Verona Pharma PLC (NASDAQ:VRNA) discussed its third-quarter financials and the commercial progress of its newly launched COPD treatment, Ohtuvayre, during its earnings call on November 7, 2024. Despite a net loss of $43 million for the quarter, the company celebrated the successful U.S. launch of Ohtuvayre, with net product sales reaching $5.6 million within the first seven weeks post-launch. Over 5,000 prescriptions were filled by the end of October, with more than 2,200 healthcare providers prescribing the drug. The strong balance sheet, with $336 million in cash and equivalents, positions the company well for future growth.
Key Takeaways
- Verona Pharma launched Ohtuvayre in the U.S. with $5.6 million in sales and over 5,000 prescriptions within seven weeks.
- A permanent J-code for Ohtuvayre has been approved by CMS, effective January 2025.
- Q3 net loss after tax was $43 million, with increased R&D costs due to new Phase 2 trials.
- The balance sheet remains strong with $336 million in cash and equivalents.
- Management is optimistic about continued sales growth and the drug's broad prescription base.
- Detailed revenue guidance is expected in early 2025, with a focus on physician outreach and additional indications for ensifentrine.
Company Outlook
- Verona Pharma plans to provide detailed revenue guidance in early 2025.
- The company is focusing on increasing interactions with Tier 1 and Tier 2 physicians to improve prescribing behavior.
- Additional indications for ensifentrine are being explored, with a primary focus on COPD treatment.
Bearish Highlights
- The net loss for Q3 2024 widened to $43 million from $14.7 million in Q3 2023.
- Approximately 25% of Q3 sales were due to inventory build rather than actual market sales.
Bullish Highlights
- Ohtuvayre's launch is considered a success with positive feedback from physicians and patients.
- The company's marketing strategies are being refined based on prescriber feedback.
- Patient data management infrastructure is functioning well, aiding in tracking patient progress.
Misses
- No specific misses were discussed in the earnings call summary.
Q&A Highlights
- The company addressed the adoption and prescription trends of Ohtuvayre, noting many physicians are becoming "heavy adopters."
- Verona Pharma is not significantly impacted by competitive pressures from Dupixent, as Ohtuvayre targets a broader patient base.
- A Phase 2 study is investigating ensifentrine's effects on sputum inflammation in COPD patients, which could inform future treatment strategies.
Verona Pharma's Q3 2024 earnings call revealed a company in a strong financial position despite a significant net loss, buoyed by the promising launch of its COPD treatment Ohtuvayre. With a robust cash reserve and strategic plans for commercial and clinical advancement, Verona Pharma remains confident in its ability to grow and meet the needs of COPD patients. The market is responding well to Ohtuvayre, with a high number of prescriptions and positive feedback from the medical community. As the company continues to refine its marketing approach and explore additional indications for its product pipeline, investors and patients alike have reasons to watch Verona Pharma's progress closely.
InvestingPro Insights
Verona Pharma's (VRNA) recent financial performance and market position are further illuminated by data from InvestingPro. Despite the company's Q3 2024 net loss, the stock has shown remarkable strength in the market. InvestingPro data reveals that VRNA has experienced a significant 143.15% price total return over the past six months, and an impressive 148.21% return over the last year. This aligns with the company's successful launch of Ohtuvayre and positive market reception.
The stock's current trading price is near its 52-week high, with the price at 96.88% of its peak, reflecting investor optimism about Verona's commercial prospects. This enthusiasm is further supported by an InvestingPro Tip indicating that VRNA holds more cash than debt on its balance sheet, which corroborates the company's reported strong cash position of $336 million.
However, investors should note that VRNA's P/E ratio stands at -23.23 for the last twelve months as of Q2 2024, underscoring that the company is not yet profitable. This is consistent with another InvestingPro Tip suggesting that analysts do not anticipate the company will be profitable this year. This information provides context to the reported Q3 net loss and the company's focus on future revenue growth.
For those seeking a deeper understanding of VRNA's financial health and market position, InvestingPro offers 16 additional tips, providing a comprehensive analysis to inform investment decisions.
Full transcript - Verona Pharma PLC ADR (VRNA) Q3 2024:
Operator: Good morning, everyone, and welcome to Verona Pharma's Third Quarter 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. 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 conference call is being recorded and will remain available for 90 days. I'd now like to turn the floor over to Dr. David Zaccardelli, Chief Executive Officer. Sir, you may begin.
David Zaccardelli: Thank you, and welcome, everyone, to today's call. We are extremely pleased to be with you today to share our remarkable achievements in the third quarter, highlighted by the launch of Ohtuvayre. With me today are Mark Hahn, our Chief Financial Officer; Dr. Kathy Rickard, our Chief Medical Officer; Chris Martin, our Chief Commercial Officer; and Dr. Tara Rheault, our Chief Development Officer. The third quarter 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 the third quarter. We are excited as demand for Ohtuvayre continues to escalate with net sales for October exceeding the third quarter. 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 1 HCPs have prescribed Ohtuvayre. As a reminder, Tier 1 HCPs write on average 150 COPD maintenance treatment prescriptions per month. We also continue to see that once an HCP prescribes Ohtuvayre, they increased 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 over 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 health care 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 1 and Tier 2 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 analysis from the Phase 3 ENHANCE studies evaluating Ohtuvayre in COPD. The presentations at CHEST and ERS conferences highlighted subgroup and pooled efficacy and safety analysis from the ENHANCE trial as well as the impact of Ohtuvayre on COPD-related health care resource utilization in 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 boots for Ohtuvayre, highlighting the high level of interest in Ohtuvayre from HCPs. While it's 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 non-steroidal 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 and 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 2 clinical programs during the third quarter. In September, enrollment began in a Phase 2 dose-ranging trial supporting a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a 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 the OPD. Following identification of an appropriate glycopyrrolate dose range, a Phase 2 trial assessing the fixed dose combination of ensifentrine and glycopyrrolate will be conducted. Also in September, enrollment began in the Phase 2 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 3 milligram 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 3 clinical trial evaluating ensifentrine for the maintenance treatment of COPD in China. Nuance Pharma expects to provide results from the pivotal Phase 3 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 the third quarter
Mark Hahn: Good morning. The third quarter 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 30, 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 manufacturer 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 third quarter 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 million 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 $0.53 per ADS for the quarter compared to a loss of $0.02 per ordinary share or $0.18 per ADS for the third quarter of 2023. Finally, our balance sheet remains 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 up Ohtuvayre in the U.S. and execute on our two ongoing Phase II clinical trial programs. I'll now turn the call back over to the operator for the Q&A.
Operator: [Operator Instructions] Our first question today comes from Andrew Tsai from Jefferies.
Andrew Tsai: Congrats on the strong launch and the strong execution. First question is your -- the data point around October net sales exceeding Q3. So does that mean we're run rating at least $17 million for fourth quarter 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 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?
David Zaccardelli: Andrew thanks for the question. Yes. 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 Ohtuvayre in their treatment paradigm. So, we're very excited about what is occurred in this very early part of the launch over the initial 12 weeks, and we expect that to continue.
Andrew Tsai: 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: Yes. 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 -- vast majority of those are unique patients. Refills have started as they should, although very early on in that process and 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 continued to be processed and we expect the patient has to continue to grow.
Operator: Our next question comes from Yasmeen Rahimi from Piper Sandler.
Yasmeen Rahimi: Yes congrats on a great quarter. I want to stick with the theme of Andrew's question. I guess it seems part things are progressing really well, but can we talk about past December into 2025? Like should we be in the beginning of the year before JPMorgan, 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, like, beyond fourth quarter, what things are going to look like in 1Q, 2Q, 3Q? That's question one. Question two is, do you have any insight on who are -- what are the type of patients that are being prescribed Ohtuvayre. We recently did a Q1 call and shockingly found out that the doctor was noting that a majority of his patients are -- patients who failed 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 like, where do you want to be in terms of physician outreach in the next -- by year and by mid next year. Sorry for that sort of three part long questions, and I'll jump back in the queue.
David Zaccardelli: Thanks for the question. I'll sort of not take 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 the fourth quarter, which we will. I think you've seen historically, we are very transparent and we've provided 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 is 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: Yes. I think when we think about physician outreach, we continue to focus on our Tier 1 and Tier 2 physicians. Those, as Dave mentioned on the call, are 14,500 doctors, give or take, on average, the Tier 1 is right about 150 prescriptions and the Tier 2 is 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 that we increase the interactions we have with these physicians, their ability and willingness to Ohtuvayre accelerates. And we believe that's an important aspect as we move into Q4 and Q1 and into 2025 as to continue to reach as many as we can, but also increase our frequency in 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 provide a direct benefit to their increasing in their overall prescribing.
Operator: Our next question comes from Ram Selvaraju from HC Wainwright.
Raghuram Selvaraju: 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 incessant, or are you really just seeing sort of no preference and the drug effectively being very broadly deployed without any underlying emerging trends at this point?
David Zaccardelli: Thanks for the question. Yes, 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 classes 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 accept 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 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 variance definitely being preferred.
Raghuram Selvaraju: 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: Yes. Thanks for the question, Ram. I think that our interest in using ensifentrine in 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 makes great sense to them, that ensifentrine pharmacology as a PD3, PD4 inhibitor as a bronchodilator and a non-steroidal antiinflammatory could have great promise in bronchiectasis. And so clearly, this interest broadly from physicians. With that said, of course, we're very focused on Ohtuvayre and 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 2 study. I think we will 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: 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?
Mark Hahn: Ram, this is Mark. The numbers that I was referring to were specifically related to inventory production costs. And so before approval, those are 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 expenses or the expense. All the commercial costs, speaker programs, travel, et cetera, marketing programs all get expensed in the period in which they are incurred as part of SG&A expense.
Operator: And our next question comes from Tom Shrader from BTIG.
Tom Shrader: 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 power users. What do they tell you to refine your marketing pitch as to why they're already committed?
David Zaccardelli: Yes, 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 they 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 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, and that just in the past couple of weeks, there are substantial numbers of being written that are currently in process on the payer side as well as being adjudicated and make sure 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: Yes, 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, or 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 and 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 and they are extremely excited about what Ohtuvayre can provide and then ultimately, what Ohtuvayre can do to help their patients. So I think what we see early on is very, very encouraging from an 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 Shrader: Can I ask a quick follow-up on your infrastructure. How often are you giving patients drug for a month? And what is your conversion rate looks like? How does all that stuff you set up seem to be operating?
Christopher Martin: Yes. 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 patients can access to the drug. What I will say today is that, of those 5,000 dispense scripts, the majority -- a significant majority of those are paid [TRXs]. We were seeing very positive trends within the payer side. We talked about Medicare Part B and medical benefit, and all those assumptions that we had earlier 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.
Operator: Our next question comes from Edward Thomason from VLK.
Edward Thomason: Just a question, please, on the ramp-up again. You mentioned 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 that -- of the initial sales we saw in Q3 is actually in market sales versus inventory build?
Mark Hahn: Thanks, Edward. I'm not sure I quite understood the second part of that question. Can you repeat that part?
Edward Thomason: I just asked whether you can disclose how much of the sales that were reported in Q3 related to inventory build versus actual in-market sales.
Mark Hahn: In the 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 in holding about two to three weeks, depending on the different specialty pharmacy partner 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 1/4 or so of the inventory of the sales would be in inventory at that time.
Edward Thomason: That's good to know. And then a separate question actually relates to the IP. I noticed a slight change where you've now talk about a couple of additional patents pending, literally one that's on COPD exacerbations. Can you just walk through how important that patent might be to commercial prospects. And does that perhaps relate just to ensifentrine or specifically the use of PD3, PD4s against COPD exacerbations?
David Zaccardelli: Yes. So let me talk broadly, of course, all our IP is, I think, very important as 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 1 to 1.5 years as they continue to be prosecuted. All of those would -- 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 reading constructed. But all our patents are important. Of course, it's grounded in the polymorph patent and our formulation patent and the additional patents limited to the effect of Ohtuvayre are also critically important.
Edward Thomason: And one last question, if I may. Just can you confirm how many patients from the ENHANCE clinical program have been converted into commercial prescriptions? And has there been demand amongst the existing user base for Ohtuvayre?
David Zaccardelli: Yes. So we -- 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.
Operator: Our next question comes from Joon Lee from Truist.
Joon Lee: Congrats on the strong quarter. Can you talk about reimbursement rate across government and commercial channels and the rate of prescription abandonment due to co-pay 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?
David Zaccardelli: So maybe I'll have Chris just sort of comment on our general pay dynamics.
Christopher Martin: Yes. So Joon, when we think about reimbursement right now, the majority, I'd say, 80-plus percent like we thought are going through a medical benefit, either through Medicare -- traditional Medicare Part B or Medicare Advantage. And like we assume at launch, these processes do not require significant hurdles for these patients to get. We're seeing movement within that metal 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 off within that process. Each plant is a little bit independent, but we're able to work through that with our SP partners and 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 about, let's just say, well over 80% of them have a co-pay of less than $10. So they have access to Ohtuvayre and they have access, so there's 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 the number, in a couple of days at that guideline, 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 and Ohtuvayre's unique novel mechanism of action with bronchodilation, non-steroidal 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 are 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 non-steroidal anti-inflammatory effect as well.
Joon Lee: Well, if I could add 1 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: 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. And when I think about the health of the launch, and the health of what is the ongoing 2025 look like being able to say that some of that real work that we daily on about unmet need and patient utilization, we're seeing that play out in these first few months of launch. And that gives us a lot of encouragement for Q4 2025.
Operator: [Operator Instructions] Our next question comes from Boobalan Pachaiyappan from Roth Capital Partners.
Boobalan Pachaiyappan: Congrats on the progress. So we have two. Firstly, the recent developments in the COPD landscape, most notably the recent approval of Dupixent. So we are wondering, do you expect potential headwinds from DUP as you think about penetrating the subscription of the COPD market comprising patients who are on triple therapy. And is there a motivation for prescribers to prioritize ensifentrine for DUP, excluding the cost benefits offered by ensifentrine?
David Zaccardelli: Yes. Thanks for the question. I think, again, it was -- it's good for patients of 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 the relatively narrow patient population or a 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 (NASDAQ:SNY) Regeneron (NASDAQ:REGN)'s own estimation, it's in the U.S. about 300,000 patients, 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, bring the spotlight on to the need for treatments and helping patients who are currently symptomatic in the 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 thought that was the right combination for that patient as well, completely different pharmacology, mechanism of action, of course, addressing inflammation for multiple modes could be beneficial. And of course, Ohtuvayre bronchodilation and impact on improving lung function acutely and helping with dyspnea on a day and day out basis is key to what see 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: And then maybe a second one and also the final one. So you mentioned about two Phase 2 clinical programs. I was looking at the clinical trials on website this morning. This website also included a trial actually you're currently recruiting for. It's a Phase 2 study to study the effect of ensifentrine on sputum inflammation in COPD patients. So I understand the mechanistic implications of the study, as you wanted to see or no if ensifentrine interferes with 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 official 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? How are you thinking about it?
David Zaccardelli: Yes. I may 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 PD3. PD4 inhibition. And I think as we see the outcome of the study, we will then look at that carefully and then utilize 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, do you want to add anything to that question.
Tara Rheault: Yes. 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 lung. So as Dave mentioned, we do expect that to be helpful to better characterize pharmacology events esifentrine in patients with COPD. Of course, we have already conducted a sputum study and healthy volunteers challenged with LPS. And saw a nice effect across neutrophils, macrophages, eosinophils or lymphocytes, though we do expect to see similar data in COPD patients, particularly given the strong exacerbation results from the ENHANCE program.
Operator: And 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: 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 2 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: 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.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.