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Aytu BioPharmaA
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-09-23
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Related articleQuarter not tagged2026-09-23

Aytu BioPharma Inc (AYTU) (Q4 2026) Earnings Call Highlights: EXXUA Launch Accelerates as ...

GuruFocus.com
This article first appeared on GuruFocus. Total Net Revenue: $16.1 million in Q4 FY2026, up 6% from $15.1 million in the prior year period; up sequentially from $12.4 million in Q3. Full-Year Net Revenue: $57.6 million for fiscal 2026. EXXUA Net Revenue: $3.9 million in Q4, up from $2.4 million in Q3; $6.6 million contributed in fiscal 2026. ADHD Portfolio Net Revenue: $10.4 million in Q4, versus $9.1 million in Q3 and $13.1 million in the prior year quarter. Pediatric Portfolio Net Revenue: $1.8 million in Q4, versus $0.9 million in Q3 and $2 million in the prior year quarter. Gross Profit: $10.4 million in Q4; $36.8 million for fiscal 2026. Gross Margin: Approximately 65% in Q4, up from 61% in Q3; 64% for fiscal 2026; expected to approach 66%67% in Q4 FY2027. Operating Expenses: $11.2 million in Q4, versus $17.9 million a year ago; $10.4 million on an adjusted basis versus $8.7 million prior year. Interest Expense: $0.4 million in Q4, down from $0.7 million a year ago; $1.9 million for fiscal 2026, down from $3.7 million. Net Loss: $0.1 million in Q4 (rounded to $0.00 per share), versus $19.8 million ($2.92 per share) prior year; $14.3 million for fiscal 2026. Adjusted EBITDA: Positive $0.5 million in Q4, versus positive $2 million prior year and negative $2.8 million in Q3; negative $3.7 million for fiscal 2026. Cash and Cash Equivalents: $26.3 million at June 30, versus $26.7 million at March 31 and $31 million at end of fiscal 2025. Operating Cash Flow: $3.3 million generated in fiscal 2026, versus $1.9 million used in fiscal 2025. Financing Activities: $7.9 million used in fiscal 2026, primarily to reduce revolver, term debt and fixed payment arrangements. Revolver Balance: Reduced to $6.1 million from $10.4 million at March 31; remaining balance repaid subsequent to year-end. Term Debt Carrying Value: Approximately $11 million at June 30. Stockholders' Equity: $35.3 million at June 30, 2026, versus $19 million a year earlier. EXXUA Prescriptions: 3,323 total in Q4, up from 1,398 in Q3; monthly progression of 973 (April), 1,089 (May), 1,261 (June), 1,377 (July), 1,408 (August). EXXUA Unit Shipments: 4,599 units in Q4. EXXUA Prescriptions per Rep: ~18/month in March (43 reps) versus ~43/month in July (32 reps). Sales Force Head Count: 43 reps at end of March, low of 32 in July, back to approximately 42, targeting 40+ (closer to 45) territories. EXXUA Un…Read full document

This article first appeared on GuruFocus. Total Net Revenue: $16.1 million in Q4 FY2026, up 6% from $15.1 million in the prior year period; up sequentially from $12.4 million in Q3. Full-Year Net Revenue: $57.6 million for fiscal 2026. EXXUA Net Revenue: $3.9 million in Q4, up from $2.4 million in Q3; $6.6 million contributed in fiscal 2026. ADHD Portfolio Net Revenue: $10.4 million in Q4, versus $9.1 million in Q3 and $13.1 million in the prior year quarter. Pediatric Portfolio Net Revenue: $1.8 million in Q4, versus $0.9 million in Q3 and $2 million in the prior year quarter. Gross Profit: $10.4 million in Q4; $36.8 million for fiscal 2026. Gross Margin: Approximately 65% in Q4, up from 61% in Q3; 64% for fiscal 2026; expected to approach 66%67% in Q4 FY2027. Operating Expenses: $11.2 million in Q4, versus $17.9 million a year ago; $10.4 million on an adjusted basis versus $8.7 million prior year. Interest Expense: $0.4 million in Q4, down from $0.7 million a year ago; $1.9 million for fiscal 2026, down from $3.7 million. Net Loss: $0.1 million in Q4 (rounded to $0.00 per share), versus $19.8 million ($2.92 per share) prior year; $14.3 million for fiscal 2026. Adjusted EBITDA: Positive $0.5 million in Q4, versus positive $2 million prior year and negative $2.8 million in Q3; negative $3.7 million for fiscal 2026. Cash and Cash Equivalents: $26.3 million at June 30, versus $26.7 million at March 31 and $31 million at end of fiscal 2025. Operating Cash Flow: $3.3 million generated in fiscal 2026, versus $1.9 million used in fiscal 2025. Financing Activities: $7.9 million used in fiscal 2026, primarily to reduce revolver, term debt and fixed payment arrangements. Revolver Balance: Reduced to $6.1 million from $10.4 million at March 31; remaining balance repaid subsequent to year-end. Term Debt Carrying Value: Approximately $11 million at June 30. Stockholders' Equity: $35.3 million at June 30, 2026, versus $19 million a year earlier. EXXUA Prescriptions: 3,323 total in Q4, up from 1,398 in Q3; monthly progression of 973 (April), 1,089 (May), 1,261 (June), 1,377 (July), 1,408 (August). EXXUA Unit Shipments: 4,599 units in Q4. EXXUA Prescriptions per Rep: ~18/month in March (43 reps) versus ~43/month in July (32 reps). Sales Force Head Count: 43 reps at end of March, low of 32 in July, back to approximately 42, targeting 40+ (closer to 45) territories. EXXUA Unique Prescribers: Nearly 1,200 to date. EXXUA Unique Patients: Nearly 2,500 to date. ADHD Market Share: Adzenys brand and authorized generic retain approximately 80% of prescriptions in the market for Adzenys and its generic equivalents. FY2027 Operating Expense Outlook: Approximately $49 million$54 million GAAP; $45 million$49 million cash-based. FY2027 Sales & Marketing Investment: Up to $6 million planned for fiscal 2027 (deferred from fiscal 2026). FY2027 Profitability Outlook: Positive adjusted EBITDA expected for the 6-month period ending June 30, 2027; lower adjusted EBITDA and operating cash flow expected in first half versus second half. Warning! GuruFocus has detected 3 Warning Signs with AYTU. Is AYTU fairly valued? Test your thesis with our free DCF calculator. Release Date: September 22, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. EXXUA net revenue grew to $3.9 million in Q4, up from $2.4 million in Q3, with total prescriptions increasing 138% to 3,323. Prescriptions per sales rep more than doubled from 18 in March to 43 in July, demonstrating improved commercial productivity. ADHD portfolio generated $10.4 million in Q4 revenue, exceeding expectations, with Adzenys retaining ~80% of prescriptions despite generic competition. Company returned to positive adjusted EBITDA of $0.5 million in Q4 and expects positive adjusted EBITDA for the 6-month period ending June 30, 2027. Cash and cash equivalents remained stable at $26.3 million, with operating cash flow improving by $5.2 million year-over-year to $3.3 million. Net loss for fiscal 2026 was $14.3 million, and adjusted EBITDA for the full year was negative $3.7 million. Sales force turnover reduced representatives from 43 in March to 32 in July, temporarily impacting coverage before recovering to ~42. ADHD revenue declined year-over-year from $13.1 million to $10.4 million in Q4, reflecting loss of exclusivity and reduced promotional support. Gross margin is expected to be lowest in early fiscal 2027 and only approach 66-67% by Q4, with first-half adjusted EBITDA and cash flow lower than second half. Teva has not yet launched its generic version of Cotempla, but potential future launch poses a risk to revenue assumptions. Q: Thomas Flaten of Lake Street Capital asked about the gross-to-net discount coming in more favorable than expected and what drove that.A: CEO Josh Disbrow attributed it to a higher-than-anticipated approval rate across commercial payers, with the titration pack lower but still materially above initial modeling, and 30-count/regular prescriptions also seeing higher approval rates. He noted government business (Medicare/Medicaid) is already well north of 20%-25% of the business and carries even better GTN, with analog products reaching 35%-40%, all achieved without commercial contracts or supplemental Medicaid/Medicare rebates. Q: Edward Woo of Ascendiant Capital asked whether there is a target sales rep head count over the next 6 months and how quickly new reps ramp up.A: CEO Josh Disbrow said the goal will be dictated by cash flow and profitability, but will be "materially higher than 42 or 49," with a plan at least a multiple of that. He said reps typically need 6-9 months to become adequately tooled, with breakeven closer to 9-12 months, and that a phased expansion would be driven by cash generation. Q: Naz Rahman of Maxim Group asked about prior authorization trends, including first-pass approval rates and back-and-forth with payers.A: CEO Josh Disbrow said prior authorizations are still early but approval rates are quite high around 70% for claims submitted through the program materially higher than most categories, which he credited to the ease of use of the process, the drug class, and the patient type (often patients who have failed multiple medications). Q: Naz Rahman of Maxim Group asked when to expect the next large bolus of reimbursement from commercial and government payers.A: CEO Josh Disbrow said the company does not view reimbursement as a single big lever and expects it to evolve organically. He said current GTN levels would be a "really good situation" even without contracts, and that Aytu is not proactively contracting on either the government or commercial side, since payer contracts don't drive demand and RxConnect already backstops commercial patients at no more than $50 out of pocket. Q: Thomas Flaten of Lake Street Capital asked about utilization of RxConnect for EXXUA.A: CEO Josh Disbrow said RxConnect utilization for EXXUA is lower than the ADHD portfolio where upwards of 80% of total prescriptions are dispensed through an RxConnect partner pharmacy but is growing, helped by prescriptions from white space and areas without rep coverage, plus a materially higher base of government business. He expects more prescribing to shift to RxConnect pharmacies over time given the moat it represents. Q: Thomas Flaten of Lake Street Capital asked how Aytu grew the ADHD portfolio sequentially with limited coverage and no Cotempla generic launch.A: CEO Josh Disbrow said the sequential uptick was largely driven by proactive management and improvement in gross-to-net reimbursement rates and pharmacy reimbursement, optimizing payer mix across the brand and authorized generic. He noted Teva's generic has barely reached 20% of the available market, and the year-on-year prescription decline is largely attributable to pulling promotion over a year ago. Q: Edward Woo of Ascendiant Capital asked whether the roughly 3,000 prescriptions for the quarter include refills.A: CEO Josh Disbrow confirmed the figure includes refills, with titration packs representing initiation and 30-count regular prescriptions representing stable-dose refills. He noted many patients only started in the first month or so, some are titrating more slowly than the label indicates, and the compounding effect from refills has yet to be seen. Q: Analysts asked about the trajectory of EXXUA prescriptions and sales force productivity during the launch.A: CEO Josh Disbrow reported Q4 EXXUA net revenue of $3.9 million, up from $2.4 million in Q3, with total prescriptions of 3,323 versus 1,398 in the March quarter. Monthly prescriptions rose from 973 in April to 1,261 in June, then 1,377 in July and 1,408 in August, and the week ending September 4 hit 394 prescriptions. Prescriptions per rep more than doubled from about 18 in March to roughly 43 in July, and 24 territories (about 60% of the sales force) drive 70% of prescriptions. Q: Analysts asked about the sales force reductions during the June and July period and the rationale behind them.A: CEO Josh Disbrow said the field force fell from 43 reps at the end of March to a low of 32 in July as Aytu held the sales organization accountable for high performance and made real-time adjustments where representatives were not performing at needed levels. The company has since rebuilt to approximately 42 representatives and continues to fill open positions, adjusting territory coverage based on what it is learning. Q: Analysts asked about the fiscal 2027 outlook for expenses, margins, and profitability.A: CFO Ryan Selhorn said the plan calls for approximately $49 million-$54 million of GAAP operating expenses, or about $45 million-$49 million on a cash basis, with the largest increase in sales and marketing (up to $6 million shifted from fiscal 2026 to fiscal 2027). He expects consolidated gross margin to be lowest early in fiscal 2027 and approach 66%-67% in Q4, with lower adjusted EBITDA and operating cash flow in the first half and positive adjusted EBITDA for the six months ending June 30, 2027. Q: Analysts asked about the durability of the ADHD franchise and the status of the Cotempla generic.A: CEO Josh Disbrow said the Adzenys brand and authorized generic together retain approximately 80% of prescriptions in the market for Adzenys and its generic equivalents, reflecting the durability of the franchise and the RxConnect model even with substantially less commercial support. He noted Teva has not yet launched its generic version of Cotempla following the July 1 date permitted under the settlement agreement, presenting potential upside to base case assumptions. Q: Analysts asked about the balance sheet, cash position, and debt reduction during the quarter.A: CFO Ryan Selhorn reported cash and cash equivalents of $26.3 million at June 30, roughly flat versus $26.7 million at March For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Related articleQuarter not tagged2026-09-23

Aytu BioPharma, Inc. Q4 2026 Earnings Call Summary

Moby
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. - Achieved positive adjusted EBITDA in Q4 fiscal 2026, driven by the scaling of EXXUA and better-than-anticipated performance in the ADHD portfolio. - Adopted a methodical launch strategy for EXXUA, prioritizing commercial productivity and return on investment over a 'spend-at-all-costs' approach to preserve cash. - Optimized the sales force by holding representatives to high performance standards, resulting in a temporary headcount dip to 32 reps in July before rebounding to 42. - Observed a twofold increase in prescriptions per sales representative between March and July, indicating improved commercial efficiency as the team matured. - Maintained a durable ADHD franchise with Adzenys retaining approximately 80% of its market share despite significantly reduced commercial support. - Benefited from favorable gross-to-net realizations for EXXUA due to higher-than-modeled approval rates across commercial payers without the need for proactive contracting. - Expects the six-month period ending June 30, 2027, to generate positive adjusted EBITDA as EXXUA continues to scale and seasonal ADHD headwinds reverse. - Plans to invest $45 million to $49 million in cash-based operating expenses, including $6 million deferred from fiscal 2026 to support EXXUA marketing and education. - Anticipates consolidated gross margins to improve throughout fiscal 2027, targeting 66% to 67% by the fourth quarter through better product mix and fixed cost absorption. - Projects a significant lift in EXXUA script levels as newly onboarded sales specialists reach full productivity, typically a 6-to-9-month ramp-up period. - Assumes potential upside for the ADHD business as a key competitor has not yet launched a generic version of Cotempla despite being permitted to do so. - Successfully deleveraged the balance sheet by paying down the revolving credit facility and fixed payment arrangements, resulting in a $5.2 million improvement in operating cash flow. - Reclassified $26.4 million from warrant liabilities to equity in March, reducing future earnings volatility associated with non-cash derivative adjustments. - Noted that while EXXUA gross-to-nets are currently favorable, management remains cautious about assuming these realization rate…Read full document

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. - Achieved positive adjusted EBITDA in Q4 fiscal 2026, driven by the scaling of EXXUA and better-than-anticipated performance in the ADHD portfolio. - Adopted a methodical launch strategy for EXXUA, prioritizing commercial productivity and return on investment over a 'spend-at-all-costs' approach to preserve cash. - Optimized the sales force by holding representatives to high performance standards, resulting in a temporary headcount dip to 32 reps in July before rebounding to 42. - Observed a twofold increase in prescriptions per sales representative between March and July, indicating improved commercial efficiency as the team matured. - Maintained a durable ADHD franchise with Adzenys retaining approximately 80% of its market share despite significantly reduced commercial support. - Benefited from favorable gross-to-net realizations for EXXUA due to higher-than-modeled approval rates across commercial payers without the need for proactive contracting. - Expects the six-month period ending June 30, 2027, to generate positive adjusted EBITDA as EXXUA continues to scale and seasonal ADHD headwinds reverse. - Plans to invest $45 million to $49 million in cash-based operating expenses, including $6 million deferred from fiscal 2026 to support EXXUA marketing and education. - Anticipates consolidated gross margins to improve throughout fiscal 2027, targeting 66% to 67% by the fourth quarter through better product mix and fixed cost absorption. - Projects a significant lift in EXXUA script levels as newly onboarded sales specialists reach full productivity, typically a 6-to-9-month ramp-up period. - Assumes potential upside for the ADHD business as a key competitor has not yet launched a generic version of Cotempla despite being permitted to do so. - Successfully deleveraged the balance sheet by paying down the revolving credit facility and fixed payment arrangements, resulting in a $5.2 million improvement in operating cash flow. - Reclassified $26.4 million from warrant liabilities to equity in March, reducing future earnings volatility associated with non-cash derivative adjustments. - Noted that while EXXUA gross-to-nets are currently favorable, management remains cautious about assuming these realization rates will hold as payer mix evolves. - Acknowledged that first-half fiscal 2027 results will likely show lower EBITDA due to front-loaded PDUFA fees and typical ADHD seasonality when children are out of school. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. - Management attributed the better-than-expected GTN to high approval rates across commercial payers and a growing contribution from government business. - Current success is being achieved without active commercial contracts or supplemental Medicaid/Medicare rebates, which management views as a position of strength. - RxConnect accounts for approximately 80% of ADHD claims and is growing for EXXUA, serving as a 'moat' to ensure patient access and long-term brand loyalty. - The program acts as a backstop to guarantee commercial patients pay no more than $50, reducing the immediate need for aggressive PBM contracting. - Management intends to expand the sales force beyond the current 42-45 territories, but timing will be strictly dictated by cash flow and profitability. - Internal modeling suggests that if reps reach 20-30 prescriptions per week—levels already achieved by top performers—the annual revenue run rate could exceed $50 million. - Approval rates for prior authorizations are approximately 70%, which management considers high for the category. - Success is driven by the product's positioning for patients who have already failed multiple previous MDD treatments, making the clinical case for coverage easier.

Related articleQuarter not tagged2026-09-22

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

ACCESS Newswire
Fourth quarter fiscal 2026 net revenue increased 6.4% to $16.1 million from $15.1 million in the prior-year quarter Fourth quarter fiscal 2026 Adjusted EBITDA of $0.5 million EXXUA net revenue of $6.6 million in fiscal 2026, including $3.9 million in the fourth quarter, following full commercial launch during third quarter fiscal 2026 EXXUA fourth quarter fiscal 2026 total prescriptions were 3,323, up approximately 138% from 1,398 in third quarter fiscal 2026 $26.3 million cash balance at June 30, 2026 Company to host conference call and webcast today, September 22, 2026, at 4:30 p.m. Eastern time DENVER, CO / ACCESS Newswire / September 22, 2026 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today announced operational and financial results for the fiscal 2026 full year and fourth quarter. Q4 Fiscal 2026 Highlights Net revenue increased 6.4% to $16.1 million versus $15.1 million in Q4 fiscal 2025. EXXUA net revenue was $3.9 million during Q4 fiscal 2026, the first full quarter of launch. ADHD Portfolio net revenue was $10.4 million versus $13.1 million in Q4 fiscal 2025. The change in net revenue is primarily due to the Company's commercial prioritization of EXXUA and generic competition. Pediatric Portfolio net revenue was $1.8 million versus $2.0 million in Q4 fiscal 2025. Net loss was approximately break-even at less than ($0.1) million and included a $1.0 million derivative warrant liabilities gain, compared to a net loss of ($19.8) million in Q4 fiscal 2025, which included $18.1 million of combined impairment expense and derivative warrant liabilities loss. Adjusted EBITDA was $0.5 million compared to $2.0 million in Q4 fiscal 2025. During Q4 fiscal 2026, the Company continued to make planned investments towards the commercialization of EXXUA. Full Year Fiscal 2026 Highlights Net revenue decreased 13.3% to $57.6 million versus $66.4 million in fiscal 2025. EXXUA net revenue was $6.6 million during fiscal 2026. EXXUA was made commercially available in mid-December 2025, and more formally launched in mid-January 2026 following the completion of sales force training, followed by full sales force deployment in late February. ADHD Portfolio, which consists of attention deficit hyperactiv…Read full document

Fourth quarter fiscal 2026 net revenue increased 6.4% to $16.1 million from $15.1 million in the prior-year quarter Fourth quarter fiscal 2026 Adjusted EBITDA of $0.5 million EXXUA net revenue of $6.6 million in fiscal 2026, including $3.9 million in the fourth quarter, following full commercial launch during third quarter fiscal 2026 EXXUA fourth quarter fiscal 2026 total prescriptions were 3,323, up approximately 138% from 1,398 in third quarter fiscal 2026 $26.3 million cash balance at June 30, 2026 Company to host conference call and webcast today, September 22, 2026, at 4:30 p.m. Eastern time DENVER, CO / ACCESS Newswire / September 22, 2026 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today announced operational and financial results for the fiscal 2026 full year and fourth quarter. Q4 Fiscal 2026 Highlights Net revenue increased 6.4% to $16.1 million versus $15.1 million in Q4 fiscal 2025. EXXUA net revenue was $3.9 million during Q4 fiscal 2026, the first full quarter of launch. ADHD Portfolio net revenue was $10.4 million versus $13.1 million in Q4 fiscal 2025. The change in net revenue is primarily due to the Company's commercial prioritization of EXXUA and generic competition. Pediatric Portfolio net revenue was $1.8 million versus $2.0 million in Q4 fiscal 2025. Net loss was approximately break-even at less than ($0.1) million and included a $1.0 million derivative warrant liabilities gain, compared to a net loss of ($19.8) million in Q4 fiscal 2025, which included $18.1 million of combined impairment expense and derivative warrant liabilities loss. Adjusted EBITDA was $0.5 million compared to $2.0 million in Q4 fiscal 2025. During Q4 fiscal 2026, the Company continued to make planned investments towards the commercialization of EXXUA. Full Year Fiscal 2026 Highlights Net revenue decreased 13.3% to $57.6 million versus $66.4 million in fiscal 2025. EXXUA net revenue was $6.6 million during fiscal 2026. EXXUA was made commercially available in mid-December 2025, and more formally launched in mid-January 2026 following the completion of sales force training, followed by full sales force deployment in late February. ADHD Portfolio, which consists of attention deficit hyperactivity disorder ("ADHD") products, net revenue was $45.8 million versus $57.6 million in fiscal 2025. The change in net revenue is primarily due to the Company's commercial prioritization of EXXUA and the introduction of generic competition. Pediatric Portfolio, which consists of a line of legacy products, net revenue was $5.1 million versus $8.8 million in fiscal 2025. The change in net revenue is primarily due to the Company's commercial prioritization of EXXUA and reduced promotional emphasis on the Pediatric Portfolio. Net loss of ($14.3) million compared to a net loss of ($13.6) million. Net loss in fiscal 2026 included a $4.7 million derivative warrant liabilities loss, while fiscal 2025 included $12.1 million of combined impairment expense, restructuring costs and derivative warrant liabilities loss. Adjusted EBITDA was ($3.7) million compared to $9.2 million in fiscal 2025. During fiscal 2026, the Company made the aforementioned planned investments towards the commercialization of EXXUA. Cash and cash equivalents were $26.3 million at June 30, 2026. Management Discussion "Although we remain in the early stages of the EXXUA launch, the continued momentum we saw throughout the fourth quarter further reinforces our confidence in this exciting opportunity," commented Josh Disbrow, Chief Executive Officer of Aytu. "EXXUA generated $3.9 million in net revenue during the quarter, up from $2.4 million in the third quarter, while more than 3,300 prescriptions were written, more than double the prior quarter. Monthly prescriptions increased throughout the quarter, reaching a record 1,261 scripts in June, and shipments increased nearly 40% sequentially to approximately 4,600 units, including 2,377 units in June. Just as importantly, adoption is broadening across prescribers, territories and geographies, rather than being driven by only a handful of prescribers or markets. We are seeing good conversion from titration packs to full prescriptions, patients being maintained on therapy, and refill activity continuing to build. Our recently launched national speaker programs are also increasing physician engagement, and early reimbursement dynamics have been favorable relative to our initial expectations. EXXUA remains early in its launch, and prescribing, payer and gross-to-net patterns will continue to evolve, however the trajectory is highly encouraging. We remain focused on disciplined and efficient commercial execution as we work to establish EXXUA as an important treatment option for adults living with major depressive disorder." "Our legacy business also delivered meaningful sequential improvement during the fourth quarter and continues to provide an important financial foundation supporting the EXXUA opportunity," Disbrow continued. "ADHD Portfolio net revenue increased to $10.4 million from $9.1 million in the third quarter, driven by higher units, improved gross-to-net economics and stable performance across the existing brands. Although generic competition continues to affect Adzenys, underlying prescription demand remains generally stable with less generic penetration than many observers expected. The portfolio's sequential improvement demonstrates the durability of these brands and their attractive economics with minimal promotional spending. The ADHD Portfolio remains highly profitable on a standalone basis and continues to be an important source of cash generation. Pediatric Portfolio net revenue increased to $1.8 million from $0.9 million in the third quarter as product availability normalized following the prior supply disruption. While we are not assuming that either legacy portfolio has returned to sustained growth, their fourth-quarter performance reinforces the value and relative stability of these brands and the strength of our commercial platform. Together, they continue to support our ability to invest behind EXXUA in a measured and disciplined manner." "Overall, we view the quarter as evidence of the operating leverage available in our model as EXXUA scales alongside the profitability and cash flow contribution from our legacy operations. Looking ahead, we are highly encouraged by EXXUA's progress, its differentiated profile and the significant opportunity within the more than $22 billion United States MDD market. When combined with the durability of our ADHD and Pediatric portfolios, disciplined expense management and a stable liquidity position, we believe Aytu is increasingly well positioned to drive sustained growth, build toward more consistent positive Adjusted EBITDA levels as fiscal 2027 progresses and create long-term shareholder value," Disbrow concluded. Net Revenue by Product Portfolio * Other includes discontinued or deprioritized products. Q4 Fiscal 2026 Financial Results Net revenue for the fourth quarter of fiscal 2026 was $16.1 million, compared to $15.1 million for the prior year period. EXXUA net revenue was $3.9 million in the fourth quarter of fiscal 2026. The ADHD Portfolio net revenue was $10.4 million in the fourth quarter of fiscal 2026, compared to $13.1 million in the prior year period. The decrease is attributable primarily to the Company's commercial prioritization of EXXUA, removal of promotion on the ADHD Portfolio and the introduction of generic competition for Adzenys. The Pediatric Portfolio net revenue was $1.8 million in the fourth quarter of fiscal 2026, compared to $2.0 million in the prior year period. The change in net revenue is attributable primarily to the Company's commercial prioritization of EXXUA and reduced promotion of the Pediatric Portfolio. Gross profit was $10.4 million, or 64.6% of net revenue, in the fourth quarter of fiscal 2026, compared to $10.3 million, or 67.8% of net revenue, in the same quarter last year. Operating expenses, excluding amortization of intangible assets, restructuring costs and impairment expense, were $10.4 million in the fourth quarter of fiscal 2026 compared to $8.7 million in the prior year period. The increase is primarily a result of increased EXXUA commercialization investments. Net loss during the fourth quarter of fiscal 2026 was approximately break-even at less than ($0.1) million, or ($0.00) net loss per share basic and diluted, compared to a net loss of ($19.8) million, or ($2.92) net loss per share basic and diluted, in the prior year period. The fiscal 2026 fourth quarter results included a $1.0 million derivative warrant liabilities gain, while the fiscal 2025 fourth quarter results included $8.3 million of impairment expense and a $9.9 million derivative warrant liabilities loss. Adjusted EBITDA was $0.5 million for the fourth quarter of fiscal 2026 compared to $2.0 million in the year ago period. The change primarily relates to planned investments towards the commercialization of EXXUA. Full Year Fiscal 2026 Financial Results Net revenue for full year fiscal 2026 was $57.6 million, compared to $66.4 million for the prior year. EXXUA net revenue was $6.6 million. EXXUA was made commercially available in mid-December 2025, and more formally launched in mid-January 2026 following the completion of sales force training, followed by full sales force deployment in late February. The ADHD Portfolio net revenue was $45.8 million in full year fiscal 2026, compared to $57.6 million in the prior year period. The decrease is attributable primarily to the Company's commercial prioritization of EXXUA, removal of promotion on the ADHD Portfolio and the introduction of generic competition for Adzenys XR-ODT® ("Adzenys"). The Pediatric Portfolio net revenue was $5.1 million in full year fiscal 2026, compared to $8.8 million in the prior year period. The change in net revenue is attributable primarily to the Company's commercial prioritization of EXXUA and reduced promotion of the Pediatric Portfolio. Gross profit was $36.8 million, or 64.0% of net revenue, in full year fiscal 2026, compared to $45.8 million, or 69.0% of net revenue, in the prior year. The decrease in gross profit percentage is primarily related to lower net revenue in the ADHD and Pediatric Portfolios as the Company focused on the commercialization and launch of EXXUA, a $2.2 million inventory write-down in fiscal 2026 compared to $0.3 million in fiscal 2025 primarily resulting from a shift from the Company's Adzenys branded products to the Adzenys authorized generic products, and the absence of a $3.3 million fiscal 2025 increase in estimated variable consideration that had no corresponding cost of goods sold impact. Operating expenses, excluding amortization of intangible assets, restructuring costs and impairment expense, were $42.6 million in full year fiscal 2026 compared to $39.6 million in the prior year. The increase is primarily a result of increased EXXUA commercialization investments, including higher spending on promotional materials, consulting services, the Company's sales force and marketing activities, partially offset by lower research and development expense. Net loss during full year fiscal 2026 was ($14.3) million, or ($1.16) net loss per share basic and diluted, compared to a net loss of ($13.6) million, or ($2.16) net loss per share basic and diluted, in the prior year. The full year fiscal 2026 results were impacted by a $4.7 million derivative warrant liabilities loss primarily driven by an increase in the Company's stock price, partially offset by gains from the exercise of liability classified warrants. The full year fiscal 2025 results included $8.3 million of impairment expense, $2.1 million of restructuring costs and a $1.7 million derivative warrant liabilities loss. Adjusted EBITDA was ($3.7) million in full year fiscal 2026, compared to $9.2 million in the prior year period. The change primarily relates to planned investments towards the commercialization of EXXUA. As previously announced, on March 31, 2026, the Company amended and restated certain warrants, which resolved the accounting ambiguity that previously required these warrants to be classified as liabilities rather than equity. As a result, the Company reduced its derivative warrant liabilities by $26.4 million and increased stockholders' equity by that same amount. As of June 30, 2026, derivative warrant liabilities were $1.2 million and stockholders' equity was $35.3 million, compared to $26.3 million and $19.0 million, respectively, at June 30, 2025. Cash and cash equivalents were $26.3 million at June 30, 2026, compared to $31.0 million at June 30, 2025. Conference Call Details Date and Time: Tuesday, September 22, 2026, at 4:30 p.m. Eastern time. Call-in Information: Interested parties can access the conference call by dialing (888) 506-0062 for United States callers or +1 (973) 528-0011 for international callers and using the participant access code 504506. Webcast Information: The webcast will be accessible live and archived at https://www.webcaster5.com/Webcast/Page/2142/54094, and accessible on the Investors section of the Company's website at https://investors.aytubio.com/ under Events & Presentations. Replay: A teleconference replay of the call will be available until October 6, 2026, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 54094. About Aytu BioPharma Aytu is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients. The Company's prescription products include EXXUA® (gepirone) extended-release tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of major depressive disorder (MDD), and treatments for attention deficit-hyperactivity disorder (ADHD). Aytu is committed to delivering the Company's medications through best-in-class patient access programs that help to enable optimal patient outcomes. For more information, please visit aytubio.com or follow us on LinkedIn. About EXXUA EXXUA is a novel oral selective serotonin 5-HT1A receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults. IMPORTANT SAFETY INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. EXXUA is not approved for use in pediatric patients. INDICATIONS AND USAGE EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults. DOSAGE AND ADMINISTRATION Important Recommendations Prior to Initiating and During Treatment with EXXUA Electrocardiogram and Electrolyte Monitoring Correct electrolyte abnormalities prior to initiating EXXUA. In patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA. Perform an electrocardiogram (ECG) prior to initiating EXXUA, during dosage titration, and periodically during treatment. Do not initiate EXXUA if QTc is > 450 msec at baseline. Monitor ECGs more frequently if EXXUA is used: concomitantly with drugs known to prolong the QT interval in patients who develop QTc ≥ 450 msec during treatment in patients with a significant risk of developing torsade de pointes Do not escalate the EXXUA dosage if the QTcF is > 450 msec. Bipolar Disorder, Mania, and Hypomania Screening Screen patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with EXXUA. Important Administration Instructions Take EXXUA orally with food at approximately the same time each day. Swallow tablets whole. Do not split, crush, or chew EXXUA. Recommended Dosage The recommended starting dosage of EXXUA is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to 36.3 mg orally once daily on Day 4 and further titrated to 54.5 mg orally once daily after Day 7 and to 72.6 mg orally once daily after an additional week. The maximum recommended daily dosage of EXXUA is 72.6 mg once daily. Dosage Recommendations in Geriatric Patients The recommended starting dosage of EXXUA in geriatric patients is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to maximum recommended dosage of 36.3 mg orally once daily after Day 7. Recommended Dosage in Patients with Renal Impairment The recommended starting dosage of EXXUA in patients with creatinine clearance < 50 mL/min is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7. The recommended dosage in patients with creatinine clearance ≥ 50 mL/min is the same as in patients with normal renal function. Recommended Dosage in Patients with Hepatic Impairment The recommended starting dose of EXXUA in patients with moderate (Child-Pugh B) hepatic impairment is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7. EXXUA is contraindicated in patients with severe (Child-Pugh C) hepatic impairment. The recommended dosage in patients with mild (Child-Pugh A) hepatic impairment is the same as patients with normal hepatic function. Dosage Modifications for Concomitant Use with CYP3A4 Inhibitors Reduce the EXXUA dose by 50% when used concomitantly with a moderate CYP3A4 inhibitor. EXXUA is contraindicated in patients receiving strong CYP3A4 inhibitors. Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days must elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with EXXUA. Conversely, at least 14 days must be allowed after stopping EXXUA before starting an MAOI antidepressant. CONTRAINDICATIONS EXXUA is contraindicated in patients: with known hypersensitivity to gepirone or components of EXXUA. with prolonged QTc interval > 450 msec at baseline. with congenital long QT syndrome. receiving concomitant strong CYP3A4 inhibitors. with severe hepatic impairment. taking, or within 14 days of stopping, MAOIs due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome. Starting EXXUA in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated. WARNINGS AND PRECAUTIONS Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients aged 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. *EXXUA is not approved for use in pediatric patients. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing EXXUA, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. QT Prolongation EXXUA prolongs the QTc interval. EXXUA is contraindicated in patients with congenital long QT syndrome and in patients with severe hepatic impairment or in patients receiving concomitant strong CYP3A4 inhibitors as they increase EXXUA plasma concentrations. Do not initiate EXXUA if QTc is > 450 msec at baseline. Correct electrolyte abnormalities prior to EXXUA initiation. In patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA. Perform an ECG prior to EXXUA initiation, during dosage titration, and periodically during treatment. Monitor patients with ECGs more frequently: 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 OfficerAytu BioPharma, [email protected] Robert BlumLytham [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

TranscriptFY2026 Q42026-09-22

FY2026 Q4 earnings call transcript

Earnings source - 72 paragraphs
Operator

Please note this conference is being recorded. I will now turn the conference over to your host, Robert Blum with Lytham Partners. You may begin.

Robert Blum

All right. Thank you, and good afternoon, everyone. As the operator indicated, during today's call, we will be discussing Aytu BioPharma's fiscal 2026 fourth quarter and full year operational and financial results for the period ended June 30th, 2026. Joining us on today's call is Aytu's Chief Executive Officer, Josh Disbrow, and Ryan 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.

Robert Blum

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. Aytu 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. Josh, please proceed.

Josh Disbrow

Thanks, Robert, and welcome everyone. I am very excited about the progress we are making and the opportunity ahead for Aytu. We finished fiscal 2026 with an encouraging fourth quarter as EXXUA continued to build, our ADHD business performed better than anticipated, and Aytu returned to positive adjusted EBITDA. EXXUA gives us something special to build around. It is the first and only selective serotonin 5-HT1A receptor agonist approved by the FDA for the treatment of major depressive disorder in adults. Its novel mechanism and differentiated tolerability profile address an important need in a category where many patients struggle to find a treatment that works well for them and that they can stay on. As a reminder, the opportunity is substantial. An estimated 21 million Americans are affected by MDD, and the U.S. prescription MDD market exceeds $22 billion.

Josh Disbrow

Even a modest foothold in a market of that size would be meaningful for Aytu. We strongly believe EXXUA has the potential to become an important treatment option and a major growth driver for our company. It's one thing to have had excitement before a launch occurs, but what makes this especially exciting is that we are now seeing that opportunity begin to take shape in clinical practice. Physicians are gaining experience, patients are continuing treatment, and our prescription base is expanding. These early results reinforce our conviction in EXXUA and give us a strong reason to keep building with the same focus on execution and financial discipline. As we have discussed for some time, our approach to EXXUA is methodical. We are building the business with a clear focus on productivity, the return on our commercial investment, and preserving cash.

Josh Disbrow

As we have communicated, this was never going to be an oversized "spend at all costs" boom or bust type of launch. This quarter gives us meaningful evidence that our approach is working. Today, let me spend most of my prepared remarks discussing the EXXUA execution, including what we're seeing in the field and the decisions we are making as the launch develops. I'll also spend a little more time on ADHD because the notable durability of that business certainly deserves attention. Ryan will then cover our financial results and our fiscal 2027 outlook. EXXUA generated $3.9 million of net revenue in the fourth quarter, up from $2.4 million in the third quarter, bringing its fiscal 2026 contribution to $6.6 million. As a reminder, our formal launch only occurred at the beginning of January, and broader field deployment in late February and early March.

Josh Disbrow

We remain early in building physician awareness and experience with EXXUA having only just completed our first full quarter of launch. During the June quarter, total prescriptions were 3,323 compared with 1,398 in the March quarter. The monthly progression was 973 prescriptions in April, 1,089 in May, and 1,261 in June. As we entered fiscal 2027, July increased further to 1,377. August was up at 1,408 prescriptions. Importantly, EXXUA grew from July to August despite the overall MDD market declining. That is meaningful progress as more physicians begin using EXXUA and patients move from initial treatment into refills. One item I think is important to understand as we look at the trajectory in the early going is that we have consistently said we would manage this launch methodically, and that includes expecting a high-performing sales organization and holding that sales organization accountable for performance.

Josh Disbrow

Where representatives have not been performing at high levels or at the high levels we need, we have made adjustments in real time. As a result, we've seen ebbs and flows in the number of sales individuals on a month-by-month basis. Importantly, several of those changes occurred during June and July, and our field force reached a low of 32 representatives in July. That was down from 43 reps at the end of March. This was intentional as we were demanding high performance across the sales organization. Standards have been set and will be upheld, and we'll remain disciplined with our capital deployment throughout the launch. Those changes temporarily reduced our coverage while we worked to fill territories and optimize the profile of our sales specialist position. Since that low, we've brought the sales force back to approximately 42 representatives, and we continue to fill open positions.

Josh Disbrow

We're also adjusting territory coverage based on what we're learning, adding resources where the opportunity supports them, and combining sales specialist coverage where that makes better economic sense. One of the key metrics we're watching is weekly and monthly prescriptions per sales rep. Using month-end field force headcount as a directional measure, in March, we had 761 prescriptions and 43 sales specialists, or about 18 prescriptions per sales rep per month. In July, we had 1,377 prescriptions and 32 representatives, or approximately 43 prescriptions per rep for the month. That's more than a twofold increase in prescriptions per rep, with total monthly prescriptions also increasing 81% over that period. We're continuing to be proactive in fine-tuning the team, but we view that as an encouraging measure of the productivity of our commercial effort.

Josh Disbrow

To add some additional color on rep performance, which is clearly going to be the key driver of our success with EXXUA, consider some other numbers. If you look at our current active sales specialists, the top 10 are averaging almost 15 prescriptions per week. The top five are averaging 18.5 prescriptions per week. Importantly, as I share these numbers, I should note that we are not top-heavy with respect to the percentage of territories driving the majority of the EXXUA prescriptions. In fact, 24 territories, or approximately 60% of the current sales force, are driving 70% of the EXXUA prescriptions, demonstrating very good breadth across many geographies and across many sales specialists. That gives us great confidence in knowing that we have a product that is being and can be broadly adopted and broadly sold.

Josh Disbrow

To see what EXXUA weekly scripts could be in the relative near term as some of our newer sales specialists we have on board have come up the curve, consider what a weekly run rate looks like by simply having 45 territories at the weekly script rate of the top five or 10 territories. By simply generating 15 prescriptions per rep per week, that gets us to 675 TRXs per week. At the current selling price, that's already a $26 million annual run rate if you were to simply dollarize TRXs for ease of math. Taking that weekly rep average to 20 TRXs per week, which again, five territories are already averaging that plus or minus, then you're looking at 900 TRXs weekly or about a $35 million run rate annually.

Josh Disbrow

At 30 TRXs per rep per week, again, a weekly number achieved by multiple reps already, that takes the annual run rate to over $50 million, again, by simply dollarizing prescriptions. With the refined sales team that will be getting us to 40+ and more likely closer to 45 territories, you can see why we're excited about a significant lift of script levels in the relative near term. Speaking of near term, and this is happening really before any of the newly hired reps are even up the curve, we're seeing EXXUA take that next leg up. For the week ending September 4, just before Labor Day, we generated 394 prescriptions, a significant jump from July and August levels. Again, when the newly onboarded folks get their feet under them, we're excited to see what the script trends look like.

Josh Disbrow

Growing refill activity is also part of the picture, alongside the work our representatives are doing to develop prescribing relationships. We look at this measure together with total prescriptions, new and repeat prescribers, and the economics of the business as we decide where to put the next dollar of investment. This is what we mean by a methodical launch. We are using the data to make staffing and spending decisions, learning from the territories that are performing well, and addressing the ones that need improvement. We believe that's how we build a commercial organization that can support EXXUA over time while maintaining the financial discipline we've worked hard to establish. Perhaps most importantly, the feedback from physicians who are gaining experience with EXXUA remains highly encouraging. In our latest launch-to-date update, nearly 1,200 unique prescribers had written EXXUA, and nearly 2,500 unique patients had received it.

Josh Disbrow

We're seeing repeat prescribing from physicians who are developing a broader base of experience with the product, along with encouraging feedback on patient response and on patient tolerability. At the same time, many physicians in that prescriber base have only used EXXUA with one or two patients. Of course, we know it takes time for a physician to identify appropriate patients and then assess their experience and then ultimately become comfortable using a new medicine more broadly. That process develops over time. Our opportunity is to deepen utilization among those early adopters while continuing to introduce EXXUA to additional prescribers. We remained very encouraged by the response from physicians who are moving beyond their first few patients and continuing to prescribe. It's precisely those prescribers who have written EXXUA for a handful or more patients that are most impressed with the results.

Josh Disbrow

We continue to hear that across the country, and of course, that gives us great confidence in the product. Access also continues to support the launch. Reimbursement approval rates remain encouraging, and we are seeing a growing contribution from Medicaid and Medicare alongside the commercial business. RxConnect remains an important part of helping patients initiate and continue treatment and helping prescribers and their practices navigate access. Ryan will touch on this a bit, but gross-to-nets are significantly higher than our initial expectations. As we move into fiscal 2027, we will continue investing in EXXUA sales and marketing and in the medical and scientific education that supports physician understanding of the product. We will continue assessing the results and directing resources toward the activities that are producing the strongest return. Our fourth quarter results are an encouraging indication of what this model can deliver.

Josh Disbrow

We grew EXXUA revenue, benefited from the continued contribution of our legacy products, and generated positive EBITDA at the company level while keeping cash relatively stable. Profitability and cash preservation remain central to how we're managing the launch. Of course, there will continue to be variability in quarterly results as we invest and as the business moves through its normal seasonal patterns. Ryan will walk through that in more detail. Our objective, however, remains to build a durable, profitable EXXUA business on the platform we already have with commercial spending tied to strong ROIs. Turning to ADHD, the portfolio performed better than anticipated in the fourth quarter. Net revenue was $10.4 million compared to $9.1 million in the March quarter and $13.1 million in the fourth quarter prior year.

Josh Disbrow

For Adzenys, our brand and authorized generic together continued to retain approximately 80% of the prescriptions in the market for Adzenys and its generic equivalents. We believe this speaks to the durability of the franchise and the value of the RxConnect model, even with substantially less commercial support behind the brand. We also have our Cotempla authorized generic in the market, and it is gaining prescriptions week over week. As of today, Teva has not yet launched its generic version of Cotempla, following the July 1 date permitted under our settlement agreement with Teva, presenting potential upside to our base case assumptions around Cotempla's revenue run rate. As always, ADHD has normal seasonality, with the earlier part of the first half of our fiscal year typically softer due to kids being out of school. The fourth quarter performance, however, reinforces our confidence in the value this portfolio brings to Aytu.

Josh Disbrow

It remains an important source of profit and cash to support our investment in EXXUA. Rounding out the legacy business, our pediatric portfolio generated $1.8 million of net revenue in the fourth quarter, compared to $0.9 million in the March quarter and $2 million in the prior year quarter. These are mature products that we continue to service efficiently, and while smaller, pediatrics does remain a useful and durable contributor to the legacy business and the financial foundation supporting EXXUA. Overall, we are highly encouraged by the progress in EXXUA and the durability of our legacy business. Our focus remains on execution, profitability, and preserving cash. With that, let me turn the call over to Ryan for financial results and fiscal 2027 outlook. Ryan?

Ryan Selhorn

Thank you, Josh. Let us jump right into it. I will primarily cover our fourth quarter results and then spend a few minutes on our outlook and how we expect fiscal 2027 to unfold. Let us start on the revenue line. Net revenue for the fourth quarter of fiscal 2026 was $16.1 million, compared to $15.1 million in the prior year period, an increase of 6%. Revenue also improved from $12.4 million in the third quarter, with sequential increases across all three portfolios. For fiscal 2026, net revenue was $57.6 million. Breaking that down, EXXUA contributed $3.9 million in the fourth quarter, compared to $2.4 million in the third quarter. We are encouraged by that progression as we build the prescriber base and expand our commercial activity. The recent prescription data Josh discussed show continued progress, with 3,300 scripts written during the fourth quarter.

Ryan Selhorn

Remember, however, that prescriptions and unit shipments are different measures. During the fourth quarter, we shipped 4,599 units. Revenue reflects product sales into the channel, net of estimated rebates, discounts, and other adjustments and will not necessarily move in lockstep with prescriptions in any given period. We continue to see favorable gross to nets for EXXUA relative to our initial launch assumptions. Payer mix reimbursement and the level of patient access support all influence these economics. It is still early, and we want to see how those factors develop over a longer period before assuming the current realization rates will hold. The ADHD portfolio generated $10.4 million in the fourth quarter net revenue compared to $13.1 million in the prior year period and $9.1 million in the third quarter. The sequential improvement benefited primarily from better gross to net realization.

Ryan Selhorn

We continue to view this portfolio as an important source of cash flow with limited promotional spending behind it. The pediatric portfolio generated $1.8 million in fourth quarter net revenue compared to $2 million a year ago and $0.9 million in the third quarter. These are mature products and payer mix, returns, and ordering patterns can affect the quarterly results. However, they continue to contribute to the cash generation of the legacy business. Gross profit was $10.4 million in the fourth quarter, with a gross margin of approximately 65%, compared to $10.3 million and 68% in the prior year period. Sequentially, gross margin improved from 61% in the third quarter, which included a $0.7 million inventory write-down. For fiscal 2026, gross profit was $36.8 million or 64%. EXXUA's underlying economics remain attractive.

Ryan Selhorn

As we discussed last quarter, the royalty and product cost structure equates to approximately 31% of cost of goods sold or roughly a 69% gross contribution margin before certain fixed costs. Our consolidated reported margin also reflects those fixed costs, product mix, and inventory adjustments. I will come back to margin outlook in a moment. Turning to operating expenses. Total operating expenses were $11.2 million in the fourth quarter compared to $17.9 million a year ago. The prior year quarter included an $8.3 million impairment charge, so excluding impairment, restructuring costs, and intangible asset amortization from both periods, operating expenses were $10.4 million compared to $8.7 million on an apples-to-apples basis. The year-over-year increase primarily reflects EXXUA commercialization costs, partially offset by continued cost discipline elsewhere in the organization.

Ryan Selhorn

We spent less on certain commercial programs than originally planned during fiscal 2026, and some of that planned activity will shift into fiscal 2027. As Josh mentioned, we want to make sure we have strong ROIs on all investments made. If we do not believe we can get the returns or need to adjust the plan to get it right, we will. Interest expense was $0.4 million in the fourth quarter, compared to $0.7 million a year ago. For the full year, interest expense declined to $1.9 million from $3.7 million, primarily due to the paydown of our fixed payment arrangements. Those arrangements had no remaining balance at June 30th. For the fourth quarter, we reported a net loss of $0.1 million. On a per-share basis, the loss rounded to $0.00 per share.

Ryan Selhorn

This is compared to a net loss of $19.8 million or $2.92 per share in the prior year period. For fiscal 2026, net loss was $14.3 million. The fourth quarter included a $1 million non-cash derivative warrant liability gain. The prior year fourth quarter included $18.1 million of combined impairment expense and derivative warrant liability loss. These items have a significant effect on the GAAP comparisons. Adjusted EBITDA was a $+0.5 million for the fourth quarter, compared to a $+2 million a year ago and a $-2.8 million in the third quarter. For fiscal 2026, adjusted EBITDA was $-3.7 million. The reconciliation of this non-GAAP measure to net loss is included in today's earnings release. Turning now to the balance sheet.

Ryan Selhorn

Cash and cash equivalents were $26.3 million at June 30th, compared to $26.7 million at March 31st and $31 million at the end of fiscal 2025. While cash was relatively stable during the quarter, we also reduced our revolving credit facility balance to $6.1 million from $10.4 million at March 31st. Subsequent to year-end, we repaid the remaining revolver balance. Separately, the carrying value of our term debt, including the current and non-current portions, was approximately $11 million at June 30th. For fiscal 2026 as a whole, we generated $3.3 million of cash from operating activities, compared to using $1.9 million in fiscal 2025, an improvement of $5.2 million. Improved receivable collections and inventory turnover were meaningful contributors. We also used $7.9 million in financing activities, primarily to reduce our revolver term debt and fixed payment arrangements.

Ryan Selhorn

Accordingly, the year-over-year reduction in cash reflects significant balance sheet de-leveraging rather than operating cash burn. Stockholders' equity was $35.3 million at June 30th, 2026, compared to $19 million a year earlier. As discussed last quarter, the March warrant amendments reclassified $26.4 million from warrant liabilities to equity. This was a non-cash reclassification that reduced our exposure to future earnings volatility associated with those warrants. Before I turn it back over to Josh, I want to walk through the financial framework for fiscal 2027. We are not providing revenue guidance, but we do want to give you a clear view of our planned expenses, margin expectations, and the expected progression of profitability and cash flow. Our current plan calls for approximately $49 million to $54 million of operating expenses on a GAAP basis. Excluding non-cash expenses, total cash-based operating expenses are expected to be approximately $45 million-$49 million.

Ryan Selhorn

The largest increase is in sales and marketing, where we expect to invest up to $6 million, now planned for fiscal 2027 rather than fiscal 2026. This was always part of the plan, but it has been deferred from fiscal 2026 to fiscal 2027. The increase will support sales force coverage, marketing programs, and physician and patient education for EXXUA. We also expect a more modest increase in G&A, including medical affairs and support for the commercial organization. Research and development expense should remain minimal, and we expect interest expense to continue to decline steadily on a full-year basis. As we mentioned, we will manage spending against the results we are seeing. The budget gives us room to support the opportunity, and the timing and level of investment will depend on the prescription trends, access, commercial performance, and available liquidity.

Ryan Selhorn

We currently expect consolidated gross margin to be lowest in the first part of fiscal 2027 and to improve as the year progresses, driven principally by anticipated product mix as EXXUA continues to scale and the absorption of fixed manufacturing and supply chain costs. Our current expectation is to approach 66%-67% gross margin in the fourth quarter of fiscal 2027. The timing of the aforementioned investments as well as the normal seasonality are important to understanding the year. We expect lower adjusted EBITDA and operating cash flow in the first half of fiscal 2027 than in the second half. We will be making planned investments in EXXUA sales and marketing ahead of their full contribution, while the ADHD business is typically seasonally softer in the first quarter to half of our fiscal year.

Ryan Selhorn

From a cash flow perspective, we also have our annual PDUFA fees that come out in the first half of the year. As we move into the second half, we expect that seasonal pressure to reverse and EXXUA to make a larger contribution as our commercial efforts build. Based on our current plans taken together, we expect the six-month period ending June 30th, 2027 to generate positive adjusted EBITDA. We also expect cash flow to improve in the second half, although the timing of collections, working capital requirements, and payments will continue to affect cash balances. As always, I am happy to go over any details during Q&A. With that, Josh, let me turn it back over to you.

Josh Disbrow

Thank you, Ryan. As we look ahead, our conviction in the EXXUA opportunity remains extremely strong. We are seeing physicians gain experience with the product, a growing patient base, and improving prescriptions per sales specialist rate. We are also taking action where execution needs to improve. This is consistent with the approach we have described from the outset. Overall, we are extremely pleased with the progress this quarter and remain excited about the path ahead. As always, I want to thank our entire team for their work and 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. 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 speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Once again, please press star one if you have a question or comment. The first question comes from Thomas Flaten with Lake Street Capital. Please proceed.

Thomas Flaten

Yeah. Hey, guys. Appreciate you taking the question. Just to start off, Ryan, well, both of you mentioned that the GTN discount was more favorable than you had expected, and it looks like it is more favorable than our model. Can you talk a little bit about the puts and takes that made that more favorable?

Josh Disbrow

I can take that to start. Ryan, feel free to fill in. Thanks, Thomas, for the question. In short, it's just a higher than anticipated approval rate, really, across commercial payers. That's the simple answer. We're seeing it consistent. We're seeing it hang on really month to month. It is lower for the titration pack, but frankly, that's come in materially higher than we modeled initially. The 30 count, sort of, regular-way prescriptions are coming in at a higher approval rate as well. That's the key piece. They are holding on. I don't want to suggest have the potential for improvement, but as we build a higher percentage of government business, as you probably know, that's an even higher excuse me, an even higher or, yeah, better GTN, I should say.

Josh Disbrow

That is representing well north of 20%-25% of the business. If you look at analog products in the category, some have achieved upwards of 35%-40% of the business coming from Medicare and Medicaid. It's a combination of that portion of the business growing and then just overall improvements, overall approval rates better than, again, we had initially modeled and initially anticipated. This all reminds you is all without any commercial contracts, and we have no supplemental Medicaid or Medicare rebates.

Thomas Flaten

Can you talk a little bit about your utilization of RxConnect for EXXUA? I know it represented a significant chunk of your ADHD portfolio, but maybe some commentary around that would be great.

Josh Disbrow

Yeah. We look at shipments into RxConnect partner pharmacies, and then we look at dispense claims. I'm most interested in dispense claims because ultimately that's where the rubber meets the road and that's where the patient obviously gets the prescription. It's lower than the current percentage of ADHD, but certainly we would expect it to grow over time. When you look at dispense claims for ADHD, that's any given month, upwards of 80% of our total prescriptions are dispensed through an RxConnect partner pharmacy or as part of the program. It's not to that level, but it is growing. Because we do have quite a few prescriptions coming from whitespace and from areas where we don't have rep coverage. We do have some what we call free range prescriptions, and we also are going to build a materially higher base of government business.

Josh Disbrow

Some of those we don't track at the moment. While those can and are filled at RxConnect partner pharmacies, in many cases, those are just filled at a pharmacy outside the network. That having been said, we would expect over time to continue to drive more and more prescribing to the RxConnect pharmacies, just given the moat that that represents and what we think can really prove out to be an elongated tail, even post loss of exclusivity. Obviously, we've got some time before we get there.

Thomas Flaten

Then final one for me, speaking of which, you obviously had a nice sequential uptick on the ADHD portfolio, and I realize that the Cotempla generic didn't come to market. Can you talk a little bit about how you've been able to not only maintain but then grow sequentially the ADHD portfolio with limited coverage? Is it just one of those things that happened, or was there something proactive that you did?

Josh Disbrow

Well, we're always monitoring the base business as it relates to gross-to-nets reimbursement rates, pharmacy reimbursement in particular. There certainly is real-time adjustments going on to ensure that we're optimizing the payer, sort of the mix there as it relates to dispensing and filled prescriptions and claims. So that's a piece of it. Certainly, there's an element of being proactive. I would say GTNs had some improvement and some uptick. I mean, that's the bulk of it, really. Yeah, I would say that has been actively managed, and that's something that could be managed with relatively few resources. We have, of course, internal resources dedicated to that, and so it largely has just been optimizing GTNs and ensuring that the pharmacies are sort of in adequate shape with respect to the AG and the brand.

Josh Disbrow

Of course, we're able to seamlessly toggle, or they're able to seamlessly toggle between the brand and the AG. Again, I'll remind you that the ANDA has really been slow. The Teva product has kind of hardly scratched 20% when you look at the overall available market of prescriptions. While prescriptions have come down year-on-year, that's largely attributable to just the pull promotion that we pulled over a year ago.

Thomas Flaten

That is awesome. Thanks for the questions. Congrats on the quarter.

Josh Disbrow

Thank you, Thomas.

Operator

The next question is from Naz Rahman with Maxim Group. Please proceed.

Naz Rahman

Hi, everyone. Congrats on the progress and thanks for taking our questions. Just a couple. First, in terms of the prior auths, could you provide some color on, I guess, how the prior auths are evolving? What I mean by that is, are you seeing the prior auths get approved first pass more frequently, or do you know what percentage of the prior auths get approved in the first pass versus how many are requiring multiple back-and-forths? I have a follow-up after that.

Josh Disbrow

Yeah. Thanks for the question, Naz. In terms of prior auth, it's a still relatively early stage, and what I'll say is because of the nature of this patient with multiple failures, we absolutely are having success from a prior authorization perspective. Obviously, we're not doing them. We can't do them on behalf of the customers. It's the prescribers that ultimately complete the paperwork, but we've made it very simple for them. It's a really straightforward process. Physicians are increasingly utilizing the service. They have to engage with a specific vendor to get signed up and so forth, and they log in and essentially do a very, very simple process. And the approval rates for prior authorizations are quite high. If you look at the success we're having with claims that are submitted through the program, it's in the neighborhood of 70%.

Josh Disbrow

We're having quite a lot of success. That's materially higher than most categories, and I think it's because of the ease of use of the program that we've implemented, also the class and the patient type. Again, this is going to be a patient that's often been on multiple medications. It's been very, very encouraging in the early stages of this.

Naz Rahman

Got it. That was helpful. And one last question. In terms of coverage and reimbursement, previously you talked a lot about the importance of government payers. At this point, when can we expect, I guess, the next large bolus of payments in terms of both commercial and government payers, and what would you expect first?

Josh Disbrow

Yeah, that's a good question, Naz. We don't really think of it as bringing on any sort of one big lever. We think it'll sort of organically evolve. Frankly, if these GTN levels just maintained with the coverage we have today without any contracts, that would be a really, really good situation, a really good story. We continue to really scrutinize the need to contract proactively. In fact, I think we're at the point of not proactively contracting, same on both sides, government and commercial. Doesn't do us any good to contract on the government side and pay large supplemental rebates when states, in one way, shape, or form, will cover this. They might require a prior authorization, but as I just described, those are not exceedingly difficult to get. And on the commercial side, we're seeing good approval rates without any active contracts in place.

Josh Disbrow

Again, understanding the placement of this product is not first line. The ability to get claims approved, understanding that this is often for a patient that has been on two or three or maybe more medications. We will, of course, continue to keep ourselves open to contracting, but we do not think of it as necessarily saying, "Okay, we are going to have a step function." Because one of the things that we know is payer contracts do not drive demand. If you sign an agreement with a large PBM, you do not automatically get a step function in your demand. It still comes down to prescribers sending prescriptions to pharmacies, and that is, of course, driven by us.

Josh Disbrow

What you can do from a payer perspective is you can optimize and tweak sort of GTNs and pricing, but you do not necessarily think of those as just because you have a contract with one of the big three PBMs, does not mean a physician will automatically prescribe. Really, it is the contrary. Because we have RxConnect set up and to some degree, we serve as the backstop, if you will, to guarantee that that patient never pays more than $50 on a commercial claim. We do not really have a need to go out and shout from the rooftops that we have a contract with a large PBM. It does not preclude the possibility that we would engage with one, but it has to be on the terms that make sense for us economically.

Josh Disbrow

We are generating enough demand to start to generate some interest and some inbound conversations, but time will tell as to really how valuable those conversations turn out to be, and we are really in a good spot based on the GTNs today. Again, do not feel a need to proactively contract on either side of the ledger, commercial or government.

Naz Rahman

Got it. That was helpful. Thanks for taking my questions.

Josh Disbrow

Thank you.

Operator

Once again, if you have a question or a comment, please indicate so by pressing star one. The next question is from Ed Woo with Ascendiant Capital Markets. Please proceed.

Ed Woo

Yeah, congratulations on all the progress. My question is on the sales rep. You mentioned that you were at 43 in March, 32 in July, 42 now. Do you have a goal in mind of where you think you want to be maybe in six months. I know you mentioned that these reps get up to speed pretty fast. Is it within three months that you feel that they are able to hit their stride?

Josh Disbrow

Yeah, good question, Ed. Thanks for that. The goal will be dictated obviously by cash flow. We said that from the beginning, but certainly materially higher than 42 or 49. We have a plan that's at least a multiple of that, if not higher, in terms of where ultimately we see the footprint getting from a sales specialist perspective. The timeline will be driven by profitability and cash flow to enable us to expand in a prudent fashion. We do not have a specified goal of it has to be 60 reps by the end of the calendar year and then 120 by the middle of next. Although that type of cadence would suggest that we are on a good trajectory and are generating an adequate level of cash flow to justify that level of investment. We are being very judicious in how we think about territories.

Josh Disbrow

In some cases, we are doubling up in areas. In other cases, we are keeping a single territory just because it is able to be efficiently managed that way. And ultimately, that is how we think about it. Sorry, I missed it. The second part of your question?

Ed Woo

In terms of how quickly do these sales rep ramp up?

Josh Disbrow

Oh, yeah. Yes. Thank you.

Ed Woo

Is it a quarter, six months?

Josh Disbrow

Yeah. Six to nine months, realistically, is a good timeframe to really think of somebody as sort of adequately tooled for the job. If you look at really sort of a break-even analysis, you would look at something closer to nine or 12 months. But in terms of really identifying, I guess there's a couple of components there. Identifying that the person has the requisite skills, drive, demeanor, all the things you need to be successful, that takes less time. To ultimately get that rep to turn that into action on the part of the prescribers, that's something more like six to nine months. As we think about a phased approach of getting to that next layer of geographies, we sort of think of it with a six to nine-month ramp-up period in mind. That's what's really encouraging.

Josh Disbrow

We hit an all-time high prescription, a weekly prescription level the week ending September 4th of almost 400 prescriptions. I'll remind you, that's still with something south of 40 reps really active. When you think about really that we had a crop that came in a few months ago, they're still just kind of getting their feet under them. So you get another three months down the road and that crop of reps starts to get turned on and deliver, and then another crop that we'll have coming in here in the fall. You can really envision that leg up, and that's why I use the numbers I did of if you just got some of those reps up to 10, 15, and certainly it's realistic to think that they could all be at 20-30 a week.

Josh Disbrow

That's significantly lower than any of our reps got on Adzenys if you looked at its historical highs. So quite confident that 40-45 reps and then expanding to 50 and beyond, getting to 20, 30, and then ultimately 50+ prescriptions a week. It's pretty exciting to think where that puts us from a revenue trajectory perspective.

Ed Woo

Just to clarify, the amounts, I think you mentioned 3,000 prescriptions for the quarter. Does that include refills?

Josh Disbrow

That includes refills. Yep. That would be starter and that would be initiation. The starter titration packs would be sort of the initiation, then we think of refills as once they get transitioned to the 30 count, regular sort of stable dose, and then a refill beyond that. Yep. Again, keeping in mind that many of these patients, they've just gotten started over the first month or so. Some patients are titrating more slowly than the label sort of indicates. Some of these patients are just getting into their first month or so we've not yet to see anything resembling sort of the compounding effect that we would expect to see as the months move forward.

Ed Woo

All right. That sounds good. Well, thanks for answering my questions, and I wish you guys good luck. Thank you.

Josh Disbrow

Thanks, Ed.

Operator

We have reached the end of the question and answer session, and I will now turn the call over to management for closing remarks.

Josh Disbrow

Thank you, John. Again, just to reiterate, we are extremely pleased with the progress this quarter, particularly as it relates to the trajectory we are seeing with EXXUA. We are increasingly encouraged by the number of territories driving meaningful prescriptions and ultimately the breadth of prescribing.

Josh Disbrow

We are most excited about the response that we are hearing through physicians due to the feedback they are getting from their patients. Patients saying things back to their physicians like, "It has been life-changing," and, "Haven't felt this good in years." That is just why we do what we do. We continue to have the pedal down, work very hard every single day to ensure that as many prescribers as we can hear about the EXXUA story and ultimately put pen to paper to prescribe what we think is an outstanding treatment, and it is proving to be that in the real world. With that, we are very encouraged.

Josh Disbrow

We are now, of course, into our fiscal 2027, towards the end already of our first quarter. We will look forward to sharing those results with you all in November. Until then, thank you for your interest in Aytu. Thanks for your time, and have a good evening.

Operator

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

Related articleQuarter not tagged2026-09-16

Aytu BioPharma to Report Fiscal 2026 Full Year and Fourth Quarter Operational and Financial Results on September 22, 2026

ACCESS Newswire

DENVER, CO / ACCESS Newswire / September 16, 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, will report its operational and financial results for its fiscal 2026 full year and fourth quarter, after the market close on Tuesday, September 22, 2026. The Company has scheduled a conference call and webcast that same day, Tuesday, September 22, 2026, at 4:30 p.m. Eastern time, to review the results followed by a question and answer session. Conference Call Details Date and Time: Tuesday, September 22, 2026, at 4:30 p.m. Eastern time. Call-in Information: Interested parties can access the conference call by dialing (888) 506-0062 for United States callers or +1 (973) 528-0011 for international callers and using the participant access code 504506. Webcast Information: The webcast will be accessible live and archived at https://www.webcaster5.com/Webcast/Page/2142/54094, and accessible on the Investors section of the Company's website at https://investors.aytubio.com/ under Events & Presentations. Replay: A teleconference replay of the call will be available until October 6, 2026, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 54094. About Aytu BioPharmaAytu 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. Contacts for InvestorsRyan Selhorn, Chief Financial OfficerAytu BioPharma, [email protected] Robert BlumLytham [email protected] SOURCE: Aytu BioPharma, Inc. View the original press release on ACCESS Newswire

Related articleQuarter not tagged2026-05-14

Aytu BioPharma Inc (AYTU) Q3 2026 Earnings Call Highlights: Strong Exua Adoption Amid Revenue ...

GuruFocus.com
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…Read full document

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.

Related articleQuarter not tagged2026-05-14

Aytu BioPharma Reports Fiscal 2026 Third Quarter Operational and Financial Results

ACCESS Newswire
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 encoura…Read full document

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

Related articleQuarter not tagged2026-05-14

Full Transcript: Aytu BioPharma Q3 2026 Earnings Call

Benzinga
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 availa…Read full document

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.

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Aytu (AYTU) Q3 2026 Earnings Transcript

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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 trea…Read full document

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

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Aytu BioPharma, Inc. Q3 2026 Earnings Call Summary

Moby
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 amend…Read full document

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.

TranscriptFY2026 Q32026-05-13

FY2026 Q3 earnings call transcript

Earnings source - 120 paragraphs
Operator

Today, welcome to the Aytu Biopharma fiscal 2026 Q3 earnings call. At this time, all participants are in a 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 zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Robert Blum, Investor Relations. You may begin.

Robert Blum

Great. Thank you very much. Good afternoon, everyone. As the operator indicated, during today's call, we will be discussing Aytu BioPharma's fiscal 2026 Q3 operational and financial results for the period ended March 31, 2026. Joining us on today's call is Aytu'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.

Robert Blum

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. I'd also like to call to your attention the customary safe harbor disclosure regarding forward-looking information.

Robert Blum

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.

Robert Blum

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 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. Josh, please proceed.

Josh Disbrow

Thanks, Robert, 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 EXXUA. As we've discussed, EXXUA represents a significant new opportunity for Aytu. 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. EXXUA is already demonstrating very solid growth trajectory within the MDD category.

Josh Disbrow

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.

Josh Disbrow

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. 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.

Josh Disbrow

The initial tranche of the sales organization completed training in January, while broader field deployment of the full 40+ sales representatives didn't actually begin until late February, early March. That timing's 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. We're just getting started.

Josh Disbrow

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 1,300 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.

Josh Disbrow

That type of sequential growth is exactly what we'd hoped 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's a 26% month-over-month sequential growth rate.

Josh Disbrow

Further, we shipped over 1,300 units shipped in April, which is 51% sequential growth, and that's more than the prescriptions generated in the entire Q1. 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.

Josh Disbrow

During the quarter, more than 450 unique prescribers wrote EXXUA prescriptions. That is meaningful because our initial focus call universe is approximately 3,500-4,000 highly targeted prescribers. At this very early stage, already 10%-13% of our target universe has written EXXUA. Yet again, we're just getting started in building a solid base of physician adoption.

Josh Disbrow

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 physicians, rather, are writing for patients.

Josh Disbrow

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.

Josh Disbrow

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. 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.

Josh Disbrow

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.

Josh Disbrow

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 EXXUA'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 Aytu relationships, and insights gained from our RxConnect platform.

Josh Disbrow

We believe that this is the right approach for EXXUA 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.

Josh Disbrow

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. Aytu RxConnect has been and will continue to be a core pillar of the EXXUA launch.

Josh Disbrow

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 EXXUA, including a no-cost 14-day titration pack and guaranteed access through the early treatment period for commercially insured patients specifically.

Josh Disbrow

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're also seeing our channel partners execute well.

Josh Disbrow

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 EXXUA and a patient is ready to begin therapy, that product is available and the process is smooth.

Josh Disbrow

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. EXXUA gives these patients and these clinicians a differentiated option with a novel mechanism of action. That message is clearly resonating.

Josh Disbrow

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 they're simply searching for something new. Our job is to continue educating, supporting access, and building confidence through clinical experience.

Josh Disbrow

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'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.

Josh Disbrow

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're hearing through our prescribers is nothing short of outstanding. Phrases from even difficult patients like, quote, "life-changing," and a specific patient saying, quote, "He has never felt this good in his entire life," are coming through at this point almost daily.

Josh Disbrow

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 EXXUA.

Josh Disbrow

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 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.

Josh Disbrow

We're 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. It remains early, but many of the positive payer dynamics we've spoken about pre-launch 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.

Josh Disbrow

We believe EXXUA has a differentiated profile, and the more physicians understand where EXXUA fits into their prescribing, the more opportunity we have to grow. We had a significant presence at a major psychiatric conference last weekend, the NEI Spring Congress. As expected, interest and feedback and follow-up from the conference attendees was excellent.

Josh Disbrow

Finally, we'll 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 EXXUA. 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.

Josh Disbrow

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 standalone basis.

Josh Disbrow

The uptake of the third-party generic against Adzenys has been quite low, which has been encouraging, with it only achieving about 14% market share through 4+ months of market availability. This tells us that the protective characteristics of the Aytu RxConnect program are proving protective, given relatively little erosion as a percentage of the overall scripts written within the Aytu RxConnect ecosystem.

Josh Disbrow

The vast majority of decline due to the generic is coming from outside the Aytu RxConnect ecosystem, things are working as we had expected and as we had designed. Our Pediatric 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.

Josh Disbrow

Overall, the legacy business continues to provide an important foundation as we transition the company towards the larger CNS opportunity, clearly represented by EXXUA. Our goal is to balance disciplined investment in EXXUA 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 EXXUA launch activity.

Josh Disbrow

We generated $2.4 million of revenue for, specifically for EXXUA, saw more than 1,300 prescriptions written in the quarter, had more than 450 unique prescribers write the product, sold more than 3,300 units into the channel during the quarter, and saw great momentum and continued growth into April with almost 1,000 prescriptions generated.

Josh Disbrow

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.

Josh Disbrow

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 Aytu. With that, let me turn the call over to Ryan to review the financials in more detail. Ryan?

Ryan Selhorn

Thank you, Josh. Let's jump right into it. Let's start on the revenue line. Net revenue for the Q3 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, EXXUA contributed $2.4 million in the quarter.

Ryan Selhorn

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. 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.

Ryan Selhorn

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 EXXUA. The ADHD portfolio generated net revenue of $9.1 million in the Q3 compared to $15.4 million in the prior year period.

Ryan Selhorn

The decrease is primarily attributable to lower total prescriptions as we have deliberately shifted 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 one of our ADHD products late in the Q2 of fiscal 2026. The Pediatric Portfolio generated net revenue of $0.9 million for the Q3 compared to $3.1 million in the prior year period.

Ryan Selhorn

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.

Ryan Selhorn

Again, I'll remind you that the legacy portfolios do generate cash even at these levels. Gross profit margin was 61% in the Q3 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.

Ryan Selhorn

Excluding that write-down, gross margin for the Q3 would have been approximately 67%. From an EXXUA perspective, the expected unit economics remain attractive. As discussed previously, EXXUA 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.

Ryan Selhorn

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 Q3 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 investments, partially offset by improved operational efficiencies such as reduced facilities expense.

Ryan Selhorn

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 previously discussed.

Ryan Selhorn

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 2026 Q3 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.

Ryan Selhorn

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 Q3 were primarily driven by increases in our stock price.

Ryan Selhorn

On April 2, 2026, we filed a Form 8-K 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 31st, 2026. We believe this should significantly reduce future non-cash earnings volatility associated with warrant liability gains and losses.

Ryan Selhorn

As of March 31st, 2026, stockholders' equity was $35.1 million compared to $14.2 million at December 31st, 2025. Finally, adjusted EBITDA was -$2.8 million for the third quarter of fiscal 2026 compared to a +$3.9 million in the year ago period.

Ryan Selhorn

The change primarily relates to the planned investments we've made towards the launch of EXXUA, 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.

Ryan Selhorn

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 EXXUA launch, along with normal working capital movements. As of March 31st, 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.

Ryan Selhorn

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 31st, 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.

Ryan Selhorn

Before I turn it back over to Josh, I want to spend a few minutes on how we are thinking about EXXUA from a financial perspective now that we have the 1st 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.

Ryan Selhorn

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 closest, 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.

Ryan Selhorn

Second, gross-to-net dynamics are still settling. During the quarter, growth to net 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, RxConnect utilization, pharmacy ordering patterns, and patient access programs mature.

Ryan Selhorn

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 Aytu RxConnect, we have deliberately reduced early access friction by offering a no-cost 14-day titration pack.

Ryan Selhorn

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.

Ryan Selhorn

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.

Ryan Selhorn

We made planned investments during the quarter across sales and marketing, service costs, 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 EXXUA opportunity appropriately without losing the operating discipline that has been central to the company's progress.

Ryan Selhorn

In the Q4 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 million-$2 million, depending on their breadth and overall impact.

Ryan Selhorn

Additionally, we have increased our speaker program events spending, medical education content, and conferences involvement, which will likely increase our G&A spending by $200,000-$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 million-$7 million and G&A to range from $5 million-$5.3 million going forward. Finally, the financial model continues to be straightforward. We expect EXXUA to have attractive gross contribution margin.

Ryan Selhorn

We expect launch-related expenses to be managed against demand and return on investment, and we expect the legacy portfolios to continue to providing an important foundation as EXXUA scales. While we are not providing formal guidance today, the general framework we discussed previously remains the right way to think about the business.

Ryan Selhorn

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'm happy to go over any details during Q&A. With that, let me turn it back over to you, Josh.

Josh Disbrow

Thanks, Ryan. As we look ahead, I want to reemphasize again what we're seeing with EXXUA. 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 EXXUA's differentiated role in the treatment of major depressive disorder.

Josh Disbrow

Again, with April posting over 900 prescriptions and over 1,300 unit shipments, we're seeing continued month over month increases in prescription and unit demand. Importantly, this momentum was achieved with only a partial quarter of full sales for support, which reinforces our confidence in both the market opportunity and the disciplined, efficient commercial strategy we have put in place.

Josh Disbrow

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'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 speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator

Once again, that will be star one on your phone at this time if you wish to ask a question. One moment, please, while we pull for questions. First question today is coming from Thomas Flaten from Lake Street. Thomas, your line is live.

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 a million and a half in quote-unquote stocking revenue in the EXXUA number for the quarter. Is that a reasonable assumption?

Ryan Selhorn

Sorry. Yeah, that is a pretty accurate calculation.

Thomas Flaten

Okay. 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.

Josh Disbrow

Yeah. I'll take weight gain first, which is that 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.

Josh Disbrow

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 EXXUA and immediately, restored his libido. We're hearing very, very good positive anecdotes, way more than just those handful.

Josh Disbrow

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 Flaten

Just one last one, if I might. You mentioned something like 10-ish% of your customers had written EXXUA. What's been the writing activity of non-customers, so to speak, people that you haven't called on? Is there any of that?

Josh Disbrow

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 who follow us closely know. You 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.

Josh Disbrow

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. It's been highly encouraging. I want to say we've had prescriptions in 42 or, yeah, 41 or 42 states at this point.

Josh Disbrow

Obviously we don't physically have presence in nearly that many, so it's been very encouraging.

Thomas Flaten

Great. Appreciate that. Thank you.

Josh Disbrow

Thank you.

Operator

Thank you. The next question will be from Naz Rahman from Maxim Group. Naz, your line is live.

Naz Rahman

Hi, everyone. Congrats on the progress, and thanks for taking my questions. I only have two. The first one is on reimbursement. I understand it's very early in the launch process, but in terms of, like, those prior authorizations, could you provide some color on, I guess, how many of those or what % of those prior auths are getting approved on the first pass versus how many or what % you have to have, like, a back and forth through prior to getting reimbursed?

Josh Disbrow

Yeah, good question. 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 prescribing EXXUA fits well within what they currently do.

Josh Disbrow

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.

Josh Disbrow

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. That's all encouraging. Medicare, relatively small numbers on Medicare. Those prescriptions are going through as well.

Josh Disbrow

Highly variable from plan to plan in terms of what is required. Most patients will have to meet a deductible. 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, I'll bifurcate that a bit as well, because we certainly have prescriptions going through the Aytu RxConnect network. That is the vast majority.

Josh Disbrow

To Thomas Flaten's previous question around prescriptions that are being dispensed and prescribers outside of our footprint, those two are going through. 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. Within the Aytu RxConnect network, we are seeing prior authorizations go through with good success.

Josh Disbrow

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 copay for the patient and a higher net selling price to us, and so that's highly encouraging.

Josh Disbrow

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 and for that first trial period, we're essentially covering those prescriptions for either $0 or potentially $50. 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.

Josh Disbrow

To reiterate what Ryan said, we'll caution of extrapolating that out too far because things are still settling out. 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.

Josh Disbrow

Very pleased.

Naz Rahman

That was very helpful. Just kind of on that point, these patients, do you know, I guess, what line they are on by the time they get to EXXUA? It sounds like in Colorado, these are like 3rd line patients. Do you have an idea of like how many of these patients are like 2nd line versus 3rd or 4th?

Josh Disbrow

Yeah, that's a good question. It's still very early, and it's very heterogeneous. We have everything from 2nd 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 the 60%+ range, those patients are being switched, which suggests minimally those patients have been on 1 therapy.

Josh Disbrow

Really, when you speak with doctors in real terms, these are patients that in the early goings have been on multiple. If I had to put a number, it's somewhere between probably 3rd and 5th line realistically. Very encouraging that you've got patients that are being prescribed 2nd line. I know of a specific patient.

Josh Disbrow

I don't know the anything other than the patient's demographics based on a prescription that was generated just last week. It was second line. It was 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 EXXUA. Still very early to know how that patient's doing.

Josh Disbrow

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, quote, "train wreck" patients that are being started. Very encouragingly, those patients in many cases are responding quite well when other things have failed. It's been quite encouraging.

Naz Rahman

That was very helpful. Thanks for taking my questions.

Josh Disbrow

Thank you.

Operator

Thank you. 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 Edward Woo from Ascendiant Capital. Edward, your line is live.

Edward Woo

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?

Josh Disbrow

Good question, Edward. We start patients off, in an optimal world, the prescriber would prescribe the 14-day titration pack. By definition, that's two weeks. That patient would then get moved to one of the top two doses in most cases, either the 54.5 mg or the 72.6 mg. Those, either of those, the 54.5 or the 72.6, would be prescribed for 30 days.

Josh Disbrow

Typically, they'll either be seen back to either stay optimized on the 54.5 or move up to the 72.6. 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.

Josh Disbrow

In some cases, doctors are more aggressive and will go to the 72.6. Again, they'll get the full 90-day. I say that all to say it's variable, but generally speaking, they're getting 30 days, and then they're typically gonna 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. 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.

Edward Woo

Okay. It's not clearly 30 days, then you see the refill. You might actually, based on your data, without disclosing much information, you're happy with the refill rate so far that you're seeing this at this point in time?

Josh Disbrow

Very. 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.

Josh Disbrow

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. It's very, very solid, and we expect it to improve over time. 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. Just getting started.

Edward Woo

That sounds good. My last question is just on geography. I know you mentioned that you guys are aiming for the coast, for the big markets. Is that your continued plan going forward is just to target the big metro markets first and then move to the smaller markets?

Josh Disbrow

You know, what I'll say already, Edward Woo, 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 Selhorn said. We'll certainly be cost-efficient.

Josh Disbrow

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. We are already looking. Certainly, you know, I mentioned a few dotted territories kind of in flyover country, so to speak.

Josh Disbrow

We are actively looking at north to south, east to west, and even. 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 1st full week of March. 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.

Edward Woo

Excellent. Well, thanks a lot for answering my questions, and I wish you guys good luck. Thank you.

Josh Disbrow

Thank you, Edward.

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

Thank you, Paul. Again, thanks everyone. We could not be more excited with the progress that we're seeing in real time here. I've got the unique benefit of not just leading the team, but in some cases, having conversations of my own. The real-world feedback is really nothing short of amazing.

Josh Disbrow

We've continued to hear positive feedback across the board with patients that have tried a lot of therapies and in some cases, quote, "everything," according to the psychiatrist. To hear the feedback that's coming back is nothing short of inspiring. We'll continue to keep the pedal down and obviously drive higher and higher adoption.

Josh Disbrow

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 and good evening until next time. Thanks very much.

Operator

This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

Related articleQuarter not tagged2026-05-07

Aytu BioPharma to Report Fiscal 2026 Third Quarter Operational and Financial Results on May 13, 2026

ACCESS Newswire

DENVER, CO / ACCESS Newswire / May 6, 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, will report its operational and financial results for its third quarter of fiscal 2026, after the market close on Wednesday, May 13, 2026. The Company has scheduled a conference call and webcast that same day, Wednesday, May 13, 2026, at 4:30 p.m. Eastern time, to review the results followed by a question and answer session. 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. Contacts for Investors Ryan Selhorn, Chief Financial Officer Aytu BioPharma, Inc. [email protected] Robert Blum Lytham Partners [email protected] SOURCE: Aytu BioPharma, Inc. View the original press release on ACCESS Newswire

As of 2026-09-26 • Updated weeklySource: Earnings sourceIngestion runbook