A replay will be available later today using the information in the earnings press release or by visiting the Achieve Life Sciences website. We also just announced that we have selected Adare Pharma Solutions, a U.S.-based manufacturing organization that will produce cytisinicline drug products as we prepare for potential commercial launch and future demand. manufacturing with Adare, we increase confidence in our supply chain security as we advance towards a planned commercial launch of cytisinicline expected in the first half of 2027. Since our last earnings call, we've continued to validate cytisinicline's clinical profile through peer-reviewed publications and scientific conference presentations.

We've established partnerships, deployed advanced analytics, created an AI-powered asset factory, and are positioning ourselves to execute at scale. We will continue to strategically deploy this campaign throughout 2026 to drive ongoing conversation and awareness around nicotine dependence as a medical condition requiring a medical solution. We will look to deploy the Willpower campaign in select audiences, complete our data and performance measurement capabilities, and finalize media channels and plans. Regarding timing, the actual clock really starts building for the demand when the drug is in channel.

We will have more time to have more conversations, but we won't start building demand. Are third-party suppliers able to meet expected demand if Sopharma is unable to do so?

What went well
  • The June 2025 NDA submission for smoking cessation was accepted by the FDA, moving cytisinicline one step closer to becoming the first new FDA-approved nicotine-dependence treatment in 20 years; management reaffirmed the PDUFA target date of June 20, 2026.
  • The vaping (e-cigarette) cessation indication was one of the first recipients of the FDA Commissioner's National Priority Voucher (CMPV), which is designed to shorten NDA review to 1-2 months (versus a typical 10-12 months) and offers an accelerated path to be the first and only FDA-approved vaping cessation treatment in an untreated market.
  • The ORCA-OL long-term open-label trial concluded, demonstrating cytisinicline's tolerability over 52 weeks of exposure with strong safety, high adherence (over 75%), and excellent patient satisfaction; late-breaking survey data showed meaningful patient-reported benefits.
  • Encouraging clinical data reinforced the program: a pooled analysis of over 1,600 phase III participants (presented at SRNT) showed consistent efficacy across prior-treatment and quit-attempt subgroups, and a post-hoc analysis published in Thorax showed cytisinicline significantly improved quit rates in COPD smokers (a ~6 million-patient U.S. population); research was also accepted for the ATS 2026 conference in May.
  • The company selected U.S.-based Adare Pharma Solutions to manufacture cytisinicline drug product, with technology transfer already underway, adding supply-chain redundancy and reducing risks tied to international importation, tariffs, and MFN uncertainty ahead of a planned first-half-2027 commercial launch.
  • The commercial organization built launch-ready infrastructure while staying lean: 3PL implementation underway, more than half of required state licenses secured, specialty-pharmacy hub setup completed, an AI-powered marketing engine via an Omnicom partnership, a unified data ecosystem and completed customer segmentation, and the provocative 'Willpower' awareness campaign launched in January to reframe nicotine dependence as a medical condition.
  • The company ended the year with $36.4 million in cash, cash equivalents, and marketable securities and maintained a relatively low operating expense base for a pre-commercial biopharma.
What went wrong
  • The manufacturer named in the cytisinicline NDA received an FDA GMP inspection with two observations related to solid oral dose manufacturing, which are being addressed through an ongoing remedial action plan with the FDA; the situation contributed to accelerating the manufacturing transfer to the U.S.
  • A notable gap remains between the June 20, 2026 PDUFA date and the anticipated first-half-2027 commercial launch, driven by the need to get drug product into the supply channel and complete commercial-operations readiness before launch.
  • As a pre-revenue clinical-stage company, Achieve reported a full-year 2025 net loss of $54.7 million against $36.4 million of year-end cash, and management said it continues to evaluate financing options and cash-management strategies (a potential financing/dilution overhang).
  • Management is limited in what it can disclose about interactions with the FDA while the NDA is under review, and Stewart noted there is some public debate around the validity of the CMPV ahead of an FDA public forum.
  • Management expects a slow ramp over the first six months of launch due to initial access restrictions such as new-to-market blocks and formulary bleed-out timing.

Guidance Changes

MetricPeriodCurrent guidance
PDUFA date (smoking cessation NDA)2026June 20, 2026 (reaffirmed; unchanged despite manufacturing observations)
Commercial launch (smoking cessation)2027Anticipated first half of 2027
Adare Pharma Solutions added to NDApost-approval / ~Q3 2026Anticipated to be added post-approval, around the third quarter
Sopharma AD added to NDApost-approvalIntend to add once NDA is approved (excluded initially over FDA inspection-readiness concerns; since made substantial progress)
ORCA-V2 phase III vaping cessation trial start1H 2026Commencement anticipated in the first half of the year; site selection and PI identification underway
Launch rampfirst ~6 months post-launchSlow ramp expected due to new-to-market access blocks and formulary timing

Performance Breakdown

MetricYoYNote
Cash, cash equivalents & marketable securities — $36.4 million as of December 31, 2025; management continues to evaluate financing and cash-management options and will update if and when appropriate.
Total operating expenses — $14.7 million for Q4 and $54.9 million for full-year 2025, reflecting ongoing investment in regulatory, clinical, pre-commercial, and commercial infrastructure activities.
Net loss — $14.7 million for Q4 and $54.7 million for full-year 2025 (pre-revenue clinical/pre-commercial stage).
Regulatory progress (smoking cessation) — NDA submitted June 2025 and accepted by the FDA; PDUFA target date of June 20, 2026 reaffirmed; active, constructive dialogue with the agency.
Regulatory progress (vaping cessation) — Received the FDA Commissioner's National Priority Voucher; ORCA-V2 phase III groundwork (site selection, PIs) underway with FDA discussions centered on protocol approval.
Clinical pipeline — ORCA-OL 52-week open-label trial concluded (safety/tolerability, >75% adherence); pooled phase III analysis (>1,600 participants) and Thorax COPD post-hoc data published/presented; ATS 2026 presentation accepted.
Manufacturing / supply chain — Technology transfer to U.S.-based Adare underway for contingency/redundancy; over three years of cytisine starting-material supply stockpiled (3-year shelf life, reprocessed as needed); synthetic API process making substantial progress.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
Regulatory pathway and NDA review—NDA accepted with a reaffirmed June 20, 2026 PDUFA date; management working constructively toward approval but limited in disclosing FDA interactions while the review is ongoing; positioned to be the first new FDA-approved nicotine-dependence treatment in two decades.—
Vaping (e-cigarette) cessation opportunity—CMPV provides an expedited path (1-2 month review) to be first-to-market in an indication with no approved treatments; ORCA-V2 phase III groundwork underway; management sees a large underserved market despite some public debate over the voucher's validity.—
Manufacturing and supply-chain onshoring—Transfer to U.S.-based Adare for redundancy and to mitigate tariff/import/MFN risk; NDA-named manufacturer addressing two GMP observations with the FDA; Sopharma AD and Adare intended for post-approval addition to the NDA; over three years of starting material stockpiled and synthetic API progressing.—
Commercial launch readiness (availability, access, awareness)—3PL and specialty-pharmacy hub setup complete, over half of state licenses secured; ~40 payer touch points in Q1 with inbound interest and ACA smoking-cessation coverage as a tailwind; awareness deliberately conserved pre-approval, to ramp near launch (e.g., ATS 2026 data).—
AI-powered, data-driven commercial model—Omni-channel digital platform with precision targeting to counter ~75% of PCPs no longer meeting reps; Omnicom-built AI marketing engine, unified data ecosystem, and completed segmentation intended to launch efficiently and 'punch above its weight.'—
Market opportunity and unmet need—~25 million U.S. adult smokers (500,000 deaths, >$600 billion annual cost) and ~18 million adult e-cigarette users (60% want to quit) with no FDA-approved vaping treatment; management draws parallels to how GLP-1s reframed obesity, positioning nicotine dependence as a treatable medical condition.—

Q&A Summary

Thomas Flaten (Lake Street Capital Markets) asked about the critical path between a late-June 2026 NDA approval and a first-half-2027 launch — whether the gap is driven by commercial scale-up or product supply.
Jaime Xinos said drug supply is the first consideration — trade and distribution (3PL, serialization, specialty pharmacy, co-pay/access) will be ready at launch, and the extra six months allows more data into the market and advocacy/policymaker partnerships. Rick Stewart added that, given the market's scale, the company is deliberately taking time to get all processes in place to optimize the launch.
Flaten (Lake Street) asked whether the NDA-named manufacturer will not supply commercial product (with Adare doing so instead), and the implications of folding Adare in during the NDA review.
Stewart said the June 20, 2026 PDUFA date remains unchanged; the decision to transfer manufacturing to the U.S. had already been made given the geopolitical situation and was simply accelerated, and it is prudent to have contingency, onshored supply given the scale of the opportunity.
Jason Butler (Citizens JMP) asked where HCP awareness stands and what awareness-building is planned for 2026, and whether there is anything to share on FDA dialogue on the vaping indication since receiving the CMPV.
Xinos said broad HCP awareness has not been a priority given pre-approval restrictions; the team is conserving resources and using disease-state education, and will ramp up product-specific education (e.g., around ATS 2026 data) closer to launch. Mark Rubinstein said FDA vaping discussions have largely concerned protocol approval, with continued engagement expected. Stewart added that site selection for ORCA-V2 is underway with a first-half commencement anticipated, noted an upcoming FDA public forum (June 14) and some debate over CMPV validity, but emphasized the large first-in-market vaping opportunity.
Brandon Folkes (H.C. Wainwright) asked whether the first-half-2027 launch assumes a June 2026 approval or a later one, how much flexibility to read into the timeline, and whether Adare would be added to the NDA before or after the June approval.
Stewart said Adare would be added post-June approval; the near-term focus is the approval itself, and the first-half-2027 launch is a deliberate stake in the ground reflecting the activities needed to get product into channel and complete commercial operations. He said there is nothing to read into the timeline beyond the two observations the third-party manufacturer is addressing with the FDA, and committed to transparency as things progress.
Folkes (H.C. Wainwright) asked how to think about insurance coverage at launch given the long lead time — normal or better than normal.
Xinos said the company has had about 40 payer touch points in Q1 (plus PCMA attendance and inbound payer interest), payers recognize cytisinicline's differentiated profile and clear unmet need, and the ACA requires coverage of smoking-cessation treatment. However, the demand clock starts when drug is in channel, and initial new-to-market access blocks mean the company still models a slow ramp over the first six months of launch.
Justin Walsh (JonesTrading) asked about the robustness of the raw plant-material supply chain and whether third parties can meet demand if Sopharma cannot.
Stewart said the company has been stockpiling starting material for years and expects to hold more than three years of supply for end-market sales by launch; the material has a three-year shelf life and is reprocessed as needed, and inventory is not expected to fall much below three years for the foreseeable future.
Walsh (JonesTrading) asked about the cytisinicline dosing schedule and whether a potential pill burden (three-times-daily) could limit real-world compliance or uptake.
Rubinstein said the ORCA-OL trial (TID dosing for up to a year) showed patients did not find it excessively burdensome, with high completion and adherence over 75%; because cravings peak around mealtimes, the three-times-daily schedule can be conveniently timed around meals, which patients found reassuring.
John Vandermosten (Zacks Investment Research) asked about the December ICER report's calculated prices for cytisinicline and how they compare with the company's internal thinking on pricing.
Xinos said the company saw and participated in the ICER process; the report affirmed a substantial unmet need despite available treatments and recommended payers make cytisinicline immediately available. The company will not comment on pricing since it has not been set, but was pleased with ICER's recommendation.
Vandermosten (Zacks) asked about the status of synthetic API manufacturing and how the three entities — Adare, a European manufacturer, and Sopharma AD — fit together.
Stewart said the synthetic route is a difficult end-process making substantial progress; Sopharma AD was excluded from the NDA over FDA inspection-readiness concerns but has since made substantial progress and is intended to be added post-approval; the third-party manufacturer is collaborating with the FDA on its observations and remedial actions; and the U.S. transfer is driven by a desire for contingency/redundancy amid tariff and MFN uncertainty, with Adare anticipated to be added to the NDA around Q3.

More on Achieve Life Sciences, Inc.

Reported 2026-03-24 · figures from the Achieve Life Sciences, Inc. Q4 2025 earnings call.

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