Okay. All right. Good morning, everyone. Welcome to our Piper Sandler Healthcare Conference. My name is Yas Rahimi, Senior Biotech Analyst here at Piper. Excited to have the team from Verona Pharma here. My God, what a year, right? You've got ensifentrine, Ohtuvayre, that sounds like a sexy perfume, approved like the only drug name that sounds so exciting, don't you guys think? Right? What are you wearing? Ohtuvayre. That's how I feel. And obviously, a very successful launch matrix that you provided in November. Great, great execution. Team, I guess the first question a lot of investors had is that the November quarter was really set a high bar. How should we be thinking about 4Q and also in 2025? As you guys are getting visibility around the uptake, could you maybe talk about sort of your managing street expectations? I'll start and Mark can fill in here. I think we're, as we said in the Q3 call, we're very excited about how the launch is going. We've seen one of the things that you go into launch for is we do a lot of prep work, we do a lot of market research, and then we have to actually go talk to customers with reps. And what we saw in the first period of our launch is it's very consistent with what we saw in our market research. So what are those consistencies? One is you have significant unmet need. These doctors are seeing patients with a ton of patients that have persistent symptoms that need additional therapy. The second thing that we saw that's very consistent is that Ohtuvayre's profile is unbelievably compelling. Being able to provide a bronchodilator and a nonsteroidal anti-inflammatory is something that the physician and patients both want. So that, I think, led to some of that early discussions that we had. At our earnings, we talked about over 2,200 writers. We talked about $5.6 million in sales for Q3, and the subsequent month was as much as that. I think what we continue to see is continued positive momentum on the launch, and we continue to see new writers, new prescribers, and now we're starting to get early feedback on our patients coming back on adherence. So those are things that we'll continue to watch through Q4, and then they'll become even more important as you move into Q1 as well. And then, team, if you follow sort of the trajectory that you had from September going into a little bit into October, one would project that in 4Q you end up somewhere between 1,200-1,500 scripts. So a lot of clients are asking us, is that a reasonable expectation or not? That's part one. And then part two, with the year coming to an end and of course you're presenting at JP Morgan, are you planning to give guidance or color or framework around it? I think those are two things that come up quite a bit right now. Mark, I'll take the first. You take the first part. Yeah. So in the first part, I think when it comes to projecting, we haven't given any idea of projections on numbers. I think the thing that we're encouraged by and excited about is what we're seeing from an adoption and a new writer standpoint and a repeat writer. As we think about the health of a brand and a launch, what you want to see is new writers coming on board and doctors that have written repeating writing. And that, I think, bodes well as we move through Q4 and into Q1 next year. Because as you get more writers and expand that base, you obviously have access to more patients and more repeat prescriptions down the road for those. As far as guidance, Mark, I don't know. Yeah, well, I think if you think about as we're heading into JP Morgan, if we don't provide some sort of information prior to the conference, it would be very difficult to talk to people in January. So I think you should expect that we will pre-announce a sales number, maybe a range sometime in early January prior to the conference. Okay. That's helpful. And when you're thinking about that, that would be guidance for 2025 then, sort of a sales number. Yeah. I'm sorry. That would be Q4 sales level. I don't think we're quite ready to go to guidance. I think give us a year-ish of history, a full calendar year of results so we can see how the different quarters act. Also, we can see a little bit more on refill rates and get a little bit more under our belts on that. Okay, and is there, let's say, in 4Q when you do report out, is there any metrics that you're going to be able to share data on that you didn't do in November? What are you going to have that we didn't have before? Or is it going to be just the same? I think very similar. Q4, your expectation should be metric should be very similar to what we saw for Q3. I think as we get deeper into 2025, we'll be able to share a little bit more color on some things like what we see with respect to refills and maybe what we see with respect to payer mix and that sort of thing. But since we're so early in launch, we don't really have enough n's to really give any good color on those other areas. Okay. And you noted that you're starting to see repeat positions. Do you have visibility whether their usage has changed? For instance, if you had a doc that used Ohtuvayre for a patient who failed triple or dual, now they're moving triple. Is their patient segments the same or has? Yeah. Can you see that? We have visibility to the physician level on kind of what they're doing from a prior medication standpoint. What I will say is that we're still early in the launch and what we're seeing is consistent with what we talked about in the earnings, which was about half of our patients that we've seen Ohtuvayre prescribed to have been on background triple, and then the other 50% of patients are on either a dual bronchodilator, LABA ICS, single bronchodilator, or no long-acting bronchodilator. What's encouraging about that is that's also consistent with all the research that we did leading up to launch where doctors said they would use Ohtuvayre across the spectrum, and we're seeing that in the first stages of launch, and we're not just getting pigeonholed in one patient population. You're actually getting use across the spectrum. Okay. And then I think, team, one of the things that investors are struggling with is the stock has done well post the approval and into the launch. And the question here is, how do I figure out at what point can I get comfortable whether this is a $500 million drug, a billion-dollar drug, or beyond that? How do you think at what point of the launch are we going to get a little bit kind of figure out what this product profile is going to truly be or what its market potential could be? I know what we believe. If we just look at the market today, and Mark, you can add color here too, but I mean, I think launches always take time. But I think when you look at what the market and COPD is today, 1% market share given our price, given our gross to net, and given a six-month length of therapy is equal to $1 billion in net revenue. And if I look at what products have done today in COPD, Daliresp still has a 1% share of patients. That's a PDE4 with a limited indication, not a bronchodilator, and tolerability issues. That's the low end of the spectrum. And then Symbicort has a 22% market share. You can see very quickly how a product with a differentiated profile like Ohtuvayre can gain market share very quickly and become a very high revenue-generating molecule for Verona in the future. I don't know, Mark, if you have. Maybe the only thing I'll add is that we did talk to one investor who told us that in his experience in order to become a blockbuster drug, you have to have $100 million in sales in the first year, the first 12 months of launch. I think if you get to a point where you can project out that you think it'll be there, in his mind, that would indicate at least blockbuster status. Okay. I got to take a poll on this and figure out. Oh God. Everybody's agreeing on how our investors all will come up with a mixed answer. They all have their own answer. Yeah. Everybody has their own answer. No, that's helpful. I think, Mark, when you noted that you're going to give guidance in early January around how fourth quarter is, I assume that's obviously a sort of informal way looking at the number of scripts that have come in and looking at the consensus. I assume that number, that whatever you give, you're going to achieve, right? Oh, well, so what I'm talking about disclosing would be the net sales number? Yeah. Or maybe a range. It's unaudited, of course, because it'll be in the first few days of the new year. So leave a little bit of room in case the auditors do some auditor things. So yeah, I think that's what you should expect, just a net sales number. Do you think sometime in 2025, later in the year, we'll be in a point where you could articulate giving guidances for the rest of the year? I think so. I think you need about a year of experience, a full year of launch to be really comfortable giving that kind of guidance. So I think give us that full year and we'll see what's going on with refill rates and etc. over that period. Okay. Let's talk about sort of uptake and physician feedback. I think in November, you noted that about 30% of the tier one docs were already called on, and I don't remember what the tier two number is, but if you want to remind me on that, and where do you want to be in the next six months from now, a year from now? If we look, we had two groups of physicians that we wanted to call, and we wanted tier ones, which is about 2,500, and tier twos, which is about 12,000 physicians out there. When we looked at our penetration of writers today, 30% of our tier ones had written at the earnings call when we came out. I think as we think about, as we move into the future, we want to see that continue to grow and grow to a very high level. We haven't given guidance on what that number is. I think the thing that we've seen is that there are things that drive doctors to write and then continue to write, and that's our increased frequency and also patient feedback, so when we get a doctor writing, we continue to drive reps in either digitally, virtually, or live in person. And then we also supplement that with trying to get patient feedback back to that doctor as easily as possible. And there's a variety of different ways that we can do that. The thing that's encouraging to me is we always said that the tier one physicians would be the earliest adopters and the ones that we had to get on board quickly. And to have a 30% penetration within nominally 12 weeks of launch is really impressive for us. And I think we continue to see writers grow month over month as we work through launch. What about tier two? What has the uptake been in tier two? Tier two has been very similar, not at the same penetration. You have a bigger N on that one. So if you have 2,200 writers, you have more Ns writing in tier two, but your penetration is lower because of the number of doctors in that segment. But we're very pleased with where the tier twos are. We also see writers outside of our target universe. And that's something we watch too because we have tier threes and tier four physicians that are more primary care related that we want to see their uptake. And we want to understand how they're adopting because it may influence some of our strategies moving forward as well. Okay. Are you able to see refill rates right now in patients? We are able to track refill and adherence based on the way we're set up, so we're able to see at a patient level how many fills that they have. As Mark said, we're early in the launch and the refills. We want to get a bigger N, but we're encouraged by what we're seeing. I think one of the things that not only the refill persistency early that we're seeing is encouraging, but the feedback that we're getting from patients back to physicians is encouraging that would indicate a high likelihood to refill. But as Mark said, we want to get a little bit more of an N there before we give any definitive there. When we went to launch, we felt like persistency was an upside because there had not been a channel that was set up the way that Ohtuvayre is set up. And we just want to continue to build on the fact that you have a specialty pharmacy distribution network. You're not in retail. Those specialty pharmacies have clear ways that they want to get patients to adhere to the drug. For example, they reach out to Medicare patients on day 20 for a refill. And they continue to follow up with those patients. They also do, if a patient doesn't fill in a certain amount of time, they try to do a reclaim or recall back the patient to recapture that patient over time. These are things that I think the network helps to increase persistency and adherence, again very early. And it was something when we went to launch we thought could be an upside, but we didn't factor that into our models when we did that. Okay. So in a normal way, that would not occur. The patient has to call the physician. If you have three or four or 12 refills at a retail pharmacy, they'll call, but it's like they're also dealing with 9,000 other drugs at that retail pharmacy. These specialty pharmacies have a very systematic approach to refills that I think help the patient adherence side of the business. To fast forward, next June, we'll probably, or even in the spring, we will probably get color on what the refill rates are because right now everybody's modeling six-month treatment duration for COPD therapies. And we've been modeling that same six months because that's what every other COPD does. And as Chris says, we think of it as upside. I think as we get mid-year, I don't know exactly when, but sometime mid-year, I think we'll be able to give a little bit more color on that. Okay. The channel checks we have done. It seems like the experience that physicians have with your product is really phenomenal, not a lot of hurdles that they have an issue with. They step in. If they're not using Ohtuvayre, what is the reason? Has your sales team come back and said, "Dr. XYZ doesn't want to use it"? And what is your rationale? Because we're always hearing these awesome stories. Let's hear some exciting. I think you have to think about it. We have 14,000 physicians. We've reached personally or digitally over 90% of them since launch. We also have to keep in mind that we're asking a doctor to change a behavior. Behavior change, as much as we say is easy, is not necessarily easy. All of us in the room, if we asked you to change a behavior that you did for the last 20 years, it would be hard, and so repetition, more calls, frequency drives that repeat kind of messaging in the doctor's head. S o there's not one single reason, but I think the important thing to keep in mind is that you have to call on doctors and you have to interact with them to change something that they've done for the last 20 years. They've been doing LAMA, LABA, ICS for 20 years. And now we have a great option for those patients that remain symptomatic or persistently symptomatic, but they still have to remember that when they're in a patient day, they're seeing 30-40 patients too. So there's a lot of just dynamics that happen in that office. I think in November, you also noted that the usage was uniform across different patient types, whether they're on mono, dual, or triple. Has that changed at all, or is that pattern consistent? No, I think we're consistent with what we've said in the past. I wouldn't expect that to change. I mean, I think that 50% split on triple and 50% split on other therapies is consistent. I also think it's very encouraging to what Ohtuvayre can do for the doctor because if they only put it in the triple patient, that doesn't signify or show their willingness to start to move ICS into a different place. The fact that this early in launch, we're getting patients that are on either a LAMA or a LABA or no background therapy or LABA ICS or LAMA LABA tells me that the doctors are thinking about it how they thought about it in market research of this drug can be used earlier in the treatment paradigm and potentially push ICS to later stage patients that are more appropriate for ICS usage than they are today. Okay. Team, your J -code, you were rushing trying to get that in right after the approval. I mean, we expect that to get cleared. Is there a reason to believe that you don't get it, and if you do get it, how does it impact sort of the launch? If you go to CMS right now, the J -code has been issued. The J -code is available. It goes into effect January 1st. We will have a product-specific J -code on January 1st. What that does is then trickle down to the local coverage determination policy, which we've asked CMS to update to include the J -code in. We would expect that to follow lag slightly in January behind. But that really just speeds access. Right now, when you're going through Medicare in particular, your Medicare Advantage, it's a manual adjudication. Every script has to be manually adjudicated. How long does that take? It depends on the plan. The majority of our scripts to dispense are under seven days. But that manual adjudication process does take time. It also slows the reimbursement back to the pharmacy. So the pharmacy gets reimbursed later. So these two dynamics, it's about time when that comes in more than access. So then what would the J -code make it into? Immediately, the turnaround would be like. For the reimbursement to the pharmacy, it's almost immediate because now it's linked to an actual dollar value, and they can get that reimbursement almost immediately, so that pharmacy reimbursement really streamlines from that. The seven days to get it, that will get shorter to like three or four? No, I think consistently we should always think about the majority of patients are under seven days, and there are two ways that extend that time. On the front end, when we send a referral form in, if the doctor misses any information, that's going to take some time because we have to work with that doctor, and as you add new prescribers every week, every month, you're always going to have new doctors doing it for the first time, so that dynamic is always going to exist. The second side is when we're in commercial or Medicaid, there is a prior auth, which we expected at launch. That extends that time a little bit as well, but we have the bridge program that can help these patients in that process. And then the final thing that we can't control and anybody can't control is once it's cleared to ship or cleared to send to a patient, the patient has to pick up the phone to accept delivery. And all of us have examples of on a Monday, we get a call from a pharmacy that our script's ready. And on Friday, we go pick it up. So that's a dynamic we don't control. And that's going to get we don't need that. It just goes out automatically. No, you're always going to need the patient to accept the script. The patient always has to call and accept a script. So that dynamic is a patient dynamic, not a physician dynamic. Have you guys just such good market research around sort of did you look at the ramp of the when you get the J- code in COPD drugs? If you get a J- code, what does it jump up to? It's hard because the only other example would be Yupelri, and Yupelri and Ohtuvayre are so different. You're talking about a LAMA versus a dual bronchodilator, nonsteroidal anti-inflammatory, so I think drawing comparisons between what the J- code does and what it doesn't do with Yupelri is not necessarily fair. I would say when we get the J- code, we're still in launch. We're six months into launch, so we should continue to see the momentum that we're having today, and that would be my expectation as we move into January. It doesn't matter the J- code. It's more about where we are in the stage of launch. Okay. No, that's helpful and then, team, I guess I know that at all points of covering the companies, strategic discussions always came up and you guys have always been very transparent saying any partner would want to see the approval, wants to see the launch. Have these people been just calling your phone, saying, "Wow, congratulations," or is it too early? You know how I ask my questions. You know I have to. Let's go back to talking about Medicare. No, no, no, no, no. No, I think it's a fair question. For investors, we talked about how to gauge what the value of the drug is. But for a partnership, how long do you need to go for a launch matrix to establish a blockbuster opportunity or a blockbuster drug? Yeah. Well, I don't know if I can really answer that because that's how other people are thinking about it. But what I can tell you is that we spend every day thinking about how to maximize the potential of Ohtuvayre. How can we make the launch better? How can we accelerate things? How can we get more patients on drug? How can we continue to expand the pipeline to continue providing value to shareholders? Okay. Another big point of contention before the approval was this whole drama about nebulization. My God, we talked a lot about people hating nebulization. So where has that come up? Zero. Zero. I mean, I think it's one of the things that we taught our reps, and we did a lot of work around that, and it doesn't come up at all, and I think one of the things it tells us is that most patients have a nebulizer, which we said going into launch, about three-quarters of patients have a nebulizer out there. The other thing I think it showcases is that when innovation happens, route of administration gets trumped, and when you have LAMA, LABA, and ICS, your route of administration matters, but when you have a dual bronchodilator, nonsteroidal anti-inflammatory that they've never seen before, route of administration goes way down the ladder as far as a reason to choose stuff, and we see this in other categories. We see it in weight loss. Who thought we'd all be taking shots for weight loss? But route of administration doesn't matter when there's innovation, so I think that's what you're seeing in COPD. They've been starved for innovation, and Ohtuvayre provides that, and the route of administration becomes less of an issue, and our reps just don't. It's not something that comes up like it comes up probably with investors. Do you think based on the work and that outreach that you could consider sizing up the sales force, or do you think based on what you're seeing, there's really no need? For the current 14,500 doctors, they live in 8,000 offices. The size of the sales force we have today is more than sufficient to reach them. If we start to see things that move more into primary care, as you see more of our tier three and tier four, you might see a little bit of an opportunity to go into that space. But we're not talking doubling the sales force. We're talking about small marginal numbers of increasing to help reach a little bit deeper. But that's not something that we're contemplating. We have plenty of work to do within the tier ones and tier twos today. All right. Well, team, thank you so much for a great discussion. It's been an awesome year, right, and really proud and excited for you and excited for 2026, so let's say thank you to the team for a thoughtful discussion and keep crushing it. So thank you for you guys. Thank you. Thanks so much. Excellent. Yeah. Yeah.