Verona Pharma - Q3 2024

Executive Summary

• Strong early U.S. launch of Ohtuvayre in Q3: $5.6M net sales in first ~7 weeks; October net sales exceeded the entire Q3, indicating accelerating demand.
• Rapid adoption and breadth: >5,000 prescriptions through October, >2,200 unique prescribers; use spans single, dual, and ~50% triple-therapy backgrounds, with growing depth per prescriber.
• Operating intensity stepped up to support launch and two new Phase 2 programs; Q3 net loss of $43.0M with R&D $10.6M and SG&A $35.2M; cash $336.0M with runway through at least end of 2026 and additional access under $650M facilities.
• Near-term catalysts: CMS permanent, product-specific J-code J7601 effective Jan 1, 2025; potential GOLD guideline placement discussed; continued growth in prescriber reach and refills.

What Went Well and What Went Wrong

What Went Well

• Broad, accelerating launch metrics: “More than 5,000 Ohtuvayre prescriptions [filled] and more than 2,200 unique HCPs [prescribed]… in just 12 weeks”; October net sales exceeded Q3 total, signaling acceleration.
• Favorable access dynamics: 80%+ of dispensed scripts with co-pay < $10; majority of prescriptions processed under medical benefit (Medicare Part B/Advantage) with limited hurdles; non-specific J-code now transitioning to permanent J7601 effective Jan 1, 2025.
• Pipeline momentum: Initiated two Phase 2 programs (ensifentrine+glycopyrrolate combo in COPD; ensifentrine in NCFBE); supportive conference data presented at ERS/CHEST; China partner completed Phase 3 enrollment.

What Went Wrong

• High operating spend during commercialization ramp: SG&A rose to $35.2M (vs $13.4M YoY), driven by sales team build-out, marketing, and support costs; net loss widened to $43.0M.
• No external revenue guidance for Q4: Management declined to provide Q4 revenue guidance despite investor interest, citing early-stage dynamics, though noted no rationale for slowdown given October trends.
• Channel inventory dynamics will modestly affect revenue recognition: Specialty pharmacies held ~2–3 weeks of inventory; CFO indicated approximately “about 1/4” of Q3 sales were inventory build given >8 weeks in market by quarter-end.

Transcript

Operator (participant)

Good morning, everyone, and welcome to Verona Pharma's Q3 2024 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen-only mode. Earlier this morning, Verona Pharma issued a press release announcing its financial results for the three months ended September 30, 2024. 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. The 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 conference call is being recorded and will remain available for 90 days. I now like to turn the floor over to Dr. David Zaccardelli, Chief Executive Officer. Sir, you may begin.

David Zaccardelli (President and CEO)

Thank you, and welcome, everyone, to today's call. We are extremely pleased to be with you today to share our remarkable achievements in Q3 highlighted by the launch of Ohtuvayre. With me today are Mark Hahn, our Chief Financial Officer, Dr. Kathleen Rickard, our Chief Medical Officer, Chris Martin, our Chief Commercial Officer, and Dr. Tara Rheault, our Chief Development Officer. Q3 was exceptional for Verona Pharma, marked by the U.S. launch of Ohtuvayre for the maintenance treatment of COPD and continued progress on our clinical development programs. First, let's review the outstanding launch of Ohtuvayre, which is grounded in its broad COPD indication and the compelling benefits Ohtuvayre provides to COPD patients. After just seven weeks, net product sales were $5.6 million for Q3. We are excited as demand for Ohtuvayre continues to escalate, with net sales for October exceeding Q3.

Now, let's review some key launch metrics. Through the end of October, only 12 weeks after fully launching Ohtuvayre, more than 5,000 Ohtuvayre prescriptions have been filled, with more than 2,200 unique HCPs prescribing Ohtuvayre. Our launch efforts continue to focus on promoting Ohtuvayre to the highest prescribing 14,500 HCPs. In 12 weeks, approximately 30% of our 2,500 tier-one HCPs have prescribed Ohtuvayre. As a reminder, tier-one HCPs write on average 150 COPD maintenance treatment prescriptions per month. We also continue to see that once an HCP prescribes Ohtuvayre, they increase their prescribing to more patients in their practice. We are impressed by the breadth and depth of prescribers and prescriptions this early in the launch. Importantly, HCPs are prescribing Ohtuvayre across a broad range of COPD patients, including background single, dual, and approximately 50% on triple therapy.

This broad utilization across all patient types is consistent with our market research and continues to highlight the significant unmet need across the COPD patient population. Initial feedback from both patients and healthcare providers about the potential of Ohtuvayre to deliver a meaningful impact against COPD, regardless of disease severity and background therapy, is extremely encouraging and is all supported by the early refill data. Our commercial activities to engage HCPs continue to increase month over month. Through the first 12 weeks of launch, we have reached more than 90% of our tier-one and tier-two HCPs through in-person or digital promotion. Our speaker programs with HCPs continue to accelerate, and we expect to have approximately 120 programs completed by the end of 2024. We recently presented new analyses from the phase 3 studies evaluating Ohtuvayre in COPD.

Presentations at CHEST and ERS conferences highlighted subgroup and pooled efficacy and safety analyses from the ENHANCE trials, as well as the impact of Ohtuvayre on COPD-related healthcare resource utilization and the unmet need in COPD based on real-world claims data. At CHEST, our team interacted with approximately 1,500 HCPs at our medical and commercial booths for Ohtuvayre, highlighting the high level of interest in Ohtuvayre from HCPs. While it is still very early in the launch, we are extremely encouraged by the strong start to the U.S. commercialization of Ohtuvayre. Ohtuvayre is the first inhaled COPD treatment to provide both bronchodilation and nonsteroidal anti-inflammatory effects, and we are confident that it can redefine the COPD treatment paradigm. We are also pleased to report the Centers for Medicare & Medicaid Services recently approved a permanent product-specific J-code for Ohtuvayre, which will be effective in January 2025.

Alongside our successful Ohtuvayre launch, we initiated two new phase two clinical programs during Q3. In September, enrollment began in a phase two dose-ranging trial supporting a fixed-dose combination formulation with ensifentrine and glycopyrrolate (LAMA) for the maintenance treatment of COPD delivered via a standard jet nebulizer. The dose-ranging trial is a randomized double-blind, placebo-controlled one-week crossover trial to assess lung function, safety, and the pharmacokinetic profile of glycopyrrolate delivered via nebulizer in approximately 40 subjects with COPD. Following identification of an appropriate glycopyrrolate dose range, a phase two trial assessing the fixed-dose combination of ensifentrine and glycopyrrolate will be conducted. Also in September, enrollment began in the phase two trial to assess nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis. The randomized double-blind, placebo-controlled parallel group trial will enroll 180 subjects with a recent history of pulmonary exacerbations.

The trial will assess the effect of ensifentrine three mg twice daily on the rate and risk of pulmonary exacerbations, symptoms, and quality of life. To ensure robust powering, the trial is event-driven, with all subjects treated for at least 24 weeks and until the required number of exacerbation events are observed. Finally, turning to our global strategy, Nuance Pharma, our development partner for ensifentrine in Greater China, announced it has completed enrollment in its pivotal phase three clinical trial evaluating ensifentrine for the maintenance treatment of COPD in China. Nuance Pharma expects to provide results from the pivotal phase three clinical trial in 2025, and we look forward to providing an update next year. I will now turn the call over to Mark to review our financial results for Q3.

Mark W. Hahn (CFO)

Good morning. Q3 was an exciting one for Verona as we recorded our first sales of Ohtuvayre. For the partial quarter starting in August and ending on September 30th, 2024, we recorded Ohtuvayre net product sales of $5.6 million. As expected, our specialty pharmacy partners are holding inventory at their contracted level of two to three weeks. Cost of goods sold related to Ohtuvayre was $500,000 for the quarter ended September 30, 2024, which consisted of supply chain, post-approval production cost of inventory sold, and royalties payable to Ligand. 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 $10.6 million for the quarter ended September 30, 2024, compared to $3 million reported for the Q3 of 2023.

The increase was primarily due to a $7.8 million increase in clinical trial costs as we initiated two Phase 2 trials over the course of the quarter. Selling, general, and administrative expenses were $35.2 million for the quarter ended September 30, 2024, compared to $13.4 million reported for the same period in 2023. The increase was driven primarily by a $9.7 million increase in people-related costs and $2.8 million in share-based compensation primarily related to our field sales team. In addition, marketing and other commercial-related activities, including travel, increased by $7.5 million, and professional and consulting fees, information technology costs, and other related support costs increased by $1.6 million as we continue to build out our organization. For the quarter ended September 30, 2024, net loss after tax was $43 compared to a net loss after tax of 14.7 million for the same period in 2023.

This represents a loss of $0.07 per ordinary share or 0.18 per ADS for the quarter, compared to a loss of $0.02 per ordinary share or 0.18 per ADS for the Q3 of 2023. Finally, our balance sheet remained strong with $336 million in cash and equivalents as of September 30, 2024. With the cash currently on hand and potential future access to the remaining $425 million under the Oaktree facilities, we expect to have sufficient runway through at least the end of 2026 as we continue the commercial ramp of Ohtuvayre in the U.S. and execute on our two ongoing phase 2 clinical trial programs. I'll now turn the call back over to the operator for the Q&A.

Operator (participant)

Ladies and gentlemen, at this time, we'll begin that question and answer session. To ask a question, you may press star and then one. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys to ensure the best sound quality. Once again, that is star and then one to join the question queue. And our first question today comes from Andrew Tsai from Jefferies. Please go ahead with your question.

Andrew Tsai (Research Analyst)

Hey, good morning. Thanks for taking my questions and congrats on the strong launch and the strong execution. First question is the data point around October net sales exceeding Q3. So does that mean we're run rating at least $17 million for the Q4 without considering any type of growth in November and December? Or should we start to think about some new variables that could come into play, like a holiday period or patients starting to drop out? Or do you think the sheer volume of patient adds can offset any type of headwinds like these discontinuations? Thanks.

David Zaccardelli (President and CEO)

Good morning, Andrew. Thanks for the question. Yeah, so clearly, we're not providing any guidance for Q4. I think your math stands as it is. At this time, we don't see any reason or rationale for any slowdown in the number of patients and the interest and the acceleration that we've seen in October. And so we'll, of course, closely monitor it and continue our efforts as we have in the past several weeks. So we look forward to a continued acceleration of use of Ohtuvayre. Clearly, there's been a lot of interest, as has already been demonstrated, a lot of need, as we've talked about in the past, for an additional novel mechanism like Ohtuvayre in COPD. And we continue to get incredible feedback from physicians and patients, for that matter, really looking forward to utilizing Ohtuvayre in their treatment paradigm.

So we're very excited about what has occurred in this very early part of the launch over the initial 12 weeks, and we expect that to continue.

Yasmeen Rahimi (Managing Director and Senior Research Analyst)

Very good to hear. And then just as a follow-up, 5,000 prescriptions filled through October. By chance, are you willing to disclose how many unique patients you have as of October? And any other metrics you're planning to provide in the next earnings call?

David Zaccardelli (President and CEO)

Yeah, no, thanks. I think the best way to characterize it at this point is it's very fluid, as you can imagine, that patient adds are increasing week over week. Of the over 5,000, of course, the majority of those are the vast majority of those are unique patients. Refills have started, as they should, although very early on in that process, as some of the first patients are starting to be refilled from earlier in the launch. So I think it's best to characterize it as accelerating at this time. There's a substantial number of patients that have been referred in over the past couple of weeks, as we expect. Those are continuing to be processed, and we expect the patient adds to continue to grow.

Andrew Tsai (Research Analyst)

Great. Congrats again.

David Zaccardelli (President and CEO)

Thanks, Andrew.

Operator (participant)

Our next question comes from Yasmeen Rahimi from Piper Sandler. Please go ahead with your question.

Yasmeen Rahimi (Managing Director and Senior Research Analyst)

Yep. Good morning, team. Congrats on a great quarter. I want to stick with the theme of Andrew's question. I guess it seems like things are progressing really well, but can we talk about past December into 2025? Should we be expecting that in the beginning of the year before J.P. Morgan, you could come out and provide some consensus or some guidance in terms of what revenue expectations are? I think it seems like you've had a great quarter, but there's just a lot of room trying to figure out how the next five quarters are going to go. So is there an opportunity to kind of help us understand beyond Q4 what things are going to look like in Q1, Q2, Q3? That's question one. Question two is, do you have any insight on what are the type of patients that are being prescribed Ohtuvayre?

We recently did a KOL call and shockingly found out that the doctor was noting that the majority of his patients are patients who fail triple therapy. So even if you don't have quantitative numbers, what are you hearing from the doctors in terms of how they're using Ohtuvayre? And then the third question is, where do you want to be in terms of physician outreach in the next by year end, by mid-next year? Sorry for the sort of three-part long questions, and I'll jump back in the queue.

David Zaccardelli (President and CEO)

Great. Good morning, yes. Thanks for those questions. I'll sort of not take them in any particular order, but I first would characterize it, as I mentioned during the call, the Ohtuvayre is being prescribed broadly across all patient segments, including patients on background single, dual, and triple therapy, as we expected. With regard to triple therapy, nearly 50% of the prescriptions are on patients that are on triple therapy. So I think we're very encouraged by the breadth of prescribing across all patient types. And as we expected from our market research, that there was keen interest in using Ohtuvayre in patients who were on triple therapy and still needing improvement. We knew that was a large unmet medical need, and that's how physicians are also utilizing it, as well as in other patient types earlier on in the treatment paradigm.

With regard to forecasting, I think it's a little premature at the moment to review it. I think we'll need to assess the continued launch dynamics through Q4, which we will. I think you've seen historically we are very transparent and will provide you the guidance the best we can while not getting ahead of ourselves and making sure that we characterize it properly, but we're very encouraged, very excited, and as you can see, there's great interest in utilizing Ohtuvayre, and so we expect 2025 to be an enormous year of growth and utilization of Ohtuvayre in the treatment of COPD, and we'll look to characterize that. I guess I'll turn it over to Chris on maybe where we'd want to be in outreach over the coming quarters.

Christopher Martin (Chief Commercial Officer)

Hello, yes. Thank you for the question. I think when we think about physician outreach, we continue to focus on our tier one and tier two physicians. Those, as Dave mentioned on the call, are 14,500 doctors, give or take, and on average, the tier one's right about 150 prescriptions and the tier two's around 50. We want to continue to reach them and increase our frequency against these customers as we move into Q4 and into Q1. One of the things that we've seen early in launch is as we increase the interactions we have with these physicians, their ability and willingness to adopt Ohtuvayre accelerates.

We believe that's an important aspect as we move into Q4 and Q1 and into 2025, is to continue to reach as many as we can, but also increase our frequency and the times that we call on them, not only with reps, but interacting with them through digital non-personal channels as well. We see this provides direct benefit to their increasing in their overall prescribing.

Yasmeen Rahimi (Managing Director and Senior Research Analyst)

Thank you. I'll jump back in the queue.

Operator (participant)

Our next question comes from Ram Selvaraju from H.C. Wainwright. Please go ahead with your question.

Raghuram Selvaraju (Managing Director of Healthcare Equity Research)

Thanks so much for taking my questions and congrats on all the progress. Really very impressive commercial metrics here. Firstly, I wanted to ask if you could comment on any emerging prescriber trends, particularly with respect to preferences in combination regimens that prescribers are expressing they have a predilection for with respect to ensifentrine. Are there specific existing modalities that they are preferring to pair ensifentrine with, or are you really just seeing sort of no preference and the drug effectively being very broadly deployed without any underlying emergent trends at this point?

David Zaccardelli (President and CEO)

Yeah. Hi, good morning, Ram. Thanks for the question. Yeah, I would say it's really the latter. I think that what we're seeing is a prescribing across the spectrum of patients. As I mentioned, patients on single, dual, and triple therapy with no particular stated interest in certain combinations or certain drugs or certain LAMAs or LABAs, but rather the class as they're generally utilized interchangeably in practices. As I mentioned, there is a great interest, of course, using it on top of triple therapy, as nearly 50% of the patients are on triple therapy currently. And we expected that, again, feedback from physicians is very positive. And they're seeing, again, responses as they'd expect to in patients being treated early on in the launch. So again, very, very excited and really shows how much Ohtuvayre and a novel mechanism was needed in the treatment of COPD.

And we're seeing it utilized, again, across the spectrum of patients. And again, currently a preference on top of triple only because that was, of course, the highest unmet medical need, as those patients really have nowhere else to go in treatment. And if they remain symptomatic on triple, Ohtuvayre is definitely being preferred.

Raghuram Selvaraju (Managing Director of Healthcare Equity Research)

Great. Thanks. And then with respect to the clinical indications that you are now starting to pursue proof of concept clinical evidence for, in particular, bronchiectasis, can you talk a little bit about how the commercial experience with Ohtuvayre, increasing awareness of Ohtuvayre among prescribers, is likely to frame these additional opportunities and how you go about pursuing them? Have those prescribers who've effectively acquainted themselves with the product since it's been launched expressed an interest in the progress of those additional indications as the drug continues to move forward on fronts beyond COPD?

David Zaccardelli (President and CEO)

Yeah. No, thanks for the question, Ram. I think that our interest in using ensifentrine in non-CF bronchiectasis came from a number of avenues, one of them being an incredibly strong interest from KOLs, physicians that, as we consulted with them, it made great sense to them that ensifentrine's pharmacology as a PDE3, PDE4 inhibitor, as a bronchodilator, and a non-steroidal anti-inflammatory could have great promise in bronchiectasis, and so clearly, there's interest broadly from physicians in it. With that said, of course, we're very focused on Ohtuvayre in COPD, specifically on the commercial front. We will continue to progress ensifentrine in research and in clinical development for non-CF bronchiectasis as we are now progressing with our phase two study.

I think we'll all see how that looks in the future as that study ultimately, because exacerbation is an endpoint and it's at least a 24-week trial. You're talking about data probably well into 2026 at the moment, but let's get the trial enrolled and see where we're at.

Raghuram Selvaraju (Managing Director of Healthcare Equity Research)

Great. And then lastly, this is just an accounting question. You mentioned earlier that certain expenses associated with manufacturing product prior to launch have now been shifted into the SG&A line or away from the R&D line, as it were. So I was just wondering if you could give us a general, maybe qualitative breakdown of which expenses going forward are likely to be segregated into the R&D line versus the SG&A line. For example, the speaker programs, how are you accounting for those? Are there any expenses, in other words, that are associated with effectively commercial activities that you are going to continue to book in the R&D line item? Thanks.

Mark W. Hahn (CFO)

Yeah. Ram, this is Mark. Thanks for the question. The numbers that I was referring to were specifically related to inventory production costs. And so before approval, those were expensed as R&D. And you can imagine, since it's a blow-fill-seal product, that the finished goods were produced after approval, so therefore put into inventory. But the API was produced before approval, and that would have been expensed as R&D expense. All the commercial costs, speaker programs, travel, etc., marketing programs, all get expensed in the period in which they're incurred as part of SG&A expense.

Raghuram Selvaraju (Managing Director of Healthcare Equity Research)

Great. Thank you very much. Congrats once again.

David Zaccardelli (President and CEO)

Thanks, Rahm.

Operator (participant)

Our next question comes from Tom Schrader from BTIG. Please go ahead with your question.

Tom Schrader (Managing Director and Healthcare Analyst)

Thank you. And congratulations. Just looking at the physician number and the prescription number, it seems like you have a lot of people writing one or two prescriptions to try the drug. Do you know what they're looking for to get more excited? And I guess the flip side is, I assume you have some power users. What do they tell you to refine your marketing pitch as to why they're already committed? So thanks.

David Zaccardelli (President and CEO)

Yeah, Tom, let me just make a few comments, and I'll turn it over to Chris for more detail. I think it's, yes, of course, there are physicians who prescribe it one or two patients and want to see how it works in their hands and in their patients. Clearly, that's a typical behavior that can be expected, and that goes on. As you mentioned, there are also physicians which are, let's just say, heavy adopters and are prescribing it quite a bit within their practice as they've seen responses in patients and as they've had really a need in order to use Ohtuvayre in their practice. So we're seeing the spectrum of that.

I think it's also challenging to look at prescriber numbers and patient prescriptions and all of that because it's very fluid, as I referred to, in that just in the past couple of weeks, there are substantial numbers being written that are currently in process on the payer side as well as being adjudicated and make sure that they're going to be filled and going through that process. So any numbers are out of date literally by the end of the day. And so we're trying to characterize for you and being very transparent about where we stand at the moment. But your characterization is also correct in how physicians look at it in their practice. And maybe Chris, you can comment on it.

Christopher Martin (Chief Commercial Officer)

Yeah, Tom, as far as when we look at the breadth and depth of these prescribers, one of the things that's been very encouraging to us and very exciting to us is the fact that what we see is, like you discussed, there's many physicians that start writing off one or two, but we also see over the course of the launch in these early stages that once they write one or two, they're exposed to the patient feedback, they continue to accelerate their usage. I think that's something Dave mentioned in his opening comments. What we see is it's a combination of patient experience and also increased frequency and interactions with our field sales personnel. We have to keep in mind that these doctors have been doing the same thing for 10 to 15 years.

Ohtuvayre, as a novel mechanism and as an add-on across all the spectrum of COPD patients that remain symptomatic in their practice, is something that we have to continue to talk to them about. They are extremely excited about what Ohtuvayre can provide and then ultimately what Ohtuvayre can do to help their patients. I think what we see early on is very, very encouraging from adoption and then moving from one to two to what we would call believers and a doctor who's much more entrenched in using Ohtuvayre.

Tom Schrader (Managing Director and Healthcare Analyst)

I can ask a quick follow-up on your infrastructure. How often are you giving patients drug for a month, and what does your conversion rate look like? How does all that stuff you set up seem to be operating?

Christopher Martin (Chief Commercial Officer)

Yeah. Good question, Tom. We're very pleased with how our infrastructure has been set up. I think one of the things that we talked about very early on was our data infrastructure and the infrastructure to understand where these patients are. And that has worked extremely well so that we're able to understand and kind of work to make sure that patient gets access to the drug. What I will say today is that of those 5,000 dispensed scripts, the majority, a significant majority of those are paid TRXs. We're seeing very positive trends within the payer side. We talked about Medicare Part B and medical benefit. And all those assumptions that we had early on are playing out to be very consistent and true to what we thought going into launch. So that makes us very encouraged about the systems and the process that we put in place.

Tom Schrader (Managing Director and Healthcare Analyst)

Great. Thanks. And congrats again.

David Zaccardelli (President and CEO)

Thanks, Tom.

Operator (participant)

Our next question comes from Edward Thomason from VLK. Please go ahead with your question.

Edward Thomason (Analyst)

Good afternoon. Good morning. Thank you for taking my question. And good to see the prints today. Well done. Just a question, please, on the ramp-up again. You mentioned this specifically to Mark about inventory build. Can you just talk through the dynamics there so we can better understand how that is playing out? And then roughly, if you can split it out, how much of the percentage of the initial sales we saw in Q3 is actually in-market sales versus inventory build?

Mark W. Hahn (CFO)

Thanks, Edward. I'm not sure I quite understood the second part of that question. Can you repeat that part?

Edward Thomason (Analyst)

I just asked whether you can disclose how much of the sales that was reported in Q3 relates to inventory build versus actual in-market sales.

Mark W. Hahn (CFO)

Oh, okay. Inventory build in the channel. Sure. So we haven't disclosed the number, but you can imagine that in a period of rising sales, they're building their inventory and holding about two to three weeks, depending on the different specialty pharmacy partner. It could be anywhere in that range. Nobody more than three weeks on hand. And so you can imagine that we've been on the market for eight weeks at the end of September. So probably about a quarter or so of the inventory of the sales would be in inventory at that time.

Edward Thomason (Analyst)

Okay. That's good to know. And then a separate question actually relates to the IP. I noticed a slight change where you now talk about a couple of additional patents pending, notably one that's on COPD exacerbations. Can you just talk through how important that patent might be to commercial prospects? And does that patent relate just to ensifentrine or specifically the use of PDE3s, PDE4s against COPD exacerbations?

David Zaccardelli (President and CEO)

Yeah. So let me talk a little bit broadly. Of course, all our IP is, I think, very important when you look at it holistically. We did file a number of patents, as you're referring to. The effect on exacerbations is one of them after the enhanced results. Those are in process. We expect a number of them to be listed in the Orange Book over the coming year to year and a half as they continue to be prosecuted. All of those are important, again, in the totality of them, as they should be in protecting our intellectual property. So I think we were specific, of course. It's related to Ohtuvayre. And we'll see at the end of the day how the claims are agreed and constructed. But all our patents are important. Of course, it's grounded in our polymorph patent and our formulation patent.

The additional patents related to the effect of Ohtuvayre are also critically important.

Edward Thomason (Analyst)

Okay. And one last question, if I may. Just can you confirm how many patients from the enhanced clinical program have been converted into commercial prescriptions? And has there been demand amongst that existing user base for Ohtuvayre?

David Zaccardelli (President and CEO)

Yeah. So when we ended the ENHANCE clinical trials, patients were discontinued at the end of the trial. We did not have any long-term follow-up studies ongoing, so as you know, that time gap was substantial between the write-up of the NDA plus the year of review at the FDA, so we wouldn't know which patients that were in the trial may have come back and be on commercial Ohtuvayre.

Edward Thomason (Analyst)

Okay. Thank you very much for taking my questions.

David Zaccardelli (President and CEO)

Thanks very much.

Operator (participant)

Our next question comes from Joon Lee from Truist. Please go ahead with your question.

Joon Lee (Managing Director and Senior Biotech Analyst.)

Hey, congrats on the strong quarter. And thanks for taking our questions. Can you talk about reimbursement rate across government and commercial channels and the rate of prescription abandonment due to copay or any reason? And then congrats on getting the permanent J-code. Is there any COPD treatment guideline or algorithm that is currently in the works that could be introduced soon given the newly approved agents in COPD? Thank you.

David Zaccardelli (President and CEO)

So maybe I'll have Chris just sort of comment on our general payer dynamics.

Christopher Martin (Chief Commercial Officer)

Yeah. So Joon, when we think about reimbursement right now, the majority, I'd say 80+% , like we thought, are going through a medical benefit either through Medicare, traditional Medicare Part B, or Medicare Advantage. And like we assumed at launch, these processes do not require significant hurdles for these patients to get. We're seeing movement within that medical benefit channel very, very, very well. What's also encouraging for us is across the pharmacy benefit side, which is commercial or Medicaid, we see patients having access to Ohtuvayre as well. It does require a prior auth within that process. Each plan is a little bit independent. But we're able to work through that with our SP partners in that process to get patients access to Ohtuvayre.

The other thing that we think is very encouraging is, and again, like what we talked about early on in launch during the setup, was of the patients that have been dispensed scripts, let's just say well over 80% of them have a copay of less than $10, so they have access to Ohtuvayre, and they have access at a very low out-of-pocket cost as well, and I think this bodes very well for the brand long-term as we think about how the launch accelerates. As far as your second question, which was regarding upcoming guidelines or conferences, we do know that the GOLD guidelines have a meeting in November in a couple of days. At that guideline meeting, we believe that Ohtuvayre has an opportunity to be placed in there. As we've talked about in the past, there is a dyspnea pathway and an exacerbation pathway within the guidelines.

Ohtuvayre's unique novel mechanism of action with bronchodilation, nonsteroidal anti-inflammatory allows the Consensus Guideline Committee to be able to put Ohtuvayre in a variety of different spots there. Again, we think this is only an upside for Ohtuvayre. When we talk to physicians today, the big thing that we hear from our reps and the feedback back from HCPs is that we have patients that have persistent symptoms regardless of what therapy they're on, single, dual, or triple background therapy. These persistently symptomatic patients need add-on therapy. And Ohtuvayre can be a very good choice for all these patients to provide additional bronchodilation and potential nonsteroidal anti-inflammatory effects as well.

Joon Lee (Managing Director and Senior Biotech Analyst.)

Great. Well, if I could add one more, Chris, you mentioned previously that 50% of the use is as an add-on to triple therapy, which is really interesting. Has that shifted at all in the first few months of launch?

Christopher Martin (Chief Commercial Officer)

No, Joon. It's still very early to kind of say if there's been any shift. I think the thing that's very encouraging for us is we have add-on use on top of triple. But what you also see is about 50% of these other patients aren't on triple. So remember, our market research early on said that Ohtuvayre could be used alone or as an add-on across all lines of therapy. And in these first through October, we're seeing that. While we're seeing about 50% of patients on triple, we're also seeing patients on a single bronchodilator. We're seeing patients on LABA ICS being added Ohtuvayre. And that is all consistent with what we said in our early market research.

When I think about the health of the launch and the health of what does the ongoing 2025 look like, being able to say that some of that real work that we did early on about unmet need and patient utilization, we're seeing that play out in these first few months of launch. That gives us a lot of encouragement for Q4 and 2025.

Joon Lee (Managing Director and Senior Biotech Analyst.)

It's really encouraging. Well, thank you so much.

Christopher Martin (Chief Commercial Officer)

Thanks, Joon.

Operator (participant)

Once again, if you would like to ask a question, please press star and then one. To remove your questions, you may press star and two. Our next question comes from Boobalan Pachaiyappan from Roth Capital Partners. Please go ahead with your question.

Boobalan Pachaiyappan (Managing Director and Senior Biotech Analyst)

Good morning. Can you hear me?

David Zaccardelli (President and CEO)

Yes, of course. Good morning.

Boobalan Pachaiyappan (Managing Director and Senior Biotech Analyst)

All right. Good morning. Thanks so much for taking our questions and congrats on the progress. We have two. First, there's been some developments in the COPD landscape, most notably the recent approval of Dupixent. We are wondering, do you expect potential headwinds from DUP as you think about penetrating the subsection of the COPD market comprising patients who are on triple therapy? And is there a motivation for prescribers to prioritize ensifentrine over DUP, excluding the cost benefits offered by ensifentrine?

David Zaccardelli (President and CEO)

Yes. Good morning. Thanks for the question. I think, again, it's good for patients with COPD to have choices. It was good to see the approval of Dupixent for the treatment of COPD. I think it highlights the need that exists for additional treatments. With that said, as you well know, Dupixent addresses a relatively narrow patient population or narrow part of the market. Those patients who are on triple therapy have a history of exacerbations, have an elevated eosinophil count. And by Sanofi and Regeneron's own estimation, it's in the U.S. about 300,000 patients. So relatively modest number considering there are about 8.5 million patients who are on maintenance treatment. Because of the large patient population and unmet medical need across the board, we don't see it impacting the commercialization of Ohtuvayre at all.

And if anything, again, brings a spotlight onto the need for treatments in helping patients who are currently symptomatic and needing additional therapy. And even with that said, there is no specific rationale that we know of why Ohtuvayre could not be used with Dupixent if the physician felt that that was the right combination for that patient as well. Completely different pharmacology mechanism of action. Of course, addressing inflammation from multiple modes could be beneficial. And of course, Ohtuvayre's bronchodilation and impact on improving lung function acutely and helping with dyspnea on a day-in and day-out basis is key to its use as well, which some of the other types of approaches don't have that acute bronchodilation. So again, I think it's very good across the board and doesn't change our view because, again, of the large patient population and unmet need.

Boobalan Pachaiyappan (Managing Director and Senior Biotech Analyst)

Yeah. Thanks for the clarity, David. And then maybe a second one and also the final one. So you mentioned about two phase two clinical programs. I was looking at the clinical trials website this morning. And this website also included a trial. Actually, you're currently recruiting for. It's the phase two study to study the effect of ensifentrine on systemic markers of inflammation in COPD patients. So I understand the mechanistic implications of the study. Essentially, you wanted to see or know if ensifentrine interferes with the Ac-PGP and the PGP pathway. So that aside, but I'm curious how you plan to integrate the study outcomes into your clinical and commercial strategy. Is this specifically to collect more data, potentially focusing on exacerbation, and then maybe develop an add-on clinical program, or this could potentially trickle down to your cystic fibrosis program in some other way?

Yasmeen Rahimi (Managing Director and Senior Research Analyst)

How are you thinking about it? Thank you.

David Zaccardelli (President and CEO)

Yes. I mean, I'll make a couple of comments, and Tara, you can comment as well on the study itself. But I think, again, this study is relatively small but very mechanistic in nature, looking at the effects on sputum markers in sputum and continuing to understand the deeper pharmacology of ensifentrine and specifically its PDE3, PDE4 inhibition, and I think as we see the outcome of this study, we will then look at that carefully and then utilize that data in the best way we can to help patients moving forward, whether in COPD or in other indications, and so with that, I don't know if Tara, you want to add anything else to that question.

Tara Rheault (Chief Development Officer)

Yeah. I think it's an eight-week crossover trial looking at inflammation through the Ac-PGP pathway and also looking at inflammatory cell migration into the lungs. So as Dave mentioned, we do expect that to be helpful to better characterize the pharmacology of ensifentrine in patients with COPD. Of course, we have already conducted a sputum study in healthy volunteers challenged with LPS and saw a nice effect across neutrophils, macrophages, eosinophils, and lymphocytes. And so we do expect to see similar data in COPD patients, particularly given the strong exacerbation results from the enhanced program.

Boobalan Pachaiyappan (Managing Director and Senior Biotech Analyst)

All right. Thanks so much for taking my questions.

Christopher Martin (Chief Commercial Officer)

Thanks.

Operator (participant)

Ladies and gentlemen, at this time, we'll be ending today's question and answer session. I'd like to turn the floor back over to Dr. Zaccardelli for any closing comments.

David Zaccardelli (President and CEO)

Great. Thank you, everyone, for joining us on today's call and for your questions. In addition, I want to thank our shareholders for their support and especially the dedicated and talented team at Verona Pharma for their work and commitment. We are extremely excited about the launch of Ohtuvayre and the advancement of our two phase two trials as well. And we look forward to updating you on future calls and look forward to seeing you at conferences as well. Thanks very much and have a great day.

Operator (participant)

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your lines.