | Operating expenses | ||||||
| Short-term lease cost | Operating expenses | ||||||||
| Total lease cost | $ | $ | |||||||
Supplemental balance sheet information related to leases is as follows:
| September 30, | June 30, | ||||||||
| 2025 | 2025 | Balance Sheet Classification | |||||||
| (in thousands) | |||||||||
| Assets: | |||||||||
| Non-current: operating leases | $ | $ | Operating lease right-of-use assets | ||||||
| Liabilities: | |||||||||
| Current: operating leases | $ | $ | Other current liabilities | ||||||
| Non-current: operating leases | Other non-current liabilities | ||||||||
| Total lease liabilities | $ | $ | |||||||
The remaining weighted-average lease term and discount rate used are as follows:
| September 30, | June 30, | |||||||
| 2025 | 2025 | |||||||
| Weighted-average remaining lease term (years): | ||||||||
| Operating lease right-of-use assets | ||||||||
| Weighted-average discount rate: | ||||||||
| Operating lease right-of-use assets | % | % | ||||||
For the three months ended September 30, 2025, the Company had operating net cash provided by operating leases of $
As of September 30, 2025, the Company’s estimated future minimum lease payments are as follows:
| Estimated Future Minimum Lease Payments | ||||
| (in thousands) | ||||
| 2026 (remaining 9 months) | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| 2030 | ||||
| 2031 | ||||
| Total lease payments | ||||
| Less: imputed interest | ( | ) | ||
| Total lease liabilities | $ | |||
Note 7 - Intangible Assets
A summary of the Company’s intangible assets, all of which are definite-lived intangible assets, as of September 30, 2025, and June 30, 2025, is as follows:
| September 30, 2025 | ||||||||||||||||
| Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount | Weighted-Average Remaining Life | |||||||||||||
| (in thousands) | (in years) | |||||||||||||||
| Product technology rights | $ | $ | ( | ) | $ | |||||||||||
| Technology rights | ( | ) | ||||||||||||||
| Commercialization rights (1) | N/A | |||||||||||||||
| Total intangible assets | $ | $ | ( | ) | $ | |||||||||||
| (1) | The commercialization rights intangible asset will be considered placed in service upon the launch of EXXUA, which the Company currently anticipates launching in the second fiscal quarter of 2026 with an initial estimated useful life through September 2030. |
| June 30, 2025 | ||||||||||||||||
| Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount | Weighted-Average Remaining Life | |||||||||||||
| (in thousands) | (in years) | |||||||||||||||
| Product technology rights (1) | $ | $ | ( | ) | $ | |||||||||||
| Technology rights | ( | ) | ||||||||||||||
| Commercialization rights (2) | N/A | |||||||||||||||
| Total intangible assets | $ | $ | ( | ) | $ | |||||||||||
| (1) | In June 2025, the Company recorded an impairment to its product technology rights intangible asset of $ |
| (2) | The commercialization rights intangible asset will be considered placed in service upon the launch of EXXUA, which the Company currently anticipates launching in the second fiscal quarter of 2026 with an initial estimated useful life through September 2030. |
Gross carrying amounts are net of any impairment charges from prior periods. An intangible asset with zero net carrying amount at the end of a reporting period is not presented in the table of a future reporting period. Certain of the Company’s amortizable intangible assets include renewal options, extending the expected life of the asset. Renewal periods generally range between approximately
Amortization expense of intangible assets from continuing operations included in the unaudited consolidated statements of operations for the three months ended September 30, 2025, and 2024, are set forth in the below table:
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| (in thousands) | ||||||||
| Statement of operations classification: | ||||||||
| Cost of goods sold | $ | $ | ||||||
| Operating expenses | ||||||||
| Total amortization of intangible assets expense | $ | $ | ||||||
As of September 30, 2025, the Company’s estimated future amortization expense is as follows:
| Estimated Future Amortization Expense | ||||
| (in thousands) | ||||
| 2026 (remaining 9 months) | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| 2030 | ||||
| 2031 | ||||
| Thereafter | ||||
| Total future amortization expense | $ | |||
Product Technology Rights
The product technology rights are related to the rights to production, supply and distribution agreements of various products.
ADHD Portfolio
The Company has developed product technology rights related to the production and sale of certain ADHD products. The formulations for the ADHD products are protected by patented technology. The estimated remaining economic life of these proprietary product technology rights is
Pediatric Portfolio
The Company acquired and assumed all rights and obligations pursuant to supply and license agreements and various assignment and release agreements. As a result of the Company’s shifted focus of its commercial efforts on EXXUA and its ADHD Portfolio the Company recorded a full impairment of these intangible assets, which resulted in impairment expense of $
Technology Rights
TRRP Proprietary Technology
The Company has time release resin particle (“TRRP”) proprietary technology, which is a proprietary drug delivery technology protected by the Company as a trade secret that allows the Company to modify the drug release characteristics of each of its respective products. The TRRP technology underlines each of the ADHD Portfolio core products and can potentially be used in future product development initiatives as well. The estimated remaining economic life of these proprietary technology rights is
Commercialization Rights
As part of the Commercialization Agreement for the exclusive commercialization rights of EXXUA in the United States, the Company capitalizes to the carrying value of intangible assets any contingent payments made that are considered a part of the Commercialization Agreement’s total consideration and which are not within the scope of derivative guidance once the contingencies related to these payments are resolved. Once the commercialization rights are considered placed in service on the launch date of EXXUA, the Company will amortize the commercialization rights on a straight-line basis over the estimated life of the asset, and the Company will adjust the carrying value of the commercialization rights on a cumulative catch-up basis as if any additional capitalized amount had been capitalized on the same date that the intangible asset was placed in service. As of September 30, 2025, the commercialization rights had not been placed in service and as a result,
Note 8 - Accrued Liabilities
Accrued liabilities consist of the following:
| September 30, | June 30, | |||||||
| 2025 | 2025 | |||||||
| (in thousands) | ||||||||
| Accrued savings offers | $ | $ | ||||||
| Return reserve | ||||||||
| Accrued customer and product related fees | ||||||||
| Accrued program liabilities | ||||||||
| Accrued employee compensation | ||||||||
| Other accrued liabilities | ||||||||
| Total accrued liabilities | $ | $ | ||||||
Accrued savings offers represent programs for the Company’s patients covered under commercial payor plans in which the cost of a prescription to such patients is discounted. The return reserve represents the Company’s accrual for estimated product returns. Accrued customer and product related fees include accrued expenses and deductions for rebates, wholesaler chargebacks and fees, and other product-related fees and deductions such as royalties for Pediatric Portfolio products, accrued distributor fees, and Medicaid liabilities. Accrued program liabilities include government and commercial rebates. Accrued employee compensation includes sales commissions, paid time off earned, accrued payroll and accrued bonus. Other accrued liabilities consist of various other accruals, none of which individually or in the aggregate represent greater than five percent of total liabilities.
Note 9 - Other Liabilities
Other liabilities consist of the following:
| September 30, | June 30, | |||||||
| 2025 | 2025 | |||||||
| (in thousands) | ||||||||
| Employee retention credit | $ | $ | ||||||
| Operating lease liabilities | ||||||||
| Other | ||||||||
| Fixed payment arrangements | ||||||||
| Total other liabilities | ||||||||
| Less: current portion of other liabilities | ( | ) | ( | ) | ||||
| Total non-current portion of other liabilities | $ | $ | ||||||
Employee Retention Credit
The $
Operating Lease Liabilities
The Company has entered into various operating lease agreements for certain of its offices. Please see Note 6 - Leases for further detail.
Other
Other consists of taxes payable, deferred cost related to the Company’s technology transfer, and various other accruals, none of which individually or in the aggregate represent greater than five percent of total liabilities.
Fixed Payment Arrangements
Fixed payment arrangements represent obligations related to the acquisition of products. As of September 30, 2025, the Company had
Note 10 - Revolving Credit Facility
On June 20, 2025, the Company and certain of its subsidiaries entered into an Amendment No. 6 to Loan and Security Agreement (the “Eclipse Amendment No. 6”) to the loan and security agreement dated October 2, 2019, as amended by Amendment No. 1, dated March 19, 2021; Amendment No. 2, dated January 26, 2022; Amendment No. 3, dated June 1, 2022; Amendment No. 4 dated March 24, 2023; and Amendment No. 5 dated June 12, 2024 (together the “Eclipse Agreement”), with Eclipse Business Capital LLC (“Eclipse”), as agent, and the lenders party thereto (agent and such lenders, collectively, the “Eclipse Lender”). Under the Eclipse Agreement, the Company has two loan agreements, a term loan (the “Eclipse Term Loan”), which is described further in Note 11 - Debt, and a revolving credit facility (the “Eclipse Revolving Loan”).
The Eclipse Revolving Loan has a potential maximum borrowing base of $
In the event that, for any reason, all or any portion of the Eclipse Agreement is terminated prior to the scheduled maturity date, in addition to the payment of all outstanding principal and unpaid accrued interest, the Company is required to pay a fee equal to (i)
The Eclipse Agreement contains customary affirmative covenants, negative covenants and events of default, as defined in the Eclipse Agreement, including covenants and restrictions that, among other things, require the Company to satisfy certain capital expenditure limitations and other financial covenants and restrict the Company’s ability to incur liens, incur additional indebtedness, make certain dividends and distributions with respect to equity securities, engage in mergers and acquisitions or make asset sales without the prior written consent of Eclipse. A failure to comply with these covenants could permit Eclipse to declare the Company’s obligations under the Eclipse Agreement, together with accrued interest and fees, to be immediately due and payable, plus any applicable additional amounts relating to a prepayment or termination, as described above. As of September 30, 2025, the Company was in compliance with the covenants under the Eclipse Agreement. The Company’s obligations under the Eclipse Agreement are secured by substantially all of the Company’s assets, as defined further in the Eclipse Agreement.
As of September 30, 2025, there was $
Note 11 - Debt
On June 20, 2025, the Company and certain of its subsidiaries entered into Eclipse Amendment No. 6, which provided for among other things, an increase in the Eclipse Term Loan principal amount to $
The Eclipse Term Loan incurs interest at a rate of the plus
In the event that, for any reason, all or any portion of the Eclipse Agreement is terminated prior to the scheduled maturity date, in addition to the payment of all outstanding principal and unpaid accrued interest, the Company is required to pay a fee equal to (i)
The Eclipse Agreement contains customary affirmative covenants, negative covenants and events of default, as defined in the Eclipse Agreement, including covenants and restrictions that, among other things, require the Company to satisfy certain capital expenditure limitations and other financial covenants and restricts the Company’s ability to incur liens, incur additional indebtedness, make certain dividends and distributions with respect to equity securities, engage in mergers and acquisitions or make certain asset sales without the prior written consent of the Eclipse Lender. A failure to comply with these covenants could permit the Eclipse Lender to declare the Company’s obligations under the agreement, together with accrued interest and fees, to be immediately due and payable, plus any applicable additional amounts relating to a prepayment or termination, as described above. As of September 30, 2025, the Company was in compliance with the covenants under the Eclipse Agreement.
As of September 30, 2025, there was $
Debt consists of the following:
| September 30, | June 30, | |||||||
| 2025 | 2025 | |||||||
| (in thousands) | ||||||||
| Term loan principal amount | $ | $ | ||||||
| Unamortized debt discount and issuance costs | ( | ) | ( | ) | ||||
| Total debt | ||||||||
| Less: current portion of debt | ( | ) | ( | ) | ||||
| Total debt, net of current portion | $ | $ | ||||||
As of September 30, 2025, the Company’s future Eclipse Term Loan principal payments are as follows:
| Future Principal Payments | ||||
| (in thousands) | ||||
| 2026 (remaining 9 months) | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| Total future principal payments | ||||
| Less: unamortized debt discount and issuance costs | ( | ) | ||
| Less: current portion of debt | ( | ) | ||
| Total debt, net of current portion | $ | |||
Note 12 - Fair Value Measurements
The Company determines the fair value of financial and non-financial assets using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value as follows:
| ● | Level 1: Inputs that reflect unadjusted quoted prices in active markets that are accessible to the Company for identical assets or liabilities |
| ● | Level 2: Inputs that include quoted prices for similar assets and liabilities in active or inactive markets or that are observable for the asset or liability either directly or indirectly; and |
| ● | Level 3: Unobservable inputs that are supported by little or no market activity. |
The Company’s financial instruments include cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, derivative warrant liabilities and current and non-current debt. The carrying amounts of certain short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to their short maturities. Current and non-current debt are reported at their amortized costs on the Company’s unaudited consolidated balance sheets. The remaining financial instruments are reported on the Company’s unaudited consolidated balance sheets at amounts that approximate current fair values. The Company’s carrying value of its consolidated amounts of cash and cash equivalents approximate their fair value as of September 30, 2025, and June 30, 2025, and are categorized within level 1 of the U.S. GAAP fair value hierarchy. The Company’s policy is to recognize transfers in and/or out of fair value hierarchy as of the date in which the event or change in circumstances caused the transfer. There were no transfers between Level 1, Level 2 and Level 3 in the periods presented.
Recurring Fair Value Measurements
The Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of September 30, 2025, and June 30, 2025, by level within the fair value hierarchy as follows:
| Fair Value at | Fair Value Measurements at September 30, 2025 | |||||||||||||||
| September 30, 2025 | (Level 1) | (Level 2) | (Level 3) | |||||||||||||
| (in thousands) | ||||||||||||||||
| Liabilities: | ||||||||||||||||
| Derivative warrant liabilities | $ | $ | $ | $ | ||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
| Fair Value at | Fair Value Measurements at June 30, 2025 | |||||||||||||||
| June 30, 2025 | (Level 1) | (Level 2) | (Level 3) | |||||||||||||
| (in thousands) | ||||||||||||||||
| Liabilities: | ||||||||||||||||
| Derivative warrant liabilities | $ | $ | $ | $ | ||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
Summary of Level 3 Input Changes
A summary of changes to those fair value measures using Level 3 inputs is as follows:
| Derivative | ||||
| Warrant Liabilities | ||||
| (in thousands) | ||||
| Balance as of June 30, 2025 | $ | |||
| Settlements (1) | ( | ) | ||
| Included in earnings | ( | ) | ||
| Balance as of September 30, 2025 | $ | |||
| (1) | Relates to the exercise of |
Significant Assumptions
The valuation methodologies and key assumptions used for the mark to market fair value measurements of derivative warrant liabilities as of September 30, 2025, are as follows:
| June 2023 Tranche A Warrants | Warrants Other (1) | |||||
| Monte Carlo & Black-Scholes | Black-Scholes | |||||
| Aytu closing stock price |
|
| ||||
| Equivalent term (years) | ||||||
| Expected volatility | | | ||||
| Risk-free rate | | | ||||
| Dividend yield | | |
| (1) | Includes all liability classified warrants and prefunded warrants except the June 2023 Tranche A Warrants (see Note 16 - Warrants for further information). |
Note 13 - Commitments and Contingencies
EXXUA Exclusive Commercialization Agreement
On June 5, 2025, the Company entered into the Commercialization Agreement with Fabre-Kramer, pursuant to which the Company acquired certain rights and obligations in connection with the commercialization of EXXUA in the United States. As consideration for the Commercialization Agreement, the Company made an upfront cash payment of $
The Commercialization Agreement can be terminated at any time upon mutual agreement between the Company and Fabre-Kramer. Either party can terminate the Commercialization Agreement at any time upon written notice for a material default or breach if the material default or breach is not cured within (1)
Pediatric Portfolio
The Company has the exclusive right to distribute and sell certain legacy products in the United States from agreements signed by the Company. The initial term of the agreement was
Legal Matters
Granules Paragraph IV
On October 31, 2024, the Company received a Paragraph IV Certification Notice Letter (the “Notice Letter”) from Granules Pharmaceuticals, Inc. (“Granules”), stating that it intends to market a generic version of Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (“Adzenys”) before the expiration of all patents currently listed in the FDA’s publication of approved drug products with therapeutic equivalence evaluations (the “Orange Book”). The Notice Letter states that Granules’ NDA for the generic version of Adzenys contains a Paragraph IV certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic version of Adzenys. On December 11, 2024, the Company filed a patent infringement lawsuit against Granules which triggered a stay precluding the FDA from approving Granules’ NDA for a generic version of Adzenys for up to 30 months or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first. On January 7, 2025, Granules submitted an answer to the complaint. On October 28, 2025, the case was reassigned to visiting judge, Judge Jennifer Choe-Groves of the United States Court of International Trade. The trial date has been moved to January 11, 2027, with all other scheduling dates remaining unchanged. The Company plans to vigorously enforce its intellectual property rights related to Adzenys.
Revive Investing
The Company had been named as a nominal plaintiff in a lawsuit by two shareholders against Armistice Capital Master Fund, Ltd (“Armistice”), entitled Revive Investing, LLC. et al v. Armistice Master Fund, Ltd. et al, Case 1:20-cv-02849-CMA-TPO, in the United States District Court for the District of Colorado, contending that Armistice was liable for short swing trading profits in violation of Section 16(b) of the Securities Exchange Act of 1934, as amended, for certain trades it made in Company stock in 2019 and 2020 and must disgorge those profits to the Company. That matter proceeded to trial before a jury, which on January 29, 2025, returned a verdict finding no liability. On March 6, 2025, the plaintiffs filed an appeal in the United States Court of Appeals for the Tenth Circuit. As with the original case, regardless of the outcome, this case will not have a materially adverse effect upon the Company’s financial condition, results of operations, or cash flows.
Note 14 - Stockholders’ Equity
The Company has
On September 26, 2024, the Company filed a shelf registration statement on Form S-3, which was declared effective by the SEC on October 15, 2024. This shelf registration statement covers the offering, issuance and sale by the Company of up to an aggregate of $
In June 2025, the Company raised gross proceeds of $
Note 15 - Equity Incentive Plan
2023 Equity Incentive Plan
On May 18, 2023, the Company’s stockholders approved the adoption of the Aytu BioPharma, Inc. 2023 Equity Incentive Plan (the “2023 Equity Incentive Plan”), which replaced all previous plans. For the 2023 Equity Incentive Plan, the stockholders approved (a)
Stock options granted under the 2023 Equity Incentive Plan and previous plans typically have contractual terms of
Stock Options
Stock option activity during the three months ended September 30, 2025, is as follows:
| Weighted | ||||||||||||
| Average | ||||||||||||
| Weighted | Remaining | |||||||||||
| Number of | Average | Contractual | ||||||||||
| Options | Exercise Price | Life in Years | ||||||||||
| Outstanding at June 30, 2025 | $ | |||||||||||
| Expired | ( | ) | $ | — | ||||||||
| Outstanding at September 30, 2025 | $ | 8.2 | ||||||||||
| Exercisable at September 30, 2025 | $ | |||||||||||
During the three months ended September 30, 2025, the Company did grant any stock options. As of September 30, 2025, there was $
Restricted Stock
Restricted stock activity under the 2023 Equity Incentive Plan during the three months ended September 30, 2025, is as follows:
| Weighted | ||||||||
| Average Grant | ||||||||
| Number of | Date Fair | |||||||
| Shares | Value | |||||||
| Unvested at June 30, 2025 | $ | |||||||
| Vested | ( | ) | $ | |||||
| Unvested at September 30, 2025 | $ | |||||||
During the three months ended September 30, 2025, the Company did grant any shares of restricted stock. As of September 30, 2025, there was $
As of September 30, 2025, there were
Restricted Stock Units
There were remaining unvested restricted stock units as of June 30, 2025, and the Company did grant any restricted stock units during the three months September 30, 2025, and 2024.
Stock-Based Compensation Expense
Stock-based compensation expense related to the fair value of stock options, restricted stock and restricted stock units were included in the unaudited consolidated statements of operations as set forth in the below table:
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| (in thousands) | ||||||||
| Cost of goods sold | $ | $ | ||||||
| Research and development | ||||||||
| Selling and marketing | ||||||||
| General and administrative | ||||||||
| Total stock-based compensation expense | $ | $ | ||||||
Note 16 - Warrants
The Company has engaged in several different types of equity financings throughout its history, some of which have resulted in the Company issuing warrants and prefunded warrants. Equity classified warrants are valued using a Black-Scholes option pricing model at issuance and are not remeasured. Liability classified warrants are carried at fair value using either the Black-Scholes option pricing model or the Monte Carlo simulation model. Changes in the fair value of liability classified warrants in subsequent periods are recorded as a gain or loss on remeasurement and reported as a component of cash flows from operations. Outstanding warrants that are classified as derivative warrant liabilities in the unaudited consolidated balance sheets are marked to market at each reporting period, with the change in fair value recorded as a gain or loss on remeasurement and reported as a component of cash flows from operations. (see Note 12 - Fair Value Measurements for further detail).
The number of warrants and prefunded warrants outstanding as of September 30, 2025, is as follows:
| Remaining | |||||||||||||||
| Number | Exercise | Contractual | |||||||||||||
| Description | Outstanding | Price | Life in Years (6) | Type | Classification | ||||||||||
| December 2020 Warrants (1) | $ | Warrant | Equity | ||||||||||||
| January 2022 Warrants (1) | $ | Warrant | Liability | ||||||||||||
| March 2022 Warrants (1) | $ | Warrant | Liability | ||||||||||||
| August 2022 Warrants (1) | $ | Warrant | Liability | ||||||||||||
| June 2023 Tranche A Warrants (2) | $ | Warrant | Liability | ||||||||||||
| June 2023 Tranche B Prefunded Warrants (3) | $ | N/A | Prefunded Warrant | Liability | |||||||||||
| June 2023 Prefunded Warrants (4) | $ | N/A | Prefunded Warrant | Liability | |||||||||||
| June 2025 Prefunded Warrants (5) | $ | N/A | Prefunded Warrant | Liability | |||||||||||
| Total outstanding | |||||||||||||||
| (1) | Each of these warrants is exercisable at any time for |
| (2) | In June 2023, the Company issued these tranche A warrants to purchase |
| (3) | In June 2024, certain warrants were exercised, generating proceeds of $ |
| (4) | Each of these prefunded warrants is exercisable at any time for |
| (5) | In June 2025, the Company raised gross proceeds of $ |
| (6) | All of the Company’s prefunded warrants do not have an expiration date. |
A summary of warrant activity, excluding prefunded warrants, during the three months ended September 30, 2025, is as follows:
| Weighted- | ||||||||||||
| Average | ||||||||||||
| Weighted- | Remaining | |||||||||||
| Number of | Average | Contractual | ||||||||||
| Warrants | Exercise Price | Life in Years | ||||||||||
| Outstanding June 30, 2025 (1) | $ | |||||||||||
| Outstanding September 30, 2025 (1) | $ | |||||||||||
| (1) | The number of warrants, excluding prefunded warrants, outstanding as of June 30, 2025, and September 30, 2025, is comprised of |
A summary of prefunded warrant activity during the three months ended September 30, 2025, is as follows:
| Number of | Weighted- | |||||||
| Prefunded | Average | |||||||
| Warrants | Exercise Price | |||||||
| Outstanding June 30, 2025 | $ | |||||||
| Prefunded warrants exercised (1) | ( | ) | $ | |||||
| Outstanding September 30, 2025 | $ | |||||||
| (1) | During the first quarter of fiscal 2026 a total of |
Note 17 - Earnings Per Share
Basic net income or loss per share is calculated by dividing net income or loss available to common stockholders by the basic weighted-average number of common shares outstanding for the respective period. Diluted net income or loss per share is calculated by dividing adjusted net income or loss by the diluted weighted-average number of common shares outstanding, which includes the effect of potentially dilutive securities. Potentially dilutive securities for this calculation consist of warrants to purchase common stock that are either liability classified or equity classified, stock options, unvested restricted stock and unvested restricted stock units (see Note 15 - Equity Incentive Plan and Note 16 - Warrants for further detail). If the Company’s adjusted numerator for net income from continuing operations divided by the diluted weighted-average number of common shares outstanding for each potentially dilutive security was greater than the net income from continuing operations per share, then the Company did not include those common equivalent shares in the computation of diluted net income or loss from continuing operations per share; diluted net income or loss from discontinued operations, net of tax; or diluted net income or loss per share because the effect would have been anti-dilutive.
The following is a reconciliation of the numerator and the denominator used in the basic per share calculations:
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| (in thousands, except share and per share data) | ||||||||
| BASIC | ||||||||
| Numerators: | ||||||||
| Net income from continuing operations | $ | $ | ||||||
| Net income from discontinued operations, net of tax | ||||||||
| Net income | $ | $ | ||||||
| Denominator: | ||||||||
| Basic weighted-average common shares outstanding | ||||||||
| Basic per share calculations: | ||||||||
| Net income per share from continuing operations | $ | $ | ||||||
| Net income per share from discontinued operations, net of tax | $ | $ | ||||||
| Net income per share | $ | $ | ||||||
The following is a reconciliation of the numerator and the denominator used in the diluted per share calculations:
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| (in thousands, except share and per share data) | ||||||||
| DILUTED | ||||||||
| Numerators: | ||||||||
| Adjusted numerator - net loss from continuing operations (1) | $ | ( | ) | $ | ( | ) | ||
| Net income from discontinued operations, net of tax | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Denominator: | ||||||||
| Basic weighted-average common shares outstanding | ||||||||
| Dilutive effect of warrants to purchase common stock | ||||||||
| Dilutive effect of options to purchase common stock | ||||||||
| Diluted weighted-average common shares outstanding | ||||||||
| Diluted per share calculations: | ||||||||
| Net loss per share from continuing operations | $ | ( | ) | $ | ( | ) | ||
| Net income per share from discontinued operations, net of tax | $ | $ | ||||||
| Net loss per share | $ | ( | ) | $ | ( | ) | ||
| (1) | The net income from continuing operations numerator has been adjusted to remove the changes in fair value of certain warrant liabilities totaling a gain of $ |
The following table sets forth securities that could be considered anti-dilutive, and therefore are excluded from the calculation of diluted weighted-average common shares outstanding and related per share calculations:
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Warrants to purchase common stock - liability classified (note 16) | ||||||||
| Warrants to purchase common stock - equity classified (note 16) | ||||||||
| Weighted-average of warrants exercised to common stock (note 16) | ||||||||
| Outstanding stock options (note 15) | ||||||||
| Unvested restricted stock (note 15) | ||||||||
| Unvested restricted stock units (note 15) | ||||||||
| Total anti-dilutive securities | ||||||||
Note 18 - License Agreements
Teva
On December 21, 2018, the Company and Teva Pharmaceuticals USA, Inc. (“Teva”) entered into an agreement granting Teva a non-exclusive license to certain patents owned by Neos by which Teva has the right to manufacture and market its generic version of one of the Company’s ADHD products under an abbreviated new drug application (“ANDA”) filed by Teva beginning on July 1, 2026, or earlier under certain circumstances. The ANDA was approved by the FDA on June 19, 2020.
Actavis
On October 17, 2017, the Company entered into an agreement granting Actavis Laboratories FL, Inc. (“Actavis”) (which is now owned by Teva Pharmaceutical Industries Limited) a non-exclusive license to certain patents owned by the Company by which Actavis has the right to manufacture and market its generic version of one of the Company’s ADHD products under its ANDA beginning on September 1, 2025. The ANDA was approved by the FDA on June 22, 2023. Through the filing date of this report, to the Company’s knowledge Teva has not launched a generic version of this ADHD product.
Note 19 - Restructuring Costs
As part of the Company’s previously announced restructuring activities related to the wind down and divestiture of the Consumer Health business and the closure of the Grand Prairie, Texas manufacturing site, the Company has incurred expenses that qualify as exit and disposal costs under U.S. GAAP. These include severance and employee benefit costs as well as other direct separation benefit costs, right of use asset impairment charges, fixed asset and other asset impairment charges, accelerated depreciation of fixed assets, contract termination costs, and inventory write-downs. Severance and employee benefit costs primarily relate to cash severance. Restructuring costs associated with the Consumer Health business are recorded within the net income from discontinued operations, net of tax in the unaudited consolidated financial statement of operations (see Note 20 - Discontinued Operations).
The expense associated with the closure of the Grand Prairie, Texas manufacturing site such as severance and employee benefits and exit and disposal activities are included in restructuring costs in the unaudited consolidated statements of operations. There were no inventory write-downs associated with this closure. During the three months ended September 30, 2025, and 2024, the Company incurred and $
Note 20 - Discontinued Operations
On July 31, 2024, after the wind down of operations, the Company entered into a definitive agreement to divest its Consumer Health business to a private, e-commerce focused company. The divested business encompassed the established e-commerce platform, certain inventory and associated consumer brands, intellectual property, external workforce and contracts, and provided for the Company to receive contingent consideration payments on certain future sales of former Consumer Health business products.
The accounting requirements for reporting the Consumer Health business as a discontinued operation were met when the wind down and divestiture was completed on July 31, 2024. Accordingly, the accompanying unaudited consolidated financial statements for all periods presented reflect this business as a discontinued operation. There were no assets or liabilities classified as discontinued operations on the accompanying unaudited consolidated balance sheets as of September 30, 2025, and June 30, 2025. The Company elected to record the contingent consideration portion of the arrangement when the consideration was determined to be realizable and, therefore, the Company did not record a contingent consideration asset at the transaction date.
There was
| Three Months Ended | ||||
| September 30, 2024 | ||||
| (in thousands) | ||||
| Net revenue | $ | |||
| Cost of goods sold | ( | ) | ||
| Selling and marketing | ( | ) | ||
| General and administrative | ( | ) | ||
| Recognized contingent consideration | ||||
| Loss on divestiture | ( | ) | ||
| Income from discontinued operations before income taxes | ||||
| Income tax benefit | ||||
| Net income from discontinued operations, net of tax | $ | |||
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This discussion should be read in conjunction with the Company’s 2025 Form 10-K. The following discussion and analysis contain forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. For additional information regarding these risks and uncertainties, please see the risk factors included in the Company’s 2025 Form 10-K, and in Part II, Item 1A of this Form 10-Q.
Objective
The purpose of the Management’s Discussion and Analysis (the “MD&A”) is to present information that management believes is relevant to an assessment and understanding of our results of operations and cash flows for the three months ended September 30, 2025, and our financial condition as of September 30, 2025. The MD&A is provided as a supplement to, and should be read in conjunction with, our unaudited consolidated financial statements and notes thereto.
Overview
We are a pharmaceutical company focused on advancing innovative medicines for complex CNS system diseases to improve the quality of life for patients. Our strategy is to become a leading pharmaceutical company that improves the lives of patients. We use a focused approach of in-licensing, acquiring, developing and commercializing novel prescription therapeutics in order to continue building our portfolio of revenue-generating products and leveraging our commercial team’s expertise to build leading brands within large therapeutic markets. In June 2025, we entered into the Commercialization Agreement with Fabre-Kramer to commercialize EXXUA in the United States. Gepirone is a new chemical entity, and we believe EXXUA to be a novel first-in-class selective serotonin 5HT1a receptor agonist approved by the FDA for the treatment of MDD in adults.
EXXUA has been extensively studied in over 5,000 patients and represents a new class of therapeutics to compete in the over $22 billion United States prescription MDD market. We believe it can become a very important treatment option for the estimated 21 million Americans affected by MDD. Over 340 million antidepressant prescriptions were written in 2024 in the United States, yet significant unmet needs remain considering the unacceptable side effects associated with current therapeutics. Importantly, we believe that EXXUA is the only antidepressant acting on serotonin receptors that does not carry a label warning about the risk of sexual dysfunction. The mechanism of the antidepressant effect of EXXUA is believed to be related to its modulation of serotonin activity and, specifically, its exclusive and strong binding affinity for 5HT1a receptors, which are key regulators of mood and emotion. EXXUA is not a SSRI and has no reuptake inhibition activity. EXXUA also exhibits no significant adverse effects on weight, blood pressure, heart rate or liver function. It is our expectation that EXXUA has the potential to serve as a major growth catalyst for us, and we anticipate launching EXXUA in the second quarter of fiscal 2026 as a centerpiece of our commercial efforts.
In addition, we will continue to focus on commercializing innovative prescription products that address other CNS conditions, including ADHD. We are focusing our efforts on accelerating the growth of our commercial business and achieving positive operating cash flows. To achieve these goals, we indefinitely suspended active development of our clinical development programs and have wound down and divested unprofitable operations. In the first quarter of fiscal 2025 we completed the previously announced wind down and divestiture of our Consumer Health business and now operate our business as a single operating and reporting segment. The accounting requirements for reporting the Consumer Health business as a discontinued operation were met when the wind down and divestiture was completed on July 31, 2024. Accordingly, our unaudited consolidated financial statements for all periods presented reflect the Consumer Health business as a discontinued operation.
Our business from continuing operations is focused on the upcoming launch of EXXUA and on our current prescription pharmaceutical products sold primarily through third party wholesalers, distributors and pharmacies and which primarily consists of two product portfolios. The first, the ADHD Portfolio, consists of products for the treatment of ADHD and the second, the Pediatric Portfolio, consists of a line of legacy products. We contract with CMOs for the manufacture and testing of all of our products.
We have entered into two international exclusive collaboration, distribution and supply agreements to commercialize certain of our ADHD products. The first agreement is with Medomie, a privately owned pharmaceutical company, which will commercialize the ADHD products in Israel and the Palestinian Authority. The second agreement is with Lupin, a subsidiary of global pharmaceutical company Lupin Limited, which will commercialize the ADHD products in Canada. We will supply the ADHD products to Medomie and Lupin based on forecasts and provide various product commercialization, regulatory and quality assurance resources. Medomie and Lupin are responsible for seeking local regulatory approvals and marketing authorizations for the ADHD products, which is expected to occur over the next 24 months.
In light of our own business activities and external developments in the biotechnology and biopharmaceutical industries, Aytu management and our Board of Directors regularly reviews our performance, prospects and risks such as the potential impact to our business resulting from our competitive landscape (i.e., entry of generic competitors, payor pressures, new branded entrants, etc.). These reviews have included consideration of potential partnerships, collaborations, and other strategic transactions such as acquisitions or divestitures of programs or technology to enhance stockholder value. Aytu management and our Board expect to continue to evaluate potential strategic transactions and business combinations.
Business Environment
We continue to experience inflationary pressures and economic uncertainty caused by global geopolitical factors and tariffs, and our industry is currently encountering supply chain disruptions related to the sourcing of raw materials, increased costs of materials as result of tariffs, energy, logistics and labor for a number of reasons, including ongoing geopolitical events. It is possible that trade wars could adversely affect some of our markets and suppliers, economic and financial markets, costs and availability of energy and materials, or cause further supply chain disruptions. Inflationary pressures, increased costs and supply chain disruptions could be significant across the business throughout fiscal 2026 and into fiscal 2027. Understanding these risks, we have not experienced stock outages for our ADHD products since the launch of those products.
In October 2024, we received the Notice Letter from Granules, stating that it intends to market a generic version of Adzenys before the expiration of all patents currently listed in the Orange Book. The Notice Letter states that Granules’ NDA for the generic version of Adzenys contains a Paragraph IV certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic version of Adzenys. We timely filed a patent infringement lawsuit on December 11, 2024, against Granules to trigger a stay precluding the FDA from approving Granules’ NDA for a generic version of Adzenys for up to 30 months or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first. On January 7, 2025, Granules submitted an answer to the complaint. On October 28, 2025, the case was reassigned to visiting judge, Judge Jennifer Choe-Groves of the United States Court of International Trade. This litigation is ongoing, and a trial has been rescheduled to begin on January 11, 2027. We plan to vigorously enforce our intellectual property rights related to Adzenys.
Results of Operations
The results of operations for the three months ended September 30, 2025, compared to the three months ended September 30, 2024, is as follows:
| Three Months Ended |
||||||||||||
| September 30, |
||||||||||||
| 2025 |
2024 |
Change |
||||||||||
| (in thousands) |
||||||||||||
| Net revenue |
$ | 13,888 | $ | 16,574 | $ | (2,686 | ) | |||||
| Cost of goods sold |
4,702 | 4,589 | 113 | |||||||||
| Gross profit |
9,186 | 11,985 | (2,799 | ) | ||||||||
| Operating expenses: |
||||||||||||
| Selling and marketing |
5,322 | 5,659 | (337 | ) | ||||||||
| General and administrative |
4,924 | 5,125 | (201 | ) | ||||||||
| Research and development |
— | 426 | (426 | ) | ||||||||
| Amortization of intangible assets |
444 | 921 | (477 | ) | ||||||||
| Restructuring costs |
— | 784 | (784 | ) | ||||||||
| Total operating expenses |
10,690 | 12,915 | (2,225 | ) | ||||||||
| Loss from operations |
(1,504 | ) | (930 | ) | (574 | ) | ||||||
| Other income, net |
201 | 542 | (341 | ) | ||||||||
| Interest expense |
(516 | ) | (994 | ) | 478 | |||||||
| Derivative warrant liabilities gain |
3,784 | 2,880 | 904 | |||||||||
| Income from continuing operations before income tax expense |
1,965 | 1,498 | 467 | |||||||||
| Income tax expense |
— | (405 | ) | 405 | ||||||||
| Net income from continuing operations |
1,965 | 1,093 | 872 | |||||||||
| Net income from discontinued operations, net of tax |
— | 381 | (381 | ) | ||||||||
| Net income |
$ | 1,965 | $ | 1,474 | $ | 491 | ||||||
Net Revenue by Product Portfolio
Net revenue disaggregated by product portfolios for the three months ended September 30, 2025, compared to the three months ended September 30, 2024, is as follows:
| Three Months Ended |
||||||||||||
| September 30, |
||||||||||||
| 2025 |
2024 |
Change |
||||||||||
| (in thousands) |
||||||||||||
| ADHD Portfolio |
$ | 13,156 | $ | 15,264 | $ | (2,108 | ) | |||||
| Pediatric Portfolio |
715 | 1,293 | (578 | ) | ||||||||
| Other |
17 | 17 | — | |||||||||
| Total net revenue |
$ | 13,888 | $ | 16,574 | $ | (2,686 | ) | |||||
During the three months ended September 30, 2025, net revenue decreased by $2.7 million, or 16% compared to the same period ended September 30, 2024, primarily due to a $3.3 million one-time increase in our ADHD Portfolio net revenue in the first quarter of fiscal 2025 related to a change is estimated variable consideration that resulted from negotiations with a vendor that resulted in a reduction to the liability purportedly owed the vendor.
Gross Profit
Gross profit and gross profit percentage for the three months ended September 30, 2025, compared to the three months ended September 30, 2024, is as follows:
| |
Three Months Ended |
|||||||||||
| |
September 30, |
|||||||||||
| |
2025 |
2024 |
Change |
|||||||||
| (in thousands, except gross profit percentage) |
||||||||||||
| Gross profit |
$ | 9,186 | $ | 11,985 | $ | (2,799 | ) | |||||
| Gross profit percentage |
66 | % | 72 | % | (6 | )% | ||||||
During the three months ended September 30, 2025, gross profit decreased by $2.8 million, or 23% compared to the three months ended September 30, 2024. Gross profit percentage was 66% for the three months ended September 30, 2025, compared to 72% for the three months ended September 30, 2024. The decrease in gross profit and gross profit percentage is primarily related to a $3.3 million one-time increase in our ADHD Portfolio net revenue in the first quarter of fiscal 2025 related to a change is estimated variable consideration that resulted from negotiations with a vendor that resulted in a reduction to the liability purportedly owed the vendor.
Selling and Marketing
During the three months ended September 30, 2025, selling and marketing expense decreased by $0.3 million, 6% compared to the same period ended September 30, 2024, primarily driven by reduced commission expense and variable commercial marketing program fees, partially offset by increases in labor, service costs and EXXUA launch costs.
General and Administrative
During the three months ended September 30, 2025, general and administrative expense decreased by $0.2 million, or 4% compared to the same period ended September 30, 2024. The decrease is primarily a result of continued cost reduction efforts and improved operational efficiencies such as reduced facilities expense, partially offset by increases in labor and service costs.
Research and Development
During the three months ended September 30, 2025, there was no research and development expense compared to $0.4 million for the same period ended September 30, 2024, primarily driven by our previously announced suspension of our development programs to focus on our commercial operations resulting in a decrease in research and development spending.
Amortization of Intangible Assets
During the three months ended September 30, 2025, amortization expense of intangible assets, excluding amounts included in cost of goods sold, decreased by $0.5 million, or 52% compared to the same period ended September 30, 2024, primarily due to impairments of certain intangible assets recorded in fiscal 2025.
Restructuring Costs
During the three months ended September 30, 2025, we incurred zero restructuring costs compared to $0.8 million during same period ended September 30, 2024. Restructuring costs during the first quarter of fiscal 2025 related to our previously announced operational realignment and related costs, which was completed during fiscal 2025.
Other Income, Net
During the three months ended September 30, 2025, other income, net was relatively consistent compared to the same periods ended September 30, 2024.
Interest Expense
During the three months ended September 30, 2025, interest expense decreased by $0.5 million, or 48% compared to the same period ended September 30, 2024, primarily due to the paydown of our fixed payment arrangements.
Derivative Warrant Liabilities Gain
The fair value of derivative warrant liabilities is calculated using either the Black-Scholes option pricing model or the Monte Carlo simulation model and is revalued at each reporting period, and changes are reflected through income or expense. For the three months ended September 30, 2025, and 2024, we recognized a gain of $3.8 million and $2.9 million, respectively, from the fair value adjustment primarily driven by a decrease in our stock price during the three months ended September 30, 2025, and 2024.
Income Tax Expense
For the three months ended September 30, 2025, and 2024, there was zero and $0.4 million of income tax expense from continuing operations, which was an effective tax rate of zero and negative 27.0%, respectively. This income tax expense was primarily driven by Section 382 limitation of the Internal Revenue Code of 1986, as amended (the “IRC”) on pre-TCJA and post-TCJA net operating loss (“NOL”) utilization, coupled with existing valuation allowances.
Net Income from Discontinued Operations, Net of Tax
Net income from discontinued operations, net of tax is related to the wind down and divestiture of our Consumer Health business that was completed in the first quarter of fiscal 2025. See Part I, Item 1, Note 20 – Discontinued Operations in this Form 10-Q for further detail.
Liquidity and Capital Resources
Sources of Liquidity
We have obligations related to our loan agreements, milestone payments for licensed products, and manufacturing purchase commitments. We finance our operations through a combination of sales of our common stock and warrants, borrowings under our revolving credit facility and from cash generated from operations.
Shelf Registrations
On September 26, 2024, we filed a shelf registration statement on Form S-3, which was declared effective by the SEC on October 15, 2024. This shelf registration statement covers the offering, issuance and sale by us of up to an aggregate of $100.0 million of our common stock, preferred stock, debt securities, warrants, rights and units (the “2024 Shelf”). Through the filing date of this Annual Report, $100.0 million remains available under the 2024 Shelf. This availability is subject to the SEC’s “baby shelf” limitation as set forth in SEC Instruction I.B.6 limitation to the Form S-3.
Equity Financing
We have engaged in several different types of equity financings throughout our history. Most recently in June 2025, we raised gross proceeds of $16.6 million from the issuance of (i) 2,806,688 shares of our common stock, at a public offering price of $1.50 and 8,233,332 prefunded warrants at a public offering price of $1.4999 to purchase 8,233,332 shares of our common stock at an exercise price of $0.0001 per share. We received $14.8 million in proceeds net of underwriting commissions and offering expenses and intend to use the net proceeds from the offering for working capital, general corporate purposes and to enable us to exclusively commercialize EXXUA.
In June 2024, the June 2023 Tranche B Warrants to purchase 2,173,912 shares of our common stock at an exercise price of $1.59 were exercised, generating proceeds of $3.5 million. The June Tranche B Warrants were converted into 367,478 shares of our common stock and 1,806,434 prefunded warrants to purchase shares of our common stock with an exercise price of $0.0001 per share. We used a portion of these proceeds as part of a $15.0 million term loan repayment made in June of 2024. For further information on our equity financings and related warrants outstanding, please refer to Note 14 - Stockholders’ Equity and Note 16 - Warrants in Part I, Item 1 of this Form 10-Q.
Eclipse Agreement
Under our Eclipse Agreement, we have two loan agreements, the Eclipse Term Loan and the Eclipse Revolving Loan. The Eclipse Term Loan consists of an outstanding principal amount of $13.0 million on the closing date of the Eclipse Amendment No. 6, at an interest rate of the SOFR plus 7.0%, with a four-year term and a straight-line loan amortization period of seven years, which would provide for a loan balance at the end of the four-year term of $5.6 million to be repaid on the June 12, 2029, maturity date, as amended. In June 2024, we used the initial proceeds from the Eclipse Term Loan and a portion of the proceeds from the warrant exercises described above to repay in full a $15.0 million term loan. The Eclipse Revolving Loan has a potential maximum borrowing base of $14.5 million at an interest rate of the SOFR plus 4.5%, which was temporarily increased pursuant to the $1.5 million Eclipse Incremental Advance, with repayment and permanent reduction of the Eclipse Incremental Advance commencing on August 1, 2025, and continuing on the first day of each calendar month thereafter, in an amount equal to $125,000 per month, until the Eclipse Incremental Advance has been reduced to $0. In addition, we are required to pay an unused line fee of 0.5% of the average unused portion of the maximum Eclipse Revolving Loan amount during the immediately preceding month. The ability to make borrowings and obtain advances of the Eclipse Revolving Loan remains subject to a borrowing base and reserve, and availability blockage requirements and the maturity date, as amended, is June 12, 2029. Please refer to Note 10 - Revolving Credit Facility and Note 11 - Debt in Part I, Item 1 of this Form 10-Q for further information.
Cash Flows
The following table shows cash flows for the three months ended September 30, 2025, and 2024:
| Three Months Ended September 30, |
||||||||||||
| 2025 |
2024 |
Change |
||||||||||
| (in thousands) |
||||||||||||
| Net cash used in operating activities |
$ | (618 | ) | $ | (1,190 | ) | $ | 572 | ||||
| Net cash provided by investing activities |
$ | — | $ | 381 | $ | (381 | ) | |||||
| Net cash provided by financing activities |
$ | 2,296 | $ | 911 | $ | 1,385 | ||||||
Net Cash Used in Operating Activities
Net cash used in operating activities during these periods primarily reflects our net income from continuing operations, partially offset by cash provided by discontinued operations and changes in working capital and non-cash charges including stock-based compensation expense, derivative warrant liabilities gain or loss, depreciation and amortization, and other charges.
During the three months ended September 30, 2025, net cash used in operating activities totaled $0.6 million, which was primarily the result of an increase in accounts receivable, net and a decrease in accrued liabilities as well as negative cash earnings (derivative warrant liabilities adjustment partially offset by net income of $2.0 million, non-cash depreciation and amortization, stock-based compensation expense, and inventory write-down), partially offset by a decrease in inventories and an increase in accounts payable.
During the three months ended September 30, 2024, net cash used in operating activities totaled $1.2 million. The use of cash was primarily the result of the decrease in accounts receivable, net; inventories; prepaid expenses and other assets; other accrued liabilities; and accrued liabilities, partially offset by positive cash earnings (net income of $1.5 million offset by non-cash depreciation and amortization, derivative warrant liabilities adjustment, and stock compensation expense). Additionally, these were partially offset by an increase in accounts payable.
Net Cash Provided by Investing Activities
There was no net cash provided by or used in investing activities during the three months ended September 30, 2025. Net cash provided by investing activities for the three months ended September 30, 2024, were driven by cash received from the sale of fixed assets, partially offset by cash payments for fixed asset purchases.
Net Cash Provided by Financing Activities
Net cash provided by financing activities of $2.3 million during the three months ended September 30, 2025, was primarily from $5.8 million of net proceeds from our Eclipse Revolving Loan, partially offset by $3.1 million of payments for fixed payment arrangements and $0.5 million of payments made against the principal balance of our Eclipse Term Loan.
Net cash provided by financing activities of $0.9 million during the three months ended September 30, 2024, was primarily from net proceeds received from our Eclipse Revolving Loan, partially offset by payments made to fixed payment arrangements and payments made against borrowings.
Contractual Obligations, Commitments and Contingencies
As a result of our acquisitions, exclusive commercialization agreement, and licensing agreements, we are contractually and contingently obliged to pay, when due, various fixed and contingent milestone payments. See Note 13 - Commitments and Contingencies in Part I, Item 1 of this Form 10-Q for further information.
In May 2022, we entered into an agreement with Tris to terminate the License, Development, Manufacturing and Supply Agreement dated November 2, 2018, related to Tuzistra (the “Tuzistra License Agreement”). Pursuant to such termination we accrued a settlement liability, which was paid in full during the first quarter of fiscal 2026.
Upon closing of the acquisition of a line of prescription pediatric products from Cerecor, Inc. in October 2019, we assumed payment obligations that required us to make fixed and product milestone payments. As of September 30, 2025, we had no remaining fixed payment arrangement accruals recorded in our unaudited consolidated balance sheet.
In connection with our suspension of active development of AR101 (enzastaurin) (“AR101”), we engaged in negotiations with EnzCo, LLC (“EnzCo”) and Rumpus VEDS LLC, (“Rumpus VEDS”), Rumpus Therapeutics LLC, (“Rumpus Therapeutics”) and Rumpus Vascular LLC, (“Rumpus Vascular” and, together with Rumpus VEDS and Rumpus Therapeutics, “Rumpus”) for the repurchase of AR101. In the first quarter of fiscal 2026, we reached terms with Rumpus and EnzCo whereby for mutual consideration and releases, we transferred all of ours and Rumpus’ rights, title and interest in AR101 to EnzCo, which extinguished and terminated all of our obligations and Rumpus’ obligations under the April 21, 2021, asset purchase agreement by and between us and Rumpus (the “Rumpus Asset Purchase Agreement”). There is no other relationship between us, EnzCo or Rumpus other than as contracting parties to terminate the Rumpus Asset Purchase Agreement, and there are no penalties or remaining obligations for us for terminating the Rumpus Asset Purchase Agreement.
Critical Accounting Estimates
The discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. For a detailed discussion about our critical accounting estimates, refer to our 2025 Form 10-K.
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources and would be considered material to investors.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide information under this item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As required by Rules 13a-15(e) and 15d-15(e) under the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Form 10-Q. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2025, at reasonable assurance levels, in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Accordingly, we believe that the financial statements presented in this Form 10-Q present fairly, in all material respects, our financial position, results of operations and cash flows for the periods presented herein.
Inherent Limitations on Effectiveness of Internal Controls over Financial Reporting
Our management team, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdown can occur because of simple errors or mistakes. In particular, many of our current processes rely upon manual reviews and processes to ensure that neither human error nor system weakness has resulted in erroneous reporting of financial data.
Changes in Internal Control over Financial Reporting
There have been no changes to our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that occurred during the first quarter of fiscal 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
From time to time, we become involved in or are threatened with legal disputes arising from our business and operations in the normal course of business. Most of these disputes are not likely to have a material effect on our business, financial condition, or operations. There were no new material legal proceedings that were initiated or terminated during the period covered by this report and there have been no material developments in the material proceedings identified in Part I, Item 3 in our 2025 Form 10-K. For a description of our material pending legal proceedings, see Note 13 - Commitments and Contingencies of the notes to the unaudited consolidated financial statements included in Part I, Item 1 of this Form 10-Q, which is incorporated herein by reference. As of the filing of this report, no legal proceedings are pending against us that we believe individually or collectively are likely to have a materially adverse effect upon our financial condition, results of operations, or cash flows.
Our business faces significant risks and uncertainties. Certain important factors may have a material adverse effect on our business prospects, financial condition, and results of operations, and you should carefully consider them. There have not been any material changes to our risk factors from those reported in our 2025 Form 10-K.
Rule 10b5-1 Trading Plans
During the quarter ended September 30, 2025, of our directors or executive officers (as defined in Rule 16a-1 under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (as those terms are defined in Item 408 of Regulation S-K).
| Exhibit No. |
Description |
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| 31.1* |
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| 31.2* |
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| 32.1** |
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| 101.INS* |
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |
| 101.SCH* | Inline XBRL Taxonomy Schema Linkbase Document. | |
| 101.CAL* | Inline XBRL Taxonomy Calculation Linkbase Document. | |
| 101.DEF* | Inline XBRL Taxonomy Definition Linkbase Document. | |
| 101.LAB* | Inline XBRL Taxonomy Labels Linkbase Document. | |
| 101.PRE* | Inline XBRL Taxonomy Presentation Linkbase Document. | |
| 104* |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
* Filed herewith.
** Furnished herewith.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AYTU BIOPHARMA, INC. |
|||
| Date: November 13, 2025 |
By: |
/s/ Joshua R. Disbrow |
|
| Joshua R. Disbrow |
|||
| Chief Executive Officer | |||
| (Principal Executive Officer) | |||
| Date: November 13, 2025 | By: | /s/ Ryan J. Selhorn | |
| Ryan J. Selhorn | |||
| Chief Financial Officer | |||
| (Principal Financial and Accounting Officer) | |||