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- **EXXUA Early Success**: 100+ prescribers wrote scripts in 30 days, with positive patient feedback on tolerability.
- **ADHD Resilience**: $13.2M revenue stable YoY, RxConnect mitigates generic competition impact.
- **Financial Challenges**: Q2 net loss $10.6M due to EXXUA launch costs, targeting breakeven at $17.3M/Q.
- **Strategic Focus**: Cautious sales expansion, limited DTC efforts, ample supply to meet demand.

**【CEO Summary Section】**
- **EXXUA Launch Momentum**: 100+ prescribers wrote prescriptions within 30 days, with scripts from 27 states, including areas without sales reps. Early patient feedback highlights good tolerability and satisfaction.
- **ADHD Portfolio Resilience**: Q2 net revenue $13.2M (flat YoY), mitigating generic competition via RxConnect (85% prescriptions within network). Authorized generic Adzenys captured 20% of scripts, limiting erosion.
- **Pediatric Portfolio Transition**: Q2 net revenue $1.7M (vs. $715K in Q1), driven by reduced returns. FDA fluoride concerns limit focus, but legacy products remain non-core.

**【CFO Financial Commentary】**
- **Q2 Financials**: Net loss $10.6M (-$1.05 EPS) vs. $0.8M net income YoY. Revenue $15.2M (-6% YoY), driven by EXXUA launch ramp-up. Gross margin 63.5% (vs. 66.5% YoY) due to $600K inventory write-down.
- **EXXUA Financial Outlook**: Breakeven at $17.3M net revenue/Q (cash breakeven $16.6M). Q2 OpEx $11.1M (+9% YoY) due to launch costs, with $8M total launch budget reduced to $7.8M via efficiencies.
- **Balance Sheet**: Cash $30M, no major balance sheet changes. EXXUA royalty structure: 28% upfront fee + 31% COGS, with $400K one-time FDA fee.

**【Q&A Key Highlights】**
- **Prescriber Adoption Drivers**: Interest in 5HT1a mechanism, RxConnect ease of use, and patient demand for non-sexual side effect profile.
- **Sales Force Expansion**: No 2026 plans; expansion contingent on cash flow and profitability, with Board approval required.
- **Direct-to-Consumer Strategy**: Limited to SEO/SEM and compliant forums; no traditional media spend due to regulatory constraints.
- **Weather Impact Resolution**: Supply chain delays resolved; RxConnect fills 85% of prescriptions, with commercial split 60-40.
- **Supply Chain Assurance**: Sufficient API and componentry to meet demand through 2026, with no production bottlenecks.

Aytu BioPharma, Inc. (AYTU) Q2 2026 Earnings Call Transcript

- **EXXUA Launch Momentum**: On track for Q4 2025 launch with 40-person sales force leveraging RxConnect for 85% of ADHD prescriptions. EXXUA's unique benefits (no sexual dysfunction, weight neutral) position it as a MDD disruptor.
- **ADHD Resilience**: Q1 2026 revenue $13.2M (10% growth vs. prior year, excluding rebate). AG of Adzenys launched in Q3 2025 with strong early adoption, mitigating generic risk.
- **Financial Focus**: EXXUA launch investment of $10M FY2026, with 28% royalty structure enabling margin expansion at scale. Q1 2026 cash breakeven at $16.6M net revenue.

**【CEO Summary Section】**
- **EXXUA Launch Progress**: On track for Q4 2025 launch with 40-person sales force targeting psychiatrists and leveraging RxConnect platform for 85% of ADHD prescriptions. EXXUA's unique benefits (weight neutrality, no sexual dysfunction side effects) position it as a game-changer in MDD treatment.
- **ADHD Portfolio Resilience**: Q1 2026 revenue $13.2M (10% growth vs. prior year, excluding one-time rebate). Authorized generic (AG) of Adzenys launched in Q3 2025 with strong early adoption, mitigating generic competition risk.
- **Fluoride Products**: Minimal impact from FDA scrutiny, with Q1 2026 revenue of $1.4M (trailing 12 months) and $300K in Q1 2026.

**【CFO Financial Commentary】**
- **Q1 2026 Financials**: Net revenue $13.9M (down 16% YoY, excluding $3.3M rebate). ADHD portfolio gross margin 66% (vs. 72% prior year). Operating expenses $10.2M (down 8% YoY, excluding EXXUA launch costs). EXXUA launch investment of $10M for FY2026, with $6M one-time costs in Q1 and Q2 2026.
- **EXXUA Economics**: 28% royalty on net sales, 24% royalty threshold at $1.3B in sales. Gross margin ~69% post-launch, with RxConnect integration for streamlined dispensing.
- **Balance Sheet**: Cash $32.6M (down $1.6M YoY). Derivative warrant liability gains ($3.8M Q1 2026) driven by stock price movements. EXXUA launch on track with manufacturing and regulatory compliance.

**【Q&A Highlights】**
- **Territory Realignment**: 1/3 of territories adjusted for MDD focus, targeting psychiatrists in high-access geographies. Incentive plans to prioritize EXXUA adoption and repeat prescribing.
- **Payer Engagement**: Focus on Medicare/Medicaid coverage (30%-40% of MDD patients) with minimal upfront contracting to preserve best price. Commercial payer coverage expected to mirror Auvelity precedent (70%+ coverage).
- **Supply Chain Flexibility**: Sufficient bulk inventory for rapid scaling. Royalty structure allows margin expansion as sales exceed $1.3B.
- **Patient Profile**: Targeting 18-50-year-olds with treatment-resistant depression seeking alternatives to SSRI/SNRI side effects.

Aytu BioPharma, Inc. (AYTU) Q1 2026 Earnings Call Transcript

- **EXXUA Launch Momentum**: FDA-approved MDD treatment with novel mechanism; $22B market opportunity. 
- **ADHD Resilience**: Authorized generic launched to counter Teva; RxConnect maintains 85% script control. 
- **Financial Strength**: $31M cash post-ATM; FY26 EXXUA launch investment of $10M. 
- **Gross Margin Outlook**: FY26 ADHD COGS improvements; EXXUA 31% gross margin contribution. 
- **Payer Strategy**: Preserve 23.1% government rebate; selective commercial contracting.

**【CEO Summary Section】**
- Fiscal 2025 net revenue: $66.4 million (slight increase YoY), with adjusted EBITDA of $9.2 million (third consecutive year positive). 
- EXXUA launch: FDA-approved MDD treatment with novel 5-HT1A receptor agonist mechanism; targeting $22B market. 
- ADHD portfolio: Authorized generic launched to counter Teva's potential entry; RxConnect platform maintains 85% script control. 
- Gross margin improvement expected in FY26 due to COGS reductions from packaging changes. 

**【CFO Financial Commentary】**
- Full year 2025: Net loss $13.6M (vs. $15.8M prior year), driven by $8.3M pediatric portfolio impairment. 
- Operating expenses: $39.6M (down 12% YoY), with pro forma annual expense target of $36.3M. 
- EXXUA launch investment: $10M in FY26, with 50% spent in Q2 (Dec 2025 quarter). 
- Cash position: $31M post-ATM offering, supporting EXXUA commercialization. 

**【Q&A Highlights】**
- **Launch Timing**: EXXUA available Q4 2025, with full launch Q1 2026. No preclearance of promotional materials. 
- **Payer Strategy**: Selective contracting to preserve 23.1% government rebate; prioritize RxConnect network. 
- **ADHD Outlook**: Base business breakeven at $52.6M annual revenue; AG launch mitigates Teva risk. 
- **Medical Affairs**: Key opinion leader engagement, peer-reviewed publications, and targeted conferences planned. 
- **COGS Structure**: EXXUA has 28% royalty + COGS, resulting in ~31% gross margin contribution.

Aytu BioPharma, Inc. (AYTU) Q4 2025 Earnings Call Transcript

- **32% Revenue Surge**: ADHD (+25%) and pediatric (+77%) portfolios drive record $18.5M Q3 revenue.
- **Profit Milestones**: 2nd consecutive quarter of positive operating income ($2.4M) and 3rd quarter of net profit ($4M).
- **RxConnect Dominance**: 85% of scripts processed through proprietary network, enabling GTN optimization.
- **Pediatric Turnaround**: Antihistamine franchise growth exceeds multivitamins; realistic $10-15M annual target.
- **Gross Margin Recovery**: 70%+ margin achievable as high-cost inventory clears.
- **Debt Reduction**: $2.5M debt repayment; $18.2M cash balance supports growth initiatives.


**【CEO Summary Section】**
- Total revenue grew 32% YoY to $18.5 million, driven by 25% growth in ADHD portfolio ($15.4M) and 77% growth in pediatric portfolio ($3.1M).
- Achieved second consecutive quarter of positive income from operations ($2.4M) and third quarter of positive net income ($4M).
- ADHD prescriptions reached 94,000, with 85% of scripts processed through Aytu RxConnect network.
- Pediatric return-to-growth plan included expanded salesforce focus, diversified prescriber base, and improved payer coverage for antihistamine and multivitamin franchises.
- Gross margin expected to improve to low-mid 70% as higher-cost inventory is sold through.

**【CFO Financial Commentary】**
- GAAP net income: $4 million (vs. $2.9M loss YoY), EPS: $0.65 (vs. -$0.52 YoY).
- Operating expenses decreased $1.6M YoY to $9.5M, driven by cost reduction initiatives.
- Adjusted EBITDA: $3.9 million (vs. $0.9M YoY), trailing 12-month EBITDA: $9.2 million.
- Cash balance: $18.2 million, with $2.5 million debt repayment in the quarter.
- Gross margin: 69% (vs. 74% YoY), impacted by higher-cost inventory from shuttered manufacturing facility.

**【Q&A Key Highlights】**
- **ADHD Growth Sustainability**: Organic growth with no one-time effects; expect continued momentum from optimized RxConnect platform.
- **Pediatric Potential**: Antihistamine franchise shows stronger growth; realistic target of $10-15 million annualized revenue (vs. prior $25M peak).
- **New Product Strategy**: Seeking CNS-aligned assets (psychiatry/neurology) with commercial readiness; prioritize assets fitting RxConnect capabilities.
- **Political Risks**: Minimal tariff impact as all products manufactured in U.S.; monitoring fluoride supplement regulation but sees limited near-term impact.
- **Breakeven Analysis**: $13.1 million quarterly revenue needed for cash breakeven at current cost structure.


Aytu BioPharma, Inc. (Aytu ) Q3 2025 Earnings Call Transcript

- **Revenue Growth Accelerates**: Q3 $12.5B (+12% YoY), beating estimates by $200M, driven by 22% YoY North America recovery.
- **AI Investment Paying Off**: 15% of revenue now from AI solutions vs. 5% last year; $1B+ R&D spend to accelerate 2025 product launch.
- **Profitability Improving**: Gross margin 62% (+120bps YoY), Non-GAAP EPS $2.15 (+18% YoY), free cash flow up 25%.
- **Strong H2 Guidance**: 15-18% revenue growth, gross margin to expand another 100bps in Q4.
- **Resilient Positioning**: 70%+ enterprise AI market share, diversified customer base, 80% FX hedged.


**【CEO Opening Remarks】**
- Q3 revenue reached $12.5B, up 12% YoY, exceeding guidance by $200M.
- North America market recovery (+22% YoY) and AI product adoption drove growth.
- Announced $1B+ investment in generative AI R&D, targeting 2025 product launch.
- Highlighted supply chain resilience, with no material disruptions in Q3.

**【CFO Financial Highlights】**
- GAAP net income: $1.8B (14% YoY), Non-GAAP EPS: $2.15 (18% YoY), both above estimates.
- Gross margin improved 120bps to 62%, benefiting from mix shift to high-margin AI solutions.
- Operating expenses +10% YoY, with R&D allocation increasing to 18% of revenue.
- Free cash flow: $3.2B, up 25% YoY, supporting dividend and share buyback programs.

**【Q&A Key Takeaways】**
- **AI Revenue Contribution**: AI-related products now account for ~15% of total revenue, up from 5% a year ago.
- **Competitive Position**: 70%+ market share in enterprise AI infrastructure, no meaningful new entrants in 2023.
- **H2 Outlook**: Guide for 15-18% revenue growth, with Q4 gross margin to expand another 100bps.
- **Risk Mitigation**: Diversified customer base (no single client >2%), hedging 80% of FX exposure.


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