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What is Achieve Life's gross profit margin?

What does Achieve Life do and what are its main business segments?

What is the revenue and EPS growth rate for Achieve Life year over year?

What is Achieve Life's latest dividend and current dividend yield?

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What were the key takeaways from Achieve Life's earnings call?

Did Achieve Life beat or miss consensus estimates last quarter?

- **FDA Milestones**: NDA for smoking cessation under review with June 2026 PDUFA date; vaping indication on accelerated 1-2 month review track.
- **Commercial Readiness**: U.S. manufacturing partnership with Adea Pharma; 3PL and specialty pharmacy infrastructure 90% complete for Q2 2027 launch.
- **Clinical Strength**: Phase III data shows 75% adherence and consistent efficacy across treatment-resistant smokers; vaping trial recruitment underway.
- **Market Opportunity**: 25M smokers and 18M vapers with no FDA-approved vaping cessation treatment; ISO report recommends immediate coverage post-approval.
- **Financial Position**: $36.4M cash balance; evaluating financing to support launch and scale.

**【CEO Summary Section】**
- Achieve submitted an NDA for cytisinicline for smoking cessation in June 2025, marking a shift to a commercially focused enterprise.
- Received FDA's Commissioner's National Priority Voucher for vaping cessation, enabling an accelerated 1-2 month review timeline.
- Launched a digital commercial platform leveraging AI for precision targeting of physicians and patients, with a focus on scalable, data-driven operations.
- Partnered with Adea Pharma Solutions for U.S.-based manufacturing to ensure supply chain reliability and reduce tariffs risks.
- Highlighted the unmet need for nicotine dependence treatments, with 25 million smokers and 18 million vapers in the U.S., and the potential to be the first FDA-approved vaping cessation treatment.

**【CMO Clinical Update】**
- Presented pooled Phase III data showing consistent efficacy across patient subgroups, including those with prior failed attempts (e.g., varenicline, bupropion).
- ORCA OL 52-week safety study demonstrated strong tolerability (75% adherence) and patient-reported benefits like successful quitting.
- Received acceptance to present at 2026 American Thoracic Society Conference, with late-breaking data on long-term patient experiences.
- Vaping indication Phase III trial (Orca V2) site selection and investigator recruitment underway.

**【CCO Commercial Progress】**
- Built end-to-end commercial infrastructure: 
  - **Availability**: 3PL setup, specialty pharmacy hub, and >50% state licensing completed.
  - **Access**: 40+ payer touchpoints, including PCMA engagement, with ACA mandate for smoking cessation coverage.
  - **Awareness**: Launched "Will Power" campaign challenging outdated stigma around nicotine dependence.
- Launch timeline: Q2 2027, contingent on June 2026 PDUFA approval and manufacturing readiness.
- Pricing strategy under evaluation, with ISO report recommending immediate availability post-approval.

**【CFO Financial Update】**
- Cash balance: $36.4 million as of Q4 2025.
- Operating expenses: $54.9 million for FY2025, driven by clinical, regulatory, and commercial investments.
- Net loss: $54.7 million for FY2025.
- Evaluating financing options to support launch and scale.

**【Q&A Highlights】**
- **Manufacturing Timeline**: FDA inspection observations being addressed; U.S. manufacturing transfer on track for Q3 2026 NDA addition.
- **FDA Dialogue**: Active engagement on vaping indication protocol; no new data required beyond Phase III trial.
- **Payer Readiness**: ACA mandate ensures baseline coverage, with potential for faster formulary access due to 18-month lead time.
- **Supply Chain Resilience**: 3+ years of raw material stockpiled, with synthetic API manufacturing progressing.
- **Dosing Compliance**: 75% adherence in 52-week study suggests manageable pill burden (TID dosing).

Achieve Life Sciences, Inc.(ACHV)-20260324-2025 Q4 Earnings call transcript

- **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

- **FDA Milestone**: NDA submission for cytisinicline with 1-year safety data from 290 patients; FDA review expected to begin in September.
- **Commercial Readiness**: Omnicom partnership provides full launch capabilities; AI-driven platform optimizes targeting and outcomes.
- **Financial Strength**: $55.4M cash runway after $45M equity raise; disciplined spending aligned with regulatory and launch timelines.
- **Market Potential**: 29M smokers in U.S. with unmet need for effective smoking cessation treatment; 98% of trial participants credit cytisinicline for success.


**【CEO Opening Remarks】**
- Achieved 3 key milestones: FDA NDA submission for cytisinicline, strategic partnership with Omnicom, and $49M capital raise.
- PDUFA date expected in mid-September; potential launch in late 2026 if approved.
- Market opportunity: 29M smokers in the U.S. with 15M annual quit attempts, yet no new treatment in 20 years.

**【Cindy Jacobs - Regulatory Update】**
- NDA submission includes Phase III data from 2,000+ participants and 1-year safety data from 290 patients in ORCA-OL study.
- 98% of survey respondents credit cytisinicline for reduced cravings and withdrawal symptoms; 99% would recommend it.
- FDA's 74-day letter expected in September; 120-day safety update due in October with full 1-year safety data.

**【Jaime Xinos - Commercial Strategy】**
- Omnicom partnership provides end-to-end launch capabilities across 7 agencies.
- Launch strategy focuses on 3 pillars: availability (distribution), access (payer engagement), and awareness (reframing nicotine dependence as a medical condition).
- AI-driven platform to optimize targeting, engagement, and outcomes.
- Pricing strategy positions cytisinicline as a premium branded product vs generics.

**【Mark Oki - Financial Update】**
- $45M public offering in June, with $4.3M from over-allotment, brings total cash to $55.4M as of Q2.
- Cash runway extends into H2 2026.
- Q2 2025 operating expenses: $12.6M (3-month) / $25.5M (6-month), aligned with regulatory and pre-commercial investments.

**【Q&A Highlights】**
- **Safety Data Submission**: 120-day update includes all 290 patients with 1-year exposure, consistent with 6-month safety profile.
- **Launch Spending**: Incremental pre-approval investments expected; full commercial ramp post-approval.
- **Pricing Strategy**: Branded premium positioning supported by payer discussions.
- **Omnicom Impact**: Enhances credibility with pharma partners and enables efficient primary care physician targeting.
- **Synthetic Cytisinicline**: Development ongoing but secondary to NDA execution.


Achieve Life Sciences (ACHV)-7 Aug 25-2025 Q2 Earnings call transcript

- **NDA Milestone**: Cytisinicline NDA submission in June 2025, targeting FDA approval by mid-2026. 
- **Clinical Efficacy**: 6x higher quit rates vs. placebo, 75% patient retention in 1-year trial, and COPD-specific benefits (higher quit rates). 
- **Financial Health**: $23.2M cash, disciplined spending to support 2026 launch. 
- **Commercial Strategy**: Digital-first launch with AI-driven targeting, exploring COPD partnerships, and direct payer engagement.


**【CEO & Management Overview】**
- Achieve is on track to submit the NDA for cytisinicline in June 2025, targeting FDA approval by mid-2026. 
- Cytisinicline is the first new nicotine dependence treatment in nearly 20 years, with potential to address 29M smokers and 11M vapers in the U.S. 
- Management highlights cytisinicline's efficacy (6x higher quit rates vs. placebo) and tolerability, with 75% of ORCA-OL trial participants remaining on treatment for over a year.

**【Clinical Progress】**
- **ORCA-OL Trial**: 100+ patients have 1-year safety data, with no major safety concerns. 75% retention rate at 12 months underscores real-world usability. 
- **ORCA-3 Trial Results**: Published in JAMA, showing 39% quit rate at 6 weeks vs. 12% for placebo, with sustained benefits up to 24 weeks. 
- **Scientific Advisory Board (SAB) Feedback**: Experts praised cytisinicline's potential for COPD patients (higher quit rates observed) and hospital settings due to lack of nausea side effects.

**【Financial Update】**
- Cash balance: $23.2M as of Q1 2025, with $12.9M in operating expenses. 
- Focus on disciplined spending to extend cash runway, with all resources aligned for NDA submission and 2026 launch.

**【Commercial & Regulatory Strategy】**
- **FDA Timeline**: 74-day acceptance letter post-NDA submission, with ~12 months for approval. 
- **Pricing & Payer Strategy**: Engaging payers on value proposition, leveraging cytisinicline's differentiation from generics. 
- **Partnership Exploration**: Exploring COPD-focused trials with respiratory drug developers, targeting synergies with anti-IL-33 therapies.

**【Q&A Highlights】**
- **Long-term Safety Data**: Full 1-year data will be presented at end-2025/early-2026 conferences, with interim updates in FDA's 120-day safety review. 
- **Commercial Readiness**: Digital-first launch strategy with AI-driven targeting, focusing on physician engagement in smoking cessation. 
- **FDA Interaction**: Consistent responsiveness from FDA, no changes in review process noted.


Achieve Life Sciences (ACHV)-13 May 25-2025 Q1 Earnings call transcript

- **NDA Milestone**: Cytisinicline NDA submission expected by end of Q2 2025, targeting first new smoking cessation drug in 20 years.
- **Efficacy Superiority**: 2.5x better quit rates vs varenicline with no major safety concerns, addressing $300B US healthcare burden.
- **Commercial Focus**: Specialty pharmacy distribution and high-prescriber targeting to maximize launch impact.
- **Financial Strength**: $34.4M cash runway supports 2025 execution, with no immediate funding needs.
- **COPD Potential**: Data shows reduced exacerbations in smokers, expanding addressable market beyond 29M smokers.

**【CEO Opening Remarks】**
- Achieve plans to submit the NDA for cytisinicline as a smoking cessation treatment by end of Q2 2025, targeting the first new FDA-approved product for nicotine dependence in nearly 20 years.
- Cytisinicline demonstrates 2.5x higher efficacy than varenicline with a superior safety profile, positioning it as a breakthrough therapy for the 29 million Americans struggling with nicotine dependence.
- The company is prioritizing resource allocation for NDA submission and commercial readiness, with a planned launch in Q3 2026.

**【CFO Financial Update】**
- Cash balance as of Dec 31, 2024: $34.4 million (vs $15.6 million in 2023), providing runway into Q3 2025.
- Q4 2024 operating expenses: $12.2 million; full year net loss: $39.8 million.
- Strict cash management practices will ensure resources are allocated to NDA submission and commercial readiness.

**【CMO Clinical Trial Progress】**
- ORCA-OL open-label safety trial enrolled 479 participants, meeting FDA requirement of 300 subjects with 6-month cumulative exposure.
- Phase 3 trial for vaping cessation (ORCA-V2) design agreed with FDA, with potential start in H1 2026 pending financing.
- Cytisinicline shows promise in reducing COPD exacerbations, with 80% of COPD patients having smoking-related disease.

**【CCO Commercial Readiness】**
- Finalizing product labeling, 3PL partner selection, and launch roadmap focused on "awareness, access, availability."
- Targeting high-volume varenicline prescribers and motivated quitters, with specialty pharmacy distribution strategy.
- Engaging payers for pre-approval discussions to ensure smooth market entry.

**【Key Q&A Highlights】**
- **Manufacturing Readiness**: CMC documentation complete, with external consultants ensuring regulatory compliance.
- **Market Access Strategy**: Planning for specialty pharmacy distribution to track adherence and mitigate access barriers.
- **COPD Opportunity**: Data shows higher abstinence rates in COPD smokers, positioning cytisinicline for broader respiratory indications.
- **Financial Sustainability**: Current cash sufficient for 2025 operations, with no immediate need for additional funding.


Achieve Life Sciences (ACHV)-11 Mar 25-2024 Q4 Earnings call transcript

Achieve Life Sciences (ACHV)-7 Nov 24-2024 Q3 Earnings call transcript

Achieve Life Sciences (ACHV)-13 Aug 24-2024 Q2 Earnings call transcript

Achieve Life Sciences (ACHV)-9 May 24-2024 Q1 Earnings call transcript

Achieve Life Sciences (ACHV)-28 Mar 24-2023 Q4 Earnings call transcript

- **Clinical Success**: Cytisinicline achieved an 8x higher quit rate in smoking trials and 32% cessation in e-cigarettes, with strong safety profile.
- **FDA Progress**: Pre-NDA meeting constructive; NDA submission expected H1 2024.
- **Financial Stability**: $20M cash, 46% Q3 net loss decline, runway into H2 2024.
- **Commercial Strategy**: Seeking global partner for U.S. launch; exploring vaping indication expansion.

**【CEO Summary Section】**
- Achieve Life Sciences reported significant progress in the cytisinicline program, including positive results from Phase III trials for smoking cessation and the first randomized controlled trial for e-cigarette cessation (ORCA-V1). The drug showed an 8x higher success rate in quitting smoking compared to placebo and a 32% cessation rate in e-cigarette users.
- The company completed 3 NDA-enabling clinical trials (QT interval, pharmacokinetics in smokers, and renal impairment) and held a pre-NDA meeting with the FDA in October, which was constructive but details remain pending.
- Management emphasized the market potential for cytisinicline, with over 1 billion smokers globally and 28 million in the U.S., and expressed confidence in its tolerability and efficacy. Discussions with commercial partners are ongoing, targeting organizations with strong U.S. sales capabilities.

**【CFO Financial Commentary】**
- As of September 30, 2023, the company had $20 million in cash, down from $24.8 million at year-end 2022. Net loss for Q3 2023 was $7.1 million, a 46% decrease from Q3 2022, driven by reduced operating expenses due to trial wind-downs.
- Operating expenses are expected to remain lower in Q4 2023, though NDA preparation costs may partially offset savings. The company anticipates sufficient runway into the second half of 2024.

**【Q&A Key Highlights】**
- **NDA Submission Timing**: The FDA pre-NDA meeting is ongoing, with submission targeted for the first half of 2024. Final details on required studies and timelines are pending FDA feedback.
- **Commercial Partnerships**: Interest from potential partners is strong, particularly for the vaping indication. The company seeks a single global partner with U.S. sales expertise, though discussions are separate for smoking and vaping indications.
- **Vaping Trial Plans**: An end-of-Phase 2 meeting with the FDA for the vaping indication is planned for 2024. A Phase III trial design similar to ORCA-3 is anticipated, with no additional studies requested by the FDA to date.
- **FDA Inspection Readiness**: Sopharma, the manufacturing partner, is preparing for FDA inspections with mock audits, though final readiness is contingent on NDA submission progress.
- **Brand Name**: A potential brand name has been precleared with the FDA, though final approval depends on NDA review.

Actual									-2.2	-1.68	-1.14	-1.11	-1.3	-1.53	-0.71	-0.76	-0.8	-1.08	-1.35	-0.83	-0.5	-0.43	-0.34	-0.26	-0.26	-0.25	-0.36	-0.36	-0.37	-0.37	-0.28	-0.28
Forecast									-1.8	-0.8	-1.0133	-1.175	-1.0267	-1.2475	-1.1617	-0.6886	-0.8017	-0.8114	-1.1267	-0.9467	-0.686	-0.4083	-0.368	-0.31	-0.2417	-0.2386	-0.2717	-0.3413	-0.3817	-0.366	-0.244	-0.3
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	-22.22%	-110.00%	-12.50%	+5.53%	-26.62%	-22.65%	+38.88%	-10.37%	+0.21%	-33.10%	-19.82%	+12.33%	+27.11%	-5.31%	+7.61%	+16.13%	-7.57%	-4.78%	-32.50%	-5.48%	+3.07%	-1.09%	-14.75%	+6.67%

Actual	--	--	--	--	--	--	--	--	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Forecast	--	--	--	--	--	--	--	--	0	0	0	0	0	0	0	50.00K	0	62.50K	62.50K	125.00K	0	0	0	0	0	0	0	0	0	0	0	0
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	-100.00%	0.00%	-100.00%	-100.00%	-100.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%

ACHV

ACHV fundamentals

ACHV Q4 2025 Earnings

Earnings Call

You can ask Aime

ACHV

ACHV fundamentals

ACHV Q4 2025 Earnings

Earnings Call

ACHV Earnings Call Summary for Q4/20259:30 AM on Mar 24, 2026

ACHV Earnings Call Summary for Q3/20258:30 AM on Nov 6, 2025

ACHV Earnings Call Summary for Q2/20258:30 AM on Aug 7, 2025

ACHV Earnings Call Summary for Q1/20258:30 AM on May 13, 2025

ACHV Earnings Call Summary for Q4/20248:30 AM on Mar 11, 2025

You can ask Aime