Verona Pharma PLC

NASDAQ:VRNA

Earnings Call Transcript

[Operator]

Good morning, ladies and gentlemen. Welcome to the Verona Pharma Fourth Quarter and Full Year 2024 Financial Results and Conference Call. [Operator Instructions] This call is being recorded on Thursday, February 27, 2025.

I would now like to turn the conference over to David Zaccardelli, the Chief Executive Officer. Please go ahead.

[David Zaccardelli, executive]

Thank you and welcome, everyone, to today's call. During the past quarter, we achieved remarkable progress with the launch of Ohtuvayre, along with advancing our development programs, and look forward to updating you today. With me are Mark Hahn, our Chief Financial Officer; Dr. Kathy Rickard, our Chief Medical Officer; Chris Martin, our Chief Commercial Officer; and Dr. Tara Rheault, our Chief Development Officer.

2024 was another transformational year for Verona Pharma with the U.S. FDA approval and commercial launch of Ohtuvayre for the maintenance treatment of COPD. 2024 was also an important year for millions of patients suffering from COPD as Ohtuvayre is the first inhaled therapy with a novel mechanism of action available for COPD in over 20 years.

In addition to the outstanding launch, which I'll walk through in a moment, we progressed our Phase II pipeline programs in COPD and bronchiectasis and have made key advances in our global partnering and regulatory strategy.

First, let's review the initial launch of Ohtuvayre, which is grounded in its broad indication for the maintenance treatment of COPD and its compelling benefit to risk profile. In the first full quarter of commercial availability, net sales of Ohtuvayre were $36.6 million in the fourth quarter and $42.3 million for the full year 2024. We are very pleased to report the extremely strong initial launch continues to build momentum with more prescriptions dispensed in the first 2 months of Q1 2025 than in Q4 2024.

Additionally, we saw month-over-month growth in dispensed prescriptions, new patient starts and refills. These early launch results are remarkable and support our belief that Ohtuvayre can become a blockbuster product.

We continue to strengthen our prescriber base with over 4,600 unique HCPs prescribing Ohtuvayre, including approximately 55% of our 2,500 Tier 1 HCPs. We continue to see HCPs expanding their prescribing to more patients. Specifically, over 275 HCPs have now prescribed Ohtuvayre to more than 20 patients in their practice.

We continue to be very encouraged by the breadth and depth of prescribers and prescription metrics. In addition to these impressive key launch metrics, we see HCPs are continuing to prescribe Ohtuvayre across a broad range of COPD patients, including patients on background single, dual and approximately 50% on triple therapy. This utilization across all patient types strengthens our belief that Ohtuvayre's novel bronchodilator and nonsteroidal anti-inflammatory activity can redefine the treatment paradigm for COPD.

Feedback from both patients and health care providers about the meaningful impact of Ohtuvayre is extremely encouraging and is also supported by our continued refill and persistency data, including patients receiving over 5 refills.

Alongside our successful Ohtuvayre launch, we have continued to advance our pipeline with 2 Phase II clinical programs. Following the end of the year, we successfully completed our Phase II dose-ranging clinical trial with glycopyrrolate, a LAMA, to support a fixed-dose combination with nebulized ensifentrine for the maintenance treatment of COPD. This study confirmed the appropriate dose range of nebulized glycopyrrolate to support further clinical development of the fixed-dose combination. We plan to initiate a dose-ranging Phase IIb trial evaluating a fixed-dose combination of ensifentrine with glycopyrrolate compared to the individual components in the second half of 2025.

In addition, enrollment continues in our Phase II trial to assess nebulized ensifentrine in patients with bronchiectasis. The randomized double-blind, placebo-controlled parallel group trial will enroll [ 180 ] subjects with a recent history of pulmonary exacerbations. The study will assess the effect of ensifentrine 3 milligrams twice daily on the rate and risk of pulmonary exacerbations, symptoms and quality of life.

Finally, turning to our global strategy. Nuance Pharma, our development partner for ensifentrine in Greater China, recently announced the approval of Ohtuvayre in Macau for the maintenance treatment of COPD in adult patients, marking the first approval of Ohtuvayre outside the U.S. This is an important step in our mission to address the needs of millions of patients across the globe still experiencing persistent COPD symptoms despite current therapies. Nuance Pharma also announced that it has completed enrollment in its pivotal Phase III clinical trial in China to evaluate ensifentrine for the maintenance treatment of COPD and expects to provide results in mid-2025.

And finally, we are also initiating activities with regulatory authorities in preparation for potential marketing authorization application submissions in the Europe Union and the United Kingdom. We look forward to updating you on this progress.

I will now turn the call over to Mark to review our financial results for Q4 and full year 2024.

[Mark Hahn, executive]

Good morning. The fourth quarter was monumental for Verona as we recorded $36.6 million in Ohtuvayre sales in the first full quarter of sales. For the year ended December 31, 2024, net Ohtuvayre sales were $42.3 million. Our specialty pharmacy partners continue to maintain inventory at their contracted levels of 2 to 3 weeks. Cost of Ohtuvayre sales was $2 million for the quarter ended December 31 and $2.6 million for the year. These costs include post-approval manufacturing costs, inventory overhead costs and royalties. Recall that Ohtuvayre was approved in June 2024 and prior to receiving FDA approval, costs associated with the manufacture of Ohtuvayre were expensed as R&D expense.

Research and development costs were $7.9 million for the quarter ended December 31, 2024, compared to [ $4.1 ] million reported for the fourth quarter of 2023 and $44.6 million for the year ended December 31, 2024, compared to $17.2 million reported for 2023. The increase across the annual period was primarily due to increases in clinical trial and other development costs related to the initiation of 2 Phase II trials of $17.5 million, the $6.3 million approval milestone, an increase in share-based compensation of $3.1 million, and increases in people-related costs and pre-approval manufacturing costs.

Selling, general and administrative expenses were $45.1 million for the quarter ended December 31, 2024, compared to $15 million reported for the same period in 2023 and $149.8 million for the year ended December 31, 2024, compared to $50.4 million for 2023. The increase across the annual period was primarily due to a $29.7 million increase in marketing and other commercial-related activities supporting the launch of Ohtuvayre, the $15 million first-sale milestone, a $26.8 million increase in people-related costs as we built out our commercial organization and an $18.8 million increase in share-based compensation.

For the quarter ended December 31, 2024, net loss after tax was $33.8 million compared to a net loss after tax of $14.1 million for the same period in 2023 and $173.4 million for the year ended December 31, 2024, compared to $54.4 million for the prior year. This represents a loss of $0.05 per ordinary share or $0.41 per ADS for the quarter compared to a loss of $0.02 per ordinary share or $0.18 per ADS for the fourth quarter of 2023 and a loss of $0.27 per ordinary share or $2.13 per ADS for the year compared to a loss of $0.09 per ordinary share or $0.69 per ADS in 2023.

Finally, our balance sheet remains strong with $400 million in cash and equivalents as of December 31, 2024. In addition, we have access to up to $425 million of additional capital through the Oaktree facilities.

I'll now turn the call back over to the operator for the Q&A.

[Operator]

[Operator Instructions] The first question comes from Andrew Tsai with Jefferies.

[Lin Tsai, analyst]

Congrats on all the progress. It's just pretty awesome to see the launch progressing nicely. So my first question is, the volume really look very healthy. So maybe a question on the pricing side as it relates to sales cadence. Can you just help us level set expectations for when you report Q1 EPS next? Can you help us somehow quantify how much impact there could be to sales with the insurance resets and deductibles that typically occur in Q1? And just to be clear, is it the gross-to-net that gets affected? And if so, by how much? Or is it the fill prescription side as well?

[David Zaccardelli, executive]

Andrew, thank you for the question. I'll turn it over to Mark to provide his thoughts on that dynamic in gross-to-nets.

[Mark Hahn, executive]

Yes. I'll talk about the gross-to-net, Andrew, and then Chris can talk about what he sees from a fill perspective. But from a gross-to-net, the real thing that you would see impacting it would be related to commercial co-pay assistance. If more of the commercial patients have -- they're high deductibles, you could see a higher amount of co-pay assistance going to them. However, as you know, the commercial patients are a very small portion of total shipments. So I don't think, if anything, it won't have much of an impact on gross-to-net in Q1. But Chris can talk about the fills.

[Christopher Martin, executive]

Yes. Andrew, thanks for the question. As far as the fills, I think, as we've stated before, were we, at the beginning of the year, subject to deductible resets, just like every other brand that works through the Medicare sector or our line of business. I think what we've also said is that we believe very strongly that the momentum of the launch outweighs any potential deductible resets that many of these patients may have.

Remember, we're still nominally in the second full quarter of launch. And our expectation is that you would expect to continue to see increasing new patients refilled and total dispenses on a monthly basis. I think you are going to deal with, at the beginning of the year, some deductible reset with patients that have Medicare Advantage and high-deductible plans. But again, I believe that's very strongly that the momentum of the initial launch can -- is going to outweigh some of those early macro dynamics that every brand faces at the beginning of the year.

[Lin Tsai, analyst]

Yes. Very good. And maybe I'll try to ask is, how do you guys feel about 2025 consensus, which is about $254 million million? And is it fair to assume you could break even this year?

[Mark Hahn, executive]

Well, let me start with the break-even portion. I've been talking about for a long time now that I think a company like Verona with a single asset, small sales, a relatively small sales team, a very focused team and a -- and no real discovery engines or R&D overhead can get to a cash flow breakeven. Cash flow breakeven, it may not profitability breakeven, but cash flow breakeven at a run rate -- a quarterly run rate that gets you to a $250 million to $300 million annual rate, probably closer to the $300 million than the $250 million actually. But I think that's where we could get. So yes, those numbers are right. I think we could be in that rate at the end of the year.

[David Zaccardelli, executive]

Andrew, I mean -- Yes. I think with regard to consensus, as you know, we don't really comment on it directly, but I think everyone can see the trajectory is increasing. We're very confident in the uptake of Ohtuvayre. The unmet need is out there, the number of patients. And so I think we're very excited about the opportunity as [ 2020 ] unfolds. And clearly, you can see the momentum this early in the first quarter.

[Operator]

The next question comes from Yasmeen Rahimi from Piper Sandler.

[Yasmeen Rahimi, analyst]

Congrats on really an incredible launch. I guess the first question that I have is one that we all analysts are getting from many of our clients want more on is given the outstanding launch, what are some of the headwinds that could be headed our direction? What are some of the risks that we're not foreseeing or anything that could happen? And I would love like -- I guess, what are the things that's keeping you guys up at night? Because the growth chart looks beautiful. That's sort of one.

Question number two is around your thoughts around European filings. Help us understand like what is the market opportunity in, I think, the U.K. and select countries. I think, in the past, pricing is substantially lower. Can your -- like what led to wanting to really pursue that? And how do we think about the opportunity there? And also, I guess, the cost needed to build out a sales force. Appreciate it. Sorry, multi-part question around that.

[David Zaccardelli, executive]

Sure. Thanks for the question, Yas. I think -- addressing the headwinds comment, we're very optimistic clearly that the unmet need is there and has been demonstrated in COPD. We knew that before we launched that's playing out as the launch has unfolded. And there is really a large number of patients, in the millions, that are currently symptomatic on current standard of care. So we are launching into an indication with a broad label in a patient population with great unmet need. So we don't see really that there is a level of patients being maxed out or tapped out or accessed. And this is merely just needing to address them in the normal cadence of how they see physicians and how they handle their medical care.

As you can see, the expanse and the breadth and depth of prescribing continues now with over 4,600 unique HCP prescribers. Approximately 55% of the Tier 1 targeted prescribers are prescribing already. I think that shows you the pent-up need for Ohtuvayre and for helping patients who remain symptomatic. So we expect that to continue.

There are clearly in our target list, 14,500 HCPs and, of course, all the HCPs that surround those in the different offices. And so we see an expanding opportunity continually to get to more prescribers and help more patients. And so from a market dynamic standpoint from a patient, from an unmet need, we really don't see any specific headwinds. From a competition perspective, again, in any time frame that -- of that foreseeable future, we don't see anything that looks like Ohtuvayre, a bronchodilator and a nonsteroidal anti-inflammatory. So I think that, that fits extremely well with helping these patients.

And then I think the things that we always have to attend to that never get maybe as much attention is running a pharmaceutical business has a lot of tests that have to be handled to manage risk. You have to make product, you have to release product, you have to make sure that you're doing all the regulatory requirements around commercializing the product properly. So we work on execution underlying all the activities. And clearly, that is an inherent risk to the pharmaceutical business and something that we can never pay enough attention to, we always do. And that's something that we work on every day as well. But I put that on just the continued execution for our pharmaceutical business. So I think, again, very optimistic on the market as we go through 2025 for sure.

As far as the European filing, just to make sure we understand, we still don't plan to start operations in Europe. What we're doing is advancing the regulatory process in Europe. As you know, that takes some time to get through. And as we go through 2025, I think we'll get greater clarity on our strategy in Europe from a regulatory perspective, from a filing time line. And then I think that feeds very well into our partnering conversations in Europe, which is still our strategy. And we have the capability and the talent and the people in order to to advance the regulatory aspect of the filings both in the European Union and in the U.K. And as we do that, we'll concurrently work with our partnering strategy. So I expect them to come together, especially as we walk through 2025.

[Operator]

The next question comes from Tiago Fauth with Wells Fargo.

[Tiago Fauth, analyst]

Congrats on the progress. We've been getting a couple of questions on duration of therapy because that's a key toggle for average revenue per patient here. In our channel checks, we're not really hearing a lot about potential discontinuations. And while still early, curious how to think about average duration. Like this -- is there upside to that 6 months average duration assumption? How can we think about that?

[David Zaccardelli, executive]

Yes. No. Tiago, thanks. Yes, I think that in our -- on our malina how we've described it, we use sort of the benchmark of typical COPD drugs that are -- their normal persistence and use over the year, and that has been based on around 6 refills per year. As you know, the way we distribute Ohtuvayre through a specialty pharmacy network and the ability to track the patients very carefully and support them through the specialty pharmacy. We think that there is some upside to that. And it is very early, though, to actually characterize that, we are encouraged by the refills.

I think that comes from the fact that Ohtuvayre is, of course, helping patients. And the refills, again, very early yet because, of course, the most refills -- as we talked about, patients now are receiving over 5 refills already. But of course, it's from earlier patients that started in the first part of the launch in 2024. So as we get through 2025, we'll have, of course, a greater number of patients, more refilled information to look at. But yes, we're very encouraged by where we are right now. And yes, we do think there is upside to the 6 refills per year.

[Operator]

The next question comes from Tom Shrader with BTIG.

[Thomas Shrader, analyst]

Congratulations. I was trying up the nerve to ask the break-even question after 1 quarter. So thank you for asking that. I have a couple of surveillance questions. Any common themes in the 45% who are not prescribing the drug? Are there any structural things you are working on?

And then the nebulizer, how big a deal is the nebulizer? This is really a peak sales question. Are you building into patients that have a nebulizer? Or is there -- are there significant numbers of patients who are anti nebulizer to add this drug?

[Christopher Martin, executive]

Thanks, Tom, for the question. Let's start with the 45% that haven't written yet. I want to focus on the -- or the other side of the -- or the number of writers that we have today. I mean, to have over 4,600 writers nominally in the second full quarter of launch is an incredible start and I think highlights what we saw in market research of the unmet need and the profile of Ohtuvayre. What you see today is typical launch dynamics of early adopters, mid-adopters and late adopters. And I think that's the dynamic that you face. No specific brands except for their adoption characteristics of these physicians.

I think one of the things that keeps us very encouraged and excited about the future of Ohtuvayre, when we do market research on physicians that have written and those that haven't written yet, all doctors see the benefits of Ohtuvayre in the -- with the profile and the potential in their patients. They also talk about how they would start writing within the next 3, 6, 12 months. So I think when we look at our market research, we understand that our writer group base will continue to grow, and we will continue to penetrate these doctors that haven't written so far because of the profile of Ohtuvayre.

As far as the nebulizer, I think this is something that we got as a question very early on of can this drug -- will people use a nebulized drug? And our hypothesis going into this was that innovation would trump route of administration, we're very clearly seeing that in the early stages of launch or this early part of launch. In fact, when we look at our data, we have patients that don't have a nebulizer patients that do have a nebulizer. And the core underlying feature that the doctors are prescribing Ohtuvayre is around persistent symptoms, and route of administration has become kind of a nonissue. It's not something that comes up from a fill perspective with the doctors. It's not something that comes up with patients. In fact, many patients talk about how nebulizer is a comforting way to deliver their product because they know it gets to their lungs. So I think that's been something early in launch that I think has been dispelled, and it really showcases the innovation that Ohtuvayre is bringing to the COPD marketplace.

[Operator]

The next question comes from Ram Selvaraju with HCW.

[Raghuram Selvaraju, analyst]

Congrats really on the phenomenal progress with the launch. It's really very impressive. Firstly, I wanted to ask whether you see any underlying market dynamic trends emerging with respect to prescriber preferences regarding the deployment of Ohtuvayre, especially now that we've gotten a little bit further into the commercial trajectory. And in particular, if you can comment on whether you expect the proportion of patients on Ohtuvayre who are also receiving tri therapy to increase over time or remain constant?

And then also with respect to the ex U.S. picker, was just wondering if there are territories beyond you and Greater China that you believe are likely to be particularly lucrative for ensifentrine and what your strategic plans are to target those territories. And if you could also perhaps comment on the pricing situation in Greater China, what the pricing dynamics look like in Macau now that the product has been approved there, just so we can get a bit of a handle on what performance Nuance might be able to realize with the drug once it's available.

[David Zaccardelli, executive]

Ram, well, there's a lot to unpack there. So let me start sort of near the back of that question. Let's -- and we'll work our way through it. Our strategy is still, of course, to partner outside the U.S. as we have already, as you mentioned, in Greater China. I think the other regions are all important in their own way. Clearly, incremental and in totality are very significant in the growth for Ohtuvayre on a global basis. Other regions, again, outside Europe, Greater China, but even in Japan, in other parts of Asia as well; and of course, the other emerging markets, South America, all become incremental and are important.

Now I've been always saying that there is nothing more important than having a successful launch in the U.S., which we continue to execute on, and that's what we'll continue to focus for sure. But we'll carry on with the strategy for -- in 2025 in partnering. And as I mentioned, we're already starting that in more progressive state by working with the regulatory authorities in Europe and the U.K.

And maybe I'll turn it over to Chris to talk about sort of the dynamics -- the market dynamics and how that has been -- what we've seen balanced on what we did in market research.

[Christopher Martin, executive]

Thanks, Dave. When we look at the patients and what's a consistent theme about who's getting prescribed Ohtuvayre, it goes back to some very simple kind of truths. These patients all have persistent symptoms, particularly dyspnea. And that's a very big trigger for the physician to add or change therapies within these patients. So when our reps go into these offices, there -- it's not about what the background therapy is. It's more about what is the patient dealing with today in regards to persistent symptoms, either dyspnea, decreasing activities and how Ohtuvayre could potentially help with these patients over time.

The other thing that I think we're very encouraged by is, as Dave talked about in his opening comments, which is 50% of our patients are on therapies that are not considered triples, so either single bronchodilator, a dual bronchodilator, a LAB-ICS or no long-acting bronchodilator. I think this is going to increase over time. As we've heard from physicians and research and seen from our interactions in the field, doctors are looking for another mechanism in another way to provide bronchodilation and nonsteroidal anti-inflammatory effects that don't involve using steroids.

So I believe, over time, the addition to triple will potentially become less than the addition to earlier lines of therapies for these patients as they look to move ICS into maybe a more appropriate place than it is used today. It really talks about the long-term potential of Ohtuvayre, not only in its current form, but potentially on a combination product, as Dave has mentioned in his comments earlier about our pipeline expansions. So I really feel like that's a great opportunity as we move through '25 and into '26 as well.

[Operator]

The next question comes from Joon Lee from Truist.

[Joon Lee, analyst]

We spoke with several pulmonologists, and there seems to be a wide range of prescription reimbursement rates, ranging from over 90% to less than half for some pulmonologists. Could you help us understand some of the pushes and pulls in reimbursement and what you are doing to improve this?

And just a clarification question on European partnership. Is it your plan to have some clawback clause like the one you have with Nuance in case someone else may merge, that may want the global rights?

[David Zaccardelli, executive]

Joon, thanks for the question. Let me start with the last one, and then I'll turn it over to Chris. Well, I think we'll have to see how our partnership discussions go. As you know, we're also looking for a partner that may have a broader base of capabilities with regard to development of MDI/DPI, manufacturing of the drug product, manufacturing of DPI and MDI. So there may be other attributes of the partnership that are quite different than the one we have with Nuance Pharma at the moment. So we'll see how that looks as we continue. But we understand your point. And clearly, we always want to make sure we do the best for Ohtuvayre and our shareholders in the kind of structured deal that we do.

And with that, I'll turn it over to Chris.

[Christopher Martin, executive]

Yes. Joon, as far as reimbursement, I think we've been very pleased with how the reimbursement looks in this early stage of launch. As we talked about at launch, we anticipated about 80% of our reimbursement or claims would fall under medical benefit, either under Medicare Part B or Medicare Advantage, and that's holding consistent as we go into these launches.

I think one of the things that I always have talked about is that we have access in those channels. I mean patients can get it. There's no prior auth, there's no real step at it. There's access to Ohtuvayre in those channels. What it becomes is an out-of-pocket cost for patients. If a patient has supplemental insurance, we see their co-pays are usually less than $10. If the patients met their deductible in Medicare Advantage, their co-pay is less than $10 or even nothing. And so that's the driver of potentially reimbursement. It's not necessarily access. It's more of an out-of-pocket cost.

Within the Medicare side, we cannot provide any assistance to patients with Medicare, so they really have to work through their deductibles or have some supplemental insurance. On the commercial side, we have robust co-pay card programs and provide that to patients. Additionally, we've created other services with -- including patient assistance programs for patients that are low income that they can get this product through that process as well.

But I would say, within these first 2 quarters -- nominally first 2 quarters of launch, we are very encouraged by the way reimbursement and access is presenting itself. And more importantly, would it come -- when we get a patient on drug, we're seeing many of these patients, the vast majority, I would say, over 80% of them having co-pays less than $10 as well.

[Operator]

The next question comes from Boobalan Pachaiyappan with ROTH.

[Boobalan Pachaiyappan, analyst]

Can you hear me okay?

[David Zaccardelli, executive]

Yes.

[Boobalan Pachaiyappan, analyst]

So I just have a couple of questions. So one of them focusing on the refill process. So as more and more patients are going for a refill, so I'm wondering how does the process work in the real-world setting? So do patients have to take spirometry test or anything just to make sure they are getting some benefit in terms of when they take the drug or when they call the doctor asking for prescription and the doctor asking what kind of symptom improvements are you seeing? So are there specific symptoms that get improved with Ohtuvayre usage? That's the first one.

And the second, are there any side-effect profile, especially the ones that are listed in the FDA label? Are physicians seeing any of those, including the psychiatric events that are listed in the label? Are there any instances of those side effects recurring in these patients in real-world setting?

[David Zaccardelli, executive]

Right. Boobalan, maybe I'll turn it over to Chris to start with the refill process and how that goes.

[Christopher Martin, executive]

Yes. I mean this is the benefit of our distribution pathway. We have amazing specialty pharmacy partners like Director X and CVS and Centerwell and Acarria that have individualized processes to ensure that a patient can refill their prescription in a timely manner. Each of them will reach out individually to the patients early in the process to encourage or talk to them about refilling their medication. And it's a very, I would say, a very organized and systematic approach to ensuring patients stay on therapy.

They also have the opportunity in these situations to be able to talk and ask questions to the pharmacy about what's going on. And I think that encourages our patients to stay on therapy and see the value of Ohtuvayre within their lives.

One of the things that I think is very encouraging early on, as Dave mentioned, is this early persistency or refill data that we're seeing. Again, little bit too early to say it's different than the initial 6-month assess our forecast, but I think we believe there's a significant upside there -- a potential upside there. But one of the things that is also encouraging is the feedback that we're getting from patients across the spectrum to specialty pharmacies to the doctors really highlights how Ohtuvayre long term is going to be very beneficial for the patient.

[David Zaccardelli, executive]

And Boobalan, with regards to side effects, as you know, we are subject and have an active pharmacovigilance program as all commercial drugs do and mitigate we capture side effects -- reported side effects on a commercial level. And that program, of course, is in place. I would say, there is nothing that we have determined to be inconsistent with the label. And so I think it's, of course, fairly early in the process at this time. I would say, our side-effect profile is consistent with the labeling.

[Operator]

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to David Zaccardelli for any closing remarks.

[David Zaccardelli, executive]

Well, thank you, everyone, for joining us this morning. And of course, we look forward to seeing all of you at upcoming conferences as we continue to progress to 2025. As you can see, we're very excited about the impact of Ohtuvayre in helping patients with COPD, and we'll continue to execute that both in the U.S. and as we continue globally as well. So look forward to keeping everyone updated as we progress, and hope you have a great day.

[Operator]

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect