A replay will be available later today using the information in the earnings press release or by visiting the Achieve Life Sciences website. If you look forward with me for a moment, now we have the capital after a meaningful financing.

Related to this, also it would be great to hear your thoughts on capacity and if you expect Adare will be able to meet potential demand. Just given the capital you now have at your disposal, you know, would you be willing to talk about if you contemplate a wider approach at launch?

I don't wanna commit to any specific numbers right now, but I'm confident that we have both the capital and the team to help lead that. First is that we have a strong capital position to execute our strategy of approval and launch.

What went well
  • Closed a transformational private placement of $180 million in upfront capital plus up to $174 million from milestone-based warrants (exercisable any time before and up to 20 trading days after FDA approval), backed by a syndicate of specialist healthcare investors including Frazier Life Sciences, TPG, venBio, Paradigm BioCapital, and Marshall Wace, giving Achieve a strong capital position to fund approval and launch preparation.
  • Assembled experienced launch leadership: new CEO Dr. Andrew Goldberg, three new board members (Chris Martin, former Chief Commercial Officer of Verona Pharma; Dr. Lucian Iancovici of TPG; and Dr. Aaron Royston of venBio), and two new commercial leaders (Mark Zappia as SVP of Commercial and Jim Willis as VP of Sales and Enablement) drawn from Verona's OHTUVAYRE launch.
  • Established a U.S.-based commercial supply chain with Adare Pharma Solutions, producing the first cytisinicline engineering batch at Adare's facility in the first quarter and completing the analytical method transfer, which management said de-risks international importation and potential tariffs.
  • Published mechanistic data in March in Nicotine & Tobacco Research showing cytisinicline selectively interacts with the alpha-4 beta-2 nicotinic receptor while exhibiting minimal interaction with the 5-HT3 serotonin receptor, a potential basis for its favorable tolerability.
  • Reaffirmed the strength of the standalone smoking NDA, supported by two Phase III double-blind, placebo-controlled trials in which both the six- and 12-week courses reached statistical significance, plus Breakthrough Designation and an FDA CNPV priority voucher for the vaping indication.
What went wrong
  • Management announced in mid-April that it expects to receive a Complete Response Letter on or by the June 20 PDUFA date because a separate third-party manufacturer received an Official Action Indicated (OAI) classification; the observations relate to general cGMP matters at that facility and are not specific to cytisinicline manufacturing.
  • As a result, the NDA resubmission is pushed to the fourth quarter of 2026 (naming Adare as the new primary commercial manufacturer), with the anticipated commercial launch remaining in the first half of 2027 and dependent on completing the technology transfer.
  • The setback coincides with a major leadership change: co-founder and former CEO Rick Stewart departed, and new CEO Andrew Goldberg is early in his tenure, still evaluating strategy, timelines, and resourcing ("looking under every nook and cranny").

Guidance Changes

MetricPeriodCurrent guidance
FDA action on smoking NDA (PDUFA)By June 20, 2026As of mid-April, expects a Complete Response Letter on or by June 20 due to a third-party manufacturer's OAI classification (general cGMP, not cytisinicline-specific)
NDA resubmissionQ4 2026Plans to resubmit in Q4 2026, naming Adare Pharma Solutions as the new and primary manufacturing partner for commercial supply, pending receipt and details of the anticipated CRL
Commercial launchFirst half 2027Continues to anticipate a first-half 2027 launch; new CEO is now ensuring readiness against that timeline
ORCA-V2 vaping Phase III initiationFY2026Hopes to initiate the randomized, placebo-controlled, multicenter ORCA-V2 trial this year; design and criteria are being finalized
52-week Phase III dataLater in 2026Expects to release 52-week safety and efficacy data later this year

Performance Breakdown

MetricYoYNote
Capital / balance sheet Strengthened A ~April 2026 private placement of $180M upfront (plus up to $174M in milestone warrants) put the company in a strong financial position to execute approval and launch preparation; no specific cash balance or runway figure was disclosed on the call.
Net loss / R&D / G&A n/a No net loss, R&D, or G&A figures were presented; CFO Mark Oki was present for Q&A but did not deliver financial results on the call.
Pipeline / regulatory progress Advancing but delayed Smoking NDA under FDA review toward the June 20 PDUFA, though a CRL is expected due to a third-party manufacturer OAI, pushing resubmission to Q4 2026; the vaping ORCA-V2 Phase III design is being finalized with a hoped-for 2026 start.
Manufacturing Transitioned to U.S. supply First cytisinicline engineering batch produced at Adare in Q1 and analytical method transfer completed, with technology transfer to Adare in progress to replace the OAI-flagged third-party manufacturer.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
CEO and leadership transitionRick Stewart as CEODr. Andrew Goldberg appointed CEO (effective ~April 18, 2026), succeeding co-founder Rick Stewart; three new directors and two Verona/OHTUVAYRE commercial leaders were added to build out the launch team.—
Manufacturing and FDA CRL risk—A separate third-party manufacturer's OAI classification (general cGMP matters, not specific to cytisinicline) is expected to trigger a CRL by the June 20 PDUFA date; Adare Pharma Solutions is named the new primary U.S. manufacturer and the NDA resubmission is planned for Q4 2026.—
Financing and capital position—A $180M upfront private placement plus up to $174M in milestone warrants from a specialist healthcare syndicate funds independent commercialization and launch preparation.—
Commercial strategy—Plans to commercialize independently with its own field force using a disease-awareness/access model (patients already know they have the problem; the barrier has been an effective, tolerable therapy); field force to start reasonably sized and scale with the opportunity toward an H1 2027 launch.—
Vaping program and CNPV voucher—Holds an FDA CNPV priority voucher and Breakthrough Designation for vaping; the ORCA-V2 randomized Phase III design is being finalized with a hoped-for 2026 initiation; vaping is a follow-on to the standalone smoking program.—
Scientific and clinical data—Published mechanistic data (alpha-4 beta-2 selectivity, minimal 5-HT3 interaction); 52-week Phase III safety/efficacy data due later in 2026; additional subgroup data (cancer, COPD, prior-therapy failures) planned for scientific channels/conferences.—

Q&A Summary

Jason Butler (Citizens) asked for more detail on the commercial strategy and what needs to be achieved in 2026 to be ready for a 2027 launch.
Goldberg said that with capital in place after the financing, the team building out, and the asset in hand, his focus is a data-driven strategy to bring cytisinicline to patients; the key change is that Achieve now plans to commercialize independently with its own field force and will share more specifics as decisions firm up.
Butler (Citizens) followed up on medical-education awareness among current Chantix prescribers of cytisinicline and the Phase III data, and what is needed in 2026 to build it.
Goldberg said the company is constrained in a pre-approval environment but can share existing and new clinical data through appropriate scientific channels, expects to present new data at conferences later in the year (including some this month), and will expand its med-ed team closer to approval.
Justin Walsh (JonesTrading) asked what additional information the NDA resubmission needs, how Adare's manufacturing is progressing, and whether Adare can meet potential demand.
Goldberg said any CRL is expected to focus on the prior third-party manufacturer's OAI classification (the basis for the Adare transition), not the drug; the company has already moved manufacturing to the U.S. and produced its first batches, aims to complete the tech transfer as fast as possible, and he personally visited Adare's headquarters in his first week; he is confident Adare, which already has multiple FDA-approved products, can meet demand and will ramp resourcing where needed.
Gary Nachman (Canaccord Genuity) asked what IP due diligence Goldberg did on cytisinicline before leading the placement and taking the CEO role, and how confident he is in the stated timeline given the fluid manufacturing transition.
Goldberg said IP diligence was done on several fronts (also by the new investors) and he is confident the IP protects the franchise well into the late 2030s and even 2040s; on timelines, he is early in his tenure but has seen nothing to suggest the company cannot meet them and pledged transparency with updates.
Nachman (Canaccord Genuity) asked about evolving vaping-market dynamics amid potential FDA leadership change and whether the FDA will stay committed to the vaping priority voucher.
Goldberg declined to speculate on the agency, called FDA interactions constructive and consistent with the standard process, and said the CNPV signals the agency's alignment on public-health urgency; he emphasized Achieve also holds Breakthrough Designation, that smoking is the lead indication standing on its own with two statistically significant Phase III trials, and that the company is not dependent on the voucher.
Nachman (Canaccord Genuity) asked how soon the vaping Phase III could start and whether a single Phase III would suffice.
Goldberg said ORCA-V2 will be a randomized, placebo-controlled, multicenter trial whose design and criteria are being finalized, and the company hopes to initiate the study this year, updating the market on timelines when able.
Brandon Folkes (H.C. Wainwright) asked whether the added capital allows a broader launch approach (beyond comorbid smokers), how the company thinks about patient-support programs, and how large the commercial investment will be.
Goldberg said the strong post-financing position supports a broader commercial strategy, and that nicotine dependence suits a disease-awareness/diagnosis model since patients already know their problem, need no new diagnostic or titration, and the true barrier has been an effective, tolerable therapy; the focus is giving prescribers a reason to treat and removing access friction, and modern digital/tele infrastructure makes patient-support programs easier to offer.
Folkes (H.C. Wainwright) asked whether Achieve anticipates additional clinical work before refiling if it receives the CRL.
Goldberg said he is always considering new studies and sees promising subsets (patients who failed prior therapies, cancer, COPD, and other small and large cohorts) to highlight, but the immediate focus is getting the drug approved via the largely completed program and ramping the vaping study; he expects the company to be thorough in generating data.
Nelson Cox (Lake Street Capital, on for Thomas) asked how the CNPV two-year clock works (whether it starts at voucher receipt or at pivotal vaping-study initiation) and how large a field team would be needed.
Goldberg declined to comment on the exact voucher specifications, said the company plans to initiate ORCA-V2 as fast as it can while working with the agency on timelines, and indicated the field force would start reasonably sized and scale with nationwide distribution in a disciplined way, without committing to specific numbers.
John Vandermosten (Zacks) asked whether the Q4 NDA resubmission would be a Class 1 or Class 2 type.
Goldberg said the company will wait for information from the agency before planning the resubmission and will update the market at that time.
Vandermosten (Zacks) asked whether ties with the European manufacturer have been fully severed or could remain an alternative supply source.
Goldberg said the manufacturer that received the OAI will no longer be used going forward and has been replaced by the new U.S. partner as the primary supplier.
Vandermosten (Zacks) asked whether the recent flurry of other smoking-cessation aids (GLP-1s, digital tools, FDA-approved flavored vapes, psilocybin) could drown out Achieve's messaging.
Goldberg said smoking cessation has been undercovered for 20 years for lack of adequate therapies and the renewed attention is actually helpful; he pointed to Achieve's robust Phase III program, forthcoming 52-week safety and efficacy data, and cytisinicline's easy-to-tolerate oral profile (standard dosing, no titrations or injections) as a strong position in the future landscape.
Vandermosten (Zacks) asked whether the relationship or objectives with Omnicom would change under the new team.
Goldberg said the company is transparently evaluating every partner across manufacturing, commercial, and future data infrastructure and will pick the best ones aligned with its strategy going forward.
Boris Tolkachev (Freedom Broker) asked whether the ORCA-V2 trial drug batches would be manufactured by Adare and whether that facility's readiness is the key to starting the trial.
Goldberg said the company has manufactured clinical trial supply before (multiple Phase III and 52-week programs, including the completed and published vaping RCT), has already ramped up U.S. batches last quarter, and is now working with its clinical-development and CMC teams to source supply for the next trial.
Tolkachev (Freedom Broker) asked what drives the decision to push the resubmission specifically to Q4 — conservatism or a genuine readiness estimate.
Goldberg said it comes down to completing the technology transfer, the analytical method transfer (already completed), and all necessary milestones for resubmission, and that the company is trying to portray the timelines accurately.

More on Achieve Life Sciences, Inc.

Reported 2026-05-12 · figures from the Achieve Life Sciences, Inc. Q1 2026 earnings call.

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