AYTU

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aytu BioPharma Inc (NASDAQ:AYTU) reported strong initial traction for Exua, with over 1,300 prescriptions written in Q3, indicating early adoption by physicians. The company saw a 26% month-over-month growth in prescriptions from March to April, demonstrating increasing demand. Exua's launch strategy is focused and disciplined, targeting high-prescribing psychiatry practices, which is yielding positive results. The RxConnect program is effectively reducing barriers to access, with over 70% of prior authorizations being approved. Positive patient feedback, including reports of life-changing experiences, suggests Exua is meeting a significant unmet need in major depressive disorder treatment. Net revenue for the third quarter decreased by 33% year-over-year, primarily due to a strategic shift in focus and generic competition. The ADHD portfolio experienced a significant decline in net revenue, dropping from $15.4 million to $9.1 million. Gross profit margin decreased from 69% to 61% due to inventory write-downs and shifts in product focus. The company reported a net loss of $5.6 million for the quarter, compared to a net income of $4 million in the prior-year period. The pediatric portfolio also saw a decline in net revenue, impacted by payer mix and increased returns. Warning! GuruFocus has detected 3 Warning Signs with AYTU. Is AYTU fairly valued? Test your thesis with our free DCF calculator. Q: Hey, Ryan, just doing some back of the envelope math, I kind of figured about a million and a half in quote-unquote stocking revenue in the XUA number for the quarter. Is that a reasonable assumption? A: Yeah, that is a pretty accurate calculation. - Ryan Sellhorn, CFO Q: Josh, you mentioned some efficacy anecdotes in the prepared remarks, but I was curious what you've heard back specifically related to weight gain and sexual side effects that the physicians have provided you with any feedback on that? A: On weight gain, it's too early to tell, but we're not hearing anything unexpected. Regarding sexual side effects, we've received very positive feedback, with some patients experiencing restored libido. - Josh Disbrow, CEO Q: You mentioned something like 10-ish percent of your customers had written EXUA, but what's been the writing activity of non-customers, so to speak, people that you haven't called on? Is there any of that? A: Yes, we've seen significant prescribing from states where we have no physical presence, which is highly encouraging. We've had prescriptions in 41 or 42 states. - Josh Disbrow, CEO Q: In terms of reimbursement, could you provide some color on how many of those prior authorizations are getting approved on the first pass versus how many require back and forth? A: We're seeing over 70% of prior authorizations getting approved, which is very encouraging. Even when prior authorizations aren't done or don't go through, we cover those prescriptions initially. - Josh Disbrow, CEO Q: Do you have an idea of how many of these patients are like second line versus third or fourth? A: It's very heterogeneous, but we know that in the 60-plus percent range, patients are being switched, suggesting they've been on multiple therapies. It's likely between third and fifth line. - Josh Disbrow, CEO Q: In terms of patient and prescriptions, is it normally prescribed for 30 days, and then after the 30 days, they would have to either go back to the physician or they will get automatic refills? A: Patients start with a 14-day titration pack, then move to a 30-day prescription. After that, they typically get a prescription for three or six months. - Josh Disbrow, CEO Q: Are you seeing, is that your continued plan going forward or just to target the big metro markets first and to move to the smaller markets? A: We're actively contemplating moving into select markets quicker than anticipated, especially where we've identified a groundswell of physicians prescribing the product. - Josh Disbrow, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.

EXXUA -- with only a partial quarter of full sales force support -- contributed $2.4 million in net revenue supported by rapid monthly compounding script growth rates Total net revenue of $12.4 million Adjusted EBITDA1 of $(2.8) million, which includes EXXUA&trade; (gepirone) extended-release tablets ("EXXUA") launch investments as the Company enters the over $22 billion United States prescription major depressive disorder ("MDD") market $26.7 million cash balance at March 31, 2026 Company to host conference call and webcast today, May 13, 2026, at 4:30 p.m. Eastern time DENVER, CO / ACCESS Newswire / May 13, 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 third quarter. Q3 Fiscal 2026 Highlights Net revenue of $12.4 million versus $18.5 million in Q3 fiscal 2025. EXXUA net revenue was $2.4 million during Q3 fiscal 2026. EXXUA was only made commercially available in mid-December 2025, and more formally launched in mid-January 2026 following the completion of sales force training highlighting strong adoption in the initial weeks of the full launch. ADHD Portfolio, which consists of attention deficit hyperactivity disorder ("ADHD") products, net revenue was $9.1 million versus $15.4 million in Q3 fiscal 2025. The change in net revenue is primarily due to a transition of sales force prioritization toward EXXUA and the recent introduction of generic competition. Pediatric Portfolio, which consists of a line of legacy products, net revenue was $0.9 million versus $3.1 million in Q3 fiscal 2025. Net loss of $5.6 million included a $1.3 million derivative warrant liability loss primarily due to the increase in the Company's stock price, compared to net income of $4.0 million in Q3 fiscal 2025, which included a $2.3 million derivative warrant liability gain. Adjusted EBITDA was $(2.8) million compared to $3.9 million in Q3 fiscal 2025. During Q3 fiscal 2026, the Company made planned investments towards the launch of EXXUA. Cash and cash equivalents were $26.7 million at March 31, 2026. Management Discussion "Although we remain in the very early stages of the EXXUA launch, the initial traction we are seeing is highly encouraging," commented Josh Disbrow, Chief Executive Officer of Aytu. "Since the formal launch in mid-January, we have seen strong month-over-month growth, with more than 1,300 prescriptions written in the quarter by more than 450 unique prescribers. Importantly, the growth we are seeing in titration packs, together with early refill activity, reinforces our belief that EXXUA is beginning to have a meaningful impact for patients and that prescribers are increasingly recognizing its differentiated role in the treatment of MDD. We are also pleased with the execution across our channel partners, as sales of more than 3,200 units demonstrate their preparedness to support the compounding growth trajectory we anticipate as awareness, access and utilization continues to expand. While the first few months of any launch naturally include noise as coverage, gross-to-net dynamics and pharmacy ordering and prescribing patterns settle, the trends we are seeing are quite positive. Overall, we are very pleased with the launch fundamentals to date and remain focused on driving disciplined, efficient commercial execution as we work to build EXXUA into an important treatment option for the millions of Americans living with major depressive disorder." "Our legacy business, including our ADHD and Pediatrics portfolios, continue to provide an important foundation for Aytu as we transition and prioritize resources behind the high-growth EXXUA opportunity," Disbrow continued. "As expected, the decrease in ADHD Portfolio net revenue during the quarter was primarily attributable to that strategic transition of sales force focus toward EXXUA, which started late last summer, as well as the recent introduction of generic competition for Adzenys XR-ODT®. That said, we continue to believe our ADHD Portfolio will remain a meaningful contributor moving forward and given the level of commercial support currently behind the portfolio, our ADHD Portfolio remains highly profitable on a standalone basis and continues to demonstrate the durability of these brands and the attractive economics of our commercial platform. Our Pediatric Portfolio net revenue decrease is attributable primarily to payor changes that have impacted prescribing and an increase in returns. As we continue to execute the EXXUA commercialization plans, we remain focused on balancing disciplined investment in our highest-growth opportunity with continued profitability and cash generation from our legacy operations." "Looking ahead, we are extremely excited by EXXUA's unique and transformational opportunity, supported by a large $22 billion market, rapid initial adoption, strong refill rates and attractive unit economics. When combined with our effective and efficient launch strategy and the cash flow contribution from our legacy operations, we believe these dynamics position Aytu to drive sustained growth and long-term shareholder value," Disbrow concluded. Net Revenue by Product Portfolio ____________________ * Other includes discontinued or deprioritized products. Q3 Fiscal 2026 Financial Results Net revenue for the third quarter of fiscal 2026 was $12.4 million, compared to $18.5 million for the prior year period. EXXUA net revenue was $2.4 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. Net revenue is attributable to a combination of scripts written and filled during the quarter, as well as inventory channel stocking to meet prescription growth expectations. The ADHD Portfolio net revenue was $9.1 million in the third quarter of fiscal 2026, compared to $15.4 million in the prior year period. The decrease is attributable to a decrease in total prescriptions primarily due to broader deemphasis in marketing of the ADHD Portfolio as the Company's marketing efforts have shifted towards EXXUA, which is now the centerpiece of its commercial efforts, as well as the introduction of Adzenys XR-ODT® ("Adzenys") generic competition. The Pediatric Portfolio net revenue was $0.9 million in the third quarter of fiscal 2026, compared to $3.1 million in the prior year period. The change in net revenue is attributable primarily to payor changes impacting prescribing of the Pediatric Portfolio and an increase in returns. Gross profit was $7.6 million, or 61% of net revenue, in the third quarter of fiscal 2026, compared to $12.8 million, or 69% of net revenue, in the same quarter last year. The decrease in gross profit percentage is primarily related to a $6.0 million decrease in net revenue driven by a broader deemphasis in marketing towards the ADHD Portfolio and payor changes affecting the Pediatric Portfolio as our marketing efforts have shifted from the ADHD Portfolio towards EXXUA and a $0.7 million inventory write-down recorded to cost of goods sold primarily resulting from a shift from our Adzenys branded products to the Adzenys generic products. Operating expenses, excluding amortization of intangible assets, were $10.9 million in the third quarter of fiscal 2026 compared to $9.5 million in the prior year period. The increase is primarily a result of increased EXXUA launch investments partially offset by improved operational efficiencies such as reduced facilities expense. Net loss during the third quarter of fiscal 2026 was $5.6 million, or $0.53 net loss per share basic compared to net income of $4.0 million, or $0.65 net income per share basic, in the prior year period. The fiscal 2026 and fiscal 2025 third quarter results were impacted by derivative warrant liability loss of $1.3 million and a gain of $2.3 million, respectively, primarily due to changes in the Company's stock price. Adjusted EBITDA was $(2.8) million for the third quarter of fiscal 2026 compared to $3.9 million in the year ago period. The change primarily relates to planned investments towards the launch 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 on March 31, 2026, while significantly reducing future non-cash earnings volatility associated with derivative warrant liability gains and losses. As of March 31, 2026, stockholders' equity was $35.1 million compared to $14.2 million at December 31, 2025. As of March 31, 2026, combining both equity classified prefunded warrants and issued and outstanding common shares, there were 19.5 million shares utilized for calculating the basic weighted-average shares outstanding for earnings per share purposes. Cash and cash equivalents were $26.7 million at March 31, 2026, compared to $31.0 million at June 30, 2025. Conference Call Details Date and Time: Wednesday, May 13, 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 273453. Webcast Information: The webcast will be accessible live and archived at https://www.webcaster5.com/Webcast/Page/2142/53861, 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 May 27, 2026, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 53861. 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, who are receiving diuretics or glucocorticoids, or have a history or 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. [email protected] Robert Blum Lytham Partners [email protected] Aytu BioPharma, Inc. Unaudited Consolidated Statements of Operations (in thousands, except share and per share data) Aytu BioPharma, Inc. Unaudited Consolidated Balance Sheets (in thousands, except share data) Aytu BioPharma, Inc. Unaudited Reconciliation of Net (Loss) Income to Adjusted EBITDA (in thousands) SOURCE: Aytu BioPharma, Inc. View the original press release on ACCESS Newswire

Aytu BioPharma (NASDAQ:AYTU) released third-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below. This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/. The full earnings call is available at https://www.webcaster5.com/Webcast/Page/2142/53861 Aytu Biopharma Inc reported a net revenue of $12.4 million for Q3 2026, down 33% year over year, impacted by a strategic shift in sales focus and the introduction of generic competition. The company launched EXUA, a treatment for major depressive disorder, with 1,300 prescriptions written in Q3, contributing $2.4 million in revenue, and showing strong early adoption and refill activity. Aytu Biopharma Inc is focusing on a disciplined and targeted commercial strategy for EXUA, with plans to expand market reach and maintain financial discipline while leveraging their RX Connect platform to improve patient access. Despite a decrease in the ADHD and pediatric portfolios, the company remains positive about EXUA's growth potential and its role as a significant growth driver. Management expressed confidence in EXUA's early success and positive feedback from prescribers and patients, stating that the product addresses a significant unmet need in the market. OPERATOR Good day. Welcome to the Aytu Biopharma Inc fiscal 2026 Q3 earnings call. This time, all participants are in listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press Star 0 on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Robert Bloom. Investor Relations. You may begin. Robert Bloom (Investor Relations) Thank you very much and good afternoon everyone. As the operator indicated, during today's call we will be discussing Aytu Biopharma Inc's fiscal 2026 third quarter operational and financial results for the period ended March 31, 2026. Joining us on today's call is a2's Chief Executive Officer Josh Disbrow and Ryan Selhorn, the company's Chief Financial Officer. At the conclusion of today's prepared remarks, we'll open the call for a question and answer session. I'd like to remind everyone that today's call is being recorded. A replay of today's call will be available by using the telephone numbers and conference ID provided in the press release issued earlier today or by utilizing the link on the company's website under Events and Presentations. Finally, I'd also like to call to your attention the customary safe harbor disclosure regarding forward looking information. The conference call today will contain certain forward looking statements, including statements regarding the goals, strategies, beliefs, expectations and future potential operating results of Aytu Biopharma Inc Biopharma Inc. Although management believes these statements are reasonable based on estimates, assumptions and projections, as of today, these statements are not guarantees of future performance. Time sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks, uncertainties and other factors, including but not limited to the factors set forth in the company's filings with the SEC. Aytu Biopharma Inc undertakes no obligation to update or revise any of these forward looking statements except as required by law. With that said, let me turn the call over to Josh Disbrow, Chief executive officer of Aytu Biopharma Inc Biopharma. Josh, please proceed. Josh Disbrow (Chief Executive Officer) Thanks, Robert and welcome everyone. I'm very pleased to be speaking with you today following what has been an exciting first partial quarter of commercial launch activity for Exua. As we've discussed, EXUA represents a significant new opportunity for A2. It's the first and only selective serotonin 5 HT1A receptor agonist ever approved by the FDA for the treatment of major depressive disorder in adults. Exua is already demonstrating very solid growth trajectory within the MDD category. During our last call and during our Investor Day back in January, we spent meaningful time in the market opportunity, the clinical rationale, the unmet need in MDD, and the strategy behind our commercial launch. Today I want to focus more directly on execution and some of the things we're seeing with respect to early adoption. Simply said, while we were still very early in the launch, the fundamentals we are seeing are highly encouraging and the launch is progressing very well. So let's dive in. As most of you are aware, we moved from initial commercial availability in our second fiscal quarter in December into a more formalized launch phase during our third fiscal quarter. XUO was made commercially available back in mid December. The initial tranche of the sales organization completed training in January, while broader field deployment of the full 40 plus sales representatives didn't actually begin until late February early March. That timing is important. While Q3 was our first meaningful commercial quarter, it was still only a partial quarter of full sales support and commercial deployment, with roughly one third of the sales force only getting into the field in March. So we're just getting started. The most important point here though, is that physicians are already writing EXUA patients are beginning therapy, and very early refill activity is already becoming evident. In Q3, more than 1300 prescriptions were written for ECSUA. The monthly progression is particularly encouraged, with prescriptions increasing from about 200 in January to about 400 in February to over 700 in March. That type of sequential growth is exactly what we'd hope we would see in the early stage of a launch. As awareness builds, our representatives increase their reach and frequency and as physicians begin to identify patients who may be appropriate for Exua. Importantly, that momentum has continued. In April, we saw over 920 prescriptions written up from the 700 in March. That's a 26% month over month sequential growth rate. Further, we shipped over 1300 units shipped in April, which is 51% sequential growth, and that's more than the prescriptions generated in the entire first quarter. While it's early, and we will avoid over extrapolating from any short period term of data, that continued month over month acceleration clearly demonstrates that physician interest is building and that the launch is getting traction. We're also encouraged by the breadth of early prescriber adoption. During the quarter, more than 450 unique prescribers wrote ECSUA prescriptions. That is meaningful because our initial focus call universe is approximately 3,500 to 4,000 highly targeted prescribers. So at this very early stage, already 10 to 13% of our target universe has written ECUA, and yet again we're just getting started in building a solid base of physician adoption. We believe this points to a substantial opportunity ahead as the sales force actively increases, as our access initiatives mature, and as peer to peer and rep based education expands. As most of you know, unit sales and prescription counts are not the same measure units reflect product moving through the channel and into distribution networks and ultimately into pharmacies, while prescriptions reflect what prescriptions are writing, what physicians rather are writing for patients. In a launch. Those numbers can move at different rates because of channel stocking, titration pack and full prescription ordering, refill timing, et cetera. With that said, during Q3 gross unit sales were 3,335 units consisting of 1,807 30 count units or full 30 day prescriptions and 1,500 titration units since launch. Total gross unit sales are 3,881 units consisting of just under 2,030 count bottles at 1,991 and 1,890 titration units. So again, highly encouraging numbers at this very early stage. When we look at the combined picture, we see a launch that is doing what we expected it to do. Physicians are beginning to prescribe, patients are starting and staying on therapy, titration packs are being utilized, channel partners are ordering and they're already reordering product. Very importantly, refills are beginning to come through and we're seeing momentum build month over month over month. Taking a Step Back A key reason we're encouraged by the launch is that the elements of our launch plan are now moving into the market and functioning as they had been designed. We built this launch to be disciplined, efficient and scalable. Initially, we are not trying to outspend larger competitors. Instead, we're being very disciplined by focusing on the prescribers most likely to understand the unmet need, evaluate ECUA's differentiated profile, value our access programs, and become early adopters. Our sales organization is specifically prioritizing high value, high prescribing psychiatry practices. Our customer targeting has been informed by market data, branded therapy, adoption behavior, existing A2 relationships, and insights gained from our RX Connect platform. We believe that this is the right approach for ECSU at this stage. The product will not benefit from broad, unfocused promotion at this important time. Right now it needs focused engagement with clinicians who treat high numbers of MDD patients every day and who understand the limitations of existing therapies and are looking for new treatment options. The phased deployment of the sales team has also been intentional with only a partial quarter of full sales force support. The early prescription and prescriber numbers are even more encouraging. We believe there remains meaningful room for growth through increased reach and frequency and of course execution against the target universe that's already been identified. Again, this is just the beginning without a full quarter of promotion even in the books. Yet a 2 Rx Connect has been and will continue to be a core pillar of the actual launch. Our objective is to remove friction for both prescribers and patients, particularly in the early months when coverage policies and payer processes are still developing. Through RX Connect, commercially insured patients have a predictable and supported pathway to access Exuote, including a no cost 14 day titration pack and guaranteed access through the early treatment period for commercially insured patients. Specifically, that allows clinicians and patients to evaluate the medicine based on clinical response rather than on early administrative or payer driven barriers. This is particularly important in major depressive disorder where patients and physicians need confidence that therapy can be initiated and continued long enough to assess response and tolerability. By reducing uncertainty at the point of prescribing, Rx Connect helps align our commercial model with real world clinical needs. We're also seeing our channel partners execute well. The more than 3,300 units sold during the quarter demonstrates preparedness across the distribution network to support the current prescription demand. Along with the growth we're seeing, the early launch period is not only about demand generation. It is also about making sure that when a physician prescribes ECSTUA and a patient is ready to begin therapy, that product is available and the process is smooth. The qualitative feedback from the field remains consistent with the launch thesis we had laid out previously. Physicians understand that many patients with MDD do not achieve adequate outcomes with existing therapies or struggle with tolerability issues that can affect adherence. ACTUA gives these patients and these clinicians a differentiated option with a novel mechanism of action and that message is clearly resonating as it relates to physician adoption that will build methodically as it always does. Physicians often start by identifying specific patient types where they believe EXUA may be especially relevant, or in some cases, patients who have been through a long list of antidepressants already and they're simply searching for something new. Our job is to continue educating, supporting, access and building confidence through clinical experience. The fact that hundreds of prescribers have already written EXUA gives us confidence that this process is working well and that even very challenging patients in fact are reporting positive results we're also highly encouraged by the early refill activity. Refills are an important proof point because they demonstrate that initial prescriptions are progressing into continued therapy. The base of patients is still relatively small, but the presence of refill activity, together with growth in titration utilization and sequential prescription increases, clearly demonstrates that prescribing is picking up and that ECSTUA is beginning to establish a role in the treatment of MDD. Most importantly, the patient feedback we're hearing through our prescribers is nothing short of outstanding. Phrases from even difficult patients like life changing and a specific patient saying he has never felt this good in his entire life are coming through at this point almost daily. Yet again, we're just getting started. We're highly confident we'll continue to hear more and more of these patient success stories as we move ahead. Our priorities are clear. First, we will continue increasing prescriber calls within the initial target prescriber universe. We are only again at the beginning of that process and our current prescriber base represents a small a tiny fraction of the opportunity we have identified and an even smaller fraction of who will ultimately be prescribing Exua. Second, we will continue leveraging RX Connect to support access and reduce friction. We expect access reimbursement, gross to net and refill dynamics to all become clearer as the launch matures, and we'll remain disciplined in adapting our approach based on the data. By the way, the early signs on both coverage and reimbursement rates are extremely positive across both commercial and government payer channels. We're seeing solid and increasingly good coverage of ECUA among commercial plans and Medicaid and Medicare scripts are making up an increasing portion of the overall script load. It remains early, but many of the positive payer dynamics we've spoken about prelaunch are in fact bearing out. Third, we will continue investing in scientific engagement, KOL development, peer to peer programs, and publication and medical Congress activity. We believe Echua has a differentiated profile and the more physicians understand where ECZUA fits into their prescribing, the more opportunity we have to grow. We had a significant presence at a major psychiatric conference last weekend, the Neuroscience Education Institute Spring Congress, and as expected, interest in feedback and follow up from the conference attendees was excellent. Finally, we will maintain commercial discipline by aligning investment with performance and using cash flows from the legacy business to support the highest growth opportunity in the company. And that is clearly Exua. Turning now briefly to our legacy portfolios, ADHD net revenue was 9.1 million in the quarter compared to 15.4 million in the prior year period. As expected, the decrease was primarily driven by our strategic shift in sales force focus late last summer towards ECUA and some impact from the introduction of generic competition for Igoxenis as well. Despite the overall shift in promotional priorities, the ADHD portfolio remains a very important contributor to A two and given the lack of commercial support currently behind the brands, we continue to view the portfolio as profitable and durable on a standalone basis. The uptake of the third party generic against Adzenis has been quite low, which has been encouraging with it only achieving about 14% market share through four plus months of market availability. This tells us that the protective characteristics of the RX Connect program are proving protective given relatively little erosion as a percentage of the overall scripts written within the RX Connect ecosystem. The vast majority of decline due to the generic is coming from outside the RX Connect ecosystem, so things are working as we had expected and as we had designed. Our pediatric portfolio generated just under a million dollars of net revenue in the quarter compared to 3.1 million in the prior year period. We continue to efficiently service our pediatric products and believe that while small, these mature products will continue to be durable sources of profitable revenue. Overall, the legacy business continues to provide an important foundation as we transition the company towards the larger CNS opportunity clearly represented by Exua. Our goal is to balance disciplined investment in EXUA with continued cash generation from the existing business and the existing base business does generate cash even at these levels and even at lower levels. In summary, we're very pleased with the first meaningful quarter of ECZUA launch activity. We generated 2.4 million of revenue specifically for ECSUA, saw more than 1300 prescriptions written in the quarter, had more than 450 unique prescribers write the product, sold more than 3300 units into the channel during the quarter and saw great momentum and continued growth into April with almost 1,000 prescriptions generated. Importantly, this was achieved with only a partial quarter of full sales force support and with only a small percentage of our initial target universe writing prescriptions. We're still very early. I can't emphasize that enough. There will be normal launch variability as market payer access, prescribing and refill dynamics all settle out. But the proof points we have in hand are encouraging and they reinforce our conviction that ECSTUA can become a significant treatment options for patients living with major depressive disorder and a very meaningful growth driver for a 2. With that, let me turn the call over to Ryan to review the financials in more detail. Ryan thank you Josh. Ryan Selhorn (Chief Financial Officer) Let's jump right into it. Let's start on the revenue line. Net revenue for the third quarter of fiscal 2026 was 12.4 million compared to 18.5 million for the prior year period. That represents a decrease of $6 million, or 33% year over year. Breaking net revenue down by Portfolio Exua contributed $2.4 million in the quarter. As Josh mentioned, EXO was made commercially available in mid December and more formally launched in mid January after completion of SAL training, with full salesforce deployment occurring late in February early March. So while we remain very early in the launch curve, we view the initial contribution as highly encouraging, particularly given that the quarter included only a partial period of full salesforce support. Further, remember that net revenue is based on gross unit sales, not scripts. During the quarter there were 3,335 units consisting of 1,807 30 count units and 1,528 titration units sold. This equates to more than $700 per script. I want to caution that this is better than our initial expectations and we will wait to see how the dust settles before making any changes to our long term assumptions around net selling price of EXUA. The ADHD portfolio generated net revenue of 9.1 million in the third quarter compared to 15.4 million in the prior year period. The decrease is primarily attributable to lower total prescriptions as we have deliberately shifted commercial focus and sales force prioritization toward exua, which is now the centerpiece of our commercial efforts, as well as the launch of a generic version of one of our ADHD products late in the second quarter of fiscal 2026. The pediatric portfolio generated net revenue of $0.9 million for the third quarter compared to $3.1 million in the prior year period. The pediatric portfolio was negatively impacted during the quarter by payer mix, which resulted in higher rebates as well as an increase in returns. Overall, the revenue story this quarter is very much about transition. We are seeing the expected impact on the legacy portfolios as we navigate payer changes, but again, I'll remind you that the legacy portfolios do generate cash even at these levels. Gross Profit margin was 61% in the third quarter of fiscal 2026 compared to 69% in the same quarter last year. The decrease in gross profit percentage was impacted by a $700,000 inventory write down recorded to cost of goods sold, primarily resulting from the shift from our Adzenys branded product to our Adzenys authorized generic excluding that write down gross margin for the third quarter would have been approximately 67%. From an Exua perspective, the expected unit economics remain attractive. As discussed previously, Exua includes a 28% royalty in addition to a true up on cost of goods sold. We continue to think about the product as having approximately 31% cost of goods sold or roughly a 69% gross contribution margin before certain fixed costs. As EXUA scales, we expect these economics to become increasingly important to the overall model. Turning to OPEX, operating expenses excluding amortization of intangible assets were $10.9 million in the third quarter compared to $9.5 million in the prior year period. Total operating expenses were 11.7 million compared to 10.4 million last year. The increase is primarily a result of planned XO launch investments partially offset by improved operational efficiencies such as reduced facilities expense. I'll touch more on the outlook in a moment. Interest expense decreased half a million dollars or 52% during the quarter and by $1.5 million for the year to date compared with the prior year, primarily due to the paydown of our fixed payment arrangements we've discussed previously discussed for the quarter, we reported a Net loss of $5.6 million or $0.53 net loss per share basic compared to a net income of $4 million or $0.65 net income per share the prior year period. The fiscal 2026 third quarter results included a $1.3 million non cash derivative warrant liability loss compared to a $2.3 million non cash derivative warrant liability gain in the prior year period. As a reminder, these changes in non cash derivative warrant liabilities are primarily related to changes in the company's stock price. When our stock price increases, we generally incur a non cash loss on those liabilities and when the stock price decreases, we generally recognize a non cash gain. The losses recognized during the third quarter were primarily driven by increases in our stock price. On April 2, 2026, we filed a Form 8K detailing warrant amendments that resolve the ambiguity of that previously required certain warrants to be classified as liabilities rather than equity. As a result, we reduced our warrant liability and increased stockholders equity by $26.4 million on March 31, 2026. We believe this should significantly reduce future non cash earnings volatility associated with warrant liability gains and losses. As of March 31, 2026, stockholders equity was $35.1 million compared to 14.2 million at December 31, 2025. Finally, adjusted EBITDA was negative $2.8 million for the third quarter of fiscal 2026 compared to a positive $3.9 million in the year ago period. The change primarily relates to the planned investments we've made towards the launch of exua, combined with the broader DE emphasis in marketing toward the ADHD portfolio and the impact of payer changes affecting the pediatric portfolio, both of which impacted net revenue and gross profit. Turning now to the balance sheet cash and cash equivalents were $26.7 million at March 31, 2026. This compares to $30 million at December 31, 2025 and $31 million at June 30, 2025. The change in cash during the quarter primarily reflects the planned investments behind the ECU launch along with normal working capital movements. As of March 31, 2026, our revolving line of credit balance was $10.4 million and total debt including the current and non current portions was approximately $11.4 million. As noted earlier, the warrant amendments completed at quarter end also had a meaningful positive impact on the balance sheet presentation, reducing derivative warrant liabilities and increasing stockholders Equity. As of March 31, 2026, combining both equity classified pre funded warrants and issued and outstanding common Shares, there were 19.5 million shares utilized for calculating the basic weighted average shares outstanding for earnings per share purposes Before I turn it back over to Josh, I want to spend a few minutes on how we are thinking about EXUA from a financial perspective now that we have the first meaningful quarter of launch activity behind us. First, EXUA net revenue of $2.4 million in the quarter was a strong initial result and ahead of our internal expectations. This revenue reflects a combination of prescriptions written and filled during the quarter as well as inventory channel stocking to meet prescription growth expectations from channel partners and pharmacies said differently, prescriptions are the clearest measure of physician written demand, while unit sales represent product moving into the channel in the early stages of a launch. These two measures will not always move in lockstep, but both are important. Second, growth to net dynamics are still settling during the quarter. Growth to nets came in materially higher than our initial launch assumption, but again it is still very early. We will continue to refine our assumptions as Payer Mix, RX Connect, utilization, pharmacy ordering patterns and patient access programs mature. The first few months of any launch include noise and that is especially true for a product like EXUA where our strategy is intentionally designed to remove early access barriers for patients and prescribers. As we discussed last quarter through RF Connect, we have deliberately reduced early access friction by offering a no cost 14 day titration pack for commercially insured patients. We are also guaranteeing coverage of both month one and month two of therapy regardless of the insurance outcome, which is intended to ensure patients can remain on treatment through dose optimization without interruption. That strategy is important clinically and commercially, but it also means that Scripps can grow ahead of net revenue in the early going as patients transition into month three refills and beyond. We expect the revenue model to begin normalizing more closely with ongoing utilization, although we will continue to see some variability as the launch matures. Third, the launch investment framework remains disciplined. We made planned investments during the quarter across sales and marketing, service cost and launch infrastructure, but we continue to manage those investments carefully and align the incremental spend with launch performance and cash flow. Our objective is to support the Expo opportunity appropriately without losing the operating discipline that has been central to the company's progress. In the fourth quarter of this fiscal year. We are launching our online promotional campaigns including paid search, programmatic displays and social media advertising to drive awareness and incremental adoption and should result in an increase in overall sales and marketing spend by 1 to $2 million depending on their breadth and overall impact. Additionally, we have increased our speaker program events spending, medical education content and conferences involvement which will likely increase our G and a spending by 2 to $300,000 in the upcoming quarter depending on the success of these programs. We currently anticipate ongoing sales and marketing quarterly spend to range from 6 to $7 million and G and A to range from 5 to $5.3 million going forward. Finally, the financial model continues to be straightforward. We expect EXAWA to have attractive gross contribution margin, we expect launch related expenses to be managed against demand and return on investment, and we expect the legacy portfolio to continue to providing an important foundation as Exuas scales. While we are not providing formal guidance today, the general framework we discussed previously remains the right way to think about the business business mid to high 60% gross margins over time, a disciplined operating expense base and the near term path to profitability as EXUA revenue builds on top of the existing platform. As always, I'm happy to go over any details during Q and A and with that let me turn it back over to you Josh. Josh Disbrow (Chief Executive Officer) Thanks Ryan. So as we look ahead, I want to reemphasize again what we're seeing with EXUA while we're still in the very early stages of product launch. The initial traction has been highly encouraging with more than 1,300 prescriptions written during the quarter by over 450 unique prescribers and continued growth in titration packs and early refill activity. We believe prescribers are increasingly recognizing Exua's differentiated role in the treatment of major depressive disorder. And again, with April posting over 900 prescriptions and over 1300 unit shipments, we're seeing continued month over month over month increases in prescription and unit demand. Importantly, this momentum was achieved with only a partial quarter of full sales force support, which reinforces our confidence in both the market opportunity and the disciplined, efficient commercial strategy we have put in place. Exua gives a 2 access to a very large MDD market with a meaningful unmet need, attractive unit economics and a clear opportunity to build long term value. We remain extremely excited about the path ahead and look forward to updating you as the launch continues to scale. As always, I want to thank everyone participating on today's call. We'll now be happy to answer any questions. Operator. OPERATOR Thank you. At this time we'll be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speakerphone, it may be necessary to pick up your handset before pressing the star keys. Once again, that will be star one on your phone at this time if you wish to ask a question. And one moment please, while we pull for questions. First question today is coming from Thomas Flatten from Lake Street. Thomas, your line is live. Thomas Flatten (Equity Analyst) Hey, good afternoon, guys. Thanks for taking the question. Hey, Ryan, just doing some back of the envelope math. I kind of figured about a million and a half in quote unquote stocking revenue in the exua number for the quarter. Is that a reasonable assumption? Sorry. Yeah, that is a pretty accurate calculation. Okay. Josh Disbrow (Chief Executive Officer) And then Josh, you mentioned some efficacy anecdotes in the prepared remarks, but I was curious what you've heard back specifically related to weight gain and sexual side effects. If the physicians have provided you with any feedback on that. Yeah, I'll take weight gain first, which is that. That'll. That'll be. That'll always be quite a while before that develops. Just because of the time it takes for someone to gain weight. What I will say is we're certainly not hearing anything unexpected there, but again, you wouldn't necessarily expect in the first few weeks much weight gain one way or the other. On the sexual side effects, I will say that's where things like life changing and never felt so good in my life. Those anecdotes sort of come from even having heard from them personally from some select physicians in my area where I've had conversations. One gentleman who had been on, quote, everything under the sun was switched to Eczua and immediately restored his libido. So we're hearing very, very good positive anecdotes. Way more than just those handful. That's just a couple that I put into the prepared remarks. And again, one I experienced myself directly from a prescriber here in Colorado. Thomas Flatten (Equity Analyst) And then just one last one, if I might. You mentioned something like 10 ish percent of your customers had written Exua. But what's been the writing activity of non customers, so to speak, people that you haven't called on. Is that, Is there any of that? Yeah, highly encouraging as well. You know, when you look at the amount of white space we have around the lower 48, it's fairly significant. As any of those followers closely know. We really cover the eastern seaboard, call it from Connecticut down to Miami, out to Florida and then some dots kind of in flyover country. We have gotten significant prescribing from states where we have no physical presence. It's been extremely encouraging finding their ways to the product without any promotion. We've had inbound calls, we've had significant prescribing in places where again, there's been no presence at all. So it's been highly encouraging. I want to say we've had prescriptions in 41 or 42 states at this point. Obviously we don't physically have presence in nearly that many. So it's been very encouraging. Great, Appreciate that. Ryan Selhorn (Chief Financial Officer) Thank you. Thank you. OPERATOR Thank you. The next question will be from Naz Rahman from Maxim Group. Naz, your line is live. Naz Rahman (Equity Analyst) Hi everyone. Congrats on the progress and thanks for taking my questions. I only have two. The first one is on reimbursement, saying it's very early in the launch process. But in terms of like those prior authorizations, could you provide some color and I guess how many of those or what percentage of those prior audits are getting approved on the first pass versus how many or what percentage you have to have like a back and forth through prior to getting reimbursed? Yeah, good question. So I'll take the. I'll sort of separate it into commercial as well as cms, Medicaid, Medicare. Medicaid Medicare is highly variable down to the individual patient, down to the individual state. What I'll say is what we're seeing early on is it fits well, prescribing Eshua fits well within what they currently do, which is to say in the state of Colorado, you need to demonstrate that you failed two, quote, preferred agents, which are really nothing more than just generic established therapies like SSRIs. And then the prior authorization goes through. We've seen that already in real time happening in numerous states. And so that's going through smoothly and as expected in some places where there are mandates to allow for psychiatric prescribers specifically to essentially be waived of any PA requirement, that's happening also in the states that we expected it to. So that's all encouraging Medicare. Relatively small numbers on Medicare, but those prescriptions are going through as well. Highly variable from plan to plan in terms of what is required. Most patients will have to meet a deductible and then the benefit from their Medicare provider, for example, like aarp, will start to kick in on the commercial side because we've got this unique setup and I'll bifurcate that a bit as well because we certainly have prescriptions going through the RS Connect network and that is the vast majority. But to Thomas, the previous question around prescriptions that are being dispensed and prescribers outside of our footprint, those two are going through and so they're completing any prior authorizations and we're actually seeing a relatively high rate of well covered claims in places again where we have no coverage. In within the RS Connect network, we are seeing prior authorizations go through with good success. We're seeing of the numbers that we're doing and it's still relatively small, over 70% of those are getting approved. And so we're seeing a very high rate. Obviously approved claims means better for everyone, a lower CO pay for the patient and a higher net selling price to us. And so that's highly encouraging. But even I'll remind you, even in cases when prior authorizations either aren't done or aren't going through that in the initial going for that first trial period, we're essentially covering those prescriptions for either $0 or potentially 50. But I'll say just as an overarching statement, as it relates to reimbursement and coverage, the approval rates continue to improve month on month, and the dollars in terms of net selling price when you aggregate government and commercial are materially higher than we initially budgeted. But to reiterate what Ryan said, we'll caution of extrapolating that out too far because things are still settling out. But I'm extremely pleased and I think we all are collectively Here on the team with what we're seeing with respect to reimbursement and frankly, the relative ease some of these prescriptions are going through with. So very pleased. That was very helpful. And just kind of on that point, these patients do, you know, I guess what line they are on by the time they get to it sounds like Colorado. These are like third line patients. Do you have an idea of like, how many of these patients are like second line versus third or fourth? Yeah, that's a good question. And it's still very early and it's very heterogeneous. We have everything from second line all the way to very late line. Kind of tried everything, so to speak. What I'll say is we have good data that we know in this, in the 60 plus percent range, those patients are being switched, which suggests minimally those patients have been on one therapy. Really, when you speak with doctors in real terms, these are patients that in the early goings have been on, have been on multiple. So if I had to put a number, it's somewhere between probably third and fifth line. Realistically, but very encouraging that you've got patients that are being prescribed second line. I know of a specific patient. I don't know anything other than the patient's demographics based on a prescription that was generated just last week. It was second line. It was a, a young patient. I believe the patient's 22 years of age, had been on a therapy and was experiencing sexual side effects and was immediately switched to ecstua. Still very early to know how that patient's doing. But so I'll say, generally speaking, I'm encouraged that we appear to be getting a little bit earlier in therapy. But certainly there are the train wreck patients that are being started. But very encouragingly, those patients in many cases are responding quite well when other things have failed. So it's been quite encouraging. That was very helpful. Thanks for taking my questions. Thank you. OPERATOR Thank you. And once again, as a reminder, it'll be star one on your phone. If you wish to ask a question on today's call, the next question is coming from Ed Wu from Ascendian Capital. Ed, your line is live. Ed Wu (Equity Analyst) Yeah, congratulations on all the progress. I just had a mechanical question. In terms of patient and prescriptions, is it normally prescribed for 30 days and then after the 30 days, they would have to either go back to the physician or they will get automatic refills and it will show up as the refill count. Yeah, good question, Ed. So we start patients off in an optimal world. The prescriber would prescribe the 14 day titration pack. So by definition that's two weeks. And that patient would then get moved to one of the top two doses in most cases, either the 54.5 milligram or the 72.6 milligram. And those, either of those, the 54.5 or the 72.6 would be prescribed for 30 days. And typically they'll either be seen back to either stay optimized on the 54.5 or move up to the 72.6. And from that point forward they would probably get a prescription for something like three months or six months in some cases. We already have pharmacies dispensing 90 days or three full months right after they get titrated to the 54.5. Or in some cases doctors are more aggressive and we'll go to the 72.6. But again they'll get the full 90 day. So I say that all to say it's variable, but generally Speaking they're getting 30 days and then they're typically going to get moved to a every three month check in with a three month prescription or a six month check in with a six month prescription. And so we're just now at the very early stages of even starting some of those sort of call that maintenance therapy on the 54.5 or the 72.6. Josh Disbrow (Chief Executive Officer) Okay, so it's not clearly 30 days. Then you see the refill. So you might actually, based on your data, without disclosing much information, you're happy with the refill rate so far that you're seeing at this point in time. When we look at patients, the percentage of patients that are moving just from titration to a full 30 day supply, which that demonstrates tolerability, it may not necessarily demonstrate that they're getting clinical benefit yet. Although I will say we're hearing very consistent anecdotes that patients are feeling better quickly. That having been said, we're still so early, we'd hesitate to put a number on what we would expect sort of conversion to be longer term. But it's very, very solid and we expect it to improve over time. So again, these numbers that we're posting are really without any material annuity value baked in in terms of repeat use and refills and so forth. So just getting started, that sounds good. And then my last question is just on geography. I know you mentioned that you guys are aiming for the coast for the big markets, but are you seeing, is that your continued plan going forward just to target the big metro markets first and then move to the smaller markets. You know, what I'll say already, Ed, is we're actively contemplating in select markets, moving into some of those potentially a little bit quicker than we'd initially anticipated. We'll be judicious, as Ryan said, we'll certainly be cost efficient. But in areas where we've already identified sort of a groundswell of physicians that have found themselves prescribing the product or in places where we have access, whether that be from a commercial or government perspective, places that we think we can optimize. So we are already looking. And certainly, you know, I mentioned a few dotted territories kind of in, in flyover country, so to speak, we are actively looking at north to south, east to west and even. But that's all that having been said with the territories we have in place to have sort of this type of momentum already, understanding that a full third or more of our sales force just got out there. You know, call it the first full week of March. And of course, we all know it takes a while for anybody new in a geography and of course, new physicians to start getting on board with anything that we would fully expect to expand into other markets and see that same type of uptake. Ed Wu (Equity Analyst) Excellent. Well, thanks a lot for answering my questions and I wish you guys good luck. Josh Disbrow (Chief Executive Officer) Thank you. Thank you, Ed. OPERATOR Thank you. There were no other questions at this time. I would now like to hand the call back to Josh Disbrow for closing remarks. Josh Disbrow (Chief Executive Officer) Thank you, Paul. And again, thanks everyone. We could not be more excited with the progress that we're seeing in real time here. And I've got the unique benefit of not just leading the team, but in some cases having conversations of my own. And the real world feedback is really nothing short of amazing. We've continued to hear positive feedback across the board with patients that have tried really a lot of therapies and in some cases quote everything according to the psychiatrist. And to hear the feedback that's coming back is nothing short of inspiring. So we'll continue to keep the pedal down and obviously drive higher and higher adoption. But until we report our fiscal Q4 and full years in September, we'll be sure to be present at conferences to make sure folks are aware of what's happening and continue to update prescription trends as we move along. Thanks for listening to today's call. Appreciate your support and I wish you a good afternoon. Good evening. Until next time. Thanks very much. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga: AYTU BIOPHARMA (AYTU): Free Stock Analysis Report This article Full Transcript: Aytu BioPharma Q3 2026 Earnings Call originally appeared on Benzinga.com ﾩ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Image source: The Motley Fool. May 13, 2026 Chief Executive Officer — Joshua R. Disbrow Chief Financial Officer — Ryan J. Selhorn Need a quote from a Motley Fool analyst? Email [email protected] Greg. Thank you very much, and good afternoon, everyone. As the operator indicated, during today's call, we will be discussing Aytu BioPharma's fiscal 26 third quarter operational and financial results. For the period ended 03/31/2026. Joining us on today's call is Aytu's chief executive officer, Joshua R. Disbrow and Ryan J. Selhorn, the company's chief financial officer. At the conclusion of today's prepared remarks, we will open the call for a question and answer session. I would like to remind everyone that today's call is being recorded. A replay of today's call will be available by using the telephone numbers and conference ID provided in the press release issued earlier today or by utilizing the link on the company's website under events and presentations. Finally, I would also like to call to your attention the customary safe harbor disclosure regarding forward looking information. The conference call today will contain certain forward looking statements including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of Aytu BioPharma. Although management believes these statements are reasonable, based on estimates, assumptions, and projections as of today, these statements are not guarantees of future performance. Time sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks uncertainties, and other factors, including, but not limited to, the factors set forth in the company's filings with the SEC. A 2 undertakes no obligation to update or revise any of these forward looking statements except as required by law. Joshua R. Disbrow: With that said, let me turn the call over to Joshua R. Disbrow, Chief Executive Officer of Aytu BioPharma. Joshua, please proceed. Thanks, Robert, and welcome, everyone. Very pleased to be speaking with you today following what has been an exciting first partial quarter of commercial launch activity for EXXUA. As we have discussed, EXXUA represents a significant new opportunity for A2. it is the first and only selective serotonin 5-HT1A receptor agonist ever approved by the FDA for the treatment of major depressive disorder in adults. EXXUA is already demonstrating very solid growth trajectory within the MDD category. During our last call and during our Investor Day back in January, we spent meaningful time in the market opportunity, the clinical rationale, the unmet need in MDD, and the strategy behind our commercial launch. Today, I want to focus more directly on execution, some of the things we are seeing with respect to early adoption. Simply said, while we are still very early in the launch, the fundamentals we are seeing are highly encouraging, and the launch is progressing very well. So let's dive in. As most of you are aware, we moved from initial commercial availability in our second fiscal quarter in December into a more formalized launch phase during our third fiscal quarter. EXXUA was made commercially available back in mid December, The initial tranche of the sales organization completed training in January, while broader field deployment of the full 40 plus sales representatives did not actually begin until late February, early March. That timing is important. While Q3 was our first meaningful commercial quarter, it was still only a partial quarter of full sales support and commercial deployment with roughly 1/3 of the sales force only getting into the field in March. So we are just getting started. The most important point here, though, is that physicians are already writing EXXUA, Patients are beginning therapy. And very early refill activity is already becoming evident. In Q3, more than 1.3 thousand prescriptions were written for EXXUA. The monthly progression is particularly encouraging with prescriptions increasing from about 200 in January to about 400 in February to over 700 in March. That type of sequential growth is exactly what we would hope we would see in the early stage of a launch as awareness builds, our representatives increase their reach and frequency, and as physicians begin to identify patients who may be appropriate for EXXUA. Importantly, that momentum has continued. In April, we saw over 920 prescriptions written, up from the 700 in March. that is a 26% month over month sequential growth rate. Further, we shipped over 1.3 thousand units shipped in April which is 51% sequential growth, and that is more than the prescriptions generated in the entire first quarter. While it is early, and we will avoid over extrapolating from any short-term period of data, that continued month over month acceleration clearly demonstrates that physician interest is building and that the launch is getting traction. We are also encouraged by the breadth of early prescriber adoption. During the quarter, more than 450 unique prescribers wrote EXXUA prescriptions. That is meaningful because our initial focus call universe is approximately 3.5 thousand to 4 thousand highly targeted prescribers. So at this very early stage, already 10-13% of our target universe has written EXXUA. And yet again, we are just getting started in building a solid base of physician adoption. We believe this points to a substantial opportunity ahead as the sales force actively increases as our access initiatives mature and as peer to peer and rep based education expands. As most of you know, unit sales and prescription counts are not the same measure. Units reflect product moving through the channel and into distribution network and ultimately into pharmacies, while prescriptions reflect what prescriptions are what physicians are writing for patients. In a launch, those numbers can move at different rates because of channel stocking, titration pack and full prescription ordering, refill timing, etcetera. With that said, during Q3, gross unit sales were 3.33 thousand units consisting of 1.81 thousand 30-count units or full 30 day prescriptions and 1.5 thousand titration units. Since launch, total gross unit sales are 3.88 thousand units, consisting of just under 2,000 30-count bottles at 1.99 thousand and 1.89 thousand titration units. So, again, highly encouraging numbers at this very early stage. When we look at the combined picture, we see a launch that is doing what we expected it to do. Physicians are beginning to prescribe Patients are starting and staying on therapy. Titration packs are being utilized. Channel partners are ordering, and they are already reordering product. Very importantly, refills are beginning to come through, and we are seeing momentum build month over month over month. Taking a step back, a key reason we are encouraged by the launch is that the elements of our launch plan are now moving into the market and functioning as they had been designed. We built this launch to be disciplined, efficient, and scalable. Initially, we are not trying to outspend larger competitors. Instead, we are being very disciplined by focusing on the prescribers most likely to understand the unmet need evaluate Exua's differentiated profile, value our access programs, and become early adopters. Our sales organization is specifically prioritizing high value, high prescribing, psychiatry practices. Our customer targeting has been informed by market data, branded therapy adoption behavior, existing a 2 relationships, and insights gained from our RxConnect platform. We believe that this is the right approach for Exua at this stage. The product will not benefit from broad, unfocused promotion at this important time. Right now, it needs focused engagement with clinicians who treat high numbers of MDD patients every day and who understand the limitations of existing therapies and are looking for new treatment options. The phased deployment of the sales team has also been intentional. With only a partial quarter of full Salesforce support, the early prescription and prescriber numbers are even more encouraging. We believe there remains meaningful room for growth through increased reach and frequency, and, of course, execution against the target universe that is already been identified. Again, this is just the beginning without a full quarter of promotion even in the books yet. A 2 RxConnect has been and will continue to be a core pillar of the EXXUA launch. Our objective is to remove friction for both prescribers and patients. Particularly in the early months when coverage policies and payer processes are still developing. Through RxConnect, commercially insured patients have a predictable and supported pathway to access exua. Including a no-cost 14-day titration pack and guaranteed access to the early treatment period for commercially insured patients specifically. That allows clinicians and patients to evaluate the medicine based on clinical response rather than on early administrative or payer driven barriers. This is particularly important in major depressive disorder where patients and physicians need confidence that therapy can be initiated and continued long enough to assess response and tolerability. By reducing uncertainty at the point of prescribing, RxConnect helps align our commercial model with real world clinical needs. We are also seeing our channel partners execute well. The more than 3.3 thousand units sold during the quarter demonstrates preparedness across the distribution network to support the current prescription demand along with the growth we are seeing. The early launch period is not only about demand generation, It is also about making sure that when a physician prescribes EXXUA, and a patient is ready to begin therapy, that product is available and the process is smooth. The qualitative feedback from the field remains consistent with the launch thesis we had laid out previously. Physicians understand that many patients with MDD do not achieve adequate outcomes with existing therapies or struggle with tolerability issues that can affect adherence. Exua gives these patients and these clinicians a differentiated option with a novel mechanism of action, and that message is clearly resonating. As it relates to physician adoption, that will build methodically as it always does. Physicians often start by identifying specific patient types where they believe EXXUA may be especially relevant, or in some cases, patients who have been through a long list of antidepressants already and are simply searching for something new. Our job is to continue educating, supporting access, and building confidence through clinical experience. The fact that hundreds of prescribers have already written EXXUA gives us confidence that this process is working well and that even very challenging patients, in fact, are reporting positive results. We are also highly encouraged by the early refill activity. Refills are an important proof point because they demonstrate that initial prescriptions are progressing into continued therapy. The base of patients is still relatively small, but the presence of refill activity together with growth in titration utilization and sequential prescription increases clearly demonstrates that prescribing is picking up and that EXXUA is beginning to establish a role in the treatment of MDD. Most importantly, the patient feedback we are hearing through our prescribers is nothing short of outstanding. Phrases from even difficult patients like, quote, life changing, and a specific pay patient saying, quote, he has never felt this good in his entire life are coming through at this point almost daily. Yet again, we are just getting started. We are highly confident we will continue to hear more and more of these patient success stories. As we move ahead, our priorities are clear. First, we will continue increasing prescriber calls within the initial target prescriber universe. We are only again at the beginning of that process. And our current prescriber base represents a small, a tiny fraction of the prescribers we have identified and an even smaller fraction of who will ultimately be prescribing EXXUA. Second, we will continue leveraging RxConnect to support access and reduce friction. We expect access, reimbursement, gross to net, and refill dynamics to all become clearer as the launch matures. And we will remain disciplined in adapting our approach based on the data. By the way, the early signs on both coverage and reimbursement rates are extremely positive across both commercial and government payer channels. We are seeing solid and increasingly good coverage of EXXUA among commercial plans, and Medicaid and Medicare scripts are making up an increasing portion of the overall script load. Remains early, but many of the positive payer dynamics we have spoken about prelaunch are in fact bearing out. Third, we will continue investing in scientific engagement KOL development, peer to peer programs, and publication in medical congress activity. We believe Exua has a differentiated profile, and the more physicians understand where fits into their prescribing, the more opportunity we have to grow. We had a significant presence at a major psychiatric conference over the weekend, the Neuroscience Education Institute Spring Congress, and as expected, interest and feedback and follow-up from the conference attendees was excellent. Finally, we will maintain commercial by aligning investment with performance and using cash flows from the legacy business to support the highest growth opportunity in the company, and that is clearly Exua. Turning now briefly to our legacy portfolios. ADHD net revenue was $9.1 million in the quarter compared to $15.4 million in the prior year period. As expected, the decrease was primarily driven by our strategic shift in sales force focus late last summer towards EXXUA and some impact from the introduction of generic competition for Adzenys as well. Despite the overall shift in promotional priorities, the ADHD portfolio remains a very important contributor to Aytu and given the lack of commercial support currently behind the brands, we continue to view the portfolio as profitable and durable on a stand alone basis. The uptake of third of the third party generic against Adzenys has been quite low, which has been encouraging, with their only achieving about 14% market share through 4 plus months of market availability. This tells us that the protective characteristics of the RxConnect program are proving protective. Given relatively little erosion as a percentage of the overall script written within the RxConnect ecosystem. The vast majority of the decline due to the generic is coming from outside the RxConnect ecosystem, So things are working as we had expected and as we had designed. Our pediatrics portfolio generated just under $1 million of net revenue in the quarter compared to $3.1 million in the prior year period. We continue to efficiently service our pediatric products and believe that while small, these mature products will continue to be durable sources of profitable revenue. Overall, the legacy business continues to provide an important foundation we transition the company towards the larger CNS opportunity clearly represented by Exua. Our goal is to balance disciplined investment in Exua with continued cash generation from the existing business. And the existing base business does generate cash even at these levels and even at lower levels. In summary, we are very pleased with the first meaningful quarter of EXXUA launch activity. We generated $2.4 million of revenue, for specifically for EXXUA, saw more than 1.3 thousand prescriptions written in the quarter, had more than 450 unique prescribers, write the product, sold more than 3.3 thousand units into the channel during the quarter, and saw great momentum and continued growth into April. With almost 1 thousand prescriptions generated. Importantly, this was achieved with only a partial quarter of full Salesforce support and with only a small percentage of our initial target universe writing prescriptions. We are still very early. I cannot emphasize that enough. There will be normal launch variability as market, payer access, prescribing, and refill dynamics all settle out, but the proof points we have in hand are encouraging. And they reinforce our conviction that EXXUA can become a significant treatment options for patients living with major depressive disorder and a very meaningful growth driver for A2. With that, let me turn the call over to Ryan to review the financials in more detail. Ryan J. Selhorn: Ryan? Thank you, Joshua. Let's jump right into it. Let's start on the revenue line. Net revenue for the 2026 was $12.4 million compared to $18.5 million for the prior year period. That represents a decrease of $6 million or 33% year over year. Breaking net revenue down by portfolio, Exua contributed $2.4 million in the quarter. As Josh mentioned, EXXUA was made commercially available in mid December and more formally launched in mid January after completion of Salesforce training with full Salesforce deployment occurring late in February, early March. So while we remain very early in the launch curve, we view the initial contribution as highly encouraging, particularly given that the quarter included only a partial period of full Salesforce support. Further, remember that net revenue is based on gross unit sales, not scripts. During the quarter, there were 3.33 thousand units, consisting of 1.81 thousand 30-count units and 1.53 thousand titration units sold. This equates to >$700 per script. I wanna caution that this is better than our initial expectations and we will wait to see how the dust settles before making any changes to our long term assumptions around net selling price of EXXUA. The ADHD portfolio generated net revenue of 9.1 million in the third quarter compared to $15.4 million in the prior year period. The decrease is primarily attributable to lower total prescriptions as we have deliberately shifted our commercial focus and sales force prioritization toward EXXUA, which is now the centerpiece of our commercial efforts. As well as the launch of a generic version of 1 of our ADHD products late in the 2026. The pediatric portfolio generated net revenue of $0.9 million for the third quarter compared to $3.1 million in the prior year period. The pediatric portfolio was negatively impacted during the quarter by payer mix which resulted in higher rebates as well as an increase in returns. Overall, the revenue story this quarter is very much about transition. We are seeing the expected impact on the legacy portfolios as we navigate payer changes. But, again, I will remind you that the legacy portfolios do generate cash even at these levels. Gross profit margin was 61% in the 2026 compared to 69% in the same quarter last year. The decrease in gross profit percentage was impacted by a $700 thousand inventory write down recorded to cost of goods sold, primarily resulting from the shift from our Adzenys branded product to our Adzenys authorized generic. Excluding that write down, gross margin for the third quarter would have been approximately 67%. From an EXXUA perspective, the expected unit economics remain attractive. As discussed previously, 28% royalty in addition to a true up on cost of goods sold. We continue to think about the product as having approximately 31% cost of goods sold or roughly a 69% gross contribution margin before certain fixed costs. As EXXUA scales, we expect these economics to become increasingly important to the overall model. Turning to OpEx. Operating expenses excluding amortization of intangible assets were $10.9 million in the third quarter compared to $9.5 million in the prior year period. Total operating expenses were $11.7 million compared to $10.4 million last year. The increase is primarily a result of planned EXXUA launch investment, partially offset by improved operational efficiencies such as reduced facilities expense, I will touch more on the outlook in a moment. Interest expense decreased $0.5 million or 52% during the quarter and by $1.5 million for the year to date compared with the prior year, primarily due to the paydown of our fixed payment arrangement. We have previously discussed. For the quarter, we reported a net loss of $5.6 million or $0.53 net loss per share basic compared to a net income of $4 million or $0.65 net income per share basic in the prior year period. The fiscal 26 third quarter results included a $1.3 million noncash derivative warrant liability loss. Compared to a $2.3 million noncash derivative warrant liability gain in the prior year period. As a reminder, these changes in noncash derivative warrant liabilities are primarily related to changes in the company's stock price. When our stock price increases, we generally incur a noncash loss on those liabilities, And when the stock price decreases, we generally recognize a noncash gain. The losses recognized during the third quarter were primarily driven by increases in our stock price. On April 2, 2026, we filed a Form 8-K detailing warrant amendment that resolved the ambiguity that previously required certain warrants to be classified as liabilities rather than equity. As a result, we reduced our warrant liability and increased stockholders' equity by $26.4 million on March 31, 2026. We believe this should significantly reduce future noncash earnings volatility associated with warrant liability gains and losses. As of 03/31/2026, stockholders' equity was $35.1 million compared to $14.2 million on December 31, 2025. Finally, adjusted EBITDA was negative $2.8 million for the 2026 compared to a positive $3.9 million in the year ago period. The change primarily relates to the planned investment we have made towards the launch of EXXUA combined with the broader deemphasis in marketing toward the ADHD portfolio and the impact of payer changes affecting the pediatric portfolio, both of which impacted net revenue and gross profit. Turning now to the balance sheet. Cash and cash equivalents were $26.7 million at March 31, 2026, This compares to $30 million at December 30, 2025 and $31 million at June 30, 2025. The change in cash during the quarter primarily reflects planned investments behind the EXXUA launch along with normal working capital movements. As of 03/31/2026, our revolving line of credit balance was $10.4 million. And total debt, including the current and noncurrent portions, was approximately $11.4 million As noted earlier, the warrant amendment completed at quarter end also had meaningful positive impact on the balance sheet presentation. Reducing derivative warrant liabilities and increasing stockholders' equity. As of 03/31/2026, combining both equity classified prefunded warrants and issued and outstanding common shares there were 19.5 million shares utilized for calculating the basic weighted average shares outstanding for earnings per share purposes. Before I turn it back over to Joshua, I wanna spend a few minutes on how we are thinking about from a financial perspective now that we have the first meaningful quarter of launch activity behind us. First, EXXUA net revenue of $2.4 million in the quarter was a strong initial result and ahead of our internal expectations. This revenue reflects the combination of prescriptions written and filled during the quarter as well as inventory channel stocking to meet prescription growth expectations from channel partners and pharmacies. Said differently, prescriptions are the closest clearest measure of physician written demand, while unit sales represent product moving into the channel. In the early stages of a launch, these 2 measures will not always move in lockstep, but both are important. Second, growth to net dynamics are still settling. During the quarter, gross to net came in materially higher than our initial launch assumption. But again, it is still very early. Will continue to refine our assumptions as payer mix, RxConnect utilization, pharmacy ordering patterns, and patient access programs mature. The first few months of any launch include noise. And that is especially true for a product like EXXUA where our strategy is intentionally designed to remove early access barriers for patients and prescribers. As we discussed last quarter, through RxConnect, we have deliberately reduced early access friction by offering a no-cost 14-day titration pack. For commercially insured patients, we are also guaranteeing coverage of both month 1 and month 2 of therapy regardless of the insurance outcome, which is intended to ensure patients can remain on treatment through dose optimization without interruption. That strategy is important clinically and commercially, but it also means that scripts can grow ahead of net revenue in the early going. As patients transition into month 3 refills and beyond, we expect the revenue model to begin normalizing more closely with ongoing utilization. Although we will continue to see some variability as the launch matures. Third, the launch investment framework remains disciplined. We made planned investments during the quarter across sales and marketing, service costs, and launch infrastructure, but we continue to manage those investments and align the incremental spend with launch performance and cash flow. Our objective is to support the Exu opportunity appropriately without losing the operating discipline that has been central to the company's progress. In the fourth quarter of this fiscal year, we are launching our online promotional campaigns, including paid search, programmatic displays, and social media advertising to drive awareness and incremental adoption and should result in an increase in overall sales and marketing spend by $1 to $2 million, depending on their breadth and overall impact. Additionally, we have increased our speaker program events spending, medical education content, and conferences involvement which will likely increase our G&A spending by $200 thousand to $300 thousand. in the upcoming quarter. Depending on the success of these programs, we currently anticipate ongoing sales and marketing quarterly spend to range from $6 million to $7 million and G&A to range from $5 million to $5.3 million going forward. Finally, the financial model continues to be straightforward. We expect Exua to have attractive gross contribution margin We expect launch related expenses to be managed against demand and on investment, and we expect the legacy portfolios to continue to providing an important foundation as Exuas scales. While we are not providing formal guidance today, the general framework we discussed previously remains the right way to think about the business. Mid to high 60% gross margins over time a disciplined operating expense base, and the near term path to profitability as EXXUA revenue builds on top of the existing platform. As always, I am happy to go over any details during Q&A. And with that, let me turn it back over to you, Joshua. Joshua R. Disbrow: Thanks, Ryan. So as we look ahead, I want to reemphasize again what we are seeing with Exua. While we are still in the very early stages of product launch, the initial traction has been highly encouraging. With more than 1.3 thousand prescriptions written during the quarter by over 450 unique prescribers and continued growth in titration packs and early refill activity, we believe prescribers are increasingly recognizing Exua's differentiated role in the treatment of major depressive disorder. And, with April posting over 900 prescriptions and over 1.3 thousand unit shipments, we are seeing continued month over month over month increases in prescription and unit demand. Importantly, this momentum was achieved with only a partial quarter of full sales force support, which reinforces our confidence in both the market opportunity and the disciplined efficient commercial strategy we put in place. EXXUA gives Aytu access to a very large MDD market with a meaningful unmet need attractive unit economics, and a clear opportunity to build long term value. We remain extremely excited about the path ahead and look forward to updating you as the launch continues to scale. As always, I want to thank everyone participating on today's call. We will now be happy to answer any questions. Operator? Operator: Thank you. At this time, we will be conducting a question and answer session. You may press *2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that will be *1 on your phone at this time. If you wish to ask a question. 1 moment, please, while we pull for questions. First question today is coming from Thomas Flaten from Lake Street. Thomas, your line is live. Analyst (Thomas Flaten): Hey, good afternoon, guys. Thanks for taking the question. Hey, Ryan, just doing some back of the envelope math I kind of figured about $1.5 million in, quote, unquote, stocking revenue in the EXXUA number for the quarter. Is that is that a reasonable assumption? Ryan J. Selhorn: Sorry. Yeah. That is a pretty accurate calculation. Analyst (Thomas Flaten): Okay. And then, Joshua, you mentioned some efficacy anecdotes in the prepared remarks, but I was curious what you have heard back specifically related to weight gain and sexual side effects if the physicians have provided you with any feedback on that? Joshua R. Disbrow: Yeah. I will take weight gain first, which is that will always be quite a while before that develops just because of the time it takes for someone to gain weight. What I will say is we are certainly not hearing anything unexpected there. But, again, you would not necessarily expect in the first 2 weeks much weight gain 1 way or the other. On the sexual side effects, I will say that is where things like life changing and never felt so good in my life, those anecdotes sort of come from. Even having heard from them personally from some select physicians in my area where I have had conversations. 1 gentleman who had been on, quote, everything under the sun was switched to EXXUA and immediately, restored his libido. So we are hearing very, very good positive anecdotes, way more than just those handful. that is just a couple that I put into the prepared remarks. And, again, 1 I experienced myself directly from a prescriber here in Colorado. Analyst (Thomas Flaten): And then just 1 last 1, if I might. You mentioned something like 10-ish percent of your customers had written EXXUA, but what is been the writing activity of non customers, so to speak, people that you have not called on? Is that is there any of that? Joshua R. Disbrow: Yeah. Highly encouraging as well. You know, when you look at the amount of white space we have around the lower 48, it is fairly significant as any of those you follow us closely know. We really cover the Eastern Seaboard, call it from Connecticut down to Miami out to Florida, and then some dots in kind of flyover country. We have gotten significant prescribing from states where we have no physical presence. it is been extremely encouraging. Finding their ways to the product without any promotion, We have had inbound calls. We have had significant prescribing in places where, again, there is been no presence at all. So it is been highly encouraging. I wanna say we have had prescriptions in 41 or 42 states at this point. Obviously, we do not physically have presence in nearly that many, so it is been very encouraging. Greg. Appreciate that. Thank you. Operator: Thank you. Thank you. The next question will be from Nazibur Rahman from Maxim Group. Naz, your line is live. Analyst (Nazibur Rahman): Hi, everyone. Congrats on the progress, and thanks for taking my questions. I only have 2. The first 1 is on reimbursement I understand it is very early in the launch process, but in terms of, like, those prior authorizations, you provide some color on, I guess, how many of those or what percentage of those prior authorizations are getting approved on the first pass versus how many or what percentage you have to have a back and forth through prior to getting reimbursed? Joshua R. Disbrow: Yep. Good question. So I will take the I will separate it into commercial as well as CMS, Medicaid, Medicare. Medicaid, Medicare is highly variable. Down to the individual patient, down to the individual state. What I will say is what we are seeing early on is it fits well. Prescribing Exua fits well within what they currently do, which is to say, in the state of Colorado, you need to demonstrate that you failed 2, quote, preferred agents, which are really nothing more than just generic established therapies like SSRIs, and then prior authorization goes through. We have seen that already in real time happening in numerous states and so that is going through smoothly and as expected. In some places where there are mandates, to allow for psychiatric prescribers specifically to essentially be waived of any prior authorization requirement. that is happening also in the states that we expected it to, so that is all encouraging. Medicare, relatively small numbers on Medicare, but those prescriptions are going through as well. Highly variable from plan to plan in terms of what is required. Most patients will have to meet a deductible and then the benefit from their Medicare provider, for example, like AARP, will start to kick in. On the commercial side, because we have got this unique setup, and I will bifurcate that a bit as well, because we have prescriptions going to the RxConnect network, and that is the vast majority. But to Thomas's previous question around prescriptions that are being dispensed and prescribers outside of our outside of our footprint, those too are going through. And so they are completing any prior authorizations, and we are actually seeing a relatively high rate of well covered claims in places, again, where we have no coverage. Within the RxConnect network, we are seeing prior authorizations go through with good success. We are seeing of the numbers that we are doing, and it is still relatively small, over 70% of those are getting approved. And so we are seeing a very high rate. Obviously, approved claims means better for everyone. A lower co pay for the patient and a higher net selling price to us And so that is highly encouraging. But even I will remind you. Even in cases when prior authorizations either are not done or are not going through, that we in the initial going in that first for that first trial period, we are essentially covering those prescriptions for either $0 or potentially $50. But I will say just as an overarching statement as it relates to reimbursement and coverage, The approval rates continue to improve month on month, and the dollars in terms of net selling price when you aggregate government and commercial are materially higher than we initially budgeted. But to reiterate what Ryan said, we will caution against extrapolating that out too far because things are still settling out. But I am extremely pleased, and I think we all are collectively here on the team with what we are seeing with respect to reimbursement. And, frankly, the relative ease some of these prescriptions are going through with. So, very pleased. Analyst (Nazibur Rahman): That was very helpful. And just kind of on that point, for these patients, do you know, I guess, what line of therapy they are on by the time they get to well, it sounds like in Colorado, these are third-line patients. Do you have an idea of, like, how many of these patients are second-line versus third or fourth? Joshua R. Disbrow: Yeah. that is a good question. And it is still very early, and it is very We have everything from second-line all the way to very late-line, who have kind of tried everything, so to speak. What I will say is we have good data that we know in the 60-plus-percent range, Before you buy stock in Aytu BioPharma, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Aytu BioPharma wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Aytu (AYTU) Q3 2026 Earnings Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. The EXXUA launch is progressing through a disciplined, phased deployment, with the full 40-plus sales force only reaching full field capacity in late February or early March. Management attributes early success to a highly targeted commercial strategy focusing on 3,500 to 4,000 high-value psychiatry practices rather than broad, unfocused promotion. Early adoption is characterized by high-quality prescriber engagement, with 10% to 13% of the target universe already writing prescriptions despite only a partial quarter of full support. The Aytu RxConnect platform is serving as a critical strategic pillar by removing administrative friction and guaranteeing early access for commercially insured patients while payer policies mature. Performance in the legacy ADHD portfolio reflects a deliberate strategic pivot of resources toward EXXUA, though the company maintains that these legacy assets remain profitable and durable. Management noted that the protective ecosystem of RxConnect has limited generic erosion for Adzenys, with the vast majority of market share loss occurring outside of their proprietary network. Future growth is expected to be driven by increased reach and frequency within the existing target universe and expansion into 'white space' geographies where organic demand is already emerging. The company plans to increase sales and marketing spend by $1 million to $2 million in the fourth quarter to launch online promotional campaigns, including paid search and social media. Management anticipates ongoing quarterly sales and marketing spend to range from $6 million to $7 million, with G&A ranging from $5 million to $5.3 million as the launch scales. Revenue modeling assumes a normalization period as patients transition from no-cost titration packs into month three refills and beyond, which will provide clearer gross-to-net visibility. The financial framework targets mid- to high 60% gross margins over time with a near-term path to profitability as EXXUA revenue builds upon the existing cash-generating legacy platform. A $700,000 inventory write-down was recorded due to the strategic shift from branded Adzenys to an authorized generic, impacting reported gross margins. The company completed a warrant amendment that reclassified $26.4 million from liabilities to equity, a move intended to significantly reduce future non-cash earnings volatility. Interest expense decreased by 52% during the quarter following the paydown of fixed payment arrangements, improving the overall capital structure. Early net selling price for EXXUA exceeded $700 per script, though management cautioned against extrapolating this figure until payer mix and access programs fully settle. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management reported that while it is too early to assess long-term weight gain, qualitative feedback regarding the absence of sexual side effects has been 'outstanding.' Physicians have shared anecdotes of patients experiencing restored libido and significant mood improvement after failing multiple prior therapies. Within the RxConnect network, approximately 70% of prior authorizations are being approved, which is higher than initial internal budgets. Management noted that Medicaid and Medicare scripts are becoming an increasing portion of the total load, with approval processes following expected failure-of-preferred-agent protocols. EXXUA has seen prescriptions written in 41 or 42 states, significantly exceeding the company's physical sales footprint on the Eastern Seaboard. This 'white space' demand is prompting management to consider accelerating expansion into select new markets sooner than originally planned. Patients typically start with a 14-day titration pack before moving to 30-day or 90-day maintenance prescriptions of higher doses. Management expressed high satisfaction with the conversion rate from titration to full supply, viewing it as a key indicator of product tolerability.

Total net revenue of $15.2 million Adjusted EBITDA1 of $(0.8) million, which includes EXXUA launch investments $30.0 million cash balance at December 31, 2025 Company launched EXXUA&trade; (gepirone) extended-release tablets ("EXXUA") in December 2025 as the 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, February 3, 2026, at 4:30 p.m. Eastern time DENVER, CO / ACCESS Newswire / February 3, 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 second quarter. The Company is also providing an update on its recent 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. Q2 Fiscal 2026 Highlights Net revenue of $15.2 million versus $16.2 million in Q2 fiscal 2025. ADHD Portfolio, which consists of attention deficit hyperactivity disorder ("ADHD") products, net revenue was $13.2 million versus $13.8 million in Q2 fiscal 2025. Pediatric Portfolio, which consists of a line of legacy products, net revenue was $1.7 million versus $2.4 million in Q2 fiscal 2025. EXXUA was made commercially available in mid-December 2025, and therefore minimal initial stocking net revenue of $0.2 million occurred during the quarter. Completion of sales force training occurred in mid-January 2026. Net loss of $10.6 million included an $8.2 million derivative warrant liability loss primarily due to the increase in the Company's stock price, compared to net income of $0.8 million in Q2 fiscal 2025, which included a $3.0 million derivative warrant liability gain. Adjusted EBITDA was $(0.8) million compared to $1.3 million in Q2 fiscal 2025. During Q2 fiscal 2026, the Company made investments towards the launch of EXXUA. Excluding EXXUA launch investments in the first half of fiscal 2026, adjusted EBITDA would have been positive for the 11th consecutive quarter. Cash and cash equivalents were $30.0 million at December 31, 2025. EXXUA Commercial Launch Following Aytu's June 2025 entry into an exclusive agreement to commercialize EXXUA in the United States, the Company successfully launched 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: All distributors and wholesalers nationwide are now fully stocked with EXXUA, physicians are engaging, and initial prescriptions have been generated. Completed launch meeting in mid-January 2026 with deployment of 40+ person sales force across a broad United States footprint with high MDD potential and strong Aytu RxConnect® coverage, aligning territories that represent approximately 140.0 million total MDD prescriptions, 18.5 million target healthcare practitioners ("HCPs") prescriptions, and an initial launch focus on roughly 5,500 target HCPs. The EXXUA commercial effort, while efficient in relative spend, will be comprehensive and focused on prescriber adoption and brand growth through a heavy emphasis on sales force promotion and metrics-based performance management, complemented by scalable initiatives such as a virtual sales team and a rolling Contract Sales Organization model to expand reach and flex in-person promotion based on product performance and cash flows. From a non-personal standpoint, a very targeted, media-based compliant consumer promotion approach will be employed. Through Aytu's Medical & Scientific Affairs team, the Company is rapidly building out a Key Opinion Leader ("KOL") network and has a strong publication and meeting plan in place. The Company is leveraging Aytu's best-in-class patient access program, Aytu RxConnect, along with full retail distribution for EXXUA through national wholesalers to ensure broad-based product availability at pharmacies throughout the United States. Aytu has implemented numerous enhancements to the Aytu RxConnect program since inception based on insights from over one million filled prescriptions, leveraging real-time data to guide EXXUA contracting for approximately 60% of commercially insured MDD patients while expecting early favorable Medicaid and Medicare coverage for much of the remaining 40%, depending on geography. The Company held an Investor Day on January 20, 2026, which was conducted both in-person and via webcast focusing largely on EXXUA. A replay of the event can be found on the Investors section of the Company's website at https://investors.aytubio.com under Events & Presentations. The event can also be accessed directly at https://app.webinar.net/Qo7DrDvVzq8. Management Discussion "This is a truly momentous time for Aytu as we commercially launched EXXUA, the first and only 5HT1a agonist approved by the FDA for the treatment of MDD, representing a new way to treat MDD," commented Josh Disbrow, Chief Executive Officer of Aytu. "Early post-launch indicators have been encouraging following initial commercial availability in mid-December 2025 and the completion of sales force training in mid-January 2026. As detailed during our Investor Day last month, the EXXUA launch has been - and will continue to be - comprehensive, with a clear focus on prescriber adoption and brand growth while maintaining efficiency in relative spend. We remain laser-focused on driving successful commercial adoption as we work to positively impact the lives of the approximately 21 million Americans living with MDD." "Our ADHD portfolio continues to perform above the industry-standard expectations given the evolving dynamics of sales force prioritization toward EXXUA and the recent introduction of generic competition," Disbrow added. "This continued stability reinforces our long-term conviction in the enhanced stickiness and attractive economic value of the Aytu RxConnect platform - through which approximately 85% of our branded ADHD prescriptions are dispensed - as well as the growing market traction of our own Adzenys XR-ODT® authorized generic." "With EXXUA, our team has accomplished in just over six months what often takes years in large pharmaceutical organizations, positioning Aytu at a true inflection point with an opportunity we believe can be transformational for both patients and shareholders," Disbrow concluded. Net Revenue by Product Portfolio * Other includes discontinued or deprioritized products. Q2 Fiscal 2026 Financial Results Net revenue for the second quarter of fiscal 2026 was $15.2 million, compared to $16.2 million for the prior year period. EXXUA net revenue was $0.2 million reflecting initial stocking orders at the end of the quarter. The ADHD Portfolio net revenue was $13.2 million in the second quarter of fiscal 2026, compared to $13.8 million in the prior year period. The decrease is attributable to a decrease in total prescriptions primarily due to broader deemphasis in marketing of the ADHD Portfolio as the Company's marketing efforts have shifted towards EXXUA, which is now the centerpiece of its commercial efforts, partially offset by product price increases and improved gross-to-nets. The Pediatric Portfolio net revenue was $1.7 million in the second quarter of fiscal 2026, compared to $2.4 million in the prior year period. The change in net revenue is attributable primarily to the broader deemphasis in marketing of the Pediatric Portfolio. Gross profit was $9.6 million, or 63% of net revenue, in the second quarter of fiscal 2026, compared to $10.8 million, or 66% of net revenue, in the same quarter last year. The decrease in gross profit percentage is primarily related to a $1.1 million decrease in net revenue driven by a broader deemphasis in marketing towards the ADHD Portfolio and the Pediatric Portfolio as well as transition related expenses relating to the growth of the Adzenys XR-ODT® authorized generic. Operating expenses, excluding amortization of intangible assets and restructuring costs, were $11.1 million in the second quarter of fiscal 2026 compared to $10.2 million in the prior year period. The increase is primarily a result of increased EXXUA launch investments partially offset by improved operational efficiencies such as reduced facilities expense. Net loss during the second quarter of fiscal 2026 was $10.6 million, or $1.05 net loss per share basic compared to net income of $0.8 million, or $0.13 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 loss of $8.2 million and a gain of $3.0 million, respectively, primarily due to changes in the Company's stock price. Adjusted EBITDA was $(0.8) million for the second quarter of fiscal 2026 compared to $1.3 million in the year ago period. The change primarily relates to the increased EXXUA launch investments and broader deemphasis in marketing towards the ADHD Portfolio and the Pediatric Portfolio impacting net revenue and gross profits. Cash and cash equivalents were $30.0 million at December 31, 2025, compared to $31.0 million at June 30, 2025. Conference Call Details Date and Time: Tuesday, February 3, 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 567381. Webcast Information: The webcast will be accessible live and archived at https://www.webcaster5.com/Webcast/Page/2142/53322, 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 February 17, 2026, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 53322. 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, who are receiving diuretics or glucocorticoids, or have a history or 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. 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. [email protected] Robert Blum Lytham Partners [email protected] &nbsp; Aytu BioPharma, Inc. Unaudited Consolidated Statements of Operations (in thousands, except share and per share data) &nbsp; Aytu BioPharma, Inc. Unaudited Consolidated Balance Sheets (in thousands, except share data) &nbsp; Aytu BioPharma, Inc. Unaudited Reconciliation of Net (Loss) Income to Adjusted EBITDA (in thousands) SOURCE: Aytu BioPharma, Inc. View the original press release on ACCESS Newswire

This article first appeared on GuruFocus. Net Revenue: $15.2 million for the quarter, down from $16.2 million in the prior year. ADHD Portfolio Net Revenue: $13.2 million, compared to $13.8 million in the prior year period. Pediatric Portfolio Net Revenue: $1.7 million, up from $715,000 in the previous quarter. Gross Margin: 63.5%, down from 66.5% last year. Operating Expenses: $11.1 million, compared to $10.2 million in the prior year period. Net Loss: $10.6 million, or $1.05 per share, compared to net income of $0.8 million, or $0.13 per share, in the prior year period. Adjusted EBITDA: Negative $0.8 million, compared to a positive $1.3 million in the prior year period. Cash and Cash Equivalents: $30 million as of December 31, 2025. EXXUA Launch Investment: Reduced to under $8 million from the original $10 million budget. Warning! GuruFocus has detected 9 Warning Signs with AYTU. Is AYTU fairly valued? Test your thesis with our free DCF calculator. Release Date: February 03, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aytu BioPharma Inc (NASDAQ:AYTU) successfully launched EXXUA, the first and only 5HT1a agonist approved by the FDA for the treatment of major depressive disorder (MDD), offering a novel treatment approach. EXXUA demonstrated a neutral sexual profile in clinical studies, with no sexual-related adverse event rates exceeding placebo, and showed no clinically meaningful weight gain compared to placebo. The commercial launch strategy for EXXUA is comprehensive, focusing on prescriber adoption and long-term brand growth, supported by a highly motivated sales organization. The Aytu RxConnect platform ensures broad patient access by guaranteeing predictable coverage for commercially insured patients and capping out-of-pocket costs at $50 per prescription. Early feedback from patients on EXXUA has been positive, with reports of good tolerability and satisfaction, and prescriptions have been written in 27 states, indicating broad opportunity. Net revenue for the quarter decreased to $15.2 million from $16.2 million in the prior year, reflecting a decline in the ADHD portfolio and pediatric portfolio revenues. Gross margin decreased to 63.5% from 66.5% last year, primarily due to decreased net revenue and transition-related expenses associated with the ADHD authorized generic performance. The company reported a net loss of $10.6 million for the quarter, compared to net income of $0.8 million in the prior year period, impacted by derivative warrant liability loss. The launch of a generic version of Adzenys by Teva has introduced competition, accounting for approximately 5% of prescriptions, which could impact future ADHD portfolio revenues. The company is facing challenges with weather-related disruptions affecting script fulfillment and sales force productivity, impacting the early stages of EXXUA's commercial launch. Q: Josh, you hinted at this a little bit in your prepared comments, but I'm curious in those 100 docs that have actually written prescriptions, if you have any anecdotal feedback from the sales team on why they made the decision to write, what was it that convinced them this would be a good alternative for the patients? A: Joshua Disbrow, CEO: Various motivations for physicians in those early days to prescribe include challenging patients not getting a robust response or experiencing side effects like sexual dysfunction or weight gain. The novel mechanism of action (MOA) of EXXUA is attractive, and the ease of prescribing through RxConnect is also a factor. We expect to see more difficult-to-treat patients initially, but over time, physicians may start positioning the product earlier in treatment. Q: In light of Ryan's comments around cash breakeven and real breakeven, you mentioned during your Analyst Day that you were contemplating a sales force expansion over time. Is there an expectation of any of that occurring in fiscal '26? What triggers are in place for that to initiate? A: Joshua Disbrow, CEO: It would be unexpected to expand quickly. We need to get through the trial periods into the June timeframe before considering expansion. The primary trigger for expansion will be overachieving internal forecasts and having cash flow to support it. There is no plan to expand without cash on hand, and we will not raise capital for this purpose. Q: You mentioned in your press release that you were working on a direct-to-consumer campaign. Could you provide a little detail on what that looks like? A: Joshua Disbrow, CEO: The campaign will largely be web-based, focusing on search engine optimization and keyword search campaigns. We are exploring social media angles and chat room forums like Reddit, while ensuring compliance with FDA regulations. The primary focus will remain on face-to-face interactions with the sales force, with consumer campaigns being secondary until awareness increases. Q: Because of the weather around so much in the United States in the last couple of weeks, have you seen any delays or issues with scripts getting filled after they were written? And the scripts that have been filled, have they mostly been from RxConnect or retail pharmacies? A: Joshua Disbrow, CEO: The weather has had a huge impact, affecting shipments to pharmacies and reps' ability to meet with doctors. Despite this, we are encouraged by the progress. Most prescriptions are coming through RxConnect, but we are also seeing prescriptions from areas without sales reps, indicating broad interest. Q: Regarding supply issues, you mentioned weather-related delays. Has that been corrected now? Do you have any issues potentially in terms of how much you could ramp up if demand increases faster than expected? A: Joshua Disbrow, CEO: The delays have been corrected, with only a few days' delay in shipments. We have adequate supply to ramp up production if demand increases, with sufficient API and componentry stateside to meet even optimistic forecasts. For the complete transcript of the earnings call, please refer to the full earnings call transcript.