AYTU

AYTU BIOPHARMA, INC

NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS

1.90

−0.08 −4.04%

USD · close Oct 23

A free account adds a watchlist, alerts when insiders, Congress or short sellers move on your tickers, and a morning brief. Sign up

Work order

WATCH · shorts 40

Insiders, 90 days

no open-market filings in 90 days

Congress, 90 days

0 / 0

no disclosures naming it

Big money

0 / 15

none of the tracked funds disclose it

Calls on record

nobody we score has called it yet

MKT CAP $20.4MP/E —DIV YIELD —FCF YIELD 8.06%REV TTM $56.6M −14.0%NET INCOME −$34.1M −2177.8%NET CASH $11.7M52W 1.90 – 2.90SEC XBRL · TTM TO Invalid Date

How AYTU rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

47%

of sentences unchanged

Added

140

new sentences

Dropped

175

sentences removed

Length

−2,521

words, now 17,525

New in FY2025

Our net loss for the years ended June 30, 2025, and 2024, was $13.6 million and $15.8 million, respectively.
Even though we expect to have net revenue growth in the next several fiscal years, it is uncertain that the net revenue growth will be significant enough to offset our expenses and generate a profit in the future.
We may be unable to adjust spending in a timely manner to compensate for any unexpected budgetary shortfall. To obtain net revenue from our products, we must succeed, either alone or with others, in a range of challenging activities, including expanding markets for our existing products, manufacturing, marketing and selling our existing products, satisfying any post-marketing requirements, and obtaining reimbursement for our products from private insurance or government payors.
We, and our collaborators, as applicable, may not be successful in these activities and, even if we or our collaborators do, we may never generate net revenue that is sufficient to achieve profitability.
We have not established sources of ongoing net revenue sufficient to cover operating costs. Since our inception, we have had significant operating losses.
As of June 30, 2025, we had accumulated deficit of $333.5 million.
We may continue to incur net losses, and our ability to generate positive cash flows from operating activities is uncertain for the foreseeable future.
We have not established an ongoing source of net revenue sufficient to consistently cover operating costs.
As of June 30, 2025, our cash and cash equivalents totaled $31.0 million.
During the year ended June 30, 2025, we received $14.8 million of net proceeds from our June 2025 public offering and $3.2 million of net proceeds from the Eclipse Amendment No. 6 that was executed in June 2025. Our operating plans may change as a result of many factors currently unknown to us, and we could need additional capital in the future to continue our operations and may need to seek additional funds sooner than planned.
We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or products or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects. If we are unable to obtain funding on a timely basis, we may be unable to expand the market for our products or expand our operations generally or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations. We may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due. As of June 30, 2025, we have a $13.0 million term loan and up to $16.0 million of secured revolving loans under the Eclipse Agreement, which includes the temporary Eclipse Incremental Advance of $1.5 million.
As of June 30, 2025, $9.1 million was outstanding under the secured revolving loan.
If we raise additional capital through debt financing, the terms of any new debt could further restrict our operating and financial flexibility. The Eclipse Agreement subjects us to financial covenants and restrictions on our 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 the lenders.
Any declaration by the lenders of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline.
Further, if we raise any additional capital through debt financing, the terms of such additional debt could further restrict our operating and financial flexibility. Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. As of June 30, 2025, we had federal net operating loss carryforwards of $516.7 million.
Previous acquisitions, financing transactions, and equity ownership changes in the past five years have caused a significant limitation on our ability to use all $516.7 million of pre-acquisition net operating loss carryovers.
As a result, we expect $324.7 million of net operating losses to expire unused by 2037, at which point we will only retain indefinite-lived carryforwards.
The ownership changes have resulted in increased future tax liability and are a driver of the change from a zero percent effective tax rate. We have been and, in the future, may become a defendant in one or more stockholder derivative, class-action, and other litigation, and any such lawsuits may adversely affect our business, financial condition, results of operations and cash flows.
In addition, any such future lawsuits could adversely impact our reputation and/or ability to launch and commercialize our products, thereby harming our ability to generate net revenue.
Accordingly, the ultimate resolution of these matters and any future matters could have a material adverse effect on our business, financial condition, results of operation and cash flows and, consequently, could negatively impact the trading price of our common stock.
To date, we have not generated sufficient net revenue from the sales of these products to achieve companywide profitability and we may never achieve or maintain profitability. Our ability to become profitable depends upon our ability to generate increased net revenue from sales of our prescription portfolios.
While we have been selling pharmaceutical products for several years, we have limited commercial experience selling our current lineup of pharmaceutical products, having only generated net revenue from the sale of our pediatric products since acquiring that portfolio in November 2019 and from our ADHD products since acquiring that portfolio in March 2021 and we are currently launching EXXUA in the United States.
None of our marketed prescription have thus far generated product revenue at levels sufficient for us to consistently attain profitability.
Due to the completion of our wind down and divestiture of our Consumer Health business in the first quarter of fiscal 2025, we 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.
Accordingly, our consolidated financial statements for all periods presented reflect the Consumer Health business as a discontinued operation and we will not generate revenue from the Consumer Health business in the future. We have incurred, and anticipate continuing to incur, significant costs associated with commercialization of our approved products and, if approved, any other product candidates that we may develop.
It is possible that we will never attain sufficient product net revenue to achieve profitability. If we are unable to differentiate our products from branded drugs or existing generic therapies for similar treatments, or if the FDA or other applicable regulatory authorities approve additional generic products that compete with any of our products, our ability to successfully commercialize such products would be adversely affected. We expect to compete against branded drugs with distinct clinical attributes and to compete with their generic counterparts that will be sold for a lower price.
Although we believe that our products are or will be differentiated from other branded drugs and their generic counterparts, if any, including through clinical efficacy or through improved patient compliance, ease of administration, and our patient support programs, it is possible that such differentiation will not impact our market position.
After an NDA, including a 505(b)(2) application, is approved, the covered product becomes a “listed drug” that, in turn, can be cited by potential competitors in support of approval of an abbreviated new drug application, or ANDA.
Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product can be lost to the generic version.
Accordingly, competition from generic equivalents to our products could materially adversely impact our net revenue, profitability and cash flows and substantially limit our ability to obtain a return on the investments we have made in our products.
For example, on July 25, 2016, we received a paragraph IV certification from Actavis advising us that Actavis filed an ANDA with the FDA for a generic version of Adzenys.
On October 17, 2017, we entered into a Settlement Agreement and a Licensing Agreement with Actavis (which is now owned by Teva Pharmaceutical Industries Limited), pursuant to which we granted Actavis the right to manufacture and market its now approved generic version of Adzenys under the ANDA beginning on September 1, 2025.
On October 31, 2017, we received a paragraph IV certification from Teva advising us that Teva filed an ANDA with the FDA for a generic version of Cotempla.
On December 21, 2018, we entered into a Settlement Agreement and a Licensing Agreement with Teva, pursuant to which we have granted Teva the right to manufacture and market its now approved generic version of Cotempla under the ANDA beginning on July 1, 2026, or earlier under certain circumstances. Our pharmaceutical products may prove to be difficult to effectively commercialize as planned or on the timeframes we announce and expect. Various commercial, regulatory, and manufacturing factors may impact our ability to maintain or grow net revenue from sales of our pharmaceutical product offerings.
Specifically, we may encounter difficulty by virtue of the following, each of which could be negatively impacted if expected timeframe goals are not achieved: ● our available capital resources; ● our inability to have clear proprietary rights to the products; ● our inability to manufacture or cost-effectively manufacture the products; ● our inability to adequately market and increase sales of any of these products; ● of adverse side effects that make using the products less desirable; ● our inability to attract and retain a skilled support team, marketing staff and sales force necessary to increase the market for our approved products and to maintain market acceptance for our products; ● our inability to secure continuous prescribing of any of these products by current or previous users of the product; ● our inability to effectively transfer and scale manufacturing as needed to maintain an adequate commercial supply of these products; ● reimbursement and medical policy changes that may adversely affect the pricing, profitability or commercial appeal of pharmaceutical products; and ● our inability to effectively identify and align with commercial partners outside the United States, or the inability of those selected partners to gain the required regulatory, reimbursement, and other approvals needed to enable commercial success of our products.
If we fail to procure supply of our products, or if the prices of the supply increases due to general economic conditions or tariffs, we could lose potential revenue and our business, financial condition, results of operation and reputation could be adversely affected. Identifying an appropriately qualified source of alternative supply for any one or more of the component substances for our products could be time consuming, and we may not be able to do so without incurring material delays in the development and commercialization of our approved products or a decrease in sales of our approved products, which could harm our financial position and commercial potential for our products.
Furthermore, if our suppliers fail to deliver the required commercial quantities of components and active pharmaceutical ingredients (“APIs”) on a timely basis and at commercially reasonable prices, including if our suppliers did not receive adequate DEA quotas for the supply of certain scheduled components, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, commercialization of our ADHD products may be delayed or we could lose potential revenue and our business, financial condition, results of operation and reputation could be adversely affected. We rely on third parties to manufacture certain products, and third-party manufacturing risks and inefficiencies may result in costs and delays that prevent us from successfully commercializing products and adversely affect our ability to produce our products. We completed the process of outsourcing the manufacturing of our Adzenys and Cotempla products during fiscal 2024 to a third-party manufacturer based in the United States, to produce commercial quantities of these products.
Manufacturers of our FDA regulated products must comply with good manufacturing practice (“GMP”) requirements enforced by the FDA, NMPA, EMA and other comparable foreign health authorities through facilities inspection programs.
Manufacturers of our FDA regulated products may be unable to comply with these GMP requirements and with other FDA, National Medical Products Administration (“NMPA”), European Medicines Agency (“EMA”), DEA, state, and foreign regulatory requirements.

and 100 more.

Gone since FY2024

Our net loss for the years ended June 30, 2024, and 2023, was $15.8 million and $17.1 million, respectively.
Even though we expect to have revenue growth in the next several fiscal years, it is uncertain that the revenue growth will be significant enough to offset our expenses and generate a profit in the future.
We may be unable to adjust spending in a timely manner to compensate for any unexpected budgetary shortfall. To obtain revenues from our products, we must succeed, either alone or with others, in a range of challenging activities, including expanding markets for our existing products, manufacturing, marketing and selling our existing products, satisfying any post-marketing requirements, and obtaining reimbursement for our products from private insurance or government payors.
We, and our collaborators, as applicable, may not be successful in these activities and, even if we or our collaborators do, we may never generate revenues that are sufficient to achieve profitability.
We have not established sources of ongoing revenue sufficient to cover operating costs. Since our inception, we have had significant operating losses.
As of June 30, 2024, we had accumulated deficit of $320.0 million.
Even though during fiscal 2024 we mitigated the conditions that gave rise to substantial doubt about our ability to continue as a going concern, we may continue to incur net losses, and our ability to generate positive cash flows from operating activities is uncertain for the foreseeable future.
We have not established an ongoing source of revenue sufficient to cover operating costs.
As of June 30, 2024, our cash and cash equivalents totaled $20.0 million.
During the year ended June 30, 2024, we received $13.0 million of proceeds from the Eclipse Term Loan and $3.6 million of proceeds from the exercise of warrants, a portion of which was used for the repayment of a $15.0 million term loan, which was replaced by the Eclipse Term Loan. Our operating plans may change as a result of many factors currently unknown to us, and we could need additional capital in the future to continue our operations and may need to seek additional funds sooner than planned.
We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or products or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects. If we are unable to obtain funding on a timely basis, we may be unable to expand the market for our products or expand our operations generally or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations. We may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due. We have a $13.0 million term loan and up to $14.5 million of secured revolving loans with the Eclipse Lender.
As of June 30, 2024, $2.4 million was outstanding under the secured revolving loan.
If we raise additional capital through debt financing, the terms of any new debt could further restrict our operating and financial flexibility. The loan agreements with the Eclipse Lender subject us to financial covenants and restrictions on our 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 the lender.
Any declaration by the lender of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline.
Further, if we raise any additional capital through debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.
We are actively engaged in discussions regarding a potential strategic transaction.
There can be no assurance that this process will result in the pursuit or consummation of any potential transaction. We are engaged in discussions regarding a potential strategic transaction which could include a sale or licensing of assets, acquisition, merger, business combination, and/or other strategic transaction or series of related transactions.
This process, including any uncertainty created by this process, involves a number of risks which could impact our business and our stockholders, including the following: ● significant fluctuations in our stock price could occur in response to developments relating to the process or market speculation regarding any such developments; ● we may encounter difficulties in hiring, retaining and motivating key personnel during this process or as a result of uncertainties generated by this process or any developments or actions relating to it; ● we may incur substantial increases in general and administrative expense associated with increased legal fees and the need to retain and compensate third-party advisors; and ● we may experience difficulties in preserving the commercially sensitive information that may need to be disclosed to third parties during this process or in connection with an assessment of our strategic options. The review process also requires significant time and attention from management, which could distract them from other tasks in operating our business or otherwise disrupt our business.
Such disruptions could cause concern to our suppliers, strategic partners or other constituencies and may have a material impact on our business and operating results and volatility in our share price. There can be no assurance that this process will result in the pursuit or consummation of any potential transaction or strategy, or that any such potential transaction or strategy, if implemented, will provide sufficient funding to conduct our operations.
Any outcome of this process would be dependent upon a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, regulatory approvals, and the availability of financing on reasonable terms.
The occurrence of any one or more of the above risks could have a material adverse impact on our business, financial condition, results of operations and cash flows. We have indefinitely suspended development of our AR101 (enzastaurin) clinical development program and shifted our strategic focus towards accelerating the growth of our commercial business.
If we fail to execute successfully on this reprioritized strategic focus, our business, results of operations and financial condition could be materially and adversely affected. We have indefinitely suspended our AR101 (enzastaurin) clinical development program and shifted our focus towards accelerating the growth of our commercial business and achieving operating cash flows.
Though we expect that the suspension of this program will save us costs related to a projected future study that if started would cost over $20 million and take three years to complete, the process of reorienting our business strategy may be costly, time consuming and complex, and we have incurred, and may in the future incur, costs related to this strategic shift.
Our strategic reprioritization may result in unexpected expenses or liabilities and/or write-offs.
There is no assurance that we will be successful at executing on our revised strategy or that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated, lead to increased stockholder value, or achieve the anticipated results. If we are unable to execute successfully on our reprioritized strategic focus, our cash resources may not last as long as estimated and our business, results of operations and financial condition could be materially and adversely affected. Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. As of June 30, 2024, we had federal net operating loss carryforwards of $519.6 million.
Previous acquisitions, financing transactions, and equity ownership changes in the past five years have caused a significant limitation on our ability to use all $519.6 million of pre-acquisition 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. If we fail to establish and maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired. Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
Pursuant to Section 404 of the Sarbanes-Oxley Act, our management conducted an assessment of the effectiveness of our internal controls over financial reporting for the quarter ended September 30, 2022, and concluded that a certain control was not effective.
We concluded that we had a material weakness in internal control over financial reporting related to accounting for complex warrant issuances and the classification of these issued warrants.
In addition, we concluded that we had a material weakness in internal control over financial reporting for the year ended June 30, 2023, related to our analysis for the accounting for valuation of our inventory.
As previously reported in our public reports, our Audit Committee conducted an internal investigation to identify and determine a plan to remediate the material weaknesses described above and to enhance our overall control environment.
We undertook steps to remediate these deficiencies and strengthen our internal control over financial reporting by enhancing existing controls and establishing additional review and procedure controls over the process of reviewing significant and complex contracts and agreements, and the valuation of inventory.
Given the remediation efforts and that a sufficient period of time has passed with successful testing performed, management has concluded that the material weaknesses set forth above were remediated as of March 31, 2024. If in the future we were to conclude that our internal controls over financial reporting were not effective, we cannot be certain as to the timing of completion of our evaluation, testing and remediation actions or their effect on our operations because there is presently no precedent available by which to measure compliance adequacy.
As a consequence, we may not be able to complete any necessary remediation process in time to meet our deadline for compliance with Section 404 of the Sarbanes-Oxley Act.
Also, there can be no assurance that we will not identify one or more material weaknesses in our internal controls in connection with evaluating our compliance with Section 404 of the Sarbanes-Oxley Act.
The presence of material weaknesses could result in financial statement errors which, in turn, could require us to restate our operating results. If we are unable to conclude that we have effective internal controls over financial reporting or if our independent auditors are unwilling or unable to provide us, when required, with an attestation report on the effectiveness of internal controls over financial reporting as required by Section 404 of the Sarbanes-Oxley Act, investors may lose confidence in our operating results, our stock price could decline and we may be subject to litigation or regulatory enforcement actions.
In addition, if we are unable to meet the requirements of Section 404 of the Sarbanes-Oxley Act, we may not be able to maintain listing on the Nasdaq Capital Market.
Due to our current filing status, we are not required to have our independent registered public accounting firm deliver an attestation report on the effectiveness of our internal control over financial reporting. We have been and, in the future, may become a defendant in one or more stockholder derivative, class-action, and other litigation, and any such lawsuits may adversely affect our business, financial condition, results of operations and cash flows.
For example: ● Two putative class action lawsuits were filed on February 9, 2022, and March 7, 2022, derivatively and on behalf of all Aytu stockholders, challenging the grant in 2021 of certain stock option awards to directors and officers, and seeking rescission of the awards, unspecified damages to stockholders as a result of the awards, and attorneys’ fees. ● A stockholder derivative suit was filed on September 12, 2022, derivatively and on behalf of all Aytu stockholders, against certain of our current and former directors and stockholders, alleging breaches of fiduciary duties in connection with certain acquisitions, and seeking unspecified damages, equitable relief, restitution, disgorgement of profits, enhanced governance and internal procedures, and attorneys’ fees.
See Part I, Item 3, Legal Proceedings for more information on these lawsuits.

and 135 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch AYTU. Know when insiders buy.

One email the day a filing lands. Free.