Verona Pharma at Leerink Global Healthcare: Eutuvera’s Promising Launch

On Monday, 10 March 2025, Verona Pharma (NASDAQ: VRNA) presented at the Leerink Global Healthcare Conference 2025, highlighting the strategic success of Eutuvera’s launch for COPD treatment. The company discussed its market position, growth prospects, and challenges, emphasizing Eutuvera’s unique benefits and the company’s future plans.

Key Takeaways

• Verona Pharma’s Eutuvera has seen a strong market entry, with over 4,600 prescribers.
• The company is optimistic about expanding into bronchiectasis and developing a fixed-dose combination product.
• A significant portion of Eutuvera’s reimbursement is through medical benefits, easing patient access.
• Verona Pharma is engaging with European regulators to introduce Eutuvera in Europe.
• The company maintains a positive financial outlook, with Eutuvera as a revenue cornerstone.

Financial Results

• Launch Performance: Eutuvera’s launch has been remarkable over the past seven months.
• Market Opportunity: 8.5 million COPD patients are under maintenance treatment, with half symptomatic.
• Prescriber Base: Over 4,600 writers have prescribed Eutuvera, including 55% of Tier 1 physicians.
• Depth of Prescribing: More than 275 doctors have written over 20 prescriptions each.
• Reimbursement: 80% through medical benefit (Medicare Part B and Advantage), 20% through pharmacy benefit.
• Patient Co-Pays: Over 80% of patients pay less than $10 per prescription.
• Future Revenue: Projecting revenue from COPD, bronchiectasis, and a fixed-dose combination product by 2035.

Operational Updates

• Sales Force: 120 field personnel, including reps and managers, cover a call list of about 14,500 physicians.
• Promotional Activities: Focus on personal and omnichannel promotion targeting physicians with symptomatic patients.
• Distribution Network: Exclusive partnerships with specialty pharmacies like CVS and AcariaHealth.
• Patient Engagement: Consent for communication from specialty pharmacies and Verona Pharma ensures adherence.

Future Outlook

• Clinical Trials: Phase II trial for bronchiectasis enrolling 180 patients; results expected in late 2026 or early 2027. A Phase II trial for a fixed-dose combination will start in the latter half of 2025.
• Expansion Opportunities: Targeting bronchiectasis market with 500,000 patients and no current standard of care. Developing a fixed-dose combination for earlier treatment use.
• Regulatory Engagement: Ongoing discussions with European agencies, with updates expected by mid-2025.
• Key Metrics for 2025: Focus on writer penetration, productivity, and refill/persistency rates.

Q&A Highlights

• Dupixent Impact: Seen as complementary with no negative impact on Eutuvera.
• Efficacy Goals: In bronchiectasis, aiming for symptom improvement and exacerbation reduction. For the combination product, demonstrating greater lung function benefits.
• IP Extension: Fixed-dose combination extends intellectual property into the 2040s.

For more detailed insights, please refer to the full transcript below.

Full transcript - Leerink Global Healthcare Conference 2025:

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: All righty. Great. Well, welcome, everyone. My name is Dave Reisinger. For those of you who don’t know me, I cover Diversified Biopharmaceuticals at Leerink Partners.

It’s very much my pleasure to welcome you to our Global Healthcare Conference here in Miami. And, it’s, it’s very much my pleasure to welcome members of the leadership team of Verona Pharma to have a discussion this morning. So with us on stage are David Zaccardelli, who is the CEO to my right and to his right is Chris Martin, the Chief Commercial Officer. So we’re going to go through a dialogue here. And, if anybody would like to ask a question since I’ll probably just keep rolling, I’ll, I won’t mind if you want to interrupt.

I will pause for a moment in about twenty minutes or so just to see if there are any questions from the audience. And so, with that, why don’t we start off here? So, David, congrats on the phenomenal execution and uptake of Otovera to date. Could you just discuss the unique position that you’re in having a drug that targets such a huge market opportunity, you know, can be added on to other treatments and is effectively not competing with other branded drugs for mind share? Yeah.

No, thanks. Thanks very much for

David Zaccardelli, CEO, Verona Pharma: the question. Thanks for having us this morning. You know, we’re very, very pleased with the progress that we’re making with Eutuvera in COPD. Just to back up, as everyone knows, we’ve been in the launch for the past seven months or so. It has been a remarkable launch to date.

That is really grounded in some of the concepts that you mentioned. First, it’s the novel mechanism of action of O2vera as a PD3PD4 inhibitor that gives bronchodilation, lung function improvement, symptom improvement and exacerbation rate and risk reduction. That is really the cornerstone of the interest in treating COPD, the unmet need that exists in patients. And along with that, novel mechanism of action, as I mentioned, there’s such a large population in COPD. You know, around eight point five million patients are currently under maintenance treatment.

About half of those are symptomatic, and really to date have had limited options for therapies. The current therapy is in treatment with a lava, a llama or an ICS and O2vera being the first novel mechanism in several decades by the inhaled route really provides us a tremendous opportunity. We also need to when we look at the label for OTUVA with a broad indication, as you’ve alluded to, for the maintenance treatment of COPD, that allows us broad use in the patient population, which we’re seeing, as we anticipated from our market research in this initial phase of the launch. It is being prescribed across a wide spectrum of patients. Those patients that are on maybe single, dual and even triple therapy with about fifty percent of them being on triple therapy currently.

But we’re very pleased with that broad spectrum of use, especially this early on. And I think I’ve started to recharacterize O2VAR’s use as just being a great drug. That is a simplification of many attributes of O2VAR, including its efficacy, safety and general benefit to risk that it has. And I think that is going to actually change the treatment paradigm for COPD. You’re going to be you’ll see a greater and greater use of O2VARE in the patient population.

And that’s all rounded in many of the things we just talked about, the fact that, there really is no direct competition for OTUVAIR. We are asked many times about, what’s your thought about Dupixent and its approval and its impact on Eutrovera use. And I really it’s really no impact. And in many ways, we find it to be complementary. I think having novel mechanisms, treating inflammation and COPD is a good thing for patient care.

And O2VAR’s profile is, of course, different than Dupixent. Its label is different, the application of how it’s used is different and in no way, really changes our view of how O2VAR will be used in the patient population. So we couldn’t be more pleased, with this initial phase of the launch, how it’s being integrated into the treatment practice and, in really helping patients. And that’s why we do what we do. So we’re seeing all of that shine through early on.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: Excellent. And Chris, could you discuss the promotional activities today, provide a framework for those?

Chris Martin, Chief Commercial Officer, Verona Pharma: Yeah. Thanks, David. I think when we think about how we went to market, we went to market with about 120 field personnel that was, reps, virtual reps, managers, field reimbursement managers and their call list was about 14,500 physicians. Those physicians were primarily pulmonologists, nurse practitioners and PAs and pulmonologists, but also some primary care doctors. And what we had focused on with them was, as Dave described, talking about patients that come into their practice with persistent symptoms and the need to continue to add or think about new therapies in these patients.

Because as these patients progress, their symptoms increase. It reduces their activities. It reduces what’s going on. So being able to offer this novel pharmacology was something very appealing to the physician base. When we think about our promotional activities to date, our reps have been able to penetrate this market really quickly.

And if we think about it, at the end of the in our earnings call recently, we talked about we had now over 4,600 writers, About 55% of our Tier one physicians had already written. For those in the room, Tier one is about 2,500 doctors. So 55% of those had already written. This for us seven months in a launch is an unbelievable base of business that doesn’t go away. Like these doctors have millions of patients under their care that are always dealing with symptoms patients with persistent symptoms.

So having over 4,600 riders having over 50% of your Tier 1s writing is a great start to the launch and we believe provides unbelievable foundation and momentum as we move through 2025. As we also think about this, we also talked about getting to greater depth within our prescriber base. So like when a doctor writes getting them to write for more patients in their practice. As you may know, our Tier one physicians see about over one hundred and sixty patients a month with COPD. And in that Q1 earnings release, we talked about now having over two seventy five doctors that have written over 20 prescriptions for patients in their practice or 20 patients within their practice.

So when we talk about our current promotional efforts, it’s really about driving new writers, but also increasing that the number of write how much they’re writing in their practice as well. And those are the two focus areas for our field. When we do this, we also supplement with non promotional or omnichannel activities. So we have a very robust digital and I would say non personal promotion effort so that when a doctor becomes a writer, when we have writers, we can amplify our reps’ ability in the field with using non personal activities to help move them to the next level as well. It’s been a very good complement between our personal promotion and non personal promotion in the first seven months.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: That’s very helpful. Thank you. And could you just discuss the uniquely attractive access that the drug has with respect to lacking insurance controls and lacking out of pocket limitations like other drugs have?

Chris Martin, Chief Commercial Officer, Verona Pharma: Yes. So O2VARE is primarily reimbursed through a medical benefit. So

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: when you

Chris Martin, Chief Commercial Officer, Verona Pharma: think about our reimbursement landscape, 80% of our reimbursement will, we believe and what we’ve seen historically with nebulizers is reimbursed under medical benefit. That can either be primarily Medicare Part B, traditional Med B or through the Medicare Advantage under the medical benefits side of the business. When we think about that line of business or those lines of business, those lines of business don’t have prior auths, PAs, step edits that allow doctors willingness to write to actually be matched with an access dynamic. If we flip the other side to the other 20% of the business, which is the pharmacy benefit, which is commercial or Medicaid, we have access within that channel. We have very high access rates within that channel.

We also see if there is a prior auth, it’s usually to label. It’s to a confirmation of COPD diagnosis and to have tried ALAMA or ALABA or some other background therapy, which makes access within that channel very easy as well. When it comes to out of pocket costs, we understand about the two sides of the channel on the medical benefit side of the patient has supplemental insurance, which up to eighty five percent of all, eighty percent to eighty five percent of all COPD patients have supplemental under Part B, they pay typically less than $10 for their drugs depending on how that works. If they’ve met their deductible in Medicare Advantage, they pay less than $10 So what we’ve seen early on is over eighty percent of our patients have a co pay on dispensed scripts of less than $10 This provides again another nice dynamic as we think about launch of access is available, doctors can write based on their belief and then the patient can get the drug at a fairly low cost, regardless of kind of where they are in that spectrum.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: Got it. And then pivoting to your specialty pharmacy network, that’s also essentially a key advantage for the company. Could you speak to those advantages as well?

Chris Martin, Chief Commercial Officer, Verona Pharma: Yes. So we distribute O2Bare through what I would call an exclusive distribution network. We start with all prescriptions go to our hub, which that hub then distributes that prescription to one of our specialty pharmacy partners. Our specialty pharmacy partners include CVS, Acarias, CenterWell and Direct Rx. Those specialty pharmacy partners then communicate with the patient, help with the adjudication.

And more importantly, they spend a lot of time with adherence programs and making sure patients stay on therapy. We understand that COPD patients can be a little bit difficult in the way that they, I would say, consume medicines over the course of the year. Historically, they fill about six scripts over the course of the year. These doctors want the patient to be on this chronically, but patient behavior leads the patient to maybe fill a drug 30 on day 35 or day 45 or day 60 instead of on a regular cadence. Having this specialty pharmacy network not only helps with the initial adjudication of the script and provides the patient with what I would call a white glove service, but also helps long term with adherence refill programs that we believe allows us to have a potential upside on what we’ve seen historically from a COPD adherence and persistency standpoint in the marketplace.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: And so then with respect to that, I’m guessing that the patients are opting into communications and direct access. Is that to just the specialty pharmacies? But or is it also to Verona? Meaning is Verona also engaging with the patients?

Chris Martin, Chief Commercial Officer, Verona Pharma: Great question. On that initial referral form, we asked for patient consent. That patient consent allows for opting in from communication from the SP and Verona. So when we talk about non personal promotion and I guess non rep delivered promotion, part of that includes some of our communication to our patients. Our hub can communicate to these patients proactively.

It allows us to interact with those patients to encourage them to either stay on medicine or help them understand why they should take a medicine. So it gives us a lot of flexibility and I would say control over the prescribing process versus a retail distribution network where you’re at the mercy of kind of mass retail chains and the patient kind of walking through and potentially getting it or not getting the product. Makes a lot of sense.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: And let’s maybe pivot to potential expansion in bronchiectasis, and pivot to that. And then, I also wanted to ask about combination development as well.

David Zaccardelli, CEO, Verona Pharma: Yes, absolutely. So we’re, you know, we’re very pleased, excited about our pipeline. And of course, we have two Phase II programs underway. First one is, as you mentioned, is in non CF bronchiectasis. And that study is enrolling one hundred and eighty patient double blind placebo controlled trial, event driven endpoint on exacerbations.

And I think that we see a lot of logic using O2VARE in bronchiectasis. We think there is read through from COPD into bronchiectasis. As many of you know, the clinical presentation of bronchiectasis is quite similar to COPD, although being a different disease has a lot of the same attributes. The amount of sputum reduction, cough reduction and symptom improvement as well as exacerbation reduction that we saw in COPD, we think reads through into bronchiectasis. So a real incredible opportunity for us as you know to date, no approved therapies.

And even with, Insmed product progressing and potentially on the market later in ’twenty five, we think there’s plenty of room for increasing the patient benefit to we think that at the end of the day, just like in COPD, multiple therapies to treat bronchiectasis will be in play. Different mechanisms to treat inflammation is a good idea, in that disease. And so, all of that, I think, has incredible promise, great promise. And, we’re very excited about being able to progress it. Very efficient development program, leveraging the CMC that we had from Eutuvair and COPD.

So a lot of attributes of it are also capital efficient. And then as you mentioned, we also have a Phase II program in our fixed dose combination. This will be, glycopyrrolate, a llama, in addition to ensifentrine as a nebulized product. First time ever in The States that there’s been a combination nebulized product. And in many ways, I think as it evolves will be considered really the new triple that is dual bronchodilation via glycopyrrolate and ensifentrine plus a non steroidal anti inflammatory via ensifentrine, I think makes a lot of sense, sets up extremely well of how combination therapy is used in COPD.

We know from the enhanced program that ensifentrine works well with llamas. The bronchodilation that you get from them, we have a tremendous amount of data from our clinical trials that we think that that is quite advantageous. I think also by the time the combination product comes out, which we would target in the late 2020s, is you know, O2VAR is entrenched in the treatment paradigm. And having the ability then to utilize the combination therapy, I think will be incredibly convenient as well as much more of a cornerstone of earlier treatment in treating patients before ICS is used, for example, especially as its use, as I guess, gets entrenched in the treatment paradigm. And we’re very excited about that layering on that opportunity, as the market

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: matures. Excellent. And could you just frame the potential timing for top line results from each of those Phase two

David Zaccardelli, CEO, Verona Pharma: trials? Yes. No, great question. I think for bronchiectasis, you know, we’re enrolling, we’re at, you know, more of the front end of enrollment. We’ll keep everyone updated.

I’d like to see us, get more of that midway through enrollment before we start setting more targeted timelines. But I think at this point, and we’ll continue to update you, as I would anticipate later in 2026 or early ’twenty seven. But I think we need to see where we are in enrollment by the end of twenty twenty five. Some of the timing around it, keep in mind, it’s an event driven endpoint on exacerbations. And so that’s a minimal of six month endpoint to start with.

So there is a duration to the endpoint that has to be accommodated in those timelines as well. With regard to the fixed dose combination, we are progressing. We mentioned we completed some dose ranging work with glycopyrrolate as a nebulized product, and we completed that setting us up very nicely to initiate the next Phase II trial, which is a dose ranging study of glycopyrrolate with ensifentrine. And we expect that to start in the second half of twenty twenty five, probably takes around nine months or so to get through that trial. Of course, we’ll keep everyone updated.

So again, that would be in the, you know, the latter part of, 2026 as well.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: Excellent. That’s very helpful. Thank you. And just to follow on, so what are the efficacy bars that you would, you know, sort of anticipate or set for those trials?

David Zaccardelli, CEO, Verona Pharma: Yes. Well, I think, you know, as Phase II work, that sort of sets us up for seeing what is the treatment effect, what are we seeing. I think in bronchiectasis, plenty of room to work with. The profile of, ensifentrine with, you know, symptom improvement, lung function improvement, exacerbation reduction, all of that profile, we want to see that the magnitude of effect in bronchiectasis. As you know, the INZOMED product reduced exacerbation rate around twenty percent.

We still think there’s plenty of of room to work with, just like in COPD, in reducing exacerbations. As many of you know, in COPD, ncfentrine reduced exacerbations by about forty percent. So we don’t have a set bar, but I think there’s plenty of room to work with. We’re very interested also in how patients feel on ncifentrine with bronchiectasis, something that I think is also an attribute of of ensifentrine as patients feel better and we want to see how that reads through in bronchiectasis. With regard to the combination product, I think it’s a bit of a different concept.

Physicians are very familiar with glycopyrrolate. They know what it can do and how it can work. Ensisentrine as well, as that product comes to market, they’ll be very clear about how it works individually and what impact it can have on patient care. So I think that becomes much more of a convenient standard of care and ability to use both products together very efficiently for the patients. And their benefits will be well understood by that time.

And I think we’re merely that program merely is a classic combination program where you just demonstrate that the combination product has a benefit around lung function that’s greater than either individual components. And I think we’re set up to approve that as well.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: Excellent. And then just thinking out to the market potential, and obviously it depends on their product profiles. But if their product profiles are what you’re hoping for and one were to look out to 02/1935 and think of a pie chart, let’s say there’s $100 in revenue that Verona is booking, you know, how would you slice the pie between Eau de Vere and those two additional opportunities?

David Zaccardelli, CEO, Verona Pharma: Yes. So good question. A little difficult to answer at this point without having the exact profile understood as you’ve alluded to. But in general, I think incremental for sure, notably incremental probably, you know, Eutovir in COPD still I think is a cornerstone of how we view the opportunity. But bronchiectasis is a large market, five hundred thousand patients, as I mentioned, really no standard of care that is in to treat that disease.

So I think that, it is definitely a substantial opportunity and very meaningful, and that’s why we’re doing it. I think the fixed dose combination is, again, an expansion in how therapies are utilized. At that time, keep in mind, it’ll be a bit of a convenience play where probably O2VAR is being used with a llama frequently. And all of those patients then can be converted as well as our view of it is much earlier in the treatment paradigm. So it’s an expansion and constant broadening use of, of Eutuvera and setting up in a more directed way of what we would view the standard of care at that time.

So again, expansion, incremental, and does many other things. It extends the IP into the 2040s. Our view is it resets the IRA clock based on a new product. And so there are other attributes of that program that make a lot of sense.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: That’s very helpful context. And then moving back to the near term, what metrics are you most focused on internally over the course of 2025 as you continue to assess Eau de Vere’s adoption and implications for longer term commercial success?

Chris Martin, Chief Commercial Officer, Verona Pharma: Yes. I think we’ve talked about a few of them already in the first few press releases that we’ve had. They include like I think writers is an extraordinarily important metric to continue to watch. That the writer penetration, total writers, new writers that’s a book of business that will not go away. And so as we continue to grow that through 2025 and into 2026, it provides a foundation for the future of OTUVAIR.

The other thing that I think is really important if we take on writers is the productivity of those writers. As they become more and more used to the profile of the drug, they see the benefit of the drug, seeing that productivity of writing increase is something that I think we’ll we continue to track. Again, we disclosed a little bit of that in the Q1 earnings release with the 20 the over two seventy five doctors that have written over 20 patients in their practice. Another important thing that we haven’t mentioned is the refill or persistency or we kind of talked about this. Because if we think about long term, this business eventually becomes a refill business because these patients fill drug between six, seven, eight months.

So tracking the refills and the persistency of our patients is going to be very critical. So we’ve always believed that O2VARE and the way we distribute the product, not only the profile of product, but also the distribution of the product that there was an upside on persistency with long term. We still need a full year of data to be able to really give a good view of what the persistency will be. But I would say early on, we’re very encouraged by what we’re seeing from a persistency standpoint. So those are probably the three things that we would talk about.

So you’re talking to writers, how much are they writing and then the overall refill persistency that we see in our patients on long term. Excellent.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: Let me pause there to see if there are any questions from the audience. All righty. So, could we just pivot to how you’re engaging with the European regulatory agencies and, you know, what, you know, where that dialogue stands and what the key questions are that are outstanding?

David Zaccardelli, CEO, Verona Pharma: Yes. No, excellent. So as we mentioned in our last press release, we have started that engagement of both the EMA as well as The U. K. Regulatory authorities.

And this is a very structured, controlled process where you submit that request, your intent is to make a submission. It happens. We then, depending on either one of them, of course, in Europe, we meet with a rapporteur, which has to be assigned and we review the data, the package and our intent to submit and we get their view on the package and work through that. Clearly, core questions that, that are part of that, of every time you interact with them is if that data is acceptable for submission and is aligned with an approval concept. So we’re going to learn a lot about that.

As you know, in Europe, they have sometimes different standards of how they view efficacy. Active comparators are highly sought out in their type of trials. With regard to the enhanced trials, it was placebo controlled, but it also had some level of active comparator in the placebo group that being that patients could have better been on a LAVA, a LAVA and about twenty percent of them around on essentially a LAVA ICS. So I think we have elements of comparison to active therapy. And so all of that will be part of the dialogue.

We are extremely confident in the benefit to risk of OTUVAIR. Clearly, that will be the cornerstone of our engagement with them and, of course the novel mechanism and its overall safety and efficacy profile. So, a lot of that will happen. I think we will be much more informed on the agencies thought about that in Europe through mid twenty twenty five. And, you know, look forward to keeping everybody updated on that.

Dave Reisinger, Cover Diversified Biopharmaceuticals, Leerink Partners: Excellent. Well, we are out of time, but, that was a great discussion. Thanks so much for being here with us

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