Achieve Life Sciences, Inc. · NASDAQ:ACHV
Achieve Life Sciences — Q2 2025 Earnings Presentation
24 slides from Achieve Life Sciences's earnings presentation, Aug 7, 2025
Slide 1: Corporate Presentation
Corporate Presentation August 2025 Transforming public health and delivering shareholder value 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval; data results and commercialization activities; the potential market si
Slide 3: Addressing nicotine dependence, an underserved public health crisis
Addressing nicotine dependence, an underserved 1 public health crisis costing billions of dollars and impacting lives. Cytisinicline, as a first Smoking cessation NDA filed with launch expected in 2H26. potential new nicotine 2 Vaping cessation indication, under FDA Breakthrough Therapy dependent tr
Slide 4: Driving toward regulatory approval and launch
Driving toward regulatory approval and launch Anticipated timeline and key milestones 6-month Completed NDA Smoking Submission NDA FDA Review FDA Approval Product launch Cessation Completed Acceptance Period Expected Cytisinicline Milestones 1H’25 2H’25 1H’26 1H’26 2H’26 E-cigarette Phase 3 Trial Ph
Slide 5: Over $600B in smoking-related U.S. health care costs annually
Over $600B in smoking- related U.S. health care 29M U.S. smokers with few treatment options2 1 costs annually Respiratory disease COPD and asthma 80% of deaths from lung cancer & COPD from smoking3 Immune Cardiovascular system disease 2-4x diseases Infections, Hypertension, heart attack and stroke a
Slide 6: ~60% of adult e-cigarette users want to quit
~60% of adult e-cigarette users want to quit1 ~17M U.S. adults reported use of e-cigarettes2 • Majority of people who vape are 18-24 and have never smoked3,4 • Instead of harm reduction, this is possible harm creation for this group • Many popular vapes used by young adults contain the nicotine equi
Slide 7: Cytisinicline: The first new potential treatment option for nicotine dependence in 20 years
Cytisinicline: The first new potential treatment option for nicotine dependence in 20 years 7
Slide 8: Nicotine dependence alters brain chemistry
Nicotine dependence alters brain chemistry Cytisinicline helps restore it Dual-acting mechanism of action SMOKER TREATMENT INITIATION TREATMENT COMPLETION Increased Nicotine Receptors Receptors Partially Blocked Receptors Normalized Cytisinicline blocks some of the Cytisinicline receptors is designe
Slide 9: Strong results from smoking cessation trials
Strong results from smoking cessation trials ORCA-2 and ORCA-3: Efficacy, tolerability, craving reduction, broad patient response 6-week Cytisinicline Treatment 12-week Cytisinicline Treatment Primary Endpoint (Weeks 3-6) Primary Endpoint (Weeks 9-12) 30.0% 35.0% 30.0% 32.6% 25.0% 30.3% 25.3% 25.0%
Slide 10: Overall effectiveness: Pooled Phase studies
Overall effectiveness: Pooled Phase 3 studies Cytisinicline demonstrates higher abstinence rates vs placebo Point prevalence abstinence rates by week for placebo vs 6-weeks or 12-weeks cytisinicline 6-week Cytisinicline Treatment 12-week Cytisinicline Treatment Abstinence by self-report of not smoki
Slide 11: Highly selective targeting improves tolerability profile
Highly selective targeting improves tolerability profile Adverse event profile compared to Chantix® Comparative Analysis of Safety Events* Selective Receptor Targeting3 Cytisinicline1 Varenicline (Chantix®)2 Cytisinicline3 Varenicline (Chantix®)2 Adverse Events Treatment Time 12 weeks 12 weeks Adver
Slide 12: Smoking cessation trials demonstrated clear benefits
Smoking cessation trials demonstrated clear benefits Efficacy, tolerability, craving reduction, broad patient response Robust efficacy Odds ratios exceeding all available treatment options in both 6- and 12-week dosing options Excellent tolerability Nearly all single-digit rates of adverse events an
Slide 13: Vaping trial expands nicotine dependence opportunity
Vaping trial expands nicotine dependence opportunity Efficacy, tolerability, compliance, Phase 3 warranted Key insights from vaping cessation trial Phase 2 ORCA-V1 trial design (N=160) Robust efficacy Nicotine E-Cigarette Cessation Trial Statistically significant quit rates despite small sample size
Slide 14: Breakthrough therapy granted (with Priority Review) for cytisinicline in vaping cessation
Breakthrough therapy granted (with Priority Review) for cytisinicline in vaping cessation Phase 3 ORCA-V2 trial design for vaping cessation Phase 3 ORCA-V2 trial design Nicotine E-cigarette cessation trial Arm ArmAA(N=53) (N=400) Placebo TID TID Placebo 12 weeks + Behavioral 12 weeks + Randomize sup
Slide 15: Innovative and Focused... a data-driven commercialization strategy for maximum impact
Innovative and Focused... a data-driven commercialization strategy for maximum impact 15
Slide 16: Attractive market conditions to launch the first smoking cessation treatment in 20 years
Attractive market conditions to launch the first smoking cessation treatment in 20 years Clearly defined Well-established Ease of market entry Quiet promotional customer segments therapeutic and prescribing landscape with high unmet category need Limited treatment Harms of smoking are ACA coverage N
Slide 17: Unlocking value by addressing a critical unmet public health need
Unlocking value by addressing a critical unmet public health need Lack of options for people who want to quit & for HCPs ~53% attempt to quit smoking annually1 ~50% who saw an HCP received advice about ~29M1 ~15.4M adults who smoke adult smokers attempt to quit annually1 $11 Billion quitting5 Estima
Slide 18: Precise targeting of high-volume prescribers and engaged quitters
Precise targeting of high-volume prescribers and engaged quitters Changing the Narrative about Nicotine Dependence Medical Issue vs. Moral Issue Drive Awareness & Education of Cytisinicline First New Treatment in 20 Years Focus at Launch on Audiences Most Likely to Take Action: High-Volume Prescribe
Slide 19: Focused Health Care Provider (HCP) launch strategy
Focused Health Care Provider (HCP) launch strategy Built for growth: initial target on varenicline market share • Chantix peaked at ~2.8M Rx (75% in U.S. market - 1,2 $800M) C e ssation Total M ark king et • Launch focus on priority, primary care HCP targets to o s sa tio n R x T Sm g Ce ota lM conv
Slide 20: Traditional pharma promotional model is evolving
Traditional pharma promotional model is evolving HCP access and engagement preferences have changed Traditional approach: Activity based & siloed Ignores HCP reality Over-indexing on F2F sales rep-to-doctor interactions and rep-provided content 1 to 3 75% 73 HCP minutes minutes IM HCPs do not Time H
Slide 21: Launch focus on data-driven omnichannel approach
Launch focus on data-driven omnichannel approach Right message, right time, right channel - to optimize reach and impact AWARENESS POST-PRESCRIPTION ADHERENCE INTEREST HCP Toolkit Patient Toolkit Examples Example Email Path To Prescription Rx Path To Advocacy KOL Content Social Banner Ads ENGAGEMENT
Slide 22: Transforming public health while delivering shareholder value
Transforming public health while delivering shareholder value 22
Slide 23: ACHV: Poised to disrupt and drive value
ACHV: Poised to disrupt and drive value Executive summary Public health priority Near-term solution Proven leadership Smoking is the leading cause of With a compelling data package Executive team and board of 1 preventable death and disease. and differentiated product profile, directors with track r
Slide 24: Thank you!
Thank you! 24
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