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- **FDA Milestones**: Smoking cessation NDA set for June 2026 approval; vaping indication could launch 8 months earlier with CNPV.
- **Clinical Success**: COPD smokers achieved comparable quit rates to non-COPD patients, with 97% patient satisfaction.
- **Commercial Readiness**: AI-driven platform and dual distribution strategy (specialty + retail) to maximize reach.
- **Financial Health**: $48.1M cash runway into 2026, but additional funding needed for vaping trial.
- **Market Differentiation**: 5x lower nausea/vomiting incidence vs. CHANTIX, targeting 7M highly motivated smokers and 17M vapors.

**【CEO Summary Section】**
- **CNPV for Vaping**: Received FDA's Commissioner's National Priority Voucher, reducing NDA approval timeline to 1-2 months for vaping cessation, potentially launching 8 months earlier than smoking cessation.
- **Smoking Cessation Milestones**: FDA accepted NDA with PDUFA date set for June 20, 2026. Submitted 120-day safety update, showing no serious adverse events in 411 participants.
- **Clinical Efficacy**: COPD smokers achieved quit rates comparable to non-COPD patients (5.3 vs. 5.2 odds ratio), with 97% of participants believing cytisinicline helped reduce nicotine use.
- **Commercial Strategy**: AI-driven platform for targeted marketing, specialty and retail distribution, and payer engagement to ensure access.
- **Team Expansion**: Promoted Dr. Mark Rubenstein to CMO, Craig Donnelly to COO, and hired Eric Atkinson as CLO.

**【CFO Financial Commentary】**
- **Cash Position**: $48.1 million as of Q3 2025, runway into H2 2026 without additional funding for smoking cessation launch.
- **Operating Expenses**: $14.7 million for Q3, $40.1 million YTD, reflecting investments in regulatory and commercial activities.
- **Net Loss**: $14.4 million for Q3, $40 million YTD.
- **Funding Needs**: Additional capital required for vaping Phase III trial, with no current plans to use existing cash runway.

**【Q&A Highlights】**
- **Distribution Strategy**: Initial focus on specialty pharmacies, complemented by retail channels post-launch.
- **Vaping Study Protocol**: Similar to smoking trials (12-week, 400-patient arms), with blood/saliva biomarkers for nicotine confirmation.
- **Pfizer's CHANTIX**: Cytisinicline's superior safety profile (5x less nausea/vomiting) positions it as a differentiated competitor.
- **Dual Launch Risks**: Separate targeting for smokers (older, digitally inclined) and vapors (younger, digitally native), with shared physician engagement strategy.
- **Manufacturing Readiness**: Same 3mg thrice-daily dosing for both indications, with smoking cessation launch in Q3/Q4 2026.


Achieve Life Sciences, Inc. (ACHV) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

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Loss on Bad Debts

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Loss on Disposal of Assets

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Operating Income

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Net Interest Expense

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Net Income

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Preferred Stock Dividends

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Total Comprehensive Income Attributable to Owners of the Company

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ACHV

ACHV fundamentals

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