Verona Pharma plc (VRNA) Earnings Call Transcript & Summary

Welcome to Verona Pharma's conference call. [Operator Instructions] Yesterday afternoon, Verona Pharma issued a press release announcing the U.S. FDA approval of Ohtuvayre for the maintenance treatment of COPD in adult patients. 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 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 Zaccardelli, Chief Executive Officer. Please go ahead.

Thank you, everyone, for joining today's call. What a great day it is. Yesterday, we announced the U.S. FDA approval of ensifentrine under its brand name Ohtuvayre for the maintenance treatment of COPD in adult patients. We are very excited to be with you to share this groundbreaking achievement. This is an important day for COPD patients, caregivers and the Verona Pharma team. Joining me to discuss this important milestone are Mark Hahn, our Chief Financial Officer; Dr. Kathy Rickard, our Chief Medical Officer; Dr. Tara Rheault, our Chief Development Officer; and Chris Martin, our Chief Commercial Officer. In addition, we are very pleased to be joined today by Dr. Mike Wells, Associate Professor in the Division of Pulmonary, Allergy and Critical Care Medicine and the Medical Director for the Lung Health Center at the University of Alabama at Birmingham. Before getting started, we want to thank the patients and health care professionals who participated in the clinical trials evaluating Ohtuvayre, including the Phase III ENHANCE program, which made the NDA submission and approval of Ohtuvayre possible. Today's approval of Ohtuvayre marks a momentous step for Verona Pharma in our mission to improve the lives of those affected by the burden of chronic respiratory diseases. And it is an important day for patients with COPD who remain symptomatic despite treatment with previously approved therapy. Ohtuvayre is the first inhaled COPD treatment that provides both bronchodilation and nonsteroidal anti-inflammatory effects. And we believe this approval continues the treatment paradigm for COPD in the U.S. We believe the label for Ohtuvayre supports broad use in COPD patients and our precommercialization efforts have positioned us for a successful launch in the quarter ahead. Turning to Slide 5. This is a large market with significant unmet medical needs. Currently, there are approximately 8.6 million maintenance treated COPD patients in the U.S. Despite the availability of existing COPD treatments, at least half of maintenance treated patients continue to experience persistent symptoms daily. That means a staggering 4.3 million symptomatic COPD patients who could potentially benefit from Ohtuvayre treatment and will be the focus of our launch. Taking a look at Slide 6. There is significant interest in using Ohtuvayre. Importantly, we have shown Ohtuvayre's profile to HCPs. They have consistently told us they plan to prescribe Ohtuvayre across all COPD patient types. HCPs indicate that they would prescribe Ohtuvayre broadly across their symptomatic COPD patients. Their interest in prescribing is due to the significant unmet need that exists in COPD, the novel mechanism of action and the compelling positive benefit to risk profile that Ohtuvayre demonstrated in clinical trials. I'd now like to turn the call over to Dr. Tara Rheault to provide more detail on Ohtuvayre's mechanism of action, clinical data and FDA-approved label. Tara, please go ahead.

Thank you, Dave and good morning, everyone. As a reminder, Ohtuvayre is a first-in-class selective PDE3 and PDE4 inhibitor that combines bronchodilator and nonsteroidal anti-inflammatory effects in 1 molecule. PDE3 and PDE4 enzymes are present in multiple lung cell types associated with COPD pathology, and inhibition of PDE3 and PDE4 results in accumulation of second messenger molecules, cyclic AMP and cyclic GMP, and can produce downstream bronchodilation, decrease in inflammatory response and increased ciliary function: effects that are all important for the treatment of COPD. As published in the American Journal of Respiratory and Critical Care Medicine, both the ENHANCE-1 and ENHANCE-2 trials successfully met the primary endpoint, showing improvements in lung function over 12 hours. Additionally, key secondary and other endpoints, including other lung function endpoints, symptoms, quality of life and exacerbations provided strong supportive data for this new mechanism in patients with COPD. Ohtuvayre was well tolerated over 24 and 48 weeks with few adverse events greater than 1% and higher than placebo. Now let's take a look at the label for Ohtuvayre. We are very pleased with the label indicating Ohtuvayre for the maintenance treatment of COPD in adult patients. This indication supports broad use across all COPD patients with no limitations based on background medication, COPD etiology, including chronic bronchitis or emphysema or blood eosinophil levels. Furthermore, the label describes Ohtuvayre's novel mechanism of action as a dual inhibitor of PDE3 and PDE4. Importantly, this novel mechanism of action language differentiates Ohtuvayre from all other approved COPD treatments. Ohtuvayre's dosing is 3 milligrams twice daily, delivered using any standard jet nebulizer. The average nebulization time is about 5 to 7 minutes. Low rates of adverse events were observed in the trials. And those that were greater than 1% reported with Ohtuvayre and higher than placebo included back pain, hypertension, urinary tract infection and diarrhea. Importantly, the 48-week safety profile was similar to the 24-week profile. Overall, discontinuation rates due to adverse events were low and similar to placebo. The warnings and precautions on Ohtuvayre's label are consistent with other inhaled COPD products and PDE4 inhibitors. There are no post-marketing requirements or commitments for Ohtuvayre. We are excited that our label positions Ohtuvayre for use across a broad population of symptomatic COPD patients. I'd now like to turn the call over to Chris Martin, our Chief Commercial Officer, to discuss our commercial strategy and plans for the commercial launch of Ohtuvayre to ensure that it's available for the patients who need it. Chris?

Thank you, Tara and Dave, and good morning, everyone. As Dave mentioned earlier, there are currently 8.6 million maintenance treated patients. These patients are suffering from persistent symptoms. At least half of these patients have that today. That means, as Dave talked about, a staggering 4.3 million patients who continually have persistent symptoms. These symptoms are things that you and I probably take for granted. Activities that we do regularly, these patients cannot do, such as walking outside to a mailbox, walking up a set of stairs and playing with a grandchild. These are difficult tasks for these patients. And it's something they're looking for other products to help them with as they continue their disease -- dealing with their disease. We also realize from market research that as a patient becomes persistently symptomatic, their treater tends to shift from a primary care physician to a pulmonologist. This allows Verona to reach the patient and the physician opportunity in a much more targeted fashion. As we discussed earlier today, Dave showed you some shares of potential usage of Ohtuvayre across a variety of different scenarios. Most recently, we've asked HCPs their willingness to prescribe Ohtuvayre based on those patient type classification. Across hundreds of surveyed HCPs, our market research indicates an overall intent to prescribe up to 80% regardless of GOLD classification. Even in the least severe group, Group A patients, HCP's willingness to prescribe is 50% with Ohtuvayre. And this rises to approximately 90% in more severe Group E patients. Since 2020, our market research has consistently shown high physician utilization and intent to prescribe. This demonstrates the significant unmet need for a novel mechanism in the maintenance treatment of COPD. Turning to the patients, because these patients continue to suffer, we continue to do market research with the patients within the COPD marketplace. And across all those projects, we see a variety of different themes. Patients continue to highlight their high daily symptom burden they face. They also highlight that nebulization is something that is very common to them and they use quite regularly. And finally, they have a high motivation to try or ask for a novel steroid-free COPD treatment. This is exciting because not only do we have physician utilization that shows high intent to prescribe and usage but our patients are excited about a molecule that looks like Ohtuvayre as well. Holding both the patient and the physician data together, it's about access. And how does the patient and the physician get the drug? From a reimbursement side, we believe Ohtuvayre will be primarily reimbursed through a medical benefit pathway. This medical benefit pathway is either through traditional Medicare Part B or through Medicare Advantage. This pathway has been used in the past with other nebulized products as well. At launch, we will use a nonspecific innovation J-code followed closely by a product-specific J-code. Additionally, we have conducted all our clinical presentations with key payers. We plan on submitting our product-specific J-code by June 28. How does Verona reach the opportunity? We will promote Ohtuvayre through a variety of different channels. You can see from this slide, our face-to-face promotion will occur in about 15,000 HCPs, who we believe are at least 8x more active than other HCPs. You can also see that in our Tier 3 physicians, we will support with a virtual sales team that will discuss Ohtuvayre with them. Across all Tier 1 through 4 segments, we will layer on nonpersonal and digital promotion to ensure that the Ohtuvayre message is reached appropriately to the right physicians. We would like to introduce today that once Ohtuvayre has been prescribed, that we want to ensure that patients have access and we provide the right customer support for our physicians. So today, we'd like to introduce Verona Pathway Plus. This program includes our hub partner, CareMetx and our exclusive accredited pharmacy network which include CVS Specialty, AcariaHealth, CenterWell and DirectRx. This pharmacy network covers 98% of the patient lives in the United States. Additionally, the program will help with coverage, affordability and provide ongoing support and education to HCPs and patients. From a pricing perspective, we strongly believe that the $2,950 per month WAC price for Ohtuvayre reflects the overall benefit and value to the health care system. As a reminder, the total annual medical costs, both indirect and direct, relating to COPD are about $50 billion in the U.S. per year. Moreover, the health care costs associated with a single exacerbation are approximately $26,000 a year. As an organization, we have conducted third-party pharmacoeconomic analysis and they have indicated a large value of Ohtuvayre to the health care system. This range of potential net prices is from $1,000 to $5,000 per month. Again, we believe that the monthly price of $2,950 per month reflects the overall value and benefit of the Ohtuvayre to the health care system. Considering the significant unmet need and Ohtuvayre's profile, from our -- market opportunity is substantial. Ohtuvayre can be used in all COPD patient types regardless of background therapy. If we just look at the number of patients treated, our WAC price month of therapy of treatment and a potential gross to net, every 1% share of treated patients is approximately $1.1 billion in net revenue. On the right-hand side of this slide, you can see the current COPD patient shares and you will realize very quickly that very slight penetration in the market produces a multibillion-dollar revenue opportunity for Verona and Ohtuvayre. Lastly, as an organization, we haven't just been waiting for this moment. We've been preparing for the last few years for the moment and we are ready to launch. If we think about what this journey looked like, we started with attending over 100 conferences, presenting multiple abstracts and publications into the marketplace. Our marketing team has executed both multiple disease awareness campaigns, highlighting the burden of COPD to physicians and the inflammatory cascade associated with COPD. This has resulted in over -- approximately 30,000 physicians engaging with Verona over the content. And today, I'm happy to say that with the approval on June 26, we have hired 120 field personnel, including sales, field reimbursement managers and sales -- regional sales directors and they are getting ready to go. Additionally, we plan to submit our J-code by June 28. We believe product will be available in Q3. And we are ready to launch the branded campaigns for physicians and patients. And to conclude, we wanted to highlight that our efforts today have resulted in over -- almost -- or approximately 1,800 HCP appointments. These appointments are with our Tier A -- our Tier 1 and Tier 2 physicians. They will occur in the first 3 months of launch. And it highlights the significant excitement that exists about a novel mechanism of action and the unmet need within the marketplace today. I will now turn it over to the operator for questions.

[Operator Instructions] Today's first question comes from Andrew Tsai with Jefferies.

Big congratulations on our side. Based on our doctor tests, which seems to be consistent with your own checks, pulmonologists seem very well aware of Ohtuvayre and they consistently say or tell us their patients who are especially on maximal therapies are motivated to try a new therapy. So do you believe there could be some type of bolus of patients ready to go in Q3? And is there any way you can quantify that potential bolus? And then secondly, we know IMS scripts will be untrackable. There will be no sales for Q2. And then Q3 sales, you'll probably report later in November. But in the meantime, what kind of KPI as the leading indicators do you plan to disclose during your Q2 EPS call in August to help us gauge the launch trajectory? And how granular could you get?

Thanks so much for the questions. I'll sort of just provide a few comments and then turn that over to others. I think with regard to bolus of patients, as you mentioned, there is awareness, of course, on Ohtuvayre from the work that's been done over the past 1 year or so. That will continue to increase, of course, as we go through the launch. As we described today, I think there's a lot of energy and need and patients that exist, of course, for treatments such as Ohtuvayre. And whether or not you can call it a bolus, we do think there are a significant number of patients who have a medical need and where Ohtuvayre could be a help for those patients. Let me ask Dr. Wells just to comment with regard to his practice on how he sees availability of Ohtuvayre and the types of -- numbers of patients he may have that would be applicable for its use.

Thank you, Dave. This -- so I'm an academic pulmonologist and our group sees roughly 1,500 patients within our sub-subspecialty COPD practice per year. And the vast majority, 80% to 90% of patients that we see oftentimes are on maintenance therapy, mostly dual or triple therapy and they're almost uniformly symptomatic despite this. Even when we consider patients stable, most of the time we're thinking that means that they have been exacerbation-free for some period but that doesn't necessarily mean that they're symptom-free. And so I think the opportunity for Ohtuvayre in this group that we're seeing, I think it has broad applicability for any of the patients that we see in our practice. And our -- overall, I think there's lots of opportunity. And I think the data from the published studies, I think it's really supportive of being very beneficial across all the different subgroups of patients that we see.

Thank you, Dr. Wells. And Andrew, with regard to KPIs and launch metrics and information, I think you can expect that we will provide a level of granularity and clarity about how the launch is going. We'll, of course, continue to work on that. And of course, in the coming quarter calls, you'll receive updates. I think, again, you've seen our -- how we approached things in the past and we'll provide a level of clarity and detail that everyone will understand, the launch trajectory, the number of patients being prescribed, the number of physicians that have been reached and those type of typical metrics to provide that information.

And our next question today comes from Yasmeen Rahimi with Piper Sandler.

Congratulations on this incredible achievement. I know you've worked incredibly hard to get here. Two questions to you. I guess the first question is on -- I did notice a high anticipation going into the label, whether exacerbation was going to be in it -- in the clinical section and we have talked greatly around maybe not the lack of importance there but what we did find which was interesting is that the quality of life measures were there. So would love to get Chris' as well as our KOL's perspective on how important is that data point? Could that drive also significant interest in the product? How -- I guess, from Chris, how will you be utilizing that from your sales force perspective to emphasize it? And how important is that for physicians? That's sort of bucket 1 question. Bucket 2, I think that, obviously, the label was very clean but there was that warning of suicidal risk due to that 1 patient. Would love to kind of get color around just why did that -- why did it end up on the label or as a warning? Any commentary beyond that, that could be helpful or whether you foresee that, happy to appreciate. And then maybe one question around just the readiness on getting the J-code up and running. Sorry for the 3-part question but appreciate your color on these topics.

Thanks, Yas. You've loaded stuff this morning. Why don't we -- Chris will comment, as well as Dr. Wells on exacerbation and quality of life measures and the label. And then Tara can comment on the warnings in the label. And I think Chris will also work the J-code into that.

Yes. Okay. I can start on just on market research and then I'll have Dr. Wells give his perspective as well. The market research that we've shown in the deck today is all based on the label that the FDA has approved. And so with that label, we didn't include exacerbations on the TPP. I think one of the things that we've heard consistently through all our market research is -- and this actually dates back even to 2020, 2021, is that the novel MOA delineates an opportunity for HCPs to prescribe Ohtuvayre very differently than they prescribe their current drugs today. When we do market research, physicians, pulmonologists especially, understand that PDE3, PDE4 can provide 2 benefits for patients. They can provide bronchodilation and can also provide nonsteroidal anti-inflammatory effects. So that novel MOA is driving the majority of that usage within our physician reports and discussions. I think the other thing that's really important is, when we talk to patients, patients don't talk about exacerbations. They talk about data that -- they talk about the things that we do -- just did this morning. They talk about going to get a cup of coffee and it's struggling to do that. I think we had an example here in the office the other day where someone went on vacation, they had someone with COPD and the person couldn't participate in many of the vacation activities that everybody else were doing. These are activities that they talk about. They don't talk about an exacerbation. So our improvements in lung function, our -- the data that's included in the CI are extremely compelling from a patient and physician perspective because that's what they feel every single day. I don't know Dr. Wells, if you have any other comments there.

No. So just to piggyback on what you've said, when we see patients, again the vast majority of patients with COPD are very symptomatic. And there is a little bit of a disconnect between what is the priority for patients versus what we can think of from a health care provider, where we really want to affect -- keep people out of the hospital, reduce mortality, those kinds of things. And so that's obviously an important priority for us. The patients certainly care about that but the main thing that -- when I'm seeing them in clinic, is they're talking about difficulty getting up the flight of stairs or coughing or being in a -- going to the grocery store and having difficulty getting around. And so things like that, that really impact their daily quality of life are tremendously important. And I think the opportunity for Ohtuvayre in this setting is that we do know that it improves lung function, that it is going to reduce symptoms, which I think are massively impactful for patients on a day-to-day basis. And then from the data that's publicly available, there's also the benefit on exacerbations. And so I think that that is a benefit as well to a provider knowing it may result in a risk reduction. And so I think this, it sort of checks all of the boxes for providers and for patients.

And then yes, before I turn it over to Tara on the warning, I wanted to just talk about the J-code. We are prepared to submit the J-code by the end of the week. I mean, I think we are as close as you can be to submitting it. We just want to do a couple of checks on it but that J-code submission will go in by the end of the week, which would be a Q2 submission, which would mean that you would have an announcement of kind of a J-code in Q4, a functioning J-code in Q1 of 2025. And again that nonspecific-inhalation J-code has been used in the past and our pharmacy network is very comfortable in using that at launch as well. Tara?

Great. Yes, so the question was around why do we think the psychiatric events warning was included in our label. And here, I think that there's a few things that add to the context there. And one, of course, is that the agency has extensive experience with systemic PDE4 inhibitors, Otezla and Daliresp, that include similar language in their label. So we do think that there is some -- a class impact on our label. But then when you get specifically into our own data, I think, and what's listed in the label specifically is that these events are incredibly small numbers in patients, which, as you saw 1 event in our Phase III program and 1 event in a Phase IIb program in terms of suicidality and this is across our 3,000-patient clinical program with clinical experience with ensifentrine. The increase in psychiatric events with ensifentrine, I think the largest number there was really insomnia and that occurred in 6 patients, which was 0.6%, I mean, very low rates versus 0.2% on placebo. So I think that if you're taking a quite cautious view of ensifentrine, Ohtuvayre, in the context of other products that are out there, it's not surprising to us that this information is detailed in our label.

Just to add from a market research perspective, we looked at this and the physicians that we talked to have said it's consistent with what they see in other labels. Remember, they also understand that COPD is a disease that has a higher rate of depression, anxiety and psychiatric issues to begin with. And you have to keep in mind why that is. These patients become confined to their home. They withdraw from society. They have other issues. And so you just -- if you look at the general population, depression, anxiety and these things exist at a much higher rate in the COPD population as well.

And even outside of PDE4 inhibitors, these events do occur in other non-PDE4 clinical programs. I think you can go take a look at the safety data from other large programs, including Trelegy or Breztri and you're going to see these events there as well. And as Chris mentioned, these are unfortunately more common in the COPD population.

And our next question today comes from Joon Lee with Truist.

Congrats on the approval and this was definitely worth the wait. $2,950 per month pricing is pretty robust but regarding your average 6-month on therapy assumptions, is that just in line with other COPD drugs? But given your closed-loop commercial strategy and [indiscernible] is there an opportunity to increase that to maybe 7, 8 or 9 months out of the year because my understanding is that COPD is a chronic disease, as the name implies. Then I have a follow-up question.

Joon, this is Chris. When we show that slide, the $2,950 in the 6 months, we're using the average length of therapy for patients on current COPD products today. Keep in mind, 6 months may mean they take 1 month, they skip 1 month, they go on the next month over the course of the year. So we wanted to be conservative in that view of taking what exists today in the marketplace. I think your comments are important, of using the network and distributing and getting Ohtuvayre to the patients like we're doing, provides an opportunity for improved adherence and compliance for patients. But when we were sharing this from just a sizing standpoint, we wanted to be conservative in the way that we looked at length of therapy. But we do believe that our network provides an opportunity for an upside on adherence with patients within the COPD marketplace.

Great. And then I have a question for Dr. Wells. Dr. Wells, what excites you the most about Ohtuvayre? And what percentage of your current COPD patients do you think you'll end up prescribing Ohtuvayre to eventually?

So thank you for the question. Based on my practice, I could see the vast majority of patients prescribing -- or me prescribing it to the vast majority of the patients that I see. Again, almost all of the patients that I see are very symptomatic. They may be -- most of them are on background therapy. And really, with the improvements in quality of life and symptoms and improvement in lung function, I think these are all things that are -- that we really strive to hit and achieve for our patients. And I think the fact that, if it makes patients feel better, then I think they're more likely to use it. And I think that's also a really important factor and that also results in compliance and things with the intervention as well.

And our next question comes from Tom Shrader with BTIG.

Congratulations. So I have a question for Dr. Wells on exacerbations. Is the paper enough for most of your colleagues? Will they be aware of this? And is there any issue with the fact that such a -- I think, a gaudy number for exacerbation reduction isn't in the label? Will they trust it? Just your sense on -- is that enough? And then I have a follow-up for Chris.

Yes. No, I think the answer is yes. I mean I think if you look at the totality of the data that there's improvement in symptoms, improvement in lung function and the reduction in exacerbation, I think the fact that there are 2 complementary studies that you see the same signal in both -- across both studies, I think, is really important for pulmonologists to feel comfortable that it's a real signal. And I think -- and it's also -- and we know that with exacerbations, thinking about frequent exacerbations and GOLD E, we know that the trajectory of exacerbations varies quite a bit over time as well. And so I think that any time there's the potential that this is going to impact exacerbations, I think people are going to be excited about it.

And then Chris or commercial people, $2,950 a month, there are obviously some rebates or cost cutting associated with that. Can you just remind us which ones are automatic and which ones are negotiated, so that we can think about the true value...

Also from a -- yes, from a -- within Medicaid, you have a 23.1% discount automatically within Medicaid. And that 23.1%, many patients with Medicare Part B have supplemental with Medicaid supplemental. So that 23.1% would apply to the supplemental. But as we think about commercial or even Medicare Part D, remember that this is an [indiscernible]. This is the only PDE3, PDE4 inhibitor. It puts us in a position where we don't feel like there will be significant discounting needed to have access for these patients. Remember that with the Medicare Part B or under Medicare benefit, that access is we believe is an early path to access within those channels that allow a physician and a patient to get the drug at a very affordable out-of-pocket cost. Because ultimately, a WAC price is a WAC price and with Dr. Wells and other doctors here it's about what the out-of-pocket cost is. And what we know about current nebulized products is, about 80% of them going through Medicare are under $10 copay.

And one quick follow-up. You said 75% of patients have a nebulizer. 75% of what patients? Is that symptomatic patients? Or is...

Yes, Tom, it's a good question. It's all -- I mean, this was a survey that we did within HCPs and we asked them to consider all their COPD patients and we asked them how many had a nebulizer. And at least 75% had a nebulizer within their practice -- or their patients had a nebulizer, so it's all COPD patients. We have to keep in mind, when a patient goes to a hospital, as many of these patients do, they don't get treated with an inhaler. They get treated with a nebulizer. So like every patient that's gone to a hospital, gone to the ER, has got on an nebulizer. It's not an uncommon device. And in fact, in our market research with patients, one of the things we've always wanted to debate and challenge is, does the nebulizer change the way that a patient feels about the drug. And what we see is the patient cares about feeling better and the novel MOA and being not on steroids and the delivery of a nebulizer is just a way to get the drug to them. And we believe that, that -- the novel MOA and the benefit-risk profile that Ohtuvayre has provides a much more positive effect than even what you would think a nebulizer could be as a negative.

[Operator Instructions] Our next question today comes from Ram Selvaraju with H.C. Wainwright.

Congratulations once again on this landmark achievement. With respect to the clinical aspects here, maybe a couple of questions for Dr. Wells. Firstly, I was wondering if you specifically are thinking about the combinability of ensifentrine with specific existing approved drugs, in particular or if you really are agnostic to this? You talked earlier about patients who are symptomatic being on dual therapy or tri therapy. And I was just wondering whether you have any preferences with respect to the kinds of drugs that you would want to combine ensifentrine with or if you're more agnostic on this front?

So thank you for the question. So in my practice, because I am -- I work in a quaternary referral center, most, if not all, of the patients that I see are already on at least dual therapy and -- if not triple therapy. And so any of these patients, because of the novel mechanism of action of Ohtuvayre, there's the potential to use it on any of the patients. Now I know the data in the published studies suggest that it works whether it's a stand-alone therapy or on top of maintenance therapy. And so I think again, that is a compelling reason. Now I guess, specifically to your question, if I'm agnostic, I guess I'm somewhat agnostic, I think, mostly because of the novel mechanism of action. But I do think that there's going to be utility regardless of what type of background therapy patients are on.

And then with respect to this question around the nonacute applicability of this drug, I just wanted to better understand what has historically been the norm in this market. And whether it would be an accurate statement to say that drugs that are typically administered via nebulization are not generally used to manage the acute symptoms of COPD patients? Or do you see examples of drugs administered via nebulization being routinely applied to treat acute symptoms?

So I think -- yes, so I think the -- I guess the sort of what is acute therapy and what is maintenance therapy. So there are nebulized treatments that are approved already for maintenance therapy and so for background therapy for COPD. And that being said, the short-acting bronchodilators are really the only ones that we use for acute therapy. So for an acute exacerbation. And so I think that there is and I think there's a pretty good understanding of that within the health care community about when to use therapies for maintenance and when to use therapies for acute disease.

Okay. And then just very quickly for Chris. I was wondering if you could comment on whether you expect trends to emerge on the reimbursement side regarding the extent to which patients have already been managed using either dual therapy or tri therapy as a precursor or prerequisite to the application of ensifentrine? Or if you anticipate that this is really not going to be a factor that it doesn't matter how long a patient may have been on dual therapy or tri therapy before reimbursement agencies would permit the application of ensifentrine and if really what matters is whether or not the patients are remaining symptomatic?

Yes. From that perspective, our discussions today, we don't believe that there would be any, let's call it, a use criteria, that said they have to be dual or triple. Remember, the indication is the maintenance treatment of COPD indication. So it's a broad label, allows the -- it allows the physician to prescribe it, as Dr. Wells has talked about here today. And so our payer conversations have highlighted that as well. So we don't anticipate any type of timing or restriction based off of you have to be on dual or triple.

And ladies and gentlemen, this concludes our question-and-answer session. I'd like to turn the conference back over to David Zaccardelli for any closing remarks.

Well, thank you, everyone, for joining us today. We believe Ohtuvayre as a bronchodilator and nonsteroidal anti-inflammatory treatment can redefine the treatment paradigm for COPD. We are very well positioned for a successful launch of Ohtuvayre for the maintenance treatment of COPD and we look forward to updating you all on our progress. That concludes today's call.

Thank you. The conference has now concluded and we thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.