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Aytu BioPharma Reports Fiscal 2026 Full Year and Fourth Quarter Operational and Financial Results

Aytu shifts focus to EXXUA, trading near-term revenue and margin pressure for launch investment while posting a nearly break-even Q4.

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Aytu BioPharma (AYTU) reported fiscal 2026 net revenue of $57.6 million, down 13.3% from $66.4 million in fiscal 2025, and a net loss of ($14.3) million.

EXXUA, launched in mid-January 2026, generated $6.6 million in fiscal 2026 net revenue, including $3.9 million in Q4, Aytu’s first full launch quarter. Q4 net revenue rose 6.4% year over year to $16.1 million, with ADHD Portfolio revenue at $10.4 million and Pediatric Portfolio revenue at $1.8 million. Full-year ADHD revenue declined to $45.8 million from $57.6 million, and Pediatric revenue fell to $5.1 million from $8.8 million, reflecting commercial prioritization of EXXUA and generic competition.

Fiscal 2026 gross profit was $36.8 million (64.0% margin), and Adjusted EBITDA was ($3.7) million versus $9.2 million in 2025. Q4 net loss was approximately break‑even and Adjusted EBITDA was $0.5 million. Cash and cash equivalents were $26.3 million at June 30, 2026. Reclassification of certain warrants reduced derivative warrant liabilities by $26.4 million and increased stockholders’ equity to $35.3 million.

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Positive

  • Q4 2026 net revenue up 6.4% year over year to $16.1 million
  • EXXUA launch generated $6.6 million in fiscal 2026, including $3.9 million in Q4
  • Q4 2026 net loss approximately break-even versus ($19.8) million prior year
  • Derivative warrant liabilities reduced by $26.4 million; equity increased to $35.3 million
  • Cash and cash equivalents of $26.3 million at June 30, 2026

Negative

  • Fiscal 2026 net revenue declined 13.3% to $57.6 million
  • ADHD Portfolio revenue fell to $45.8 million from $57.6 million in 2025
  • Pediatric Portfolio revenue declined to $5.1 million from $8.8 million
  • Gross margin decreased to 64.0% from 69.0%, impacted by inventory write-downs
  • Adjusted EBITDA swung to ($3.7) million from $9.2 million in 2025
  • Cash balance decreased to $26.3 million from $31.0 million year over year

News Explained

The completed fiscal 2026 results add that EXXUA remained in an early commercial launch, with more than 3,300 prescriptions in the fourth quarter, a June record of 1,261, and approximately 4,600 units shipped; management said prescribing, payer and gross-to-net patterns were still evolving.

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Market Reaction – AYTU

$2.13 $2.38 Day Range
$24.15M Market Cap

Following this news, AYTU has gained 0.90%, reflecting a mild positive market reaction. Our momentum scanner has triggered 14 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $2.25. Trading volume is exceptionally heavy at 10.6x the average, suggesting very strong buying interest.

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Market Context

On May 13, Aytu's prior earnings release disclosed EXXUA revenue of $2.4 million and a 0.89% 24-hour...
Analysis

On May 13, Aytu's prior earnings release disclosed EXXUA revenue of $2.4 million and a 0.89% 24-hour price reaction; the current release was another earnings update for the same commercial launch.

Key Figures

Q4 net revenue: $16.1 million vs. $15.1 million Full-year net revenue: $57.6 million vs. $66.4 million EXXUA net revenue: $3.9 million +5 more
Q4 net revenue
$16.1 million vs. $15.1 million
Q4 fiscal 2026 vs. Q4 fiscal 2025
Full-year net revenue
$57.6 million vs. $66.4 million
Fiscal 2026 vs. fiscal 2025
EXXUA net revenue
$3.9 million
Q4 fiscal 2026, first full quarter of launch
Full-year adjusted EBITDA
($3.7) million vs. $9.2 million
Fiscal 2026 vs. fiscal 2025
Q4 net loss
Less than ($0.1) million vs. ($19.8) million
Q4 fiscal 2026 vs. Q4 fiscal 2025
Cash and cash equivalents
$26.3 million
At June 30, 2026
EXXUA prescriptions
More than 3,300 prescriptions
Q4 fiscal 2026
June prescriptions
1,261 scripts
Record monthly level in June

Previous Earnings Reports

4 past events · Latest: May 13
Same Type 4 events
  1. May 13

    Q3 earnings report

    24h Move
    +0.9%

    Reported EXXUA revenue growth in early launch while ADHD and Pediatric revenues declined.

  2. Feb 03

    Q2 earnings report

    24h Move
    -10.3%

    Reported initial EXXUA stocking revenue amid lower quarterly revenue and a net loss.

  3. Nov 13

    Q1 earnings report

    24h Move
    +1.5%

    Reported early EXXUA launch preparation while legacy ADHD and Pediatric portfolios remained stable.

  4. Sep 23

    FY25 earnings report

    24h Move
    -17.9%

    Outlined EXXUA commercial launch plans alongside fiscal revenue growth and legacy portfolio results.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

adjusted ebitda, derivative warrant liabilities, gross-to-net, cyp3a4 inhibitors, +1 more
5 terms
adjusted ebitda financial
"Adjusted EBITDA was $0.5 million compared to $2.0 million"
Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.
derivative warrant liabilities financial
"included a $1.0 million derivative warrant liabilities gain"
Derivative warrant liabilities are the obligation a company records for outstanding warrants—contracts that give holders the right to receive cash or shares based on the company’s stock price. They matter to investors because these liabilities signal potential future cash outflows or share dilution that can reduce earnings per share, change available cash, and increase stock volatility; think of them as outstanding IOUs that may force a company to pay money or issue more shares.
gross-to-net financial
"improved gross-to-net economics and stable performance"
Gross-to-net describes the difference between a product’s total billed sales (the “sticker” or list price) and the cash a company actually keeps after subtracting discounts, rebates, returns and other deductions. For investors it matters because large or growing deductions can make reported sales look strong on paper while actual revenue and profit are much smaller, similar to a store advertising high prices but taking many coupons at checkout.
cyp3a4 inhibitors medical
"Dosage Modifications for Concomitant Use with CYP3A4 Inhibitors"
CYP3A4 inhibitors are substances that slow or block the activity of CYP3A4, a key liver enzyme that acts like a conveyor belt breaking down many medicines. When that conveyor slows, drugs can stay in the body longer and reach higher levels, which can change a treatment’s safety, dose, or how it’s prescribed; investors watch for these interactions because they affect a drug’s regulatory approval, marketability, and potential liability.
qtcF medical
"Do not escalate the EXXUA dosage if the QTcF is > 450 msec"
QTcF is the QT interval on an electrocardiogram adjusted for heart rate using the Fridericia formula; it measures how long the heart’s electrical system takes to reset between beats. Like timing how long it takes an engine to restart, an unusually long QTcF can signal a risk of dangerous heart rhythm problems, so investors watch it because drug safety or regulatory concerns tied to QTcF values can affect clinical trial outcomes, approvals and commercial prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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DENVER, CO / ACCESS Newswire / September 22, 2026 / 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 full year and fourth quarter.

Q4 Fiscal 2026 Highlights

  • Net revenue increased 6.4% to $16.1 million versus $15.1 million in Q4 fiscal 2025.
  • EXXUA net revenue was $3.9 million during Q4 fiscal 2026, the first full quarter of launch.
  • ADHD Portfolio net revenue was $10.4 million versus $13.1 million in Q4 fiscal 2025. The change in net revenue is primarily due to the Company's commercial prioritization of EXXUA and generic competition.
  • Pediatric Portfolio net revenue was $1.8 million versus $2.0 million in Q4 fiscal 2025.
  • Net loss was approximately break-even at less than ($0.1) million and included a $1.0 million derivative warrant liabilities gain, compared to a net loss of ($19.8) million in Q4 fiscal 2025, which included $18.1 million of combined impairment expense and derivative warrant liabilities loss.
  • Adjusted EBITDA was $0.5 million compared to $2.0 million in Q4 fiscal 2025. During Q4 fiscal 2026, the Company continued to make planned investments towards the commercialization of EXXUA.

Full Year Fiscal 2026 Highlights

  • Net revenue decreased 13.3% to $57.6 million versus $66.4 million in fiscal 2025.
  • EXXUA net revenue was $6.6 million during fiscal 2026. EXXUA was made commercially available in mid-December 2025, and more formally launched in mid-January 2026 following the completion of sales force training, followed by full sales force deployment in late February.
  • ADHD Portfolio, which consists of attention deficit hyperactivity disorder ("ADHD") products, net revenue was $45.8 million versus $57.6 million in fiscal 2025. The change in net revenue is primarily due to the Company's commercial prioritization of EXXUA and the introduction of generic competition.
  • Pediatric Portfolio, which consists of a line of legacy products, net revenue was $5.1 million versus $8.8 million in fiscal 2025. The change in net revenue is primarily due to the Company's commercial prioritization of EXXUA and reduced promotional emphasis on the Pediatric Portfolio.
  • Net loss of ($14.3) million compared to a net loss of ($13.6) million. Net loss in fiscal 2026 included a $4.7 million derivative warrant liabilities loss, while fiscal 2025 included $12.1 million of combined impairment expense, restructuring costs and derivative warrant liabilities loss.
  • Adjusted EBITDA was ($3.7) million compared to $9.2 million in fiscal 2025. During fiscal 2026, the Company made the aforementioned planned investments towards the commercialization of EXXUA.
  • Cash and cash equivalents were $26.3 million at June 30, 2026.

Management Discussion

"Although we remain in the early stages of the EXXUA launch, the continued momentum we saw throughout the fourth quarter further reinforces our confidence in this exciting opportunity," commented Josh Disbrow, Chief Executive Officer of Aytu. "EXXUA generated $3.9 million in net revenue during the quarter, up from $2.4 million in the third quarter, while more than 3,300 prescriptions were written, more than double the prior quarter. Monthly prescriptions increased throughout the quarter, reaching a record 1,261 scripts in June, and shipments increased nearly 40% sequentially to approximately 4,600 units, including 2,377 units in June. Just as importantly, adoption is broadening across prescribers, territories and geographies, rather than being driven by only a handful of prescribers or markets. We are seeing good conversion from titration packs to full prescriptions, patients being maintained on therapy, and refill activity continuing to build. Our recently launched national speaker programs are also increasing physician engagement, and early reimbursement dynamics have been favorable relative to our initial expectations. EXXUA remains early in its launch, and prescribing, payer and gross-to-net patterns will continue to evolve, however the trajectory is highly encouraging. We remain focused on disciplined and efficient commercial execution as we work to establish EXXUA as an important treatment option for adults living with major depressive disorder."

"Our legacy business also delivered meaningful sequential improvement during the fourth quarter and continues to provide an important financial foundation supporting the EXXUA opportunity," Disbrow continued. "ADHD Portfolio net revenue increased to $10.4 million from $9.1 million in the third quarter, driven by higher units, improved gross-to-net economics and stable performance across the existing brands. Although generic competition continues to affect Adzenys, underlying prescription demand remains generally stable with less generic penetration than many observers expected. The portfolio's sequential improvement demonstrates the durability of these brands and their attractive economics with minimal promotional spending. The ADHD Portfolio remains highly profitable on a standalone basis and continues to be an important source of cash generation. Pediatric Portfolio net revenue increased to $1.8 million from $0.9 million in the third quarter as product availability normalized following the prior supply disruption. While we are not assuming that either legacy portfolio has returned to sustained growth, their fourth-quarter performance reinforces the value and relative stability of these brands and the strength of our commercial platform. Together, they continue to support our ability to invest behind EXXUA in a measured and disciplined manner."

"Overall, we view the quarter as evidence of the operating leverage available in our model as EXXUA scales alongside the profitability and cash flow contribution from our legacy operations. Looking ahead, we are highly encouraged by EXXUA's progress, its differentiated profile and the significant opportunity within the more than $22 billion United States MDD market. When combined with the durability of our ADHD and Pediatric portfolios, disciplined expense management and a stable liquidity position, we believe Aytu is increasingly well positioned to drive sustained growth, build toward more consistent positive Adjusted EBITDA levels as fiscal 2027 progresses and create long-term shareholder value," Disbrow concluded.

Net Revenue by Product Portfolio

Three Months Ended Twelve Months Ended
June 30, June 30,
2026 2025 2026 2025
(in thousands)
EXXUA
$3,936 $- $6,574 $-
ADHD Portfolio
10,360 13,107 45,825 57,576
Pediatric Portfolio
1,810 2,017 5,135 8,769
Other*
- 11 36 37
Total net revenue
$16,106 $15,135 $57,570 $66,382

* Other includes discontinued or deprioritized products.

Q4 Fiscal 2026 Financial Results

Net revenue for the fourth quarter of fiscal 2026 was $16.1 million, compared to $15.1 million for the prior year period.

EXXUA net revenue was $3.9 million in the fourth quarter of fiscal 2026.

The ADHD Portfolio net revenue was $10.4 million in the fourth quarter of fiscal 2026, compared to $13.1 million in the prior year period. The decrease is attributable primarily to the Company's commercial prioritization of EXXUA, removal of promotion on the ADHD Portfolio and the introduction of generic competition for Adzenys.

The Pediatric Portfolio net revenue was $1.8 million in the fourth quarter of fiscal 2026, compared to $2.0 million in the prior year period. The change in net revenue is attributable primarily to the Company's commercial prioritization of EXXUA and reduced promotion of the Pediatric Portfolio.

Gross profit was $10.4 million, or 64.6% of net revenue, in the fourth quarter of fiscal 2026, compared to $10.3 million, or 67.8% of net revenue, in the same quarter last year.

Operating expenses, excluding amortization of intangible assets, restructuring costs and impairment expense, were $10.4 million in the fourth quarter of fiscal 2026 compared to $8.7 million in the prior year period. The increase is primarily a result of increased EXXUA commercialization investments.

Net loss during the fourth quarter of fiscal 2026 was approximately break-even at less than ($0.1) million, or ($0.00) net loss per share basic and diluted, compared to a net loss of ($19.8) million, or ($2.92) net loss per share basic and diluted, in the prior year period.

The fiscal 2026 fourth quarter results included a $1.0 million derivative warrant liabilities gain, while the fiscal 2025 fourth quarter results included $8.3 million of impairment expense and a $9.9 million derivative warrant liabilities loss.

Adjusted EBITDA was $0.5 million for the fourth quarter of fiscal 2026 compared to $2.0 million in the year ago period. The change primarily relates to planned investments towards the commercialization of EXXUA.

Full Year Fiscal 2026 Financial Results

Net revenue for full year fiscal 2026 was $57.6 million, compared to $66.4 million for the prior year.

EXXUA net revenue was $6.6 million. EXXUA was made commercially available in mid-December 2025, and more formally launched in mid-January 2026 following the completion of sales force training, followed by full sales force deployment in late February.

The ADHD Portfolio net revenue was $45.8 million in full year fiscal 2026, compared to $57.6 million in the prior year period. The decrease is attributable primarily to the Company's commercial prioritization of EXXUA, removal of promotion on the ADHD Portfolio and the introduction of generic competition for Adzenys XR-ODT® ("Adzenys").

The Pediatric Portfolio net revenue was $5.1 million in full year fiscal 2026, compared to $8.8 million in the prior year period. The change in net revenue is attributable primarily to the Company's commercial prioritization of EXXUA and reduced promotion of the Pediatric Portfolio.

Gross profit was $36.8 million, or 64.0% of net revenue, in full year fiscal 2026, compared to $45.8 million, or 69.0% of net revenue, in the prior year. The decrease in gross profit percentage is primarily related to lower net revenue in the ADHD and Pediatric Portfolios as the Company focused on the commercialization and launch of EXXUA, a $2.2 million inventory write-down in fiscal 2026 compared to $0.3 million in fiscal 2025 primarily resulting from a shift from the Company's Adzenys branded products to the Adzenys authorized generic products, and the absence of a $3.3 million fiscal 2025 increase in estimated variable consideration that had no corresponding cost of goods sold impact.

Operating expenses, excluding amortization of intangible assets, restructuring costs and impairment expense, were $42.6 million in full year fiscal 2026 compared to $39.6 million in the prior year. The increase is primarily a result of increased EXXUA commercialization investments, including higher spending on promotional materials, consulting services, the Company's sales force and marketing activities, partially offset by lower research and development expense.

Net loss during full year fiscal 2026 was ($14.3) million, or ($1.16) net loss per share basic and diluted, compared to a net loss of ($13.6) million, or ($2.16) net loss per share basic and diluted, in the prior year.

The full year fiscal 2026 results were impacted by a $4.7 million derivative warrant liabilities loss primarily driven by an increase in the Company's stock price, partially offset by gains from the exercise of liability classified warrants. The full year fiscal 2025 results included $8.3 million of impairment expense, $2.1 million of restructuring costs and a $1.7 million derivative warrant liabilities loss.

Adjusted EBITDA was ($3.7) million in full year fiscal 2026, compared to $9.2 million in the prior year period. The change primarily relates to planned investments towards the commercialization of EXXUA.

As previously announced, on March 31, 2026, the Company amended and restated certain warrants, which resolved the accounting ambiguity that previously required these warrants to be classified as liabilities rather than equity. As a result, the Company reduced its derivative warrant liabilities by $26.4 million and increased stockholders' equity by that same amount. As of June 30, 2026, derivative warrant liabilities were $1.2 million and stockholders' equity was $35.3 million, compared to $26.3 million and $19.0 million, respectively, at June 30, 2025.

Cash and cash equivalents were $26.3 million at June 30, 2026, compared to $31.0 million at June 30, 2025.

Conference Call Details

Date and Time: Tuesday, September 22, 2026, 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 504506.

Webcast Information: The webcast will be accessible live and archived at https://www.webcaster5.com/Webcast/Page/2142/54094, 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 6, 2026, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 54094.

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 5-HT1A receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increase 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.

INDICATIONS AND USAGE

EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.

DOSAGE AND ADMINISTRATION

Important Recommendations Prior to Initiating and During Treatment with EXXUA

Electrocardiogram and Electrolyte Monitoring

Correct electrolyte abnormalities prior to initiating EXXUA. In patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA.

Perform an electrocardiogram (ECG) prior to initiating EXXUA, during dosage titration, and periodically during treatment. Do not initiate EXXUA if QTc is > 450 msec at baseline. Monitor ECGs more frequently if EXXUA is used:

  • concomitantly with drugs known to prolong the QT interval
  • in patients who develop QTc ≥ 450 msec during treatment
  • in patients with a significant risk of developing torsade de pointes

Do not escalate the EXXUA dosage if the QTcF is > 450 msec.

Bipolar Disorder, Mania, and Hypomania Screening

Screen patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with EXXUA.

Important Administration Instructions

Take EXXUA orally with food at approximately the same time each day. Swallow tablets whole. Do not split, crush, or chew EXXUA.

Recommended Dosage

The recommended starting dosage of EXXUA is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to 36.3 mg orally once daily on Day 4 and further titrated to 54.5 mg orally once daily after Day 7 and to 72.6 mg orally once daily after an additional week. The maximum recommended daily dosage of EXXUA is 72.6 mg once daily.

Dosage Recommendations in Geriatric Patients

The recommended starting dosage of EXXUA in geriatric patients is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to maximum recommended dosage of 36.3 mg orally once daily after Day 7.

Recommended Dosage in Patients with Renal Impairment

The recommended starting dosage of EXXUA in patients with creatinine clearance < 50 mL/min is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7. The recommended dosage in patients with creatinine clearance ≥ 50 mL/min is the same as in patients with normal renal function.

Recommended Dosage in Patients with Hepatic Impairment

The recommended starting dose of EXXUA in patients with moderate (Child-Pugh B) hepatic impairment is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7. EXXUA is contraindicated in patients with severe (Child-Pugh C) hepatic impairment. The recommended dosage in patients with mild (Child-Pugh A) hepatic impairment is the same as patients with normal hepatic function.

Dosage Modifications for Concomitant Use with CYP3A4 Inhibitors

Reduce the EXXUA dose by 50% when used concomitantly with a moderate CYP3A4 inhibitor. EXXUA is contraindicated in patients receiving strong CYP3A4 inhibitors.

Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant

At least 14 days must elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with EXXUA. Conversely, at least 14 days must be allowed after stopping EXXUA before starting an MAOI antidepressant.

CONTRAINDICATIONS

EXXUA is contraindicated in patients:

  • with known hypersensitivity to gepirone or components of EXXUA.
  • with prolonged QTc interval > 450 msec at baseline.
  • with congenital long QT syndrome.
  • receiving concomitant strong CYP3A4 inhibitors.
  • with severe hepatic impairment.
  • taking, or within 14 days of stopping, MAOIs due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome. Starting EXXUA in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated.

WARNINGS AND PRECAUTIONS

Suicidal Thoughts and Behaviors in Adolescents and Young Adults

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients aged 24 years and younger was greater than in placebo-treated patients.

There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD.

*EXXUA is not approved for use in pediatric patients.

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing EXXUA, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

QT Prolongation

EXXUA prolongs the QTc interval.

  • EXXUA is contraindicated in patients with congenital long QT syndrome and in patients with severe hepatic impairment or in patients receiving concomitant strong CYP3A4 inhibitors as they increase EXXUA plasma concentrations.
  • Do not initiate EXXUA if QTc is > 450 msec at baseline.
  • Correct electrolyte abnormalities prior to EXXUA initiation. In patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA.
  • Perform an ECG prior to EXXUA initiation, during dosage titration, and periodically during treatment. Monitor patients with ECGs more frequently:
    • If EXXUA is used concomitantly with drugs known to prolong the QT interval.
    • In patients who develop QTc ≥ 450 msec during treatment with EXXUA. Do not escalate the EXXUA dosage if QTcF is > 450 msec.
    • In patients with a significant risk of developing torsade de pointes, including those with uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism.
  • Reduce the EXXUA dosage when used concomitantly with moderate CYP3A4 inhibitors, as they may increase EXXUA concentrations.

Serotonin Syndrome

Concomitant use of EXXUA with SSRIs or tricyclic antidepressants may cause serotonin syndrome, a potentially life-threatening condition with changes including altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor. The concomitant use of EXXUA with MAOIs is contraindicated. In addition, do not initiate EXXUA in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking EXXUA discontinue EXXUA before initiating treatment with the MAOI.

If concomitant use of EXXUA with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms. Discontinue EXXUA and/or concomitant serotonergic drug immediately if the above symptoms occur and initiate supportive symptomatic treatment.

Activation of Mania or Hypomania

Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating treatment with EXXUA, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). EXXUA is not approved for use in treating bipolar depression.

ADVERSE REACTIONS

Most common adverse reactions (incidence of ≥5% and at least twice incidence of placebo) were dizziness, nausea, insomnia, abdominal pain, and dyspepsia.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Suicidal Thoughts and Behaviors in Adolescents and Young Adults
  • QT Prolongation
  • Serotonin Syndrome
  • Activation of Mania or Hypomania

To report SUSPECTED ADVERSE REACTIONS, contact Aytu BioPharma at 1-855-298-8246 or http://www.exxua.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including EXXUA, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

Lactation

There is no data on the presence of gepirone in human milk, the effects on the breastfed infant, or the effects on milk production. Gepirone is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. There are reports of breastfed infants exposed to other serotonergic antidepressants experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EXXUA and any adverse effects on the breastfed infant from EXXUA or from the underlying maternal condition.

OVERDOSAGE

In clinical studies, cases of acute ingestions up to 454 mg (6.25 times the maximum recommended dose) of EXXUA alone or in combination with other drugs, were reported. Signs and symptoms reported with overdose of EXXUA at doses up to 454 mg included vomiting and transient incomplete bundle branch block; an unknown dose of EXXUA produced altered level of consciousness and a 60-second convulsion. No specific antidotes for EXXUA are known. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Please see 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) 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 (loss) 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 Twelve Months Ended
June 30, June 30,
2026 2025 2026 2025
Net revenue
$16,106 $15,135 $57,570 $66,382
Cost of goods sold
5,697 4,881 20,752 20,551
Gross profit
10,409 10,254 36,818 45,831
Operating expenses:
Selling and marketing
6,120 4,781 23,369 20,906
General and administrative
4,305 3,696 19,272 17,379
Research and development
- 216 - 1,326
Amortization of intangible assets
761 921 2,492 3,683
Restructuring costs
- - - 2,101
Impairment expense
- 8,263 - 8,263
Total operating expenses
11,186 17,877 45,133 53,658
Loss from operations
(777) (7,623) (8,315) (7,827)
Other income (expense), net
173 (1,230) 713 (512)
Interest expense
(383) (730) (1,895) (3,703)
Derivative warrant liabilities (loss) gain
983 (9,860) (4,734) (1,703)
Loss from continuing operations before income tax expense
(4) (19,443) (14,231) (13,745)
Income tax expense
(11) (437) (21) (437)
Net loss from continuing operations
(15) (19,880) (14,252) (14,182)
Net income (loss) from discontinued operations, net of tax
- 62 - 620
Net loss
$(15) $(19,818) $(14,252) $(13,562)
Basic and diluted weighted-average common shares outstanding
19,323,098 6,791,532 12,318,817 6,279,744
Net (loss) income per share:
Basic and diluted - continuing operations
$(0.00) $(2.93) $(1.16) $(2.26)
Basic and diluted - discontinued operations, net of tax
$- $0.01 $- $0.10
Basic and diluted - net loss
$(0.00) $(2.92) $(1.16) $(2.16)

Aytu BioPharma, Inc.
Unaudited Consolidated Balance Sheets
(in thousands, except share data)

June 30,
2026 2025
ASSETS
Current assets:
Cash and cash equivalents
$26,308 $30,952
Accounts receivable, net
22,779 31,155
Inventories
6,860 11,434
Prepaid expenses and other current assets
5,814 5,638
Total current assets
61,761 79,179
Non-current assets:
Property and equipment, net
385 532
Operating lease right-of-use assets
857 1,061
Intangible assets, net
41,403 42,201
Other non-current assets
601 1,204
Total non-current assets
43,246 44,998
Total assets
$105,007 $124,177
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$11,284 $10,601
Accrued liabilities
35,205 38,164
Revolving credit facility
6,074 9,063
Current portion of debt
1,857 1,857
Other current liabilities
239 3,379
Total current liabilities
54,659 63,064
Non-current liabilities:
Debt, net of current portion
9,101 10,895
Derivative warrant liabilities
1,199 26,334
Other non-current liabilities
4,774 4,918
Total non-current liabilities
15,074 42,147
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; 10,728,208 and 8,976,913 shares issued and outstanding, respectively
1 1
Additional paid-in capital
383,060 352,500
Accumulated deficit
(347,787) (333,535)
Total stockholders' equity
35,274 18,966
Total liabilities and stockholders' equity
$105,007 $124,177

Aytu BioPharma, Inc.
Unaudited Reconciliation of Net (Loss) Income to Adjusted EBITDA
(in thousands)

Three Months Ended Year Ended
June 30, June 30,
2026 2025 2026 2025
Net loss - GAAP
$(15) $(19,818) $(14,252) $(13,562)
Interest expense
383 730 1,895 3,703
Income tax expense
11 437 21 437
Depreciation and amortization
1,121 1,278 3,930 5,191
Stock-based compensation expense
146 113 691 576
Other expense (income), net
(173) 1,230 (713) 512
Derivative warrant liabilities loss (gain)
(983) 9,860 4,734 1,703
Non-recurring legal fees
- - - 402
Restructuring costs
- - - 2,101
Impairment expense
- 8,263 - 8,263
Pipeline research and development costs
- 8 - 480
Net (income) loss from discontinued operations, net of tax
- (62) - (620)
Adjusted EBITDA - non-GAAP
$490 $2,039 $(3,694) $9,186

SOURCE: Aytu BioPharma, Inc.



View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How did Aytu’s product portfolios perform in Q4 fiscal 2026?

In Q4 fiscal 2026, EXXUA net revenue was $3.9 million in its first full launch quarter. The ADHD Portfolio generated $10.4 million versus $13.1 million a year earlier, with the decline attributed to EXXUA prioritization, removal of promotion, and generic competition for Adzenys. The Pediatric Portfolio delivered $1.8 million versus $2.0 million, reflecting EXXUA focus and reduced promotion.

What were the key drivers of Aytu’s lower gross margin in fiscal 2026?

Fiscal 2026 gross margin was 64.0% versus 69.0% in 2025. The company cites lower net revenue in the ADHD and Pediatric portfolios as resources shifted to EXXUA, a $2.2 million inventory write-down versus $0.3 million in 2025 tied primarily to a shift from Adzenys branded to authorized generic products, and the absence of a $3.3 million 2025 increase in estimated variable consideration that carried no cost of goods sold.

How did operating expenses change for Aytu in fiscal 2026?

Operating expenses, excluding amortization of intangible assets, restructuring costs and impairment expense, were $42.6 million in fiscal 2026 compared to $39.6 million in 2025. The increase was mainly due to higher EXXUA commercialization spending on promotional materials, consulting, sales force and marketing, partially offset by lower research and development expense.

What impact did warrant accounting changes have on Aytu’s balance sheet?

On March 31, 2026, Aytu amended and restated certain warrants, resolving an accounting ambiguity that had required liability classification. As a result, derivative warrant liabilities decreased by $26.4 million and stockholders’ equity increased by the same amount. At June 30, 2026, derivative warrant liabilities were $1.2 million and stockholders’ equity was $35.3 million, compared with $26.3 million and $19.0 million, respectively, a year earlier.

When and how can investors access Aytu’s fiscal 2026 earnings conference call and replay?

The conference call is scheduled for Tuesday, September 22, 2026, at 4:30 p.m. Eastern time. U.S. callers can dial (888) 506-0062 and international callers can dial +1 (973) 528-0011 using access code 504506. A live and archived webcast will be available at this link and via the Investors section of Aytu’s website under Events & Presentations. A replay is available until October 6, 2026, at (877) 481-4010 for U.S. callers or +1 (919) 882-2331 for international callers with replay code 54094.

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