We're going to get started with the next session. I'm Andrew Tsai, Senior Biotech Analyst at Jefferies, and it's my pleasure to have the Verona team with me. To my direct left, Chris Martin, CCO, and to his left, David Zaccardelli, President and CEO. Welcome, both of you. Thanks, Andrew. Maybe spend one or two minutes talking about the Verona story. I think a lot of people are familiar, but there are still people unfamiliar with your story. So maybe talk about what you're working on, milestones over the next 6 to 12 months. That would be helpful. Sure, sure. Happy to give a brief recap. Hopefully, everyone knows that Verona Pharma has asset ensifentrine, which is a phosphodiesterase 3 and 4 inhibitor, commercially known as Ohtuvayre, which has been developed and looked at in a number of respiratory diseases, but has been progressed and now commercialized for the maintenance treatment of COPD. We launched Ohtuvayre in the latter part of 2024, and it has been going extremely well as we've posted the first couple full quarters of the launch for Ohtuvayre and COPD. In many ways, as I've articulated, I think will be transformational in the treatment of COPD and fundamentally change how COPD is treated as we go forward, especially with the additional new products that are coming into the market for COPD in addition to Ohtuvayre. In addition, our pipeline contains two very important phase II programs. One in non-CF bronchiectasis, which is a phase II study with an endpoint of exacerbation that is progressing and looking for a readout on it probably at the back end of 2026, early 2027, as well as our combination product of glycopyrrolate, which is a LAMA, and NC Ventrin as the first dual product that's nebulized and really as a follow-on from Ohtuvayre. We continue to progress that program in phase II. We are very pleased with not only the launch, which has been phenomenal, but also our progress on the development front. Wonderful. You have executed really nicely all this time. People do put a lot of weight to what you say. When we last met in November in London last year, I think you hinted that you strongly believe this could be the strongest COPD launch in history. Is that still the case for you? Are you willing to say this could be the strongest respiratory launch in history? Yes. I think Chris can talk a little bit about it, but it already is, depending on how you want to measure it or look at it. If you look at all the key launches in COPD, it definitely has exceeded all those launches, especially in the first two to three quarters, by a large margin. It continues to progress as it should. It is a large market. There are over 8 million patients that are under maintenance treatment for COPD, 16 million that are diagnosed in the U.S., huge unmet need of patients remaining symptomatic on the current standard of care, and Ohtuvayre as being able to be prescribed broadly in the indication across patients that are on single, dual, triple therapy as an add-on. We are seeing incredible take-up from physicians and interest and a lot of positive feedback. The setup is extremely good, and we're very pleased with the progress to date and, again, continue to progress every day. We see a great future. I think all of this revolves around, again, the pharmacology and that Ohtuvayre, ensifentrine is what I classify as a great drug in the sense of a compelling benefit to risk when you get lung function improvement, symptom improvement, exacerbation rate, and risk reduction with a safety profile that's favorable. That is a compelling use case. I think that's what's really driving it. Ultimately, we see it's fitting into the treatment paradigm in a way that you're able to use nonsteroidal anti-inflammatories as a way to manage patients, which has not been available until now, especially through the inhaled route. Okay. To level set things, I think you've mentioned in the past, 1% market share is a $1 billion in sales. We now know your gross to net has been better than what you have expected. Maybe compliance is better than what you have expected. Is it still the case that 1% is $1 billion, or could it be like 0.5% at this juncture? I think the metric still is that as a general rule, I think that's where we want to stay. I mean, a lot of things around persistency and refills per year and all of that, which could change it, is favorable to that 1% equal a billion. I think we're very early in the launch, generally speaking, a couple, three quarters in. I think it needs another several quarters in order to actually start to identify what is the persistency, what is the refill rate, and the other metrics that could affect that. In either case, it's an incredibly favorable position to be in. Understood. I think I estimate so far as of first quarter, you've had 20,000 patients -21,000 patients on the drug. I could be off, but let's just say it's around there. You did suggest sales of this drug is beating any other drug out there. Can you give us a sense of how many patients the best-selling drugs did have at the same time point? I don't know. Chris, you want to comment? I mean, I don't know. I don't think I'd have to go back and look at historicals. What I can talk about today is that when you look at what the potential of Ohtuvayre could be, it's, as Dave talked about, there are drugs that have a profile that don't look like Ohtuvayre today. There are drugs that have 22% patient share. There are drugs that have 13% patient share. There are drugs that have 5% patient share. Those profiles of those drugs and molecules don't look like what Ohtuvayre provides them. Instead of me kind of looking back at where they were, I think what those drugs tell me is the future of Ohtuvayre and what this peak could be is extraordinary. I think we have a drug that Dave described in Ohtuvayre that is a differentiated clinical profile. The bronchodilation and nonsteroidal benefits that Ohtuvayre provides these patients is something that, what we heard in market research early before launch, was desperately needed by the physicians. I think one of the underappreciated things from this launch story, even early on, was how much of an unmet need still existed in COPD. When we walk into physician offices today, our physicians have constant complaints from patients that are dealing with daily dyspnea, daily decreasing activities, the inability to do things that you and I take for granted. That has led to what we're seeing in this uptake and what we believe the potential of this drug can be, especially as Dave described, when you start inserting it before steroids and using it earlier and earlier in the treatment paradigm. I think if I look at the future, there are drugs that have significant numbers of patients on them today that we believe our profile is very differentiated from. Right. Okay. First full quarter sales, $37 million in Q4, then it went to $71 million in Q1. We're two months in to Q2. How do you think, how do you feel about the shape of the curve? Is it linear or is it slowing down? Or can you give us some hints? Yeah, not now, Andrew. I would say that, as you'd expect, we feel confident that the launch continues to progress and progress well. I think if you look at launch curves in the respiratory and COPD space, there is a level of linearity to it. Clearly, we can talk about the slope and slope changing, but that is the shape of the curve that is most representative of sort of the field. I think that speaks to a lot of how physicians see patients, the cadence of patient care, how often patients come in to see the physician. That is why you have that sort of feel to it. Now, it is a dynamic process in the launch, especially this early phase, because the refill component to a chronically administered drug like Ohtuvayre also starts to come into play. That is some of the concepts we talked about, persistency, refills, number of refills. We are really focused on two fronts. One is making sure physicians are aware, educated, and that those patients that are applicable for Ohtuvayre treatment, that we get new patients started on Ohtuvayre. Of course, there are millions of them. In addition to that, it is very important to look at refills and persistency, which, again, feedback from both physicians and patients is very favorable on Ohtuvayre. I think we hear externally many people who do doc checks and everything else is consistent with that comment. I think what I just would characterize as a setup is extremely strong, and we just need to continue to do the work. Okay. I mean, sell-side consensus is 92. It is technically a slowdown. I mean, you're confident you would beat that number? Now, Andrew. I would say that we're confident that the launch continues to progress and grow. I think you can do the math, you can do projections, and make your own understanding of what you think it is. To us, constant progress, constant expansion of prescribers, then depth of prescribing are all components to having a successful base that then carries us into 2026 and 2027. I would say also, this is very early in the launch and where Ohtuvayre is being prescribed, I would say a little bit more tactically and in a way where physicians are getting used to using it in their practice. Remember, it does not show up on day one and all become the standard of care. No drug does that in that way, especially in this space in COPD. I think I'm very excited about as we look into the end of 2025, 2026, and especially into 2027, as Ohtuvayre entrenches itself more in the treatment paradigm where it becomes more of the standard use is the direction that we want to take it. I think that its benefit to risk profile allows it to be used that way. I think that's a whole another level of integration and prescribing that's different than what we see today as good as it is. Right. Thanks. When I did my own doctor discussion, some of them at the time of the launch wanted to prescribe this drug because it's novel to a handful of the patients. And they told me, "Andrew, call me back six months later because I don't know if the drug is working across my patients." What has been your kind of feedback on your side? We're well over six months in. Yeah, Andrew, I think what we're hearing from physicians is very positive feedback on what these patients experience. I mean, you hear anecdotal stories of things that patients are able to do again. If I take a general theme that we hear, our reps hear from physicians, the KOLs tell us, "I just feel better. The drug makes me feel better." If you think about what a COPD patient deals with on a day-to-day basis, they feel bad. They're stuck to a couch. They're not able to move. For a doctor to hear themes of, "I feel better," is an empowering thing for them, especially in a field that's seen no innovation for 15 to 20 years. I think when we think about this patient feedback back to the doctor, it's an important aspect of getting greater depth of our prescribing. We talk in our quarterly calls about the number of prescribers that have written for over 20 patients. One of the things that we know that accelerates a doctor to go to 20 is patient feedback and hearing these patients tell them how they're doing. Andrew, you mentioned something, a dynamic that just exists. Most docs don't see their patient back next week. It takes them two, three, four months. Our team, the marketing team, our patient services team have done a really nice job of developing ways where we can close that feedback loop back with the physician. It can be simple marketing tactics, and it can be simple training that we do with the reps. When a doctor says, "I haven't seen it. I don't know how my patients are doing," you can ask a series of questions and quickly understand very quickly from that physician perspective how often they heard from that patient before Ohtuvayre and how often they hear from them now. I think that's a dynamic that's really important as we go for launch. I think we're very pleased by how we're seeing this feedback come out. Right. You mentioned the patient mix so far still is 50% triples remaining on background singles, duals. How do you envision that mix to evolve into steady state? Yeah. If you think about this year, this 50/50 split of on triple, on maybe double dual bronchodilator, single bronchodilator, I think it's going to be fairly consistent for this year. The dynamic that Dave talked about, I think you'll see a shift potentially to more moderate patients, which is these patients on single bronchodilator, dual bronchodilators where you're looking to avoid using ICS. It's very clear in the guidelines where and when ICS should be used. Up until Ohtuvayre's approval, there's not been really a chance for them to properly administer that ICS because when they have a patient in front of them, they've got to help them, and they tend to just prescribe ICS. I think in the future, you'll see some of that shift move a little bit more to the moderate patient, which puts you in front of ICS. The one thing that I think we're very encouraged by is this 50/50 mix early on is probably a little bit sooner than we expected. I think we expected most of our patients to be on background triple. What I think this early mix shows is and highlights the dynamic that both Dave and I are talking about, which is the desire to use nonsteroidal anti-inflammatories and bronchodilators earlier in the treatment paradigm to help these patients avoid some of the risks that are associated with ICS. Makes sense. As we think about the 2025 volume drivers, you mentioned breadth, depth of prescribing, validation from patients that they're feeling better immediately. Anything else that you would allude to to help drive uptake further in terms of new patient starts, DTC ad, sales rep increase, so forth? Yeah, there's a lot there. Let's talk about we are expanding and adding 30 more reps. The genesis of adding those reps is based on data that we see. You mentioned two things, which is new writers and depth of writing. Based on nine months of launch, we see what it takes to get someone to write their first write to 20. We believe that there's an opportunity with these 30 reps to accelerate that momentum and add more new writers and increase the depth of prescribing of these physicians. Those reps are training right now. They will be in the field July 1. We are active and ready to go with that. I think that provides additional momentum. As you think you've liked how the launch is going now, imagine another 30 reps that are coming into the field in the back half of the year. The other side is our marketing teams have done a really nice job in what I would call direct to patient today. We know we're in 8,700 offices. There's about 45,000 physicians in those offices. We can directly target patients that we know we're interacting with in the office. The marketing team has done a very nice job of doing targeted media, targeted advertising to supplement what our reps are doing. I think that will continue through this year. You'll continue to accelerate that. On the patient services side, with the amount of data that we have, 80%-85% of our patients are consented. That allows us to communicate to them. It allows us to give them information. It allows us to give them reminders. We are not reliant on a pharmacy to make sure a patient does a refill. Those types of tactics and initiatives, I think, are always growth drivers for the brand as you move not only through the rest of 2025, but in the lifetime. It is part of the reason why we chose the channel and the distribution pathway, as it gave us control in communication and keeping these patients informed. Got it. Got it. And then refill rates, can you remind us what the refill rates were in Q1 and how do you envision that mix relative to new starts to unfold by year end? In Q1, we said that 60% of our dispense scripts, which was about we had about 25,000 dispense scripts, 60% mix was a refill percentage. Eventually, this becomes a refill business. If you look at Trelegy today, the vast majority of their prescriptions are refills. That will continue to creep up over the course of the time. If you look historically at COPD, COPD patients take about six fills a year. It does not mean they discontinue. It just means behaviorally, they sometimes skip doses, they delay fills. When we have modeled our launch, we have used that. We have also said that we felt like there was an upside there. The upside was based on two scenarios. One is we believe the drug provided a meaningful benefit that made patients feel better and ultimately wanting to take that drug. I think as Dave described in the KOL checks, that hypothesis appears true. The second thing is our distribution pathway. Owning the data, white glove service, we believe is different than what's ever been seen in COPD and would allow for a differentiated persistency. Remember, we don't have to go from six to eight fills to have a meaningful impact on the overall brand long-term or patients. You go from six and a half, six to six and a half, it makes a big deal. I would say with that 60% of our dispenses being refills, that the early persistency is very encouraging to play out that upside. As Dave mentioned earlier, we need a little bit more ends and time. You want a full year. We have more patients every month than we had the prior month. The ones that have had the most eligible refills are also our smallest ends. More time, I think we'll be able to provide more clarity, but we feel very comfortable the way the curve is shaping on that. Despite the small end for the initial batch of patients who started at launch, are they showing upside to your estimate right now? I think what we've said is we were very encouraged by that persistency. I think in February, we also talked about patients having a significant number of refills already, and those are the smallest ends. I think we're seeing really good early signs that the persistency can play out as the upside. Got it. With all this said, I just can't help but think, why can sales accelerate even stronger in the second half? Can you maybe talk me down in my thinking? I mean, I'll just a broad statement. Of course, that's what we're all endeavoring to continue to push to. I think, as Chris mentioned, we are expanding the sales force based on information that we've received in the first part of the launch. You don't add 30 people and maintain the curve. That's not our intent. I think inherently, we should expect in the second half of the year, increased prescriptions, increased sales related to the additional sales reps. I think, like any other launch, there is a component that's not directly under your control as peer-to-peer conversations continue on, speaker programs continue, education, forums. We just came off of ATS. The presence in different ways all plays a role in it. I think that will also be part of the story in the second half of 2025. With that all said, again, traditionally, and if you look at all the curves, there is a level of linearity to this growth. It is our intent to maximize it to the best of our ability and, of course, to change the curve as we progress. In any way you think about it, though, the setup is incredibly strong coming out of the first couple full quarters of launch. When you are launching a drug with a compelling benefit to risk in a large market with high unmet need and great access, again, there is nothing that really should slow that down. Yep. And going back to gross genet, it came in better than your expectations in first quarter. Is it safe to assume it will not bounce back towards the 25% level originally from here? Yeah, I think that it's early days on it, but at the same time, we think there is growing stability around it. I think, as Marc has guided, that somewhere in the mid to upper teens is where we think it'll settle out. Of course, we need more time to really get a sense of that. That's how we've been looking at it and expect it to be in that range. A couple of other housekeeping questions. Inventory, should we expect some build in Q2 or remain unchanged? It depends on how you want to look at it. I think contractually with the specialty pharmacies, they're to hold between two and three weeks of inventory. But when you have increasing dispenses and increasing patients, that two to three week inventory by definition, two to three week inventory is more inventory because it has to support the growing patients and prescriptions. It inherently grows, but it's still always tagged to that two to three weeks, which I find to be very minimal in the channel. On the payer access side, what is the success rate like? Is it close to 100%, essentially, or how would you describe the payer success or payer access? Yeah, from a payer access standpoint, we don't have, it's not your classic, "Oh, I have 100% access," because on the Medicare side of the business, we have what I would classify as access. There's no real prior auth step edits. They can get the drug. On the commercial Medicaid side, same scenario through those prior auths. The dilemma or the situation really comes out of out-of-pocket cost is why a patient may or may not fill a prescription. On traditional Med B, 80%-85% of these patients have supplemental insurance, so that covers your copay. So those patients, in theory, pay $0. If you have Medicare Advantage, if they've met their deductible, they pay $0. On the commercial Medicaid side, it's low copays because of the copay card and the system that Medicaid is. If I look in totality, of all our dispense scripts, about more than 80% of these patients have paid less than $10. For the vast majority of these patients, we get very low copays. The other thing that's nice is because of the way that we own the data, we're able to go when a patient hasn't met their deductible in January, we can always rerun their benefits at a different point in time in the year and help that patient navigate kind of their situation. Remember, COPD patients are not, they have a lot of other health issues. They go through their deductible over the course of the time. The channel and the distribution pathway allows us to manage and navigate that for them as well as they go through the year. Right. Maybe a slightly separate topic is maybe just remind investors one more time why you are superior to biologics out there. We had some major news recently. I'm not sure I would characterize superior to biologics. Let's just call it completely different pharmacology. I think that our view on biologics is, on one hand, good for patients. I think that developing nonsteroidal targeted anti-inflammation is good. We think that that's helpful for patient care. Our view of it with Ohtuvayre is that it's not competitive in any way, but more complementary. The pharmacology is completely different. Ohtuvayre is a bronchodilator as well as a nonsteroidal anti-inflammatory through the PDE3, PDE4 pathway. I think that ultimately approaching COPD treatment in ways that you can use targeted nonsteroidal anti-inflammatory approaches is good. We'll see how that all plays out in the coming years. We are very supportive of it conceptually. We think it's helpful for patient care, and we don't think it's competitive with Ohtuvayre. Understood. You're going to be generating a lot of cash this year already, profitable possibly or likely. What are you going to do with all that cash? Right. Right. I think that it's a good place to be. We will continue to invest in our pipeline programs and making sure that those are properly funded. They are already through phase II, but it definitely supports us setting up into the further development of them as we progress. We'll continue to lean in and make sure commercially we're managing the launch optimally. We will spend as needed and prudently in that area, but also wanting to make sure we maximize. I think we have plenty to do and invest internally currently. We'll see how we look as we roll through 2025 and into 2026. Clearly, there will be opportunities also to acquire assets. Our focus already is on assets that may be in the pulmonary respiratory space, taking advantage of our clinical, regulatory, and commercial capabilities. All of that sets up extremely well by being profitable. As we think about the potential other indication areas you can pursue with Ohtuvayre, can you give us a teaser what indications you might be thinking about and when we can learn more? Yeah. I mean, I think you should look to our pipeline currently. I think we're very excited about bronchiectasis. And a huge market, unmet need. I think that there's plenty of opportunity there. Clearly, the use of ensifentrine can be done in other respiratory diseases, asthma, for example, cystic fibrosis. All of those are different types of development programs, including larger programs, dose-ranging studies. I mean, we need to look at that very carefully on the investment, the time, and the return. We're going to stay very focused, at least through 2025, on our current internal programs and making sure we advance them. Great. I think we'll wrap it up there, but thank you for the updates. I feel really good about the launch. Thanks, everyone.