Q2 2024 Verona Pharma PLC Earnings Call

Operator: are in a listen-only mode. Earlier this morning, Verona Pharma issued a press release announcing its financial results for the three months ended June 30th, 2024. A copy can be found in the Investor Relations tab on the corporate website www.veronapharma.com.

Earlier this morning, Verona pharma issued a press release announcing its financial results for the three months ended June 30th 'twenty 'twenty four a copy can be found in the Investor Relations tab on the corporate website www dot for in a form of Dot com before we begin I'd like to.

Operator: Before we begin, I'd like to remind you that today's call, statements about the company's future expectations, plans, and prospects, are forward-looking statements. These forward-looking statements are based on management's current expectations. These 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 management's 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 cause its views to change.

Speaker Change: Remind you that today's call statements about the company's future expectations plans and prospects are forward looking statements. These forward looking statements are based on management's current expectations.

Speaker Change: These 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.

Speaker Change: Our achievements to be material to materially different from our expectations expressed or implied by the forward looking statements.

Unknown Executive: Any such forward-looking statements represent management's estimates as of the date of this conference call.

Unknown Executive: All such forward-looking statements represent management's 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 cause its views to change. As a reminder, this call is being recorded and will remain available for 90 days. I'd now like to turn the call over to Dr. David Zaccardelli, Chief Executive Officer.

Speaker Change: Any such forward looking statements represent managements estimates as of the date of this conference call.

Speaker Change: 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 cause it views to change as a reminder, this call is being reworked courted and will remain available for 90 days.

Operator: As a reminder, this call is being recorded and will remain available for 90 days.

Operator: I'd now like to turn the call over to Dr. David Sacridelli, Chief Executive Officer.

Speaker Change: I'd now like to turn the call over to Dr. David Soccer Daly Chief Executive Officer.

David Zaccardelli: Thank you and welcome everyone to today's call. With me today are Marcon, our Chief Financial Officer, Dr. Kathy Rickard, our Chief Medical Officer, Chris Martin, our Chief Commercial Officer, and Dr. Tara Rowe, our Chief Development Officer. The second quarter was exceptional for Verona-Farma, marked by the U.S. FDA approval of O2VAR for the maintenance treatment of COPD. O2VAR is the first-inhaled COPD treatment to provide both bronchidialation and non-steroidal anti-inflammatory effects, and we believe this approval can redefine the treatment paradigm for COPD in the U.S. Today, we announced O2VAR is now available through our exclusive network of specialty pharmacies, and patient shipments have begun.

David Zaccardelli: Thank you and welcome everyone to today's call. With me today are Mark Hahn, our Chief Financial Officer; Dr. Kathy Rickard, our Chief Medical Officer; Chris Martin, our Chief Commercial Officer; and Dr. Tara Rheault, our Chief Development Officer.

Speaker Change: Thank you and welcome everyone to today's call.

Speaker Change: With me today are Mark Hahn, our Chief Financial Officer.

Speaker Change: Dr. Kathy Rick <unk>, our Chief Medical Officer, Chris.

Chris Martin: Chris Martin, our Chief Commercial Officer, which differentiates it from all other approved COPD treatments. In addition to the U.S. launch of O2Bear, we plan to initiate two new Phase II programs in the third quarter. The trial is a randomized, double-blind, placebo-controlled, one-week crossover trial to assess lung function, safety, and the pharmacokinetic profile of glycoparalase in the novel formulation delivered via nebulizer in approximately 40 patients with COPD. The randomized, double-blind, placebo-controlled, parallel group trial will enroll 180 patients with a recent history of pulmonary exacerbation. The trial will assess the effect of 3 mg of entufentrin twice daily on the rate and risk of pulmonary exacerbation, in addition to symptoms and quality of life.

Speaker Change: Chris Martin our Chief commercial officer.

Speaker Change: And Dr. Tara <unk>, our Chief Development Officer.

David Zaccardelli: The second quarter was exceptional for Verona Pharma, marked by the U.S. FDA approval of O2-VER for the treatment of COPD. OcuVer is the first inhaled COPD treatment to provide both bronchodilation and non-steroidal anti-inflammatory effects. And we believe this approval can redefine the treatment paradigm for COPD in the U.S. Today, we announce O2 Bear is now available through our exclusive network of specialty pharmacies, and patient shipments have begun.

Speaker Change: The second quarter.

Speaker Change: He is an exceptional or Verona pharma marked by the U S. FDA approval, Oh, two there without treatment for the maintenance treatment of COPD.

Speaker Change: Okay. There is the first inhaled MPD treatment to provide both broncho dilation and nonsteroidal anti inflammatory effects.

Speaker Change: And we believe this approval and redefine the treatment paradigm for COPD in the U S.

Speaker Change: Today, you know Oh to bear is now available through our <unk>.

Speaker Change: Goosen network of specialty pharmacy, and patient shipments have begun.

David Zaccardelli: We are very excited to share this achievement with you and are confident that our extensive preparation positioned us for the successful commercialization of O2VAR in the U.S. As a reminder, O2VAR's label supports broad youth across all COPD patients, without restrictions to background medications, COPD etiology, including chronic bronchitis or empathy month, or blood-geostinopital levels. The label also describes O2VAR's mechanism of action, which differentiates it from all other approved COPD treatments. Things on O2VAR's novel mechanism of action and compelling benefit to us profile. Our market research shows ATPs have significant interest in prescribing O2VAR broadly across all symptomatic COPD patient types.

David Zaccardelli: We are very excited to share this achievement with you and are confident that our extensive preparation positioned us for the successful commercialization of O2VaR in the U.S. As a reminder, O2 Bear's label supports broad use across all COPD patients without restriction to background medication, DOPD etiology including chronic bronchitis or emphysema, or blood eosinophil level. The label also describes O2 Bayer's mechanism of action, which differentiates it from all other approved COPD treatments. It is based on O2Bear's novel mechanism of action and compelling benefit-to-risk profile.

Speaker Change: We are very excited to share. This achievement with you and are confident that our extensive preparation this or not but that's it.

Speaker Change: That's the commercialization of O two there in the U S.

Speaker Change: As a reminder, O two bears label support what have you across all COPD patients without restriction for background medications.

Speaker Change: C O P D etiology, including chronic bronchitis emphysema.

Speaker Change: Oh blood NFL level.

Speaker Change: The label also described Oh, two Baird mechanism of action, which.

Speaker Change: Which differentiates it from all other approved COPD treatment.

Speaker Change: Based on O two bears novel mechanism of action and compelling benefit to risk profile.

David Zaccardelli: Our market research shows ATPs have significant interest in prescribing O2vera broadly across all symptomatic COPD patient types. Initially, our launch efforts are focused on promoting O2-VaR to the most active HDPs that treat DOPD patients, which our market analysis shows is approximately 14,500 providers. These providers include pulmonologists, primary care physicians, nurse practitioners, and physician assistants. Our sales and field reimbursement teams are fully hired and have been in the field since late July. During that time, they have interacted with over 2000 HCPs, with over 85% being top prescribers.

Speaker Change: Market research shows.

Speaker Change: <unk> had significant interest in prescribing old jubair broadly across all symptomatic COPD patient type.

David Zaccardelli: Initially, our launch efforts are focused on promoting O2 VAIR to the most active HDPs that treat COPD patients, which our market analysis shows is approximately 14,500 providers. These providers include pulmonologists, primary care physicians, nurse practitioners, and physician assistants. Our sales and fields reimbursement teams are fully hired and have been in the field since late July. During that time, they have interacted with over 2,000 HCPs, with over 85% being top prescribers. Although it has just been a few days, over 100 HCPs have prescribed O2 VAIR.

Speaker Change: Initially our launch effort are okay.

Speaker Change: Promoting O to bear to the most active HCP that treat COPD patient.

Speaker Change: It's our market analysis shows is approximately 14500 providers.

Speaker Change: These providers include Pulmonologist primary care physician.

Speaker Change: Practitioners and physician assistance.

Speaker Change: Our sales and field reimbursement teams are fully hired and have been in the field since late July.

Speaker Change: During that time, they have interacted with over 2000, HCP with over 85% being top prescribers.

David Zaccardelli: Although it has just been a few days, over 100 healthcare professionals have prescribed O2Vir. In addition to the U.S. launch of O2VaR, we plan to initiate two new Phase II programs in the third quarter. First, we are developing a fixed-dose combination formulation with N-defensin and glycopyrrolate, ALAMA, for the maintenance treatment of COPD delivered via a standard jet nebulizer. In July, we submitted an IND to the FDA, and subject to clearance, we plan to start a phase two dose-ranging trial in the third quarter.

Speaker Change: Although it has just been a few days over 100 HCP have prescribed Oh Gee there.

David Zaccardelli: In addition to the U.S.

Speaker Change: In addition to the U S launch of both to bear we plan to initiate two new phase two program in the third quarter.

David Zaccardelli: launch of O2 VAIR, we plan to initiate two new Phase 2 programs in the third quarter. First, we are developing a fixed dose combination formulation with N.D. Pension and glycoparolate, Alama, for the maintenance treatment of COPD delivered via standard jet nebulizer. In July, we submitted an IND to the FDA, and subject to clearance, we plan to start a phase 2 dose-ranging trial in the third quarter. The trial is a randomized double-blind placebo-controlled one-week cross-over trial to assess lung function, safety, and the pharmacokinetic profile of glycoparolate in the novel formulation delivered via nebulizer, in approximately 40 patients with COPD.

Speaker Change: First we are developing a fixed dose combination formulation with any pension and glad compare like a llama well the maintenance treatment of COPD delivered yeah standard jet nebulizer.

Speaker Change: In July we submitted and indeed for the FDA and subject to clearing we plan to start a phase two dose ranging trial in the third quarter.

David Zaccardelli: The trial is a randomized, double-blind, placebo-controlled, one-week crossover trial to assess lung function, safety, and the pharmacokinetic profile of glycoparalase in the novel formulation delivered via nebulizer in approximately 40 patients with COPD. Following identification of an appropriate micropara light dose, a Phase II trial assessing the fixed-dose combination of n-bifenthrin and glycoparalase compared to placebo and Additionally, we plan to initiate a Phase II trial to assess nebulize and defense in patients with non-specific fibrosis prostatectomy in the third quarter.

Speaker Change: The trial is a randomized double blind placebo control one week crossover trial to assess lung function safety and pharmacokinetic kinetic profile like apparently in the novel formulation delivered via a nebulizer.

Speaker Change: Timothy 40 patients with COPD.

David Zaccardelli: Following the identification of an appropriate glycoparolate dose range, a phase 2 trial assessing the fixed dose combination of N.D. Pension and glycoparolate, compared to placebo, and individual components, will be conducted.

Speaker Change: Following identification of an appropriate like apparel like those range.

Speaker Change: Jude trial assessing the fixed dose combination and keep entrant like apparel late compared to placebo.

Speaker Change: An individual component will be conducted.

David Zaccardelli: Additionally, we plan to initiate a Phase 2 trial to assess nebulized N.D. Pension in patients with non-specific fibrosis-prosy-actases in the third quarter. The randomized double-blind placebo-controlled parallel group trial will enroll 180 patients with a recent history of pulmonary exacerbations. The trial will assess the effect of three milligrams of N.D. Pension twice daily on the rate and width of pulmonary exacerbations in addition to symptoms and quality of life. To ensure robust powering, the trial is planned as events driven, where all patients enrolled will be treated for at least 24 weeks and until they require a number of exacerbation events are observed.

Speaker Change: Additionally, we plan to initiate a phase two trial to assess that'd be life and pension in patients with non cystic fibrosis.

Speaker Change: At the end of third quarter.

David Zaccardelli: The randomized, double-blind, placebo-controlled, parallel group trial will enroll 180 patients with a recent history of pulmonary exacerbation. The trial will assess the effect of 3 mg of N2Fentron twice daily on the rate and risk of pulmonary exacerbation in addition to symptoms and quality of life.

Speaker Change: The randomized double blind placebo controlled parallel group trial will enroll 180 patients with a recent history.

Speaker Change: Minerva exacerbation.

Speaker Change: The trial will assess the effect of three milligrams events, you've mentioned twice daily on the rate of pulmonary exacerbations. In addition to symptoms and quality of life.

David Zaccardelli: To ensure robust powering, the trial is planned as event-driven, where all patients enrolled will be treated for at least 24 weeks and until the required number of exacerbation events are observed. Lastly, our balance sheet remains strong, with over $400 million of cash on hand and optionality for future draws under our Oak Tree facility. I will now turn the call over to Mark to review our financial results for the second quarter. Mark, please go ahead.

Speaker Change: To ensure a robust powering the trial is planned as event driven where all patients enrolled will be treated for at least 24 weeks.

Speaker Change: And until the required number of exacerbation events are observed.

David Zaccardelli: Lastly, our balance sheet remains strong with over $400 million of cash on hand and optionality for future draws under our Oak Tree facility.

Speaker Change: Lastly, our balance sheet remains strong with over $400 million of cash on hand, and optionality for future draws under our old treat facility.

Mark Hahn: I will now turn the call over to Mark to review our financial results for the second quarter. Mark, please go ahead. As Dave mentioned, our balance sheet is strong with in excess of $400 million of cash on equivalents at June 30, 2024. This includes $70 million drawn under our debt facility and $100 million drawn under the RIPSA had approval. with the cash currently on hand and potential future access to the remaining $425 million under the Oak Tree Facilities.

Mark: I will now turn the call over to Mark to review our financial results for the second quarter. $70 million drawn under our debt facility, with the cash currently on hand, including a commercial launch of O2 there in the U.S., would be approximately $37 million for the quarter, in line with our previous guidance and an $8.8 million increase. $49 million for the quarter ended June 30, 2024, compared to $12.4 million reported, is driven primarily by an accrual of the $15 million first sale milestone due to life.

Speaker Change: I will now turn the call over to Marc to review, our financial results for the second quarter.

Marc: Please go ahead.

Mark Hahn: As Dave mentioned, our balance sheet is strong, with in excess of $400 million in cash and equivalents at June 30, 2024. This includes... $70 million dollars drawn under our debt facility, and $100 million drawn under the RIPSA at approval, with the cash currently on hand, and the potential future access to the remaining $425 million under the Oak Creek facility. We expect to have sufficient cash runway beyond 2026, including a commercial launch of O2 there in the U.S, and our two new Phase II clinical programs. Total operating expenses for the second quarter of 2024 were higher than the historical level, as a result of the recognition of one-time expenses, for Milestone Payments due to Ligand. Performance-Based RSU.

Marc: As Dave mentioned, our balance sheet is strong.

Marc: The $400 million in cash and equivalents at June 32024.

Speaker Change: This include.

Speaker Change: $70 million drawn under our debt facility.

Speaker Change: And $100 million drawn under the ripsaw at approval.

Speaker Change: With the cash currently on hand, and potential future access to the remaining $425 million under the old facilities.

Mark Hahn: We expect to have sufficient cash runway beyond 2026, including the commercial launch of O2 there in the US and our two new Phase 2 clinical programs.

Speaker Change: We expect to have sufficient cash runway beyond 2026, including the commercial launch of O. Two there in the U S.

Speaker Change: And our two new phase III clinical program.

Speaker Change: Total operating expenses for the second quarter of 2024 were higher than historical level.

Mark Hahn: Total as a result of the recognition of one-time expenses for milestone payments due to ligand and performance-based RSU. Excluding these one-time costs, our quarterly R&D and SG&A expenses would be approximately $37 million for the quarter, in line with our previous guidance. Research and development costs from $19.4 million for the quarter compared to a net reversal of costs of $2.5 million were reported for the second quarter of 2023. This increase was primarily due to a cruel of the $6.3 million approval milestone to Ligand. A $2.5 million increase in share-based compensation, largely driven by the recognition of expenditure due to the performance-based RSU, $1.7 million of expense related to pre-approval inventory production, and an $8.8 million increase in clinical trial costs from Q2 2023 to Q2 2024.

Speaker Change: As a result of the recognition of one time expenses.

Speaker Change: Milestone payments due to ligand and performance based rsum.

Mark Hahn: Excluding these one-time costs, quarterly R&D and SG&A expenses would be approximately $37 million for the quarter, in line with our previous guidance. Research and development costs were $19.4 million for the quarter, compared to a net reversal of costs. $25 million, were reported for the second quarter of 2023. The Simpry, The Simpry, Raghuram Selvaraju, primarily due to a cruel $6.3 Million Approval Milestone July; A $2.5 million increase in share-based competition, largely driven by the recognition of expensory to the performance-based RFUs.

Speaker Change: Excluding these one time costs, our quarterly R&D and SG&A expenses would.

Speaker Change: It would be approximately $37 million for the quarter in line with our previous guidance.

Speaker Change: Research and development costs of $19 $4 million for the quarter compared to a net reversal of cost too.

Speaker Change: $2 $5 million.

Speaker Change: Reported for the second quarter of 2023.

Speaker Change: This increase was primarily due to a pool of the $6 3 million dollar approval milestone July again.

Speaker Change: A $2.5 million increase in share based compensation.

Speaker Change: Archie driven by the recognition of expense related to performance based argued.

Mark Hahn: $1.7 million of expense related to pre-approval inventory and an $8.8 million increase in clinical trial costs from Q2 2023 to Q2 2024. Selling, General, and Administrative. $49 million for the quarter ended June 30, 2024, compared to $12.4 million reported for the same period in 2023. The Thin Priest is driven primarily by an accrual of the $15 million first sale milestone due to life and increases of $7.4 million for marketing and

Speaker Change: One $7 million of expense relate.

Speaker Change: Related to pre approval inventory production.

Speaker Change: And an $8 8 million dollar increase in clinical trial costs from Q2 2023 for Q2 2024.

Mark Hahn: Selling, general and administrative expenses for $49 million for the quarter and in June 30, 2024, compared to $12.4 million reported for the same period in 2023. This increase was driven primarily by a cruel of the $15 million first sale milestone due to ligand and increases of $7.4 million from marketing and other commercial launch-related activities, $4.3 million and cheaper-related costs as we built out our commercial organization, as well as an increase in share-based compensation of approximately $8 million largely driven by performance-based RSU expense.

Speaker Change: Selling general and administrative expenses were $49 million for the quarter ended June 32024, compared to $12 $4 million reported for the same period in 2023.

Speaker Change: This increase was driven primarily by an accrual of the 15 million dollar first sale milestone due to ligand.

Mark: And increases of $7.4 million for marketing and other commercial launch-related activities, and $4.3 million in FIPA-related costs as we built out our commercial organization. I'll now turn the call back over to the operator for the Q&A. We will now begin the question and answer session.

Speaker Change: And increases of seven $4 million from marketing and other commercial launch related activities.

Mark Hahn: $4.3 million in people-related costs as we built out our commercial organization, as well as an increase in share-based compensation. Approximately $8 million, largely driven by performance-based RSU expenses. I'll now turn the call back over to the operator for the Q&A. We will now begin the question and answer session.

Speaker Change: $4 $3 million and people related costs as we built out our commercial organization as.

Speaker Change: As well as an increase in share based compensation.

Speaker Change: Approximately $8 million largely driven by performance based or do you expect.

Operator: I now turn the call back over to the operator for the Q&A. We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you were using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two.

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

Operator: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been answered and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Andrew Tsai with Jeffreys. Please go ahead.

Speaker Change: We will now begin the question and answer session.

Speaker Change: Ask a question you May press Star then one on your telephone keypad.

Speaker Change: If you were using a speakerphone please pick up your handset before pressing the keys.

Speaker Change: Any time your question has been addressed and you would like to withdraw your question. Please press Star then two.

Operator: At this time, we will pause momentarily to assemble our roster.

Speaker Change: At this time, we will pause momentarily to assemble our roster.

Andrew Sy: The first question comes from Andrew Sy with Jefferies. Please go ahead. Hey, thanks. Good morning and congratulations on the execution of the launch. Thanks for taking my question.

Speaker Change: The first question comes from Andrew Tsai with Jefferies. Please go ahead.

Andrew Tsai: Hey, thanks, good morning, and congratulations on the execution and launch. Thanks for taking my questions. So, the first one is, as we tweak around our models, what kind of payer rejection and patient abandonment rate should we be modeling for end-to-pension? And can you remind us if there will be free drugs?

Andrew Tsai: Hey, thanks, good morning, and congratulations on the execution and launch. Thanks for taking my questions. So, the first one is, as we tweak around our models, what kind of payer rejection and patient abandonment rate should we be modeling for emphysentrin? And can you remind us if there will be a free drug?

Andrew Tsai: Hey, Thanks, good morning, and congratulations on the execution of the launch thanks for taking my questions. So first one is as we took around our models what kind of payer rejection in patient abandonment rate should we be modeling for epicentral and can you remind us if there will be free drug.

Andrew Sy: First one is as we took around our models, what kind of payer rejection and patient abandonment rate should we be modeling for ampute tension?

Andrew Sy: Can you remind us if there will be free drug?

David Zaccardelli: Good morning, Andrew. Thanks for the questions. With regard to free drug, we do have programs in place to support patients based on economic need, for example. Also, we do have what we would call a bridging program for those patients that may have delayed benefits and allowing them to start on drug in the short term while those benefits become in effect. So there is not a sampling program for say, but there is an ability to provide O2 bears to those patients that need it and to support them through any short-term benefit verification.

Speaker Change: Hi, Good morning, Andrew Thanks for thanks for the question.

David Zaccardelli: Good morning, Andrew. Thanks for the questions. With regard to free drugs, you know, we do have programs in place to support patients based on economic need, for example. And also, we do have what we would call a bridging program for those patients that may have delayed benefits, allowing them to start on drugs in the short term while those benefits become in effect. So there is not a sampling program per se, but there is an ability to provide O2VARES to those patients that need it and to support them through any short-term benefit verification.

Unknown Executive: Good morning, Andrew. Thanks for the questions. With regard to free drugs, you know, we do have programs in place to support patients based on economic need, for example. And also, we do have what we would call a bridging program for those patients that may have delayed benefits, allowing them to start on drugs in the short term while those benefits become in effect. So there is not a sampling program per se, but there is an ability to provide O2VARES to those patients that need it and to support them through any short-term benefit verification.

Speaker Change: With regard to redraw the we do have programs in place to support.

Speaker Change: Patient based on economic need for example.

Speaker Change: And also we do have what we would call. It raging program for those patients that may have delayed benefit Ah and allowing them to start on drug and in the short term, while those benefits become in effect. So.

Speaker Change: There is not a sampling program per se, but there isn't the ability to provide oh to bear to those patients that need it.

Speaker Change: And to support them through any short term benefit verification.

David Zaccardelli: With that, I guess I'll turn it over to... Chris on payer dynamics, at least from a modeling standpoint, and as you know, it's incredibly early in the launch to understand that based on current prescriptions that have been written. Andrew, this is Chris. Thank you for the question.

Christopher Martin: With that, I guess I'll turn it over to Chris on payer dynamics, at least from a modeling standpoint. And as you know, it's incredibly early in the launch to understand that based on current prescriptions that have been written.

Speaker Change: With that I guess I'll turn it over to.

Speaker Change: Chris on payer dynamics at least from a modeling standpoint, and as you know it.

Chris Martin: Ratably early in the launch to understand that based on current prescriptions that have been written.

Christopher Martin: Andrew, this is Chris. Thank you for the question. When we think about the overall payer abandonment and rejection, as Dave mentioned, we're very early in the launch here, but I'm going to go back to using older analog within the nebulizer space. And what you see within those spaces, keep in mind that O2 bear will be primarily reimbursed under a medical benefit. Within our historical analog that we looked at under a medical benefit side, which can either be under traditional med B. Or through Medicare Advantage, those abandonments are lower than what you see in Medicare Part D and commercial, but they do exist early on.

Speaker Change: Andrew This is Chris. Thank you for the question when we think about the overall payer abandonment and rejection I E. L F.

Christopher Martin: When we think about the overall payer abandonment and rejection, as Dave mentioned, we're very early in the launch here, but I'm gonna go back to using older analogs within the nebulizer space, and what you see within those spaces, keep in mind that O2 payers will be primarily reimbursed under a medical benefit. Within our historical analogs that we've looked at under the medical benefit side, which can either be under traditional Med B or through Medicare Advantage, those abandonments are lower than what you see in Medicare Part D and commercial, but they do exist early on.

Dave: Dave mentioned, we're very early in the launch here, but you know I'm going to go back to using older older analog within the nebulizer space and what you see with enough space and keep in mind that Oh, two Bayer will be primarily reimbursed under a medical benefit within our historical analogs that we've looked at under a medical benefit side, which can either be.

Speaker Change: Under traditional med D or through Medicare advantage, those abandonment or are lower than what you see in Medicare part D and commercial but they do exist early on there's just a natural pace.

Christopher Martin: There's just a natural patient dynamic that some patients, regardless of co-pay, even if it's low and zero, may have walked away from a prescription. But we believe that everything that we have from a patient assistance program through Verona Pathway Plus provides access to the medication in a variety of different ways. Additionally, if you think about rejection rates and how rejection works, I'll go back to the same statement there around medical benefit versus pharmacy benefit. We believe the majority of our prescriptions will run through the medical benefit side of the business. And within that medical benefit side of the business, we have data on what those rejection rates look like.

Christopher Martin: There's just a natural patient dynamic that some patients, regardless of copay, even if it's low and zero, may walk away from a prescription. But we believe that everything that we have from a patient assistance program through Verona Pathway Plus provides access to the medication in a variety of different ways. Additionally, if you think about rejection rates and how rejection works, I'll go back to the same statement there around medical benefit versus pharmacy benefit. We believe the majority of our prescriptions will run through the medical benefit side of the business, and within that medical benefit side of the business, we have data on what those rejection rates look like.

Speaker Change: Patient dynamic that some patients regardless of co pay even if it's low and zero may have walked away from a from a.

Speaker Change: Scripture, but we believe that everything that we have from a.

Speaker Change: Patient assistance program through blown up halfway plus provides access to the medication in a variety of different way. Additionally, if you think about rejection rates are and how rejection works I I'll go back to the same statement there around medical benefit versus pharmacy benefit. We believe the majority of our prescriptions will run through the medical.

Speaker Change: Outside.

Speaker Change: Of the business and within that medical benefit side of the business, we have a data and on what those rejection rate look like we also know that during this time will be using a non specific J code that non specific J code exists the local coverage determination exist and we believe that the product is able to flow.

Christopher Martin: We also know that during this time, we'll be using a nonspecific J-code. Because the nonspecific J-code exists, the local coverage determination exists, and we believe that the product is able to flow through that channel very freely. Additionally, as we talked about on the approval call, we submitted our J-code application in LCD. We did that on June 27th. It is currently under review at CMS, and we would expect a product-specific J-code at the beginning of 2025 to be in effect. So I hope that helps with your questions, and again, I appreciate it.

Christopher Martin: We also know that during this time we'll be using a non-specific Jacob, that non-specific Jacob exists, the local coverage determination exists, and we believe that the product is able to flow through that channel very freely. Additionally, as we talked about on an approval call, we have submitted our Jacob application in LCD. We did that on June 27th. It is currently under a U.S. CMS, and we would expect a product-specific Jacob at the beginning of 2025 to be in effect. So I hope that helps with your questions, and again, I appreciate it.

Speaker Change: Through that channel are very freely. Additionally, as we talked about on the approval call. We have submitted our J code application in LCD. We did that on June 27th and is currently under review at CMS, and we would expect a product specific J code.

are in a listen only mode.

Unknown Executive: Earlier this morning, Verona Pharma issued a press release announcing its financial results for the three months ended June 30th, 2024. A copy can be found in the Investor Relations tab on the corporate website www.veronapharma.com.

Speaker Change: At the beginning of 2025 to be in effect. So I hope that helps with your question again appreciate it.

David Zaccardelli: No, yep. And secondly, you know, consensus for Q3 is $1.5 million. If we assume patients who get reimbursed this quarter maybe get treated for an average of half a month, then by my calculation, the number of patients needed is 1,400 or more. Would you feel comfortable meeting or exceeding that patient number in Q3 or exiting on September 30th?

Andrew Tsai: No, yep. And secondly, you know, consensus for Q3 is 1.5 million. If we assume patients who get reimbursed this quarter maybe get treated for an average of half a month, then by my calculation, the number of patients needed is 1400 or more. Would you feel comfortable meeting or exceeding that patient number in Q3 or exiting on September 30th?

Andrew Sy: Yep, and secondly, you know, consensus for Q3 is 1.5 million.

Speaker Change: No yeah and secondly.

Speaker Change: You know consensus for Q3 is a $1 5 million.

Andrew Sy: If we assumed patients who get reimbursed quarter, maybe get treated for an average of half a month, then by my calculation, the number of patients needed is 1,400 or more. Would you feel comfortable meeting or exceeding that patient number in Q3, or exiting out of September 30th?

Speaker Change: If we assumed Ah patients, who get reimburses corner, maybe get treated for an average of half a month then by my calculation the number of patients.

Unknown Executive: Before we begin, I'd like to remind you that today's call, statements about the company's future expectations, plans, and prospects are forward-looking statements. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees and involves 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 management's 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 its subsequent events cause its views to change.

Speaker Change: It's 1400 or more would you feel comfortable meeting or exceeding that patient number in.

Speaker Change: Q3 exiting out of September 30th.

David Zaccardelli: Yeah, maybe I'll take that one, Andrew.

Speaker Change: Yeah, maybe I'll take that one Andrew.

David Zaccardelli: Yeah, maybe I'll take that one, Andrew. I don't think we're prepared to talk about patient numbers. I will note, however, that in doing your math, you do have to consider there will be some inventory making its way into the channel, not actually getting the patients quite yet that will impact revenue.

David Zaccardelli: I don't think we're prepared to talk about patient numbers. I will note, however, that in doing your math, you do have to consider there will be some inventory making its way to the channel, not actually getting to the patients quite yet that will impact revenues.

Andrew Tsai: We're prepared to talk about patient numbers I will note however that.

Speaker Change: In doing your math you do have to consider there will be some some inventory, making its way into the channel not not actually get into patients quite yet that will impact our revenue.

Andrew Sy: Okay, great. Thank you.

Unknown Executive: Okay, great. Thank you.

Unknown Executive: Okay, great. Thank you.

Andrew Tsai: Okay, great. Thank you.

Operator: Thanks, Andrew.

Andrew Tsai: Thanks, Andrew.

Yasmeen Rahimi: The next question comes from Yasmeen Rahimi with Piper Sandler. Please go ahead.

Operator: The next question comes from Yasmeen Rahimi with Piper Sandler. Please go ahead.

Operator: The next question comes from Yasmeen Rahimi with Piper Sandler. Please go ahead.

Speaker Change: The next question comes from Yasmin Rahimi with Piper Sandler. Please go ahead.

Emma Andreath: Hi, this is Emma Andreath. Thanks for taking our questions. Firstly, do you provide any color on patient starting forms and how that ties into how you're thinking about patient uptake? And with that, what type of matrix do you plan to share at next earnings in November to help us track the launch progress and guide future expectations? Yes.

Emma andreotti: Hi, This is Emma andreotti, thanks for taking my questions. Firstly can you provide any color on patient starting farms and how that ties into how you're thinking about patient uptake and with that what type of metrics do you plan to share at next earnings in November to help US track the launch progress and guide to Jakafi.

Unknown Executive: As a reminder, this call is being recorded and will remain available for 90 days.

David Zaccardelli: I'd now like to turn the call over to Dr. David Sacridelli, Chief Executive Officer. Thank you and welcome everyone to today's call.

Speaker Change: Patients.

Yasmeen Rahimi: Yes, good morning Alma. Thanks for the question. You know, I think I'll start with the latter part. You know, as clearly as you do

Speaker Change: Yeah. Good morning, Thanks for the question.

Emma Andreath: Good morning, Emma. Thanks. Thanks for the question.

David Zaccardelli: With me today, our Marcon, our Chief Financial Officer, Dr. Kathy Rickard, our Chief Medical Officer, Chris Martin, our Chief Commercial Officer, and Dr. Tara Rowe, our Chief Development Officer. The second quarter was an exceptional for Verona-Farma marked by the U.S. FDA approval of O2VAR for the maintenance treatment of COPD. O2VAR is the first-inhaled COPD treatment to provide both bronchidialation and non-steroidal anti-inflammatory effects, and we believe this approval can redefine the treatment paradigm for COPD in the U.S. Today, we announced O2VAR is now available through our exclusive network of specialty pharmacies and patient shipments have begun.

David Zaccardelli: You know, I think I'll start with the latter part. You know, clearly, as you've seen in our history, we're as transparent as we can be, as we progress. We expect our metrics to continually evolve as we get further into the launch, and we'll show assessing which shows our core of the next quarterly call. As you can see, just in a few days, the uptake is quite strong with O2BAR, with over 100 HTTPs already writing for it, and we've barely just begun. And so we will, of course, again, be informative, be transparent, and give you metrics to understand the launch dynamics, and we expect again that to change over time.

Speaker Change: I think I'll start with the latter part.

Speaker Change: Nearly as you've seen in our history, we were as transparent as we can be as we progress we expect our metrics to continually evolve.

Speaker Change: As we get further into the launch and well still assessing which throws arc or the next quarterly call.

Speaker Change: As you can see just in a in a few days the uptake is quite strong.

Speaker Change: For those who bear with over 100 HCP is already writing for it and we barely just begun and so we will of course again be informative be transparent and give you metrics to understand that the launch dynamic and we expect again that's changed over time.

David Zaccardelli: We are very excited to share this achievement with you and are confident that our extensive preparation positioned us for the successful commercialization of O2VAR in the U.S. As a reminder, O2VAR's label supports broad youth across all COPD patients, without restrictions to background medications, COPD etiology, including chronic bronchitis or empathy month, or blood-geostinopital levels. The label also describes O2VAR's mechanism of action, which differentiates it from all other approved COPD treatment. Things on O2VAR's novel mechanism of action and compelling benefit to us profile.

Speaker Change: Okay.

Tom Schrader: For the next question, comes from Tom Schrader with BTIG. Please go ahead. Good morning. Congratulations. I have what's probably an annoying question, but you've written 100 prescriptions. Do you have any read on who they're for? Are they all patients unhappy on triple, or are you already seeing people try the drug earlier?

Operator: Our next question comes from Tom Shrader with BTIG. Please go ahead.

Operator: Our next question comes from Tom Shrader with BTIG. Please go ahead. Again, thank you for joining us. We appreciate it. Thank you.

Speaker Change: Our next question comes from Tom Shrader with P. T. I G. Please go ahead.

Thomas Shrader: Good morning and congratulations. I have what's probably an annoying question, but you've written a hundred prescriptions. Do you have any idea who they're for? Are they all patients unhappy on triple, or have you already... People tried the drug earlier.

Tom Shrader: Hi, good morning, and congratulations I have what's probably an annoying question, but you've written 100 prescriptions do you have any read on who they are for are they all patients unhappy on triple or are you already seeing people tried the drug earlier.

David Zaccardelli: Again, I'll have Chris comment, but keep in mind that we're just a few days into this. And so all the analyses that you'd expect on a maturing launch haven't quite started yet.

Unknown Executive: Again, I'll have Chris comment, but keep in mind that we're just a few days into this, and so all the analyses that you'd expect on a maturing launch haven't quite started yet. But with that, I'll have Chris comment.

David Zaccardelli: Again, I'll have Chris comment, but keep in mind that we're just a few days into this, and so all the analyses that you'd expect on a maturing launch haven't quite started yet. But with that, I'll have Chris comment.

Speaker Change: Again, I'll have Chris comment.

Speaker Change: But keep in mind, we're just just a few days into this and so all the analyses that you would expect on a maturing longevity quite started yet.

Christopher Martin: But with that, I'll have Chris comment. And Tom, thanks for the question.

Speaker Change: But with that I'll have Chris comment.

Christopher Martin: Tom, thanks for the question, and just for clarification, we have over 100 writers of prescribers for O2 there. What we know about those prescribers is they come from our TARP target list, so if we think back to our other calls, these are the highest prescribing positions, both what I would call Segment 1 and Segment 2 positions that our reps are calling on. What we're also hearing very clearly from our early field conversations is that the unmet need that we've expressed throughout the last year and a half is very high within these offices.

Chris Martin: Tom Thanks for the question I, just just for clarity we have over 100 writers of Oh.

Christopher Martin: Just for clarity, we have over 100 writers of O2BAR. What we know about those prescribers is they come from our TARP target list. So we think back to our other calls.

David Zaccardelli: Our market research shows ATPs have significant interest in prescribing O2VAR broadly across all symptomatic COPD patient types. Initially, our launch efforts are focused on promoting O2 VAIR to the most active HDPs that treat COPD patients, which our market analysis shows is approximately 14,500 providers. These providers include pulmonologists, primary care physicians, nurse practitioners, and physician assistants. Our sales and fields reimbursement teams are fully hired and have been in the field since late July. During that time, they have interacted with over 2,000 HCPs with over 85% being top prescribers. Although it has just been a few days, over 100 HCPs have prescribed O2 VAIR.

Chris Martin: Oh gosh drivers of O T. There.

Speaker Change: What we know about those prescribers as they come from our top target list. So if we think back to our other call. These are the highest prescribing physicians.

Christopher Martin: These are the highest prescribing positions, both that I would call segment one and segment two positions that our reps are calling on. We're also hearing very clearly from our early field conversation. Do the unmet need that we've expressed throughout the last year, year and a half, is very high within these offices. The doctors are reporting back to our reps. They have significant numbers of patients who continually have persistent symptoms. And they look at O2BAR as a new tool in their toolkit for treating these patients. And it allows them to use it in a variety of different ways.

Speaker Change: Both what I would call segment, one segment two physicians that our reps are calling on what we're also hearing very clearly from our early field conversations as the unmet need that we've expressed throughout the last year year and a half is very high with him he's off.

Christopher Martin: The doctors are reporting back to our reps; they have significant numbers of patients who continually have persistent symptoms, and they look at O2 there as a new tool in their toolkit for treating these patients, and it allows them to use it in a variety of different ways. As Dave said, it's very early to kind of give an analysis of what the patient profile looks like, and the ways that these doctors have prescribed it.

Speaker Change: The doctors are reporting back to our reps they have significant numbers of patients who continually have persistent symptom and they look at O. Two there is a new tool in their toolkit for treating these patients and it allows them to use it in a variety of different ways as Dave said, it's very early to kind of give an analysis of what the patient profile looks like.

Christopher Martin: As they said, it's very early to kind of give an analysis of what the patient profile looks like of those of the ways that these doctors have prescribed it. However, what we do know is that they are telling us every single time our reps go into the office that these patients continue to have persistent symptoms. And that will drive utilization as we move through the third quarter and into the fourth quarter as well.

Speaker Change: Of those of the of the ways that these doctors have prescribed. It. However, what we do know is that they are telling us every single time, our reps go into the office that these patients continue to have persistent symptoms and that will drive utilization as we move through the third quarter and into the fourth quarter as well.

Christopher Martin: However, what we do know is that they tell us every single time our reps go into the office that these patients continue to have persistent symptoms, and that will drive utilization as we move through the third quarter and into the fourth quarter as well.

David Zaccardelli: In addition to the U.S, launch of O2 VAIR, we plan to initiate two new phase 2 programs in the third quarter. First, we are developing a fixed dose combination formulation with N.D. Pension and glycoparolate, Alama, for the maintenance treatment of COPD delivered via standard jet nebulizer. In July, we submitted an IND to the FDA and subject to clearance we plan to start a phase 2 dose-ranging trial in the third quarter. The trial is a randomized double blind placebo-controlled one-week cross-over trial to assess lung function, safety, and the pharmacokinetic profile of glycoparolate in the novel formulation delivered via nebulizer, in approximately 40 patients with COPD.

Unknown Speaker: Okay, and then a quick question on the fixed dose.

Speaker Change: Okay, and then a quick question on the fixed dose could try a fixed dose in a handheld device do you have to get the monotherapy approved in a handheld device first where could you in fact try that a car.

Unknown Executive: Okay, and then a quick question on the fixed dose. To try a fixed dose in a handheld device, do you have to get monotherapy approved in a handheld device first?

Unknown Speaker: To try a fixed dose in a handheld device, do you have to get the monotherapy approved in a handheld device first? Or could you, in fact, try that combination in a different device? Yeah, I think the way that the programs are typically designed for a fixed dose combination, you actually, one way or another, work through the entire development of a monotherapy in that formulation, whether it's in a handheld device or a nebulizer. Got it.

Speaker Change: A combination in a in a different device.

Unknown Executive: Yeah, I think the way that the programs are typically made.

Speaker Change: Yeah, I think the way that the programs are typically designed for a fixed dose combination you actually one way or another work through the entire development of a mono therapy in that formulation, whether it's in a handheld device or a nebulizer.

Unknown Executive: Got it. Okay. Thank you very much.

Speaker Change: Got it okay. Thank you very much.

Unknown Speaker: Okay. Thank you very much.

Joon Lee: Yeah. Thanks. The next question comes from Joon Lee with Truist. Please go ahead. Hi, thank you.

Speaker Change: Yeah.

David Zaccardelli: Following the identification of an appropriate glycoparolate dose range, a phase 2 trial, assessing the fixed dose combination of N.D. Pension and glycoparolate, compared to placebo, and individual components will be conducted. Additionally, we plan to initiate a phase 2 trial to assess nebulized N.D. Pension in patients with non-specific fibrosis-prosy-actases in the third quarter. The randomized double blind placebo-controlled parallel group trial will enroll 180 patients with a recent history of pulmonary exacerbations. The trial will assess the effect of three milligrams of N.D. Pension twice daily on the rate and width of pulmonary exacerbations in addition to symptoms and quality of life. To ensure robust powering, the trial is planned as events driven, where all patients enrolled will be treated for at least 24 weeks and until they require a number of exacerbation events are observed.

Matt: Thanks, Matt.

Operator: The next question comes from Joon Lee with Truist. Please go ahead.

Speaker Change: The next question comes from Joon Lee with <unk>. Please go ahead.

Joon Lee: Hi, thank you. This is Jane for June, and thanks for taking my questions and also congratulating you on your progress. So, I have other questions regarding your drug – can you give more color on the drug when compared to treating non-CF bronchitis, especially compared with your competitors like Enzimax and Parenzyl?

Speaker Change: Hi. Thank you this is Jean Claude Kihn, and thanks for taking my questions and also congratulations on the progress.

Joon Lee: This is Jean-Paul Joon, and thanks for taking my questions, and also congratulate you on your progress.

David Zaccardelli: So I have other questions regarding about your can you give you know give more color on the drug can treat compare with treating the non-CF branch test test especially compare with your competitors like Anzumette, Branzo, test tape, and then also could you give some provide some unique of this mechanism for this drug can be offered better, you know, a competitive edge over other drugs. Thanks. Yeah, so, you know, we think end-suffentrant has the potential to make a difference in patients with non-CF bronchiectasis because it targets neutrophilic inflammation, including both neutrophils and macrophage-based inflammatory processes. It also works through increasing filiary function and cop and pseudom in particular is one of the most problematic issues associated with brachyectasis, and it's that dysfunctional nucleary processes in these patients that cause continual infections and further pulmonary exacerbation.

Speaker Change: I have other questions regarding a bothering you at a time.

Speaker Change: Okay, you know give more color on that.

Speaker Change: So I can see a comparator with taking the Dol yes.

Speaker Change: Yes tap it.

Speaker Change: Especially compared with your competitors like <unk> and that's Grenfell S T.

Speaker Change: And also could you.

Speaker Change: So I'm probably have something unique.

Speaker Change: Magnesium shot can be off by a bathroom companion for agile way either tax.

Speaker Change: Thanks.

Unknown Executive: Yeah, so, you know, we think encephentrin has the potential to make a difference in patients with non-CF bronchiectasis because it targets neutrophilic inflammation, including both neutrophils and macrophages-based inflammatory processes. It also works through increasing filiary function, cough, and sputum. Sputum, in particular, is one of the most problematic issues associated with bronchiectasis, and it's the dysfunctional mucociliary processes in these patients that cause continual infections and further pulmonary exacerbations. So our trial, of course, is designed to assess the effect of antifentrin on pulmonary exacerbations.

Speaker Change: Yeah. So you know.

Speaker Change: We think <unk> has the potential to make a difference in patients with non CF bronchiectasis, because it targets neutrophil like inflammation, including both neutrophils and Macrofossil Beast inflammatory processes.

Mark Hahn: Lastly, our balance sheet remains strong with over $400 million of cash on hand and optionality for future draws under our oak tree facility.

Speaker Change: It also works through.

Speaker Change: Creasing ciliary function and cotton sputum eat them in particular is one of the most problematic issues associated with bronchiectasis and it's at a dysfunctional.

Mark Hahn: I will now turn the call over to Mark to review our financial results for the second quarter. Mark, please go ahead. As Dave mentioned, our balance sheet is strong with in excess the $400 million of cash on equivalents at June 30, 2024. This includes $70 million drawn under our debt facility and $100 million drawn under the RIPSA had approval, with the cash currently on hand and potential future access to the remaining $425 million under the Oak Tree Facilities.

Speaker Change: Mucociliary processes in these patients that caused continual.

Speaker Change: Infections and further pulmonary exacerbations.

David Zaccardelli: So our trial, of course, is designed to assess the effect of end-suffentrant on pulmonary exacerbation. He saw very strong data against pulmonary exacerbations and reducing rate and risk of exacerbations in the COPD population. We certainly think that, based on the mechanism, this will extrapolate to a bronchiectasis population. Regarding how end-suffentrant might impact patients with bronchiectasis compared to other competitor drugs that are out there, we really think that end-suffentrant has the opportunity to actually make these patients feel better rather than just reducing exacerbation rates. And so that's the goal, and those are some of the end points that will be assessing in this first trial.

Speaker Change: So our trial of course is designed to assess the effect of events are centering on pulmonary exacerbation, you saw very strong data against pulmonary exacerbations and reducing rate.

Unknown Executive: We saw very strong data against pulmonary exacerbations and reducing rates and risk of exacerbations in the COPD population. We certainly think that, based on the mechanism, this will extrapolate to a bronchiectasis population regarding how InfoCentrin might impact patients with bronchiectasis compared to other competitor drugs that are out there. We really think that antifentrin has the opportunity to actually make these patients feel better rather than just reducing exacerbation rates. And so that's the goal, and those are some of the endpoints that we'll be assessing in this first trial.

Speaker Change: And rent of exacerbations in the COPD population, we certainly think that based on the mechanism will extrapolate to a bronchiectasis population.

Mark Hahn: We expect to have sufficient cash runway beyond 2026, including the commercial launch of O2 there in the US and our two new Phase 2 clinical program. Total As a result of the recognition of one-time expenses for milestone payments due to ligand and performance-based RSU. Excluding these one-time costs, our quarterly R&D and SGNA expenses would be approximately $37 million for the quarter in line with our previous guidance. Research and development costs from $19.4 million for the quarter compared to a net reversal of costs of $2.5 million were reported for the second quarter of 2023.

Unknown Executive: regarding how InfoCentrin might...

Speaker Change: Regarding how and to send trend might.

Speaker Change: Impact patients with bronchiectasis compared to other competitor drugs that are out there. We really think that emphasis entrant has the opportunity to actually make these patients feel better rather than just reducing exacerbation rate and so that's the goal and those are some of the endpoints that we'll be assessing in this first trial.

Unknown Speaker: Great, thanks.

Unknown Executive: Great, thank you. But do you have any preclinical data to support what you have for this indication?

Speaker Change: Oh, great. Thanks, but don't have any pre clinical data to support a lot of you have for that indication.

Unknown Speaker: But do you have any pre-communical data to support what do you have for this indication? Well, I'm not aware of any model specifically relating to bronchiectasis, but certainly we have a wealth of data with similar pathosis, physiological processes, and patients with COPD. Lee, including Reduction and Coffin's Feudum that was important in the Phase 3 program.

Unknown Executive: Well, I'm not aware of any models specifically relating to bronchiectasis, but certainly, we have a wealth of data with similar pathophysiological processes in patients with COPD, including reduction in coffin sputum that was important in the phase three program.

Speaker Change: Well I'm not aware of any model specifically relating to bronchiectasis, but certainly we have a wealth of data with similar pathophysiological processes in patients with COPD.

Speaker Change: Including reduction in cost that was important in the phase III program.

Mark Hahn: This increase was primarily due to a cruel of the $6.3 million approval milestone to ligand. A $2.5 million increase in share-based compensation largely driven by the recognition of expenditure due to the performance-based RSU, $1.7 million of expense related to pre-approval inventory production and an $8.8 million increase in clinical trial costs from Q2 2023 to Q2 2024.

Unknown Speaker: Okay, thank you so much.

Unknown Executive: Okay, thank you so much. Thanks for taking my call.

Speaker Change: Okay. Thank you so much thanks for taking my question.

Bram Selvaraju: Thanks for taking my question. The next question comes from Bram Selvaraju with HC Waitwright. Please go ahead.

Operator: The next question comes from Ram Selvaraju, with H.C. Wainwright. Please go ahead.

Operator: The next question comes from Ram Selvaraju, with H.C. Wainwright. Please go ahead.

Speaker Change: The next question comes from Graham Selfish Arab with H C. Wainwright. Please go ahead.

Raghuram Selvaraju: Thanks so much for taking my questions. On the commercial front, this is probably for Chris, I wanted to see if you could provide us with some more granularity on what you are currently engaged in doing on the social media front and what you plan to do in the course of the coming months with respect to marketing outreach and also when you anticipate involving direct-to-consumer advertising as part of the overall commercial process for O2VAIR and if so, you know, what forms that might potentially take and what you might think about doing on, for example, the speaker program side with physicians as well as what you're seeing in terms of patient advocacy involvement in support of O2VAIR within the COPD community.

Bram Selvaraju: Thanks so much for taking my questions. On the commercial front, this is probably for Chris.

Speaker Change: Thanks, very much for taking my questions on.

Speaker Change: On the commercial front. This is probably for Chris I wanted to see if you could provide us with some more granularity on what you are currently engaged in doing on the social media front and what you plan to do in the course of the coming months with respect to marketing outreach and also when you anticipate involving.

Bram Selvaraju: I wanted to see if you could provide us with some more granularity on what you are currently engaged in doing on the social media front and what you plan to do in the course of the coming months with respect to marketing outreach and also when you anticipate involving direct to consumer advertising as part of the overall commercial process grow to here. And if so, you know, what forms that might potentially take and what you might think about doing on, for example, the speaker program side with the positions as well as what you're seeing in terms of patient advocacy involvement in support of O2VAR within the COPD community.

Mark Hahn: Selling general and administrative expenses for $49 million for the quarter and in June 30, 2024 compared to $12.4 million reported for the same period in 2023. This increase was driven primarily by a cruel of the $15 million first sale milestone due to ligand and increases of $7.4 million from marketing and other commercial launch-related activities, $4.3 million and cheaper-related costs as we built out our commercial organization as well as an increase in share-based compensation of approximately $8 million largely driven by performance-based RSU expense.

Chris Martin: Direct to consumer advertising, that's part of the overall commercial process.

Speaker Change: Two there and if so you know what form that might potentially take and what you might think about doing on for example, the speaker program side with.

Speaker Change: With physicians as well as what you're seeing in terms of patient advocacy involvement and support of O to bear with him to COPD community.

Christopher Martin: Thanks, Ram.

Speaker Change: Thanks, Rob so accurate yeah, thanks, Rob I'm going to I'm going to take these kind of step wise on just our promotion through our marketing.

Christopher Martin: I'm going to take these kinds of stepwise steps on just our promotion through our marketing. One of the things that the team did a very good job of, and we talked about this throughout the commercial launch preparation, was setting up our infrastructure, specifically from a data side, to be very flexible for marketing programs and digital programs to HCPs and patients. And we've seen that in execution already. I'll give you a good example here.

Christopher Martin: Go ahead, Chris. Yeah, thanks, Ram. I'm going to take these kinds of stepwise on just our promotion through a marketing standpoint.

Speaker Change: And one of the things that the team did a very good job of is and we talked about this throughout the commercial launch preparation with setting up our infrastructure specifically from a data side to be very flexible for marketing programs and digital programs to HCP and patient and we've seen that in execution already.

Christopher Martin: One of the things that the team did a very good job of is, and we talked about this throughout the commercial launch preparation, was setting up our infrastructure specifically from a data side to be very flexible. For marketing programs and digital programs to HTTPs and patients. And we've seen that in execution already. I'll give you a good example here. Our marketing team, through digital avenues, have reached out to our over 50,000 positions multiple times through email, banner ad, and other types of channels to engage with position. And what we've seen over the course and approval is we have over almost 7,000 positions that are highly engaged with our marketing content over the last month.

Unknown Executive: I now turn the call back over to the operator for the Q&A. We will now begin the question and answer session. To ask a question you may press star than one on your telephone keypad. If you were using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time we will pause momentarily to assemble our roster.

Speaker Change: I'll give you a good example here our marketing team through digital avenues have reached out to our over 50000 physicians multiple times through email banner AD and other types of channels.

Christopher Martin: Our marketing team through Digital Avenues reached out to our over 50,000 physicians multiple times through email, banner ads, and other types of channels to engage with physicians. And what we've seen over the course of since approval is that we have almost 7,000 physicians that have been highly engaged with our marketing content over the last month. And what I mean by highly engaged means they're clicking on emails, they're going to our website, and they're interacting with the communications the marketing team is doing.

Speaker Change: Channels to engage with physician and what we've seen over the course since approval as we have over almost 7000 physicians that are highly engaged with our marketing content over the last month and what I mean by highly engage names are clicking on email or going to our website.

Chris Martin: And what we've seen over the course of since approval is that we have almost 7,000 physicians that have been highly engaged with our marketing content over the last month. And what I mean by highly engaged is that they're clicking on emails, they're going to our website, they're interacting with the communications the marketing team is doing.

Andrew Sy: The first question comes from Andrew Sy with Jeffries. Please go ahead.

Christopher Martin: And what I mean by highly engaged means they're clicking on email, they're going to our website, they're interacting with the communications the marketing team is doing. Additionally, what that's allowing our reps to do is give them high-profile leads so that they can go into offices with positions that are ready to prescribe O2VAR very quickly.

Andrew Sy: Hey, thanks good morning and congratulations on the execution of the launch. Thanks for taking my question. First one is as we took around our models, what kind of payer rejection and patient abandonment rate should we be modeling for ampute tension? Can you remind us if there will be free drug?

Speaker Change: Interacting with with the communications and marketing team is doing Additionally, what that's allowing our reps to do is give them high profile leads so that they can go into the offices with physicians that are ready to prescribe O T. There very quickly. So it's been a really nice oh.

Christopher Martin: Additionally, what that's allowing our reps to do is give them high-profile leads so that they can go into offices with physicians that are ready to prescribe O2 there very quickly. So it's been a really nice process and system in place from a marketing perspective. I think as we think about the future from the HCP side, we will continue to support our field messaging with what I would classify as omni-channel promotion.

Chris Martin: Additionally, what that's allowing our reps to do is give them high-profile leads so that they can go into offices with physicians that are ready to prescribe O2 there very quickly. So it's been a really nice process and system in place from a marketing perspective. I think as we think about the future from the HCP side, we will continue to support our field messaging with what I would classify as omni-channel promotion.

Christopher Martin: So it's been a really nice process and system in place from a marketing perspective. I think, as we think about the future from the HTTP side. And we will continue to support our field messaging with what I would classify on the channel promotion. On the channel, promotion is not only digital, but as you talk about some speaker programs and other things.

David Zaccardelli: Good morning, Andrew. Thanks for the questions. With regard to free drug, we do have programs in place to support patients based on economic need, for example. Also, we do have what we would call a bridging program for those patients that may have delayed benefits and allowing them to start on drug in the short term while those benefits become in effect. So there is not a sampling program for say, but there is an ability to provide O2 bears to those patients that need it and to support them through any short term benefit verification.

Speaker Change: And the system in place from a marketing perspective.

Speaker Change: I think as we think about the future from the HCC side, we will continue to support our field messaging with what I would classify as Omnichannel promotion Omnichannel promotion is not only digital but as you talked about some speaker programs and other things.

Chris Martin: And omni-channel promotion is not only digital, but as you talked about some speaker programs and other things. Today, if you go to the O2 there HCP website, it is fully updated and launched, as well as the O2there.com website for patients.

Christopher Martin: Omni-channel promotion is not only digital, but as you talked about some speaker programs and other things. We today, if you go on the O2 there HCP website, it is fully updated and launched as well as the O2there.com website for patients is fully launched as well.

Christopher Martin: We today, if you go on the O2VAR HTTP website, is fully updated and launched, as well as the O2VAR.com website for patients, is fully launched as well. So those are avenues to continue to reach positions outside of the traditional rep standpoint. From a speaker program standpoint, we will have speaker programs; our reps have the ability to have speaker programs. We have trained a group of speakers already. And the reps have already started scheduling future speaker programs to with positions in their location. So that is part of that on the channel plan.

Speaker Change: We today if you go on the O two very H D. T website, you just fully updated and launched as well as the O T. Their dot com website for patients is fully launched as well.

Christopher Martin: So those are avenues to continue to reach physicians outside of the traditional rep standpoint. From a speaker program standpoint, we will have speaker programs. Our reps have the ability to have speaker programs. We have trained a group of speakers already. And the reps have already started scheduling future speaker programs with physicians at their locations. So that is part of that omni-channel plan.

Chris Martin: So those are avenues to continue to reach physicians outside of the traditional rep standpoint. From a speaker program standpoint, we will have speaker programs. Our reps have the ability to have speaker programs. We have trained a group of speakers already. And the reps have already started scheduling future speaker programs with physicians at their locations. So that is part of that omni-channel plan.

Speaker Change: So those are avenues to continue to reach physicians outside the traditional rep standpoint from a speaker program standpoint, we will have speaker programs. Our reps have the ability to have speaker programs. We have trained a group of speakers already.

Christopher Martin: With that, I guess I'll turn it over to Chris on payer dynamics, at least from a modeling standpoint. And as you know, it's incredibly early in the launch to understand that based on current prescriptions that have been written.

Speaker Change: And our reps have already started scheduling future speaker programs to work with physicians and their location. So that is part of that omni channel plan.

Chris Martin: When I think about patients, patients have always been part of our plan. It's the reason why we have a patient website today. It's also a reason why we collect patient data through our interactions on social media and other channels. We also think that in the future, there are very good avenues of point of care patient marketing where we're able to interact with the patient in physician offices where the doctors are already prescribing. So the team has put together a very robust both physician and patient marketing plan to ensure that we support our field force as they're out there interacting with these physicians.

Christopher Martin: When I think about patients, patients have always been part of our plan. It's the reason why we have a patient website today. It's also the reason why we collect patient information from our patient data through our interactions on social and other channels. We also think that in the future there's very good avenues of point of care patient marketing where we're able to interact with the patient in position offices where the doctors are already prescribing. So the team has put together a very robust position and patient marketing plan to ensure that we support our field force as they're out there interacting with these positions.

Christopher Martin: When I think about patients, patients have always been part of our plan. It's the reason why we have a patient website today. It's also a reason why we collect patient data through our interactions on social media and other channels. We also think that in the future, there are very good avenues of point of care patient marketing where we're able to interact with the patient in physician offices where the doctors are already prescribing. So the team has put together a very robust both physician and patient marketing plan to ensure that we support our field force as they're out there interacting with these physicians.

Speaker Change: When I think about patients patients who have always been part of our plan and that's the reason why we have a patient websites about Oh. It's also a reason why we collect Ah patient.

Christopher Martin: Andrew, this is Chris, thank you for the question. When we think about the overall payer abandonment and rejection, as Dave mentioned, we're very early in the launch here, but I'm going to go back to using older analog within the nebulizer space. And what you see within those spaces, keep in mind that O2 bear will be primarily reimbursed under a medical benefit within our historical analog that we looked at under a medical benefit side, which can either be under traditional med B.

Speaker Change: Ah patient data through our interactions on social and other channels. We also think that in the future. There's very good avenues of point of care patient marketing, where we're able to interact with the patient and physician offices, where the doctors are already prescribing.

Speaker Change: The team has put together a very robust both physician and patient marketing plan to ensure that we support our field force is there out there interacting with these physicians.

Christopher Martin: Or through Medicare advantage, those abandonments are lower than what you see in Medicare part D and commercial, but they do exist early on. There's just a natural patient dynamic that some patients, regardless of co-pay, even if it's low and zero, may have walked away from a prescription. But we believe that everything that we have from a patient assistance program through Verona Pathway Plus provides access to the medication in a variety of different ways.

Christopher Martin: Great, and then just very quickly on the non-CF bronchiectasis, I was wondering if you could give us some additional color on the timeline to reach full enrollment and potentially the timeline to data, or if you don't have, you know, that greater read on that yet. Sure, it's, it's this population's not a real easy one to project out, but we do anticipate this could take around two years to get to the end of the study. Remember, the population is essentially just somewhat larger than a rare disease, so the patients are a bit harder to find.

Unknown Executive: And then just very quickly on the non-CF bronchiectasis, I was wondering if you could give us some additional color on the timeline to reach full enrollment and potentially the timeline to data, or if you don't have that great of a read on that yet. Sure.

Speaker Change: Great and then just very quickly on the non CF Bronchiectasis I was wondering if you could give us some additional color on the timeline to reach full enrollment and potentially the timeline to data or if you don't have that great a read on that yet.

Unknown Executive: Sure, this population isn't a real easy one to project out, but we do anticipate this could take around two years to get to the end of the study. Remember, the population is essentially just somewhat larger than a rare disease, so the patients are a bit harder to find.

Speaker Change: Sure.

Speaker Change: It's just the population, it's not a real easy one to project out.

Christopher Martin: Additionally, if you think about rejection rates and how rejection works, I'll go back to the same statement there around medical benefit versus pharmacy benefit, we believe the majority of our prescriptions will run through the medical benefit side of the business. And within that medical benefit side of the business, we have data and on what those rejection rates look like. We also know that during this time we'll be using a non-specific Jacob, that non-specific Jacob exists, the local coverage determination exists, and we believe that the product is able to flow through that channel very freely. Additionally, as we talked about on a approval call, we have submitted our Jacob application in LCD. We did that on June 27th. It is currently under a U.S.

Speaker Change: But we do anticipate that could take around two years to get to the end of the study I remember the population is essentially just somewhat larger than a rare disease. So the patients are harder to find.

Edward Thomason: Thank you. Again, if you have a question, please press star, then one. Our next question comes from Edward Thomason with Kenton. Please go ahead.

Speaker Change: Thank you.

Operator: Again, if you have a question, please press star then 1. Our next question comes from Edward Thomason with Kempen, please go ahead.

Operator: Again, if you have a question, please press star then 1. Our next question comes from Edward Thomason on Kempin. Please go ahead.

Speaker Change: Again, if you have a question. Please press Star then one.

Unknown Executive: Edward, thank you for the question, and I appreciate that. Yeah, I think we believe that we have priced O2VeR at an appropriate value for both the healthcare system and the patient. If we look, we've done significant pharmacoeconomic analysis on O2VeR and the benefits it provides the system, and we've had ranges of prices per month upwards of $5,000 a month that you could have charged for O2VeR. As you know, our WAC price is $22,950.

Speaker Change: Our next question comes from Edward Thomassen with Kempen. Please go ahead.

Edward Thomason: Good afternoon, good morning. Thank you for taking my question. I had a quick question just about the pricing. In recent weeks, we've seen news about how the pricing differs from the ICR cost-effective pricing on an annual basis. Does that have any implications on reimbursement, and how does that play into your strategy for the OTAVAIR launch?

Edward Thomason: Good afternoon, Good morning. I'm trying to take my question. I had a question just about the pricing. There was in recent weeks, we've seen news how the pricing differences; this is from the ICR cost effective pricing on a manual basis.

Edward Thomassen: Good afternoon, good morning, and thank you for taking my question.

Edward Thomassen: A quick question was just about the pricing there.

Speaker Change: Sweet Shreve scene.

Speaker Change: News, how the pricing differences.

Speaker Change: This is from the ICR cost effective pricing.

Andrew Sy: CMS, and we would expect a product-specific Jacob at the beginning of 2025 to be in effect. So I hope that helps with your questions, and again, I appreciate it. Yep, and secondly, you know, consensus for Q3 is 1.5 million. If we assumed patients who get reimbursed quarter, maybe get treated for an average of half a month, then by my calculation, the number of patients needed is 1,400 or more. Would you feel comfortable meeting or exceeding that patient number in Q3 or exiting out of September 30th? Yeah, maybe I'll take that one, Andrew.

Speaker Change: On an annual basis.

Edward Thomason: Does that have any implications on reimbursant and how does that play into your strategy for the OTAVR launch?

Speaker Change: Have any implications on reimbursement and how does that play into your strategy.

Speaker Change: It's a bad launch.

David Zaccardelli: Edward, thank you for the question, and I appreciate that. Yeah, I think we believe that we have priced O2 there as the appropriate value to both the healthcare system and the patient. If we look, we've done significant pharmaceutical economic analysis on O2 there, and the benefits it provides the system. And we've had ranges of prices per month upwards of $5,000 a month that you could have charged for O2 there. As you know, our whack price is $22,950. We feel like that represents an appropriate value for what O2 there brings to the overall healthcare system. When it comes to reimbursant, we don't believe that, and we haven't seen anything from an indication standpoint from any of our interactions with payers that that price is dictating how it will be covered.

Unknown Executive: We feel like that represents an appropriate value for what O2VeR brings to the overall healthcare system. When it comes to reimbursement, we have not, we don't believe that, and we haven't seen anything from an indication standpoint from any of our interactions with payers that that price is dictating how it will be covered. Keep in mind, O2VeR is reimbursed under a medical benefit, and that is different than how traditional pharmacy benefit drugs work.

Christopher Martin: Edward, thank you for the question, and I appreciate that. Yeah, I think we believe that we have priced O2VaR at an appropriate value for both the healthcare system and the patient. If we look, we've done significant pharmacoeconomic analysis on O2VaR and the benefits it provides the system, and we've had ranges of prices per month upwards of $5,000 a month that you could have charged for O2VaR. As you know, our WAC price is $22,950.

Edward Thomassen: Edward Thank you for the question and I appreciate that yeah. I think we we believe that we have right Oh, two there are the appropriate value to both the.

Speaker Change: Health care system and the patient if we look we've done significant pharmacopeia economic analysis is on Oh, Gee, there and the benefits. It provides the system and we've had we've had ranges of prices per month upwards of $5000. A month that you could have charged for O. Two here as you know.

David Zaccardelli: I don't think we're prepared to talk about patient numbers. I will note, however, that in doing your math, you do have to consider there will be some inventory making it way to the channel, not actually getting the patients quite yet that will impact revenues. Okay, great. Thank you. Thanks, Andrew.

Speaker Change: Though our WAC price is $22950, we feel like that represents an appropriate value for what O. Two there brings to the overall health care system. When it comes to reimbursement we have not we don't believe that and we haven't seen anything from an indication standpoint from any of our interactions with payers that that pricing.

Christopher Martin: We feel like that represents an appropriate value for what O2VaR brings to the overall healthcare system. When it comes to reimbursement, we have not, we don't believe that, and we haven't seen anything from an indication standpoint from any of our interactions with payers that that price is dictating how it will be covered. Keep in mind, O2VaR is reimbursed under a medical benefit, and that is different than how traditional pharmacy benefit drugs work.

Speaker Change: Catering how it will be covered keep in mind, Oh Gee, there is reimbursed under a medical benefit and that is different than how traditional pharmacy benefit drugs work. So again from all the work the team has done across the pricing and payer community. We believe that price appropriately reflects the value, but also appropriately allows the patient to get access.

David Zaccardelli: Keep the mind, O2 there is reimbursant under a medical benefit and that is different than how traditional pharmacy benefits drugs work. So, again, from all the work, the team has done across the pricing and payer community. We believe that price appropriately reflects the value, but also appropriately allows the patient to get access to the medication long-term as well.

Yasmeen Rahimi: The next question comes from Yasmeen Rahimi with Piper Sandler. Please go ahead.

Yasmeen Rahimi: Hi, this is Emma Andreath. Thanks for taking our questions. Firstly, do you provide any color on patient starting forms and how that ties into how you're thinking about patient uptake? And with that, what type of matrix do you plan to share at next earnings in November to help us track the launch progress and guide future expectations? Yes.

Christopher Martin: So, again, from all the work the team has done across the pricing and payer community, we believe that price appropriately reflects value but also appropriately allows the patient to get access to the medication long-term as well.

Unknown Executive: So again, from all the work the team has done across the pricing and payer community, we believe that price appropriately reflects value but also appropriately allows the patient to get access to the medication long-term as well.

Speaker Change: Two the medication long term as well.

Edward Thomason: Okay, thank you.

Unknown Executive: Okay, thank you. And then I just had a follow-up question actually on the data that we might be expecting at ERS and CHESS later in the year. Can you just give us a flavor of what we might expect from those releases, whether it be subgroup analysis or patient populations or background therapies, just so we can whet the appetite ahead of that.

Speaker Change: Okay. Thank you and then I just had a follow up question actually on the data that you might be expecting tax E. R. S and chess later in the year can you just give us a flavor on what we might expect some news releases, whether that'd be subgroup analysis. So hum.

Unknown Speaker: And then I just had a follow-up question actually on the data that we might be expecting at the RS and CHES later in the year. Can you just give us a flavor on what we might expect most releases, whether it'll be self-group analysis or I don't have patient populations or background therapies, just so we can wet the upside ahead of that? Sure, and all of those things, actually. At the ERF, you'll see some analyses specifically on the European population that was enrolled in the enhanced program, additional analyses on the effective end-centrant on cough and futum from enhanced pool patient-reported outcome assessments, and a look at exacerbation effect by COPD phenotypes.

David Zaccardelli: Good morning, Emma. Thanks. Thanks for the question. You know, I think I'll start with the latter part. You know, clearly, as you've seen in our history, we're as transparent as we can be, as we progress. We expect our metrics to continually evolve as we get further into the launch and we'll show assessing which shows our core of the next quarterly call. As you can see, just in a few days, the uptake is quite strong with O2BAR with over 100 HTTPs already writing for it and we've barely just begun. And so we will, of course, again, be informative, be transparent and give you metrics to understand the launch dynamics and we expect again that to change over time.

Speaker Change:

Speaker Change: Patient populations or background therapies, and just so we can get back sorry, I had it.

Speaker Change: No.

Unknown Executive: Sure, and all of those things, actually. At the ERS, you'll see some analyses specifically on the European population that was enrolled in the ENHANCE program, additional analyses on the effect of endocentrin on cough and sputum from ENHANCE, pooled patient-reported outcome assessments, and a look at exacerbation effects by COPD phenotypes, so chronic bronchitis or not chronic At CHESS, you'll see some additional analyses on COPD severity, on smoking status, again on data from COPD phenotypes, chronic bronchitis or emphysema, an analysis of pooled lung function, and also a look at healthcare resource utilization over 48 weeks.

Speaker Change: Sure and all of those things actually at the ear out you'll see some analyses specifically on the European population that was enrolled in the enhanced program.

Unknown Executive: Okay, that's very clear. Thank you so much.

Speaker Change: Additional analysis on the effect of an entrant on cotton you done from enhanced pooled patient reported outcome assessments.

Speaker Change: And I don't look at exacerbation effects by COPD phenotype, so chronic bronchitis, they're not chronic bronchitis.

Unknown Speaker: So chronic bronchitis, they're not chronic, Curtis. At chess, you'll see some additional analyses on COPD severity on smoking status, again on data from COPD phenotypes, chronic bronchitis or emphysema, and analysis of pool of lung function, and also a look at healthcare resource utilization over 48 weeks.

Speaker Change: It just you'll see some additional analyses on C O P D severity on smoking status.

Speaker Change: Then on data from you know what types of chronic bronchitis or emphysema.

Tom Schrader: For next question comes from Tom Schrader with BTIG. Please go ahead. Good morning, congratulations. I have what's probably an annoying question, but you've written 100 prescriptions. Do you have any read on who they're for? Are they all patients unhappy on triple or are you already seeing people try the drug earlier? Again, I'll have Chris comment, but keep in mind that we're just a few days into this. And so all the analyses that you'd expect on a maturing launch haven't quite started yet.

Speaker Change: An analysis of pooled lung function and also a look at health care resource utilization over 48 weeks.

Unknown Speaker: Okay, that's right, clear. Thanks so much.

Speaker Change: Okay, that's very clear thank you so much.

Operator: This concludes our question and answer session.

Operator: This concludes our question and answer session. I would like to turn the conference back over to David Zaccardelli for any closing remarks. Thank you.

Operator: This concludes our question and answer session. I would like to turn the conference back over to David Zaccardelli for any closing remarks.

Speaker Change: This concludes our question and answer session I would like to turn the conference back over to David Soccer Daly for any closing remarks.

David Zaccardelli: I would like to turn the conference back over to David Zaccardelli for any closing remarks. Thank you, everyone, for joining today's call. As you can see, we are very excited about O2 VAERS launch in the US. I think we're off to an incredible start just a few days into it, and we look very much to updating you in the future. We'll look forward to seeing you all soon at various meetings and investor conferences. Thanks very much.

David Zaccardelli: Thank you everyone for joining today's call. As you can see, we are very excited.

David Zaccardelli: Thank you, everyone, for joining today's call. As you can see, we are very excited about O2VAIR's launch in the US. I think we're off to an incredible start just a few days into it, and we look very much forward to updating you in the future.

Speaker Change: Thank you everyone for joining today's call as you can see we are very excited about Oh too bearish launch in the U S.

Speaker Change: I think we're off to an incredible start just a few days into it and we look very much to updating you in the future.

Tom Schrader: But with that, I'll have Chris comment. And Tom, thanks for the question. Just for clarity, we have over 100 writers of O2BAR. What we know about those prescribers is they come from our tarp target list. So we think back to our other calls. These are the highest prescribing positions, both that I would call segment one and segment two positions that our reps are calling on. We're also hearing very clearly from our early field conversation.

Speaker Change: I look forward to seeing you all soon at various meetings and investor conferences. Thank you very much.

Speaker Change: Yeah.

Operator: The conference has now concluded. Thank you for attending today's presentation.

Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Speaker Change: Okay.

Tom Schrader: Do the unmet need that we've expressed throughout the last year, year and a half is very high within these offices. The doctors are reporting back to our reps. They have significant numbers of patients who continually have persistent symptoms. And they look at O2BAR as a new tool in their tool kit for treating these patients. And it allows them to use it in a variety of different ways. As they said, it's very early to kind of give an analysis of what the patient profile looks like of those of the ways that these doctors have prescribed it.

Christopher Martin: However, what we do know is that they are telling us every single time our reps go into the office that these patients continue to have persistent symptoms. And that will drive utilization as we move through the third quarter and into the fourth quarter as well.

Unknown Executive: Okay, and then a quick question on the fixed dose. To try a fixed dose in a handheld device, do you have to get the monotherapy approved in a handheld device first? Or could you in fact try that combination in a different device?

Unknown Executive: Yeah, I think the way that the programs are typically designed for a fixed dose combination, you actually, one way or another, work through the entire development of a monotherapy in that formulation, whether it's in a handheld device or a nebulizer. Got it. Okay. Thank you very much. Yeah. Thanks.

Joon Lee: The next question comes from Joon Lee with Truist. Please go ahead. Hi, thank you.

David Zaccardelli: This is Jean-Paul Joon and thanks for taking my questions and also congratulate you on your progress. So I have other questions regarding about your can you give you know give more color on the drug can treat compare with treating the non-CF branch test test especially compare with your competitors like Anzumette, Branzo, test tape, and then also could you give some provide some unique of this mechanism for this drug can be offered better, you know, a competitive edge over other drugs.

David Zaccardelli: Thanks. Yeah, so, you know, we think end-suffentrant has the potential to make a difference in patients with non-CF bronchiectasis because it targets nutrophilic inflammation, including both nutrophils and macrophage based inflammatory processes. It also works through increasing filiary function and cop and pseudom in particular is one of the most problematic issues associated with brachyectasis and it's that dysfunctional nucleary processes in these patients that cause continual infections and further pulmonary exacerbation. So our trial, of course, is designed to assess the effect of end-suffentrant on pulmonary exacerbation.

David Zaccardelli: He saw very strong data against pulmonary exacerbations and reducing rate and risk of exacerbations in the COPD population. We certainly think that based on the mechanism, this will extrapolate to a bronchiectasis population. Regarding how end-suffentrant might impact patients with bronchiectasis compared to other competitor drugs that are out there, we really think that end-suffentrant has the opportunity to actually make these patients feel better rather than just reducing exacerbation rates. And so that's the goal and those are some of the end points that will be assessing in this first trial. Great, thanks.

Unknown Executive: But do you have any pre-communical data to support what do you have for this indication? Well, I'm not aware of any model specifically relating to bronchiectasis, but certainly we have a wealth of data with similar pathosis, physiological processes, and patients with COPD. Lee, including Reduction and Coffin's Feudum that was important in the Phase 3 program. Okay, thank you so much. Thanks for taking my question.

Bram Selvaraju: The next question comes from Bram Selvaraju with HC Waitwright. Please go ahead. Thanks so much for taking my questions.

Christopher Martin: On the commercial front, this is probably for Chris. I wanted to see if you could provide us with some more granularity on what what you are currently engaged in doing on the social media front and what you plan to do in the course of the coming months with respect to marketing outreach and also when you anticipate involving direct to consumer advertising as part of the overall commercial process grow to here. And if so, you know, what forms that might potentially take and what you might think about doing on, for example, the speaker program side with the positions as well as what you're seeing in terms of patient advocacy involvement in support of O2VAR within the COPD community.

Christopher Martin: Thanks, Ram. Go ahead, Chris. Yeah, thanks, Ram. I'm going to take these kind of stepwise on just our promotion through a marketing standpoint. One of the things that the team did a very good job of is, and we talked about this throughout the commercial launch preparation was setting up our infrastructure specifically from a data side to be very flexible. For marketing programs and digital programs to HTTPs and patients. And we've seen that in execution already.

Christopher Martin: I'll give you a good example here. Our marketing team through digital avenues have reached out to our over 50,000 positions multiple times through email, banner ad and other types of channels to engage with position. And what we've seen over the course and approval is we have over almost 7,000 positions that are highly engaged with our marketing content over the last month. And what I mean by highly engaged means they're clicking on email, they're going to our website, they're interacting with the communications the marketing team is doing.

Christopher Martin: Additionally, what that's allowing our reps to do is give them high profile leads so that they can go into offices with positions that are ready to prescribe O2VAR very quickly. So it's been a really nice process and system in place from a marketing perspective. I think as we think about the future from the HTTP side. And we will continue to support our field messaging with what I would classify on the channel promotion.

Christopher Martin: On the channel promotion is not only digital, but as you talk about some speaker programs and other things. We today, if you go on the O2VAR HTTP website is fully updated and launched as well as the O2VAR.com website for patients is fully launched as well. So those are avenues to continue to reach positions outside of the traditional rep standpoint. From a speaker program standpoint, we will have speaker programs, our reps have the ability to have speaker programs.

Christopher Martin: We have trained a group of speakers already. And the reps have already started scheduling future speaker programs to with with positions in their location. So that is part of that on the channel plan. When I think about patients, patients have always been part of our plan. It's the reason why we have a patient website today. It's also the reason why we collect patient information from our patient data through our interactions on social and other channels.

Christopher Martin: We also think that in the future there's very good avenues of point of care patient marketing where we're able to interact with the patient in position offices where the doctors are already prescribing. So the team has put together a very robust position and patient marketing plan to ensure that we support our field force as they're out there interacting with these positions.

Unknown Executive: Great, and then just very quickly on the non-CF bronchiectasis, I was wondering if you could give us some additional color on the timeline to reach full enrollment and potentially the timeline to data, or if you don't have, you know, that greater read on that yet. Sure, it's, it's this population's not a real easy one to project out, but we do anticipate this could take around two years to get to the end of the study.

Edward Thomason: Remember, the population is essentially just somewhat larger than a rare disease, so the patients are a bit harder to find. Thank you. Again, if you have a question, please press star then one.

Edward Thomason: Our next question comes from Edward Thomason with Kenton. Please go ahead. Good afternoon, good morning. I'm trying to take my question. I had a question just about the pricing. There was in recent weeks, we've seen news how the pricing differences, this is from the ICR cost effective pricing on a manual basis. Does that have any implications on reimbursant and how does that play into your strategy for the OTAVR launch?

David Zaccardelli: Edward, thank you for the question and I appreciate that. Yeah, I think we believe that we have priced O2 there as the appropriate value to both the healthcare system and the patient. If we look, we've done significant pharmaceutical economic analysis on O2 there and the benefits it provides the system and we've had, we've had ranges of prices per month upwards of $5,000 a month that you could have charged for O2 there.

David Zaccardelli: As you know, our whack price is $22,950. We feel like that represents an appropriate value for what O2 there brings to the overall healthcare system. When it comes to reimbursant, we don't believe that and we haven't seen anything from an indication standpoint from any of our interactions with payers that that price is dictating how it will be covered. Keep the mind, O2 there is reimbursant under a medical benefit and that is different than how traditional pharmacy benefits drugs work.

David Zaccardelli: So, again, from all the work, the team has done across the pricing and payer community. We believe that price appropriately reflects the value but also appropriately allows the patient to get access to the medication long-term as well.

Unknown Executive: Okay, thank you.

Unknown Executive: And then I just had a follow-up question actually on the data that we might be expecting at the RS and CHES later in the year. Can you just give us a flavor on what we might expect most releases, whether it'll be self-group analysis or I don't have patient populations or background therapies, just so we can wet the upside ahead of that? Sure, and all of those things actually. At the ERF, you'll see some analyses specifically on the European population that was enrolled in the enhanced program, additional analyses on the effective end-centrant on cough and futum from enhanced pool patient-reported outcome assessments, and a look at exacerbation effect by COPD phenotypes.

Unknown Executive: So chronic bronchitis, they're not chronic Curtis. At chess, you'll see some additional analyses on COPD severity on smoking status, again on data from COPD phenotypes, chronic bronchitis or emphysema, and analysis of pool of lung function, and also a look at healthcare resource utilization over 48 weeks. Okay, that's right, clear.

Unknown Executive: Thanks so much.

Unknown Executive: This concludes our question and answer session.

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

David Zaccardelli: Thank you, everyone, for joining today's call. As you can see, we are very excited about O2 VAERS launch in the US. I think we're off to an incredible start just a few days into it, and we look very much to updating you in the future. We'll look forward to seeing you all soon at various meetings and investor conferences. Thanks very much.

Unknown Executive: The conference has now concluded.

Unknown Executive: Thank you for attending today's presentation.