Verona Pharma PLC (VRNA) 2024 Q4 法說會逐字稿

Good morning ladies and gentlemen. Welcome to the Verona Pharma's fourth quarter and full year 2024 financial results and conference call.

(Operator Instructions).

This call is being recorded on Thursday, February 27, 2025. I would now like to turn the conference over to David Zaccardelli, the Chief Executive Officer. Please go ahead.

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 W. Hahn, our Chief Financial Officer; Dr. Kathleen Rickard, our Chief Medical Officer; Christopher Martin, our Chief Commercial Officer; and Dr. Tara Rheault, our Chief Development Officer.

2024 was another transformational year for Verona Pharma with the US 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've progressed our Phase 2 pipeline programs and 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 there 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 dispense 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 non-steroidal 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 US. 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.

And finally, we are also initiating activities with regulatory authorities in preparation for potential marketing authorization application submissions in the Europe Union and the United Kingdom.

We look forward to updating you on this progress.

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

Good morning.

The fourth quarter was monumental for Verona as we recorded $36.6 million in Ohtuvayre sales in the first full quarter of sales.

For the year ended December 31, 2024, net Ohtuvayre sales were $42.3 million.

Our specialty pharmacy partners continue to maintain inventory at their contracted levels of 2 to 3 weeks. Cost of Ohtuvayre sales was $2 million for the quarter end of 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 for $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 2 trials of $17.5 million. The $6.3 million approval milestone.

An increase in share-based compensation of $3.1 billion 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 end of December 31, 2024 compared to $50.4 million for 2023. The increase across the annual period was primarily due to a $29.7 million increase in marketing and other commercial related activities supporting the launch of Ohtuvayre.

The $15 million first sale milestone, a $26.8 million increase in people related cost as we built out our commercial organization and an $18.8 million dollar 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 end of 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 for ADS for the year compared to a loss of $0.09 for 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 Ohtuvayre facilities.

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

Thank you.

Ladies and gentlemen, we will now begin the question and answer session.

(Operator Instructions)

Andrew Tsai, Jefferies

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?

Thank you.

Right, good morning, Andrew.

Thank you for the question. I'll turn it over to Mark and to provide his thoughts on that dynamic and growth to nets.

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

Yeah, Andrew, thanks for the question. As far as the fills, I think as we've stated before, where we 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 the launch outweighs any potential deductible recess 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, new refills, and total dispenses on a monthly basis. I think you know 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.

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?

Well, let me start with the break even portion. I've been talking about for a long time now that I think a company like Verona with a single asset 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, maybe not profitability break even, but cash flow break even at a quarterly run rate that gets you to a $250 million to $300 million annual rate, probably closer to the $300 million than the $250 million actually, but I think that's where you could get. So yeah, those numbers are right. I think we could be in that rate by the end of the year.

Okay, and I think Andrew, I mean.

Yeah, I think with regard to consensus as, 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.

Right. Thank you very much. Congrats again.

Thanks.

Thank you.

Yasmeen Rahimi, Piper Sandler

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 is given the outstanding launch, what are some of the headwinds that could be headed our direction? What are some of the risks that we're not foreseeing or anything that could happen and I would love, like I guess, what are the things that's keeping you guys up at night because, the growth chart looks beautiful. That's sort of one and question number two is around your thoughts around Europe, European filing?

Help us understand like what is the market opportunity in, I think the UK and select countries. I think in the past pricing is substantially lower in Europe, like what led to wanting to really pursue that and how do we think about the opportunity there and I guess the cost needed to build out a sales force?

Appreciate, sorry, multi-part question around that. So, thank you.

Sure, thanks for the question. Yes, good morning.

I think, addressing the headwinds comment, we're very, optimistic clearly that the unmet need is there and it's 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 expansion in the breadth and depth of prescribing continues now with over 4,600 unique HCP prescribers, approximately 55% of the Tier1 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 time frame that foreseeable future, we don't see anything that looks like Ohtuvayre, a bronchodilator, and a non-steroidal anti-inflammatory. So I think that fits extremely well with helping these patients.

And then, I think 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 the 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 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 UK and as we do that, we'll concurrently work with our partner and strategy. So I expect them to come together, especially as we walk through 2025.

Thank you so much, David.

Thank you.

Tiago Fauth, Wells Fargo

Hey, thanks for taking the question and congrats on the progress.

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

Yeah, 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 normal persistence and 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 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 an upside to the six refills per year.

Fair enough. Thanks again for taking the question.

Thank you.

Thomas Shrader, BTIG

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, or 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.

Thanks, Tom, for the question. Let's start with the 45% that haven't written yet. I want to focus on the, or the other side of the number of writers that we have today. I mean, to have over 4,600 riders 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 3,6,12 months. So I think when we look at our market research, we understand that our writer group base will continue to grow and we will continue to penetrate. These doctors that haven't written so far because of the profile of Ohtuvayre.

As far as the nebulizer, I think this is something that we got as a question very early on of can this drug, will people use a nebulized drug? and our hypothesis going into this was that innovation would trump route of administration, 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 the field perspective with the doctor. 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.

Great. Thank you.

Thank you.

Raghuram Selvaraju, H.C.W

Thanks so much for taking my questions and congrats really on the phenomenal progress with the launch. It's really very impressive.

Firstly, I wanted to ask whether you see any underlying market dynamic trends emerging with respect to prescriber preferences regarding the deployment of Ohtuvayre, especially now that we've gotten a little bit further into the commercial trajectory? And in particular, if you can comment on whether you expect the proportion of patients on Ohtuvayre who are also receiving tri-therapy to increase over time or remain constant and then also with respect to the ex-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 entering and what your strategic plans to target those territories and if you could also perhaps comment on the pricing situation in Greater China? what the pricing dynamics look like in Macau? now that the product has been approved there just so we can get a bit of a handle on what performance Nuance might be able to realize with the drug once it's available?

Thank you.

Well, there's a lot to unpack there, so let me 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 US as we have already 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 there 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 US which we continue to execute on, and that's what we'll continue to focus for sure, but we'll carry on with the strategy for in 2025 in partnering and as I mentioned, we're already starting that in more, a progressive state by working with the regulatory authorities in Europe and the UK.

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

Thanks, David. When we look at, the patients and what's the consistent theme about who's getting prescribed Ohtuvayre, it goes back to some very simple kind of truths. These patients 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 air could potentially help with these patients over time.

The other thing that I think we're very encouraged by is as David 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 lab ICS or no long anti-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 non-steroidal 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 David has mentioned in his comments earlier about our pipeline expansions.

So I really feel like that's a great opportunity as we move through '25 and into '26 as well.

Thank you very much.

Thank you.

Joon Lee, Truist

Hey, thanks for the updates 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. You should 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 claw back clause like the one you have a Nuance, in case someone else may emerge that may want the the global right?

Thank you.

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.

Well, I think we'll have to see how our partnership discussions go, as you, as we're also looking for a partner that may have a broader base of capabilities with regard to development of pMDI, DPI, manufacturing of the drug product, manufacturing of DPI and pMDI. 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.

Joon, as far as reimbursement, I think we've been very pleased with how the reimbursement looks in this 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 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 off. There's no real step at it. There's a, there's access to Ohtuvayre in those channels.

What it becomes is an out of pocket cost for patients. If a patient has supplemental insurance, we see their co-pays are usually less than $10. If the patients met their deductible and Medicare Advantage, their copay is less than $10 or even nothing. And 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 co-pay card programs and provide that to patients. Additionally, we've created other services with including patient assistance programs for patients that are of 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 co-pays less than $10 as well.

Thank you.

Thank you.

Boobalan Pachaiyappan, Roth

Good morning. Can you hear me okay?

Yes, good morning.

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 prescription and when the doctor asked 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, or 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?

Right. Maybe I'll turn it over to Chris to start with the refill process and how that goes. Yeah.

I mean this is the benefit of our distribution pathway. We have amazing specialty pharmacy partners like DirectorX and CVS and Centerwell and Aaria that have individualized processes to ensure that a patient can refill their prescription in a timely manner.

Each of them will reach out individually to the patients early in the process to encourage or talk to them about refilling their medication. And it's a very, I would say a very organized and systematic approach to ensuring patients stay on therapy.

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

One of the things that I think is very encouraging early on, as David 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 assess our forecast, but I think we believe there's a significant upside there, a potential upside there. But one of the things that is also encouraging is the feedback that we're getting from patients across the spectrum, to especially pharmacies, to the doctors, really highlights how Ohtuvayre or long term is going to be very beneficial for for the patient.

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

Thank you very much.

Thank you.

(Operator Instructions)

This concludes our question and answer session.

I would like to turn the conference back over to David Zaccardelli for any closing remarks.

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

Ladies and gentlemen, this concludes today's conference call.

Thank you for your participation. You may not disconnect.