Verona Pharma PLC (VRNA) 2024 Q2 法說會逐字稿

Welcome to Verona Pharma's second-quarter 2024 financial results and operating highlights conference call. At this time, all participants 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 30, 2024. A copy can be found in the Investor Relations tab on the corporate website, www.veronapharma.com.

歡迎參加 Verona Pharma 2024 年第二季財務業績和營運亮點電話會議。此時，所有參與者都處於只聽模式。今天早上早些時候，維羅納製藥公司發布了一份新聞稿，公佈了截至 2024 年 6 月 30 日的三個月的財務表現。您可以在公司網站 www.veronapharma.com 的投資者關係標籤中找到副本。

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.

在開始之前，我想提醒您，今天有關公司未來期望、計劃和前景的電話會議聲明均為前瞻性聲明。這些前瞻性陳述是基於管理階層目前的預期。這些陳述既不是承諾，也不是保證，涉及已知和未知的風險、不確定性和其他重要因素，可能導致我們的實際結果、績效或成就與前瞻性陳述所表達或暗示的預期有重大差異。

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

任何此類前瞻性陳述均代表管理階層截至本次電話會議之日的估計。儘管該公司可能選擇在未來某個時候更新此類前瞻性聲明，但即使後續事件導致其觀點發生變化，該公司也不承擔任何這樣做的義務。請注意，此通話正在錄音，並將保留 90 天。

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

我現在想將電話轉給執行長 David Zaccardelli 博士。

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. The second quarter was an exceptional for Verona Pharma, marked by the US FDA approval of Ohtuvayre for the maintenance treatment of COPD.

謝謝。歡迎大家參加今天的電話會議。今天和我在一起的有我們的財務長馬克‧哈恩 (Mark Hahn)； Kathy Rickard 博士，我們的首席醫療官；克里斯馬丁，我們的首席商務官；以及我們的首席開發長 Tara Rheault 博士。第二季度對 Verona Pharma 來說是一個特殊的季度，美國 FDA 批准 Ohtuvayre 用於慢性阻塞性肺病的維持治療。

Ohtuvayre 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 US. Today, we announced Ohtuvayre is now available through our exclusive network of specialty pharmacies, and patient shipments have begun.

Ohtuvayre 是第一個具有支氣管擴張和非類固醇抗發炎作用的吸入性慢性阻塞性肺病治療藥物，我們相信這項批准可以重新定義美國慢性阻塞性肺病的治療範例。今天，我們宣布 Ohtuvayre 現已透過我們的獨家專業藥房網絡提供，並且已經開始向患者發貨。

We are very excited to share this achievement with you and are confident that our extensive preparation positioned us for the successful commercialization of Ohtuvayre in the US.

我們非常高興與您分享這項成就，並相信我們的廣泛準備使我們能夠在美國成功商業化 Ohtuvayre。

As a reminder, Ohtuvayre's label supports broad use across all COPD patients without restrictions to background medications; COPD etiology, including chronic bronchitis or emphysema; or blood eosinophil levels. The label also describes Ohtuvayre's mechanism of action, which differentiates it from all other approved COPD treatments.

提醒一下，Ohtuvayre 的標籤支持在所有 COPD 患者中廣泛使用，不受背景藥物的限制； COPD病因，包括慢性支氣管炎或肺氣腫；或血液嗜酸性粒細胞水平。該標籤還描述了 Ohtuvayre 的作用機制，這將其與所有其他批准的慢性阻塞性肺病治療方法區分開來。

Based on Ohtuvayre's novel mechanism of action and compelling benefit to risk profile, our market research shows HCPs have significant interest in prescribing Ohtuvayre broadly across all symptomatic COPD patient types. Initially, our launch efforts are focused on promoting Ohtuvayre to the most active HCPs that treat COPD patients, which our market analysis shows is approximately 14,500 providers.

基於 Ohtuvayre 的新穎作用機制和對風險狀況的顯著益處，我們的市場研究表明，HCP 對在所有有症狀的 COPD 患者類型中廣泛開出 Ohtuvayre 處方具有濃厚的興趣。最初，我們的推出工作重點是向治療 COPD 患者的最活躍的 HCP 推廣 Ohtuvayre，我們的市場分析顯示，大約有 14,500 名提供者。

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 2,000 HCPs, with over 85% being top prescribers. Although it has just been a few days, over 100 HCPs have prescribed Ohtuvayre.

這些提供者包括肺科醫生、初級保健醫生、執業護士和醫師助理。我們的銷售和現場報銷團隊已全部聘用，自 7 月下旬以來一直在現場。在此期間，他們與 2,000 多名 HCP 進行了互動，其中超過 85% 是頂級處方醫生。儘管才幾天，已有 100 多名 HCP 開了 Ohtuvayre 處方。

In addition to the US launch of Ohtuvayre, we plan to initiate two new Phase 2 programs in the third quarter. First, we are developing a fixed-dose combination formulation with ensifentrine and glycopyrrolate, or LAMA, for the maintenance treatment of COPD delivered via standard jet nebulizer.

除了在美國推出 Ohtuvayre 之外，我們還計劃在第三季啟動兩個新的第二階段計畫。首先，我們正在開發一種包含 ensifentrine 和格隆溴銨 (LAMA) 的固定劑量組合製劑，用於透過標準噴射霧化器進行慢性阻塞性肺病的維持治療。

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 crossover trial to assess lung function, safety, and the pharmacokinetic profile of glycopyrrolate in the novel formulation delivered via nebulizer in approximately 40 patients with COPD.

7月，我們向FDA提交了IND。如果獲得批准，我們計劃在第三季開始第二階段劑量範圍試驗。該試驗是一項隨機、雙盲、安慰劑對照、為期一周的交叉試驗，旨在評估約40 名COPD 患者的肺功能、安全性以及透過霧化器輸送的新型製劑中格隆溴銨的藥代動力學特徵。

Following identification of an appropriate glycopyrrolate dose range, a Phase 2 trial assessing the fixed-dose combination of ensifentrine and glycopyrrolate compared to placebo and individual components will be conducted. Additionally, we plan to initiate a Phase 2 trial to assess nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis in the third quarter.

在確定適當的格隆溴銨劑量範圍後，將進行 2 期試驗，評估 ensifentrine 和格隆溴銨的固定劑量組合與安慰劑和單一成分的比較。此外，我們計劃在第三季啟動 2 期試驗，以評估霧化恩西芬汀治療非囊性纖維化支氣管擴張患者的情況。

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 milligrams of ensifentrine twice daily on the rate and risk of pulmonary exacerbation in addition to symptoms and quality of life.

這項隨機、雙盲、安慰劑對照、平行組試驗將招募 180 名近期有肺部疾病惡化史的患者。該試驗將評估每日兩次 3 毫克的 ensifentrine 對肺部病情惡化的發生率和風險以及症狀和生活品質的影響。

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 they require a 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 Oaktree facility.

為了確保強大的動力，該試驗被計劃為事件驅動，所有入組患者將接受至少 24 週的治療，直到他們需要觀察到一些惡化事件。最後，我們的資產負債表仍然強勁，手頭上有超過 4 億美元的現金，並且在我們的橡樹資本設施下可以選擇未來提取。

I will now turn the call over to Mark to review our financial results for the second quarter. Mark, please go ahead.

我現在將把電話轉給馬克，以審查我們第二季度的財務表現。馬克，請繼續。

As Dave mentioned, our balance sheet is strong, within excess of $400 million in cash and equivalents at June 30, 2024. This includes $70 million drawn under our debt facility, and $100 million drawn under the RIPSA at approval. With the cash currently on hand and potential future access to the remaining $425 million under the Oaktree facilities, we expect to have sufficient cash runway beyond 2026, including the commercial launch of Ohtuvayre in the US and our two new Phase 2 clinical programs.

正如 Dave 所提到的，我們的資產負債表穩健，截至 2024 年 6 月 30 日，現金及等價物超過 4 億美元。其中包括根據我們的債務融資提取的 7,000 萬美元，以及根據批准後的 RIPSA 提取的 1 億美元。憑藉目前手頭上的現金以及未來可能動用橡樹資本設施下剩餘的 4.25 億美元，我們預計 2026 年之後將擁有充足的現金跑道，包括 Ohtuvayre 在美國的商業推出以及我們的兩個新的 2 期臨床項目。

Total operating expenses for the second quarter of 2024 were higher than historical levels 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.

由於確認了配體和基於績效的 RSU 的一次性里程碑付款費用，2024 年第二季的總營運費用高於歷史水準。排除這些一次性成本，根據我們先前的指導，我們本季的季度研發和銷售、一般管理費用約為 3700 萬美元。

Research and development costs were $19.4 million for the quarter compared to a net reversal of costs of $2.5 million reported for the second quarter of 2023. This increase was primarily due to accrual of the $6.3 million approval milestone to Ligand; a $2.5 million increase in share-based compensation, largely driven by the recognition of expense related 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.

本季的研發成本為 1,940 萬美元，而 2023 年第二季報告的成本淨逆轉為 250 萬美元。這一增長主要是由於 Ligand 獲得了 630 萬美元的批准里程碑；基於股份的薪酬增加 250 萬美元，主要是由於確認了與基於績效的 RSU 相關的費用；與預先批准的庫存生產相關的 170 萬美元費用；從 2023 年第二季到 2024 年第二季度，臨床試驗成本增加了 880 萬美元。

Selling, general, and administrative expenses were $49 million for the quarter ended June 30, 2024, compared to $12.4 million reported for the same period in 2023. This increase was driven primarily by an accrual of the $15 million first sale milestone due to Ligand, an increase of $7.4 million from marketing and other commercial-launch-related activities, $4.3 million in people-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.

截至 2024 年 6 月 30 日的季度，銷售、一般及管理費用為 4,900 萬美元，而 2023 年同期報告的銷售、一般及管理費用為 1,240 萬美元。這一增長主要是由於 Ligand 帶來的 1500 萬美元首次銷售里程碑的應計、營銷和其他商業啟動相關活動增加了 740 萬美元、我們建立商業組織時與人員相關的成本增加了 430 萬美元，以及基於股票的薪酬增加約800 萬美元，這主要是由基於績效的RSU 費用推動的。

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

我現在將把電話轉回給接線員進行問答。

(Operator Instructions) Andrew Tsai, Jefferies.

（操作員說明）Andrew Tsai，Jefferies。

Hey. Thanks, good morning, and congratulations on the execution of the launch. Thanks for taking my question. 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 ensifentrine? And can you remind us if there will be free drug? Thanks.

嘿。謝謝，早安，恭喜發布的執行。感謝您提出我的問題。因此，第一個是當我們調整我們的模型時，我們應該為 ensifentrine 建模什麼樣的付款人拒絕和患者放棄率？您能提醒我們是否有免費藥品嗎？謝謝。

Good morning, Andrew. Thanks for the question. With regard to free drug, 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 benefit and allowing them to start on drug in the short term while those benefits become in effect.

早安，安德魯。謝謝你的提問。例如，在免費藥物方面，我們確實制定了根據經濟需求支持患者的計劃。此外，我們確實為那些可能延遲受益的患者制定了所謂的過渡計劃，允許他們在這些福利生效期間在短期內開始用藥。

So there is not a sampling program per se, but there is an ability to provide Ohtuvayre to those patients that need it and to support them through any short-term benefit verification. 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.

因此，本身沒有抽樣計劃，但有能力向需要的患者提供 Ohtuvayre 並通過任何短期效益驗證來支持他們。有了這個，我想我會把它交給克里斯關於付款人動態，至少從建模的角度來看。如您所知，根據目前已製定的處方來了解這一點還為時過早。

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 analogs within the nebulizer space. And what you see within those spaces, keep in mind that Ohtuvayre will be primarily reimbursed under a medical benefit.

安德魯，這是克里斯。謝謝你的提問。正如戴夫所提到的，當我們考慮付款人的整體放棄和拒絕時，我們還處於啟動的早期階段。但我將繼續在霧化器領域使用舊的類似物。您在這些空間中看到的內容，請記住 Ohtuvayre 將主要根據醫療福利進行報銷。

Within our historical analogs that we've 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. There is just a natural patient dynamic that some patients, regardless of copay, even if it's low and zero, may walk away from a prescription.

在我們在醫療福利方面（可以是傳統 Med B 或透過 Medicare Advantage）進行的歷史類比中，這些放棄率低於您在 Medicare D 部分和商業中看到的水平，但它們確實很早就存在。這是一種自然的患者動態，即某些患者，無論自付額如何，即使自付額很低且為零，也可能會放棄處方。

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.

但我們相信，我們透過 Verona Pathway Plus 的患者援助計劃所擁有的一切都可以透過各種不同的方式提供藥物。此外，如果您考慮拒絕率以及拒絕的運作方式，我將回到有關醫療福利與藥品福利的相同聲明。我們相信我們的大部分處方將貫穿業務的醫療福利方面。

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 J-code. That non-specific J-code exists, the local coverage determination exists, and we believe that the product is able to flow through that channel very freely.

在業務的醫療福利方面，我們有數據以及有關拒絕率的數據。我們也知道，在此期間，我們將使用非特定的 J 代碼。存在非特定 J 代碼，存在本地覆蓋範圍確定，並且我們相信產品能夠非常自由地流經該渠道。

Additionally, as we talked about on the approval call, we have submitted our J-code application and LCD. We did that on June 27. 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, appreciate it.

此外，正如我們在批准電話會議上談到的那樣，我們已經提交了 J 代碼應用程式和 LCD。我們在 6 月 27 日做到了這一點。目前 CMS 正在對其進行審查，我們預計特定於產品的 J 代碼將於 2025 年初生效。所以我希望這對您的問題有所幫助，並再次表示感謝。

No -- yes. And secondly, consensus for Q3 is $1.5 million. If we assumed 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 out of September 30? Thanks.

不——是的。其次，第三季的共識是 150 萬美元。如果假設本季報銷的患者平均治療時間可能是半個月，那麼根據我的計算，需要的患者數量是1400人甚至更多。您是否願意在第三季達到或超過該患者人數，或在 9 月 30 日之後退出？謝謝。

Yes. 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.

是的。也許我會選擇那個，安德魯。我認為我們還沒有準備好談論患者數量。然而，我要指出的是，在進行數學計算時，您確實必須考慮到會有一些庫存進入管道，但實際上尚未獲得患者，這會影響收入。

Okay, great. Thank you.

好的，太好了。謝謝。

Thanks Andrew.

謝謝安德魯。

Yasmeen Rahimi, Piper Sandler.

亞斯明·拉希米，派珀·桑德勒。

Hi. This is Emma on for Yas. 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 metrics do you plan to share at next earnings in November to help us track the launch progress and guide future expectations?

你好。這是亞斯的艾瑪。感謝您回答我們的問題。首先，您是否在患者起始表格上提供了任何顏色，以及這與您對患者接受情況的考慮有何關聯？那麼，您計劃在 11 月的下一次財報中分享什麼類型的指標來幫助我們追蹤發布進度並指導未來的預期？

Yes. Good morning, Emma. Thanks for the question. I think I'll start with the latter part. 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 still assessing which those are for the next quarterly call.

是的。早安，艾瑪。謝謝你的提問。我想我將從後一部分開始。顯然，正如您在我們的歷史中看到的那樣，隨著我們的進步，我們將盡可能保持透明。我們預計，隨著我們進一步推出，我們的指標將持續發展，我們仍將評估哪些指標適用於下一個季度的電話會議。

As you can see, just in a few days, the uptake is quite strong for those who bear with over 100 HCPs 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 dynamic. And we expect, again, for that to change over time.

正如您所看到的，僅僅幾天之內，對於那些已經有超過 100 名 HCP 為其撰寫文章的人來說，吸收率就相當強勁，而我們才剛剛開始。因此，我們當然會再次提供信息，保持透明，並為您提供指標以了解發布動態。我們再次期望這種情況會隨著時間的推移而改變。

Tom Shrader, BTIG.

湯姆‧施雷德 (Tom Shrader)，BTIG。

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're for? Or are they all patients unhappy on triple, or are you already seeing people try the drug earlier?

早上好，恭喜你。我有一個可能很煩人的問題，但你已經開了 100 個處方。您知道它們是為誰服務的嗎？或者他們都是對三重療法不滿意的患者，還是您已經看到人們更早嘗試這種藥物？

Again, I'll let 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.

再次，我會讓克里斯發表評論，但請記住，我們才剛開始幾天。因此，您對成熟發布所期望的所有分析尚未完全開始。但接下來，我會讓克里斯發表評論。

Yes. Tom, thanks for the question. Just for clarity, we have over 100 writers or prescribers of Ohtuvayre. What we know about those prescribers is they come from our 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 physicians that our reps are calling on.

是的。湯姆，謝謝你的提問。為清楚起見，我們有 100 多名 Ohtuvayre 的作者或處方者。我們對這些處方者的了解是他們來自我們的目標名單。因此，如果我們回想一下我們的其他呼叫，這些都是我們的代表所呼叫的最高處方位置，我所說的 1 段和 2 段醫生。

We're also hearing very clearly from our early field conversations is 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 Ohtuvayre as a new tool in their toolkit for treating these patients and it allows them to use it in a variety of different ways.

我們也從早期的現場對話中清楚地聽到，我們在過去一年半中表達的未滿足的需求在這些辦公室中非常高。醫生正在向我們的代表報告。他們有大量持續出現持續症狀的患者，他們將 Ohtuvayre 視為治療這些患者工具包中的新工具，並允許他們以各種不同的方式使用它。

As Dave said, it's very early to kind of give an analysis of what the patient profile looks like 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

正如戴夫所說，現在對這些醫生開藥方式的患者概況進行分析還為時過早。然而，我們所知道的是，每次我們的代表進入辦公室時，他們都會告訴我們這些患者仍然有持續的症狀，這將在我們進入第三季度和第四季度時推動利用率

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?

好的。然後是關於固定劑量的快速問題。要在手持裝置中嘗試固定劑量，您是否必須先獲得手持裝置中核准的單一療法？或者您實際上可以在不同的設備中嘗試該組合嗎？

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.

我認為這些程序通常是為固定劑量組合而設計的，實際上，無論是在手持設備還是霧化器中，您實際上都會以一種或另一種方式完成該配方中單一療法的整個開發。

Got it. Okay. Thank you very much.

知道了。好的。非常感謝。

Thanks, Tom.

謝謝，湯姆。

Joon Lee, Truist. Please go ahead.

李俊，真理主義者。請繼續。

Hi. Thank you. This is Jing for Joon, and thanks for taking my questions. And also, congratulations on your progress. So I have other questions regarding about your -- can you give more color on the drug compared with treating the non-CF bronchiectasis, especially compared with your competitors like [EnziMed], [Preventol], (inaudible)? And then also could you give some -- provide some unique -- this mechanism for this drug can be offered better, a competitive edge over other drugs. Thanks.

你好。謝謝。我是Jing，感謝您回答我的問題。另外，恭喜你的進步。所以我還有其他關於您的問題——與治療非 CF 支氣管擴張症相比，您能否對該藥物給予更多的說明，特別是與您的競爭對手相比[EnziMed]、[Preventol]、（聽不清楚）？然後你也可以提供一些——提供一些獨特的——這種藥物的這種機制可以提供更好的，比其他藥物具有競爭優勢。謝謝。

Yes. So we think ensifentrine 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 ciliary function and cough and sputum. Sputum, in particular, is one of the most problematic issues associated with bronchiectasis. And it's that dysfunctional mucociliary processes in these patients that cause continual infections and further pulmonary exacerbations.

是的。因此，我們認為恩西芬鹼有可能對非 CF 支氣管擴張患者產生影響，因為它針對中性粒細胞炎症，包括基於中性粒細胞和巨噬細胞的炎症過程。它還透過增強纖毛功能以及咳嗽和咳痰來發揮作用。尤其是痰，是與支氣管擴張相關的最成問題的問題之一。正是這些患者的黏液纖毛過程功能失調導致持續感染和進一步的肺部病情惡化。

So our trial, of course, is designed to assess the effect of ensifentrine non-pulmonary exacerbations. We saw very strong data against pulmonary exacerbations and reducing rates and risks of exacerbations in the COPD population. We certainly think that based on the mechanism, this will extrapolate to a bronchiectasis population.

因此，我們的試驗當然是為了評估恩西芬汀非肺部急性惡化的效果。我們看到了非常有力的數據，顯示慢性阻塞性肺病患者肺部病情加重以及病情加重的發生率和風險有所降低。我們當然認為，根據該機制，這將推斷出支氣管擴張人群。

Regarding how ensifentrine might impact patients with bronchiectasis compared to other competitor drugs that are out there, we really think that ensifentrine 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.

與現有的其他競爭藥物相比，關於恩西芬鹼對支氣管擴張患者的影響，我們確實認為恩西芬鹼有機會真正讓這些患者感覺更好，而不僅僅是降低病情惡化率。這就是目標，這些是我們將在第一次試驗中評估的一些終點。

Great, thanks. But do you have any pre-clinical data to support what you have for this indication?

太好了，謝謝。但是您有任何臨床前數據來支持您對該適應症的了解嗎？

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 cough and sputum that was important in the Phase 3 program.

嗯，我不知道有任何專門與支氣管擴張相關的模型。但當然，我們擁有大量關於 COPD 患者類似病理生理過程的數據，包括咳嗽和痰的減少，這在第 3 階段項目中非常重要。

Okay, thank you so much. Thanks for taking my questions.

好的，非常感謝。感謝您回答我的問題。

Ram Selvaraju, H.C. Wainwright.

塞爾瓦拉朱 (Ram Selvaraju)，H.C.溫賴特。

Thanks very 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 Ohtuvayre?

非常感謝您回答我的問題。在商業方面，這可能是針對克里斯的，我想看看您是否能為我們提供更多關於您目前在社交媒體方面所做的事情以及您計劃在未來幾個月內做什麼的信息關於營銷推廣，以及您何時預計將直接面向消費者的廣告作為Ohtuvayre 整體商業流程的一部分？

And if so, 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 Ohtuvayre within the COPD community?

如果是這樣，可能會採取什麼形式？例如，您可能會考慮在與醫生的演講者計劃方面做什麼，以及您在慢性阻塞性肺病社區內支持 Ohtuvayre 的患者倡導活動方面看到了什麼？

Thanks, Ram. Go ahead, Chris.

謝謝，拉姆。繼續吧，克里斯。

Yes. 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, 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.

是的。謝謝，拉姆。我將從行銷的角度逐步採取這些步驟來進行我們的促銷活動。團隊做得非常好的一件事是建立我們的基礎設施，特別是從數據方面，為醫療保健專業人員和患者提供非常靈活的營銷計劃和數位計劃，我們在整個商業發布準備過程中都談到了這一點。我們已經在執行上看到了這一點。

I'll give you a good example here. Our marketing team through digital avenues have reached out to our over 50,000 physicians multiple times through emails, banner ads, and other types of channels to engage with physicians. And what we've seen over the course since approval is we have almost 7,000 physicians that are highly engaged with our marketing content over the last month.

我在這裡給你一個很好的例子。我們的行銷團隊透過數位管道多次透過電子郵件、橫幅廣告和其他類型的管道與醫生接觸，超過 50,000 名醫生。自從批准以來，我們在課程中看到的是，我們有近 7,000 名醫生在上個月對我們的行銷內容高度參與。

And what I mean by highly engaged means they're clicking on emails, 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 physicians that are ready to prescribe Ohtuvayre very quickly. So it's been a really nice process and system in place from a marketing perspective.

我所說的高度參與意味著他們點擊電子郵件、造訪我們的網站、與行銷團隊正在進行的溝通互動。此外，我們的代表可以為他們提供高調的線索，以便他們可以與準備好快速開出 Ohtuvayre 處方的醫生一起進入辦公室。因此，從行銷的角度來看，這是一個非常好的流程和系統。

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. 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 Ohtuvayre HCP website, it is fully updated and launched, as well as the ohtuvayre.com website for patients is fully launched as well.

我認為，當我們從 HCP 方面思考未來時，我們將繼續透過我將其歸類為全通路推廣的方式來支持我們的現場訊息傳遞。全通路推廣不僅是數位化的，而且正如您談到的一些演講者計劃和其他事情一樣，我們今天 - 如果您訪問 Ohtuvayre HCP 網站，它已經完全更新並啟動，還有 ohtuvayre.com 網站針對患者的服務也全面啟動。

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, and the reps have already started scheduling future speaker programs with physicians in their locations. So that is part of that omni-channel plan.

因此，這些是在傳統代表觀點之外繼續接觸醫生的途徑。從演講者計劃的角度來看，我們將有演講者計劃。我們的代表有能力舉辦演講節目。我們已經培訓了一組演講者，代表們也已經開始與當地的醫生一起安排未來的演講者計畫。這是全通路計劃的一部分。

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 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 physician offices where the doctors are already prescribing.

當我想到患者時，患者一直是我們計劃的一部分。這就是我們今天擁有患者網站的原因。這也是我們透過社交和其他管道的互動收集患者資料的原因。我們也認為，未來會有非常好的即時患者行銷途徑，我們可以在醫生已經開處方的醫生辦公室與患者互動。

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.

因此，該團隊制定了一個非常強大的醫生和患者行銷計劃，以確保我們在現場人員與這些醫生互動時為他們提供支援。

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?

然後，很快就非 CF 支氣管擴張問題，我想知道您是否可以在時間表上給我們一些額外的顏色，以達到完全登記和可能的數據時間表，或者如果您沒有很好的閱讀那還沒有？

Sure. This population is 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.

當然。這一人口並不是一個容易預測的人口。但我們確實預計研究可能需要大約兩年的時間才能結束。請記住，該族群本質上只比罕見疾病多一些，因此患者更難找到。

Thank you.

謝謝。

(Operator Instructions) Edward Thomason, Kempen.

（操作員說明）Edward Thomason，Kempen。

Good afternoon, good morning, and thanks for taking my question. I had a quick question just about the pricing. In recent weeks, we've seen news how the pricing differences -- this is 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 Ohtuvayre launch?

下午好，早安，感謝您提出我的問題。我有一個關於定價的快速問題。最近幾週，我們看到了定價差異的新聞——這是來自 ICR 每年的成本效益定價。這對報銷有什麼影響嗎？

Edward, thank you for the question, and I appreciate that. Yes, I think we believe that we have priced Ohtuvayre at the appropriate value to both the healthcare system and the patient. If we look, we've done significant pharmacoeconomic analyses on Ohtuvayre and the benefits that provide the system. And we've had ranges of prices per month upwards of $5,000 a month that you could have charged for Ohtuvayre.

愛德華，謝謝你的提問，我很感激。是的，我認為我們相信我們已將 Ohtuvayre 定價為對醫療保健系統和患者而言合適的價值。如果我們看一下，我們已經對 Ohtuvayre 以及提供該系統的好處進行了重要的藥物經濟學分析。我們的 Ohtuvayre 每月價格範圍高達 5,000 美元以上。

As you know, our WAC price is $22,950. We feel like that represents an appropriate value for what Ohtuvayre 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.

如您所知，我們的 WAC 價格為 22,950 美元。我們認為這代表了 Ohtuvayre 為整個醫療保健系統帶來的適當價值。當涉及報銷時，我們沒有，我們不相信這一點，而且從我們與付款人的任何互動來看，我們也沒有看到任何跡象表明該價格決定瞭如何報銷。

Keep in mind, Ohtuvayre 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 to the medication long term as well.

請記住，Ohtuvayre 是根據醫療福利報銷的，這與傳統藥房福利藥物的工作方式不同。因此，從團隊在定價和付款人群體中所做的所有工作來看，我們相信價格適當地反映了價值，但也適當地允許患者長期獲得藥物。

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

好的。謝謝。然後我有一個後續問題，實際上是關於我們可能在今年稍後在 ERS ​​和 CHEST 上預期的數據。您能否為我們介紹一下我們對這些發布的預期，無論是亞組分析、患者群體還是背景治療，以便我們能夠在此之前激發興趣？

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 enhanced program, additional analyses on the effective ensifentrine on cough and sputum from enhanced pools, patient-reported outcome assessments, and a look at exacerbation effect by COPD phenotypes, so chronic bronchitis or not chronic bronchitis.

當然，實際上所有這些事情。在ERS，您將看到一些專門針對參加增強計劃的歐洲人群的分析、對來自增強池的恩西芬汀對咳嗽和痰有效的額外分析、患者報告的結果評估，以及對急性加重效應的研究。

At CHEST, 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.

在CHEST，您將看到一些關於吸煙狀況的COPD 嚴重程度的額外分析，同樣是關於COPD 表型、慢性支氣管炎或肺氣腫的數據、匯總肺功能的分析，以及48 週內醫療資源利用率的分析。

That's very clear. Thank you very much.

這非常清楚。非常感謝。

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

我們的問答環節到此結束。我想將會議轉回給 David Zaccardelli 發表閉幕詞。

Thank you, everyone, for joining today's call. As you can see, we are very excited about Ohtuvayre'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 to updating you in the future. So I look forward to seeing you all soon at various meetings and investor conferences. Thanks very much.

謝謝大家參加今天的電話會議。正如您所看到的，我們對 Ohtuvayre 在美國的推出感到非常興奮。我認為僅僅幾天後我們就已經有了一個令人難以置信的開始，我們非常希望在未來向您通報最新情況。因此，我期待很快在各種會議和投資者會議上見到你們。非常感謝。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。