Aytu BioPharma Reports Fiscal 2025 Full Year and Fourth Quarter Operational and Financial Results and Outlines Commercial Launch Plans for EXXUA(TM)
Rhea-AI Summary
Aytu BioPharma (NASDAQ:AYTU) reported its fiscal 2025 results with net revenue of $66.4 million, a 2% increase from fiscal 2024. The company posted a net loss of $13.6 million and adjusted EBITDA of $9.2 million, with a strong cash position of $31.0 million as of June 30, 2025.
The company's ADHD Portfolio generated $57.6 million in revenue, while the Pediatric Portfolio contributed $8.8 million. A significant highlight is Aytu's exclusive agreement to commercialize EXXUA, a novel first-in-class treatment for major depressive disorder (MDD), with launch planned for Q4 2025 targeting the $22 billion U.S. MDD market.
Positive
- Secured exclusive rights to commercialize EXXUA for the $22 billion U.S. MDD market
- Net revenue increased 2% to $66.4 million in fiscal 2025
- Strong cash position of $31.0 million at fiscal year-end
- Pediatric Portfolio revenue grew 20% to $8.8 million
- Achieved 9th consecutive quarter of positive adjusted EBITDA
Negative
- Net loss of $13.6 million in fiscal 2025
- Gross profit margin decreased from 75% to 69% year-over-year
- $8.3 million impairment expense on Pediatric Portfolio
- ADHD Portfolio revenue slightly declined to $57.6 million
- Incurred $12.1 million in combined impairment, restructuring, and warrant liability losses
News Market Reaction – AYTU
On the day this news was published, AYTU declined 17.93%, reflecting a significant negative market reaction. Argus tracked a peak move of +7.0% during that session. Argus tracked a trough of -24.7% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $5M from the company's valuation, bringing the market cap to $25M at that time. Trading volume was exceptionally heavy at 10.8x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Full year fiscal 2025 net revenue of
Full year fiscal 2025 net loss of
Full year fiscal 2025 adjusted EBITDA1 of
Exclusive agreement in June 2025 to commercialize EXXUA™ (gepirone) extended-release tablets ("EXXUA") is expected to serve as a major growth catalyst; the Company anticipates launching EXXUA in the fourth calendar quarter of 2025 as a centerpiece of its commercial efforts as it enters the over
Company to host conference call and webcast today, September 23, 2025, at 4:30 p.m. Eastern time
DENVER, CO / ACCESS Newswire / September 23, 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 2025 full year and fourth quarter. The Company is also providing an update on its planned commercial launch of EXXUA, which it believes 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 MDD in adults.
Full Year Fiscal 2025 Highlights
● | Net revenue increased |
● | ADHD Portfolio (primarily Adzenys XR-ODT® and Cotempla XR-ODT®) net revenue was |
● | Pediatric Portfolio (primarily Karbinal® ER, Poly-Vi-Flor® and Tri-Vi-Flor®) net revenue was |
● | Net loss of |
● | Adjusted EBITDA was |
● | Cash and cash equivalents were |
Q4 Fiscal 2025 Highlights
● | Net revenue increased |
● | ADHD Portfolio net revenue was |
● | Pediatric Portfolio net revenue was |
● | Net loss of |
● | Adjusted EBITDA was |
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 the Company believes 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 is expected to serve as a major growth catalyst for Aytu moving forward as it enters the over
Key launch activities include:
● | Finalization of product manufacturing, labeling, serialization and delivery to the Company's third-party logistics provider. |
● | Ongoing key opinion leader engagement. |
● | Refinement of sales territory alignment and physician targeting. |
● | Product positioning, preparation of promotional materials and refinement of physician messaging. |
● | Commercial and government payor assessment. |
Further, the Company has engaged in discussions to expand upon the existing intellectual property ("IP") through various potential life cycle management approaches.
Management Discussion
"We enter fiscal 2026 with an opportunity to significantly transform Aytu into one of the industry leaders in addressing complex CNS diseases following our recent exclusive agreement to commercialize EXXUA for major depressive disorder," commented Josh Disbrow, Chief Executive Officer of Aytu. "EXXUA is a perfect strategic fit and will be a centerpiece of Aytu's commercial efforts going forward considering the significant commercial potential, uniqueness of the product, our sales force's CNS focus and alignment with our proprietary Aytu RxConnect patient access platform. We remain on track to launch EXXUA in the fourth quarter of calendar 2025."
"The results of the fourth quarter and fiscal year highlight the stability within our existing ADHD and Pediatric portfolios as well as our focus on driving efficiencies across our operations to report our 9th consecutive quarter of positive adjusted EBITDA," Disbrow continued. "As we ramp up our commercial focus on EXXUA, it is our expectation that we will exit fiscal 2026 on a trajectory that positions Aytu as one of the fastest growing CNS-focused companies in the industry. We look forward to the realization of the significant market potential of EXXUA while positively impacting the lives of MDD patients," Disbrow concluded.
Net Revenue by Product Portfolio
Three Months Ended | Twelve Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
(in thousands) | ||||||||||||||||
ADHD Portfolio | $ | 13,107 | $ | 13,758 | $ | 57,576 | $ | 57,784 | ||||||||
Pediatric Portfolio | 2,017 | 841 | 8,769 | 7,280 | ||||||||||||
Other* | 11 | (6 | ) | 37 | 119 | |||||||||||
Total net revenue | $ | 15,135 | $ | 14,593 | $ | 66,382 | $ | 65,183 | ||||||||
* Other includes discontinued or deprioritized products.
Full Year Fiscal 2025 Financial Results
Net revenue for full year fiscal 2025 was
The ADHD Portfolio net revenue was
The Pediatric Portfolio was
Gross profit was
Operating expenses, excluding amortization of intangible assets, restructuring costs and impairment expense, were
Net income from discontinued operations, net of tax for full year fiscal 2025 was
Net loss during full year fiscal 2025 was
Adjusted EBITDA was
Cash and cash equivalents were
Q4 Fiscal 2025 Financial Results
Net revenue for the fourth quarter of fiscal 2025 was
The ADHD Portfolio net revenue was
The Pediatric Portfolio net revenue was
Gross profit was
Operating expenses, excluding amortization of intangible assets, restructuring costs and impairment expense, were
Net income from discontinued operations, net of tax for the fourth quarter of fiscal 2025 was
Net loss during the fourth quarter of fiscal 2025 was
Adjusted EBITDA was
Conference Call Details
Date and Time: Tuesday, September 23, 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 447137.
Webcast Information: The webcast will be accessible live and archived at https://www.webcaster4.com/Webcast/Page/2142/52803, 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 October 7, 2025, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 52803.
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), Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), and a line of legacy products, including Karbinal® ER (carbinoxamine maleate), Poly-Vi-Flor® and Tri-Vi-Flor®. To learn more, please visit aytubio.com.
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 loss 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 loss 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.
Consolidated Statements of Operations
(in thousands, except share and per share data)
Three Months Ended | Twelve Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Net revenue | $ | 15,135 | $ | 14,593 | $ | 66,382 | $ | 65,183 | ||||||||
Cost of goods sold | 4,881 | 3,541 | 20,551 | 16,129 | ||||||||||||
Gross profit | 10,254 | 11,052 | 45,831 | 49,054 | ||||||||||||
Operating expenses: | ||||||||||||||||
Selling and marketing | 4,781 | 5,422 | 20,906 | 22,083 | ||||||||||||
General and administrative | 3,696 | 4,028 | 17,379 | 19,954 | ||||||||||||
Research and development | 216 | 1,042 | 1,326 | 2,769 | ||||||||||||
Amortization of intangible assets | 921 | 921 | 3,683 | 3,683 | ||||||||||||
Restructuring costs | - | 1,912 | 2,101 | 2,156 | ||||||||||||
Impairment expense | 8,263 | - | 8,263 | - | ||||||||||||
Total operating expenses | 17,877 | 13,325 | 53,658 | 50,645 | ||||||||||||
Loss from operations | (7,623 | ) | (2,273 | ) | (7,827 | ) | (1,591 | ) | ||||||||
Other (expense) income, net | (1,230 | ) | 120 | (512 | ) | 870 | ||||||||||
Interest expense | (730 | ) | (1,253 | ) | (3,703 | ) | (5,059 | ) | ||||||||
Derivative warrant liabilities (loss) gain | (9,860 | ) | 1,463 | (1,703 | ) | (4,004 | ) | |||||||||
Loss on extinguishment of debt | - | (594 | ) | - | (594 | ) | ||||||||||
Loss from continuing operations before income tax expense | (19,443 | ) | (2,537 | ) | (13,745 | ) | (10,378 | ) | ||||||||
Income tax expense | (437 | ) | (841 | ) | (437 | ) | (2,142 | ) | ||||||||
Net loss from continuing operations | (19,880 | ) | (3,378 | ) | (14,182 | ) | (12,520 | ) | ||||||||
Net income (loss) from discontinued operations, net of tax | 62 | (1,239 | ) | 620 | (3,324 | ) | ||||||||||
Net loss | $ | (19,818 | ) | $ | (4,617 | ) | $ | (13,562 | ) | $ | (15,844 | ) | ||||
Basic and diluted weighted-average common shares outstanding | 6,791,532 | 5,619,726 | 6,279,744 | 5,537,957 | ||||||||||||
Net (loss) income per share: | ||||||||||||||||
Basic and diluted - continuing operations | $ | (2.93 | ) | $ | (0.60 | ) | $ | (2.26 | ) | $ | (2.26 | ) | ||||
Basic and diluted - discontinued operations, net of tax | $ | 0.01 | $ | (0.22 | ) | $ | 0.10 | $ | (0.60 | ) | ||||||
Basic and diluted - net loss | $ | (2.92 | ) | $ | (0.82 | ) | $ | (2.16 | ) | $ | (2.86 | ) | ||||
Aytu BioPharma, Inc.
Consolidated Balance Sheets
(in thousands, except share data)
June 30, | ||||||||
2025 | 2024 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 30,952 | $ | 20,006 | ||||
Accounts receivable, net | 31,155 | 23,526 | ||||||
Inventories | 11,434 | 12,141 | ||||||
Prepaid expenses and other current assets | 5,638 | 5,097 | ||||||
Current assets of discontinued operations | - | 1,121 | ||||||
Total current assets | 79,179 | 61,891 | ||||||
Non-current assets: | ||||||||
Property and equipment, net | 532 | 693 | ||||||
Operating lease right-of-use assets | 1,061 | 829 | ||||||
Intangible assets, net | 42,201 | 52,453 | ||||||
Other non-current assets | 1,204 | 2,185 | ||||||
Non-current assets of discontinued operations | - | 44 | ||||||
Total non-current assets | 44,998 | 56,204 | ||||||
Total assets | $ | 124,177 | $ | 118,095 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 10,601 | $ | 10,314 | ||||
Accrued liabilities | 38,164 | 38,143 | ||||||
Revolving credit facility | 9,063 | 2,395 | ||||||
Current portion of debt | 1,857 | 1,857 | ||||||
Other current liabilities | 3,379 | 8,962 | ||||||
Current liabilities of discontinued operations | - | 557 | ||||||
Total current liabilities | 63,064 | 62,228 | ||||||
Non-current liabilities: | ||||||||
Debt, net of current portion | 10,895 | 10,877 | ||||||
Derivative warrant liabilities | 26,334 | 12,745 | ||||||
Other non-current liabilities | 4,918 | 4,529 | ||||||
Total non-current liabilities | 42,147 | 28,151 | ||||||
Stockholders' equity: | ||||||||
Preferred stock, par value $.0001; 50,000,000 shares authorized; no shares issued or outstanding | - | - | ||||||
Common stock, par value $.0001; 200,000,000 shares authorized; 8,976,913 and 5,972,638 shares issued and outstanding, respectively | 1 | 1 | ||||||
Additional paid-in capital | 352,500 | 347,688 | ||||||
Accumulated deficit | (333,535 | ) | (319,973 | ) | ||||
Total stockholders' equity | 18,966 | 27,716 | ||||||
Total liabilities and stockholders' equity | $ | 124,177 | $ | 118,095 | ||||
Aytu BioPharma, Inc.
Reconciliation of Net Loss to Adjusted EBITDA
(in thousands)
Three Months Ended | Year Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Net loss - GAAP | $ | (19,818 | ) | $ | (4,617 | ) | $ | (13,562 | ) | $ | (15,844 | ) | ||||
Interest expense | 730 | 1,253 | 3,703 | 5,059 | ||||||||||||
Income tax expense | 437 | 841 | 437 | 2,142 | ||||||||||||
Depreciation and amortization | 1,278 | 1,398 | 5,191 | 5,910 | ||||||||||||
Stock-based compensation expense | 113 | 243 | 576 | 2,374 | ||||||||||||
Other expense (income), net | 1,230 | (120 | ) | 512 | (870 | ) | ||||||||||
Derivative warrant liabilities loss (gain) | 9,860 | (1,463 | ) | 1,703 | 4,004 | |||||||||||
One-time transactions | - | 150 | - | 1,001 | ||||||||||||
Non-recurring legal fees | - | - | 402 | - | ||||||||||||
Restructuring costs | - | 1,912 | 2,101 | 2,156 | ||||||||||||
Impairment expense | 8,263 | - | 8,263 | - | ||||||||||||
Loss on extinguishment of debt | - | 594 | - | 594 | ||||||||||||
Pipeline research and development costs | 8 | 599 | 480 | 983 | ||||||||||||
Net (income) loss from discontinued operations, net of tax | (62 | ) | 1,239 | (620 | ) | 3,324 | ||||||||||
Adjusted EBITDA - non-GAAP | $ | 2,039 | $ | 2,029 | $ | 9,186 | $ | 10,833 | ||||||||
SOURCE: Aytu BioPharma, Inc.
View the original press release on ACCESS Newswire
FAQ
What were Aytu BioPharma's (AYTU) key financial results for fiscal 2025?
When will Aytu BioPharma launch EXXUA for major depressive disorder?
How did Aytu's ADHD Portfolio perform in fiscal 2025?
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What caused Aytu's decline in gross profit margin for fiscal 2025?
