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AYTU BIOPHARMA, INC (AYTU)·Q1 2026 Earnings Summary

Executive Summary

  • Q1 FY26 net revenue was $13.9M; versus consensus $12.6M, a revenue beat of ~10% driven by ADHD portfolio pricing and improved gross-to-net despite lower prescriptions (Revenue Consensus Mean: $12.60M; Values retrieved from S&P Global). EPS beat: actual Primary EPS of $(0.09)* versus $(0.26)* consensus as derivative warrant gains offset launch investments (Primary EPS Consensus Mean: $(0.26); Values retrieved from S&P Global).
  • Gross margin was 66% (vs 65% YoY ex-rebate and 68% in Q4 FY25), showing sequential resilience as elevated ADHD COGS from the prior manufacturing transition normalize .
  • Management reiterated EXXUA launch timing (initial shipments December 2025; full commercial launch after mid-January launch meeting), with ~$10M FY26 launch investment and ~69% gross contribution margin (28% royalty + COGS true-up) .
  • ADHD revenue held stable: excluding a $3.3M one-time rebate in Q1 FY25, ADHD net revenue rose 10% YoY and increased sequentially; authorized generic strategy and RxConnect (~85% of branded ADHD scripts) underpin share retention amid expected generic entry .
  • Stock reaction catalysts: revenue/EPS beat, clarity on EXXUA timeline/IP extension to September 2030, and CFO break-even math ($16.6M cash breakeven per quarter including launch spend) support estimate upward revisions and de-risk the launch ramp .

What Went Well and What Went Wrong

What Went Well

  • ADHD portfolio resilience: Excluding the prior-year rebate, ADHD net revenue grew 10% YoY and was up sequentially, reflecting price increases and improved gross-to-net despite fewer scripts . CEO: “ADHD Portfolio remains stable… up on a sequential basis as well” .
  • EXXUA launch readiness: Manufacturing, labeling, serialization on track; sales force training, territory realignment, pricing, RxConnect integration, and KOL engagement advancing; shipments slated for December 2025 .
  • Margin signaling: Gross margin 66% in Q1 FY26; ex-rebate the prior year would have been 65%, showing underlying margin improvement versus adjusted prior-year baseline .

What Went Wrong

  • Pediatric portfolio softness: Net revenue fell to $0.7M from $1.3M YoY due to manufacturing delays, product returns, and de-emphasis ahead of regulatory signals; being resolved .
  • Adjusted EBITDA moved to $(0.6)M from $1.9M YoY, driven by last year’s rebate benefit and current EXXUA launch investments .
  • Diluted EPS from continuing operations was $(0.08) as derivative warrant liability accounting creates volatility tied to stock price; CFO highlighted remaining pre-funded warrants and associated P&L swings .

Financial Results

Consolidated Performance vs Prior Periods and Consensus

MetricQ1 2025Q4 2025Q1 2026 ActualQ1 2026 Consensus
Revenue ($USD)$16.57M $15.14M $13.89M $12.60M*
Gross Margin (%)72% 68% 66% —
Net Income ($USD)$1.47M $(19.82)M $1.97M —
Basic EPS ($)$0.24 $(2.92) $0.21 —
Diluted EPS – Continuing Ops ($)$(0.20) $(2.93) $(0.08) $(0.26)*
Adjusted EBITDA ($USD)$1.93M $2.04M $(0.59)M —
  • Bolded beats/misses: Revenue beat vs consensus ($13.89M vs $12.60M) and EPS beat (Primary EPS $(0.09)* vs $(0.26)*). Values marked with * retrieved from S&P Global.

Segment Net Revenue

SegmentQ1 2025Q1 2026
ADHD Portfolio ($USD)$15.26M $13.16M
Pediatric Portfolio ($USD)$1.29M $0.72M
Other ($USD)$0.02M $0.02M
Total ($USD)$16.57M $13.89M
  • Note: Prior-year Q1 included a $3.3M rebate benefit; excluding rebate, total revenue would have been up 5% YoY; ADHD up 10% YoY .

KPIs

KPIQ4 2025Q1 2026
Cash & Cash Equivalents ($USD)$31.0M $32.6M
Adjusted EBITDA ($USD)$2.0M $(0.59)M
Gross Margin (%)68% 66%
RxConnect share of branded ADHD scripts (%)—~85%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
EXXUA launch timingQ4 CY2025 / Q2 FY26Product load-in by end CY2025; minimal revenue in Q2 FY26; ramp from Q3, inflection from Q4 FY26 Shipments December 2025; launch meeting mid-January; same revenue phasing reiterated Maintained
EXXUA gross contribution marginOngoing~69% (28% royalty + COGS true-up) ~69% reiterated; fixed COGS to be incurred post-launch; upfront/milestones amortized in OpEx Maintained
Launch investment (OpEx)FY26~$10M launch spend ~$10M; ~$6M one-time items concentrated in Dec/Mar quarters Maintained/clarified timing
OpEx baseline run-rateExit FY26~ $11.4M quarterly normalized run rate; ~$0.5M non-cash Reaffirmed Maintained
Quarterly break-even revenueFY26Cash breakeven ~$13.2M for base business (earlier context) All-in break-even ~$17.3M per quarter incl. EXXUA spend; cash breakeven ~$16.6M Raised (reflects launch spend)
IP/exclusivityThrough 2030Patent/NCE exclusivity targeted to late 2030/31 Method-of-use patent extended to Sept 2, 2030; exploring lifecycle IP extensions Strengthened

Earnings Call Themes & Trends

TopicQ3 FY25 (May 2025)Q4 FY25 (Sep 2025)Q1 FY26 (Nov 2025)Trend
EXXUA launch readinessPlatform optimization; initial KOL/med affairs plans Manufacturing/packaging/territories; government coverage tailwind; launch load-in by YE Finalizing manufacturing; pricing set; RxConnect integration; shipments Dec; launch mtg Jan Steady execution; timeline reaffirmed
ADHD portfolio durability vs genericsGTN improvements; 25% YoY revenue growth; ~94k scripts Authorized generic launched; RxConnect buffers generic impact ADHD up 10% YoY ex-rebate; sequential growth; RxConnect ~85% of scripts Resilient with AG strategy
Payer strategyRxConnect drives economics Judicious contracting; avoid best-price resets; gov’t coverage strong “Wait and see” on commercial contracting; gov’t coverage 30–40%; target smart PBM deals Conservative, data-driven
Pediatric/business mixReturn-to-growth plan; 77% YoY FY25 growth; impairment recognized; refocus to CNS Q1 FY26 decline from manufacturing delays; de-emphasis Mixed; near-term headwinds
Regulatory signalsTariffs minimal; fluoride policy monitored Pre-clear promotional materials not planned; standard submissions FDA fluoride communication noted; ADA support; limited revenue exposure Monitoring; low impact

Management Commentary

  • CEO on EXXUA launch execution: “The EXXUA launch remains on track… including KOL engagement, sales force training, product positioning and pricing, payor assessments and integration with our proprietary Aytu RxConnect” .
  • CEO on ADHD stability: “ADHD Portfolio net revenue… was also up on a sequential basis as well… approximately 85% of our branded ADHD prescriptions are dispensed [via RxConnect]” .
  • CFO on break-even math: “Baseline total operating expense… about $10M per quarter… incremental investment of about $10M… break-even at about $17.3M of net revenue per quarter… Cash break-even would be $16.6M per quarter” .
  • CFO on EXXUA margins: “28% royalty… think of it as a 31% cost of goods sold or 69% gross contribution margin” .

Q&A Highlights

  • Sales territory realignment and IC: About a third of territories altered; incentive comp heavily focused on EXXUA activation and depth within psychiatry .
  • Payer contracting approach: Reluctant to proactively contract at launch to preserve gov’t best price; expect strong gov’t coverage; judicious commercial PBM contracting informed by RxConnect data .
  • Target prescriber profile: Younger adults (18–50) dissatisfied with SSRI/SNRI side effects (sexual dysfunction, weight gain); pursue switches post initial lines .
  • Supply chain and scaling: Bulk supply multiples above 24-month base-case forecast; API in hand; ability to ramp; royalty steps down from 28% to 24% beyond ~$1.3B cumulative sales .
  • Promotional compliance: No FDA pre-clear; standard 2253 submissions; confident in compliant messaging .

Estimates Context

  • Q1 FY26 results vs consensus: Revenue $13.89M vs $12.60M*, a clear beat; Primary EPS $(0.09)* vs $(0.26), a smaller-than-expected loss. Estimate counts: Revenue 3, EPS 2* . Values retrieved from S&P Global.
  • Consensus recommendation text unavailable*; Target price consensus ~$9.17* (3 estimates)*. Values retrieved from S&P Global.
  • Implications: Expect upward estimate revisions to base business revenue and reduced EPS losses near term; ramp assumptions for EXXUA unchanged per management phasing .

Key Takeaways for Investors

  • Near-term trading: Revenue/EPS beat and patent/exclusivity clarity are positive catalysts; CFO’s break-even math provides downside guardrails during launch investment .
  • Base business: ADHD appears more resilient than feared amid authorized generic deployment and RxConnect economics; sequential growth supports FY26 base stability .
  • Launch execution: Concrete December shipments and January launch meeting timelines reduce event risk; early KOL response and prescriber targeting strategy support an accelerated launch curve within psychiatry .
  • Margin trajectory: Gross margin stable sequentially; fixed COGS and royalty construct for EXXUA yield ~69% gross contribution—monitor mix shift as launch scales .
  • Cash runway: $32.6M cash with reduced interest expense and defined launch spend timing (front-loaded) should bridge to initial EXXUA ramp by June quarter .
  • Risks: Pediatric softness and regulatory noise (fluoride) are manageable given small revenue contribution; derivative warrant liability introduces EPS volatility tied to stock price .
  • Medium-term thesis: If EXXUA achieves even a fraction of branded antidepressant uptake, Aytu’s CNS-focused platform and payer-aware strategy could drive sustained top-line growth and operating leverage beyond FY26 .

Footnote: Asterisk-marked values are from S&P Global; Values retrieved from S&P Global.