Q3 2024 Verona Pharma PLC Earnings Call
Good morning, everyone and welcome to Verona pharma as third quarter 2024 financial results and operating highlights conference call.
At this time all participants are in a listen only mode.
Earlier this morning run a pharma issued a press release announcing its financial results for the three months ended September 30th 24.
A copy can be found in the Investor Relations tab on our corporate website Www Dot run a pharma dotcom.
Before we begin.
To remind you that during today's call statements about the company's future expectations plans and prospects are forward looking statements.
Forward looking statements are based on management's current expectations.
Statements are neither promises nor guarantees and involve known and unknown risks uncertainties and other important factors that may cause our actual results performance or achievements to be materially different from our expectations expressed or implied by the forward looking statements.
Any such forward looking statements represent managements estimates as of the date of this conference call.
While the company may elect to update such forward looking statements at some point in the future. It disclaims any obligation to do so even if subsequent events closets views to change.
Speaker Change: As a reminder, this conference call is being recorded and will remain available for 90 days.
I'd now like to turn the floor over to Dr. David Recker Daly Chief Executive Officer.
Speaker Change: Sir you may begin.
Speaker Change: Thank you and welcome everyone to today's call. We are extremely pleased to be with you today to share a remarkable achievement in the third quarter highlighted by the launch of O to bear.
With me today are Mark Hahn, our Chief Financial Officer.
Dr. Kathy Ricard, our Chief Medical Officer, Chris Martin, Our Chief Commercial Officer, and Dr. Tara Row, our Chief Development Officer.
The third quarter was exceptional for Verona pharma marked by the U S launch of O to bear for the maintenance treatment of COPD and continued progress on our clinical development program.
First let's review the outstanding launch of O. Two there, which is grounded in its broad C. O P D and the indication and the compelling benefits Oh to bear provides to COPD patients.
After just seven weeks net product sales were $5.6 million for the third quarter.
Speaker Change: We are excited at the man for O. Two bear continues to escalate with net sales for October exceeding the third quarter.
Speaker Change: Now, let's review some key launch metrics.
Speaker Change: Through the end of October only 12 weeks after fully launching Eau two there.
More than 5000, Oh, two very prescriptions have been filled with more than 2200 unique HCP prescribing O two there.
Speaker Change: Our launch efforts continue to focus on promoting O to bear to the highest prescribing 14500 H C piece.
Speaker Change: In 12 weeks, approximately 30% of our 2500 tier one H C piece have prescribed Doe to there.
Speaker Change: As a reminder, tier one H C piece right on average 150 C O P D maintenance treatment prescriptions per month.
Speaker Change: We also continued to see that once an H C. P prescribe, though too there they increased their prescribing to more patients in their practice.
Speaker Change: We are impressed by the breadth and depth of prescribers and prescriptions. This early in the launch.
Speaker Change: Importantly, H C piece are prescribing owe to bear across a broad range of COPD patients.
Speaker Change: Including background single dual and approximately 50% on triple therapy.
Speaker Change: This broad utilization across all patient types, it's consistent with our market research and continues to highlight the significant unmet need across the C. O P D patient population.
Speaker Change: Initial feedback from both patients and health care providers about the potential oh to bear to deliver a meaningful impact again C. O P D. Regardless of disease severity and background therapy is extremely encouraging and that's all supported by the early refill data.
Speaker Change: Our commercial activities to engage Hcp's continued to increase month over month.
Speaker Change: Through the first 12 weeks of launch we have reached more than 90% of our tier one and tier two H C piece through in person or digital promotion.
Speaker Change: Our speaker programs with Hcp's continued to accelerate and we expect to have approximately 120 programs completed by the end of 2024.
Speaker Change: We recently presented new analyses from the phase III enhance study evaluating <unk> in COPD.
Speaker Change: The presentations at chest and E. R. S conferences highlighted subgroup and pooled efficacy and safety analyses from the enhance trial.
Speaker Change: As well as the impact of O to bear on C. O P. D related health care resource utilization and the unmet need and C. O P. D based on real World claims data.
Speaker Change: At chest, our team interacted with approximately 1500 H C piece at our medical and commercial Booth for O. Two there highlighting the high level of interest you know to bear from HCP.
Speaker Change: While it is still very early in the launch we are extremely encouraged by the strong start to the U S commercialization of O two there.
Speaker Change: Oh two there is the first inhaled COPD treatment to provide both broncho dilation and non stroik anti inflammatory effects.
Speaker Change: And we are confident that it can be defined C. O P D treatment paradigm.
Speaker Change: We are also pleased to report the centers for Medicare and Medicaid services recently approved a permanent product specific J code for O to bear which will be effective in January 2025.
Speaker Change: Alongside our successful O to bear Lodge, we initiated two.
Speaker Change: New phase II clinical programs during the third quarter.
Speaker Change: In September enrollment began in a phase two dose ranging trial supporting a fixed dose combination formulation with N C pentron and apparently a lama for the maintenance treatment of COPD delivered via a standard jet nebulizer.
Speaker Change: The dose ranging trial is a randomized double blind placebo controlled one week crossover trial to assess lung function safety and pharmacokinetic profile of <unk>.
Speaker Change: Apparel late delivered via that'd be elisor in approximately 40 subjects with D O P D.
Speaker Change: Following identification had been appropriate cycle parallel dose range, a phase two trial assessing the fixed dose combination I've been see pension and glycol parallel will be conducted.
Speaker Change: Also in September enrollment began in the phase two trial to assess the nebulizer N C. Pentron in patients with non cystic fibrosis bronchiectasis.
Speaker Change: The randomized double blind placebo controlled parallel group trial will enroll 180 subjects with a recent history of pulmonary exacerbations.
Speaker Change: The trial will assess the effect of N C. Pentron three milligram twice daily on the rate and risk of pulmonary exacerbation symptoms and quality of life.
Speaker Change: To ensure robust powering the trial is event driven with all subjects treated for at least 24 weeks and until the required number of exacerbation events are observed.
Speaker Change: Finally, turning to our global strategy.
Speaker Change: Nuance pharma, our development partner for N P pension in greater China announced it has completed enrollment in its pivotal phase III clinical trial evaluating <unk> pension for the maintenance treatment of COPD in China.
Speaker Change: Nuance pharma expects to provide results from the pivotal phase III clinical trial in 2025, and we look forward to providing an update next year.
Speaker Change: I will now turn the call over to Marc to review, our financial results for the third quarter.
Speaker Change: Good morning.
Marc: Third quarter was an exciting one for Corona because we recorded our first sales will go to there.
Speaker Change: For the partial quarter, starting in August and ending on September 30th 'twenty 'twenty four.
Speaker Change: We've recorded owe to bear net product sales of $5 $6 million.
Speaker Change: As expected our specialty pharmacy partners are holding inventory at their contracted level of two to three weeks.
Speaker Change: Cost of goods sold related to O. Two there was $500000 for the quarter ended September 32024, which.
Speaker Change: Which consisted of supply chain post approval production cost of inventory sold and royalties payable to ligand.
Speaker Change: Recall that O. Two there was approved in June 2024, and prior to receiving FDA approval cost associated with the manufacturer of O two here.
Speaker Change: Where expense is.
Speaker Change: R&D expense.
Speaker Change: Research and development costs were $10 $6 million for the quarter ended September 32024.
Speaker Change: Compared to $3 million reported for the third quarter of 2023.
Speaker Change: The increase was primarily due to a $7 8 million dollar increase in clinical trial costs as we initiated two phase two trials.
Speaker Change: Over the course of the quarter.
Speaker Change: Selling general and administrative expenses were $35 $2 million for the quarter ended September 32024, compared to $13 $4 million reported for the same period in 2023.
Speaker Change: The increase was driven primarily by a $9 7 million dollar increase in people related costs and $2 $8 million and share based compensation primarily related to our field sales team.
Speaker Change: In addition, marketing and other commercial related activities, including travel increased by $7.5 million in professional and consulting fees and information technology costs and other related support costs increased by $1 $6 million as we continue to build out our organs.
Speaker Change: Station.
Speaker Change: For the quarter ended September 32024, net loss after tax was $43 million compared to a net loss after tax of $14 $7 million for the same period in 2023.
Speaker Change: This represents a loss of seven cents per ordinary share.
Speaker Change: Or 53 cents per ADR.
Speaker Change: For the quarter compared to a loss of <unk> <unk> per ordinary share.
Speaker Change: Or 18 cents per <unk> for the third quarter of 2023.
Speaker Change: Finally, our balance sheet remains strong with $336 million in cash and equivalents as of September 32024.
Speaker Change: With the cash currently on hand, and potential future access to the remaining $425 million under the Oaktree facilities.
Speaker Change: We expect to have sufficient runway through at least the end of 2026 as we continue the commercial ramp of both to bear in the U S and executing our two ongoing phase II clinical trial programs.
Speaker Change: I'll now turn the call back over to the operator for the Q&A.
Speaker Change: Ladies and gentlemen at this time, we'll begin the question and answer session.
Speaker Change: To ask a question you May press Star and then one to withdraw your question you May press star into it.
Speaker Change: If you are using a speaker phone we do ask you. Please pick up the handset prior to pressing the keys to ensure the best sound quality.
Speaker Change: Once again that is star one to join the question queue.
Speaker Change: And our first question today comes from Andrew Tsai from Jefferies. Please go ahead with your question.
Andrew Tsai: Hey, good morning, Thanks for taking my questions and congrats on the strong launch and the strong execution. First question is your that the data point around October and that sounds like CAE exceed in Q3. So does that mean, we're run rating at at least 17 million for the fourth quarter without considering.
Speaker Change: Any type of growth in November and December or should we start to think about some new variables that could come into play like a holiday period or a patient starting to drop out or do you think the sheer volume of patient adds can offset any type of headwinds like these discontinuation. Thanks.
Speaker Change: Good morning, Andrew Thanks for the question.
Speaker Change: So clearly we're not providing any guidance so for Q4.
Speaker Change: I think you know your math stands as it as it is.
Speaker Change: At this time, we don't see any reason or rationale for any slowdown in.
Speaker Change: The number of patients and the interest.
Speaker Change: And the acceleration that we've seen in October.
Speaker Change: And so we will of course closely monitor it and continue our efforts as we have in the past.
Speaker Change: Several weeks so.
Speaker Change: We look forward to a continued.
Speaker Change: Acceleration of our use of O. Two there are clearly theres been a lot of interest as has already been demonstrated a lot of need as we've talked about in the past for an additional novel mechanism like Goto there in COPD and we continue to get incredible feedback from physicians.
Speaker Change: <unk> and patients for that matter.
Speaker Change: Really.
Speaker Change: Looking forward to utilizing ultra there in their treatment paradigm. So we're very excited about what has occurred in this very early part of the launch over the initial 12 weeks and we expect that to continue.
Speaker Change: Very good to hear and then just as a follow up.
Speaker Change: 5000 prescriptions filled through October by chance are you willing to disclose how many unique patients you have as of October and any other metrics you are planning to provide in the next earnings call.
Speaker Change: Yeah no. Thanks.
Speaker Change: The best way to characterize it at this point is it's very fluid as you can imagine.
Speaker Change: That Ah patient.
Speaker Change: Our increasing week over week.
Speaker Change: Of the over 5000 of course, the majority of those are.
Speaker Change: The vast majority of those are unique patients.
Speaker Change: Refills have started as they should although very early on in that process and in some of the first patients.
Speaker Change: Turning to be refilled.
Speaker Change: From from earlier in the launch so.
Speaker Change: So I think you know, it's it's best to characterize it as accelerating at this time.
Speaker Change: There is a.
Speaker Change: A substantial number of patients that have been referred and over the past couple of weeks as we expect those are continued to continue to be processed and then we expect that the patient has to continue to grow.
Speaker Change: Great Congrats again.
Speaker Change: Thanks, Andrew.
Speaker Change: And our next question comes from you asked me in.
Speaker Change: What do you need from Piper Sandler. Please go ahead with your question.
Speaker Change: Yeah, Good morning team and congrats on a great quarter I wanted to stick with the theme of Andrew's question.
Speaker Change: I guess it seems like things are progressing really wow them, but can we talk about.
Speaker Change: December into 2020 five like should we be expecting on it at the beginning of the year before J P. Morgan you could come out and provide them you know some consensus or or some guidance in terms of like revenue expectations are I think it seems like you have had a great quarter, but theres just a lot.
Speaker Change: Where I'm trying to figure out how the next five quarters aren't going to go out. So is there an opportunity to kind of <unk>.
Speaker Change: Help us understand like beyond fourth quarter, what things are going to look like in one Q2 Q3 Q. That's question. One question Chinh Chu is do you have any insight on who are what are the type of patients that are being pushed crap out of there. We recently did.
Speaker Change: Okay, well I'll call and shockingly found out that the doctor with noting that the majority of his patients on Ah patients who failed triple therapy. So even if you don't have quantitative numbers. What are you hearing from the doctors are in terms of how they're using all of their and then the third question, it's like where do you want it.
Speaker Change: B in terms of physician outreach, you know and and then act by your and by mid next year, sorry for that sort of a three part long question and I'll jump back in the queue.
Speaker Change: Right. Good morning, guys. Thanks for those questions.
Speaker Change: I'll sort of take them in any particular order, but I would characterize it as I mentioned during the call.
Speaker Change: Oh, two there is being prescribed broadly across all patient segments, including Ah patients on background single dual and triple therapy.
Speaker Change: As we expected with regard to triple therapy, nearly 50% of the prescriptions are on pace for patients that are.
Speaker Change: On Triple therapy.
Speaker Change: So.
I think we're very encouraged by the breadth of prescribing across all patient types and as we expected from our market research that there was keen interest in using Oh, two there in patients who are on triple therapy, and still needing improvement we knew that was a large unmet medical need.
Speaker Change: And that's how physicians are also utilizing it as well as another patient types earlier on in the treatment paradigm.
Speaker Change: With regard to our forecasting I think it's a little premature at the moment to to review it I think we'll we'll need to assess the continued launch dynamics through the fourth quarter, which we will I think you've seen historically, we are very transparent and we'll provide you the guidance the best we can well not.
Speaker Change: Getting ahead of ourselves in making sure that we characterized it properly but.
Speaker Change: We're very encouraged very excited and as you can see there is great interest in utilizing up to there and so we expect 2025 to be and enormous a year of growth and utilization of O. Two there in the treatment of COPD and we'll look to characterize that.
Speaker Change: I'll turn it over to Chris on maybe where we'd want to be an outreach.
Speaker Change: Over the coming quarters.
Speaker Change: Hello, Yes. Thank you for the question I think when we think about physician outreach you know we continue to focus on our tier one and tier two physicians.
Chris Martin: As Dave mentioned on the call are 14500, doctors give or take and on average the tier ones right about 150 prescriptions of tier twos around 50, we want to continue to reach them.
Chris Martin: And increase our frequency against these these customers as we move into Q4 and into Q1, one of the things that we've seen early and launches as we increase the interactions we have with these physicians their ability and willingness to adopt owe to their accelerates.
Chris Martin: And we believe that's an important aspect as we move into Q4 and Q1 and into 2025 is to continue to reach as many as we can but also increase our frequency in the times that we call on them not only with reps, but interacting with them through digital non personal channels as well we see this provides a direct benefit to there.
Chris Martin: Increasing their overall prescribing.
Speaker Change: Right.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: I'll jump back in the camp.
Speaker Change: Our next question comes from Ron So overall Hu from H C. Wainwright. Please go ahead with your question.
Speaker Change: Thanks, so much for taking my questions and congrats on all the progress really very impressive commercial metrics here.
Speaker Change: Firstly I wanted to ask if you could comment on any emerging prescriber trends, particularly with respect to our profile preferences and combination regimens that prescribers are expressing they are have a predilection for with respect to <unk> centrum.
Speaker Change: You know are there specific existing modalities that they are preferring to parents the center and with or are you really just seeing sort of no preference and the drug effectively being very broadly deployed without any underlying emerging trends at this point.
Speaker Change: Yeah, Hi, good morning, Ron Thanks for the question, Yeah, I would say, it's really the latter I think that what we're seeing is a prescribing across the spectrum of patients are you know as.
Speaker Change: As I mentioned patients on single dual and Triple therapy with no particular you.
Speaker Change: You know stated interest in certain combinations or certain drugs or certain lamas are lobbies, but rather the class says is they're generally utilized interchangeably and practices.
Speaker Change: As I mentioned, there is a great interest of course, using it and on top of Triple therapy is nearly 50% of the patients are on triple therapy currently.
Speaker Change: And we expected that again feedback from physicians is very positive.
Speaker Change: And they're seeing again responses as they would expect to and patients being treated early on.
Speaker Change: In the launch so again very very excited.
Speaker Change: And really shows how much Oh, two there and a novel mechanism was needed in.
Speaker Change: In the treatment of COPD and and we're seeing it utilized again across the spectrum of patients.
Speaker Change: And again.
Speaker Change: Currently a preference on top of a triple because that was of course, the highest unmet medical need as those patients really have nowhere else to go in treatment and if they remain symptomatic on triple.
Speaker Change: Oh to bear it's definitely being preferred.
Speaker Change: Great. Thanks, and then with respect to the clinical indications that you are now starting to pursue proof of concept clinical evidence for in particular bronchiectasis can you talk a little bit about how the commercial experience with O. Two they're increasing awareness of OCA were among prescribers.
Speaker Change: It's likely to frame these additional opportunities and how you go about pursuing them have those prescribers, who are effectively acquainted themselves with the products. Since it's been launched expressed an interest in the progress of those additional indications are as the drug continues to move forward on.
Speaker Change: Fronts beyond COPD.
Speaker Change: Yeah no. Thanks for the question Ron I think that you know our interest in.
Speaker Change: Using and spend trends in.
Speaker Change: In non CF bronchiectasis came from a number of avenues, one of them being an incredibly strong interest from Kols and physicians that.
Speaker Change: As we consulted with them it made great sense to them that a N C pensions pharmacology as a P. D. Three P. D. Four inhibitor as a bronchodilator in a nonsteroidal anti inflammatory could have great promise in.
Speaker Change: Bronchiectasis and so clear.
Speaker Change: Clearly there's interest broadly from physicians in it would that said of course, you know, we're very focused on Oh to bear and C. O P D.
Speaker Change: Specifically on the commercial front, we will continue to progress.
Speaker Change: N C venturing in research and in clinical development for non CF bronchiectasis as we are now progressing with our phase two study I think you know we will all see how that looks in the future as you know that study ultimately because exacerbation changed any.
Dan: Dan It's at least a 24 week trial.
Dan: Youre talking about data, probably well into 2026 at the moment, but let's let's get the trial enrolled and see where we're at.
Dan: Great and then lastly, this is just an accounting question you mentioned earlier that certain expenses associated with manufacturing product prior to launch have now been.
Dan: Been shifted into the.
Speaker Change: The Oh SG&A line or away from the R&D line as it were so I was just wondering if you could give us a general maybe qualitative breakdown of which expenses going forward are likely to be a segregated into the R&D line versus the SG&A line for example.
Dan: Speaker programs, how are you accounting for those are there any expenses in other words that are associated with effectively commercial activities that you are going to continue to book in the R&D line item. Thanks.
Mark Hahn: Yeah, Rob this is mark thanks for the question.
Dan: <unk>.
Dan: The numbers that I was referring to specifically related to inventory production costs.
Dan: So before approval.
Dan: Those were expensed as R&D and you can imagine since it's a blow fill seal product.
Dan: The finished goods were produced after approval. So therefore put into inventory, but the API was produced before approval and that would've been expenses R&D expense.
Dan: All the commercial costs speak.
Dan: Speaker programs travel et cetera, marketing programs, all get Expensed in the period in which they are incurred as part of SG&A expense.
Dan: Okay.
Speaker Change: Thank you very much congrats once again.
Speaker Change: Thanks, Ron.
Speaker Change: And our next question comes from Tom Shrader from V. T. I G. Please go ahead with your question.
Tom Shrader: Thank you and congratulations Jim.
Tom Shrader: Looking at the physician number and the and the prescription number it seems like you have a lot of people writing one or two prescriptions to try the drug do you know what they're looking for to get more excited than I guess, the flipside is I assume you'll have some power users what do they tell you that to refine your marketing pitch as to why there.
Speaker Change: Already committed so thanks.
Speaker Change: Thanks.
Speaker Change: Yeah, Tom Let me make a few comments and I'll turn it over to Chris for more detail.
Speaker Change: I think it's you know.
Speaker Change: Yes of course, there are physician to.
Speaker Change: Prescribe it one or two patients and wanted to see how it works in their hands and their patients clearly that's a.
Speaker Change: Typical behaviors that can be expected and that goes on.
Speaker Change: As you mentioned, they're also physicians, which are let's just say heavy adopters and are prescribing it.
Speaker Change: So quite a bit within their practice.
Speaker Change: They've seen.
Speaker Change: Responses in patients and has they've had really a need in order to use oh two they're in their practice. So we're seeing that the spectrum of that I think it's also you know.
Speaker Change: Challenging to look at prescriber numbers and patient prescriptions and all of that because it's very fluid as I referred to in that.
Speaker Change: Just in the past couple of weeks there are substantial numbers of being written that are currently in process are you know.
Speaker Change: On the payer side as well as being an adjudicated make sure that that there's going to be filled in going through that process. So any numbers are out of date literally by the end of the day.
Speaker Change: And so we're trying to characterize for you and being very transparent about where we stand at the moment.
Speaker Change: But your characterization is also correct in how physicians look at it in their practice and maybe Chris you can comment on it yeah, Tom as far as when we look at the breadth and depth of these prescribers one of the things that's been very encouraging to us and very exciting to US is the fact that what we see as you know like you discussed theres many.
Speaker Change: Physicians have start writing off one or two but we also see over the course of the launch in these early stages that once they write one or two they are exposed to the patient feedback they continue to accelerate their usage I think thats something Dave mentioned in his opening comments you know what we see is a it's a combination of patient experience and also increased.
Speaker Change: Frequency and interactions with our field sales personnel.
Speaker Change: We have to keep in mind that these doctors have been doing the same thing for 10 to 15 years and Oh two there.
Speaker Change: As a novel mechanism and as an add on across all the spectrum of COPD patients that remain symptomatic and their practice is something that we have to continue to talk to them about and there are they are extremely excited about what <unk> can provide and then ultimately what <unk> can do to help their patients. So I think I think what we see early on is <unk>.
Speaker Change: Very encouraging from our adoption and then moving from one to two to what we would call believers and.
Speaker Change: A doctor who is much more entrenched and using O to bear.
Speaker Change: I guess, a quick follow up on your infrastructure.
Speaker Change: How often are you, giving patients drug for moms and what is your conversion rate looks like how does all that stuff you setup seem to be operating.
Speaker Change: Yes. Good question, Tom we're very pleased with how our infrastructure has been set up I think one of the things that we talked about very early on was our data infrastructure.
Speaker Change: And the infrastructure to understand where these patients are and that has worked extremely well so that we're able to understand and and.
Speaker Change: And kind of work to make sure that patient gets access to the drug what I will say today is that you know of those 5000 dispense scripts. The majority a significant majority of those are paid purex as you know we were.
Speaker Change: We're seeing very positive trends within the payer side, we talked about Medicare part B and medical benefits and all those assumptions that we had earlier on are playing out to be very consistent and true to what we thought going into launch so.
Speaker Change: So that that makes us very encouraged about the systems and the process that we've put in place.
Speaker Change: Great Thanks, and congrats again.
Speaker Change: Thanks, Tom.
Speaker Change: Our next question comes from Edward Palmerston from E. L. K. Please go ahead with your question.
Edward Palmerston: Good afternoon. Good morning. Thank you for taking my question and could see the prints today okay.
Edward Palmerston: Just a question. Please on the ramp up again, you mentioned specifically to mark them about inventory build can you just talk through the dynamics. There. So we can better understand how that is playing out and then roughly if you can.
Edward Palmerston: Can spit it out how much of a percentage of out of the initial sales. We saw in Q3 is actually in market sales for inventory build.
Speaker Change: Thanks, and what I'm not sure I quite understood the second part of that.
Speaker Change: Question can you repeat that part.
Speaker Change: Just ask whether you can disclose how much of the sales.
Speaker Change: It was reported in Q3 relates to inventory build the actual in market sales.
Speaker Change: Oh, Okay, and the channel inventory build in the channel sure.
Speaker Change: So we haven't disclosed the number but you can imagine that in a period of rising.
Speaker Change: Sales they are building their inventory.
Speaker Change: And holding about two to three weeks depending on the different.
Speaker Change: Specialty pharmacy partner it could be anywhere in that in that range nobody more than three weeks on hand.
Speaker Change: So you can imagine that we've been on the market for eight eight weeks at the end of September so.
Speaker Change: Probably about a quarter or so of the inventory of those sales would be in inventory at that time.
Speaker Change: Yeah.
Speaker Change: Okay. That's good to know and then a separate question actually relates to the I T.
Speaker Change: No just the slight change where you've.
Speaker Change: Now talk about a couple of additional patents pending noticeably.
Speaker Change: Notably one not on sue could be exasperation alright concentrations.
Speaker Change: Can you just talk through how important that perhaps it might be two commercial prospect.
Speaker Change: And does that perhaps since relate just to and defensive or specifically they use though P. D. Three P pause again COPD exacerbations.
Speaker Change: Yes, So let me talk broadly of course, you know all of our IP. Our IP is I think very important.
Speaker Change: As it.
Speaker Change: It is when you look at it holistically.
Speaker Change: We did file a number of patents says you're referring to are.
Speaker Change: The effect on exacerbations is one of them.
Speaker Change: After the enhance our results.
Speaker Change: Those are in process, we expect a number of them to be listed in the Orange book over the coming year to year and a half as they continued to be prosecuted.
Speaker Change: All of those are important again in the in the totality of them.
Speaker Change: As they should be and protecting our intellectual property.
Speaker Change: So you know.
Speaker Change: I think we were.
Speaker Change: Of course.
Speaker Change: It's related to O two there.
Speaker Change: And we will see at the end of the day, how the claims are.
Speaker Change: Go ahead and construct it but.
Speaker Change: You know all of our patents are important.
Speaker Change: Of course, it's grounded in our polymorph patent and a formulation patent and the additional patents related to the effective O two there.
Speaker Change: Oh, so critically important.
Speaker Change: Okay.
Speaker Change: Okay and one last question if I may just can you confirm how many patients from the enhance clinical program have been converted into commercial prescriptions and how is that being demand amongst our existing.
Speaker Change: User base for Tibet.
Speaker Change: Yeah, So we win.
Speaker Change: When we ended the enhanced clinical trials patients were discontinued at the end of the trial. We did not have any long term follow up studies ongoing. So as you know that that time gap was substantial between the write up of the NDA plus the year of review at the FDA.
Speaker Change: So we wouldn't know which patients that were in the trial may have come back and be on a commercial.
Speaker Change: Commercial O two there.
Speaker Change: Okay. Thanks, very much for taking my questions.
Speaker Change: Okay.
Speaker Change: Thanks very much.
Speaker Change: Our next question comes from Joon Lee from Truest. Please go ahead with your question.
Joon Lee: Hey, congrats on the strong quarter and that's taking our questions can you talk about reimbursement rate across government and commercial channels and the rate of prescription abandonment due to co pay or any reason and congrats on getting the permanent J code.
Speaker Change: Is there any COPD treatment guideline or algorithm that is kind of in the works that could be introduced soon given the newly approved agents in COPD.
Speaker Change: So maybe I'll have Fred just sort of comment on her general payer dynamics.
Speaker Change: Yeah, So Jim when we think about reimbursement right now the majority I'd say 80 plus percent like we saw are going through a medical benefit either through Medicare traditional Medicare part b or Medicare advantage.
Speaker Change: And like we assumed at launch. These these processes do not require a prior significant hurdles for these patients to get we're seeing movement within that medical benefit channel very very very well what is it.
Speaker Change: Also encouraging for us is across the pharmacy benefit side, which is commercial or Medicaid, we see patients having access to owe to bear as well it does require a prior off within that process. Each plan is a little bit the independent.
Speaker Change: But we're able to work through that with our S. P. A partners in that process to get patients access to owe to bear.
Speaker Change: Other thing that we think is very encouraging is and again like what we talked about early on and launch during during the setup was of the patients that had been dispense scripts about let's just say well over 80% of them have a co pay of less than $10. So they have access to O. Two there and they have access without very low out of pocket.
Speaker Change: Cost as well and.
Speaker Change: And I think this bodes very well for the brand long term as we think about how the how the how the launch accelerates.
Speaker Change: As far as your second question, which was regarding upcoming guidelines or conferences, we do know that the gold guidelines have a meeting in November.
Speaker Change: We coupled with a couple of days at that that guideline meeting.
Speaker Change: We believe that O. Two there has a has an opportunity to be to be placed in there as we've talked about in the past there is a disney a pathway and an exacerbation pathway within the guidelines in Ocho bears unique novel mechanism of action with broncho dilation or non steroidal anti inflammatory allows both the concern.
Speaker Change: The guideline committee to be able to put <unk> in a variety of different spots there again.
Speaker Change: Again, we think this is only an upside.
Speaker Change: Four O to bear.
Speaker Change: When we talk to physicians today, the big thing that we hear from our reps and the feedback back from HCP is is that we.
Speaker Change: We have patients that have persistent symptoms, regardless of what therapy be ever on single dual or triple background therapy. These persistently symptomatic patients need add on therapy.
Speaker Change: And <unk> there can be a very good choice for all these patients to provide additional broncho dilation and potential non steroidal anti inflammatory effects as well.
Speaker Change: Great well, if I could ask one more Chris you mentioned previously that 50% of the use is as an add on to triple therapy, which is really interesting has that shifted at all in the first few months of launch.
Chris Martin: No June it's still very early to kind of.
Speaker Change: Say, if theres been any shift I think the thing that's very encouraging for US is we have an on use on top of triple but what you also see is about 50% of these other patients that aren't on triple. So remember our market research early on said that <unk> could be used alone or as an add on across all lines of therapy and in these first or through <unk>.
Speaker Change: October we're seeing that while we're seeing about 50% of patients on Triple. We're also seeing patients on a single bronchodilator, we're seeing patients on LABA Ics being added O two there.
Speaker Change: That is all consistent with what we said in our early market research and when I think about the health of the launch and the health of what is the what is the ongoing 2025 look like being able to say that you know some of that real work that we did early on about unmet need and patient utilization, we're seeing that play out in these first few more.
Speaker Change: Of launch and that gives us a lot of encouragement for Q4 and 2025.
Speaker Change: It's really encouraging well thank you so much.
Jim: Thanks, Jim.
Speaker Change: Once again, if you would like to ask a question. Please press star and then one sort of move your questions you May press star and two.
Speaker Change: Our next question comes from.
Speaker Change: Alan.
Speaker Change: Shopping from Roth Capital Partners. Please go ahead with your question.
Alan Shopping: Good morning, Tim can you hear me.
Speaker Change: Yes of course good morning.
Alan Shopping: Alright. Good morning, Thanks, so much for taking my questions and congrats on the progress.
Speaker Change: We have two firstly, there's been some developments in the COPD landscape.
Speaker Change: Notably the recent approval of <unk>.
Speaker Change: We I'm wondering do you expect potential headwinds from D. O P. As you think about penetrating to subsection of the COPD market comprising patients who are on triple therapy.
Speaker Change: Ah is a motivation for prescribers to prioritize its essentially what would you be excluding the cost benefits offered by intervention.
Speaker Change: Yes. Good morning. Thanks. Thanks for the question I think again it was it's good for patients with COPD they have choices.
Speaker Change: Good to see the approval of <unk>, but the treatment of COPD I think it highlights the need that exists for additional treatments with that said as you well know.
Speaker Change: Depicts since addresses the relatively narrow patient.
Speaker Change: Population or narrow part of the market.
Speaker Change: Those patients who you know.
Speaker Change: Our triple therapy.
Speaker Change: <unk> have a history of exacerbations.
Speaker Change: <unk> has been elevated eosinophil count and by our incentive fee regeneron own estimation, it's in the U S about 300000 patients.
Speaker Change: So relatively small.
Speaker Change: This number considering there are about eight and a half million patients who are on maintenance treatment.
Speaker Change: Because of the large patient population and unmet medical need across the board, we don't see it impacting the commercialization of O. Two there at all.
Speaker Change: If anything again brings a spotlight onto the need.
Speaker Change: Treatments and helping patients who are currently symptomatic and need additional.
Speaker Change: Therapy.
Speaker Change: And even with that said there is no specific rationale that that we know of a y O. Two there could not be used with picks and if the physicians felt that that was the right combination for that patient as well you know completely different pharmacology mechanism of action of course addressing.
Speaker Change: Inflammation for multiple modes.
Speaker Change: It could be beneficial and of course, you know to various broncho dilation and impact on improving lung function acutely.
Speaker Change: And helping with Disney on a day in day out basis is his keating with teams as well.
Speaker Change: Which are some of the other types of approaches don't have that acute broncho dilation. So again I think it's very good across the board and doesn't change our view because again of the large patient population an unmet need.
Speaker Change: Yeah. Thanks for the fact that David and then maybe a second one I can answer the final one you mentioned the other two phase two clinical programs I was looking at the clinical trials website. This morning, and this let's say it also included Ah trial actually it's just you're currently recruiting for the phase II study.
Speaker Change: The effect of centering on sports on markers of inflammation and see what PD patients.
Speaker Change: So I understand the mechanistic implications of the study isn't she'll do you wanted to see or know if it's the central and interfere Smith.
Speaker Change: See PGP and P. G. P pathway, so that aside but I'm curious to know how you plan to integrate this study all comes into your clinic.
Speaker Change: Commercial status. It is this specifically to collect more data potentially focusing on exacerbation and then maybe double up on add on clinical program or a or this could potentially trickle down to our cystic fibrosis program in some other way how how are you thinking thank you.
Speaker Change: Yes.
Speaker Change: A couple of comments and.
Speaker Change: Tara you can comment as well on the study itself, but you know I think again there.
Speaker Change: This study is relatively small, but very mechanistic in nature I'm looking at the affects on the sputum.
Speaker Change: Ah markers in sputum, and continuing to understand the deeper pharmacology.
Speaker Change: <unk> and <unk> and specifically its PD <unk> four inhibition.
Speaker Change: And I think as we see the outcome of this study we will then.
Speaker Change: Look at that carefully and then utilize that data and the best way, we can to help patients moving forward, whether in COPD or in other indications.
Speaker Change: And so with that I don't know if Terry do you want to add anything else to that question.
Terry: Yeah, I think you know, it's an eight week crossover trial I'm looking at inflammation through the E. C. P. G. P pathway and also looking at inflammatory cell migration.
Speaker Change: Into the into the lung.
Speaker Change: So as Dave mentioned, we do expect that to be helpful to better characterize the pharmacology events the center and in patients with COPD and of course, we have already conducted a sputum study in healthy volunteers challenged with L. P. S and saw a nice effect across neutrophil macro fashion, you kind of felt.
Speaker Change: The lymphocytes and so we do expect to see similar data in COPD patients, particularly given the strong and get Acervation results from the enhanced program.
Speaker Change: Alright, thanks, so much for taking my questions.
Speaker Change: Thanks.
Speaker Change: Ladies and gentlemen at this time will be ending today's question and answer session I'd like to turn the floor back over to Doctor Sacredh Ali for any closing comments.
Speaker Change: Great. Thank you everyone for joining us.
Speaker Change: On today's call and for your question you know in addition, I want to thank our shareholders for their support and especially the dedicated and talented team at Verona pharma for their work and commitment.
Speaker Change: We're extremely excited about the launch of both to bear and the advancement of our two phase two trials as well and we look forward to updating you on future calls and look forward to seeing you at conferences as well.
Speaker Change: Thanks, very much and have a great day.
Speaker Change: Ladies and gentlemen, with that we'll conclude today's conference call and presentation. We do thank you for joining you may now disconnect your lines.
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change: Okay.