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AYTU BIOPHARMA, INC (AYTU)·Q4 2025 Earnings Summary

Executive Summary

  • Q4 FY2025 net revenue was $15.1M (+4% YoY) with gross margin 68%; adjusted EBITDA was $2.0M; GAAP net loss was $(19.8)M driven by $8.3M impairment and $(9.9)M derivative warrant loss .
  • Revenue and EBITDA missed S&P Global consensus: $15.1M vs $17.9M revenue and $2.0M vs $2.8M EBITDA; Primary EPS came in at $(0.0764) vs $(0.05) estimate; Q3 FY2025 had broad beats and GAAP profitability [GetEstimates]* .
  • Management reiterated EXXUA (gepirone ER) U.S. launch timing in Q4 calendar 2025 and outlined launch economics (~69% gross contribution after a 28% royalty plus COGS) and ~$10M FY2026 launch OpEx; base business break-even ~ $13.2M quarterly .
  • ADHD franchise: authorized generic for Adzenys launched Sept 2; management expects controlled impact from potential Teva generic entry due to RxConnect channel and pricing levers; PDUFA fee savings (~$2M annual historically; $1.5M fixed cost in FY2025 COGS) and packaging changes are expected to lower COGS over time .
  • Balance sheet strengthened: cash $31.0M at June 30, 2025; term loan upsized to $13.0M; revolver availability increased for launch working capital .

What Went Well and What Went Wrong

What Went Well

  • Nine consecutive quarters of positive adjusted EBITDA; Q4 adjusted EBITDA was $2.0M, and FY2025 adjusted EBITDA was $9.2M, reflecting cost discipline and RxConnect leverage .
  • Pediatric portfolio growth: Q4 Pediatric net revenue rose to $2.0M (vs $0.8M YoY) on return-to-growth plan and broader coverage; full-year grew to $8.8M (+21% YoY) .
  • Strategic positioning and confidence in EXXUA launch: “We remain on track to launch EXXUA in the fourth quarter of calendar 2025…centerpiece of Aytu’s commercial efforts” — CEO Josh Disbrow . “Think ~31% COGS (~69% gross contribution)” — CFO Ryan Selhorn on EXXUA economics .

What Went Wrong

  • Q4 headline miss vs consensus: revenue $15.1M vs $17.9M and EBITDA $2.0M vs $2.8M; Primary EPS $(0.0764) vs $(0.05) estimate; driven by softer ADHD scripts and margin compression [GetEstimates]* .
  • Gross margin pressure (68% vs 76% YoY) due to higher-cost ADHD inventory as manufacturing transitioned from Grand Prairie, TX to a contract manufacturer; margin expected to normalize as inventory sells through .
  • Large non-cash/non-core charges: $8.3M impairment (pediatric portfolio), $(9.9)M derivative warrant loss due to stock price/warrant revaluation, and restructuring related to facility closure elevated GAAP net loss to $(19.8)M .

Financial Results

Quarterly Results (Actual) vs Prior Year and Prior Quarter

MetricQ4 2024Q3 2025Q4 2025
Revenue ($USD Millions)$14.6 $18.5 $15.1
Gross Margin (%)76% 69% 68%
Adjusted EBITDA ($USD Millions)$2.03 $3.94 $2.04
GAAP EPS (Basic/Diluted) ($)$(0.82) $0.65 / $0.21 $(2.92)

Actual vs S&P Global Consensus

MetricQ3 2025 EstimateQ3 2025 ActualQ4 2025 EstimateQ4 2025 ActualQ1 2026 EstimateQ1 2026 Actual
Revenue ($USD Millions)$13.74*$18.45 $17.92*$15.14 $12.60*$13.89*
EBITDA ($USD Millions)$2.14*$3.74 $2.76*$1.93 $(0.81)*$(0.70)*
Primary EPS ($)$(0.17)*—$(0.05)*$(0.0764)*$(0.255)*$(0.0934)*

Values retrieved from S&P Global.*

Segment Net Revenue

Segment ($USD Millions)Q4 2024Q3 2025Q4 2025
ADHD Portfolio$13.76 $15.39 $13.11
Pediatric Portfolio$0.84 $3.06 $2.02
Other$(0.03) $0.00 $0.01
Total Net Revenue$14.59 $18.45 $15.14

KPIs and Cost Structure

KPI ($USD Millions unless noted)Q4 2024Q3 2025Q4 2025
Operating Expenses (ex amort., restructuring, impairment)$10.5 $9.5 $8.7
Cash & Cash Equivalents (period-end)$20.01 $18.17 $30.95
Accounts Receivable (net) (period-end)$23.53 $35.83 $31.15
Stockholders’ Equity (period-end)$27.72 $34.90 $18.97

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
EXXUA U.S. launch timingCalendar Q4 2025N/A“On track to launch…by end of calendar 2025” Introduced
EXXUA unit economicsOngoingN/A~28% royalty + COGS; ~69% gross contribution assumed Introduced
Launch OpExFY2026N/A~$10M total launch investment, ~50% in Q2 FY2026, remainder Q3–Q4 Introduced
Base business break-evenOngoingN/A~$52.6M annual / ~$13.2M quarterly revenue to break-even (ADHD + Pediatric) Introduced
ADHD COGS savingsLate FY2026–FY2027N/APackaging reconfiguration expected to lower COGS; PDUFA fee eliminated after Sept 2025 Positive
Working capital2025N/ATerm loan upsized to $13.0M; revolver incremental advance $1.5M for launch flexibility Positive

Earnings Call Themes & Trends

TopicQ2 FY2025 (Dec-24 quarter)Q3 FY2025 (Mar-25 quarter)Q4 FY2025 (Jun-25 quarter)Trend
Portfolio prescription trendsFirst sequential increase in both ADHD and Pediatric since 2022; ADHD +16% seq (ex one-time), Pediatric +86% seq ADHD +11% seq; Pediatric +27% seq; strong net revenue growth ADHD scripts down YoY; Pediatric growth sustained Mixed: ADHD normalizing; Pediatric improving
Gross margin trajectory66% (pressure from high-cost ADHD inventory) 69% (still elevated inventory costs) 68% (expected to normalize as high-cost inventory clears) Stabilizing; normalization ahead
EXXUA launch readinessN/AN/AManufacturing, labeling, serialization and 3PL delivery in process; KOL engagement; sales alignment Accelerating
Payor/market access strategyRxConnect success; selective contracting focus (ADHD) RxConnect driving improved gross-to-net Government coverage for MDD; avoid “best price” pitfalls; case-by-case commercial contracting via RxConnect Strategic, disciplined
ADHD competitive dynamicsN/AN/AAuthorized generic launched; Teva ANDA activated but not launched; RxConnect mitigants Defensive posture
Cost structure optimization$2.0M annual savings program; facility closure completed OpEx down; EBITDA up; debt paydown OpEx down to $8.7M ex special items; balance sheet strengthened Positive

Management Commentary

  • “EXXUA is a perfect strategic fit and will be a centerpiece of Aytu’s commercial efforts…we remain on track to launch EXXUA in the fourth quarter of calendar 2025.” — CEO Josh Disbrow .
  • “This is now three consecutive years of positive adjusted EBITDA…we positioned ourselves to build upon the uniqueness of our sales force’s psychiatry focus and alignment with the proprietary Aytu RxConnect patient access platform.” — CEO Josh Disbrow .
  • “Think about [EXXUA] in essence as about a 31% cost of goods sold or 69% gross contribution margin…we expect to invest approximately $10 million in the initial launch in fiscal 2026.” — CFO Ryan Selhorn .
  • “Gross margin decreased primarily related to increased cost of sales in our ADHD inventory…higher cost inventory is expected to be liquidated in the coming quarters resulting in normalization.” — Company press release .

Q&A Highlights

  • Launch sequencing: channel load-in by end-2025 with national sales meeting and full detailing in calendar Q1 2026; promotional materials via standard 2253 submission, no pre-clear planned given compliance posture and timing .
  • Payor strategy: highly selective commercial contracting to avoid “best price” issues; leverage universal government coverage for MDD; run scripts preferentially through RxConnect to minimize access barriers and optimize margins .
  • Base business outlook: promotional focus shifts to EXXUA; ADHD/Peds expected to be margin positive with reduced expense burden; break-even at ~$13.2M quarterly revenue .
  • Launch OpEx phasing: ~50% of ~$10M in Q2 FY2026, remainder in Q3–Q4; spend on reps and marketing materials .

Estimates Context

  • Q4 FY2025 miss: revenue $15.14M vs $17.92M estimate; EBITDA $1.93M vs $2.76M; Primary EPS $(0.0764) vs $(0.05). Drivers: fewer ADHD prescriptions and gross margin pressure from high-cost inventory; GAAP loss amplified by impairment and derivative warrant revaluation [GetEstimates]* .
  • Q3 FY2025 beat: revenue $18.45M vs $13.74M; EBITDA $3.74M vs $2.14M; GAAP net income posted; reflects improved gross-to-net and pediatric coverage gains [GetEstimates]* .
  • Near-term (Q1 FY2026) actuals modestly ahead of revenue and EPS consensus, with EBITDA slightly better than expected; meaningful EXXUA contribution not expected until June quarter and beyond per CFO [GetEstimates]* .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Near-term: Q4 headline miss reflects transient margin and inventory mix; expectation of margin normalization as high-cost ADHD inventory sells through; watch gross margin trajectory in coming quarters .
  • EXXUA launch is the primary 2026 catalyst: once-daily 5-HT1A agonist with differentiated side-effect profile; launch readiness and economics outlined; minimal revenue expected in December quarter with ramp in March and more visible in June .
  • Risk management in ADHD: authorized generic deployed; RxConnect channel control and pricing analytics likely to dampen impact from future generic entry; PDUFA fee removal and packaging changes should benefit COGS over time .
  • Cost discipline intact: OpEx ex special items down to $8.7M in Q4; FY2025 adjusted EBITDA positive; base business break-even threshold provides cushion during EXXUA ramp .
  • Balance sheet/liquidity positioned for launch: $31.0M cash at FY-end; term loan upsized to $13.0M; revolver flexibility added for working capital .
  • Modeling notes: EXXUA gross contribution ~69% (28% royalty plus COGS), ~$10M FY2026 launch OpEx, and minimal initial revenue in Q2 FY2026; base ADHD/Peds expected to fund G&A .
  • Watch payor strategy execution: government coverage in MDD favorable; selective commercial contracting via RxConnect aims to optimize access without margin dilution; monitor early coverage and formulary traction .