Achieve (ACHV) Q1 2026 Earnings Transcript

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DATE

Tuesday, May 12, 2026 at 8:30 a.m. ET

Call participants

• Chief Executive Officer — Andrew Goldberg, M.D.

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Takeaways

• Financing -- Achieve Life Sciences (NASDAQ:ACHV) closed a private placement providing $180 million in upfront capital, plus up to $174 million in milestone-based warrants exercisable before or within 20 days after FDA approval.
• Manufacturing strategy -- The company completed its first U.S.-based cytisinicline production batch at Adare Pharma Solutions and plans to resubmit the NDA in the fourth quarter by designating Adare as its new primary manufacturer.
• Commercial launch timeline -- Management stated an expectation for commercialization in the first half of 2027, enabled by the shift to a U.S. manufacturing partner and strengthened operational team.
• FDA status -- The company anticipates a complete response letter from the FDA on or before the June 20 PDUFA date, related to a third-party manufacturer's cGMP status and not specific to cytisinicline.
• Clinical data -- Phase III data presented included continuous abstinence rates of 32.4% for cytisinicline versus 6% for placebo in patients with prior varenicline and bupropion use, with an odds ratio of 7.5.
• Mechanism of action -- Recently published research indicates cytisinicline targets the alpha 4 beta 2 nicotinic receptor with minimal 5-HT3 serotonin receptor interaction, which may explain its low nausea rates in trials.
• Leadership and board changes -- Three new Board members and multiple executives with recent, relevant pulmonary and commercial launch experience joined the company this quarter.
• Commercialization approach -- Management confirmed intent to commercialize cytisinicline independently with an internal field force, scaling personnel and infrastructure in line with nationwide market entry plans.
• Intellectual property -- Management expressed confidence in the durability of cytisinicline's intellectual property portfolio with protection estimated into the late 2030s and potentially the 2040s.
• Clinical supply readiness -- The company reported completion or ongoing production of clinical supply batches for both completed and planned trials at its new U.S. manufacturing partner.

Summary

Management emphasized a new capital structure and leadership team with direct experience in drug commercialization as essential to the company’s next phase. The company plans to resubmit the NDA in the fourth quarter using a new U.S. manufacturing partner, eliminating reliance on the prior European third-party supplier. Participants discussed executional readiness for commercial launch, highlighting the intent to build a scalable internal field force and digital support infrastructure. Near-term clinical milestones include ongoing and new studies, most notably for vaping cessation, supported by an extensive safety and efficacy data set. The company’s approach to patient engagement leverages digital and telehealth tools, aiming to reduce access friction and differentiate from historical models.

• The company strategy prioritizes transparency and adaptability, with resources reserved for potential scaling of manufacturing and commercial operations.
• CEO Goldberg said, "we're honored to be a part of the program. And remember, we also have breakthrough designation," underscoring regulatory alignment for both smoking and vaping indications.
• The planned ORCA-V2 pivotal vaping cessation study design is being finalized, with management targeting a start date within the year subject to coordination with the FDA.
• Phase III data presented at major scientific meetings included over 1,600 participants and supported cytisinicline’s consistent efficacy across multiple patient subgroups.
• Commercial model development focuses on physician enablement, targeted patient access, and leveraging prior launch success from new commercial leadership hires.

Industry glossary

• PDUFA date: The Prescription Drug User Fee Act deadline by which the FDA is expected to complete the review of a New Drug Application.
• Complete response letter (CRL): An FDA communication that informs a company that the review cycle for an application is complete and that the application is not ready for approval.
• cGMP: Current Good Manufacturing Practice regulations enforced by the FDA.
• CNPV: Center for Nicotine Products Priority Review Voucher, an FDA-issued voucher providing priority review for new therapies in vaping cessation.
• ORCA-V2: The planned pivotal Phase III clinical trial evaluating cytisinicline for vaping cessation.
• Tech transfer: The process of transferring manufacturing technology and processes from one facility or organization to another.

Full Conference Call Transcript

Andrew Goldberg: Thank you, Nicole, and good morning, everyone. I'm honored to step into the role of Chief Executive Officer at such an important time. I joined Achieve to lead a mission-driven company. We are developing a new treatment for cessation of smoking, the leading cause of preventable death, as well as vaping that is putting a new generation at risk. We are going to make sure the public and the people most directly affected get the help they deserve. Before turning to the quarter, a word about my background and why I'm here.

For the last decade, I've been an investor and governance leader, serving as a director or observer on 19 health care boards, most recently at Veradermics and currently with Tarsus Pharmaceuticals through their national launch of XDEMVY. My expertise is helping companies cross the chasm from late-stage development to commercial with disciplined execution, all in service of bringing next-generation therapies to market for patients. Improving patient care has been the focus of my career. I have spent nearly 20 years as a physician, dual board certified in critical care and emergency medicine. I trained in practice at the Mayo Clinic, Los Angeles General Medical Center, and the VA Health System.

I published my first research on tobacco when I was 19. Through treating critically ill patients with respiratory failure, vascular events and complications of cancer, I've since seen firsthand the total nicotine dependence takes on patients and their families. Today, in the United States, nearly 50 million adults use nicotine. Approximately 25 million are smokers, 18 million vape. And though the majority want to quit, most fail because current treatment options fall short. Despite the scale of this problem, there has not been a new FDA-approved smoking cessation therapy in more than 2 decades. And there has never been an approved therapy for vaping cessation.

At Achieve, the strength of the clinical data and the favorable tolerability profile gave me conviction that we have an opportunity to fill that gap between patient need and available solutions and champion a category-defining public health intervention. Before I jump into this quarter's updates, I want to acknowledge Rick Stewart, our Co-Founder and former CEO. Rick was instrumental in building this company from recognizing cytisinicline's potential through NDA acceptance, and we are deeply grateful for his vision, leadership and unwavering dedication to this mission. We would not be where we are today without him. We also recently appointed 3 new Board members: Chris Martin, most recently the Chief Commercial Officer of Verona Pharma; Dr.

Lucian Iancovici, Managing Director at TPG; and Dr. Aaron Royston, Managing Partner at venBio. Chris recently led the launch of Ohtuvayre, widely regarded as one of the most successful pulmonary launches in industry history and brings exemplary commercial execution experience to our Board. Dr. Iancovici and Dr. Royston each bring deep expertise in company scaling, investing and board governance and have guided numerous companies through FDA approval. I'm pleased to welcome all 3 to the Board.

And earlier this morning, we also announced 2 of Chris' prior colleagues from Verona joining us as key leaders in our commercial team, Mark Zappia as Senior Vice President of Commercial; and Jim Willis as Vice President of Sales and Enablement, where he will lead the field force. Together with Chris, this team brings deep experience from, Ohtuvayre, widely regarded as one of the best launches in industry history, and we are thrilled to have their leadership for what comes next. Today, I'd like to touch on 3 key highlights from the quarter. First, we closed a transformational financing, which positions us for success.

This private placement included $180 million in upfront capital, plus up to $174 million from milestone-based warrants that may be exercised at any time prior to and up to 20 trading days following FDA approval. This financing came together because a syndicate of leading specialist healthcare investors chose to support this company's next chapter. And I want to personally thank Frazier Life Sciences, TPG, venBio, Paradigm BioCapital, Marshall Wace and our other new and existing investors for the conviction they have placed in this team and this mission. Second, we continue to make operational progress. As mentioned last quarter, the company has partnered with U.S.-based Adare Pharma Solutions to manufacture cytisinicline drug product for potential commercial supply.

We expect this partnership will help decrease risk related to international importation of pharmaceuticals, including potential tariffs. In the first quarter, we produced our first cytisinicline engineering batch at their facility. In mid-April, the company announced it expects to receive a complete response letter from the FDA on or by our June 20 PDUFA date due to a separate third-party manufacturer having received an official action indicated classification. It is important to note that these observations relate to general cGMP matters at the facility and are not specific to cytisinicline manufacturing.

The company's plan, as previously stated, is to resubmit the NDA in the fourth quarter of 2026 naming Adare Pharma Solutions as our new and primary manufacturing partner for commercial supply. The company's stated expectation is for a commercial launch in the first half of 2027. I am now ensuring our readiness against that timeline. Third, let's now turn to the continued advancement of our scientific data. In March, we published mechanistic data in nicotine and tobacco research, providing evidence that cytisinicline selectively interacts with the alpha 4 beta 2 nicotinic receptor while exhibiting minimal interaction with the 5-HT3 serotonin receptor, a key mechanism potentially underlying its tolerability. These findings help explain the low nausea rates observed in clinical trials.

At the Society for Research on Nicotine and Tobacco Conference, our team presented an analysis of over 1,600 Phase III participants, demonstrating consistent efficacy regardless of prior treatment history or previous quit attempt patterns. Importantly, among participants with prior varenicline and bupropion use, those receiving 12 weeks of cytisinicline achieved continuous abstinence rates of 32.4% versus 6% on placebo with an odds ratio of 7.5. This is a particularly difficult-to-treat population, and these results highlight cytisinicline's potential to address a significant unmet need among patients who have failed existing therapies. In closing, my focus now is on growing our team and executing the strategy required to launch this important medicine at the scale the opportunity deserves.

We understand the stakes and with multiple physician officers and directors at Achieve, we have direct experience with the limited tools currently available to help patients. Our goal is to build a company that our shareholders, the public health community and every patient and family affected by nicotine dependence want to see succeed. That is what this company is for, and what I am here to do. Thank you for joining us this morning. I look forward to updating you on our continued progress in the months and years to come.

Operator: [Operator Instructions] Our first question comes from the line of Jason Butler with Citizens.

Jason Butler: I really appreciate all the detail you provided this morning. Can you maybe just give us a few more comments on the commercial strategy and what you think really needs to be achieved in 2026 to be ready for launch next year?

Andrew Goldberg: Thank you. I appreciate asking that question. It's something we've obviously been thinking about carefully, especially since I've joined. If you look forward with me for a moment, now we have the capital after a meaningful financing. We're building our team. And fortunately, now we have the time and above all, the asset. And so my job right now is to make sure we have the right data-driven strategy to bring cytisinicline to patients. I think the team announcements this morning are some of the most visible evidence of that work, and we'll continue to build on that in the months and years to come.

And I think the main change in our strategy going forward is, yes, we plan to commercialize independently with our own field force, and we recruited a fantastic leader today. And so with this team, the asset, what we know about the category, we believe that Achieve is best positioned to bring cytisinicline to patients ourselves, and we'll share more specifics as our decisions firm up.

Jason Butler: Great. And then just one follow-up. Just on the medical education side, where do you think awareness is with current CHANTIX prescribers of cytisinicline in the Phase III data? And again, what do you need to do in 2026 to keep building that awareness?

Andrew Goldberg: Thank you for that. So we're constrained about what we can communicate in a pre-approval environment, and we take those rules seriously. But what we can do is share our existing clinical data and any new data generated from our trials through the appropriate scientific channels. We expect to present some new data at conferences later that year, including some this month. And as we get closer to approval and the launch, our MedEd team will expand, and we'll continue to update throughout the course of the year.

Operator: Our next question comes from the line of Justin Walsh with JonesTrading.

Justin Walsh: It would be great if you could provide some color on what additional information will need to go into the NDA resubmission and how Adare is progressing in its manufacturing efforts? And 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?

Andrew Goldberg: So we expect the -- any CRL that focus on the OAI classification of a prior third-party manufacturer, which is the basis of -- for the Adare transition. And so the three words I kind of want to use to characterize our position here are going forward are transparency, proactiveness and importantly, adaptability. So we'll continue to be transparent with our investors and analysts. What we know is that based on observations at that prior third-party manufacturing, they are unrelated to our drug. But although we haven't received that notification yet, the company has already been proactive. We've already moved our manufacturing to the U.S., and we've already produced our first batches this quarter.

And so our principal goal and my principal goal is completing that tech transfer to Adare on as fast a time line as possible while maintaining our completeness. And so I'm early in my tenure, but we're evaluating every strategy and expenditure as we do this right and we will not hesitate to adjust resourcing where it is needed, including ramping up where we believe that it's necessary. I am personally engaged in this process. I've already visited Adare headquarters in my first week to help ensure that we're ready, and we're committed to getting this done. Importantly, now we have the resources to do so, and we recognize what's at stake.

The patients waiting for this medicine can't afford for us to get this wrong. And so we will ramp up where it's needed to get this right. And we're confident that our current U.S. partner who has multiple FDA-approved products already can help us get there.

Operator: Our next question comes from the line of Gary Nachman with Canaccord Genuity.

Gary Nachman: Congrats on the next phase for the company. Andrew, before you led this last private placement and decided to take over as CEO, what sort of due diligence did you do on the IP for cytisinicline? And how comfortable you are with the durability of that product? And then just on the last question that you answered, how confident are you with the stated timeline given the transition to manufacturing, and it sounds like that's a fluid process.

Andrew Goldberg: So let me take the first question on IP. So I've looked at Achieve for -- I followed this company for a long time, both as a position and as an investor. And so we've done diligence on the intellectual property on several fold. And I would also add that was done by other investors who have come into this significant financing as well. And we're confident we have the IP to protect our franchise going forward well into the late 2030s and even the 2040s. With respect to your question about the timeline, I'm, again, early in my tenure. We are trying to look under every nook and cranny to ensure that we can meet those timelines.

Right now, I've not seen anything to suggest that we will not be able to meet them. And -- but I can assure you that we'll be transparent with the analysts and our investor community and the market and share any updates as they come forward.

Gary Nachman: Okay. Great. And then just a follow-up. With the likely change in leadership at FDA if Makary leaves, how are you thinking about the evolving dynamics in the vaping market if more vapes end up being approved? And also with respect to the priority voucher for vaping that you got last fall, if you think FDA will be committed to that as a priority?

Andrew Goldberg: Okay. So I won't speculate on the agency or comment on any of the internal dynamics that have been reported. What I can say is that our interactions with the FDA have been constructive and consistent with the standard submission process. What the CNPV means to us is that the agency is aligned with the public health need to get this therapy to patients as fast as possible. And so we're honored to be a part of the program. And remember, we also have breakthrough designation. So not only is this a public health imperative, it's also novel. It's the first ever for the indication, and that's important.

But I think what separates us from some of the other CNPV recipients is this. Smoking is our lead indication and vaping, the indication with the CNPV is a follow-on program. So the smoking NDA stands on its own 2 feet. We have 2 Phase III double-blind, placebo-controlled trials where not one, but both of our 6- and 12-week courses reached statistical significance. And so we're proud to be a recipient of the voucher, but we're not dependent on it to be successful. The voucher tells us that the agency understands the urgency, but it does not change the substance of what we're doing.

Gary Nachman: Okay. And then just lastly, how soon do you think it will be before you could start the vaping Phase III? Is there still a lot of work you want to do just going back to the FDA ensuring you just need that single Phase III? Is that something that could happen later this year?

Andrew Goldberg: Yes. So -- thank you for that. ORCA-V2 will be a randomized placebo-controlled multicenter trial, and we're finalizing that design and aligning on the criteria to ensure the highest probability of success. And so we hope to initiate the study this year, and we'll update the markets on timelines when we're able to do so.

Operator: Our next question comes from the line of Brandon Folkes with H.C. Wainwright.

Brandon Folkes: Congratulations on all the progress. Three for me, if I may. The previous team had mentioned initially focusing on those smokers that need to stop smoking and may have comorbidities. Just given the capital you now have at your disposal, would you be willing to talk about if you contemplate a wider approach at launch? I'll ask my second one because it stays along those lines. How do you think about patient support programs for the launch, just things such as patient hotlines, et cetera.

Can you just help us think about how large of an investment do you contemplate across the commercial organization at launch, I guess, especially in light of if we look back at the CHANTIX launch and sort of the importance of those programs as they were described?

Andrew Goldberg: Thank you for that. So, yes, after our financing, which we closed, we're in a very strong financial position to be able to execute on our goals and our launch preparation. So we have the resources now that we need to execute on a broader commercial strategy. I think the commercial model here matters as much as the budget. Nicotine dependence is uniquely well suited to a disease awareness and diagnosis approach. Patients already know they have the problem. We don't need a new diagnostic test. We don't need a long referral pathway, and we don't need extensive titration or monitoring. The vast majority of people with nicotine dependence are already in front of a healthcare provider for other reasons.

And so the barrier to treatment has not been awareness of the disease to date and with prior attempts. It's been with the lack of an effective and tolerable therapy that prescribers feel confident offering. And so that for us changes a bit of the commercial map. Launch efficacy -- launch efficiency in this category is not about saturating awareness. Patients already raised their hands. It's about where we're going to be focused is about giving prescribers a reason to treat, equipping them with the right therapy and removing that access friction. And that's what our commercial team, Mark, Jim and Chris, who were announced this morning has done before.

And so with this team, this asset and category, we believe we can effectively launch at scale. With respect to your second question around investment in patient support programs, the world now is very different than it was 20 years ago. And with a digital and tele-infrastructure and now everyone with a cellphone in their pocket, the ability to provide support programs for our patients has really never been easier. And so I can see -- I can foresee a potential future where we're able to offer not just that therapy, but also some of those support programs going forward in order to help our patients and the clinicians meet the goals.

Brandon Folkes: Great. And one more, if I may. Given your focus on the data, do you anticipate doing any additional small clinical work or any clinical work you would like to do before refiling should you get the CRL?

Andrew Goldberg: So as a physician and a prior researcher, I'm always considering and thinking about new unique studies we can run. I do think that there are unique subsets within the smoking community that are well positioned to study. We've already shared some unique information today and over the last quarter around patients, the success rates in patients who have tried prior therapies before and the impressive efficacy and tolerability in those cohorts. We're also sharing some information later this year on patients with cancer and how this drug improves smoking in that cohort. We've already described how we work pretty effectively in patients with COPD.

I think there's additional subsets, some small and some, frankly, very large that we can also continue to highlight. The focus will be right now getting the drug approved through our primarily completed clinical program and ramping up our vaping study to get that follow-on indication. But I think you can expect that we will be thorough in generating data going forward. And I think we have an excited and committed research community that's going to help support us in that.

Operator: Our next question comes from the line of Nelson Cox with Lake Street Capital.

Nelson Cox: This is Nelson on for Thomas. I'll ask kind of, both mine upfront, which are follow-ups to previous questions. But on the CNPV, can you kind of walk us through your understanding of the 2-year clock? And specifically, does it start at receipt of the voucher or at the initiation of the pivotal vaping study? Or what's kind of the -- what's the -- how does that work there? And then how large of a field team would you anticipate needing to meet your commercial expectations?

Andrew Goldberg: I don't want to comment on the exact specifications around the voucher. We've received it. We plan on initiating the ORCA-V2 trial as fast as we can, and we will work with the agency in order to try and stay on any needed timelines. With respect to the size of our field force, I think we're going to be smart about how we scale that up. I could see us starting with a reasonable sized field force. I don't want to commit to any specific numbers right now, but I'm confident that we have both the capital and the team to help lead that.

And as we branch out into a broader nationwide distribution, we -- our field force will scale in accordance with that. I think the main thing is we want to build both the company and the field force to scale with the magnitude of the opportunity, but we're going to be disciplined about when we start and how we do it.

Operator: Our next question comes from the line of John Vandermosten with Zacks.

John Vandermosten: Dr. Goldberg, with respect to the fourth quarter resubmission of the NDA, do you expect a Class I or Class II type of resubmission?

Andrew Goldberg: I think we'll wait for -- we're trying to be proactive here in what we plan. I think right now, we'll wait for the information from the agency and then plan our resubmission at that time, and we'll update the market when we do that.

John Vandermosten: Okay. And with respect to the European manufacturer, have you completely severed ties with them? Is that all the way in the past now? Or is that something that may continue as an alternative supply source?

Andrew Goldberg: Yes. So the manufacturer that received the OAI, we plan on no longer using them as part of our path forward. We've replaced them with our new U.S. partner as our primary supplier.

John Vandermosten: Got it. And it seems like there's been a lot of messaging recently around new aids for smoking cessation. GLP-1s, mentioned digital tools on your phone, and the FDA approved some flavored vapes, which I assume they're using that for nicotine -- they're intending that for nicotine cessation and then the psilocybin discussions as well going on about that. Does that drown out or potentially drown out the messaging that you guys will have about smoking cessation and using cytisinicline?

Andrew Goldberg: So I think that the area of smoking cessation has been undercovered for the last 20 years, and that's been because there has not been adequate therapies to meet the needs of patients -- and there's never been one, as we've discussed for vaping. I think some of the new resurgence in some of these other therapies is frankly helpful. We're going to get more attention to the condition. It's going to help more patients. Ultimately, we have a pretty robust and far along program with our Phase III clinical trials, and we have 52-week data that should be released on safety and both efficacy later this year.

And so we're confident that our asset has an extremely easy to tolerate profile. We're an oral pill, easy to take, standard dosing, no titration, no injections. And so we're confident that we have a strong position in that future landscape.

John Vandermosten: Okay. And then finally, with the new team, is your relationship or objectives with Omnicom going to change at all?

Andrew Goldberg: I think the company has had some fantastic partners to get to where they are today. And we are in full transparency, evaluating every partner as to how we've done on manufacturing to commercial to future data-driven infrastructures. And so we'll continue to evaluate our partners and pick the best ones for the time where we are and the ones that will align us best for the strategy going forward.

Operator: Our next question will be from the line of Boris Tolkachev with Freedom Broker.

Boris Tolkachev: Just a quick one for me. Should we assume that the drug batches for the ORCA-V trial will be already manufactured by Adare Pharma? And should we think that the readiness of this facility is the key to really start the trial?

Andrew Goldberg: Sorry, if I heard the question correctly, it was about manufacturing readiness for the clinical trial supply?

Boris Tolkachev: Yes.

Andrew Goldberg: Okay. So the company has manufactured clinical trial supply before. We've manufactured it for multiple Phase III programs, 52-week programs, including trial supply for our randomized controlled trial for vaping, which we've already completed and published. And so we have the ability to generate clinical trial supply. We have also already ramped up manufacturing. We've done our batches already last quarter at our U.S. manufacturer. And so we're working now with our clinical development teams and our CMC teams to source this next trial with appropriate supply, and we're making those decisions right now.

Boris Tolkachev: And just a last quick one. Maybe you could reiterate what is the -- what is driving the decision to push the resubmission exactly to Q4? Is it like something conservative? Or is it like a real assumption that you will be ready up to the point?

Andrew Goldberg: Yes. So it really just comes down to doing the technology transfer completely, doing the analytical method transfer, which we've already completed and all the necessary milestones to build up for a resubmission. We're trying to be accurate in how we portray the timelines.

Operator: And we have reached the end of the question-and-answer session. Therefore, I would like to turn the floor back over to Dr. Andrew Goldberg for closing remarks.

Andrew Goldberg: Thank you. In closing, I think there are three main things to take away this quarter, and thank you for the questions. First is that we have a strong capital position to execute our strategy of approval and launch. Second is that we have a U.S.-based supply chain that derisks our manufacturing and our launch timing. And third, we have new commercial leadership with directly relevant launch experience joining a team and company that has already done the hard work of getting to NDA acceptance. Achieve is positioned to address one of the largest preventable public health problems we know, and we're building the company to deliver on that opportunity.

Thank you for joining us today, and I look forward to speaking again soon.

Operator: Thank you. This concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation.

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