Insmed Inc (INSM) 2025 Q3 法說會逐字稿

Thank you for standing by. My name is Kayla, and I will be your conference operator today. At this time, I'd like to welcome everyone to the Insmed third quarter 2025 financial results. (Operator Instructions)

感謝您的耐心等待。我叫凱拉，今天我將擔任你們的會議接線生。在此，我謹代表 Insmed 公司，歡迎大家參加 2025 年第三季財務業績發表會。（操作說明）

I would now like to turn the call over to Bryan Dunn, Head of Investor Relations. You may begin.

現在我將把電話交給投資者關係主管布萊恩鄧恩。你可以開始了。

Thank you, Kayla. Good day, everyone, and welcome to today's conference call to discuss Insmed's third quarter 2025 financial results and provide an update on our business.

謝謝你，凱拉。大家好，歡迎參加今天的電話會議，我們將討論 Insmed 2025 年第三季的財務業績，並提供我們業務的最新進展。

Before we start, please note that today's call will include forward-looking statements. These statements represent our judgment as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the projections discussed. Please refer to our filings with the Securities and Exchange Commission for more information.

在開始之前，請注意，今天的電話會議將包含前瞻性陳述。這些陳述代表了我們截至今日的判斷，其中必然包含風險和不確定性，可能導致實際結果與所討論的預測有重大差異。更多資訊請參閱我們向美國證券交易委員會提交的文件。

Also note that our call today will include blinded observations from our ongoing Phase 2 study of brensocatib in CRS without nasal polyps. These observations may not be representative of results once the study is completed and all data is collected and analyzed. As a result, any future interim data readouts and the final data from this study may be materially different than the observations described today. The information we will discuss on today's call is meant for the benefit of the investment community. It is not intended for promotional purposes and it is not sufficient for prescribing decisions.

另請注意，我們今天的電話會議將包括我們正在進行的針對無鼻息肉的 CRS 患者的 brensocatib 2 期研究的盲法觀察結果。一旦研究完成，所有資料收集和分析完畢，這些觀察可能無法代表研究結果。因此，未來任何中期數據讀數和本研究的最終數據可能與今天描述的觀察結果有實質差異。我們今天電話會議將討論的資訊旨在為投資界帶來益處。它並非用於促銷目的，也不足以作為處方決策的依據。

Today's call will feature prepared comments by Will Lewis, Chair and Chief Executive Officer; Roger Adsett, Chief Operating Officer; and Sara Bonstein, Chief Financial Officer. After their comments, they will be joined by Martina Flammer, Chief Medical Officer, for the Q&A session.

今天的電話會議將包括董事長兼首席執行官 Will Lewis、首席營運官 Roger Adsett 和首席財務官 Sara Bonstein 的準備好的發言。發言結束後，首席醫療官瑪蒂娜·弗拉默將加入問答環節。

I will now turn the call over to Will.

現在我將把通話轉給威爾。

Thank you, Bryan. I'm enormously pleased to welcome all of you to Insmed's first earnings call as a company with multiple commercial products. The FDA approval of BRINSUPRI in August marked a new day for patients living with bronchiectasis and a step change in the number of patients Insmed can now serve with its medicines. Financial success is a downstream result of accomplishing the primary goal of developing first and best-in-class medicines that provide real meaningful benefits to patients.

謝謝你，布萊恩。我非常高興地歡迎各位參加 Insmed 作為一家擁有多款商業產品的公司舉行的首次財報電話會議。8 月 BRINSUPRI 獲得 FDA 批准，標誌著支氣管擴張症患者的新時代，也標誌著 Insmed 的藥物能夠服務的患者數量發生了巨大變化。財務上的成功是實現首要目標的下游結果，即開發出能夠為患者帶來真正有意義的益處的首創和一流藥物。

Today's update, in my view, confirms that we have a medicine in BRINSUPRI that achieves that primary goal. While we're still early in the launch and only have a few weeks of data to steer our interpretation, the positive reception we have seen to date supports our expectations of a large commercial opportunity for BRINSUPRI.

在我看來，今天的更新證實了我們在 BRINSUPRI 中擁有一種能夠實現該主要目標的藥物。雖然我們仍處於產品發布初期，只有幾週的數據來指導我們的解讀，但迄今為止我們看到的積極反響支持了我們對 BRINSUPRI 巨大商業機會的預期。

So far, we have seen physicians who are motivated to prescribe it, patients who are eager to take it and payers that have been willing to reimburse it. Please bear in mind that today's results represent only 6 weeks of sales and include inventory stocking and other factors that make it difficult to discern the underlying dynamics in the early days of any launch. Given these considerations, it is challenging to glean much insight into the longer-term slope of the launch from this partial period.

到目前為止，我們已經看到有積極開處方的醫生、渴望服用該藥的患者以及願意報銷該藥的支付方。請注意，今天的業績僅代表 6 週的銷售情況，並且包含庫存和其他因素，這些因素使得在任何產品上市初期都難以辨別其潛在動態。考慮到這些因素，從這一部分很難深入了解發射的長期趨勢。

Our first full quarter of launch, which we anticipate reporting in early 2026, will provide a clearer look at how the launch is progressing. While we are very pleased with these results, we recognize that a lot can change as the launch progresses, and we will need to continue to execute for this launch to live up to its potential.

我們預計將於 2026 年初發布首個完整的季度報告，屆時將更清楚地了解產品上市的進展。雖然我們對這些結果非常滿意，但我們也意​​識到，隨著發布會的進行，很多事情都可能發生變化，我們需要繼續努力執行，才能使這次發布會發揮其應有的潛力。

For now, we can say that the breadth of prescribing achieved in these first 6 weeks of launch is impressive. We will continue our education efforts to build the depths to match the clear unmet medical need for this important medicine.

就目前而言，我們可以說，上市前 6 週所取得的處方覆蓋範圍令人印象深刻。我們將繼續努力深化教育，以滿足目前對這種重要藥物尚未滿足的醫療需求。

As we have said many times, our ambition is to place BRINSUPRI in the conversation with some of the strongest respiratory launches the industry has ever seen, including DUPIXENT, Fasenra, Tezpire and Ofev. These products, on average, produced revenues in the high double-digit millions in their first two full quarters combined. For BRINSUPRI, that period would correspond to fourth quarter 2025 and first quarter 2026 combined.

正如我們多次所說，我們的目標是讓 BRINSUPRI 與業內一些最強大的呼吸系統藥物上市產品相媲美，包括 DUPIXENT、Fasenra、Tezpire 和 Ofev。這些產品在上市的前兩個完整季度，平均總計創造了數千萬美元的收入。對於 BRINSUPRI 而言，該時期相當於 2025 年第四季和 2026 年第一季總計。

As much excitement and attention has been rightfully placed on the US launch of BRINSUPRI, it is important to remember that Insmed has three late-stage or commercial programs, each with the ability to address multiple populations. In addition, beyond these programs is a significant pipeline of earlier-stage programs that have the potential to contribute catalysts over the near and medium term.

儘管人們對 BRINSUPRI 在美國的上市給予了極大的關注和興奮，但重要的是要記住，Insmed 有三個處於後期或商業化階段的項目，每個項目都有能力滿足多個群體的需求。此外，除了這些項目之外，還有大量早期項目正在籌備中，這些項目有可能在近期和中期內發揮催化劑的作用。

Let's take a closer look at the commercial and clinical catalysts we are expecting from across our portfolio. As illustrated on this slide, Insmed's pipeline is poised to deliver far more catalysts over the next 18 months than it achieved in the previous 18-month period. On the commercial side, we have the continued US launch and the expected future launches of brensocatib in the EU, UK and Japan, if approved.

讓我們仔細看看我們產品組合中預期會出現的商業和臨床催化劑。如本投影片所示，Insmed 的產品線預計在未來 18 個月內提供比前 18 個月更多的催化劑。在商業方面，我們將繼續在美國推出 brensocatib，如果獲得批准，預計未來將在歐盟、英國和日本推出。

In addition, we expect continued commercial execution for ARIKAYCE's current label and the anticipated label expansion to include recently diagnosed patients with NTM MAC lung disease, assuming approval for that much broader indication.

此外，我們預期 ARIKAYCE 的現有標籤將繼續進行商業推廣，並預期標籤範圍將擴大到包括最近診斷出的 NTM MAC 肺病患者，前提是該更廣泛的適應症獲得批准。

Simultaneously, we expect a host of clinical drivers in that same time frame, including data readouts from the Phase 2 BiRCh study in CRS without nasal polyps, the Phase 3 ENCORE study in recently diagnosed NTM MAC lung disease, the Phase 2 CEDAR study in hidradenitis suppurativa and continued progress on our Phase 3 TPIP program, which will include pivotal Phase 3 trial starts in PH-ILD, PAH, PPF and IPF. We also expect to see the first of our next generation of DPP1 enter the clinic to potentially address a range of unmet medical needs for diseases with very large populations such as rheumatoid arthritis and inflammatory bowel disease.

同時，我們預計在同一時間段內將出現一系列臨床進展，包括針對無鼻息肉的慢性鼻竇炎的 2 期 BiRCh 研究的數據公佈、針對近期診斷的非結核分枝桿菌 MAC 肺病的 3 期 ENCORE 研究、針對化膿性汗腺炎的 2 期 CEDAR 研究，以及我們 3 期 TPIP 項目的持續性動脈。 (PH-ILD)、肺動脈高壓 (PAH)、原發性肺纖維化 (PPF) 和特發性肺纖維化 (IPF) 中啟動關鍵的 3 期試驗。我們也期待看到我們的下一代 DPP1 的第一個藥物進入臨床試驗，以期解決類風濕性關節炎和炎症性腸病等患者群體龐大的疾病領域中一系列尚未滿足的醫療需求。

Finally, in the next 18 months, we hope to have first looks at human data from our DMD and ALS gene therapy programs. Behind these programs is a growing and increasingly promising pipeline of first or potentially best-in-class therapies, which we expect to enter the clinic at a rate of 1 to 2 INDs per year. It is going to be a busy 2026 and 2027, and we believe we are prepared and well resourced to achieve these important milestones. Let me now take a moment to walk you through our recent regulatory and clinical progress.

最後，我們希望在接下來的 18 個月內，能夠首次看到我們 DMD 和 ALS 基因治療計畫的人體數據。這些項目背後是一條不斷成長且越來越有前景的首創或潛在同類最佳療法研發管線，我們預計每年將有 1 至 2 個 IND 進入臨床階段。2026 年和 2027 年將會非常忙碌，我們相信我們已經做好了充分的準備，擁有充足的資源來實現這些重要的里程碑。現在請容許我花一點時間向您介紹我們最近在監管和臨床方面取得的進展。

Let's start with brensocatib. Earlier this month, Europe's CHMP issued a positive opinion recommending the approval of brensocatib for the treatment of non-cystic fibrosis bronchiectasis in the EU. We now expect a decision from the EMA by the end of this year, setting up a potential launch in the EU in the early part of 2026. We look forward to potentially expanding brensocatib reach to include the approximately 600,000 patients with bronchiectasis in the EU.

我們先從布倫索卡替布說起。本月初，歐洲人用藥品委員會 (CHMP) 發布了一份積極意見，建議批准 brensocatib 用於治療歐盟的非囊性纖維化支氣管擴張症。我們現在預計歐洲藥品管理局 (EMA) 將在今年年底前做出決定，從而有可能在 2026 年初在歐盟推出該產品。我們期待將 brensocatib 的適用範圍擴大到歐盟約 60 萬名支氣管擴張患者。

As with our prior launch of ARIKAYCE, we intend to launch BRINSUPRI in the EU at the same list price as the US. Elsewhere in the world, I'm pleased to report that our regulatory filing for brensocatib in the UK continues to progress on schedule, and our filing has now been accepted in Japan. We anticipate each of these filings could open up additional growth opportunities with potential approvals and launches in the UK in the first half and Japan in the second half of 2026.

與我們之前推出 ARIKAYCE 一樣，我們打算在歐盟以與美國相同的定價推出 BRINSUPRI。在世界其他地方，我很高興地報告，我們在英國提交的 brensocatib 監管申請繼續按計劃進行，並且我們的申請現在已被日本接受。我們預計，這些申請中的每一項都可能帶來額外的成長機會，並有可能在 2026 年上半年在英國獲得批准並上市，在日本下半年上市。

Moving now to our clinical progress. The BiRCh trial of brensocatib in patients with CRS without nasal polyps, continues to progress on schedule for completion by the end of 2025. Depending on the time it takes to thoroughly clean and lock the data, we expect to announce the top line results for the study no later than the early part of January. As you know, our practice is to clearly define what we believe to be the bar for success ahead of any top line readout.

接下來談談我們的臨床進展。針對無鼻息肉的慢性鼻竇炎患者的 Brensocatib 的 BiRCh 試驗正在按計劃進行，預計將於 2025 年底完成。根據徹底清理和鎖定數據所需的時間，我們預計最遲將於 1 月初公佈研究的主要結果。如您所知，我們的做法是在任何主要數據公佈之前，明確定義我們認為的成功標準。

Currently, the only approved treatment option for CRS without nasal polyps is a nasal steroid device that showed a 0.7 placebo-adjusted improvement for the lowest approved dose on the same scale being used as the primary endpoint in BiRCh.

目前，唯一核准用於治療無鼻息肉的慢性鼻竇炎的方法是使用鼻用類固醇裝置，該裝置在最低批准劑量下，與安慰劑相比改善了 0.7 倍，而該劑量與 BiRCh 的主要終點相同。

As a reminder, brensocatib is being studied on top of a stable course of nasal steroids, so any treatment effect shown would be additive to the standard of care. As such, we would consider a placebo-adjusted 0.7 treatment benefit, a clear win, matching what was adequate for FDA approval in the past.

提醒大家，brensocatib 是在穩定的鼻用類固醇療程基礎上進行研究的，因此任何顯示的治療效果都將是對標準治療的附加效果。因此，我們認為安慰劑調整後的 0.7 倍治療效果是一個明顯的勝利，與過去 FDA 批准的療效相當。

BiRCh is 80% powered to show a 0.97 placebo-adjusted treatment effect, which is a larger treatment effect than what we believe would be adequate for approval. If the study were to demonstrate that level of effect for brensocatib, that would represent a home-run scenario.

BiRCh 有 80% 的把握顯示 0.97 的安慰劑調整治療效果，比我們認為足以獲得批准的治療效果還要大。如果研究證實布倫索卡替具有這種程度的效果，那將是一次巨大的成功。

Please note that BiRCh powering, I just mentioned, is based on an alpha level of 0.1. Given that this is the first study ever conducted for this mechanism in this patient population, the goal is to gather strong directional information as quickly as possible to inform our potential pursuit and design of a future Phase 3 program in CRS without nasal polyps.

請注意，我剛才提到的 BiRCh 功率是基於 0.1 的 alpha 水準。鑑於這是首次針對該機制在該患者群體中進行的研究，目標是盡快收集強有力的方向性信息，以指導我們未來針對無鼻息肉的 CRS 開展的 3 期臨床試驗項目的潛在研究和設計。

And alpha of 0.1 is a stringent bar for a Phase 2 that is designed to detect early evidence of efficacy. This level of powering means that a successful outcome could generate a p-value for the primary endpoint that is higher than 0.05, presuming the magnitude of the treatment effect is meaningful, and we see consistency of improvement across multiple efficacy end points.

α 值 0.1 是 2 期臨床試驗的一個嚴格標準，該試驗旨在檢測早期療效證據。這種統計功效意味著，如果治療效果顯著，且我們在多個療效終點上觀察到一致的改善，那麼成功的結果可能會產生高於 0.05 的主要終點 p 值。

With nearly 30 million patients diagnosed with CRS without nasal polyps in the US, we will be interested in selling any subpopulations in the trial where the treatment appears to have the greatest impact. While we have no reason to believe at this time that only a subpopulation will respond, even a subset of these patients could represent a very large additional patient population for us to serve should a future Phase 3 program demonstrate adequate safety and efficacy results.

美國有近 3000 萬名患者被診斷出患有慢性鼻竇炎但沒有鼻息肉，因此，對於試驗中治療效果最顯著的任何亞群體，我們都有興趣出售。雖然目前我們沒有理由相信只有一部分患者會有反應，但即使是這些患者中的一小部分，如果未來的 3 期臨床試驗項目能夠證明其安全性和有效性，也可能代表著我們能夠服務的一個非常龐大的額外患者群體。

We continue to observe promising blended blinded data from the study with the improvement across all patients who have completed the study exceeding a 2 point change from baseline. We look forward to sharing the top line results with you after the study is completed.

我們繼續觀察到研究的混合盲法數據令人鼓舞，所有完成研究的患者的病情改善程度均超過基線水平的 2 分。研究結束後，我們期待與您分享主要研究結果。

Now let me provide an update on our CEDAR trial in hidradenitis suppurativa. I'm very excited to report that due to strong patient interest, the CEDAR trial is now fully enrolled. This timing is well ahead of our internal projections and exceeded the study's 204 patient enrollment target with 214 total participants randomized.

現在讓我來報告我們針對化膿性汗腺炎的 CEDAR 試驗的最新進展。我非常高興地宣布，由於患者表現出濃厚的興趣，CEDAR 試驗現已全部招募完畢。這一時間遠遠超過了我們內部的預測，並且超過了該研究的 204 名患者入組目標，共有 214 名參與者被隨機分配。

In fact, the trial completed enrollment so quickly that the final readout is now expected only weeks after our planned interim futility analysis of the first 100 patients. For this reason, we have decided to forgo the interim futility analysis, which was planned for the first quarter of 2026 and instead plan to report CEDAR's top line readout, including data from all 214 patients in the first half of 2026.

事實上，該試驗的入組速度非常快，預計在對前 100 名患者進行計劃中的中期無效性分析後幾週內即可得出最終結果。因此，我們決定放棄原計劃於 2026 年第一季進行的中期無效性分析，而是計劃在 2026 年上半年公佈 CEDAR 的主要結果，包括來自全部 214 名患者的數據。

The primary endpoint in the study is the percentage reduction in abscess and nodule count, or AN count from baseline. AN count differs slightly from the commonly used high score endpoint because there is no requirement to show a stabilization or decrease in draining tunnels. While we believe that brensocatib is likely to have a positive impact on tunnels, we think that impact may take longer to manifest itself, which is why we chose and count as the primary endpoint for this 16-week study.

研究的主要終點是膿瘍和結節計數（或 AN 計數）相對於基線的減少百分比。AN 計數與常用的高分終點略有不同，因為它不要求顯示排水隧道的穩定或減少。雖然我們相信 brensocatib 可能對隧道產生積極影響，但我們認為這種影響可能需要更長時間才能顯現出來，因此我們選擇並將其作為這項為期 16 週的研究的主要終點。

Let me also provide you with a clear definition of what we would consider a win for this top line readout. We view an approximately 20% placebo-adjusted reduction in AN count for either dose to be the bar for success in this trial. We believe that this magnitude of effect would be viewed as clinically meaningful and would encourage us to advance the program into Phase 3. Our CEDAR trial is 95% powered to show a 40% placebo-adjusted reduction in AN count. We would consider this outcome to be a home run for this data readout.

我也想向您明確定義一下，對於這個主要指標而言，我們認為什麼樣的結果才算成功。我們認為，無論服用哪種劑量，AN 計數減少約 20%（安慰劑調整後）是本次試驗成功的標準。我們相信，這種程度的效果將被視為具有臨床意義，並將鼓勵我們推進該計畫進入第三階段。我們的 CEDAR 試驗有 95% 的把握顯示，與安慰劑相比，AN 計數減少了 40%。我們認為這次數據解讀的結果非常成功。

Like the BiRCh trial, CEDAR is powered at an alpha of 0.1 so they can more quickly inform the design of a Phase 3 program, if warranted. As we've said before, HS is a challenging disease to treat successfully with recent clinical trial results from other programs underscoring this sentiment. However, we remain hopeful that our novel approach will yield a positive outcome for moderate to severe HS patients that we believe would welcome a safe and effective oral treatment option.

與 BiRCh 試驗一樣，CEDAR 的 alpha 值為 0.1，因此如果需要，他們可以更快地為 3 期專案的設計提供資訊。正如我們之前所說，HS 是一種難以成功治療的疾病，其他計畫的最新臨床試驗結果也印證了這一點。然而，我們仍然希望我們的新方法能夠為中度至重度化膿性汗腺炎患者帶來積極的結果，我們相信他們會歡迎安全有效的口服治療方案。

Turning now to TPIP. We continue to receive consistently positive feedback from the treating community for our Phase 2 data in patients with PAH. Last month, we presented the full results at the European Respiratory Society's meeting in Amsterdam, and we're pleased by the reception it received. We are now focused on conducting an expansive registrational TPIP program, which will include Phase 3 studies in PH-ILD, PAH, PPF and IPF.

現在轉向TPIP。我們持續收到來自治療界對我們治療 PAH 患者的 2 期數據的正面回饋。上個月，我們在阿姆斯特丹舉行的歐洲呼吸學會會議上發表了整個研究結果，我們對所受到的迴響感到滿意。我們現在專注於開展一項廣泛的註冊性 TPIP 項目，其中包括 PH-ILD、PAH、PPF 和 IPF 的 3 期研究。

The first of these studies is called PALM-ILD, a 344 patient trial in PH-ILD, which remains on track to open sites before the end of the year. This trial will measure the change in 6-minute walk distance at 24 weeks of treatment as the primary endpoint, and we'll take those measurements one to three hours post-administration of the most recent dose.

這些研究的第一項名為 PALM-ILD，是一項針對 PH-ILD 的 344 名患者的試驗，目前仍按計劃在年底前開設試驗點。這項試驗將以治療 24 週後 6 分鐘步行距離的變化作為主要終點，我們將在最近一次給藥後 1 至 3 小時內進行這些測量。

Measuring the primary endpoint one to three hours post-dose is the change from the approach we took in Phase 2, where all efficacy measures were taken approximately 24 hours after the most recent dose. We designed the prior trials that way, so we could definitively answer the question of whether our once-daily formulation provide a benefit throughout the entire dosing interval.

與我們在 2 期試驗中採用的方法不同，本研究在給藥後 1 至 3 小時內測量主要終點，而 2 期試驗中所有療效指標均在最近一次給藥後約 24 小時進行測量。我們之前就是這樣設計試驗的，這樣我們就可以明確地回答我們的每日一次配方是否在整個給藥間隔內都能帶來益處這個問題。

Now that we have clearly established that benefit, we have chosen to design our pivotal trials more consistently with the trials of other approved prostanoid treatments, which took their measurements at peak exposures. Importantly, treatment effect on 6-minute walk distance at crop exposure or approximately 24 hours after the most recent dose will also be captured as a secondary endpoint.

既然我們已經明確證實了這一益處，我們就選擇按照其他已批准的前列腺素治療的試驗設計關鍵性試驗，這些試驗是在峰值暴露量時進行測量的。重要的是，還將評估作物暴露時或最近一次給藥後約 24 小時對 6 分鐘步行距離的治療效果，作為次要終點。

I'm pleased to share that the data monitoring committee for TPIP convened earlier this month and reviewed unblinded data from Phase 2 programs and the open-label extension studies for PAH and PH-ILD. Not only did they recommend that the OLE studies continue unmodified, but they also strongly encouraged us to move into Phase 3 based on their review of the data.

我很高興地宣布，TPIP 的資料監測委員會於本月初召開會議，審查了 2 期項目和 PAH 及 PH-ILD 開放標籤擴展研究的非盲數據。他們不僅建議繼續進行 OLE 研究而不做任何修改，而且根據他們對數據的審查，還強烈鼓勵我們進入 3 期臨床試驗。

Additionally, we recently completed our end of Phase 2 meeting with the FDA and align with the agency on the data package that will be required to support a regulatory submission for TPIP and PAH. Based on the outcome of that meeting, we plan to conduct a single Phase 3 study in patients with PAH with the primary endpoint of 6-minute walk measured at an alpha level of 0.05.

此外，我們最近完成了與 FDA 的第二階段結束會議，並與該機構就支持 TPIP 和 PAH 監管申報所需的資料包達成協議。根據那次會議的結果，我們計劃對 PAH 患者進行一項 3 期研究，主要終點是 6 分鐘步行測試，α 水平為 0.05。

If successful and as discussed at the end of Phase 2 meeting, we will submit an NDA that will include the Phase 3 data, along with our Phase 2 trial data as confirmatory evidence. We expect to initiate the single Phase 3 trial of TPIP in patients with PAH in the early part of 2026.

如果成功，並且如第二階段會議結束時所討論的那樣，我們將提交一份新藥申請，其中將包括第三階段數據以及我們的第二階段試驗數據作為確認證據。我們預計將於 2026 年初啟動 TPIP 治療 PAH 患者的單一 3 期試驗。

We have also begun ramping up our manufacturing of TPIP to adequately source the additional supply needs of the Phase 3 studies in PPF and IPS. Given those supply requirements and the need to align with the FDA on trial design, we anticipate initiating the registrational trials in PPF and IPF as soon as possible, but likely in the second half of 2026.

我們也已開始加大 TPIP 的生產力度，以充分滿足 PPF 和 IPS 第三階段研究的額外供應需求。鑑於這些供應要求以及與 FDA 在試驗設計上保持一致的需要，我們預計盡快啟動 PPF 和 IPF 的註冊試驗，但可能要到 2026 年下半年。

When you add potential Phase 3 starts for brensocatib in CRS without nasal polyps and HS pending positive Phase 2 results we may be kicking off as many as six new Phase 3 programs requiring up to almost a dozen Phase 3 clinical trials in just the next 12 months alone.

如果將 brensocatib 治療無鼻息肉的 CRS 和 HS 的潛在 3 期臨床試驗啟動時間（取決於 2 期臨床試驗的積極結果），我們可能會啟動多達 6 個新的 3 期臨床試驗項目，僅在接下來的 12 個月內就需要開展近 12 項 3 期臨床試驗。

Now let's touch on ARIKAYCE. Even with an enormous amount of activity happening at the company, ARIKAYCE has continued to perform. Not only did ARIKAYCE posted another strong quarter of year-over-year revenue growth, but the Phase 3 ENCORE trial continues to progress on schedule towards its readout. If successful, ENCORE could expand the label for ARIKAYCE to include all patients with the MAC lung infection, increasing the addressable patient population in the US from around 15,000 today to more than 100,000.

現在我們來談談 ARIKAYCE。即使公司內部活動非常繁忙，ARIKAYCE 仍然保持良好的表現。ARIKAYCE 不僅再次實現了強勁的季度同比增長，而且 3 期 ENCORE 試驗也繼續按計劃推進，即將公佈結果。如果成功，ENCORE 可以將 ARIKAYCE 的適應症擴大到所有 MAC 肺部感染患者，使美國可治療的患者人數從目前的約 15,000 人增加到超過 100,000 人。

The number of patients who could be served by this medicine in Japan would be even larger, resulting in more than 25 million patients worldwide. As a result, we believe success in ENCORE could lead to ARIKAYCE becoming a blockbuster product.

在日本，這種藥物能夠惠及的患者人數將會更多，全球將有超過2500萬名患者受益。因此，我們相信 ENCORE 的成功可能會讓 ARIKAYCE 成為一款爆款產品。

Recall that in our first Phase 3 study in this patient population, ARISE, patients treated with ARIKAYCE showed faster, greater and more durable effects on culture conversion compared to the active control. In fact, about 80% of patients in the ARIKAYCE arm achieved and maintained a negative sputum culture at month seven, which was one month off treatment compared to 47% of patients in the control arm.

回想一下，在我們針對該患者群體進行的第一項 3 期研究 ARISE 中，接受 ARIKAYCE 治療的患者與活性對照組相比，在培養物轉化方面表現出更快、更大、更持久的效果。事實上，ARIKAYCE 組約 80% 的患者在治療 7 個月後（即停藥一個月後）痰培養結果為陰性，而對照組患者中只有 47% 達到此結果。

These results emphasize the benefits of treating earlier with ARIKAYCE, given that in our Phase 3 refractory trial convert about a third of patients converted by month 6. And on a much more challenging endpoint of durable culture conversion after three months off treatment, 16% of patients in the ARIKAYCE arm were able to show durable culture conversion compared to zero of the patients in the control arm. ARISE also validated a patient-reported outcome tool while showing encouraging directional benefits on that measure.

這些結果強調了儘早使用 ARIKAYCE 進行治療的好處，因為在我們的 3 期難治性試驗中，大約三分之一的患者在 6 個月內發生了轉化。在更具挑戰性的終點指標——停藥三個月後持續培養轉陰——方面，ARIKAYCE 組有 16% 的患者能夠表現出持續培養轉陰，而對照組患者則沒有一人達到這一結果。ARISE 也驗證了一種病患報告結果工具，並在該指標上顯示出令人鼓舞的方向性益處。

The ENCORE trial was recruited at the same time and for many of the same sites as the ARISE trial and the patient demographics look very similar between the studies. So we remain cautiously optimistic that the trial results will also be similarly positive. As a reminder, a primary endpoint of culture conversion will be used in Japan, while the PRO will be the primary endpoint in the US. We look forward to turning over this data card in the first half of 2026.

ENCORE 試驗與 ARISE 試驗同時招募受試者，並在許多相同的地點進行，兩項研究的患者人口統計特徵非常相似。因此，我們仍然謹慎樂觀地認為，試驗結果也將同樣是正面的。提醒一下，在日本，文化轉化率將作為主要終點；而在美國，PRO 將作為主要終點。我們期待在 2026 年上半年移交這份數據卡。

Moving on to our early-stage pipeline. The Phase 1 ASCEND trial of our gene therapy for DMD has completed dosing of its first cohort of three patients. While early, no concerning safety signals have been observed to date, which is encouraging.

接下來，我們來看看早期研發管線。我們針對 DMD 的基因療法的 1 期 ASCEND 試驗已完成首批三名患者的給藥。雖然現在還處於早期階段，但迄今尚未發現任何令人擔憂的安全訊號，這令人鼓舞。

We believe this may reflect the benefit of our intrathecal delivery approach, which was designed to avoid passing through the liver prior to getting to the skeletal muscle and cardiac tissues where it is needed. We look forward to expanding the ASCEND trial to include a cohort of younger patients and a cohort testing a higher dose in patients of the same age as the first group.

我們認為這可能反映了我們鞘內給藥方法的優勢，該方法旨在避免藥物在到達所需的骨骼肌和心臟組織之前經過肝臟。我們期待擴大 ASCEND 試驗的範圍，納入一組較年輕的患者，以及一組與第一組患者年齡相同的患者，測試更高劑量。

Our second gene therapy program for the treatment of patients with ALS is also making strong progress. The IND for the treatment recently was cleared to move forward into the clinic, so we are now preparing for the start of a Phase 1 trial.

我們針對 ALS 患者的第二個基因治療計畫也取得了顯著進展。此療法的IND申請最近已獲準進入臨床試驗階段，因此我們現在正準備開始1期臨床試驗。

Like our DMD therapy, this treatment will be administered intrathecally. We are particularly excited for this program because we will be studying it in both SOD1 and the much larger population of sporadic patients based on strong data generated preclinically for models for both populations.

與我們的 DMD 療法一樣，這種療法也將透過鞘內注射給藥。我們對這個計畫感到特別興奮，因為我們將基於臨床前針對這兩個人群模型產生的強大數據，在 SOD1 和更大的散發性患者群體中進行研究。

In addition to our gene therapies, we continue to advance our next-generation DPP1 candidates were the first expected to enter the clinic in 2026. These novel next-gen molecules will be used to pursue indications in very large patient populations where there still exists significant unmet need. We'll begin by introducing INS1033 in simultaneous studies in rheumatoid arthritis and inflammatory bowel disease, followed by other novel DPP1 in COPD and possibly many other indicaions. We look forward to sharing more details as these programs progress.

除了我們的基因療法外，我們還在繼續推進下一代 DPP1 候選藥物的研發，這些藥物預計將於 2026 年率先進入臨床試驗階段。這些新型的下一代分子將用於在龐大的患者群體中探索適應症，這些患者群體中仍然存在著巨大的未滿足需求。我們將首先在類風濕性關節炎和發炎性腸道疾病的同步研究中引入 INS1033，隨後在 COPD 和其他可能的許多其他適應症中引入其他新型 DPP1。隨著這些專案的進展，我們期待與大家分享更多細節。

Before I pass the call over to my colleagues, I want to reiterate that we are just at the start of this wave of commercial and clinical readouts trial initiations and research translation into the clinic. As gratified as we are by our recent achievements, we are even more enthusiastic about Insmed's future.

在將電話交給我的同事之前，我想重申，我們才剛開始這波商業和臨床結果試驗啟動以及研究成果轉化為臨床的浪潮。儘管我們對近期的成就感到欣慰，但我們對 Insmed 的未來更加充滿熱情。

Over the next 18 months, we will be focused on executing on the many opportunities we have just reviewed. This is a very exciting time for Insmed as the many years of planning are finally yielding the results for which we had all hoped. This presents us with the opportunity to further realize our mission of bringing these promising first or best-in-class medicines to patients with serious diseases.

在接下來的18個月裡，我們將專注於落實我們剛才討論過的眾多機會。對 Insmed 來說，這是一個非常令人興奮的時刻，因為多年的規劃終於取得了我們一直以來所希望的結果。這為我們提供了一個機會，讓我們能夠進一步實現我們的使命，為患有嚴重疾病的患者帶來這些有前途的首創或同類最佳藥物。

Finally, I must mention that for the fifth year in a row, we were awarded the distinction of the number 1 ranking on Science Magazine's Top Employers list. The only other organization to achieve this in the 20-year history of the survey was Genentech, which puts us in rare company. We are extremely proud of this accomplishment, which punctuates the preservation and success of our culture despite our rapid growth.

最後，我必須提到，我們連續第五年榮獲《科學》雜誌「最佳雇主」榜單第一名的殊榮。在過去 20 年的調查歷史中，只有 Genentech 一家公司取得了這樣的成績，這使我們躋身於少數幾家獲此殊榮的公司之列。我們為這項成就感到無比自豪，這標誌著儘管我們發展迅速，但我們的文化仍然得以傳承和成功。

Let me now turn the call over to Roger, who will walk us through the recent launch performance of BRINSUPRI in the US and the third quarter's commercial performance of ARIKAYCE.

現在我把電話交給羅傑，他將帶我們了解 BRINSUPRI 最近在美國的上市表現以及 ARIKAYCE 第三季的商業表現。

Thank you, Will. I'm delighted to provide some detail on BRINSUPRI's performance. In its first partial quarter of launch, BRINSUPRI achieved $28 million in net sales. We are very pleased by the strength of BRINSUPRI launch in these early days and the reception it has received from the treating and patient communities.

謝謝你，威爾。我很高興能提供一些關於 BRINSUPRI 演出的詳細資訊。BRINSUPRI 在上市後的第一個季度（部分季度）實現了 2800 萬美元的淨銷售額。我們對 BRINSUPRI 在上市初期取得的強勁勢頭以及它受到治療和患者群體的歡迎感到非常高興。

As of the end of September, approximately 2,550 new patients had started treatment with BRINSUPRI and about 1,700 physicians had written at least one script including physicians in academic centers as well as many in the community setting.

截至 9 月底，約有 2550 名新患者開始接受 BRINSUPRI 治療，約有 1700 名醫生至少開立過一張處方，其中包括學術中心的醫生以及社區的許多醫生。

Most of these prescribers through September have written just one or two scripts in total. This pattern is consistent with the common practice of trying out a new medicine by prescribing it to a small number of more severe patients and then waiting to see how those patients do on the treatment before expanding the medicine's usage.

截至9月份，這些開處方的醫生大多總共只開了一到兩張處方。這種模式與常見的做法一致，即先將一種新藥開給少數病情較重的患者進行試驗，然後觀察這些患者對治療的反應，再決定是否擴大藥物的使用範圍。

Remember that it can take 4 to 6 weeks for BRINSUPRI to reach its full pharmacodynamic effect and potentially much longer than that for patients and physicians to notice this effects. So those physicians who are testing their medicine in a few patients may need time to determine whether they will expand their prescribing habits.

請記住，BRINSUPRI 可能需要 4 到 6 週才能達到其全部藥效，而患者和醫生可能需要更長的時間才能注意到這些效果。因此，那些正在少數患者身上試驗藥物的醫生可能需要時間來決定是否會擴大他們的處方習慣。

Overall, I would describe the early days of the launch is seeing very broad prescribing in terms of the number of physicians. If we also see deeper prescribing patterns where physicians move to the adoption phase and begin prescribing BRINSUPRI to larger percentages of the patients both at centers of excellence and in the community, we should see the launch accelerate. But of course, it's too early to know if or when that will happen.

總的來說，我認為產品上市初期最顯著的特點是醫生開處方的範圍非常廣泛。如果我們也看到更深層的處方模式，即醫生進入採用階段，開始在卓越中心和社區中為更大比例的患者開立 BRINSUPRI 處方，我們應該會看到上市速度加快。當然，現在判斷這是否會發生以及何時發生還為時過早。

This is why we feel BRINSUPRI's first full quarter Q4 and will provide us far greater insight. The medicine specific inclusion in electronic medical records for selection of prescribing and prior authorization criteria at insurance companies getting more standardized should together enable the wide range of physicians an easier path for prescribing. This is particularly true at the centers of excellence where large numbers of patients are treated and back office logistics can limit the number of new prescriptions processed each week. None of this comes as a surprise to us, and we believe we have extensive compliance support systems to assist where we can.

這就是為什麼我們認為 BRINSUPRI 的第一個完整季度（第四季度）將為我們提供更深入的見解。在保險公司中，將特定藥物納入電子病歷，用於選擇處方和事先授權標準，這一做法日趨標準化，應該能夠使廣大醫生更容易開處方。這一點在醫療中心尤其明顯，因為那裡治療的患者數量眾多，而後台物流可能會限制每週處理的新處方數量。這一切對我們來說並不意外，我們相信我們擁有完善的合規支援體系，可以在力所能及的範圍內提供幫助。

Additionally, just last week, we saw an update on US guidelines for the treatment of patients with non-CF bronchiectasis at the CHEST conference in Chicago. We are encouraged that BRINSUPRI has been included in the preliminary CHEST guidelines, and we look forward to the forthcoming publication.

此外，就在上週，我們在芝加哥舉行的 CHEST 會議上看到了美國關於非 CF 支氣管擴張患者治療指南的更新。我們很高興看到 BRINSUPRI 被納入 CHEST 初步指南，並期待即將發布的正式指南。

We hope that these guidelines, once published, will help physicians to make treatment decisions that are best for their patients while providing supportive guidance of best medical practice to payers in setting their prior authorization criteria.

我們希望這些指南一旦發布，就能幫助醫生做出最適合患者的治療決策，同時為支付方制定事先授權標準提供最佳醫療實踐方面的支持性指導。

On the market access side, the early days of the launch have also been encouraging. Due to BRINSUPRI being the only approved therapy for this condition, broad patient access has been achieved from day 1 as we expected. Even without formal contracts in place, the vast majority of prescriptions have been approved for coverage, both on the Medicare and the commercial side of the business.

在市場進入方面，上市初期的情況也令人鼓舞。由於 BRINSUPRI 是目前唯一獲準用於治療該疾病的療法，因此從第一天起，正如我們所預期的那樣，患者就廣泛獲得了該療法。即使沒有正式合同，絕大多數處方藥都已獲得醫保報銷，無論是聯邦醫療保險還是商業保險。

However, there is still plenty of work to be done. We continue to engage with payers in both the national and regional level to establish simple and convenient prior authorization and reauthorization requirements that can allow access to BRINSUPRI that is as frictionless as possible.

然而，仍有許多工作要做。我們繼續與國家和地區層面的支付方合作，制定簡單便捷的事先授權和再授權要求，以便盡可能順利地獲得 BRINSUPRI 服務。

These discussions are still ongoing, and we will need more time before we have a good sense as to where contracting and access requirements will shake out. As it is common to see some slowdown, once criteria are firmly established and enforced it is important to interpret this quarter's relative ease of access within that context.

這些討論仍在進行中，我們需要更多時間才能清楚地了解合約簽訂和准入要求最終會如何確定。由於增速放緩是常有的事，一旦標準確立並嚴格執行，就必須在此背景下解讀本季相對容易准入的情況。

When assessing the revenue and patient figures achieved this quarter, it's important to recognize that these sales numbers benefited from a couple of factors. Firstly, based on our prior experience with ARIKAYCE, we had said it could take up to a month from the time of FDA approval for the first sales to be recorded. In the case of BRINSUPRI, we accomplish this in less than half that time, which is a testament to the readiness of our commercial and technical operations teams. This meant that the third quarter reflected about 6 weeks of revenue and patient starts rather than the 2 or 3 weeks we have previously expected.

在評估本季取得的收入和患者人數時，必須認識到這些銷售額得益於以下幾個因素。首先，根據我們之前對 ARIKAYCE 的經驗，我們曾說過，從獲得 FDA 批准到記錄到第一筆銷售額，可能需要長達一個月的時間。以 BRINSUPRI 為例，我們在不到一半的時間內就完成了這項工作，這證明了我們的商業和技術營運團隊的準備。這意味著第三季反映的是大約 6 週的收入和患者數量，而不是我們之前預期的 2 到 3 週。

Secondly, these results reflect the impact of necessary inventory stock in the channel, which accounted for approximately 40% of BRINSUPRI revenue this quarter. Importantly, our specialty pharmacies can get BRINSUPRI within 24 hours of placing an order and aim to hold only a limited number of weeks of supply on hand at any given time. As a result, we do not anticipate a significant contribution from inventory stocking in the fourth quarter.

其次，這些結果反映了通路中必要的庫存的影響，約佔 BRINSUPRI 本季收入的 40%。重要的是，我們的特藥藥房可以在下單後 24 小時內獲得 BRINSUPRI，並且力求在任何時候都只儲備有限週的供應量。因此，我們預計第四季度庫存不會帶來顯著貢獻。

In summary, the early days of the launch have left us feeling excited about the future possibilities for this new medicine. There is plenty of work ahead to ensure that in super is successful in the way that we hope and believe it can be. We are wholly committed to working tirelessly toward that goal.

總而言之，上市初期的情況讓我們對這種新藥的未來前景感到興奮。要確保退休金計劃能夠按照我們希望和相信的方式取得成功，還有很多工作要做。我們將全力以赴，不懈地努力，朝著這個目標前進。

Now let me provide some commentary on ARIKAYCE's performance in the third quarter. We continue to be extremely pleased by the strength of the brand even as we approach the end of its seventh year on the market. This quarter, ARIKAYCE once again posted its largest quarter of revenue ever up 22% compared to the same quarter last year. This result was driven by double-digit growth in each of our geographic regions.

現在讓我對 ARIKAYCE 在第三季的表現做一些評論。儘管該品牌已進入市場七年，但我們仍然對其強勁的市場表現感到非常滿意。本季度，ARIKAYCE 再次創下有史以來最高的季度營收紀錄，比去年同期成長了 22%。這項結果得益於我們各個地理區域兩位數的成長。

In the US, despite the significant attention that has been placed on BRINSUPRI's launch, ARIKAYCE grew 11% compared to last year, demonstrating our commercial team's ability to execute with excellence on multiple products at once.

在美國，儘管BRINSUPRI的上市受到了廣泛關注，但ARIKAYCE的銷售額與去年相比增長了11%，這表明我們的商業團隊有能力同時出色地執行多個產品。

Outside the US, we saw a continuation of the impressive growth we've seen for several quarters now. With our international business comprised of Japan and Europe, setting a new all-time high and growing more than 50% compared to the same quarter last year. We are proud of the dedicated work of our commercial teams across the globe to bring this medicine to ever more patients who need it.

在美國以外，我們看到了過去幾個季度以來令人矚目的成長勢頭的延續。我們的國際業務涵蓋日本和歐洲，創下歷史新高，與去年同期相比成長超過 50%。我們為全球商業團隊的辛勤工作感到自豪，他們致力於將這種藥物帶給更多需要的患者。

So with that, let me turn the call over to Sara.

那麼，接下來我將把電話交給薩拉。

Thank you, Roger, and good morning, everyone. On the heels of Rogers commercial review of our two approved products. I am pleased to report that we are raising our 2025 full year global ARIKAYCE net revenue guidance to $420 million to $430 million, up from a range of $405 million to $425 million previously. As a reminder, this guidance range is specific to ARIKAYCE only.

謝謝你，羅傑，大家早安。在 Rogers 對我們兩款核准產品進行商業評估後。我很高興地宣布，我們將 2025 年全年 ARIKAYCE 全球淨收入預期從先前的 4.05 億美元至 4.25 億美元上調至 4.2 億美元至 4.3 億美元。再次提醒，此指導範圍僅適用於 ARIKAYCE。

The updated guidance range demonstrates the team's ability to execute across multiple products as well as reflects the excellent execution of our commercial teams around the globe. Now representing a 15% to 18% increase over full year 2024 ARIKAYCE revenues.

更新後的指導範圍顯示了團隊在多個產品上的執行能力，同時也反映了我們全球商業團隊的出色執行力。目前，這比 ARIKAYCE 2024 年全年營收成長了 15% 至 18%。

Now let me spend a moment on our cash position. At approximately $1.7 billion in cash, cash equivalents and marketable securities as of the end of the quarter. I believe Insmed continues to be well capitalized. Excluding cash received related to option exercises, our underlying cash burn for the quarter was relatively consistent with the underlying burn levels that we have seen for the past several quarters. Keep in mind that only a portion of the BRINSUPRI revenue we recognized this quarter have been received in cash as of September 30. So our cash burn does not yet reflect that full benefit.

現在讓我花點時間談談我們的現金狀況。截至季末，公司持有現金、現金等價物及有價證券約17億美元。我認為Insmed的資金依然非常充足。除去與選擇權行使相關的現金收入，本季我們的基本現金消耗與過去幾季的基本消耗水準基本一致。請注意，截至 9 月 30 日，我們本季確認的 BRINSUPRI 收入中只有一部分已收到現金。因此，我們的現金消耗尚未反映出全部收益。

As we have said before, we expect both revenue and spending to continue to increase as we fully resource and support BRINSUPRI's launch as well as the other portfolio programs expected to initiate in the near term. We are pleased to be entering this exciting period in a strong cash position.

正如我們之前所說，隨著我們為 BRINSUPRI 的啟動以及預計在近期啟動的其他投資組合項目提供充足的資源和支持，我們預計收入和支出都將繼續增長。我們很高興能夠以強勁的現金流進入這個令人興奮的時期。

Moving now to the other relevant financial metrics for the third quarter, which are shown here on the slide. Cost of product revenues in the third quarter of 2025 was $29.4 million or 20.6% of revenues, which is lower on a percentage basis than our historical performance, reflecting the positive contribution of BRINSUPRI to the company's gross margin profile.

接下來來看第三季的其他相關財務指標，這些指標如投影片所示。2025 年第三季產品收入成本為 2,940 萬美元，佔營收的 20.6%，以百分比計算低於我們歷史業績，反映了 BRINSUPRI 對公司毛利率的正面貢獻。

Additionally, as expected, research and development and SG&A expenses increased this quarter compared to the prior year period. due to the necessary investment made to support the US launch of BRINSUPRI and to continue to fund our growing pipeline.

此外，如預期，本季研發費用和銷售、管理及行政費用較上年同期有所增加，這是由於為支持BRINSUPRI在美國上市以及繼續為我們不斷增長的產品線提供資金而進行的必要投資所致。

In closing, we have so much to look forward to. The remarkable string of clinical and commercial successes we have experienced in the past 18 months have provided us with new opportunities to serve patients in need, whether that be with the launch of a new product to hopefully change the lives of patients or the initiation of new Phase 3 programs, which can provide hope to patients waiting for new treatment options. Insmed remains in a uniquely strong financial position from which to execute on each of these opportunities.

最後，我們有很多值得期待的事情。在過去 18 個月裡，我們取得了一系列令人矚目的臨床和商業成功，這為我們提供了新的機會來服務有需要的患者，無論是推出有望改變患者生活的新產品，還是啟動新的 3 期項目，為等待新治療方案的患者帶來希望。Insmed 仍擁有極為雄厚的財務實力，可以把握住每一個機會。

We would now like to open the call to questions. Operator, may we take the first question, please?

現在我們開始接受提問。接線員，請問可以回答第一個問題嗎？

(Operator Instructions) Jessica Fye, JPMorgan.

（操作說明）潔西卡費伊，摩根大通。

Hey guys, good morning and congrats on the launch. I was curious if you could talk a little bit about some of just the early feedback you're hearing from the field about the physician experience with BRINSUPRI? Both in terms of how they feel like their patients are doing kind of speaking to that phenomenon where they might try it in a few first and then go from there, but also their experience with the reimbursement process.

各位，早安，恭喜你們發表會！我想請您談談您從第一線醫生那裡聽到的關於 BRINSUPRI 使用體驗的一些早期回饋？一方面，他們感覺自己的病人情況如何，這反映了他們可能會先在幾個病人身上嘗試，然後再根據情況調整的現象；另一方面，他們也了解報銷流程。

Thank you.

謝謝。

Yes. So I'll just make a quick general comment and then turn it over to Roger. I think the word from the field net-net is positive. We've attended both European Respiratory Society, but more relevantly, CHEST recently, where we had the opportunity to interact with a lot of physicians. And I would say to a person that I encountered there's nothing but enthusiasm out there for this, and its potential. And I've heard anecdotes that are supportive of the statements that Roger made related to market access.

是的。所以我先簡單提幾句，然後把麥克風交給羅傑。我認為從這個角度來看，淨值是正面的。我們參加了歐洲呼吸學會年會，但更重要的是，我們最近參加了 CHEST 年會，在那裡我們有機會與許多醫生交流。我會對遇到的每個人說，大家對這項技術及其潛力都充滿熱情。我也聽到了一些軼事，這些軼事支持羅傑關於市場准入的說法。

But Roger, I wonder any other thoughts you might want to add?

羅傑，你還有什麼其他想法想補充嗎？

Yes. Thanks, Will. No, I think the sentiment is, as we described, quite positive. I think that the broad prescribing base that we've seen so far reflects some enthusiasm for these physicians to at least try with their more severe patients who are in the office and need that attention. And so as we talked about that, they're in that trial phase and hopefully, we'll move into an adoption phase.

是的。謝謝你，威爾。不，我認為正如我們所描述的那樣，這種情緒相當積極。我認為，我們目前看到的廣泛的處方基礎反映出這些醫生對至少嘗試用這種藥物治療那些病情較重、需要就診的病人抱有一定的熱情。正如我們之前討論的，他們目前處於試用階段，希望我們能夠進入推廣階段。

And it's still early days, right? So I think as we talked about the pharmacodynamic effect of BRINSUPRI and the way that it works, it could take a little while for that response, and we're hoping that the positive feedback that comes from patients to the physicians, once they feel that impact, hopefully, less coughing, et cetera, will encourage additional prescribing.

現在還為時過早，對吧？所以，正如我們討論的 BRINSUPRI 的藥效學作用及其作用方式，這種反應可能需要一段時間才能顯現，我們希望患者向醫生反饋的積極意見，一旦他們感受到這種影響（希望咳嗽減少等），將鼓勵醫生開具更多處方。

On the market access side, I think what we're hearing is actually some positive sentiment there. It's been quite straightforward to get for most patients to get this through from a payer perspective. It's not uncommon for that to happen in the early days of launch as we talked about. The payers haven't yet finalized their criteria. Medicare has to review this within a certain time period. And so we expect that patients are experiencing that a little bit of a honeymoon period from the first approvals.

在市場准入方面，我認為我們聽到的實際上是一些正面的回饋。從支付方的角度來看，對大多數患者來說，獲得這筆費用相當容易。正如我們之前討論的，這種情況在產品發布初期並不罕見。付款方尚未最終確定付款標準。聯邦醫療保險必須在一定期限內對此進行審查。因此，我們預期患者會經歷一段從首批藥物獲準到最終獲準的蜜月期。

As payers start to finalize their criteria and as they start to enforce that criteria, while the physicians and their back office staff adjusted that, and we can help them with what that criteria looks like in a compliant manner. It may slow down just a little bit. But we expect that given that profile is the only approved product in the category into the disease state that we can achieve our goal of having frictionless access for patients and physicians going forward. And that's what we continue to work towards.

當支付方開始最終確定其標準並開始執行這些標準時，醫生及其後台工作人員也隨之進行了調整，我們可以幫助他們以合規的方式理解這些標準。速度可能會稍微減慢一點。但我們預計，鑑於該產品是該類別中唯一獲批准的針對該疾病狀態的產品，我們可以實現為患者和醫生提供無摩擦獲取途徑的目標。這就是我們一直努力的方向。

And let me just say, I want everyone to take away from this call. We feel great about where we are with the launch, but we're just incredibly cautious because we only have 6-weeks of data to work off of. And it's very difficult to extrapolate that because there are lots of puts and takes in these data in this short period of time.

最後我想說的是，我希望每個人都能從這通電話中有所收穫。我們對目前的發布感到非常滿意，但我們非常謹慎，因為我們只有 6 週的數據可供參考。因為在這麼短的時間內，這些數據中有很多買賣操作，所以很難從中推論出什麼規律。

We really feel like we need the fourth quarter to know what the directions are that are being established in both physician treatment across the spectrum of community to centers of excellence. So sort of encouraging, but let's hold off on reading too much into this until we've got a full quarter under our belt.

我們真的覺得我們需要第四季度的時間來了解從社區到卓越中心，醫生治療的各個方面正在建立的方向是什麼。所以這多少有點令人鼓舞，但我們還是不要過度解讀，等一個季度過去之後再做決定吧。

Ritu Baral, Cowen.

Ritu Baral，Cowen。

Good morning guys. Thanks for taking the question. Roger, well, you guys have been really good at sort of setting thresholds and bars for success across data, et cetera.

各位早安。感謝您回答這個問題。羅傑，你們在設定數據等方面的成功閾值和標準方面做得非常出色。

What threshold do you see for that payer coverage that we should keep in mind going forward? Are you going to set a bogey for us going forward and they covered lives or time to fill. We've had great feedback on so far, but to your point of early coverage. Also, what criteria are you aiming for, for that final threshold for prior ops and the reauthorizations, Will, that you mentioned?

您認為我們應該在未來關注的支付方覆蓋範圍的門檻是什麼？你們打算給我們設定一個前進的目標嗎？他們是為了保護生命還是為了填補時間空缺？到目前為止，我們收到的回饋都很好，但關於您提到的早期報道問題。另外，威爾，你提到的先前操作和重新授權的最終門檻標準是什麼？

I'll make the general comment that our objectives with market access are to accomplish what we described as a frictionless launch. What that looks like is in the practical setting, is that the criteria for approval are clear and well established and are not overly burdensome to physicians.

我在此作總體評價，我們市場准入的目標是實現我們所謂的「無摩擦啟動」。在實際應用中，這意味著審批標準要明確、完善，並且不會對醫生造成過重的負擔。

These are patients who have two or more exacerbations and have a confirmed diagnosis of bronchiectasis. And we think it's appropriate for physicians to be able to attest to that without necessarily providing all of the backup documentation for that kind of a diagnosis. If it's required to do all of that, then so be it. But we would prefer that, that not be the case. And we're willing to do some modest discounting out of the gate to try to accomplish that set of criteria and to make it easy for physicians and back office and also for the process of reauthorization. And I think so far, we're making very good progress on that front.

這些患者出現兩次或兩次以上病情加重，並已確診患有支氣管擴張症。我們認為，醫生在不必提供此類診斷的所有佐證文件的情況下，能夠證明這一點是合適的。如果必須做到這些，那就做到吧。但我們更希望情況並非如此。我們願意一開始就進行一些適度的折扣，以達到這些標準，方便醫生、後台部門以及重新授權流程。我認為到目前為止，我們在這方面取得了非常好的進展。

I don't know, Roger, if you want to add anything to that?

羅傑，我不知道你是否還有什麼要補充的？

I think you captured it well, Will. I think the only thing I would add is that as we look to get this criteria established and that's really our goal, and we've been as you know, pre-approval, we've been engaging with payers representing about 90% of our targeted lives.

我覺得你捕捉得很好，威爾。我唯一要補充的是，我們正在努力確立這些標準，這才是我們的真正目標。如您所知，在獲得批准之前，我們一直在與代表我們目標人群約 90% 的支付方進行溝通。

And we -- at both the national and the regional level. And what our goal is, as Will described it, to get -- to make this as easy as possible for patients to get the product and easy on the back office of physicians as they're tax with all the usual paperwork that they have to go through across a variety of medicines.

我們——無論是在國家層級或區域層面。正如威爾所描述的那樣，我們的目標是盡可能方便患者獲得該產品，並減輕醫生後台的負擔，因為他們需要處理各種藥物的常規文書工作。

Our goal is not necessarily a formulary addition. So we don't really have targets for that. Our goal is to get that criteria clear and as easy as possible for the physicians, as Will described, and we continue to work towards that.

我們的目標不一定是將其添加到現有配方中。所以我們並沒有為此設定目標。正如威爾所描述的那樣，我們的目標是讓這些標準對醫生來說盡可能清晰易懂，我們將繼續朝著這個目標努力。

Great. Thank you.

偉大的。謝謝。

Joseph Schwartz, Leerink Partners.

Joseph Schwartz，Leerink Partners。

Great, thanks so much and hats off to such strong execution so far. So I guess how frictionless has the launch been to date in your view based on the amount of documentation physicians have had to provide to payers? Do you have any early reads on how this dynamic has been playing out so far?

太好了，非常感謝，也對目前為止如此出色的執行力表示敬佩。所以，根據醫生需要向支付方提供的文件數量來看，您認為迄今為止的啟動過程有多順利？您目前對這種動態的發展有什麼初步了解嗎？

Well, I think what we would say is that, so far, so good. There is actually a mix of what has been required in terms of the medical exception process. And in some cases, it has been necessary for physicians to provide both the documentation of CT scan with a positive diagnosis and documentation of the exacerbations.

嗯，我想我們可以說，到目前為止，一切順利。實際上，醫療豁免流程中需要滿足多種條件。在某些情況下，醫師需要同時提供 CT 掃描確診結果的證明文件和病情加重的證明文件。

And in those cases, what we've heard from physicians is it's not that bad or onerous to do that. We're just trying to make it easier for them through some potential modest discounting there's not a ton of room to be able to do that. I mean if we look at benchmarks for what Sara has commented on in terms of -- it's not guidance, but it's what you would see in early launch of a product of this profile fully half of that discount is attributed to our contribution needed under IRA.

在這些情況下，我們從醫生那裡了解到，這樣做並不那麼糟糕或繁重。我們只是想透過一些可能的適度折扣來讓他們更容易購買，但我們在這方面的空間並不大。我的意思是，如果我們看看薩拉評論過的基準——這不是指導意見，而是你在這種類型的產品早期推出時會看到的情況——其中一半的折扣都歸因於我們根據 IRA 需要繳納的款項。

So it doesn't leave a huge amount to offer in terms of discount, but we're doing what we can to try to make this process easier for the physicians in the back office, as Roger described it. And I think, so far, so good. But time will tell. And all I would say is that whether we need to provide all of that documentation or none of it that will be something we determine in the coming months. But either way, we're going to be able to ensure that we can support compliantly the efforts to gain access to this medicine for patients.

因此，在折扣方面能提供的餘地並不大，但正如羅傑所描述的那樣，我們正在盡我們所能，努力讓後台醫生的這個過程變得更容易。我覺得，目前為止，一切都很好。但時間會證明一切。我只想說，是否需要提供所有這些文件，或者根本不需要提供任何文件，將在未來幾個月內決定。但無論如何，我們將能夠確保我們能夠合規地支持為患者獲取這種藥物所做的努力。

And I think this is one point that's really in our favor. This is a great medicine. This has a low AE profile from its Phase 3 data as published in the New England Journal of Medicine. Its efficacy is clear. It's across multiple end points. highly statistically significant. And this is easy to take with a low burden on patients. So it really suggests itself both by its ease of use and by its potential for these patients in terms of them getting better. So for all those reasons, I think market access should continue to be something that we're able to navigate.

我認為這一點對我們非常有利。這是很好的藥。根據發表在《新英格蘭醫學雜誌》上的 3 期臨床試驗數據，該藥物不良反應發生率較低。其功效顯而易見。它跨越多個終點，具有高度統計意義。而且服用方便，對患者的負擔很輕。因此，無論從易用性還是從幫助患者康復的角度來看，它確實值得考慮。因此，基於以上所有原因，我認為市場准入應該仍然是我們能夠掌控的事情。

Very helpful, thanks for the color.

非常有用，謝謝你提供的顏色資訊。

Jason Zemansky, Bank of America.

傑森‧澤曼斯基，美國銀行。

Morning. Congrats on the great progress. Will, I was hoping you could provide some additional color on some of the softer dynamics about the patient journey for BRINSUPRI's launch. How has the DTC impacted awareness? Are you seeing more sort of interest from the patient side of things, more from the prescriber side of things? As they inquire about treatment for their disease. Thanks.

早晨。祝賀你們取得巨大進展。Will，我希望你能就 BRINSUPRI 上市後患者就醫過程中的一些比較溫和的方面提供一些補充說明。DTC模式對消費者認知度產生了怎樣的影響？您覺得是病人方面更感興趣了，還是處方醫師方面更感興趣了？當他們詢問有關疾病的治療方法時。謝謝。

Thanks for the question. Look, it's always hard to discern the qualitative side of the launch from both the physician and patient side. What I can tell you is that there is clear enthusiasm from the patient side of the equation. One of the most gratifying things to us when we got a product in the channel and patients were getting their first prescriptions filled is that they were posting images of themselves holding the bottle on social media. That's about as good as it gets in terms of patients' enthusiasm for the arrival of a medicine that can make a difference in their lives, and that is what we're all about at Insmed.

謝謝你的提問。你看，從醫生和病人的角度來看，總是很難區分產品上市的定性方面。我可以告訴你的是，患者一方表現出了明顯的積極性。當我們的產品進入市場，患者第一次拿到處方藥時，最讓我們感到欣慰的事情之一就是他們在社群媒體上發布自己拿著藥瓶的照片。就患者對能夠改變他們生活的藥物的到來所表現出的熱情而言，這已經算是非常好了，而這正是 Insmed 的宗旨所在。

I think the physicians are also similarly well aware of the arrival of the medicine by virtue of all the excellent work that our commercial team has done. But the practical application of the awareness of the medicine to a patient population is where the rubber meets the road, and it's too early in these early weeks to discern what that pattern of behavior is going to look like.

我認為，由於我們商業團隊所做的出色工作，醫生們也同樣清楚地了解了這種藥物的到來。但將這種藥物意識實際應用於患者群體才是關鍵所在，而現在才剛開始幾週，還無法確定這種行為模式會是什麼樣子。

And I think that's what Roger was commenting on in his prepared statements in describing trial use of the medicine and then a broader adoption phase and depth of prescribing. And that's what we're really going to be looking for in Q4 and indeed in 2026 to ensure that this launch continues to go the way we hope it does.

我認為羅傑在事先準備好的聲明中，描述的是藥物的試用階段，以及更廣泛的推廣階段和處方深度，他所評論的就是這一點。而這正是我們在第四季以及 2026 年真正要關注的，以確保此次發布能夠繼續按照我們希望的方式進行。

Andrea Newkirk, Goldman Sachs.

安德里亞·紐柯克，高盛。

Good morning. Thanks for taking the question. Just as you look to launch in Europe in early next year, what types of investments are needed to prepare for commercialization, maybe particularly with respect to your sales force infrastructure. And then, Sara, I was just wondering if you might be willing to share what your gross to net adjustment looked like for BRINSUPRI in the quarter?

早安.感謝您回答這個問題。鑑於您計劃於明年初在歐洲推出產品，需要進行哪些類型的投資來為商業化做好準備，尤其是在銷售團隊基礎設施方面。薩拉，我還想問問你是否願意分享一下本季 BRINSUPRI 的毛利潤到淨利的調整情況？

Sure. I think thematically, our strategy in Europe is to sort of ensure that the reimbursement ends up the way we need it. to end up before we start doing significant additional investments. We've done some in preparation, obviously.

當然。我認為，從主題上看，我們在歐洲的策略是確保報銷最終能夠達到我們想要的效果，在我們開始進行重大額外投資之前完成。我們顯然已經做了一些準備工作。

And in Japan, we have expanded our sales force already by virtue of the opportunities for ARIKAYCE, which has proven to be a very wise decision, and I think prepares us for the launch of BRINSUPRI if and when that receives approval, which we expect in the second half of next year. At that time, we would also consider expanding even more in Japan.

在日本，我們已經利用 ARIKAYCE 的機會擴大了銷售隊伍，事實證明這是一個非常明智的決定，我認為這為我們推出 BRINSUPRI 做好了準備（如果 BRINSUPRI 獲得批准的話），我們預計 BRINSUPRI 將在明年下半年獲得批准。當時我們也會考慮進一步拓展在日本的業務。

But I don't know, Sara, perhaps you want to comment in greater detail on that on the margin question.

但是，薩拉，我不知道，或許你想就這個邊緣問題更詳細地發表一下看法。

Sure. Happy to. Thanks, Andrea, for the question. So on the margin question, we're not providing quarter-to-quarter BRINSUPRI gross to net. What I can say, obviously, most folks are where off the bat of any launch, you see a little bit of flexibility lumpiness in your gross to net, while not formal guidance, as Will mentioned earlier, we did provide sort of those analogs of 25% to 35% at launch.

當然。樂意之至。謝謝安德里亞的提問。所以關於利潤率問題，我們沒有提供 BRINSUPRI 季度毛利與淨利的比較數據。我可以說的是，很明顯，大多數人在任何產品發布之初都會遇到毛利潤和淨利潤之間略有波動的情況，雖然沒有正式的指導，但正如威爾之前提到的，我們確實提供了類似這樣的預期，即發佈時毛利潤佔比在 25% 到 35% 之間。

When you take in the half of that is the IRA impact and then sort of normal standard contracting for an at-launch product, and we remain to say those are still reasonable analogs. As you're thinking about investment, as Will said, will be a little bit more cautious in Europe as we're thinking through sort of the reimbursement piece there.

考慮到其中一半是 IRA 的影響，以及產品上市時的正常標準合同，我們仍然認為這些是合理的類比。正如威爾所說，在考慮投資時，我們會對歐洲市場更加謹慎，因為我們正在考慮那裡的補償問題。

Vamil Divan, Guggenheim Securities.

瓦米爾·迪萬，古根漢證券公司。

Great, thanks for taking my questions. Great progress. Obviously with BRINSUPRI, I wanted to actually ask about TPIP, which we're also very excited about. I'm curious -- at it all is on the Phase 3 design. As you're thinking about it for the IPF and PPF trials.

太好了，謝謝你回答我的問題。進展順利。顯然，對於 BRINSUPRI，我其實想問 TPIP 的情況，我們也對 TPIP 非常感興趣。我很好奇——這一切都與第三階段的設計有關。就像你在考慮IPF和PPF試驗時那樣。

And specifically, we've been getting questions from them. Your potential -- new potentially need to overcome orphan drug exclusivity in that space, given the progress United Therapeutics is showing. I'm just curious if maybe you can comment on how you would need to design that program to ensure your ability to launch it? Thank you.

具體來說，我們收到了他們提出的問題。鑑於 United Therapeutics 所取得的進展，您的潛力—可能需要克服該領域孤兒藥獨佔權的問題。我只是好奇，您能否談談您需要如何設計這個程式才能確保它順利啟動？謝謝。

Sure. Well, as you are well aware, there are a number of ways to overcome the orphan designation, which would be over in a second. But I think it's still early for IPF and PPF. We are ramping up our production. We certainly intend to go into Phase 3, and it is our strong belief that it will not be a too high a hurdle for us to overcome the orphan designation.

當然。如你所知，有很多方法可以擺脫孤兒身份，這很快就會過去。但我認為現在討論IPF和PPF還為時過早。我們正在提高產量。我們當然打算進入第三階段，我們堅信，克服孤兒藥認定對我們來說不會是太大的障礙。

But I wonder, Martina, if you want to just walk in a little bit more detail where we are in our thoughts about that.

但我想知道，瑪蒂娜，你是否願意更詳細地談談我們目前對此事的想法。

Yes. So on IPF and PPF, I mean, as you know, TETON was a clear win for patients. And we will take the TETON study and what we've learned from that in how we -- how it informs our design. What we've taken away is also -- and you've seen that in the TETON study that the dosing, it has a big impact. And I think our ability to dose and titrate the dose up to a need optimally for the patient. So it's an individual dosing exercise gives us certainly an advantage.

是的。所以對於 IPF 和 PPF，我的意思是，正如你所知，TETON 對患者來說是一個明顯的勝利。我們將借鑒 TETON 研究以及從中學到的知識，來指導我們的設計。我們還了解到——正如你在 TETON 研究中看到的那樣——劑量會產生很大的影響。我認為我們有能力根據患者的需求調整劑量，並逐步增加劑量，以達到最佳療效。因此，個體化給藥練習無疑為我們帶來了優勢。

And otherwise, I think you look at what TETON has shown that gives you a very good road map of how we think about IPF and PPF. And when you -- especially when you think about orphan, I know that was one of your questions, if you are intending to be better than on currently existing orphan designation, exclusivity, you have the ability to show you superiority in terms of efficacy, safety or an impact on patient care, one or more of them.

否則，我認為你可以看看 TETON 所展示的內容，它為你提供了一個很好的路線圖，讓你了解我們如何思考 IPF 和 PPF。尤其當你想到孤兒藥時，我知道這是你的問題之一，如果你打算比現有的孤兒藥資格、獨佔權做得更好，你就有能力在療效、安全性或對患者護理的影響方面，或者其中一項或多項方面，證明你的藥物具有優越性。

We have the opportunity to do that from an efficacy perspective, you've seen our strong results in PAH from a trial impact perspective, but also how we are able to provide maybe a once-daily dosing, this is not only important from a tolerability perspective, but it is also an impact on how patients are able to actually stay on treatment and to increase the dose on the treatment. So both on efficacy, safety and potential impact on patient care are opportunities for us to show how good TPIP can be in this indication.

從療效的角度來看，我們有機會做到這一點。從試驗影響的角度來看，你們已經看到了我們在肺動脈高壓方面取得的顯著成果，而且我們也能夠提供或許每天一次的給藥方案。這不僅從耐受性的角度來看很重要，而且還會影響患者如何堅持治療以及增加治療劑量。因此，無論從療效、安全性或對患者護理的潛在影響來看，都是我們展示 TPIP 在該適應症中表現如何好的機會。

Gavin Clark-Gartner, Evercore ISI.

Gavin Clark-Gartner，Evercore ISI。

Hey guys, congrats on a really fantastic quarter. I just wanted to ask a couple of questions on BiRCh really quickly. What's your expectation for the control arm TSS reduction from baseline?

嘿，夥計們，恭喜你們度過了一個非常棒的季度。我只想快速問幾個關於 BiRCh 的問題。您對對照組 TSS 評分較基線降低幅度的預期為何？

And then just on the baseline characteristics of the trial, what's the baseline TSS score? And how many patients are above or below 300 for the eosinophil fill cutoff?

那麼，就試驗的基線特徵而言，基線 TSS 評分是多少？嗜酸性粒細胞計數臨界值高於或低於 300 的患者分別有多少？

Thank you.

謝謝。

Martina, do you want to take that?

瑪蒂娜，你想拿嗎？

Yes. So with regards to what our placebo background rate or placebo assumptions are. So we get some indication from other trials that have been done, the reopen trial, which was on with the Optinose exhale device, which is based on a steroid treatment then also we're looking at trials like the ORION trial that was done with DUPIXENT.

是的。那麼，關於我們的安慰劑背景率或安慰劑假設是什麼。因此，我們從其他已完成的試驗中得到了一些啟示，例如使用 Optinose 呼氣裝置進行的重新開放試驗，該裝置基於類固醇治療，此外，我們還在研究像使用 DUPIXENT 進行的 ORION 試驗這樣的試驗。

But I do want to keep in mind for all of you that we are conducting our BiRCh trial on top of a steroid. So patients are already 4 weeks on a stable steroid therapy, and patients come into the trial with baseline score of the sTSS or the final total symptom score of 5 or above.

但我希望大家記住，我們是在服用類固醇的情況下進行 BiRCh 試驗的。因此，患者已經接受了 4 週穩定的類固醇治療，並且患者進入試驗時，其 sTSS 基線評分或最終總症狀評分達到 5 分或以上。

And we're looking at that at screening as well as baseline sort of randomization. We look also at the last 7 days of this score. So we are taking the 7-day average of the sTSS and look for above 5. Just so you know, the most severe is 9.

我們正在研究篩檢以及基線隨機化。我們也會查看過去 7 天的得分情況。因此，我們取 sTSS 的 7 天平均值，並尋找高於 5 的值。需要說明的是，最嚴重的等級是9。

And your second question was about what do we see with eosinophils at baseline. So we enrolled both for the low and above 300 eosinophils, and we're looking what will be -- irregardless of where patients are our ITT analysis will be based on the entire population. So both for patients above and below 300 will be the assessment for the primary endpoint.

你的第二個問題是關於基線嗜酸性粒細胞的情況。因此，我們招募了嗜酸性粒細胞計數低和高於 300 的患者，我們正在觀察結果——無論患者處於什麼水平，我們的 ITT 分析都將基於整個人群。因此，對於高於 300 和低於 300 的患者，都將進行主要終點的評估。

Okay. Great, thank you.

好的。太好了，謝謝。

Clara Dong, Jefferies.

克拉拉‧董，傑富瑞。

Thanks for taking our question and congrats on the great quarter. Really great to see BRINSUPRI your launch of a real good start.

感謝您回答我們的問題，並祝賀您本季業績出色。很高興看到 BRINSUPRI 取得如此好的開端。

So just for BRINSUPRI, are you anticipating any seasonality effect for the patient flow in fourth quarter and beyond such as weather-related factors or availability of diagnostic procedures like CT scans during the holiday season?

那麼就 BRINSUPRI 而言，您是否預期第四季度及以後的患者流量會受到季節性因素的影響，例如天氣因素或假日期間 CT 掃描等診斷程序的可用性？

Thank you.

謝謝。

Roger or Martina, do you want to take that?

羅傑還是瑪蒂娜，你們想拿那個？

So maybe I can just comment on generally, seasonality is always something that you see in it could be a trigger of exacerbations. We've not seen really a significant limitation on patients being able to access CT scans. I mean, over the holidays, patients usually don't seek out unless they are in an acute situation, their physicians, but it has not been a limitation as far as we know at this point.

所以，我或許可以就此發表一些看法，一般來說，季節性總是會成為病情惡化的誘因之一。我們還沒有看到患者接受CT掃描方面有任何重大限制。我的意思是，在假期期間，除非病情危急，否則患者通常不會主動去看醫生，但就我們目前所知，這並沒有造成任何限制。

And maybe I can just share some color from -- as we think about it from a commercial perspective, I think obviously, with the holidays, sometimes you see a little slowdown from physicians seeing patients. But I think probably what we're watching more closely is as we go into 2026 and we think about the reset from a Medicare perspective and the co-pays that will be required for the deductibles, we'll keep a close eye on that as well as any kind of reauthorization criteria.

或許我可以分享一些看法——從商業角度來看，很明顯，在假日期間，醫生接診病人的數量有時會減少。但我認為，我們更關注的是，隨著我們進入 2026 年，當我們從醫療保險的角度考慮重置以及自付額所需的共同支付額時，我們會密切關注這一點以及任何形式的重新授權標準。

So that's -- again, I don't know what's going to happen there, but we'll continue to monitor that and see what impact we have going forward.

所以，我不知道那裡會發生什麼，但我們會繼續關注，看看未來會產生什麼影響。

Got it thank you.

明白了，謝謝。

Ash Verma, UBS.

阿什維爾馬，瑞銀集團。

Thanks for taking our questions and congrats on this strong quarter. So just on the BiRCh study, do you have this data in-house already just realizing that the primary completion was also August and I think you mentioned that it will come in early Jan, depending on how much time it takes to clean and process. But as of today, do you have this in-house?

感謝您回答我們的問題，並祝賀您本季業績出色。關於 BiRCh 研究，你們內部是否已經有這些數據了？我注意到主要完成時間也是 8 月，我想您提到數據將在 1 月初公佈，具體取決於清理和處理需要多少時間。但截至目前，你們公司內部是否具備這項能力？

Thanks.

謝謝。

So I know that we're moving as quickly as we can to process the data and lock the database and do all the necessary cleaning in order to accomplish that. I don't know, Martina, if you can give any more color on it than that.

所以我知道我們正在盡最大努力盡快處理資料、鎖定資料庫並進行所有必要的清理工作，以完成這項任務。瑪蒂娜，我不知道你還能不能提供更多細節。

Certainly, our time line is as soon as we can get it, but it may just end up making more sense for this to be coordinated in the early part of January, versus trying to blow up people's holidays and have it put out between something like Christmas and New Year's, which I don't think would serve anyone's interest. But Martina, any commentary?

當然，我們的時間表是盡快完成，但或許在一月初協調此事會更有意義，而不是試圖破壞人們的假期，在聖誕節和新年之間發布，我認為這對任何人都沒有好處。但是瑪蒂娜，你有什麼看法嗎？

Yes. So for BiRCh, like many of our studies, we tend to get data in-house almost in real time. The last patients are still just completing the study. So there is still some data that is coming in, but the vast majority is in the cleaning process.

是的。因此，對於 BiRCh，就像我們的許多研究一樣，我們傾向於幾乎即時地在內部獲取數據。最後幾名患者仍在完成這項研究。所以目前還有一些資料正在接收，但絕大部分資料還在清洗過程中。

And as you know, we've done this also in ASPEN or also in TPIP. When we look at the database close when we look at how we clean the data, we do this from a perspective so that it meets the highest regulatory standards, and it will always then put us in a position to also demonstrate that these are supporting evidence. And that's why we're taking our time to ensure that we have the highest regulatory standards with database lock as well as with the cleaning of the data.

如你所知，我們也曾在 ASPEN 或 TPIP 中這樣做過。當我們仔細查看資料庫，查看我們如何清理資料時，我們這樣做是為了使其符合最高的監管標準，這樣我們就能始終證明這些是佐證。因此，我們正在花時間確保我們在資料庫鎖定和資料清理方面達到最高的監管標準。

Ben Burnett, Wells Fargo.

本·伯內特，富國銀行。

Hey, thank you very much and congrats on the quarter so far. Just on BRINSUPRI, I appreciate that it sounds like some of the early use of this has been with severe patients. some of the early adopters. But I guess what's been like the feedback among physicians and sort of the appetite among physicians to use this in maybe more moderate patients or even patients with only one recent sort of exacerbation?

嘿，非常感謝，也祝賀你本季迄今為止的出色表現。關於 BRINSUPRI，我了解到早期使用這種藥物的患者似乎病情比較嚴重。一些早期使用者就是如此。但我很好奇醫生們的回饋如何，以及醫生們對於在病情較輕的患者，甚至是最近只有一次病情加重的患者中使用這種療法的意願如何？

Well, I think it's still early days with the medicine. We can start with the parameters that we know, beginning with the label, which is, as you know, quite broad, I think from our point of view, we've heard from physicians, and we try to stay in close dialogue with them that they feel that the most obvious patient that's a candidate for this would map the entry criteria of the ASPEN study.

嗯，我認為這種藥物還處於早期階段。我們可以從我們已知的參數入手，首先是標籤，正如您所知，這個標籤相當寬泛。我認為從我們的角度來看，我們已經聽取了醫生的意見，並且我們努力與他們保持密切對話，他們認為最明顯的候選人將符合 ASPEN 研究的入組標準。

So two or more exacerbations in the last 12 months. And that's really where their early efforts have been focused and I would call that a moderate to severe patient profile. And I think that's certainly the sweet spot for the medicine out of the gate.

也就是說，過去 12 個月內出現兩次或兩次以上的病情惡化。而這正是他們早期努力的重點，我認為這屬於中度至重度患者族群。我認為這絕對是該藥物上市初期最理想的狀態。

We'll learn more about other populations that may be appropriate. Those could include patients who are a little bit more moderate than what was described. But I think just to work clear, our focus with the market access world has been on two or more exacerbations to match the entry criteria of our Phase 3 program. We'll see what physicians want and where they want to take it.

我們將進一步了解其他可能合適的群體。這些患者可能病情比之前描述的要輕微一些。但我認為，為了明確起見，我們與市場准入領域的合作重點是兩個或兩個以上病情惡化，以符合我們第三階段計劃的准入標準。我們將看看醫生們想要什麼，以及他們希望將治療推進到什麼程度。

I also think that it's interesting for us to consider as time goes on, the opportunity to get to the COPD and asthma comorbid patients who may either have been misdiagnosed and have bronchiectasis or are comorbid with those indications. Remembering that in Phase 3 in our ASPEN study, there were about 15% to 20% of the patients who are actually comorbid with either asthma or COPD and bronchiectasis and they were all responsive to treatment.

我也認為，隨著時間的推移，我們應該考慮如何接觸到那些可能被誤診為支氣管擴張或同時患有慢性阻塞性肺病和氣喘的患者。回想一下，在我們 ASPEN 研究的 3 期中，大約有 15% 到 20% 的患者實際上合併有氣喘或 COPD 和支氣管擴張，而且他們都對治療有反應。

So there's a big opportunity out there for sure. One step at a time. And as physicians learn their way with this medicine and see the patient response to it, I think that will shape this as much as anything.

所以，這裡肯定蘊藏著巨大的機會。一步一步來。隨著醫生逐漸熟悉這種藥物的使用方法，並觀察患者的反應，我認為這將對藥物的療效產生最大的影響。

Great, thank you.

太好了，謝謝。

Leonid Timashev, RBC Capital Markets.

列昂尼德‧蒂馬舍夫，加拿大皇家銀行資本市場。

Hey, thanks for taking my question and congrats on the quarter. I wanted to ask on CRS. And you guys mentioned subgroups that you may be looking at. I just wonder if you could speak a little bit more about which subgroups you might be considering diving deeper into beyond maybe just being the eosinophil counts and whether that's driven by your thoughts around the commercial opportunity given that CRS is a much larger population than pharmacy ectasis or whether it's driven by trying to maximize clinical benefit in some of these populations?

嘿，謝謝你回答我的問題，也恭喜你這季度成績優異。我想問關於CRS的問題。你們也提到了一些你們可能正在關注的子群體。我想知道您能否再詳細談談，除了嗜酸性粒細胞計數之外，您可能還會考慮深入研究哪些亞群？這是出於您對商業機會的考慮（因為 CRS 患者群體比藥房開瞳症患者群體大得多），還是出於試圖最大限度地提高某些人群的臨床獲益？

Thanks.

謝謝。

Yes, I think the short answer to that question is we don't know yet. There isn't a lot of background in CRS without nasal polyps generally in terms of subsegmenting the population. The overall population is in excess of 30 million patients in the US. And this study is designed to look for signals and directional groups that might benefit from it. It could be that we see benefit as we did with ASPEN across all etiologies that gave rise to the bronchiectasis.

是的，我認為這個問題的簡短答案是：我們目前還不知道。對於沒有鼻息肉的慢性鼻竇炎患者，在人群細分方面，並沒有太多背景資料。美國患者總數超過3000萬人。這項研究旨在尋找可能從中受益的信號和方向性群體。我們可能會像使用 ASPEN 一樣，看到它對所有引起支氣管擴張的病因都有益處。

In this case, for CRS without nasal polyps, there may be all patients benefit. It may be just a subpopulation. We don't really have any theories about which group might be responsive in that way. And I want to be really clear, we're not suggesting based on anything we've seen that it will only be subpopulations, we just want to highlight that if it is a subpopulation still could be a very substantial opportunity given the enormity of patients with this condition.

在這種情況下，對於沒有鼻息肉的慢性鼻竇炎患者，所有患者都可能受益。這可能只是一個亞群體。我們目前還沒有任何理論可以解釋哪個群體可能會有這樣的反應。我想非常明確地說明，我們並不是根據我們所看到的任何事情來推測它只會針對特定人群，我們只是想強調，即使它只是一個特定人群，考慮到患有這種疾病的患者數量龐大，它仍然可能是一個非常大的機會。

So we're going to follow the science. We're going to see what the data shows us, and we'll certainly share that -- those conclusions as we move forward. Eosinophil count is an interesting one because we theorize that, that could be relevant. But once we looked at the ASPEN data, it became clear that it was not going to be controlling on the performance of the medicine in these patient populations. And so we consolidated that stratification we'll still be examining it in the study, but it's no longer in our judgment required out of the gate to separate patient populations with regard to the primary endpoint.

所以我們要遵循科學。我們將觀察數據，並會在後續工作中分享這些結論。嗜酸性粒細胞計數是一個很有趣的指標，因為我們推測它可能具有相關性。但當我們查看 ASPEN 數據後，就清楚地認識到，它並不能控制這些患者群體中藥物的療效。因此，我們整合了這種分層方法，我們仍將在研究中對其進行研究，但我們認為，在研究初期就根據主要終點對患者群體進行區分已不再必要。

So it's an example of the kind of learning we're going to do as we go. And as I said, we'll follow the science and see where the medicine is of greatest benefit, and that's where you can expect us to concentrate our efforts should the data be strong enough to take us into Phase 3.

所以，這是我們將在實踐中進行學習的一個例子。正如我所說，我們將遵循科學，看看這種藥物在哪些方面最有益，如果數據足夠有力，能夠讓我們進入第三階段，那麼你們可以期待我們將努力集中精力於此。

Olivia Brayer, Cantor Fitzgerald.

奧利維亞·布雷耶，坎托·菲茨杰拉德。

Hi, good morning, and thank you for the question. On brenso's EU list price, can you just comment on the decision to keep that the same in Europe versus the US? What's been the feedback from payers on the price point?

您好，早安，感謝您的提問。關於 Brenso 在歐盟的標價，您能否就歐洲和美國價格保持一致的決定發表一下看法？付費方對價格有何回饋？

And is there anything that you can tell us at this point just around how gross to net discounts in Europe might look versus those in the US? And then just quickly on the prescriber mix in the US, what proportion of those initial 1,700 writers or from an academic versus community settings? And how does that compare to the overall mix in the broader bronchiectasis market?

您目前能否透露一下歐洲的毛折扣與淨折扣與美國相比有何不同？然後，簡單談談美國處方醫生的組成，在最初的 1700 名處方醫生中，有多少比例來自學術機構，又有多少比例來自社區機構？與更廣泛的支氣管擴張市場整體組成相比，情況如何？

Thank you so much.

太感謝了。

So thanks for the questions. The prescriber breadth, I think, is a point that we've called out as something of strength because it indicates that we're getting access to -- with that number of prescribers obviously are gaining access to both centers of excellence, which we fully expected, but also much more broadly in the community, which was a deliberate focus of our calling effort.

謝謝大家的提問。我認為，處方醫生的廣泛性是我們強調的一大優勢，因為它表明我們正在獲得——如此多的處方醫生顯然能夠獲得卓越中心的資源，這完全符合我們的預期，而且在更廣泛的社區中也獲得了資源，這正是我們此次招募工作的重點。

So we're excited to see that breadth of prescribing. We now need to see those physicians and more like them go deeper with multiple prescriptions written for patients and that will become clear in the coming quarters. Whether or not that's happening in which way. But there's nothing we can discern at this moment other than the engagement from physicians has been very broad.

所以我們很高興看到處方範圍如此廣泛。現在我們需要看到這些醫生以及更多像他們一樣的醫生深入研究，為病人開出多種處方，這一點將在接下來的幾季中變得明顯。無論這種情況是否以何種方式發生。但目前我們除了看到醫生們的參與非常廣泛之外，並沒有發現其他任何情況。

With regard to the EU list price, it's our practice as we did with ARIKAYCE to match the list price in the U.S. with Europe and Japan. They all are often negotiations that take place in the gross to net discussions with payers that can impact the ultimate net price paid quite substantially in some cases, but we have less control over that.

關於歐盟的定價，我們的做法和 ARIKAYCE 一樣，就是將美國和歐洲、日本的定價一致。這些通常都是與付款方在毛利到淨利的談判中進行的，在某些情況下，這些談判可能會對最終支付的淨價產生相當大的影響，但我們對此的控制力較小。

What we want to make clear is that we think this medicine has value for patients. We think the price we've selected is the appropriate one, and we look forward to the discussions with the different reimbursement authorities to determine what the ultimate net price will be.

我們想明確表明的是，我們認為這種藥物對患者有價值。我們認為我們選擇的價格是合適的，我們期待與不同的報銷機構進行討論，以確定最終的淨價。

Okay, great, thank.

好的，太好了，謝謝。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

Yeah, good morning. Thanks for taking the question and congrats on execution. Just a TPIP question. So should we assume that the single Phase 3 PAH trial that you reached alignment on with FDA will be looking at a patient population that's similar to the Phase 2?

早安.感謝您回答這個問題，並祝賀您執行成功。只是一個關於TPIP的問題。那麼我們是否可以假設，您與FDA達成一致的唯一一項3期PAH試驗將針對與2期試驗類似的患者群體？

And then also curious if there was any feedback around kind of what a label might be able to claim and how you may be thinking about additional studies to potentially support utilization of TPIP across a broader spectrum of functional class patients? Thanks.

另外，我還想知道，對於標籤可以宣稱的內容，以及您是否考慮過開展額外的研究來支持​​在更廣泛的功能類別患者中使用 TPIP，是否有任何反饋意見？謝謝。

Appreciate the question. I'll ask Martina to comment in a minute. What I would just say is that our perspective on this medicine because of our ability to titrate higher, because of our ability to deliver once a day and its formulation is a dry powder we have really the high ground with regard to patient potential impact and convenience, and that is a very important driver in this population.

感謝您的提問。我稍後會請瑪蒂娜發表意見。我想說的是，由於我們能夠提高劑量，能夠每天給藥一次，而且它的劑型是乾粉，因此我們對這種藥物的看法是，我們在對患者的潛在影響和便利性方面確實佔據了優勢，而這對於這一群體來說是一個非常重要的驅動因素。

But what is most remarkable to me was that we were able to see a 35.5% PVR reduction, which, to the best of our knowledge, the very best score ever achieved for any medicine in any clinical study in PAH. We keep looking for something better. We haven't seen it. Sotatercept, I think, came in around 33 or 35, so we edged that out, and it's a different kind of medicine, obviously, and it's not an apples-to-apples comparison, but using that metric as an anchor point, we can see that TPIP really has quite a bit to offer these patients.

但最令我驚訝的是，我們能夠看到 PVR 降低 35.5%，據我們所知，這是 PAH 任何臨床研究中任何藥物所取得的最佳結果。我們一直在尋找更好的選擇。我們還沒見過。索他西普的評分大概在 33 或 35 左右，所以我們略勝一籌。顯然，這是一種不同的藥物，不能直接比較，但以這個指標為基準，我們可以看出 TPIP 確實能為這些患者帶來許多好處。

Where we go from here will be determined by the strength of the Phase 3 data for sure in terms of label. But Martina, perhaps over to you for some commentary on our TPIP drug.

接下來的發展方向，肯定取決於第三階段資料的可靠性，尤其是在標籤方面。不過，Martina，或許該由你來談談我們的 TPIP 藥物了。

Yes. So for PAH, as you know, it is our practice that we try to keep our Phase 3 studies consistent with what we've seen in our Phase 2 studies. And that is what we are looking to do also in this particular study.

是的。所以對於 PAH，如您所知，我們的做法是盡量使我們的 3 期研究與我們在 2 期研究中看到的結果保持一致。而這正是我們在這項研究中想要達到的目的。

What we have now seen in between this in the OLE program that we were able to titrate patients up to a higher dose. In the Phase 2 study, we did not have the dose up to 1,280 micrograms. And in the Phase 3 study, the plan is to allow titration up to 1,280 the maximum tolerated dose on the individual level.

我們現在在 OLE 計畫中看到的是，我們能夠將患者的劑量逐漸增加到更高的劑量。在第二階段研究中，我們沒有達到 1280 微克的劑量。在第 3 期研究中，計劃允許將劑量滴定至個體可耐受的最大劑量 1,280。

And that is something which will likely be a change, but we're doing this also based on the experience and what we have seen from both the safety side in the open-label extension study already. But otherwise, you can expect some consistency over from the Phase 2 study.

這很可能是一個變化，但我們這樣做也是基於經驗，以及我們在開放標籤擴展研究中從安全性方面所看到的情況。但除此之外，您可以期待 2 期研究的結果與此保持一致。

All right, thanks for taking the question.

好的，謝謝你回答這個問題。

Matthew Phipps, William Blair.

馬修·菲普斯，威廉·布萊爾。

Thanks for taking my question and congrats on all the infection at pipeline and commercially. Do you have any sense yet on what dose is getting preference for prescription of BRINSUPRI? Is the 25 mg potential loan function benefit resonating with physicians to go with that and may help some of the kind of feedback loop you talked about earlier?

感謝您回答我的問題，並祝賀您在管道和商業方面取得的所有進展。您目前對服用 BRINSUPRI 時首選的劑量有什麼了解嗎？25毫克的潛在貸款功能益處是否引起了醫生的共鳴，並可能有助於您之前提到的那種回饋循環？

Thank you.

謝謝。

Roger, do you want to take that?

羅傑，你想拿嗎？

Yes, sure. So right now, we're seeing the majority of the prescriptions coming in for the 25 milligrams, but we are seeing that some of the physicians are choosing to start with a 10. So we do think that the lung function is resonating, particularly with the thought leader community.

當然可以。所以目前我們看到大部分處方都是 25 毫克的劑量，但我們也看到一些醫生選擇從 10 毫克開始。所以我們認為肺功能這個主題引起了共鳴，尤其是在思想領袖群體中。

But as it's not atypical with new medicines, some physicians start to choose to start low, and they may be increasing their dose as they go forward and move into that adoption phase as they get more experience with the medicine.

但對於新藥來說，這種情況並不罕見，有些醫生會選擇從小劑量開始，隨著對藥物經驗的積累，他們可能會逐漸增加劑量，進入適應期。

Operator, are you there?

接線生，有人嗎？

Maxwell Skor, Morgan Stanley.

麥克斯韋‧斯科爾，摩根士丹利。

Great, thank you very much and congratulations on a very strong quarter. So I appreciate that we're still early in the launch, but how would you characterize BRINSUPRI's performance to date relative to the launch analogs you provided?

太好了，非常感謝，恭喜你們取得了非常出色的季度業績。我知道我們仍處於發布初期，但與您提供的發布同類產品相比，您如何評價 BRINSUPRI 迄今為止的表現？

And how is this stacking up to expectations for the next two full quarters and then the following four quarters, I believe that you've provided some guidance towards?

那麼，您已經對接下來兩個完整季度以及之後四個季度的預期做出了一些預測，那麼目前的狀況與預期相比如何呢？

Yes. So to be clear, we haven't provided formal guidance of any kind. We've only tried to put out benchmarks for what good looks like in our industry with regard to launches that are in or around the respiratory space. And using those analogs, which we've mentioned a number of times, we take note that the first two full quarters combined usually end up in the high double-digit millions and those products that have accomplished that represents some of the strongest launches that you can find in the commercial setting.

是的。所以要先明確的是，我們沒有提供任何形式的正式指導。我們只是想為呼吸系統領域或相關領域的產品上市設定行業標準，以此來衡量行業內的優秀產品是什麼樣的。用我們多次提到的這些類比，我們注意到，前兩個完整季度的總銷售額通常達到數千萬美元，而那些達到這一目標的產品代表了你在商業環境中能找到的最強勁的發布。

So those are our ambitions. It's certainly not something we're providing guidance on today, and we're cautious about interpreting the first 6 weeks of data that we have because it really is not a lot, and there's a lot of sorting out going on at this stage as different physicians are taking different approaches to the medicine that the market access is getting sorted out.

這就是我們的目標。這當然不是我們今天會提供指導的內容，而且我們對解讀目前掌握的前 6 週數據持謹慎態度，因為數據量確實不多，而且在這個階段還有很多工作要做，因為不同的醫生對這種藥物採取了不同的方法，市場准入問題也正在解決。

And while that, as Roger said, can be easier at the start once the criteria gets established and in force that can change that dynamic. So I would say we're very pleased with the breadth of prescribing. We now want to see the depth of prescribing take hold as we move into the adoption phase. That will take several quarters in my mind. But we'll be looking very carefully at Q4, and we should have enough data in Q4 to really begin to discern some of these issues and be much more specifically responsive to your question.

正如羅傑所說，雖然一開始可能會比較容易，但一旦標準確立並生效，情況就會改變。所以我覺得我們對處方範圍非常滿意。我們現在希望看到處方深度在進入推廣階段後得以落實。我覺得這需要好幾季的時間。但我們會非常仔細地研究第四季度，第四季度我們應該會有足夠的數據來真正開始辨別其中的一些問題，並更具體地回答您的問題。

I just -- at this point, I think we're just cautious about over-interpreting what is a quarter that includes inventory build. It includes first trials. It includes certainly some patients who are waiting for day 1 for the medicine to arrive and some physicians looking to prescribe it right away. But as that dissipates, what is the real landscape look like. And that's something we're going to have to learn over time.

我只是——目前，我認為我們應該謹慎對待包含庫存增加的季度數據，避免過度解讀。其中包括初步試驗。這其中當然包括一些正在等待藥物到貨的患者，以及一些希望立即開立處方的醫生。但隨著這種氛圍消散，真實的景象又會是什麼樣子呢？這是我們隨著時間推移需要學習的東西。

Great. Congrats again. Thank.

偉大的。再次恭喜。感謝。

Graig Suvannavejh, Mizuho.

Graig Suvannavejh，瑞穗。

This is Sam on for Graig. Thanks for taking our question and Congrats on the awesome launch. Maybe just a follow-up with Ben's question on the more mild to moderate population for BRINSUPRI. I know it's still early days, but curious have you seen any payers start to restrict use to patients who have less than two more pulmonary exacerbations?

這裡是Sam替Graig報道。感謝您回答我們的問題，並祝賀你們的發布會圓滿成功。或許可以跟進一下 Ben 關於 BRINSUPRI 中輕度至中度人群的問題。我知道現在還為時過早，但我很好奇，您是否看到有支付方開始限制該藥物的使用，僅用於肺部急性加重次數少於兩次的患者？

So I want to be clear, the focus is on those with two or more out of the gate. That's really where we think the medicine is going to be quite obviously, the most successful because you'll higher exacerbations, the better the chance to show the reduction in those events. But it's equally important for everyone to appreciate that these other secondary endpoints where we were highly statistically significant in Phase 3 in the 10 and 25-milligram arms are really quite relevant. That is how long before your next exacerbation, the probability that you may have no exacerbations in the next year.

所以我想明確一點，重點是那些一開始就取得兩場或兩場以上勝利的人。我們認為，藥物最有可能成功的地方就在這裡，因為病情加重的次數越多，就越有可能減少這些事件的發生。但同樣重要的是，每個人都應該認識到，我們在 3 期 10 毫克和 25 毫克劑量組中取得高度統計意義的其他次要終點確實非常重要。也就是說，距離你下次病情加重還有多長時間，以及你未來一年內可能不會出現病情加重的機率。

These kinds of metrics, which were favorable to BRINSUPRI, I think also bear on the consideration of the physicians when they're trying to disc who they're going to prescribe this for. But to be clear, out of the gate, I think it's appropriate, the focus is squarely on those with two or more exacerbations.

我認為，這些對 BRINSUPRI 有利的指標，也與醫生在決定給哪些病人開這種藥時的考慮有關。但要先明確的是，我認為一開始就應該把重點放在那些病情加重兩次或兩次以上的病人身上。

I don't know, Roger, if you want to comment or anything you've heard from the field on those with less than two.

羅傑，我不知道你是否想就那些擁有少於兩個孩子的人發表一些評論，或者你從一線聽到了什麼消息。

No, I think that, that characterizes it will. And we do see the patients who are exacerbating the ones that are in front of the physicians. And I do think that as we go forward and that criteria from pairs gets formalized they're going to be looking to mimic the clinical trial and what we saw with ASPEN with that two or more exacerbations.

不，我認為，這就是它的特點。我們也看到一些患者的病情加重了正在接受醫生診治的患者。而且我認為，隨著我們不斷推進，配對標準逐漸正式化，他們將力求模仿臨床試驗，以及我們在 ASPEN 中看到的兩次或兩次以上病情加重的情況。

So the focus really has not been on sort of the patients who don't have those recorded exacerbations at this point. The enthusiasm from physicians for those patients who have been waiting for this is those patients who are frequent exacerbators. And that's what we primarily believe is going through at this point.

所以，目前為止，重點並沒有放在那些沒有記錄在案的病情加重的病人身上。醫生們對那些一直期待著這種治療的患者——那些病情經常加重的患者——表現出極大的熱情。而這正是我們目前主要認為正在發生的事情。

Got it. Very helpful. Thanks so much.

知道了。很有幫助。非常感謝。

Andy Chen, Wolfe Research.

Andy Chen，Wolfe Research。

Hey, Brandon, on for Andy, thanks for taking the question. On HS, will you be sharing HiSCR data at the top line readout? And how do you imagine brenso fitting into the HS landscape?

嘿，布蘭登，我代替安迪發言，謝謝你回答這個問題。在 HS 上，你們會分享 HiSCR 資料的第一行讀數嗎？你認為 Brenso 將如何融入高中教育體系？

Thank you.

謝謝。

So I'm sorry, I'm not sure I caught the first part of the question. Will we be sharing what?

抱歉，我不太確定我是否聽懂了問題的第一部分。我們將分享什麼？

HiSCR data.

HiSCR 數據。

The HiSCR data. So Martina, you want to describe the different secondary end points we're going to be looking at?

HiSCR 數據。瑪蒂娜，你想描述我們將要研究的不同次要終點嗎？

Yes. So the HiSCR, we will look at the secondary endpoint of the HiSCR 50 as well as for a HiSCR 75. And right now, we anticipate that would not necessarily be something that you see right away at the week 16. You will see some 16-week treatment period, but what that really should indicate for us is we will go on to 52 weeks, and it's the HiSCR at 52 weeks both for 50 and 75 that we will be also looking at for Phase 3. But you will see it at the top line results, the 16-week treatment period.

是的。因此，對於 HiSCR，我們將檢視 HiSCR 50 和 HiSCR 75 的次要終點。而目前，我們預計這不一定會在第 16 週立即發生。你會看到一些 16 週的治療期，但這實際上應該向我們表明，我們將進行 52 週的治療，而 52 週時 50 和 75 的 HiSCR 也將是我們在 3 期研究中關注的內容。但您會在最終結果中看到這一點，也就是 16 週治療期的結果。

Thank you.

謝謝。

And there are no further questions at this time. This does conclude today's conference call, and you may now disconnect.

目前沒有其他問題了。今天的電話會議到此結束，您可以斷開連線了。