Earnings Call Transcript - ACHV Q2 2025

Operator, Operator

Greetings, and welcome to the Achieve Life Sciences Second Quarter 2025 Earnings Conference Call and Webcast. As a reminder, this conference is being recorded. I would now like to turn the call over to Nicole Jones, Achieve Investor Relations. Thank you. You may begin.

Nicole Jones, Investor Relations

Thank you, operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, Chief Executive Officer; Dr. Cindy Jacobs, President and Chief Medical Officer; Jaime Xinos, Chief Commercial Officer; and Mark Oki, Chief Financial Officer. The management team will be available for Q&A following the prepared remarks. A replay will be available later today using the information in the earnings press release or by visiting the Achieve website. Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations and future potential operating results of Achieve. Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks, uncertainties and other factors, including, but not limited to, the factors set forth in the company's filings with the SEC. Achieve undertakes no obligation to update or revise any of these forward-looking statements. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that could affect the company. I'll now turn the call over to Rick.

Rick Stewart, CEO

Thank you, Nicole, and good morning, everyone. We appreciate your time and participation in today's call. This quarter marks a defining moment in Achieve's progress toward the first new treatment for nicotine dependence in nearly 20 years. We achieved 3 transformative milestones. Firstly, the successful submission of our new drug application for cytisinicline as a treatment for nicotine dependence for smoking cessation to the FDA; secondly, a strategic commercial partnership with the exceptional team at Omnicom; and thirdly, a $49 million capital raise that positions us to reach critical value inflection points in 2026, including potential product approval. The NDA submission starts the regulatory clock and the PDUFA date will be defined on NDA acceptance, which we expect in mid-September. This is an exciting moment for Achieve after years of dedication to bring cytisinicline to FDA review and for patients and physicians who currently lack adequate tools to successfully quit. The opportunity to collaborate with Omnicom, a world-recognized leader in health care marketing, advertising and technology, positions Achieve to quickly scale and leverage external expertise and infrastructure to execute our commercial launch strategy. Omnicom's deep experience and proven success with pharma and biotech clients includes successfully executing more than 100 product launches and new indications over the last 3 years. Finally, we're profoundly grateful to our stockholders whose continued investment support reflects an unwavering belief in our potential to create meaningful change in public health. The market opportunity is huge. 29 million Americans smoke. Every year, more than 15 million try to quit with poor success rates. The narrative needs to change to recognize nicotine dependence as a medical condition, much like how the GLP-1s did for obesity. Patients and physicians currently lack adequate tools to be successful. For nearly a generation, innovation has stood still in nicotine dependence for smoking cessation, leaving patients frustrated, providers powerless and public health carrying the burden of over $600 billion in annual costs in the U.S. Historically, individuals seeking to quit smoking have faced limited options, and we aim to change this. As we move forward, we will work with the FDA through the review process and should we receive approval, be prepared to launch cytisinicline in late 2026. Before the team dives into the details, I want to express our gratitude to those who have been instrumental in supporting our progress. Firstly, the patients and physicians who participated in our clinical program, their engagement and commitment has been invaluable. Secondly, our entire Achieve team for their dedication in delivering the NDA submission on time through a significant company-wide effort. And thirdly, our investors for their continued support, guidance and belief in our mission. On today's call, Cindy will update you on regulatory time lines and progress on the ORCA-OL study. Jaime will provide an update on our commercial planning, and Mark will conclude the details on the recent financing and current cash runway. In short, our 3 announcements this quarter demonstrate that we are advancing confidently on 3 fronts: regulatory, commercial and financial. Our path is clear, and we are committed to executing it to the fullest. With that, I'll turn it over to Cindy.

Cindy Jacobs, President and Chief Medical Officer

Thank you, Rick. Our regulatory accomplishment with the NDA submission during the second quarter was the result of years of focused development work. As Rick just mentioned, in June, we officially submitted our NDA for cytisinicline as a treatment for nicotine dependence to achieve smoking cessation as our first indication. This is a comprehensive and well-supported application incorporating nonclinical data and manufacturing information as well as the clinical trial results from 2 well-controlled Phase III studies, ORCA-2 and ORCA-3, along with the long-term safety exposure data from our ORCA-OL clinical trial. The NDA submission is supported by data from over 2,000 clinical trial participants providing a comprehensive foundation and characterizing cytisinicline's efficacy, safety and tolerability. Regarding tolerability and as requested by FDA, we included long-term exposure safety results in over 300 participants who had completed at least 6 months of cumulative cytisinicline treatment. Also important to highlight this last quarter was reaching the second major milestone of FDA's request for having over 100 participants completing 1 year of cumulative cytisinicline treatment before approval. This safety data will be submitted in the standard 120-day safety update during the NDA review period. Meeting both critical thresholds for safety exposure data on schedule was essential in completing the NDA submission and for FDA's review toward market approval. As of the end of July, 290 participants have completed 1 year of cytisinicline treatment in the OL study, and the last participant is projected to complete treatment by early October. We are also in the process of collecting exit survey responses from participants when they complete the OL study. And so far, we have survey responses from 40% of the 290. These responses and their comments have been encouraging as to the impact cytisinicline has had on them and potentially could have on the lives of other people battling nicotine dependence. For example, 98% of the survey respondents stated they believe cytisinicline contributed to their ability to either stop or reduce their nicotine dependence, citing fewer cravings and less intense withdrawal symptoms compared to their previous quit attempts and with very few or manageable side effects. Impressively, 99% stated they would recommend cytisinicline to a friend or family member. Many also expressed their gratitude with specific comments, highlighting their extensive battle with nicotine for decades and that they finally feel that they have won. Although the final study results from this ORCA-OL study is not required by FDA for market approval of cytisinicline, we plan on completing all trial activities to lock the final study database by the end of this year. And we will look for future opportunities to publish and present the completed trial results in 2026. As we look ahead in the next few months, we expect to receive the 74-day letter from FDA in September, and we will be submitting our 120-day safety update documents and data sets in October. The 74-day letter will also indicate that the NDA submission has been accepted for review and give targeted completion review dates, which will begin the official countdown to a potential approval decision. Now I'll turn the call over to Jaime to share more about our commercial launch preparations.

Jaime Xinos, Chief Commercial Officer

Thank you, Cindy, and good morning, everyone. This quarter, we made meaningful progress toward executing our core commercial objective, delivering cytisinicline to patients who are ready to quit using the most advanced tools and strategies available. Over the next several months, we will be building our brand, driving stakeholder engagement and finalizing our go-to-market activities in preparation for potential launch in 2026. Our path to launch is on track and full of momentum as evidenced by the selection of Omnicom to provide a diverse range of critical launch capabilities. Our partnership brings together 7 specialized Omnicom agencies operating as a single unified team across brand development, provider and patient initiatives, market access, public relations, media and marketing technology. This partnership gives us access to the scale, speed and capabilities of a much larger organization and allows us to maintain a lean internal team who will lead key functional areas. This collaboration also supports our commitment to a modern data-driven approach to launch. We are building and will leverage a proprietary AI-enabled commercial platform and tools that will enable precision, agility and measurable outcomes to support smarter decision-making across the entire organization. From targeting and engagement to performance optimization, our tech-focused strategy will help us to reduce costs, mitigate risk and remain highly adaptive to real-world signals. Our strategy is intentional, insight-led and focused on driving both commercial value and improved patient outcomes. As we look ahead to a potential launch in '26, we are confident in our ability to execute efficiently, scale effectively and deliver long-term value for patients, providers and shareholders alike. Our launch readiness efforts are anchored in 3 strategic imperatives: availability, access and awareness, all underpinned by a commitment to measurable impact to ensure the efficiency and effectiveness of our investments. I'll provide a brief update on our recent progress and near-term priorities across each of these pillars. Starting with availability. This work stream encompasses trade and distribution activities to ensure product readiness at launch. We've made meaningful progress in this area, supported by external expert consultants and now guided by an internal Achieve lead. We have contracted with a leading third-party logistics provider or 3PL, named in our NDA and plan to begin implementation in the fourth quarter. Our home state licensing application has been submitted and once accepted, will trigger the sequential submission of additional state applications. Following a comprehensive evaluation, we have shortlisted potential partners for specialty distribution services. We believe this capability will be especially important in the early phase of launch to help ensure that prescriptions written are prescriptions filled. On the access front, we've built a strong foundation and are now accelerating our efforts. Our new Vice President of Market Access has joined the team, and we've engaged a best-in-class access agency to expand upon the foundational work we've already completed, including extensive payer research and market assessment to ensure the value of cytisinicline is clearly reflected in our pricing, contracting and coverage strategies. Our key priorities in the coming quarter include finalizing our pricing strategy, refining our value message and completing payer segmentation and communication plans. We anticipate beginning the pre-approval information exchange with payers in Q4 with outsourced account managers beginning field work in Q1 of next year. We are laser-focused on clearly defining and communicating the differentiated value of cytisinicline backed by rigorous clinical evidence to support favorable coverage decisions. Early engagement with payers is critical to building the relationships and understanding required to enable rapid access following approval. Securing access and insurance coverage for our patients is a top priority. Turning to awareness. Our efforts are focused on building product-specific awareness and establishing Achieve's reputation as a trusted science-driven partner. Unlike therapeutic categories that require broad disease education, the need in smoking cessation is well understood. Our strategy centers on reframing nicotine dependence as a medical condition, not a lifestyle choice, and one that warrants the use of effective and well-tolerated treatments like cytisinicline. We are taking a focused data-driven approach, engaging 2 high-impact audiences: motivated patients who are ready to quit and most likely to succeed with cytisinicline and health care providers who are already prescribing high volumes of smoking cessation therapies. Our goal is to activate these patients to initiate conversations with their providers and ensure those providers are informed, equipped and ready to prescribe. To support this strategy, we are now triangulating multiple data sources, including prescribing patterns, patient behavioral signals and public health data sets to identify and prioritize the highest impact targets. In parallel, we're developing advanced analytics and machine learning capabilities that will continuously evaluate and optimize how we reach and convert these targets. This includes building dynamic audience models and segmentation strategies that allow us to personalize messaging based on where both patients and providers are in their decision-making journey. Whether it's raising initial awareness, addressing clinical questions or prompting action, our content and channels will be designed to meet each stakeholder with the right message at the right time. This precision-targeted approach not only enhances effectiveness, it also improves efficiency and return on investment, ensuring that every dollar spent contributes to measurable outcomes and long-term value creation. As we look ahead, we are energized by the opportunity in front of us. We know that launching a drug, especially as a small company and for the first time, is often seen as a high-risk endeavor, but we are not doing this alone. We have built deep strategic relationships with experienced partners, including Omnicom and others who are not just vendors, but believers in our mission and co-architects of our path forward. These partners bring a wealth of experience across every critical function, and they are fully aligned with our vision for cytisinicline to become a powerful life-changing option for the millions of people still struggling with nicotine dependence. Their investment in our success, both operationally and philosophically adds strength, stability and confidence as we move towards launch. We are guided by data, driven by purpose and supported by a team, both internal and external, that is all in on delivering something truly transformative. The work ahead is substantial, but our focus is clear. We believe cytisinicline can change the way the world approaches smoking cessation, and we are ready to lead that change. I'll now turn the call over to Mark to review the financials.

Mark Oki, Chief Financial Officer

Thanks, Jaime. We are excited to have closed the second quarter with a strengthened balance sheet following the successful completion of a $45 million underwritten public offering in June. And just last week, the underwriters partially exercised their overallotment option, generating additional gross proceeds of $4.3 million to the company. The offering included common stock and warrants and was met with strong support from current shareholders as well as new institutional and retail investors. As of June 30, 2025, we had cash, cash equivalents and marketable securities totaling $55.4 million. These funds are expected to support operations into the second half of 2026. Total operating expenses for the 3 and 6 months ended June 30, 2025, were $12.6 million and $25.5 million, respectively, consistent with our expectations as we increased investment in regulatory, quality and pre-commercial planning. With respect to net loss for the 3 and 6 months ended June 30, 2025, it was $12.7 million and $25.5 million, respectively. Our funding strategy has always been designed to support our highest priorities. And with this recent capital raise, we believe we are well positioned to execute our regulatory and early commercial initiatives while remaining committed to financial discipline. With that, I'll turn the call to Rick for closing remarks.

Rick Stewart, CEO

Thank you, Mark. This past quarter has been a defining one for Achieve. We delivered 3 separate milestones with more to come in the next 12 months as we anticipate product approval and launch. In the near term, we expect to receive the FDA's day 74 NDA acceptance letter in mid-September. We'll add the 100-plus paid subjects with 1 year's exposure from the ORCA-OL open-label safety study at the 120-day safety update, and we'll accelerate our commercial launch preparation. Achieve is disciplined in executing its strategy with a clear focus on financial prudency, on executing a clear regulatory strategy with the FDA and also optimizing its product launch capabilities by collaborating with Omnicom and other external partners who are recognized leaders in the space. These accomplishments are the result of extraordinary determination by Achieve's dedicated team who've worked tirelessly to bring this vision to life and by the over 2,000 patients who enrolled in our trials committing to quit smoking and vaping in pursuit of a better health and lifestyle. We are confident that our focused efforts will have a meaningful impact on patients and create long-term value for all stockholders. Again, thank you for your time, and we look forward to updating you on our continued progress in the coming quarters. With that, operator, we are now ready for Q&A.

Operator, Operator

And our first question comes from Thomas Flaten with Lake Street Capital.

Thomas Flaten, Analyst

Cindy, just a quick one for you just to confirm, in the 120-day safety update, will you submit only 100 patients or the full 290 that you now have access to?

Cindy Jacobs, President and Chief Medical Officer

We'll be submitting all of the subjects at the time of the database cut that occurred in June. So it will be more than 100, but not exactly the 290 over the 200 that we have right now.

Thomas Flaten, Analyst

Got it. And Rick, you mentioned launch in late '26. And if we assume an approval in late June, how should we think about your ramp in commercial spending ahead of launch? Is it going to be completely approval dependent? Or will you begin ramping that spend, let's say, first half of next year?

Rick Stewart, CEO

Yes, it will be incremental. I mean we have to invest in the pre-commercial activities prior to the approval. So I think you'll see an increase over the coming quarters. But as soon as we reach approval, then you'll see an increase. But I think the key message here is that we keep a very disciplined approach to that commercial investment. But again, I think you'll look at this once we've got the NDA acceptance, you'll start to see a ramp-up, but not excessive.

Thomas Flaten, Analyst

And then one final one, if I may, for Jaime. I might be getting ahead of the pricing work you're already doing, but are you assuming that a premium price relative to the generic CHANTIX will be available to you? Or should we be thinking about something closer to the generic pricing that we see today?

Jaime Xinos, Chief Commercial Officer

Thank you for the question. We see this as a branded product offered at a premium price. I believe this aligns well with our differentiation from current options, which we've been discussing with payers, who are in agreement with our approach.

Operator, Operator

Your next question comes from John Vandermosten with Zacks.

John Vandermosten, Analyst

I had a question for Jaime about the initial contact methods for reaching out to providers. In the presentation, you mentioned email and social media. Could you walk us through all those initial contact methods? Additionally, could you explain the flow chart based on the response and how you communicate at different levels?

Jaime Xinos, Chief Commercial Officer

Yes. Thanks for the question. So I think that's still yet to be determined because as we've noted in a lot of our conversations, we really want to identify the individual needs of the physicians that we are targeting and meet them where they are. And so I think there are obviously opportunities for engagement across all of those channels that you mentioned, such as social and e-mail, putting reps where it is appropriate, where they can get strong access and where they need to have those conversations in person. Virtual reps as well will be another option that we'll be looking at. But again, it's really going to depend on what we define further through our targeting exercise as where they want to have those engagements with pharma.

Operator, Operator

And your next question comes from Gary Nachman with Raymond James.

Gary Nachman, Analyst

Congrats on all the progress. So back to the full safety data for the 290 patients at 12 months. Any commentary just on the overall safety profile, if it was consistent with the 6-month data? And how will you be releasing that, assuming after you provide the updated safety data to FDA at 120 days? And then are there any communications with the FDA prior to the day 74 letter? Or is that the first time that you hear back from them? And then I have a follow-up.

Cindy Jacobs, President and Chief Medical Officer

Sure. We will be submitting the 120 safety day update in October. The data has been reviewed by the Data Safety Monitoring Committee throughout this process, and there have been no different or unique safety signals observed. It aligns with our expectations at the 6-month and 1-year marks. What was the second question?

Gary Nachman, Analyst

Yes. In regard to your communications with the FDA regarding the day 74 letter, is that when you expect to hear from them next, or will there be any communication before that?

Cindy Jacobs, President and Chief Medical Officer

Normally, at this time, there's back and forth with FDA, and that's what we're experiencing, and that's what's happening. So it's all normal procedures in that regard. They're contacting us, asking where various things are. We're very responsive, letting them know where they are in the NDA. And so it is a back-and-forth process that's been and it's normal.

Gary Nachman, Analyst

Okay. And any chance for a priority review or I guess you're anticipating a standard review, that's the most likely scenario?

Cindy Jacobs, President and Chief Medical Officer

Well, at this point, we are. However, we're always hopeful for a priority review. We have requested it. And also there is the new Commissioners National Priority Voucher that they just published a couple of weeks ago, how to kind of request it, and we have requested it. We don't view that, that is a likely possibility. But in all of our interactions, we are trying as best as we can to highlight this submission and NDA review process for priority as best as we can.

Jaime Xinos, Chief Commercial Officer

Yes. I'll start with the first part of that question. We have engaged all seven of our agencies and are fully operational with various work streams that we consider high-priority activities that need to be conducted now to better inform what we need to do at launch and how we will allocate resources going forward. Across all the functional areas mentioned on the call, as well as in the press release, we have teams that are activated. We are also working aggressively on building our launch roadmap and our AI-enabled platform, which will allow each of these functional areas to function as one seamless team in a single ecosystem where all data are collected, analyzed, and used to inform decision-making and eventually drive performance metrics. All of this is underway, and we are working diligently as a lean team within Achieve. We have leadership overseeing all the work streams and leaders within the Omnicom organizations pushing this launch forward. We are well on our way. Regarding awareness activities, our early focus will be to reignite the conversation, as it has been 20 years since something new has come to market. It’s important for people to know that a new treatment will be available, and we need to emphasize the seriousness of these discussions. This initial work will focus on elevating the conversation and ensuring the right patients are identified for physicians who should prescribe this product, shifting the medical dialogue to illustrate that this is a medical condition requiring a medical solution rather than a moral or lifestyle choice. The more product-specific efforts will come closer to the launch, as we want to direct our resources towards prescribing to effectively track and monitor the success of those communications.

Boris Tolkachev, Analyst

It might be too early to ask. However, I was wondering if we could expect any updates on future clinical development roadmap before the end of the year? And also, do you plan to share any interim results from the ORCA-OL trial ahead of full publication?

Cindy Jacobs, President and Chief Medical Officer

I'm not sure I heard the first question. This is Cindy. But we are planning on completing the entire database for the ORCA-OL study, and that's going to happen quickly actually by the end of this year. And we will be looking at conferences as well as getting publications ready early next year for hopefully a conference maybe by quarter 2 or during the 2026 year, a number of times that we can present the data because there will be a lot of safety as well as efficacy data for us to present. That is the only ongoing trial we have right now. So obviously, our focus on that trial will allow us to hopefully proceed quickly with getting results in 2026 out to everyone.

Rick Stewart, CEO

Boris, we see great value in the data from an open-label safety study. I think with 1 year's exposure to the drug, so far, we've seen an important element, which is the tolerability of the drug to patients during that period. And we think that's going to stand us in good stead in the future. So as Cindy said in her prepared remarks, the safety profile looks pretty much in line with what we've seen in the Phase III trials. And of course, the secondary endpoint is efficacy. And we're really, really interested to see what that long-term efficacy data will look like.

Operator, Operator

And we have reached the end of the question-and-answer session. I'll hand it back to Rick Stewart for closing remarks.

Rick Stewart, CEO

Great. So thank you, everyone, for joining us today and for your questions, and thank you to the patients and the health care professionals who have participated in our clinical program to date, enabling us to submit the new drug application for cytisinicline. We're very excited about the potential for cytisinicline, and we look forward to providing you with future updates. And finally, I'd like to thank our shareholders for their continued support and the dedicated and talented team at Achieve for their commitment. Operator, that concludes today's call.

Operator, Operator

That concludes today's call. All parties may disconnect. Have a good day.