Good morning, everyone. My name is Brandon Foulks. I am one of the biopharma analysts here at HC Wainwright. Next up with me, we have a fireside chat with Achieve Life Sciences. With me from Achieve, we have CEO Richard A. Stewart. Richard, thanks very much for joining us. Obviously an extremely busy time at the company, an exciting time. I think just to start, I'd love you to just give an introduction of the company, give the update of sort of all the exciting events that have been going on recently.
Thank you very much for having us. It is an exciting time. We received the NDA acceptance for cytisinicline from the FDA last week. That is the culmination of a significant amount of time and effort. The importance of cytisinicline as a treatment for nicotine dependence is that this is going to be the first treatment in this space for nearly 20 years. We recognize that both patients and physicians are frustrated about the current availability of products to treat the condition. I think, given our efficacy and safety profile, we genuinely think that this is going to have a significant impact. There are 29 million smokers here in the U.S. There are 17 million vapers. Over time, we really think that this is going to have a dramatic impact on the public health crisis that is nicotine dependence.
One of the missions is the commercialization of the drug using a novel approach. It is an integration of existing capabilities and technologies working alongside Omnicom. That provides us with a significant advantage because we are actually building that commercial infrastructure from a blank piece of paper where others are impaired by their existing hierarchies that we have got in place. The final message here is that what we intend to do is to change the narrative around both smoking and vaping because nicotine dependence is a medical condition. This is not a lifestyle issue. In very much the same way that the GLP-1s did with obesity, we are going to do that with nicotine dependence.
Fantastic. You know, and if we just think about the review timeline and sort of a potential approval, you know, how long after potential approval could you be in a position to launch the drug? What are some of the gating factors between approval and launch? Maybe rolled in that, how do we think about manufacturing and sort of the ability to supply the market at launch?
A lot of questions in there. Look, I think our launch preparation is ongoing at the moment. You know, the longer that we prepare for that launch, the better we will be. Anticipating that we have the PDUFA date and approval in June of 2026, all of our activities at the moment are geared towards a successful launch. That really is anticipating the whole manufacturing supply chain. That is geared towards potentially an approval earlier, not that we're going to be anticipating that, but we need to be in a position where we've got everything in place perhaps three months before the actual launch itself. Looking towards the end of 2026, there's some timeline between the actual approval and the actual launch. It'll be a kind of, for want of a better word, a gated launch just to make sure that we don't overreach ourselves.
Great. Just coming back to the actual FDA review and the data, the ORCA clinical trials obviously demonstrated very robust efficacy in terms of quit rates. Safety looked good as well. What do you think the FDA is going to really focus on during the review here? Given the data looks good, the risk-benefit question is quite well characterized, given how long smoking has been a problem. What keeps you up at night in terms of a review, or what are some of the questions we should think about here just given the safety looks to be off the table in terms of an issue? It looks to be really good.
We have been anticipating this kind of regulatory review period for quite a long time. I think typically you would look at CMC and manufacturing as a risk factor. Our supply chain is actually pretty robust. Both of our drug substance manufacturer and our drug product manufacturer are FDA inspected. Indeed, the drug product manufacturer is already producing six FDA-approved products. That is not to take anything for granted. We have been very robust in our internal review of all the quality systems, data integrity, et cetera, with both of those CMOs. On the actual NDA review itself, we're just anticipating a kind of standard review. There's nothing specific that we're overly concerned about on that process.
Great. Maybe moving now to the commercial rollout, right? I think the commercial opportunity is obviously incredibly large. You touched on there hasn't been any innovation in this space, right? With that, there's obviously a thirst for a product, but sometimes there's a challenge to change prescribing habits as well. How are you initially positioning a profile with the prescribing community, patients, and KOL? How do some of these novel approaches you've taken help you or change that?
There are, despite the fact that there's something like 46,000 primary care physicians in the U.S. who are actually writing nicotine dependence prescriptions, only about 7,000 are the high prescribers. They are our target market for cytisinicline. We're looking at the early adopters and those who have got enthusiasm and proactively talk to their patients about smoking cessation. They're a real prime target for us. On the patient side, we've got a very carefully defined profile of the target patients. They're typically, they're similar in nature, but they are about 10 years separated. One of them is less digitally oriented than the other. The second one is far more digitally oriented. Both of them have got concerns about their health related to long-term smoking. Certainly, they're starting to experience some level of comorbidity, whether that's asthma or COPD. Certainly, the older age group is starting to experience that.
I think with a well-defined patient population and the ability to target the right messaging at the right time to the right people, that's going to stand us in really good stead.
Does that messaging change by demographic? What I mean by that is obviously the younger generation may not have experience with Chantix, maybe the older generation may have had experience with Chantix where maybe the safety profile resonates, but you know the efficacy profile, I imagine, should resonate across the board. Just how do you change different messaging to different audiences?
It's an input-output kind of process. As we're actually, especially on an interactive basis, to be honest, that's the beauty of the Omnicom relationship. What traditionally would take perhaps a week to change the messaging, we can do in a few hours. It is a very interactive process. As we get a response from the patient that maybe the messaging isn't quite correct, I'm not saying we're down at the personalized level quite at all, but we are actually at that level where we can be far more defined in that targeting than historically. Same with the physician. The physician, I think, is kind of key to all of this. These early adopters are looking for a new solution. They are frustrated. They need to provide their patients with a new treatment. It's awareness.
We've got to build the awareness with that population, principally via digital means, but there are other ways of doing it. There may be webinars, maybe using Medscape, et cetera, to build that awareness and to take it through a process of moving from awareness to actually writing a prescription. We're estimating there's probably around about four touch points to get to that point. That can happen very quickly. As you go through that journey with the physician and with the patients, we're able to adapt the messaging extremely quickly.
Great. As we look at your initial launch and your high-volume prescriber targets, any way to contextualize the market opportunity within those high prescribers? How do we think about it? How do we think about what it is now and what the potential is, given giving them a better product?
Sure. I think there's several metrics that we can actually look at. On a monthly basis, there's roughly, I think it's 500, nearly 600,000 prescriptions written for nicotine dependence products. That's generic varenicline, it is bupropion, and it's nicotine replacement therapy. I think within that, there's a clear market opportunity for us with a superior product. I think the scope of that market is pretty well defined. The other metric I would suggest is a good one would be Chantix at peak had $880 million in revenues here in the U.S. with only 4% penetration of the smoking cessation market. I think on kind of all of the metrics that we're looking at, that on the smoking side, clearly it's substantial, clearly it's underserved, and it's something that we can address. Of course, back then there was no vaping cessation market at all.
With a kind of incremental 17 million target patients to go after, we genuinely believe that the size of that market opportunity is immense.
The other key part to any successful launch is obviously insurance coverage. There's obviously a lot of benefits here, right? Can you just firstly, maybe let's just start talking about the broad smoking cessation coverage that is mandated?
Sure. Under the Affordable Care Act, there are two free treatments available to patients. Within that, you take it down to the next level in terms of the payer accessibility. Our objective is to make cytisinicline as available as possible to patients as quickly as we possibly can. Within that, the goal is to really minimize the challenges and the barriers to that availability. We're in the process at the moment of, we've had preliminary discussions with payers, and now we're taking that down to the next level. In the first quarter, we'll be conducting a much more detailed payer engagement in the field with those payers. It's an ongoing process.
Would a lot of that, you know, what's mandated in the Affordable Care Act, what's the process in practice once you've launched? Is that pretty easy for the patients to get drug? Is it still a bit of a process?
It will be in the initial stages, yes. The payers are going to take six to nine months to engage. In the meantime, what we're going to be doing is putting in place a number of processes to make the drug available. I think that the underlying message here is we need to get that drug available as quickly as possible to as many people as possible. The engagement of the payers will take a little bit more time. That is the goal.
Okay. Maybe just touching on your strategy behind the partnering with Omnicom, can you just sort of elaborate, help us understand the benefits there for you?
Absolutely. There are roughly seven agencies within the Omnicom group. Big Pharma uses them individually. We're doing something entirely different. We're using them all as an integrated platform. That ability to combine the resources internally in Achieve with the resources of Omnicom, which I believe is either the leading agency in the world or about to become the leading agency in the world, provides an opportunity, as I said, to use that blank piece of paper to optimize the targeting of the patients and the physicians going forward. I think it's a unique opportunity. Some of the pharma that we've been in discussion with are scratching their heads as to how can Tiny Achieve manage to get this unique situation. Now, let's be clear, these resources deployed by Omnicom already exist. That's the important thing. Some people have asked us, isn't there risk associated with these new technologies?
They're not new technologies. They've just never been integrated. I think one of the keys is each of the workstreams has got two captains. One is an Achieve captain. One is an Omnicom captain. We've got this integration across the agencies as well.
You mentioned something there that's interesting, right? You said in your discussions with pharma. I'm going to touch on your strategic rationale for self-commercialization in a very large market.
Right.
What is your long-term thinking there? I'm sure if you get this product to $500 million, those discussions intensify, right? You could think about broad-based DTC, stuff like that, where maybe a big balance sheet and a big sort of organization could take it to the next level. Strategically, we'll get on to vaping just now, right? There is more to the company than just sort of one indication. Strategically, how are you thinking about growing this company and what you're thinking with this commercialization near-term and maybe longer-term for the company?
Sure. The goal right now is to build the company. I mean, that is, we're in the build mode. We're in the growing mode. Yeah, that is our objective. To a degree, we can't afford to be distracted. On the other hand, of course, the size of this market does dictate that if you're going to optimize revenues, then we're definitely going to need some help. Quite how that is manifested is unclear at the moment. Certainly, we've had discussions with a variety of people who have the capability to help us, not just with the U.S. market, but this is, in one regard, a global opportunity. You know, there's a billion smokers in the world, but we are solely focused on the launch here in the U.S.
I think increasingly, strategics are starting to see the bigger picture here in terms of the lack of new treatments recently and also the scale of the global opportunity. I mean, China has got 300 million smokers alone. In Europe, there's roughly 100 million smokers. Those are a challenge for somebody like us, and there's not one that we're going to be going after. Certainly here in the U.S., we believe that we can have substantial revenues from our current commercial strategy.
Great. I do want to just move on to vaping because I think it's a tremendously interesting program and a growing problem. Maybe can you just talk about the phase 3 trial and vaping cessation?
Yeah, sure. I mean, in many respects, that phase 3 trial design mirrors what we did for smoking. It's an 800-patient study, 400 patients in each arm. Where it differs is that it is only a 12-week treatment period, whereas for smoking cessation, you had six weeks or 12 weeks. The reason for that is that there's a thought process that vapers have got a heavier level, a higher level of nicotine dependence given that higher level of nicotine that's in a vape. Other than that, it's pretty much the same trial design. We're aiming to kick that off in the middle of next year sometime. We're devoting all our resources to the NDA approval and the launch for smoking cessation, and then we'll move on to vaping cessation.
In terms of commercialization, is it a pretty easy plug and play if you've got the smoking cessation commercial infrastructure to add vaping? Obviously, perceived age demographic difference maybe, but just anything beyond that?
Not necessarily, no. I mean, it's the same kind of principle, but I think that age difference is important to focus in on. I think that certainly our experience in the phase 2 trial where the average age of the patient population was 33 to 35 versus 55 in the smoking cessation, what it does say is that on a relatively shorter duration of taking vapes, they're starting to experience some level of health concern. The health harms associated with vaping are a real harm that needs to be taken seriously. On the other hand, vapes were originally intended to be a smoking cessation tool in itself. There is a dichotomy here because for some patients, it is an important tool for smoking cessation itself.
I think that has changed in the regard that when the advent of flavors and colorings is appealing to a much younger population who are actually taking a much higher dose of nicotine. I mean, an elf bar in itself can contain up to 250 doses. We know of teenagers who are taking one of those a day. The longer-term health harms are going to be significant. Our focus is principally on those who are highly motivated to quit. That'll be a question of time just to look at how we address that market.
All right. We're almost out of time here, but I do want to just touch on you did show up your balance sheet earlier this year. Can you just contextualize what that does for you in terms of launching the product, the sort of focused approach you're taking on the launch, and then in terms of running that phase 3 vaping trial?
Sure. Yeah, we raised a total of $49 million gross. That is enough of a platform to take us into the second half of 2026. We can certainly get to the NDA approval. Our strategy in terms of financing going forward is our preference is not to raise additional equity, but more to focus in on debt and royalty funding to go beyond in terms of funding the phase 3 trial for nicotine dependence and optimizing the launch for smoking cessation. I think that we're really pleased about the quality of the investors in that June fundraising. We're in active discussions on the debt and royalty financing to drive the company forward.
Great. I appreciate you and your time today. Congratulations on all the progress so far. Best of luck. A very exciting 12 months or less than that ahead.
Thank you very much, Brandon.
Thank you.