Verona Pharma - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 net product sales accelerated to $36.6M from $5.6M in Q3; total Q4 revenue was $36.7M, with operating loss narrowing versus Q3 due to higher gross profit from launch momentum.
• Ohtuvayre adoption broadened: 4,600+ unique prescribers, ~55% Tier 1 penetration, and >275 HCPs with 20+ patients; ~50% of patients are on triple therapy, reinforcing use across lines of COPD care.
• Infrastructure tailwinds: permanent J-code became effective Jan 1, 2025, and management reported more prescriptions dispensed through February 2025 than in the entire Q4, pointing to sustained Q1 momentum.
• Strategic progress: glycopyrrolate dose-ranging completed; Phase 2b fixed-dose combo planned H2’25; EU/UK regulatory activities underway; Macau approval and mid-2025 data read for China partner Nuance.
• Estimates: S&P Global Wall Street consensus data were unavailable at time of analysis; on the call, an analyst referenced 2025 consensus of ~$254M, and CFO outlined cash-flow break-even at ~$250–$300M annualized run-rate by year end, implying continued ramp as the principal stock catalyst.
  Note: S&P Global consensus not retrieved due to data access limitations; comparisons to Street estimates are therefore not provided.

What Went Well and What Went Wrong

What Went Well

• Rapid commercial ramp: Q4 net product sales reached $36.6M, totaling $42.3M for FY 2024 after launch in August, demonstrating strong early adoption.
• Broad prescriber engagement: Over 4,600 unique HCPs prescribed, ~55% of Tier 1 HCPs engaged, and >275 HCPs prescribing to 20+ patients; “These early launch results are remarkable and support our belief that Ohtuvayre can become a blockbuster product.” — CEO.
• Patient access/reimbursement: Management cited majority claims under medical benefit (Medicare B/Advantage), with “over 80%” of dispensed patients seeing co-pays < $10, reducing abandonment risk.

What Went Wrong

• Elevated operating spend: Q4 SG&A rose to $45.1M (Q4 2023: $15.0M), driven by launch-related marketing, people costs, and share-based compensation; net loss widened YoY to $(33.8)M.
• Gross-to-net sensitivity: While impact in Q1 expected to be limited, commercial co-pay assistance and deductible resets were flagged as toggles to monitor; CFO noted any effect should be small given commercial mix is a “very small portion” of shipments.
• No quantitative revenue guidance: Management declined to provide quarterly revenue guidance, and S&P Global estimates were unavailable; investors must rely on operational KPIs and run-rate commentary for trajectory.
  Note: S&P Global consensus not retrieved due to data access limitations.

Transcript

Operator (participant)

Good morning, ladies and gentlemen. Welcome to the Verona Pharma Fourth Quarter and Full Year 2024 Financial Results and Conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, February 27, 2025. I would now like to turn the conference over to David Zaccardelli, the Chief Executive Officer. Please go ahead.

David Zaccardelli (President and CEO)

Thank you, and welcome everyone to today's call. During the past quarter, we achieved remarkable progress with the launch of Ohtuvayre, along with advancing our development programs, and look forward to updating you today. With me are Mark Hahn, our Chief Financial Officer, Dr. Kathleen Rickard, our Chief Medical Officer, Chris Martin, our Chief Commercial Officer, and Dr. Tara Rheault, our Chief Development Officer. 2024 was another transformational year for Verona Pharma, with the U.S. FDA approval and commercial launch of Ohtuvayre for the maintenance treatment of COPD. 2024 was also an important year for millions of patients suffering from COPD, as Ohtuvayre is the first inhaled therapy with a novel mechanism of action available for COPD in over 20 years.

In addition to the outstanding launch, which I'll walk through in a moment, we progressed our Phase II pipeline programs in COPD and bronchiectasis and have made key advances in our global partnering and regulatory strategy. First, let's review the initial launch of Ohtuvayre, which is grounded in its broad indication for the maintenance treatment of COPD and its compelling benefit-to-risk profile. In the first full quarter of commercial availability, net sales of Ohtuvayre were $36.6 million in the fourth quarter and $42.3 million for the full year 2024. We are very pleased to report the extremely strong initial launch continues to build momentum, with more prescriptions dispensed in the first two months of Q1 2025 than in Q4 2024. Additionally, we saw month-over-month growth in dispensed prescriptions, new patient starts, and refills. These early launch results are remarkable and support our belief that Ohtuvayre can become a blockbuster product.

We continue to strengthen our prescriber base with over 4,600 unique HCPs prescribing Ohtuvayre, including approximately 55% of our 2,500 Tier 1 HCPs. We continue to see HCPs expanding their prescribing to more patients. Specifically, over 275 HCPs have now prescribed Ohtuvayre to more than 20 patients in their practice. We continue to be very encouraged by the breadth and depth of prescribers and prescription metrics. In addition to these impressive key launch metrics, we see HCPs are continuing to prescribe Ohtuvayre across a broad range of COPD patients, including patients on background single, dual, and approximately 50% on triple therapy. This utilization across all patient types strengthens our belief that Ohtuvayre's novel bronchodilator and nonsteroidal anti-inflammatory activity can redefine the treatment paradigm for COPD.

Feedback from both patients and healthcare providers about the meaningful impact of Ohtuvayre is extremely encouraging and is also supported by our continued refill and persistency data, including patients receiving over five refills. Alongside our successful Ohtuvayre launch, we have continued to advance our pipeline with two Phase 2 clinical programs. Following the end of the year, we successfully completed our Phase 2 dose-ranging clinical trial with glycopyrrolate LAMA, to support a fixed-dose combination with nebulized ensifentrine for the maintenance treatment of COPD. This study confirmed the appropriate dose range of nebulized glycopyrrolate to support further clinical development of the fixed-dose combination. We plan to initiate a dose-ranging Phase 2b trial evaluating a fixed-dose combination of ensifentrine with glycopyrrolate compared to the individual components in the second half of 2025. In addition, enrollment continues in our Phase 2 trial to assess nebulized ensifentrine in patients with bronchiectasis.

The randomized double-blind placebo-controlled parallel group trial will enroll 180 subjects with a recent history of pulmonary exacerbations. The study will assess the effect of ensifentrine 3 mg twice daily on the rate and risk of pulmonary exacerbations, symptoms, and quality of life. Finally, turning to our global strategy, Nuance Pharma, our development partner for ensifentrine in Greater China, recently announced the approval of Ohtuvayre in Macau for the maintenance treatment of COPD in adult patients, marking the first approval of Ohtuvayre outside the U.S. This is an important step in our mission to address the needs of millions of patients across the globe still experiencing persistent COPD symptoms despite current therapies. Nuance Pharma also announced it has completed enrollment in its pivotal Phase 3 clinical trial in China to evaluate ensifentrine for the maintenance treatment of COPD and expects to provide results in mid-2025.

Finally, we are also initiating activities with regulatory authorities in preparation for potential marketing authorization application submissions in the European Union and the United Kingdom. We look forward to updating you on this progress. I will now turn the call over to Mark to review our financial results for Q4 and full year 2024.

Mark Hahn (CFO)

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

Research and development costs were $7.9 million for the quarter ended December 31, 2024, compared to $4.1 million reported for the fourth quarter of 2023, and $44.6 million for the year ended December 31, 2024, compared to $17.2 million reported for 2023. The increase across the annual periods was primarily due to increases in clinical trial and other development costs related to the initiation of two Phase II trials of $17.5 million, the $6.3 million approval milestone, an increase in share-based compensation of $3.1 million, and increases in people-related costs and pre-approval manufacturing costs. Selling, general, and administrative expenses were $45.1 million for the quarter ended December 31, 2024, compared to $15 million reported for the same period in 2023, and $149.8 million for the year ended December 31, 2024, compared to $50.4 million for 2023.

The increase across the annual periods was primarily due to a $29.7 million increase in marketing and other commercial-related activities supporting the launch of Ohtuvayre, the $15 million first sale milestone, a $26.8 million increase in people-related costs as we built out our commercial organization, and an $18.8 million increase in share-based compensation. For the quarter ended December 31, 2024, net loss after tax was $33.8 million, compared to a net loss after tax of $14.1 million for the same period in 2023, and $173.4 million for the year ended December 31, 2024, compared to $54.4 million for the prior year.

This represents a loss of $0.05 per ordinary share or $0.41 per ADS for the quarter, compared to a loss of $0.02 per ordinary share or $0.18 per ADS for the fourth quarter of 2023, and a loss of $0.27 per ordinary share or $2.13 per ADS for the year, compared to a loss of $0.09 per ordinary share or $0.69 per ADS in 2023. Finally, our balance sheet remains strong, with $400 million in cash and equivalents as of December 31, 2024. In addition, we have access to up to $425 million of additional capital through the Oaktree facilities. I'll now turn the call back over to the operator for the Q&A.

Operator (participant)

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the number one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you are using a speakerphone, please lift the handset before pressing any keys. The first question comes from Andrew Tsai with Jefferies. Please go ahead.

Andrew Tsai (Equity Analyst)

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

David Zaccardelli (President and CEO)

Thank you.

Right. Good morning, Andrew. Thank you for the question. I'll turn it over to Mark to provide his thoughts on that dynamic and gross to nets.

Mark Hahn (CFO)

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

Christopher Martin (Chief Commercial Officer)

Yeah. Andrew, thanks for the question. As far as the fills, I think, as we've stated before, we're, at the beginning of the year, subject to deductible resets, just like every other brand that works through the Medicare sector or line of business. I think what we've also said is that we believe very strongly that the momentum of launch outweighs any potential deductible resets that many of these patients may have. Remember, we're still nominally in the second full quarter of launch, and our expectation is that you would expect to continue to see increasing new patients, refills, and total dispenses on a monthly basis. I think you are going to deal with, at the beginning of the year, some deductible reset with patients that have Medicare Advantage and high deductible plans.

But again, I believe that's very strongly that the momentum of the initial launch is going to outweigh some of those early macro dynamics that every brand faces at the beginning of the year.

Andrew Tsai (Equity Analyst)

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

Mark Hahn (CFO)

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

Andrew Tsai (Equity Analyst)

Okay, and I think.

Mark Hahn (CFO)

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

Andrew Tsai (Equity Analyst)

Right. Thank you very much. Congrats again.

Mark Hahn (CFO)

Thanks.

Operator (participant)

Thank you. The next question comes from Yasmin Rahimi from Piper Sandler. Please go ahead.

Yasmin Rahimi (Managing Director and Senior Research Analyst)

Good morning, team, and congrats on really an incredible launch. I guess the first question that I have is one that we all analysts are getting from many of our clients owning Verona is, given the outstanding launch, what are some of the headwinds that could be headed our direction? What are some of the risks that we're not foreseeing or anything that could happen? And I would love, I guess, what are the things that's keeping you guys up at night? Because the growth chart looks beautiful. That's sort of one. And question number two is around your thoughts around European filing. Help us understand what is the market opportunity in, I think, the UK and select countries. I think in the past, pricing is substantially lower in Europe. What led to wanting to really pursue that? And how do we think about the opportunity there?

And also, I guess, the cost needed to build out a sales force. Appreciate, sorry, multi-part question around that. So thank you.

David Zaccardelli (President and CEO)

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

As you can see, the expanse and the breadth and depth of prescribing continues now with over 4,600 unique HCP prescribers. Approximately 55% of the tier one targeted prescribers are prescribing already. I think that shows you of the pent-up need for Ohtuvayre and for helping patients who remain symptomatic, so we expect that to continue. There are clearly in our target list, 14,500 HCPs and, of course, all the HCPs that surround those in the different offices, and so we see an expanding opportunity continually to get to more prescribers and help more patients, and so from a market dynamic standpoint, from a patient, from an unmet need, we really don't see any specific headwinds. From a competition perspective, again, in any timeframe of the foreseeable future, we don't see anything that looks like Ohtuvayre, a bronchodilator, and a nonsteroidal anti-inflammatory.

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

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

Yasmin Rahimi (Managing Director and Senior Research Analyst)

Thank you so much, David.

David Zaccardelli (President and CEO)

Great.

Operator (participant)

Thank you. The next question comes from Tiago Fauth with Wells Fargo. Please go ahead.

Tiago Fauth (Director and Senior Equity Research Analyst)

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

David Zaccardelli (President and CEO)

Yeah. No. Hi, Tiago. Thanks. Good morning. So yeah, I think that in our modeling and how we've described it, we use sort of the benchmark of typical COPD drugs that are their normal persistence and use over the year. And that has been based on around six refills per year. As you know, the way we distribute Ohtuvayre through a specialty pharmacy network and the ability to track the patients very carefully and support them through the specialty pharmacy, we think that there is some upside to that. And it is very early, though, to actually characterize that. We are encouraged by the refills. I think that comes from the fact that Ohtuvayre is, of course, helping patients. And the refills, again, very early yet because, of course, the most refills, as we talked about, patients now receiving over five refills already.

But of course, it's from earlier patients that started in the first part of the launch in 2024. So as we get through 2025, we'll have, of course, a greater number of patients, more refilled information to look at. But yes, we're very encouraged by where we are right now. And yes, we do think there is upside to the six refills per year.

Tiago Fauth (Director and Senior Equity Research Analyst)

Fair enough. Thanks again for taking the question.

David Zaccardelli (President and CEO)

Thanks.

Operator (participant)

Thank you. The next question comes from Thomas Shrader with BTIG. Please go ahead.

Thomas Shrader (Managing Director and Senior Biotechnology Equity Research Analyst)

Good morning. Congratulations. I was trying to get up the nerve to ask the break-even question after one quarter. So thank you for asking. I have a couple of surveillance questions. Any common themes in the 45% who are not prescribing the drug? Are there any structural things you are working on? And then the nebulizer. How big a deal is the nebulizer? This is really a peak sales question. Are you building into patients that have a nebulizer, or are there significant numbers of patients who are adding a nebulizer to add this drug? Thank you.

David Zaccardelli (President and CEO)

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

I think one of the things that keeps us very encouraged and excited about the future of Ohtuvayre is when we do market research on physicians that have written and those that haven't written yet. All doctors see the benefits of Ohtuvayre with the profile and the potential in their patients. They also talk about how they would start writing within the next three, six, 12 months. So I think when we look at our market research, we understand that our writer group base will continue to grow, and we will continue to penetrate these doctors that haven't written so far because of the profile of Ohtuvayre. As far as the nebulizer, I think this is something that we got as a question very early on of, can this drug will people use a nebulized drug? And our hypothesis going into this was that innovation would trump route of administration.

And we're very clearly seeing that in the early stages of launch or this early part of launch. In fact, when we look at our data, we have patients that don't have a nebulizer, patients that do have a nebulizer. And the core underlying feature that the doctors are prescribing Ohtuvayre is around persistent symptoms. And route of administration has become kind of a non-issue. It's not something that comes up from a field perspective with the doctors. It's not something that comes up with patients. In fact, many patients talk about how nebulizer is a comforting way to deliver their product because they know it gets to their lungs. So I think that's been something early in launch that I think has been dispelled. And it really showcases the innovation that Ohtuvayre is bringing to the COPD marketplace.

Thomas Shrader (Managing Director and Senior Biotechnology Equity Research Analyst)

Great. Thank you.

Operator (participant)

Thank you. The next question comes from Ram Selvaraju with HCW. Please go ahead.

Ram Selvaraju (Managing Director and Senior Healthcare Equity Research Analyst)

Thanks so much for taking my questions. Congrats early on the phenomenal progress with the launch. It's really very impressive. Firstly, I wanted to ask whether you see any underlying market dynamic trends emerging with respect to prescriber preferences regarding the deployment of Ohtuvayre, especially now that we've gotten a little bit further into the commercial trajectory. In particular, if you can comment on whether you expect the proportion of patients on Ohtuvayre who are also receiving tri-therapy to increase over time or remain constant. Also with respect to the ex-US picture, I was just wondering if there are territories beyond EU and Greater China that you believe are likely to be particularly lucrative for ensifentrine and what your strategic plans are to target those territories.

If you could also perhaps comment on the pricing situation in Greater China, what the pricing dynamics look like in Macau now that the product has been approved there, just so we can get a bit of a handle on what performance Nuance might be able to realize with the drug once it's available. Thank you.

David Zaccardelli (President and CEO)

Hi, Ram. There's a lot to unpack there. Let me start sort of near the back of that question list, and we'll work our way through it. Our strategy is still, of course, to partner outside the U.S. as we have already, as you mentioned, in Greater China. I think the other regions are all important in their own way. Clearly, incremental and in totality are very significant in the growth for Ohtuvayre on a global basis. Other regions, again, outside Europe, Greater China, but even in Japan, in other parts of Asia as well. And of course, the other emerging markets, South America, all become incremental and are important. Now, I've been always saying that there was nothing more important than having a successful launch in the U.S., which we continue to execute on. That's what we'll continue to focus for sure.

But we'll carry on with the strategy in 2025 in partnering. And as I mentioned, we're already starting that in more progressive state by working with the regulatory authorities in Europe and the U.K. And maybe I'll turn it over to Chris to talk about sort of the dynamics, the market dynamics, and how that has been what we've seen based on what we did in market research.

Christopher Martin (Chief Commercial Officer)

Thanks, Dave. When we look at the patients and what's a consistent theme about who's getting prescribed Ohtuvayre, it goes back to some very simple kind of truths. These patients all have persistent symptoms, particularly dyspnea, and that's a very big trigger for the physician to add or change therapies within these patients, so when our reps go into these offices, it's not about what the background therapy is. It's more about what is the patient dealing with today in regards to persistent symptoms, either dyspnea, decreasing activities, and how Ohtuvayre could potentially help with these patients over time. The other thing that I think we're very encouraged by is, as Dave talked about in his opening comments, which is 50% of our patients are on therapies that are not considered triples. So either a single bronchodilator, a dual bronchodilator, a LABA ICS, or a no-long-acting bronchodilator.

I think this is going to increase over time. As we've heard from physicians and research and seen from our interactions in the field, doctors are looking for another mechanism and another way to provide bronchodilation and nonsteroidal anti-inflammatory effects that don't involve using steroids. So I believe over time, the addition to triple will potentially become less than the addition to earlier lines of therapies for these patients as they look to move ICS into maybe a more appropriate place than it is used today. It really talks about the long-term potential of Ohtuvayre, not only in its current form, but potentially as a combination product, as Dave has mentioned in his comments earlier about our pipeline expansions. So I really feel like that's a great opportunity as we move through 2025 and into 2026 as well.

Ram Selvaraju (Managing Director and Senior Healthcare Equity Research Analyst)

Thank you very much.

Operator (participant)

Thank you. The next question comes from Joon Lee from Truist. Please go ahead.

Joon Lee (Managing Director and Senior Biotechnology Equity Research Analyst)

Thanks for the update and for taking our questions. We spoke with several pulmonologists, and there seems to be a wide range of prescription reimbursement rates ranging from over 90% to less than half for some pulmonologists. Could you help us understand some of the pushes and pulls on reimbursement and what you are doing to improve this? And just a clarification question on European partnership. Is it your plan to have some clawback clauses like the one you have in Nuance in case someone else may merge that may want the global right? Thank you.

David Zaccardelli (President and CEO)

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

Christopher Martin (Chief Commercial Officer)

Yeah, Joon. As far as reimbursement, I think we've been very pleased with how the reimbursement looks in this early stage of launch. As we talked about at launch, we anticipated about 80% of our reimbursement or claims would fall under a medical benefit, either under Medicare Part B or Medicare Advantage. And that's holding consistent as we go into these launches. I think one of the things that I always have talked about is that we have access in those channels, meaning patients can get it. There's no prior auth. There's no real step edits. There's access to Ohtuvayre in those channels. What it becomes is an out-of-pocket cost for patients. If a patient has supplemental insurance, we see their copays are usually less than $10. If the patient's met their deductible and Medicare Advantage, their copays less than $10 or even nothing.

And so that's the driver of potentially reimbursement. It's not necessarily access. It's more of an out-of-pocket cost. Within the Medicare side, we cannot provide any assistance to patients within Medicare. So they really have to work through their deductibles or have some supplemental insurance. On the commercial side, we have robust copay card programs and provide that to patients. Additionally, we've created other services including patient assistance programs for patients that are low income that they can get this product through that process as well. But I would say within these first two quarters, nominally first two quarters of launch, we are very encouraged by the way reimbursement and access is presenting itself. And more importantly, when we get a patient on drug, we're seeing many of these patients, the vast majority, I would say over 80% of them having copays less than $10 as well.

Joon Lee (Managing Director and Senior Biotechnology Equity Research Analyst)

Thank you.

Operator (participant)

Thank you. The next question comes from Boobalan Pachaiyappan with Roth. Please go ahead.

Boobalan Pachaiyappan (Managing Director and Senior Healthcare Equity Research Analyst)

Good morning, Tim. Can you hear me okay?

David Zaccardelli (President and CEO)

Yes. Good morning.

Boobalan Pachaiyappan (Managing Director and Senior Healthcare Equity Research Analyst)

All right. Hi. Okay. Thanks for that. So I just have a couple of questions. So one of them focusing on the refill process. So as more and more patients are going for refill, so I'm wondering how does the process work in the real-world setting? So do patients have to take spirometry tests or anything just to make sure they are getting some benefit in terms of when they take the drug or when they call the doctor asking for a prescription or when the doctor asks them what kind of symptom improvements are you seeing? So are there specific symptoms that get improved with Ohtuvayre usage? That's the first one. And the second, are there any side effect profile, especially the ones that are listed in the FDA label? Are physicians seeing any of those, including the psychiatric events that are listed in the label?

Are there any instances of those side effects recurring in these patients in real-world setting?

David Zaccardelli (President and CEO)

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

Christopher Martin (Chief Commercial Officer)

Yeah. I mean, this is the benefit of our distribution pathway. We have amazing specialty pharmacy partners like DirectRx and CVS and CenterWell and Accredo that have individualized processes to ensure that a patient can refill their prescription in a timely manner. Each of them will reach out individually to the patients early in the process to encourage or talk to them about refilling their medication, and it's a very, I would say, a very organized and systematic approach to ensuring patients stay on therapy. They also have the opportunity in these situations to be able to talk and ask questions to the pharmacy about what's going on. I think that encourages our patients to stay on therapy and see the value of Ohtuvayre within their lives.

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

David Zaccardelli (President and CEO)

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

Boobalan Pachaiyappan (Managing Director and Senior Healthcare Equity Research Analyst)

Thank you very much.

Operator (participant)

Thank you. As a reminder, if you wish to ask a question, please press star one. This concludes our question-and-answer session. I would like to turn the conference back over to David Zaccardelli for any closing remarks.

David Zaccardelli (President and CEO)

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

Operator (participant)

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