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ACHIEVE LIFE SCIENCES, INC. (ACHV)·Q1 2025 Earnings Summary

Executive Summary

  • Achieve reiterated it is “on track” to submit the cytisinicline NDA in June 2025, with management expecting an FDA 74-day acceptance letter and ~12-month review thereafter; commercial launch targeted in 2026 .
  • Q1 2025 financials: cash/cash equivalents/marketable securities $23.2M, total operating expenses $12.9M, net loss $(12.8)M, and EPS $(0.37) .
  • Clinical/regulatory momentum: ORCA-3 results published in JAMA Internal Medicine; ORCA-OL safety exposure milestones achieved (≥300 at 6 months; ≥100 at 1 year) and third DSMC review with no safety concerns; ~75% ORCA-OL participants remain on treatment .
  • Pre-commercial readiness accelerating: distribution/3PL selection, pricing/payer strategy, and digital-first omnichannel plan with AI-enabled targeting; near-term catalysts include NDA submission and subsequent acceptance letter .
  • Street estimates were unavailable via S&P Global for Q1 2025, limiting beat/miss analysis; framing shifts to regulatory and execution catalysts that may drive stock reaction near-term (NDA submission/acceptance, safety updates, payer insights) [GetEstimates – no data; values unavailable]*.

What Went Well and What Went Wrong

  • What Went Well

    • NDA timing reaffirmed; management emphasized being “weeks away” from submission, with clarity on 74-day acceptance and ~12-month approval timeline .
    • ORCA-3 publication in JAMA strengthens efficacy/tolerability narrative and craving reduction with sustained benefits to 24 weeks, bolstering regulatory package and physician messaging .
    • Long-term safety progress: ≥300 at 6 months (Jan); ≥100 at 1 year (Apr); DSMC reviews found no safety concerns; ~75% retention underscores tolerability/adherence .

  • What Went Wrong

    • Operating expenses stepped up Q/Q and Y/Y as the company advances regulatory and commercial preparation, widening net losses and EPS to $(0.37) vs $(0.36) in Q4 2024 and $(0.26) in Q1 2024 .
    • Cash declined to $23.2M by Mar 31, 2025 from $34.4M at year-end, narrowing runway; while disciplined spend was reiterated, financing needs remain a watch item ahead of launch .
    • Lack of Wall Street consensus estimates limits near-term beat/miss framing; trading narrative hinges more on regulatory milestones and safety updates than on financial outperformance [GetEstimates – no data; values unavailable]*.

Financial Results

  • Quarter-over-quarter and year-over-year comparisons
MetricQ3 2024Q4 2024Q1 2025
Total Operating Expenses ($USD Millions)$12.466 $12.190 $12.894
Net Loss ($USD Millions)$(12.512) $(12.360) $(12.827)
Basic & Diluted EPS ($USD)$(0.36) $(0.36) $(0.37)
Cash, Cash Equivalents & Short-term Investments ($USD Millions)$42.911 $34.360 $23.245
Weighted Avg Diluted Shares (Millions)34.355 34.511 34.685
MetricQ1 2024
Total Operating Expenses ($USD Millions)$5.982
Net Loss ($USD Millions)$(6.494)
Basic & Diluted EPS ($USD)$(0.26)
Weighted Avg Diluted Shares (Millions)25.048

Notes:

  • Revenue: Company reported no product revenue; press releases present operating expenses and net loss only .
  • Margins: Gross/operating/net margins are not meaningful without revenue (N/M).

KPIs and operational metrics

KPIQ3 2024Q4 2024Q1 2025
ORCA-OL Enrollment (sites/participants)29 sites / 479 enrolled 29 sites / 479 enrolled 29 sites / 479 enrolled
ORCA-OL 6-month exposure (≥300 participants)Target statedAchieved Jan 2025 (post-Q4) Achieved
ORCA-OL 1-year exposure (≥100 participants)Target statedPlanned for Q2 2025 Achieved April 2025
ORCA-OL Retention——~75% remain on treatment
DSMC ReviewsFirst, no safety concerns Second, no safety concerns Third, no safety concerns
ORCA-3 Publication——JAMA Internal Medicine published

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cytisinicline NDA Submission (Smoking Cessation)Q2 2025“End of Q2 2025” “June 2025” Maintained/clarified timing
FDA Acceptance Letter (74-day)Post-submissionNot explicitly datedExpect 74-day letter acknowledging acceptance New specificity
FDA Review DurationPost-acceptance~12 months from submission ~12 months from submission Maintained
Commercial Launch Timing (U.S.)2026Q3 2026 (prior call reference) 2026; launch as close to approval as possible Maintained; nuance on ramp/availability
ORCA-OL 1-year safety exposureQ2 2025Planned during review ≥100 reached in April; to be included in 120-day safety update Achieved ahead of plan
Cash Runway2025Into Q3 2025 (as of Dec 31) Not updated in Q1 release; cash $23.2M Monitoring required

Earnings Call Themes & Trends

TopicQ3 2024 (Narrative)Q4 2024 (Narrative)Q1 2025 (Narrative)Trend
NDA Submission TimingTargeting Q2 2025; path laid out End of Q2 reiterated June 2025 affirmed; 74-day acceptance and ~12-month review Steadily advancing; increased specificity
Long-term Safety (ORCA-OL)Enrollment complete; first DSMC positive ≥300 at 6 months; second DSMC positive ≥100 at 1 year; third DSMC positive; ~75% retention Milestones achieved; strong adherence
Commercial ReadinessDigital-first strategy forming Label/packaging/3PL selection; payer planning Distribution channel, pricing/payer strategy; AI-enabled digital roadmap Execution intensifying
Partnerships (COPD/respiratory)Strategic lens openNon-dilutive options considered; vaping study funding Specifying partnering objectives; evaluating COPD synergy Ongoing, targeted
Manufacturing/SupplyNot detailedConsultant support; readiness emphasized “Get drug in channel” planning; timing post-approval Building readiness
Vaping IndicationBTD granted (July 2024) EoP2 outcome; sNDA plan; adult-only Phase 3 design Reinforced timing (Phase 3 later; focus on NDA) Secondary priority after NDA
AI/Technology Use——AI to inform targeting/content efficiency via agency partners Emerging capability

Management Commentary

  • CEO Rick Stewart: “We are on track and weeks away from reaching this milestone… Once the NDA is submitted, we anticipate receiving a 74-day letter… we expect the NDA approval to take approximately 12 months from the date of submission.”
  • CMO Cindy Jacobs: “In April, we reached the second requirement of having at least 100 participants with cumulative cytisinicline safety exposure data for a total of 1 year… [DSMC] reported no safety concerns and required no modifications.”
  • CFO Mark Oki: “As of March 31, 2025, the company’s cash, cash equivalents and marketable securities were $23.2 million… total operating expenses… $12.9 million and… net loss… $12.8 million.”
  • CCO Jaime Xinos: “We’re building out our digital road map… an omnichannel, very efficient platform… AI will help to inform every stage of the process from improving targeting strategies to… content development and measurement.”

Q&A Highlights

  • Safety data timing and disclosure: Most subjects will exceed 6 months; 1-year data compiled for the 120-day safety update; public presentation targeted late-2025/2026 .
  • Pre-commercial priorities: Availability, access, awareness; prepare distribution channels and payer strategies; aim to launch as close to approval as possible while acknowledging operational lead times .
  • Partnerships and COPD: Discussions ongoing; specifying clinical design to demonstrate efficacy improvements, including in contexts where some therapies underperform in smokers .
  • FDA interactions: No changes in responsiveness; continued normal dialogue approaching the NDA .
  • Pricing/payer: Formulary and reimbursement will depend on price; clear differentiation from generics; pharmacoeconomic emphasis on adherence→compliance→outcomes rather than re-running established cost-of-disease studies .

Estimates Context

  • S&P Global consensus for Q1 2025 EPS and revenue was unavailable for ACHV; thus, beat/miss analysis versus Street cannot be determined [GetEstimates – no data; values unavailable]*.
  • Implications: Near-term estimate revisions are likely to be less relevant than regulatory catalysts (NDA submission and acceptance) and clinical safety clarity; any future financing steps and commercial readiness updates may shape medium-term models .

Key Takeaways for Investors

  • NDA submission remains the core near-term catalyst; acceptance letter (~74 days post-submission) and clarity on PDUFA-like timeline (~12 months) will be stock-moving events .
  • Strong clinical momentum: JAMA publication and ORCA-OL safety milestones (including 1-year exposure) with positive DSMC reviews reinforce the efficacy/tolerability and long-term safety narrative .
  • Cash declined to $23.2M; watch for financing strategies (equity/partnering/debt tranches) to bridge to approval and launch readiness .
  • Commercial plan is credible: distribution/3PL, payer strategy, focused prescriber targeting (high varenicline writers), and AI-enabled omnichannel engagement should enhance launch efficiency .
  • COPD/comorbidity angle adds optionality: higher quit rates observed in COPD patients in Phase 3 trials could support future partnering and indication expansion .
  • Near-term trading setup: NDA submission/acceptance, continued safety disclosures (120-day update), payer conversations, and manufacturing/logistics updates; absence of revenue/EPS consensus shifts focus to regulatory execution .
  • Medium-term thesis: First new nicotine dependence Rx in ~20 years with best-in-class profile could unlock a substantial, underpenetrated market; execution on access/pricing and adherence messaging will be critical .

Footnote:
*Estimates and any SPGI-derived values were unavailable; where used, values would be “Values retrieved from S&P Global”.