Alrighty, great. Welcome, everyone. My name is Dave Risinger. For those of you who do not know me, I cover diversified biopharmaceuticals at Leerink Partners. It is very much my pleasure to welcome you to our Global Healthcare Conference here in Miami. It is very much my pleasure to welcome members of the leadership team of Verona Pharma to have a discussion this morning. With us on stage are David Zaccardelli, who is the CEO, to my right. To his right is Chris Martin, the Chief Commercial Officer. We are going to go through a dialogue here. If anybody would like to ask a question, since I will probably just keep rolling, I will not mind. If you want to interrupt, I will pause for a moment in about 20 minutes or so just to see if there are any questions from the audience. With that, why don't we start off here? David, congrats on the phenomenal execution and uptake of Ohtuvayre to date. Could you just discuss the unique position that you're in, having a drug that targets such a huge market opportunity, can be added on to other treatments, and is effectively not competing with other branded drugs for mind share? Yeah, no, thanks very much for the question. Thanks for having us this morning. We're very, very pleased with the progress that we're making with Ohtuvayre in COPD. Just to back up, as everyone knows, we've been in the launch for the past seven months or so. It has been a remarkable launch to date. That is really grounded in some of the concepts that you mentioned. First, it's the novel mechanism of action of Ohtuvayre as a PDE3, PDE4 inhibitor that gives bronchodilation, lung function improvement, symptom improvement, and exacerbation rate and risk reduction. That is really the cornerstone of the interest in treating COPD, the unmet need that exists in patients. Along with that novel mechanism of action, as I mentioned, there is such a large population in COPD. Around 8.5 million patients are currently under maintenance treatment. About half of those are symptomatic and really, to date, have had limited options for therapies. The current therapy is in treatment with a LABA, a LAMA, or an ICS. Ohtuvayre, being the first novel mechanism in several decades by the inhaled route, really provides us a tremendous opportunity. We also need to, when we look at the label for Ohtuvayre with a broad indication, as you've alluded to, for the maintenance treatment of COPD, that allows us broad use in the patient population, which we're seeing, as we anticipated from our market research in this initial phase of the launch. It is being prescribed across a wide spectrum of patients, those patients that are on maybe single, dual, and even triple therapy, with about 50% of them being on triple therapy currently. We're very pleased with that broad spectrum of use, especially this early on. I think I've started to re-characterize Ohtuvayre's use as just being a great drug that is a simplification of many attributes of Ohtuvayre, including its efficacy, safety, and general benefit to risk that it has. I think that is going to actually change the treatment paradigm for COPD. You're going to see a greater and greater use of Ohtuvayre in the patient population. That's all grounded in many of the things we just talked about, the fact that there really is no direct competition for Ohtuvayre. We are asked many times about what your thought about Dupixent and its approval and its impact on Ohtuvayre use. It's really a no impact. In many ways, we find it to be complementary. I think having novel mechanisms treating inflammation in COPD is a good thing for patient care. Ohtuvayre's profile is, of course, different than Dupixent. Its label is different. The application of how it's used is different and in no way really changes our view of how Ohtuvayre will be used in the patient population. We could not be more pleased with this initial phase of the launch, how it's being integrated in the treatment practice, and really helping patients. That is why we do what we do. We are seeing all of that shine through early on. Excellent. Chris, could you discuss the promotional activities to date, provide a framework for those? Yeah, thanks, David. I think when we think about how we went to market, we went to market with about 120 field personnel. That was reps, virtual reps, managers, field reimbursement managers. Their call list was about 14,500 physicians. Those physicians were primarily pulmonologists, nurse practitioners, and PAs and pulmonologists, but also some primary care doctors. What we had focused on with them was, as Dave described, talking about patients that come into their practice with persistent symptoms and the need to continue to add or think about new therapies in these patients. Because as these patients progress, their symptoms increase. It reduces their activities. It reduces what's going on. Being able to offer this novel pharmacology was something very appealing to the physician base. When we think about our promotional activities to date, our reps have been able to penetrate this market really quickly. If we think about it, at the end of the, in our earnings call recently, we talked about we had now over 4,600 writers. About 55% of our Tier 1 physicians had already written. For those in the room, Tier 1 is about 2,500 doctors. So 55% of those had already written. This, for us, seven months into launch, is an unbelievable base of business that does not go away. These doctors have millions of patients under their care that are always dealing with symptoms, patients with persistent symptoms. Having over 4,600 writers, having over 50% of your tier 1's writing is a great start to the launch, and we believe provides unbelievable foundation and momentum as we move through 2025. As we also think about this, we also talked about getting to greater depth within our prescriber base. When a doctor writes, getting them to write for more patients in their practice. As you may know, our Tier 1 physicians see about over 160 patients a month with COPD. In that Q1 earnings release, we talked about now having over 275 doctors that have written over 20 prescriptions for patients in their practice or 20 patients within their practice. When we talk about our current promotional efforts, it is really about driving new writers, but also increasing the number of how much they are writing in their practice as well. Those are the two focus areas for our field. When we do this, we also supplement with non-promotional or omnichannel activities. We have a very robust digital and, I would say, non-personal promotion effort so that when a doctor becomes a writer, when we have writers, we can amplify our reps' ability in the field with using non-personal activities to help move them to the next level as well. It's been a very good complement between our personal promotion and non-personal promotion in the first seven months. That's very helpful. Thank you. Could you just discuss the uniquely attractive access that the drug has with respect to lacking insurance controls and lacking out-of-pocket limitations like other drugs have? Yeah, so Ohtuvayre is primarily reimbursed through a medical benefit. When you think about our reimbursement landscape, 80% of our reimbursement, we believe, and what we've seen historically with nebulizers, is reimbursed under medical benefit. That can either be primarily Medicare Part B, traditional Med B, or through the Medicare Advantage under the medical benefit side of the business. When we think about that line of business or those lines of business, those lines of business do not have prior auths, PAs, step edits that allow doctors' willingness to write to actually be matched with an access dynamic. If we flip to the other side, to the other 20% of the business, which is the pharmacy benefit, which is commercial or Medicaid, we have access within that channel. We have very high access rates within that channel. We also see if there is a prior auth, it is usually to label. It's to a confirmation of COPD diagnosis and to have tried a LAMA or a LABA or some other background therapy, which makes access within that channel very easy as well. When it comes to out-of-pocket costs, what we understand about the two sides of the channel on the medical benefit side is a patient has supplemental insurance, which up to 85% of all, 80%-85% of all COPD patients have supplemental under Part B. They pay typically less than $10 for their drugs, depending on how that works. If they've met their deductible in Medicare Advantage, they pay less than $10. What we've seen early on is over 80% of our patients have a copay on dispensed scripts of less than $10. This provides, again, another nice dynamic as we think about launch of access is available, doctors can write based on their belief, and then the patient can get the drug at a fairly low cost, regardless of kind of where they are in that spectrum. Got it. Pivoting to your specialty pharmacy network, that's also essentially a key advantage for the company. Could you speak to those advantages as well? Yeah, so we distribute Ohtuvayre through what I would call an exclusive distribution network. All prescriptions go to our hub, which that hub then distributes that prescription to one of our specialty pharmacy partners. Our specialty pharmacy partners include CVS, Acaria, CenterWell, and Direct Rx. Those specialty pharmacy partners then communicate with the patient, help with the adjudication, and more importantly, they spend a lot of time with adherence programs and making sure patients stay on therapy. We understand that COPD patients can be a little bit difficult in the way that they, I would say, consume medicines over the course of the year. Historically, they fill about six scripts over the course of the year. These doctors want the patient to be on this chronically, but patient behavior leads the patient to maybe fill a drug on day 35 or day 45 or day 60 instead of on a regular cadence. Having this specialty pharmacy network not only helps with the initial adjudication of the script and provides the patient with what I would call a white glove service, but also helps long term with adherence refill programs that we believe allows us to have a potential upside on what we've seen historically from a COPD adherence and persistency standpoint in the marketplace. With respect to that, I'm guessing that the patients are opting into communications and direct access. Is that to just the specialty pharmacies, or is it also to Verona? Meaning, is Verona also engaging with the patients? Great question. On that initial referral form, we asked for patient consent. That patient consent allows for opting in from communication from the SP and Verona. When we talk about non-personal promotion and, I guess, non-rep delivered promotion, part of that includes some of our communication to our patients. Our hub can communicate to these patients proactively. It allows us to interact with those patients to encourage them to either stay on medicine or help them understand why they should take a medicine. It gives us a lot of flexibility and, I would say, control over the prescribing process versus a retail distribution network where you're at the mercy of kind of mass retail chains and the patient kind of walking through and potentially getting it or not getting the product. Makes a lot of sense. Let's maybe pivot to potential expansion in bronchiectasis and pivot to that. I also wanted to ask about combination development as well. Yeah, absolutely. We are very pleased, excited about our pipeline. Of course, we have two phase II programs underway. The first one, as you mentioned, is in non-CF bronchiectasis. That study is enrolling 180 patient double-blind placebo-controlled trial, event-driven endpoint on exacerbations. I think that we see a lot of logic of using Ohtuvayre in bronchiectasis. We think there is read-through from COPD into bronchiectasis. As many of you know, the clinical presentation of bronchiectasis is quite similar to COPD, although being a different disease has a lot of the same attributes. The amount of sputum reduction, cough reduction, and symptom improvement, as well as exacerbation reduction that we saw in COPD, we think reads through into bronchiectasis. A real incredible opportunity for us, as you know, to date, no approved therapies. Even with Insmed product progressing and potentially on the market later in 2025, we think there's plenty of room for increasing the patient benefit. We think that at the end of the day, just like in COPD, multiple therapies to treat bronchiectasis will be in play. Different mechanisms to treat inflammation is a good idea in that disease. All of that, I think, has incredible promise, great promise. We are very excited about being able to progress it. Very efficient development program, leveraging the CMC that we had from Ohtuvayre and COPD. A lot of attributes of it are also capital efficient. As you mentioned, we also have a phase II program in our fixed dose combination. This will be glycopyrrolate, a LAMA, in addition to ensifentrine as a nebulized product. First time ever in the States that there's been a combination nebulized product. In many ways, I think as it evolves, will be considered really the new triple. That is dual bronchodilation via glycopyrrolate and ensifentrine, plus a non-steroidal anti-inflammatory via ensifentrine. I think makes a lot of sense, sets up extremely well of how combination therapy is used in COPD. We know from the ENHANCE program that ensifentrine works well with LAMAs. The bronchodilation that you get from them, we have a tremendous amount of data from our clinical trials that we think that that is quite advantageous. I think also by the time the combination product comes out, which we would target the late 2020s, Ohtuvayre is entrenched in the treatment paradigm. Having the ability then to utilize the combination therapy, I think will be incredibly convenient, as well as much more of a cornerstone of earlier treatment in treating patients before ICS is used, for example, especially as its use, as I guess, gets entrenched in the treatment paradigm. We are very excited about that layering on that opportunity as the market matures. Excellent. Could you just frame the potential timing for top-line results from each of those phase II trials? Yep. No, great question. I think for bronchiectasis, we're enrolling, we're at more of the front end of enrollment. We'll keep everyone updated. I'd like to see us get more of that midway through enrollment before we start setting more targeted timelines. I think at this point, and we'll continue to update you, as I would anticipate later in 2026 or early 2027, but I think we need to see where we are in enrollment by the end of 2025. Some of the timing around it, keep in mind, it's an event-driven endpoint on exacerbations. That is a minimal six-month endpoint to start with. There is a duration to the endpoint that has to be accommodated in those timelines as well. With regard to the fixed dose combination, we are progressing. We mentioned we completed some dose ranging work with glycopyrrolate as a nebulized product. We completed that, setting us up very nicely to initiate the next phase II trial, which is a dose ranging study of glycopyrrolate with ensifentrine. We expect that to start in the second half of 2025. Probably takes around nine months or so to get through that trial. Of course, we'll keep everyone updated. That would be in the latter part of 2026 as well. Excellent. That's very helpful. Thank you. Just to follow on, what are the efficacy bars that you would sort of anticipate or set for those trials? Yes. I think as phase II work, that sort of sets us up for seeing what is the treatment effect, what are we seeing. I think in bronchiectasis, plenty of room to work with. The profile of ensifentrine with symptom improvement, lung function improvement, exacerbation reduction, all of that profile, we want to see the magnitude of effect in bronchiectasis. As you know, the Insmed product reduced exacerbation rate around 20%. We still think there's plenty of room to work with, just like in COPD in reducing exacerbations. As many of you know, in COPD, ensifentrine reduced exacerbations by about 40%. We do not have a set bar, but I think there's plenty of room to work with. We're very interested also in how patients feel on ensifentrine with bronchiectasis, something that I think is also an attribute of ensifentrine is patients feel better. We want to see how that reads through in bronchiectasis. With regard to the combination product, I think it's a bit of a different concept. Physicians are very familiar with glycopyrrolate. They know what it can do and how it can work. Ensifentrine as well, as that product comes to market, they'll be very clear about how it works individually and what impact it can have on patient care. I think that becomes much more of a convenient standard of care and ability to use both products together very efficiently for the patients. Their benefits will be well understood by that time. I think that program merely is a classic combination program where you just demonstrate that the combination product has a benefit around lung function that's greater than either individual component. I think we're set up to prove that as well. Excellent. Just thinking out to the market potential, and obviously it depends on their product profiles. If their product profiles are what you're hoping for and one were to look out to 2035 and think of a pie chart, let's say there's $100 in revenue that Verona's booking, how would you slice the pie between Ohtuvayre and those two additional opportunities? Yeah, good question. A little difficult to answer at this point without having the exact profile understood, as you've alluded to. In general, I think incremental for sure, notably incremental, probably. Ohtuvayre in COPD still, I think, is a cornerstone of how we view the opportunity. Bronchiectasis is a large market, 500,000 patients, as I mentioned, really no standard of care that is in to treat that disease. I think that it is definitely a substantial opportunity and very meaningful. That is why we're doing it. I think the fixed dose combination is, again, an expansion in how therapies are utilized. At that time, keep in mind, it'll be a bit of a convenience play where probably Ohtuvayre is being used with a LAMA frequently. All of those patients then can be converted, as well as our view of it is much earlier in the treatment paradigm. It is an expansion and constant broadening use of Ohtuvayre and setting up in a more directed way of what we would view the standard of care at that time. Again, expansion, incremental, and does many other things. It extends the IP into the 2040s. Our view is it resets the IRA clock based on a new product. There are other attributes of that program that make a lot of sense. That's very helpful context. Thank you. Then moving back to the near term, what metrics are you most focused on internally over the course of 2025 as you continue to assess Ohtuvayre's adoption and implications for longer-term commercial success? Yeah, I think we've talked about a few of them already in the first few press releases that we've had. They include, I think, writers is an extraordinarily important metric to continue to watch. The writer penetration, total writers, new writers, that's a book of business that will not go away. As we continue to grow that through 2025 and into 2026, it provides a foundation for the future of Ohtuvayre. The other thing that I think is really important if we take on writers is the productivity of those writers. As they become more and more used to the profile of the drug, they see the benefit of the drug. Seeing that productivity of writing increase is something that I think we continue to track. Again, we disclosed a little bit of that in the Q1 earnings release with the over 275 doctors that have written over 20 patients in their practice. Another important thing that we haven't mentioned is the refill or persistency. We kind of talked about this because if we think about long term, this business eventually becomes a refill business because these patients fill drug between six, seven, eight months. Tracking the refills and the persistency of our patients is going to be very critical. We have always believed that Ohtuvayre and the way we distribute the product, not only the profile of the product, but also the distribution of the product, that there was an upside on persistency with long term. We still need a full year of data to be able to really give a good view of what the persistency will be. I would say early on, we're very encouraged by what we're seeing from a persistency standpoint. Those are probably the three things that we would talk about. You're talking to writers, how much are they writing, and then the overall refill persistency that we see in our patients on long term. Excellent. Let me pause there to see if there are any questions from the audience. All righty. Could we just pivot to how you're engaging with the European regulatory agencies and where that dialogue stands and what the key questions are that are outstanding? Yeah, no, excellent. As we mentioned in our last press release, we have started that engagement of both the EMA as well as the U.K. regulatory authorities. This is a very structured, controlled process where you submit that request, your intent is to make a submission, it happens. We then, depending on either one of them, of course, in Europe, we meet with the rapporteur, which has to be assigned. We review the data, the package, and our intent to submit. We get their view on the package and work through that. Clearly, core questions that are part of that, of every time you interact with them, is if that data is acceptable for a submission and is aligned with an approval concept. We are going to learn a lot about that. As you know, in Europe, they have sometimes different standards of how they view efficacy. Active comparators are highly sought out in their type of trials. With regard to the enhanced trials, it was placebo controlled, but it also had some level of active comparator in the placebo group, that being that patients could have been on a LAMA and about 20% of them were on essentially a LAMA ICS. I think we have elements of comparison to active therapy. All of that will be part of the dialogue. We are extremely confident in the benefit to risk of Ohtuvayre. Clearly, that'll be the cornerstone of our engagement with them and, of course, the novel mechanism and its overall safety and efficacy profile. A lot of that'll happen. I think we will be much more informed on the agency's thought about that in Europe through mid-2025. I look forward to keeping everybody updated on that. Excellent. We are out of time, but that was a great discussion. Thanks so much for being here with us.