MannKind Corp (MNKD) 2025 Q1 法說會逐字稿

Good morning, and welcome to the MannKind Corporation first quarter 2025 financial results earnings call. As a reminder, this call is being recorded on May 8, 2025, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and available for approximately 90 days.

早上好，歡迎參加 MannKind Corporation 2025 年第一季財務業績收益電話會議。提醒一下，本次通話將於 2025 年 5 月 8 日錄製，並將在通話結束後不久在 MannKind Corporation 網站上播放，播放期約為 90 天。

This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which can cause actual risks to differ materially from these stated expectations. For further information on the company's risk factors, please see the Form 10-Q for the quarterly period ended March 31, 2025, on file with the SEC, the earnings release and the slides prepared for this presentation.

本次電話會議將包含前瞻性陳述。此類前瞻性陳述受風險和不確定性的影響，可能導致實際風險與這些陳述的預期有重大差異。有關公司風險因素的更多信息，請參閱提交給美國證券交易委員會 (SEC) 的截至 2025 年 3 月 31 日的季度 10-Q 表、收益報告和為本次演示準備的幻燈片。

Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Chris Prentiss.

今天與我們一起參加活動的有 MannKind 執行長 Michael Castagna；和財務長 Chris Prentiss。

I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

現在我想將會議交給卡斯塔尼亞先生。先生，請繼續。

Thank you, everyone, for joining us this morning. Today, joining me is Chris Prentiss, our Chief Financial Officer. We'll be going through operational pipeline highlights, our financial review and some of my remarks at the end.

感謝大家今天上午加入我們。今天，與我一起參加的是我們的財務長 Chris Prentiss。我們將介紹營運管道亮點、財務審查以及我的最後一些評論。

As we've engaged with the investment community over the last several months, our discussions highlight that investors, especially in these uncertain times, are seeking commercial stage companies that have a profile of growing revenue, promising pipeline and a strong financial position, combined with very little debt that we have going forward. I'm proud to share that this depicts where MannKind is today and are excited by our five key pillars of growth above.

在過去幾個月與投資界的接觸中，我們的討論強調，投資者，尤其是在這些不確定的時期，正在尋找商業階段的公司，這些公司具有收入不斷增長、前景看好的渠道和強大的財務狀況，而且未來的債務很少。我很自豪地告訴大家，這描繪了 MannKind 今天的狀況，並對我們上述五大增長支柱感到興奮。

Now I'm going to highlight our Q1 2025 key points. Our endocrine business grew 20% on NRxs and 14% on TRxs. We have filed for a label change for our adult, which is a 2x round-down conversion. We expect that to be hopefully approved in Q4 of this year. We plan to file the pediatric expansion in mid-2025.

現在我將重點介紹我們 2025 年第一季的重點。我們的內分泌業務在 NRxs 上成長了 20%，在 TRxs 上成長了 14%。我們已經為我們的成年人申請了標籤變更，這是一個 2 倍的向下舍入轉換。我們預計該提案將在今年第四季獲得批准。我們計劃在 2025 年中期提交兒科擴展申請。

Our Tyvaso collaboration remains strong. I'm sure many of you have listened to the UT call, and we are excited about our great partnership together, which resulted in Q1 royalty revenue of $30 million and manufacturing revenue of $29 million. In terms of clofazimine and nintedanib, I will highlight those later in this call. And our financial results were very strong for the quarter, and we had non-GAAP income of $22 million or 43% growth over last year.

我們與 Tyvaso 的合作依然強勁。我相信你們中的許多人都聽過 UT 的電話會議，我們對彼此的良好合作感到非常興奮，這使得第一季的版權收入達到 3000 萬美元，製造收入達到 2900 萬美元。關於氯法齊明和尼達尼布，我將在稍後的電話會議中重點介紹。本季我們的財務表現非常強勁，非公認會計準則收入為 2,200 萬美元，比去年增長 43%。

Now let me bridge to our diabetes business. Since we last spoke, we had a very successful ATT showing with multiple KOL interactions that have earned a very positive reception for Afrezza, unlike anything before due to the positive INHALE-3 data and the excitement that is building in the pediatric opportunity. All of this gives us reason to believe the steps we have taken and continue to take sets the stage for Afrezza to realize its true potential.

現在讓我來談談我們的糖尿病業務。自從我們上次談話以來，我們與多個 KOL 的互動取得了非常成功的 ATT 展示，為 Afrezza 贏得了非常積極的反響，這與以前的情況不同，這得益於積極的 INHALE-3 數據和人們對兒科機會日益增長的興奮。所有這些都讓我們有理由相信，我們已經採取和繼續採取的措施為 Afrezza 實現其真正潛力奠定了基礎。

After leaving ATTD and interacting with hundreds of US and international customers from around the world, the global expansion and demand opportunity is real as evidenced by our booth at ATTD, which was nonstop with traffic over the three days we were there. Additionally, I have met many US customers on my travels around the US, and I no longer hear the objections I used to.

離開 ATTD 並與來自世界各地的數百名美國和國際客戶進行互動後，全球擴張和需求機會是真實存在的，這從我們在 ATTD 的展位上可以看出來，我們在那裡的三天裡，展位上人流不斷。此外，我在美國旅行時遇到了許多美國客戶，我不再聽到以前的反對意見。

And now what I hear is, why don't we increase patient request? Why is it not top of mind with our sales force? How do you dose and write a prescription versus previously, we heard about safety, payer roadblocks and dosing in fixed doses. We're very excited, and we believe pediatrics is a real opportunity to cause an inflection in Afrezza. And additionally, we recently had a payer app board that also described how they would probably allow pediatrics to go through relative to the history where they would block Afrezza to injectable insulin.

現在我聽到的是，為什麼我們不增加病人的要求？為什麼它不是我們銷售人員最關心的問題？您如何確定劑量並開處方？之前我們聽到的是安全性、付款人障礙和固定劑量給藥。我們非常興奮，我們相信兒科是推動 Afrezza 發生轉變的真正機會。此外，我們最近有一個付款人申請委員會，該委員會還描述了他們可能如何允許兒科醫生根據歷史記錄阻止 Afrezza 注射胰島素。

Now as I look at the performance driven by our strong NRx growth, we've really seen this improvement. But what's more important is the 26% year-over-year growth in our top 50 prescribers -- top 50% of our prescribers. We're very pleased with the early indicators here and continue to go deeper on our call list to increase the number of prescribers that we can target.

現在，當我看到我們強勁的 NRx 成長所推動的業績時，我們確實看到了這種改善。但更重要的是，我們的前 50 名處方者（占我們處方者的前 50%）的成長率為 26%。我們對這裡的早期指標非常滿意，並將繼續深入研究我們的呼叫列表，以增加我們可以定位的處方者數量。

Our TRx activity is consistent with our gross revenues. And while net sales appear to be relatively in line with the prior year, this is due to onetime adjustments of our gross to net in Q1 and ordering patterns at the end of 2024. Data since the last -- end of the last quarter continues to give us confidence that our messages are resonating and our team is on the right path to continue making impact.

我們的 TRx 活動與我們的總收入一致。雖然淨銷售額似乎與去年基本持平，但這是由於我們在第一季對毛銷售額進行了一次性調整，並在 2024 年底進行了訂購模式調整。自上一季末以來的數據繼續讓我們相信，我們的訊息引起了共鳴，我們的團隊正走在繼續產生影響的正確道路上。

Now I'll bridge over to the orphan lung opportunity. First, on Tyvaso DPI, this revenue coming in from United Therapeutics will provide the nondilutive pipeline funding that we need to move clofazimine MannKind-101 forward as well as nintedanib, our MannKind-201.

現在我將討論孤兒肺的機會。首先，對於 Tyvaso DPI，來自 United Therapeutics 的收入將提供我們所需的非稀釋性管道資金，以推動氯法齊明 MannKind-101 以及尼達尼布（我們的 MannKind-201）的發展。

What's really encouraging is we had about $1.1 billion of Tyvaso DPI-related revenue from United Therapeutics in the previous four quarters, and we received obviously 10% royalty on those sales. We recorded $29 million in manufacturing revenue in Q1, and we await the readouts of the TETON 1 and 2 trials that United Therapeutics is conducting.

真正令人鼓舞的是，我們在前四個季度從 United Therapeutics 獲得了約 11 億美元的 Tyvaso DPI 相關收入，並且我們顯然獲得了這些銷售額 10% 的特許權使用費。我們在第一季實現了 2,900 萬美元的製造收入，我們正在等待 United Therapeutics 正在進行的 TETON 1 和 2 試驗的讀數。

As I look to the NTM market, we get very excited that this market will likely exceed $1 billion by the end of the decade. Our focus is on the US and Japan, which have the highest addressable populations, and this disease continues to grow 7% year-over-year. We see a large market opportunity with one branded treatment in the US and Japan, and we believe MannKind will be the next potential launch with clofazimine as we look out.

當我展望 NTM 市場時，我們非常興奮，因為到本世紀末，這個市場的規模很可能超過 10 億美元。我們的重點是美國和日本，這兩個國家擁有最多的可及人口，這種疾病的發生率每年持續增加 7%。我們看到，在美國和日本，單一品牌療法蘊藏著巨大的市場機遇，我們相信，MannKind 將成為下一個與氯法齊明一起上市的潛在療法。

Current NTM therapies have their limitations in efficacy, safety and tolerability. As we look at the drug combinations, they have low efficacy and high systemic toxicity. These AEs are very severe and cause long-term consequences for patients. And the frequent dosing, these are almost like TB-like regimens and/or nebulizers that contribute to patient fatigue and low adherence to therapy.

目前的NTM療法在療效、安全性和耐受性方面有其限制。從藥物組合來看，它們的療效較低且全身毒性較高。這些不良事件非常嚴重，會對患者帶來長期後果。而且頻繁服藥，這些幾乎就像結核病治療方案和/或霧化器，會導致患者疲勞和治療依從性低。

Now let me bridge over to the inhaled development rationale for inhaled clofazimine. The first thing we were trying to do is make sure we maximize the anti-mycobacterium activity at the site of infection by bypassing the GI tract and minimizing systemic exposure to hopefully improve the tolerability profile.

現在讓我來談談吸入氯法齊明的吸入開發原理。我們要做的第一件事是確保透過繞過胃腸道並盡量減少全身暴露來最大限度地提高感染部位的抗分枝桿菌活性，以期改善耐受性。

Oral clofazimine is recommended by the clinical guidelines, and we've done some prework to really have comfort in the animal studies as we move forward in the progress of human development. Additionally, because clofazimine has a long half-life, we've been able to create a very convenient dosing cycle with the drug holiday, meaning they take the product for 28 days and load the lung and then 56 days off. And we hope this will alleviate the patient treatment burden as well as noncompliance.

臨床指引建議口服氯法齊明，隨著人類發展的不斷推進，我們已經做了一些前期工作，以便在動物研究中能夠真正感到安心。此外，由於氯法齊明的半衰期很長，我們能夠利用藥物假期創建一個非常方便的給藥週期，這意味著他們服用該產品 28 天並加載肺部，然後停藥 56 天。我們希望這將減輕患者的治療負擔以及不依從性。

Now let me update you on our MannKind-101 study. First, 85% of our sites have been activated across four countries. Two, we've had 55 patients randomized with minimal dropouts and patients are now starting to move past the six month time point rolling over to extension. And as of today, there's been no down dosing to a lower dose. So we believe people are tolerating the product, and this is an indication of the direction the product hopefully will go.

現在讓我向您介紹我們的 MannKind-101 研究的最新進展。首先，我們的 85% 的站點已在四個國家啟動。第二，我們已經有 55 名患者被隨機分配，退出率極低，現在患者開始從六個月的時間點轉入延長期。截至今天，還沒有降低劑量。因此，我們相信人們能夠容忍該產品，這也預示了該產品有望發展的方向。

We remain confident in achieving 100 patients in the interim analysis enrolled by the end of the year. And even once we hit that number, we will continue to enroll so that when we get that readout in 2026, if it says we needed more patients, hopefully, we'll hit that mark by the time we get to that data point.

我們仍有信心在今年年底前實現 100 名患者入組中期分析。即使我們達到了這個數字，我們仍會繼續招募，以便當我們在 2026 年獲得讀數時，如果它表明我們需要更多的患者，那麼希望我們能夠在到達該數據點時達到這個標準。

Now I'll bridge over to IPF. For those of you who don't know IPF, it's a progressive and fatal disease, 80% of people will die within the first five years of diagnosis. There are only two drugs approved and the majority of the patients cannot tolerate either one of those products, hence, why we continue to move this forward and believe there's a real opportunity to help patients. We believe nintedanib will be the background of therapy as new combinations continue to come out and get approved over the coming years.

現在我將轉到 IPF。對於那些不了解 IPF 的人來說，這是一種進行性致命疾病，80% 的人會在確診後的前五年內死亡。目前只有兩種藥物獲得批准，而大多數患者無法耐受其中任何一種藥物，因此，我們繼續推進這一進程，並相信這是一個真正有機會幫助患者的計畫。我們相信，隨著未來幾年新組合療法的不斷出現和獲得批准，尼達尼布將成為治療的基礎。

We previously talked about our Phase 1 study, which was complete and met its safety and tolerability objectives in healthy volunteers. We had no serious AEs, and AEs typically seen with nintedanib such as diarrhea have not shown up, and we expect to continue to develop this in the next phase of development in a global trial, and I look forward to sharing those details at a future meeting.

我們之前談到了我們的第一階段研究，該研究已經完成並在健康志願者中達到了安全性和耐受性目標。我們沒有出現嚴重的不良事件，而且尼達尼布常見的不良事件（如腹瀉）也沒有出現，我們預計將在全球試驗的下一階段繼續開發這一點，我期待在未來的會議上分享這些細節。

I'll now turn it over to Chris.

現在我將把發言權交給克里斯。

Thanks, Mike, and good morning, everyone. I will now discuss our first quarter 2025 financial results. For a summary of our financials, please review our press release issued before this call and our Form 10-Q, which is now on file with the SEC.

謝謝，麥克，大家早安。我現在將討論我們 2025 年第一季的財務表現。有關我們財務狀況的摘要，請參閱本次電話會議之前發布的新聞稿以及我們目前已向美國證券交易委員會提交的 10-Q 表。

Before we get into the details of the quarterly results, I want to highlight our revenue growth over the last five years as we compare the trailing four quarters on an annual basis. It demonstrates impressive growth across our three revenue categories over this time frame, a testament to the extraordinary work of our team.

在我們了解季度業績細節之前，我想先重點介紹一下我們過去五年的收入成長情況，因為我們將過去四個季度與年度情況進行了比較。這表明我們的三個收入類別在這段時間內都實現了令人矚目的成長，這證明了我們團隊的出色工作。

Looking forward, we expect our royalty revenue to continue to grow based on the impressive performance of Tyvaso DPI. We expect our collaboration and services revenue to remain relatively flat on an annual basis in the near term due to production scale-up and efficiencies and will fluctuate over time based on UT's production orders.

展望未來，我們預計，基於 Tyvaso DPI 的出色表現，我們的特許權使用費收入將持續成長。我們預計，由於生產規模擴大和效率提高，我們的協作和服務收入在短期內將在年度基礎上保持相對平穩，並將根據 UT 的生產訂單隨時間波動。

The commercial metrics that are unfolding give us confidence and excitement for the future of Afrezza, and we anticipate change in its growth trajectory, especially if we are able to gain approval for a pediatric indication.

正在展開的商業指標讓我們對 Afrezza 的未來充滿信心和興奮，我們預計其成長軌跡將會發生變化，特別是如果我們能夠獲得兒科適應症的批准。

Our overall revenues in the first quarter grew 18%, led by revenues related to Tyvaso DPI. Tyvaso DPI royalties contributed $30 million in the first quarter, an increase of 32% over the same quarter last year. Collaboration and services revenue consists primarily of manufacturing revenue based on production volumes sold through to UT and the recognition of deferred revenue. We recorded revenue of $29 million in the current quarter, an 18% increase from the prior year quarter.

我們第一季的總營收成長了 18%，其中主要來自 Tyvaso DPI 相關的營收。Tyvaso DPI 特許權使用費在第一季貢獻了 3,000 萬美元，比去年同期成長了 32%。協作和服務收入主要包括基於透過 UT 銷售的生產量的製造收入和遞延收入的確認。本季我們的營收為 2,900 萬美元，比去年同期成長 18%。

Afrezza net revenues for the first quarter were $15 million, a 3% increase over the prior year. It's important to note that the first quarter of 2024 benefited from a onetime favorable adjustment to gross to nets. Additionally, the current quarter was negatively impacted based on the timing of shipments at the end of the year. As we look at the performance of Afrezza, we are encouraged by the growth in new and recurring prescriptions over the prior year and expect this trend to continue.

Afrezza 第一季淨收入為 1500 萬美元，比上年增長 3%。值得注意的是，2024 年第一季受益於一次性的總額與淨額的有利調整。此外，由於年底的發貨時間，本季也受到了負面影響。當我們回顧 Afrezza 的表現時，我們對去年新處方和重複處方的成長感到鼓舞，並預計這一趨勢將持續下去。

V-Go net revenue was approximately $4 million for the first quarter, a 6% decrease driven by lower product demand. As discussed on previous calls, the sales force is no longer actively promoting V-Go as of the fourth quarter of 2024.

V-Go 第一季淨收入約 400 萬美元，因產品需求下降而下降 6%。正如之前的電話會議中所討論的那樣，自 2024 年第四季起，銷售團隊不再積極推廣 V-Go。

For the first quarter of 2025, we reported net income of $13 million or $0.04 in earnings per share, a 24% increase compared to $11 million or $0.04 per share for the first quarter of 2024. On a non-GAAP basis, we reported $22 million of net income or $0.07 of earnings per share for the first quarter compared to $15 million of non-GAAP net income or $0.06 per share for the same period in 2024, a 43% increase.

2025 年第一季度，我們報告淨收入為 1,300 萬美元或每股收益 0.04 美元，與 2024 年第一季的 1,100 萬美元或每股 0.04 美元相比增長 24%。根據非公認會計準則 (Non-GAAP)，我們報告第一季淨收入為 2,200 萬美元，即每股收益 0.07 美元，而 2024 年同期的非公認會計準則淨收入為 1,500 萬美元，即每股收益 0.06 美元，成長 43%。

We started the year strong. Our operational results, combined with our quarter end cash and investments of $198 million will allow us to continue investing in our differentiated pipeline and execute on our objectives, including driving commercial growth. Mike and I will be at the RBC and Jefferies conferences over the next month, and we look forward to engaging with all of you there.

我們以強勁的勢頭開啟了新的一年。我們的營運表現加上本季末的 1.98 億美元現金和投資將使我們能夠繼續投資於我們的差異化產品線並實現我們的目標，包括推動商業成長。麥克和我將於下個月參加 RBC 和 Jefferies 會議，我們期待在那裡與大家交流。

With that, I will turn the call back over to Mike.

說完這些，我將把電話轉回給麥克。

Thank you, Chris. Quickly, I'll talk about some anticipated catalysts over the first and second half of this year. As we look ahead, there are a series of catalysts in our pillars here to highlight a few. INHALE-1, we just had our last patient enrolled last week and last visit, and now we can lock the database and get top line results here shortly and submit the sBLA in the next few months.

謝謝你，克里斯。很快，我將談論今年上半年和下半年的一些預期催化劑。展望未來，我們的支柱中有一系列催化劑，這裡僅強調幾個。INHALE-1，我們上週剛招募了最後一位患者並進行了最後一次訪問，現在我們可以鎖定資料庫並很快獲得頂線結果，並在接下來的幾個月內提交 sBLA。

For MannKind-101, the key metric we're tracking is interim enrollment target, which we expect to meet by year-end. And on 201, it's continue to finalize details behind our global trial and work with the CROs to get a proposal to kick this off in the second half of 2025.

對於 MannKind-101，我們追蹤的關鍵指標是中期招生目標，我們預計該目標將在年底前實現。201，我們將繼續敲定全球試驗的細節，並與 CRO 合作，取得一份在 2025 年下半年啟動試驗的提案。

As we look to continue to build shareholder value in 2025 and beyond, obviously, there's a pillar of Tyvaso DPI and that for every 10,000 patients covered on insurance, we'll see $300 million to $350 million of revenue between manufacturing and royalties. We know there's a big opportunity here in TETON 1 and 2, and we anxiously await those results from United Therapeutics as well as the bridging work that has to be done in order to get that into IPF patients.

我們希望在 2025 年及以後繼續創造股東價值，顯然，Tyvaso DPI 是一個支柱，每 10,000 名享受保險的患者，我們將看到製造和特許權使用費之間的 3 億至 3.5 億美元的收入。我們知道 TETON 1 和 2 中存在著巨大的機遇，我們焦急地等待 United Therapeutics 的結果以及為了將其應用於 IPF 患者而必須完成的銜接工作。

With the endocrine business, we previously talked about what the opportunity of pediatrics means. It's a long-term strategy we've been pursuing as we ran the endocrine business for profitability versus significant growth. We now believe that every 10% share in kids will represent about $150 million in net revenue to MannKind. As we look out, the INHALE-3 data continues to be educated out there in the marketplace and presented and the international opportunity continues to grow.

關於內分泌業務，我們之前討論過兒科的機會意味著什麼。這是我們經營內分泌業務時一直追求的長期策略，旨在實現盈利而不是大幅增長。我們現在相信，每 10% 的兒童份額將為 MannKind 帶來約 1.5 億美元的淨收入。正如我們所看到的，INHALE-3 數據繼續在市場上宣傳和展示，國際機會也不斷增長。

And as we close out here on 101 and 201, 101 is a significant unmet need here in NTM and every 1,000 patients, we believe, will be $100 million in net revenue. And on 201, the market is so large, we just need to make sure we have a product that works to help these patients who really have very little options to extend or enhance their life. We are looking forward to continue to build upon these catalysts to make MannKind a great opportunity.

當我們結束 101 和 201 時，101 是 NTM 中一個尚未滿足的重要需求，我們相信每 1,000 名患者將帶來 1 億美元的淨收入。201 的市場如此之大，我們只需要確保我們有一個產品可以幫助這些幾乎沒有選擇來延長或改善生命的患者。我們期待繼續利用這些催化劑，讓 MannKind 成為一個絕佳的機會。

We have several upcoming scientific conferences, starting with ISPOR in Montreal here in May, where we'll present one of our first pharmacoeconomic analysis of Afrezza, followed by ACE, which is a clinical endocrine conference by an ADA here in Chicago in June. We look forward to these opportunities to discuss and present our new data.

我們即將舉辦幾場科學會議，首先是 5 月在蒙特婁舉行的 ISPOR，屆時我們將展示我們對 Afrezza 的首次藥物經濟學分析之一，然後是 6 月在芝加哥舉行的 ACE，這是 ADA 舉辦的臨床內分泌會議。我們期待這些機會來討論和展示我們的新數據。

And with that said, operator, we'll now turn our call over for Q&A.

接線員，話雖如此，我們現在將電話轉入問答環節。

(Operator Instructions)

（操作員指示）

Faisal Khurshid, Leerink.

費薩爾·庫爾希德（Faisal Khurshid），Leerink。

Hi, This is Heidi on for Faisal. Thanks for taking our question. Regarding MannKind-201, can you provide some initial thoughts on what a Phase 2/3 trial design for MannKind-201 could look like? And any feedback you received from the FDA? And did they align on a seamless study design? Thanks.

大家好，我是費薩爾的海蒂。感謝您回答我們的問題。關於 MannKind-201，您能否就 MannKind-201 的 2/3 期試驗設計提供一些初步想法？您收到 FDA 的任何回饋嗎？他們是否在無縫研究設計上達成一致？謝謝。

Hi, Thank you for the question. We aren't giving too much guidance yet on the feedback from the FDA. What I can say on the -- the Phase 2/3 design is more for a global trial. So I think that will be more of a question as we get to ex US authorities.

你好，謝謝你的提問。我們還沒有根據 FDA 的回饋給予太多指導。我可以說的是－第 2/3 階段的設計更適合全球試驗。因此我認為當我們談到前美國當局時這將是一個更大的問題。

I think on the trial design, we are thinking a several dose arm trial compared to placebo. And I think there's a few last-minute discussion points we're having around is it on top of pirfenidone or naive patients or patients that are previously treated but not tolerating existing products. So that's probably the extent we can share at this point.

我認為在試驗設計上，我們正​​在考慮與安慰劑相比的多個劑量組試驗。我認為我們正在進行一些最後的討論，討論的重點是吡非尼酮或初治患者或以前接受過治療但不能耐受現有產品的患者。這可能就是我們目前能夠分享的全部內容。

Got it. Thanks so much.

知道了。非常感謝。

Olivia Brayer, Cantor.

奧莉薇亞·布雷爾，領唱。

Hi, good morning, guys. Thank you for the question. Mike, I wanted to follow up on your IPF study, especially as it relates to endpoints. Maybe it's a little premature to ask, but are you guys looking to measure FVC in that study? And maybe just any comments around whether you're hoping to actually show improvement from baseline versus the delta from the placebo arm? And then also if there's anything you can tell us with respect to dose levels? And then I've got a follow-up question on Tyvaso.

大家好，早安。謝謝你的提問。麥克，我想跟進你的 IPF 研究，特別是與終點相關的研究。也許現在問這個問題有點為時過早，但你們是否想在該​​研究中測量 FVC？也許只是關於您是否希望真正顯示出與基線相比的改善，而不是與安慰劑組的差異的任何評論？另外，您能告訴我們有關劑量水平的任何資訊嗎？然後我有一個關於泰瓦索的後續問題。

Sure. So I think the -- we'll be looking at a couple of different doses. We're still finalizing the protocol, as you can imagine. But conceptually, we're looking at a couple of doses. And I think the question is, do you combine those doses for an analysis versus placebo?

當然。所以我認為——我們會考慮幾種不同的劑量。正如您所想的，我們仍在最終確定協議。但從概念上來說，我們正在考慮幾種劑量。我認為問題是，您是否將這些劑量與安慰劑結合進行分析？

Or do we look for a dose response by the highest dose versus mid or low? That's generally where we're going at this point. We are looking for a delta from placebo. We're not scaling it for a statistical endpoint or powering it to have a distinct difference in terms of should it be 100 delta versus 50. But we are looking to get enough patients enrolled so that we can see a delta to have comfort as we go into Phase 3 what that efficacy could look like as we scale the next generation -- the next part of the trial.

或者我們應該尋找最高劑量與中劑量或低劑量之間的劑量反應？這基本上就是我們現在要去的地方。我們正在尋找安慰劑的增量。我們不會為了統計終點而對其進行縮放，也不會使其具有明顯的差異，例如應該是 100 增量還是 50 增量。但我們希望招募足夠的患者，這樣當我們進入第三階段時，我們就能清楚地看到療效的差異，以便我們能夠放心，因為我們可以擴大下一代試驗（即試驗的下一部分）的規模。

Okay. Understood. And then obviously, Tyvaso IPF data coming up in a few months for the nebulizer. I know they've talked about a potential bridging study for DPI. Do you know at this point if that would be an inferiority study between the two DPI and the nebulized formulation? And anything you can tell us at this point in terms of timing around when that could kick off and how long that could realistically take?

好的。明白了。顯然，Tyvaso IPF 霧化器的數據將在幾個月後公佈。我知道他們已經討論過 DPI 的潛在橋接研究。您是否知道現在這是否會是兩種 DPI 和霧化製劑之間的劣勢研究？現在您能告訴我們什麼時候可以開始以及實際需要多長時間嗎？

I think it's too premature to comment yet. I think UT and us will be meeting very shortly to discuss these things, and we'll have some insights from the IPF meeting we had for 201 that I think will feed into the Tyvaso discussion as well. So I think give us another quarter or two. I know waiting for the TETON 2 results, on one of the first focus is to obviously get that readout. But then the second focus, they have some preliminary ideas, and I think we'll have a solid plan.

我認為現在發表評論還為時過早。我認為 UT 和我們很快就會開會討論這些事情，而且我們會從 201 年的 IPF 會議中獲得一些見解，我認為這些見解也會對 Tyvaso 討論有所啟發。所以我認為再給我們一兩個季度。我知道等待 TETON 2 的結果時，首要關注點顯然是獲取讀數。但對於第二個重點，他們有一些初步的想法，我認為我們會有一個可靠的計劃。

I think we believe it will be a BREEZE-like study as opposed to a large-scale trial. So I think that's the direction I've heard from UT. But again, I would defer to them to comment for their initial thoughts, but that's generally the comments I've heard.

我認為我們相信這將是一項類似 BREEZE 的研究，而不是大規模試驗。所以我認為這就是我從 UT 聽到的方向。但再次強調，我會聽取他們的初步想法，但這基本上就是我聽到的評論。

Okay, understood. Helpful. Thank you, guys. Congrats on the quarter.

好的，明白了。很有幫助。謝謝你們。恭喜本季取得佳績。

Thank you.

謝謝。

Gregory Renza, RBC.

格雷戈里·倫扎（Gregory Renza），RBC。

Good morning, Mike and team. It's Anish on for Greg. Congrats on the progress this quarter. And thanks for taking our questions. Just a couple from us. First, on the label update for adults that you spoke about. Maybe if you could just give some color on the rationale behind the update and how you're thinking about the delta in uptake in adults?

早上好，麥克和團隊。阿尼什 (Anish) 取代格雷格 (Greg)。恭喜本季取得的進展。感謝您回答我們的問題。距離我們只有幾對。首先，關於您談到的成人標籤更新。也許您可以解釋一下更新背後的理由以及您對成年人吸收量差異的看法？

And second, just given the macro backdrop, how are you thinking about the potential impact to supply chain for Afrezza, the manufacturing of Tyvaso DPI and even longer term that on 101 and 201, just as we think about APIs, parts related to Technosphere, dry powder, et cetera? Thanks so much.

其次，僅從宏觀背景來看，您如何看待對 Afrezza 供應鏈、Tyvaso DPI 製造甚至 101 和 201 的長期影響，就像我們考慮 API、與 Technosphere 相關的零件、乾粉等一樣？非常感謝。

Sure. Lot of questions wrapped up there. I'll try to hit them all. I think on the dosing, we are looking to -- we know from all the data we've given, we've published and presented that a better conversion dose leads to better time and range, better control in the first two hours. So we're hoping that, that label change will be approved here in Q4.

當然。那裡有很多問題。我會盡力擊中他們所有人。我認為在劑量方面，我們正在尋求——從我們提供、發布和展示的所有數據中我們知道，更好的轉化劑量會帶來更好的時間和範圍，以及前兩個小時內更好的控制。因此我們希望該標籤變更能夠在第四季度獲得批准。

There's another part of label change we're asking for that we'll see if that happens as well that should help us commercially. I think on the adult uptake, we are looking to scale faster where we are even with the current footprint, but maybe expanding that footprint as we go into the second half. So we do believe there's upside growth in the execution on the adult side. But the real focus of the team right now is preparing for peds and getting the core functional parts of the launch in place now that we're being with the Board very shortly.

我們還要求進行另一部分標籤更改，我們將看看這是否也會發生，這應該會對我們的商業有所幫助。我認為，就成人的接受度而言，我們希望在現有規模的基礎上更快地擴大規模，但進入下半年，我們可能會擴大這一規模。因此，我們確實相信，成人方面的執行力將有上升空間。但現在團隊真正的重點是為 peds 做準備，並讓發布的核心功能部分到位，因為我們很快就會與董事會會面。

On the supply chain, given that we're predominantly US manufactured, we don't anticipate much impact from tariffs. Maybe I'll let Chris comment on a couple of those.

在供應鏈方面，鑑於我們主要在美國製造，我們預計關稅不會產生太大影響。也許我會讓克里斯對其中幾個問題發表評論。

Yeah. I think it's just important to remember that Afrezza as well as Tyvaso DPI as well as our two pipeline programs in 101 and 201 are all manufactured out of our Connecticut facility. So there are certainly certain materials that are purchased from other places throughout the world. The tariff situation is still evolving, I think, it's fair to say. But what we are aware of right now, we feel good that our key products are either exempt at this point in time or we are in a good position to manage through it.

是的。我認為重要的是要記住，Afrezza 以及 Tyvaso DPI 以及我們在 101 和 201 的兩個管道項目都是在我們康乃狄克州的工廠生產的。因此，肯定有一些材料是從世界其他地方購買的。我認為，公平地說，關稅情況仍在不斷變化。但我們目前意識到的是，我們很高興看到我們的主要產品目前是免稅的，或者我們處於良好的位置來應對這種情況。

And the other thing is we had several quarters of V-Go supplies here in the US. We were able to slow down shipments there just to kind of see where this goes to minimize any impact. But we do believe V-Go will be exempt from tariffs if it does go forward as is. So we feel pretty good about minimal impact overall. But again, time will tell.

另一件事是，我們在美國有幾個季度的 V-Go 供應。我們能夠放慢那裡的運輸速度，只是為了看看這會造成什麼後果，從而將影響降到最低。但我們確實相信，如果 V-Go 按原計劃繼續推進，它將免關稅。因此，我們對整體影響極小感到十分滿意。但時間會證明一切。

Great, thanks. I appreciate it.

太好了，謝謝。我很感激。

Andreas.

安德烈亞斯。

All right. Good morning and thanks for taking our questions. Lots of focus on IPF, understandably so. Could you just give us a sense of -- I mean, with the rapidly evolving clinical development treatment landscape, can you give us a sense of where you see 201 and even some color on DPI fitting in the treatment landscape? And then I have a quick follow-up after that. Thanks.

好的。早安，感謝您回答我們的問題。大量關注 IPF，這是可以理解的。您能否為我們介紹一下—我的意思是，隨著臨床開發治療領域的快速發展，您能否為我們介紹一下您認為 201 以及 DPI 在治療領域中的地位？然後我會快速跟進。謝謝。

Yeah, surprising, none of you're asking about 101, but I'll hold back. On the 201, I think as we look out, the landscape, obviously, is challenging, meaning Pliant had an abysmal failure there in Q4. It's unfortunate for patients. We know this is a very tough disease to treat. But as we look out for nintedanib, remember, 80% of patients generally aren't on treatment or can't tolerate existing treatments.

是的，令人驚訝的是，你們都沒有問到 101，但我會忍住。在 201 上，我認為，正如我們所看到的，情況顯然充滿挑戰，這意味著 Pliant 在第四季度在那裡遭遇了慘敗。這對患者來說是不幸的。我們知道這是一種很難治療的疾病。但是，當我們關注尼達尼佈時，請記住，80％的患者通常沒有接受治療或無法耐受現有治療。

So our real focus is on how do we expand the opportunity to help more patients and hopefully bring a tolerable OFEV like regimen to market. We believe inhaled nintedanib could be a background of therapy for the other new drugs coming. So we think about Tyvaso DPI or the new BI launch or the Bristol-Myers one.

因此，我們真正關注的是如何擴大機會來幫助更多的患者，並希望將類似 OFEV 的耐受性方案推向市場。我們相信吸​​入式尼達尼布可以作為其他新藥治療的背景。因此，我們考慮 Tyvaso DPI 或新的 BI 發布或百時美施貴寶的 BI 發布。

If these products make it to market, we'll be very excited because we do believe they'll be used in combination and that combo treatments will hopefully provide better efficacy for patients, assuming they can get the tolerability, which I think has been the rate-limiting issue to date is the two drugs out there are not very tolerable. And when you combine them, you're getting overlapping toxicity.

如果這些產品能夠上市，我們會非常興奮，因為我們確實相信它們將被聯合使用，並且聯合治療有望為患者提供更好的療效，前提是他們能夠獲得耐受性，我認為迄今為止的限速問題是現有的兩種藥物耐受性不太好。當你將它們結合在一起時，就會產生重疊的毒性。

So to have something that we think could provide some efficacy at potentially the equivalent dose or higher doses, then how do we then think about that in combination with the new treatments coming. And I think that's really evolving quickly over the next year or two as our trials move to Phase 2/3.

因此，如果我們認為某種藥物可以在等效劑量或更高劑量下提供一定的療效，那麼我們如何將其與即將出現的新療法結合起來考慮。我認為，隨著我們的試驗進入第 2/3 階段，這種情況將在未來一兩年內迅速發展。

And that's also creating one of the -- I don't want to comment too much on the study design because we're trying to think through what do you do as these new agents come online over the next one and two years? And how would you add those into your trial or add a nintedanib inhaled on top of them.

這也創造了一個——我不想對研究設計發表太多評論，因為我們正在思考，在未來一兩年內這些新代理商上線時，你會做什麼？您將如何將它們添加到您的試驗中或在它們之上添加吸入性尼達尼布？

So there's a lot of differences of opinion on can you run a placebo trial? Can you run a naive trial? Can it be on top of background? And in the case of nintedanib, it doesn't make sense always to have it on top of background therapy because one of the drugs we're trying to replace would be oral OFEV. So hopefully, that helps give you some color.

那麼，對於是否可以進行安慰劑試驗有許多意見分歧嗎？你能進行一次簡單的試驗嗎？它可以位於背景之上嗎？就尼達尼布而言，總是將其置於背景療法之上是沒有意義的，因為我們試圖替代的藥物之一是口服的 OFEV。希望這能給你一些幫助。

Yeah. And then obviously, when it comes to inhaled therapies, delivery is paramount, and we contend that device plays a key role in that. How are you guys thinking just broadly, maybe it's too soon or you do have a lot on your plate, but how are you thinking about opportunities to collaborate with other companies on the delivery side of things? thanks.

是的。顯然，當涉及吸入療法時，輸送是至關重要的，我們認為設備在其中起著關鍵作用。你們是怎麼想的，也許現在還為時過早，或者你們確實有很多事情要做，但是你們是如何考慮在交付方面與其他公司合作的機會的？謝謝。

So I think on 201, obviously, our device platform has been very successful in the PAH and PH-ILD market. I would say in the diabetes market, the device platform is not the reason it's not successful. So we're planning to use the same device platform for 201, and that device has been used quite widely now amongst pulmonologist treaters in that space. So we think that's an advantage of having the clinical experience with the device and the training that it will just blend into those centers.

因此我認為，在 201 年，我們的設備平台顯然在 PAH 和 PH-ILD 市場上取得了非常成功。我想說，在糖尿病市場，設備平台並不是它不成功的原因。因此，我們計劃在 201 中使用相同的設備平台，該設備目前已在該領域的肺病治療師中廣泛使用。因此，我們認為擁有使用該設備的臨床經驗和培訓的優勢在於它可以融入這些中心。

On the case of clofazimine, we'll start with a nebulizer, a jet nebulizer that is pretty widely utilized in this patient population already because they have other products for nebulizing. But we have a dry powder version that we are looking to hopefully fit into the Dreamboat platform. And so as we look out, that's one of our core focuses. I'm not sure we need other device platforms that are usually off the shelf and not many of them have been scaled successfully. But we'll keep -- we're always open to ideas for innovation and patient support.

就氯法齊明的情況而言，我們將從霧化器開始，噴射霧化器已在該患者群體中廣泛應用，因為他們還有其他霧化產品。但我們有一個乾粉版本，我們希望能夠適合 Dreamboat 平台。因此，從我們的觀察來看，這是我們的核心關注點之一。我不確定我們是否需要其他現成的設備平台，而且其中許多平台都沒有成功擴展。但我們會繼續下去——我們始終對創新的想法和患者支持持開放態度。

I appreciate it, and congrats on the quarter. I'll jump back in the queue.

我對此表示感謝，並祝賀本季取得的成績。我會重新回到隊列中。

Thank you.

謝謝。

Yun Zhong, Wedbush.

雲中，韋德布希。

Hi, good morning. Thank you very much for taking the question. And so my question is on Afrezza. It's very encouraging to see a higher increase in NRx versus TRx. Would you attribute that to maybe higher promotional activity or new data or the combination of both?

嗨，早安。非常感謝您回答這個問題。我的問題是關於 Afrezza 的。看到 NRx 相對於 TRx 有更高的成長是非常令人鼓舞的。您是否認為這是由於促銷活動增加或新數據增加，或者兩者兼而有之？

I think it's a combination of what you just said, the new data combined with the execution of the sales force. So we started a strong education campaign around October time frame on the INHALE-3 data set. And I would say we had several speaker events and national events that led to a strong Q4. And in Q1, we didn't make any major changes to our sales force. We did increase our sales force a little bit in terms of having more feet on the ground.

我認為這是您剛才所說的新數據與銷售人員的執行力相結合的結果。因此，我們在 10 月左右針對 INHALE-3 數據集開始了強有力的教育活動。我想說的是，我們舉辦了幾場演講活動和全國性活動，帶來了強勁的第四季業績。在第一季度，我們沒有對銷售團隊做出任何重大調整。我們確實增加了一些銷售人員，以增加實際行動能力。

We did increase our share of voice at the ATTD Conference, which I think were good investments and hopefully, those will continue to propel us as we come into Q2 and Q3. So we're hearing good feedback. We're hearing less resistance. We're hearing good managed care coverage this year. So I'd say, overall, for Afrezza, I mean, I'm very optimistic that we'll continue to see nice progress, especially as the new team comes on board and starts to make the changes they're making and those flow out through the field for customers.

我們確實在 ATTD 會議上增加了發言權，我認為這是很好的投資，希望這些投資能夠在我們進入第二季和第三季時繼續推動我們。所以我們聽到了很好的回饋。我們聽到的反對聲音越來越少。我們聽說今年的管理式醫療覆蓋狀況良好。因此我想說，總體而言，對於 Afrezza 而言，我非常樂觀地認為我們將繼續看到良好的進展，特別是當新團隊加入並開始做出他們所做的改變，並且這些改變在整個領域惠及客戶時。

Would you say the strategy will be the same for pediatric patient?

您認為針對兒科病患的策略是否相同？

Say that again, I'm sorry, I heard pediatric patient.

再說一遍，對不起，我聽到的是兒科病人。

Right. So going into pediatric potential launch and what would be your strategy just like the same as you took for adult patient?

正確的。那麼，進入兒科潛在推廣階段時，您的策略是什麼，就像對待成人患者一樣？

I think the strategy for peds is actually be very different. 80% of the patients are treated in a children's hospital or academic medical center, and that will take a very different launch strategy as we go forward. And I think you'll be hearing some of that rollout as we get to the next quarter. We have a pretty comprehensive plan we're working on. And I think that will be shared once it's approved by the Board.

我認為針對兒科的策略其實是非常不同的。 80% 的患者在兒童醫院或學術醫療中心接受治療，因此，隨著我們未來的發展，這將採取截然不同的啟動策略。我認為，當我們進入下個季度時，您就會聽到一些有關這一舉措的消息。我們正在製定一個非常全面的計劃。我認為，一旦董事會批准，就會分享。

But at this point, it is not going to be the same as the adult side. We expect that to be a very different launch and the launch trajectory from where we are in adults.

但到了這個地步，它就和成年人那邊不一樣了。我們預計，這將是與成年人截然不同的發射，發射軌跡也是如此。

Thank you very much.

非常感謝。

Thank you.

謝謝。

Anthony Petrone, Mizuho.

瑞穗的安東尼‧佩特羅內 (Anthony Petrone)。

Hi, thanks and congrats on a strong start to the year here. I'll start with one on pediatric Afrezza and then move over to the pipeline. On pediatric Afrezza, maybe, Mike, can you give us an idea when you think about how that patient population behaves and your thoughts on adherence? Obviously, with peds, you have a caregiver, tends to be a slightly more diligent sort of patient population relative to adult.

嗨，謝謝，並祝賀您今年有一個良好的開端。我將從兒科 Afrezza 開始，然後轉到管道。關於兒科 Afrezza，Mike，您能否告訴我們，當您考慮該患者群體的行為方式以及您對依從性的看法時？顯然，對於兒科患者來說，他們有一名護理人員，相對於成人患者來說，他們往往是更勤奮的患者群體。

So maybe just your thoughts here on what adherence looks like in pediatric diabetes and really what the uptake could be? I would imagine maybe there's a potential for a more rapid uptake in peds versus adults. And I'll have a follow-up.

那麼，也許您只是對兒童糖尿病的依從性以及實際的接受度有什麼看法？我想也許兒科的接受速度可能比成人更快。我會進行跟進。

Yeah, thank you. Nice to hear you, and thank you for your initiation there. The ped side, to your point, has different dynamics than the adult side. Number one, I think ped endos are much more progressive doctors, and they're more used to trying new technologies. An example is that you just have a group of patients who have parents that are very active in their kids life.

是的，謝謝。很高興聽到您的訊息，並感謝您的加入。正如您所說，兒童方面的動態與成人方面的動態有所不同。首先，我認為兒科內科醫生是更進步的醫生，他們更習慣嘗試新技術。舉個例子，你有一群病人，他們的父母在孩子的生活中非常活躍。

Anyone that has kids knows you're going to fight for your children more than anything in the world. And when it comes to newly diagnosed children, you're dealt with a life sentence, unfortunately.

任何有孩子的人都知道，為了孩子，你會比世界上任何事情都更努力奮鬥。不幸的是，對於剛被診斷出患有這種疾病的孩子來說，他們可能將被判處終身監禁。

And you're going to -- I think that's where we have a strong opportunity with Afrezza, who really wants to learn how to count carbs, inject insulin multiple times a day, worry about hypo, nocturnal dead in bed. These are not fun things as a parent. Hearing the stories of parent sleeping next to their child because they're afraid they're going to go into the seizure at night. These are all the things that go through pediatric diabetes.

你會 — — 我認為這就是我們與 Afrezza 合作的強大機會，它真正想學習如何計算碳水化合物、每天多次注射胰島素、擔心低血糖、夜間死在床上。對父母來說，這些都不是什麼有趣的事。聽到一些故事，父母睡在孩子旁邊，因為他們害怕孩子晚上會癲癇發作。這些都是兒童糖尿病會出現的情況。

And so we do think having something like Afrezza, which we've seen over time has less hypos in our pivotal trials. The onset and offset of action allows you to predict a little bit more of your control. And use of CGM these days, I think, will give parents some comfort when they start to get used to the Afrezza profile.

因此，我們確實認為，像 Afrezza 這樣的藥物在我們的關鍵試驗中隨著時間的推移已經看到了較低的低血糖發生率。動作的開始和結束可以讓你更好地預測你的控制。我認為，現在使用 CGM 會讓父母在開始習慣 Afrezza 治療方案時感到些許安心。

So I think net-net, what that means is a consumer approach will be important in peds. And whether that's the parents in educating them and the kids that are teenagers and camps, that's a whole different game than what we've had to deal with in Afrezza adults.

所以我認為，總的來說，這意味著消費者方法對兒科來說很重要。無論是父母對孩子的教育，或是青少年和夏令營的孩子，這都與我們在 Afrezza 成人版中要處理的問題完全不同。

The doctors themselves, I mean, I've met at least 10, 15 of them in the last two months here, they are very open to Afrezza. Once they saw the lung safety data, that was the number one question coming into peds. And that lung safety data looks very strong over the 26 and 52 weeks. So I think that question is off the table in terms of any concerns of lung safety or any impact of Afrezza there. So that's also an important point for launch.

至於醫生本身，我的意思是，在過去兩個月裡，我在這裡見過至少 10 到 15 位醫生，他們對 Afrezza 非常開放。一旦他們看到肺部安全數據，這就是兒科最關心的問題。而 26 週和 52 週的肺部安全數據看起來非常強勁。因此，我認為就肺部安全問題或 Afrezza 的影響而言，這個問題已經不存在了。所以這也是發布的一個重要點。

And then the last one is your comment on compliance. And that's one of our surprises in the Afrezza trial was how well, especially the teenagers did. They're hormonal. They're taking high doses. They are rebellious in some cases. They're worried about weight gain of insulin. We saw very high success rates in that population.

最後一個是您對合規性的評論。這是 Afrezza 試驗中令我們驚訝的一點，試驗結果非常出色，尤其是對青少年而言。它們是荷爾蒙性的。他們服用了高劑量的藥物。在某些情況下，他們是叛逆的。他們擔心胰島素會導致體重增加。我們發現該族群的成功率非常高。

And so I think your average diagnosis is around 12 years old, and those kids are going through major hormonal changes between 12 and 15. So we think that so far, people will probably more likely adhere to Afrezza. Where the younger kids may have some challenges in the schools and the nurses and administration, we'll continue to work on programs to support that where the teenagers can take the product themselves and carry it much easier for them to control their sugar.

所以我認為平均診斷年齡是在 12 歲左右，這些孩子在 12 至 15 歲之間會經歷重大的荷爾蒙變化。因此我們認為，到目前為止，人們可能更有可能堅持服用 Afrezza。年紀較小的孩子在學校、護士和管理人員那裡可能會遇到一些挑戰，我們將繼續開展支持計劃，讓青少年可以自己服用產品，並更輕鬆地控制血糖。

So that's generally what we see and feel on the Afrezza peds and some of the high-level thoughts on the launch.

這就是我們在 Afrezza 藥物上看到和感受到的，以及在發布會上的一些高層想法。

Very helpful. And pipeline, this is more of a totality question. Really when you look at the TETON programs with United and then you take 101 clofazimine, 201 in IPF, both you and your partner go for the same indication. And just looking at a blue sky scenario, that's a heck of a lot of Technosphere devices if it all comes to fruition. So just a recap on the Danbury capacity, if the blue sky scenario plays out over the next five years, would you need a growth CapEx injection? Thanks.

非常有幫助。至於管道，這更是整體性問題。實際上，當您查看 United 的 TETON 計劃，然後服用 101 克氯法齊明、201 克 IPF 藥物時，您和您的伴侶都會得到相同的指示。僅從藍天場景來看，如果一切順利的話，那將是大量的技術領域設備。因此，只需回顧一下丹伯里的產能，如果藍天情境在未來五年內得以實現，您是否需要注入成長資本支出？謝謝。

Yeah. I think we can all thank Al Mann for dreaming big. He built a huge scale facility for diabetes. And as you know, that disease is 30 million people just in the US, let alone 300 million to 500 million worldwide. So when you think about capacity of device manufacturing, we have a very high capacity to scale up there if needed, and I don't expect any major CapEx.

是的。我想我們都應該感謝艾爾曼的遠大夢想。他建造了一座規模龐大的糖尿病治療中心。眾所周知，光在美國就有 3,000 萬人患有這種疾病，更不用說全世界有 3 億到 5 億人患有這種疾病。因此，當您考慮設備製造能力時，如果需要，我們擁有非常高的擴大產能，而且我預計不會有任何重大的資本支出。

On the filling equipment lines, we believe 201 can be fit into the current facility we already built and whether that's excess capacity on the Afrezza line or an old production line as we scale up to Tyvaso. And we have another line that's idle. So we have plenty of equipment to fill cartridges for 201 if that continues to grow as well as Afrezza. So we're not too worried about the capacity there.

在灌裝設備生產線上，我們相信 201 可以適應我們已經建成的現有設施，無論是 Afrezza 生產線上的過剩產能，還是我們擴大到 Tyvaso 的舊生產線。我們還有另一條線路處於空閒狀態。因此，如果 201 和 Afrezza 的銷量繼續成長，我們就有足夠的設備來填充墨盒。所以我們並不太擔心那裡的容量。

And then on 101, you may or may not have noticed over the last couple of quarters, but we actually have been building out the manufacturing capacity there in Danbury. The equipment has been coming in. We're actually doing a field application test this week. And that is already being built and in our CapEx run rate. So I think most of the pipeline and CapEx is already behind us.

然後關於 101，您可能已經註意到，或者可能沒有註意到過去幾個季度的情況，但我們實際上一直在丹伯里建立製造能力。設備已進場。我們本週實際上正在進行現場應用測試。並且它已在建設中，並已包含在我們的資本支出運行率中。所以我認為大部分管道和資本支出已經完成。

I'm sure there'll be small things here and there, Chris, but I don't see any major coming in the next five years unless we were to buy something that needed something, that will be different. But where we are today, I think we don't need to build another plant in the next five years. and we have plenty of capacity to support the growth of the company.

克里斯，我確信這裡或那裡會有一些小事情發生，但我看不到未來五年內會發生任何重大事情，除非我們要購買我們需要的東西，那將會有所不同。但就我們目前的狀況而言，我認為我們不需要在未來五年內再建造另一家工廠。我們有足夠的能力支持公司的發展。

Thank you.

謝謝。

Thank you. That concludes the question-and-answer portion of today's call. I will now hand the call back to the MannKind team for closing remarks.

謝謝。今天電話會議的問答部分到此結束。現在我將把電話交還給 MannKind 團隊，請他們作最後發言。

Well, thank you, everyone, for all your interest in MannKind and the questions here. We're really proud of the work we've done. 201, we had a great discussion. We got great direction we need to go. On 101, the pipeline with clofazimine, which we were nervous that how fast or slow that trial would go.

好吧，謝謝大家對 MannKind 的興趣以及這裡提出的問題。我們對於我們所做的工作感到非常自豪。 201，我們進行了一次愉快的討論。我們找到了我們需要前進的正確方向。在 101 號管線上，我們擔心試驗會進展得多快或多慢。

As you can see, the trial has done very well in terms of enrollment, and we remain on track there. And then the peds for Afrezza is on track to be filed here midyear. So everything is going in the right direction. The tariffs obviously are impacting the overall economy. But for MannKind, we believe we can navigate through those headwinds. And we've got a great company for investors and a great company for employees and patients.

如您所見，試驗在招募方面進展順利，我們仍保持著正軌。然後，Afrezza 的兒科申請將在年中提交。所以一切都在朝著正確的方向發展。關稅顯然正在影響整體經濟。但對於 MannKind 來說，我們相信我們可以克服這些阻力。對投資人來說，我們是一家優秀的公司；對員工和病人來說，我們是一家優秀的公司。

So thank you again for everything and look forward to talking to you soon at the upcoming conferences or on the next quarterly call. Talk soon.

再次感謝您的一切，並期待在即將召開的會議或下一次季度電話會議上與您交談。很快再談。