Verona Pharma plc

Verona Pharma issued a press release announcing its financial results for the three months ended March 31st, 2025. A copy can be found in the investor relations tab on the corporate website, www.veronapharma.com. Before we begin, I'd like to remind you that during today's call, statements about the company's future expectations, plans and prospects are forward-looking statements. These forward-looking statements are based on the management's current expectations These statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements. Any such forward-looking statements represent management's estimates as of the date of this conference call. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so. even if subsequent events cause its views to change. As a reminder, this call is being recorded and will remain available for 90 days. I'd now like to turn the call over to Dr. David Zaccadadi, Chief Executive Officer.

Thank you, and welcome, everyone, to today's call. With me today are Mark Hahn, our Chief Financial Officer, Dr. Kathy Rickard, our Chief Medical Officer, Chris Martin, our Chief Commercial Officer, and Dr. Tara Rowe, our Chief Development Officer. The first quarter of 2025 was phenomenal for Verona Pharma as we continue to drive the highly successful US launch of O2Ver for the maintenance treatment of COPD, as well as advance our clinical development programs and global regulatory strategy. I am incredibly pleased to report for the first time Verona's quarterly revenue exceeded our quarterly operating expenses excluding non-cash charges. First, let's review the ongoing launch of O2Ver, which continues to accelerate quarter over quarter. The remarkable uptake of O2Ver, which is the first inhaled product with a novel mechanism of action to treat COPD in more than 20 years, underscores the unmet need of patients with COPD. Its rapid adoption is grounded in O2VAIR's broad indication for the maintenance treatment of COPD and its compelling benefit to risk profile. In the first quarter of 2025, which is only the second full quarter of commercial availability, we almost doubled sales of O2VAIR compared to the fourth quarter of 2024, recording $71.3 million in net product sales with continued month-over-month growth. The launch is demonstrating success across every measure. Prescriptions increased to approximately 25,000 filled during the first quarter. New patient starts grew over 25% compared to Q4 2024, and refills represented 60% of all dispenses during the first quarter. Total prescribers grew about 50% relative to Q4, to approximately 5,300, of which 60% are Varonis Tier 1 HCPs. Prescriber depth is also increasing, with over 425 HCPs prescribing O2-Ver to 20 patients or more. This dramatic early adoption reinforces our belief that O2-Ver is the most successful COPD launch and is tracking to become what we consider a blockbuster product. HCPs continue to prescribe O2-VER to a wide spectrum of their COPD patients, including patients on background single, dual, and approximately 50% on triple therapy. This broad application across diverse patient types highlights our confidence that O2-VER's novel bronchodilator and non-steroidal anti-inflammatory activity has the potential to redefine the standard of care in COPD treatments. We continue to receive meaningful and extremely encouraging feedback from patients and HCPs regarding the impact of O2Vir, which is reflected in our growing refill and persistency data. With our launch momentum, we are planning to expand our field sales team to around 30 representatives to about 120 total in the third quarter. We believe this expanded field presence will enable us to further support accelerating the launch. As part of our ongoing strategic work to solidify the long-term success of O2VAIR, a new orange book listed patent has been granted with an expiration date in 2044, giving us a total of four orange book listed patents. In parallel with our successful launch of O2-VeR, we continue to advance our pipeline with two Phase II clinical programs. We plan to initiate a dose-ranging Phase IIb trial in the second half of this year, evaluating a fixed-dose combination of Ncfentrin with glycopyrrolate compared to the individual components. In addition, enrollment is ongoing in our Phase II clinical trial of nebulized Ncfentrin in non-CF bronchiectasis. The study will assess the effect of Ncfentrin, three milligrams, twice daily on the rate and risk of pulmonary exacerbations, symptoms, and quality of life. Turning to our global strategy, in February, Nuance Pharma, our development partner for Ncfentrin in Greater China, announced O2vera was approved in Macau for the maintenance treatment of COPD in adults. This is the first regulatory approval of O2Vir outside the US. In addition, Nuance Pharma is expected to report results from its pivotal phase three trial evaluating antifungal for the maintenance treatment of COPD in China in the second quarter. Finally, we continue to advance regulatory activities for potential marketing authorization application submissions for O2Vir for the maintenance treatment of COPD in the European Union and in the UK. We look forward to keeping you updated on this progress. I will now turn the call over to Mark to review our financial results for the quarter.

Good morning. Our full financial results can be found in the press release issued this morning with additional details in the Form 10Q also filed today. I'll walk through the financial results for the first quarter of 2025 and review our recent strategic financing. As Dave described, in the first quarter, we recorded $71.3 million in O2Var net sales. With the achievement of a $5 million clinical milestone from Nuance Pharma, total net revenue for the first quarter was $76.3 million. And in line with prior quarters, our specialty pharmacy partners continue to maintain inventory at their contracted levels of two to three weeks. Cost of O2Vir sales was $3.4 million for the quarter ending March 31, 2025, in line with the level of net sales of O2Vir. Research and development expenses were $14.1 million for the first quarter, reflecting increases in share-based compensation and clinical trial and development costs related to our two Phase II studies. Selling, general, and administrative expenses were $69.1 million in the first quarter, reflecting increases in share-based compensation and the hiring of our field-based sales team, marketing, and other commercialization expenses related to the launch of O2 there. In total, our operating expenses for the first quarter were $86.6 million, resulting in an operating loss of $10.3 million and a net loss after tax of $16.3 million for the period. Excluding the $36.8 million in share-based compensation recorded in Q1, on an adjusted basis, we had an adjusted net income for the quarter of $20.5 million. You can find the gap to non-gap reconciliation for adjusted net income on the last page of today's press release. Finally, our balance sheet remains strong with $401.4 million in cash and equivalents as of March 31, 2025, compared to $399.8 million as of December 31, 2024. In addition, in March of this year, we amended our strategic financing arrangement with Oaktree and OMERS, repurchasing the previously existing $100 million obligation under the RPSA, and increasing the existing debt facility to $450 million on more favorable terms. With this amendment, we have increased our financial flexibility, reduced the cost of capital, and simplified the balance sheet, leaving us in a strong financial position. As a result of this amendment, at March 31, 2025, the company had $250 million outstanding under the Oak Tree and Omer's facility and $200 million available in potential future draws. With our cash and equivalent and up to $200 million of additional potential draws under the debt facility, we feel very confident in our ability to fund the ongoing U.S. launch of O2Vera as well as our development programs. Given the success of the O2VAIR launch, it is our intention to use future draws on the deck facility primarily to support the in-license or acquisition of products as needed. With that, I'll now turn the call back over to the operator for the Q&A.

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. We'll take our first question from Andrew Tsai at Jefferies.

Hey, good morning. Congrats on another great quarter. Thanks for taking my questions. I have two this morning. So first is as we exit Q1 and enter Q2, can you talk about the trends that you're seeing? Can you share any color or characterize how healthy these metrics are looking in April so far and how might they look in May and June? Thanks.

Good morning, Andrew. Thanks for the question. You know, I think that first I want to just sort of level set that, make sure that we are, you know, updating on Q1 and not providing, you know, projections of Q2 and beyond. With that said, As we've indicated previously, the launch is going extremely well, as we talked about this morning. The adoption is very high. We are expanding on every metric, including overall prescriptions, new prescribers, new patients, refills, and very encouraged by persistency. um there every expectation that the launch um well as a reminder is so early uh and at the same time has such great traction um we believe that um of course that continues uh as it should right um and then as it relates to my second part which is a bigger picture you know q1 my understanding saw some seasonality the typical industry phenomenon

which, based on my understanding, affected the pace of uptake, not necessarily growth to net. And so that should not play out going forward this year. And I think refills will continue on as well. So I guess the second part of my question is, do you think sales could inflect even faster in Q2, Q3, Q4? Just trying to envision or gauge how you're envisioning the sales curve to look, whether it's more parabolic or linear from here. Thank you.

Yeah, I think that, again, early on, but extremely encouraged, as you know how the launch curve will start to take shape chronically as a refill business as more and more patients come on and persistency occurs over the years. You know, we're very encouraged by the new patient ads, which builds the foundation. That'll be a continued focus, of course, for us. When you have the expanding prescriber base, as we talked about, over 5,300 prescribers, that's a tremendous base of additional prescriptions, additional new patients. And as I mentioned, we're very encouraged by the growth in the refill rates. and the persistency overall. So, you know, shape of the curve remains. I would say that we are extremely encouraged and confident on the growth trajectory. And in many ways, as you know, there are millions of patients who remain symptomatic on current standard of care. And so, while the growth is phenomenal, there is a lot to go. And we've barely just started.

Great. Thank you again and congrats.

We'll go next to Yasmeen Rahimi at Piper Sandler.

Good morning team and congrats for an outstanding quarter. I guess kind of like going along with Andrew's questions that he started off as within that theme, I think, I mean, it's pretty remarkable. You've doubled from 4Q to 1Q. There's a big TAM. This is a really safe and effective drug. I guess just to be like, why couldn't you continue seeing such a rapid growth? Like, guess what I'm trying to figure out is what is the difference between 2Q and 1Q? And we know 1Q had the seasonality aspect. Like, I guess what I'm trying to figure out is before you put up this number, the consensus, I think the run rate for this year was around 300 to 350. That was the range. But now with this 71 million on hand, you would basically project this to be substantially higher. So if you could just kind of help us understand sort of with this really remarkable one queue, what the run rate could look like, that would be really helpful. And then if you could comment on what the growth to net is now and how it will change going into the year, that would be helpful. And I'll jump back into the queue.

Great. Thanks, Yaz. Good morning. So maybe we'll start in reverse on gross to net. And I know Mark can provide some guidance on that.

Yep. Yep. Good morning, Yaz. So one of the things that we've talked about over time is that we saw the opportunity for the gross to net to improve over time. And it has. It's continued to decrease. And in Q1, I'd characterize it as well below 20% as we exited the quarter.

And so I think in addition to the growth that we expect through 2025, I think some of the concepts that you mentioned are correct. You know, clearly we saw as the whole industry sees a level of blunting that happens early on in Q1, which as you can see, you know, prescriptions have been written through that, albeit we noticed it as well as I'm sure everyone did as deductibles are reset, copays are reset, things like that. But with that said, you know, we see tremendous growth as we've seen already. I think we continue to focus on the important aspects, as I mentioned already, that is growing the prescriber base. growing new prescriptions, being attentive, of course, to the refill dynamics that occur. And as you look at it, it becomes very much a stacking phenomenon as the weeks and months and quarters unfold. And all of that, of course, is continued to build on the base. We have Richard Schauffler, M.D.: : mentioned well grown substantially over just two full quarters still plenty of room to go in having. Richard Schauffler, M.D.: : A huge opportunity in new patients so yeah I think that the growth is substantial we expect it to be continued to be substantial and and we're just such early on in the process there's there's plenty of room to go.

Thank you.

Congrats again.

Thanks.

Our next question comes from Olivia Breyer at Cantor Fitzgerald.

Hi, good morning. Congrats on the quarter and thank you guys for the questions. Maybe just following up on gross to net quickly. It's obviously trending much better than that 25% discount that you guys have previously talked about. So maybe just any thoughts on where you think that could ultimately shake out. And then on hitting operating cash flow positive this quarter, is that something you think you can maintain going forward? And just any thoughts on the kind of earnings power that you could start to have, especially as we think about 2026 and beyond? Thank you, guys.

Sure. Good morning, Olivia. So first, on the course of that, I think we've talked about this in the past, that while we started at launch, we said we thought it could be in the 25% range where we thought it could actually work out to be much lower. And then in Q3, we talked about it being below 25%. Now, well below 20%. I think we're getting to a point of stabilizing. There may be a little bit of room for improvement yet, but not a dramatic amount. As far as the cash flow break even, And to be technical from an accounting and financial reporting perspective, as I think my job is, we were not a cash flow break even from operations because of the accounts receivable bill. We were, however, at a run rate of revenue that exceeds cash expenses. And yeah, I think as we continue to grow and execute on sales, I do think that we will be able to continue that pace going forward. And I think we've talked many times about the long-term profitability of the business. I think that as sales continue to grow, the expenses will only grow so much over time. There's a relatively tight sales force and relatively, I'd say, a lean commercial spend against it as well.

Great. Thanks, guys. Congrats on the great quarter.

Thanks.

Thank you.

We'll go next to Tara Bancroft at TD Cowan. Hi, good morning. Thanks for taking the questions and congrats on the fantastic quarter. So I was hoping if you could provide any more color on the refill rate for patients who initiated O2-vair treatment six or more months ago. Like what are the rate of refills per year also that you're expecting at steady state? Basically any color you could provide on how you expect this to evolve would be really helpful. Thanks.

Sure. Good morning, Tara. Yeah. Maybe, Chris, you can provide some color on what we're seeing in refill rates and persistency. Yeah.

Thanks, Dave, and thanks, Tara. You know, the thing that, as Dave mentioned, we've been very encouraged by the way the persistency and refill rates have been progressing since launch. Keep in mind, as Dave talked about, we're adding more new patients every single month. The number of patients that could be eligible for five, six refills is smaller than the ends of patients that we have today. But when we look historically at that right now, we are very encouraged at how those refill and persistency rates look. I think we talked about in a previous call that we were starting to see patients have a significant number of refills already in their path on treatment. And we felt like there was a potential for an upside on the overall persistency that we saw with patients. Remember, in COPD, we see patients fill about six times a month or six times a year, excuse me. And over time, we felt like there was a potential upside there based on the product and O2Vir's benefits to provide these patients, but also our distribution channel and the way that we provide a white glove service to these patients. I think early on, there's no reason to believe that this upside doesn't still exist. And again, we're very encouraged by how we're seeing that refill rate kind of progress over time. I think we need a few more months so that we have more ends and a full look back on the totality of a year. But again, very encouraged by what we see early on in these patients.

Okay, great. Yeah, thank you so much. Just briefly, separately, just do you have the option or the interest to repurchase China rights and any kind of description of the size of the China market would be really, really helpful too. Thanks.

Yeah, thanks for the question. You know, I think that there is that opportunity, although It requires certain conditions to be met on other types of transactions that we're making. So I think that at this time, that is not part of any plan or thinking. And we continue to have a very strong collaboration with Nuance Pharma, as we talked about on the call this morning.

Okay. Thank you so much.

Thanks.

We'll move next to Tiago Faust at Wells Fargo.

Great. Let me add my congrats and thanks for taking the questions. Just on the persistent question, when we do our channel checks, the discontinuation rate seems to be very low, so it's fairly anecdotal. But I'm curious if you have any insights from the field in terms of if there are discontinuations, what might be driving that? It doesn't feel like it's safety tolerability or anything like that. It feels a little bit more random, at least when we do those channel checks. So any color there would be helpful. And my second question is more related to long-term competition with biologics. I've been getting a lot of inbounds on how that could potentially impact the opportunity here, especially if you have more upstream mechanisms of action. I'm curious how you guys are seeing the long-term play here. Thank you.

Hi, good morning, Tiago. Thanks for those questions. I'll just start with, you know, a bit of color on discontinuations. I think it's a little early to speak with clarity around discontinuations. As you've mentioned, you know, in your calls with physicians, it can be sporadic and for different reasons. I think also what constitutes a discontinuation is a bit unclear because as we've talked about, patients can be somewhat sporadic in timing on when they refill prescriptions. And so they may, you know, take longer to refill, and yet it's not technically a discontinuation. It's more of how they're going to use O2 very chronically. So I think, again, along with refills, it takes a bit more time to provide some clarity around true discontinuations. As we've talked about in the past, and as you alluded to just now, you know, tolerability is very favorable with O2Vir. That comes, of course, from the clinical trial data and is our general experience in the commercial setting as well. With regard to biologics, you know, I think it's incredibly great for the field for patients with COPD to have different mechanisms approaching or applying to different mechanisms for inflammation. So I think all of that's great. We don't view it as competitive in any way with O2-Ver. In many ways, it can be very complementary. I think approaching inflammation from multiple mechanisms will be a solid approach for the treatment of COPD. And also keep in mind that O2-Ver has bronchodilator and acute bronchodilator effects as part of it. pharmacology and its clinical profile, which the biologics are more focused on inflammation and not bronchodilation. And I still think patients with COPD will require chronic bronchodilation to treat them along with different approaches on anti-inflammation. So I think it's great for the field. I think we're looking forward to it. And I don't think there's any pharmacologic reason that O2-vera could not be used in conjunction with biologics if physicians thought that was appropriate for a patient.

Fair enough. Thank you so much. Thanks.

We'll go next to Tom Scheider at BTIG.

Good morning and congratulations for essentially hitting our 2Q number. I'm doing some reading on bronchiectasis. And as far as I understand it, a fair number of COPD patients also have that diagnosis. Do you know how you do well in those patients or were they excluded? And then a real quick one for either Mark or Chris, are you guys completely outside of the Medicare Part D redesign or is that something you also have to think about?

Great. Good morning, Tom. So maybe the last question first. I don't know, Chris, you want to talk about being outside Part D? And then I think Tara and Kathy can comment on bronchiectasis.

Yeah, Tom, thanks for the question. I appreciate the context. I'm hitting the Q2 consensus number two. I think for Medicare Part D redesign, I think it's an interesting, you know, we are primarily through a medical benefit reimbursement. So 80% of our reimbursement is through medical benefit, either through traditional Part B or through Medicare Advantage. We can see Medicare Part D reimbursement in a long-term care facility or a skilled nursing home facility. But that is such a small percentage that I would say we're not affected by any of this redesign that is going on with purely Med-D products that exist today.

Great. And then touching on the bronchiectasis question as well, you know, we really had few patients with confirmed bronchiectasis by a CT scan in the enhanced program. You know, certainly the reason we're doing that program is because we think the mechanisms that help improve COPD in patients with COPD are also applicable to patients with bronchiectasis. And it's the, you know, anti-inflammatory mechanism targeting neutrophilic inflammation and also the effects on cough and sputum that we saw in COPD patients stemming from, you know, potentially CFTR activation, which we've seen in non-clinical studies, helping those patients to clear their cough and sputum, which are the two main symptoms in bronchiectasis.

Just to follow up, what is the overlap? Is it very small?

Go ahead, Kathy. Go ahead. So patients with COPD could have isolated areas of bronchiectasis, certainly, and Sarah talked about their sputum, cough, things like that. are similar to patients who have bronchiectasis by itself. But patients with COPD have a much broader spectrum because they have bronchitis, or so they're affecting their bronchial tubes, but it also affects their airways. They have emphysema, and then they'll have some localized areas of bronchiectasis. Patients with bronchiectasis primarily have just effects on their bronchial airways, the larger airways. This results from usually past infections and things like that in the past. versus patients with COPD who have underlying disease, primarily related to cigarette smoke and other toxic exposures. So the bronchiectasis patient will have some things in common with COPD, but not the overall, the whole overall look of the disease, so to speak. And as Tara said, because of our effects on cough and sputum and so forth, we would expect it to work on those patients with bronchiectasis alone. Tara?

And the overlap, if you look at the diagnosed bronchiectasis population, you might find around 20% of those patients also have a COPD diagnosis. I think going the other direction and looking at the COPD population, I think what we're understanding as the understanding of bronchiectasis progresses is that the more they look for it in COPD patients, the more they find it.

We'll move next to Ron Savaraju at HC Wainwright.

Thanks very much for taking my questions, and congrats again on this excellent quarter. Really impressive performance. I was wondering if you could maybe give us some more information and insight on the competitive landscape and what you are hearing from physicians as we approach potential readouts from biologics that are kind of in the same vein as dupilumab. In particular, drugs like itopecumab or astagolamab. And in particular, you know, this kind of follows on from one of, I think, the earlier questions about competition from biologics. If there are any physician opinions indicating that prescribers might look at the lower frequency of administration for biologics as a potential advantage or reason to put patients on a biologic versus NC-Sentry. And if you are not seeing evidence of that, you know, maybe give us a sense of why, and in particular, if this might be traced back to not only NC-Centering's unique mechanism of action, but also the safety advantages that it would likely continue to enjoy over any future biologic competitors. Thank you.

Hi. Good morning. No, thanks for the question. provide a general comment, and then Chris can talk about what's been, you know, what we're seeing in the field. I think from a pharmacology basis, we don't see it as competitive in any particular way. I think the use case for a biologic, again, assuming that we'll have to see what the results actually say, is different than for O2-ver. Um, O2 Vera is a PD3 PD4 inhibitor with both bronchodilation and non-steroidal anti-inflammatory has a unique profile. And as we talked about on the call, a very compelling benefit to risk profile, um, and other drugs will have to, you know, stand on their own with regard to that. I, as I. As I look at it, you know, patients who are symptomatic and need additional treatment, a lot of that is around treating their dyspnea, which, you know, typically requires bronchodilation. That is a use case for O2-ver in addition to supporting the treatment with anti-inflammatory effects through the PD3, PD4 pathway. So, I think that all of the treatments coming along can be complementary. to O2-ver. As I mentioned, treating inflammation from multiple pharmacologic pathways seems to make some sense broadly, and I think the use case for them are going to be different. And so we're very confident that O2-ver has a place in the treatment paradigm, and as I've talked about, has the potential to redefine exactly how patients are treated for their symptoms. I don't know, Chris, do you want to add anything to that with what we're seeing in the field from physicians?

Yeah, Dave, I think you covered it really well. I would just say anecdotally, when we hear our field reps interact with physicians, they express very similar things to what Dave talks about, which is that O2 VAERS profile is a broad use COPD treatment. Because these patients, as Dave described, come in complaining of dyspnea, they need that bronchodilation effect. And O2Vir is always going to provide bronchodilation and non-steroidal anti-inflammatory effects as a base for these patients. And they look at the biologics as an add-on or something that they can hit inflammation in another way at another point in time for these patients. So I think we're very pleased and encouraged at how physicians view O2Vir as as a broad-based COPD treatment for all their patients that are persistently symptomatic. So, I think it goes back to what Dave talked about, which is the profile of O2 there.

That's very helpful. Just one other quick one. You mentioned earlier in the call about the possibility of turning attention towards in-licensing or acquiring additional potential products or product opportunities. Can you elaborate on that a little bit just from a broad strategic perspective? And if you are looking specifically, I would imagine, at pulmonology-focused products, and how broadly you expect to cast your net, and if you are going to specifically only concentrate on those opportunities that are likely to be directly complementary to O2 there. Thank you.

Yeah, no, that's a great question. I think that, yes, we, you know, as we continue to have great success with the launch of O2 there and as we expand our global footprint, we want to, you know, again, grow the business. And we are a development based commercial company. So we want to look at assets that would leverage our capabilities, of course, in development, regulatory and commercial. That would sit primarily in the respiratory space. Of course, pulmonology as a call point would be a strength. And I think there are opportunities and mid and later stage products that currently are out there that exist in that space. We have an eye out for that. Clearly, we want to continue to have success with the U.S. launch and continue to expand our global reach with O2VAIR. But as we build the company, acquiring assets will be the core of that.

Thank you very much. We'll move next to June Lee at Truist Securities.

Good morning and congrats on the really strong quarter. This is awesome on for June. Thanks for taking the questions. Just a couple from us. So for the tier one doctors who haven't yet prescribed Otover, what are you hearing from them? And then on the patent update, you know, you had several patents that were potentially eligible for an orange book listing. Can you remind us which one was granted for June 2044? Thank you.

Great. No, thanks for the question. I guess I'll start with the latter one and then turn it over to Chris on talking about our Tier 1 HCPs. Yes, we're very pleased that we have an additional patent listed in the Orange Book with the 2044 expiration. And so that patent centers around what can be just generically called the purity aspects of ncfentrin and what i would say is sort of a fingerprint of what ncfentrin looks like from a chemical basis so a lot of that has to do with the novel aspects of ncfentrin's both purity and impurities that exist within its fingerprint and i don't know if you want to talk about tier one

Yeah, as far as tier ones, Dave, you know, when we look at our tier ones and we see approximately 60% of them writing within nominally the first two full quarters of launch, it's something that I think is an impressive start for the brand. Remember, these tier one physicians are seeing upwards of more than 150 COPD patients a month. So the opportunity within this group is tremendous. You know, what we've done over the course of the last few months is also try to understand within physicians that have written to date and those that haven't, is there a difference in sentiment? And I think the thing that we've seen in our market research is that regardless of if a doctor has written O2 there today or if they haven't, they all see the utility of O2 there in the future and eventually get the same share levels or capture rate of patients within their practice. You know, sometimes physicians are a little bit slower in adopting, and that's usually contributed to needing to see it in the guidelines, having a peer discuss it with them. And those are all things that, if you think about it, we got added to the gold guidelines at the end of November. We've continued to do speaker programs. So I would suspect, as we continue through this year, we'll continue to increase the number of Tier 1 prescribers that we have. And I think what is very encouraging to me is that regardless of what they've done today, is the outcome in the future between the writers and non-writers today is very similar because the benefit and the profile of O2-VeR is so compelling for them by providing bronchodilation and non-steroidal anti-inflammatory effects for them. Thank you.

We'll go next to Sushila Hernandez at Van Lanshot Campen.

Yes, thank you for taking my question and congrats on the quarter. Azure continues to progress in regulatory activities for potential marketing authorization, application submissions in the EU and UK. Could you share your latest thinking on strategy and partnering in these regions? Thank you.

Yes, good morning. Thanks for the question. Yeah, we continue to engage both the EMA and the MHRA in the sort of very structured approach to discussing the applications. That's ongoing as we speak, and it's, as you know, it's a very calendared approach for both of them. I would say that sometime around mid-year, we would be better informed as to their responses and thoughts on our application. And so I think we look forward to updating you as we get into the next quarter and beyond in 2025 to bring more clarity as to what the exact plan in Europe will be. Our strategy around partnering in Europe remains the same. And I guess you would imagine that having regulatory clarity is also part of that discussion with partners. So all of it kind of comes together as we progress through 2025.

Okay, that's clear. Thank you.

And we'll go next to Vivalen Pachayapan at Roth Capital.

Hi. Good morning, team, and congrats on the progress. So I have a couple of questions. So firstly, with respect to price stability, so with all the news about tariffs and inflation taking the center stage, so I wonder if price stability will be maintained for over 2025. Any thoughts on that? That's the first question. And a second, with respect to your phase 2B fixed dose study, I was wondering if you could provide some high-level thoughts, you know, what to expect in the study that you're planning to start second half of this year. And then in that regard, I wonder if you are planning to measure pre-dose FEV1, because my understanding is that this is one of the important efficacy markers, the FEV1. FDA is looking for, even though the 0 to 12-hour EV1 is also a good one. Thank you.

Great. Good morning, Bhuvan. So, with regards to price stability, you know, as you can imagine, things are somewhat fluid and never changing, but with that said, We see the price of O2 air as stable through 2025. There's nothing that we have in concrete form that would change our thinking on that. And I'll turn it over to Tara to talk about the Phase IIb study and our endpoints and what we're measuring.

Sure. So, the team has really done a great job progressing the fixed dose combination program. And we, as we stated in the release, are planning to start our kind of pivotal phase 2B study later this year on the fixed dose combination. In terms of endpoints there, you know, I think we'll take the same approach that we took with O2-ver. You know, ensacentrin is a twice daily drug with a 12-hour duration of action. Spice daily drug is operationally difficult to get a clear picture of a trough, pre-dose trough FEV1. And so while we'll measure it, I don't expect that will be necessarily our primary endpoint. We'll continue to look at the lung function effects over the dosing interval.

All right. Thank you very much.

And that concludes our Q&A session. I will now turn the conference back over to David Zacardelli for closing remarks.

Great. Thank you very much. And thank you, everyone, for joining us today on the call. I just wanted to reiterate how pleased we are with our progress and how O2VeR is impacting patients' lives. And we very much look forward to keeping you updated through 2025. And have a great day.

And this concludes today's conference call. Thank you for your participation. You may now disconnect.