All right, starting. All right. Good morning, everyone. I'm Tara Bancroft, one of the senior analysts here at TD Cowen, and thank you very much for joining us for TD Cowen's 45th Annual Healthcare Conference. So for this next session, we have Verona Pharma here, and with us, we have Verona's President and CEO, David Zaccardelli, Mark Hahn, the company's CFO, and Chris Martin, the CCO. It's a privilege to have you all here, and thank you so much for joining us. So I guess to start out, either David, Chris, or Mark, could you give us a brief overview and any general updates, maybe even key takeaways from your earnings report last week? Right. So thanks very much for having us, and happy to give you an overview. I think, of course, our fourth quarter earnings focused on a number of topics. Of course, the launch of Ohtuvayre, which, as we reviewed, is going remarkably well. Really the strongest launch in COPD ever, and has really been demonstrating how much unmet need and actually the clinical profile of Ohtuvayre and how that's playing out in this early stage of launch. So we're very pleased with that, and of course, we gave a number of metrics around that with regard to the growth that happened in January and February, even exceeding the Q4. So we're very pleased with the launch. We also talked about progress of our phase II programs, both in non-CF bronchiectasis, which we're very excited about, and glad to be enrolling in that phase II 180-patient trial. We also talked about our progress on our combination ensifentrine plus glycopyrrolate nebulized product for COPD, which is our extension of Ohtuvayre as we see it over the coming years, where combining LAMA with glycopyrrolate and ensifentrine are going to be another foundational treatment for COPD as Ohtuvayre matures. Very happy with the progress of the company commercially and also from development. Okay, great. And yeah, as you said, I mean, you guys have had a fantastic first partial year. I guess next, it would be helpful to more qualitatively understand KOL feedback that you guys have been getting, promotional efforts on the team that are and are not working, to maybe try and see where you guys are focusing the most in 2025. Yeah, great question. I think as we think about what we learned going into launch, as Dave mentioned, we had a significant unmet need that existed in the market. Over half of COPD patients are symptomatic with persistent symptoms like dyspnea, decreased activities, and potentially exacerbations. So the introduction of a drug like Ohtuvayre that provided bronchodilation and nonsteroidal anti-inflammatory was very important to the KOL and physician community. What we've heard early on from physicians is tremendous feedback. I think what they've played back to us is what we heard in market research. And to be fair, I've done market research my whole career. Sometimes you go into a launch and it doesn't match what your reps are hearing in the field. But it's matching or exceeding what we heard in that early stages of market research. And what the doctors are playing back to us is we have a significant unmet need. We have patients with persistent symptoms that are dealing with a progressive disease that doesn't stop. It doesn't go away. So at some point in time, we're going to have to add other therapies to these patients to help improve their lung function, help improve symptoms, and potentially reduce exacerbation. So they played back to us in these first nominally two quarters the same things that we heard in that market research. What have we learned in the first six months? We've learned that our message is compelling. Our message is simple. We don't have to tell the doctors a lot. We have to tell them that we have a novel MOA that provides bronchodilation and nonsteroidal anti-inflammatory effects, and we have to tell them the safety profile and some of the data regarding lung function and symptom improvement. When you tell them that simple story, they're very quick to adopt on patients that come into their practice with persistent symptoms. More than likely, the number one driver is dyspnea, so that's a trouble breathing, and so they add Ohtuvayre to those patients. So we've learned our message is very good. The other thing that we've learned is that doctors are creatures of habit. It takes promotion to call on these doctors and get them to move. And so what we've seen is repetition and consistent interactions with our physicians helps, one, create a new writer, and then move a new writer from being what I would call a new writer to a believer. That's someone that we mentioned in the press release that's writing over 20 prescriptions within their practice. It takes frequency. And then the other thing we've learned is that doctors like patient feedback. So they want to hear how their patients are doing. So over the course of the last few months, we've worked on ways to teach our reps and also provide materials to our reps so that they can encourage and elicit feedback back from the patients so the doctor can get feedback back on the patients they put on Ohtuvayre. Remember, many doctors may see a patient every two to three months, so we want to close that gap of time that they potentially don't get feedback from a patient that's going on Ohtuvayre. I think those are the main learnings. I mean, there hasn't been anything that has surprised us. I think we've been very pleasantly excited about how consistent our early market, all our market research was with the execution we're seeing from the field today. Okay. And as far as prescribers that you're engaging, I know on the Q4 call, you said that you're currently at 45% of Tier 1 prescribers. So do you have a goal for where you want that to go this year, not just in Tier 1, but other tiers as well? Yeah, we've updated that slightly even on the call last week. We're up to 55% on Tier 1s in that short in an extra two-month period. We added another 10% there, added another about 1,000 writers in that two-month period as well. I think if we think about where we stand today, the number of writers we have is incredible. If we look at historical COPD products, Trelegy has about 16,000 physicians in year eight that do 80% of their business. And to think that in two quarters, you've gotten 4,600 plus writers is an incredible feat. Our focus for our reps is adding new writers today and increasing the depth of prescribing. So our expectation over the course of 2025 is that we will continue to increase the writers, both in a Tier 1 standpoint, but also Tier 2. From a penetration standpoint, we haven't given any true guidance on we want to be 80%-90%. But one of the things that I can say is that we've done market research across users and non-users, and what we see consistently is their reaction, even if they haven't written today, their reaction to the Ohtuvayre profile is consistent with someone that's writing. They are just someone that, again, we're two months into a launch, so they're just someone that hasn't put pen to paper today. What they have told us in this research is that they plan to write at very similar rates to the current writers over the next six to 12 months. That gives us great confidence on the future trajectory of the launch as we move through 2025. For the ones that plan to write and haven't yet, what is the difference between the ones that have and have not yet? What dictates an early versus later adopter? There's a couple of things. Some is attitudinal. There are some people that are just like human nature. Some of us, we're the last to adopt an iPhone. There are some doctors that are just slower to adopt new technologies. The second is just frequency. We know that frequency with these physicians matters to get them to start writing. One would suspect that you call in a doctor once and they automatically start writing. Well, human behavior doesn't dictate that all the time. So sometimes these offices are a little bit more closed from an access standpoint, and we haven't had the ability to get in there as many times as we want. But that's where our digital promotion is important because it allows us to supplement and kind of push the doctor down a pathway. We use digital promotion to actually give our reps future calls on doctors. So if a doctor's interacting with us in a digital setting in a high rate, we can trigger that to a rep to say he's receptive to our interaction today. And it will help us be more efficient even on that rep interaction. So I think it really comes back to their overall attitudes on human behavior more so than the product of anything else. Okay. Yeah, that makes sense. So while we're still on the topic of prescribers, can you? Actually this is a slightly different question, but what goes into the decision for a prescriber to give either Ohtuvayre or DUPIXENT? I think very different patient populations. When we talk to physicians today, Ohtuvayre is thought of as a mainstay. I can add this to any patient that walks into my practice. Anybody that has persistent symptoms, I have a drug that provides bronchodilation and anti-inflammatory effects, nonsteroidal anti-inflammatory effects. When we talk to physicians about DUPIXENT, they place them in a very small category of high Eos, significant number of exacerbations, and think of it more of an ancillary role than what Ohtuvayre provides. I think we get questions about DUPIXENT all the time, and it's great for COPD to have two new drugs launching because we haven't had anything in 20 years. But there's a big difference between the two. One is the biggest difference is that all these patients complain about dyspnea. They all complain about the ability to breathe, and Ohtuvayre is an acute bronchodilator. It will always be able to improve lung function and help these patients breathe a little bit better. That's something that in a situation when a patient is in front of a doctor, they're always looking for. It's very different than what DUPIXENT will provide a patient long term. I'll just sort of extend it with regard to all biologics that are DUPIXENT being on the market, but other biologics that are addressing inflammation from other mechanisms I think are all complementary to Ohtuvayre. As Chris mentioned, the biologics addressing inflammation I think is a good thing. I think addressing inflammation from multiple mechanisms is a positive in COPD. I think Ohtuvayre as a PDE3, PDE4 inhibitor, being a bronchodilator and an anti-inflammatory, is highly complementary to any of the biologics that we see in development as well. Okay. And then I guess to follow up on that, can you tell us more about the types of patients that are being treated now? And are there a type of patients that are going to be harder to get into, or is this really just a numbers game and getting more prescriptions? I think, I mean, right now, what we're seeing is let's start with what is the initial hook for a doctor. It's about persistent symptoms. So our reps talk about persistent symptoms regardless of background therapy. And that's how you would treat because that's a moment in time where a doctor we know is making a treatment change because they're worried about persistent symptoms leading to something else. So then when this patient's prescribed with persistent symptoms, what does background look like? Today, about half our patients are on background triple. And then the other half are on other therapies. So that could be single bronchodilator. It could be LABA/ ICS or dual bronchodilators. Additionally, we have patients where we're the only long-acting bronchodilator. One of the things that we've been very pleased about is that split early on. I think the hypothesis was that all your patients early on would be on background triple or vast majority. But seeing a 50/50 split in the first two quarters really is showing that the doctors have this hope to be able to use Ohtuvayre earlier in the treatment paradigm and use ICS in a place where it's potentially more appropriate than it is today. We also see this in our doctors that are writing over 20 prescriptions. As they become a frequent or a believer, their use changes. Their use changes from starting in triple to earlier lines of therapy. So I think what we'll see over the course of the next year into 2026, into 2027, is more and more patients, your split will move to more of the non-triple patients, which shows the utility not only of the Ohtuvayre, but also the utility of what the combination product could provide in the future as well because you've essentially given the doctor a nonsteroidal triple in that combination product as well. Would you say that over time would be you expect that shift to maybe even start occurring this year? I think toward the end of the year, you can see that shift happening. I still think it's a 20 because you still need real-world evidence. You need experience. But there's enough mounting to see that happening over time, and the back half of 2026, you can see a little bit of shift, but it's more 2020 excuse me, 2025, 2026, 2027. Yeah, and how about earlier line patients? Pre-ICS, is that something that could happen sooner rather than later? I mean, it's happening today. We have patients on single LAMAs. We have LAMA+LABA that are getting added to Ohtuvayre where they're forgoing putting an ICS on these patients and looking at the profile of Ohtuvayre. That's where I think the future is for the drug is ICS is and I don't blame a physician today. They haven't had many choices, and today, now they have a nonsteroidal anti-inflammatory that allows them to properly put ICS where it says. If you look at the GOLD Report, ICS should be used in a certain group of patients, but broadly, it's not really done today in that manner, so I think long term, that's definitely a place for Ohtuvayre. Yeah, and I think if you look at the ENHANCE trials, that's sort of the foundation of Ohtuvayre is utilizing it prior to ICS. I think the data when you can get symptom improvement, lung function improvement, and exacerbation rate and risk reduction without using an ICS, and that really is what comes out of the ENHANCE trials. As Chris mentioned, that's why it's going to be used prior to ICS as it gets entrenched in the treatment paradigm. And that's why we speak about how it's going to change the paradigm and redefine the treatment paradigm. Okay, and let's talk about diving a little bit more into 2025 outlook. So without providing exact guidance, could you give us a better idea of what you expect for cadence throughout this year? Do you expect growth to be more linear, exponential, or what? I think we're still quite early in the phase. I think we're incredibly encouraged by the uptake. We've talked about the breadth of prescribers as that breadth starts to create depth. As we continue to add prescribers, I think it's going to be increasing month over month as a general principle. There's plenty of opportunity. You don't run out of patients or there is not a patient bolus. There is a huge patient population and a large unmet medical need which is playing out. We continue to see that growth. I think the dynamic which is starting to take hold now and will continue to really show itself through 2025, and that cadence is the refill concept. We talked about it back in the Q3 and Q4. That is, the percent of refills was starting to gain. That will continue to gain month over month as you'd expect. That stacking of when you're adding patients, and that's going up, plus you start the refill and the refill stacking. So if we've added more patients in the last few months, now if you look out two to four months, all of those patients start stacking on all the patients previously on a refill basis. And that's really where when you look at the growth of the underlying reason. While new patients are critically important, don't get me wrong, is the persistency and the refill that's leading to that growth. Okay, and then I guess more specifically, for 2025, correct me if I'm wrong, but consensus is just under $300 million. I think it's around $270 million. How comfortable are you with that number, being able to achieve that this year? Yeah. So we're not giving any guidance particularly, but we understand what it is and let's just say we don't object. Okay. So you think you could do better than that? We don't object. Other than refills, I guess what metrics should we be looking at throughout the year as you report your different earnings calls? Yeah, great question. We try to be transparent, tell the story, explain through the numbers how the launch is developing. And I think you'll see that continue to evolve over the course of the year. We've given a lot of information on prescriptions and prescribers. We've touched a little bit on refill rates. So I think you'll see more about that in the future. And we'll continue to talk about prescriptions and prescribers. I think we'll get more to a normal quarterly cadence. We've been giving some interim looks at the quarters. But I think going forward, we'll get to more of just a pure quarterly cadence over time. I see. And what would be the best leading indicator for each quarter to look at? Yeah, very close. I think it does become a refill business over time, right? So I think that'll be an important thing to look at. Yeah. What percent would you say would be a good split between refills and new patients? Oh, it's at steady state. Let's just take Trelegy today. 90% of their business is refills or more of existing patients. I would say that this is still the first full year of launch. So we've got to add more new patients. And as Dave said, there's millions of patients sitting out there that need therapy. So I think new patients is a big focus, but the refills just continue to stack on the back end. Okay. So then I guess let's talk about the eventual market a little bit. What are your expectations for what penetration of the market that this could actually achieve? That's a good question. And we ask that frequently. I think one of the ways we've addressed it is that when we look back at the profile of Ohtuvayre and you look at the unmet need and the competitive landscape and anything else you'd want to factor into that thinking, we ask ourselves, well, I've never heard anyone articulate why it couldn't achieve five percent of the market penetration, eight percent, 10%. And these aren't necessarily large expectations. It's not like we're saying you need 80% of the market in order to be a blockbuster drug. So as we've articulated, every one percent market penetration is, well, it's over $1 billion of revenue. So I think it has incredible potential. And that's just in the U.S., not the rest of the world. As you know, our partner in China has data coming out mid-2025. And so there's great opportunity there as we go forward, our partnering strategy outside the U.S., our other indications. And so the opportunity for Ohtuvayre is very substantial. And even in, of course, if you just look at it in the U.S., by definition on that is many billions of dollars of revenue. Yeah. You said you don't need to achieve something like 80% market penetration to be a blockbuster drug. Can you give us an idea of the drugs that are blockbusters already? What percent penetration are they getting? What's a good comp to look at here? I mean, if you look at the data that Dave just talked about, the number one share in the marketplace in COPD is Symbicort right now. It has 22% of the market. Trelegy has about 12% of the market. So if you think about what Ohtuvayre's profile is, Symbicort's a LABA/ ICS, Trelegy's a triple. We look like those products except we're providing a different MOA that provides bronchodilation and nonsteroidals. So I will say that finding a comp in COPD is hard because everything up until this point has been the same type of drugs. They've been recycled, reformulated, LAMA/ LABA/ ICS. So I think what Ohtuvayre is bringing to the market is something they haven't seen in such a long time that it kind of throws all conventional comps out of the window. But the nice thing is one of the nicest things for our reps is they don't have to walk in and tell a doctor to stop doing something. They walk in and tell a doctor that they understand their situation. They understand they're faced with patients that are struggling, and we have something to help. We don't ask them to stop doing something. We ask them to add something that can provide an additional benefit. That is a very good place from a launch standpoint to walk in versus other launches I've been involved in where they're like, "You got to stop doing X to do Y." And that causes friction. We're walking in in a fairly frictionless place with these conversations. Yes. Any pushback on pricing? Yeah. The question was, "Is there any pushback on pricing? Great question. I think when we priced Ohtuvayre, we priced it to the value that we felt like was appropriate for the molecule. We had pricing models that showed a price significantly higher than where Ohtuvayre is today. I think one of the things that we also factored into is what would the out-of-pocket cost be for patients? Because WAC price doesn't matter if your out-of-pocket cost is high or low. You can have a low WAC with a high out-of-pocket cost. What we see today is about 80% of our patients who pay less than $10. So I think that plays to what we believe the managed care dynamics are and that the pricing still allows our patients to get at a very affordable cost. We don't have any pushbacks from payers on the pricing. We haven't had any pushbacks from patients. I mean, you have your normal out-of-pocket copay issues, but that's no different from any brand that's launching or going through the dynamics today. What's our average sale? Our WAC price is $29.50 a month. If there are no more questions on the Ohtuvayre launch, I mean, I guess we can ask for ex-U.S. updates very briefly because I do want to get to BE and the maintenance combo. Yeah, ex-U.S. I mean, our strategy is still to partner outside the U.S. like we talked about. I've mentioned a bit about the progress in China with Nuance Pharma, our partner there. We did mention in the press release that we are progressing regulatory interaction discussions with both the EMA and the U.K. That will, I think, also be helpful in defining our partnering conversations in Europe. So very active in 2025 on that front. Okay. Great, so I want to spend the last few minutes. Can you talk about expectations and timing of both the BE and the maintenance combo data? Yeah. So, in bronchiectasis, introductory remarks, we are enrolling in a phase II trial, 180-patient blinded placebo-controlled trial, exacerbation event-driven endpoint. At this time, while we need to get enrollment more progressed, and I think we can be better as to tell you exactly when it would read out, but I would generally set your expectations of a readout in later 2026 or early 2027, and we'll keep everyone updated on our progress on a quarterly basis. The combination product, great progress. We had to complete some ensifentrine dose ranging work, which we did successfully to give us the information on what doses to move forward in an ensifentrine plus glycopyrrolate dose ranging study. That'll start in the second half of 2025. Again, that will give us great insight as to the dose to choose for the follow-on study, as well as making sure we understand the effect size and differentiation of the combo product with each individual component. All of this is underpinned by a lot of insight from our ENHANCE trials, which we understand how ensifentrine worked with LAMA. Okay. Thank you, so I guess I just have one more question that we can have you guys all expand upon in the last two minutes, but what do you feel is the most underappreciated aspect of Verona? I mean, I think we've talked a lot about it today. I don't know if it's underappreciated. It's starting to be actually appreciated. I've been now describing, I think Ohtuvayre is showing itself to be a great drug. And that encompasses a lot of attributes. It's a very simple phrase, but when you have an efficacy profile improving lung function, symptoms, exacerbation rate reduction, you get its safety and tolerability, which is so important clinically and for physicians when drugs are well tolerated and have no safety concerns. And you don't have to navigate subsets of patient populations and a lot of follow-up and laboratory following and all of that. So what I would say is like a relatively easy drug to administer from a technical perspective. And you have that going for you in this patient population. That is what's starting to show itself. And I think what's going to become more appreciated is the profile of Ohtuvayre is very good. And again, what I would classify as a great drug. I mean, the only thing else, I think early on, people probably asked if a company like Verona could launch a drug like this into a broad space. I think we've proven in the first two quarters that we're more than capable of launching this very effectively and be able to reach the full potential of the drug. The team, with the support of everybody here, has been able to do all the right work before launch so that we're in a position to really capitalize on it early on. Yeah. Question from the audience. Go ahead, mister y eah. Can you expand on the patent estate that comes with the product, particularly when you see patents expiring? The question was to talk about patents and expiry. Yeah. Your ability to get patents and extension. Yes. So we have core patents that are a polymorph patent and a formulation patent. And I would say we're very comfortable with those two patents through the mid-2030s, say 2035. We also have additional IP being filed and expect to be Orange Book listed. And those go into the 2040s. And so I think that however you want to look at it, we're in and we challenge ourselves routinely on our IP portfolio is that we're comfortable with it in through that 2035 - 2040s range. Okay. With that, we thank you to the entire Verona team and everyone for listening.