Q4 2024 Verona Pharma plc Earnings Call
Time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session, but any time. During this call you require immediate assistance. Please press star zero for the operator this call is being recorded on Thursday.
Speaker Change: February 27, 2025, I would now like to turn the conference over to David Zucker Delhi, The Chief Executive Officer. Please go ahead.
Good morning, ladies and gentlemen, welcome to the very Ona pharma fourth quarter and full year 'twenty 'twenty four financial results and conference call. At this time all lines are in listen only mode. Following the presentation, we will conduct a question and answer session.
Speaker Change: Thank you and welcome everyone to today's call.
Speaker Change: During the past quarter, we achieved remarkable progress with the launch of OTA, there along with advancing our development programs and look forward to updating you today with.
But any time during this call you require immediate assistance. Please press star zero for the operator this call is being recorded on Thursday.
Speaker Change: With me are Mark Hahn, our Chief Financial Officer, Dr. Kathie Ricard, our Chief Medical Officer, Chris Martin, Our Chief Commercial Officer, and Dr. Terry <unk>, our Chief Development Officer.
Speaker Change: February 27, 2025, I would now like to turn the conference over to David is that great Deli, The Chief Executive Officer. Please go ahead.
Speaker Change: 2024 was another transformational year for Verona pharma with the U S FDA approval and commercial launch of <unk> for the maintenance treatment of COPD.
David: Thank you and welcome everyone to today's call.
David: During the past quarter, we achieved remarkable progress with the launch of OTA, there along with advancing our development programs and look forward to updating you today.
Speaker Change: 2024 was also an important year for millions of patients suffering from COPD as <unk> is the first inhaled therapy with a novel mechanism of action available for COPD in over 20 years.
Speaker Change: With me are Mark Hahn, our Chief Financial Officer, Dr. Kathie Ricard, our Chief Medical Officer, Chris Martin, Our Chief Commercial Officer and Dr. Terri wrote our Chief Development Officer.
Speaker Change: In addition to the outstanding launch, which I'll walk through in a moment, we progressed, our phase II pipeline programs in COPD Bronchiectasis and have made key advances in our global partnering and regulatory strategy.
Speaker Change: 'twenty 'twenty four was another transformational year for Verona pharma with the U S. FDA approval and commercial launch of O to bear for the maintenance treatment of COPD.
Speaker Change: First let's review the initial launch of <unk>, which is grounded in its broad indication for the maintenance treatment of COPD and it's compelling benefit to risk profile.
Speaker Change: 2024 was also an important year for millions of patients suffering from COPD as O. Two there is the first inhaled therapy with a novel mechanism of action available for COPD in over 20 years.
Speaker Change: In the first full quarter of commercial availability net sales of O. Two there were $36 6 million in the fourth quarter and $42 3 million for the full year 2024.
Speaker Change: In addition to the outstanding launch, which I'll walk through in a moment, we progressed our phase two pipeline programs in COPD bronchiectasis and have made key advances in our global partnering and regulatory strategy.
Speaker Change: 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, then in Q4 2024.
Speaker Change: First let's review the initial launch of O. Two there, which is grounded in its broad indication for the maintenance treatment of COPD and it's compelling benefit to risk profile.
Speaker Change: Additionally, we saw a month over month growth and dispense prescriptions.
Speaker Change: In the first full quarter of commercial availability net sales of O. Two there were $36 $6 million in the fourth quarter and $42 $3 million for the full year 2024.
Speaker Change: New patient starts and refills.
Speaker Change: <unk> early launch results are remarkable and support our belief that <unk> can become a blockbuster product.
Speaker Change: 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, then in Q4 2024.
Speaker Change: We continue to strengthen our prescriber base with over 4600 unique hcp's prescribing <unk>, including approximately 55% of our 2005 hundred tier one hcp's.
Speaker Change: Additionally, we saw a month over month growth in dispense prescriptions, new patient starts and we felt.
Speaker Change: We continue to see hcp's expanding their prescribing to more patients.
Speaker Change: Specifically over 275, Hcp's have now prescribed <unk> to more than 20 patients in their practice.
Speaker Change: These early launch results are remarkable and support our belief that ought to bear can become a blockbuster product.
Speaker Change: Okay.
Speaker Change: We continue to be very encouraged by the breadth and depth of prescribers and prescription metrics.
Speaker Change: We continue to strengthen our prescriber base with over 4600 unique hcp's prescribing <unk> to their including approximately 55% of our 2005 hundred tier one hcp's.
Speaker Change: In addition to these impressive key launch metrics, we see hcp's are continuing to prescribe <unk> across a broad range of COPD patients, including patients on background single dual and approximately 50% on triple therapy.
Speaker Change: We continue to see H C. P is expanding their prescribing to more patients spitz.
Speaker Change: Specifically over to 275, Hcp's have now prescribed owe to bear to more than 20 patients in their practice.
Speaker Change: Fifth utilization across all patient types strengthens our belief that <unk> novel Bronchodilator in non steroidal anti inflammatory activity can redefine the treatment paradigm for COPD.
Speaker Change: We continue to be very encouraged by the breadth and depth of prescribers and prescription metrics.
Speaker Change: Feedback from both patients and healthcare providers about the meaningful impact of O to bear is extremely encouraging and is also supported by our continued refill and persistency data, including patients receiving over five refills.
Speaker Change: In addition to these impressive key launch metrics, we see hcp's are continuing to prescribe <unk> across a broad range of COPD patients, including patients on background single dual and approximately 50% on triple therapy.
Speaker Change: Alongside our successful <unk> launch we have continued to advance our pipeline with two phase III clinical programs.
Speaker Change: Fifth utilization across all patient types strengthens our belief that O. Two bears novel, Bronchodilator, and non Australia anti inflammatory activity can redefine the treatment paradigm for COPD.
Speaker Change: Following the end of the year, we successfully completed our phase II dose ranging clinical trial with clinical peer late Lama to support a fixed dose combination with nebulizer NC pension for the maintenance treatment of COPD.
Speaker Change: Feedback from both patients and health care providers about the meaningful impact of O to bear is extremely encouraging and is also supported by our continued refill and persistency data, including patients receiving over five refills.
Speaker Change: This study confirm the appropriate dose range of <unk> to support further clinical development of the fixed dose combination.
Speaker Change: Alongside our successful O. Two very large we have continued to advance our pipeline with two phase two clinical programs.
Speaker Change: We plan to initiate a dose ranging phase <unk> trial evaluating a fixed dose combination of <unk> pension with clinical pair late compared to the individual components in the second half of 2025.
Speaker Change: Following the end of the year, we successfully completed our phase II dose ranging clinical trial with clinical pair late Obama to support a fixed dose combination with nebulizer NC pension for the maintenance treatment of COPD.
Speaker Change: In addition, enrollment continues in our phase II trial to assess nebulize empty <unk> in patients with bronchiectasis.
Speaker Change: The randomized double blind placebo controlled parallel group trial will enroll 180 subjects with a recent history of pulmonary exacerbations. This.
Speaker Change: This study confirm the appropriate dose range of maybe your lifecycle parallel to support further clinical development of the fixed dose combination.
Speaker Change: This study will assess the effect of <unk> three milligrams twice daily on the rate and risk of pulmonary exacerbations symptoms and quality of life.
Speaker Change: We plan to initiate a dose ranging phase two b trial evaluating a fixed dose combination of etsy pension with clinical pair late compared to the individual components in the second half of 2025.
Speaker Change: Finally, turning to our global strategy.
Speaker Change: In addition, enrollment continues in our phase II trial to assess nebulize empty pension in patients with bronchiectasis.
Speaker Change: Nuanced pharma our development partner for <unk> in Greater China recently announced the approval of <unk> in Macau for the maintenance treatment of COPD in adult patients, marking the first approval of <unk> outside the U S.
The randomized double blind placebo controlled parallel group trial will enroll 180 subjects with a recent history of pulmonary exacerbations. This study will assess the effect of NC Pentron three milligrams twice daily on the rate and risk of pulmonary exacerbations symptoms and quality of life.
Speaker Change: 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.
Speaker Change: Nuance pharma also announced it has completed enrollment in its pivotal phase III clinical trial in China to evaluate and see pension for the maintenance treatment of COPD and expects to provide results in mid 2025.
Speaker Change: Finally, turning to our global strategy.
Speaker Change: Once pharma our development partner for <unk> in Greater China recently announced the approval of O. Two there in Macau for the maintenance treatment of COPD in adult patients, marking the first approval of O. Two there outside the U S.
Speaker Change: And finally, we are also initiating activities with regulatory authorities in preparation for a potential marketing authorization application submissions in the Europe Union and the United Kingdom.
Speaker Change: 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.
Speaker Change: We look forward to updating you on this progress.
Speaker Change: I'll now turn the call over to Marc to review, our financial results for Q4 and full year 2024.
Once pharma also announced it has completed enrollment in our pivotal phase III clinical trial in China to evaluate and see pension for the maintenance treatment of COPD and expects to provide results in mid 2025.
Good morning.
Speaker Change: The fourth quarter was monumental Corona as we recorded $36 $6 million in <unk> sales in the first full quarter of sales for.
Speaker Change: And finally, we are also initiating activities with regulatory authorities in preparation for a potential marketing authorization application submissions in the Europe Union and the United Kingdom.
Speaker Change: For the year ended December 31, 2024, net <unk> sales were $42 3 million.
Speaker Change: Our specialty pharmacy partners continued to maintain inventory at their contracted levels of two to three weeks.
Speaker Change: We look forward to updating you on this progress.
Speaker Change: I will now turn the call over to Marc to review, our financial results for Q4 and full year 2024.
Speaker Change: Cost of <unk> sales was $2 million for the quarter ended December 31, and $2 $6 million for the year.
Marc: Good morning.
Marc: The fourth quarter was monumental for Royal not recorded $36 $6 million in O two where sales in the first full quarter of sales.
Speaker Change: These costs include post approval manufacturing costs inventory overhead cost and royalties.
Marc: For the year ended December 31 2024.
Speaker Change: Recall that <unk> was approved in June 2024, and prior to receiving FDA approval costs associated with the manufacturer of OTA there were expensed as R&D expense.
Marc: Net O to their sales were $42 $3 million.
Marc: Our specialty pharmacy partners continued to maintain inventory at.
Marc: Their contracted levels of two to three weeks.
Speaker Change: Research and development costs were $7 9 million for the quarter ended December 31, 2024, compared to $4 1 million reported for the fourth quarter of 2023.
Marc: Cost of vote to bear sales was $2 million for the quarter ended December 31, and $2 $6 million for the year.
Marc: These costs include post approval manufacturing costs inventory overhead cost and royalties.
Speaker Change: And $44 6 million for the year ended December 31, 2024, compared to $17 $2 million reported for 2023.
Marc: Recall that <unk> was approved in June 2024, and prior to receiving FDA approval.
Speaker Change: The increase across the annual period.
Marc: Costs associated with the manufacturer of O. Two there were expensed as R&D expense.
Speaker Change: It was primarily due to increases in clinical trial and other development costs related to the initiation of two phase two trial of $17 $5 million.
Marc: Research and development costs were $7 $9 million for the quarter ended December 31 2024.
Speaker Change: The $6 $3 million of approval milestone.
Marc: Third to $4 $1 million reported for the fourth quarter of 2023.
Speaker Change: An increase in share based compensation of $3 1 billion.
Marc: $44 $6 million for the year ended December 31 2024.
Speaker Change: And increases in people related costs.
Speaker Change: And pre approval manufacturing costs.
Marc: Compared to $17 $2 million reported for 2023.
Speaker Change: Selling general and administrative expenses were $45 $1 million for the quarter ended December 31 2024.
Marc: The increase across the annual period.
Marc: It was primarily due to increases in clinical trial and other development costs related to the initiation of two phase two trial.
Speaker Change: Compared to $15 million reported for the same period in 2023.
Marc: $17 $5 million.
And $149 8 million for the year ended December 31, 2024 compared to $54 million for 2023.
Marc: The $6 3 million dollar approval milestone.
Marc: An increase in share based compensation of $3 $1 billion and increases in people related costs and pre approval manufacturing costs.
Speaker Change: The increased across the annual period was primarily due to a $29 $7 million increase in.
Marc: Selling general and administrative expenses were $45 $1 million for the quarter ended December 31 2024.
Speaker Change: In marketing and other commercial related activities supporting the launch of <unk>.
Speaker Change: The $15 million first sale milestone.
Marc: Compared to $15 million reported for the same period in 2023.
A $26 $8 million increase in people related costs as we built out our commercial organization.
Marc: And $149 $8 million for the year ended December 31, 2024, compared to $50 4 million for.
Speaker Change: And an $18 $8 million increase in share based compensation.
Marc: For 2023.
Speaker Change: For the quarter ended December 31, 2024 net loss after tax was $33 8 million compared.
Marc: The increased across the annual period was primarily due to a $29 7 million dollar increase in.
Speaker Change: Compared to a net loss after tax of $14 1 million.
Marc: In marketing and other commercial related activities supporting the launch of O two there.
Speaker Change: At the same period in 2023.
Marc: The $15 million first sale milestone.
Speaker Change: And $173 $4 million for the year ended December 31 2024.
Marc: A $26 $8 million increase in people related costs as we built out our commercial organization.
Speaker Change: Compared to $54 4 million for the prior year.
Marc: And an $18 $8 million increase in share based compensation.
Speaker Change: This represents a loss of <unk> five per ordinary share or <unk> 41 per <unk> for the for the quarter compared to a loss of <unk> <unk> per ordinary share or <unk> 18 per ads for the fourth quarter of 2023.
Marc: For the quarter ended December 31, 2024 net loss after tax was $33 8 million compared.
Marc: Compared to a net loss after tax of $14 $1 million the same period in 2023.
Speaker Change: And a loss of 27 per ordinary share or $2 13.
Marc: And $173 $4 million for the year ended December 31 2024.
Speaker Change: For <unk> for the year compared to a loss of <unk> nine per ordinary share or <unk> 69 per ads in 2023.
Marc: Compared to $54 4 million for the prior year.
Marc: This represents a loss of five cents per ordinary share or <unk> 41 per <unk> for the for the quarter compared to a loss of <unk> <unk> per ordinary share or 18 cents per <unk> for the fourth quarter of 2023.
Speaker Change: Finally, our balance sheet remained strong with $400 million in cash and equivalents.
Speaker Change: 31, 2024 and.
Speaker Change: In addition, we have access to up to $425 million of additional capital.
Speaker Change: <unk> facilities.
Marc: And a loss of 27 cents per ordinary share or $2 13.
Speaker Change: I'll now turn the call back over to the operator for the Q&A.
Marc: For <unk> for the year compared to a loss of nine per ordinary share or <unk> 69 per <unk> in 2023.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the number one on your Touchtone filing you will hear a prompt that your hand hasn't been raised should you wish to decline from the polling process. Please press the star followed by the number two.
Marc: Finally, our balance sheet remains strong with $400 million in cash and equivalents as of December 31, 'twenty 'twenty four.
Marc: In addition, we have access to up to $425 million of additional capital.
Speaker Change: Hugh.
Speaker Change: If you are using a speaker phone please lift the handset before pressing any keith.
Marc: Oh Creek facility.
Marc: I'll now turn the call back over to the operator for the Q&A.
Speaker Change: The first question comes from.
Marc: Yeah.
Marc: Thank you.
Speaker Change: Andrew.
Speaker Change: Ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the number one on your Touchtone filing you will hear a problem. That's your hand hasn't been raised should you wish to decline from the polling process. Please press the star followed by the number.
Speaker Change: With Jefferies. Please go ahead.
Speaker Change: Hi, Thanks, Good morning, Congrats on all the progress its just pretty awesome to see.
Speaker Change: The entrepreneurs asking nicely.
Speaker Change: 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.
Marc: Sue.
If you are using a speaker phone please lift the handset before pressing any keys.
Speaker Change: The first question comes from.
Speaker Change: <unk> 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 that the gross to net that gets affected and if so by how much or is it the filled prescription side as well. Thank you.
Speaker Change: Andrew would try.
Speaker Change: With Jefferies. Please go ahead.
Speaker Change: Hi, Thanks, Good morning, Congrats on all the progress its just pretty awesome to see a little entrepreneur asking 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.
Alright, good morning, Andrew Thank you for the question.
Speaker Change: Now I'll turn it over to Mark and to provide his thoughts on that dynamic and gross to nets.
Speaker Change: <unk> set expectations for when you report Q1.
Speaker Change: I'll talk about the gross to net Andrew and then Chris can talk about what he sees from a field perspective, but from a from a gross to net the real thing that you would see impacting it.
Speaker Change: E. P. S. Max can you help us somehow quantify how much impact there could be T cells with the insurance resets and deductibles that typically occur in Q1, and just to be clear is it the gross to net that gets affected and if so by how much or is it the filled prescription side as well. Thank you.
Speaker Change: Would be related to commercial co pay assistance.
Speaker Change: <unk>.
Speaker Change: If more.
Speaker Change: Of the commercial patients have their high deductibles when you could see a higher amount of.
Speaker Change: Alright, good morning, Andrew. Thank you for the question now I will turn it over to Mark <unk> to provide his thoughts on that dynamic of gross to nets, Yes, I'll talk about the gross to net Andrew and then Chris can talk about what he sees from a field perspective, but from a from a gross to net there the real thing that you would see impacting it.
Speaker Change: Of co pay assistance go into them. However.
Speaker Change: The commercial the commercial patients are a very small portion of total 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 sales.
Speaker Change: Would be related to commercial co pay assistance.
Chris: Yes, Andrew Thanks for the question as far as the field I think as we've stated before we are 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 moat.
Speaker Change: If more.
Speaker Change: Of the commercial patients have their high deductibles, you could see a higher amount of of co pay assistance go into them. However, as you know the commercial pay the commercial patients are a very small portion of total total shipments. So I don't think if anything it won't have much of an impact on.
Speaker Change: Mentum of the launch.
Speaker Change: Outweighs any potential deductible resets at many of these patients may have remember we're still nominally.
Speaker Change: Gross to net in Q1, but Chris can talk about the fields.
Speaker Change: The fifth.
Chris: Yes, 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.
Speaker Change: Second full quarter of launch and our expectation is that you would expect to continue to see increasing new patients new.
Speaker Change: Refills in total dispenses on a monthly basis I think you are going to deal with at the beginning of the year. Some deductible reset with patients that have Medicare advantage in high deductible plans.
Speaker Change: Some of the launch.
Speaker Change: Again, I believe thats very strongly that the momentum.
Speaker Change: Outweighs any potential deductible resets at many of these patients may have remember we're still nominally.
Speaker Change: The initial launch is going to outweigh some of those early.
Speaker Change: The fifth.
Speaker Change: Macro dynamics that every brand faces at the beginning of the year.
Speaker Change: Second full quarter of launch and our expectation is that you would expect to continue to see increasing new patients new refills in total dispensers on a monthly basis. I think you are going to deal with at the beginning of the year. Some deductible reset with patients that have Medicare advantage in high deductible plans.
Speaker Change: Very good and maybe.
Speaker Change: 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.
Speaker Change: You could breakeven this year.
Speaker Change: But again I believe thats very strongly that the momentum.
Speaker Change: Yes.
Speaker Change: Well, let me start with the breakeven portion.
Speaker Change: The initial launch is going to outweigh some of those early.
Speaker Change: I've been.
Speaker Change: Looking about for a long time now that I think a company like <unk>. The single asset small sales are relatively small sales team very focused team.
Speaker Change: Macro dynamics that every brand faces at the beginning of the year.
Speaker Change: 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.
Speaker Change: A.
Speaker Change: And no real discovery engines, or R&D overhead can get to a cash flow breakeven cash flow break even maybe not profitability breakeven with the cash flow breakeven at a run rate a quarterly run rate that gets you to a $2 $50 million to $300 million annually.
Speaker Change: You could break even this year.
Speaker Change: Yeah.
Speaker Change: Well, let me start with the breakeven portion.
Speaker Change: Annual rate.
Speaker Change: Are we closer to the three hundreds and the $2 50, actually but I think thats, where you can get so yes. Those numbers are right I think we could be in that in that rate and that rate by the end of the year.
Speaker Change: I've been talking about for a long time now that I think a company like Verona with a single asset.
Speaker Change: <unk> sales are relatively small sales team very focused team and.
Speaker Change: And a.
Speaker Change: Okay.
Speaker Change: And no real discovery engines, or R&D overhead can get to a cash flow breakeven cash flow break, even maybe not profitability breakeven, but cash flow breakeven at a run rate a quarterly run rate that gets you to a $2 $50 million to $300 million annual rate probably closer to the three hundreds and the $2 50 actually.
Speaker Change: Andrew.
Speaker Change: Yes, I think with regard to consensus as you know, we don't really comment on it directly but I think everyone can see the trajectory is.
Speaker Change: Increasing.
Speaker Change: Very confident and the uptake of OTA there the unmet need is out there the number of patients and so I think we're very.
Speaker Change: But I think that's where we can get so yes. Those numbers are right I think we could be in that in that rate and that rate by the end of the year.
Speaker Change: Excited about the opportunity as 2020 unfolds and clearly you can see the momentum this early in the first quarter.
Speaker Change: Okay, and I forget that you know Andrew I mean.
Speaker Change: Right.
Speaker Change: Yes, I think with regard to consensus as you know, we don't really comment on it directly but I think everyone can see the trajectory is.
Speaker Change: Thank you very much congrats again.
Speaker Change: Thanks.
Speaker Change: Thank you.
The next question comes from yes.
Speaker Change: Increasing.
Speaker Change: We're very confident in the uptake of O. Two there the unmet need is out there the number of patients.
Speaker Change: <unk> Rahimi from Piper Sandler. Please go ahead.
Good morning team and congrats on really an incredible launch I guess, the first question that I have and it's one that we all analysts are getting many of our clients.
Speaker Change: And so I think we're very.
Speaker Change: Sorry.
Speaker Change: Excited about the opportunity as well as 2020 unfolds and clearly you can see the momentum this early in the first quarter.
Speaker Change: Given the outstanding lines, 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 you know like I guess.
Speaker Change: Right.
Speaker Change: Very much congrats again.
Speaker Change: Thanks.
Speaker Change: Thank you.
Speaker Change: The next question comes from yes.
Speaker Change: You know what are the things that's keeping you guys up at night.
Speaker Change: Yes mean rahimi from Piper Sandler. Please go ahead.
Speaker Change: Because.
Speaker Change: The growth chart looks beautiful.
Speaker Change: Good morning team and congrats on really an incredible launch I guess the first question that I have it's one luckily all analysts are getting many of our clients when they went on and given.
Speaker Change: That's sort of one and question number two is around your thoughts around in Europe.
Speaker Change: European filing.
Speaker Change: Given the outstanding.
Speaker Change: <unk>.
Speaker Change: Help us understand like what is the market opportunity in I think the U K and select countries I think in the past pricing is substantially lower.
Speaker Change: Mines, what are some of the headwinds that could be had at our direction. What are some of the risks that we're not foreseeing or anything that could happen and I would love you know like I guess you know what are the things that's keeping you guys up at night.
Speaker Change: I was like what.
Speaker Change: What led to wanting to really pursue that and.
Speaker Change: Because you know the growth chart looks beautiful.
Speaker Change: How do we think about.
Speaker Change: The opportunity there and also the <unk>.
Speaker Change: It's sort of one and question number two is around your thoughts around in Europe, our European filing.
Speaker Change: Got the costs needed to build out a sales force I appreciate sorry multipart question around that thank you.
Speaker Change: Help us understand like what is the market opportunity and I think the U K and select countries I think in the past pricing is substantially lower in Europe like what what what led to wanting to really pursue that Ed.
Speaker Change: Sure thing Thanks for the question, yes, good morning.
Speaker Change: I think.
Speaker Change: Addressing the headwinds.
Speaker Change: Comment.
Speaker Change: We're very optimistic clearly that the unmet need is there and has been demonstrated in COPD. We knew that before we launched that is playing out.
Speaker Change: How do we think about the opportunity there and also the.
Speaker Change: As the launch has unfolded.
Speaker Change: I got the costs needed to build out our sales force I appreciate sorry, multipart question around that.
Speaker Change: And there is really a.
Speaker Change: Large number of patients in.
Speaker Change: In the millions that.
Speaker Change: Yep.
Speaker Change: Sure. Thanks, Thanks for the question, yes, good morning.
Speaker Change: Our currently symptomatic on current standard of care.
Speaker Change: I think you know didn't addressing the headwinds.
Speaker Change: So we are launching into.
Speaker Change: An indication with a broad label in a patient population with great unmet need so.
Speaker Change: Comment.
Speaker Change: 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.
Speaker Change: We don't see really that there is.
Speaker Change: A level of patients being maxed out or tapped out or or accessed in this is merely.
Speaker Change: And there is really a <unk>.
Speaker Change: This needing to address them in the normal cadence of how they see physicians and how they handle their medical care.
Speaker Change: A large number of patients.
Speaker Change: In the millions that.
Speaker Change: Our currently symptomatic on current standard of care.
Speaker Change: As you can see the expanse in the breadth and depth of prescribing continues.
Speaker Change: So we are launching into.
Speaker Change: You know an indication with a broad label in a patient population with great unmet need so.
Speaker Change: Now with over 4600 unique HCP prescribers.
Approximately 55% of the tier one targeted prescribers are prescribing already I.
Speaker Change: We don't see really that there is.
Speaker Change: Level of patients being maxed out or tapped out or accessed in this is merely.
Speaker Change: I think that shows you the pent up need.
Speaker Change: For <unk>, there and for helping patients who remain symptomatic so.
Speaker Change: Needing to address them in the normal cadence of how they see physicians and how they handle their medical care.
Speaker Change: We expect that to continue there are clearly in our target list 14500, Hcp's and of course, all the hcp's that surround those in the different offices.
Speaker Change: As you can see the expanse in the breadth and depth of prescribing continues.
Speaker Change: Now with over 4600 unique HCP prescribers.
Speaker Change: And so we see an expanding opportunity continually.
Speaker Change: The 55% of the tier one targeted prescribers are prescribing already.
Speaker Change: <unk>.
Speaker Change: Get to more prescribers and help more patients.
Speaker Change: That shows you the pent up need.
Speaker Change: And so from a market dynamic standpoint from a patient from an unmet need.
Speaker Change: 402, there and for helping patients who remain symptomatic so.
Speaker Change: We really don't see any any specific headwinds.
Speaker Change: We expect that to continue there are clearly in our target list 14500, Hcp's and of course, all the hcp's that surround those in the different offices.
Speaker Change: From a competition perspective again in any timeframe that.
Speaker Change: Metro foreseeable future, we don't see anything that looks like <unk>, there are bronchodilator and a nonsteroidal anti inflammatory so I think that that fits extremely well with helping these patients.
Speaker Change: And so we see an expanding opportunity continually.
Speaker Change: <unk>.
Speaker Change: Get to more prescribers and help more patients.
Speaker Change: And then.
Speaker Change: And so from a market dynamic standpoint from a patient from an unmet need.
Speaker Change: The things that we always have to attend to that never get maybe as much attention is.
Speaker Change: We really don't see any any specific headwinds.
Speaker Change: Running our pharmaceutical business has a lot of tests that have to be handled to manage risk you have to make product you have to release product you have to make sure that youre doing all of the regulatory requirements around.
Speaker Change: From a competition perspective again in any timeframe that.
Speaker Change: That's for foreseeable future, we don't see anything that looks like Oh, two there are bronchodilator and a non steroidal anti inflammatory so I think that that fits extremely well with helping these patients.
Speaker Change: 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.
Speaker Change: And then I think the things that we always have to attend to that never get it maybe as much attention is.
Speaker Change: Never.
Speaker Change: We didn't 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 our pharmaceutical business.
Running our pharmaceutical business has a lot of tests that have to be handled to manage risk you have to make product you have to release product you have to make sure that youre doing all of the regulatory requirements around.
Speaker Change: So I think again very very optimistic on the market as we go through 2025 for sure.
Speaker Change: 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.
Speaker Change: As far as the European filing 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.
Speaker Change: As you know that takes some time to get through.
Speaker Change: Never.
Speaker Change: We didn't 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 our pharmaceutical business.
Speaker Change: And as we go through 2025, I think we'll get greater clarity on our strategy in Europe.
Speaker Change: 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.
Speaker Change: So I think again very very optimistic on the market as we go through 2025 for sure.
Speaker Change: As far as European filings, just make sure we understand we still don't plan to start operations in Europe, what we're doing is advancing the regulatory process in Europe.
Speaker Change: And we have the capability and the talent and the people in order to Advair.
Speaker Change: Advance the regulatory aspect of the filings both in the European Union and in the UK and as we do that we will concurrently work with our partnering strategy. So I expect them to come together, especially as we work through 2025.
Speaker Change: As you know that takes some time to get through.
Speaker Change: And as we go through 2025, I think we'll get greater clarity on our strategy in Europe.
Speaker Change: 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.
Speaker Change: Thank you so much you bet.
Speaker Change: Great.
Speaker Change: Thank you.
Jakob <unk>: The next question comes from Jakob <unk> with Wells Fargo. Please go ahead.
Speaker Change: And we have the capability and the talent and the people in order to Advair.
Jakob <unk>: Alright, Thanks for taking my question and congrats on the progress.
Speaker Change: Advance the regulatory aspect of the filings both in the European Union and in the UK and as we do that we will concurrently work with our partnering strategy. So I expect them to come together, especially as we work through 2025.
Speaker Change: We've been getting a couple of questions on duration of therapy, because that's a key target for average revenue per patient here.
Speaker Change: Channel checks, we're not really hearing a lot about potential continuations and while still early curious how to think about the average duration on like this.
Speaker Change: Thank you so much you bet.
Speaker Change: Is there upside to that six months average duration assumption, how can we think about that.
Speaker Change: Great.
Speaker Change: Thank you.
Speaker Change: The next question comes from Chuckled files with Wells Fargo. Please go ahead.
Speaker Change: Yes.
Speaker Change: Yes, no hi, Thiago thanks, good morning, so yeah.
Speaker Change: Hey, Thanks for taking my question and congrats on the progress.
Speaker Change: Yes, I think that in our on our modeling and as we've described it we use sort of the benchmark of typical.
Speaker Change: We've been getting a couple of questions on duration of therapy, because that's a key toggle for average revenue per patient here.
Speaker Change: COPD drugs that are their normal persistence and end use over the year and that has been based on around six refills per year.
Channel checks, we're not really hearing a lot about potential continuations and while still early curious how to think about the average duration like this.
Speaker Change: As you know the way, we distribute to bear through a specialty pharmacy network.
Speaker Change: Is there upside to that six months average duration assumption, how can we think about that.
Speaker Change: 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 <unk> of course, helping patients.
Speaker Change: <unk>.
Yeah, No hi, Thiago thanks, good morning, so yeah.
Speaker Change: Yes, I think that in our on our modeling and as we've described it we use sort of the benchmark of typical.
Speaker Change: <unk> drugs that are their normal persistence and end use over the year and that has been based on around six three fills per year.
Speaker Change: And the refills again very early yet because of course.
Speaker Change: The most refills as.
Speaker Change: As you know the way, we distribute to bear through a specialty pharmacy network.
Speaker Change: As we talked about patients now receiving over five refills already.
Speaker Change: 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 Oh, two various of course, helping patients.
Speaker Change: 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.
Speaker Change: We'll have of course, a greater number of patients more rebuild information to look at.
Speaker Change: But yes, we're very encouraged by where we are right now and yes. We we do think there is upside to the six refills per year.
Speaker Change: And in the refills again very early yet because of course.
Speaker Change: Fair enough. Thanks again for taking my question.
Speaker Change: The most refills as we talked about patients now receiving over five refills already.
Speaker Change: Thank you. Thank you.
Tom Shrader: The next question comes from Tom Shrader with BP AG. Please go ahead.
Speaker Change: But of course, it's from earlier patients that started.
Speaker Change: In the first part of the launch in 2024, so as we get through 2025, we will have of course, a greater number of patients more refilled information to look at but.
Tom Shrader: Good morning, Congratulations I was trying to get up the nerve to ask the breakeven question. After one quarter. So thank you for that.
Tom Shrader: I have a couple of surveillance questions any common themes in the 45% who are not prescribing the drug there are any structural things.
Speaker Change: But yes, we're very encouraged by where we are right now and yes. We we do think there is upside to the six refills per year.
Speaker Change: Fair enough. Thanks again for taking my question.
Tom Shrader: We are working on and then the nebulizer, how big a deal as the Nebulizer. This is really a peak sales question are you building into patients that have a nebulizer or is there are there are significant numbers of patients who are adding a nebulizer to add this drug. Thank you.
Speaker Change: Thanks, Thank you.
Speaker Change: The next question comes from Tom Shrader with BP AG. Please go ahead.
Tom Shrader: Good morning, Congratulations I was trying to get up the nerve to ask the breakeven question. After one quarter. So thank you for it.
Tom Shrader: Thanks, Tom for the question, let's start with the.
Speaker Change: I have a couple of surveillance questions any common themes in the 45% who are not prescribing the drug there are any structural things.
Tom Shrader: 45% that Havent written yet I want to focus on me.
Tom Shrader: Are the other side of it or the number of riders that we have today.
Speaker Change: We are working on and then the nebulizer, how big a deal as the Nebulizer. This is really a peak sales question or are you building into patients that have a nebulizer or is there are there are significant numbers of patients who are adding a nebulizer to add this drug. Thank you.
To have over 4600 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 in the profile of O two there.
Tom Shrader: What you see today is typical launch dynamics of early adopters mid adopters in late adopters.
Speaker Change: Yeah.
Speaker Change: Thanks, Tom for the question let's.
Speaker Change: Let's start with the <unk>.
Tom Shrader: And I think that's the dynamic that you face there is 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 <unk>. When we do market research on physicians that have written and those that havent written yet all doctors see the benefits of <unk>.
Speaker Change: 45% that Havent written yet I want to focus on me.
Speaker Change: Are the other side of it.
Speaker Change: The number of riders that we have today I mean to have over 4600 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 in the profile of O two there.
Two there in the with the profile and the potential in their patients. They also talk about how they would start writing within the next three 612 months. So I think when we look at our market research, we understand that our rider group base will continue to grow and we will continue to penetrate.
Speaker Change: You see today is typical launch dynamics of early adopters mid adopters in late adopters.
Speaker Change: And I think that's the dynamic that you face there is 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 <unk>. When we do market research on physicians that have written and those that havent written yet all doctors see the benefits of <unk>.
Tom Shrader: These doctors that haven't written so far because of the profile of <unk>.
Tom Shrader: As far as the Nebulizer I think this is something that we got as a question very early on of Ken This drug.
Tom Shrader: People use an <unk> drug and our hypothesis going into this was that innovation would Trump route of administration and we are very clearly seeing that in the early stages of launch or of this early part of launch.
Speaker Change: Oh to bear in the with the profile and the potential in their patients. They also talk about how they would start writing within the next three 612 months. So I think when we look at our market research, we understand that our rider group base will continue to grow and we will continue to penetrate.
Tom Shrader: In fact, when we look at our data we have.
Tom Shrader: <unk> that don't have an <unk> patients that do have an advisor and the core underlying feature that the doctors are prescribing <unk> is around per system symptoms and route of administration has become kind of a non issue.
Speaker Change: These doctors that haven't written so far because of the profile of O two there.
Speaker Change: As far as the Nebulizer I think this is something that we got as a question very early on of Ken This drug.
It's not something that comes up from a field perspective with the doctors, it's not something that comes up with patients. In fact, many patients talk about how nebulizer is a comforting way to deliver their product because they know it gets to their long. So I think thats been something early in launch that I think has been dispelled and it really showcases the.
Speaker Change: People use <unk> drug and our hypothesis going into this was that innovation would Trump route of administration and work very clearly seeing that in the early stages of launch or of this early part of launch.
Speaker Change: In fact, when we look at our data we haven't.
Speaker Change: <unk> that don't have <unk> patients that do have a nebulizer and the core underlying feature that the doctors are prescribing <unk> is around persistent symptoms and route of administration has become kind of a non issue.
Tom Shrader: And that <unk> is bringing to the COPD marketplace.
Tom Shrader: Great. Thank you.
Tom Shrader: Thank you.
Tom Shrader: The next question comes from Ram Silverado.
Speaker Change: It's not something that comes up from a field perspective with the doctors, it's not something that comes up with patients. In fact, many patients talk about how nebulizer is a comforting way to deliver their product because they know it gets to their long. So I think thats been something early in launch that I think has been dispelled and it really showcases the.
Tom Shrader: H C. W. Please go ahead.
Tom Shrader: Thanks, so much for taking my questions and congrats on the phenomenal progress with the launch so really very impressive.
Tom Shrader: Firstly I wanted to ask whether you see any underlying market dynamic trends emerging with respect to prescriber preferences regarding the deployment of ultra rare.
Speaker Change: And that <unk> is bringing to the COPD marketplace.
Speaker Change: Great. Thank you.
Tom Shrader: 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 <unk>.
Speaker Change: Thank you.
Speaker Change: The next question comes from Ron Silver Ihle with H C. W. Please go ahead.
Tom Shrader: Who are also receiving tried therapy to increase over time or remain constant and then also with respect to the ex U S picture.
Speaker Change: Thanks, so much for taking my questions and congrats on the phenomenal progress with the launch it's really very impressive.
Speaker Change: Firstly I wanted to ask whether you see any underlying market dynamic trends emerging with respect to prescriber preferences regarding the deployment of ultra rare.
Tom Shrader: Was just wondering if there are territories beyond you in greater China that you believe are likely to be particularly lucrative <unk> century, and what your strategic plans are 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 <unk>.
Speaker Change: Especially now that we've gotten a little bit further into the commercial trajectory and in particular you know if you can comment on whether you expect the proportion of patients on O two hair.
Tom Shrader: Cow.
Tom Shrader: 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.
Speaker Change: Who are also receiving tried therapy to increase over time or remain constant and then also with respect to the ex U S picture with just wondering if there are territories beyond you in greater China that you believe are likely to be particularly lucrative for <unk> and what your strategic.
Hi, Ron model, where there is a lot to unpack there. So let me start sort of near the back of that question listen we'll work our way through it.
Tom Shrader: Our strategy is still of course to partner outside the U S. As we have already as you mentioned and in greater China.
Speaker Change: It's hard 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.
Tom Shrader: The other regions are all important in their own way clearly incremental and in totality are very significant.
Speaker Change: 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.
Tom Shrader: In the growth.
Speaker Change: For <unk>, there on a global basis.
Speaker Change: Well, so theres a lot to unpack there. So let me start sort of near the back of that question listen we'll work our way through it.
Tom Shrader: Other regions again outside Europe.
Tom Shrader: Greater China, but.
Tom Shrader: Even in Japan.
Speaker Change: Our strategy is still of course to partner outside the U S. As we have already as you mentioned and in greater China.
Tom Shrader: In other parts of Asia.
Tom Shrader: As well.
Tom Shrader: And of course, the other emerging markets.
Speaker Change: I think the other regions are all important in their own way clearly incremental and in totality are very significant.
Tom Shrader: South America, all become incremental and are important now have been always saying that though is nothing more important than having a successful launch in the U S, which will continue to execute on.
Speaker Change: In the growth.
Speaker Change: For <unk>, there on a global basis.
Speaker Change: Other regions again outside Europe.
Tom Shrader: And that's what we'll continue to focus for sure, but we'll carry on with our strategy for 2025 in partnering and as I mentioned, we're already starting that and more.
Speaker Change: Later, China, but.
Speaker Change: Even in Japan.
Speaker Change: In other parts of Asia.
Speaker Change: As well.
Speaker Change: And of course, the other emerging markets.
Tom Shrader: Progressive state by working with the regulatory authorities in Europe, and the U K.
Speaker Change: South America, all become incremental and are important now I've been always saying that there is nothing more important than having a successful launch in the U S, which will continue to execute on.
Tom Shrader: And maybe I'll turn it over to Chris to talk about.
Chris: The dynamics the market dynamics and how that has been.
Speaker Change: While we've seen balanced on what we did in market research. Thanks, Dave.
Speaker Change: And that's what we'll continue to focus for sure, but we'll we'll carry on with our strategy for 2025 in partnering and as I mentioned, we're already starting that and more.
Speaker Change: When we look at the patients in what's a consistent theme about who's getting prescribed <unk>. It goes back to some very simple kind of truce. These patients all have.
Speaker Change: Progressive state.
Speaker Change: I'll have persistent symptoms, particularly just fail.
Speaker Change: Working with the regulatory authorities in Europe, and the U K.
Speaker Change: 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 there.
Speaker Change: And maybe I'll turn it over to Chris to talk about sort of the dynamics the market dynamics and how that has been.
Speaker Change: 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 Disney decreasing activities and how to air could potentially help with these patients over time.
Chris: Well, we've seen balanced on what we did in market research. Thanks, Dave when we look at the patients in what's a consistent theme about who's getting prescribed bow to bear. It's it goes back to some very simple kind of truce. These patients all have.
Speaker Change: The other thing that I think we're very encouraged by is as Dave talked about in his opening comments, which is 50% of our patients are on therapies that are not considered triples. So either single bronchodilator dual bronchodilator, a LABA Ics are no long acting bronchodilator I think this is going to increase over time.
Chris: All have persistent symptoms, particularly just fail.
Chris: And Thats, a very big trigger for the physician to add or change therapies within these patients. So when our reps go into these offices there 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 Disney decreasing activities and how to air could potentially.
Speaker Change: <unk>.
Speaker Change: As we heard from physicians in research <unk> seen from our interactions in the field.
Chris: We help with these patients over time.
Speaker Change: Doctors are looking for another mechanism and another way to provide broncho dilation 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.
Chris: The other thing that I think we're very encouraged by is as Dave talked about in his opening comments, which is 50% of our patients are on therapies that are not considered triples. So either single bronchodilator dual bronchodilator, a LABA Ics are no long acting bronchodilator.
Speaker Change: And maybe a more appropriate place than it is used today.
Chris: I think this is going to increase over time.
Chris: As we heard from physicians in research <unk> seen from our interactions in the field.
Speaker Change: Talks about the long term potential of OTO, there not only in its current form but potentially as a combination product as Dave has mentioned in his comments earlier about our pipeline expansions. So.
Chris: Doctors are looking for another mechanism and another way to provide broncho dilation 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.
Speaker Change: So I really feel like that that's a great opportunity as we move through 25 and enter 2006 as well.
Speaker Change: Thank you very much.
Thank you.
Speaker Change: The next question comes from Joon Lee from Truest. Please go ahead.
And maybe a more appropriate place than it is used today.
Speaker Change: It really talks about the long term potential of OTO there not only in its current form but potentially as a combination product as Dave has mentioned in his comments earlier about our pipeline expansions.
Joon Lee: Thanks for the update and for taking our questions.
Joon Lee: With several pulmonologist and there seems to be a wide range of prescription reimbursement rates ranging from over 90% to less than half or some pulmonologist could you help us understand some of the pushes and pulls.
Speaker Change: So I really feel like that that's a great opportunity as we move through 25 and enter 2006 as well.
Joon Lee: Reimbursement and what you are doing to improve this and just a clarification question on European partnership is.
Speaker Change: Thank you very much.
Speaker Change: Thank you.
Speaker Change: The next question comes from Julian Lee from Truest. Please go ahead.
Joon Lee: Is it your plan to have some copper clause like the one you have a nuance NK.
Joon Lee: In case someone else may emerge that may want the global right. Thank you.
Speaker Change: On the update and for taking our questions.
Joon Lee: Hi June good morning, Yeah. Thanks for the question, let me start with the last one and then I'll turn it over to Chris.
Speaker Change: Spoke with several pulmonologists and there seems to be a wide range of prescription reimbursement rates are ranging from over 90% to less than half or some pulmonologist could you help us understand some of the pushes and pulls.
Joon Lee: Well I think we'll have to see how our partnership discussions go as you as you know we're also looking for a partner that may have a broader base of capabilities with regard to.
Speaker Change: Reimbursement and what you are doing to improve this and just a clarification question on European partnerships is it your plan to have some copper costs like the one you have with nuance.
Joon Lee: Development of MDI DPI manufacturing of the drug product manufacturing of DPI in MDI. So there may be other attributes of the partnership that are quite different than the one we have with nuance pharma at the moment. So we'll see how that looks as we <unk>.
Speaker Change: Someone else may emerge that may want the global right. Thank you.
Speaker Change: Hi, Joe and good morning, Yeah. Thanks for the question, let me start with the last one and then I'll turn it over to Chris.
Speaker Change: Well I think we'll have to see how our partnership discussions go as you as you know we're also looking for a partner that may have a broader base of capabilities with regard to.
Joon Lee: As we continue but we understand your point and clearly we always wanted to make sure we do the best for <unk> there.
Joon Lee: And our shareholders and the kind of structured deal that we do and with that I'll turn it over to Chris Yes June as far as reimbursement I think we've been very pleased with how the reimbursement looks.
Speaker Change: Development of MDI DPI manufacturing of the drug product manufacturing of BPI in MDI. So there may be other attributes of the partnership that.
Chris Yes: In this early stage of launches as we talked about at launch we anticipated about 80% of our reimbursement our 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 are always have talked about is that we have.
Speaker Change: Are quite different than the one we have with nuance pharma at the moment. So we'll see how that looks as we as we continue but we understand your point and clearly we always wanted to make sure. We do the best for O two there.
Speaker Change: And our shareholders and the kind of cost structure deal that we do and with that I'll turn it over to Chris Yes June as far as reimbursement I think we've been very pleased with how the reimbursement looks in this in this early stage of launches as we talked about at launch we anticipated about 80% of our reimbursement or claims would fall under a medical bent.
Chris Yes: Access in those channels, meaning patients can get us there is no prior offs, there's no real step out if theres. There is access to <unk> in those channels, where it becomes as an out of pocket cost for patients. If a patient has supplemental insurance, we see their co pays are usually less than $10 of patients met their deductible and Medicare advantage.
Speaker Change: Either under Medicare part D 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 us. There is no. Prior offs, there's no real step edits theres there is access to <unk> in those channels.
Chris Yes: Their co pays less than $10 or even nothing.
Chris Yes: And so that's the driver of potentially.
Chris Yes: Reimbursement is not necessarily access it's more of an out of pocket costs 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.
Speaker Change: What it becomes is an out of pocket cost for patients if a patient has supplemental insurance.
Chris Yes: On the commercial side, we have robust copay card programs and provide that to patients. Additionally, we've created other services with including patient assistance programs for patients that are low income that they can get this product through that process as well, but I would say within these first two quarters of nominally one too.
Speaker Change: We see their co pays are usually less than $10 of patients met their deductible and Medicare advantage their co pays less than $10 or even nothing.
Speaker Change: And so that's the driver of potentially.
Speaker Change: Reimbursement, it's not necessarily access it's more of an out of pocket costs 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.
Chris Yes: Quarters of launch.
Chris Yes: We are very encouraged by the way reimbursement and access is presenting itself and more importantly, what it comes 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.
Speaker Change: 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 low income that they can get this product through that process as well.
Chris Yes: Thank you.
Chris Yes: Thank you.
Chris Yes: The next question comes from Bill Berlin Touchy happen.
Speaker Change: But I would say within these first two quarters of nominally first two quarters of launch.
Ross: Ross. Please go ahead.
Speaker Change: Good morning, Tim can you hear me okay.
Speaker Change: We are very encouraged by the way reimbursement and access is presenting itself and more importantly, what it comes 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.
Ross: Yes, good morning, Alright.
Speaker Change: Okay. Thanks for that.
Speaker Change: So I just have a couple of questions. So one of them focusing on the recent process. So as more and more patients are going for repo. So im wondering how does the process work in the renewable is sitting.
Speaker Change: Thank you.
Speaker Change: <unk> have to take Spirometry test or anything just to make sure. They are getting some benefit in terms of when they take the drug are.
Speaker Change: Thank you.
The next question comes from Berlin.
Speaker Change: When they call the doctor asking for a prescription and the Doctor estimate what kind of symptom improvements are you seeing so are there specific symptoms that good improvement.
Speaker Change: Ross. Please go ahead.
Ross: Good morning, Tim can you hear me okay.
Ross: Yes, good morning, Alright, hi, okay. Thanks for that.
Speaker Change: <unk> that's the first one on the second are there any side effect profile, especially the ones that are listed in the FDA label or physicians seeing any of those.
Speaker Change: So I just have a couple of questions. So one of them focusing on the recently process. So as more and more patients are going for repo. So I'm wondering how does the process work in the renewable is sitting so do patients have to take the spirometry test or anything just to make sure. They are getting some benefit in terms of when they take their drug are.
Including the thank you actually even if they are listed in the labor are there.
Speaker Change: Any instances of those side effects recurring in these patients and railroad sitting.
Speaker Change: When they called the Doctor asking for a prescription and then the doctor asking that what kind of symptom improvements are you seeing so are there specific symptoms that getting through that.
Speaker Change: Great move.
Speaker Change: Maybe I'll turn it over to Chris to start with the refill.
Speaker Change: <unk> and how that goes yes, I mean this is the best excuse me. This is the benefit of our.
Speaker Change: Oh Tulare usage, that's the first one on 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 including the psychiatric even if they were listed in the labor are there.
Speaker Change: Distribution pathway, we have amazing specialty pharmacy partners like director acts and Cvs.
Speaker Change: In center, while on a carrier that have individualized processes to ensure that a patient can refill their prescription in a timely manner.
Speaker Change: Any instances of those side effects occurring in these patients in the real world setting.
Speaker Change: Each of them will reach out individually to the patients early in the process to encourage or talk to them about refilling their medication.
Speaker Change: Great Hi, move on and maybe I'll turn it over to Chris to start with the the refill process and how that goes yes. I mean this is the best excuse me. This is the benefit of our disc.
Speaker Change: And it's a very.
Speaker Change: I would say a very organized and systematic approach to ensuring patients stay on therapy.
Speaker Change: Distribution pathway, we have amazing specialty pharmacy partners like director acts and Cvs.
Speaker Change: You also have the opportunity in these situations to be able to.
Speaker Change: In center, while on a carrier that have individualized processes to ensure that a patient can refill their prescription in a timely manner.
Speaker Change: 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 <unk> with them.
Speaker Change: Each of them will reach out individually to the patients.
Speaker Change: Early in the process to encourage or talk to them about refilling their medication.
Speaker Change: 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.
Speaker Change: And it's a very.
Speaker Change: I would say a very organized and systematic approach to ensuring patients stay on therapy.
Speaker Change: 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.
Speaker Change: You also have the opportunity in these situations to be able to.
Speaker Change: 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 <unk> with them.
Speaker Change: But one of the things that is also encouraging is the feedback that we're getting from patients across the spectrum to specialty pharmacies to the doctors really highlights how <unk> long term is going to be very beneficial for for the patient.
Speaker Change: Their lives one of the things that I think is very encouraging early on as Dave mentioned is this early persistency or refill data that we're seeing again, a little bit too early to say.
Speaker Change: And bill on with regards to side effects as you know we are.
Speaker Change: Subject and have enacted pharmacovigilance program as all commercial drugs do.
Speaker Change: It's different than the initial six months of SaaS or forecast, but I think we believe there's a significant upside there a potential upside there.
Speaker Change: Mark will get it to make sure we capture.
Speaker Change: But one of the things that is also encouraging is the feedback that we're getting from patients across the spectrum to specialty pharmacies to the doctors really highlights how to their long term is going to be very beneficial for for the patient.
Speaker Change: Side effects reported side effects on a commercial level in that program of course is in place.
Speaker Change: I would say there is nothing that we have determined to be inconsistent with the label.
Speaker Change: And so I think it's of course fairly early in the process.
Speaker Change: And bill on with regards to side effects as you know we are.
Speaker Change: At this time.
Speaker Change: I would say our.
Speaker Change: Subject and have an active pharmacovigilance program as all commercial drugs do.
Speaker Change: Side effect profile is consistent with the labeling.
Speaker Change: Thank you very much.
Mark: Mark will get it to make sure we capture.
Speaker Change: Thank you.
Mark: Side effects reported side effects on a commercial level in that program of course is in place.
Speaker Change: As a reminder, if you wish to ask a question. Please press star one.
Mark: I would say, there's nothing that we have determined to be inconsistent with the label.
Mark: And so I think it's of course fairly early in the process.
Speaker Change: This concludes our question and answer session I would like to turn the conference back over to David is that Garden Delhi for any closing remarks.
Mark: At this time.
Mark: I would say our.
Mark: Side effect profile is consistent with the labeling.
Mark: Okay.
Mark: Thank you very much.
Speaker Change: Well. Thank you everyone for joining us this morning.
Mark: Yeah.
Mark: Thank you.
Speaker Change: And of course, we look forward to seeing all of you at upcoming conferences as.
Mark: Yeah.
Speaker Change: As a reminder, if you wish to ask a question. Please press star one.
Speaker Change: As we continue to progress through 2025.
Mark: Yeah.
Speaker Change: As you can see we're very excited about the impact of OTA, there in helping patients with COPD and we'll continue to execute that both in the U S and as we continue globally as well so look forward to keeping everyone updated as we progress and hope you have a great day.
Mark: Yeah.
Mark: This concludes our question and answer session.
Speaker Change: I would like to turn the conference back over to David is that guard Delhi for any closing remarks.
Speaker Change: Well. Thank you everyone for joining us this morning.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
Speaker Change: And of course, we look forward to seeing all of you at upcoming conferences.
Speaker Change: We continue to progress through 2025.
Speaker Change: As you can see we're very excited about the impact of O. Two there in helping patients with COPD and we will continue to execute that both in the U S and as we continue globally as well so look forward to keeping everyone updated as we progress and hope you have a great day.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.