8-K
AYTU BIOPHARMA, INC (AYTU)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
November 13, 2025
Date of Report (Date of earliest event reported):
AYTU BIOPHARMA, INC .
(Exact name of registrant as specified in its charter)
| Delaware | 001-38247 | 47-0883144 |
|---|---|---|
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
7900 East Union Avenue, Suite 920
Denver, CO 80237
(Address of principal executive offices, including zip code)
(720) 437-6580
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | AYTU | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 13, 2025, Aytu BioPharma, Inc. (the “Company”) issued a press release announcing its fiscal 2026 first quarter operational and financial results. As indicated in the press release, the Company scheduled a conference call and live audio webcast for November 13, 2025, at 4:30 p.m. Eastern time to discuss the operational and financial results and to answer questions. The conference call is publicly accessible via webcast and telephone (available live and for replay), and the press release includes instructions for accessing the webcast via the Company’s website or dialing in to the call. A replay of the call will be made available after the call on the Company’s website and via a telephone replay. Availability of the call replay posted on the Company’s website and via the telephone replay is at the Company’s discretion and may be discontinued at any time. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in the press release attached as Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Exhibit Description |
|---|---|
| 99.1 | Press Release dated November 13, 2025 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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/ Ryan J. Selhorn |
| Ryan J. Selhorn | ||
| Chief Financial Officer |
ex_864172.htm
Exhibit 99.1
Aytu BioPharma Reports Fiscal 2026 First Quarter Operational and Financial Results
Total net revenue of $13.9 million
Net income of $2.0 million, or $0.21 net income per share basic
Adjusted EBITDA^1^ of $(0.6) million, which includes EXXUA launch investments
$32.6 million cash balance at September 30, 2025
Company remains on track to launch EXXUA™ (gepirone) extended-release tablets (“EXXUA”) in the fourth calendar quarter of 2025 as a centerpiece of its commercial efforts as it enters the over $22 billion United States prescription major depressive disorder (“MDD”) market
Company to host conference call and webcast today, November 13, 2025, at 4:30 p.m. Eastern time
DENVER, CO / November 13 , 2025 / Aytu BioPharma, Inc. (the “Company” or “Aytu”) (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today announced operational and financial results for the fiscal 2026 first quarter.
The Company is also providing an update on its planned commercial launch of EXXUA, a novel first-in-class selective serotonin 5HT1a receptor agonist approved by the United States Food and Drug Administration (“FDA”) for the treatment of MDD in adults.
Q1 Fiscal 2026 Highlights
| ● | Net revenue of $13.9 million versus $16.6 million in Q1 fiscal 2025. The year ago quarter included a one-time benefit due to an accrued rebate liability related to the ADHD Portfolio, which consists of attention deficit hyperactivity disorder (“ADHD”) products, of $3.3 million, which resulted in an increase in Q1 fiscal 2025 net revenue of $3.3 million (the “rebate”). Excluding the rebate, net revenue would have increased 5% compared to the year ago quarter. |
|---|---|
| ● | ADHD Portfolio net revenue was $13.2 million versus $15.3 million in Q1 fiscal 2025. Excluding the aforementioned rebate, ADHD Portfolio net revenue would have increased 10% compared to the year ago quarter. |
| --- | --- |
| ● | Pediatric Portfolio, which consists of a line of legacy products, net revenue was $0.7 million versus $1.3 million in Q1 fiscal 2025. |
| --- | --- |
| ● | Net income of $2.0 million compared to net income of $1.5 million in Q1 fiscal 2025. |
| --- | --- |
| ● | Adjusted EBITDA was $(0.6) million compared to $1.9 million in Q1 fiscal 2025. During Q1 fiscal 2026, the Company made investments towards the upcoming launch of EXXUA. Excluding these EXXUA launch investments, adjusted EBITDA would have been positive for the 10^th^ consecutive quarter. |
| --- | --- |
| ● | Cash and cash equivalents were $32.6 million at September 30, 2025. |
| --- | --- |
EXXUA Calendar Fourth Quarter 2025 Commercial Launch Remains on Track
Following Aytu’s June 2025 entry into an exclusive agreement to commercialize EXXUA in the United States, the Company is on track to launch EXXUA in the fourth quarter of calendar 2025. Gepirone is a new chemical entity and is the first and only selective serotonin 5HT1a receptor agonist approved by the FDA for the treatment of MDD in adults. EXXUA is expected to serve as a major growth catalyst for Aytu moving forward as it enters the over $22 billion United States prescription MDD market.
Key launch activity updates include:
| ● | Finalizing product manufacturing, labeling, serialization and shipment to the Company’s third-party logistics provider with initial shipments on track for delivery in December 2025. |
|---|---|
| ● | Sales force nearing completion of training with finalization to occur in the coming weeks. Launch meeting scheduled to take place in mid-January 2026. |
| --- | --- |
| ● | Product positioning, preparation of promotional materials, refinement of physician messaging and development of patient support materials is nearing completion. |
| --- | --- |
| ● | Refinement of sales territory alignments completed with initial physician targeting also completed. |
| --- | --- |
| ● | Product pricing has been established. |
| --- | --- |
| ● | New independent, peer-reviewed articles published on EXXUA. |
| --- | --- |
| ● | Ongoing key opinion leader engagement occurring with initial medical conference attendance completed at the Neuroscience Education Institute (“NEI”) Fall Conference in Colorado Springs. |
| --- | --- |
| ● | Continuing discussions with commercial and government payors. |
| --- | --- |
| ● | Finalizing EXXUA integration into the Aytu RxConnect® patient access platform. |
| --- | --- |
On October 28, 2025, the Company announced that the method of use patent (U.S. Patent No. 7,538,116) for EXXUA had been extended through September 2, 2030, under 35 U.S.C. 156. The patent extension further expands upon the new chemical entity (“NCE”) exclusivity period granted by the FDA. Further, the Company has engaged in discussions to expand upon the existing intellectual property (“IP”) through various potential life cycle management approaches.
Management Discussion
“The Aytu team is fully executing on the tremendous opportunity ahead of us to become one of the leaders in addressing complex central nervous system diseases, with a focus on the upcoming launch of EXXUA for major depressive disorder, as well as our ongoing ADHD Portfolio,” commented Josh Disbrow, Chief Executive Officer of Aytu. “The EXXUA launch remains on track to occur by the end of the fourth quarter of calendar 2025, with significant advancements being made to ensure success, including KOL engagement, sales force training, product positioning and pricing, payor assessments and integration with our proprietary Aytu RxConnect® patient access platform.”
“While much of our commercial efforts are focused on the launch of EXXUA, it is gratifying to see that our ADHD Portfolio remains stable. In fact, excluding the one-time benefit from the rebate received in the year ago quarter, ADHD Portfolio net revenue would have increased 10% compared to the year ago period, and was also up on a sequential basis as well. This stability reinforces our long-term belief on the added stickiness and positive economic benefits that are inherent in our Aytu RxConnect® platform through which approximately 85% of our branded ADHD prescriptions are dispensed.”
“The coming months are going to be exciting for Aytu. We are laser focused on a successful commercial launch of EXXUA as we focus on positively impacting the lives of the estimated 21 million Americans affected by MDD,” Disbrow concluded.
Net Revenue by Product Portfolio
| Three Months Ended | ||||
|---|---|---|---|---|
| September 30, | ||||
| 2025 | 2024 | |||
| (in thousands) | ||||
| ADHD Portfolio | $ | 13,156 | $ | 15,264 |
| Pediatric Portfolio | 715 | 1,293 | ||
| Other* | 17 | 17 | ||
| Total net revenue | $ | 13,888 | $ | 16,574 |
* Other includes discontinued or deprioritized products.
Q1 Fiscal 2026 Financial Results
Net revenue for the first quarter of fiscal 2026 was $13.9 million, compared to $16.6 million for the prior year period. The year ago quarter includes the rebate that resulted in a one-time increase in Q1 fiscal 2025 net revenue of $3.3 million. Excluding the rebate, net revenue would have increased 5% compared to the year ago quarter.
The ADHD Portfolio net revenue was $13.2 million in the first quarter of fiscal 2026, compared to $15.3 million in the prior year period. Excluding the aforementioned one-time rebate, ADHD Portfolio net revenue would have increased 10% compared to the year ago quarter. The increase is attributable primarily to product price increases and improved gross-to-nets, partially offset by a decrease in total prescriptions.
The Pediatric Portfolio net revenue was $0.7 million in the first quarter of fiscal 2026, compared to $1.3 million in the prior year period. The change in net revenue is attributable primarily to manufacturing delays with one of the Company’s suppliers, which are in the process of being resolved, as well as certain product returns, and a broader deemphasis in marketing towards the Pediatric Portfolio.
Gross profit was $9.2 million, or 66% of net revenue, in the first quarter of fiscal 2026, compared to $12.0 million, or 72% of net revenue, in the same quarter last year. Excluding the aforementioned rebate, gross margins in the year ago period would have been 65%.
Operating expenses, excluding amortization of intangible assets and restructuring costs, were $10.2 million in the first quarter of fiscal 2026 compared to $11.2 million in the prior year period. The decrease is primarily a result of continued cost reduction efforts and improved operational efficiencies as part of the Company’s overall strategic realignment, offset by increased EXXUA launch investments.
Net income during the first quarter of fiscal 2026 was $2.0 million, or $0.21 net income per share basic compared to net income of $1.5 million, or $0.24 net income per share basic, in the prior year period. The fiscal 2026 and fiscal 2025 first quarter results were impacted by derivative warrant liability gains of $3.8 million and $2.9 million, respectively, primarily due to a change in the Company’s stock price.
Adjusted EBITDA was $(0.6) million for the first quarter of fiscal 2026 compared to $1.9 million in the year ago period. The change primarily relates to the benefit received in the year ago period from the rebate, as well as EXXUA launch investments.
Cash and cash equivalents were $32.6 million at September 30, 2025, compared to $31.0 million at June 30, 2025.
Conference Call Details
Date and Time: Thursday, November 13, 2025, at 4:30 p.m. Eastern time
Call-in Information: Interested parties can access the conference call by dialing (888) 506-0062 for United States callers or +1 (973) 528-0011 for international callers and using the participant access code 240426.
Webcast Information: The webcast will be accessible live and archived at https://www.webcaster5.com/Webcast/Page/2142/53111, and accessible on the Investors section of the Company’s website at https://investors.aytubio.com/ under Events & Presentations.
Replay: A teleconference replay of the call will be available until November 27, 2025, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 53111.
About Aytu BioPharma
Aytu is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients. The Company’s prescription products include EXXUA™ (gepirone) extended-release tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of major depressive disorder (MDD) and treatments for attention deficit-hyperactivity disorder (ADHD). Aytu is committed to delivering the Company’s medications through best-in-class patient access programs that help to enable optimal patient outcomes. For more information, please visit aytubio.com or follow us on LinkedIn.
About EXXUA
EXXUA is a novel oral selective serotonin 5HT1a receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults. EXXUA is also being developed for other psychiatric disorders.
INDICATIONS and IMPORTANT SAFETY INFORMATION for EXXUA
INDICATIONS
EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.
IMPORTANT SAFETY INFORMATION
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.
EXXUA is not approved for use in pediatric patients.
Do not take EXXUA if you:
| ● | are allergic to EXXUA or any of the ingredients in EXXUA. |
|---|---|
| ● | have a prolonged QTc interval greater than 450 msec or congenital long QT syndrome. |
| ● | are taking medicines known as strong CYP3A4 inhibitors. Ask your healthcare provider if you are not sure if you are taking one of these medicines. |
| ● | have severe liver problems. |
| ● | are taking, or have stopped taking within the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue. |
Do not start taking an MAOI for at least 14 days after you have stopped treatment with EXXUA.
EXXUA may cause serious side effects, including:
Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your levels of body salts (electrolytes) before and during treatment with EXXUA. Your healthcare provider may check your electrolytes more often during treatment if you have heart failure, a slow heart rate, abnormal levels of electrolytes in your blood, or if you take other medications that can prolong the QT interval of your heartbeat.
A potentially life-threatening problem called serotonin syndrome can happen when EXXUA is taken with certain other medicines.
Manic episodes may happen in people with bipolar disorder who take EXXUA.
Please read FULL PRESCRIBING INFORMATION for EXXUA.
Footnote 1
Aytu uses the term adjusted EBITDA, which is a term not defined under United States generally accepted accounting principles (“U.S. GAAP”). The Company uses this term because it is a widely accepted financial indicator utilized to analyze and compare companies on the basis of operating performance. The Company believes that presenting adjusted EBITDA by certain categories allows investors to evaluate the various performance of these categories. The Company’s method of computation of adjusted EBITDA may or may not be comparable to other similarly titled measures used by other companies. The Company believes that net income is the performance measure calculated and presented in accordance with U.S. GAAP that is most directly comparable to adjusted EBITDA. See below for a reconciliation of net income to adjusted EBITDA.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). All statements other than statements of historical facts contained in this press release, 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,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. These statements are predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others, risks associated with: the Company’s overall financial and operational performance, potential adverse changes to the Company’s financial position or its business, the results of operations, strategy and plans, changes in capital markets and the ability of the Company to finance operations in the manner expected, risks relating to gaining market acceptance of its products, its partners performing their required activities, its anticipated future cash position, regulatory and compliance challenges and future events under current and potential future collaborations. The Company also refers you to (i) the risks described in “Risk Factors” in Part I, Item 1A of the Company’s most recent Annual Report on Form 10‑K and in the other reports and documents it files with the United States Securities and Exchange Commission.
Contacts for Investors
Ryan Selhorn, Chief Financial Officer
Aytu BioPharma, Inc.
rselhorn@aytubio.com
Robert Blum
Lytham Partners
aytu@lythampartners.com
Aytu BioPharma, Inc.
Unaudited Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | ||||||
|---|---|---|---|---|---|---|
| September 30, | ||||||
| 2025 | 2024 | |||||
| Net revenue | $ | 13,888 | $ | 16,574 | ||
| Cost of goods sold | 4,702 | 4,589 | ||||
| Gross profit | 9,186 | 11,985 | ||||
| Operating expenses: | ||||||
| Selling and marketing | 5,322 | 5,659 | ||||
| General and administrative | 4,924 | 5,125 | ||||
| Research and development | — | 426 | ||||
| Amortization of intangible assets | 444 | 921 | ||||
| Restructuring costs | — | 784 | ||||
| Total operating expenses | 10,690 | 12,915 | ||||
| Loss from operations | (1,504 | ) | (930 | ) | ||
| Other income, net | 201 | 542 | ||||
| Interest expense | (516 | ) | (994 | ) | ||
| Derivative warrant liabilities gain | 3,784 | 2,880 | ||||
| Income from continuing operations before income tax expense | 1,965 | **** | 1,498 | **** | ||
| Income tax expense | — | (405 | ) | |||
| Net income from continuing operations | 1,965 | **** | 1,093 | **** | ||
| Net income from discontinued operations, net of tax | — | 381 | ||||
| Net income | $ | 1,965 | **** | $ | 1,474 | **** |
| Basic weighted-average common shares outstanding | 9,441,073 | 6,068,019 | ||||
| Diluted weighted-average common shares outstanding | 19,476,635 | 9,099,601 | ||||
| Net income (loss) per share: | ||||||
| Basic - continuing operations | $ | 0.21 | $ | 0.18 | ||
| Diluted - continuing operations | $ | (0.08 | ) | $ | (0.20 | ) |
| Basic - discontinued operations, net of tax | $ | — | $ | 0.06 | ||
| Diluted - discontinued operations, net of tax | $ | — | $ | 0.04 | ||
| Basic - net income | $ | 0.21 | $ | 0.24 | ||
| Diluted - net loss | $ | (0.08 | ) | $ | (0.15 | ) |
Aytu BioPharma, Inc.
Unaudited Consolidated Balance Sheets
(in thousands, except share data)
| June 30, | |||||
|---|---|---|---|---|---|
| 2025 | |||||
| ASSETS | **** | **** | |||
| Current assets: | |||||
| Cash and cash equivalents | 32,630 | $ | 30,952 | ||
| Accounts receivable, net | 33,225 | 31,155 | |||
| Inventories | 10,100 | 11,434 | |||
| Prepaid expenses and other current assets | 5,154 | 5,638 | |||
| Total current assets | 81,109 | 79,179 | |||
| Non-current assets: | |||||
| Property and equipment, net | 500 | 532 | |||
| Operating lease right-of-use assets | 1,010 | 1,061 | |||
| Intangible assets, net | 41,430 | 42,201 | |||
| Other non-current assets | 939 | 1,204 | |||
| Total non-current assets | 43,879 | 44,998 | |||
| Total assets | 124,988 | $ | 124,177 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | **** | **** | |||
| Current liabilities: | |||||
| Accounts payable | 12,342 | $ | 10,601 | ||
| Accrued liabilities | 36,700 | 38,164 | |||
| Revolving credit facility | 14,873 | 9,063 | |||
| Current portion of debt | 1,857 | 1,857 | |||
| Other current liabilities | 221 | 3,379 | |||
| Total current liabilities | 65,993 | 63,064 | |||
| Non-current liabilities: | |||||
| Debt, net of current portion | 10,447 | 10,895 | |||
| Derivative warrant liabilities | 20,424 | 26,334 | |||
| Other non-current liabilities | 4,953 | 4,918 | |||
| Total non-current liabilities | 35,824 | 42,147 | |||
| Stockholders’ equity: | |||||
| Preferred stock, par value 0.0001; 50,000,000 shares authorized; no shares issued or outstanding | — | — | |||
| Common stock, par value 0.0001; 200,000,000 shares authorized; 9,911,913 and 8,976,913 shares issued and outstanding, respectively | 1 | 1 | |||
| Additional paid-in capital | 354,740 | 352,500 | |||
| Accumulated deficit | (331,570 | ) | (333,535 | ) | |
| Total stockholders’ equity | 23,171 | 18,966 | |||
| Total liabilities and stockholders’ equity | 124,988 | $ | 124,177 |
All values are in US Dollars.
Aytu BioPharma, Inc.
Unaudited Reconciliation of Net Income to Adjusted EBITDA
(in thousands)
| Three Months Ended | ||||||
|---|---|---|---|---|---|---|
| September 30, | ||||||
| 2025 | 2024 | |||||
| Net income - GAAP | $ | 1,965 | **** | $ | 1,474 | **** |
| Interest expense | 516 | 994 | ||||
| Income tax expense | — | 405 | ||||
| Depreciation and amortization | 803 | 1,334 | ||||
| Stock-based compensation expense | 114 | 173 | ||||
| Other income, net | (201 | ) | (542 | ) | ||
| Derivative warrant liabilities gain | (3,784 | ) | (2,880 | ) | ||
| Non-recurring legal fees | — | 402 | ||||
| Restructuring costs | — | 784 | ||||
| Pipeline research and development costs | — | 168 | ||||
| Net income from discontinued operations, net of tax | — | (381 | ) | |||
| Adjusted EBITDA - non-GAAP | $ | (587 | ) | $ | 1,931 |