Verona Pharma PLC (VRNA) 2025 Q1 法說會逐字稿

Welcome to Verona Pharma's first quarter 2025 financial results and operating highlights conference call.

歡迎參加維羅納製藥 2025 年第一季財務業績和經營亮點電話會議。

(Operator Instructions)

（操作員指示）

I'd now like to turn the call over to Victoria Stewart, senior director, Investor Relations and communications. Please go ahead.

現在我想將電話轉給投資者關係和傳播高級總監維多利亞·斯圖爾特。請繼續。

Thank you.

謝謝。

Earlier this morning, Verona Pharma issued a press release announcing its financial results for the three months ended March 31st, 2025. A copy can be found in the investor relations tab on the corporate website www.veronapharma.com.

今天早些時候，維羅納製藥發布了一份新聞稿，公佈了截至 2025 年 3 月 31 日三個月的財務業績。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 during today's call, statements about the company's future expectations, plans and prospects are forward-looking statements. These forward-looking statements are based on the 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.

在我們開始之前，我想提醒您，在今天的電話會議中，有關公司未來預期、計劃和前景的陳述都是前瞻性的陳述。這些前瞻性陳述是基於管理階層目前的預期。這些聲明既不是承諾也不是保證，並且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表達或暗示的預期有重大差異。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。儘管公司可能選擇在未來某個時間點更新此類前瞻性聲明，但公司不承擔任何這樣做的義務，即使後續事件導致其觀點發生變化。

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.

提醒一下，本次通話正在錄音，並將保留 90 天。現在我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. Kathleen Rickard, our Chief Medical Officer, Chris Martin, our Chief Commercial Officer, and Dr. Tara Rheault, our Chief Development Officer.

謝謝大家，歡迎大家參加今天的電話會議。今天與我一起的有我們的財務長馬克·哈恩 (Mark Hahn)、我們的首席醫療官凱瑟琳·里卡德 (Kathleen Rickard) 博士、我們的首席商務官克里斯·馬丁 (Chris Martin) 和我們的首席開發官塔拉·羅特 (Tara Rheault) 博士。

The first quarter of 2025 was phenomenal for Verona Pharma as we continued to drive the highly successful US launch of Ohtuvayre for the maintenance treatment of COPD as well as advance our clinical development programs and global regulatory strategy. I am incredibly pleased to report, for the first time, Verona's quarterly revenue exceeded our quarterly operating expenses, excluding non-cash charges.

2025 年第一季對維羅納製藥來說是意義非凡的，因為我們繼續推動 Ohtuvayre 在美國成功上市，用於 COPD 的維持治療，並推進我們的臨床開發計劃和全球監管策略。我非常高興地報告，維羅納的季度收入首次超過了我們的季度營運費用（不包括非現金費用）。

First, let's review the ongoing launch of Ohtuvayre, which continues to accelerate quarter over quarter. The remarkable uptake of Ohtuvayre, which is the first inhaled product with a novel mechanism of action to treat COPD in more than 20 years, underscores the unmet need of patients with COPD. Its rapid adoption is grounded in Ohtuvayre's broad indication for the maintenance treatment of COPD and its compelling benefit to risk profile.

首先，讓我們回顧一下 Ohtuvayre 的持續發布，其發布速度逐季加快。Ohtuvayre 是 20 多年來首個用於治療 COPD 的新型作用機制吸入產品，其受歡迎程度引人注目，凸顯了 COPD 患者尚未得到滿足的需求。其迅速普及是基於 Ohtuvayre 對 COPD 維持治療的廣泛適應症及其對風險狀況的顯著益處。

In the first quarter of 2025, which is only the second full quarter of commercial availability, we almost doubled sales of Ohtuvayre there compared to the fourth quarter of 2024, recording $71.3 million in net product sales with continued month over month growth. The launch is demonstrating success across every measure. Prescriptions increased to approximately 25,000 filled during the first quarter. New patient starts grew over 25% compared to Q4, 2024, and refills represented 60% of all dispenses during the first quarter.

2025 年第一季度，也就是 Ohtuvayre 正式投入商業銷售的第二個完整季度，與 2024 年第四季度相比，Ohtuvayre 的銷售額幾乎翻了一番，淨產品銷售額達到 7130 萬美元，並且持續逐月增長。此次發布會的各項措施均取得成功。第一季處方量增加至約 25,000 份。與 2024 年第四季相比，新患者數量增加了 25% 以上，續藥量佔第一季所有配藥量的 60%。

Total prescribers grew about 50% relative to Q4 to approximately 5,300 of which 60% of Verona's Tier 1 HCPs. Prescriber depth is also increasing, with over 425 HCPs prescribing Ohtuvayre to 20 patients or more. This dramatic early adoption reinforces our belief that Ohtuvayre is the most successful COPD launch and is tracking to become what we consider a blockbuster product. HCPs continue to prescribe Ohtuvayre to a wide spectrum of their COPD patients, including patients on background single, dual, and approximately 50% on triple therapy.

與第四季相比，處方總人數增加了約 50%，達到約 5,300 人，其中 60% 為維羅納一級醫療保健提供者。處方深度也在增加，超過 425 名 HCP 為 20 名或更多患者開出了 Ohtuvayre 處方。這種引人注目的早期採用強化了我們的信念：Ohtuvayre 是最成功的 COPD 產品，並有望成為我們所認為的重磅產品。HCP 繼續向廣泛的 COPD 患者開出 Ohtuvayre 處方，包括接受單一療法、雙重療法的患者以及約 50％ 接受三聯療法的患者。

This broad application across diverse patient types highlights our confidence that Ohtuvayre's novel bronchodilation, and non-steroidal anti-inflammatory activity has the potential to redefine the standard of care in COPD treatment. We continue to receive meaningful and extremely encouraging feedback from patients and HCPs regarding the impact of Ohtuvayre, which is reflected in our growing refill and persistency data. With our launch momentum, we are planning to expand our field sales team to around 30 representatives to about 120 total in the third quarter.

本產品廣泛應用於不同類型的患者，凸顯了我們的信心：Ohtuvayre 的新型支氣管擴張和非類固醇抗發炎活性有可能重新定義 COPD 治療的護理標準。我們不斷收到來自患者和 HCP 的 Ohtuvayre 影響的有意義且極其令人鼓舞的回饋，這反映在我們不斷增長的補充和持久性數據中。憑藉我們的發布勢頭，我們計劃在第三季將我們的現場銷售團隊擴大到約 30 名代表，總數達到約 120 名。

We believe this expanded field presence will enable us to further support accelerating the launch. As part of our ongoing strategic work to solidify the long-term success of Ohtuvayre, a new orange book listed patent has been granted with an expiration date in 2044, giving us a total of four orange book listed patents. In parallel with our successful launch of Ohtuvayre, we continue to advance our pipeline with two Phase 2 clinical programs. We plan to initiate a dose ranging phase 2b trial in the second half of this year, evaluating a fixed dose combination of ensifentrine with Glycopyrrolate compared to the individual components.

我們相信，擴大實地影響力將使我們能夠進一步支持加速發布。作為我們為鞏固 Ohtuvayre 的長期成功而開展的持續策略工作的一部分，我們已獲得一項新的橙皮書專利，有效期至 2044 年，使我們總共擁有四項橙皮書專利。在成功推出 Ohtuvayre 的同時，我們繼續透過兩個 2 期臨床計畫來推進我們的產品線。我們計劃在今年下半年啟動劑量範圍 2b 期試驗，評估恩替芬鹼與格隆溴銨的固定劑量組合與單獨成分的比較。

In addition, enrollment is ongoing in our Phase 2 clinical trial of Nebulized ensifentrine in non-CF bronchiectasis. The study will assess the effect of ensifentrine 3 mg twice daily on the rate and risk of pulmonary exacerbations, symptoms, and quality of life. Turning to our global strategy, in February, Nuance Pharma, our development partner for ensifentrine in Greater China, announced Ohtuvayre was approved in Macau for the maintenance treatment of COPD in adults. This is the first regulatory approval of Ohtuvayre there outside the US.

此外，我們正在進行霧化恩替芬特林治療非 CF 支氣管擴張症的 2 期臨床試驗的招募工作。該研究將評估每日兩次服用 3 毫克恩替芬特林對肺部疾病發作率和風險、症狀和生活品質的影響。談到我們的全球策略，今年 2 月，我們在大中華區的恩替芬特林開發合作夥伴 Nuance Pharma 宣布，Ohtuvayre 在澳門獲得批准，用於成人 COPD 的維持治療。這是 Ohtuvayre 在美國以外首次獲得監管部門的批准。

In addition, Nuance Pharma is expected to report results from its pivotal phase 3 trial evaluating ensifentrine for the maintenance treatment of COPD in China in the second quarter. Finally, we continue to advance regulatory activities for potential marketing authorization application submissions for Ohtuvayre for the maintenance treatment of COPD in the European Union and in the UK. We look forward to keeping you updated on this progress.

此外，Nuance Pharma 預計將於第二季公佈其在中國評估恩替芬特林用於 COPD 維持治療的關鍵性 3 期試驗結果。最後，我們繼續推進監管活動，以便在歐盟和英國提交 Ohtuvayre 用於 COPD 維持治療的潛在行銷授權申請。我們期待向您通報這項進展。

I will now turn the call over to Mark to review our financial results for the quarter.

現在我將把電話轉給馬克來回顧我們本季的財務表現。

Good morning. Our full financial results can be found in the press release issued this morning with additional details in the Form 10 also filed today. I'll walk through the financial results for the first quarter of 2025 and review our recent strategic financing. As Dave described in the first quarter, we recorded $71.3 million in Ohtuvayre their net sales with the achievement of a $5 million clinical milestone from Nuance Pharma. Total net revenue for the first quarter was $76.3 million and in line with prior quarters, our specialty pharmacy partners continue to maintain inventory at their contracted levels of 2 weeks to 3 weeks. Cost of Ohtuvayre sales was $3.4 million for the quarter ending March 31, 2025 in line with the level of net sales of Ohtuvayre.

早安.您可在今天早上發布的新聞稿中找到我們的完整財務業績，更多詳細資訊請參閱今天提交的 10 號表格。我將介紹 2025 年第一季的財務表現並回顧我們最近的策略融資。正如戴夫在第一季所描述的，我們記錄了 Ohtuvayre 7,130 萬美元的淨銷售額，其中 Nuance Pharma 實現了 500 萬美元的臨床里程碑。第一季的總淨收入為 7,630 萬美元，與前幾季一致，我們的專業藥局合作夥伴繼續將庫存維持在合約規定的 2 週至 3 週的水平。截至 2025 年 3 月 31 日的季度，Ohtuvayre 的銷售成本為 340 萬美元，與 Ohtuvayre 的淨銷售額水準一致。

Research and development expenses were $14.1 million for the first quarter reflecting increases in share-based compensation and clinical trial and development costs related to our two Phase 2 studies. Selling general and administrative expenses were $69.1 million in the first quarter. Reflecting increases in share-based compensation and the hiring of our field-based sales team, marketing, and other commercialization expenses related to the launch of our Ohtuvayre.

第一季研發費用為 1,410 萬美元，反映了股權激勵以及與我們的兩項第 2 階段研究相關的臨床試驗和開發成本的增加。第一季銷售總務及行政開支為 6,910 萬美元。反映了股權激勵的增加以及與推出 Ohtuvayre 相關的現場銷售團隊、行銷和其他商業化費用的聘用。

In total, our operating expenses for the first quarter were $86.6 million resulting in an operating loss of $10.3 million and a net loss after tax of $16.3 million for the period. Excluding the $36.8 million in share-based compensation recorded in Q1 on an adjusted basis. We had an adjusted net income for the quarter of $20.5 million. You can find the GAAP to non-GAAP reconciliation for adjusted net income on the last page of today's press release. Finally, our balance sheet remains strong, with $401.4 million in cash and equivalent as of March 31, 2025. Compared to $399.8 million as of December 31, 2024.

整體而言，我們第一季的營運費用為 8,660 萬美元，導致當期營運虧損 1,030 萬美元，稅後淨虧損 1,630 萬美元。不包括第一季調整後記錄的 3,680 萬美元股權激勵費用。本季我們的調整後淨收入為 2,050 萬美元。您可以在今天的新聞稿的最後一頁找到調整後淨收入的 GAAP 與非 GAAP 對帳表。最後，我們的資產負債表依然強勁，截至 2025 年 3 月 31 日，現金及等價物為 4.014 億美元。相比之下，截至 2024 年 12 月 31 日為 3.998 億美元。

In addition, in March of this year, we amended our strategic financing arrangement with Oaktree and OMERS, repurchasing the previously existing $100 million obligation under the RIPSA and increasing the existing debt facility to $450 million on more favorable terms. With this amendment, we have increased our financial flexibility, reduced the cost of capital, and simplified the balance sheet, leaving us in a strong financial position.

此外，今年 3 月，我們修改了與 Oaktree 和 OMERS 的戰略融資協議，回購了先前在 RIPSA 下存在的 1 億美元債務，並以更優惠的條件將現有債務額度增加到 4.5 億美元。透過此次修訂，我們提高了財務靈活性，降低了資本成本，簡化了資產負債表，使我們的財務狀況更加穩健。

As a result of this amendment, on March 31, 2025, the company had $250 million outstanding under the Oaktree and OMERS facility and $200 million available in potential future draws. With our cash and equivalent and up to $200 million of additional potential draws under the debt facility, we feel very confident in our ability to fund the ongoing US launch of Ohtuvayre as well as our development programs. Given the success of the Ohtuvayre launch it is our intention to use future draws on the deck facility primarily to support the in license or acquisition of products as needed.

由於此修訂，截至 2025 年 3 月 31 日，該公司在 Oaktree 和 OMERS 貸款機制下未償還金額為 2.5 億美元，未來可提取金額為 2 億美元。憑藉我們的現金和等價物以及債務融資下高達 2 億美元的額外潛在提款，我們對為 Ohtuvayre 在美國的持續推出以及我們的開發計劃提供資金的能力充滿信心。鑑於 Ohtuvayre 發射的成功，我們打算利用未來甲板設施的抽水主要用於支援所需的產品許可或採購。

With that, I'll turn the call back over to the operator for the Q&A.

說完這些，我將把電話轉回給接線生進行問答。

Thank you. We will now begin the question-and-answer session.(Operator Instructions)

謝謝。我們現在開始問答環節。 （操作員指示）

We'll take our first question from Andrew Tsai at Jefferies.

我們將回答 Jefferies 的 Andrew Tsai 提出的第一個問題。

Hey, good morning. Congrats on another great quarter. Thanks for taking my questions. I have two this morning. So first is, as we exit Q1 and enter Q2, can you talk about the trends that you're seeing? Can you share any color or characterize how healthy these metrics are looking in April so far and how might they look in May and June? Thanks.

嘿，早安。恭喜您又一個出色的季度。感謝您回答我的問題。我今天早上有兩個。首先，當我們退出 Q1 並進入 Q2 時，您能談談您看到的趨勢嗎？您能否分享任何顏色或描述這些指標在四月份到目前為止的健康狀況以及它們在五月和六月的狀況如何？謝謝。

Good morning, Andrew. Thanks for the question. I think that first I want to just sort of level set that make sure that we are, updating on Q1 and not providing, projections of Q2 and beyond. With that said, as we've indicated previously, the launch is going extremely well as we talked about this morning.

早安，安德魯。謝謝你的提問。我認為首先我要進行某種程度的水平設置，確保我們更新的是第一季的數據，而不是提供第二季及以後的預測。話雖如此，正如我們之前所指出的，正如我們今天早上談到的，發布會進展非常順利。

The adoption is very high, we are expanding on every metric, including overall prescriptions, new prescribers, new patients, refills, and very encouraged by persistency, So, the every expectation that the launch, well as a reminder is so early and at the same time has such great traction, we believe that of course, that continues as it should.

採用率非常高，我們正在擴大每一個指標，包括整體處方、新處方者、新患者、續藥，並且非常鼓勵堅持，所以，每一個期望的推出，以及提醒是如此之早，同時有如此大的吸引力，我們相信，當然，這種情況會繼續下去。

Right, and then as it relates to my second part, which is a bigger picture, one, my understanding saw some seasonality, the typical industry phenomenon. Which based on my understanding, affected the pace of uptake, not necessarily gross to net, and so that should not play out going forward this year and I think refills will continue on as well.

是的，然後與我的第二部分相關，這是一個更大的圖景，首先，我的理解是看到了一些季節性，典型的行業現象。據我了解，這影響了吸收速度，不一定影響總吸收速度到淨吸收速度，因此今年這種情況不會再發生，而且我認為補充也將繼續。

So I guess the second part of my question is, do you think sales could inflect even faster in Q2, Q3, Q4? Just trying to envision or gauge how you're envisioning the sales curve to look, whether it's more parabolic or linear from here.

所以我想我的問題的第二部分是，您是否認為第二季、第三季、第四季的銷售額變化速度會更快？只是嘗試設想或衡量您所設想的銷售曲線是什麼樣子，無論它是拋物線形還是線性的。

Thank you.

謝謝。

Yes, I think that again early on but extremely encouraged, as you know how the launch curve will start to take shape chronically as a refill business as more and more patients come on and persistency occurs over the years. So you know we're very encouraged by the new patient ads which builds the foundation. That will be a continued focus of course for us when you have the expanding prescriber base as we talked about over 5,300 prescribers, that's a tremendous base of additional prescriptions, additional new patients.

是的，我很早就想到了這一點，但非常受鼓舞，因為你知道，隨著越來越多的患者出現並且多年來堅持不懈，啟動曲線將如何開始逐漸形成補充業務。所以你知道，我們對建立基礎的新患者廣告感到非常鼓舞。當然，當我們擁有不斷擴大的處方者基礎時，這將繼續成為我們的關注重點，正如我們所說的，超過 5,300 名處方者，這是一個巨大的額外處方基礎，可以帶來額外的新患者。

And as I mentioned, we're very encouraged by the growth in the refill rates and the persistency overall, so. Shape of the curve remains, I would say that we are extremely encouraged and confident on the growth trajectory, and in many ways, as there are millions of patients who remain symptomatic on current standard of care. And so, while the growth is phenomenal, there is a lot to go and we've barely just started.

正如我所提到的，我們對補充率的成長和整體持久性感到非常鼓舞。曲線形狀保持不變，我想說，我們對成長軌跡感到非常鼓舞和有信心，而且在許多方面，因為有數百萬患者在目前的護理標準下仍然存在症狀。因此，儘管成長速度驚人，但仍有許多工作要做，我們才剛開始。

Great, thank you again and congrats.

太好了，再次感謝並祝賀你。

Then we'll go next to Yasmeen Rahimi at Piper Sandler.

然後我們接下來會去 Piper Sandler 拜訪 Yasmeen Rahimi。

Good morning team and congrats for an outstanding quarter, I guess kind of like going along with Andrew's questions that he started off as within that theme, I think, I mean it's pretty remarkable. You've doubled from 4Q to 1Q. There's a big TAM. This is a really safe and effective drug, I guess just to be like, why couldn't you continue seeing such a rapid growth? Like, guess what I'm trying to figure out is what is the difference between 2Q and 1Q and now we know one had the seasonality aspect. Like, I guess what I'm trying to figure out is before you put up this number the consensus.

早安，團隊，恭喜你們取得了出色的季度業績，我想這有點像安德魯在那個主題下開始提出的問題，我認為，這是非常了不起的。您已從 4Q 翻倍至 1Q。有一個很大的 TAM。這是一種真正安全有效的藥物，我想問的是，為什麼不能繼續看到如此快速的成長呢？例如，我想弄清楚的是第二季和第一季之間的差異是什麼，現在我們知道其中一個有季節性因素。就像，我想在你提出這個數字之前弄清楚的是共識。

I think the run rate for this year was around $300 million to $350 million, that was the range, but now with this $71 million on hand, you would basically project this to be substantially higher. So, if you could just kind of help us understand sort of with this really remarkable one what the run rate could look like that would be really helpful. And then if you could comment on what the growth to net is now and how it will change going into the year, that would be helpful, and I'll jump back into the queue.

我認為今年的運行率約為 3 億至 3.5 億美元，這是一個範圍，但現在手頭上有 7,100 萬美元，你基本上可以預期這個數字會大幅提高。因此，如果您能幫助我們了解這個真正了不起的事物的運行率會是什麼樣子，那將會非常有幫助。然後，如果您可以評論一下現在的淨增長情況以及今年的增長情況將如何變化，那將會很有幫助，然後我將重新回到隊列中。

Great, thanks, good morning. So maybe we'll start in reverse, on gross and that, and I know Mark can provide some guidance on that. Yes.

太好了，謝謝，早安。因此，也許我們會從總體上反向開始，我知道馬克可以在這方面提供一些指導。是的。

Good morning. Yes. So, one of the things that we've talked about over time is that we saw the opportunity for the gross net to improve over time, and it has, it's continued to decrease and in 1. I'd characterize it as well below 20% as we as we exited the quarter.

早安.是的。因此，我們一直在談論的一件事是，我們看到了毛淨值隨著時間的推移而改善的機會，而且它一直在持續下降，並且在 1。當我們結束本季時，我認為它遠低於 20%。

And so I think in addition to the growth that we expect in 2025, I think some of the concepts that you mentioned are correct, clearly we saw as the whole industry sees a level of blunting that happens early on in Q1, which, as you can see prescriptions have been written through that, I'll be we noticed it as well as I'm sure everyone did as deductibles are reset, co-pays are reset, things like that. But with that said, we see tremendous growth as we've seen already.

因此，我認為除了我們預期的 2025 年增長之外，我認為您提到的一些概念是正確的，很明顯我們看到整個行業在第一季度初期就出現了一定程度的減弱，正如您所見，處方就是通過這種方式開出的，我相信我們也注意到了這一點，因為免賠額被重置，共同支付被重置，諸如此類的事情。但話雖如此，我們已經看到了巨大的成長。

I think we continue to focus on the important aspects, as I mentioned already, that is growing the prescriber base, growing new prescriptions, being attentive, of course, to the refill dynamics. That occur and as you look at it becomes very much a stacking phenomenon as the weeks and months and quarters unfold and all of that, of course, is continued to build on the base we have.

我認為我們將繼續關注重要方面，正如我已經提到的那樣，那就是擴大處方基礎，增加新處方，當然也要專注於補充動態。這種情況發生了，正如你所看到的，隨著幾週、幾個月和幾個季度的展開，它變成了一種堆積現象，當然，所有這些都是在我們所擁有的基礎上繼續建立的。

While grown substantially over just two full quarters, still plenty of room to go in having a huge opportunity in new patients. So yes, I think the growth is substantial. We expect it to continue to be substantial, and we're just such early on in the process there's plenty of room to go.

雖然在短短兩個季度內就實現了大幅成長，但在吸引新患者方面仍有很大的發展空間。是的，我認為成長是顯著的。我們預計這一成長將持續保持強勁，而且我們目前正處於這一進程的早期階段，還有很大的發展空間。

Thank you. Congrats again.

謝謝。再次恭喜。

Thanks.

謝謝。

Our next question comes from Olivia Brayer at Cantor Fitzgerald.

我們的下一個問題來自 Cantor Fitzgerald 的 Olivia Brayer。

Hi, good morning. Congrats on the quarter and thank you guys for the questions. Maybe just following up on Growth Tonet quickly. It's obviously trending much better than that 25%. Discount that you guys have previously talked about. So maybe just any thoughts on where you think that could ultimately shake out.

嗨，早安。恭喜本季取得佳績，感謝大家的提問。也許只是快速跟進 Growth Tonet。顯然，其趨勢比那 25% 好得多。你們之前談到的折扣。所以也許您只是對最終結果有什麼想法。

And then on hitting operating cash flow positive this quarter, is that something you think you can maintain going forward and just any thoughts on the kind of earnings power that you could start to have, especially as we think about 2026 and beyond.

然後，關於本季實現經營現金流為正，您認為這是未來可以維持的嗎？對於您可能開始擁有的盈利能力，您有什麼看法，特別是當我們考慮 2026 年及以後的時候。

Thank you guys.

謝謝你們。

Sure. Good morning, Olivia.

當然。早上好，奧莉薇亞。

So, first on the question that, I think we've talked about this in the past that while we started at launch, we said we thought it could be in the 25% range, but we thought it could actually work out to be much lower. And then in Q3 we talked about it being below 25%. Now well below 20%. I think we're getting to a point of stabilizing. There may be a little bit of room for improvement yet, but not a dramatic amount. As far as the cash flow break even to be technical from an accounting and financial reporting perspective. As I think my job is, we were not at cash flow break even from operations because of the accounts receivable bill. We were, however, at a run rate of revenue.

因此，首先關於這個問題，我想我們過去曾討論過這個問題，雖然我們在發佈時就說過我們認為它可能在 25% 的範圍內，但我們認為實際上可能會低得多。然後在第三季我們談到它低於 25%。現在遠低於20%。我認為我們正處於穩定階段。可能還有一點改進的空間，但不會太大。從會計和財務報告的角度來看，現金流損益平衡是技術性的。我認為我的工作是，由於應收帳款帳單，我們的營運現金流量未能達到收支平衡。然而，我們的收入處於運行率水準。

That exceeds cash expenses and yes, I think as we continue to grow and execute on sales, I do think that we will be able to continue that pace going forward and I think we've talked many times about the long term. Profitability of the business. I think that as sales continue to grow, the expenses will only grow so much over time. There's a relatively tight sales force and relatively I'd say a lean commercial spend against it as well.

這超過了現金支出，是的，我認為隨著我們繼續成長和執行銷售，我確實認為我們將能夠繼續保持這種速度，我認為我們已經多次談論長期問題。業務盈利能力。我認為，隨著銷售額的不斷增長，費用只會隨著時間的推移而增長這麼多。銷售隊伍相對緊張，而且我認為商業支出也相對精簡。

Great, thanks guys. Congrats on the great quarters.

太好了，謝謝大家。恭喜你們取得如此出色的成績。

Thank you.

謝謝。

We'll go next to Tara Bancroft at TD Cowen.

接下來我們將拜訪 TD Cowen 的 Tara Bancroft。

Hi, good morning. Thanks for taking the questions and congrats on the fantastic quarter. So, I was hoping if you could provide any more color on the refill rate for patients who initiated Ohtuvayre treatment six or more months ago. Like, what are the rate of refills per year also that you're expecting at steady state? Basically any color you could provide on how you expect this to evolve would be really helpful. Thanks.

嗨，早安。感謝您回答這些問題，並祝賀本季取得了出色的成績。因此，我希望您能為六個月或更早開始 Ohtuvayre 治療的患者提供更多有關補充率的資訊。例如，您預計在穩定狀態下每年的補充率是多少？基本上，只要您能提供任何有關其如何發展的細節，都會非常有幫助。謝謝。

Sure. Good morning, Tara. Yes, maybe, Chris, you can provide some color on what we're seeing in refill rates and persistency.

當然。早上好，塔拉。是的，也許，克里斯，您可以提供一些關於我們所看到的補充率和持久性的信息。

Yes, thanks Dave and thanks Tara. The thing that as Dave mentioned, we've been very encouraged by the way the persistency and refill rates have been progressing since launch. Keep in mind that Dave talked about, we're adding more new patients every single month, so. The number of patients that could be eligible for five refills- six refills is smaller than the patients that we have the ends of patients that we have today. But when we look historically at that right now, we are very encouraged at how those refill and persistency rates look.

是的，謝謝戴夫，謝謝塔拉。正如戴夫所提到的那樣，自推出以來，持久性和補充率的進步讓我們感到非常鼓舞。請記住，正如戴夫所說，我們每個月都會增加新患者。有資格進行五次續藥至六次續藥的患者數量比我們今天擁有的患者數量要少。但當我們從歷史角度回顧時，我們對這些補充率和持久率感到非常鼓舞。

I think we talked about in a previous call that, we were starting to see patients have a significant number of refills already in their path on treatment, and we felt like there was a potential for an upside on the overall persistency that we saw with patients. Remember in COPD, we see patients still about 6 times a year and over time we felt like there was a potential upside there based on the product and Ohtuvayre's benefits to provide these patients, but also our distribution channel and the way that we provide a white glove service to these patients.

我想我們在之前的電話會議中討論過，我們開始看到患者在接受治療的過程中已經有大量的續藥，我們覺得患者的整體堅持率有可能上升。記住，在 COPD 方面，我們每年仍會探望患者約 6 次，隨著時間的推移，我們覺得基於產品和 Ohtuvayre 為這些患者提供的益處，以及我們的分銷管道和我們為這些患者提供白手套服務的方式，存在潛在的上升空間。

I think early on there's no reason to believe that this upside doesn't still exist, and again we're very encouraged by how we're seeing that refill rate. A kind of progress over time. I think we need a few more months so that we have more ends and a full look back on the totality of a of a year, but again, very encouraged by what we see early on in these patients.

我認為早期沒有理由相信這種好處不存在，而且我們對所看到的補充率感到非常鼓舞。一種隨著時間的推移而取得的進步。我認為我們還需要幾個月的時間才能得到更多的結果並全面回顧一年來的全部情況，但同樣，我們對這些患者早期的表現感到非常鼓舞。

Okay, great. Yes, thank you so much. And just briefly, separately, just, do you have the option or the interest to repurchase China rights and any kind of description of the size of the China market would be really helpful too. Thanks.

好的，太好了。是的，非常感謝。簡單來說，另外，您是否有選擇或興趣回購中國權利？任何有關中國市場規模的描述都將非常有幫助。謝謝。

Yes, thanks for the question. I think that there is that opportunity, although it requires certain conditions to be met on other types of transactions that we're making. So, I think that at this time that is not part of any plan or thinking. And we continue to have a very strong collaboration with Nuance Pharma, as we talked about on the call this morning.

是的，謝謝你的提問。我認為有這樣的機會，儘管這需要我們在進行其他類型的交易時滿足某些條件。所以，我認為目前這不是任何計劃或想法的一部分。正如我們今天早上在電話會議上談到的那樣，我們繼續與 Nuance Pharma 保持著非常密切的合作。

Okay, thank you so much.

好的，非常感謝。

Thing we'll move next to Tiago Fauth at Wells Fargo.

我們將搬到富國銀行的 Tiago Fauth 旁邊。

Great, let me add my congrats and thanks for taking the questions.

太好了，請允許我向您表示祝賀，並感謝您回答這些問題。

Just on the persistent question, when we do our channel checks, the discontinuation rate seems to be very low, so it's fairly anecdotal, but I'm curious if you have any insights from the field in terms of if there are discontinuations, what might be driving that that doesn't feel like it's safety tolerability or anything like that. It feels a little bit more random, at least when we do those channel checks so, any color there would be helpful.

就這個一直存在的問題而言，當我們進行通路檢查時，停產率似乎非常低，所以這相當具有軼事性，但我很好奇您是否對該領域有任何見解，如果出現停產，是什麼原因導致的，感覺不像是安全耐受性或類似的東西。感覺有點隨機，至少當我們進行那些通道檢查時，那裡的任何顏色都會有幫助。

And my second question is more related to long term competition of biologics. I've been getting a lot of inbounds on how that could potentially impact the opportunity here, especially if you have more upstream mechanisms of action. I'm curious how you guys are seeing the long term play here.

我的第二個問題更與生物製劑的長期競爭有關。我已經收到了很多關於這可能會如何影響這裡的機會的信息，特別是如果你有更多的上游行動機制。我很好奇你們如何看待這裡的長期發展。

Thank you.

謝謝。

Hi, good morning, Tiago. Thanks for those questions.

嗨，早上好，蒂亞戈。謝謝你提出這些問題。

I'll just start with, a bit of color on discontinuations. I think it's a little early to speak with clarity around discontinuations as you've mentioned, in your calls with physicians, it can be sporadic and for different reasons. I think also what constitutes a discontinuation is a bit unclear, because as we've talked about, patients can be somewhat sporadic in timing on when they refill prescriptions and so they may take longer to refill and yet it's not technically a discontinuation. It's more of how they're going to use Ohtuvayre chronically.

我首先要介紹一下停產的情況。我認為現在就明確談論停藥還為時過早，正如您在與醫生的通話中提到的那樣，停藥可能是偶爾發生的，並且原因也各不相同。我認為，什麼構成停藥也有點不清楚，因為正如我們所討論的，患者在重新開藥的時間上可能有些不規律，因此他們可能需要更長的時間來重新開藥，但從技術上講這並不是停藥。這更多的是關於他們將如何長期使用 Ohtuvayre。

So, I think again along with the refills it takes a bit more time to provide some clarity around true discontinuations as we've talked about in the past and as you alluded to just now, tolerability is very favorable with Ohtuvayre that comes, of course, from the clinical trial data and is our general experience in the commercial setting as well. With regard to biologics, I think it's incredibly great for the field for patients with COPD to have different mechanisms approaching or applying to different mechanisms for inflammation. So I think all of that's great. We don't view it as competitive in any way with Ohtuvayre.

因此，我認為，隨著藥物補充的進行，需要更多的時間來明確真正的停藥情況，正如我們過去討論過的，正如您剛才提到的，Ohtuvayre 的耐受性非常好，當然，這是來自臨床試驗數據，也是我們在商業環境中的一般經驗。關於生物製劑，我認為對於 COPD 患者來說，使用不同的機制來治療或應用不同的發炎機制是非常有益的。所以我認為這一切都很棒。我們認為它在任何方面都無法與 Ohtuvayre 競爭。

In many ways it can be very complementary. I think approaching inflammation from multiple mechanisms will be a solid approach for the treatment of COPD. And also keep in mind that Ohtuvayre has bronchodilator and acute bronchodilator effects as part of its pharmacology and its clinical profile, which the biologics are more focused on inflammation and not bronchodilation, and I still think Patients with COPD will require chronic bronchodilation to treat them along with different approaches on anti-inflammation. So, I think it's great for the field. I think we're looking forward to it, and I don't think there's any pharmacologic reason that Ohtuvayre could not be used in conjunction with biologics if physicians thought that was appropriate for a patient.

從很多方面來說，它們可以起到很好的互補作用。我認為從多種機制來治療發炎是治療 COPD 的有效方法。還要記住的是，Ohtuvayre 的藥理學和臨床特徵包括支氣管擴張劑和急性支氣管擴張劑作用，而生物製劑更側重於發炎而不是支氣管擴張，我仍然認為 COPD 患者需要慢性支氣管擴張劑來治療，同時採用不同的抗發炎方法。所以，我認為這對這個領域很有幫助。我想我們對此充滿期待，並且我認為如果醫生認為這對患者合適，那麼沒有任何藥理學原因導致 Ohtuvayre 不能與生物製劑一起使用。

Fair enough. Alright, thank you so much.

很公平。好的，非常感謝。

We'll go next to Tom Shrader at BTIG.

接下來我們來談談 BTIG 的 Tom Shrader。

Good morning and congratulations for essentially hitting Our 2Q Number. I have a I'm doing some reading on a bronchiectasis, and as far as I understand it. A fair number of COPD patients also have that diagnosis. Do you know how you do well in those patients or were they excluded? And then a real quick one for either Mark or Chris. Are you guys completely outside of the Medicare Part D redesign or is that something that you also have to think about? Thanks.

早安，恭喜您基本上達到了我們的第二季業績。我正在閱讀一些關於支氣管擴張的資料，據我所知。相當多的 COPD 患者也患有這種診斷。你知道這些病人的狀況如何嗎？或者他們被排除在外了？然後對馬克或克里斯來說這是一個非常快速的問題。你們是否完全不了解醫療保險 D 部分的重新設計，還是這也是你們需要考慮的？謝謝。

Great. Good morning, Tom. So maybe the last question first, I don't know, Chris, you want to talk about being outside part D and then I think, Tara and Kathy can comment on bronchiectasis.

偉大的。早上好，湯姆。所以也許最後一個問題首先，我不知道，克里斯，你想談談 D 部分之外的事情，然後我想，塔拉和凱西可以評論一下支氣管擴張。

Yes, Tom, thanks for the question. I appreciate the context I'm hitting the Q2 consensus number 2. I think for Medicare Part D redesign, I think it's an interesting, we are primarily through a medical benefit reimbursement, so 80% of our reimbursement is through medical benefit either through traditional Part B or through Medicare Advantage. We can see Medicare Part D reimbursement in a in a long-term care facility or a skilled nursing home facility, but that is such a small percentage that I would say we're not affected by any of this redesign that is going on with purely med the products that exist today again.

是的，湯姆，謝謝你的提問。我很感激我達成第二季共識 2 的背景。我認為對於 Medicare D 部分的重新設計很有趣，我們主要透過醫療福利報銷，因此 80% 的報銷是透過醫療福利，無論是透過傳統的 B 部分還是透過 Medicare Advantage。我們可以在長期照護機構或專業療養院中看到醫療保險 D 部分的報銷，但這個比例太小了，我想說我們不會受到正在進行的任何重新設計的影響，純粹重新設計目前存在的產品。

Great. Great. And then touching on the bronchiectasis question, as well, we really had few patients with confirmed bronchiectasis by a CT scan in the enhanced program. Certainly the reason we're doing that program is because we think the mechanisms that help improve COPD in patients with COPD are also applicable to patients with bronchiectasis and it's the, anti-inflammatory mechanism targeting neutrophilic inflammation and also the effects on cough and sputum that we saw in COPD patients stemming from, potentially CFTR activation, which we've seen in non-clinical studies, helping those patients to clear their cough and sputum, which are the two main symptoms in bronchiectasis.

偉大的。偉大的。然後談到支氣管擴張的問題，我們在增強項目中確實有少數患者透過 CT 掃描確診為支氣管擴張。當然，我們進行此計畫的原因是因為我們認為有助於改善 COPD 患者 COPD 的機制也適用於支氣管擴張患者，它是針對中性粒細胞炎症的抗炎機制，也是我們在 COPD 患者中看到的可能源於 CFTR 激活的咳嗽和痰液影響，我們在非臨床研究中看到它幫助擴張這些患者清除咳嗽和痰液，這是支氣管的兩個主要症狀。

Just to follow up, what is the overlap? Is it very small?

只是想跟進一下，重疊部分是什麼？是不是很小？

Yes.

是的。

Go ahead, Kathy. Go.

繼續吧，凱西。去。

Ahead. Is this a com in a perspective. So patients with COPD can have isolated areas of bronchiectasis, certainly in that as Tara talked about their sputum, cough, things like that are similar to patients who have bronchiectasis by itself. But patients with COPD have a much broader spectrum because they have bronchiectasis or so it's affecting their bronchial tubes, but it also affects their airways. They have emphysema, and then they'll have some localized areas of bronchitis. Patients with bronchiectasis primarily have just effects on their bronchial airways, the larger airways.

前方。從某個角度來看，這是一個 com 嗎？因此，患有 COPD 的患者可能會出現孤立的支氣管擴張區域，正如 Tara 所說的那樣，他們的痰液、咳嗽等症狀與單獨患有支氣管擴張的患者相似。但患有 COPD 的患者的情況則更為廣泛，因為他們患有支氣管擴張症，這不僅影響他們的支氣管，還影響他們的呼吸道。他們患有肺氣腫，然後會出現局部支氣管炎。支氣管擴張症患者的支氣管氣道（較大的氣道）主要受到影響。

This results from usually past infections and things like that in the past, versus patients with COPD who have underlying disease primarily related to cigarette smoke and other toxic exposures. So the bronchiectasis patient will have some things in common with COPD but not the overall, the whole overall look of the disease, so to speak. And as Tara said, because of our effects on cough and sputum and so forth, we would expect it to work on those patients with bronchiectasis alone.

這通常是由於過去的感染和類似情況造成的，而 COPD 患者的潛在疾病主要與吸煙和其他有毒物質接觸有關。因此，支氣管擴張症患者與 COPD 有一些共同之處，但可以說，在整體上，即疾病的整體外觀上，並不完全相同。正如塔拉所說，由於我們對咳嗽和痰液等有效果，我們預計它對單獨患有支氣管擴張的患者也有效。

Okay.

好的。

And the overlap, if you look at the diagnosed bronchiectasis population, you might find around 20% of those patients also have a COPD diagnosis. I think going the other direction and looking at the COPD population, I think what we're understanding is, as the, understanding of bronchiectasis progresses, is that the more they look for it in COPD patients, the more they find it.

如果你觀察確診為支氣管擴張症的人群，你可能會發現其中約 20% 的患者也患有 COPD。我認為從另一個方向來看 COPD 人群，我認為我們理解的是，隨著對支氣管擴張的了解不斷深入，他們在 COPD 患者中尋找得越多，發現的就越多。

Great, thank you.

太好了，謝謝。

We'll move next to Raghuram Selvaraju at HC Wainwright.

接下來我們將前往 HC Wainwright 的 Raghuram Selvaraju。

Thanks very much for taking my questions and congrats again on this excellent quarter, really impressive performance. I was wondering if you could maybe give us some more information and insight on the competitive landscape and what you are hearing from physicians as we approach potential readouts from biologics that are kind of in the same vein as talizumab, in particular drugs like Ipecac or --.

非常感謝您回答我的問題，並再次祝賀本季度取得的優異成績，這確實令人印象深刻。我想知道您是否可以提供一些關於競爭格局的更多信息和見解，以及您從醫生那裡聽到的信息，我們正在研究與他利珠單抗類似的生物製劑的潛在讀數，特別是像吐根或--.

And in particular you know this kind of follows on from one of I think the earlier questions about competition from biologics. If there are any physician opinions indicating that prescribers might look at the lower frequency of administration for biologics as a potential advantage or reason to put patients on a biologic versus ensifentrine. And if you are not seeing evidence of that, maybe give us a sense of why and in particular if this might be traced back to not only ensifentrine's unique mechanism of action but also the safety advantages that it would likely continue to enjoy over any future biologic competitors.

特別是您知道，這是對先前關於生物製劑競爭的問題的延續。如果有任何醫生的意見表明，開處方者可能會將生物製劑的較低給藥頻率視為讓患者使用生物製劑而非恩替芬特林的潛在優勢或理由。如果您沒有看到這方面的證據，請讓我們了解原因，特別是這是否可以追溯到不僅是恩替芬特林獨特的作用機制，而且還可能追溯到它可能繼續享有的安全優勢，超越任何未來的生物製劑競爭對手。

Thank you.

謝謝。

Hi, good morning. No thanks for the question. I may provide a general comment and then Chris can talk about what's been, what we're seeing in the field. I think from a pharmacology basis, we don't see it as competitive in any particular way. I think the use case for a biologic, again, assuming that we'll have to see what the results actually say. Is different than for Ohtuvayre is a PDE3 and PDE4 inhibitor with both bronchodilation and non-steroidal anti-inflammatory, has a unique profile and as we talked about on the call, a very compelling benefit to risk profile and other drugs will have to, stand on their own with regard to that as I look at it, patients who are symptomatic and need additional treatment, a lot of that is around treating their dyspnea which typically requires bronchodilation.

嗨，早安。不用了，謝謝您的提問。我可以提供一個總體評論，然後克里斯可以談談我們在該領域所看到的情況。我認為從藥理學角度來看，我們認為它在任何特定方面都不具有競爭力。我認為生物製劑的用例，再次假設我們必須看看結果實際上是什麼。與 Ohtuvayre 不同的是，它是一種 PDE3 和 PDE4 抑製劑，具有支氣管擴張和非類固醇抗發炎作用，具有獨特的特性，正如我們在電話會議上所討論的那樣，它對風險狀況具有非常顯著的益處，而其他藥物必須在這方面獨樹一幟，在我看來，對於有症狀並需要額外治療的患者，這通常需要著治療的患者。

That is a use case for Ohtuvayre in addition to supporting the treatment with anti-inflammatory effects through the PDE3, PDE4 pathway. So I think that all of the treatments coming along can be complementary to Ohtuvayre, as I mentioned, treating. Inflammation from multiple pharmacologic pathways seems to make some sense broadly, and I think the use case for them are going to be different and so we're very confident that Ohtuvayre has a place in the treatment paradigm and as I've talked about has the potential to redefine exactly how patients are treated for their symptoms. I don't know Chris, do you want to add anything to that of what we're seeing in the field from physicians.

這是 Ohtuvayre 的一個用例，此外還支援透過 PDE3、PDE4 路徑發揮抗發炎作用的治療。因此我認為，所有隨之而來的治療方法都可以與 Ohtuvayre 治療相輔相成，正如我所提到的。來自多種藥理途徑的發炎似乎具有廣泛的意義，我認為它們的用例將會有所不同，因此我們非常有信心 Ohtuvayre 在治療範例中佔有一席之地，正如我所說的那樣，它有可能重新定義如何治療患者的症狀。我不知道克里斯，你想對我們在醫生領域看到的情況做些補充嗎？

Yes, Dave, I think you covered it really well. I would just say anecdotally when we hear our field reps interact with physicians, they express very similar things to what Dave talks about, which is that Ohtuvayre's profile is a broad use COPD treatment because these patients, as Dave described, come in complaining of dyspnea. They need that bronchodilation effect, and Ohtuvayre is always going to provide bronchodilation and non-steroidal anti-inflammatory effects as a base for these patients.

是的，戴夫，我認為你講得非常好。我想說的是，當我們聽到我們的現場代表與醫生互動時，他們表達的內容與戴夫所說的非常相似，那就是 Ohtuvayre 的概況是一種廣泛使用的 COPD 治療方法，因為這些患者，正如戴夫所描述的，來的時候都抱怨呼吸困難。他們需要支氣管擴張作用，而 Ohtuvayre 始終會為這些患者提供支氣管擴張和非類固醇抗發炎作用作為基礎。

And they look at the biologics as an add-on or something that they can hit inflammation in another way at another point in time for these patients. So I think we're very pleased and encouraged at how physicians view Ohtuvayre as a broad-based COPD treatment for all their patients that are persistently symptomatic. So, I think it goes back to what Dave talked about, which is the profile of Ohtuvayre.

他們將生物製劑視為一種附加藥物，可以在其他時間點以其他方式緩解這些患者的發炎。因此，我認為，我們非常高興和鼓舞地看到醫生們將 Ohtuvayre 視為一種適用於所有持續出現症狀的 COPD 患者的廣泛治療方法。所以，我認為這又回到了戴夫所說的內容，即 Ohtuvayre 的簡介。

That's very helpful. Just one other quick one you mentioned earlier in the call about the possibility of turning attention towards in licensing or acquiring additional potential products or product opportunities. Can you elaborate on that a little bit just from a broad strategic perspective and if you are looking specifically, I would imagine at pulmonology focused products and how broadly you expect to cast your net and if you are going to specifically only concentrate on those opportunities that are likely to be directly complementary to.

這非常有幫助。您剛才在電話中簡單提到了另一個問題，即將注意力轉向許可或獲取其他潛在產品或產品機會的可能性。您能否從廣泛的戰略角度詳細闡述這一點，如果您具體地看，我會想像您關注的是以肺病學為重點的產品，以及您希望將網絡撒到多大範圍內，以及您是否只專注於那些可能直接互補的機會。

Thank you.

謝謝。

Yes, I know that's a great question. I think that yes, we, as we continue to have great success with the launch of Ave and as we expand our global footprint, we want to, again grow the business and we are a development. Based commercial company, so we want to look at assets that would leverage our capabilities of course in development, regulatory, and commercial that would sit primarily in the respiratory space.

是的，我知道這是一個很好的問題。我認為是的，隨著 Ave 的推出我們繼續取得巨大成功，並且我們不斷擴大全球影響力，我們希望再次發展業務，我們正在不斷發展。作為一家商業公司，我們希望尋找能夠利用我們在開發、監管和商業方面的能力的資產，這些資產主要集中在呼吸領域。

Of course pulmonology as a call point would be a strength. And I think there are opportunities and mid and later stage products that currently are out there that exist in that space. So, we have an eye out for that clearly, we want to continue to have success with the US launch and continue to expand our global reach with Ohtuvayre there, but as we build the company, acquiring assets will be the core of that.

當然，肺病學作為呼叫點將是一個優勢。我認為該領域目前存在著機會和中後期產品。因此，我們對此有著清晰的認識，我們希望繼續在美國取得成功，並繼續透過 Ohtuvayre 擴大我們的全球影響力，但隨著我們建立公司，收購資產將是其中的核心。

Thank you very much.

非常感謝。

We'll move next to Joon Lee at Tru Securities.

接下來我們來談談 Tru Securities 的 Joon Lee。

Good morning and congrats on the really strong quarter. This is awesome on for Zoom. Thanks for taking the questions. Just a couple from us. So, for the tier one doctors who haven't yet prescribed Ohtuvayre, what are you hearing from them?

早安，恭喜本季業績表現強勁。這對於 Zoom 來說太棒了。感謝您回答這些問題。距離我們只有幾對。那麼，對於尚未開出 Ohtuvayre 處方的一級醫生，您聽到了什麼消息？

And then on the patent update, you had several patents that were potentially eligible for an orange book listing. Can you remind us which one was granted for June 2044?

然後在專利更新中，您有幾項專利可能有資格列入橙皮書。您能提醒我們哪一個是 2044 年 6 月授予的嗎？

Thank you.

謝謝。

Great, thanks for the question. I guess I'll start with the latter one and then turn it over to Chris on talking about our tier one HCPs. Yes, we're very pleased that we have an additional patent listed in the Orange Book with the 2044 expiration and so.

太好了，謝謝你的提問。我想我先從後者開始，然後交給克里斯談論我們的一級 HCP。是的，我們很高興橙皮書中列出了一項額外的專利，其有效期為 2044 年。

That patent centers around what can be just generically called the purity aspects of ensifentrine and what I would say is sort of a fingerprint of what ensifentrine looks like from a chemical basis. So, a lot of that has to do with the novel aspects of ensifentrine's both purity and impurities that exist within its fingerprint. And I don't know if you want to talk about tier one?

專利主要圍繞著恩替芬鹼的純度方面，我認為它是從化學角度對恩替芬鹼進行的一種指紋識別。因此，這在很大程度上與恩替芬特林的純度及其指紋中存在的雜質的新穎方面有關。我不知道您是否想談論第一層？

Yes, as far as tier ones, Dave, when we look at our tier ones and we see approximately 60% of them riding within nominally the first two full quarters of launch, it's something that I think is an impressive start for the brand. Remember, these tier one physicians are seeing upwards of more than 10 COPD patients a month, so the opportunity within this group is tremendous.

是的，就一級市場而言，戴夫，當我們觀察我們的一級市場時，我們發現其中大約 60% 在產品發布後的前兩個完整季度內就取得了成功，我認為這對該品牌來說是一個令人印象深刻的開端。請記住，這些一級醫生每月要接診超過 10 名 COPD 患者，因此這個群體中的機會是巨大的。

You know what we've done over the course of the last few months is also try to understand within physicians that have written to date and those that haven't, is there a difference in sentiment and I think the thing that we've seen in our market research is that regardless of if a doctor has written Ohtuvayre there today or if they haven't. All see the utility of in the future and eventually get the same share levels of our capture rate of patients within their practice, sometimes physicians are a little bit slower in adopting and what that's usually contributed to needing to see it in the guidelines. Having a peer discussed it with them, and those are all things that if you think about it, we got added to the gold guidelines at the end of November.

您知道，我們在過去幾個月中所做的就是試圖了解迄今為止寫過信的醫生和沒有寫信的醫生在情緒上是否存在差異，我認為我們在市場調查中看到的情況是，無論醫生今天是否在那裡寫過信給 Ohtuvayre。所有人都看到了未來的效用，並最終在他們的實踐中獲得相同比例的患者捕獲率，有時醫生的採用速度會慢一點，這通常導致需要在指南中看到它。讓同行與他們討論一下，這些都是如果你想想的事情，我們在 11 月底就將其添加到了黃金指南中。

We've continued to do speaker programs, so I would suspect as we continue through this year we'll continue to increase the number of tier one prescribers that we have, and I think what is Very encouraging to me is that regardless of what they've done today, the outcome in the future between the writers and non-writers today is very similar because the benefit and the profile of there is so compelling for them by providing bronchodilation and nonsteroidal anti-inflammatory effects for them.

我們一直在做演講者計劃，所以我認為隨著今年的繼續，我們將繼續增加一級處方人員的數量，我認為對我來說非常令人鼓舞的是，無論他們今天做了什麼，未來的結果在今天的作家和非作家之間非常相似，因為通過為他們提供支氣管擴張和非類固醇抗炎作用，他們的利益和形像是如此引人注目。

Thank you.

謝謝。

We'll go next to Sushila Hernandez at Van Lanschot Kempen.

我們將前往 Van Lanschot Kempen 的 Sushila Hernandez 旁邊。

Yes, thank you for taking my question and congrats on a quarter.

是的，感謝您回答我的問題，並祝賀您取得本季的佳績。

I share continue to progress the regulatory activities for potential marketing authorization applications submissions in the EU and UK. Could you share your latest thinking on strategy and partnering in these regions?

我分享繼續推動歐盟和英國潛在行銷授權申請提交的監管活動。您能否分享一下您對這些地區的策略和合作的最新想法？

Thank you.

謝謝。

Yes, good morning. Thanks for the question.

是的，早安。謝謝你的提問。

Yes, we continue to engage both the EMA and the MHRA in the sort of very structured approach to discussing the applications. Ongoing as we speak and as it's a very calendared approach for both of them. I would say that sometime around mid-year we would be better informed as to the responses and thoughts on her application and so I think we look forward to updating you, as we get into the next quarter and beyond in 2025 to bring more clarity as to what the exact plan in Europe will be.

是的，我們將繼續以非常結構化的方式與 EMA 和 MHRA 討論申請。正如我們所說的那樣，這正在進行中，因為這對他們雙方來說都是一個非常有日程安排的方法。我想說，大約在年中的時候，我們會更好地了解對她的申請的回復和想法，因此我認為我們期待著在進入下一季及 2025 年以後向您更新最新情況，以便更清楚地了解歐洲的具體計劃。

Our strategy around partnering in Europe remains the same, and I guess you would imagine that having regulatory clarity is also part of that discussion with partners, so all of it kind of comes together as we progress through 2025.

我們在歐洲的合作策略保持不變，我想你會想​​像，監管明確性也是與合作夥伴討論的一部分，因此，隨著我們邁向 2025 年，所有這些都會融合在一起。

Okay, that's clear. Thank you.

好的，很清楚。謝謝。

And we'll go next to people in Boobalan Pachaiyappan at Roth Capital.

接下來我們將拜訪 Roth Capital 的 Boobalan Pachaiyappan。

Hi, good morning and congrats on the progress. So I have a couple of questions. So firstly, with respect to price stability, so with all the news about tariffs on inflation taking the center stage, so I wonder if price stability will be maintained for in 2025. Any thoughts on that? That's the first question. And then second, with respect to your face to be fixed or study, I was wondering if you could provide some high-level thoughts.

你好，早安，祝賀你的進展。我有幾個問題。首先，關於價格穩定，由於有關通膨關稅的所有新聞都佔據了中心位置，所以我想知道 2025 年價格穩定是否能夠保持。對此有什麼想法嗎？這是第一個問題。第二，關於您要修復或研究的臉部問題，我想知道您是否可以提供一些高層次的想法。

What to expect in the study that you're planning to start the second half of this year. And then in that regard, I wonder if you are planning to measure pre pre-dose FEV1 because my understanding is that this is one of the important efficacy markers that FDA is looking for, even though the 0 hour to 12 hours FEV1 is also a good one.

您計劃在今年下半年開始的研究中期待什麼。然後在這方面，我想知道您是否計劃測量給藥前 FEV1，因為我的理解是，這是 FDA 正在尋找的重要功效標記物之一，即使 0 小時至 12 小時 FEV1 也是一個很好的標誌物。

Thank you.

謝謝。

Right, good morning.

好的，早安。

So, with regards to price stability, as you can imagine, things are somewhat fluid and ever changing, but with that said, we see the price of Ohtuvayre as stable through 2025.

因此，關於價格穩定性，正如您所想像的，事情有些不穩定且不斷變化，但話雖如此，我們認為 Ohtuvayre 的價格到 2025 年都將保持穩定。

There's nothing that we have in concrete form that would change our thinking on that. And I'll turn it over to Tara to talk about the phase 2 B study and our end points and what we're measuring?

我們沒有任何具體的東西可以改變我們對此的想法。我將把主題交給塔拉，讓她談談第 2 階段 B 研究、我們的終點以及我們要測量的內容？

Sure. So, the team has really done a great job progressing the fixed dose combination program, and we, as we stated in the release, are planning to start our kind of pivotal phase 2 B study later this year on the fixed dose combination. In terms of end points there, I think we'll take the same approach that we took with Ohtuvayre there, ensifentrine is a twice daily drug with a 12-hour duration of action. Twice daily drug is operationally difficult to get a clear picture of a trough, pre-dose trough FEV1. And so, while we're we'll measure it, I don't expect that will be necessarily our primary endpoint. We'll continue to look at the lung function effects over the dosing interval.

當然。因此，團隊在固定劑量組合專案進度方面確實做得非常出色，而且正如我們在新聞稿中所述，我們計劃在今年稍後啟動針對固定劑量組合的關鍵性 2B 期研究。就終點而言，我認為我們將採取與 Ohtuvayre 相同的方法，恩替芬特林是一種每日兩次的藥物，作用時間為 12 小時。每日兩次用藥在操作上很難得到清晰的谷值、服藥前谷值FEV1。因此，雖然我們會對其進行測量，但我並不認為這一定是我們的主要終點。我們將繼續觀察給藥間隔期間肺功能的影響。

All right, thank you very much.

好的，非常感謝。

And that concludes our Q&A session. I will now turn the conference back over to David Zaccardelli for closing remarks.

我們的問答環節到此結束。現在我將會議交還給 David Zaccardelli 並請他致閉幕詞。

Great, thank you very much and thank you everyone for joining us today on the call.

太好了，非常感謝，也感謝大家今天參加我們的電話會議。

I just wanted to reiterate how pleased we are with our progress and how Ohtuvayre is impacting patients' lives, and we very much look forward to keeping you updated through 2025 and have a great day.

我只是想重申，我們對我們的進展以及 Ohtuvayre 如何影響患者的生活感到多麼高興，我們非常期待在 2025 年之前向您提供最新進展，祝您有美好的一天。

And this concludes today's conference call.

今天的電話會議到此結束。

Thank you for your participation. You may not disconnect.

感謝您的參與。您不能斷開連線。