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ACHIEVE LIFE SCIENCES, INC. (ACHV)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 marked regulatory momentum: FDA accepted the cytisinicline NDA for smoking cessation and set a PDUFA action date of June 20, 2026; Achieve also received the FDA Commissioner’s National Priority Voucher (CNPV) for vaping cessation, enabling a 1–2 month review once materials are submitted .
  • Financials: Total operating expenses were $14.7M; net loss was $14.4M; EPS was $(0.28); cash, cash equivalents and marketable securities were $48.1M at quarter-end, with runway expected into H2 2026 .
  • Operational execution: ORCA-OL long-term safety trial concluded with 334 participants completing one year; 120-day safety update submitted (411 ≥6 months, 214 ≥1 year exposure); DSMC’s final review found no safety concerns .
  • Commercial readiness progressing: 3PL selected; state licensing underway; specialty “light hub” chosen; payer pricing research completed; AI-enabled omnichannel launch infrastructure advancing with Omnicom .
  • Estimates: S&P Global consensus EPS and revenue for Q3 2025 were unavailable; investors should anchor on cash runway, regulatory timing, and capital needs for vaping Phase 3 [GetEstimates — Q3 2025 unavailable]. Values retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • FDA accepted the smoking cessation NDA and assigned a firm PDUFA date, a key de-risking milestone: “The FDA’s acceptance of our NDA… is an important milestone” (CEO) .
  • CNPV designation for vaping provides a potential 1–2 month expedited review once submitted—an outsized accelerant: “This… expedited NDA review timeline… reducing… to 1–2 months” (CEO) .
  • Strong long-term safety execution and retention: ORCA-OL met and exceeded FDA exposure thresholds; DSMC found no safety concerns; 334 completed one year: “Adverse events… mostly mild… no serious adverse events… treatment related” .

What Went Wrong

  • Net loss widened year over year in Q3, driven by higher G&A and regulatory/pre-commercial investment: Q3 net loss $(14.4)M vs $(12.5)M in Q3 2024; G&A $9.4M vs $4.9M YoY .
  • Vaping Phase 3 (ORCA-V2) requires incremental capital: “To complete the vaping study, we'll need to raise additional capital” (CFO) .
  • No top-line revenue; the company remains pre-commercial with continued cash burn; Q3 operating expenses rose to $14.7M vs $12.6M in Q2, reflecting increased pre-launch activities .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Research & Development ($USD Millions)$7.10 $6.71 $5.32
General & Administrative ($USD Millions)$5.80 $5.86 $9.37
Total Operating Expenses ($USD Millions)$12.89 $12.56 $14.69
Other Income (Expense) ($USD Millions)$0.07 $(0.16) $0.25
Net Loss ($USD Millions)$(12.83) $(12.72) $(14.44)
Basic & Diluted EPS ($USD)$(0.37) $(0.37) $(0.28)
Weighted Avg Shares (Millions)34.69 34.69 51.02
Cash, Cash Equivalents & Marketable Securities ($USD Millions, period end)$23.25 $55.40 $48.11

YoY Comparison (Q3 2025 vs Q3 2024):

MetricQ3 2024Q3 2025YoY Change
Research & Development ($USD Millions)$7.61 $5.32 Down ~$2.29M
General & Administrative ($USD Millions)$4.86 $9.37 Up ~$4.51M
Total Operating Expenses ($USD Millions)$12.47 $14.69 Up ~$2.22M
Net Loss ($USD Millions)$(12.51) $(14.44) Wider by ~$1.93M
EPS ($USD)$(0.36) $(0.28) Improved by $0.08

KPIs and Balance Sheet Highlights:

KPIQ1 2025Q2 2025Q3 2025
Cash Runway CommentaryFocus on prudent spend; cash $23.2M Funding expected to provide runway into H2 2026 Runway into H2 2026; cash $48.1M
ORCA-OL ≥6 months exposure (participants)≥300 achieved ≥300 achieved; ongoing 411 included in 120-day update
ORCA-OL ≥12 months exposure (participants)≥100 achieved ≥100; ongoing 214 in update; 334 completed full year

Note: ACHV reported no commercial revenue; financials reflect operating expenses and net loss .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PDUFA Action Date (Smoking Cessation NDA)FDA Approval TimingN/A (pre-acceptance)June 20, 2026 Set/Confirmed
Commercial Launch Timing (Smoking)2026“Late 2026” (Q2) “Q3 or Q4 2026” (Q3) Clarified window
Cash RunwayOperations FundingInto H2 2026 (Q2) Into H2 2026 (Q3) Maintained
Vaping CNPV Review TimelinePost-Submission ReviewN/A1–2 months expedited review New (accelerated)
Vaping Phase 3 FundingStudy FinancingN/AAdditional capital required New (capital need)

Earnings Call Themes & Trends

TopicQ1 2025 (Previous)Q2 2025 (Previous)Q3 2025 (Current)Trend
Regulatory milestonesPlan to submit NDA in June; SAB engagement; ORCA-OL thresholds met NDA submitted; expecting Day-74 letter; meeting FDA exposure requirements NDA accepted with PDUFA 6/20/2026; 120-day safety submitted; DSMC final review Strengthening
AI-enabled commercializationBuilding omnichannel digital roadmap; partner planning Omnicom partnership; AI-enabled platform build; data integration Integrated HIPAA-compliant data warehouse; “next-best action” orchestration; ROI tracking Advancing
Supply chain & distributionPre-commercial groundwork 3PL named in NDA; licensing process; specialty distribution shortlisted 3PL selected; WA licensing accepted; Specialty Light Hub chosen Operationalizing
Payer access & pricingEarly payer research; plan for PIE; focus on value messaging Pricing strategy and payer segmentation underway; PIE starting Q4/Q1 Pricing and payer research completed; proactive payer engagement from Q1 2026 Execution phase
Vaping program (CNPV)Breakthrough Therapy noted; design discussions Design aligned for ORCA-V2; priority review sought CNPV awarded; preparing to initiate Phase 3; potential biochem confirmation via cotinine Acceleration
Clinical insights (COPD)Highlighted COPD comorbid benefits in trials Ongoing safety; interest in COPD collaborations Thorax publication: COPD subgroup quit benefit; placebo quit difficulty Supportive data

Management Commentary

  • CEO perspective on CNPV and acceleration: “The CNPV is designed to provide enhanced FDA communications and an expedited NDA review timeline, reducing the potential NDA approval to 1–2 months from the standard 10–12 months” .
  • CMO on long-term safety: “Adverse events were mostly mild in severity, and no serious adverse events were deemed to be treatment related… no concerns with respect to drug safety” .
  • CEO on competitive differentiation vs varenicline: “Cytisinicline has five times less incidence of nausea and vomiting than varenicline… less than half of other side effects” .
  • CCO on commercial build: “We’ve selected our third-party logistics provider… our home state licensing application was accepted in Washington State… selected our Specialty Light Hub partner” .

Q&A Highlights

  • Channel strategy: Specialty distribution initially, complemented by retail over time (CEO) .
  • Financing: Vaping Phase 3 requires additional capital (CFO) .
  • Vaping Phase 3 design: 12-week, 3 mg TID cytisinicline vs placebo; ~400 patients per arm; cotinine blood/saliva for biochem confirmation (CEO/CMO) .
  • Competitive landscape: Reintroduction of Chantix unlikely to impede given cytisinicline’s tolerability profile (CEO) .
  • Launch timing and spend: Incremental pre-commercial spend pre-approval; disciplined approach; launch targeted Q3/Q4 2026 (CEO) .

Estimates Context

  • S&P Global consensus for Q3 2025 EPS and revenue was unavailable for ACHV; as a pre-commercial company, estimates coverage may be limited. Values retrieved from S&P Global.

Where estimates may need to adjust:

  • Given higher Q3 G&A tied to regulatory and pre-commercial work, near-term loss trajectory could reflect continued investment into NDA review and launch readiness; consensus, if established, should reflect sustained opex and no revenue until post-approval in 2026 .

Key Takeaways for Investors

  • Regulatory de-risking: PDUFA date set; 120-day safety update submitted; DSMC final review clean—key milestones ahead of mid-2026 approval window .
  • Accelerated second indication: CNPV for vaping establishes a path to a materially shorter FDA review (1–2 months) upon submission, potentially bringing forward a second revenue stream timing .
  • Commercial readiness: Logistics, licensing, specialty hub, and AI-enabled launch platform advancing—supports efficient initial uptake upon approval .
  • Financial runway and needs: Cash of $48.1M with runway into H2 2026; additional capital will be needed to fund vaping Phase 3—watch for financing catalysts .
  • COPD data strengthens clinical narrative: Thorax post hoc analysis supports efficacy in high-need COPD subgroup; potential partnering optionality in pulmonary comorbidities .
  • Launch timing clarity: Management guiding to Q3/Q4 2026 for smoking cessation; investors should model first commercial revenues in late 2026 with ramp dependent on access and channel execution .
  • Trading implications: Near-term stock catalysts include FDA interactions (labels, review updates), financing news for vaping, and further clinical/regulatory disclosures—CNPV creates optionality on accelerated vaping timeline .

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